TDMS Study 05120-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst BENZYL ACETATE DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 TIME: 03:57:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: JAMES HEATH SCOT EUSTIS CAS: 140-11-4 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst BENZYL ACETATE DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 TIME: 03:57:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: JAMES HEATH SCOT EUSTIS CAS: 140-11-4 MICE(B6C3F1) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Bone Marrow Brain Clitoral Gland Epididymis Gallbladder Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst BENZYL ACETATE DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 TIME: 03:57:58 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: JAMES HEATH SCOT EUSTIS CAS: 140-11-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BENZYL ACETATE ==================================================================================================== MALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Liver Hepatocellular Adenoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE MICE ------------- ORGAN MORPHOLOGY ------- ------------ Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Uterus Polyp Stromal Sarcoma Stromal or Polyp Stromal All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 11.9% 7.0% 2.4% 2.6% | 0.0% 6.7% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/39 (10%) 3/43 (7%) 1/41 (2%) 1/39 (3%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | 457 (I) 729 (T) 729 (T) 729 (T) | --- 723 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.095N P=0.312N P=0.096N P=0.105N | P=0.305N P=0.238 (e) (e) | |INCIDENTAL TUMOR | P=0.095N P=0.312N P=0.096N P=0.105N | P=0.897N P=0.348 (e) (e) | |LOGISTIC REGRESSION | P=0.091N P=0.349N P=0.102N P=0.104N | P=0.333N P=0.247 (e) (e) | |COCHRAN-ARMITAGE | P=0.090N | P=0.379N | |FISHER EXACT | P=0.359N P=0.103N P=0.103N | P=0.248 (e) (e) | |=================================================================================================================================| | | |Bone | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.2% 0.0% 2.4% | 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 0/41 (0%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | --- 562 --- 701 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.610 P=0.244 (e) P=0.495 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.645 P=0.288 (e) P=0.536 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.673 P=0.224 (e) P=0.500 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.615 | (e) | |FISHER EXACT | P=0.248 (e) P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 4.2% 2.0% 4.5% | 0.0% 0.0% 5.4% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 0/41 (0%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 2/37 (5%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | --- 562 618 584 | --- --- 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.310 P=0.244 P=0.513 P=0.240 | P=0.476 (e) P=0.293 P=0.583 | |INCIDENTAL TUMOR | P=0.292 P=0.288 P=0.602 P=0.260 | P=0.476 (e) P=0.293 P=0.583 | |LOGISTIC REGRESSION | P=0.370 P=0.224 P=0.491 P=0.237 | P=0.476 (e) P=0.293 P=0.583 | |COCHRAN-ARMITAGE | P=0.314 | P=0.354 | |FISHER EXACT | P=0.248 P=0.500 P=0.248 | (e) P=0.248 P=0.500 | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 6/60 (10%) 5/60 (8%) | 3/60 (5%) 4/60 (7%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 9.9% 4.7% 13.8% 11.9% | 8.3% 13.3% 5.2% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 3/39 (8%) 2/43 (5%) 4/41 (10%) 2/39 (5%) | 1/29 (3%) 2/28 (7%) 1/37 (3%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 724 729 (T) 708 683 | 600 723 723 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.288 P=0.298N P=0.400 P=0.495 | P=0.085N P=0.501 P=0.400N P=0.220N | |INCIDENTAL TUMOR | P=0.415 P=0.365N P=0.347 P=0.553 | P=0.259N P=0.542 P=0.537N P=0.467N | |LOGISTIC REGRESSION | P=0.292 P=0.314N P=0.391 P=0.493 | P=0.129N P=0.514 P=0.463N P=0.287N | |COCHRAN-ARMITAGE | P=0.313 | P=0.165N | |FISHER EXACT | P=0.340N P=0.372 P=0.500 | P=0.500 P=0.500N P=0.309N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Intestine Small | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 6.9% 2.3% 2.4% 0.0% | 2.7% 2.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/43 (2%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 729 (T) --- | 656 628 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.120N P=0.281N P=0.294N P=0.123N | P=0.286N P=0.738N P=0.452N P=0.465N | |INCIDENTAL TUMOR | P=0.120N P=0.281N P=0.294N P=0.123N | P=0.476N P=0.735 P=0.436N (e) | |LOGISTIC REGRESSION | P=0.116N P=0.307N P=0.308N P=0.122N | P=0.308N P=0.762 P=0.500N P=0.499N | |COCHRAN-ARMITAGE | P=0.116N | P=0.305N | |FISHER EXACT | P=0.309N P=0.309N P=0.122N | P=0.752N P=0.500N P=0.500N | |=================================================================================================================================| | | |Intestine Small: Jejunum | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 6.9% 2.3% 2.4% 0.0% | 2.7% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/43 (2%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 729 (T) --- | 656 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.120N P=0.281N P=0.294N P=0.123N | P=0.451N P=0.484N P=0.452N P=0.465N | |INCIDENTAL TUMOR | P=0.120N P=0.281N P=0.294N P=0.123N | P=0.904N P=0.403N P=0.436N (e) | |LOGISTIC REGRESSION | P=0.116N P=0.307N P=0.308N P=0.122N | P=0.471N P=0.500N P=0.500N P=0.499N | |COCHRAN-ARMITAGE | P=0.116N | P=0.472N | |FISHER EXACT | P=0.309N P=0.309N P=0.122N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 3/59 (5%) 0/60 (0%) | 3/60 (5%) 2/60 (3%) 2/60 (3%) 0/59 (0%) | |ADJUSTED (b) | 0.0% 4.7% 7.2% 0.0% | 8.8% 7.1% 4.8% 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 2/43 (5%) 2/40 (5%) 0/39 (0%) | 2/29 (7%) 2/28 (7%) 1/37 (3%) 0/43 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) 711 --- | 533 729 (T) 702 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.399N P=0.260 P=0.129 (e) | P=0.054N P=0.517N P=0.398N P=0.079N | |INCIDENTAL TUMOR | P=0.362N P=0.260 P=0.113 (e) | P=0.101N P=0.529N P=0.596N P=0.139N | |LOGISTIC REGRESSION | P=0.395N P=0.260 P=0.123 (e) | P=0.085N P=0.492N P=0.467N P=0.120N | |COCHRAN-ARMITAGE | P=0.385N | P=0.101N | |FISHER EXACT | P=0.248 P=0.119 (e) | P=0.500N P=0.500N P=0.125N | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.2% 2.1% 2.1% | 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 0/41 (0%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | --- 562 620 584 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.613 P=0.244 P=0.509 P=0.504 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.590 P=0.288 P=0.602 P=0.500 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.614 P=0.224 P=0.492 P=0.496 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.614 | (e) | |FISHER EXACT | P=0.248 P=0.500 P=0.500 | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/60 (18%) 14/60 (23%) 10/60 (17%) 2/60 (3%) | 7/60 (12%) 10/60 (17%) 8/60 (13%) 8/60 (13%) | |ADJUSTED (b) | 26.3% 31.5% 21.8% 4.2% | 20.8% 28.5% 19.8% 17.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 9/39 (23%) 13/43 (30%) 7/41 (17%) 1/39 (3%) | 5/29 (17%) 6/28 (21%) 6/37 (16%) 6/44 (14%) | |FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 457 (I) 456 (I) | 456 (I) 507 458 (I) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003N** P=0.418 P=0.460N P=0.010N** | P=0.235N P=0.297 P=0.545N P=0.455N | |INCIDENTAL TUMOR | P=0.002N** P=0.378 P=0.483N P=0.009N** | P=0.528N P=0.331 P=0.539N P=0.532 | |LOGISTIC REGRESSION | P=0.002N** P=0.345 P=0.483N P=0.009N** | P=0.486N P=0.304 P=0.566 P=0.553 | |COCHRAN-ARMITAGE | P=0.002N** | P=0.537N | |FISHER EXACT | P=0.327 P=0.500N P=0.008N** | P=0.301 P=0.500 P=0.500 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/60 (20%) 14/60 (23%) 11/60 (18%) 8/60 (13%) | 10/60 (17%) 8/60 (13%) 6/60 (10%) 7/60 (12%) | |ADJUSTED (b) | 26.6% 29.6% 24.7% 18.5% | 27.0% 20.9% 14.1% 15.9% | |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%) 0/10 (0%) | |TERMINAL (d) | 7/39 (18%) 10/43 (23%) 8/41 (20%) 5/39 (13%) | 4/29 (14%) 3/28 (11%) 3/37 (8%) 7/44 (16%) | |FIRST INCIDENCE (DAYS) | 508 508 618 584 | 520 507 568 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.155N P=0.497 P=0.454N P=0.241N | P=0.121N P=0.387N P=0.106N P=0.107N | |INCIDENTAL TUMOR | P=0.098N P=0.275 P=0.577 P=0.236N | P=0.493N P=0.470N P=0.338N P=0.500N | |LOGISTIC REGRESSION | P=0.088N P=0.413 P=0.434N P=0.154N | P=0.505N P=0.463N P=0.371N P=0.220N | |COCHRAN-ARMITAGE | P=0.125N | P=0.315N | |FISHER EXACT | P=0.412 P=0.500N P=0.232N | P=0.399N P=0.211N P=0.301N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/60 (38%) 23/60 (38%) 20/60 (33%) 10/60 (17%) | 15/60 (25%) 15/60 (25%) 14/60 (23%) 14/60 (23%) | |ADJUSTED (b) | 49.5% 47.6% 41.9% 22.2% | 38.5% 39.6% 32.3% 30.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 16/39 (41%) 18/43 (42%) 14/41 (34%) 6/39 (15%) | 7/29 (24%) 8/28 (29%) 9/37 (24%) 12/44 (27%) | |FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 457 (I) 456 (I) | 456 (I) 507 458 (I) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005N** P=0.443N P=0.302N P=0.010N* | P=0.120N P=0.567N P=0.260N P=0.171N | |INCIDENTAL TUMOR | P=0.002N** P=0.490 P=0.427N P=0.007N** | P=0.535 P=0.546 P=0.519N P=0.468 | |LOGISTIC REGRESSION | P=0.002N** P=0.552N P=0.322N P=0.004N** | P=0.500 P=0.529 P=0.421N P=0.412N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.457N | |FISHER EXACT | P=0.574N P=0.352N P=0.007N** | P=0.583N P=0.500N P=0.500N | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/60 (38%) 23/60 (38%) 20/60 (33%) 10/60 (17%) | 15/60 (25%) 15/60 (25%) 14/60 (23%) 14/60 (23%) | |ADJUSTED (b) | 49.5% 47.6% 41.9% 22.2% | 38.5% 39.6% 32.3% 30.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 2/10 (20%) 1/10 (10%) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 16/39 (41%) 18/43 (42%) 14/41 (34%) 6/39 (15%) | 7/29 (24%) 8/28 (29%) 9/37 (24%) 12/44 (27%) | |FIRST INCIDENCE (DAYS) | 458 (I) 458 (I) 457 (I) 456 (I) | 456 (I) 507 458 (I) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.005N** P=0.443N P=0.302N P=0.010N* | P=0.120N P=0.567N P=0.260N P=0.171N | |INCIDENTAL TUMOR | P=0.002N** P=0.490 P=0.427N P=0.007N** | P=0.535 P=0.546 P=0.519N P=0.468 | |LOGISTIC REGRESSION | P=0.002N** P=0.552N P=0.322N P=0.004N** | P=0.500 P=0.529 P=0.421N P=0.412N | |COCHRAN-ARMITAGE | P=0.002N** | P=0.457N | |FISHER EXACT | P=0.574N P=0.352N P=0.007N** | P=0.583N P=0.500N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/60 (17%) 15/60 (25%) 8/60 (13%) 6/60 (10%) | 1/60 (2%) 5/60 (8%) 1/60 (2%) 5/60 (8%) | |ADJUSTED (b) | 23.3% 33.9% 17.6% 15.4% | 3.4% 15.3% 2.6% 10.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 7/39 (18%) 14/43 (33%) 5/41 (12%) 6/39 (15%) | 1/29 (3%) 3/28 (11%) 0/37 (0%) 3/44 (7%) | |FIRST INCIDENCE (DAYS) | 458 (I) 508 457 (I) 729 (T) | 729 (T) 628 723 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.074N P=0.256 P=0.367N P=0.214N | P=0.330 P=0.109 P=0.703N P=0.185 | |INCIDENTAL TUMOR | P=0.055N P=0.159 P=0.412N P=0.196N | P=0.167 P=0.085 P=0.697N P=0.150 | |LOGISTIC REGRESSION | P=0.062N P=0.196 P=0.380N P=0.209N | P=0.193 P=0.111 P=0.695N P=0.104 | |COCHRAN-ARMITAGE | P=0.061N | P=0.176 | |FISHER EXACT | P=0.184 P=0.399N P=0.211N | P=0.103 P=0.752N P=0.103 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 1/60 (2%) 3/60 (5%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 12.1% 7.0% 2.4% 6.8% | 0.0% 0.0% 2.7% 0.0% | |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%) 0/10 (0%) | |TERMINAL (d) | 4/39 (10%) 3/43 (7%) 1/41 (2%) 1/39 (3%) | 0/29 (0%) 0/28 (0%) 1/37 (3%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | 508 729 (T) 729 (T) 457 (I) | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.419N P=0.310N P=0.095N P=0.361N | P=0.719N (e) P=0.549 (e) | |INCIDENTAL TUMOR | P=0.397N P=0.377N P=0.165N P=0.374N | P=0.719N (e) P=0.549 (e) | |LOGISTIC REGRESSION | P=0.402N P=0.347N P=0.100N P=0.357N | P=0.720N (e) P=0.549 (e) | |COCHRAN-ARMITAGE | P=0.400N | P=0.785N | |FISHER EXACT | P=0.359N P=0.103N P=0.359N | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/60 (25%) 17/60 (28%) 9/60 (15%) 8/60 (13%) | 1/60 (2%) 5/60 (8%) 2/60 (3%) 5/60 (8%) | |ADJUSTED (b) | 34.2% 38.5% 19.9% 19.1% | 3.4% 15.3% 5.2% 10.3% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | 11/39 (28%) 16/43 (37%) 6/41 (15%) 6/39 (15%) | 1/29 (3%) 3/28 (11%) 1/37 (3%) 3/44 (7%) | |FIRST INCIDENCE (DAYS) | 458 (I) 508 457 (I) 457 (I) | 729 (T) 628 723 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.042N* P=0.532 P=0.112N P=0.088N | P=0.361 P=0.109 P=0.586 P=0.185 | |INCIDENTAL TUMOR | P=0.028N* P=0.370 P=0.173N P=0.080N | P=0.197 P=0.085 P=0.593 P=0.150 | |LOGISTIC REGRESSION | P=0.032N* P=0.443 P=0.114N P=0.080N | P=0.212 P=0.111 P=0.608 P=0.104 | |COCHRAN-ARMITAGE | P=0.032N* | P=0.190 | |FISHER EXACT | P=0.418 P=0.127N P=0.082N | P=0.103 P=0.500 P=0.103 | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/58 (5%) 0/59 (0%) 0/58 (0%) 1/57 (2%) | 9/58 (16%) 11/56 (20%) 4/60 (7%) 5/59 (8%) | |ADJUSTED (b) | 7.9% 0.0% 0.0% 2.6% | 29.0% 36.3% 10.8% 10.9% | |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%) 0/10 (0%) | |TERMINAL (d) | 3/38 (8%) 0/43 (0%) 0/39 (0%) 1/39 (3%) | 7/29 (24%) 9/27 (33%) 4/37 (11%) 4/44 (9%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- --- 729 (T) | 722 521 729 (T) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.451N P=0.100N P=0.116N P=0.296N | P=0.014N* P=0.345 P=0.047N* P=0.051N | |INCIDENTAL TUMOR | P=0.451N P=0.100N P=0.116N P=0.296N | P=0.037N* P=0.334 P=0.044N* P=0.202N | |LOGISTIC REGRESSION | P=0.451N P=0.100N P=0.116N P=0.296N | P=0.040N* P=0.370 P=0.033N* P=0.104N | |COCHRAN-ARMITAGE | P=0.451N | P=0.082N | |FISHER EXACT | P=0.119N P=0.122N P=0.316N | P=0.370 P=0.107N P=0.187N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/58 (5%) 0/59 (0%) 1/58 (2%) 1/57 (2%) | 9/58 (16%) 11/56 (20%) 4/60 (7%) 5/59 (8%) | |ADJUSTED (b) | 7.9% 0.0% 2.0% 2.6% | 29.0% 36.3% 10.8% 10.9% | |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%) 0/10 (0%) | |TERMINAL (d) | 3/38 (8%) 0/43 (0%) 0/39 (0%) 1/39 (3%) | 7/29 (24%) 9/27 (33%) 4/37 (11%) 4/44 (9%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 571 729 (T) | 722 521 729 (T) 544 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.444N P=0.100N P=0.294N P=0.296N | P=0.014N* P=0.345 P=0.047N* P=0.051N | |INCIDENTAL TUMOR | P=0.463N P=0.100N P=0.224N P=0.296N | P=0.037N* P=0.334 P=0.044N* P=0.202N | |LOGISTIC REGRESSION | P=0.443N P=0.100N P=0.301N P=0.296N | P=0.040N* P=0.370 P=0.033N* P=0.104N | |COCHRAN-ARMITAGE | P=0.445N | P=0.082N | |FISHER EXACT | P=0.119N P=0.309N P=0.316N | P=0.370 P=0.107N P=0.187N | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 2/60 (3%) 3/60 (5%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 6.0% 7.1% 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 0/41 (0%) 0/39 (0%) | 0/29 (0%) 1/28 (4%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 656 712 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.284N P=0.244 P=0.182 (e) | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.647 P=0.288 P=0.172 (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.342N P=0.242 P=0.163 (e) | |COCHRAN-ARMITAGE | (e) | P=0.385N | |FISHER EXACT | (e) (e) (e) | P=0.248 P=0.122 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.4% 2.1% 4.4% 0.0% | 0.0% 0.0% 2.4% 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | 725 589 618 --- | --- --- 722 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.340N P=0.753N P=0.516 P=0.505N | P=0.733N (e) P=0.556 (e) | |INCIDENTAL TUMOR | P=0.311N P=0.703 P=0.538 P=0.464N | P=0.884 (e) P=0.564 (e) | |LOGISTIC REGRESSION | P=0.332N P=0.761 P=0.506 P=0.503N | P=0.759N (e) P=0.553 (e) | |COCHRAN-ARMITAGE | P=0.332N | P=0.785N | |FISHER EXACT | P=0.752N P=0.500 P=0.500N | (e) P=0.500 (e) | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 4.2% 4.4% 2.1% | 0.0% 0.0% 2.7% 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 0/43 (0%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 1/37 (3%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | --- 562 618 584 | --- --- 729 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.610 P=0.244 P=0.252 P=0.504 | P=0.719N (e) P=0.549 (e) | |INCIDENTAL TUMOR | P=0.588 P=0.288 P=0.301 P=0.500 | P=0.719N (e) P=0.549 (e) | |LOGISTIC REGRESSION | P=0.628N P=0.224 P=0.239 P=0.496 | P=0.720N (e) P=0.549 (e) | |COCHRAN-ARMITAGE | P=0.615 | P=0.785N | |FISHER EXACT | P=0.248 P=0.248 P=0.500 | (e) P=0.500 (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Carcinoma or Papilloma Squamous | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 1/60 (2%) 3/60 (5%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 7.3% 8.8% 2.4% 6.3% | 0.0% 3.6% 5.4% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 3/43 (7%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 1/28 (4%) 2/37 (5%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 670 508 729 (T) 457 (I) | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.558N P=0.541 P=0.292N P=0.659 | P=0.635 P=0.493 P=0.293 P=0.583 | |INCIDENTAL TUMOR | P=0.480N P=0.393 P=0.313N P=0.623N | P=0.635 P=0.493 P=0.293 P=0.583 | |LOGISTIC REGRESSION | P=0.544N P=0.506 P=0.293N P=0.615N | P=0.635 P=0.493 P=0.293 P=0.583 | |COCHRAN-ARMITAGE | P=0.544N | P=0.500 | |FISHER EXACT | P=0.500 P=0.309N P=0.660N | P=0.500 P=0.248 P=0.500 | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/60 (5%) 4/60 (7%) 1/60 (2%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 7.3% 8.8% 2.4% 4.1% | 0.0% 3.6% 5.4% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 3/43 (7%) 1/41 (2%) 0/39 (0%) | 0/29 (0%) 1/28 (4%) 2/37 (5%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 670 508 729 (T) 457 (I) | --- 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.352N P=0.541 P=0.292N P=0.500N | P=0.635 P=0.493 P=0.293 P=0.583 | |INCIDENTAL TUMOR | P=0.310N P=0.393 P=0.313N P=0.467N | P=0.635 P=0.493 P=0.293 P=0.583 | |LOGISTIC REGRESSION | P=0.338N P=0.506 P=0.293N P=0.501N | P=0.635 P=0.493 P=0.293 P=0.583 | |COCHRAN-ARMITAGE | P=0.338N | P=0.500 | |FISHER EXACT | P=0.500 P=0.309N P=0.500N | P=0.500 P=0.248 P=0.500 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 1/60 (2%) 2/60 (3%) 1/60 (2%) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 1/60 (2%) | |ADJUSTED (b) | 5.1% 2.3% 4.9% 2.6% | 5.1% 0.0% 0.0% 2.3% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/39 (5%) 1/43 (2%) 2/41 (5%) 1/39 (3%) | 1/29 (3%) 0/28 (0%) 0/37 (0%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 457 (I) --- --- 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.493N P=0.466N P=0.677N P=0.500N | P=0.564N P=0.244N P=0.213N P=0.404N | |INCIDENTAL TUMOR | P=0.493N P=0.466N P=0.677N P=0.500N | P=0.564N P=0.244N P=0.213N P=0.404N | |LOGISTIC REGRESSION | P=0.493N P=0.466N P=0.677N P=0.500N | P=0.652N P=0.227N P=0.243N P=0.507N | |COCHRAN-ARMITAGE | P=0.477N | P=0.646N | |FISHER EXACT | P=0.500N P=0.691N P=0.500N | P=0.248N P=0.248N P=0.500N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 8/60 (13%) 2/60 (3%) 1/60 (2%) 6/60 (10%) | |ADJUSTED (b) | | 25.2% 7.1% 2.7% 13.6% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 6/29 (21%) 2/28 (7%) 1/37 (3%) 6/44 (14%) | |FIRST INCIDENCE (DAYS) | | 656 729 (T) 729 (T) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.411N P=0.050N P=0.006N** P=0.139N | |INCIDENTAL TUMOR | | P=0.529N P=0.036N* P=0.006N** P=0.319N | |LOGISTIC REGRESSION | | P=0.547N P=0.038N* P=0.006N** P=0.223N | |COCHRAN-ARMITAGE | | P=0.478 | |FISHER EXACT | | P=0.047N* P=0.016N* P=0.389N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | | 0.0% 2.2% 4.4% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | | 0/29 (0%) 0/28 (0%) 1/37 (3%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | | --- 544 457 (I) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.469N P=0.504 P=0.266 (e) | |INCIDENTAL TUMOR | | P=0.619N P=0.464 P=0.266 (e) | |LOGISTIC REGRESSION | | P=0.541N P=0.528 P=0.231 (e) | |COCHRAN-ARMITAGE | | P=0.516N | |FISHER EXACT | | P=0.500 P=0.248 (e) | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 8/60 (13%) 3/60 (5%) 3/60 (5%) 6/60 (10%) | |ADJUSTED (b) | | 25.2% 9.2% 7.0% 13.6% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | | 6/29 (21%) 2/28 (7%) 2/37 (5%) 6/44 (14%) | |FIRST INCIDENCE (DAYS) | | 656 544 457 (I) 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.333N P=0.106N P=0.048N* P=0.139N | |INCIDENTAL TUMOR | | P=0.492N P=0.087N P=0.046N* P=0.319N | |LOGISTIC REGRESSION | | P=0.535N P=0.090N P=0.070N P=0.223N | |COCHRAN-ARMITAGE | | P=0.553 | |FISHER EXACT | | P=0.102N P=0.102N P=0.389N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |All Organs | | Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.3% 0.0% 0.0% | 6.9% 3.6% 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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 1/43 (2%) 0/41 (0%) 0/39 (0%) | 2/29 (7%) 1/28 (4%) 0/37 (0%) 0/44 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 729 (T) 729 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.592N P=0.519 (e) (e) | P=0.113N P=0.512N P=0.186N P=0.152N | |INCIDENTAL TUMOR | P=0.592N P=0.519 (e) (e) | P=0.113N P=0.512N P=0.186N P=0.152N | |LOGISTIC REGRESSION | P=0.592N P=0.519 (e) (e) | P=0.113N P=0.512N P=0.186N P=0.152N | |COCHRAN-ARMITAGE | P=0.584N | P=0.169N | |FISHER EXACT | P=0.500 (e) (e) | P=0.500N P=0.248N P=0.248N | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 2/60 (3%) 5/60 (8%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 4/60 (7%) 1/60 (2%) | |ADJUSTED (b) | 4.9% 4.2% 11.1% 4.5% | 0.0% 0.0% 10.3% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 0/43 (0%) 3/41 (7%) 0/39 (0%) | 0/29 (0%) 0/28 (0%) 3/37 (8%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 725 562 618 584 | --- --- 722 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.592N P=0.675N P=0.242 P=0.689 | P=0.562 (e) P=0.101 P=0.583 | |INCIDENTAL TUMOR | P=0.572N P=0.687 P=0.276 P=0.663N | P=0.442 (e) P=0.103 P=0.583 | |LOGISTIC REGRESSION | P=0.492N P=0.704N P=0.226 P=0.694N | P=0.525 (e) P=0.108 P=0.583 | |COCHRAN-ARMITAGE | P=0.579N | P=0.410 | |FISHER EXACT | P=0.691N P=0.219 P=0.691N | (e) P=0.059 P=0.500 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 5/60 (8%) 2/60 (3%) | 2/60 (3%) 1/60 (2%) 4/60 (7%) 1/60 (2%) | |ADJUSTED (b) | 4.9% 6.4% 11.1% 4.5% | 6.9% 3.6% 10.3% 2.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 1/39 (3%) 1/43 (2%) 3/41 (7%) 0/39 (0%) | 2/29 (7%) 1/28 (4%) 3/37 (8%) 1/44 (2%) | |FIRST INCIDENCE (DAYS) | 725 562 618 584 | 729 (T) 729 (T) 722 729 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.515N P=0.526 P=0.242 P=0.689 | P=0.281N P=0.512N P=0.457 P=0.356N | |INCIDENTAL TUMOR | P=0.489N P=0.491 P=0.276 P=0.663N | P=0.354N P=0.512N P=0.460 P=0.356N | |LOGISTIC REGRESSION | P=0.412N P=0.500 P=0.226 P=0.694N | P=0.310N P=0.512N P=0.485 P=0.356N | |COCHRAN-ARMITAGE | P=0.500N | P=0.459N | |FISHER EXACT | P=0.500 P=0.219 P=0.691N | P=0.500N P=0.340 P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | 8/60 (13%) 8/60 (13%) 9/60 (15%) 10/60 (17%) | |ADJUSTED (b) | 4.4% 7.0% 4.4% 2.6% | 23.3% 24.9% 22.8% 21.3% | |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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 3/43 (7%) 0/41 (0%) 1/39 (3%) | 5/29 (17%) 5/28 (18%) 7/37 (19%) 8/44 (18%) | |FIRST INCIDENCE (DAYS) | 577 729 (T) 618 729 (T) | 494 681 716 302 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.319N P=0.530 P=0.676N P=0.505N | P=0.413N P=0.589 P=0.512N P=0.508N | |INCIDENTAL TUMOR | P=0.270N P=0.474 P=0.654N P=0.479N | P=0.348 P=0.544N P=0.492 P=0.497 | |LOGISTIC REGRESSION | P=0.305N P=0.507 P=0.692 P=0.500N | P=0.413 P=0.588N P=0.587N P=0.431 | |COCHRAN-ARMITAGE | P=0.303N | P=0.333 | |FISHER EXACT | P=0.500 P=0.691N P=0.500N | P=0.605N P=0.500 P=0.399 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/60 (3%) 3/60 (5%) 2/60 (3%) 1/60 (2%) | 8/60 (13%) 7/60 (12%) 9/60 (15%) 9/60 (15%) | |ADJUSTED (b) | 4.4% 7.0% 4.4% 2.6% | 23.3% 22.8% 22.8% 19.5% | |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%) 0/10 (0%) | |TERMINAL (d) | 0/39 (0%) 3/43 (7%) 0/41 (0%) 1/39 (3%) | 5/29 (17%) 5/28 (18%) 7/37 (19%) 8/44 (18%) | |FIRST INCIDENCE (DAYS) | 577 729 (T) 618 729 (T) | 494 691 716 302 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.319N P=0.530 P=0.676N P=0.505N | P=0.350N P=0.521N P=0.512N P=0.407N | |INCIDENTAL TUMOR | P=0.270N P=0.474 P=0.654N P=0.479N | P=0.472 P=0.460N P=0.492 P=0.590N | |LOGISTIC REGRESSION | P=0.305N P=0.507 P=0.692 P=0.500N | P=0.493 P=0.479N P=0.587N P=0.441N | |COCHRAN-ARMITAGE | P=0.303N | P=0.399 | |FISHER EXACT | P=0.500 P=0.691N P=0.500N | P=0.500N P=0.500 P=0.500 | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 30/60 (50%) 28/60 (47%) 24/60 (40%) 17/60 (28%) | 32/60 (53%) 29/60 (48%) 17/60 (28%) 24/60 (40%) | |ADJUSTED (b) | 66.3% 62.0% 49.4% 37.1% | 81.1% 75.2% 39.8% 48.6% | |INTERIM SACRIFICE 1 (c)| 2/10 (20%) 1/10 (10%) 3/10 (30%) 2/10 (20%) | 3/10 (30%) 0/10 (0%) 1/10 (10%) 2/10 (20%) | |TERMINAL (d) | 24/39 (62%) 26/43 (60%) 17/41 (41%) 11/39 (28%) | 22/29 (76%) 19/28 (68%) 12/37 (32%) 19/44 (43%) | |FIRST INCIDENCE (DAYS) | 457 (I) 458 (I) 457 (I) 456 (I) | 456 (I) 507 458 (I) 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.012N* P=0.250N P=0.139N P=0.016N* | P=0.002N** P=0.392N P<0.001N** P=0.002N** | |INCIDENTAL TUMOR | P=0.003N** P=0.403N P=0.153N P=0.006N** | P=0.056N P=0.360N P<0.001N** P=0.044N* | |LOGISTIC REGRESSION | P=0.006N** P=0.376N P=0.138N P=0.010N** | P=0.053N P=0.315N P<0.001N** P=0.052N | |COCHRAN-ARMITAGE | P=0.007N** | P=0.112N | |FISHER EXACT | P=0.428N P=0.179N P=0.012N* | P=0.358N P=0.004N** P=0.100N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% .033% .1% .3% | 0% .033% .1% .3% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 25/60 (42%) 21/60 (35%) 20/60 (33%) 15/60 (25%) | 17/60 (28%) 24/60 (40%) 25/60 (42%) 16/60 (27%) | |ADJUSTED (b) | 50.8% 42.8% 40.6% 31.5% | 42.8% 56.4% 50.6% 33.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | |TERMINAL (d) | 15/39 (38%) 15/43 (35%) 12/41 (29%) 7/39 (18%) | 8/29 (28%) 11/28 (39%) 13/37 (35%) 13/44 (30%) | |FIRST INCIDENCE (DAYS) | 458 (I) 508 571 457 (I) | 494 17 114 302 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.075N P=0.214N P=0.202N P=0.062N | P=0.025N* P=0.163 P=0.353 P=0.163N | |INCIDENTAL TUMOR | P=0.015N* P=0.397N P=0.197N P=0.023N* | P=0.470N P=0.143 P=0.071 P=0.508 | |LOGISTIC REGRESSION | P=0.013N* P=0.270N P=0.172N P=0.016N* | P=0.134N P=0.122 P=0.119 P=0.443N | |COCHRAN-ARMITAGE | P=0.042N* | P=0.212N | |FISHER EXACT | P=0.287N P=0.225N P=0.040N* | P=0.124 P=0.090 P=0.500N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 45/60 (75%) 41/60 (68%) 38/60 (63%) 25/60 (42%) | 38/60 (63%) 40/60 (67%) 35/60 (58%) 35/60 (58%) | |ADJUSTED (b) | 86.5% 81.9% 71.6% 50.7% | 85.7% 86.7% 69.7% 67.1% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 1/10 (10%) 3/10 (30%) 2/10 (20%) | 3/10 (30%) 0/10 (0%) 2/10 (20%) 2/10 (20%) | |TERMINAL (d) | 32/39 (82%) 34/43 (79%) 26/41 (63%) 15/39 (38%) | 23/29 (79%) 22/28 (79%) 22/37 (59%) 27/44 (61%) | |FIRST INCIDENCE (DAYS) | 457 (I) 458 (I) 457 (I) 456 (I) | 456 (I) 17 114 302 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001N** P=0.128N P=0.107N P=0.002N** | P=0.003N** P=0.427 P=0.060N P=0.014N* | |INCIDENTAL TUMOR | P<0.001N** P=0.272N P=0.077N P<0.001N** | P=0.310N P=0.526 P=0.167N P=0.333N | |LOGISTIC REGRESSION | P<0.001N** P=0.185N P=0.078N P<0.001N** | P=0.114N P=0.527 P=0.232N P=0.262N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.247N | |FISHER EXACT | P=0.272N P=0.118N P<0.001N** | P=0.424 P=0.354N P=0.354N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 04 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- BENZYL ACETATE 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): 456 (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).