TDMS Study 05133-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest ACETONITRILE DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 TIME: 06:27:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01ES55073 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 242 PATHOLOGIST: R. RENNE CAS: 75-05-8 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest ACETONITRILE DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 TIME: 06:27:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55073 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 242 PATHOLOGIST: R. RENNE CAS: 75-05-8 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney 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 ACETONITRILE DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 TIME: 06:27:19 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01ES55073 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 242 PATHOLOGIST: R. RENNE CAS: 75-05-8 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ACETONITRILE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Carcinoma or Adenoma Liver Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Skin Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma Testes Adenoma ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Mammary Gland Fibroadenoma Fibroma, Fibroadenoma, Carcinoma, or Adenoma ==================================================================================================== DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/56 (7%) 15/53 (28%) 12/53 (23%) 7/56 (13%) | 1/56 (2%) 2/55 (4%) 2/55 (4%) 2/55 (4%) | |ADJUSTED (b) | 25.0% 56.9% 52.1% 22.1% | 4.3% 8.9% 6.0% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 1/7 (14%) 0/5 (0%) 0/8 (0%) | 0/8 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 2/11 (18%) 3/13 (23%) 2/9 (22%) 0/17 (0%) | 1/23 (4%) 1/21 (5%) 1/26 (4%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 646 456 (I) 507 632 | 734 (T) 719 534 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.309N P=0.015 * P=0.025 * P=0.441 | P=0.519 P=0.456 P=0.542 P=0.576 | |INCIDENTAL TUMOR | P=0.497N P=0.002 ** P=0.019 * P=0.315 | P=0.443 P=0.515 P=0.503 P=0.564 | |LOGISTIC REGRESSION | P=0.432N P=0.004 ** P=0.020 * P=0.244 | P=0.457 P=0.470 P=0.505 P=0.542 | |COCHRAN-ARMITAGE | P=0.536 | P=0.417 | |FISHER EXACT | P=0.003 ** P=0.021 * P=0.264 | P=0.493 P=0.493 P=0.493 | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 2/53 (4%) 2/53 (4%) 1/56 (2%) | 0/56 (0%) 0/55 (0%) 1/55 (2%) 0/55 (0%) | |ADJUSTED (b) | 0.0% 4.4% 6.0% 5.0% | 0.0% 0.0% 1.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 1/7 (14%) 0/5 (0%) 0/8 (0%) | 0/8 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 456 (I) 583 727 | --- --- 376 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.540 P=0.228 P=0.233 P=0.602 | P=0.702 (e) P=0.511 (e) | |INCIDENTAL TUMOR | P=0.498 P=0.278 P=0.338 P=0.489 | P=0.605 (e) P=0.455 (e) | |LOGISTIC REGRESSION | P=0.446 P=0.221 P=0.225 P=0.580 | P=0.524 (e) P=0.306 (e) | |COCHRAN-ARMITAGE | P=0.474 | P=0.692 | |FISHER EXACT | P=0.234 P=0.234 P=0.500 | (e) P=0.495 (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/56 (7%) 17/53 (32%) 14/53 (26%) 8/56 (14%) | 1/56 (2%) 2/55 (4%) 3/55 (5%) 2/55 (4%) | |ADJUSTED (b) | 25.0% 58.8% 55.0% 26.2% | 4.3% 8.9% 7.7% 5.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 2/7 (29%) 0/5 (0%) 0/8 (0%) | 0/8 (0%) 0/7 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 2/11 (18%) 3/13 (23%) 2/9 (22%) 0/17 (0%) | 1/23 (4%) 1/21 (5%) 1/26 (4%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 646 456 (I) 507 632 | 734 (T) 719 376 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.342N P=0.006 ** P=0.010 ** P=0.358 | P=0.498 P=0.456 P=0.346 P=0.576 | |INCIDENTAL TUMOR | P=0.544N P<0.001 ** P=0.009 ** P=0.214 | P=0.384 P=0.515 P=0.283 P=0.564 | |LOGISTIC REGRESSION | P=0.522N P=0.001 ** P=0.006 ** P=0.173 | P=0.407 P=0.470 P=0.275 P=0.542 | |COCHRAN-ARMITAGE | P=0.479 | P=0.398 | |FISHER EXACT | P<0.001 ** P=0.006 ** P=0.180 | P=0.493 P=0.302 P=0.493 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/55 (0%) 0/55 (0%) 1/55 (2%) 0/56 (0%) | 1/54 (2%) 1/50 (2%) 1/55 (2%) 3/53 (6%) | |ADJUSTED (b) | 0.0% 0.0% 11.1% 0.0% | 4.5% 2.3% 3.8% 10.7% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 1/9 (11%) 0/17 (0%) | 1/22 (5%) 0/21 (0%) 1/26 (4%) 3/28 (11%) | |FIRST INCIDENCE (DAYS) | --- --- 733 (T) --- | 734 (T) 600 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.732 (e) P=0.460 (e) | P=0.231 P=0.749N P=0.725N P=0.393 | |INCIDENTAL TUMOR | P=0.732 (e) P=0.460 (e) | P=0.223 P=0.741N P=0.725N P=0.393 | |LOGISTIC REGRESSION | P=0.732 (e) P=0.460 (e) | P=0.199 P=0.754 P=0.725N P=0.393 | |COCHRAN-ARMITAGE | P=0.696 | P=0.166 | |FISHER EXACT | (e) P=0.500 (e) | P=0.733 P=0.748N P=0.302 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/55 (9%) 1/55 (2%) 2/55 (4%) 1/56 (2%) | 4/54 (7%) 1/50 (2%) 4/55 (7%) 3/53 (6%) | |ADJUSTED (b) | 15.8% 2.9% 8.7% 2.1% | 14.7% 2.3% 15.4% 8.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (13%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 2/22 (9%) 0/21 (0%) 4/26 (15%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 472 567 665 485 | 623 588 734 (T) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.075N P=0.112N P=0.257N P=0.081N | P=0.461N P=0.192N P=0.576N P=0.407N | |INCIDENTAL TUMOR | P=0.139N P=0.131N P=0.232N P=0.286N | P=0.480N P=0.152N P=0.548N P=0.426N | |LOGISTIC REGRESSION | P=0.097N P=0.101N P=0.218N P=0.126N | P=0.528N P=0.188N P=0.635N P=0.469N | |COCHRAN-ARMITAGE | P=0.090N | P=0.575N | |FISHER EXACT | P=0.103N P=0.219N P=0.099N | P=0.206N P=0.632N P=0.511N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/55 (9%) 1/55 (2%) 3/55 (5%) 1/56 (2%) | 5/54 (9%) 2/50 (4%) 5/55 (9%) 6/53 (11%) | |ADJUSTED (b) | 15.8% 2.9% 18.8% 2.1% | 19.0% 4.5% 19.2% 19.4% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (13%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 1/9 (11%) 0/17 (0%) | 3/22 (14%) 0/21 (0%) 5/26 (19%) 5/28 (18%) | |FIRST INCIDENCE (DAYS) | 472 567 665 485 | 623 588 734 (T) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.087N P=0.112N P=0.413N P=0.081N | P=0.424 P=0.224N P=0.547N P=0.615N | |INCIDENTAL TUMOR | P=0.157N P=0.131N P=0.391N P=0.286N | P=0.403 P=0.175N P=0.521N P=0.621 | |LOGISTIC REGRESSION | P=0.115N P=0.101N P=0.367N P=0.126N | P=0.345 P=0.229N P=0.623N P=0.564 | |COCHRAN-ARMITAGE | P=0.111N | P=0.285 | |FISHER EXACT | P=0.103N P=0.358N P=0.099N | P=0.251N P=0.617N P=0.487 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 4/55 (7%) 5/56 (9%) 1/56 (2%) | 0/56 (0%) 0/56 (0%) 2/56 (4%) 0/54 (0%) | |ADJUSTED (b) | 3.6% 18.9% 22.8% 5.9% | 0.0% 0.0% 7.7% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 1/17 (6%) | 0/23 (0%) 0/21 (0%) 2/26 (8%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 651 559 539 733 (T) | --- --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.357N P=0.196 P=0.090 P=0.697N | P=0.649 (e) P=0.265 (e) | |INCIDENTAL TUMOR | P=0.465N P=0.207 P=0.074 P=0.720N | P=0.649 (e) P=0.265 (e) | |LOGISTIC REGRESSION | P=0.417N P=0.176 P=0.096 P=0.722N | P=0.649 (e) P=0.265 (e) | |COCHRAN-ARMITAGE | P=0.476N | P=0.588 | |FISHER EXACT | P=0.176 P=0.103 P=0.752N | (e) P=0.248 (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 0/55 (0%) 3/56 (5%) 1/56 (2%) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 1/54 (2%) | |ADJUSTED (b) | 5.9% 0.0% 9.8% 5.9% | 0.0% 3.8% 0.0% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 1/17 (6%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 693 --- 560 733 (T) | --- 713 --- 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.555 P=0.468N P=0.295 P=0.676N | P=0.445 P=0.478 (e) P=0.545 | |INCIDENTAL TUMOR | P=0.517 P=0.581N P=0.362 P=0.720N | P=0.395 P=0.562 (e) P=0.517 | |LOGISTIC REGRESSION | P=0.502 P=0.497N P=0.299 P=0.701N | P=0.420 P=0.503 (e) P=0.505 | |COCHRAN-ARMITAGE | P=0.472 | P=0.397 | |FISHER EXACT | P=0.505N P=0.309 P=0.752N | P=0.500 (e) P=0.491 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/56 (4%) 4/55 (7%) 8/56 (14%) 2/56 (4%) | 0/56 (0%) 1/56 (2%) 2/56 (4%) 1/54 (2%) | |ADJUSTED (b) | 9.2% 18.9% 30.4% 11.8% | 0.0% 3.8% 7.7% 2.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 2/17 (12%) | 0/23 (0%) 0/21 (0%) 2/26 (8%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 651 559 539 733 (T) | --- 713 734 (T) 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413N P=0.367 P=0.045 * P=0.572N | P=0.437 P=0.478 P=0.265 P=0.545 | |INCIDENTAL TUMOR | P=0.530N P=0.341 P=0.042 * P=0.627N | P=0.403 P=0.562 P=0.265 P=0.517 | |LOGISTIC REGRESSION | P=0.498N P=0.333 P=0.044 * P=0.613N | P=0.401 P=0.503 P=0.265 P=0.505 | |COCHRAN-ARMITAGE | P=0.566N | P=0.355 | |FISHER EXACT | P=0.331 P=0.047 * P=0.691N | P=0.500 P=0.248 P=0.491 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/55 (2%) 1/56 (2%) 3/56 (5%) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 0.0% 3.4% 4.8% 16.2% | 0.0% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 2/17 (12%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 623 673 727 | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.110 P=0.480 P=0.465 P=0.214 | P=0.524N P=0.482 (e) (e) | |INCIDENTAL TUMOR | P=0.083 P=0.615 P=0.477 P=0.171 | P=0.524N P=0.482 (e) (e) | |LOGISTIC REGRESSION | P=0.085 P=0.497 P=0.490 P=0.204 | P=0.524N P=0.482 (e) (e) | |COCHRAN-ARMITAGE | P=0.055 | P=0.573N | |FISHER EXACT | P=0.495 P=0.500 P=0.122 | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 0/55 (0%) 0/56 (0%) 3/56 (5%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 3.3% 0.0% 0.0% 14.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 1/17 (6%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 637 --- --- 693 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.150 P=0.514N P=0.514N P=0.438 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.112 P=0.385N P=0.412N P=0.361 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.123 P=0.503N P=0.504N P=0.380 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.087 | (e) | |FISHER EXACT | P=0.505N P=0.500N P=0.309 | (e) (e) (e) | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/55 (2%) 1/56 (2%) 5/56 (9%) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 3.3% 3.4% 4.8% 25.2% | 0.0% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 3/17 (18%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 637 623 673 693 | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067 P=0.742 P=0.733 P=0.213 | P=0.524N P=0.482 (e) (e) | |INCIDENTAL TUMOR | P=0.046 * P=0.630N P=0.727N P=0.168 | P=0.524N P=0.482 (e) (e) | |LOGISTIC REGRESSION | P=0.047 * P=0.759 P=0.755 P=0.166 | P=0.524N P=0.482 (e) (e) | |COCHRAN-ARMITAGE | P=0.026 * | P=0.573N | |FISHER EXACT | P=0.748 P=0.752N P=0.103 | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/55 (2%) 1/56 (2%) 5/56 (9%) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 3.3% 3.4% 4.8% 25.2% | 0.0% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 3/17 (18%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 637 623 673 693 | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067 P=0.742 P=0.733 P=0.213 | P=0.524N P=0.482 (e) (e) | |INCIDENTAL TUMOR | P=0.046 * P=0.630N P=0.727N P=0.168 | P=0.524N P=0.482 (e) (e) | |LOGISTIC REGRESSION | P=0.047 * P=0.759 P=0.755 P=0.166 | P=0.524N P=0.482 (e) (e) | |COCHRAN-ARMITAGE | P=0.026 * | P=0.573N | |FISHER EXACT | P=0.748 P=0.752N P=0.103 | P=0.500 (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 0/56 (0%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 2/54 (4%) | |ADJUSTED (b) | 4.2% 5.6% 0.0% 0.0% | 0.0% 0.0% 0.0% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 2/29 (7%) | |FIRST INCIDENCE (DAYS) | 679 707 --- --- | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.205N P=0.743N P=0.547N P=0.469N | P=0.068 (e) (e) P=0.290 | |INCIDENTAL TUMOR | P=0.235N P=0.670 P=0.523N P=0.511N | P=0.068 (e) (e) P=0.290 | |LOGISTIC REGRESSION | P=0.210N P=0.761N P=0.512N P=0.471N | P=0.068 (e) (e) P=0.290 | |COCHRAN-ARMITAGE | P=0.235N | P=0.044 * | |FISHER EXACT | P=0.748 P=0.500N P=0.500N | (e) (e) P=0.239 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/56 (4%) 2/55 (4%) 1/56 (2%) 0/56 (0%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 2/54 (4%) | |ADJUSTED (b) | 12.9% 12.8% 1.8% 0.0% | 0.0% 0.0% 0.0% 6.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 1/11 (9%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 2/29 (7%) | |FIRST INCIDENCE (DAYS) | 679 707 371 --- | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095N P=0.649N P=0.550N P=0.177N | P=0.068 (e) (e) P=0.290 | |INCIDENTAL TUMOR | P=0.131N P=0.654 P=0.549N P=0.198N | P=0.068 (e) (e) P=0.290 | |LOGISTIC REGRESSION | P=0.106N P=0.679N P=0.430N P=0.183N | P=0.068 (e) (e) P=0.290 | |COCHRAN-ARMITAGE | P=0.125N | P=0.044 * | |FISHER EXACT | P=0.684 P=0.500N P=0.248N | (e) (e) P=0.239 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 1/56 (2%) 1/56 (2%) | 2/56 (4%) 4/56 (7%) 3/56 (5%) 3/56 (5%) | |ADJUSTED (b) | 0.0% 0.0% 4.5% 5.9% | 8.7% 13.4% 11.5% 8.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 1/17 (6%) | 2/23 (9%) 1/21 (5%) 3/26 (12%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 666 733 (T) | 734 (T) 671 734 (T) 672 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.304 (e) P=0.474 P=0.587 | P=0.536N P=0.319 P=0.557 P=0.589 | |INCIDENTAL TUMOR | P=0.287 (e) P=0.477 P=0.587 | P=0.577 P=0.387 P=0.557 P=0.579 | |LOGISTIC REGRESSION | P=0.282 (e) P=0.491 P=0.587 | P=0.570 P=0.348 P=0.557 P=0.561 | |COCHRAN-ARMITAGE | P=0.237 | P=0.500 | |FISHER EXACT | (e) P=0.500 P=0.500 | P=0.339 P=0.500 P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 2/55 (4%) 0/56 (0%) 2/56 (4%) | 16/56 (29%) 27/56 (48%) 22/56 (39%) 25/56 (45%) | |ADJUSTED (b) | 0.0% 15.4% 0.0% 10.6% | 55.9% 72.7% 60.8% 62.5% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 1/8 (13%) 2/8 (25%) | |TERMINAL (d) | 0/11 (0%) 2/13 (15%) 0/9 (0%) 1/17 (6%) | 11/23 (48%) 12/21 (57%) 13/26 (50%) 15/29 (52%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) --- 727 | 525 478 457 (I) 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.372 P=0.273 (e) P=0.348 | P=0.449 P=0.022 * P=0.255 P=0.221 | |INCIDENTAL TUMOR | P=0.339 P=0.273 (e) P=0.280 | P=0.235 P=0.034 * P=0.230 P=0.131 | |LOGISTIC REGRESSION | P=0.365 P=0.273 (e) P=0.335 | P=0.215 P=0.032 * P=0.168 P=0.113 | |COCHRAN-ARMITAGE | P=0.249 | P=0.125 | |FISHER EXACT | P=0.243 (e) P=0.248 | P=0.026 * P=0.159 P=0.058 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 2/55 (4%) 1/56 (2%) 3/56 (5%) | 17/56 (30%) 30/56 (54%) 24/56 (43%) 26/56 (46%) | |ADJUSTED (b) | 0.0% 15.4% 4.5% 16.2% | 59.6% 77.2% 66.8% 65.2% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 1/8 (13%) 2/8 (25%) | |TERMINAL (d) | 0/11 (0%) 2/13 (15%) 0/9 (0%) 2/17 (12%) | 12/23 (52%) 13/21 (62%) 15/26 (58%) 16/29 (55%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) 666 727 | 525 478 457 (I) 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.202 P=0.273 P=0.474 P=0.214 | P=0.521 P=0.010 * P=0.206 P=0.234 | |INCIDENTAL TUMOR | P=0.173 P=0.273 P=0.477 P=0.171 | P=0.297 P=0.014 * P=0.181 P=0.141 | |LOGISTIC REGRESSION | P=0.178 P=0.273 P=0.491 P=0.204 | P=0.269 P=0.012 * P=0.122 P=0.120 | |COCHRAN-ARMITAGE | P=0.105 | P=0.153 | |FISHER EXACT | P=0.243 P=0.500 P=0.122 | P=0.011 * P=0.120 P=0.060 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 2/55 (4%) 0/56 (0%) 2/56 (4%) | 1/56 (2%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 0.0% 14.3% 0.0% 11.8% | 4.3% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 2/17 (12%) | 1/23 (4%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 732 --- 733 (T) | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.362 P=0.286 (e) P=0.337 | P=0.275N P=0.518N P=0.476N P=0.454N | |INCIDENTAL TUMOR | P=0.339 P=0.212 (e) P=0.337 | P=0.275N P=0.518N P=0.476N P=0.454N | |LOGISTIC REGRESSION | P=0.361 P=0.278 (e) P=0.337 | P=0.275N P=0.518N P=0.476N P=0.454N | |COCHRAN-ARMITAGE | P=0.249 | P=0.306N | |FISHER EXACT | P=0.243 (e) P=0.248 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Ovary | | Granulosa-Theca Tumor Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 0/56 (0%) 2/56 (4%) 0/56 (0%) 0/55 (0%) | |ADJUSTED (b) | | 0.0% 6.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | | --- 517 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.384N P=0.238 (e) (e) | |INCIDENTAL TUMOR | | P=0.484N P=0.214 (e) (e) | |LOGISTIC REGRESSION | | P=0.421N P=0.229 (e) (e) | |COCHRAN-ARMITAGE | | P=0.409N | |FISHER EXACT | | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/56 (48%) 29/53 (55%) 25/56 (45%) 23/54 (43%) | 27/56 (48%) 26/56 (46%) 30/55 (55%) 33/53 (62%) | |ADJUSTED (b) | 73.0% 88.9% 83.4% 68.2% | 71.6% 73.0% 76.1% 79.5% | |INTERIM SACRIFICE 1 (c)| 2/8 (25%) 2/7 (29%) 2/8 (25%) 0/7 (0%) | 3/8 (38%) 0/8 (0%) 2/8 (25%) 4/8 (50%) | |TERMINAL (d) | 4/11 (36%) 10/13 (77%) 6/9 (67%) 8/17 (47%) | 13/23 (57%) 12/21 (57%) 17/26 (65%) 21/29 (72%) | |FIRST INCIDENCE (DAYS) | 394 331 371 485 | 457 (I) 600 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.044N* P=0.523 P=0.542 P=0.082N | P=0.491 P=0.520 P=0.491 P=0.517 | |INCIDENTAL TUMOR | P=0.195N P=0.279 P=0.497N P=0.362N | P=0.165 P=0.280N P=0.437 P=0.298 | |LOGISTIC REGRESSION | P=0.139N P=0.325 P=0.435N P=0.258N | P=0.129 P=0.378N P=0.379 P=0.215 | |COCHRAN-ARMITAGE | P=0.207N | P=0.052 | |FISHER EXACT | P=0.313 P=0.425N P=0.345N | P=0.500N P=0.317 P=0.100 | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/56 (4%) 0/53 (0%) 0/56 (0%) 0/54 (0%) | 0/56 (0%) 1/56 (2%) 0/55 (0%) 0/53 (0%) | |ADJUSTED (b) | 4.2% 0.0% 0.0% 0.0% | 0.0% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/7 (0%) 0/8 (0%) 0/7 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) --- --- --- | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.116N P=0.249N P=0.240N P=0.241N | P=0.524N P=0.482 (e) (e) | |INCIDENTAL TUMOR | P=0.157N P=0.331N P=0.251N P=0.415N | P=0.524N P=0.482 (e) (e) | |LOGISTIC REGRESSION | P=0.132N P=0.245N P=0.215N P=0.341N | P=0.524N P=0.482 (e) (e) | |COCHRAN-ARMITAGE | P=0.117N | P=0.576N | |FISHER EXACT | P=0.262N P=0.248N P=0.257N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/56 (2%) 2/55 (4%) 1/56 (2%) 5/56 (9%) | 2/56 (4%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 1.9% 13.1% 4.5% 27.4% | 8.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 4/17 (24%) | 2/23 (9%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) 718 666 727 | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.118 P=0.550 P=0.746 P=0.206 | P=0.094N P=0.257N P=0.211N P=0.188N | |INCIDENTAL TUMOR | P=0.092 P=0.473 P=0.747 P=0.175 | P=0.094N P=0.257N P=0.211N P=0.188N | |LOGISTIC REGRESSION | P=0.081 P=0.495 P=0.756N P=0.138 | P=0.094N P=0.257N P=0.211N P=0.188N | |COCHRAN-ARMITAGE | P=0.049 * | P=0.115N | |FISHER EXACT | P=0.493 P=0.752N P=0.103 | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/56 (5%) 2/55 (4%) 1/56 (2%) 3/56 (5%) | 1/56 (2%) 1/56 (2%) 0/56 (0%) 1/56 (2%) | |ADJUSTED (b) | 17.3% 12.6% 7.7% 10.4% | 2.8% 4.8% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 1/11 (9%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 602 701 707 560 | 625 734 (T) --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.471N P=0.448N P=0.347N P=0.527N | P=0.553N P=0.753 P=0.500N P=0.717N | |INCIDENTAL TUMOR | P=0.549N P=0.491N P=0.306N P=0.597N | P=0.577N P=0.720N P=0.406N P=0.735N | |LOGISTIC REGRESSION | P=0.534N P=0.494N P=0.327N P=0.614N | P=0.588N P=0.753N P=0.501N P=0.746N | |COCHRAN-ARMITAGE | P=0.571 | P=0.616N | |FISHER EXACT | P=0.509N P=0.309N P=0.661N | P=0.752N P=0.500N P=0.752N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/56 (5%) 3/55 (5%) 1/56 (2%) 3/56 (5%) | 2/56 (4%) 3/56 (5%) 0/56 (0%) 1/56 (2%) | |ADJUSTED (b) | 17.3% 19.8% 7.7% 10.4% | 4.5% 12.8% 0.0% 3.4% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 1/11 (9%) 2/13 (15%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 2/21 (10%) 0/26 (0%) 1/29 (3%) | |FIRST INCIDENCE (DAYS) | 602 701 707 560 | 310 706 --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.394N P=0.603N P=0.347N P=0.527N | P=0.199N P=0.479 P=0.240N P=0.454N | |INCIDENTAL TUMOR | P=0.463N P=0.645N P=0.306N P=0.597N | P=0.313N P=0.443 P=0.308N P=0.735N | |LOGISTIC REGRESSION | P=0.453N P=0.657N P=0.327N P=0.614N | P=0.242N P=0.491 P=0.300N P=0.583N | |COCHRAN-ARMITAGE | P=0.541N | P=0.242N | |FISHER EXACT | P=0.652 P=0.309N P=0.661N | P=0.500 P=0.248N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/55 (2%) 0/56 (0%) 0/56 (0%) | 1/56 (2%) 2/56 (4%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 0.0% 7.7% 0.0% 0.0% | 1.8% 8.2% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) --- --- | 310 706 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.505N P=0.533 (e) (e) | P=0.173N P=0.480 P=0.500N P=0.496N | |INCIDENTAL TUMOR | P=0.505N P=0.533 (e) (e) | P=0.308N P=0.381 P=0.773N (e) | |LOGISTIC REGRESSION | P=0.505N P=0.533 (e) (e) | P=0.211N P=0.466 P=0.713N P=0.799N | |COCHRAN-ARMITAGE | P=0.566N | P=0.188N | |FISHER EXACT | P=0.495 (e) (e) | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) | 0/56 (0%) 2/56 (4%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 8.2% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 706 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.371N P=0.219 (e) (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.383N P=0.263 (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.378N P=0.233 (e) (e) | |COCHRAN-ARMITAGE | (e) | P=0.405N | |FISHER EXACT | (e) (e) (e) | P=0.248 (e) (e) | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 4/56 (7%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 1.9% 5.9% 0.0% 23.5% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 4/17 (24%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) 718 --- 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123 P=0.731N P=0.500N P=0.293 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.111 P=0.716 P=0.500N P=0.293 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.093 P=0.758 P=0.468N P=0.222 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.063 | (e) | |FISHER EXACT | P=0.748 P=0.500N P=0.182 | (e) (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous Tumor | | (malignant or NOS), or Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 0/56 (0%) | 2/56 (4%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 8.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 2/23 (9%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.094N P=0.257N P=0.211N P=0.188N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.094N P=0.257N P=0.211N P=0.188N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.094N P=0.257N P=0.211N P=0.188N | |COCHRAN-ARMITAGE | (e) | P=0.115N | |FISHER EXACT | (e) (e) (e) | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/56 (2%) 1/55 (2%) 0/56 (0%) 4/56 (7%) | 1/56 (2%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 1.9% 5.9% 0.0% 23.5% | 4.3% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 4/17 (24%) | 1/23 (4%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 456 (I) 718 --- 733 (T) | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123 P=0.731N P=0.500N P=0.293 | P=0.275N P=0.518N P=0.476N P=0.454N | |INCIDENTAL TUMOR | P=0.111 P=0.716 P=0.500N P=0.293 | P=0.275N P=0.518N P=0.476N P=0.454N | |LOGISTIC REGRESSION | P=0.093 P=0.758 P=0.468N P=0.222 | P=0.275N P=0.518N P=0.476N P=0.454N | |COCHRAN-ARMITAGE | P=0.063 | P=0.306N | |FISHER EXACT | P=0.748 P=0.500N P=0.182 | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 2/55 (4%) 0/56 (0%) 0/56 (0%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/53 (0%) | |ADJUSTED (b) | 0.0% 10.6% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 588 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.352N P=0.248 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.355N P=0.323 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.384N P=0.236 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.404N | (e) | |FISHER EXACT | P=0.243 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/56 (70%) 43/55 (78%) 48/56 (86%) 50/56 (89%) | | |ADJUSTED (b) | 97.2% 100.0% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 6/8 (75%) 8/8 (100%) 8/8 (100%) 8/8 (100%) | | |TERMINAL (d) | 10/11 (91%) 13/13 (100%) 9/9 (100%) 17/17 (100%)| | |FIRST INCIDENCE (DAYS) | 456 (I) 446 395 456 (I) | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.497N P=0.508 P=0.054 P=0.517N | | |INCIDENTAL TUMOR | P=0.031 * P=0.220 P=0.018 * P=0.075 | | |LOGISTIC REGRESSION | P=0.010 * P=0.204 P=0.019 * P=0.020 * | | |COCHRAN-ARMITAGE | P=0.005 ** | | |FISHER EXACT | P=0.210 P=0.034 * P=0.009 ** | | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/56 (11%) 5/55 (9%) 8/56 (14%) 6/56 (11%) | 3/56 (5%) 4/56 (7%) 5/56 (9%) 5/54 (9%) | |ADJUSTED (b) | 31.1% 25.5% 37.0% 27.3% | 10.5% 18.2% 17.0% 14.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 1/8 (13%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 1/8 (13%) 1/8 (13%) | |TERMINAL (d) | 2/11 (18%) 2/13 (15%) 2/9 (22%) 3/17 (18%) | 1/23 (4%) 3/21 (14%) 4/26 (15%) 3/29 (10%) | |FIRST INCIDENCE (DAYS) | 646 525 456 (I) 672 | 702 721 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397N P=0.432N P=0.316 P=0.379N | P=0.428 P=0.429 P=0.389 P=0.448 | |INCIDENTAL TUMOR | P=0.515N P=0.605 P=0.375 P=0.516N | P=0.393 P=0.544 P=0.372 P=0.441 | |LOGISTIC REGRESSION | P=0.510N P=0.500N P=0.361 P=0.465N | P=0.335 P=0.477 P=0.367 P=0.396 | |COCHRAN-ARMITAGE | P=0.491 | P=0.269 | |FISHER EXACT | P=0.513N P=0.388 P=0.619N | P=0.500 P=0.358 P=0.338 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/56 (5%) 1/55 (2%) 0/56 (0%) 1/56 (2%) | 0/56 (0%) 1/56 (2%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 10.7% 7.7% 0.0% 5.9% | 0.0% 4.8% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 1/17 (6%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 511 733 (T) --- 733 (T) | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.161N P=0.299N P=0.150N P=0.239N | P=0.524N P=0.482 (e) (e) | |INCIDENTAL TUMOR | P=0.206N P=0.428N P=0.143N P=0.396N | P=0.524N P=0.482 (e) (e) | |LOGISTIC REGRESSION | P=0.174N P=0.309N P=0.123N P=0.280N | P=0.524N P=0.482 (e) (e) | |COCHRAN-ARMITAGE | P=0.199N | P=0.573N | |FISHER EXACT | P=0.316N P=0.122N P=0.309N | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/56 (16%) 6/55 (11%) 8/56 (14%) 7/56 (13%) | 3/56 (5%) 5/56 (9%) 5/56 (9%) 5/54 (9%) | |ADJUSTED (b) | 38.4% 32.3% 37.0% 32.5% | 10.5% 22.7% 17.0% 14.9% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 1/8 (13%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 1/8 (13%) 1/8 (13%) | |TERMINAL (d) | 2/11 (18%) 3/13 (23%) 2/9 (22%) 4/17 (24%) | 1/23 (4%) 4/21 (19%) 4/26 (15%) 3/29 (10%) | |FIRST INCIDENCE (DAYS) | 511 525 456 (I) 672 | 702 721 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.217N P=0.244N P=0.595N P=0.184N | P=0.488 P=0.291 P=0.389 P=0.448 | |INCIDENTAL TUMOR | P=0.325N P=0.482N P=0.529N P=0.348N | P=0.454 P=0.388 P=0.372 P=0.441 | |LOGISTIC REGRESSION | P=0.301N P=0.288N P=0.525N P=0.254N | P=0.391 P=0.325 P=0.367 P=0.396 | |COCHRAN-ARMITAGE | P=0.416N | P=0.316 | |FISHER EXACT | P=0.303N P=0.500N P=0.394N | P=0.358 P=0.358 P=0.338 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/55 (2%) 0/56 (0%) 0/56 (0%) | 0/56 (0%) 2/56 (4%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 0.0% 7.7% 0.0% 0.0% | 0.0% 7.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) --- --- | --- 665 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.505N P=0.533 (e) (e) | P=0.359N P=0.236 (e) (e) | |INCIDENTAL TUMOR | P=0.505N P=0.533 (e) (e) | P=0.383N P=0.263 (e) (e) | |LOGISTIC REGRESSION | P=0.505N P=0.533 (e) (e) | P=0.388N P=0.245 (e) (e) | |COCHRAN-ARMITAGE | P=0.566N | P=0.412N | |FISHER EXACT | P=0.495 (e) (e) | P=0.248 (e) (e) | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/56 (0%) 1/55 (2%) 1/56 (2%) 0/56 (0%) | 1/56 (2%) 2/56 (4%) 0/56 (0%) 0/54 (0%) | |ADJUSTED (b) | 0.0% 7.7% 5.0% 0.0% | 2.0% 7.5% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 1/13 (8%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 1/21 (5%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- 733 (T) 674 --- | 427 665 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.534N P=0.533 P=0.455 (e) | P=0.163N P=0.505 P=0.489N P=0.485N | |INCIDENTAL TUMOR | P=0.544N P=0.533 P=0.477 (e) | P=0.214N P=0.467 P=0.545N P=0.682N | |LOGISTIC REGRESSION | P=0.542N P=0.533 P=0.490 (e) | P=0.205N P=0.485 P=0.596N P=0.661N | |COCHRAN-ARMITAGE | P=0.593N | P=0.193N | |FISHER EXACT | P=0.495 P=0.500 (e) | P=0.500 P=0.500N P=0.509N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 7/56 (13%) 5/56 (9%) 10/56 (18%) 6/56 (11%) | |ADJUSTED (b) | | 27.5% 15.9% 31.8% 18.1% | |INTERIM SACRIFICE 1 (c)| | 0/8 (0%) 1/8 (13%) 1/8 (13%) 1/8 (13%) | |TERMINAL (d) | | 6/23 (26%) 2/21 (10%) 7/26 (27%) 4/29 (14%) | |FIRST INCIDENCE (DAYS) | | 331 457 (I) 457 (I) 457 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.369N P=0.414N P=0.378 P=0.351N | |INCIDENTAL TUMOR | | P=0.488N P=0.448N P=0.322 P=0.475N | |LOGISTIC REGRESSION | | P=0.506N P=0.357N P=0.316 P=0.438N | |COCHRAN-ARMITAGE | | P=0.554 | |FISHER EXACT | | P=0.381N P=0.300 P=0.500N | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/56 (0%) 0/55 (0%) 0/56 (0%) 1/56 (2%) | 2/56 (4%) 1/56 (2%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 2.6% | 5.4% 2.2% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 0/13 (0%) 0/9 (0%) 0/17 (0%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- 597 | 588 517 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.226 (e) (e) P=0.522 | P=0.092N P=0.472N P=0.243N P=0.207N | |INCIDENTAL TUMOR | P=0.194 (e) (e) P=0.557 | P=0.124N P=0.468N P=0.208N P=0.230N | |LOGISTIC REGRESSION | P=0.190 (e) (e) P=0.484 | P=0.112N P=0.530N P=0.238N P=0.243N | |COCHRAN-ARMITAGE | P=0.200 | P=0.101N | |FISHER EXACT | (e) (e) P=0.500 | P=0.500N P=0.248N P=0.248N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 29/56 (52%) 32/55 (58%) 35/56 (63%) 32/56 (57%) | 18/56 (32%) 23/56 (41%) 20/56 (36%) 24/56 (43%) | |ADJUSTED (b) | 85.4% 85.4% 85.3% 85.6% | 45.6% 62.8% 55.6% 57.8% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 1/8 (13%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 7/11 (64%) 8/13 (62%) 4/9 (44%) 12/17 (71%) | 5/23 (22%) 9/21 (43%) 11/26 (42%) 12/29 (41%) | |FIRST INCIDENCE (DAYS) | 418 530 442 547 | 331 328 534 427 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.214N P=0.486 P=0.142 P=0.231N | P=0.513 P=0.212 P=0.513 P=0.416 | |INCIDENTAL TUMOR | P=0.447 P=0.326 P=0.152 P=0.549 | P=0.141 P=0.198 P=0.367 P=0.077 | |LOGISTIC REGRESSION | P=0.498 P=0.310 P=0.146 P=0.562N | P=0.267 P=0.234 P=0.445 P=0.200 | |COCHRAN-ARMITAGE | P=0.338 | P=0.195 | |FISHER EXACT | P=0.313 P=0.170 P=0.352 | P=0.216 P=0.421 P=0.165 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/56 (5%) 5/55 (9%) 2/56 (4%) 1/56 (2%) | 0/56 (0%) 0/56 (0%) 0/56 (0%) 0/56 (0%) | |ADJUSTED (b) | 7.4% 26.8% 15.3% 5.9% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) | |TERMINAL (d) | 0/11 (0%) 2/13 (15%) 1/9 (11%) 1/17 (6%) | 0/23 (0%) 0/21 (0%) 0/26 (0%) 0/29 (0%) | |FIRST INCIDENCE (DAYS) | 492 639 673 733 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.087N P=0.384 P=0.545N P=0.250N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.135N P=0.308 P=0.508N P=0.494N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.111N P=0.349 P=0.498N P=0.342N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.135N | (e) | |FISHER EXACT | P=0.348 P=0.500N P=0.309N | (e) (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 53/56 (95%) 53/55 (96%) 53/56 (95%) 55/56 (98%) | 41/56 (73%) 40/56 (71%) 43/56 (77%) 43/56 (77%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 100.0% 92.8% 91.2% 93.2% | |INTERIM SACRIFICE 1 (c)| 8/8 (100%) 8/8 (100%) 8/8 (100%) 8/8 (100%) | 3/8 (38%) 1/8 (13%) 5/8 (63%) 5/8 (63%) | |TERMINAL (d) | 11/11 (100%) 13/13 (100%) 9/9 (100%) 17/17 (100%)| 23/23 (100%) 18/21 (86%) 22/26 (85%) 26/29 (90%) | |FIRST INCIDENCE (DAYS) | 394 331 371 456 (I) | 331 457 (I) 457 (I) 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.101N P=0.411N P=0.329 P=0.105N | P=0.176N P=0.476 P=0.504N P=0.218N | |INCIDENTAL TUMOR | P=0.480 P=0.466 P=0.668N P=0.511 | P=0.452N P=0.298N P=0.588N P=0.391N | |LOGISTIC REGRESSION | P=0.349 P=0.508 P=0.629 P=0.418 | P=0.510N P=0.218N P=0.564 P=0.440N | |COCHRAN-ARMITAGE | P=0.262 | P=0.311 | |FISHER EXACT | P=0.509 P=0.661N P=0.309 | P=0.500N P=0.414 P=0.414 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 100 PPM 200 PPM 400 PPM | CONTROL 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 36/56 (64%) 36/55 (65%) 38/56 (68%) 34/56 (61%) | 29/56 (52%) 29/56 (52%) 23/56 (41%) 28/56 (50%) | |ADJUSTED (b) | 88.6% 89.7% 86.7% 86.5% | 67.3% 74.4% 60.1% 64.4% | |INTERIM SACRIFICE 1 (c)| 0/8 (0%) 1/8 (13%) 0/8 (0%) 0/8 (0%) | 0/8 (0%) 1/8 (13%) 0/8 (0%) 1/8 (13%) | |TERMINAL (d) | 7/11 (64%) 9/13 (69%) 4/9 (44%) 12/17 (71%) | 10/23 (43%) 12/21 (57%) 12/26 (46%) 14/29 (48%) | |FIRST INCIDENCE (DAYS) | 418 456 (I) 371 485 | 310 328 292 427 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.078N P=0.453N P=0.293 P=0.076N | P=0.142N P=0.485 P=0.155N P=0.228N | |INCIDENTAL TUMOR | P=0.301N P=0.487 P=0.427 P=0.414N | P=0.525N P=0.579 P=0.228N P=0.535 | |LOGISTIC REGRESSION | P=0.212N P=0.581 P=0.413 P=0.227N | P=0.309N P=0.523N P=0.157N P=0.419N | |COCHRAN-ARMITAGE | P=0.371N | P=0.402N | |FISHER EXACT | P=0.528 P=0.421 P=0.423N | P=0.575N P=0.172N P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 56/56 (100%) 55/55 (100%) 56/56 (100%) 56/56 (100%)| 50/56 (89%) 48/56 (86%) 50/56 (89%) 51/56 (91%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 100.0% 97.9% 94.3% 98.1% | |INTERIM SACRIFICE 1 (c)| 8/8 (100%) 8/8 (100%) 8/8 (100%) 8/8 (100%) | 3/8 (38%) 2/8 (25%) 5/8 (63%) 5/8 (63%) | |TERMINAL (d) | 11/11 (100%) 13/13 (100%) 9/9 (100%) 17/17 (100%)| 23/23 (100%) 20/21 (95%) 23/26 (88%) 28/29 (97%) | |FIRST INCIDENCE (DAYS) | 394 331 371 456 (I) | 310 328 292 394 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.373N P=0.333 P=0.069N | P=0.133N P=0.543 P=0.383N P=0.163N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.351 P=0.276N P=0.583N P=0.638 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.516N P=0.116N P=0.480N P=0.407N | |COCHRAN-ARMITAGE | (e) | P=0.347 | |FISHER EXACT | P=1.000N P=1.000N P=1.000N | P=0.388N P=0.619N P=0.500 | |=================================================================================================================================| DATE: 05/20/95 EXPERIMENT: 05133 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ACETONITRILE TERMINAL SACRIFICE AT 105 WEEKS (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (c) Observed incidence at interim kill. Male interim sacrifices(days): 456 Female interim sacrifices(days): 457 (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).