TDMS Study 88034-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest OZONE/NNK DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 TIME: 23:08:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1 CONT: N01-ES-95262 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034C PATHOLOGIST: P. MELLICK 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/NNK DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 TIME: 23:08:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95262 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034C PATHOLOGIST: P. MELLICK 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/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Larynx Liver Lung Nose Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Northwest OZONE/NNK DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 TIME: 23:08:51 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE CONT: N01-ES-95262 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 88034C PATHOLOGIST: P. MELLICK CAS: 10028-15-6 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF THE STUDY OF 6 OZONE/NNK ==================================================================================================== MALE RATS ------------- ORGAN MORPHOLOGY ------- ------------ Adrenal Medulla Pheochromocytoma Benign Pheochromocytoma: Benign, Complex, Malignant, NOS Lung Alveolar/Bronchiolar Adenoma Alveolar/Bronchiolar Carcinoma Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) Papilloma Squamous or Papilloma Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma Testes Adenoma All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated Benign Tumors Malignant Tumors ==================================================================================================== DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 1 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/4 (75%) 0/0 (0%) 0/1 (0%) 1/1 (100%) | |ADJUSTED (b) | 14.7% 0.0% 0.0% 6.3% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 611 --- --- 677 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.282N P=0.167N P=0.020N* P=0.443N | |INCIDENTAL TUMOR | P=0.500N (e) P=0.500N (e) | |LOGISTIC REGRESSION | P=0.500N (e) P=0.500N (e) | |COCHRAN-ARMITAGE | P=0.715N | |FISHER EXACT | P=1.000N P=0.400N P=0.800 | |==============================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/4 (100%) 0/0 (0%) 1/1 (100%) 1/1 (100%) | |ADJUSTED (b) | 16.7% 0.0% 1.2% 6.3% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 540 --- 610 677 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.188N P=0.095N P=0.020N* P=0.289N | |INCIDENTAL TUMOR | (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | P=1.000N P=1.000N P=1.000N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 2 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Clitoral/Preputial Gland | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/8 (0%) 2/6 (33%) 0/13 (0%) 0/9 (0%) | |ADJUSTED (b) | 0.0% 8.7% 0.0% 0.0% | |TERMINAL (d) | 0/1 (0%) 0/0 0/1 (0%) 0/1 (0%) | |FIRST INCIDENCE (DAYS) | --- 466 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.192N P=0.212 (e) (e) | |INCIDENTAL TUMOR | P=0.193N P=0.314 (e) (e) | |LOGISTIC REGRESSION | P=0.193N P=0.151 (e) (e) | |COCHRAN-ARMITAGE | P=0.195N | |FISHER EXACT | P=0.165 (e) (e) | |==============================================================================| | | |Clitoral/Preputial Gland | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/8 (13%) 2/6 (33%) 1/13 (8%) 0/9 (0%) | |ADJUSTED (b) | 100.0% 8.7% 0.8% 0.0% | |TERMINAL (d) | 1/1 (100%) 0/0 0/1 (0%) 0/1 (0%) | |FIRST INCIDENCE (DAYS) | 736 (T) 466 487 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.116N P=0.212 P=0.653N P=0.500N | |INCIDENTAL TUMOR | P=0.090N P=0.314 P=0.593N P=0.500N | |LOGISTIC REGRESSION | P=0.120N P=0.395 P=0.679N P=0.500N | |COCHRAN-ARMITAGE | P=0.119N | |FISHER EXACT | P=0.385 P=0.629N P=0.471N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 3 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Islets, Pancreatic | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 2/5 (40%) 0/1 (0%) 0/1 (0%) | |ADJUSTED (b) | 0.0% 13.7% 0.0% 0.0% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | --- 557 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.210N P=0.214 (e) (e) | |INCIDENTAL TUMOR | P=0.489N P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.447N P=0.828 (e) (e) | |COCHRAN-ARMITAGE | P=0.449N | |FISHER EXACT | P=0.667 (e) (e) | |==============================================================================| | | |Islets, Pancreatic | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 3/5 (60%) 1/1 (100%) 1/1 (100%) | |ADJUSTED (b) | 2.2% 18.3% 3.4% 12.5% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 484 551 704 695 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.323N P=0.256 P=0.537N P=0.680 | |INCIDENTAL TUMOR | P=0.489 P=0.500 (e) (e) | |LOGISTIC REGRESSION | P=0.447 P=0.828N (e) (e) | |COCHRAN-ARMITAGE | P=0.449 | |FISHER EXACT | P=0.667N P=1.000N P=1.000N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 4 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 5/5 (100%) 1/1 (100%) 1/1 (100%) | |ADJUSTED (b) | 2.2% 29.4% 3.4% 12.5% | |TERMINAL (d) | 0/0 0/0 0/0 0/0 | |FIRST INCIDENCE (DAYS) | 484 551 704 695 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.140N P=0.080 P=0.537N P=0.680 | |INCIDENTAL TUMOR | (e) (e) (e) (e) | |LOGISTIC REGRESSION | (e) (e) (e) (e) | |COCHRAN-ARMITAGE | (e) | |FISHER EXACT | P=1.000N P=1.000N P=1.000N | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/48 (6%) 2/48 (4%) 27/144 (19%) 20/48 (42%) | |ADJUSTED (b) | 37.5% 7.7% 57.7% 91.7% | |TERMINAL (d) | 3/8 (38%) 0/6 (0%) 5/14 (36%) 3/4 (75%) | |FIRST INCIDENCE (DAYS) | 736 (T) 625 557 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.597N P=0.009 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.560N P=0.013 * P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.591N P=0.017 * P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.500N P=0.027 * P<0.001 ** | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 5 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/48 (2%) 0/48 (0%) 11/144 (8%) 8/48 (17%) | |ADJUSTED (b) | 12.5% 0.0% 37.4% 62.4% | |TERMINAL (d) | 1/8 (13%) 0/6 (0%) 4/14 (29%) 1/4 (25%) | |FIRST INCIDENCE (DAYS) | 736 (T) --- 640 603 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.557N P=0.064 P=0.003 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.557N P=0.083 P=0.007 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.557N P=0.094 P=0.004 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.500N P=0.150 P=0.015 * | |==============================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/48 (6%) 2/48 (4%) 32/144 (22%) 23/48 (48%) | |ADJUSTED (b) | 37.5% 7.7% 68.6% 93.2% | |TERMINAL (d) | 3/8 (38%) 0/6 (0%) 7/14 (50%) 3/4 (75%) | |FIRST INCIDENCE (DAYS) | 736 (T) 625 557 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P<0.001 ** P=0.597N P=0.002 ** P<0.001 ** | |INCIDENTAL TUMOR | P<0.001 ** P=0.560N P=0.003 ** P<0.001 ** | |LOGISTIC REGRESSION | P<0.001 ** P=0.591N P=0.004 ** P<0.001 ** | |COCHRAN-ARMITAGE | P<0.001 ** | |FISHER EXACT | P=0.500N P=0.008 ** P<0.001 ** | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 6 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Lung | | Squamous Cell Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/144 (1%) 1/48 (2%) | |ADJUSTED (b) | 0.0% 0.0% 8.1% 2.9% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 1/14 (7%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 582 583 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.176 (e) P=0.423 P=0.489 | |INCIDENTAL TUMOR | P=0.176 (e) P=0.440 P=0.511 | |LOGISTIC REGRESSION | P=0.206 (e) P=0.477 P=0.517 | |COCHRAN-ARMITAGE | P=0.211 | |FISHER EXACT | (e) P=0.562 P=0.500 | |==============================================================================| | | |Mesentery | | Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 3/144 (2%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 3.4% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 567 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.497 (e) P=0.347 (e) | |INCIDENTAL TUMOR | P=0.541 (e) P=0.392 (e) | |LOGISTIC REGRESSION | P=0.542 (e) P=0.379 (e) | |COCHRAN-ARMITAGE | P=0.536 | |FISHER EXACT | (e) P=0.420 (e) | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 7 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Papilloma Squamous or Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/48 (2%) 3/48 (6%) 0/144 (0%) 0/48 (0%) | |ADJUSTED (b) | 6.3% 16.1% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 698 635 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.048N* P=0.221 P=0.356N P=0.665N | |INCIDENTAL TUMOR | P=0.030N* P=0.243 P=0.290N P=0.512N | |LOGISTIC REGRESSION | P=0.039N* P=0.261 P=0.321N P=0.570N | |COCHRAN-ARMITAGE | P=0.033N* | |FISHER EXACT | P=0.308 P=0.250N P=0.500N | |==============================================================================| | | |Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) | | Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/48 (2%) 3/48 (6%) 0/144 (0%) 0/48 (0%) | |ADJUSTED (b) | 6.3% 16.1% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 698 635 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.048N* P=0.221 P=0.356N P=0.665N | |INCIDENTAL TUMOR | P=0.030N* P=0.243 P=0.290N P=0.512N | |LOGISTIC REGRESSION | P=0.039N* P=0.261 P=0.321N P=0.570N | |COCHRAN-ARMITAGE | P=0.033N* | |FISHER EXACT | P=0.308 P=0.250N P=0.500N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 8 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Oral Mucosa | | Squamous Cell Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 2/48 (4%) 0/144 (0%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 10.6% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 635 --- --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.199N P=0.196 (e) (e) | |INCIDENTAL TUMOR | P=0.176N P=0.222 (e) (e) | |LOGISTIC REGRESSION | P=0.191N P=0.220 (e) (e) | |COCHRAN-ARMITAGE | P=0.181N | |FISHER EXACT | P=0.247 (e) (e) | |==============================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 32/34 (94%) 32/35 (91%) 76/86 (88%) 31/34 (91%) | |ADJUSTED (b) | 94.2% 100.0% 97.0% 100.0% | |TERMINAL (d) | 4/5 (80%) 4/4 (100%) 7/8 (88%) 3/3 (100%) | |FIRST INCIDENCE (DAYS) | 484 444 389 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.284 P=0.272 P=0.522N P=0.170 | |INCIDENTAL TUMOR | P=0.440N P=0.459N P=0.294N P=0.507N | |LOGISTIC REGRESSION | P=0.418N P=0.469N P=0.309N P=0.471N | |COCHRAN-ARMITAGE | P=0.389N | |FISHER EXACT | P=0.514N P=0.282N P=0.500N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 9 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Carcinoma or Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 33/34 (97%) 32/35 (91%) 76/86 (88%) 31/34 (91%) | |ADJUSTED (b) | 94.4% 100.0% 97.0% 100.0% | |TERMINAL (d) | 4/5 (80%) 4/4 (100%) 7/8 (88%) 3/3 (100%) | |FIRST INCIDENCE (DAYS) | 484 444 389 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.320 P=0.317 P=0.457N P=0.204 | |INCIDENTAL TUMOR | P=0.320N P=0.257N P=0.142N P=0.320N | |LOGISTIC REGRESSION | P=0.295N P=0.258N P=0.148N P=0.266N | |COCHRAN-ARMITAGE | P=0.271N | |FISHER EXACT | P=0.318N P=0.125N P=0.307N | |==============================================================================| | | |Skin | | Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal | | Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoep|thelioma | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 3/48 (6%) 4/48 (8%) 12/144 (8%) 3/48 (6%) | |ADJUSTED (b) | 25.4% 35.4% 15.8% 28.9% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 681 544 416 678 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.424 P=0.361 P=0.318 P=0.393 | |INCIDENTAL TUMOR | P=0.503N P=0.423 P=0.465 P=0.589 | |LOGISTIC REGRESSION | P=0.549N P=0.396 P=0.454 P=0.484 | |COCHRAN-ARMITAGE | P=0.532N | |FISHER EXACT | P=0.500 P=0.456 P=0.661N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 10 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Skin | | Fibroma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 4/48 (8%) 3/144 (2%) 1/48 (2%) | |ADJUSTED (b) | 18.0% 20.9% 6.1% 2.1% | |TERMINAL (d) | 1/8 (13%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 698 417 529 450 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.190N P=0.249 P=0.519N P=0.669N | |INCIDENTAL TUMOR | P=0.111N P=0.313 P=0.433N P=0.507N | |LOGISTIC REGRESSION | P=0.122N P=0.314 P=0.443N P=0.501N | |COCHRAN-ARMITAGE | P=0.121N | |FISHER EXACT | P=0.339 P=0.367N P=0.500N | |==============================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocyt|ma | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 5/48 (10%) 8/48 (17%) 15/144 (10%) 6/48 (13%) | |ADJUSTED (b) | 29.8% 50.5% 32.9% 37.9% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 664 417 234 450 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.424 P=0.147 P=0.416 P=0.257 | |INCIDENTAL TUMOR | P=0.418N P=0.165 P=0.599N P=0.567 | |LOGISTIC REGRESSION | P=0.482N P=0.194 P=0.569 P=0.487 | |COCHRAN-ARMITAGE | P=0.459N | |FISHER EXACT | P=0.276 P=0.594N P=0.500 | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 11 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Skin | | Keratoacanthoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 3/48 (6%) 8/144 (6%) 2/48 (4%) | |ADJUSTED (b) | 21.3% 33.7% 9.0% 20.0% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 717 704 416 678 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.497 P=0.369 P=0.403 P=0.462 | |INCIDENTAL TUMOR | P=0.512N P=0.374 P=0.520 P=0.618 | |LOGISTIC REGRESSION | P=0.533N P=0.362 P=0.527 P=0.535 | |COCHRAN-ARMITAGE | P=0.516N | |FISHER EXACT | P=0.500 P=0.524 P=0.692N | |==============================================================================| | | |Skin | | Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 3/48 (6%) 4/48 (8%) 12/144 (8%) 5/48 (10%) | |ADJUSTED (b) | 14.4% 37.5% 28.5% 36.5% | |TERMINAL (d) | 0/8 (0%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 664 683 234 528 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.170 P=0.341 P=0.308 P=0.195 | |INCIDENTAL TUMOR | P=0.336 P=0.348 P=0.471 P=0.432 | |LOGISTIC REGRESSION | P=0.289 P=0.390 P=0.421 P=0.341 | |COCHRAN-ARMITAGE | P=0.311 | |FISHER EXACT | P=0.500 P=0.456 P=0.357 | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 12 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Skin | | Squamous Cell Papilloma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 1/48 (2%) 3/144 (2%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 2.6% 4.6% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- 544 470 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.612N P=0.485 P=0.326 (e) | |INCIDENTAL TUMOR | P=0.525N P=0.638 P=0.397 (e) | |LOGISTIC REGRESSION | P=0.558N P=0.522 P=0.386 (e) | |COCHRAN-ARMITAGE | P=0.572N | |FISHER EXACT | P=0.500 P=0.420 (e) | |==============================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacan|homa | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 3/48 (6%) 4/48 (8%) 11/144 (8%) 2/48 (4%) | |ADJUSTED (b) | 25.4% 35.4% 13.1% 20.0% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 681 544 416 678 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.510N P=0.361 P=0.383 P=0.623 | |INCIDENTAL TUMOR | P=0.333N P=0.423 P=0.530 P=0.585N | |LOGISTIC REGRESSION | P=0.364N P=0.396 P=0.526 P=0.677N | |COCHRAN-ARMITAGE | P=0.356N | |FISHER EXACT | P=0.500 P=0.519 P=0.500N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 13 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Skin | | Squamous Cell Papilloma, Papilloma, or Keratoacanthoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 4/48 (8%) 11/144 (8%) 2/48 (4%) | |ADJUSTED (b) | 21.3% 35.4% 13.1% 20.0% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 717 544 416 678 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.516 P=0.230 P=0.230 P=0.462 | |INCIDENTAL TUMOR | P=0.451N P=0.281 P=0.337 P=0.618 | |LOGISTIC REGRESSION | P=0.481N P=0.247 P=0.337 P=0.535 | |COCHRAN-ARMITAGE | P=0.476N | |FISHER EXACT | P=0.339 P=0.324 P=0.692N | |==============================================================================| | | |Testes | | Adenoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 15/20 (75%) 9/9 (100%) 62/68 (91%) 12/13 (92%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 5/5 (100%) 3/3 (100%) 12/12 (100%) 1/1 (100%) | |FIRST INCIDENCE (DAYS) | 638 589 529 579 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.031 * P=0.426N P=0.025 * P=0.166 | |INCIDENTAL TUMOR | P=0.315 P=0.304 P=0.131 P=0.478 | |LOGISTIC REGRESSION | P=0.172 P=0.130 P=0.043 * P=0.270 | |COCHRAN-ARMITAGE | P=0.152 | |FISHER EXACT | P=0.131 P=0.068 P=0.217 | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 14 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |Tissue NOS | | Sarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 1/48 (2%) 0/48 (0%) 4/144 (3%) 0/48 (0%) | |ADJUSTED (b) | 4.2% 0.0% 10.1% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 1/14 (7%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 663 --- 440 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.608N P=0.569N P=0.513 P=0.557N | |INCIDENTAL TUMOR | P=0.560N P=0.554N P=0.587 P=0.512N | |LOGISTIC REGRESSION | P=0.545N P=0.520N P=0.607 P=0.529N | |COCHRAN-ARMITAGE | P=0.546N | |FISHER EXACT | P=0.500N P=0.633 P=0.500N | |==============================================================================| | | |Zymbal's Gland | | Carcinoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 4/144 (3%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 7.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 481 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.440 (e) P=0.240 (e) | |INCIDENTAL TUMOR | P=0.520 (e) P=0.298 (e) | |LOGISTIC REGRESSION | P=0.494 (e) P=0.284 (e) | |COCHRAN-ARMITAGE | P=0.490 | |FISHER EXACT | (e) P=0.313 (e) | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 15 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |All Organs | | Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 28/48 (58%) 25/48 (52%) 100/144 (69%) 37/48 (77%) | |ADJUSTED (b) | 89.4% 82.5% 97.2% 100.0% | |TERMINAL (d) | 6/8 (75%) 3/6 (50%) 12/14 (86%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 327 460 389 486 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.002 ** P=0.449 P=0.032 * P=0.008 ** | |INCIDENTAL TUMOR | P=0.002 ** P=0.386N P=0.062 P=0.013 * | |LOGISTIC REGRESSION | P=0.002 ** P=0.337N P=0.061 P=0.033 * | |COCHRAN-ARMITAGE | P=0.004 ** | |FISHER EXACT | P=0.341N P=0.109 P=0.040 * | |==============================================================================| | | |All Organs | | Mesothelioma: Benign, Malignant, NOS | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 2/48 (4%) 0/48 (0%) 2/144 (1%) 0/48 (0%) | |ADJUSTED (b) | 6.8% 0.0% 7.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | 466 --- 669 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.274N P=0.282N P=0.359N P=0.272N | |INCIDENTAL TUMOR | P=0.206N P=0.190N P=0.267N P=0.171N | |LOGISTIC REGRESSION | P=0.232N P=0.212N P=0.289N P=0.217N | |COCHRAN-ARMITAGE | P=0.227N | |FISHER EXACT | P=0.247N P=0.261N P=0.247N | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 16 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |All Organs | | Osteosarcoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/144 (1%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.1% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 641 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.543 (e) P=0.447 (e) | |INCIDENTAL TUMOR | P=0.608 (e) P=0.506 (e) | |LOGISTIC REGRESSION | P=0.575 (e) P=0.469 (e) | |COCHRAN-ARMITAGE | P=0.601 | |FISHER EXACT | (e) P=0.562 (e) | |==============================================================================| | | |All Organs | | Osteosarcoma or Osteoma | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 0/48 (0%) 0/48 (0%) 2/144 (1%) 0/48 (0%) | |ADJUSTED (b) | 0.0% 0.0% 5.1% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/14 (0%) 0/4 (0%) | |FIRST INCIDENCE (DAYS) | --- --- 641 --- | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.543 (e) P=0.447 (e) | |INCIDENTAL TUMOR | P=0.608 (e) P=0.506 (e) | |LOGISTIC REGRESSION | P=0.575 (e) P=0.469 (e) | |COCHRAN-ARMITAGE | P=0.601 | |FISHER EXACT | (e) P=0.562 (e) | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 17 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |All Organs | | Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 41/48 (85%) 40/48 (83%) 113/144 (78%) 42/48 (88%) | |ADJUSTED (b) | 97.5% 100.0% 99.0% 100.0% | |TERMINAL (d) | 7/8 (88%) 6/6 (100%) 13/14 (93%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 484 417 389 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.076 P=0.237 P=0.237 P=0.048 * | |INCIDENTAL TUMOR | P=0.406 P=0.559N P=0.328N P=0.482 | |LOGISTIC REGRESSION | P=0.375 P=0.593 P=0.432N P=0.369 | |COCHRAN-ARMITAGE | P=0.503 | |FISHER EXACT | P=0.500N P=0.203N P=0.500 | |==============================================================================| | | |All Organs | | Malignant Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 36/48 (75%) 30/48 (63%) 118/144 (82%) 40/48 (83%) | |ADJUSTED (b) | 93.0% 88.4% 98.1% 100.0% | |TERMINAL (d) | 6/8 (75%) 3/6 (50%) 12/14 (86%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 327 460 234 486 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.010 * P=0.530 P=0.057 P=0.030 * | |INCIDENTAL TUMOR | P=0.016 * P=0.174N P=0.168 P=0.150 | |LOGISTIC REGRESSION | P=0.013 * P=0.142N P=0.143 P=0.190 | |COCHRAN-ARMITAGE | P=0.021 * | |FISHER EXACT | P=0.135N P=0.200 P=0.226 | |==============================================================================| DATE: 05/08/95 EXPERIMENT: 88034 TEST: 07 PAGE 18 STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MALE RATS(FISCHER344) -- 6 OZONE/NNK TERMINAL SACRIFICE AT 106 WEEKS |==============================================================================| |DOSE | TRIOCT./ .1MG/KG 1M/K NNK 1 MG/KG | | | AIR NNK/AIR /OZONE NNK/AIR | |==============================================================================| | | |All Organs | | Malignant and Benign Tumors | | | |------------------------------------------------------------------------------| |TUMOR RATES | # # # # | |----------- | | |OVERALL (a) | 48/48 (100%) 48/48 (100%)139/144 (97%) 48/48 (100%) | |ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 8/8 (100%) 6/6 (100%) 14/14 (100%) 4/4 (100%) | |FIRST INCIDENCE (DAYS) | 327 417 234 429 | |-----------------------| | |STATISTICAL TESTS (f) | | |-----------------------| | |LIFE TABLE | P=0.095 P=0.185 P=0.155 P=0.061 | |INCIDENTAL TUMOR | P=0.451N (e) P=0.296N (e) | |LOGISTIC REGRESSION | P=0.529N (e) P=0.436N (e) | |COCHRAN-ARMITAGE | P=0.454N | |FISHER EXACT | P=1.000N P=0.233N P=1.000N | |==============================================================================| (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).