TDMS Study 89002-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:47:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 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: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:47:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PENTACHLOROPHENOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Degeneration Fatty Hypertrophy Adrenal Medulla Hyperplasia Bone Marrow Hyperplasia Heart Cardiomyopathy Chronic Heart: Atrium Thrombosis Kidney Mineralization Nephropathy Chronic Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Clear Cell Focus Eosinophilic Focus Hepatodiaphragmatic Nodule Inflammation Chronic Mixed Cell Focus Liver: Artery Inflammation Chronic Liver: Bile Duct Hyperplasia Liver: Centrilobular Hypertrophy Liver: Hepatocyte Degeneration Cystic Vacuolization Cytoplasmic Liver: Hepatocyte, Centrilobular Hypertrophy Lung Inflammation Chronic Lung: Alveolus Infiltration Cellular Histiocyte Lymph Node, Mediastinal Pigmentation Hemosiderin Lymph Node, Mesenteric Ectasia Hyperplasia Lymphoid Mammary Gland Hyperplasia Cystic Mesentery: Fat Necrosis Nose Fungus Inflammation Chronic Nose: Respiratory Epithelium Hyperplasia Metaplasia Pancreas: Acinus Atrophy Parathyroid Gland Hyperplasia Pituitary Gland: Pars Distalis Hyperplasia Preputial Gland Hyperplasia Inflammation Chronic Prostate Inflammation Chronic Skin: Epidermis Hyperkeratosis Spleen Fibrosis Hematopoietic Cell Proliferation Stomach, Forestomach Inflammation Chronic Stomach, Forestomach: Epithelium Hyperplasia NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:47:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 Ulcer Testes: Interstitial Cell Hyperplasia Thyroid Gland: C-Cell Hyperplasia =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Degeneration Cystic Degeneration Fatty Hyperplasia Hypertrophy Bone Osteopetrosis Bone Marrow Hyperplasia Brain Hemorrhage Clitoral Gland Inflammation Chronic Eye: Lens Cataract Eye: Retina Atrophy Heart Cardiomyopathy Chronic Intestine Large, Colon Parasite Metazoan Intestine Large, Rectum Parasite Metazoan Kidney Mineralization Nephropathy Chronic Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Clear Cell Focus Liver: Centrilobular Hypertrophy Liver: Hepatocyte Necrosis Vacuolization Cytoplasmic Liver: Hepatocyte, Centrilobular Hypertrophy Lung: Alveolus Infiltration Cellular Histiocyte Lymph Node, Mediastinal Pigmentation Hemosiderin Mammary Gland Cyst Hyperplasia Cystic Nose Fungus Inflammation Chronic Nose: Respiratory Epithelium Hyperplasia Metaplasia Pituitary Gland: Pars Distalis Cyst Thyroid Gland: C-Cell Hyperplasia =============================================================== Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.6% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 2/31 (7%) 0/27 (0%) | |FIRST INCIDENCE | --- --- 736 (T) 736 (T) 565 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.126 (e) P=0.612 P=0.463 P=0.273 | |POLY 3 | P=0.078 (e) P=0.503 P=0.273 P=0.266 | |POLY 1.5 | P=0.068 (e) P=0.496 P=0.249 P=0.251 | |POLY 6 | P=0.100 (e) P=0.508 P=0.301 P=0.291 | |LOGISTIC REGRESSION| P=0.072 (e) P=0.612 P=0.463 P=0.242 | |COCH-ARM / FISHERS | P=0.069 (e) P=0.455 P=0.204 P=0.248 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.7% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 2/33 (6%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 738 (T) 738 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.115N P=0.558 P=0.461N P=0.500N P=0.500N | |POLY 3 | P=0.098N P=0.513 P=0.492N P=0.503N P=0.493N | |POLY 1.5 | P=0.101N P=0.495 P=0.501N P=0.506N P=0.498N | |POLY 6 | P=0.098N P=0.529 P=0.485N P=0.505N P=0.489N | |LOGISTIC REGRESSION| P=0.115N P=0.558 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.117N P=0.431 P=0.545N P=0.545N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 2.8% 2.6% 0.0% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 1/16 (6%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | 736 (T) 736 (T) 624 --- 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.343N P=0.698N P=0.704N P=0.311N P=0.571N | |POLY 3 | P=0.459N P=0.753 P=0.755N P=0.471N P=0.737N | |POLY 1.5 | P=0.477N P=0.751 P=0.758 P=0.490N P=0.750N | |POLY 6 | P=0.440N P=0.753 P=0.748N P=0.449N P=0.715N | |LOGISTIC REGRESSION| P=0.453N P=0.698N P=0.763 (e) P=0.571N | |COCH-ARM / FISHERS | P=0.512N P=0.705 P=0.705 P=0.545N P=0.752N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 4/50 (8%) 3/50 (6%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 9.3% 7.0% 0.0% 4.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 4/33 (12%) 3/34 (9%) 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- 738 (T) 738 (T) --- 600 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.537 P=0.085 P=0.157 (e) P=0.250 | |POLY 3 | P=0.510N P=0.065 P=0.126 (e) P=0.247 | |POLY 1.5 | P=0.524N P=0.058 P=0.118 (e) P=0.241 | |POLY 6 | P=0.505N P=0.072 P=0.133 (e) P=0.253 | |LOGISTIC REGRESSION| P=0.565 P=0.085 P=0.157 (e) P=0.241 | |COCH-ARM / FISHERS | P=0.575N P=0.040 * P=0.091 (e) P=0.248 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 28/60 (47%) 19/50 (38%) 16/50 (32%) 20/50 (40%) 25/60 (42%) | |POLY-3 ADJUSTED (b)| 63.0% 46.9% 38.1% 43.5% 53.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 8/12 (67%) 6/16 (38%) 6/21 (29%) 12/31 (39%) 12/27 (44%) | |FIRST INCIDENCE | 396 507 443 518 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.020N* P=0.064N P=0.005N** P<0.001N** P=0.017N* | |POLY 3 | P=0.316N P=0.089N P=0.013N* P=0.043N* P=0.246N | |POLY 1.5 | P=0.391N P=0.093N P=0.017N* P=0.077N P=0.301N | |POLY 6 | P=0.211N P=0.099N P=0.012N* P=0.024N* P=0.166N | |LOGISTIC REGRESSION| P=0.342N P=0.096N P=0.024N* P=0.071N P=0.259N | |COCH-ARM / FISHERS | P=0.418N P=0.236N P=0.085N P=0.306N P=0.357N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/60 (15%) 11/50 (22%) 17/50 (34%) 15/50 (30%) 14/60 (23%) | |POLY-3 ADJUSTED (b)| 21.1% 25.5% 37.7% 35.6% 32.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/28 (14%) 10/33 (30%) 10/34 (29%) 11/28 (39%) 8/28 (29%) | |FIRST INCIDENCE | 585 620 451 586 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.103 P=0.545 P=0.139 P=0.122 P=0.219 | |POLY 3 | P=0.128 P=0.414 P=0.070 P=0.105 P=0.180 | |POLY 1.5 | P=0.130 P=0.377 P=0.053 P=0.099 P=0.171 | |POLY 6 | P=0.124 P=0.441 P=0.084 P=0.095 P=0.189 | |LOGISTIC REGRESSION| P=0.131 P=0.440 P=0.053 P=0.106 P=0.197 | |COCH-ARM / FISHERS | P=0.165 P=0.242 P=0.017 * P=0.048 * P=0.177 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 13/60 (22%) 11/50 (22%) 13/50 (26%) 15/50 (30%) 17/60 (28%) | |POLY-3 ADJUSTED (b)| 32.0% 29.3% 33.1% 34.0% 39.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/12 (33%) 7/16 (44%) 8/21 (38%) 12/31 (39%) 13/27 (48%) | |FIRST INCIDENCE | 564 524 605 619 460 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.218N P=0.313N P=0.291N P=0.088N P=0.280N | |POLY 3 | P=0.217 P=0.493N P=0.557 P=0.516 P=0.328 | |POLY 1.5 | P=0.172 P=0.483N P=0.542 P=0.435 P=0.290 | |POLY 6 | P=0.305 P=0.541N P=0.544 P=0.590 P=0.389 | |LOGISTIC REGRESSION| P=0.299 P=0.460N P=0.575N P=0.590N P=0.362 | |COCH-ARM / FISHERS | P=0.162 P=0.574 P=0.378 P=0.218 P=0.264 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 12/50 (24%) 23/50 (46%) 12/50 (24%) 17/60 (28%) | |POLY-3 ADJUSTED (b)| 16.9% 28.0% 51.6% 29.1% 39.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/28 (21%) 12/33 (36%) 19/34 (56%) 10/28 (36%) 14/28 (50%) | |FIRST INCIDENCE | 698 738 (T) 451 634 600 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.016 * P=0.255 P=0.003 ** P=0.141 P=0.016 * | |POLY 3 | P=0.047 * P=0.166 P<0.001 ** P=0.142 P=0.018 * | |POLY 1.5 | P=0.046 * P=0.140 P<0.001 ** P=0.134 P=0.016 * | |POLY 6 | P=0.046 * P=0.192 P<0.001 ** P=0.135 P=0.020 * | |LOGISTIC REGRESSION| P=0.033 * P=0.255 P<0.001 ** P=0.120 P=0.021 * | |COCH-ARM / FISHERS | P=0.059 P=0.074 P<0.001 ** P=0.074 P=0.019 * | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 2/50 (4%) 4/50 (8%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 2.7% 5.1% 9.2% 7.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 4/31 (13%) 2/27 (7%) | |FIRST INCIDENCE | --- 619 443 736 (T) 677 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.136 P=0.489 P=0.244 P=0.238 P=0.253 | |POLY 3 | P=0.068 P=0.494 P=0.248 P=0.082 P=0.139 | |POLY 1.5 | P=0.057 P=0.491 P=0.237 P=0.068 P=0.129 | |POLY 6 | P=0.092 P=0.496 P=0.259 P=0.103 P=0.160 | |LOGISTIC REGRESSION| P=0.058 P=0.468 P=0.095 P=0.238 P=0.164 | |COCH-ARM / FISHERS | P=0.057 P=0.455 P=0.204 P=0.040 * P=0.122 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 6/50 (12%) 8/50 (16%) 7/50 (14%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 2.4% 14.0% 18.6% 17.2% 7.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 6/33 (18%) 8/34 (24%) 7/28 (25%) 3/28 (11%) | |FIRST INCIDENCE | 738 (T) 738 (T) 738 (T) 738 (T) 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.338 P=0.085 P=0.033 * P=0.029 * P=0.304 | |POLY 3 | P=0.428 P=0.061 P=0.018 * P=0.027 * P=0.317 | |POLY 1.5 | P=0.418 P=0.053 P=0.015 * P=0.026 * P=0.309 | |POLY 6 | P=0.434 P=0.070 P=0.020 * P=0.025 * P=0.324 | |LOGISTIC REGRESSION| P=0.338 P=0.085 P=0.033 * P=0.029 * P=0.304 | |COCH-ARM / FISHERS | P=0.433 P=0.033 * P=0.007 ** P=0.016 * P=0.309 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 18/60 (30%) 27/50 (54%) 22/50 (44%) 25/50 (50%) 28/60 (47%) | |POLY-3 ADJUSTED (b)| 46.0% 65.0% 51.8% 53.9% 61.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/12 (50%) 9/16 (56%) 9/21 (43%) 17/31 (55%) 17/27 (63%) | |FIRST INCIDENCE | 647 563 521 544 460 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.145N P=0.167 P=0.477N P=0.118N P=0.396N | |POLY 3 | P=0.268 P=0.054 P=0.376 P=0.301 P=0.111 | |POLY 1.5 | P=0.161 P=0.037 * P=0.282 P=0.165 P=0.062 | |POLY 6 | P=0.467 P=0.088 P=0.491 P=0.495 P=0.235 | |LOGISTIC REGRESSION| P=0.183 P=0.023 * P=0.283 P=0.337 P=0.088 | |COCH-ARM / FISHERS | P=0.105 P=0.009 ** P=0.093 P=0.026 * P=0.045 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/60 (5%) 7/50 (14%) 6/50 (12%) 7/50 (14%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 7.3% 16.0% 13.6% 16.3% 9.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/28 (11%) 5/33 (15%) 4/34 (12%) 2/28 (7%) 2/28 (7%) | |FIRST INCIDENCE | 738 (T) 430 399 417 516 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.488 P=0.223 P=0.327 P=0.163 P=0.509 | |POLY 3 | P=0.521N P=0.181 P=0.274 P=0.172 P=0.533 | |POLY 1.5 | P=0.539N P=0.157 P=0.247 P=0.156 P=0.515 | |POLY 6 | P=0.506N P=0.206 P=0.297 P=0.180 P=0.552 | |LOGISTIC REGRESSION| P=0.535 P=0.159 P=0.236 P=0.120 P=0.512 | |COCH-ARM / FISHERS | P=0.545 P=0.097 P=0.163 P=0.097 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Blood Vessel: Aorta | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 2.3% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 1/27 (4%) | |FIRST INCIDENCE | 715 --- --- 736 (T) 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.305 P=0.490N P=0.462N P=0.591N P=0.670 | |POLY 3 | P=0.191 P=0.508N P=0.497N P=0.726N P=0.538 | |POLY 1.5 | P=0.182 P=0.510N P=0.504N P=0.749N P=0.518 | |POLY 6 | P=0.210 P=0.510N P=0.493N P=0.699N P=0.570 | |LOGISTIC REGRESSION| P=0.240 P=0.504N P=0.483N P=0.666N P=0.577 | |COCH-ARM / FISHERS | P=0.191 P=0.545N P=0.545N P=0.705 P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Blood Vessel: Aorta | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% 7.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | 715 --- --- --- 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.126 P=0.490N P=0.462N P=0.396N P=0.488 | |POLY 3 | P=0.078 P=0.508N P=0.497N P=0.471N P=0.345 | |POLY 1.5 | P=0.075 P=0.510N P=0.504N P=0.490N P=0.324 | |POLY 6 | P=0.083 P=0.510N P=0.493N P=0.450N P=0.382 | |LOGISTIC REGRESSION| P=0.091 P=0.504N P=0.483N P=0.440N P=0.384 | |COCH-ARM / FISHERS | P=0.075 P=0.545N P=0.545N P=0.545N P=0.309 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 614 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.431N P=0.489 (e) (e) (e) | |POLY 3 | P=0.388N P=0.495 (e) (e) (e) | |POLY 1.5 | P=0.398N P=0.491 (e) (e) (e) | |POLY 6 | P=0.384N P=0.496 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.452N P=0.465 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.451N P=0.455 (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/60 (10%) 1/50 (2%) 4/50 (8%) 2/50 (4%) 2/59 (3%) | |POLY-3 ADJUSTED (b)| 14.4% 2.3% 9.3% 4.9% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/28 (11%) 0/33 (0%) 4/34 (12%) 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 698 698 738 (T) 634 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.156N P=0.040N* P=0.273N P=0.154N P=0.127N | |POLY 3 | P=0.169N P=0.051N P=0.349N P=0.135N P=0.128N | |POLY 1.5 | P=0.163N P=0.058N P=0.374N P=0.142N P=0.136N | |POLY 6 | P=0.179N P=0.045N* P=0.334N P=0.138N P=0.122N | |LOGISTIC REGRESSION| P=0.141N P=0.048N* P=0.312N P=0.140N P=0.123N | |COCH-ARM / FISHERS | P=0.143N P=0.091N P=0.491N P=0.203N P=0.142N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 30/60 (50%) 33/50 (66%) 36/50 (72%) 32/50 (64%) 38/60 (63%) | |POLY-3 ADJUSTED (b)| 67.4% 74.9% 77.7% 67.1% 79.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/12 (42%) 11/16 (69%) 16/21 (76%) 19/31 (61%) 21/27 (78%) | |FIRST INCIDENCE | 396 435 360 518 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.048N* P=0.477 P=0.505N P=0.019N* P=0.181N | |POLY 3 | P=0.242 P=0.281 P=0.180 P=0.579N P=0.138 | |POLY 1.5 | P=0.169 P=0.244 P=0.124 P=0.452 P=0.098 | |POLY 6 | P=0.356 P=0.279 P=0.207 P=0.475N P=0.199 | |LOGISTIC REGRESSION| P=0.193 P=0.221 P=0.101 P=0.523 P=0.125 | |COCH-ARM / FISHERS | P=0.155 P=0.067 P=0.015 * P=0.100 P=0.099 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/60 (18%) 14/50 (28%) 17/50 (34%) 21/50 (42%) 16/59 (27%) | |POLY-3 ADJUSTED (b)| 25.2% 31.4% 38.2% 45.1% 34.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/28 (11%) 6/33 (18%) 12/34 (35%) 9/28 (32%) 2/28 (7%) | |FIRST INCIDENCE | 475 535 535 444 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.114 P=0.474 P=0.273 P=0.046 * P=0.263 | |POLY 3 | P=0.149 P=0.342 P=0.137 P=0.036 * P=0.236 | |POLY 1.5 | P=0.123 P=0.298 P=0.117 P=0.026 * P=0.200 | |POLY 6 | P=0.180 P=0.383 P=0.146 P=0.043 * P=0.279 | |LOGISTIC REGRESSION| P=0.110 P=0.279 P=0.123 P=0.010 * P=0.179 | |COCH-ARM / FISHERS | P=0.126 P=0.164 P=0.049 * P=0.006 ** P=0.178 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 5.5% 0.0% 2.3% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 684 698 --- 708 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.340N P=0.516 P=0.500N P=0.645N P=0.672N | |POLY 3 | P=0.442N P=0.486 P=0.498N P=0.726N P=0.738N | |POLY 1.5 | P=0.459N P=0.483 P=0.504N P=0.749N P=0.750N | |POLY 6 | P=0.420N P=0.485 P=0.494N P=0.699N P=0.717N | |LOGISTIC REGRESSION| P=0.430N P=0.486 P=0.499N P=0.739N P=0.735N | |COCH-ARM / FISHERS | P=0.489N P=0.431 P=0.545N P=0.705 P=0.752N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/59 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.3% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 705 698 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.166N P=0.722N P=0.470N P=0.513N P=0.488N | |POLY 3 | P=0.156N P=0.752N P=0.492N P=0.503N P=0.498N | |POLY 1.5 | P=0.156N P=0.758 P=0.501N P=0.506N P=0.502N | |POLY 6 | P=0.159N P=0.741N P=0.486N P=0.506N P=0.494N | |LOGISTIC REGRESSION| P=0.163N P=0.764N P=0.496N P=0.505N P=0.497N | |COCH-ARM / FISHERS | P=0.168N P=0.705 P=0.545N P=0.545N P=0.504N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/60 (7%) 0/50 (0%) 6/50 (12%) 2/50 (4%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 10.2% 0.0% 14.7% 4.5% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | 564 --- 527 518 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.141N P=0.080N P=0.388 P=0.235N P=0.112N | |POLY 3 | P=0.177N P=0.069N P=0.395 P=0.281N P=0.157N | |POLY 1.5 | P=0.206N P=0.068N P=0.367 P=0.318N P=0.169N | |POLY 6 | P=0.137N P=0.073N P=0.419 P=0.246N P=0.141N | |LOGISTIC REGRESSION| P=0.222N P=0.079N P=0.248 P=0.439N P=0.167N | |COCH-ARM / FISHERS | P=0.219N P=0.084N P=0.262 P=0.430N P=0.182N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 4.7% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 392 --- 444 652 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.264 P=0.496 (e) P=0.237 P=0.520 | |POLY 3 | P=0.261 P=0.511 (e) P=0.242 P=0.508 | |POLY 1.5 | P=0.257 P=0.500 (e) P=0.235 P=0.503 | |POLY 6 | P=0.267 P=0.521 (e) P=0.243 P=0.514 | |LOGISTIC REGRESSION| P=0.335 P=0.268 (e) P=0.048 * P=0.502 | |COCH-ARM / FISHERS | P=0.276 P=0.455 (e) P=0.204 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 12/50 (24%) 14/48 (29%) 11/50 (22%) 10/59 (17%) | |POLY-3 ADJUSTED (b)| 23.6% 27.4% 33.5% 25.7% 23.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/28 (21%) 10/33 (30%) 13/34 (38%) 6/28 (21%) 9/27 (33%) | |FIRST INCIDENCE | 523 535 600 586 703 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.523 P=0.554 P=0.410 P=0.487 P=0.587 | |POLY 3 | P=0.467N P=0.434 P=0.220 P=0.509 P=0.587 | |POLY 1.5 | P=0.462N P=0.387 P=0.191 P=0.480 P=0.578 | |POLY 6 | P=0.485N P=0.477 P=0.241 P=0.514 P=0.592 | |LOGISTIC REGRESSION| P=0.461N P=0.429 P=0.251 P=0.463 P=0.575N | |COCH-ARM / FISHERS | P=0.428N P=0.236 P=0.094 P=0.320 P=0.580 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 11/50 (22%) 4/48 (8%) 5/50 (10%) 5/59 (8%) | |POLY-3 ADJUSTED (b)| 20.6% 24.1% 9.3% 12.0% 11.4% | |INT SACRIFICE 1 (c)| 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |TERMINAL (d) | 1/28 (4%) 6/33 (18%) 2/34 (6%) 3/28 (11%) 2/27 (7%) | |FIRST INCIDENCE | 184 (I) 337 417 572 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.034N* P=0.080 P=0.590N P=0.502 P=0.116N | |POLY 3 | P=0.054N P=0.437 P=0.111N P=0.208N P=0.179N | |POLY 1.5 | P=0.051N P=0.401 P=0.121N P=0.204N P=0.177N | |POLY 6 | P=0.059N P=0.478 P=0.104N P=0.225N P=0.179N | |LOGISTIC REGRESSION| P=0.026N* P=0.055 P=0.557 P=0.564 P=0.112N | |COCH-ARM / FISHERS | P=0.039N* P=0.320 P=0.161N P=0.232N P=0.142N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Coagulating Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/2 (100%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 715 736 (T) --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Coagulating Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- 507 --- --- 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.590N P=0.229 (e) (e) P=0.662 | |POLY 3 | P=0.594N P=0.233 (e) (e) P=0.521 | |POLY 1.5 | P=0.611N P=0.228 (e) (e) P=0.510 | |POLY 6 | P=0.578N P=0.235 (e) (e) P=0.539 | |LOGISTIC REGRESSION| P=0.588 P=0.184 (e) (e) P=0.662 | |COCH-ARM / FISHERS | P=0.586 P=0.204 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) 0/3 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/3 (67%) 0/3 (0%) 0/2 (0%) 0/2 (0%) 1/2 (50%) | |POLY-3 ADJUSTED (b)| 70.3% 0.0% 0.0% 0.0% 50.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 2/2 (100%) 0/2 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) | |FIRST INCIDENCE | 738 (T) --- --- --- 701 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.570N P=0.193N P=1.000N P=0.362N P=0.682N | |POLY 3 | P=0.612N P=0.146N P=0.485N P=0.350N P=0.657N | |POLY 1.5 | P=0.585N P=0.152N P=0.404N P=0.318N P=0.664N | |POLY 6 | P=0.639N P=0.134N P=0.572N P=0.393N P=0.644N | |LOGISTIC REGRESSION| P=0.601N (e) (e) (e) P=0.737N | |COCH-ARM / FISHERS | P=0.539N P=0.200N P=0.300N P=0.300N P=0.700N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 3/4 (75%) 0/1 (0%) 3/3 (100%) 3/3 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 77.1% 0.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/1 (0%) 3/3 (100%) 1/1 (100%) | |FIRST INCIDENCE | 396 592 --- 736 (T) 677 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.418 P=0.738 P=0.510N (e) (e) | |POLY 3 | P=0.313 P=0.783N P=1.000 (e) (e) | |POLY 1.5 | P=0.308 P=0.766N P=1.000 (e) (e) | |POLY 6 | P=0.324 P=0.817N P=1.000 (e) (e) | |LOGISTIC REGRESSION| P=0.228 (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.325 P=0.800N P=0.500N (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/3 (0%) 2/3 (67%) 2/2 (100%) 2/2 (100%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 70.3% 100.0% 100.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/2 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- 738 (T) 417 586 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.567 P=0.193 P=0.262 P=0.161 (e) | |POLY 3 | P=0.574 P=0.146 P<0.001 ** P<0.001 ** (e) | |POLY 1.5 | P=0.592 P=0.152 P<0.001 ** P<0.001 ** (e) | |POLY 6 | P=0.535 P=0.134 P<0.001 ** P<0.001 ** (e) | |LOGISTIC REGRESSION| P=0.630N P=0.193 (e) P=0.174 (e) | |COCH-ARM / FISHERS | P=0.567 P=0.200 P=0.100 P=0.100 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Synechia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/1 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) 0/3 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/1 (0%) 0/3 (0%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Synechia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/3 (0%) 2/3 (67%) 0/2 (0%) 0/2 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 66.7% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/2 (0%) 1/2 (50%) 0/0 (0%) 0/1 (0%) 0/1 (0%) | |FIRST INCIDENCE | --- 698 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.363N P=0.258 (e) (e) (e) | |POLY 3 | P=0.385N P=0.172 (e) (e) (e) | |POLY 1.5 | P=0.358N P=0.165 (e) (e) (e) | |POLY 6 | P=0.422N P=0.185 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.389N P=0.186 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.353N P=0.200 (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/1 (100%) 4/4 (100%) 0/1 (0%) 3/3 (100%) 3/3 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/1 (0%) 3/3 (100%) 1/1 (100%) | |FIRST INCIDENCE | 396 592 --- 736 (T) 677 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.587 (e) P=0.510N (e) (e) | |POLY 3 | P=1.000N (e) P=1.000 (e) (e) | |POLY 1.5 | P=1.000N (e) P=1.000 (e) (e) | |POLY 6 | P=1.000N (e) P=1.000 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.620 (e) P=0.500N (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/3 (0%) 3/3 (100%) 2/2 (100%) 2/2 (100%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% 0.0% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 0/2 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- 698 417 586 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.514N P=0.104 P=0.262 P=0.161 (e) | |POLY 3 | P=0.999N P<0.001 ** P<0.001 ** P<0.001 ** (e) | |POLY 1.5 | P=1.000N P<0.001 ** P<0.001 ** P<0.001 ** (e) | |POLY 6 | P=0.970N P<0.001 ** P<0.001 ** P<0.001 ** (e) | |LOGISTIC REGRESSION| P=0.499N P=0.051 (e) P=0.174 (e) | |COCH-ARM / FISHERS | P=0.579N P=0.050 P=0.100 P=0.100 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 50/60 (83%) 41/50 (82%) 41/50 (82%) 44/50 (88%) 55/60 (92%) | |POLY-3 ADJUSTED (b)| 89.8% 87.0% 89.0% 89.3% 95.2% | |INT SACRIFICE 1 (c)| 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 12/12 (100%) 15/16 (94%) 21/21 (100%) 27/31 (87%) 26/27 (96%) | |FIRST INCIDENCE | 184 (I) 410 360 213 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004N** P=0.391N P=0.094N P<0.001N** P=0.019N* | |POLY 3 | P=0.111 P=0.446N P=0.595N P=0.601N P=0.199 | |POLY 1.5 | P=0.087 P=0.442N P=0.518N P=0.555 P=0.170 | |POLY 6 | P=0.181 P=0.504N P=0.606 P=0.496N P=0.266 | |LOGISTIC REGRESSION| P=0.069 P=0.513N P=0.427N P=0.364 P=0.138 | |COCH-ARM / FISHERS | P=0.065 P=0.525N P=0.525N P=0.340 P=0.135 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 29/60 (48%) 31/50 (62%) 36/50 (72%) 35/50 (70%) 26/60 (43%) | |POLY-3 ADJUSTED (b)| 60.4% 66.8% 79.6% 77.2% 57.6% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 15/28 (54%) 22/33 (67%) 29/34 (85%) 22/28 (79%) 17/28 (61%) | |FIRST INCIDENCE | 184 (I) 284 535 459 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.437N P=0.554 P=0.290 P=0.114 P=0.328N | |POLY 3 | P=0.500N P=0.331 P=0.029 * P=0.055 P=0.473N | |POLY 1.5 | P=0.434N P=0.279 P=0.029 * P=0.055 P=0.445N | |POLY 6 | P=0.475 P=0.371 P=0.024 * P=0.042 * P=0.509N | |LOGISTIC REGRESSION| P=0.284N P=0.248 P=0.072 P=0.073 P=0.329N | |COCH-ARM / FISHERS | P=0.248N P=0.107 P=0.010 * P=0.017 * P=0.357N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 7/50 (14%) 4/50 (8%) 2/50 (4%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 18.5% 18.4% 10.4% 4.6% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/12 (25%) 1/16 (6%) 2/21 (10%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | 684 507 640 708 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.532N P=0.109N P=0.004N** P=0.003N** | |POLY 3 | P=0.003N** P=0.614N P=0.245N P=0.049N* P=0.020N* | |POLY 1.5 | P=0.004N** P=0.594 P=0.268N P=0.067N P=0.025N* | |POLY 6 | P=0.002N** P=0.596N P=0.226N P=0.034N* P=0.014N* | |LOGISTIC REGRESSION| P=0.002N** P=0.578 P=0.210N P=0.017N* P=0.008N** | |COCH-ARM / FISHERS | P=0.006N** P=0.466 P=0.378N P=0.133N P=0.031N* | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 0.0% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 620 --- --- 668 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.408 P=0.514 (e) (e) P=0.527 | |POLY 3 | P=0.433 P=0.509 (e) (e) P=0.508 | |POLY 1.5 | P=0.426 P=0.498 (e) (e) P=0.503 | |POLY 6 | P=0.438 P=0.520 (e) (e) P=0.513 | |LOGISTIC REGRESSION| P=0.413 P=0.451 (e) (e) P=0.503 | |COCH-ARM / FISHERS | P=0.413 P=0.455 (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 3/50 (6%) 1/50 (2%) 3/49 (6%) 3/59 (5%) | |POLY-3 ADJUSTED (b)| 2.7% 7.9% 2.6% 7.0% 7.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 1/21 (5%) 1/30 (3%) 2/27 (7%) | |FIRST INCIDENCE | 736 (T) 410 736 (T) 708 565 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.454 P=0.330 P=0.633N P=0.596 P=0.536 | |POLY 3 | P=0.309 P=0.308 P=0.758N P=0.354 P=0.342 | |POLY 1.5 | P=0.280 P=0.297 P=0.757 P=0.317 P=0.319 | |POLY 6 | P=0.363 P=0.317 P=0.752N P=0.399 P=0.381 | |LOGISTIC REGRESSION| P=0.267 P=0.194 P=0.633N P=0.439 P=0.342 | |COCH-ARM / FISHERS | P=0.262 P=0.244 P=0.705 P=0.237 P=0.303 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 2/50 (4%) 1/50 (2%) 5/50 (10%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 2.3% 12.3% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 5/28 (18%) 1/28 (4%) | |FIRST INCIDENCE | --- 738 (T) 417 738 (T) 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.234 P=0.275 P=0.500 P=0.032 * P=0.500 | |POLY 3 | P=0.256 P=0.245 P=0.512 P=0.029 * P=0.507 | |POLY 1.5 | P=0.252 P=0.234 P=0.502 P=0.028 * P=0.502 | |POLY 6 | P=0.263 P=0.257 P=0.520 P=0.027 * P=0.511 | |LOGISTIC REGRESSION| P=0.269 P=0.275 P=0.250 P=0.032 * P=0.500 | |COCH-ARM / FISHERS | P=0.285 P=0.204 P=0.455 P=0.017 * P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 5/50 (10%) 3/50 (6%) 3/49 (6%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 2.6% 13.1% 7.7% 7.0% 12.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 3/30 (10%) 5/27 (19%) | |FIRST INCIDENCE | 643 507 583 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.432 P=0.098 P=0.373 P=0.577 P=0.322 | |POLY 3 | P=0.251 P=0.101 P=0.312 P=0.348 P=0.124 | |POLY 1.5 | P=0.221 P=0.095 P=0.299 P=0.315 P=0.112 | |POLY 6 | P=0.301 P=0.106 P=0.322 P=0.388 P=0.146 | |LOGISTIC REGRESSION| P=0.212 P=0.062 P=0.295 P=0.392 P=0.178 | |COCH-ARM / FISHERS | P=0.191 P=0.067 P=0.244 P=0.237 P=0.103 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 5/50 (10%) 8/50 (16%) 5/50 (10%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 4.8% 11.7% 18.3% 12.1% 9.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 2/28 (7%) 5/33 (15%) 7/34 (21%) 2/28 (7%) 1/28 (4%) | |FIRST INCIDENCE | 738 (T) 738 (T) 451 605 516 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.349 P=0.284 P=0.081 P=0.216 P=0.353 | |POLY 3 | P=0.437 P=0.230 P=0.055 P=0.216 P=0.362 | |POLY 1.5 | P=0.421 P=0.210 P=0.046 * P=0.207 P=0.348 | |POLY 6 | P=0.452 P=0.250 P=0.062 P=0.216 P=0.378 | |LOGISTIC REGRESSION| P=0.400 P=0.284 P=0.052 P=0.206 P=0.348 | |COCH-ARM / FISHERS | P=0.421 P=0.151 P=0.024 * P=0.151 P=0.340 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 0.0% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 1/30 (3%) 0/27 (0%) | |FIRST INCIDENCE | 736 (T) --- --- 736 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.079N P=0.175N P=0.124N P=0.200N P=0.085N | |POLY 3 | P=0.204N P=0.245N P=0.233N P=0.464N P=0.214N | |POLY 1.5 | P=0.208N P=0.248N P=0.241N P=0.497N P=0.226N | |POLY 6 | P=0.195N P=0.245N P=0.227N P=0.426N P=0.195N | |LOGISTIC REGRESSION| P=0.079N (e) (e) P=0.200N (e) | |COCH-ARM / FISHERS | P=0.196N P=0.295N P=0.295N P=0.584N P=0.248N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.5% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) 1/28 (4%) | |FIRST INCIDENCE | --- --- --- 738 (T) 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.126 (e) (e) P=0.500 P=0.500 | |POLY 3 | P=0.138 (e) (e) P=0.497 P=0.507 | |POLY 1.5 | P=0.139 (e) (e) P=0.494 P=0.502 | |POLY 6 | P=0.139 (e) (e) P=0.495 P=0.511 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P=0.500 | |COCH-ARM / FISHERS | P=0.157 (e) (e) P=0.455 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 2.6% 10.8% 2.6% 2.3% 7.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 1/31 (3%) 2/27 (7%) | |FIRST INCIDENCE | 681 507 736 (T) 736 (T) 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.468N P=0.198 P=0.704N P=0.616N P=0.508 | |POLY 3 | P=0.525 P=0.171 P=0.759N P=0.727N P=0.343 | |POLY 1.5 | P=0.492 P=0.166 P=0.757 P=0.749N P=0.323 | |POLY 6 | P=0.570 P=0.172 P=0.755N P=0.701N P=0.378 | |LOGISTIC REGRESSION| P=0.498 P=0.158 P=0.751N P=0.717N P=0.375 | |COCH-ARM / FISHERS | P=0.444 P=0.130 P=0.705 P=0.705 P=0.309 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 738 (T) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.245N P=0.467N P=0.461N P=0.500N P=0.500N | |POLY 3 | P=0.259N P=0.493N P=0.492N P=0.503N P=0.493N | |POLY 1.5 | P=0.251N P=0.503N P=0.501N P=0.506N P=0.498N | |POLY 6 | P=0.271N P=0.483N P=0.485N P=0.505N P=0.489N | |LOGISTIC REGRESSION| P=0.245N (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.247N P=0.545N P=0.545N P=0.545N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 8/60 (13%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 9/60 (15%) | |POLY-3 ADJUSTED (b)| 17.6% 0.0% 0.0% 0.0% 17.8% | |INT SACRIFICE 1 (c)| 8/10 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/10 (90%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 184 (I) --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.357 P=1.000 P=1.000 P=1.000 P=0.500 | |POLY 3 | P=0.225 P=0.009N** P=0.007N** P=0.004N** P=0.598 | |POLY 1.5 | P=0.203 P=0.009N** P=0.008N** P=0.006N** P=0.555 | |POLY 6 | P=0.258 P=0.010N* P=0.007N** P=0.003N** P=0.549N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.192 P=0.006N** P=0.006N** P=0.006N** P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 10/60 (17%) | |POLY-3 ADJUSTED (b)| 19.6% 2.3% 0.0% 0.0% 19.0% | |INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 184 (I) 650 --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.451N P=0.520 P=1.000 P=1.000 P=1.000 | |POLY 3 | P=0.314 P=0.010N* P=0.002N** P=0.003N** P=0.571N | |POLY 1.5 | P=0.324 P=0.011N* P=0.002N** P=0.003N** P=0.588N | |POLY 6 | P=0.295 P=0.008N** P=0.002N** P=0.003N** P=0.556N | |LOGISTIC REGRESSION| P=0.412N P=0.479N (e) (e) P=0.503N | |COCH-ARM / FISHERS | P=0.336 P=0.010N* P=0.002N** P=0.002N** P=0.596N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 60/60 (100%) 49/50 (98%) 50/50 (100%) 49/50 (98%) 58/60 (97%) | |POLY-3 ADJUSTED (b)| 100.0% 99.3% 100.0% 100.0% 99.9% | |INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/10 (90%) | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%) 27/27 (100%) | |FIRST INCIDENCE | 184 (I) 410 360 518 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.359N (e) P<0.001N** P<0.001N** | |POLY 3 | P=0.910 P=0.977N (e) P=1.000N P=1.000N | |POLY 1.5 | P=0.695N P=0.747N (e) P=1.000N P=0.995N | |POLY 6 | P=1.000 P=1.000N (e) P=1.000N P=1.000N | |LOGISTIC REGRESSION| P=0.217N P=0.386N (e) P=0.053N P=0.234N | |COCH-ARM / FISHERS | P=0.124N P=0.455N (e) P=0.455N P=0.248N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 47/60 (78%) 46/50 (92%) 44/50 (88%) 48/50 (96%) 52/60 (87%) | |POLY-3 ADJUSTED (b)| 95.7% 96.2% 92.8% 97.9% 99.8% | |INT SACRIFICE 1 (c)| 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |TERMINAL (d) | 28/28 (100%) 33/33 (100%) 34/34 (100%) 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 184 (I) 284 451 417 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.105 P=0.267N P=0.126N P=0.279 P=0.335 | |POLY 3 | P=0.075 P=0.709 P=0.405N P=0.475 P=0.111 | |POLY 1.5 | P=0.038 * P=0.381 P=0.617N P=0.152 P=0.047 * | |POLY 6 | P=0.201 P=0.655N P=0.267N P=0.895 P=0.738 | |LOGISTIC REGRESSION| P=0.029 * P=0.479 P=0.357N P=0.267 P=0.054 | |COCH-ARM / FISHERS | P=0.142 P=0.042 * P=0.139 P=0.006 ** P=0.168 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | 695 --- --- --- 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.327 P=0.500N P=0.484N P=0.408N P=0.687 | |POLY 3 | P=0.228 P=0.509N P=0.498N P=0.471N P=0.537 | |POLY 1.5 | P=0.222 P=0.510N P=0.504N P=0.490N P=0.518 | |POLY 6 | P=0.239 P=0.510N P=0.493N P=0.451N P=0.568 | |LOGISTIC REGRESSION| P=0.262 P=0.508N P=0.495N P=0.474N P=0.580 | |COCH-ARM / FISHERS | P=0.225 P=0.545N P=0.545N P=0.545N P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- 719 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.140 (e) (e) (e) P=0.513 | |POLY 3 | P=0.151 (e) (e) (e) P=0.507 | |POLY 1.5 | P=0.152 (e) (e) (e) P=0.503 | |POLY 6 | P=0.151 (e) (e) (e) P=0.512 | |LOGISTIC REGRESSION| P=0.148 (e) (e) (e) P=0.510 | |COCH-ARM / FISHERS | P=0.160 (e) (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 49/60 (82%) 48/50 (96%) 49/50 (98%) 50/50 (100%) 57/60 (95%) | |POLY-3 ADJUSTED (b)| 98.3% 98.4% 99.8% 100.0% 95.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%) 25/27 (93%) | |FIRST INCIDENCE | 396 410 443 213 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.008N** P=0.353N P=0.114N P<0.001N** P=0.064N | |POLY 3 | P=0.128N P=0.860 P=0.670 P=0.603 P=0.355N | |POLY 1.5 | P=0.430N P=0.568 P=0.241 P=0.122 P=0.617N | |POLY 6 | P=0.051N P=0.953 P=0.898 P=0.891 P=0.286N | |LOGISTIC REGRESSION| P=0.003 ** P=0.679N P=0.740 P=0.142 P=0.014 * | |COCH-ARM / FISHERS | P=0.006 ** P=0.019 * P=0.005 ** P<0.001 ** P=0.022 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 48/60 (80%) 48/50 (96%) 50/50 (100%) 50/50 (100%) 59/60 (98%) | |POLY-3 ADJUSTED (b)| 98.1% 99.6% 100.0% 100.0% 100.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 28/28 (100%) 33/33 (100%) 34/34 (100%) 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 391 337 399 417 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.025 * P=0.179N P=0.246N P=0.408 P=0.099 | |POLY 3 | P=0.119 P=0.673 P=0.530 P=0.530 P=0.475 | |POLY 1.5 | P=0.003 ** P=0.226 P=0.061 P=0.061 P=0.039 * | |POLY 6 | P=0.779 P=0.998 P=0.997 P=0.997 P=0.996 | |LOGISTIC REGRESSION| P<0.001 ** P=0.366 P=0.162 P=0.197 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% 2.3% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) 2/27 (7%) | |FIRST INCIDENCE | 647 --- 736 (T) 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.542N P=0.241N P=0.422N P=0.312N P=0.481N | |POLY 3 | P=0.449 P=0.247N P=0.498N P=0.452N P=0.660N | |POLY 1.5 | P=0.431 P=0.249N P=0.508N P=0.483N P=0.678N | |POLY 6 | P=0.483 P=0.250N P=0.493N P=0.418N P=0.630N | |LOGISTIC REGRESSION| P=0.541 P=0.248N P=0.488N P=0.444N P=0.627N | |COCH-ARM / FISHERS | P=0.439 P=0.295N P=0.569N P=0.569N P=0.691N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- 613 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.547 (e) (e) P=0.495 (e) | |POLY 3 | P=0.500 (e) (e) P=0.500 (e) | |POLY 1.5 | P=0.500 (e) (e) P=0.495 (e) | |POLY 6 | P=0.506 (e) (e) P=0.499 (e) | |LOGISTIC REGRESSION| P=0.552 (e) (e) P=0.447 (e) | |COCH-ARM / FISHERS | P=0.549 (e) (e) P=0.455 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 18/60 (30%) 14/50 (28%) 20/50 (40%) 16/50 (32%) 32/60 (53%) | |POLY-3 ADJUSTED (b)| 43.3% 37.9% 49.6% 36.2% 71.6% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 10/12 (83%) 12/16 (75%) 16/21 (76%) 14/31 (45%) 25/27 (93%) | |FIRST INCIDENCE | 184 (I) 563 360 544 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.468 P=0.091N P=0.197N P=0.002N** P=0.520N | |POLY 3 | P=0.003 ** P=0.394N P=0.355 P=0.322N P=0.004 ** | |POLY 1.5 | P=0.002 ** P=0.377N P=0.335 P=0.417N P=0.003 ** | |POLY 6 | P=0.008 ** P=0.437N P=0.354 P=0.218N P=0.007 ** | |LOGISTIC REGRESSION| P=0.006 ** P=0.315N P=0.388 P=0.352N P=0.011 * | |COCH-ARM / FISHERS | P=0.003 ** P=0.493N P=0.185 P=0.492 P=0.008 ** | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 45/60 (75%) 42/50 (84%) 44/50 (88%) 35/50 (70%) 34/60 (57%) | |POLY-3 ADJUSTED (b)| 87.1% 92.9% 93.8% 79.0% 76.0% | |INT SACRIFICE 1 (c)| 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 27/28 (96%) 33/33 (100%) 34/34 (100%) 25/28 (89%) 27/28 (96%) | |FIRST INCIDENCE | 184 (I) 522 399 417 516 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.018N* P=0.220N P=0.302N P=0.186N P=0.020N* | |POLY 3 | P=0.008N** P=0.250 P=0.184 P=0.186N P=0.103N | |POLY 1.5 | P=0.006N** P=0.273 P=0.189 P=0.163N P=0.073N | |POLY 6 | P=0.012N* P=0.231 P=0.149 P=0.281N P=0.130N | |LOGISTIC REGRESSION| P<0.001N** P=0.575N P=0.394 P=0.074N P=0.011N* | |COCH-ARM / FISHERS | P<0.001N** P=0.179 P=0.068 P=0.354N P=0.027N* | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/60 (10%) 2/50 (4%) 7/50 (14%) 5/50 (10%) 9/60 (15%) | |POLY-3 ADJUSTED (b)| 16.0% 5.5% 18.3% 11.5% 21.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/12 (50%) 2/16 (13%) 7/21 (33%) 5/31 (16%) 9/27 (33%) | |FIRST INCIDENCE | 736 (T) 736 (T) 736 (T) 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.473N P=0.043N* P=0.287N P=0.031N* P=0.267N | |POLY 3 | P=0.159 P=0.140N P=0.513 P=0.397N P=0.365 | |POLY 1.5 | P=0.130 P=0.147N P=0.486 P=0.463N P=0.323 | |POLY 6 | P=0.217 P=0.137N P=0.535 P=0.322N P=0.440 | |LOGISTIC REGRESSION| P=0.473N P=0.043N* P=0.287N P=0.031N* P=0.267N | |COCH-ARM / FISHERS | P=0.123 P=0.203N P=0.361 P=0.622 P=0.291 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/60 (18%) 10/50 (20%) 8/50 (16%) 3/50 (6%) 16/60 (27%) | |POLY-3 ADJUSTED (b)| 26.7% 23.4% 18.6% 7.4% 37.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 11/28 (39%) 10/33 (30%) 8/34 (24%) 3/28 (11%) 15/28 (54%) | |FIRST INCIDENCE | 738 (T) 738 (T) 738 (T) 738 (T) 690 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.136 P=0.322N P=0.146N P=0.016N* P=0.155 | |POLY 3 | P=0.244 P=0.462N P=0.266N P=0.018N* P=0.204 | |POLY 1.5 | P=0.250 P=0.514N P=0.305N P=0.021N* P=0.188 | |POLY 6 | P=0.228 P=0.411N P=0.236N P=0.018N* P=0.222 | |LOGISTIC REGRESSION| P=0.145 P=0.322N P=0.146N P=0.016N* P=0.179 | |COCH-ARM / FISHERS | P=0.257 P=0.507 P=0.475N P=0.047N* P=0.191 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 2/50 (4%) 1/50 (2%) 9/50 (18%) 7/60 (12%) | |POLY-3 ADJUSTED (b)| 5.3% 5.5% 2.6% 20.4% 16.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 7/31 (23%) 7/27 (26%) | |FIRST INCIDENCE | 619 649 736 (T) 605 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.081 P=0.672N P=0.393N P=0.243 P=0.356 | |POLY 3 | P=0.009 ** P=0.681 P=0.498N P=0.045 * P=0.101 | |POLY 1.5 | P=0.007 ** P=0.676 P=0.508N P=0.031 * P=0.089 | |POLY 6 | P=0.015 * P=0.680 P=0.493N P=0.068 P=0.124 | |LOGISTIC REGRESSION| P=0.025 * P=0.678 P=0.491N P=0.058 P=0.173 | |COCH-ARM / FISHERS | P=0.010 * P=0.619 P=0.569N P=0.012 * P=0.081 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 4.8% 2.3% 2.3% 7.3% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 1/33 (3%) 1/34 (3%) 2/28 (7%) 2/28 (7%) | |FIRST INCIDENCE | 620 738 (T) 738 (T) 634 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.381 P=0.454N P=0.452N P=0.491 P=0.690N | |POLY 3 | P=0.381 P=0.491N P=0.489N P=0.494 P=0.686N | |POLY 1.5 | P=0.385 P=0.506N P=0.503N P=0.486 P=0.692N | |POLY 6 | P=0.376 P=0.477N P=0.480N P=0.488 P=0.681N | |LOGISTIC REGRESSION| P=0.410 P=0.502N P=0.499N P=0.483 P=0.682N | |COCH-ARM / FISHERS | P=0.425 P=0.569N P=0.569N P=0.414 P=0.691N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 7/50 (14%) 6/50 (12%) 8/50 (16%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 2.6% 18.6% 15.1% 17.7% 11.9% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 3/16 (19%) 3/21 (14%) 5/31 (16%) 3/27 (11%) | |FIRST INCIDENCE | 184 (I) 505 521 213 715 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.531N P=0.015 * P=0.039 * P=0.043 * P=0.281 | |POLY 3 | P=0.279 P=0.025 * P=0.059 P=0.030 * P=0.120 | |POLY 1.5 | P=0.232 P=0.024 * P=0.052 P=0.020 * P=0.109 | |POLY 6 | P=0.368 P=0.026 * P=0.066 P=0.045 * P=0.144 | |LOGISTIC REGRESSION| P=0.221 P=0.016 * P=0.019 * P=0.002 ** P=0.111 | |COCH-ARM / FISHERS | P=0.214 P=0.016 * P=0.033 * P=0.007 ** P=0.103 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/60 (15%) 4/50 (8%) 7/50 (14%) 3/50 (6%) 13/60 (22%) | |POLY-3 ADJUSTED (b)| 21.0% 9.0% 15.8% 7.3% 27.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |TERMINAL (d) | 6/28 (21%) 2/33 (6%) 5/34 (15%) 2/28 (7%) 3/28 (11%) | |FIRST INCIDENCE | 475 337 417 704 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.129 P=0.089N P=0.285N P=0.068N P=0.280 | |POLY 3 | P=0.120 P=0.099N P=0.363N P=0.067N P=0.325 | |POLY 1.5 | P=0.125 P=0.116N P=0.397N P=0.070N P=0.293 | |POLY 6 | P=0.113 P=0.087N P=0.342N P=0.073N P=0.357 | |LOGISTIC REGRESSION| P=0.145 P=0.188N P=0.444N P=0.070N P=0.240 | |COCH-ARM / FISHERS | P=0.136 P=0.203N P=0.551N P=0.114N P=0.240 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 29/60 (48%) 16/50 (32%) 22/50 (44%) 22/50 (44%) 39/60 (65%) | |POLY-3 ADJUSTED (b)| 58.1% 40.0% 52.0% 48.9% 74.3% | |INT SACRIFICE 1 (c)| 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) | |TERMINAL (d) | 9/12 (75%) 9/16 (56%) 13/21 (62%) 19/31 (61%) 20/27 (74%) | |FIRST INCIDENCE | 184 (I) 428 360 544 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.441N P=0.080N P=0.156N P=0.003N** P=0.329N | |POLY 3 | P=0.010 * P=0.057N P=0.346N P=0.236N P=0.052 | |POLY 1.5 | P=0.006 ** P=0.050N P=0.341N P=0.287N P=0.037 * | |POLY 6 | P=0.027 * P=0.068N P=0.354N P=0.170N P=0.101 | |LOGISTIC REGRESSION| P=0.008 ** P=0.107N P=0.511N P=0.517N P=0.047 * | |COCH-ARM / FISHERS | P=0.008 ** P=0.061N P=0.397N P=0.397N P=0.048 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 41/60 (68%) 36/50 (72%) 33/50 (66%) 27/50 (54%) 46/60 (77%) | |POLY-3 ADJUSTED (b)| 75.0% 78.5% 73.5% 62.9% 82.3% | |INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 22/28 (79%) 29/33 (88%) 28/34 (82%) 19/28 (68%) 27/28 (96%) | |FIRST INCIDENCE | 184 (I) 284 399 592 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.242 P=0.557 P=0.323N P=0.306N P=0.236 | |POLY 3 | P=0.334 P=0.429 P=0.523N P=0.127N P=0.226 | |POLY 1.5 | P=0.331 P=0.410 P=0.501N P=0.105N P=0.204 | |POLY 6 | P=0.305 P=0.475 P=0.547N P=0.173N P=0.229 | |LOGISTIC REGRESSION| P=0.338 P=0.412 P=0.485N P=0.095N P=0.202 | |COCH-ARM / FISHERS | P=0.349 P=0.418 P=0.477N P=0.090N P=0.207 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 2.6% 2.3% 12.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 5/27 (19%) | |FIRST INCIDENCE | 736 (T) --- 645 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.042 * P=0.443N P=0.711N P=0.537N P=0.371 | |POLY 3 | P=0.014 * P=0.508N P=0.756N P=0.726N P=0.126 | |POLY 1.5 | P=0.012 * P=0.510N P=0.758 P=0.749N P=0.113 | |POLY 6 | P=0.017 * P=0.509N P=0.748N P=0.697N P=0.151 | |LOGISTIC REGRESSION| P=0.023 * (e) P=0.760N P=0.537N P=0.371 | |COCH-ARM / FISHERS | P=0.012 * P=0.545N P=0.705 P=0.705 P=0.103 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 7/50 (14%) 5/50 (10%) 2/50 (4%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 17.0% 16.4% 11.6% 4.9% 11.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 7/28 (25%) 7/33 (21%) 5/34 (15%) 2/28 (7%) 4/28 (14%) | |FIRST INCIDENCE | 738 (T) 738 (T) 738 (T) 738 (T) 714 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.187N P=0.482N P=0.244N P=0.075N P=0.372N | |POLY 3 | P=0.147N P=0.586N P=0.349N P=0.079N P=0.352N | |POLY 1.5 | P=0.148N P=0.604 P=0.381N P=0.085N P=0.369N | |POLY 6 | P=0.151N P=0.549N P=0.325N P=0.080N P=0.334N | |LOGISTIC REGRESSION| P=0.183N P=0.482N P=0.244N P=0.075N P=0.353N | |COCH-ARM / FISHERS | P=0.156N P=0.466 P=0.514N P=0.133N P=0.381N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Bile | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- 725 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.202 (e) (e) (e) P=0.624 | |POLY 3 | P=0.163 (e) (e) (e) P=0.522 | |POLY 1.5 | P=0.158 (e) (e) (e) P=0.510 | |POLY 6 | P=0.173 (e) (e) (e) P=0.540 | |LOGISTIC REGRESSION| P=0.182 (e) (e) (e) P=0.575 | |COCH-ARM / FISHERS | P=0.160 (e) (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Bile | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% 2.3% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 1/34 (3%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 620 738 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.304N P=0.271 P=0.539 (e) (e) | |POLY 3 | P=0.245N P=0.248 P=0.508 (e) (e) | |POLY 1.5 | P=0.255N P=0.235 P=0.499 (e) (e) | |POLY 6 | P=0.241N P=0.262 P=0.515 (e) (e) | |LOGISTIC REGRESSION| P=0.294N P=0.212 P=0.539 (e) (e) | |COCH-ARM / FISHERS | P=0.295N P=0.204 P=0.455 (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 4.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 704 --- --- --- 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.215 P=0.471N P=0.477N P=0.513N P=0.526 | |POLY 3 | P=0.206 P=0.493N P=0.492N P=0.503N P=0.519 | |POLY 1.5 | P=0.211 P=0.503N P=0.501N P=0.506N P=0.508 | |POLY 6 | P=0.200 P=0.485N P=0.486N P=0.506N P=0.529 | |LOGISTIC REGRESSION| P=0.234 P=0.498N P=0.496N P=0.505N P=0.500 | |COCH-ARM / FISHERS | P=0.225 P=0.545N P=0.545N P=0.545N P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 4.7% 2.3% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 391 698 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.063N P=0.462N P=0.220N P=0.243N P=0.241N | |POLY 3 | P=0.065N P=0.494N P=0.233N P=0.244N P=0.234N | |POLY 1.5 | P=0.064N P=0.509N P=0.241N P=0.247N P=0.238N | |POLY 6 | P=0.068N P=0.479N P=0.227N P=0.248N P=0.231N | |LOGISTIC REGRESSION| P=0.068N P=0.606N P=0.339N P=0.331N P=0.238N | |COCH-ARM / FISHERS | P=0.065N P=0.569N P=0.295N P=0.295N P=0.248N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 4.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 (e) (e) (e) P=0.234 | |POLY 3 | P=0.038 * (e) (e) (e) P=0.273 | |POLY 1.5 | P=0.036 * (e) (e) (e) P=0.257 | |POLY 6 | P=0.042 * (e) (e) (e) P=0.296 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.036 * (e) (e) (e) P=0.248 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Artery | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 49/60 (82%) 47/50 (94%) 46/50 (92%) 48/50 (96%) 48/60 (80%) | |POLY-3 ADJUSTED (b)| 98.8% 95.4% 94.6% 99.1% 96.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 20/21 (95%) 31/31 (100%) 27/27 (100%) | |FIRST INCIDENCE | 396 410 443 518 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.313N P=0.062N P<0.001N** P=0.002N** | |POLY 3 | P=0.494N P=0.323N P=0.247N P=0.916 P=0.378N | |POLY 1.5 | P=0.390N P=0.571N P=0.447N P=0.474 P=0.354N | |POLY 6 | P=0.577N P=0.293N P=0.227N P=1.000 P=0.477N | |LOGISTIC REGRESSION| P=0.382N P=0.592N P=0.274N P=0.409N P=0.477N | |COCH-ARM / FISHERS | P=0.304N P=0.047 * P=0.097 P=0.019 * P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 24/60 (40%) 18/50 (36%) 22/50 (44%) 19/50 (38%) 18/60 (30%) | |POLY-3 ADJUSTED (b)| 55.9% 39.5% 46.8% 44.3% 41.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 16/28 (57%) 10/33 (30%) 13/34 (38%) 14/28 (50%) 13/28 (46%) | |FIRST INCIDENCE | 585 430 535 586 647 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.262N P=0.073N P=0.218N P=0.238N P=0.146N | |POLY 3 | P=0.224N P=0.086N P=0.255N P=0.187N P=0.122N | |POLY 1.5 | P=0.205N P=0.139N P=0.368N P=0.226N P=0.141N | |POLY 6 | P=0.262N P=0.055N P=0.176N P=0.189N P=0.111N | |LOGISTIC REGRESSION| P=0.163N P=0.138N P=0.398N P=0.218N P=0.085N | |COCH-ARM / FISHERS | P=0.155N P=0.409N P=0.409 P=0.493N P=0.169N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 6.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.056 (e) (e) (e) P=0.111 | |POLY 3 | P=0.009 ** (e) (e) (e) P=0.153 | |POLY 1.5 | P=0.009 ** (e) (e) (e) P=0.139 | |POLY 6 | P=0.011 * (e) (e) (e) P=0.175 | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) (e) P=0.122 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 4.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123 (e) (e) (e) P=0.234 | |POLY 3 | P=0.033 * (e) (e) (e) P=0.255 | |POLY 1.5 | P=0.034 * (e) (e) (e) P=0.248 | |POLY 6 | P=0.033 * (e) (e) (e) P=0.261 | |LOGISTIC REGRESSION| P=0.148 (e) (e) (e) P=0.291 | |COCH-ARM / FISHERS | P=0.036 * (e) (e) (e) P=0.248 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 16/60 (27%) 22/50 (44%) 28/50 (56%) 39/50 (78%) 28/60 (47%) | |POLY-3 ADJUSTED (b)| 39.9% 55.6% 65.2% 81.7% 62.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/12 (33%) 11/16 (69%) 14/21 (67%) 24/31 (77%) 16/27 (59%) | |FIRST INCIDENCE | 576 507 527 561 550 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.431N P=0.289 P=0.182 P=0.218 P=0.532 | |POLY 3 | P=0.005 ** P=0.107 P=0.013 * P<0.001 ** P=0.023 * | |POLY 1.5 | P=0.002 ** P=0.103 P=0.008 ** P<0.001 ** P=0.015 * | |POLY 6 | P=0.026 * P=0.097 P=0.018 * P<0.001 ** P=0.049 * | |LOGISTIC REGRESSION| P=0.010 * P=0.099 P=0.011 * P<0.001 ** P=0.039 * | |COCH-ARM / FISHERS | P=0.004 ** P=0.044 * P=0.002 ** P<0.001 ** P=0.018 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.5% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- 738 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.536 (e) (e) P=0.500 (e) | |POLY 3 | P=0.502 (e) (e) P=0.497 (e) | |POLY 1.5 | P=0.501 (e) (e) P=0.494 (e) | |POLY 6 | P=0.510 (e) (e) P=0.495 (e) | |LOGISTIC REGRESSION| (e) (e) (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.549 (e) (e) P=0.455 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/60 (5%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 7.7% 0.0% 5.2% 2.3% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | 535 --- 521 736 (T) 536 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.394N P=0.139N P=0.451N P=0.188N P=0.423N | |POLY 3 | P=0.487N P=0.130N P=0.500N P=0.265N P=0.458N | |POLY 1.5 | P=0.510N P=0.130N P=0.511N P=0.292N P=0.480N | |POLY 6 | P=0.450N P=0.134N P=0.495N P=0.238N P=0.423N | |LOGISTIC REGRESSION| P=0.517N P=0.148N P=0.581N P=0.344N P=0.493N | |COCH-ARM / FISHERS | P=0.518N P=0.159N P=0.586N P=0.381N P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 4.7% 0.0% 8.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/10 (30%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 2/34 (6%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 337 738 (T) --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.072 P=0.496 P=0.282 (e) P=0.062 | |POLY 3 | P=0.039 * P=0.511 P=0.246 (e) P=0.075 | |POLY 1.5 | P=0.039 * P=0.500 P=0.236 (e) P=0.070 | |POLY 6 | P=0.039 * P=0.521 P=0.255 (e) P=0.080 | |LOGISTIC REGRESSION| P=0.078 P=0.207 P=0.282 (e) P=0.068 | |COCH-ARM / FISHERS | P=0.036 * P=0.455 P=0.204 (e) P=0.059 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 3/50 (6%) 5/50 (10%) 7/50 (14%) 21/60 (35%) | |POLY-3 ADJUSTED (b)| 24.5% 8.0% 13.0% 15.7% 41.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 4/21 (19%) 6/31 (19%) 10/27 (37%) | |FIRST INCIDENCE | 396 450 676 213 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.026 * P=0.050N P=0.071N P=0.051N P=0.166 | |POLY 3 | P<0.001 ** P=0.044N* P=0.150N P=0.228N P=0.071 | |POLY 1.5 | P<0.001 ** P=0.045N* P=0.154N P=0.275N P=0.050 | |POLY 6 | P=0.003 ** P=0.049N* P=0.159N P=0.188N P=0.102 | |LOGISTIC REGRESSION| P<0.001 ** P=0.066N P=0.149N P=0.394N P=0.015 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.074N P=0.232N P=0.455N P=0.018 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 2/50 (4%) 1/50 (2%) 3/50 (6%) 9/60 (15%) | |POLY-3 ADJUSTED (b)| 16.7% 4.5% 2.3% 7.3% 20.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/28 (11%) 0/33 (0%) 1/34 (3%) 1/28 (4%) 6/28 (21%) | |FIRST INCIDENCE | 645 337 738 (T) 613 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.118 P=0.065N P=0.022N* P=0.188N P=0.417 | |POLY 3 | P=0.116 P=0.065N P=0.027N* P=0.160N P=0.416 | |POLY 1.5 | P=0.126 P=0.078N P=0.031N* P=0.168N P=0.400 | |POLY 6 | P=0.106 P=0.057N P=0.024N* P=0.163N P=0.430 | |LOGISTIC REGRESSION| P=0.141 P=0.113N P=0.026N* P=0.168N P=0.437 | |COCH-ARM / FISHERS | P=0.157 P=0.133N P=0.053N P=0.246N P=0.395 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 5.3% 2.8% 2.6% 2.3% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 617 726 593 621 502 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.518N P=0.488N P=0.466N P=0.387N P=0.588N | |POLY 3 | P=0.579 P=0.518N P=0.494N P=0.450N P=0.653N | |POLY 1.5 | P=0.556 P=0.519N P=0.506N P=0.482N P=0.674N | |POLY 6 | P=0.553N P=0.523N P=0.486N P=0.414N P=0.619N | |LOGISTIC REGRESSION| P=0.550 P=0.516N P=0.534N P=0.529N P=0.683N | |COCH-ARM / FISHERS | P=0.547 P=0.569N P=0.569N P=0.569N P=0.691N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 2.5% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 733 738 (T) 704 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.057 (e) P=0.545 P=0.500 P=0.257 | |POLY 3 | P=0.068 (e) P=0.508 P=0.497 P=0.246 | |POLY 1.5 | P=0.068 (e) P=0.499 P=0.494 P=0.240 | |POLY 6 | P=0.068 (e) P=0.515 P=0.495 P=0.252 | |LOGISTIC REGRESSION| P=0.064 (e) P=0.524 P=0.500 P=0.246 | |COCH-ARM / FISHERS | P=0.075 (e) P=0.455 P=0.455 P=0.248 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 7/60 (12%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 14.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.005 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.021 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.016 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.030 * | |LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.006 ** | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/60 (10%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 12.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** (e) (e) (e) P=0.009 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.027 * | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.023 * | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.029 * | |LOGISTIC REGRESSION| P=0.006 ** (e) (e) (e) P=0.017 * | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.014 * | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 5.3% 10.7% 2.6% 4.6% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | 729 410 640 708 502 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.230N P=0.390 P=0.400N P=0.381N P=0.520N | |POLY 3 | P=0.328N P=0.333 P=0.491N P=0.638N P=0.649N | |POLY 1.5 | P=0.359N P=0.322 P=0.505N P=0.675N P=0.672N | |POLY 6 | P=0.286N P=0.340 P=0.480N P=0.594N P=0.610N | |LOGISTIC REGRESSION| P=0.388N P=0.302 P=0.486N P=0.515N P=0.671N | |COCH-ARM / FISHERS | P=0.402N P=0.257 P=0.569N P=0.619 P=0.691N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 4.7% 0.0% 4.6% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 391 --- 399 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.133N P=0.244N P=0.668N P=0.230N P=0.237N | |POLY 3 | P=0.149N P=0.236N P=0.684N P=0.247N P=0.237N | |POLY 1.5 | P=0.145N P=0.244N P=0.690 P=0.248N P=0.239N | |POLY 6 | P=0.157N P=0.229N P=0.675N P=0.252N P=0.235N | |LOGISTIC REGRESSION| P=0.138N P=0.390N P=0.457 P=0.404N P=0.234N | |COCH-ARM / FISHERS | P=0.137N P=0.295N P=0.619 P=0.295N P=0.248N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 0/50 (0%) 5/50 (10%) 4/50 (8%) 12/60 (20%) | |POLY-3 ADJUSTED (b)| 21.8% 0.0% 13.0% 9.2% 25.1% | |INT SACRIFICE 1 (c)| 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 4/21 (19%) 4/31 (13%) 5/27 (19%) | |FIRST INCIDENCE | 184 (I) --- 676 736 (T) 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.416 P=0.126N P=0.533 P=0.478N P=0.575N | |POLY 3 | P=0.132 P=0.003N** P=0.220N P=0.085N P=0.449 | |POLY 1.5 | P=0.108 P=0.002N** P=0.216N P=0.103N P=0.417 | |POLY 6 | P=0.177 P=0.003N** P=0.226N P=0.064N P=0.514 | |LOGISTIC REGRESSION| P=0.107 P=0.094N P=0.502 P=0.540 P=0.350 | |COCH-ARM / FISHERS | P=0.098 P=0.002N** P=0.232N P=0.142N P=0.407 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 19/60 (32%) 12/50 (24%) 17/50 (34%) 15/50 (30%) 20/60 (33%) | |POLY-3 ADJUSTED (b)| 37.9% 27.4% 39.6% 36.1% 41.0% | |INT SACRIFICE 1 (c)| 7/10 (70%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) | |TERMINAL (d) | 7/28 (25%) 10/33 (30%) 17/34 (50%) 13/28 (46%) 12/28 (43%) | |FIRST INCIDENCE | 184 (I) 522 738 (T) 605 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.309 P=0.447N P=0.362 P=0.315 P=0.521 | |POLY 3 | P=0.263 P=0.191N P=0.521 P=0.515N P=0.458 | |POLY 1.5 | P=0.276 P=0.206N P=0.524 P=0.486N P=0.452 | |POLY 6 | P=0.239 P=0.173N P=0.506 P=0.577N P=0.460 | |LOGISTIC REGRESSION| P=0.349 P=0.435N P=0.344 P=0.506 P=0.499 | |COCH-ARM / FISHERS | P=0.341 P=0.250N P=0.477 P=0.508N P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 5/50 (10%) 3/50 (6%) 2/50 (4%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 2.7% 13.5% 7.8% 4.6% 7.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 2/21 (10%) 2/31 (7%) 2/27 (7%) | |FIRST INCIDENCE | 736 (T) 435 593 736 (T) 460 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.314N P=0.153 P=0.459 P=0.672N P=0.538 | |POLY 3 | P=0.501N P=0.095 P=0.314 P=0.551 P=0.351 | |POLY 1.5 | P=0.547N P=0.092 P=0.300 P=0.518 P=0.328 | |POLY 6 | P=0.438N P=0.095 P=0.327 P=0.589 P=0.388 | |LOGISTIC REGRESSION| P=0.549 P=0.091 P=0.317 P=0.672N P=0.329 | |COCH-ARM / FISHERS | P=0.507 P=0.067 P=0.244 P=0.431 P=0.309 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 5/60 (8%) 2/50 (4%) 5/50 (10%) 3/50 (6%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 12.0% 4.7% 11.6% 7.2% 11.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/28 (14%) 1/33 (3%) 4/34 (12%) 1/28 (4%) 4/28 (14%) | |FIRST INCIDENCE | 645 731 690 588 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.413 P=0.164N P=0.525N P=0.360N P=0.619N | |POLY 3 | P=0.435 P=0.203N P=0.607N P=0.354N P=0.612N | |POLY 1.5 | P=0.440 P=0.222N P=0.627 P=0.368N P=0.624N | |POLY 6 | P=0.425 P=0.187N P=0.587N P=0.354N P=0.600N | |LOGISTIC REGRESSION| P=0.452 P=0.182N P=0.582N P=0.380N P=0.596N | |COCH-ARM / FISHERS | P=0.471 P=0.301N P=0.509 P=0.464N P=0.628N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 39/60 (65%) 37/50 (74%) 39/50 (78%) 40/50 (80%) 44/60 (73%) | |POLY-3 ADJUSTED (b)| 84.1% 81.9% 84.1% 86.4% 90.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 10/12 (83%) 11/16 (69%) 18/21 (86%) 28/31 (90%) 24/27 (89%) | |FIRST INCIDENCE | 396 435 443 544 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009N** P=0.344N P=0.143N P<0.001N** P=0.034N* | |POLY 3 | P=0.147 P=0.497N P=0.621 P=0.490 P=0.274 | |POLY 1.5 | P=0.112 P=0.566N P=0.506 P=0.375 P=0.196 | |POLY 6 | P=0.223 P=0.474N P=0.616N P=0.524 P=0.406 | |LOGISTIC REGRESSION| P=0.201 P=0.565N P=0.538 P=0.413N P=0.236 | |COCH-ARM / FISHERS | P=0.182 P=0.209 P=0.099 P=0.062 P=0.215 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 41/60 (68%) 42/50 (84%) 45/50 (90%) 46/50 (92%) 46/60 (77%) | |POLY-3 ADJUSTED (b)| 88.7% 90.5% 93.8% 96.0% 96.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 28/28 (100%) 32/33 (97%) 33/34 (97%) 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 461 430 399 417 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.071 P=0.221N P=0.365N P=0.218 P=0.298 | |POLY 3 | P=0.041 * P=0.527 P=0.280 P=0.124 P=0.117 | |POLY 1.5 | P=0.043 * P=0.349 P=0.140 P=0.058 P=0.093 | |POLY 6 | P=0.046 * P=0.668N P=0.385 P=0.152 P=0.181 | |LOGISTIC REGRESSION| P=0.045 * P=0.492 P=0.206 P=0.095 P=0.124 | |COCH-ARM / FISHERS | P=0.188 P=0.045 * P=0.005 ** P=0.002 ** P=0.207 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.2% 2.3% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) 1/27 (4%) | |FIRST INCIDENCE | --- --- 666 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.437 (e) P=0.300 P=0.689 P=0.662 | |POLY 3 | P=0.308 (e) P=0.242 P=0.529 P=0.521 | |POLY 1.5 | P=0.282 (e) P=0.233 P=0.510 P=0.510 | |POLY 6 | P=0.356 (e) P=0.249 P=0.551 P=0.539 | |LOGISTIC REGRESSION| P=0.343 (e) P=0.245 P=0.689 P=0.662 | |COCH-ARM / FISHERS | P=0.276 (e) P=0.204 P=0.455 P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 698 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.247N P=0.468N P=0.489N P=0.525N P=0.483N | |POLY 3 | P=0.258N P=0.498N P=0.493N P=0.503N P=0.494N | |POLY 1.5 | P=0.250N P=0.507N P=0.501N P=0.506N P=0.498N | |POLY 6 | P=0.268N P=0.490N P=0.487N P=0.506N P=0.490N | |LOGISTIC REGRESSION| P=0.242N P=0.506N P=0.500N P=0.507N P=0.494N | |COCH-ARM / FISHERS | P=0.247N P=0.550N P=0.545N P=0.545N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.9% 0.0% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 3/21 (14%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- 736 (T) 736 (T) --- 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.460N P=0.557 P=0.232 (e) P=0.662 | |POLY 3 | P=0.589 P=0.492 P=0.120 (e) P=0.521 | |POLY 1.5 | P=0.552 P=0.490 P=0.115 (e) P=0.510 | |POLY 6 | P=0.557N P=0.491 P=0.124 (e) P=0.539 | |LOGISTIC REGRESSION| (e) P=0.557 P=0.232 (e) P=0.662 | |COCH-ARM / FISHERS | P=0.511 P=0.455 P=0.091 (e) P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 25/60 (42%) 19/50 (38%) 23/50 (46%) 36/50 (72%) 24/60 (40%) | |POLY-3 ADJUSTED (b)| 57.8% 46.6% 55.8% 77.6% 53.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/12 (42%) 7/16 (44%) 11/21 (52%) 25/31 (81%) 13/27 (48%) | |FIRST INCIDENCE | 396 507 593 605 502 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.044N* P=0.156N P=0.147N P=0.127N P=0.035N* | |POLY 3 | P=0.242 P=0.198N P=0.515N P=0.028 * P=0.418N | |POLY 1.5 | P=0.188 P=0.213N P=0.526N P=0.013 * P=0.468N | |POLY 6 | P=0.379 P=0.214N P=0.546N P=0.053 P=0.337N | |LOGISTIC REGRESSION| P=0.399 P=0.228N P=0.418N P=0.060 P=0.364N | |COCH-ARM / FISHERS | P=0.253 P=0.423N P=0.396 P<0.001 ** P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 30/60 (50%) 22/50 (44%) 21/50 (42%) 24/50 (48%) 26/60 (43%) | |POLY-3 ADJUSTED (b)| 65.8% 48.4% 43.9% 52.9% 56.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 18/28 (64%) 14/33 (42%) 11/34 (32%) 13/28 (46%) 13/28 (46%) | |FIRST INCIDENCE | 507 337 399 417 571 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.480N P=0.038N* P=0.032N* P=0.223N P=0.261N | |POLY 3 | P=0.407N P=0.066N P=0.024N* P=0.141N P=0.241N | |POLY 1.5 | P=0.406N P=0.093N P=0.043N* P=0.176N P=0.268N | |POLY 6 | P=0.409N P=0.055N P=0.017N* P=0.146N P=0.217N | |LOGISTIC REGRESSION| P=0.368N P=0.089N P=0.090N P=0.209N P=0.225N | |COCH-ARM / FISHERS | P=0.333N P=0.332N P=0.259N P=0.493N P=0.292N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) 6/60 (10%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.7% 14.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/30 (3%) 5/27 (19%) | |FIRST INCIDENCE | --- --- 666 684 614 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** (e) P=0.500 P=0.385 P=0.084 | |POLY 3 | P<0.001 ** (e) P=0.505 P=0.268 P=0.022 * | |POLY 1.5 | P<0.001 ** (e) P=0.497 P=0.245 P=0.019 * | |POLY 6 | P<0.001 ** (e) P=0.511 P=0.297 P=0.030 * | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.493 P=0.281 P=0.031 * | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.455 P=0.200 P=0.014 * | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 3/34 (9%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 738 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.575N (e) P=0.157 (e) (e) | |POLY 3 | P=0.534N (e) P=0.126 (e) (e) | |POLY 1.5 | P=0.535N (e) P=0.118 (e) (e) | |POLY 6 | P=0.540N (e) P=0.133 (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.157 (e) (e) | |COCH-ARM / FISHERS | P=0.543N (e) P=0.091 (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 7.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/30 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- --- --- --- 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012 * (e) (e) (e) P=0.201 | |POLY 3 | P=0.009 ** (e) (e) (e) P=0.143 | |POLY 1.5 | P=0.009 ** (e) (e) (e) P=0.131 | |POLY 6 | P=0.010 * (e) (e) (e) P=0.165 | |LOGISTIC REGRESSION| P=0.010 * (e) (e) (e) P=0.122 | |COCH-ARM / FISHERS | P=0.009 ** (e) (e) (e) P=0.122 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 58 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/59 (0%) 0/47 (0%) 1/50 (2%) 1/49 (2%) 2/58 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 2.3% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 2/27 (7%) | |FIRST INCIDENCE | --- --- 722 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.146 (e) P=0.560 P=0.689 P=0.429 | |POLY 3 | P=0.085 (e) P=0.507 P=0.530 P=0.263 | |POLY 1.5 | P=0.077 (e) P=0.500 P=0.511 P=0.249 | |POLY 6 | P=0.101 (e) P=0.513 P=0.552 P=0.286 | |LOGISTIC REGRESSION| P=0.124 (e) P=0.527 P=0.689 P=0.429 | |COCH-ARM / FISHERS | P=0.075 (e) P=0.459 P=0.454 P=0.244 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 4.7% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 2/28 (7%) 1/33 (3%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 738 (T) 731 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.046N* P=0.634N P=0.196N P=0.238N P=0.238N | |POLY 3 | P=0.043N* P=0.681N P=0.228N P=0.239N P=0.229N | |POLY 1.5 | P=0.044N* P=0.690 P=0.238N P=0.243N P=0.234N | |POLY 6 | P=0.044N* P=0.663N P=0.221N P=0.242N P=0.224N | |LOGISTIC REGRESSION| P=0.045N* P=0.635N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.049N* P=0.619 P=0.295N P=0.295N P=0.248N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 59 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 36/59 (61%) 34/47 (72%) 24/50 (48%) 28/49 (57%) 26/58 (45%) | |POLY-3 ADJUSTED (b)| 79.4% 79.9% 56.7% 62.6% 60.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) | |TERMINAL (d) | 8/12 (67%) 11/16 (69%) 11/21 (52%) 20/31 (65%) 18/27 (67%) | |FIRST INCIDENCE | 396 524 443 561 613 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.346N P=0.005N** P<0.001N** P<0.001N** | |POLY 3 | P=0.009N** P=0.589 P=0.012N* P=0.052N P=0.036N* | |POLY 1.5 | P=0.010N* P=0.520 P=0.014N* P=0.085N P=0.035N* | |POLY 6 | P=0.008N** P=0.610 P=0.020N* P=0.043N* P=0.038N* | |LOGISTIC REGRESSION| P<0.001N** P=0.565 P=0.010N* P=0.023N* P=0.007N** | |COCH-ARM / FISHERS | P=0.014N* P=0.155 P=0.121N P=0.416N P=0.058N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 43/60 (72%) 44/50 (88%) 45/50 (90%) 42/50 (84%) 45/60 (75%) | |POLY-3 ADJUSTED (b)| 87.9% 93.4% 94.3% 86.4% 93.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 24/28 (86%) 32/33 (97%) 32/34 (94%) 24/28 (86%) 27/28 (96%) | |FIRST INCIDENCE | 461 392 451 417 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.306 P=0.267N P=0.288N P=0.513N P=0.509 | |POLY 3 | P=0.387 P=0.275 P=0.216 P=0.533N P=0.240 | |POLY 1.5 | P=0.413 P=0.216 P=0.163 P=0.616 P=0.265 | |POLY 6 | P=0.342 P=0.271 P=0.212 P=0.574N P=0.213 | |LOGISTIC REGRESSION| P=0.457 P=0.358 P=0.343 P=0.537 P=0.408 | |COCH-ARM / FISHERS | P=0.477N P=0.030 * P=0.014 * P=0.095 P=0.418 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 60 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/15 (80%) 8/12 (67%) 8/15 (53%) 8/11 (73%) 11/15 (73%) | |POLY-3 ADJUSTED (b)| 83.4% 73.2% 60.3% 77.5% 87.8% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 3/3 (100%) 0/1 (0%) 3/6 (50%) 5/5 (100%) 9/9 (100%) | |FIRST INCIDENCE | 593 534 563 610 680 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.012N* P=0.393N P=0.091N P=0.025N* P=0.012N* | |POLY 3 | P=0.397 P=0.443N P=0.158N P=0.560N P=0.603 | |POLY 1.5 | P=0.470 P=0.408N P=0.140N P=0.542N P=0.691 | |POLY 6 | P=0.335 P=0.495N P=0.188N P=0.574N P=0.506 | |LOGISTIC REGRESSION| P=0.462N P=0.302N P=0.119N P=0.497N P=0.542N | |COCH-ARM / FISHERS | P=0.519N P=0.364N P=0.123N P=0.509N P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/8 (38%) 0/1 (0%) 3/5 (60%) 1/5 (20%) 3/6 (50%) | |POLY-3 ADJUSTED (b)| 42.2% 0.0% 71.7% 25.2% 60.9% | |INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |TERMINAL (d) | 2/5 (40%) 0/1 (0%) 2/2 (100%) 1/2 (50%) 1/1 (100%) | |FIRST INCIDENCE | 391 --- 684 738 (T) 600 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.108 P=0.322N P=0.358 P=0.575N P=0.316 | |POLY 3 | P=0.368 P=0.611N P=0.367 P=0.532N P=0.479 | |POLY 1.5 | P=0.408 P=0.620N P=0.396 P=0.503N P=0.503 | |POLY 6 | P=0.299 P=0.599N P=0.308 P=0.591N P=0.441 | |LOGISTIC REGRESSION| P=0.438 P=0.714N P=0.419 P=0.495N P=0.531 | |COCH-ARM / FISHERS | P=0.449 P=0.667N P=0.413 P=0.490N P=0.529 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 61 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Fungus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 21/60 (35%) 15/50 (30%) 10/50 (20%) 11/50 (22%) 7/60 (12%) | |POLY-3 ADJUSTED (b)| 48.9% 36.9% 24.9% 24.2% 16.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/12 (50%) 3/16 (19%) 5/21 (24%) 6/31 (19%) 2/27 (7%) | |FIRST INCIDENCE | 396 450 557 544 565 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.157N P=0.004N** P<0.001N** P<0.001N** | |POLY 3 | P<0.001N** P=0.178N P=0.016N* P=0.012N* P<0.001N** | |POLY 1.5 | P<0.001N** P=0.192N P=0.019N* P=0.021N* P<0.001N** | |POLY 6 | P<0.001N** P=0.174N P=0.017N* P=0.006N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.237N P=0.021N* P=0.028N* P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.363N P=0.062N P=0.099N P=0.002N** | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Fungus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/60 (10%) 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 13.8% 4.6% 2.3% 0.0% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 0/33 (0%) 1/34 (3%) 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 461 337 738 (T) --- 652 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.054N P=0.123N P=0.051N P=0.021N* P=0.135N | |POLY 3 | P=0.057N P=0.128N P=0.056N P=0.018N* P=0.134N | |POLY 1.5 | P=0.055N P=0.140N P=0.061N P=0.018N* P=0.137N | |POLY 6 | P=0.062N P=0.119N P=0.055N P=0.020N* P=0.133N | |LOGISTIC REGRESSION| P=0.053N P=0.242N P=0.085N P=0.028N* P=0.134N | |COCH-ARM / FISHERS | P=0.052N P=0.203N P=0.091N P=0.023N* P=0.136N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 62 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 28/60 (47%) 19/50 (38%) 22/50 (44%) 18/50 (36%) 22/60 (37%) | |POLY-3 ADJUSTED (b)| 60.1% 46.7% 52.8% 39.5% 49.7% | |INT SACRIFICE 1 (c)| 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 7/12 (58%) 7/16 (44%) 13/21 (62%) 11/31 (36%) 13/27 (48%) | |FIRST INCIDENCE | 184 (I) 450 521 544 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.142N P=0.075N P<0.001N** P=0.004N** | |POLY 3 | P=0.152N P=0.136N P=0.306N P=0.032N* P=0.207N | |POLY 1.5 | P=0.183N P=0.133N P=0.306N P=0.053N P=0.210N | |POLY 6 | P=0.102N P=0.153N P=0.339N P=0.018N* P=0.176N | |LOGISTIC REGRESSION| P=0.121N P=0.161N P=0.300N P=0.096N P=0.132N | |COCH-ARM / FISHERS | P=0.162N P=0.236N P=0.465N P=0.175N P=0.177N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 17/60 (28%) 13/50 (26%) 7/50 (14%) 6/50 (12%) 8/60 (13%) | |POLY-3 ADJUSTED (b)| 35.7% 28.9% 16.1% 14.4% 17.7% | |INT SACRIFICE 1 (c)| 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 7/28 (25%) 8/33 (24%) 6/34 (18%) 4/28 (14%) 3/28 (11%) | |FIRST INCIDENCE | 184 (I) 337 544 571 11 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.013N* P=0.450N P=0.062N P=0.072N P=0.041N* | |POLY 3 | P=0.011N* P=0.317N P=0.026N* P=0.017N* P=0.039N* | |POLY 1.5 | P=0.010N* P=0.352N P=0.030N* P=0.017N* P=0.040N* | |POLY 6 | P=0.013N* P=0.283N P=0.024N* P=0.020N* P=0.038N* | |LOGISTIC REGRESSION| P=0.008N** P=0.573N P=0.091N P=0.054N P=0.035N* | |COCH-ARM / FISHERS | P=0.009N** P=0.478N P=0.056N P=0.030N* P=0.035N* | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 63 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/60 (10%) 6/50 (12%) 6/50 (12%) 5/50 (10%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 15.6% 16.3% 14.9% 11.5% 9.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 2/16 (13%) 2/21 (10%) 4/31 (13%) 1/27 (4%) | |FIRST INCIDENCE | 617 631 482 712 613 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.053N P=0.544N P=0.469N P=0.118N P=0.157N | |POLY 3 | P=0.176N P=0.592 P=0.589N P=0.409N P=0.302N | |POLY 1.5 | P=0.214N P=0.585 P=0.621N P=0.469N P=0.336N | |POLY 6 | P=0.127N P=0.588 P=0.563N P=0.347N P=0.252N | |LOGISTIC REGRESSION| P=0.186N P=0.595 P=0.588 P=0.307N P=0.299N | |COCH-ARM / FISHERS | P=0.248N P=0.486 P=0.486 P=0.622 P=0.372N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/60 (15%) 6/50 (12%) 10/50 (20%) 6/50 (12%) 10/60 (17%) | |POLY-3 ADJUSTED (b)| 21.1% 13.9% 22.6% 14.2% 22.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/28 (18%) 4/33 (12%) 6/34 (18%) 3/28 (11%) 5/28 (18%) | |FIRST INCIDENCE | 523 701 600 459 11 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.356 P=0.200N P=0.554N P=0.301N P=0.528 | |POLY 3 | P=0.409 P=0.279N P=0.535 P=0.289N P=0.537 | |POLY 1.5 | P=0.413 P=0.307N P=0.493 P=0.304N P=0.521 | |POLY 6 | P=0.398 P=0.255N P=0.567 P=0.295N P=0.552 | |LOGISTIC REGRESSION| P=0.409 P=0.275N P=0.498 P=0.344N P=0.512 | |COCH-ARM / FISHERS | P=0.429 P=0.432N P=0.330 P=0.432N P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 64 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 24/60 (40%) 16/50 (32%) 17/50 (34%) 13/50 (26%) 11/60 (18%) | |POLY-3 ADJUSTED (b)| 55.9% 40.1% 41.9% 28.9% 25.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 7/12 (58%) 5/16 (31%) 10/21 (48%) 8/31 (26%) 5/27 (19%) | |FIRST INCIDENCE | 396 507 527 610 565 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.080N P=0.019N* P<0.001N** P<0.001N** | |POLY 3 | P=0.002N** P=0.100N P=0.132N P=0.007N** P=0.003N** | |POLY 1.5 | P=0.003N** P=0.109N P=0.145N P=0.014N* P=0.004N** | |POLY 6 | P<0.001N** P=0.101N P=0.138N P=0.003N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.115N P=0.113N P=0.011N* P=0.002N** | |COCH-ARM / FISHERS | P=0.005N** P=0.252N P=0.327N P=0.089N P=0.008N** | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 3/50 (6%) 2/50 (4%) 4/50 (8%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 23.1% 7.0% 4.7% 9.7% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/28 (18%) 2/33 (6%) 2/34 (6%) 2/28 (7%) 1/28 (4%) | |FIRST INCIDENCE | 461 700 738 (T) 586 652 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.019N* P=0.026N* P=0.010N* P=0.086N P=0.018N* | |POLY 3 | P=0.022N* P=0.034N* P=0.013N* P=0.082N P=0.013N* | |POLY 1.5 | P=0.021N* P=0.040N* P=0.015N* P=0.086N P=0.014N* | |POLY 6 | P=0.024N* P=0.030N* P=0.012N* P=0.088N P=0.013N* | |LOGISTIC REGRESSION| P=0.016N* P=0.044N* P=0.018N* P=0.096N P=0.015N* | |COCH-ARM / FISHERS | P=0.017N* P=0.074N P=0.032N* P=0.142N P=0.015N* | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 65 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 12/60 (20%) 9/50 (18%) 8/50 (16%) 7/50 (14%) 5/60 (8%) | |POLY-3 ADJUSTED (b)| 28.7% 23.0% 20.0% 15.6% 11.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 2/16 (13%) 4/21 (19%) 3/31 (10%) 1/27 (4%) | |FIRST INCIDENCE | 396 450 527 544 565 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004N** P=0.338N P=0.144N P=0.032N* P=0.017N* | |POLY 3 | P=0.024N* P=0.369N P=0.252N P=0.110N P=0.044N* | |POLY 1.5 | P=0.031N* P=0.369N P=0.261N P=0.143N P=0.049N* | |POLY 6 | P=0.016N* P=0.387N P=0.259N P=0.082N P=0.035N* | |LOGISTIC REGRESSION| P=0.031N* P=0.446N P=0.312N P=0.229N P=0.048N* | |COCH-ARM / FISHERS | P=0.035N* P=0.493N P=0.387N P=0.284N P=0.057N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/60 (5%) 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 7.2% 7.0% 0.0% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 2/33 (6%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 543 700 --- 571 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.032N* P=0.598N P=0.101N P=0.298N P=0.125N | |POLY 3 | P=0.032N* P=0.651N P=0.114N P=0.310N P=0.115N | |POLY 1.5 | P=0.032N* P=0.654 P=0.121N P=0.316N P=0.118N | |POLY 6 | P=0.032N* P=0.632N P=0.110N P=0.313N P=0.112N | |LOGISTIC REGRESSION| P=0.032N* P=0.662 P=0.130N P=0.357N P=0.118N | |COCH-ARM / FISHERS | P=0.034N* P=0.570 P=0.159N P=0.381N P=0.122N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 66 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 5/60 (8%) 6/50 (12%) 4/50 (8%) 8/50 (16%) 9/60 (15%) | |POLY-3 ADJUSTED (b)| 11.7% 13.8% 9.2% 18.8% 19.8% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) | |TERMINAL (d) | 3/28 (11%) 5/33 (15%) 2/34 (6%) 5/28 (18%) 4/28 (14%) | |FIRST INCIDENCE | 184 (I) 535 647 444 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.118 P=0.456 P=0.551N P=0.194 P=0.214 | |POLY 3 | P=0.123 P=0.510 P=0.492N P=0.269 P=0.226 | |POLY 1.5 | P=0.120 P=0.479 P=0.516N P=0.255 P=0.211 | |POLY 6 | P=0.123 P=0.541 P=0.473N P=0.268 P=0.242 | |LOGISTIC REGRESSION| P=0.127 P=0.405 P=0.602N P=0.166 P=0.197 | |COCH-ARM / FISHERS | P=0.126 P=0.373 P=0.615N P=0.173 P=0.197 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 67 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 14/60 (23%) 27/50 (54%) 16/50 (32%) 27/48 (56%) 19/60 (32%) | |POLY-3 ADJUSTED (b)| 33.9% 62.4% 41.5% 61.2% 43.1% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/12 (33%) 7/16 (44%) 13/21 (62%) 18/30 (60%) 12/27 (44%) | |FIRST INCIDENCE | 184 (I) 428 666 605 502 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.040N* P=0.014 * P=0.479N P=0.390 P=0.323N | |POLY 3 | P=0.424 P=0.005 ** P=0.315 P=0.007 ** P=0.252 | |POLY 1.5 | P=0.334 P=0.003 ** P=0.315 P=0.003 ** P=0.208 | |POLY 6 | P=0.470N P=0.009 ** P=0.285 P=0.022 * P=0.342 | |LOGISTIC REGRESSION| P=0.458 P=0.002 ** P=0.405 P=0.005 ** P=0.260 | |COCH-ARM / FISHERS | P=0.345 P<0.001 ** P=0.211 P<0.001 ** P=0.207 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 11/60 (18%) 14/49 (29%) 14/50 (28%) 9/50 (18%) 13/60 (22%) | |POLY-3 ADJUSTED (b)| 25.4% 32.8% 31.9% 21.6% 29.4% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 6/28 (21%) 12/33 (36%) 12/34 (35%) 6/28 (21%) 8/28 (29%) | |FIRST INCIDENCE | 184 (I) 535 544 605 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.483 P=0.391 P=0.412 P=0.512N P=0.439 | |POLY 3 | P=0.480N P=0.302 P=0.330 P=0.435N P=0.427 | |POLY 1.5 | P=0.486N P=0.263 P=0.294 P=0.448N P=0.405 | |POLY 6 | P=0.485N P=0.340 P=0.355 P=0.448N P=0.449 | |LOGISTIC REGRESSION| P=0.502N P=0.279 P=0.306 P=0.459N P=0.428 | |COCH-ARM / FISHERS | P=0.473N P=0.150 P=0.164 P=0.582N P=0.410 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 68 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 5.1% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/30 (0%) 0/27 (0%) | |FIRST INCIDENCE | 184 (I) --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123N P=1.000N P=1.000N P=1.000N P=0.234N | |POLY 3 | P=0.083N P=0.256N P=0.244N P=0.226N P=0.224N | |POLY 1.5 | P=0.085N P=0.256N P=0.249N P=0.243N P=0.234N | |POLY 6 | P=0.083N P=0.259N P=0.240N P=0.206N P=0.207N | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.088N P=0.295N P=0.295N P=0.306N P=0.248N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 69 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/50 (18%) 3/45 (7%) 0/47 (0%) 0/46 (0%) 7/56 (13%) | |POLY-3 ADJUSTED (b)| 24.7% 9.1% 0.0% 0.0% 17.2% | |INT SACRIFICE 1 (c)| 0/3 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) | |TERMINAL (d) | 3/12 (25%) 1/14 (7%) 0/20 (0%) 0/28 (0%) 1/26 (4%) | |FIRST INCIDENCE | 681 544 --- --- 680 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.112N P=0.059N P<0.001N** P<0.001N** P=0.110N | |POLY 3 | P=0.231N P=0.076N P<0.001N** P<0.001N** P=0.295N | |POLY 1.5 | P=0.250N P=0.074N P=0.002N** P<0.001N** P=0.327N | |POLY 6 | P=0.207N P=0.082N P<0.001N** P<0.001N** P=0.237N | |LOGISTIC REGRESSION| P=0.233N P=0.084N P=0.002N** P<0.001N** P=0.252N | |COCH-ARM / FISHERS | P=0.279N P=0.087N P=0.002N** P=0.002N** P=0.302N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/54 (2%) 0/44 (0%) 0/41 (0%) 0/47 (0%) 1/53 (2%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 0.0% 2.6% | |INT SACRIFICE 1 (c)| 0/8 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/8 (0%) | |TERMINAL (d) | 0/25 (0%) 0/29 (0%) 0/26 (0%) 0/26 (0%) 0/26 (0%) | |FIRST INCIDENCE | 704 --- --- --- 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.561 P=0.471N P=0.477N P=0.513N P=0.743N | |POLY 3 | P=0.541 P=0.499N P=0.519N P=0.500N P=0.758N | |POLY 1.5 | P=0.547 P=0.509N P=0.525N P=0.502N P=0.759 | |POLY 6 | P=0.535 P=0.489N P=0.514N P=0.502N P=0.751N | |LOGISTIC REGRESSION| P=0.568 P=0.504N P=0.521N P=0.501N P=0.759N | |COCH-ARM / FISHERS | P=0.571 P=0.551N P=0.568N P=0.535N P=0.748 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 70 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 8/50 (16%) 3/49 (6%) 6/50 (12%) 6/60 (10%) | |POLY-3 ADJUSTED (b)| 18.2% 21.7% 7.8% 13.5% 14.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 3/12 (25%) 6/16 (38%) 1/21 (5%) 3/31 (10%) 4/27 (15%) | |FIRST INCIDENCE | 579 563 583 614 614 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.062N P=0.587N P=0.080N P=0.117N P=0.137N | |POLY 3 | P=0.262N P=0.463 P=0.150N P=0.387N P=0.423N | |POLY 1.5 | P=0.305N P=0.456 P=0.169N P=0.459N P=0.463N | |POLY 6 | P=0.204N P=0.454 P=0.136N P=0.310N P=0.360N | |LOGISTIC REGRESSION| P=0.236N P=0.465 P=0.157N P=0.392N P=0.369N | |COCH-ARM / FISHERS | P=0.345N P=0.350 P=0.256N P=0.593 P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 36/60 (60%) 28/50 (56%) 34/50 (68%) 32/50 (64%) 24/60 (40%) | |POLY-3 ADJUSTED (b)| 76.3% 61.5% 75.4% 68.9% 52.3% | |INT SACRIFICE 1 (c)| 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 23/28 (82%) 19/33 (58%) 27/34 (79%) 19/28 (68%) 13/28 (46%) | |FIRST INCIDENCE | 184 (I) 392 563 444 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.086N P=0.040N* P=0.151N P=0.385N P=0.027N* | |POLY 3 | P=0.027N* P=0.085N P=0.562N P=0.277N P=0.010N* | |POLY 1.5 | P=0.030N* P=0.122N P=0.592 P=0.344N P=0.013N* | |POLY 6 | P=0.026N* P=0.064N P=0.572N P=0.265N P=0.008N** | |LOGISTIC REGRESSION| P=0.021N* P=0.101N P=0.393N P=0.382N P=0.011N* | |COCH-ARM / FISHERS | P=0.022N* P=0.409N P=0.252 P=0.409 P=0.022N* | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 71 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 22/60 (37%) 13/50 (26%) 15/49 (31%) 21/50 (42%) 27/60 (45%) | |POLY-3 ADJUSTED (b)| 53.6% 33.2% 36.0% 45.9% 59.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) | |TERMINAL (d) | 6/12 (50%) 3/16 (19%) 8/21 (38%) 13/31 (42%) 17/27 (63%) | |FIRST INCIDENCE | 593 534 360 544 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.337N P=0.054N P=0.029N* P=0.010N* P=0.124N | |POLY 3 | P=0.075 P=0.044N* P=0.074N P=0.306N P=0.351 | |POLY 1.5 | P=0.055 P=0.054N P=0.106N P=0.435N P=0.284 | |POLY 6 | P=0.125 P=0.044N* P=0.061N P=0.205N P=0.454 | |LOGISTIC REGRESSION| P=0.086 P=0.060N P=0.127N P=0.266N P=0.353 | |COCH-ARM / FISHERS | P=0.059 P=0.161N P=0.323N P=0.354 P=0.229 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 24/60 (40%) 21/50 (42%) 26/50 (52%) 27/50 (54%) 24/60 (40%) | |POLY-3 ADJUSTED (b)| 53.7% 47.5% 56.8% 58.7% 52.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 16/28 (57%) 15/33 (46%) 19/34 (56%) 16/28 (57%) 13/28 (46%) | |FIRST INCIDENCE | 475 620 451 417 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.299 P=0.172N P=0.442N P=0.356 P=0.524N | |POLY 3 | P=0.403 P=0.354N P=0.465 P=0.390 P=0.541N | |POLY 1.5 | P=0.389 P=0.410N P=0.393 P=0.329 P=0.571N | |POLY 6 | P=0.410 P=0.305N P=0.515 P=0.406 P=0.506N | |LOGISTIC REGRESSION| P=0.395 P=0.323N P=0.422 P=0.257 P=0.536N | |COCH-ARM / FISHERS | P=0.449 P=0.493 P=0.143 P=0.101 P=0.574N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 72 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 3/49 (6%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.7% 2.3% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | --- 708 572 736 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376N P=0.520 P=0.127 P=0.689 (e) | |POLY 3 | P=0.410N P=0.493 P=0.124 P=0.529 (e) | |POLY 1.5 | P=0.447N P=0.490 P=0.115 P=0.510 (e) | |POLY 6 | P=0.356N P=0.493 P=0.134 P=0.551 (e) | |LOGISTIC REGRESSION| P=0.477N P=0.493 P=0.086 P=0.689 (e) | |COCH-ARM / FISHERS | P=0.488N P=0.455 P=0.088 P=0.455 (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 2.4% 4.7% 0.0% 2.5% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 1/28 (4%) 2/28 (7%) | |FIRST INCIDENCE | 698 738 (T) --- 738 (T) 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.398 P=0.557 P=0.489N P=0.747 P=0.510 | |POLY 3 | P=0.441 P=0.511 P=0.493N P=0.758 P=0.511 | |POLY 1.5 | P=0.438 P=0.495 P=0.501N P=0.754 P=0.504 | |POLY 6 | P=0.441 P=0.526 P=0.487N P=0.755 P=0.517 | |LOGISTIC REGRESSION| P=0.417 P=0.531 P=0.500N P=0.757 P=0.520 | |COCH-ARM / FISHERS | P=0.439 P=0.431 P=0.545N P=0.705 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 73 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/60 (12%) 7/50 (14%) 7/50 (14%) 4/50 (8%) 8/59 (14%) | |POLY-3 ADJUSTED (b)| 18.1% 18.5% 17.9% 9.1% 19.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/12 (42%) 3/16 (19%) 4/21 (19%) 3/31 (10%) 6/27 (22%) | |FIRST INCIDENCE | 396 435 572 660 613 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.123N P=0.497N P=0.337N P=0.022N* P=0.211N | |POLY 3 | P=0.444N P=0.603 P=0.605N P=0.192N P=0.560 | |POLY 1.5 | P=0.495N P=0.584 P=0.598 P=0.238N P=0.518 | |POLY 6 | P=0.367N P=0.617 P=0.580N P=0.145N P=0.595N | |LOGISTIC REGRESSION| P=0.457N P=0.563 P=0.608N P=0.193N P=0.598 | |COCH-ARM / FISHERS | P=0.541 P=0.466 P=0.466 P=0.378N P=0.486 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 74 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 52/60 (87%) 40/50 (80%) 47/50 (94%) 47/50 (94%) 54/59 (92%) | |POLY-3 ADJUSTED (b)| 93.5% 86.0% 96.8% 97.0% 95.5% | |INT SACRIFICE 1 (c)| 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) | |TERMINAL (d) | 12/12 (100%) 13/16 (81%) 20/21 (95%) 30/31 (97%) 26/27 (96%) | |FIRST INCIDENCE | 184 (I) 410 443 518 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.306N P=0.279N P<0.001N** P=0.004N** | |POLY 3 | P=0.104 P=0.139N P=0.337 P=0.319 P=0.469 | |POLY 1.5 | P=0.068 P=0.184N P=0.222 P=0.197 P=0.344 | |POLY 6 | P=0.211 P=0.087N P=0.638 P=0.637 P=0.731 | |LOGISTIC REGRESSION| P=0.081 P=0.204N P=0.262 P=0.350 P=0.297 | |COCH-ARM / FISHERS | P=0.074 P=0.247N P=0.170 P=0.170 P=0.290 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 75 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/59 (0%) | |POLY-3 ADJUSTED (b)| 5.2% 0.0% 5.2% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 561 --- 666 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.072N P=0.238N P=0.608N P=0.152N P=0.172N | |POLY 3 | P=0.119N P=0.248N P=0.692N P=0.210N P=0.221N | |POLY 1.5 | P=0.130N P=0.249N P=0.687 P=0.228N P=0.232N | |POLY 6 | P=0.105N P=0.250N P=0.685N P=0.191N P=0.205N | |LOGISTIC REGRESSION| P=0.124N P=0.257N P=0.690 P=0.251N P=0.232N | |COCH-ARM / FISHERS | P=0.139N P=0.295N P=0.619 P=0.295N P=0.252N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 76 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 43/60 (72%) 34/50 (68%) 32/50 (64%) 26/49 (53%) 44/60 (73%) | |POLY-3 ADJUSTED (b)| 81.0% 73.1% 67.9% 54.9% 82.3% | |INT SACRIFICE 1 (c)| 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 7/10 (70%) | |TERMINAL (d) | 8/12 (67%) 10/16 (63%) 10/21 (48%) 15/30 (50%) 24/27 (89%) | |FIRST INCIDENCE | 184 (I) 410 360 213 184 (I) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.009N** P=0.260N P=0.072N P<0.001N** P=0.019N* | |POLY 3 | P=0.455N P=0.227N P=0.088N P=0.003N** P=0.537 | |POLY 1.5 | P=0.468N P=0.230N P=0.101N P=0.005N** P=0.545 | |POLY 6 | P=0.432N P=0.257N P=0.090N P=0.002N** P=0.527 | |LOGISTIC REGRESSION| P=0.502N P=0.393N P=0.253N P=0.043N* P=0.523 | |COCH-ARM / FISHERS | P=0.493N P=0.416N P=0.256N P=0.036N* P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 77 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 0.0% 4.6% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 1/31 (3%) 2/27 (7%) | |FIRST INCIDENCE | --- 736 (T) --- 707 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.224 P=0.557 (e) P=0.428 P=0.429 | |POLY 3 | P=0.119 P=0.492 (e) P=0.273 P=0.261 | |POLY 1.5 | P=0.109 P=0.490 (e) P=0.250 P=0.249 | |POLY 6 | P=0.140 P=0.491 (e) P=0.303 P=0.283 | |LOGISTIC REGRESSION| P=0.177 P=0.557 (e) P=0.318 P=0.429 | |COCH-ARM / FISHERS | P=0.109 P=0.455 (e) P=0.204 P=0.248 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 2.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- --- --- --- 738 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.134 (e) (e) (e) P=0.500 | |POLY 3 | P=0.151 (e) (e) (e) P=0.507 | |POLY 1.5 | P=0.152 (e) (e) (e) P=0.502 | |POLY 6 | P=0.151 (e) (e) (e) P=0.511 | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.160 (e) (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 78 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.9% 6.9% 9.6% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 3/21 (14%) 3/31 (10%) 3/27 (11%) | |FIRST INCIDENCE | --- 726 736 (T) 736 (T) 715 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.135 P=0.525 P=0.232 P=0.328 P=0.186 | |POLY 3 | P=0.046 * P=0.492 P=0.120 P=0.149 P=0.075 | |POLY 1.5 | P=0.038 * P=0.490 P=0.115 P=0.129 P=0.067 | |POLY 6 | P=0.065 P=0.492 P=0.124 P=0.175 P=0.089 | |LOGISTIC REGRESSION| P=0.097 P=0.506 P=0.232 P=0.328 P=0.132 | |COCH-ARM / FISHERS | P=0.035 * P=0.455 P=0.091 P=0.091 P=0.059 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 79 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 663 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.210N P=0.521N P=0.507N P=0.448N P=0.448N | |POLY 3 | P=0.245N P=0.509N P=0.498N P=0.472N P=0.480N | |POLY 1.5 | P=0.244N P=0.511N P=0.504N P=0.490N P=0.490N | |POLY 6 | P=0.250N P=0.512N P=0.494N P=0.452N P=0.463N | |LOGISTIC REGRESSION| P=0.238N P=0.514N P=0.509N P=0.508N P=0.487N | |COCH-ARM / FISHERS | P=0.247N P=0.545N P=0.545N P=0.545N P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.6% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/28 (4%) 0/33 (0%) 1/34 (3%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 738 (T) --- 600 --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.299N P=0.467N P=0.553 P=0.500N P=0.500N | |POLY 3 | P=0.301N P=0.493N P=0.518 P=0.503N P=0.493N | |POLY 1.5 | P=0.297N P=0.503N P=0.501 P=0.506N P=0.498N | |POLY 6 | P=0.310N P=0.483N P=0.532 P=0.505N P=0.489N | |LOGISTIC REGRESSION| P=0.294N (e) P=0.494 (e) (e) | |COCH-ARM / FISHERS | P=0.295N P=0.545N P=0.431 P=0.545N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 80 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 5/60 (8%) 3/50 (6%) 3/50 (6%) 1/50 (2%) 6/60 (10%) | |POLY-3 ADJUSTED (b)| 13.2% 8.3% 7.8% 2.3% 14.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 4/12 (33%) 2/16 (13%) 2/21 (10%) 1/31 (3%) 6/27 (22%) | |FIRST INCIDENCE | 603 723 645 736 (T) 736 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.259N P=0.231N P=0.158N P=0.007N** P=0.244N | |POLY 3 | P=0.511 P=0.381N P=0.347N P=0.073N P=0.567 | |POLY 1.5 | P=0.477 P=0.386N P=0.366N P=0.091N P=0.532 | |POLY 6 | P=0.548N P=0.386N P=0.332N P=0.057N P=0.625 | |LOGISTIC REGRESSION| P=0.447N P=0.361N P=0.324N P=0.046N* P=0.515N | |COCH-ARM / FISHERS | P=0.446 P=0.464N P=0.464N P=0.151N P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 696 --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.250N P=0.473N P=0.494N P=0.531N P=0.489N | |POLY 3 | P=0.258N P=0.494N P=0.493N P=0.503N P=0.494N | |POLY 1.5 | P=0.251N P=0.503N P=0.501N P=0.506N P=0.498N | |POLY 6 | P=0.269N P=0.485N P=0.487N P=0.506N P=0.490N | |LOGISTIC REGRESSION| P=0.243N P=0.502N P=0.501N P=0.507N P=0.494N | |COCH-ARM / FISHERS | P=0.247N P=0.545N P=0.545N P=0.545N P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 81 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/60 (7%) 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/60 (5%) | |POLY-3 ADJUSTED (b)| 10.3% 0.0% 2.6% 0.0% 7.1% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 396 --- 593 --- 614 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.393N P=0.058N P=0.138N P=0.023N* P=0.327N | |POLY 3 | P=0.493N P=0.068N P=0.178N P=0.047N* P=0.451N | |POLY 1.5 | P=0.509N P=0.068N P=0.187N P=0.056N P=0.478N | |POLY 6 | P=0.474N P=0.070N P=0.171N P=0.039N* P=0.404N | |LOGISTIC REGRESSION| P=0.517N P=0.081N P=0.233N P=0.081N P=0.480N | |COCH-ARM / FISHERS | P=0.518N P=0.084N P=0.244N P=0.084N P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 9/60 (15%) 12/50 (24%) 6/50 (12%) 10/50 (20%) 7/60 (12%) | |POLY-3 ADJUSTED (b)| 21.0% 27.6% 13.6% 23.3% 15.5% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/28 (18%) 10/33 (30%) 3/34 (9%) 6/28 (21%) 0/28 (0%) | |FIRST INCIDENCE | 391 535 399 417 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.300N P=0.450 P=0.200N P=0.499 P=0.378N | |POLY 3 | P=0.214N P=0.324 P=0.263N P=0.505 P=0.343N | |POLY 1.5 | P=0.230N P=0.287 P=0.293N P=0.481 P=0.370N | |POLY 6 | P=0.200N P=0.362 P=0.243N P=0.502 P=0.313N | |LOGISTIC REGRESSION| P=0.245N P=0.309 P=0.339N P=0.412 P=0.388N | |COCH-ARM / FISHERS | P=0.237N P=0.170 P=0.432N P=0.330 P=0.395N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 82 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 5.2% 4.6% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | 690 --- 617 709 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.163N P=0.229N P=0.631N P=0.435N P=0.139N | |POLY 3 | P=0.278N P=0.246N P=0.686N P=0.640N P=0.215N | |POLY 1.5 | P=0.299N P=0.248N P=0.690 P=0.675N P=0.226N | |POLY 6 | P=0.241N P=0.247N P=0.675N P=0.598N P=0.197N | |LOGISTIC REGRESSION| P=0.243N P=0.243N P=0.692N P=0.581N P=0.187N | |COCH-ARM / FISHERS | P=0.295N P=0.295N P=0.619 P=0.619 P=0.248N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 573 --- --- 634 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.425N P=0.495N P=0.491N P=0.759N P=0.486N | |POLY 3 | P=0.461N P=0.495N P=0.494N P=0.758 P=0.496N | |POLY 1.5 | P=0.455N P=0.504N P=0.502N P=0.754 P=0.499N | |POLY 6 | P=0.468N P=0.488N P=0.489N P=0.755 P=0.493N | |LOGISTIC REGRESSION| P=0.426N P=0.580N P=0.591N P=0.707 P=0.500N | |COCH-ARM / FISHERS | P=0.430N P=0.545N P=0.545N P=0.705 P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 83 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 4/50 (8%) 3/50 (6%) 2/50 (4%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 25.5% 10.7% 7.6% 4.5% 4.7% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 579 544 360 561 265 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.084N P=0.028N* P=0.002N** P=0.004N** | |POLY 3 | P=0.004N** P=0.080N P=0.029N* P=0.007N** P=0.008N** | |POLY 1.5 | P=0.005N** P=0.085N P=0.035N* P=0.011N* P=0.010N* | |POLY 6 | P=0.002N** P=0.081N P=0.026N* P=0.004N** P=0.005N** | |LOGISTIC REGRESSION| P=0.006N** P=0.090N P=0.046N* P=0.011N* P=0.012N* | |COCH-ARM / FISHERS | P=0.006N** P=0.142N P=0.074N P=0.032N* P=0.015N* | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 6.8% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 731 --- 451 684 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.399N P=0.468N P=0.335 P=0.750 P=0.507N | |POLY 3 | P=0.408N P=0.493N P=0.331 P=0.759 P=0.493N | |POLY 1.5 | P=0.406N P=0.503N P=0.310 P=0.755 P=0.498N | |POLY 6 | P=0.414N P=0.484N P=0.350 P=0.758 P=0.489N | |LOGISTIC REGRESSION| P=0.388N P=0.475N P=0.212 P=0.757 P=0.489N | |COCH-ARM / FISHERS | P=0.390N P=0.545N P=0.244 P=0.705 P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 84 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 8/60 (13%) 8/50 (16%) 4/50 (8%) 3/50 (6%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 20.4% 21.1% 9.9% 6.8% 9.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 2/16 (13%) 0/21 (0%) 0/31 (0%) 1/27 (4%) | |FIRST INCIDENCE | 579 544 360 561 265 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.014N* P=0.579N P=0.156N P=0.022N* P=0.074N | |POLY 3 | P=0.031N* P=0.583 P=0.158N P=0.064N P=0.125N | |POLY 1.5 | P=0.040N* P=0.570 P=0.178N P=0.086N P=0.147N | |POLY 6 | P=0.022N* P=0.584 P=0.147N P=0.047N* P=0.100N | |LOGISTIC REGRESSION| P=0.057N P=0.561 P=0.241N P=0.087N P=0.169N | |COCH-ARM / FISHERS | P=0.056N P=0.449 P=0.281N P=0.170N P=0.181N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 3/60 (5%) 1/50 (2%) 3/50 (6%) 3/50 (6%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 7.1% 2.3% 6.8% 7.2% 9.2% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 543 620 451 605 472 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.257 P=0.280N P=0.625N P=0.644 P=0.520 | |POLY 3 | P=0.244 P=0.295N P=0.637N P=0.660 P=0.521 | |POLY 1.5 | P=0.248 P=0.311N P=0.660N P=0.650 P=0.508 | |POLY 6 | P=0.238 P=0.281N P=0.619N P=0.659 P=0.532 | |LOGISTIC REGRESSION| P=0.280 P=0.355N P=0.550 P=0.602 P=0.505 | |COCH-ARM / FISHERS | P=0.276 P=0.381N P=0.570 P=0.570 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 85 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia Basal Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.2% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 2/21 (10%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- 736 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.441N (e) P=0.367 (e) (e) | |POLY 3 | P=0.522N (e) P=0.240 (e) (e) | |POLY 1.5 | P=0.549N (e) P=0.233 (e) (e) | |POLY 6 | P=0.487N (e) P=0.246 (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.367 (e) (e) | |COCH-ARM / FISHERS | P=0.587N (e) P=0.204 (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia Basal Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 86 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 8/60 (13%) 3/50 (6%) 4/50 (8%) 1/50 (2%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 20.7% 8.1% 10.0% 2.3% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) 0/27 (0%) | |FIRST INCIDENCE | 600 544 527 561 715 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001N** P=0.101N P=0.138N P=0.003N** P=0.003N** | |POLY 3 | P=0.004N** P=0.105N P=0.155N P=0.009N** P=0.010N* | |POLY 1.5 | P=0.005N** P=0.111N P=0.177N P=0.013N* P=0.013N* | |POLY 6 | P=0.002N** P=0.104N P=0.137N P=0.005N** P=0.007N** | |LOGISTIC REGRESSION| P=0.005N** P=0.115N P=0.196N P=0.011N* P=0.009N** | |COCH-ARM / FISHERS | P=0.006N** P=0.170N P=0.281N P=0.031N* P=0.016N* | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 0.0% 6.8% 2.4% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 475 --- 451 684 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.225N P=0.227N P=0.525 P=0.513N P=0.246N | |POLY 3 | P=0.245N P=0.233N P=0.525 P=0.509N P=0.233N | |POLY 1.5 | P=0.240N P=0.242N P=0.502 P=0.513N P=0.237N | |POLY 6 | P=0.254N P=0.225N P=0.544 P=0.514N P=0.230N | |LOGISTIC REGRESSION| P=0.219N P=0.294N P=0.336 P=0.571N P=0.238N | |COCH-ARM / FISHERS | P=0.221N P=0.295N P=0.414 P=0.569N P=0.248N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 87 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/60 (3%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 2.3% 4.8% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 1/27 (4%) | |FIRST INCIDENCE | 715 --- --- 736 (T) 684 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.305 P=0.490N P=0.462N P=0.591N P=0.670 | |POLY 3 | P=0.191 P=0.508N P=0.497N P=0.726N P=0.538 | |POLY 1.5 | P=0.182 P=0.510N P=0.504N P=0.749N P=0.518 | |POLY 6 | P=0.210 P=0.510N P=0.493N P=0.699N P=0.570 | |LOGISTIC REGRESSION| P=0.240 P=0.504N P=0.483N P=0.666N P=0.577 | |COCH-ARM / FISHERS | P=0.191 P=0.545N P=0.545N P=0.705 P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 88 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 1/50 (2%) 0/50 (0%) 2/50 (4%) 1/60 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 2.7% 0.0% 4.5% 2.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 0/27 (0%) | |FIRST INCIDENCE | 603 614 --- 518 708 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.341N P=0.480N P=0.180N P=0.498N P=0.343N | |POLY 3 | P=0.456N P=0.514N P=0.235N P=0.638N P=0.466N | |POLY 1.5 | P=0.471N P=0.517N P=0.242N P=0.674N P=0.484N | |POLY 6 | P=0.429N P=0.515N P=0.231N P=0.596N P=0.437N | |LOGISTIC REGRESSION| P=0.462N P=0.531N P=0.242N P=0.665 P=0.466N | |COCH-ARM / FISHERS | P=0.469N P=0.569N P=0.295N P=0.619 P=0.500N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/60 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 4.6% 2.3% 4.8% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 696 620 733 572 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.303N P=0.542 P=0.733N P=0.480 P=0.489N | |POLY 3 | P=0.294N P=0.516 P=0.752N P=0.502 P=0.494N | |POLY 1.5 | P=0.298N P=0.497 P=0.760 P=0.493 P=0.498N | |POLY 6 | P=0.294N P=0.534 P=0.745N P=0.502 P=0.490N | |LOGISTIC REGRESSION| P=0.296N P=0.470 P=0.753N P=0.436 P=0.494N | |COCH-ARM / FISHERS | P=0.295N P=0.431 P=0.705 P=0.431 P=0.500N | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 89 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/60 (3%) 2/50 (4%) 4/50 (8%) 4/50 (8%) 4/60 (7%) | |POLY-3 ADJUSTED (b)| 5.3% 5.3% 10.4% 9.1% 9.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 2/21 (10%) 2/31 (7%) 0/27 (0%) | |FIRST INCIDENCE | 733 507 702 621 502 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.443 P=0.663N P=0.537 P=0.655N P=0.550 | |POLY 3 | P=0.272 P=0.694 P=0.346 P=0.414 P=0.401 | |POLY 1.5 | P=0.234 P=0.684 P=0.329 P=0.365 P=0.368 | |POLY 6 | P=0.345 P=0.692N P=0.360 P=0.473 P=0.455 | |LOGISTIC REGRESSION| P=0.233 P=0.649 P=0.406 P=0.456 P=0.372 | |COCH-ARM / FISHERS | P=0.217 P=0.619 P=0.257 P=0.257 P=0.340 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 90 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 10/60 (17%) 10/50 (20%) 6/50 (12%) 5/50 (10%) 8/60 (13%) | |POLY-3 ADJUSTED (b)| 24.6% 24.1% 14.6% 11.1% 17.9% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 1/31 (3%) 3/27 (11%) | |FIRST INCIDENCE | 435 435 360 518 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.090N P=0.571 P=0.166N P=0.033N* P=0.166N | |POLY 3 | P=0.140N P=0.585N P=0.194N P=0.086N P=0.310N | |POLY 1.5 | P=0.167N P=0.583 P=0.215N P=0.115N P=0.350N | |POLY 6 | P=0.108N P=0.559N P=0.183N P=0.061N P=0.257N | |LOGISTIC REGRESSION| P=0.212N P=0.392 P=0.346N P=0.201N P=0.383N | |COCH-ARM / FISHERS | P=0.201N P=0.418 P=0.340N P=0.232N P=0.399N | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 91 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/59 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) 0/58 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/20 (0%) 0/28 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | (e) (e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/58 (0%) 1/44 (2%) 3/48 (6%) 0/47 (0%) 0/59 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 7.3% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/26 (0%) 0/31 (0%) 3/33 (9%) 0/27 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 392 738 (T) --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.409N P=0.496 P=0.165 (e) (e) | |POLY 3 | P=0.354N P=0.500 P=0.128 (e) (e) | |POLY 1.5 | P=0.362N P=0.486 P=0.119 (e) (e) | |POLY 6 | P=0.351N P=0.514 P=0.137 (e) (e) | |LOGISTIC REGRESSION| P=0.391N P=0.248 P=0.165 (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.431 P=0.090 (e) (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 92 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Ectopic Parathyroid Gland | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/59 (0%) 1/46 (2%) 0/49 (0%) 0/47 (0%) 0/58 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 3.0% 0.0% 0.0% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/20 (0%) 0/28 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 708 --- --- --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.376N P=0.520 (e) (e) (e) | |POLY 3 | P=0.393N P=0.476 (e) (e) (e) | |POLY 1.5 | P=0.401N P=0.475 (e) (e) (e) | |POLY 6 | P=0.393N P=0.474 (e) (e) (e) | |LOGISTIC REGRESSION| P=0.421N P=0.475 (e) (e) (e) | |COCH-ARM / FISHERS | P=0.451N P=0.438 (e) (e) (e) | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Ectopic Parathyroid Gland | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/58 (0%) 0/44 (0%) 0/48 (0%) 2/47 (4%) 0/59 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/26 (0%) 0/31 (0%) 0/33 (0%) 0/27 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- 634 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.409 (e) (e) P=0.222 (e) | |POLY 3 | P=0.366 (e) (e) P=0.237 (e) | |POLY 1.5 | P=0.367 (e) (e) P=0.229 (e) | |POLY 6 | P=0.371 (e) (e) P=0.241 (e) | |LOGISTIC REGRESSION| P=0.423 (e) (e) P=0.188 (e) | |COCH-ARM / FISHERS | P=0.422 (e) (e) P=0.198 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 93 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 16/60 (27%) 8/50 (16%) 21/50 (42%) 19/50 (38%) 17/60 (28%) | |POLY-3 ADJUSTED (b)| 39.7% 21.1% 50.5% 42.8% 38.4% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 5/12 (42%) 3/16 (19%) 11/21 (52%) 16/31 (52%) 11/27 (41%) | |FIRST INCIDENCE | 579 507 521 619 360 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.152N P=0.042N* P=0.567N P=0.049N* P=0.105N | |POLY 3 | P=0.290 P=0.056N P=0.215 P=0.471 P=0.541N | |POLY 1.5 | P=0.216 P=0.061N P=0.181 P=0.370 P=0.573 | |POLY 6 | P=0.431 P=0.060N P=0.234 P=0.569 P=0.454N | |LOGISTIC REGRESSION| P=0.325 P=0.063N P=0.206 P=0.547N P=0.543N | |COCH-ARM / FISHERS | P=0.207 P=0.132N P=0.068 P=0.143 P=0.500 | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 16/60 (27%) 23/50 (46%) 27/50 (54%) 20/50 (40%) 17/60 (28%) | |POLY-3 ADJUSTED (b)| 37.6% 51.6% 60.3% 47.1% 38.3% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 9/28 (32%) 19/33 (58%) 21/34 (62%) 15/28 (54%) 12/28 (43%) | |FIRST INCIDENCE | 620 430 544 572 365 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.501N P=0.272 P=0.113 P=0.259 P=0.529 | |POLY 3 | P=0.324N P=0.132 P=0.024 * P=0.249 P=0.564 | |POLY 1.5 | P=0.339N P=0.096 P=0.016 * P=0.229 P=0.531 | |POLY 6 | P=0.333N P=0.164 P=0.032 * P=0.233 P=0.586 | |LOGISTIC REGRESSION| P=0.366N P=0.130 P=0.029 * P=0.232 P=0.555 | |COCH-ARM / FISHERS | P=0.340N P=0.028 * P=0.003 ** P=0.100 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 94 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | | |POLY-3 ADJUSTED (b)| | |INT SACRIFICE 1 (c)| | |TERMINAL (d) | | |FIRST INCIDENCE | | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | | |POLY 3 | | |POLY 1.5 | | |POLY 6 | | |LOGISTIC REGRESSION| | |COCH-ARM / FISHERS | | |=================================================================================================================================| | | | | | | Females | |Dose | 0 PPM 200 PPM 400 PPM | 600 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/60 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/60 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% 4.9% 0.0% | |INT SACRIFICE 1 (c)| 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) | |TERMINAL (d) | 0/28 (0%) 2/33 (6%) 0/34 (0%) 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- 738 (T) --- 692 --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.543N P=0.275 (e) P=0.226 (e) | |POLY 3 | P=0.494N P=0.245 (e) P=0.235 (e) | |POLY 1.5 | P=0.503N P=0.234 (e) P=0.231 (e) | |POLY 6 | P=0.486N P=0.257 (e) P=0.233 (e) | |LOGISTIC REGRESSION| P=0.524N P=0.275 (e) P=0.232 (e) | |COCH-ARM / FISHERS | P=0.512N P=0.204 (e) P=0.204 (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).