TDMS Study 05120-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Southern Research Inst BENZYL ACETATE DATE: 09/15/94 EXPERIMENT: 05120 TEST: 03 TIME: 14:10:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: DR FARNELL 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: 09/15/94 EXPERIMENT: 05120 TEST: 03 TIME: 14:10:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: DR FARNELL SCOT EUSTIS CAS: 140-11-4 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 Gland Bone Marrow Brain Clitoral Gland Epididymis 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: 09/15/94 EXPERIMENT: 05120 TEST: 03 TIME: 14:10:55 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-55082 ROUTE: DOSED FEED NTP C#: 06508B PATHOLOGIST: DR FARNELL SCOT EUSTIS CAS: 140-11-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF BENZYL ACETATE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Skin Keratoacanthoma All Organs Malignant Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Islets, Pancreatic Adenoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Thyroid Gland: C-Cell Carcinoma Uterus Polyp Stromal Sarcoma Stromal Sarcoma Stromal or Polyp Stromal All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 3/60 (5%) 2/60 (3%) 1/60 (2%) 1/60 (2%) | |ADJUSTED (b) | 2.6% 0.0% 6.2% 0.0% | 8.7% 6.7% 2.5% 2.9% | |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) | 0/27 (0%) 0/34 (0%) 1/30 (3%) 0/33 (0%) | 2/30 (7%) 2/30 (7%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 654 --- 701 --- | 603 731 (T) 725 707 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.449N P=0.495N P=0.520 P=0.500N | P=0.198N P=0.500N P=0.247N P=0.316N | |INCIDENTAL TUMOR | P=0.535N P=0.657N P=0.533 P=0.657N | P=0.188N P=0.550N P=0.402N P=0.301N | |LOGISTIC REGRESSION | P=0.454N P=0.500N P=0.516 P=0.499N | P=0.187N P=0.494N P=0.282N P=0.297N | |COCHRAN-ARMITAGE | P=0.461N | P=0.200N | |FISHER EXACT | P=0.500N P=0.500 P=0.500N | P=0.500N P=0.309N P=0.309N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/60 (28%) 12/60 (20%) 16/60 (27%) 14/60 (23%) | 1/60 (2%) 5/60 (8%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 51.8% 32.2% 45.1% 40.0% | 3.3% 16.1% 2.2% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 12/27 (44%) 10/34 (29%) 11/30 (37%) 12/33 (36%) | 1/30 (3%) 4/30 (13%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 600 457 (I) 633 724 | 731 (T) 726 700 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.270N P=0.075N P=0.389N P=0.158N | P=0.133N P=0.104 P=0.709N P=0.514N | |INCIDENTAL TUMOR | P=0.369N P=0.129N P=0.380N P=0.305N | P=0.110N P=0.114 P=0.737N P=0.514N | |LOGISTIC REGRESSION | P=0.351N P=0.163N P=0.402N P=0.261N | P=0.125N P=0.096 P=0.737N P=0.514N | |COCHRAN-ARMITAGE | P=0.410N | P=0.135N | |FISHER EXACT | P=0.197N P=0.500N P=0.339N | P=0.103 P=0.752N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Complex | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.3% 5.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/27 (0%) 0/34 (0%) 0/30 (0%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 600 618 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183N P=0.506 P=0.482N P=0.495N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.200N P=0.410 P=0.531N P=0.473N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.189N P=0.500 P=0.510N P=0.504N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.188N | (e) | |FISHER EXACT | P=0.500 P=0.500N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 2.8% 5.0% 6.7% 6.1% | 3.3% 3.3% 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) | 0/27 (0%) 1/34 (3%) 2/30 (7%) 2/33 (6%) | 1/30 (3%) 1/30 (3%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 682 504 729 (T) 729 (T) | 731 (T) 731 (T) 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.462 P=0.535 P=0.534 P=0.550 | P=0.314N P=0.762 P=0.715N P=0.514N | |INCIDENTAL TUMOR | P=0.418 P=0.413 P=0.534 P=0.458 | P=0.314N P=0.762 P=0.715N P=0.514N | |LOGISTIC REGRESSION | P=0.432 P=0.499 P=0.522 P=0.516 | P=0.314N P=0.762 P=0.715N P=0.514N | |COCHRAN-ARMITAGE | P=0.423 | P=0.312N | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.752N P=0.752N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/60 (32%) 16/60 (27%) 18/60 (30%) 15/60 (25%) | 2/60 (3%) 6/60 (10%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 54.2% 39.6% 50.9% 42.9% | 6.7% 19.4% 4.8% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 12/27 (44%) 11/34 (32%) 13/30 (43%) 13/33 (39%) | 2/30 (7%) 5/30 (17%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 600 457 (I) 633 724 | 731 (T) 726 700 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165N P=0.175N P=0.379N P=0.117N | P=0.075N P=0.133 P=0.613N P=0.253N | |INCIDENTAL TUMOR | P=0.249N P=0.317N P=0.378N P=0.251N | P=0.062N P=0.144 P=0.636N P=0.253N | |LOGISTIC REGRESSION | P=0.225N P=0.314N P=0.395N P=0.202N | P=0.070N P=0.123 P=0.639N P=0.253N | |COCHRAN-ARMITAGE | P=0.281N | P=0.078N | |FISHER EXACT | P=0.344N P=0.500N P=0.272N | P=0.136 P=0.691N P=0.248N | |=================================================================================================================================| | | |Brain | | Oligodendroglioma, Glioma, or Astrocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 5.2% 0.0% 2.2% | 1.8% 2.9% 2.7% 0.0% | |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) | 0/27 (0%) 1/34 (3%) 0/30 (0%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 600 --- 573 | 457 (I) 710 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.558 P=0.265 (e) P=0.509 | P=0.318N P=0.757N P=0.737N P=0.500N | |INCIDENTAL TUMOR | P=0.571 P=0.265 (e) P=0.527 | P=0.280N P=0.732N P=0.737N P=0.500N | |LOGISTIC REGRESSION | P=0.537 P=0.239 (e) P=0.494 | P=0.318N P=0.760 P=0.750 P=0.551N | |COCHRAN-ARMITAGE | P=0.539 | P=0.312N | |FISHER EXACT | P=0.248 (e) P=0.500 | P=0.752N P=0.752N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 2/60 (3%) 3/60 (5%) 2/60 (3%) | 0/60 (0%) 1/60 (2%) 1/60 (2%) 1/59 (2%) | |ADJUSTED (b) | 9.1% 4.6% 10.0% 6.1% | 0.0% 3.2% 2.7% 3.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/27 (7%) 1/34 (3%) 3/30 (10%) 2/33 (6%) | 0/30 (0%) 0/30 (0%) 1/37 (3%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 456 (I) 729 (T) 729 (T) | --- 726 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.406N P=0.437N P=0.622N P=0.427N | P=0.370 P=0.500 P=0.542 P=0.486 | |INCIDENTAL TUMOR | P=0.406N P=0.437N P=0.622N P=0.427N | P=0.412 P=0.552 P=0.542 P=0.486 | |LOGISTIC REGRESSION | P=0.450N P=0.502N P=0.647N P=0.493N | P=0.371 P=0.502 P=0.542 P=0.486 | |COCHRAN-ARMITAGE | P=0.457N | P=0.380 | |FISHER EXACT | P=0.500N P=0.660N P=0.500N | P=0.500 P=0.500 P=0.496 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/60 (5%) 3/60 (5%) 4/60 (7%) 2/60 (3%) | 1/60 (2%) 2/60 (3%) 1/60 (2%) 1/59 (2%) | |ADJUSTED (b) | 9.1% 7.0% 12.9% 6.1% | 3.3% 6.0% 2.7% 3.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/27 (7%) 1/34 (3%) 3/30 (10%) 2/33 (6%) | 1/30 (3%) 0/30 (0%) 1/37 (3%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 456 (I) 724 729 (T) | 731 (T) 710 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.371N P=0.603N P=0.541 P=0.427N | P=0.549N P=0.503 P=0.715N P=0.747 | |INCIDENTAL TUMOR | P=0.416N P=0.659 P=0.547 P=0.427N | P=0.482N P=0.561 P=0.715N P=0.747 | |LOGISTIC REGRESSION | P=0.412N P=0.661 P=0.522 P=0.493N | P=0.530N P=0.505 P=0.715N P=0.747 | |COCHRAN-ARMITAGE | P=0.421N | P=0.536N | |FISHER EXACT | P=0.660N P=0.500 P=0.500N | P=0.500 P=0.752N P=0.748 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 7.4% 0.0% 2.2% 3.0% | 10.0% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/27 (7%) 0/34 (0%) 0/30 (0%) 1/33 (3%) | 3/30 (10%) 1/30 (3%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 633 729 (T) | 731 (T) 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.467N P=0.189N P=0.459N P=0.430N | P=0.040N* P=0.304N P=0.086N P=0.132N | |INCIDENTAL TUMOR | P=0.461N P=0.189N P=0.493N P=0.430N | P=0.040N* P=0.304N P=0.086N P=0.132N | |LOGISTIC REGRESSION | P=0.490N P=0.189N P=0.483N P=0.430N | P=0.040N* P=0.304N P=0.086N P=0.132N | |COCHRAN-ARMITAGE | P=0.500N | P=0.044N* | |FISHER EXACT | P=0.248N P=0.500N P=0.500N | P=0.309N P=0.122N P=0.122N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | 3/60 (5%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 7.4% 0.0% 2.2% 5.2% | 10.0% 3.3% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 2/27 (7%) 0/34 (0%) 0/30 (0%) 1/33 (3%) | 3/30 (10%) 1/30 (3%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 633 613 | 731 (T) 731 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.504 P=0.189N P=0.459N P=0.632N | P=0.040N* P=0.304N P=0.086N P=0.132N | |INCIDENTAL TUMOR | P=0.513 P=0.189N P=0.493N P=0.626N | P=0.040N* P=0.304N P=0.086N P=0.132N | |LOGISTIC REGRESSION | P=0.477 P=0.189N P=0.483N P=0.683N | P=0.040N* P=0.304N P=0.086N P=0.132N | |COCHRAN-ARMITAGE | P=0.470 | P=0.044N* | |FISHER EXACT | P=0.248N P=0.500N P=0.691N | P=0.309N P=0.122N P=0.122N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 6/60 (10%) 3/60 (5%) 3/60 (5%) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 3/60 (5%) | |ADJUSTED (b) | 18.5% 17.1% 8.0% 9.1% | 5.0% 2.3% 2.2% 8.4% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/27 (15%) 5/34 (15%) 0/30 (0%) 3/33 (9%) | 1/30 (3%) 0/30 (0%) 0/37 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 710 641 729 (T) | 457 (I) 633 700 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.109N P=0.492N P=0.216N P=0.172N | P=0.335 P=0.492N P=0.448N P=0.498 | |INCIDENTAL TUMOR | P=0.130N P=0.542N P=0.231N P=0.167N | P=0.382 P=0.563N P=0.476N P=0.582 | |LOGISTIC REGRESSION | P=0.127N P=0.606N P=0.232N P=0.231N | P=0.324 P=0.503N P=0.513N P=0.499 | |COCHRAN-ARMITAGE | P=0.141N | P=0.325 | |FISHER EXACT | P=0.619N P=0.245N P=0.245N | P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 6/60 (10%) 3/60 (5%) 3/60 (5%) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 4/60 (7%) | |ADJUSTED (b) | 18.5% 17.1% 8.0% 9.1% | 5.0% 2.3% 2.2% 11.1% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/27 (15%) 5/34 (15%) 0/30 (0%) 3/33 (9%) | 1/30 (3%) 0/30 (0%) 0/37 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 710 641 729 (T) | 457 (I) 633 700 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.109N P=0.492N P=0.216N P=0.172N | P=0.172 P=0.492N P=0.448N P=0.339 | |INCIDENTAL TUMOR | P=0.130N P=0.542N P=0.231N P=0.167N | P=0.227 P=0.563N P=0.476N P=0.451 | |LOGISTIC REGRESSION | P=0.127N P=0.606N P=0.232N P=0.231N | P=0.166 P=0.503N P=0.513N P=0.340 | |COCHRAN-ARMITAGE | P=0.141N | P=0.165 | |FISHER EXACT | P=0.619N P=0.245N P=0.245N | P=0.500N P=0.500N P=0.340 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/60 (10%) 6/60 (10%) 3/60 (5%) 3/60 (5%) | 2/60 (3%) 1/60 (2%) 1/60 (2%) 4/60 (7%) | |ADJUSTED (b) | 18.5% 17.1% 8.0% 9.1% | 5.0% 2.3% 2.2% 11.1% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 4/27 (15%) 5/34 (15%) 0/30 (0%) 3/33 (9%) | 1/30 (3%) 0/30 (0%) 0/37 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | 458 (I) 710 641 729 (T) | 457 (I) 633 700 658 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.109N P=0.492N P=0.216N P=0.172N | P=0.172 P=0.492N P=0.448N P=0.339 | |INCIDENTAL TUMOR | P=0.130N P=0.542N P=0.231N P=0.167N | P=0.227 P=0.563N P=0.476N P=0.451 | |LOGISTIC REGRESSION | P=0.127N P=0.606N P=0.232N P=0.231N | P=0.166 P=0.503N P=0.513N P=0.340 | |COCHRAN-ARMITAGE | P=0.141N | P=0.165 | |FISHER EXACT | P=0.619N P=0.245N P=0.245N | P=0.500N P=0.500N P=0.340 | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.4% 0.0% 4.6% 4.7% | 0.0% 0.0% 0.0% 0.0% | |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%) 0/10 (0%) | |TERMINAL (d) | 1/27 (4%) 0/34 (0%) 0/30 (0%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 457 (I) --- 456 (I) 456 (I) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.461 P=0.215N P=0.687N P=0.658N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.430 P=0.215N P=0.677N P=0.658N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.433 P=0.238N P=0.673 P=0.687 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.444 | (e) | |FISHER EXACT | P=0.248N P=0.691N P=0.691N | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/60 (3%) 0/60 (0%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 5.4% 0.0% 4.6% 4.7% | 3.0% 0.0% 0.0% 0.0% | |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%) 0/10 (0%) | |TERMINAL (d) | 1/27 (4%) 0/34 (0%) 0/30 (0%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 457 (I) --- 456 (I) 456 (I) | 721 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.461 P=0.215N P=0.687N P=0.658N | P=0.309N P=0.512N P=0.462N P=0.526N | |INCIDENTAL TUMOR | P=0.430 P=0.215N P=0.677N P=0.658N | P=0.256N P=0.448N P=0.500N P=0.394N | |LOGISTIC REGRESSION | P=0.433 P=0.238N P=0.673 P=0.687 | P=0.298N P=0.497N P=0.471N P=0.498N | |COCHRAN-ARMITAGE | P=0.444 | P=0.306N | |FISHER EXACT | P=0.248N P=0.691N P=0.691N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 12/60 (20%) 17/60 (28%) 12/60 (20%) 18/60 (30%) | |ADJUSTED (b) | 12.0% 5.9% 0.0% 3.0% | 30.3% 44.6% 29.3% 43.5% | |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%) 2/10 (20%) | |TERMINAL (d) | 2/27 (7%) 2/34 (6%) 0/30 (0%) 1/33 (3%) | 4/30 (13%) 10/30 (33%) 8/37 (22%) 7/28 (25%) | |FIRST INCIDENCE (DAYS) | 631 729 (T) --- 729 (T) | 584 430 715 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.273N P=0.053N P=0.146N | P=0.185 P=0.225 P=0.381N P=0.157 | |INCIDENTAL TUMOR | P=0.069N P=0.269N P=0.065N P=0.131N | P=0.318 P=0.250 P=0.575 P=0.307 | |LOGISTIC REGRESSION | P=0.080N P=0.326N P=0.059N P=0.172N | P=0.212 P=0.200 P=0.482N P=0.159 | |COCHRAN-ARMITAGE | P=0.087N | P=0.188 | |FISHER EXACT | P=0.340N P=0.059N P=0.182N | P=0.197 P=0.590N P=0.146 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 12/60 (20%) 17/60 (28%) 12/60 (20%) 18/60 (30%) | |ADJUSTED (b) | 12.0% 5.9% 0.0% 3.0% | 30.3% 44.6% 29.3% 43.5% | |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%) 2/10 (20%) | |TERMINAL (d) | 2/27 (7%) 2/34 (6%) 0/30 (0%) 1/33 (3%) | 4/30 (13%) 10/30 (33%) 8/37 (22%) 7/28 (25%) | |FIRST INCIDENCE (DAYS) | 631 729 (T) --- 729 (T) | 584 430 715 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.273N P=0.053N P=0.146N | P=0.185 P=0.225 P=0.381N P=0.157 | |INCIDENTAL TUMOR | P=0.069N P=0.269N P=0.065N P=0.131N | P=0.318 P=0.250 P=0.575 P=0.307 | |LOGISTIC REGRESSION | P=0.080N P=0.326N P=0.059N P=0.172N | P=0.212 P=0.200 P=0.482N P=0.159 | |COCHRAN-ARMITAGE | P=0.087N | P=0.188 | |FISHER EXACT | P=0.340N P=0.059N P=0.182N | P=0.197 P=0.590N P=0.146 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 12/60 (20%) 17/60 (28%) 13/60 (22%) 18/60 (30%) | |ADJUSTED (b) | 12.0% 5.9% 0.0% 3.0% | 30.3% 44.6% 31.7% 43.5% | |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%) 2/10 (20%) | |TERMINAL (d) | 2/27 (7%) 2/34 (6%) 0/30 (0%) 1/33 (3%) | 4/30 (13%) 10/30 (33%) 9/37 (24%) 7/28 (25%) | |FIRST INCIDENCE (DAYS) | 631 729 (T) --- 729 (T) | 584 430 715 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.071N P=0.273N P=0.053N P=0.146N | P=0.179 P=0.225 P=0.457N P=0.157 | |INCIDENTAL TUMOR | P=0.069N P=0.269N P=0.065N P=0.131N | P=0.309 P=0.250 P=0.486 P=0.307 | |LOGISTIC REGRESSION | P=0.080N P=0.326N P=0.059N P=0.172N | P=0.206 P=0.200 P=0.567N P=0.159 | |COCHRAN-ARMITAGE | P=0.087N | P=0.182 | |FISHER EXACT | P=0.340N P=0.059N P=0.182N | P=0.197 P=0.500 P=0.146 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 1.7% | 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) | 0/27 (0%) 0/34 (0%) 1/30 (3%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 622 431 | --- --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.260 (e) P=0.267 P=0.500 | P=0.696 (e) P=0.542 (e) | |INCIDENTAL TUMOR | P=0.254 (e) P=0.234 P=0.455 | P=0.696 (e) P=0.542 (e) | |LOGISTIC REGRESSION | P=0.240 (e) P=0.243 P=0.455 | P=0.696 (e) P=0.542 (e) | |COCHRAN-ARMITAGE | P=0.246 | P=0.694 | |FISHER EXACT | (e) P=0.248 P=0.500 | (e) P=0.500 (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 4.6% | 3.3% 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) | 0/27 (0%) 0/34 (0%) 1/30 (3%) 1/33 (3%) | 1/30 (3%) 0/30 (0%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 622 431 | 731 (T) --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.097 (e) P=0.267 P=0.262 | P=0.410N P=0.500N P=0.715N P=0.514N | |INCIDENTAL TUMOR | P=0.097 (e) P=0.234 P=0.236 | P=0.410N P=0.500N P=0.715N P=0.514N | |LOGISTIC REGRESSION | P=0.085 (e) P=0.243 P=0.231 | P=0.410N P=0.500N P=0.715N P=0.514N | |COCHRAN-ARMITAGE | P=0.086 | P=0.405N | |FISHER EXACT | (e) P=0.248 P=0.248 | P=0.500N P=0.752N P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 2/60 (3%) 3/60 (5%) 1/59 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.7% 5.9% 10.0% 3.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/27 (4%) 2/34 (6%) 3/30 (10%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.525N P=0.581 P=0.342 P=0.717N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.525N P=0.581 P=0.342 P=0.717N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.525N P=0.581 P=0.342 P=0.717N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.584N | (e) | |FISHER EXACT | P=0.500 P=0.309 P=0.748 | (e) (e) (e) | |=================================================================================================================================| | | |Pharynx | | Squamous Cell Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.4% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/27 (0%) 0/34 (0%) 1/30 (3%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 622 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.615 (e) P=0.267 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.619 (e) P=0.234 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.598 (e) P=0.243 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.595 | (e) | |FISHER EXACT | (e) P=0.248 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/59 (19%) 9/60 (15%) 10/60 (17%) 6/58 (10%) | 38/60 (63%) 34/60 (57%) 31/60 (52%) 33/60 (55%) | |ADJUSTED (b) | 26.8% 25.7% 28.3% 16.2% | 82.3% 78.6% 68.7% 76.2% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/27 (11%) 8/34 (24%) 7/30 (23%) 3/33 (9%) | 22/30 (73%) 21/30 (70%) 23/37 (62%) 18/28 (64%) | |FIRST INCIDENCE (DAYS) | 456 (I) 710 458 (I) 644 | 458 (I) 430 592 582 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.099N P=0.286N P=0.430N P=0.116N | P=0.273N P=0.303N P=0.020N* P=0.332N | |INCIDENTAL TUMOR | P=0.147N P=0.425N P=0.456N P=0.251N | P=0.074N P=0.248N P=0.118N P=0.075N | |LOGISTIC REGRESSION | P=0.133N P=0.383N P=0.479N P=0.154N | P=0.094N P=0.234N P=0.039N* P=0.130N | |COCHRAN-ARMITAGE | P=0.145N | P=0.214N | |FISHER EXACT | P=0.387N P=0.483N P=0.156N | P=0.288N P=0.134N P=0.229N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/59 (19%) 9/60 (15%) 10/60 (17%) 6/58 (10%) | 39/60 (65%) 35/60 (58%) 31/60 (52%) 33/60 (55%) | |ADJUSTED (b) | 26.8% 25.7% 28.3% 16.2% | 84.5% 81.0% 68.7% 76.2% | |INTERIM SACRIFICE 1 (c)| 3/10 (30%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 3/27 (11%) 8/34 (24%) 7/30 (23%) 3/33 (9%) | 23/30 (77%) 22/30 (73%) 23/37 (62%) 18/28 (64%) | |FIRST INCIDENCE (DAYS) | 456 (I) 710 458 (I) 644 | 458 (I) 430 592 582 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.099N P=0.286N P=0.430N P=0.116N | P=0.212N P=0.301N P=0.013N* P=0.280N | |INCIDENTAL TUMOR | P=0.147N P=0.425N P=0.456N P=0.251N | P=0.044N* P=0.243N P=0.075N P=0.048N* | |LOGISTIC REGRESSION | P=0.133N P=0.383N P=0.479N P=0.154N | P=0.056N P=0.226N P=0.023N* P=0.087N | |COCHRAN-ARMITAGE | P=0.145N | P=0.155N | |FISHER EXACT | P=0.387N P=0.483N P=0.156N | P=0.287N P=0.097N P=0.176N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/59 (0%) 0/60 (0%) 0/60 (0%) 0/58 (0%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.3% 0.0% 5.0% 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) | 0/27 (0%) 0/34 (0%) 0/30 (0%) 0/33 (0%) | 1/30 (3%) 0/30 (0%) 1/37 (3%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 731 (T) --- 711 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.470N P=0.500N P=0.579 P=0.514N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.426N P=0.500N P=0.548 P=0.514N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.455N P=0.500N P=0.557 P=0.514N | |COCHRAN-ARMITAGE | (e) | P=0.461N | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 15.3% 0.0% 2.9% 0.0% | 0.0% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/27 (4%) 0/34 (0%) 0/30 (0%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 705 --- 701 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.017N* P=0.027N* P=0.109N P=0.028N* | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.025N* P=0.088N P=0.073N P=0.089N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.016N* P=0.028N* P=0.088N P=0.028N* | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.018N* | (e) | |FISHER EXACT | P=0.029N* P=0.103N P=0.029N* | (e) (e) (e) | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Skin | | Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, | | Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 1/60 (2%) 1/60 (2%) 1/60 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 15.3% 2.9% 2.9% 2.7% | 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) | 1/27 (4%) 1/34 (3%) 0/30 (0%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 705 729 (T) 701 686 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.067N P=0.081N P=0.109N P=0.089N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.108N P=0.212N P=0.073N P=0.274N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.065N P=0.090N P=0.088N P=0.254N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.072N | (e) | |FISHER EXACT | P=0.103N P=0.103N P=0.103N | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 4/60 (7%) 2/60 (3%) 3/60 (5%) 3/60 (5%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 12.6% 5.2% 7.6% 8.7% | 3.3% 0.0% 5.4% 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) | 0/27 (0%) 1/34 (3%) 0/30 (0%) 2/33 (6%) | 1/30 (3%) 0/30 (0%) 2/37 (5%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 705 600 641 715 | 731 (T) --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.466N P=0.294N P=0.491N P=0.434N | P=0.470N P=0.500N P=0.573 P=0.514N | |INCIDENTAL TUMOR | P=0.543 P=0.570N P=0.469N P=0.557 | P=0.470N P=0.500N P=0.573 P=0.514N | |LOGISTIC REGRESSION | P=0.483N P=0.325N P=0.470N P=0.467N | P=0.470N P=0.500N P=0.573 P=0.514N | |COCHRAN-ARMITAGE | P=0.500N | P=0.461N | |FISHER EXACT | P=0.340N P=0.500N P=0.500N | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Fibrosarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/60 (0%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 0.0% 2.9% 0.0% 5.1% | 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) | 0/27 (0%) 1/34 (3%) 0/30 (0%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | --- 729 (T) --- 539 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.156 P=0.546 (e) P=0.267 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.146 P=0.546 (e) P=0.236 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.141 P=0.546 (e) P=0.236 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.140 | (e) | |FISHER EXACT | P=0.500 (e) P=0.248 | (e) (e) (e) | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, Sarcoma, | | Neurofibroma, or Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/60 (8%) 3/60 (5%) 3/60 (5%) 5/60 (8%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 0/60 (0%) | |ADJUSTED (b) | 14.9% 8.1% 7.6% 13.5% | 3.3% 0.0% 5.4% 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) | 0/27 (0%) 2/34 (6%) 0/30 (0%) 3/33 (9%) | 1/30 (3%) 0/30 (0%) 2/37 (5%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 654 600 641 539 | 731 (T) --- 731 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.541 P=0.303N P=0.347N P=0.557N | P=0.470N P=0.500N P=0.573 P=0.514N | |INCIDENTAL TUMOR | P=0.372 P=0.603N P=0.309N P=0.347 | P=0.470N P=0.500N P=0.573 P=0.514N | |LOGISTIC REGRESSION | P=0.515 P=0.343N P=0.165N P=0.611N | P=0.470N P=0.500N P=0.573 P=0.514N | |COCHRAN-ARMITAGE | P=0.500 | P=0.461N | |FISHER EXACT | P=0.359N P=0.359N P=0.628N | P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Skin: Subcutaneous Tissue | | Neurofibrosarcoma, Fibrosarcoma, or Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 2/60 (3%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 2.6% 2.9% 0.0% 5.1% | 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) | 0/27 (0%) 1/34 (3%) 0/30 (0%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 654 729 (T) --- 539 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.389 P=0.732N P=0.480N P=0.528 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.333 P=0.707 P=0.483N P=0.409 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.368 P=0.758N P=0.500N P=0.499 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.367 | (e) | |FISHER EXACT | P=0.752N P=0.500N P=0.500 | (e) (e) (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 57/60 (95%) 58/60 (97%) 60/60 (100%) 59/60 (98%) | | |ADJUSTED (b) | 98.2% 98.3% 100.0% 100.0% | | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%)| | |TERMINAL (d) | 26/27 (96%) 33/34 (97%) 30/30 (100%) 33/33 (100%)| | |FIRST INCIDENCE (DAYS) | 456 (I) 396 456 (I) 431 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.352N P=0.199N P=0.497N P=0.271N | | |INCIDENTAL TUMOR | P=0.183 P=0.526 P=0.121 P=0.413 | | |LOGISTIC REGRESSION | P=0.162 P=0.499 P=0.113 P=0.293 | | |COCHRAN-ARMITAGE | P=0.164 | | |FISHER EXACT | P=0.500 P=0.122 P=0.309 | | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/60 (15%) 4/59 (7%) 7/60 (12%) 7/58 (12%) | 4/60 (7%) 4/60 (7%) 9/60 (15%) 5/60 (8%) | |ADJUSTED (b) | 26.2% 10.7% 23.3% 20.5% | 11.1% 11.0% 21.9% 16.7% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 5/27 (19%) 2/34 (6%) 7/30 (23%) 6/33 (18%) | 2/30 (7%) 2/30 (7%) 6/37 (16%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | 457 (I) 618 729 (T) 715 | 606 458 (I) 700 704 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.397N P=0.082N P=0.320N P=0.277N | P=0.332 P=0.635N P=0.221 P=0.474 | |INCIDENTAL TUMOR | P=0.479N P=0.147N P=0.328N P=0.423N | P=0.415 P=0.640 P=0.118 P=0.520 | |LOGISTIC REGRESSION | P=0.479N P=0.117N P=0.348N P=0.391N | P=0.374 P=0.641N P=0.162 P=0.517 | |COCHRAN-ARMITAGE | P=0.510N | P=0.353 | |FISHER EXACT | P=0.126N P=0.395N P=0.423N | P=0.641N P=0.120 P=0.500 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/60 (2%) 1/59 (2%) 5/60 (8%) 1/58 (2%) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | |ADJUSTED (b) | 3.7% 2.9% 15.4% 3.0% | 0.0% 0.0% 0.0% 7.1% | |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) | 1/27 (4%) 1/34 (3%) 4/30 (13%) 1/33 (3%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 2/28 (7%) | |FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 668 729 (T) | --- --- --- 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.551 P=0.710N P=0.129 P=0.717N | P=0.038 * (e) (e) P=0.223 | |INCIDENTAL TUMOR | P=0.516 P=0.710N P=0.128 P=0.717N | P=0.038 * (e) (e) P=0.223 | |LOGISTIC REGRESSION | P=0.513 P=0.710N P=0.116 P=0.717N | P=0.038 * (e) (e) P=0.223 | |COCHRAN-ARMITAGE | P=0.488 | P=0.046 * | |FISHER EXACT | P=0.748 P=0.103 P=0.744 | (e) (e) P=0.248 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/60 (17%) 5/59 (8%) 12/60 (20%) 8/58 (14%) | 4/60 (7%) 4/60 (7%) 9/60 (15%) 7/60 (12%) | |ADJUSTED (b) | 29.6% 13.5% 38.2% 23.4% | 11.1% 11.0% 21.9% 23.6% | |INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 6/27 (22%) 3/34 (9%) 11/30 (37%) 7/33 (21%) | 2/30 (7%) 2/30 (7%) 6/37 (16%) 6/28 (21%) | |FIRST INCIDENCE (DAYS) | 457 (I) 618 668 715 | 606 458 (I) 700 704 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.430N P=0.084N P=0.504 P=0.268N | P=0.137 P=0.635N P=0.221 P=0.238 | |INCIDENTAL TUMOR | P=0.524N P=0.147N P=0.495 P=0.406N | P=0.191 P=0.640 P=0.118 P=0.269 | |LOGISTIC REGRESSION | P=0.528N P=0.129N P=0.466 P=0.393N | P=0.166 P=0.641N P=0.162 P=0.275 | |COCHRAN-ARMITAGE | P=0.534 | P=0.154 | |FISHER EXACT | P=0.142N P=0.407 P=0.430N | P=0.641N P=0.120 P=0.264 | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/60 (0%) 0/59 (0%) 0/60 (0%) 0/58 (0%) | 1/60 (2%) 0/60 (0%) 2/60 (3%) 1/60 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.3% 0.0% 5.4% 3.6% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 0/27 (0%) 0/34 (0%) 0/30 (0%) 0/33 (0%) | 1/30 (3%) 0/30 (0%) 2/37 (5%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 731 (T) --- 731 (T) 731 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.488 P=0.500N P=0.573 P=0.747 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.488 P=0.500N P=0.573 P=0.747 | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.488 P=0.500N P=0.573 P=0.747 | |COCHRAN-ARMITAGE | (e) | P=0.500 | |FISHER EXACT | (e) (e) (e) | P=0.500N P=0.500 P=0.752N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Uterus | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | | 6.2% 0.0% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 1/30 (3%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | | 710 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.111N P=0.237N P=0.190N P=0.261N | |INCIDENTAL TUMOR | | P=0.096N P=0.211N P=0.217N P=0.189N | |LOGISTIC REGRESSION | | P=0.108N P=0.234N P=0.206N P=0.234N | |COCHRAN-ARMITAGE | | P=0.115N | |FISHER EXACT | | P=0.248N P=0.248N P=0.248N | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 15/60 (25%) 18/60 (30%) 4/60 (7%) 11/60 (18%) | |ADJUSTED (b) | | 41.1% 44.7% 10.2% 28.1% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 3/10 (30%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | | 10/30 (33%) 10/30 (33%) 3/37 (8%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | | 457 (I) 456 (I) 711 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.088N P=0.351 P=0.002N** P=0.303N | |INCIDENTAL TUMOR | | P=0.045N* P=0.389 P=0.002N** P=0.161N | |LOGISTIC REGRESSION | | P=0.069N P=0.347 P=0.004N** P=0.235N | |COCHRAN-ARMITAGE | | P=0.078N | |FISHER EXACT | | P=0.342 P=0.005N** P=0.253N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) | |ADJUSTED (b) | | 0.0% 0.0% 1.7% 5.6% | |INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | | 0/30 (0%) 0/30 (0%) 0/37 (0%) 1/28 (4%) | |FIRST INCIDENCE (DAYS) | | --- --- 367 631 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.071 (e) P=0.500 P=0.244 | |INCIDENTAL TUMOR | | P=0.019 * (e) P=0.419 P=0.196 | |LOGISTIC REGRESSION | | P=0.062 (e) P=0.419 P=0.242 | |COCHRAN-ARMITAGE | | P=0.070 | |FISHER EXACT | | (e) P=0.500 P=0.248 | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 15/60 (25%) 18/60 (30%) 5/60 (8%) 12/60 (20%) | |ADJUSTED (b) | | 41.1% 44.7% 11.7% 29.6% | |INTERIM SACRIFICE 1 (c)| | 2/10 (20%) 3/10 (30%) 0/10 (0%) 1/10 (10%) | |TERMINAL (d) | | 10/30 (33%) 10/30 (33%) 3/37 (8%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | | 457 (I) 456 (I) 367 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.144N P=0.351 P=0.005N** P=0.378N | |INCIDENTAL TUMOR | | P=0.101N P=0.389 P=0.007N** P=0.237N | |LOGISTIC REGRESSION | | P=0.121N P=0.347 P=0.003N** P=0.311N | |COCHRAN-ARMITAGE | | P=0.130N | |FISHER EXACT | | P=0.342 P=0.013N* P=0.331N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |Zymbal's Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) | 1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.7% 0.0% 1.7% 2.4% | 2.1% 4.1% 0.0% 0.0% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 1/27 (4%) 0/34 (0%) 0/30 (0%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) --- 456 (I) 631 | 525 487 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.554 P=0.454N P=0.749N P=0.735N | P=0.184N P=0.500 P=0.500N P=0.492N | |INCIDENTAL TUMOR | P=0.560 P=0.454N P=0.749N P=0.723N | P=0.444N P=0.432 P=0.581N (e) | |LOGISTIC REGRESSION | P=0.533 P=0.454N P=0.750 P=0.758N | P=0.308N P=0.494 P=0.511N P=0.527N | |COCHRAN-ARMITAGE | P=0.539 | P=0.188N | |FISHER EXACT | P=0.500N P=0.752N P=0.752N | P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, | | or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 16/60 (27%) 19/60 (32%) 18/60 (30%) 15/60 (25%) | 9/60 (15%) 6/60 (10%) 12/60 (20%) 12/60 (20%) | |ADJUSTED (b) | 40.4% 42.6% 41.3% 34.4% | 24.3% 14.8% 27.1% 30.0% | |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) | 6/27 (22%) 10/34 (29%) 6/30 (20%) 6/33 (18%) | 5/30 (17%) 1/30 (3%) 6/37 (16%) 4/28 (14%) | |FIRST INCIDENCE (DAYS) | 542 396 457 431 | 420 584 521 593 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.303N P=0.503 P=0.525 P=0.375N | P=0.159 P=0.288N P=0.502 P=0.319 | |INCIDENTAL TUMOR | P=0.483N P=0.267 P=0.385 P=0.480 | P=0.190 P=0.265N P=0.376 P=0.369 | |LOGISTIC REGRESSION | P=0.378N P=0.280 P=0.462 P=0.510N | P=0.197 P=0.286N P=0.364 P=0.332 | |COCHRAN-ARMITAGE | P=0.386N | P=0.150 | |FISHER EXACT | P=0.344 P=0.420 P=0.500N | P=0.291N P=0.316 P=0.316 | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/60 (2%) 3/60 (5%) 2/60 (3%) 0/60 (0%) | 1/60 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | |ADJUSTED (b) | 3.7% 7.8% 5.8% 0.0% | 2.1% 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) | 1/27 (4%) 1/34 (3%) 1/30 (3%) 0/33 (0%) | 0/30 (0%) 0/30 (0%) 0/37 (0%) 0/28 (0%) | |FIRST INCIDENCE (DAYS) | 729 (T) 600 674 --- | 560 --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.222N P=0.352 P=0.537 P=0.460N | P=0.301N P=0.500N P=0.496N P=0.492N | |INCIDENTAL TUMOR | P=0.260N P=0.278 P=0.534 P=0.460N | P=0.377N P=0.612N P=0.872N P=0.567N | |LOGISTIC REGRESSION | P=0.234N P=0.311 P=0.521 P=0.460N | P=0.317N P=0.503N P=0.513N P=0.519N | |COCHRAN-ARMITAGE | P=0.242N | P=0.306N | |FISHER EXACT | P=0.309 P=0.500 P=0.500N | P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 60/60 (100%) 59/60 (98%) 60/60 (100%) 60/60 (100%)| 47/60 (78%) 45/60 (75%) 39/60 (65%) 47/60 (78%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 92.1% 91.7% 84.7% 93.9% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%)| 4/10 (40%) 4/10 (40%) 0/10 (0%) 3/10 (30%) | |TERMINAL (d) | 27/27 (100%) 34/34 (100%) 30/30 (100%) 33/33 (100%)| 26/30 (87%) 26/30 (87%) 30/37 (81%) 25/28 (89%) | |FIRST INCIDENCE (DAYS) | 456 (I) 396 456 (I) 431 | 457 (I) 430 592 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.247N P=0.115N P=0.316N P=0.173N | P=0.493 P=0.418N P=0.007N** P=0.471 | |INCIDENTAL TUMOR | P=0.567 P=0.500N (e) (e) | P=0.240N P=0.361N P=0.036N* P=0.266N | |LOGISTIC REGRESSION | P=0.577 P=0.542N (e) (e) | P=0.371N P=0.378N P=0.012N* P=0.466N | |COCHRAN-ARMITAGE | P=0.567 | P=0.520N | |FISHER EXACT | P=0.500N P=1.000N P=1.000N | P=0.415N P=0.078N P=0.588N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BENZYL ACETATE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | 0% 0.3% 0.6% 1.2% | 0% 0.3% 0.6% 1.2% | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 20/60 (33%) 29/60 (48%) 29/60 (48%) 24/60 (40%) | 15/60 (25%) 14/60 (23%) 18/60 (30%) 18/60 (30%) | |ADJUSTED (b) | 49.0% 60.1% 59.5% 50.2% | 37.9% 31.4% 39.0% 44.8% | |INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | |TERMINAL (d) | 8/27 (30%) 15/34 (44%) 11/30 (37%) 10/33 (30%) | 8/30 (27%) 3/30 (10%) 10/37 (27%) 8/28 (29%) | |FIRST INCIDENCE (DAYS) | 542 396 456 (I) 431 | 420 487 367 593 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.529 P=0.215 P=0.178 P=0.466 | P=0.247 P=0.489N P=0.573 P=0.330 | |INCIDENTAL TUMOR | P=0.242 P=0.018 * P=0.044 * P=0.153 | P=0.207 P=0.456N P=0.419 P=0.349 | |LOGISTIC REGRESSION | P=0.356 P=0.036 * P=0.051 P=0.240 | P=0.282 P=0.519N P=0.377 P=0.365 | |COCHRAN-ARMITAGE | P=0.379 | P=0.238 | |FISHER EXACT | P=0.068 P=0.068 P=0.285 | P=0.500N P=0.342 P=0.342 | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 60/60 (100%) 59/60 (98%) 60/60 (100%) 60/60 (100%)| 53/60 (88%) 51/60 (85%) 45/60 (75%) 52/60 (87%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 98.1% 94.4% 90.0% 98.1% | |INTERIM SACRIFICE 1 (c)| 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%)| 5/10 (50%) 4/10 (40%) 0/10 (0%) 3/10 (30%) | |TERMINAL (d) | 27/27 (100%) 34/34 (100%) 30/30 (100%) 33/33 (100%)| 29/30 (97%) 27/30 (90%) 32/37 (86%) 27/28 (96%) | |FIRST INCIDENCE (DAYS) | 456 (I) 396 456 (I) 431 | 420 430 367 456 (I) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.247N P=0.115N P=0.316N P=0.173N | P=0.497N P=0.419N P=0.006N** P=0.526 | |INCIDENTAL TUMOR | P=0.567 P=0.500N (e) (e) | P=0.323N P=0.376N P=0.021N* P=0.343N | |LOGISTIC REGRESSION | P=0.577 P=0.542N (e) (e) | P=0.259N P=0.364N P=0.009N** P=0.337N | |COCHRAN-ARMITAGE | P=0.567 | P=0.418N | |FISHER EXACT | P=0.500N P=1.000N P=1.000N | P=0.395N P=0.049N* P=0.500N | |=================================================================================================================================| DATE: 09/16/94 EXPERIMENT: 05120 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 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).