TDMS Study 05160-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 05 TIME: 15:09:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: STEDHAM, M. CAS: 127-00-4 Rats(FISCHER344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research 1-CHLORO-2-PROPANOL DATE: 08/01/97 EXPERIMENT: 05160 TEST: 05 TIME: 15:09:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-05300 ROUTE: DOSED WATER NTP C#: 61983C PATHOLOGIST: STEDHAM, M. CAS: 127-00-4 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF 1-CHLORO-2-PROPANOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Hyperplasia Liver Basophilic Focus Clear Cell Focus Lung Hemorrhage Lymph Node, Mandibular Ectasia Lymph Node, Mediastinal Hyperplasia Lymphoid Lymph Node: Renal Hemorrhage Mammary Gland Hyperplasia Inflammation Chronic Nose: Olfactory Epithelium Inflammation Chronic Nose: Respiratory Epithelium Foreign Body Inflammation Chronic Pancreas: Acinus Hyperplasia Skin Ulcer Spleen Fibrosis Thymus Atrophy =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Medulla Hyperplasia Bone Marrow Atrophy Bone Marrow: Myeloid Cell Hyperplasia Clitoral Gland Atrophy Heart Cardiomyopathy Kidney Nephropathy Liver Angiectasis Deformity Hepatodiaphragmatic Nodule Inflammation Granulomatous Mammary Gland Dilatation Nose: Olfactory Epithelium Degeneration Hyaline Nose: Respiratory Epithelium Degeneration Hyaline Hyperplasia Inflammation Chronic Pancreas: Acinus Atrophy Pituitary Gland: Pars Distalis Hyperplasia Spleen Hematopoietic Cell Proliferation Spleen: Capsule Fibrosis Stomach, Forestomach Inflammation Chronic Uterus Hydrometra =============================================================== Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |7/49 (14%) 8/50 (16%) 9/50 (18%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |16.0% 17.5% 20.3% 22.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |5/25 (20%) 7/33 (21%) 7/30 (23%) 8/31 (26%) | |FIRST INCIDENCE | --- --- 729 (T) --- |597 728 714 449 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.705 (e) P=0.536 (e) |P=0.331 P=0.521N P=0.526 P=0.438 | |POLY 3 | P=0.752 (e) P=0.607 (e) |P=0.260 P=0.548 P=0.413 P=0.334 | |POLY 1.5 | P=0.725 (e) P=0.557 (e) |P=0.259 P=0.529 P=0.410 P=0.324 | |POLY 6 | P=0.789 (e) P=0.681 (e) |P=0.266 P=0.578 P=0.422 P=0.353 | |LOGISTIC REGRESSION| (e) (e) P=0.536 (e) |P=0.254 P=0.568 P=0.424 P=0.314 | |COCH-ARM / FISHERS | P=0.689 (e) P=0.495 (e) |P=0.253 P=0.517 P=0.410 P=0.314 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 2/49 (4%) 0/50 (0%) |5/49 (10%) 3/50 (6%) 1/50 (2%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% 4.9% 0.0% |11.5% 6.6% 2.3% 8.9% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 1/24 (4%) 0/23 (0%) |3/25 (12%) 3/33 (9%) 1/30 (3%) 3/31 (10%) | |FIRST INCIDENCE | --- 555 408 --- |653 734 (T) 734 (T) 562 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.466N P=0.263 P=0.262 (e) |P=0.387N P=0.232N P=0.076N P=0.401N | |POLY 3 | P=0.482N P=0.309 P=0.307 (e) |P=0.445N P=0.342N P=0.106N P=0.492N | |POLY 1.5 | P=0.482N P=0.273 P=0.273 (e) |P=0.440N P=0.347N P=0.102N P=0.491N | |POLY 6 | P=0.489N P=0.366 P=0.363 (e) |P=0.451N P=0.334N P=0.111N P=0.490N | |LOGISTIC REGRESSION| P=0.562N P=0.214 P=0.181 (e) |P=0.434N P=0.291N P=0.093N P=0.485N | |COCH-ARM / FISHERS | P=0.488N P=0.242 P=0.242 (e) |P=0.435N P=0.346N P=0.098N P=0.487N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 0/49 (0%) 1/50 (2%) |2/49 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 2.4% 0.0% 2.4% |4.5% 6.5% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 711 --- 697 |519 677 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.596N P=0.719N P=0.464N P=0.733N |P=0.068N P=0.556 P=0.239N P=0.242N | |POLY 3 | P=0.634N P=0.800N P=0.594N P=0.796N |P=0.072N P=0.541 P=0.264N P=0.261N | |POLY 1.5 | P=0.622N P=0.784N P=0.552N P=0.779N |P=0.069N P=0.524 P=0.250N P=0.249N | |POLY 6 | P=0.655N P=0.824N P=0.658N P=0.825N |P=0.074N P=0.570 P=0.285N P=0.278N | |LOGISTIC REGRESSION| P=0.593N P=0.731N (e) P=0.737N |P=0.066N P=0.543 P=0.164N P=0.143N | |COCH-ARM / FISHERS | P=0.611N P=0.747 P=0.505N P=0.753N |P=0.067N P=0.510 P=0.242N P=0.242N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/49 (6%) 0/50 (0%) |4/49 (8%) 5/50 (10%) 7/50 (14%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.4% 0.0% |9.2% 10.8% 15.6% 17.8% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 2/24 (8%) 0/23 (0%) |1/25 (4%) 2/33 (6%) 4/30 (13%) 3/31 (10%) | |FIRST INCIDENCE | --- --- 603 --- |646 636 659 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.555 (e) P=0.150 (e) |P=0.163 P=0.617 P=0.338 P=0.269 | |POLY 3 | P=0.593 (e) P=0.159 (e) |P=0.125 P=0.552 P=0.287 P=0.201 | |POLY 1.5 | P=0.567 (e) P=0.138 (e) |P=0.125 P=0.531 P=0.280 P=0.193 | |POLY 6 | P=0.626 (e) P=0.194 (e) |P=0.128 P=0.586 P=0.302 P=0.217 | |LOGISTIC REGRESSION| P=0.540 (e) P=0.124 (e) |P=0.124 P=0.510 P=0.274 P=0.193 | |COCH-ARM / FISHERS | P=0.531 (e) P=0.117 (e) |P=0.125 P=0.513 P=0.274 P=0.188 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 8/49 (16%) 8/49 (16%) 4/50 (8%) |5/49 (10%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 24.9% 18.9% 19.6% 9.5% |11.4% 0.0% 2.3% 4.5% | |TERMINAL (d) | 4/20 (20%) 4/23 (17%) 6/24 (25%) 2/23 (9%) |2/25 (8%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 551 544 592 569 |635 --- 734 (T) 731 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.046N* P=0.297N P=0.286N P=0.056N |P=0.217N P=0.023N* P=0.086N P=0.167N | |POLY 3 | P=0.052N P=0.365N P=0.403N P=0.062N |P=0.253N P=0.030N* P=0.109N P=0.223N | |POLY 1.5 | P=0.055N P=0.386N P=0.406N P=0.065N |P=0.245N P=0.030N* P=0.104N P=0.218N | |POLY 6 | P=0.053N P=0.343N P=0.405N P=0.061N |P=0.265N P=0.030N* P=0.116N P=0.230N | |LOGISTIC REGRESSION| P=0.050N P=0.370N P=0.352N P=0.057N |P=0.240N P=0.031N* P=0.099N P=0.209N | |COCH-ARM / FISHERS | P=0.062N P=0.416N P=0.416N P=0.074N |P=0.240N P=0.027N* P=0.098N P=0.210N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |6/50 (12%) 7/50 (14%) 7/50 (14%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 2.5% 2.4% 0.0% 2.4% |13.5% 15.1% 15.5% 8.9% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 4/33 (12%) 3/30 (10%) 2/31 (7%) | |FIRST INCIDENCE | 616 630 --- 520 |635 627 506 698 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.589N P=0.736N P=0.489N P=0.742N |P=0.236N P=0.581N P=0.574 P=0.294N | |POLY 3 | P=0.634N P=0.796N P=0.593N P=0.793N |P=0.283N P=0.543 P=0.527 P=0.380N | |POLY 1.5 | P=0.623N P=0.780N P=0.550N P=0.777N |P=0.281N P=0.519 P=0.514 P=0.377N | |POLY 6 | P=0.654N P=0.821N P=0.658N P=0.820N |P=0.282N P=0.580 P=0.549 P=0.379N | |LOGISTIC REGRESSION| P=0.620 P=0.738 P=0.520N P=0.664 |P=0.276N P=0.509 P=0.499 P=0.363N | |COCH-ARM / FISHERS | P=0.612N P=0.753N P=0.500N P=0.753N |P=0.276N P=0.500 P=0.500 P=0.370N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/47 (9%) 0/45 (0%) 1/47 (2%) 3/49 (6%) |0/47 (0%) 0/50 (0%) 0/47 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 10.2% 0.0% 2.6% 7.1% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | 502 --- 653 520 |--- --- --- 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.580N P=0.058N P=0.172N P=0.459N |P=0.049 * (e) (e) P=0.261 | |POLY 3 | P=0.595N P=0.077N P=0.204N P=0.486N |P=0.051 (e) (e) P=0.280 | |POLY 1.5 | P=0.590N P=0.072N P=0.192N P=0.479N |P=0.049 * (e) (e) P=0.264 | |POLY 6 | P=0.606N P=0.086N P=0.225N P=0.503N |P=0.055 (e) (e) P=0.307 | |LOGISTIC REGRESSION| P=0.450 P=0.092N P=0.227N P=0.617 |P=0.037 * (e) (e) P=0.279 | |COCH-ARM / FISHERS | P=0.585N P=0.064N P=0.181N P=0.476N |P=0.047 * (e) (e) P=0.258 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 0/45 (0%) 2/47 (4%) 0/49 (0%) |0/47 (0%) 0/50 (0%) 0/47 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.1% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 667 --- |--- --- --- 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.610 (e) P=0.268 (e) |P=0.205 (e) (e) P=0.527 | |POLY 3 | P=0.652 (e) P=0.304 (e) |P=0.221 (e) (e) P=0.560 | |POLY 1.5 | P=0.630 (e) P=0.273 (e) |P=0.211 (e) (e) P=0.536 | |POLY 6 | P=0.680 (e) P=0.352 (e) |P=0.236 (e) (e) P=0.597 | |LOGISTIC REGRESSION| P=0.604 (e) P=0.245 (e) |P=0.198 (e) (e) P=0.508 | |COCH-ARM / FISHERS | P=0.598 (e) P=0.247 (e) |P=0.199 (e) (e) P=0.510 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/47 (4%) 4/45 (9%) 2/47 (4%) 1/49 (2%) |1/47 (2%) 3/50 (6%) 0/47 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 10.1% 5.1% 2.4% |2.4% 6.5% 0.0% 2.3% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |0/25 (0%) 2/33 (6%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | 585 544 408 648 |719 691 --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234N P=0.395 P=0.659N P=0.453N |P=0.360N P=0.381 P=0.494N P=0.726N | |POLY 3 | P=0.234N P=0.387 P=0.716N P=0.522N |P=0.396N P=0.362 P=0.547N P=0.775N | |POLY 1.5 | P=0.232N P=0.356 P=0.704N P=0.503N |P=0.393N P=0.345 P=0.526N P=0.765N | |POLY 6 | P=0.242N P=0.431 P=0.738N P=0.554N |P=0.398N P=0.390 P=0.579N P=0.789N | |LOGISTIC REGRESSION| P=0.301N P=0.262 P=0.653 P=0.514N |P=0.381N P=0.347 P=0.495N P=0.739N | |COCH-ARM / FISHERS | P=0.235N P=0.318 P=0.692N P=0.484N |P=0.388N P=0.332 P=0.500N P=0.742N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow: Myeloid Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/47 (0%) 1/45 (2%) 0/47 (0%) 0/49 (0%) |3/47 (6%) 0/50 (0%) 0/47 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |7.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 388 --- --- |727 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.549N P=0.504 (e) (e) |P=0.042N* P=0.082N P=0.097N P=0.090N | |POLY 3 | P=0.581N P=0.593 (e) (e) |P=0.054N P=0.114N P=0.131N P=0.122N | |POLY 1.5 | P=0.562N P=0.548 (e) (e) |P=0.050N P=0.113N P=0.126N P=0.118N | |POLY 6 | P=0.615N P=0.657 (e) (e) |P=0.059N P=0.117N P=0.139N P=0.128N | |LOGISTIC REGRESSION| P=0.872 P=0.350 (e) (e) |P=0.044N* P=0.089N P=0.103N P=0.094N | |COCH-ARM / FISHERS | P=0.542N P=0.489 (e) (e) |P=0.050N P=0.110N P=0.121N P=0.113N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Bone: Femur | | Hyperostosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |629 --- 694 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.187N P=0.205N P=0.475N P=0.216N | |POLY 3 | (e) (e) (e) (e) |P=0.213N P=0.255N P=0.529N P=0.264N | |POLY 1.5 | (e) (e) (e) (e) |P=0.205N P=0.248N P=0.516N P=0.252N | |POLY 6 | (e) (e) (e) (e) |P=0.226N P=0.264N P=0.546N P=0.281N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.196N P=0.236N P=0.499N P=0.236N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.196N P=0.247N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.6% 4.8% 2.4% 9.5% |4.5% 4.4% 6.7% 4.5% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 637 723 533 682 |519 677 663 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.134 P=0.549 P=0.738N P=0.229 |P=0.578 P=0.638N P=0.510 P=0.676N | |POLY 3 | P=0.133 P=0.577 P=0.801N P=0.232 |P=0.573 P=0.702N P=0.522 P=0.713N | |POLY 1.5 | P=0.125 P=0.543 P=0.782N P=0.208 |P=0.569 P=0.701N P=0.510 P=0.704 | |POLY 6 | P=0.146 P=0.626 P=0.830N P=0.268 |P=0.583 P=0.704N P=0.544 P=0.722N | |LOGISTIC REGRESSION| P=0.116 P=0.527 P=0.729 P=0.197 |P=0.564 P=0.675N P=0.525 P=0.671N | |COCH-ARM / FISHERS | P=0.113 P=0.500 P=0.753N P=0.181 |P=0.566 P=0.691N P=0.500 P=0.691N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/49 (0%) 0/49 (0%) 0/49 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | |0/25 (0%) 0/32 (0%) 0/29 (0%) 0/31 (0%) | |FIRST INCIDENCE | |--- --- --- 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.048 * (e) (e) P=0.261 | |POLY 3 | |P=0.050 (e) (e) P=0.272 | |POLY 1.5 | |P=0.048 * (e) (e) P=0.255 | |POLY 6 | |P=0.054 (e) (e) P=0.302 | |LOGISTIC REGRESSION| |P=0.046 * (e) (e) P=0.238 | |COCH-ARM / FISHERS | |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/49 (8%) 4/49 (8%) 5/49 (10%) 6/49 (12%) | |POLY-3 ADJUSTED (b)| |9.3% 8.9% 11.5% 13.8% | |TERMINAL (d) | |4/25 (16%) 3/32 (9%) 2/29 (7%) 6/31 (19%) | |FIRST INCIDENCE | |734 (T) 699 708 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.342 P=0.509N P=0.582 P=0.510 | |POLY 3 | |P=0.275 P=0.635N P=0.527 P=0.396 | |POLY 1.5 | |P=0.272 P=0.642N P=0.513 P=0.382 | |POLY 6 | |P=0.282 P=0.622N P=0.554 P=0.424 | |LOGISTIC REGRESSION| |P=0.295 P=0.557N P=0.538 P=0.510 | |COCH-ARM / FISHERS | |P=0.269 P=0.643N P=0.500 P=0.370 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/49 (6%) 0/49 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |7.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | |3/25 (12%) 0/32 (0%) 0/29 (0%) 0/31 (0%) | |FIRST INCIDENCE | |734 (T) --- 721 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.076N P=0.080N P=0.259N P=0.085N | |POLY 3 | |P=0.101N P=0.125N P=0.327N P=0.132N | |POLY 1.5 | |P=0.095N P=0.123N P=0.318N P=0.126N | |POLY 6 | |P=0.109N P=0.127N P=0.339N P=0.139N | |LOGISTIC REGRESSION| |P=0.081N (e) P=0.274N (e) | |COCH-ARM / FISHERS | |P=0.092N P=0.121N P=0.309N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 100.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- 605 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.205 (e) (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=1.000N (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=1.000N (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=1.000N (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.280 (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM /FISHERS | P=0.187 (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 35/50 (70%) 41/50 (82%) 42/50 (84%) 33/50 (66%) |18/50 (36%) 21/50 (42%) 15/50 (30%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 74.3% 85.6% 88.4% 71.1% |39.4% 44.5% 32.5% 24.4% | |TERMINAL (d) | 12/20 (60%) 18/23 (78%) 21/24 (88%) 17/23 (74%) |10/25 (40%) 12/33 (36%) 6/30 (20%) 8/31 (26%) | |FIRST INCIDENCE | 362 502 533 520 |541 627 528 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.173N P=0.497 P=0.420 P=0.238N |P=0.025N* P=0.494N P=0.231N P=0.042N* | |POLY 3 | P=0.274N P=0.125 P=0.058 P=0.460N |P=0.035N* P=0.392 P=0.326N P=0.095N | |POLY 1.5 | P=0.246N P=0.119 P=0.062 P=0.434N |P=0.034N* P=0.358 P=0.333N P=0.096N | |POLY 6 | P=0.342N P=0.138 P=0.060 P=0.517N |P=0.035N* P=0.456 P=0.305N P=0.091N | |LOGISTIC REGRESSION| P=0.194N P=0.131 P=0.086 P=0.397N |P=0.032N* P=0.370 P=0.334N P=0.084N | |COCH-ARM / FISHERS | P=0.236N P=0.121 P=0.077 P=0.415N |P=0.033N* P=0.341 P=0.335N P=0.093N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 579 --- --- 648 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.449N P=0.224N P=0.234N P=0.463N |(e) (e) (e) (e) | |POLY 3 | P=0.507N P=0.279N P=0.288N P=0.533N |(e) (e) (e) (e) | |POLY 1.5 | P=0.490N P=0.259N P=0.264N P=0.516N |(e) (e) (e) (e) | |POLY 6 | P=0.534N P=0.314N P=0.329N P=0.564N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.529N P=0.280N P=0.269N P=0.592N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.470N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 6/50 (12%) 4/50 (8%) |4/50 (8%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 7.6% 0.0% 14.5% 9.4% |9.0% 4.3% 6.7% 6.7% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 3/24 (13%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 658 --- 648 520 |635 627 571 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.236 P=0.099N P=0.310 P=0.563 |P=0.485N P=0.295N P=0.483N P=0.437N | |POLY 3 | P=0.223 P=0.136N P=0.294 P=0.577 |P=0.522N P=0.332N P=0.510N P=0.513N | |POLY 1.5 | P=0.210 P=0.128N P=0.271 P=0.545 |P=0.514N P=0.337N P=0.506N P=0.509N | |POLY 6 | P=0.238 P=0.153N P=0.329 P=0.618 |P=0.529N P=0.323N P=0.514N P=0.516N | |LOGISTIC REGRESSION| P=0.207 P=0.110N P=0.267 P=0.516 |P=0.508N P=0.330N P=0.495N P=0.500N | |COCH-ARM / FISHERS | P=0.193 P=0.121N P=0.243 P=0.500 |P=0.506N P=0.339N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/46 (2%) 3/46 (7%) 1/48 (2%) 2/47 (4%) |3/47 (6%) 2/49 (4%) 2/49 (4%) 1/48 (2%) | |POLY-3 ADJUSTED (b)| 2.8% 7.8% 2.5% 5.1% |7.2% 4.5% 4.6% 2.3% | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 0/24 (0%) 2/23 (9%) |1/25 (4%) 2/33 (6%) 2/30 (7%) 1/31 (3%) | |FIRST INCIDENCE | 729 (T) 555 571 729 (T) |712 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570 P=0.357 P=0.735N P=0.549 |P=0.194N P=0.397N P=0.430N P=0.246N | |POLY 3 | P=0.599 P=0.381 P=0.791N P=0.591 |P=0.238N P=0.487N P=0.502N P=0.314N | |POLY 1.5 | P=0.577 P=0.346 P=0.773N P=0.554 |P=0.235N P=0.487N P=0.493N P=0.308N | |POLY 6 | P=0.628 P=0.433 P=0.820N P=0.642 |P=0.242N P=0.486N P=0.514N P=0.322N | |LOGISTIC REGRESSION| P=0.556 P=0.318 P=0.762N P=0.549 |P=0.207N P=0.428N P=0.458N P=0.270N | |COCH-ARM / FISHERS | P=0.547 P=0.308 P=0.742N P=0.508 |P=0.229N P=0.480N P=0.480N P=0.301N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/45 (7%) 3/47 (6%) 3/46 (7%) 2/47 (4%) |6/49 (12%) 4/49 (8%) 3/48 (6%) 7/49 (14%) | |POLY-3 ADJUSTED (b)| 8.4% 7.5% 8.0% 5.0% |14.0% 8.9% 7.0% 15.9% | |TERMINAL (d) | 3/20 (15%) 2/23 (9%) 2/24 (8%) 2/23 (9%) |6/25 (24%) 4/33 (12%) 3/30 (10%) 6/31 (19%) | |FIRST INCIDENCE | 729 (T) 388 686 729 (T) |734 (T) 734 (T) 734 (T) 722 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.348N P=0.608N P=0.586N P=0.435N |P=0.457 P=0.204N P=0.153N P=0.578N | |POLY 3 | P=0.375N P=0.648N P=0.677N P=0.493N |P=0.379 P=0.357N P=0.259N P=0.535 | |POLY 1.5 | P=0.376N P=0.642N P=0.665N P=0.484N |P=0.375 P=0.367N P=0.257N P=0.517 | |POLY 6 | P=0.380N P=0.662N P=0.697N P=0.512N |P=0.387 P=0.340N P=0.260N P=0.569 | |LOGISTIC REGRESSION| P=0.359N P=0.642N P=0.632N P=0.435N |P=0.449 P=0.204N P=0.153N P=0.611N | |COCH-ARM / FISHERS | P=0.380N P=0.641N P=0.651N P=0.479N |P=0.370 P=0.370N P=0.254N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/49 (0%) 2/49 (4%) 3/50 (6%) |1/46 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 7.7% 0.0% 4.9% 7.2% |2.5% 0.0% 0.0% 4.5% | |TERMINAL (d) | 2/20 (10%) 0/23 (0%) 1/24 (4%) 3/23 (13%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 2/31 (7%) | |FIRST INCIDENCE | 703 --- 653 729 (T) |734 (T) --- --- 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.432 P=0.095N P=0.435N P=0.600N |P=0.264 P=0.445N P=0.464N P=0.575 | |POLY 3 | P=0.417 P=0.138N P=0.528N P=0.669N |P=0.265 P=0.525N P=0.536N P=0.560 | |POLY 1.5 | P=0.407 P=0.130N P=0.518N P=0.663N |P=0.261 P=0.510N P=0.512N P=0.545 | |POLY 6 | P=0.431 P=0.152N P=0.545N P=0.685N |P=0.272 P=0.549N P=0.571N P=0.584 | |LOGISTIC REGRESSION| P=0.423 P=0.094N P=0.467N P=0.607N |P=0.264 (e) (e) P=0.575 | |COCH-ARM / FISHERS | P=0.392 P=0.125N P=0.510N P=0.661N |P=0.254 P=0.484N P=0.479N P=0.532 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |24/46 (52%) 28/49 (57%) 26/50 (52%) 30/50 (60%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 2.4% |55.8% 58.8% 55.7% 65.1% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |16/25 (64%) 18/33 (55%) 19/30 (63%) 23/31 (74%) | |FIRST INCIDENCE | 579 --- --- 648 |519 217 525 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.449N P=0.224N P=0.234N P=0.463N |P=0.364 P=0.440N P=0.475N P=0.481 | |POLY 3 | P=0.507N P=0.282N P=0.290N P=0.533N |P=0.224 P=0.472 P=0.590N P=0.244 | |POLY 1.5 | P=0.489N P=0.263N P=0.267N P=0.516N |P=0.252 P=0.432 P=0.585N P=0.260 | |POLY 6 | P=0.534N P=0.314N P=0.329N P=0.564N |P=0.188 P=0.538 P=0.593N P=0.227 | |LOGISTIC REGRESSION| P=0.529N P=0.286N P=0.276N P=0.592N |P=0.285 P=0.388 P=0.580N P=0.286 | |COCH-ARM / FISHERS | P=0.469N P=0.253N P=0.253N P=0.500N |P=0.292 P=0.390 P=0.574N P=0.286 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 46/49 (94%) 46/49 (94%) 49/50 (98%) |23/46 (50%) 23/49 (47%) 15/50 (30%) 20/50 (40%) | |POLY-3 ADJUSTED (b)| 95.1% 97.1% 95.8% 98.9% |53.8% 50.8% 33.6% 43.9% | |TERMINAL (d) | 20/20 (100%) 23/23 (100%) 23/24 (96%) 23/23 (100%)|13/25 (52%) 19/33 (58%) 10/30 (33%) 16/31 (52%) | |FIRST INCIDENCE | 445 502 408 502 |541 682 694 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.455N P=0.239N P=0.254N P=0.408N |P=0.117N P=0.207N P=0.036N* P=0.141N | |POLY 3 | P=0.213 P=0.528 P=0.655 P=0.284 |P=0.148N P=0.480N P=0.043N* P=0.239N | |POLY 1.5 | P=0.182 P=0.521 P=0.606 P=0.239 |P=0.142N P=0.484N P=0.039N* P=0.232N | |POLY 6 | P=0.251 P=0.554 P=0.706 P=0.345 |P=0.153N P=0.470N P=0.048N* P=0.243N | |LOGISTIC REGRESSION| P=0.226 P=0.662N P=0.586 P=0.291 |P=0.137N P=0.369N P=0.034N* P=0.207N | |COCH-ARM / FISHERS | P=0.136 P=0.511 P=0.511 P=0.181 |P=0.137N P=0.463N P=0.036N* P=0.218N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/49 (6%) 4/49 (8%) 3/50 (6%) |2/46 (4%) 2/49 (4%) 4/50 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.2% 7.2% 9.7% 7.1% |4.8% 4.4% 9.0% 2.2% | |TERMINAL (d) | 3/20 (15%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 1/33 (3%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | 673 630 627 683 |635 678 659 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.409N P=0.422N P=0.572N P=0.435N |P=0.410N P=0.622N P=0.377 P=0.479N | |POLY 3 | P=0.450N P=0.500N P=0.645N P=0.494N |P=0.420N P=0.681N P=0.391 P=0.499N | |POLY 1.5 | P=0.453N P=0.504N P=0.648N P=0.494N |P=0.412N P=0.679N P=0.384 P=0.487N | |POLY 6 | P=0.452N P=0.496N P=0.640N P=0.501N |P=0.429N P=0.684N P=0.404 P=0.516N | |LOGISTIC REGRESSION| P=0.454N P=0.469N P=0.640N P=0.445N |P=0.400N P=0.668N P=0.379 P=0.457N | |COCH-ARM / FISHERS | P=0.463N P=0.511N P=0.631 P=0.500N |P=0.401N P=0.667N P=0.379 P=0.468N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 11/50 (22%) 7/50 (14%) 9/50 (18%) |1/50 (2%) 5/50 (10%) 3/50 (6%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 12.8% 25.9% 17.2% 21.4% |2.3% 10.9% 6.8% 15.6% | |TERMINAL (d) | 4/20 (20%) 8/23 (35%) 6/24 (25%) 6/23 (26%) |1/25 (4%) 4/33 (12%) 3/30 (10%) 5/31 (16%) | |FIRST INCIDENCE | 693 613 710 682 |734 (T) 678 734 (T) 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.393 P=0.140 P=0.503 P=0.270 |P=0.057 P=0.174 P=0.371 P=0.058 | |POLY 3 | P=0.376 P=0.123 P=0.440 P=0.255 |P=0.044 * P=0.122 P=0.333 P=0.036 * | |POLY 1.5 | P=0.350 P=0.105 P=0.414 P=0.228 |P=0.042 * P=0.111 P=0.320 P=0.033 * | |POLY 6 | P=0.406 P=0.155 P=0.479 P=0.293 |P=0.048 * P=0.142 P=0.357 P=0.042 * | |LOGISTIC REGRESSION| P=0.378 P=0.129 P=0.461 P=0.261 |P=0.043 * P=0.131 P=0.371 P=0.037 * | |COCH-ARM / FISHERS | P=0.313 P=0.086 P=0.380 P=0.194 |P=0.041 * P=0.102 P=0.309 P=0.030 * | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |29/50 (58%) 33/50 (66%) 27/50 (54%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 7.6% 0.0% 0.0% 0.0% |63.9% 69.9% 59.5% 68.9% | |TERMINAL (d) | 2/20 (10%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |22/25 (88%) 26/33 (79%) 22/30 (73%) 26/31 (84%) | |FIRST INCIDENCE | 551 --- --- --- |609 484 525 449 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.044N* P=0.104N P=0.098N P=0.103N |P=0.364N P=0.297N P=0.126N P=0.362N | |POLY 3 | P=0.060N P=0.137N P=0.143N P=0.136N |P=0.442 P=0.350 P=0.418N P=0.389 | |POLY 1.5 | P=0.054N P=0.128N P=0.131N P=0.127N |P=0.435 P=0.298 P=0.422N P=0.364 | |POLY 6 | P=0.070N P=0.153N P=0.164N P=0.154N |P=0.460 P=0.448 P=0.402N P=0.442 | |LOGISTIC REGRESSION| P=0.051N P=0.118N P=0.119N P=0.118N |P=0.420 P=0.456 P=0.359N P=0.392 | |COCH-ARM / FISHERS | P=0.051N P=0.121N P=0.121N P=0.121N |P=0.422 P=0.268 P=0.420N P=0.341 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/50 (16%) 7/50 (14%) 3/50 (6%) |3/50 (6%) 7/50 (14%) 7/50 (14%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 18.0% 19.2% 17.2% 7.2% |6.8% 15.3% 15.8% 4.5% | |TERMINAL (d) | 7/20 (35%) 8/23 (35%) 7/24 (29%) 3/23 (13%) |3/25 (12%) 7/33 (21%) 7/30 (23%) 2/31 (7%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |734 (T) 734 (T) 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049N* P=0.619N P=0.465N P=0.093N |P=0.209N P=0.286 P=0.234 P=0.401N | |POLY 3 | P=0.080N P=0.587 P=0.609N P=0.144N |P=0.286N P=0.185 P=0.171 P=0.516N | |POLY 1.5 | P=0.088N P=0.549 P=0.609N P=0.149N |P=0.289N P=0.170 P=0.164 P=0.510N | |POLY 6 | P=0.074N P=0.640 P=0.613N P=0.143N |P=0.277N P=0.212 P=0.185 P=0.523N | |LOGISTIC REGRESSION| P=0.049N* P=0.619N P=0.465N P=0.093N |P=0.209N P=0.286 P=0.234 P=0.401N | |COCH-ARM / FISHERS | P=0.101N P=0.500 P=0.613N P=0.159N |P=0.290N P=0.159 P=0.159 P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 362 --- --- --- |--- 676 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.120N P=0.237N P=0.240N P=0.235N |P=0.379N P=0.293 (e) (e) | |POLY 3 | P=0.142N P=0.281N P=0.290N P=0.280N |P=0.396N P=0.275 (e) (e) | |POLY 1.5 | P=0.131N P=0.260N P=0.265N P=0.259N |P=0.392N P=0.257 (e) (e) | |POLY 6 | P=0.162N P=0.315N P=0.330N P=0.316N |P=0.399N P=0.307 (e) (e) | |LOGISTIC REGRESSION| P=0.242N P=0.316N P=0.320N P=0.753N |P=0.385N P=0.239 (e) (e) | |COCH-ARM / FISHERS | P=0.120N P=0.247N P=0.247N P=0.247N |P=0.384N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Deformity | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 6/50 (12%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 4.8% 2.4% 0.0% |6.8% 13.0% 6.7% 0.0% | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |2/25 (8%) 3/33 (9%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 716 667 --- |722 677 525 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.216N P=0.560 P=0.729N P=0.472N |P=0.040N* P=0.374 P=0.599N P=0.090N | |POLY 3 | P=0.245N P=0.581 P=0.804N P=0.583N |P=0.048N* P=0.282 P=0.672N P=0.131N | |POLY 1.5 | P=0.242N P=0.545 P=0.784N P=0.543N |P=0.049N* P=0.261 P=0.668N P=0.126N | |POLY 6 | P=0.254N P=0.634 P=0.833N P=0.646N |P=0.047N* P=0.319 P=0.677N P=0.139N | |LOGISTIC REGRESSION| P=0.222N P=0.559 P=0.750N (e) |P=0.050N P=0.271 P=0.663 P=0.099N | |COCH-ARM / FISHERS | P=0.241N P=0.500 P=0.753N P=0.500N |P=0.050N P=0.243 P=0.661N P=0.121N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 8/50 (16%) 12/50 (24%) 12/50 (24%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 30.3% 19.0% 29.4% 28.1% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 8/20 (40%) 6/23 (26%) 11/24 (46%) 6/23 (26%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 579 643 695 582 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.132N P=0.409N P=0.458N |(e) (e) (e) (e) | |POLY 3 | P=0.464 P=0.190N P=0.587N P=0.530N |(e) (e) (e) (e) | |POLY 1.5 | P=0.438 P=0.205N P=0.586N P=0.554N |(e) (e) (e) (e) | |POLY 6 | P=0.495 P=0.174N P=0.595N P=0.505N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.489 P=0.133N P=0.486N P=0.470N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.399 P=0.227N P=0.592N P=0.592N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 10/50 (20%) 10/50 (20%) 3/50 (6%) |6/50 (12%) 3/50 (6%) 7/50 (14%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 10.1% 23.8% 24.6% 7.2% |13.6% 6.6% 15.8% 8.9% | |TERMINAL (d) | 3/20 (15%) 8/23 (35%) 10/24 (42%) 3/23 (13%) |4/25 (16%) 3/33 (9%) 6/30 (20%) 3/31 (10%) | |FIRST INCIDENCE | 532 630 729 (T) 729 (T) |641 734 (T) 697 649 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.181N P=0.115 P=0.119 P=0.430N |P=0.369N P=0.139N P=0.616N P=0.268N | |POLY 3 | P=0.225N P=0.098 P=0.087 P=0.506N |P=0.454N P=0.236N P=0.519 P=0.375N | |POLY 1.5 | P=0.238N P=0.086 P=0.081 P=0.500N |P=0.451N P=0.242N P=0.509 P=0.374N | |POLY 6 | P=0.215N P=0.117 P=0.097 P=0.521N |P=0.455N P=0.226N P=0.539 P=0.370N | |LOGISTIC REGRESSION| P=0.204N P=0.106 P=0.095 P=0.450N |P=0.431N P=0.188N P=0.535 P=0.350N | |COCH-ARM / FISHERS | P=0.266N P=0.074 P=0.074 P=0.500N |P=0.447N P=0.243N P=0.500 P=0.370N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 555 --- --- |659 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.366N P=0.263 (e) (e) |P=0.121N P=0.204N P=0.234N P=0.231N | |POLY 3 | P=0.395N P=0.313 (e) (e) |P=0.134N P=0.255N P=0.267N P=0.264N | |POLY 1.5 | P=0.388N P=0.278 (e) (e) |P=0.126N P=0.249N P=0.254N P=0.252N | |POLY 6 | P=0.412N P=0.371 (e) (e) |P=0.146N P=0.265N P=0.288N P=0.282N | |LOGISTIC REGRESSION| P=0.403N P=0.220 (e) (e) |P=0.120N P=0.228N P=0.231N P=0.229N | |COCH-ARM / FISHERS | P=0.384N P=0.247 (e) (e) |P=0.120N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 5/50 (10%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 12/50 (24%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 5.1% 7.2% 11.9% 0.0% |4.6% 6.6% 26.3% 8.8% | |TERMINAL (d) | 0/20 (0%) 2/23 (9%) 3/24 (13%) 0/23 (0%) |2/25 (8%) 3/33 (9%) 7/30 (23%) 0/31 (0%) | |FIRST INCIDENCE | 693 721 408 --- |734 (T) 734 (T) 525 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.195N P=0.562 P=0.270 P=0.226N |P=0.251 P=0.627 P=0.012 * P=0.392 | |POLY 3 | P=0.203N P=0.574 P=0.276 P=0.277N |P=0.220 P=0.541 P=0.005 ** P=0.375 | |POLY 1.5 | P=0.208N P=0.541 P=0.250 P=0.257N |P=0.207 P=0.520 P=0.004 ** P=0.356 | |POLY 6 | P=0.203N P=0.620 P=0.314 P=0.314N |P=0.245 P=0.575 P=0.006 ** P=0.408 | |LOGISTIC REGRESSION| P=0.214N P=0.569 P=0.210 P=0.213N |P=0.200 P=0.627 P=0.005 ** P=0.338 | |COCH-ARM / FISHERS | P=0.220N P=0.500 P=0.218 P=0.247N |P=0.200 P=0.500 P=0.004 ** P=0.339 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |12/50 (24%) 5/50 (10%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |27.1% 10.9% 20.2% 24.3% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |8/25 (32%) 5/33 (15%) 8/30 (27%) 9/31 (29%) | |FIRST INCIDENCE | --- --- --- --- |641 734 (T) 655 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.538 P=0.016N* P=0.185N P=0.309N | |POLY 3 | (e) (e) (e) (e) |P=0.430 P=0.046N* P=0.316N P=0.488N | |POLY 1.5 | (e) (e) (e) (e) |P=0.429 P=0.051N P=0.316N P=0.495N | |POLY 6 | (e) (e) (e) (e) |P=0.434 P=0.039N* P=0.312N P=0.475N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.438 P=0.026N* P=0.268N P=0.463N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.424 P=0.054N P=0.312N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 2/50 (4%) 5/50 (10%) |4/50 (8%) 8/50 (16%) 5/50 (10%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 15.2% 14.4% 4.9% 11.9% |8.9% 17.4% 11.3% 13.4% | |TERMINAL (d) | 5/20 (25%) 6/23 (26%) 2/24 (8%) 4/23 (17%) |1/25 (4%) 7/33 (21%) 5/30 (17%) 5/31 (16%) | |FIRST INCIDENCE | 551 729 (T) 729 (T) 676 |597 677 734 (T) 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.276N P=0.527N P=0.082N P=0.402N |P=0.543 P=0.305 P=0.576 P=0.461 | |POLY 3 | P=0.339N P=0.612N P=0.140N P=0.486N |P=0.464 P=0.197 P=0.509 P=0.382 | |POLY 1.5 | P=0.343N P=0.614N P=0.136N P=0.489N |P=0.464 P=0.186 P=0.504 P=0.375 | |POLY 6 | P=0.338N P=0.613N P=0.147N P=0.489N |P=0.472 P=0.219 P=0.521 P=0.399 | |LOGISTIC REGRESSION| P=0.297N P=0.527N P=0.109N P=0.424N |P=0.472 P=0.181 P=0.501 P=0.371 | |COCH-ARM / FISHERS | P=0.352N P=0.620N P=0.134N P=0.500N |P=0.466 P=0.178 P=0.500 P=0.370 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 5/50 (10%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 4.8% |6.7% 4.3% 11.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 683 |519 676 506 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.076 (e) P=0.536 P=0.266 |P=0.311N P=0.451N P=0.397 P=0.298N | |POLY 3 | P=0.085 (e) P=0.611 P=0.313 |P=0.339N P=0.505N P=0.380 P=0.326N | |POLY 1.5 | P=0.077 (e) P=0.561 P=0.278 |P=0.333N P=0.506N P=0.369 P=0.318N | |POLY 6 | P=0.097 (e) P=0.685 P=0.368 |P=0.344N P=0.502N P=0.401 P=0.336N | |LOGISTIC REGRESSION| P=0.074 (e) P=0.536 P=0.260 |P=0.323N P=0.474N P=0.384 P=0.266N | |COCH-ARM / FISHERS | P=0.068 (e) P=0.500 P=0.247 |P=0.324N P=0.500N P=0.357 P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 9.6% 2.4% |2.3% 4.4% 6.8% 6.7% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 2/24 (8%) 1/23 (4%) |0/25 (0%) 1/33 (3%) 2/30 (7%) 2/31 (7%) | |FIRST INCIDENCE | 611 --- 457 729 (T) |720 676 733 733 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.555N P=0.214N P=0.390 P=0.459N |P=0.271 P=0.574 P=0.366 P=0.381 | |POLY 3 | P=0.598N P=0.278N P=0.403 P=0.534N |P=0.237 P=0.543 P=0.332 P=0.335 | |POLY 1.5 | P=0.592N P=0.258N P=0.374 P=0.516N |P=0.233 P=0.522 P=0.319 P=0.320 | |POLY 6 | P=0.612N P=0.313N P=0.445 P=0.566N |P=0.246 P=0.577 P=0.356 P=0.361 | |LOGISTIC REGRESSION| P=0.602N P=0.235N P=0.324 P=0.478N |P=0.237 P=0.508 P=0.336 P=0.347 | |COCH-ARM / FISHERS | P=0.590N P=0.247N P=0.339 P=0.500N |P=0.227 P=0.500 P=0.309 P=0.309 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.5% 4.8% 7.4% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 3/24 (13%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 579 592 729 (T) --- |709 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.305N P=0.538 P=0.355 P=0.491N |P=0.307N P=0.477N P=0.488N P=0.488N | |POLY 3 | P=0.332N P=0.577 P=0.363 P=0.582N |P=0.347N P=0.538N P=0.552N P=0.549N | |POLY 1.5 | P=0.330N P=0.543 P=0.337 P=0.543N |P=0.330N P=0.523N P=0.529N P=0.527N | |POLY 6 | P=0.341N P=0.626 P=0.404 P=0.644N |P=0.373N P=0.563N P=0.588N P=0.581N | |LOGISTIC REGRESSION| P=0.326N P=0.467 P=0.321 P=0.588N |P=0.311N P=0.496N P=0.498N P=0.497N | |COCH-ARM / FISHERS | P=0.334N P=0.500 P=0.309 P=0.500N |P=0.311N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 4.7% 2.4% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 693 544 408 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.510N P=0.541 P=0.754N P=0.741N |(e) (e) (e) (e) | |POLY 3 | P=0.529N P=0.584 P=0.799N P=0.798N |(e) (e) (e) (e) | |POLY 1.5 | P=0.524N P=0.547 P=0.781N P=0.780N |(e) (e) (e) (e) | |POLY 6 | P=0.542N P=0.637 P=0.828N P=0.827N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.619N P=0.451 P=0.714 P=0.738N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.523N P=0.500 P=0.753N P=0.753N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.5% 9.5% |2.3% 0.0% 4.5% 4.4% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | --- 706 729 (T) 630 |672 --- 659 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.022 * P=0.551 P=0.536 P=0.085 |P=0.242 P=0.462N P=0.527 P=0.517 | |POLY 3 | P=0.022 * P=0.611 P=0.611 P=0.089 |P=0.250 P=0.538N P=0.534 P=0.537 | |POLY 1.5 | P=0.020 * P=0.561 P=0.561 P=0.076 |P=0.245 P=0.523N P=0.518 P=0.519 | |POLY 6 | P=0.026 * P=0.683 P=0.685 P=0.112 |P=0.259 P=0.563N P=0.561 P=0.566 | |LOGISTIC REGRESSION| P=0.020 * P=0.521 P=0.536 P=0.071 |P=0.236 P=0.496N P=0.500 P=0.510 | |COCH-ARM / FISHERS | P=0.018 * P=0.500 P=0.500 P=0.059 |P=0.238 P=0.500N P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.3% 2.4% |6.7% 0.0% 2.3% 4.5% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |1/25 (4%) 0/33 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | --- --- 641 648 |629 --- 734 (T) 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.280 (e) P=0.148 P=0.539 |P=0.547N P=0.101N P=0.278N P=0.455N | |POLY 3 | P=0.286 (e) P=0.163 P=0.610 |P=0.587N P=0.126N P=0.331N P=0.519N | |POLY 1.5 | P=0.266 (e) P=0.142 P=0.561 |P=0.578N P=0.124N P=0.320N P=0.512N | |POLY 6 | P=0.315 (e) P=0.199 P=0.683 |P=0.600N P=0.130N P=0.346N P=0.526N | |LOGISTIC REGRESSION| P=0.236 (e) P=0.122 P=0.484 |P=0.568N P=0.114N P=0.304N P=0.499N | |COCH-ARM / FISHERS | P=0.241 (e) P=0.121 P=0.500 |P=0.568N P=0.121N P=0.309N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) 6/50 (12%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.1% 2.4% 14.6% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 1/23 (4%) 4/24 (17%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 551 729 (T) 648 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235N P=0.149N P=0.459 P=0.146N |(e) (e) (e) (e) | |POLY 3 | P=0.279N P=0.191N P=0.424 P=0.189N |(e) (e) (e) (e) | |POLY 1.5 | P=0.278N P=0.184N P=0.400 P=0.183N |(e) (e) (e) (e) | |POLY 6 | P=0.287N P=0.203N P=0.460 P=0.205N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.258N P=0.167N P=0.398 P=0.166N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.285N P=0.181N P=0.370 P=0.181N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 0.0% 6.8% 4.5% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |1/25 (4%) 0/33 (0%) 3/30 (10%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- --- |734 (T) --- 734 (T) 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.268 P=0.445N P=0.371 P=0.575 | |POLY 3 | (e) (e) (e) (e) |P=0.242 P=0.538N P=0.333 P=0.536 | |POLY 1.5 | (e) (e) (e) (e) |P=0.238 P=0.523N P=0.320 P=0.519 | |POLY 6 | (e) (e) (e) (e) |P=0.250 P=0.563N P=0.357 P=0.567 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.268 (e) P=0.371 P=0.575 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.233 P=0.500N P=0.309 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/24 (4%) 1/23 (4%) 0/23 (0%) 1/24 (4%) |1/11 (9%) 2/9 (22%) 1/15 (7%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 5.6% 0.0% 5.0% |11.5% 24.1% 8.6% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/9 (0%) 0/6 (0%) |0/3 (0%) 1/3 (33%) 1/4 (25%) 0/0 (0%) | |FIRST INCIDENCE | 709 657 --- 672 |680 627 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.582N P=0.726N P=0.469N P=0.727N |P=0.370N P=0.525 P=0.722N P=0.479N | |POLY 3 | P=0.635N P=0.799 P=0.593N P=0.805N |P=0.314N P=0.525 P=0.766N P=0.684N | |POLY 1.5 | P=0.622N P=0.777 P=0.553N P=0.784N |P=0.297N P=0.479 P=0.731N P=0.636N | |POLY 6 | P=0.661N P=0.835 P=0.659N P=0.840N |P=0.359N P=0.598 P=0.824N P=0.774N | |LOGISTIC REGRESSION| P=0.606N P=0.745 P=0.499N P=0.763N |P=0.284N P=0.408 P=0.695N P=0.588N | |COCH-ARM / FISHERS | P=0.610N P=0.745 P=0.511N P=0.755N |P=0.282N P=0.421 P=0.677N P=0.611N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 8/50 (16%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 18.8% 4.9% 7.2% |2.3% 0.0% 2.3% 0.0% | |TERMINAL (d) | 1/20 (5%) 4/23 (17%) 2/24 (8%) 2/23 (9%) |1/25 (4%) 0/33 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 611 729 (T) 676 |734 (T) --- 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450N P=0.033 * P=0.564 P=0.361 |P=0.385N P=0.445N P=0.721N P=0.457N | |POLY 3 | P=0.470N P=0.026 * P=0.576 P=0.379 |P=0.444N P=0.538N P=0.788N P=0.554N | |POLY 1.5 | P=0.485N P=0.021 * P=0.542 P=0.346 |P=0.432N P=0.523N P=0.776N P=0.532N | |POLY 6 | P=0.455N P=0.036 * P=0.627 P=0.428 |P=0.462N P=0.563N P=0.805N P=0.586N | |LOGISTIC REGRESSION| P=0.470N P=0.024 * P=0.564 P=0.348 |P=0.385N (e) P=0.721N (e) | |COCH-ARM / FISHERS | P=0.511N P=0.015 * P=0.500 P=0.309 |P=0.417N P=0.500N P=0.753N P=0.505N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |6/50 (12%) 4/50 (8%) 4/50 (8%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 7.6% 2.4% 7.3% 4.8% |13.3% 8.6% 9.0% 4.5% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |2/25 (8%) 1/33 (3%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 578 711 573 697 |597 627 663 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505N P=0.261N P=0.613N P=0.462N |P=0.104N P=0.272N P=0.328N P=0.115N | |POLY 3 | P=0.536N P=0.327N P=0.681N P=0.515N |P=0.125N P=0.361N P=0.390N P=0.150N | |POLY 1.5 | P=0.532N P=0.316N P=0.671N P=0.506N |P=0.121N P=0.369N P=0.382N P=0.147N | |POLY 6 | P=0.546N P=0.347N P=0.698N P=0.535N |P=0.130N P=0.347N P=0.398N P=0.153N | |LOGISTIC REGRESSION| P=0.519N P=0.295N P=0.658N P=0.483N |P=0.115N P=0.366N P=0.368N P=0.136N | |COCH-ARM / FISHERS | P=0.532N P=0.309N P=0.661N P=0.500N |P=0.116N P=0.370N P=0.370N P=0.141N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 5.0% 9.5% 11.9% 4.8% |2.3% 0.0% 9.0% 2.3% | |TERMINAL (d) | 0/20 (0%) 2/23 (9%) 3/24 (13%) 2/23 (9%) |0/25 (0%) 0/33 (0%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | 529 643 408 729 (T) |597 --- 655 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467N P=0.399 P=0.267 P=0.660N |P=0.449 P=0.496N P=0.216 P=0.755 | |POLY 3 | P=0.507N P=0.394 P=0.262 P=0.719N |P=0.438 P=0.538N P=0.196 P=0.786 | |POLY 1.5 | P=0.507N P=0.369 P=0.242 P=0.706N |P=0.432 P=0.523N P=0.187 P=0.772 | |POLY 6 | P=0.514N P=0.432 P=0.291 P=0.743N |P=0.451 P=0.562N P=0.212 P=0.799N | |LOGISTIC REGRESSION| P=0.539N P=0.312 P=0.169 P=0.649 |P=0.422 P=0.449N P=0.179 P=0.697N | |COCH-ARM / FISHERS | P=0.515N P=0.339 P=0.218 P=0.691N |P=0.424 P=0.500N P=0.181 P=0.747 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 12.5% 4.8% 7.1% 4.8% |2.3% 0.0% 4.4% 0.0% | |TERMINAL (d) | 3/20 (15%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 532 655 408 676 |722 --- 525 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188N P=0.179N P=0.297N P=0.176N |P=0.464N P=0.468N P=0.516 P=0.474N | |POLY 3 | P=0.219N P=0.219N P=0.359N P=0.220N |P=0.498N P=0.538N P=0.539 P=0.554N | |POLY 1.5 | P=0.216N P=0.217N P=0.356N P=0.217N |P=0.488N P=0.523N P=0.520 P=0.532N | |POLY 6 | P=0.225N P=0.223N P=0.369N P=0.229N |P=0.512N P=0.563N P=0.569 P=0.586N | |LOGISTIC REGRESSION| P=0.250N P=0.227N P=0.398N P=0.221N |P=0.484N P=0.480N P=0.530 P=0.493N | |COCH-ARM / FISHERS | P=0.216N P=0.218N P=0.357N P=0.218N |P=0.475N P=0.500N P=0.500 P=0.505N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 11/50 (22%) 8/50 (16%) 11/50 (22%) |4/50 (8%) 2/50 (4%) 7/50 (14%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 26.4% 24.7% 19.3% 25.0% |9.0% 4.4% 15.3% 2.2% | |TERMINAL (d) | 4/20 (20%) 2/23 (9%) 3/24 (13%) 1/23 (4%) |1/25 (4%) 1/33 (3%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | 445 555 639 564 |635 678 571 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.424N P=0.470N P=0.224N P=0.480N |P=0.249N P=0.261N P=0.315 P=0.158N | |POLY 3 | P=0.484N P=0.543N P=0.321N P=0.552N |P=0.276N P=0.340N P=0.286 P=0.192N | |POLY 1.5 | P=0.492N P=0.565N P=0.313N P=0.568N |P=0.270N P=0.342N P=0.274 P=0.187N | |POLY 6 | P=0.476N P=0.513N P=0.335N P=0.535N |P=0.281N P=0.336N P=0.308 P=0.198N | |LOGISTIC REGRESSION| P=0.528N P=0.548 P=0.294N P=0.557 |P=0.265N P=0.338N P=0.263 P=0.177N | |COCH-ARM / FISHERS | P=0.509N P=0.595N P=0.306N P=0.595N |P=0.264N P=0.339N P=0.262 P=0.181N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.5% 4.8% 0.0% 0.0% |0.0% 0.0% 2.2% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 532 592 --- --- |--- --- 525 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035N* P=0.439N P=0.112N P=0.106N |P=0.687 (e) P=0.500 (e) | |POLY 3 | P=0.042N* P=0.515N P=0.144N P=0.137N |P=0.718 (e) P=0.556 (e) | |POLY 1.5 | P=0.040N* P=0.507N P=0.132N P=0.127N |P=0.705 (e) P=0.530 (e) | |POLY 6 | P=0.046N* P=0.531N P=0.166N P=0.156N |P=0.740 (e) P=0.597 (e) | |LOGISTIC REGRESSION| P=0.043N* P=0.528N P=0.129N P=0.138N |P=0.673 (e) P=0.662 (e) | |COCH-ARM / FISHERS | P=0.039N* P=0.500N P=0.121N P=0.121N |P=0.689 (e) P=0.500 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 5/50 (10%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.7% 4.7% 2.5% 0.0% |4.5% 0.0% 11.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |1/25 (4%) 0/33 (0%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | 673 609 729 (T) --- |582 --- 571 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.055N P=0.431N P=0.270N P=0.105N |P=0.372N P=0.209N P=0.258 P=0.221N | |POLY 3 | P=0.065N P=0.510N P=0.337N P=0.135N |P=0.404N P=0.255N P=0.239 P=0.264N | |POLY 1.5 | P=0.063N P=0.504N P=0.321N P=0.127N |P=0.395N P=0.249N P=0.228 P=0.253N | |POLY 6 | P=0.070N P=0.522N P=0.365N P=0.154N |P=0.413N P=0.265N P=0.260 P=0.281N | |LOGISTIC REGRESSION| P=0.057N P=0.483N P=0.278N P=0.105N |P=0.389N P=0.223N P=0.221 P=0.225N | |COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N |P=0.387N P=0.247N P=0.218 P=0.247N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |646 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.116N P=0.216N P=0.230N P=0.224N | |POLY 3 | (e) (e) (e) (e) |P=0.135N P=0.255N P=0.273N P=0.264N | |POLY 1.5 | (e) (e) (e) (e) |P=0.128N P=0.248N P=0.259N P=0.252N | |POLY 6 | (e) (e) (e) (e) |P=0.148N P=0.265N P=0.294N P=0.281N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.121N P=0.236N P=0.240N P=0.237N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.121N P=0.247N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.7% 2.4% 4.9% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 1/23 (4%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 611 729 (T) 639 729 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.248N P=0.260N P=0.435N P=0.262N |(e) (e) (e) (e) | |POLY 3 | P=0.291N P=0.321N P=0.519N P=0.320N |(e) (e) (e) (e) | |POLY 1.5 | P=0.285N P=0.309N P=0.505N P=0.308N |(e) (e) (e) (e) | |POLY 6 | P=0.304N P=0.342N P=0.542N P=0.344N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.262N P=0.270N P=0.476N P=0.270N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.280N P=0.301N P=0.490N P=0.301N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 4/50 (8%) 4/50 (8%) 6/50 (12%) |7/50 (14%) 3/50 (6%) 6/49 (12%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 10.0% 9.4% 9.7% 14.0% |15.4% 6.5% 13.7% 11.1% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 1/24 (4%) 2/23 (9%) |1/25 (4%) 2/33 (6%) 2/30 (7%) 2/31 (7%) | |FIRST INCIDENCE | 362 611 641 605 |635 627 663 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.330 P=0.574N P=0.574N P=0.440 |P=0.428N P=0.108N P=0.447N P=0.323N | |POLY 3 | P=0.316 P=0.640N P=0.660N P=0.439 |P=0.485N P=0.158N P=0.542N P=0.396N | |POLY 1.5 | P=0.304 P=0.637N P=0.647N P=0.414 |P=0.476N P=0.161N P=0.531N P=0.390N | |POLY 6 | P=0.332 P=0.645N P=0.677N P=0.476 |P=0.493N P=0.155N P=0.555N P=0.400N | |LOGISTIC REGRESSION| P=0.268 P=0.598 P=0.631 P=0.309 |P=0.466N P=0.157N P=0.515N P=0.379N | |COCH-ARM / FISHERS | P=0.287 P=0.631N P=0.631N P=0.383 |P=0.466N P=0.159N P=0.516N P=0.380N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 4/49 (8%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 6.6% 9.1% 4.5% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 3/33 (9%) 3/30 (10%) 2/31 (7%) | |FIRST INCIDENCE | --- --- --- --- |--- 734 (T) 525 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.352 P=0.173 P=0.083 P=0.286 | |POLY 3 | (e) (e) (e) (e) |P=0.324 P=0.141 P=0.068 P=0.271 | |POLY 1.5 | (e) (e) (e) (e) |P=0.315 P=0.130 P=0.063 P=0.255 | |POLY 6 | (e) (e) (e) (e) |P=0.342 P=0.162 P=0.078 P=0.300 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.308 P=0.173 P=0.061 P=0.286 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.307 P=0.121 P=0.056 P=0.247 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 10.2% 4.8% 0.0% 4.7% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 2/23 (9%) 0/24 (0%) 1/23 (4%) |0/25 (0%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 551 729 (T) --- 582 |--- 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.204N P=0.285N P=0.052N P=0.289N |P=0.533N P=0.555 (e) (e) | |POLY 3 | P=0.238N P=0.344N P=0.070N P=0.336N |P=0.578N P=0.555 (e) (e) | |POLY 1.5 | P=0.233N P=0.336N P=0.064N P=0.330N |P=0.567N P=0.530 (e) (e) | |POLY 6 | P=0.248N P=0.361N P=0.081N P=0.352N |P=0.592N P=0.597 (e) (e) | |LOGISTIC REGRESSION| P=0.227N P=0.315N P=0.062N P=0.350N |(e) P=0.555 (e) (e) | |COCH-ARM / FISHERS | P=0.228N P=0.329N P=0.056N P=0.329N |P=0.552N P=0.500 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/24 (4%) 1/23 (4%) 0/23 (0%) 0/24 (0%) |2/11 (18%) 1/9 (11%) 0/15 (0%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 5.5% 0.0% 0.0% |22.2% 12.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 0/6 (0%) 0/9 (0%) 0/6 (0%) |0/3 (0%) 0/3 (0%) 0/4 (0%) 0/0 (0%) | |FIRST INCIDENCE | 445 555 --- --- |659 627 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.224N P=0.750N P=0.496N P=0.492N |P=0.101N P=0.459N P=0.229N P=0.226N | |POLY 3 | P=0.267N P=0.789 P=0.592N P=0.588N |P=0.130N P=0.566N P=0.220N P=0.406N | |POLY 1.5 | P=0.250N P=0.770 P=0.552N P=0.546N |P=0.116N P=0.566N P=0.189N P=0.369N | |POLY 6 | P=0.299N P=0.821 P=0.656N P=0.661N |P=0.161N P=0.576N P=0.284N P=0.493N | |LOGISTIC REGRESSION| P=0.458N P=0.637 (e) (e) |P=0.103N P=0.708N P=0.165N P=0.337N | |COCH-ARM / FISHERS | P=0.230N P=0.745 P=0.511N P=0.500N |P=0.104N P=0.579N P=0.169N P=0.359N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/24 (4%) 4/23 (17%) 2/23 (9%) 5/24 (21%) |2/11 (18%) 0/9 (0%) 2/15 (13%) 1/7 (14%) | |POLY-3 ADJUSTED (b)| 5.2% 21.8% 10.3% 24.5% |22.2% 0.0% 17.0% 17.3% | |TERMINAL (d) | 1/8 (13%) 0/6 (0%) 0/9 (0%) 0/6 (0%) |0/3 (0%) 0/3 (0%) 1/4 (25%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) 630 606 672 |659 --- 694 698 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144 P=0.211 P=0.542 P=0.127 |P=0.619N P=0.211N P=0.652N P=0.476N | |POLY 3 | P=0.133 P=0.178 P=0.551 P=0.116 |P=0.637 P=0.297N P=0.654N P=0.711N | |POLY 1.5 | P=0.124 P=0.168 P=0.520 P=0.105 |P=0.630 P=0.284N P=0.619N P=0.684N | |POLY 6 | P=0.150 P=0.198 P=0.601 P=0.139 |P=0.653 P=0.329N P=0.712N P=0.766N | |LOGISTIC REGRESSION| P=0.120 P=0.139 P=0.488 P=0.095 |P=0.621 P=0.300N P=0.584N P=0.660N | |COCH-ARM / FISHERS | P=0.114 P=0.160 P=0.484 P=0.094 |P=0.625 P=0.289N P=0.574N P=0.674N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/24 (0%) 3/23 (13%) 0/23 (0%) 0/24 (0%) |0/11 (0%) 0/9 (0%) 0/15 (0%) 0/7 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 17.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/8 (0%) 2/6 (33%) 0/9 (0%) 0/6 (0%) |0/3 (0%) 0/3 (0%) 0/4 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- 711 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.303N P=0.097 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.316N P=0.124 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.297N P=0.115 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.353N P=0.144 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.284N P=0.083 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.287N P=0.109 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/24 (13%) 3/23 (13%) 1/23 (4%) 8/24 (33%) |3/11 (27%) 2/9 (22%) 4/15 (27%) 1/7 (14%) | |POLY-3 ADJUSTED (b)| 14.8% 16.5% 5.3% 38.4% |33.4% 23.5% 33.0% 17.3% | |TERMINAL (d) | 1/8 (13%) 1/6 (17%) 1/9 (11%) 4/6 (67%) |1/3 (33%) 0/3 (0%) 0/4 (0%) 0/0 (0%) | |FIRST INCIDENCE | 445 555 729 (T) 520 |659 627 663 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.029 * P=0.654 P=0.283N P=0.074 |P=0.323N P=0.452N P=0.564 P=0.470N | |POLY 3 | P=0.033 * P=0.653 P=0.363N P=0.089 |P=0.444N P=0.555N P=0.710N P=0.518N | |POLY 1.5 | P=0.032 * P=0.648 P=0.341N P=0.086 |P=0.422N P=0.573N P=0.684N P=0.494N | |POLY 6 | P=0.035 * P=0.666 P=0.399N P=0.096 |P=0.494N P=0.538N P=0.746N P=0.576N | |LOGISTIC REGRESSION| P=0.034 * P=0.669N P=0.333N P=0.082 |P=0.401N P=0.654N P=0.664N P=0.454N | |COCH-ARM / FISHERS | P=0.034 * P=0.646 P=0.321N P=0.084 |P=0.399N P=0.604N P=0.655N P=0.485N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/24 (13%) 4/23 (17%) 2/23 (9%) 7/24 (29%) |1/11 (9%) 2/9 (22%) 1/15 (7%) 1/7 (14%) | |POLY-3 ADJUSTED (b)| 15.3% 22.3% 10.4% 34.4% |11.8% 24.1% 8.5% 17.3% | |TERMINAL (d) | 2/8 (25%) 3/6 (50%) 1/9 (11%) 4/6 (67%) |1/3 (33%) 0/3 (0%) 0/4 (0%) 0/0 (0%) | |FIRST INCIDENCE | 693 609 639 585 |734 (T) 678 668 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.072 P=0.403 P=0.454N P=0.096 |P=0.597N P=0.539 P=0.729N P=0.522 | |POLY 3 | P=0.117 P=0.493 P=0.545N P=0.167 |P=0.650N P=0.537 P=0.758N P=0.741 | |POLY 1.5 | P=0.111 P=0.486 P=0.532N P=0.156 |P=0.639N P=0.484 P=0.726N P=0.701 | |POLY 6 | P=0.125 P=0.509 P=0.568N P=0.183 |P=0.677N P=0.630 P=0.810N P=0.807 | |LOGISTIC REGRESSION| P=0.114 P=0.399 P=0.504N P=0.135 |P=0.639N P=0.497 P=0.696N P=0.650 | |COCH-ARM / FISHERS | P=0.103 P=0.475 P=0.521N P=0.143 |P=0.633N P=0.421 P=0.677N P=0.641 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 13/45 (29%) 9/48 (19%) 6/47 (13%) |34/50 (68%) 33/50 (66%) 25/49 (51%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 19.3% 32.9% 22.2% 14.7% |69.1% 69.1% 54.9% 57.0% | |TERMINAL (d) | 2/20 (10%) 7/23 (30%) 5/24 (21%) 2/23 (9%) |14/25 (56%) 21/33 (64%) 17/30 (57%) 18/31 (58%) | |FIRST INCIDENCE | 502 502 571 569 |519 636 597 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.141N P=0.269 P=0.582 P=0.316N |P=0.044N* P=0.155N P=0.040N* P=0.059N | |POLY 3 | P=0.173N P=0.132 P=0.500 P=0.418N |P=0.076N P=0.589 P=0.110N P=0.151N | |POLY 1.5 | P=0.183N P=0.118 P=0.484 P=0.423N |P=0.065N P=0.572N P=0.088N P=0.133N | |POLY 6 | P=0.165N P=0.153 P=0.523 P=0.417N |P=0.095N P=0.590 P=0.144N P=0.177N | |LOGISTIC REGRESSION| P=0.202N P=0.103 P=0.457 P=0.511N |P=0.056N P=0.497N P=0.066N P=0.114N | |COCH-ARM / FISHERS | P=0.204N P=0.103 P=0.463 P=0.436N |P=0.057N P=0.500N P=0.064N P=0.109N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/45 (7%) 5/48 (10%) 6/47 (13%) |20/50 (40%) 23/50 (46%) 14/49 (29%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 2.6% 7.9% 12.7% 15.1% |43.4% 48.8% 31.4% 40.6% | |TERMINAL (d) | 1/20 (5%) 2/23 (9%) 5/24 (21%) 5/23 (22%) |10/25 (40%) 15/33 (46%) 9/30 (30%) 12/31 (39%) | |FIRST INCIDENCE | 729 (T) 707 729 (T) 569 |541 636 659 489 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.048 * P=0.364 P=0.142 P=0.078 |P=0.204N P=0.446N P=0.087N P=0.291N | |POLY 3 | P=0.046 * P=0.340 P=0.122 P=0.070 |P=0.291N P=0.382 P=0.169N P=0.480N | |POLY 1.5 | P=0.041 * P=0.307 P=0.108 P=0.059 |P=0.297N P=0.353 P=0.167N P=0.492N | |POLY 6 | P=0.054 P=0.393 P=0.147 P=0.088 |P=0.280N P=0.438 P=0.166N P=0.455N | |LOGISTIC REGRESSION| P=0.043 * P=0.345 P=0.142 P=0.064 |P=0.304N P=0.373 P=0.151N P=0.500N | |COCH-ARM / FISHERS | P=0.035 * P=0.270 P=0.093 P=0.047 * |P=0.305N P=0.343 P=0.162N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/45 (0%) 0/48 (0%) 2/47 (4%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- 729 (T) |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049 * (e) (e) P=0.269 |P=0.293N P=0.445N P=0.464N P=0.457N | |POLY 3 | P=0.055 (e) (e) P=0.296 |P=0.348N P=0.538N P=0.552N P=0.549N | |POLY 1.5 | P=0.049 * (e) (e) P=0.262 |P=0.331N P=0.523N P=0.530N P=0.527N | |POLY 6 | P=0.063 (e) (e) P=0.351 |P=0.374N P=0.563N P=0.586N P=0.582N | |LOGISTIC REGRESSION| (e) (e) (e) P=0.269 |P=0.293N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.232 |P=0.312N P=0.500N P=0.505N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/12 (75%) 10/11 (91%) 9/10 (90%) 12/14 (86%) |8/9 (89%) 10/11 (91%) 11/12 (92%) 9/10 (90%) | |POLY-3 ADJUSTED (b)| 75.1% 90.9% 92.2% 90.0% |91.2% 90.9% 96.7% 90.1% | |TERMINAL (d) | 4/6 (67%) 2/3 (67%) 5/5 (100%) 4/4 (100%) |2/2 (100%) 8/9 (89%) 7/7 (100%) 4/4 (100%) | |FIRST INCIDENCE | 578 544 457 520 |635 627 655 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.229 P=0.389 P=0.570 P=0.235 |P=0.498 P=0.095N P=0.347N P=0.456N | |POLY 3 | P=0.267 P=0.330 P=0.319 P=0.320 |P=0.650N P=0.781N P=0.717 P=0.764N | |POLY 1.5 | P=0.329 P=0.329 P=0.341 P=0.368 |P=0.649 P=0.758 P=0.698 P=0.774N | |POLY 6 | P=0.183 P=0.332 P=0.283 P=0.254 |P=0.625N P=0.755N P=0.799 P=0.743N | |LOGISTIC REGRESSION| P=0.421 (e) P=0.412 P=0.428 |P=0.605 P=0.749 P=0.680 P=0.725 | |COCH-ARM / FISHERS | P=0.406 P=0.329 P=0.368 P=0.422 |P=0.624 P=0.711 P=0.686 P=0.737 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/47 (4%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.0% 0.0% 2.4% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 2/23 (9%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 729 (T) --- 648 |--- --- 708 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.587 P=0.269 (e) P=0.539 |P=0.695 (e) P=0.517 (e) | |POLY 3 | P=0.620 P=0.298 (e) P=0.610 |P=0.718 (e) P=0.552 (e) | |POLY 1.5 | P=0.593 P=0.263 (e) P=0.561 |P=0.704 (e) P=0.526 (e) | |POLY 6 | P=0.657 P=0.354 (e) P=0.683 |P=0.740 (e) P=0.594 (e) | |LOGISTIC REGRESSION| P=0.573 P=0.269 (e) P=0.484 |P=0.688 (e) P=0.498 (e) | |COCH-ARM / FISHERS | P=0.558 P=0.232 (e) P=0.500 |P=0.687 (e) P=0.495 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/47 (0%) 0/49 (0%) 2/50 (4%) |2/50 (4%) 9/48 (19%) 4/49 (8%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 4.7% |4.5% 20.3% 9.2% 6.8% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 6/33 (18%) 2/30 (7%) 2/31 (7%) | |FIRST INCIDENCE | 729 (T) --- --- 630 |698 678 694 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.271 P=0.472N P=0.464N P=0.559 |P=0.322N P=0.070 P=0.395 P=0.565 | |POLY 3 | P=0.270 P=0.589N P=0.595N P=0.585 |P=0.369N P=0.027 * P=0.354 P=0.525 | |POLY 1.5 | P=0.259 P=0.554N P=0.553N P=0.547 |P=0.378N P=0.024 * P=0.341 P=0.508 | |POLY 6 | P=0.287 P=0.643N P=0.659N P=0.638 |P=0.350N P=0.035 * P=0.378 P=0.555 | |LOGISTIC REGRESSION| P=0.245 (e) (e) P=0.505 |P=0.369N P=0.034 * P=0.340 P=0.503 | |COCH-ARM / FISHERS | P=0.246 P=0.515N P=0.505N P=0.500 |P=0.385N P=0.021 * P=0.329 P=0.490 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 2/47 (4%) 6/49 (12%) 5/50 (10%) |2/50 (4%) 2/48 (4%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 24.4% 5.0% 14.4% 11.7% |4.6% 4.5% 0.0% 0.0% | |TERMINAL (d) | 6/20 (30%) 1/23 (4%) 1/24 (4%) 2/23 (9%) |2/25 (8%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 362 630 564 569 |734 (T) 484 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.193N P=0.010N* P=0.157N P=0.097N |P=0.072N P=0.620N P=0.198N P=0.192N | |POLY 3 | P=0.212N P=0.016N* P=0.203N P=0.116N |P=0.090N P=0.705N P=0.269N P=0.265N | |POLY 1.5 | P=0.213N P=0.017N* P=0.211N P=0.121N |P=0.088N P=0.700 P=0.257N P=0.255N | |POLY 6 | P=0.214N P=0.014N* P=0.190N P=0.111N |P=0.092N P=0.701N P=0.288N P=0.279N | |LOGISTIC REGRESSION| P=0.243N P=0.022N* P=0.235N P=0.147N |P=0.086N P=0.688 (e) (e) | |COCH-ARM / FISHERS | P=0.220N P=0.018N* P=0.220N P=0.131N |P=0.085N P=0.676 P=0.253N P=0.253N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/47 (4%) 1/49 (2%) 0/50 (0%) |6/50 (12%) 3/48 (6%) 8/49 (16%) 12/49 (24%) | |POLY-3 ADJUSTED (b)| 0.0% 5.0% 2.5% 0.0% |13.7% 6.8% 17.7% 27.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |5/25 (20%) 3/33 (9%) 2/30 (7%) 8/31 (26%) | |FIRST INCIDENCE | --- 723 714 --- |729 734 (T) 597 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426N P=0.270 P=0.532 (e) |P=0.032 * P=0.127N P=0.483 P=0.200 | |POLY 3 | P=0.442N P=0.298 P=0.607 (e) |P=0.017 * P=0.251N P=0.421 P=0.103 | |POLY 1.5 | P=0.439N P=0.263 P=0.557 (e) |P=0.017 * P=0.260N P=0.396 P=0.094 | |POLY 6 | P=0.452N P=0.354 P=0.681 (e) |P=0.019 * P=0.236N P=0.466 P=0.122 | |LOGISTIC REGRESSION| P=0.424N P=0.274 P=0.517 (e) |P=0.018 * P=0.143N P=0.372 P=0.127 | |COCH-ARM / FISHERS | P=0.442N P=0.232 P=0.495 (e) |P=0.017 * P=0.264N P=0.371 P=0.088 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Foreign Body | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/47 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 7.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 709 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.043N* P=0.096N P=0.094N P=0.100N |(e) (e) (e) (e) | |POLY 3 | P=0.062N P=0.143N P=0.144N P=0.135N |(e) (e) (e) (e) | |POLY 1.5 | P=0.055N P=0.137N P=0.133N P=0.126N |(e) (e) (e) (e) | |POLY 6 | P=0.073N P=0.155N P=0.163N P=0.152N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.044N* P=0.093N P=0.100N P=0.097N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.051N P=0.133N P=0.125N P=0.121N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 20/47 (43%) 16/49 (33%) 28/50 (56%) |1/50 (2%) 10/48 (21%) 1/49 (2%) 5/49 (10%) | |POLY-3 ADJUSTED (b)| 51.8% 46.6% 37.6% 61.3% |2.3% 21.9% 2.3% 11.3% | |TERMINAL (d) | 13/20 (65%) 7/23 (30%) 9/24 (38%) 14/23 (61%) |1/25 (4%) 3/33 (9%) 1/30 (3%) 3/31 (10%) | |FIRST INCIDENCE | 445 502 457 520 |734 (T) 484 734 (T) 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.250 P=0.255N P=0.076N P=0.370 |P=0.501 P=0.016 * P=0.721N P=0.153 | |POLY 3 | P=0.160 P=0.403N P=0.135N P=0.249 |P=0.473 P=0.005 ** P=0.788 P=0.112 | |POLY 1.5 | P=0.148 P=0.458N P=0.149N P=0.207 |P=0.455 P=0.004 ** P=0.773 P=0.105 | |POLY 6 | P=0.174 P=0.327N P=0.120N P=0.315 |P=0.507 P=0.008 ** P=0.807N P=0.128 | |LOGISTIC REGRESSION| P=0.153 P=0.472N P=0.142N P=0.213 |P=0.440 P=0.004 ** P=0.721N P=0.123 | |COCH-ARM / FISHERS | P=0.131 P=0.525N P=0.170N P=0.159 |P=0.440 P=0.003 ** P=0.747 P=0.098 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 15/47 (32%) 23/49 (47%) 28/50 (56%) |2/50 (4%) 0/47 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 47.6% 36.0% 51.2% 60.6% |5.1% 0.0% 0.0% 0.0% | |TERMINAL (d) | 8/20 (40%) 9/23 (39%) 11/24 (46%) 13/23 (57%) |0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) | |FIRST INCIDENCE | 362 544 457 520 |580 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.096 P=0.092N P=0.538N P=0.302 |P=0.113N P=0.220N P=0.221N P=0.220N | |POLY 3 | P=0.041 * P=0.196N P=0.458 P=0.151 |P=0.146N P=0.287N P=0.290N P=0.277N | |POLY 1.5 | P=0.037 * P=0.201N P=0.425 P=0.135 |P=0.133N P=0.270N P=0.267N P=0.257N | |POLY 6 | P=0.046 * P=0.190N P=0.504 P=0.171 |P=0.169N P=0.316N P=0.328N P=0.314N | |LOGISTIC REGRESSION| P=0.030 * P=0.213N P=0.356 P=0.107 |P=0.124N P=0.261N P=0.247N P=0.248N | |COCH-ARM / FISHERS | P=0.032 * P=0.207N P=0.385 P=0.115 |P=0.120N P=0.263N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/47 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 4.7% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 726 --- --- 582 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.514 P=0.215N P=0.206N P=0.651N |(e) (e) (e) (e) | |POLY 3 | P=0.518 P=0.286N P=0.289N P=0.705N |(e) (e) (e) (e) | |POLY 1.5 | P=0.508 P=0.269N P=0.266N P=0.698N |(e) (e) (e) (e) | |POLY 6 | P=0.533 P=0.315N P=0.327N P=0.721N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.500 P=0.199N P=0.204N P=0.684N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.496 P=0.263N P=0.253N P=0.691N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/47 (0%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 1/48 (2%) 0/49 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 10.1% 0.0% 0.0% 2.4% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 658 --- --- 502 |--- 636 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123N P=0.050N P=0.058N P=0.154N |P=0.553N P=0.518 (e) (e) | |POLY 3 | P=0.147N P=0.073N P=0.073N P=0.183N |P=0.574N P=0.547 (e) (e) | |POLY 1.5 | P=0.138N P=0.071N P=0.068N P=0.179N |P=0.566N P=0.521 (e) (e) | |POLY 6 | P=0.162N P=0.079N P=0.084N P=0.195N |P=0.585N P=0.588 (e) (e) | |LOGISTIC REGRESSION| P=0.143N P=0.063N P=0.060N P=0.200N |P=0.563N P=0.515 (e) (e) | |COCH-ARM / FISHERS | P=0.131N P=0.066N P=0.061N P=0.181N |P=0.553N P=0.490 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |7/50 (14%) 4/50 (8%) 10/50 (20%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| |15.5% 8.7% 22.2% 17.8% | |TERMINAL (d) | |2/25 (8%) 3/33 (9%) 7/30 (23%) 6/31 (19%) | |FIRST INCIDENCE | |519 728 571 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.345 P=0.176N P=0.392 P=0.598N | |POLY 3 | |P=0.266 P=0.264N P=0.302 P=0.508 | |POLY 1.5 | |P=0.268 P=0.267N P=0.298 P=0.501 | |POLY 6 | |P=0.269 P=0.257N P=0.313 P=0.526 | |LOGISTIC REGRESSION| |P=0.272 P=0.264N P=0.296 P=0.499 | |COCH-ARM / FISHERS | |P=0.272 P=0.262N P=0.298 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/48 (21%) 9/45 (20%) 13/46 (28%) 12/48 (25%) |12/47 (26%) 4/49 (8%) 3/49 (6%) 5/48 (10%) | |POLY-3 ADJUSTED (b)| 25.5% 23.0% 32.5% 28.7% |28.1% 8.9% 6.8% 11.4% | |TERMINAL (d) | 6/20 (30%) 6/23 (26%) 8/24 (33%) 7/23 (30%) |7/25 (28%) 2/33 (6%) 1/30 (3%) 2/31 (7%) | |FIRST INCIDENCE | 551 502 533 520 |582 678 528 700 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.379 P=0.381N P=0.472 P=0.537 |P=0.045N* P=0.011N* P=0.009N** P=0.032N* | |POLY 3 | P=0.347 P=0.521N P=0.345 P=0.488 |P=0.050N P=0.019N* P=0.008N** P=0.045N* | |POLY 1.5 | P=0.326 P=0.540N P=0.312 P=0.452 |P=0.049N* P=0.020N* P=0.008N** P=0.046N* | |POLY 6 | P=0.371 P=0.495N P=0.400 P=0.537 |P=0.051N P=0.016N* P=0.008N** P=0.043N* | |LOGISTIC REGRESSION| P=0.312 P=0.532N P=0.311 P=0.436 |P=0.052N P=0.021N* P=0.010N* P=0.043N* | |COCH-ARM / FISHERS | P=0.295 P=0.563N P=0.275 P=0.404 |P=0.053N P=0.021N* P=0.009N** P=0.048N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/45 (0%) 1/46 (2%) 3/48 (6%) |0/47 (0%) 1/49 (2%) 1/49 (2%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 7.4% |0.0% 2.2% 2.3% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 2/23 (9%) |0/25 (0%) 0/33 (0%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | --- --- 668 605 |--- 728 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024 * (e) P=0.513 P=0.146 |P=0.560N P=0.546 P=0.536 (e) | |POLY 3 | P=0.026 * (e) P=0.596 P=0.161 |P=0.595N P=0.560 P=0.560 (e) | |POLY 1.5 | P=0.023 * (e) P=0.548 P=0.141 |P=0.591N P=0.536 P=0.536 (e) | |POLY 6 | P=0.029 * (e) P=0.668 P=0.197 |P=0.600N P=0.597 P=0.598 (e) | |LOGISTIC REGRESSION| P=0.022 * (e) P=0.490 P=0.127 |P=0.570N P=0.531 P=0.536 (e) | |COCH-ARM / FISHERS | P=0.021 * (e) P=0.489 P=0.121 |P=0.585N P=0.510 P=0.510 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Artery | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/48 (4%) 0/45 (0%) 0/46 (0%) 0/48 (0%) |0/47 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/20 (10%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.106N P=0.207N P=0.198N P=0.207N |(e) (e) (e) (e) | |POLY 3 | P=0.146N P=0.289N P=0.289N P=0.278N |(e) (e) (e) (e) | |POLY 1.5 | P=0.133N P=0.272N P=0.269N P=0.258N |(e) (e) (e) (e) | |POLY 6 | P=0.170N P=0.318N P=0.322N P=0.315N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.106N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.121N P=0.264N P=0.258N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 2/49 (4%) 1/50 (2%) 0/47 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% 2.5% 0.0% |0.0% 2.2% 0.0% 0.0% | |TERMINAL (d) | 1/19 (5%) 1/23 (4%) 1/24 (4%) 0/22 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) 613 729 (T) --- |--- 627 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.216N P=0.556 P=0.710N P=0.471N |P=0.556N P=0.513 (e) (e) | |POLY 3 | P=0.243N P=0.596 P=0.797N P=0.582N |P=0.580N P=0.555 (e) (e) | |POLY 1.5 | P=0.242N P=0.557 P=0.776N P=0.545N |P=0.570N P=0.530 (e) (e) | |POLY 6 | P=0.250N P=0.653 P=0.829N P=0.644N |P=0.593N P=0.597 (e) (e) | |LOGISTIC REGRESSION| P=0.225N P=0.534 P=0.710N (e) |P=0.564N P=0.529 (e) (e) | |COCH-ARM / FISHERS | P=0.244N P=0.508 P=0.742N P=0.505N |P=0.555N P=0.500 (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/48 (6%) 1/49 (2%) 3/49 (6%) 5/50 (10%) |1/49 (2%) 0/50 (0%) 4/50 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 7.6% 2.4% 7.3% 11.7% |2.3% 0.0% 9.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 1/24 (4%) 2/23 (9%) |0/25 (0%) 0/33 (0%) 3/30 (10%) 0/31 (0%) | |FIRST INCIDENCE | 445 636 572 520 |659 --- 721 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188 P=0.279N P=0.623N P=0.431 |P=0.463 P=0.472N P=0.227 P=0.748N | |POLY 3 | P=0.179 P=0.324N P=0.680N P=0.429 |P=0.447 P=0.534N P=0.200 P=0.781N | |POLY 1.5 | P=0.173 P=0.312N P=0.667N P=0.408 |P=0.442 P=0.519N P=0.193 P=0.771N | |POLY 6 | P=0.187 P=0.343N P=0.698N P=0.458 |P=0.456 P=0.558N P=0.213 P=0.796N | |LOGISTIC REGRESSION| P=0.134 P=0.353N P=0.643 P=0.306 |P=0.437 P=0.484N P=0.188 P=0.757N | |COCH-ARM / FISHERS | P=0.164 P=0.301N P=0.651N P=0.381 |P=0.438 P=0.495N P=0.187 P=0.747N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/48 (2%) 3/49 (6%) 2/49 (4%) 2/50 (4%) |13/49 (27%) 11/50 (22%) 11/50 (22%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 2.6% 7.2% 4.9% 4.8% |29.2% 23.7% 24.4% 29.0% | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 1/24 (4%) 0/23 (0%) |8/25 (32%) 7/33 (21%) 9/30 (30%) 11/31 (36%) | |FIRST INCIDENCE | 729 (T) 548 603 682 |519 636 528 691 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547 P=0.352 P=0.551 P=0.542 |P=0.473N P=0.210N P=0.274N P=0.387N | |POLY 3 | P=0.568 P=0.381 P=0.577 P=0.587 |P=0.493 P=0.368N P=0.402N P=0.594N | |POLY 1.5 | P=0.550 P=0.350 P=0.546 P=0.555 |P=0.502 P=0.384N P=0.396N P=0.585N | |POLY 6 | P=0.593 P=0.430 P=0.624 P=0.634 |P=0.486 P=0.340N P=0.406N P=0.597N | |LOGISTIC REGRESSION| P=0.518 P=0.304 P=0.516 P=0.534 |P=0.513 P=0.375N P=0.385N P=0.549N | |COCH-ARM / FISHERS | P=0.523 P=0.316 P=0.508 P=0.515 |P=0.515 P=0.385N P=0.385N P=0.567N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% 0.0% |4.6% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |1/25 (4%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |729 734 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536N P=0.528 (e) (e) |P=0.085N P=0.413N P=0.205N P=0.195N | |POLY 3 | P=0.589N P=0.605 (e) (e) |P=0.109N P=0.507N P=0.262N P=0.259N | |POLY 1.5 | P=0.568N P=0.560 (e) (e) |P=0.104N P=0.503N P=0.249N P=0.248N | |POLY 6 | P=0.623N P=0.672 (e) (e) |P=0.115N P=0.512N P=0.282N P=0.276N | |LOGISTIC REGRESSION| (e) P=0.528 (e) (e) |P=0.088N P=0.434N P=0.214N P=0.206N | |COCH-ARM / FISHERS | P=0.546N P=0.505 (e) (e) |P=0.099N P=0.492N P=0.242N P=0.242N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/48 (17%) 5/49 (10%) 5/49 (10%) 7/50 (14%) |4/49 (8%) 6/50 (12%) 6/50 (12%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 19.7% 11.9% 12.2% 16.4% |9.2% 13.0% 13.6% 0.0% | |TERMINAL (d) | 3/20 (15%) 3/23 (13%) 3/24 (13%) 4/23 (17%) |3/25 (12%) 4/33 (12%) 6/30 (20%) 0/31 (0%) | |FIRST INCIDENCE | 551 548 457 520 |701 636 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450N P=0.221N P=0.222N P=0.404N |P=0.037N* P=0.521 P=0.479 P=0.044N* | |POLY 3 | P=0.501N P=0.267N P=0.284N P=0.478N |P=0.052N P=0.425 P=0.399 P=0.064N | |POLY 1.5 | P=0.493N P=0.264N P=0.272N P=0.469N |P=0.051N P=0.402 P=0.390 P=0.062N | |POLY 6 | P=0.518N P=0.274N P=0.304N P=0.500N |P=0.051N P=0.462 P=0.416 P=0.067N | |LOGISTIC REGRESSION| P=0.513N P=0.297N P=0.282N P=0.500N |P=0.047N* P=0.419 P=0.427 P=0.052N | |COCH-ARM / FISHERS | P=0.491N P=0.263N P=0.263N P=0.465N |P=0.052N P=0.383 P=0.383 P=0.056N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 3/49 (6%) | | |POLY-3 ADJUSTED (b)| 7.5% 2.4% 4.9% 7.3% | | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 1/24 (4%) 2/23 (9%) | | |FIRST INCIDENCE | 529 729 (T) 667 672 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.515 P=0.269N P=0.451N P=0.605N | | |POLY 3 | P=0.489 P=0.331N P=0.532N P=0.682N | | |POLY 1.5 | P=0.476 P=0.318N P=0.517N P=0.675N | | |POLY 6 | P=0.506 P=0.353N P=0.558N P=0.697N | | |LOGISTIC REGRESSION| P=0.465 P=0.328N P=0.515N P=0.643 | | |COCH-ARM / FISHERS | P=0.459 P=0.309N P=0.500N P=0.651 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/50 (4%) 4/50 (8%) 6/49 (12%) | | |POLY-3 ADJUSTED (b)| 12.4% 4.8% 9.8% 14.4% | | |TERMINAL (d) | 3/20 (15%) 1/23 (4%) 2/24 (8%) 3/23 (13%) | | |FIRST INCIDENCE | 362 697 710 630 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.334 P=0.176N P=0.413N P=0.588 | | |POLY 3 | P=0.294 P=0.226N P=0.526N P=0.549 | | |POLY 1.5 | P=0.283 P=0.222N P=0.515N P=0.520 | | |POLY 6 | P=0.311 P=0.233N P=0.542N P=0.594 | | |LOGISTIC REGRESSION| P=0.277 P=0.246N P=0.507N P=0.455 | | |COCH-ARM / FISHERS | P=0.268 P=0.218N P=0.500N P=0.486 | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | | |POLY-3 ADJUSTED (b)| 2.6% 4.8% 2.5% 4.7% | | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 1/24 (4%) 1/23 (4%) | | |FIRST INCIDENCE | 729 (T) 675 729 (T) 564 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.490 P=0.551 P=0.722N P=0.543 | | |POLY 3 | P=0.499 P=0.582 P=0.805N P=0.584 | | |POLY 1.5 | P=0.478 P=0.545 P=0.785N P=0.547 | | |POLY 6 | P=0.527 P=0.636 P=0.836N P=0.637 | | |LOGISTIC REGRESSION| P=0.466 P=0.543 P=0.722N P=0.505 | | |COCH-ARM / FISHERS | P=0.449 P=0.500 P=0.753N P=0.500 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 7/50 (14%) 5/50 (10%) | | |POLY-3 ADJUSTED (b)| 5.1% 11.8% 17.0% 11.9% | | |TERMINAL (d) | 0/20 (0%) 3/23 (13%) 5/24 (21%) 4/23 (17%) | | |FIRST INCIDENCE | 658 611 653 690 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272 P=0.277 P=0.119 P=0.271 | | |POLY 3 | P=0.262 P=0.276 P=0.102 P=0.271 | | |POLY 1.5 | P=0.247 P=0.249 P=0.092 P=0.248 | | |POLY 6 | P=0.279 P=0.317 P=0.119 P=0.304 | | |LOGISTIC REGRESSION| P=0.255 P=0.231 P=0.096 P=0.260 | | |COCH-ARM / FISHERS | P=0.222 P=0.218 P=0.080 P=0.218 | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 714 --- --- 663 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.439N P=0.204N P=0.203N P=0.446N |(e) (e) (e) (e) | |POLY 3 | P=0.511N P=0.278N P=0.286N P=0.529N |(e) (e) (e) (e) | |POLY 1.5 | P=0.492N P=0.258N P=0.262N P=0.514N |(e) (e) (e) (e) | |POLY 6 | P=0.541N P=0.312N P=0.327N P=0.558N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.453N P=0.203N P=0.213N P=0.467N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.470N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Skin | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.8% |2.3% 0.0% 0.0% 2.2% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- 697 |712 --- --- 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.049 * (e) (e) P=0.267 |P=0.596 P=0.471N P=0.482N P=0.741N | |POLY 3 | P=0.056 (e) (e) P=0.312 |P=0.605 P=0.538N P=0.552N P=0.785N | |POLY 1.5 | P=0.051 (e) (e) P=0.278 |P=0.598 P=0.523N P=0.529N P=0.774N | |POLY 6 | P=0.066 (e) (e) P=0.368 |P=0.616 P=0.563N P=0.588N P=0.799N | |LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.263 |P=0.588 P=0.494N P=0.497N P=0.760N | |COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.587 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 703 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112N P=0.197N P=0.211N P=0.215N |(e) (e) (e) (e) | |POLY 3 | P=0.146N P=0.278N P=0.286N P=0.277N |(e) (e) (e) (e) | |POLY 1.5 | P=0.133N P=0.258N P=0.263N P=0.257N |(e) (e) (e) (e) | |POLY 6 | P=0.168N P=0.312N P=0.327N P=0.314N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.112N P=0.213N P=0.221N P=0.214N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.120N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 7.5% 0.0% 4.9% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 2/24 (8%) 0/23 (0%) |1/25 (4%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 532 --- 729 (T) --- |734 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118N P=0.110N P=0.439N P=0.110N |P=0.293N P=0.445N P=0.464N P=0.457N | |POLY 3 | P=0.144N P=0.138N P=0.536N P=0.138N |P=0.347N P=0.538N P=0.552N P=0.547N | |POLY 1.5 | P=0.138N P=0.129N P=0.519N P=0.128N |P=0.331N P=0.523N P=0.529N P=0.528N | |POLY 6 | P=0.155N P=0.155N P=0.565N P=0.157N |P=0.373N P=0.563N P=0.589N P=0.578N | |LOGISTIC REGRESSION| P=0.141N P=0.147N P=0.510N P=0.163N |P=0.293N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.133N P=0.121N P=0.500N P=0.121N |P=0.314N P=0.500N P=0.500N P=0.505N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 16/50 (32%) 19/50 (38%) 14/50 (28%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 25.3% 36.8% 44.1% 32.6% |6.8% 4.4% 4.5% 2.3% | |TERMINAL (d) | 6/20 (30%) 9/23 (39%) 10/24 (42%) 7/23 (30%) |0/25 (0%) 1/33 (3%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | 658 592 572 648 |698 699 721 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.405 P=0.249 P=0.109 P=0.375 |P=0.204N P=0.417N P=0.454N P=0.253N | |POLY 3 | P=0.368 P=0.196 P=0.060 P=0.331 |P=0.247N P=0.502N P=0.522N P=0.325N | |POLY 1.5 | P=0.331 P=0.162 P=0.048 * P=0.292 |P=0.244N P=0.504N P=0.512N P=0.320N | |POLY 6 | P=0.415 P=0.249 P=0.084 P=0.388 |P=0.250N P=0.498N P=0.534N P=0.332N | |LOGISTIC REGRESSION| P=0.350 P=0.186 P=0.051 P=0.339 |P=0.227N P=0.474N P=0.484N P=0.286N | |COCH-ARM / FISHERS | P=0.278 P=0.127 P=0.038 * P=0.241 |P=0.240N P=0.500N P=0.500N P=0.316N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |7/50 (14%) 2/50 (4%) 3/50 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 7.6% 11.7% 4.8% 4.8% |15.7% 4.4% 6.6% 2.3% | |TERMINAL (d) | 0/20 (0%) 2/23 (9%) 0/24 (0%) 1/23 (4%) |2/25 (8%) 1/33 (3%) 1/30 (3%) 0/31 (0%) | |FIRST INCIDENCE | 585 544 592 648 |646 691 525 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.232N P=0.436 P=0.467N P=0.438N |P=0.029N* P=0.051N P=0.141N P=0.026N* | |POLY 3 | P=0.255N P=0.428 P=0.523N P=0.515N |P=0.033N* P=0.076N P=0.159N P=0.033N* | |POLY 1.5 | P=0.257N P=0.397 P=0.512N P=0.505N |P=0.032N* P=0.079N P=0.159N P=0.033N* | |POLY 6 | P=0.257N P=0.471 P=0.544N P=0.535N |P=0.034N* P=0.072N P=0.158N P=0.033N* | |LOGISTIC REGRESSION| P=0.277N P=0.345 P=0.519N P=0.503N |P=0.034N* P=0.077N P=0.156N P=0.033N* | |COCH-ARM / FISHERS | P=0.264N P=0.357 P=0.500N P=0.500N |P=0.033N* P=0.080N P=0.159N P=0.032N* | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 7.6% 2.4% 4.9% 2.4% |0.0% 0.0% 0.0% 2.2% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 1/24 (4%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 580 548 641 630 |--- --- --- 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.257N P=0.265N P=0.446N P=0.265N |P=0.195 (e) (e) P=0.510 | |POLY 3 | P=0.296N P=0.321N P=0.527N P=0.323N |P=0.215 (e) (e) P=0.551 | |POLY 1.5 | P=0.290N P=0.313N P=0.514N P=0.313N |P=0.206 (e) (e) P=0.526 | |POLY 6 | P=0.307N P=0.338N P=0.550N P=0.343N |P=0.231 (e) (e) P=0.593 | |LOGISTIC REGRESSION| P=0.306N P=0.332N P=0.492N P=0.316N |P=0.183 (e) (e) P=0.495 | |COCH-ARM / FISHERS | P=0.286N P=0.309N P=0.500N P=0.309N |P=0.193 (e) (e) P=0.495 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |7/50 (14%) 11/50 (22%) 8/50 (16%) 10/49 (20%) | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 4.8% 4.7% |15.6% 23.8% 17.4% 21.8% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 1/23 (4%) |3/25 (12%) 7/33 (21%) 3/30 (10%) 4/31 (13%) | |FIRST INCIDENCE | 579 --- 571 597 |629 682 506 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.456 P=0.224N P=0.678N P=0.659N |P=0.440 P=0.398 P=0.574 P=0.406 | |POLY 3 | P=0.465 P=0.279N P=0.721N P=0.713N |P=0.383 P=0.244 P=0.531 P=0.324 | |POLY 1.5 | P=0.451 P=0.259N P=0.708N P=0.702N |P=0.365 P=0.228 P=0.517 P=0.304 | |POLY 6 | P=0.484 P=0.314N P=0.741N P=0.734N |P=0.412 P=0.271 P=0.555 P=0.358 | |LOGISTIC REGRESSION| P=0.368 P=0.280N P=0.651 P=0.636 |P=0.337 P=0.240 P=0.502 P=0.265 | |COCH-ARM / FISHERS | P=0.432 P=0.247N P=0.691N P=0.691N |P=0.343 P=0.218 P=0.500 P=0.282 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Spleen: Capsule | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 5.1% 4.8% 4.9% 0.0% |0.0% 0.0% 0.0% 4.5% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 2/24 (8%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 1/31 (3%) | |FIRST INCIDENCE | 709 711 729 (T) --- |--- --- --- 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.140N P=0.624N P=0.630N P=0.212N |P=0.049 * (e) (e) P=0.266 | |POLY 3 | P=0.163N P=0.713N P=0.724N P=0.277N |P=0.048 * (e) (e) P=0.269 | |POLY 1.5 | P=0.162N P=0.703N P=0.709N P=0.257N |P=0.046 * (e) (e) P=0.251 | |POLY 6 | P=0.169N P=0.731N P=0.749N P=0.314N |P=0.052 (e) (e) P=0.298 | |LOGISTIC REGRESSION| P=0.141N P=0.642N P=0.655N P=0.209N |P=0.042 * (e) (e) P=0.228 | |COCH-ARM / FISHERS | P=0.162N P=0.691N P=0.691N P=0.247N |P=0.044 * (e) (e) P=0.242 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/49 (4%) 2/48 (4%) 0/49 (0%) |5/50 (10%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 7.5% 4.9% 5.1% 0.0% |11.1% 2.2% 0.0% 6.7% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 502 716 686 --- |597 627 --- 698 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.080N P=0.443N P=0.465N P=0.112N |P=0.344N P=0.087N P=0.034N* P=0.321N | |POLY 3 | P=0.093N P=0.532N P=0.549N P=0.142N |P=0.370N P=0.103N P=0.036N* P=0.376N | |POLY 1.5 | P=0.091N P=0.521N P=0.534N P=0.132N |P=0.360N P=0.104N P=0.034N* P=0.369N | |POLY 6 | P=0.099N P=0.551N P=0.571N P=0.160N |P=0.382N P=0.102N P=0.040N* P=0.383N | |LOGISTIC REGRESSION| P=0.093N P=0.535N P=0.543N P=0.171N |P=0.354N P=0.089N P=0.029N* P=0.354N | |COCH-ARM / FISHERS | P=0.090N P=0.510N P=0.520N P=0.125N |P=0.352N P=0.102N P=0.028N* P=0.357N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 10/49 (20%) 8/48 (17%) 13/49 (27%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 23.9% 23.3% 19.3% 30.0% |4.5% 4.3% 6.7% 8.8% | |TERMINAL (d) | 1/20 (5%) 0/23 (0%) 1/24 (4%) 3/23 (13%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 362 555 533 502 |653 699 608 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.362 P=0.479N P=0.332N P=0.440 |P=0.231 P=0.634N P=0.518 P=0.373 | |POLY 3 | P=0.288 P=0.591N P=0.419N P=0.363 |P=0.224 P=0.700N P=0.527 P=0.365 | |POLY 1.5 | P=0.273 P=0.605N P=0.427N P=0.334 |P=0.220 P=0.700N P=0.514 P=0.351 | |POLY 6 | P=0.308 P=0.569N P=0.406N P=0.406 |P=0.233 P=0.700N P=0.550 P=0.390 | |LOGISTIC REGRESSION| P=0.213 P=0.528 P=0.489N P=0.249 |P=0.212 P=0.695N P=0.507 P=0.339 | |COCH-ARM / FISHERS | P=0.252 P=0.579 P=0.435N P=0.298 |P=0.214 P=0.691N P=0.500 P=0.339 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 4/49 (8%) 2/48 (4%) 1/49 (2%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 7.4% 9.5% 5.1% 2.4% |8.9% 6.5% 6.7% 6.6% | |TERMINAL (d) | 0/20 (0%) 1/23 (4%) 1/24 (4%) 1/23 (4%) |0/25 (0%) 2/33 (6%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 362 611 720 729 (T) |597 484 506 561 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139N P=0.556 P=0.457N P=0.284N |P=0.418N P=0.424N P=0.472N P=0.459N | |POLY 3 | P=0.166N P=0.554 P=0.553N P=0.339N |P=0.454N P=0.494N P=0.514N P=0.511N | |POLY 1.5 | P=0.164N P=0.524 P=0.537N P=0.326N |P=0.450N P=0.499N P=0.508N P=0.507N | |POLY 6 | P=0.171N P=0.600 P=0.576N P=0.363N |P=0.458N P=0.488N P=0.523N P=0.513N | |LOGISTIC REGRESSION| P=0.188N P=0.403 P=0.562N P=0.424N |P=0.445N P=0.486N P=0.487N P=0.490N | |COCH-ARM / FISHERS | P=0.163N P=0.489 P=0.520N P=0.316N |P=0.444N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.0% 2.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/20 (5%) 1/23 (4%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 362 729 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.092N P=0.468N P=0.220N P=0.224N |(e) (e) (e) (e) | |POLY 3 | P=0.116N P=0.544N P=0.295N P=0.278N |(e) (e) (e) (e) | |POLY 1.5 | P=0.109N P=0.527N P=0.272N P=0.258N |(e) (e) (e) (e) | |POLY 6 | P=0.128N P=0.571N P=0.333N P=0.315N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.124N P=0.563N P=0.298N P=0.369N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.102N P=0.508N P=0.258N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 14/49 (29%) 13/48 (27%) 17/50 (34%) |12/50 (24%) 6/50 (12%) 7/50 (14%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 39.6% 32.0% 30.2% 36.3% |26.0% 12.8% 15.3% 15.3% | |TERMINAL (d) | 4/20 (20%) 0/23 (0%) 0/24 (0%) 1/23 (4%) |0/25 (0%) 1/33 (3%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 494 548 533 502 |635 627 528 656 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480N P=0.227N P=0.209N P=0.432N |P=0.187N P=0.066N P=0.158N P=0.136N | |POLY 3 | P=0.494N P=0.310N P=0.253N P=0.467N |P=0.199N P=0.090N P=0.159N P=0.162N | |POLY 1.5 | P=0.531N P=0.328N P=0.272N P=0.511N |P=0.194N P=0.095N P=0.157N P=0.160N | |POLY 6 | P=0.456N P=0.290N P=0.232N P=0.421N |P=0.205N P=0.084N P=0.163N P=0.163N | |LOGISTIC REGRESSION| P=0.412 P=0.375N P=0.328N P=0.485 |P=0.186N P=0.099N P=0.148N P=0.154N | |COCH-ARM / FISHERS | P=0.489 P=0.358N P=0.301N P=0.583N |P=0.188N P=0.096N P=0.154N P=0.154N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 0/24 (0%) 0/23 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 694 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.603 (e) P=0.260 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.612 (e) P=0.271 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.601 (e) P=0.255 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.632 (e) P=0.299 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.587 (e) P=0.239 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.587 (e) P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 9/49 (18%) 12/50 (24%) 8/50 (16%) | | |POLY-3 ADJUSTED (b)| 20.1% 21.1% 28.3% 18.3% | | |TERMINAL (d) | 3/20 (15%) 3/23 (13%) 6/24 (25%) 1/23 (4%) | | |FIRST INCIDENCE | 599 544 564 520 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.463N P=0.584N P=0.350 P=0.496N | | |POLY 3 | P=0.482N P=0.586 P=0.288 P=0.549N | | |POLY 1.5 | P=0.509N P=0.541 P=0.261 P=0.571N | | |POLY 6 | P=0.456N P=0.643N P=0.329 P=0.526N | | |LOGISTIC REGRESSION| P=0.535N P=0.531 P=0.260 P=0.592N | | |COCH-ARM / FISHERS | P=0.543 P=0.482 P=0.227 P=0.607N | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Testes: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 2/50 (4%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 4.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/20 (0%) 0/23 (0%) 2/24 (8%) 1/23 (4%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- 729 (T) 676 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.097 (e) P=0.278 P=0.276 |(e) (e) (e) (e) | |POLY 3 | P=0.104 (e) P=0.309 P=0.313 |(e) (e) (e) (e) | |POLY 1.5 | P=0.095 (e) P=0.275 P=0.278 |(e) (e) (e) (e) | |POLY 6 | P=0.117 (e) P=0.364 P=0.369 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.092 (e) P=0.278 P=0.258 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.085 (e) P=0.247 P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 11/49 (22%) 10/50 (20%) 8/50 (16%) | | |POLY-3 ADJUSTED (b)| 18.7% 24.9% 22.7% 18.2% | | |TERMINAL (d) | 0/20 (0%) 3/23 (13%) 2/24 (8%) 2/23 (9%) | | |FIRST INCIDENCE | 494 502 457 520 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.398N P=0.414 P=0.466 P=0.529N | | |POLY 3 | P=0.439N P=0.340 P=0.435 P=0.603N | | |POLY 1.5 | P=0.440N P=0.318 P=0.420 P=0.601N | | |POLY 6 | P=0.447N P=0.372 P=0.458 P=0.612N | | |LOGISTIC REGRESSION| P=0.507 P=0.155 P=0.281 P=0.397 | | |COCH-ARM / FISHERS | P=0.450N P=0.288 P=0.398 P=0.607N | | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/49 (61%) 19/47 (40%) 18/48 (38%) 27/47 (57%) |16/48 (33%) 10/49 (20%) 17/50 (34%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 63.1% 44.0% 41.8% 60.7% |35.7% 21.8% 36.5% 30.2% | |TERMINAL (d) | 7/20 (35%) 5/22 (23%) 5/22 (23%) 11/22 (50%) |6/25 (24%) 4/33 (12%) 9/30 (30%) 6/31 (19%) | |FIRST INCIDENCE | 362 544 559 520 |541 676 506 562 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.382N P=0.030N* P=0.029N* P=0.252N |P=0.475N P=0.064N P=0.526N P=0.293N | |POLY 3 | P=0.499 P=0.050N P=0.032N* P=0.496N |P=0.530N P=0.110N P=0.563 P=0.375N | |POLY 1.5 | P=0.509 P=0.042N* P=0.024N* P=0.469N |P=0.523N P=0.115N P=0.559 P=0.373N | |POLY 6 | P=0.486 P=0.063N P=0.043N* P=0.530N |P=0.533N P=0.101N P=0.570 P=0.369N | |LOGISTIC REGRESSION| P=0.430 P=0.068N P=0.021N* P=0.568 |P=0.513N P=0.116N P=0.561 P=0.362N | |COCH-ARM / FISHERS | P=0.523 P=0.033N* P=0.016N* P=0.433N |P=0.514N P=0.113N P=0.557 P=0.362N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/49 (6%) 0/47 (0%) 3/48 (6%) 2/47 (4%) |1/48 (2%) 1/49 (2%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 7.6% 0.0% 7.6% 5.0% |2.3% 2.2% 2.2% 6.5% | |TERMINAL (d) | 0/20 (0%) 0/22 (0%) 1/22 (5%) 0/22 (0%) |0/25 (0%) 0/33 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 551 --- 457 663 |641 484 663 449 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.573N P=0.113N P=0.627N P=0.451N |P=0.172 P=0.753N P=0.755N P=0.333 | |POLY 3 | P=0.599 P=0.143N P=0.697N P=0.530N |P=0.181 P=0.768N P=0.779N P=0.352 | |POLY 1.5 | P=0.587 P=0.135N P=0.681 P=0.523N |P=0.178 P=0.764N P=0.767N P=0.338 | |POLY 6 | P=0.617 P=0.159N P=0.721N P=0.546N |P=0.187 P=0.776N P=0.796N P=0.376 | |LOGISTIC REGRESSION| P=0.512 P=0.164N P=0.619 P=0.598N |P=0.154 P=0.694N P=0.743N P=0.421 | |COCH-ARM / FISHERS | P=0.569 P=0.129N P=0.651 P=0.520N |P=0.171 P=0.747N P=0.742N P=0.324 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thymus: Epithelial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 3/47 (6%) 2/48 (4%) 3/47 (6%) |7/48 (15%) 6/49 (12%) 9/50 (18%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 13.1% 7.5% 5.2% 7.6% |16.5% 13.3% 20.3% 9.0% | |TERMINAL (d) | 4/20 (20%) 2/22 (9%) 2/22 (9%) 3/22 (14%) |5/25 (20%) 5/33 (15%) 7/30 (23%) 4/31 (13%) | |FIRST INCIDENCE | 703 592 729 (T) 729 (T) |712 682 694 734 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.262N P=0.293N P=0.174N P=0.299N |P=0.189N P=0.312N P=0.528 P=0.159N | |POLY 3 | P=0.313N P=0.358N P=0.238N P=0.366N |P=0.247N P=0.468N P=0.443 P=0.245N | |POLY 1.5 | P=0.312N P=0.366N P=0.231N P=0.369N |P=0.244N P=0.480N P=0.435 P=0.244N | |POLY 6 | P=0.321N P=0.352N P=0.254N P=0.370N |P=0.250N P=0.447N P=0.462 P=0.245N | |LOGISTIC REGRESSION| P=0.267N P=0.303N P=0.185N P=0.298N |P=0.217N P=0.390N P=0.461 P=0.183N | |COCH-ARM / FISHERS | P=0.314N P=0.381N P=0.226N P=0.381N |P=0.239N P=0.484N P=0.428 P=0.239N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/50 (10%) 4/50 (8%) |10/50 (20%) 11/50 (22%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 10.2% 14.4% 12.2% 9.6% |22.5% 23.8% 13.4% 17.8% | |TERMINAL (d) | 2/20 (10%) 5/23 (22%) 4/24 (17%) 3/23 (13%) |7/25 (28%) 9/33 (27%) 4/30 (13%) 7/31 (23%) | |FIRST INCIDENCE | 611 707 648 721 |646 678 597 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.409N P=0.464 P=0.586 P=0.577N |P=0.174N P=0.438N P=0.136N P=0.245N | |POLY 3 | P=0.456N P=0.436 P=0.559 P=0.645N |P=0.250N P=0.551 P=0.206N P=0.397N | |POLY 1.5 | P=0.462N P=0.407 P=0.534 P=0.641N |P=0.251N P=0.522 P=0.208N P=0.400N | |POLY 6 | P=0.457N P=0.476 P=0.595 P=0.659N |P=0.247N P=0.598 P=0.202N P=0.388N | |LOGISTIC REGRESSION| P=0.422N P=0.447 P=0.542 P=0.584N |P=0.239N P=0.599 P=0.197N P=0.355N | |COCH-ARM / FISHERS | P=0.478N P=0.370 P=0.500 P=0.643N |P=0.249N P=0.500 P=0.207N P=0.398N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |0.0% 2.2% 4.5% 0.0% | |TERMINAL (d) | |0/25 (0%) 1/33 (3%) 2/30 (7%) 0/31 (0%) | |FIRST INCIDENCE | |--- 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.581N P=0.555 P=0.279 (e) | |POLY 3 | |P=0.626N P=0.555 P=0.270 (e) | |POLY 1.5 | |P=0.621N P=0.530 P=0.254 (e) | |POLY 6 | |P=0.631N P=0.597 P=0.298 (e) | |LOGISTIC REGRESSION| |(e) P=0.555 P=0.279 (e) | |COCH-ARM / FISHERS | |P=0.612N P=0.500 P=0.247 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/50 (8%) 0/50 (0%) 3/50 (6%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| |9.1% 0.0% 6.7% 11.2% | |TERMINAL (d) | |3/25 (12%) 0/33 (0%) 2/30 (7%) 3/31 (10%) | |FIRST INCIDENCE | |635 --- 655 693 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.237 P=0.039N* P=0.426N P=0.603 | |POLY 3 | |P=0.199 P=0.063N P=0.516N P=0.526 | |POLY 1.5 | |P=0.199 P=0.063N P=0.510N P=0.512 | |POLY 6 | |P=0.201 P=0.063N P=0.522N P=0.553 | |LOGISTIC REGRESSION| |P=0.199 P=0.060N P=0.496N P=0.520 | |COCH-ARM / FISHERS | |P=0.199 P=0.059N P=0.500N P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 05160 TEST: 05 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - 1-CHLORO-2-PROPANOL Terminal Sacrifice at 104 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 150 PPM 325 PPM 650 PPM |0 PPM 150 PPM 325 PPM 650 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| |0.0% 2.2% 6.8% 0.0% | |TERMINAL (d) | |0/25 (0%) 1/33 (3%) 3/30 (10%) 0/31 (0%) | |FIRST INCIDENCE | |--- 734 (T) 734 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.597N P=0.555 P=0.154 (e) | |POLY 3 | |P=0.645N P=0.555 P=0.137 (e) | |POLY 1.5 | |P=0.641N P=0.530 P=0.128 (e) | |POLY 6 | |P=0.648N P=0.597 P=0.153 (e) | |LOGISTIC REGRESSION| |(e) P=0.555 P=0.154 (e) | |COCH-ARM / FISHERS | |P=0.633 P=0.500 P=0.121 (e) | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers 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).