TDMS Study 88034-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest OZONE DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 TIME: 21:56:11 TEST TYPE: CHRONIC 30-MONTH CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95239 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034B PATHOLOGIST: S. GRUMBEIN CAS: 10028-15-6 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest OZONE DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 TIME: 21:56:11 TEST TYPE: CHRONIC 30-MONTH CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95239 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034B PATHOLOGIST: S. GRUMBEIN CAS: 10028-15-6 RATS(FISCHER344) ---------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Cortex Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest OZONE DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 TIME: 21:56:11 TEST TYPE: CHRONIC 30-MONTH CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95239 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034B PATHOLOGIST: S. GRUMBEIN CAS: 10028-15-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 6 OZONE ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Islets, Pancreatic Carcinoma Carcinoma or Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma Testes Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== FEMALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Clitoral/Preputial Gland Carcinoma or Adenoma Pituitary Gland: Pars Distalis or Unspecified Site Adenoma Carcinoma or Adenoma All Organs Benign Tumors Malignant and Benign Tumors ==================================================================================================== DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 10.6% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 566 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.071N P=0.158N P=0.199N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.109N P=0.263N P=0.258N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.104N P=0.260N P=0.244N | |COCHRAN-ARMITAGE | (e) | P=0.096N | |FISHER EXACT | (e) (e) | P=0.253N P=0.247N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 18/49 (37%) 23/50 (46%) | 13/50 (26%) 15/49 (31%) 14/50 (28%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 81.2% 67.5% 78.5% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 4/6 (67%) 2/6 (33%) 4/7 (57%) | |FIRST INCIDENCE (DAYS) | 580 601 383 | 577 585 536 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.010N** P=0.176N P=0.023N* | P=0.396N P=0.332N P=0.428N | |INCIDENTAL TUMOR | P=0.080N P=0.139N P=0.110N | P=0.543 P=0.506 P=0.583 | |LOGISTIC REGRESSION | P=0.039N* P=0.095N P=0.078N | P=0.478N P=0.489N P=0.502N | |COCHRAN-ARMITAGE | P=0.183N | P=0.456 | |FISHER EXACT | P=0.042N* P=0.212N | P=0.387 P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Malignant | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) | 1/50 (2%) 0/49 (0%) 1/50 (2%) | |ADJUSTED (b) | 21.4% 5.3% 0.0% | 16.7% 0.0% 14.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 691 650 --- | 874 (T) --- 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.072N P=0.545N P=0.094N | P=0.636N P=0.500N P=0.735N | |INCIDENTAL TUMOR | P=0.130N P=0.564N P=0.212N | P=0.636N P=0.500N P=0.735N | |LOGISTIC REGRESSION | P=0.119N P=0.557N P=0.185N | P=0.636N P=0.500N P=0.735N | |COCHRAN-ARMITAGE | P=0.143N | P=0.668 | |FISHER EXACT | P=0.508N P=0.247N | P=0.505N P=0.753N | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 19/49 (39%) 23/50 (46%) | 13/50 (26%) 16/49 (33%) 14/50 (28%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 81.2% 75.6% 78.5% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 4/6 (67%) 3/6 (50%) 4/7 (57%) | |FIRST INCIDENCE (DAYS) | 580 495 383 | 577 585 536 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.010N* P=0.223N P=0.023N* | P=0.391N P=0.409N P=0.428N | |INCIDENTAL TUMOR | P=0.084N P=0.194N P=0.110N | P=0.544N P=0.414 P=0.583 | |LOGISTIC REGRESSION | P=0.045N* P=0.157N P=0.078N | P=0.469N P=0.553N P=0.502N | |COCHRAN-ARMITAGE | P=0.184N | P=0.456 | |FISHER EXACT | P=0.065N P=0.212N | P=0.306 P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/48 (0%) 1/50 (2%) | 3/45 (7%) 3/48 (6%) 6/47 (13%) | |ADJUSTED (b) | 2.6% 0.0% 14.3% | 13.8% 21.4% 41.8% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 1/6 (17%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 583 --- 760 | 635 513 685 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.622N P=0.552N P=0.733N | P=0.254 P=0.526N P=0.366 | |INCIDENTAL TUMOR | P=0.649 P=0.550N P=0.746 | P=0.225 P=0.628N P=0.309 | |LOGISTIC REGRESSION | P=0.642N P=0.482N P=0.749N | P=0.227 P=0.628N P=0.344 | |COCHRAN-ARMITAGE | P=0.668 | P=0.193 | |FISHER EXACT | P=0.510N P=0.753N | P=0.630N P=0.265 | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/48 (6%) 2/50 (4%) | 0/45 (0%) 2/48 (4%) 3/47 (6%) | |ADJUSTED (b) | 0.0% 20.8% 19.2% | 0.0% 8.0% 21.4% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | --- 411 751 | --- 756 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.374 P=0.098 P=0.400 | P=0.109 P=0.407 P=0.167 | |INCIDENTAL TUMOR | P=0.209 P=0.153 P=0.264 | P=0.106 P=0.300 P=0.158 | |LOGISTIC REGRESSION | P=0.206 P=0.149 P=0.342 | P=0.099 P=0.300 P=0.157 | |COCHRAN-ARMITAGE | P=0.203 | P=0.086 | |FISHER EXACT | P=0.114 P=0.247 | P=0.264 P=0.129 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/48 (6%) 3/50 (6%) | 3/45 (7%) 5/48 (10%) 9/47 (19%) | |ADJUSTED (b) | 2.6% 20.8% 30.7% | 13.8% 27.7% 55.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 1/6 (17%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | 583 411 751 | 635 513 670 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.413 P=0.247 P=0.456 | P=0.083 P=0.576 P=0.140 | |INCIDENTAL TUMOR | P=0.242 P=0.333 P=0.314 | P=0.064 P=0.425 P=0.098 | |LOGISTIC REGRESSION | P=0.251 P=0.369 P=0.393 | P=0.062 P=0.426 P=0.112 | |COCHRAN-ARMITAGE | P=0.240 | P=0.047 * | |FISHER EXACT | P=0.293 P=0.309 | P=0.394 P=0.070 | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 4/50 (8%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 26.6% 10.2% 17.9% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 468 623 653 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.165N P=0.178N P=0.206N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.289N P=0.179N P=0.358N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.275N P=0.145N P=0.368N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.290N | (e) | |FISHER EXACT | P=0.134N P=0.370N | (e) (e) | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 1/50 (2%) | 2/49 (4%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | 58.1% 37.8% 3.6% | 16.5% 16.7% 6.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 1/6 (17%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 580 674 650 | 718 874 (T) 775 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.038N* P=0.355N P=0.072N | P=0.318N P=0.402N P=0.426N | |INCIDENTAL TUMOR | P=0.068N P=0.310N P=0.119N | P=0.340N P=0.459N P=0.462N | |LOGISTIC REGRESSION | P=0.049N* P=0.274N P=0.098N | P=0.317N P=0.371N P=0.446N | |COCHRAN-ARMITAGE | P=0.060N | P=0.372N | |FISHER EXACT | P=0.218N P=0.102N | P=0.500N P=0.492N | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 4/50 (8%) 5/50 (10%) | 2/49 (4%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | 69.2% 44.1% 20.9% | 16.5% 16.7% 6.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 1/6 (17%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 468 623 650 | 718 874 (T) 775 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.022N* P=0.116N P=0.036N* | P=0.318N P=0.402N P=0.426N | |INCIDENTAL TUMOR | P=0.056N P=0.089N P=0.091N | P=0.340N P=0.459N P=0.462N | |LOGISTIC REGRESSION | P=0.043N* P=0.067N P=0.083N | P=0.317N P=0.371N P=0.446N | |COCHRAN-ARMITAGE | P=0.053N | P=0.372N | |FISHER EXACT | P=0.045N* P=0.086N | P=0.500N P=0.492N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 14.5% 25.0% 55.6% | 0.0% 5.3% 14.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 580 719 756 | --- 803 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.533N P=0.336N | P=0.376 P=0.672 P=0.531 | |INCIDENTAL TUMOR | P=0.402N P=0.595N P=0.513N | P=0.360 P=0.535 P=0.531 | |LOGISTIC REGRESSION | P=0.301N P=0.563N P=0.418N | P=0.372 P=0.571 P=0.531 | |COCHRAN-ARMITAGE | P=0.406N | P=0.331 | |FISHER EXACT | P=0.500N P=0.500N | P=0.500 P=0.500 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 14.5% 25.0% 55.6% | 16.7% 5.3% 14.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 580 719 756 | 874 (T) 803 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.200N P=0.533N P=0.336N | P=0.586N P=0.669N P=0.735N | |INCIDENTAL TUMOR | P=0.402N P=0.595N P=0.513N | P=0.602N P=0.741N P=0.735N | |LOGISTIC REGRESSION | P=0.301N P=0.563N P=0.418N | P=0.579N P=0.665N P=0.735N | |COCHRAN-ARMITAGE | P=0.406N | P=0.640 | |FISHER EXACT | P=0.500N P=0.500N | P=0.753N P=0.753N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 2.2% 25.0% 17.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 521 735 643 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.530 P=0.716 P=0.560 | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.370 P=0.730N P=0.469 | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.408 P=0.755 P=0.499 | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.378 | (e) | |FISHER EXACT | P=0.753N P=0.500 | (e) (e) | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |ADJUSTED (b) | 25.9% 22.3% 0.0% | 0.0% 3.0% 3.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 708 581 --- | --- 710 685 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.075N P=0.475 P=0.085N | P=0.351 P=0.581 P=0.529 | |INCIDENTAL TUMOR | P=0.197N P=0.411 P=0.212N | P=0.351 P=0.535 P=0.522 | |LOGISTIC REGRESSION | P=0.161N P=0.427 P=0.169N | P=0.330 P=0.507 P=0.500 | |COCHRAN-ARMITAGE | P=0.202N | P=0.331 | |FISHER EXACT | P=0.500 P=0.247N | P=0.500 P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 25.9% 26.2% 0.0% | 12.5% 8.7% 3.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 708 581 --- | 827 710 685 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.091N P=0.307 P=0.085N | P=0.564N P=0.684 P=0.719N | |INCIDENTAL TUMOR | P=0.210N P=0.250 P=0.212N | P=0.591N P=0.562 P=0.738N | |LOGISTIC REGRESSION | P=0.182N P=0.266 P=0.169N | P=0.594N P=0.598 P=0.738N | |COCHRAN-ARMITAGE | P=0.222N | P=0.622N | |FISHER EXACT | P=0.339 P=0.247N | P=0.500 P=0.753N | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 8/50 (16%) 5/50 (10%) 7/50 (14%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 43.4% 44.4% 45.7% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 2/6 (33%) 2/6 (33%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 417 571 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.334N P=0.193N P=0.385N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.451N P=0.322N P=0.520N | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.422N P=0.270N P=0.498N | |COCHRAN-ARMITAGE | (e) | P=0.442N | |FISHER EXACT | (e) (e) | P=0.277N P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 8/50 (16%) 5/50 (10%) 8/50 (16%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 43.4% 44.4% 47.2% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 2/6 (33%) 2/6 (33%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 417 571 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.444N P=0.193N P=0.485N | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.536 P=0.322N P=0.574 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.543N P=0.270N P=0.605 | |COCHRAN-ARMITAGE | (e) | P=0.557 | |FISHER EXACT | (e) (e) | P=0.277N P=0.607N | |=================================================================================================================================| | | |Mammary Gland | | Fibroadenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 19/50 (38%) 28/50 (56%) 25/50 (50%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 93.1% 100.0% 79.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 5/6 (83%) 6/6 (100%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 557 579 580 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.450 P=0.528 P=0.481 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.203 P=0.087 P=0.227 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.234 P=0.288 P=0.250 | |COCHRAN-ARMITAGE | (e) | P=0.135 | |FISHER EXACT | (e) (e) | P=0.054 P=0.157 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 19/50 (38%) 28/50 (56%) 25/50 (50%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 93.1% 100.0% 79.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 5/6 (83%) 6/6 (100%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 557 579 580 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.450 P=0.528 P=0.481 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.203 P=0.087 P=0.227 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.234 P=0.288 P=0.250 | |COCHRAN-ARMITAGE | (e) | P=0.135 | |FISHER EXACT | (e) (e) | P=0.054 P=0.157 | |=================================================================================================================================| | | |Mammary Gland | | Fibroma, Fibroadenoma, Carcinoma, or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 24/50 (48%) 29/50 (58%) 30/50 (60%) | |ADJUSTED (b) | 0.0% 0.0% 0.0% | 93.9% 100.0% 89.9% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 5/6 (83%) 6/6 (100%) 4/7 (57%) | |FIRST INCIDENCE (DAYS) | --- --- --- | 417 571 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.478 P=0.337N P=0.521 | |INCIDENTAL TUMOR | (e) (e) (e) | P=0.192 P=0.296 P=0.218 | |LOGISTIC REGRESSION | (e) (e) (e) | P=0.229 P=0.478 P=0.251 | |COCHRAN-ARMITAGE | (e) | P=0.134 | |FISHER EXACT | (e) (e) | P=0.212 P=0.158 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 100.0% | 0.0% 19.9% 0.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 0/6 (0%) 1/6 (17%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 666 | --- 756 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.317 (e) P=0.555 | P=0.628N P=0.314 (e) | |INCIDENTAL TUMOR | P=0.294 (e) P=0.523 | P=0.640N P=0.259 (e) | |LOGISTIC REGRESSION | P=0.178 (e) P=0.366 | P=0.635N P=0.325 (e) | |COCHRAN-ARMITAGE | P=0.095 | P=0.669 | |FISHER EXACT | (e) P=0.247 | P=0.247 (e) | |=================================================================================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |ADJUSTED (b) | 0.0% 0.0% 100.0% | 4.8% 19.9% 2.8% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 0/6 (0%) 1/6 (17%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 619 | 719 756 663 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.127 (e) P=0.285 | P=0.565N P=0.626 P=0.722N | |INCIDENTAL TUMOR | P=0.096 (e) P=0.224 | P=0.585N P=0.541 P=0.738N | |LOGISTIC REGRESSION | P=0.064 (e) P=0.167 | P=0.596N P=0.599 P=0.762N | |COCHRAN-ARMITAGE | P=0.037 * | P=0.622N | |FISHER EXACT | (e) P=0.121 | P=0.500 P=0.753N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | |ADJUSTED (b) | 0.0% 0.0% 100.0% | 0.0% 19.9% 0.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 0/6 (0%) 1/6 (17%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 666 | --- 756 --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.317 (e) P=0.555 | P=0.628N P=0.314 (e) | |INCIDENTAL TUMOR | P=0.294 (e) P=0.523 | P=0.640N P=0.259 (e) | |LOGISTIC REGRESSION | P=0.178 (e) P=0.366 | P=0.635N P=0.325 (e) | |COCHRAN-ARMITAGE | P=0.095 | P=0.669 | |FISHER EXACT | (e) P=0.247 | P=0.247 (e) | |=================================================================================================================================| | | |Pancreas | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) | |ADJUSTED (b) | 13.5% 0.0% 10.8% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 674 --- 708 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.381N P=0.247N P=0.438N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.579N P=0.278N P=0.654N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.547N P=0.270N P=0.634N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.622N | (e) | |FISHER EXACT | P=0.247N P=0.691N | (e) (e) | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 30/48 (63%) 34/50 (68%) | 44/50 (88%) 40/49 (82%) 37/50 (74%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 100.0% 97.4% 100.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 6/6 (100%) 5/6 (83%) 7/7 (100%) | |FIRST INCIDENCE (DAYS) | 467 346 383 | 406 513 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.048N* P=0.464N P=0.068N | P=0.047N* P=0.022N* P=0.061N | |INCIDENTAL TUMOR | P=0.346N P=0.350N P=0.402N | P=0.033N* P=0.197N P=0.053N | |LOGISTIC REGRESSION | P=0.336N P=0.316N P=0.385N | P=0.016N* P=0.074N P=0.025N* | |COCHRAN-ARMITAGE | P=0.374N | P=0.048N* | |FISHER EXACT | P=0.216N P=0.414N | P=0.274N P=0.062N | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/50 (72%) 30/48 (63%) 34/50 (68%) | 44/50 (88%) 41/49 (84%) 37/50 (74%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 100.0% 97.6% 100.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 6/6 (100%) 5/6 (83%) 7/7 (100%) | |FIRST INCIDENCE (DAYS) | 467 346 383 | 406 513 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.048N* P=0.464N P=0.068N | P=0.046N* P=0.028N* P=0.061N | |INCIDENTAL TUMOR | P=0.346N P=0.350N P=0.402N | P=0.031N* P=0.275N P=0.053N | |LOGISTIC REGRESSION | P=0.336N P=0.316N P=0.385N | P=0.014N* P=0.112N P=0.025N* | |COCHRAN-ARMITAGE | P=0.374N | P=0.046N* | |FISHER EXACT | P=0.216N P=0.414N | P=0.371N P=0.062N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 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) | 4/50 (8%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 24.7% 28.4% 59.8% | 24.3% 0.0% 28.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | 610 636 632 | 691 --- 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.385N P=0.416N P=0.449N | P=0.333N P=0.080N P=0.428N | |INCIDENTAL TUMOR | P=0.418 P=0.441N P=0.497 | P=0.339N P=0.103N P=0.436N | |LOGISTIC REGRESSION | P=0.538 P=0.401N P=0.604 | P=0.316N P=0.081N P=0.401N | |COCHRAN-ARMITAGE | P=0.424 | P=0.390N | |FISHER EXACT | P=0.339N P=0.500 | P=0.121N P=0.500N | |=================================================================================================================================| | | |Skin | | Fibroma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | |ADJUSTED (b) | 0.0% 8.9% 7.7% | 5.0% 16.7% 16.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 1/6 (17%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | --- 628 741 | 722 874 (T) 643 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.500 P=0.212 P=0.690 | P=0.420 P=0.713N P=0.545 | |INCIDENTAL TUMOR | P=0.330 P=0.183 P=0.523 | P=0.388 P=0.741N P=0.497 | |LOGISTIC REGRESSION | P=0.391 P=0.221 P=0.584 | P=0.417 P=0.689N P=0.535 | |COCHRAN-ARMITAGE | P=0.360 | P=0.378 | |FISHER EXACT | P=0.247 P=0.500 | P=0.753N P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 2/50 (4%) 2/50 (4%) 3/50 (6%) | |ADJUSTED (b) | 0.0% 8.9% 7.7% | 20.8% 18.5% 20.8% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 1/6 (17%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | --- 628 741 | 722 513 643 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.500 P=0.212 P=0.690 | P=0.464 P=0.653N P=0.570 | |INCIDENTAL TUMOR | P=0.330 P=0.183 P=0.523 | P=0.415 P=0.692 P=0.522 | |LOGISTIC REGRESSION | P=0.391 P=0.221 P=0.584 | P=0.441 P=0.645N P=0.567 | |COCHRAN-ARMITAGE | P=0.360 | P=0.406 | |FISHER EXACT | P=0.247 P=0.500 | P=0.691N P=0.500 | |=================================================================================================================================| | | |Skin | | Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 24.7% 28.4% 19.6% | 5.6% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 610 636 632 | 731 --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277N P=0.416N P=0.351N | P=0.230N P=0.398N P=0.460N | |INCIDENTAL TUMOR | P=0.563 P=0.441N P=0.633 | P=0.252N P=0.465N P=0.478N | |LOGISTIC REGRESSION | P=0.502N P=0.401N P=0.591N | P=0.259N P=0.480N P=0.485N | |COCHRAN-ARMITAGE | P=0.579 | P=0.269N | |FISHER EXACT | P=0.339N P=0.643N | P=0.500N P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 0/50 (0%) 2/50 (4%) | |ADJUSTED (b) | 24.7% 28.4% 59.8% | 24.3% 0.0% 28.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | 610 636 632 | 691 --- 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.385N P=0.416N P=0.449N | P=0.333N P=0.080N P=0.428N | |INCIDENTAL TUMOR | P=0.418 P=0.441N P=0.497 | P=0.339N P=0.103N P=0.436N | |LOGISTIC REGRESSION | P=0.538 P=0.401N P=0.604 | P=0.316N P=0.081N P=0.401N | |COCHRAN-ARMITAGE | P=0.424 | P=0.390N | |FISHER EXACT | P=0.339N P=0.500 | P=0.121N P=0.500N | |=================================================================================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | |ADJUSTED (b) | 24.7% 28.4% 19.6% | 21.3% 0.0% 14.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 610 636 632 | 731 --- 874 (T) | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.277N P=0.416N P=0.351N | P=0.313N P=0.185N P=0.440N | |INCIDENTAL TUMOR | P=0.563 P=0.441N P=0.633 | P=0.322N P=0.220N P=0.451N | |LOGISTIC REGRESSION | P=0.502N P=0.401N P=0.591N | P=0.292N P=0.160N P=0.414N | |COCHRAN-ARMITAGE | P=0.579 | P=0.360N | |FISHER EXACT | P=0.339N P=0.643N | P=0.247N P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Testes | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 33/50 (66%) 33/50 (66%) | | |ADJUSTED (b) | 100.0% 100.0% 100.0% | | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | | |FIRST INCIDENCE (DAYS) | 468 411 419 | | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.030N* P=0.410 P=0.045N* | | |INCIDENTAL TUMOR | P=0.309N P=0.446 P=0.332N | | |LOGISTIC REGRESSION | P=0.265N P=0.382 P=0.283N | | |COCHRAN-ARMITAGE | P=0.375N | | |FISHER EXACT | P=0.415N P=0.415N | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 8/50 (16%) 6/50 (12%) | 7/50 (14%) 6/49 (12%) 4/50 (8%) | |ADJUSTED (b) | 50.8% 54.5% 59.0% | 56.9% 40.0% 26.5% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 2/6 (33%) 1/6 (17%) 1/7 (14%) | |FIRST INCIDENCE (DAYS) | 610 531 383 | 696 723 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.403N P=0.187 P=0.565N | P=0.127N P=0.226N P=0.173N | |INCIDENTAL TUMOR | P=0.432 P=0.186 P=0.480 | P=0.179N P=0.395N P=0.234N | |LOGISTIC REGRESSION | P=0.470 P=0.188 P=0.502 | P=0.138N P=0.234N P=0.185N | |COCHRAN-ARMITAGE | P=0.440 | P=0.216N | |FISHER EXACT | P=0.277 P=0.500 | P=0.516N P=0.262N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 4/50 (8%) 3/49 (6%) 4/50 (8%) | |ADJUSTED (b) | 2.6% 4.2% 0.0% | 32.8% 16.0% 40.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 1/6 (17%) 0/6 (0%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | 583 623 --- | 678 767 744 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.335N P=0.718 P=0.516N | P=0.447N P=0.237N P=0.521N | |INCIDENTAL TUMOR | P=0.389N P=0.707 P=0.550N | P=0.510N P=0.418N P=0.574N | |LOGISTIC REGRESSION | P=0.333N P=0.759N P=0.498N | P=0.478N P=0.349N P=0.528N | |COCHRAN-ARMITAGE | P=0.331N | P=0.576 | |FISHER EXACT | P=0.753N P=0.500N | P=0.511N P=0.643N | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) 6/50 (12%) | 10/50 (20%) 9/49 (18%) 8/50 (16%) | |ADJUSTED (b) | 52.1% 56.4% 59.0% | 65.3% 49.6% 59.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 2/6 (33%) 1/6 (17%) 3/7 (43%) | |FIRST INCIDENCE (DAYS) | 583 531 383 | 678 723 566 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.311N P=0.191 P=0.450N | P=0.193N P=0.144N P=0.242N | |INCIDENTAL TUMOR | P=0.528 P=0.182 P=0.587 | P=0.271N P=0.354N P=0.326N | |LOGISTIC REGRESSION | P=0.533N P=0.200 P=0.617 | P=0.213N P=0.130N P=0.253N | |COCHRAN-ARMITAGE | P=0.557 | P=0.348N | |FISHER EXACT | P=0.288 P=0.620N | P=0.520N P=0.398N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 19 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Carcinoma or Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/49 (2%) 1/50 (2%) | |ADJUSTED (b) | 53.1% 0.0% 5.3% | 0.0% 4.3% 5.3% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 674 --- 708 | --- 775 753 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.235N P=0.322N P=0.330N | P=0.387 P=0.647 P=0.576 | |INCIDENTAL TUMOR | P=0.332N P=0.278N P=0.459N | P=0.351 P=0.535 P=0.522 | |LOGISTIC REGRESSION | P=0.264N P=0.272N P=0.385N | P=0.350 P=0.550 P=0.523 | |COCHRAN-ARMITAGE | P=0.360N | P=0.332 | |FISHER EXACT | P=0.247N P=0.500N | P=0.495 P=0.500 | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 3/50 (6%) 6/50 (12%) | |ADJUSTED (b) | | 29.5% 23.8% 37.1% | |TERMINAL (d) | | 0/6 (0%) 1/6 (17%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | | 556 616 486 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.478N P=0.105N P=0.518N | |INCIDENTAL TUMOR | | P=0.559N P=0.229N P=0.603N | |LOGISTIC REGRESSION | | P=0.548N P=0.200N P=0.602N | |COCHRAN-ARMITAGE | | P=0.566 | |FISHER EXACT | | P=0.243N P=0.620N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 20 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Sarcoma Stromal or Polyp Stromal | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | # # # | |----------- | | | |OVERALL (a) | | 6/50 (12%) 3/50 (6%) 7/50 (14%) | |ADJUSTED (b) | | 29.5% 23.8% 42.8% | |TERMINAL (d) | | 0/6 (0%) 1/6 (17%) 2/7 (29%) | |FIRST INCIDENCE (DAYS) | | 556 616 486 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | | P=0.532 P=0.105N P=0.610N | |INCIDENTAL TUMOR | | P=0.447 P=0.229N P=0.523 | |LOGISTIC REGRESSION | | P=0.462 P=0.200N P=0.533 | |COCHRAN-ARMITAGE | | P=0.436 | |FISHER EXACT | | P=0.243N P=0.500 | |=================================================================================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 23/50 (46%) 29/50 (58%) | 21/50 (42%) 22/50 (44%) 20/50 (40%) | |ADJUSTED (b) | 100.0% 100.0% 92.7% | 74.9% 80.1% 85.6% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 2/6 (33%) 3/6 (50%) 5/7 (71%) | |FIRST INCIDENCE (DAYS) | 481 411 419 | 467 452 486 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.123N P=0.404N P=0.174N | P=0.256N P=0.239N P=0.284N | |INCIDENTAL TUMOR | P=0.446 P=0.321N P=0.473 | P=0.449N P=0.512 P=0.477N | |LOGISTIC REGRESSION | P=0.462 P=0.287N P=0.453 | P=0.408N P=0.566 P=0.427N | |COCHRAN-ARMITAGE | P=0.540 | P=0.460N | |FISHER EXACT | P=0.158N P=0.580N | P=0.500 P=0.500N | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 21 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |ADJUSTED (b) | 5.6% 13.6% 10.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 0/6 (0%) 0/6 (0%) 0/7 (0%) | |FIRST INCIDENCE (DAYS) | 539 433 754 | --- --- --- | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.346N P=0.264 P=0.407N | (e) (e) (e) | |INCIDENTAL TUMOR | P=0.452N P=0.337 P=0.531N | (e) (e) (e) | |LOGISTIC REGRESSION | P=0.414N P=0.435 P=0.504N | (e) (e) (e) | |COCHRAN-ARMITAGE | P=0.406N | (e) | |FISHER EXACT | P=0.339 P=0.500N | (e) (e) | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 49/50 (98%) 46/50 (92%) 48/50 (96%) | 47/50 (94%) 45/50 (90%) 48/50 (96%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 6/6 (100%) 6/6 (100%) 7/7 (100%) | |FIRST INCIDENCE (DAYS) | 467 346 383 | 406 513 467 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.045N* P=0.379 P=0.066N | P=0.230N P=0.035N* P=0.249N | |INCIDENTAL TUMOR | P=0.501N P=0.583N P=0.707N | P=0.469 P=0.230N P=0.546 | |LOGISTIC REGRESSION | P=0.588N P=0.689 P=0.632N | P=0.525N P=0.084N P=0.705N | |COCHRAN-ARMITAGE | P=0.406N | P=0.421 | |FISHER EXACT | P=0.181N P=0.500N | P=0.357N P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 22 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 WEEKS |=================================================================================================================================| | | | | | | MALES | FEMALES | | | | | |DOSE | CONTROL 0.5 PPM 1.0 PPM | CONTROL 0.5 PPM 1.0 PPM | | | | | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 35/50 (70%) 31/50 (62%) 33/50 (66%) | 34/50 (68%) 31/50 (62%) 32/50 (64%) | |ADJUSTED (b) | 100.0% 100.0% 94.7% | 93.1% 95.2% 96.0% | |TERMINAL (d) | 0/0 0/0 0/1 (0%) | 4/6 (67%) 5/6 (83%) 6/7 (86%) | |FIRST INCIDENCE (DAYS) | 468 345 419 | 417 452 285 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.062N P=0.517 P=0.090N | P=0.168N P=0.054N P=0.187N | |INCIDENTAL TUMOR | P=0.454N P=0.364N P=0.542N | P=0.359N P=0.338N P=0.404N | |LOGISTIC REGRESSION | P=0.323N P=0.387N P=0.371N | P=0.313N P=0.238N P=0.342N | |COCHRAN-ARMITAGE | P=0.376N | P=0.377N | |FISHER EXACT | P=0.263N P=0.415N | P=0.338N P=0.417N | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 50/50 (100%) 48/50 (96%) 49/50 (98%) | 49/50 (98%) 48/50 (96%) 50/50 (100%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% | 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 0/0 1/1 (100%) | 6/6 (100%) 6/6 (100%) 7/7 (100%) | |FIRST INCIDENCE (DAYS) | 467 345 383 | 406 452 285 | |-----------------------| | | |STATISTICAL TESTS (f) | | | |-----------------------| | | |LIFE TABLE | P=0.048N* P=0.334 P=0.070N | P=0.232N P=0.047N* P=0.251N | |INCIDENTAL TUMOR | P=0.484N P=0.597N (e) | P=0.358 P=0.455N P=0.500 | |LOGISTIC REGRESSION | P=0.623N P=0.990N (e) | P=0.605 P=0.242N P=0.500 | |COCHRAN-ARMITAGE | P=0.360N | P=0.360 | |FISHER EXACT | P=0.247N P=0.500N | P=0.500N P=0.500 | |=================================================================================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 05 PAGE 23 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- 6 OZONE TERMINAL SACRIFICE AT 125 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. (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).