TDMS Study 05210-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: I. I. T. Research Inst ETHYLBENZENE DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 TIME: 12:05:20 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-75193 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56393 PATHOLOGIST: BRENNECKE, LUK CAS: 100-41-4 ------------------------------------------------------------------------------------------------------------------------------------ CORE STUDY REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: I. I. T. Research Inst ETHYLBENZENE DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 TIME: 12:05:20 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75193 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56393 PATHOLOGIST: BRENNECKE, LUK CAS: 100-41-4 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 Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: I. I. T. Research Inst ETHYLBENZENE DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 TIME: 12:05:20 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-75193 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56393 PATHOLOGIST: BRENNECKE, LUK CAS: 100-41-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF ETHYLBENZENE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Clitoral/Preputial Gland Adenoma Carcinoma or Adenoma Islets, Pancreatic Adenoma Kidney: Renal Tubule Adenoma Carcinoma Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ All Organs Malignant Tumors ==================================================================================================== DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 13/50 (26%) 9/49 (18%) 12/48 (25%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 48.8% 62.0% 42.6% 100.0% | 6.5% 5.6% 0.0% 0.0% | |TERMINAL (d) | 4/15 (27%) 7/14 (50%) 4/13 (31%) 2/2 (100%) | 2/31 (6%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 584 584 590 546 | 734 (T) 719 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.003 ** P=0.545 P=0.279N P=0.014 * | P=0.112N P=0.677N P=0.218N P=0.212N | |INCIDENTAL TUMOR | P=0.296 P=0.514 P=0.233N P=0.447 | P=0.116N P=0.658 P=0.218N P=0.212N | |LOGISTIC REGRESSION | P=0.211 P=0.552 P=0.233N P=0.307 | P=0.108N P=0.686N P=0.218N P=0.212N | |COCHRAN-ARMITAGE | P=0.516N | P=0.124N | |FISHER EXACT | P=0.590N P=0.251N P=0.547N | P=0.691N P=0.247N P=0.253N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/48 (4%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 7.1% 0.0% 5.2% | 0.0% 3.2% 5.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/14 (7%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 1/31 (3%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 734 (T) --- 507 | --- 734 (T) 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.060 P=0.486 (e) P=0.216 | P=0.480N P=0.500 P=0.254 (e) | |INCIDENTAL TUMOR | P=0.144 P=0.486 (e) P=0.361 | P=0.506N P=0.500 P=0.213 (e) | |LOGISTIC REGRESSION | P=0.161 P=0.486 (e) P=0.290 | P=0.514N P=0.500 P=0.234 (e) | |COCHRAN-ARMITAGE | P=0.143 | P=0.521N | |FISHER EXACT | P=0.500 (e) P=0.237 | P=0.500 P=0.247 (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 13/50 (26%) 9/49 (18%) 14/48 (29%) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 48.8% 62.0% 42.6% 100.0% | 6.5% 8.6% 5.0% 0.0% | |TERMINAL (d) | 4/15 (27%) 7/14 (50%) 4/13 (31%) 2/2 (100%) | 2/31 (6%) 1/31 (3%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 584 584 590 507 | 734 (T) 719 659 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.545 P=0.279N P=0.005 ** | P=0.101N P=0.516 P=0.664N P=0.212N | |INCIDENTAL TUMOR | P=0.152 P=0.514 P=0.233N P=0.312 | P=0.108N P=0.464 P=0.694 P=0.212N | |LOGISTIC REGRESSION | P=0.106 P=0.552 P=0.233N P=0.214 | P=0.105N P=0.514 P=0.678N P=0.212N | |COCHRAN-ARMITAGE | P=0.379 | P=0.120N | |FISHER EXACT | P=0.590N P=0.251N P=0.450 | P=0.500 P=0.691N P=0.253N | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 1/49 (2%) 4/50 (8%) | 2/47 (4%) 0/49 (0%) 0/48 (0%) 0/47 (0%) | |ADJUSTED (b) | 12.5% 2.3% 7.7% 42.7% | 6.9% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/14 (7%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 2/29 (7%) 0/30 (0%) 0/32 (0%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 574 560 734 (T) 500 | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.048 * P=0.318N P=0.314N P=0.172 | P=0.221N P=0.230N P=0.216N P=0.204N | |INCIDENTAL TUMOR | P=0.260 P=0.300N P=0.328N P=0.566 | P=0.221N P=0.230N P=0.216N P=0.204N | |LOGISTIC REGRESSION | P=0.228 P=0.291N P=0.302N P=0.502 | P=0.221N P=0.230N P=0.216N P=0.204N | |COCHRAN-ARMITAGE | P=0.227 | P=0.244N | |FISHER EXACT | P=0.301N P=0.309N P=0.511 | P=0.237N P=0.242N P=0.247N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 1/49 (2%) 4/50 (8%) | 3/47 (6%) 0/49 (0%) 1/48 (2%) 0/47 (0%) | |ADJUSTED (b) | 12.5% 2.3% 7.7% 42.7% | 10.3% 0.0% 3.1% 0.0% | |TERMINAL (d) | 1/14 (7%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 3/29 (10%) 0/30 (0%) 1/32 (3%) 0/34 (0%) | |FIRST INCIDENCE (DAYS) | 574 560 734 (T) 500 | 734 (T) --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.048 * P=0.318N P=0.314N P=0.172 | P=0.137N P=0.114N P=0.269N P=0.094N | |INCIDENTAL TUMOR | P=0.260 P=0.300N P=0.328N P=0.566 | P=0.137N P=0.114N P=0.269N P=0.094N | |LOGISTIC REGRESSION | P=0.228 P=0.291N P=0.302N P=0.502 | P=0.137N P=0.114N P=0.268N P=0.094N | |COCHRAN-ARMITAGE | P=0.227 | P=0.162N | |FISHER EXACT | P=0.301N P=0.309N P=0.511 | P=0.113N P=0.301N P=0.121N | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 16.0% 17.5% 22.5% 60.5% | 3.2% 0.0% 2.8% 2.3% | |TERMINAL (d) | 1/15 (7%) 1/14 (7%) 2/13 (15%) 1/2 (50%) | 1/31 (3%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 692 560 671 645 | 734 (T) --- 699 655 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.033 * P=0.492 P=0.477 P=0.043 * | P=0.580 P=0.500N P=0.744N P=0.736N | |INCIDENTAL TUMOR | P=0.323 P=0.472 P=0.545 P=0.298 | P=0.552 P=0.500N P=0.760 P=0.758N | |LOGISTIC REGRESSION | P=0.220 P=0.483 P=0.509 P=0.163 | P=0.546 P=0.500N P=0.750N P=0.763N | |COCHRAN-ARMITAGE | P=0.493 | P=0.539 | |FISHER EXACT | P=0.500 P=0.500 P=0.500 | P=0.500N P=0.753N P=0.747 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 8.6% 7.1% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 1/14 (7%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 590 734 (T) --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.308N P=0.504N P=0.244N P=0.449N | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.189N P=0.512N P=0.242N P=0.187N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.201N P=0.510N P=0.238N P=0.267N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.169N | (e) | |FISHER EXACT | P=0.500N P=0.247N P=0.247N | (e) (e) (e) | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 5/50 (10%) 4/50 (8%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 23.3% 23.9% 22.5% 60.5% | 3.2% 0.0% 2.8% 2.3% | |TERMINAL (d) | 1/15 (7%) 2/14 (14%) 2/13 (15%) 1/2 (50%) | 1/31 (3%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 590 560 671 645 | 734 (T) --- 699 655 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.116 P=0.617 P=0.523N P=0.152 | P=0.580 P=0.500N P=0.744N P=0.736N | |INCIDENTAL TUMOR | P=0.581 P=0.600 P=0.462N P=0.643N | P=0.552 P=0.500N P=0.760 P=0.758N | |LOGISTIC REGRESSION | P=0.464 P=0.612 P=0.492N P=0.462 | P=0.546 P=0.500N P=0.750N P=0.763N | |COCHRAN-ARMITAGE | P=0.429N | P=0.539 | |FISHER EXACT | P=0.630N P=0.500N P=0.500N | P=0.500N P=0.753N P=0.747 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 11.2% 11.0% 56.9% | 0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/13 (8%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- 617 671 587 | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.006 ** P=0.120 P=0.236 P=0.008 ** | P=0.232 (e) (e) P=0.524 | |INCIDENTAL TUMOR | P=0.095 P=0.126 P=0.251 P=0.033 * | P=0.232 (e) (e) P=0.524 | |LOGISTIC REGRESSION | P=0.064 P=0.119 P=0.240 P=0.037 * | P=0.232 (e) (e) P=0.524 | |COCHRAN-ARMITAGE | P=0.109 | P=0.210 | |FISHER EXACT | P=0.121 P=0.247 P=0.059 | (e) (e) P=0.495 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.7% 12.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 734 (T) 587 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.002 ** (e) P=0.471 P=0.063 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.016 * (e) P=0.471 P=0.177 | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.018 * (e) P=0.471 P=0.129 | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.021 * | (e) | |FISHER EXACT | (e) P=0.500 P=0.121 | (e) (e) (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 11.2% 18.4% 62.4% | 0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 2/13 (15%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- 617 671 587 | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.120 P=0.111 P<0.001 ** | P=0.232 (e) (e) P=0.524 | |INCIDENTAL TUMOR | P=0.005 ** P=0.126 P=0.118 P=0.007 ** | P=0.232 (e) (e) P=0.524 | |LOGISTIC REGRESSION | P=0.003 ** P=0.119 P=0.121 P=0.006 ** | P=0.232 (e) (e) P=0.524 | |COCHRAN-ARMITAGE | P=0.007 ** | P=0.210 | |FISHER EXACT | P=0.121 P=0.121 P=0.006 ** | (e) (e) P=0.495 | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 9.7% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 560 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.326N P=0.112 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.208N P=0.126 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.246N P=0.125 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.259N | (e) | |FISHER EXACT | P=0.121 (e) (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 12.2% 5.3% 0.0% 10.0% | 3.2% 3.2% 2.9% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 1/31 (3%) 1/31 (3%) 1/34 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 714 713 --- 679 | 734 (T) 734 (T) 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.521 P=0.495N P=0.270N P=0.532 | P=0.295N P=0.762 P=0.741N P=0.476N | |INCIDENTAL TUMOR | P=0.555N P=0.544N P=0.227N P=0.660N | P=0.295N P=0.762 P=0.741N P=0.476N | |LOGISTIC REGRESSION | P=0.664 P=0.511N P=0.236N P=0.688 | P=0.295N P=0.762 P=0.741N P=0.476N | |COCHRAN-ARMITAGE | P=0.500N | P=0.327N | |FISHER EXACT | P=0.500N P=0.247N P=0.500N | P=0.753N P=0.753N P=0.505N | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) | |ADJUSTED (b) | 18.4% 5.3% 0.0% 10.0% | 3.2% 3.2% 2.9% 0.0% | |TERMINAL (d) | 2/15 (13%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 1/31 (3%) 1/31 (3%) 1/34 (3%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 714 713 --- 679 | 734 (T) 734 (T) 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.643 P=0.309N P=0.146N P=0.593 | P=0.295N P=0.762 P=0.741N P=0.476N | |INCIDENTAL TUMOR | P=0.458N P=0.346N P=0.122N P=0.595N | P=0.295N P=0.762 P=0.741N P=0.476N | |LOGISTIC REGRESSION | P=0.635N P=0.310N P=0.119N P=0.740N | P=0.295N P=0.762 P=0.741N P=0.476N | |COCHRAN-ARMITAGE | P=0.339N | P=0.327N | |FISHER EXACT | P=0.309N P=0.121N P=0.309N | P=0.753N P=0.753N P=0.505N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 0.0% 3.0% 0.0% | 2.4% 6.5% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 2/31 (6%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- --- 643 --- | 651 734 (T) --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.807 (e) P=0.519 (e) | P=0.515N P=0.488 P=0.491N P=0.742N | |INCIDENTAL TUMOR | P=0.721N (e) P=0.443 (e) | P=0.523N P=0.477 P=0.519N P=0.758N | |LOGISTIC REGRESSION | P=0.796N (e) P=0.500 (e) | P=0.533N P=0.512 P=0.513N P=0.765N | |COCHRAN-ARMITAGE | P=0.786N | P=0.558N | |FISHER EXACT | (e) P=0.500 (e) | P=0.500 P=0.500N P=0.747 | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 9.2% 3.2% 4.5% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 2/31 (6%) 1/31 (3%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- --- --- --- | 704 734 (T) 502 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) (e) | P=0.306N P=0.301N P=0.471N P=0.263N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.347N P=0.324N P=0.475N P=0.283N | |LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.353N P=0.295N P=0.511N P=0.266N | |COCHRAN-ARMITAGE | (e) | P=0.351N | |FISHER EXACT | (e) (e) (e) | P=0.309N P=0.500N P=0.316N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 2/49 (4%) | |ADJUSTED (b) | 0.0% 0.0% 3.0% 0.0% | 11.4% 6.5% 4.5% 5.7% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 2/31 (6%) 2/31 (6%) 0/34 (0%) 2/35 (6%) | |FIRST INCIDENCE (DAYS) | --- --- 643 --- | 651 734 (T) 502 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.807 (e) P=0.519 (e) | P=0.327N P=0.342N P=0.313N P=0.290N | |INCIDENTAL TUMOR | P=0.721N (e) P=0.443 (e) | P=0.368N P=0.369N P=0.323N P=0.315N | |LOGISTIC REGRESSION | P=0.796N (e) P=0.500 (e) | P=0.378N P=0.322N P=0.349N P=0.303N | |COCHRAN-ARMITAGE | P=0.786N | P=0.385N | |FISHER EXACT | (e) P=0.500 (e) | P=0.339N P=0.339N P=0.349N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | 19/50 (38%) 19/50 (38%) 21/50 (42%) 21/49 (43%) | |ADJUSTED (b) | 13.3% 21.4% 13.8% 0.0% | 55.8% 49.7% 55.0% 53.8% | |TERMINAL (d) | 2/15 (13%) 3/14 (21%) 1/13 (8%) 0/2 (0%) | 16/31 (52%) 12/31 (39%) 17/34 (50%) 17/35 (49%) | |FIRST INCIDENCE (DAYS) | 734 (T) 734 (T) 720 --- | 687 609 651 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.547N P=0.467 P=0.657 P=0.726N | P=0.512N P=0.564N P=0.561 P=0.541N | |INCIDENTAL TUMOR | P=0.414N P=0.467 P=0.681 P=0.726N | P=0.530 P=0.566 P=0.516 P=0.557 | |LOGISTIC REGRESSION | P=0.503N P=0.467 P=0.681 P=0.726N | P=0.549N P=0.554N P=0.509 P=0.543N | |COCHRAN-ARMITAGE | P=0.116N | P=0.333 | |FISHER EXACT | P=0.500 P=0.691N P=0.247N | P=0.582N P=0.419 P=0.387 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 7.2% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 549 --- --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.495N P=0.240 (e) (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.320N P=0.235 (e) (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.361N P=0.242 (e) (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.369N | (e) | |FISHER EXACT | P=0.247 (e) (e) | (e) (e) (e) | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | 20/50 (40%) 20/50 (40%) 21/50 (42%) 21/49 (43%) | |ADJUSTED (b) | 13.3% 27.1% 16.5% 0.0% | 56.9% 52.3% 55.0% 53.8% | |TERMINAL (d) | 2/15 (13%) 3/14 (21%) 1/13 (8%) 0/2 (0%) | 16/31 (52%) 13/31 (42%) 17/34 (50%) 17/35 (49%) | |FIRST INCIDENCE (DAYS) | 734 (T) 549 643 --- | 651 609 651 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382N P=0.193 P=0.470 P=0.726N | P=0.421N P=0.567N P=0.519N P=0.458N | |INCIDENTAL TUMOR | P=0.194N P=0.191 P=0.457 P=0.726N | P=0.475N P=0.557 P=0.573N P=0.532N | |LOGISTIC REGRESSION | P=0.180N P=0.199 P=0.507 P=0.726N | P=0.454N P=0.550N P=0.575N P=0.466N | |COCHRAN-ARMITAGE | P=0.073N | P=0.419 | |FISHER EXACT | P=0.218 P=0.500 P=0.247N | P=0.581N P=0.500 P=0.466 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 3/50 (6%) 0/50 (0%) | 22/50 (44%) 20/50 (40%) 23/50 (46%) 22/49 (45%) | |ADJUSTED (b) | 13.3% 27.1% 16.5% 0.0% | 61.0% 52.3% 57.0% 56.3% | |TERMINAL (d) | 2/15 (13%) 3/14 (21%) 1/13 (8%) 0/2 (0%) | 17/31 (55%) 13/31 (42%) 17/34 (50%) 18/35 (51%) | |FIRST INCIDENCE (DAYS) | 734 (T) 549 643 --- | 651 609 502 699 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.382N P=0.193 P=0.470 P=0.726N | P=0.396N P=0.412N P=0.509N P=0.367N | |INCIDENTAL TUMOR | P=0.194N P=0.191 P=0.457 P=0.726N | P=0.464N P=0.451N P=0.563N P=0.441N | |LOGISTIC REGRESSION | P=0.180N P=0.199 P=0.507 P=0.726N | P=0.449N P=0.377N P=0.561N P=0.368N | |COCHRAN-ARMITAGE | P=0.073N | P=0.436 | |FISHER EXACT | P=0.218 P=0.500 P=0.247N | P=0.420N P=0.500 P=0.545 | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 12.6% 0.0% 7.7% 4.0% | 0.0% 0.0% 2.9% 2.9% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 1/34 (3%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 570 --- 734 (T) 596 | --- --- 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.618 P=0.132N P=0.335N P=0.639N | P=0.330 (e) P=0.518 P=0.524 | |INCIDENTAL TUMOR | P=0.548N P=0.130N P=0.335N P=0.358N | P=0.330 (e) P=0.518 P=0.524 | |LOGISTIC REGRESSION | P=0.505N P=0.124N P=0.303N P=0.348N | P=0.330 (e) P=0.518 P=0.524 | |COCHRAN-ARMITAGE | P=0.442N | P=0.298 | |FISHER EXACT | P=0.121N P=0.309N P=0.309N | (e) P=0.500 P=0.495 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/49 (2%) | |ADJUSTED (b) | 12.6% 0.0% 7.7% 4.0% | 0.0% 0.0% 2.9% 2.9% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 1/34 (3%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 570 --- 734 (T) 596 | --- --- 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.618 P=0.132N P=0.335N P=0.639N | P=0.330 (e) P=0.518 P=0.524 | |INCIDENTAL TUMOR | P=0.548N P=0.130N P=0.335N P=0.358N | P=0.330 (e) P=0.518 P=0.524 | |LOGISTIC REGRESSION | P=0.505N P=0.124N P=0.303N P=0.348N | P=0.330 (e) P=0.518 P=0.524 | |COCHRAN-ARMITAGE | P=0.442N | P=0.298 | |FISHER EXACT | P=0.121N P=0.309N P=0.309N | (e) P=0.500 P=0.495 | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 10.6% 0.0% 7.7% 4.0% | 0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 1/13 (8%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 689 --- 734 (T) 596 | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.405 P=0.252N P=0.533N P=0.628 | P=0.232 (e) (e) P=0.524 | |INCIDENTAL TUMOR | P=0.594 P=0.265N P=0.504N P=0.632N | P=0.232 (e) (e) P=0.524 | |LOGISTIC REGRESSION | P=0.612 P=0.244N P=0.496N P=0.642N | P=0.232 (e) (e) P=0.524 | |COCHRAN-ARMITAGE | P=0.619N | P=0.210 | |FISHER EXACT | P=0.247N P=0.500N P=0.500N | (e) (e) P=0.495 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/49 (51%) 19/50 (38%) 19/50 (38%) 18/45 (40%) | 30/49 (61%) 23/49 (47%) 25/50 (50%) 27/49 (55%) | |ADJUSTED (b) | 79.7% 66.7% 65.8% 82.7% | 78.5% 61.2% 63.6% 65.4% | |TERMINAL (d) | 9/14 (64%) 7/14 (50%) 6/13 (46%) 1/2 (50%) | 23/31 (74%) 17/31 (55%) 20/34 (59%) 21/35 (60%) | |FIRST INCIDENCE (DAYS) | 391 518 420 377 | 496 475 449 629 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.034 * P=0.222N P=0.237N P=0.068 | P=0.298N P=0.122N P=0.112N P=0.155N | |INCIDENTAL TUMOR | P=0.362N P=0.187N P=0.110N P=0.300N | P=0.374N P=0.059N P=0.071N P=0.137N | |LOGISTIC REGRESSION | P=0.355N P=0.147N P=0.135N P=0.234N | P=0.377N P=0.061N P=0.096N P=0.151N | |COCHRAN-ARMITAGE | P=0.314N | P=0.546 | |FISHER EXACT | P=0.135N P=0.135N P=0.194N | P=0.112N P=0.178N P=0.341N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/49 (51%) 19/50 (38%) 19/50 (38%) 18/45 (40%) | 30/49 (61%) 24/49 (49%) 26/50 (52%) 27/49 (55%) | |ADJUSTED (b) | 79.7% 66.7% 65.8% 82.7% | 78.5% 62.3% 66.2% 65.4% | |TERMINAL (d) | 9/14 (64%) 7/14 (50%) 6/13 (46%) 1/2 (50%) | 23/31 (74%) 17/31 (55%) 21/34 (62%) 21/35 (60%) | |FIRST INCIDENCE (DAYS) | 391 518 420 377 | 496 475 449 629 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.034 * P=0.222N P=0.237N P=0.068 | P=0.264N P=0.167N P=0.149N P=0.155N | |INCIDENTAL TUMOR | P=0.362N P=0.187N P=0.110N P=0.300N | P=0.330N P=0.091N P=0.101N P=0.137N | |LOGISTIC REGRESSION | P=0.355N P=0.147N P=0.135N P=0.234N | P=0.332N P=0.089N P=0.134N P=0.151N | |COCHRAN-ARMITAGE | P=0.314N | P=0.511N | |FISHER EXACT | P=0.135N P=0.135N P=0.194N | P=0.155N P=0.235N P=0.341N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/49 (0%) | |ADJUSTED (b) | 20.1% 15.6% 26.2% 69.7% | 0.0% 0.0% 8.8% 0.0% | |TERMINAL (d) | 2/15 (13%) 1/14 (7%) 3/13 (23%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 3/34 (9%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 528 637 688 672 | --- --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.183 P=0.393N P=0.548N P=0.358 | P=0.617N (e) P=0.137 (e) | |INCIDENTAL TUMOR | P=0.576 P=0.378N P=0.545N P=0.569N | P=0.617N (e) P=0.137 (e) | |LOGISTIC REGRESSION | P=0.535 P=0.368N P=0.497N P=0.575N | P=0.617N (e) P=0.137 (e) | |COCHRAN-ARMITAGE | P=0.389N | P=0.656N | |FISHER EXACT | P=0.357N P=0.500N P=0.357N | (e) P=0.121 (e) | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 6.7% 5.3% 18.8% 0.0% | 3.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 2/13 (15%) 0/2 (0%) | 1/31 (3%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 713 688 --- | 734 (T) --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.624 P=0.759 P=0.269 P=0.882N | P=0.456N P=0.500N P=0.482N P=0.476N | |INCIDENTAL TUMOR | P=0.579N P=0.735 P=0.287 P=0.882N | P=0.456N P=0.500N P=0.482N P=0.476N | |LOGISTIC REGRESSION | P=0.690N P=0.759 P=0.302 P=0.882N | P=0.456N P=0.500N P=0.482N P=0.476N | |COCHRAN-ARMITAGE | P=0.339N | P=0.478N | |FISHER EXACT | P=0.753N P=0.309 P=0.500N | P=0.500N P=0.500N P=0.505N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/50 (8%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 6.7% 15.6% 20.4% 0.0% | 3.2% 6.5% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 2/13 (15%) 0/2 (0%) | 1/31 (3%) 2/31 (6%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 734 (T) 560 266 --- | 734 (T) 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.487N P=0.182 P=0.157 P=0.882N | P=0.189N P=0.500 P=0.482N P=0.476N | |INCIDENTAL TUMOR | P=0.282N P=0.155 P=0.169 P=0.882N | P=0.189N P=0.500 P=0.482N P=0.476N | |LOGISTIC REGRESSION | P=0.323N P=0.171 P=0.181 P=0.882N | P=0.189N P=0.500 P=0.482N P=0.476N | |COCHRAN-ARMITAGE | P=0.155N | P=0.213N | |FISHER EXACT | P=0.181 P=0.181 P=0.500N | P=0.500 P=0.500N P=0.505N | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 10.9% 0.0% 0.0% | 0.0% 6.5% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 2/31 (6%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 560 --- --- | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.380N P=0.122 (e) (e) | P=0.345N P=0.238 (e) (e) | |INCIDENTAL TUMOR | P=0.211N P=0.110 (e) (e) | P=0.345N P=0.238 (e) (e) | |LOGISTIC REGRESSION | P=0.259N P=0.120 (e) (e) | P=0.345N P=0.238 (e) (e) | |COCHRAN-ARMITAGE | P=0.255N | P=0.373N | |FISHER EXACT | P=0.121 (e) (e) | P=0.247 (e) (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 11.2% 9.1% 15.4% 54.5% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/15 (7%) 0/14 (0%) 2/13 (15%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 528 637 734 (T) 672 | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.306 P=0.516N P=0.543N P=0.462 | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.613 P=0.525N P=0.529N P=0.682N | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.608 P=0.501N P=0.500N P=0.606N | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.491N | (e) | |FISHER EXACT | P=0.500N P=0.500N P=0.500N | (e) (e) (e) | |=================================================================================================================================| | | |Skin | | Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 8.8% 0.0% 0.0% | 0.0% 3.2% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 1/31 (3%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 668 --- --- | --- 734 (T) --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.574N P=0.235 (e) (e) | P=0.556N P=0.500 (e) (e) | |INCIDENTAL TUMOR | P=0.331N P=0.202 (e) (e) | P=0.556N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.447N P=0.230 (e) (e) | P=0.556N P=0.500 (e) (e) | |COCHRAN-ARMITAGE | P=0.369N | P=0.580N | |FISHER EXACT | P=0.247 (e) (e) | P=0.500 (e) (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 9.6% 7.1% 7.7% 0.0% | 0.0% 0.0% 5.9% 0.0% | |TERMINAL (d) | 1/15 (7%) 1/14 (7%) 1/13 (8%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 2/34 (6%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 640 734 (T) 734 (T) --- | --- --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.453N P=0.536N P=0.530N P=0.498N | P=0.670N (e) P=0.259 (e) | |INCIDENTAL TUMOR | P=0.378N P=0.502N P=0.567N P=0.362N | P=0.670N (e) P=0.259 (e) | |LOGISTIC REGRESSION | P=0.338N P=0.512N P=0.495N P=0.357N | P=0.670N (e) P=0.259 (e) | |COCHRAN-ARMITAGE | P=0.194N | P=0.702N | |FISHER EXACT | P=0.500N P=0.500N P=0.247N | (e) P=0.247 (e) | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/49 (0%) | |ADJUSTED (b) | 20.1% 15.6% 23.1% 54.5% | 0.0% 0.0% 8.8% 0.0% | |TERMINAL (d) | 2/15 (13%) 1/14 (7%) 3/13 (23%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 3/34 (9%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 528 637 734 (T) 672 | --- --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.483 P=0.393N P=0.407N P=0.646 | P=0.617N (e) P=0.137 (e) | |INCIDENTAL TUMOR | P=0.453N P=0.378N P=0.417N P=0.407N | P=0.617N (e) P=0.137 (e) | |LOGISTIC REGRESSION | P=0.422N P=0.368N P=0.353N P=0.342N | P=0.617N (e) P=0.137 (e) | |COCHRAN-ARMITAGE | P=0.225N | P=0.656N | |FISHER EXACT | P=0.357N P=0.357N P=0.218N | (e) P=0.121 (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | |ADJUSTED (b) | 20.1% 15.6% 23.1% 54.5% | 0.0% 0.0% 5.9% 0.0% | |TERMINAL (d) | 2/15 (13%) 1/14 (7%) 3/13 (23%) 1/2 (50%) | 0/31 (0%) 0/31 (0%) 2/34 (6%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | 528 637 734 (T) 672 | --- --- 734 (T) --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.483 P=0.393N P=0.407N P=0.646 | P=0.670N (e) P=0.259 (e) | |INCIDENTAL TUMOR | P=0.453N P=0.378N P=0.417N P=0.407N | P=0.670N (e) P=0.259 (e) | |LOGISTIC REGRESSION | P=0.422N P=0.368N P=0.353N P=0.342N | P=0.670N (e) P=0.259 (e) | |COCHRAN-ARMITAGE | P=0.225N | P=0.702N | |FISHER EXACT | P=0.357N P=0.357N P=0.218N | (e) P=0.247 (e) | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 33/50 (66%) 40/50 (80%) 44/50 (88%) | | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | | |TERMINAL (d) | 15/15 (100%) 14/14 (100%) 13/13 (100%) 2/2 (100%) | | |FIRST INCIDENCE (DAYS) | 497 538 420 483 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.480N P=0.259 P<0.001 ** | | |INCIDENTAL TUMOR | P<0.001 ** P=0.463N P=0.146 P=0.002 ** | | |LOGISTIC REGRESSION | P<0.001 ** P=0.404N P=0.194 P=0.001 ** | | |COCHRAN-ARMITAGE | P=0.010 ** | | |FISHER EXACT | P=0.333N P=0.241 P=0.039 * | | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/49 (12%) 3/50 (6%) 2/50 (4%) | 2/48 (4%) 4/50 (8%) 2/50 (4%) 3/49 (6%) | |ADJUSTED (b) | 20.0% 32.7% 13.0% 30.8% | 6.2% 12.4% 5.9% 8.6% | |TERMINAL (d) | 3/15 (20%) 3/14 (21%) 1/13 (8%) 0/2 (0%) | 1/31 (3%) 3/31 (10%) 2/34 (6%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | 734 (T) 617 591 665 | 721 731 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.366 P=0.223 P=0.633 P=0.208 | P=0.580N P=0.348 P=0.666N P=0.554 | |INCIDENTAL TUMOR | P=0.478N P=0.205 P=0.617 P=0.463 | P=0.591N P=0.307 P=0.677N P=0.535 | |LOGISTIC REGRESSION | P=0.539N P=0.217 P=0.659N P=0.390 | P=0.585N P=0.354 P=0.675N P=0.558 | |COCHRAN-ARMITAGE | P=0.217N | P=0.567 | |FISHER EXACT | P=0.233 P=0.661N P=0.500N | P=0.359 P=0.676N P=0.510 | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 9.4% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | 661 --- --- --- | --- --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.370N P=0.242N P=0.238N P=0.495N | P=0.232 (e) (e) P=0.524 | |INCIDENTAL TUMOR | P=0.211N P=0.270N P=0.183N P=0.207N | P=0.232 (e) (e) P=0.524 | |LOGISTIC REGRESSION | P=0.289N P=0.245N P=0.236N P=0.359N | P=0.232 (e) (e) P=0.524 | |COCHRAN-ARMITAGE | P=0.241N | P=0.213 | |FISHER EXACT | P=0.253N P=0.247N P=0.247N | (e) (e) P=0.505 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/49 (12%) 3/50 (6%) 2/50 (4%) | 2/48 (4%) 4/50 (8%) 2/50 (4%) 4/49 (8%) | |ADJUSTED (b) | 27.5% 32.7% 13.0% 30.8% | 6.2% 12.4% 5.9% 11.4% | |TERMINAL (d) | 3/15 (20%) 3/14 (21%) 1/13 (8%) 0/2 (0%) | 1/31 (3%) 3/31 (10%) 2/34 (6%) 4/35 (11%) | |FIRST INCIDENCE (DAYS) | 661 617 591 665 | 721 731 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.553 P=0.481 P=0.384N P=0.444 | P=0.436 P=0.348 P=0.666N P=0.394 | |INCIDENTAL TUMOR | P=0.255N P=0.441 P=0.363N P=0.505N | P=0.426 P=0.307 P=0.677N P=0.377 | |LOGISTIC REGRESSION | P=0.342N P=0.474 P=0.349N P=0.676N | P=0.431 P=0.354 P=0.675N P=0.396 | |COCHRAN-ARMITAGE | P=0.112N | P=0.371 | |FISHER EXACT | P=0.486 P=0.357N P=0.218N | P=0.359 P=0.676N P=0.349 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 3/50 (6%) 5/50 (10%) 3/49 (6%) | |ADJUSTED (b) | | 6.2% 7.5% 14.7% 8.6% | |TERMINAL (d) | | 1/31 (3%) 0/31 (0%) 5/34 (15%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | | 721 601 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.569 P=0.511 P=0.252 P=0.554 | |INCIDENTAL TUMOR | | P=0.543 P=0.571 P=0.244 P=0.535 | |LOGISTIC REGRESSION | | P=0.546 P=0.508 P=0.238 P=0.558 | |COCHRAN-ARMITAGE | | P=0.495 | |FISHER EXACT | | P=0.500 P=0.218 P=0.490 | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 4/50 (8%) 5/50 (10%) 3/49 (6%) | |ADJUSTED (b) | | 6.2% 9.3% 14.7% 8.6% | |TERMINAL (d) | | 1/31 (3%) 0/31 (0%) 5/34 (15%) 3/35 (9%) | |FIRST INCIDENCE (DAYS) | | 721 462 734 (T) 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.545N P=0.355 P=0.252 P=0.554 | |INCIDENTAL TUMOR | | P=0.590 P=0.433 P=0.244 P=0.535 | |LOGISTIC REGRESSION | | P=0.585 P=0.309 P=0.238 P=0.558 | |COCHRAN-ARMITAGE | | P=0.568 | |FISHER EXACT | | P=0.339 P=0.218 P=0.490 | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |ADJUSTED (b) | 0.0% 2.7% 0.0% 0.0% | 5.7% 0.0% 0.0% 2.9% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 1/35 (3%) | |FIRST INCIDENCE (DAYS) | --- 601 --- --- | 683 --- --- 734 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.664N P=0.490 (e) (e) | P=0.617N P=0.233N P=0.231N P=0.458N | |INCIDENTAL TUMOR | P=0.515N P=0.523 (e) (e) | P=0.641N P=0.280N P=0.256N P=0.508N | |LOGISTIC REGRESSION | P=0.558N P=0.515 (e) (e) | P=0.635N P=0.230N P=0.228N P=0.477N | |COCHRAN-ARMITAGE | P=0.576N | P=0.656N | |FISHER EXACT | P=0.500 (e) (e) | P=0.247N P=0.247N P=0.508N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 26/50 (52%) 32/50 (64%) 9/50 (18%) | 13/50 (26%) 18/50 (36%) 16/50 (32%) 11/49 (22%) | |ADJUSTED (b) | 74.7% 79.3% 83.1% 62.2% | 34.0% 46.2% 38.3% 25.0% | |TERMINAL (d) | 7/15 (47%) 8/14 (57%) 7/13 (54%) 1/2 (50%) | 7/31 (23%) 11/31 (35%) 9/34 (26%) 5/35 (14%) | |FIRST INCIDENCE (DAYS) | 570 582 496 383 | 507 412 486 448 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.412N P=0.543 P=0.264 P=0.287N | P=0.118N P=0.217 P=0.429 P=0.315N | |INCIDENTAL TUMOR | P<0.001N** P=0.562N P=0.175 P<0.001N** | P=0.171N P=0.198 P=0.402 P=0.398N | |LOGISTIC REGRESSION | P<0.001N** P=0.555N P=0.166 P<0.001N** | P=0.195N P=0.222 P=0.370 P=0.458N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.196N | |FISHER EXACT | P=0.500N P=0.208 P<0.001N** | P=0.194 P=0.330 P=0.430N | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |ADJUSTED (b) | 0.0% 10.7% 2.2% 0.0% | 0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/15 (0%) 0/14 (0%) 0/13 (0%) 0/2 (0%) | 0/31 (0%) 0/31 (0%) 0/34 (0%) 0/35 (0%) | |FIRST INCIDENCE (DAYS) | --- 692 527 --- | --- --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.579N P=0.250 P=0.496 (e) | (e) (e) (e) (e) | |INCIDENTAL TUMOR | P=0.271N P=0.202 P=0.581 (e) | (e) (e) (e) (e) | |LOGISTIC REGRESSION | P=0.390N P=0.229 P=0.525 (e) | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.378N | (e) | |FISHER EXACT | P=0.247 P=0.500 (e) | (e) (e) (e) | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 48/50 (96%) 44/50 (88%) 48/50 (96%) 48/50 (96%) | 37/50 (74%) 39/50 (78%) 37/50 (74%) 39/49 (80%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 90.1% 88.5% 88.0% 86.7% | |TERMINAL (d) | 15/15 (100%) 14/14 (100%) 13/13 (100%) 2/2 (100%) | 27/31 (87%) 26/31 (84%) 29/34 (85%) 29/35 (83%) | |FIRST INCIDENCE (DAYS) | 391 518 266 377 | 496 475 449 629 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.452N P=0.475 P<0.001 ** | P=0.293N P=0.441 P=0.341N P=0.386N | |INCIDENTAL TUMOR | P=0.291 P=0.310N P=0.679N P=0.725N | P=0.442N P=0.544N P=0.316N P=0.495N | |LOGISTIC REGRESSION | P=0.184 P=0.205N P=0.667 P=0.586 | P=0.444N P=0.565 P=0.381N P=0.500N | |COCHRAN-ARMITAGE | P=0.296 | P=0.346 | |FISHER EXACT | P=0.134N P=0.691N P=0.691N | P=0.408 P=0.590N P=0.337 | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 33/50 (66%) 32/50 (64%) 37/50 (74%) 17/50 (34%) | 20/50 (40%) 25/50 (50%) 22/50 (44%) 14/49 (29%) | |ADJUSTED (b) | 83.6% 85.7% 89.6% 85.3% | 47.8% 56.7% 49.2% 31.9% | |TERMINAL (d) | 9/15 (60%) 9/14 (64%) 9/13 (69%) 1/2 (50%) | 10/31 (32%) 13/31 (42%) 12/34 (35%) 7/35 (20%) | |FIRST INCIDENCE (DAYS) | 497 560 420 383 | 318 412 393 448 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.225 P=0.532 P=0.310 P=0.368 | P=0.029N* P=0.264 P=0.538 P=0.107N | |INCIDENTAL TUMOR | P<0.001N** P=0.576 P=0.265 P=0.001N** | P=0.054N P=0.316 P=0.453 P=0.184N | |LOGISTIC REGRESSION | P=0.001N** P=0.551N P=0.247 P=0.003N** | P=0.055N P=0.335 P=0.527 P=0.165N | |COCHRAN-ARMITAGE | P<0.001N** | P=0.044N* | |FISHER EXACT | P=0.500N P=0.257 P=0.001N** | P=0.211 P=0.420 P=0.162N | |=================================================================================================================================| DATE: 03/14/96 EXPERIMENT: 05210 TEST: 03 PAGE 24 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- ETHYLBENZENE TERMINAL SACRIFICE AT 105 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 75 PPM 250 750 | CONTROL 75 PPM 250 750 | | | PPM PPM | PPM PPM | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # # | # # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 45/50 (90%) 50/50 (100%) 50/50 (100%)| 42/50 (84%) 45/50 (90%) 44/50 (88%) 46/49 (94%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 93.3% 90.0% 89.8% 93.9% | |TERMINAL (d) | 15/15 (100%) 14/14 (100%) 13/13 (100%) 2/2 (100%) | 28/31 (90%) 26/31 (84%) 29/34 (85%) 32/35 (91%) | |FIRST INCIDENCE (DAYS) | 391 518 266 377 | 318 412 393 448 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P<0.001 ** P=0.454N P=0.430 P<0.001 ** | P=0.389N P=0.395 P=0.470N P=0.494N | |INCIDENTAL TUMOR | P=0.160 P=0.220N P=0.500 (e) | P=0.231 P=0.611 P=0.552N P=0.342 | |LOGISTIC REGRESSION | P=0.059 P=0.151N P=0.349 (e) | P=0.236 P=0.442 P=0.595 P=0.318 | |COCHRAN-ARMITAGE | P=0.081 | P=0.124 | |FISHER EXACT | P=0.102N P=0.500 P=0.500 | P=0.277 P=0.387 P=0.106 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for intercurrent mortality. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. The incidental tumor test regards these lesions as non-fatal. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fisher's exact tests compare directly the overall incidence rates. For all tests, a negative trend is indicated by "N". (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).