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 Adrenal Medulla Hyperplasia Heart Cardiomyopathy Chronic Heart: Atrium Thrombosis Kidney Nephropathy Chronic Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Hepatodiaphragmatic Nodule Inflammation Chronic Liver: Bile Duct Hyperplasia Liver: Hepatocyte Degeneration Cystic Lung: Alveolus Infiltration Cellular Histiocyte Lymph Node, Mediastinal Pigmentation Hemosiderin Lymph Node, Mesenteric Ectasia Mammary Gland Hyperplasia Cystic Mesentery: Fat Necrosis Nose Fungus Inflammation Chronic Nose: Respiratory Epithelium Hyperplasia Metaplasia Preputial Gland Inflammation Chronic Prostate Inflammation Chronic Stomach, Forestomach Inflammation Chronic Stomach, Forestomach: Epithelium Ulcer =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Kidney Nephropathy Chronic Nose: Respiratory Epithelium Hyperplasia Pituitary Gland: Pars Distalis Cyst =============================================================== 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.7% | 2.4% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | --- 565 | 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.273 | P=0.500N | |POLY 3 | P=0.253 | P=0.487N | |POLY 1.5 | P=0.245 | P=0.495N | |POLY 6 | P=0.269 | P=0.478N | |LOGISTIC REGRESSION| P=0.224 | (e) | |COCH-ARM / FISHERS | P=0.247 | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.7% 2.4% | 0.0% 4.7% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) 736 (T) | --- 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.571N | P=0.250 | |POLY 3 | P=0.725N | P=0.242 | |POLY 1.5 | P=0.743N | P=0.239 | |POLY 6 | P=0.695N | P=0.246 | |LOGISTIC REGRESSION| P=0.571N | P=0.238 | |COCH-ARM / FISHERS | P=0.753N | P=0.247 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 25/50 (50%) | 9/50 (18%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 63.2% 54.1% | 21.2% 32.2% | |TERMINAL (d) | 8/12 (67%) 12/27 (44%) | 4/28 (14%) 8/28 (29%) | |FIRST INCIDENCE | 396 360 | 585 647 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017N* | P=0.219 | |POLY 3 | P=0.245N | P=0.180 | |POLY 1.5 | P=0.299N | P=0.171 | |POLY 6 | P=0.164N | P=0.188 | |LOGISTIC REGRESSION| P=0.354N | P=0.192 | |COCH-ARM / FISHERS | P=0.344N | P=0.171 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 17/50 (34%) | 7/50 (14%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 32.2% 39.1% | 17.0% 39.3% | |TERMINAL (d) | 4/12 (33%) 13/27 (48%) | 6/28 (21%) 14/28 (50%) | |FIRST INCIDENCE | 564 460 | 698 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.280N | P=0.016 * | |POLY 3 | P=0.326 | P=0.017 * | |POLY 1.5 | P=0.290 | P=0.016 * | |POLY 6 | P=0.384 | P=0.019 * | |LOGISTIC REGRESSION| P=0.318 | P=0.021 * | |COCH-ARM / FISHERS | P=0.257 | P=0.017 * | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) | 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 7.2% | 2.4% 7.1% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 1/28 (4%) 3/28 (11%) | |FIRST INCIDENCE | --- 677 | 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.253 | P=0.304 | |POLY 3 | P=0.133 | P=0.314 | |POLY 1.5 | P=0.125 | P=0.308 | |POLY 6 | P=0.148 | P=0.320 | |LOGISTIC REGRESSION| P=0.163 | P=0.304 | |COCH-ARM / FISHERS | P=0.121 | P=0.309 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 28/50 (56%) | 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 46.2% 61.2% | 7.3% 9.2% | |TERMINAL (d) | 6/12 (50%) 17/27 (63%) | 3/28 (11%) 2/28 (7%) | |FIRST INCIDENCE | 647 460 | 738 (T) 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.396N | P=0.509 | |POLY 3 | P=0.108 | P=0.529 | |POLY 1.5 | P=0.061 | P=0.513 | |POLY 6 | P=0.228 | P=0.546 | |LOGISTIC REGRESSION| P=0.080 | P=0.501 | |COCH-ARM / FISHERS | P=0.035 * | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Blood Vessel: Aorta | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 715 684 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.670 | (e) | |POLY 3 | P=0.527 | (e) | |POLY 1.5 | P=0.513 | (e) | |POLY 6 | P=0.551 | (e) | |LOGISTIC REGRESSION| P=0.575 | (e) | |COCH-ARM / FISHERS | P=0.500 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 7.2% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 715 684 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.488 | (e) | |POLY 3 | P=0.336 | (e) | |POLY 1.5 | P=0.320 | (e) | |POLY 6 | P=0.366 | (e) | |LOGISTIC REGRESSION| P=0.382 | (e) | |COCH-ARM / FISHERS | P=0.309 | (e) | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 6/50 (12%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 14.5% 4.8% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 3/28 (11%) 0/28 (0%) | |FIRST INCIDENCE | --- --- | 698 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.128N | |POLY 3 | (e) | P=0.128N | |POLY 1.5 | (e) | P=0.136N | |POLY 6 | (e) | P=0.121N | |LOGISTIC REGRESSION| (e) | P=0.124N | |COCH-ARM / FISHERS | (e) | P=0.141N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 38/50 (76%) | 11/50 (22%) 16/49 (33%) | |POLY-3 ADJUSTED (b)| 67.6% 79.3% | 25.3% 34.4% | |TERMINAL (d) | 5/12 (42%) 21/27 (78%) | 3/28 (11%) 2/28 (7%) | |FIRST INCIDENCE | 396 360 | 475 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.181N | P=0.262 | |POLY 3 | P=0.137 | P=0.234 | |POLY 1.5 | P=0.098 | P=0.200 | |POLY 6 | P=0.195 | P=0.275 | |LOGISTIC REGRESSION| P=0.081 | P=0.163 | |COCH-ARM / FISHERS | P=0.066 | P=0.168 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 10.3% 2.4% | 0.0% 2.3% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 564 736 (T) | --- 652 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.112N | P=0.520 | |POLY 3 | P=0.154N | P=0.500 | |POLY 1.5 | P=0.166N | P=0.500 | |POLY 6 | P=0.135N | P=0.501 | |LOGISTIC REGRESSION| P=0.190N | P=0.503 | |COCH-ARM / FISHERS | P=0.181N | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 10/50 (20%) 10/49 (20%) | |POLY-3 ADJUSTED (b)| | 23.7% 24.0% | |TERMINAL (d) | | 6/28 (21%) 9/27 (33%) | |FIRST INCIDENCE | | 523 703 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.587 | |POLY 3 | | P=0.588 | |POLY 1.5 | | P=0.578 | |POLY 6 | | P=0.592 | |LOGISTIC REGRESSION| | P=0.577N | |COCH-ARM / FISHERS | | P=0.579 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 4/50 (8%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| | 9.4% 7.2% | |TERMINAL (d) | | 1/28 (4%) 2/27 (7%) | |FIRST INCIDENCE | | 544 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.482N | |POLY 3 | | P=0.510N | |POLY 1.5 | | P=0.515N | |POLY 6 | | P=0.508N | |LOGISTIC REGRESSION| | P=0.510N | |COCH-ARM / FISHERS | | P=0.511N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Coagulating Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 0.0% | 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 715 --- | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | (e) | |POLY 3 | (e) | (e) | |POLY 1.5 | (e) | (e) | |POLY 6 | (e) | (e) | |LOGISTIC REGRESSION| (e) | (e) | |COCH-ARM / FISHERS | (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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/3 (0%) | 2/3 (67%) 1/2 (50%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 70.3% 50.0% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) | 2/2 (100%) 0/1 (0%) | |FIRST INCIDENCE | --- --- | 738 (T) 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.682N | |POLY 3 | (e) | P=0.702N | |POLY 1.5 | (e) | P=0.712N | |POLY 6 | (e) | P=0.684N | |LOGISTIC REGRESSION| (e) | P=0.737N | |COCH-ARM / FISHERS | (e) | P=0.700N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 3/3 (100%) | 0/3 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% | 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) | 0/2 (0%) 0/1 (0%) | |FIRST INCIDENCE | 396 677 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | (e) | |POLY 3 | (e) | (e) | |POLY 1.5 | (e) | (e) | |POLY 6 | (e) | (e) | |LOGISTIC REGRESSION| (e) | (e) | |COCH-ARM / FISHERS | (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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 3/3 (100%) | 0/3 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% | 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) | 0/2 (0%) 0/1 (0%) | |FIRST INCIDENCE | 396 677 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | (e) | |POLY 3 | (e) | (e) | |POLY 1.5 | (e) | (e) | |POLY 6 | (e) | (e) | |LOGISTIC REGRESSION| (e) | (e) | |COCH-ARM / FISHERS | (e) | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/50 (82%) 45/50 (90%) | 27/50 (54%) 25/50 (50%) | |POLY-3 ADJUSTED (b)| 87.8% 94.2% | 58.9% 56.8% | |TERMINAL (d) | 12/12 (100%) 26/27 (96%) | 15/28 (54%) 17/28 (61%) | |FIRST INCIDENCE | 396 265 | 461 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.012N* | P=0.386N | |POLY 3 | P=0.205 | P=0.509N | |POLY 1.5 | P=0.186 | P=0.488N | |POLY 6 | P=0.268 | P=0.543N | |LOGISTIC REGRESSION| P=0.244 | P=0.390N | |COCH-ARM / FISHERS | P=0.194 | P=0.421N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 18.5% 2.4% | 0.0% 2.3% | |TERMINAL (d) | 3/12 (25%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 708 | --- 668 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003N** | P=0.527 | |POLY 3 | P=0.019N* | P=0.500 | |POLY 1.5 | P=0.024N* | P=0.500 | |POLY 6 | P=0.012N* | P=0.501 | |LOGISTIC REGRESSION| P=0.008N** | P=0.500 | |COCH-ARM / FISHERS | P=0.030N* | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 7.2% | 0.0% 2.4% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) 565 | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536 | P=0.500 | |POLY 3 | P=0.334 | P=0.500 | |POLY 1.5 | P=0.316 | P=0.500 | |POLY 6 | P=0.365 | P=0.501 | |LOGISTIC REGRESSION| P=0.327 | P=0.500 | |COCH-ARM / FISHERS | P=0.301 | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) | 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 2.7% 12.0% | 4.9% 9.2% | |TERMINAL (d) | 0/12 (0%) 5/27 (19%) | 2/28 (7%) 1/28 (4%) | |FIRST INCIDENCE | 643 736 (T) | 738 (T) 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322 | P=0.353 | |POLY 3 | P=0.120 | P=0.359 | |POLY 1.5 | P=0.110 | P=0.347 | |POLY 6 | P=0.139 | P=0.372 | |LOGISTIC REGRESSION| P=0.177 | P=0.338 | |COCH-ARM / FISHERS | P=0.102 | P=0.339 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% | 0.0% 2.4% | |TERMINAL (d) | 2/12 (17%) 0/27 (0%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) --- | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085N | P=0.500 | |POLY 3 | P=0.204N | P=0.500 | |POLY 1.5 | P=0.220N | P=0.500 | |POLY 6 | P=0.179N | P=0.501 | |LOGISTIC REGRESSION| (e) | P=0.500 | |COCH-ARM / FISHERS | P=0.247N | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 7.2% | 2.4% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 681 684 | 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.508 | P=0.500N | |POLY 3 | P=0.335 | P=0.487N | |POLY 1.5 | P=0.320 | P=0.495N | |POLY 6 | P=0.362 | P=0.478N | |LOGISTIC REGRESSION| P=0.372 | (e) | |COCH-ARM / FISHERS | P=0.309 | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) | 44/50 (88%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 100.0% 99.9% | 95.7% 100.0% | |TERMINAL (d) | 12/12 (100%) 27/27 (100%) | 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 396 360 | 507 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002N** | P=0.326 | |POLY 3 | P=1.000N | P=0.103 | |POLY 1.5 | P=1.000N | P=0.036 * | |POLY 6 | P=1.000N | P=0.698 | |LOGISTIC REGRESSION| (e) | P=0.016 * | |COCH-ARM / FISHERS | P=0.500N | P=0.056 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% | 0.0% 2.3% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 695 708 | --- 719 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.687 | P=0.513 | |POLY 3 | P=0.526 | P=0.500 | |POLY 1.5 | P=0.513 | P=0.500 | |POLY 6 | P=0.549 | P=0.501 | |LOGISTIC REGRESSION| P=0.579 | P=0.510 | |COCH-ARM / FISHERS | P=0.500 | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 47/50 (94%) | 48/50 (96%) 49/50 (98%) | |POLY-3 ADJUSTED (b)| 98.7% 94.4% | 98.4% 100.0% | |TERMINAL (d) | 12/12 (100%) 25/27 (93%) | 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 396 265 | 391 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002N** | P=0.546N | |POLY 3 | P=0.257N | P=0.640 | |POLY 1.5 | P=0.279N | P=0.391 | |POLY 6 | P=0.227N | P=0.997 | |LOGISTIC REGRESSION| P=0.347N | P=0.290 | |COCH-ARM / FISHERS | P=0.309N | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 647 736 (T) | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.481N | (e) | |POLY 3 | P=0.651N | (e) | |POLY 1.5 | P=0.673N | (e) | |POLY 6 | P=0.615N | (e) | |LOGISTIC REGRESSION| P=0.631N | (e) | |COCH-ARM / FISHERS | P=0.691N | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 31/50 (62%) | 41/50 (82%) 34/50 (68%) | |POLY-3 ADJUSTED (b)| 42.0% 71.2% | 86.2% 76.3% | |TERMINAL (d) | 10/12 (83%) 25/27 (93%) | 27/28 (96%) 27/28 (96%) | |FIRST INCIDENCE | 396 550 | 391 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.522N | P=0.088N | |POLY 3 | P=0.003 ** | P=0.150N | |POLY 1.5 | P=0.003 ** | P=0.132N | |POLY 6 | P=0.006 ** | P=0.178N | |LOGISTIC REGRESSION| P=0.013 * | P=0.058N | |COCH-ARM / FISHERS | P=0.004 ** | P=0.083N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/50 (18%) | 11/50 (22%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 16.0% 21.6% | 26.8% 37.5% | |TERMINAL (d) | 6/12 (50%) 9/27 (33%) | 11/28 (39%) 15/28 (54%) | |FIRST INCIDENCE | 736 (T) 736 (T) | 738 (T) 690 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.267N | P=0.155 | |POLY 3 | P=0.360 | P=0.203 | |POLY 1.5 | P=0.322 | P=0.188 | |POLY 6 | P=0.431 | P=0.220 | |LOGISTIC REGRESSION| P=0.267N | P=0.179 | |COCH-ARM / FISHERS | P=0.288 | P=0.184 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) | 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.3% 16.8% | 4.8% 4.7% | |TERMINAL (d) | 0/12 (0%) 7/27 (26%) | 1/28 (4%) 2/28 (7%) | |FIRST INCIDENCE | 619 736 (T) | 620 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.356 | P=0.690N | |POLY 3 | P=0.098 | P=0.683N | |POLY 1.5 | P=0.088 | P=0.691N | |POLY 6 | P=0.119 | P=0.678N | |LOGISTIC REGRESSION| P=0.173 | P=0.685N | |COCH-ARM / FISHERS | P=0.080 | P=0.691N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) | 9/50 (18%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 0.0% 12.0% | 21.1% 22.5% | |TERMINAL (d) | 0/12 (0%) 3/27 (11%) | 6/28 (21%) 3/28 (11%) | |FIRST INCIDENCE | --- 715 | 475 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.130 | P=0.535 | |POLY 3 | P=0.038 * | P=0.538 | |POLY 1.5 | P=0.034 * | P=0.515 | |POLY 6 | P=0.047 * | P=0.566 | |LOGISTIC REGRESSION| P=0.080 | P=0.500 | |COCH-ARM / FISHERS | P=0.028 * | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 34/50 (68%) | 31/50 (62%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 51.3% 71.8% | 69.4% 78.4% | |TERMINAL (d) | 9/12 (75%) 20/27 (74%) | 22/28 (79%) 27/28 (96%) | |FIRST INCIDENCE | 396 265 | 507 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.449N | P=0.236 | |POLY 3 | P=0.028 * | P=0.214 | |POLY 1.5 | P=0.018 * | P=0.195 | |POLY 6 | P=0.060 | P=0.217 | |LOGISTIC REGRESSION| P=0.012 * | P=0.225 | |COCH-ARM / FISHERS | P=0.013 * | P=0.198 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) | 7/50 (14%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.7% 12.0% | 17.0% 11.7% | |TERMINAL (d) | 1/12 (8%) 5/27 (19%) | 7/28 (25%) 4/28 (14%) | |FIRST INCIDENCE | 736 (T) 736 (T) | 738 (T) 714 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.371 | P=0.372N | |POLY 3 | P=0.122 | P=0.350N | |POLY 1.5 | P=0.111 | P=0.368N | |POLY 6 | P=0.143 | P=0.331N | |LOGISTIC REGRESSION| P=0.371 | P=0.353N | |COCH-ARM / FISHERS | P=0.102 | P=0.380N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 2.4% 4.6% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- | 704 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.526 | |POLY 3 | (e) | P=0.513 | |POLY 1.5 | (e) | P=0.506 | |POLY 6 | (e) | P=0.520 | |LOGISTIC REGRESSION| (e) | P=0.522 | |COCH-ARM / FISHERS | (e) | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 4.8% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- | 391 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.241N | |POLY 3 | (e) | P=0.233N | |POLY 1.5 | (e) | P=0.238N | |POLY 6 | (e) | P=0.228N | |LOGISTIC REGRESSION| (e) | P=0.186N | |COCH-ARM / FISHERS | (e) | P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 46/50 (92%) | 24/50 (48%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 99.1% 96.1% | 56.1% 41.6% | |TERMINAL (d) | 12/12 (100%) 27/27 (100%) | 16/28 (57%) 13/28 (46%) | |FIRST INCIDENCE | 396 265 | 585 647 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.146N | |POLY 3 | P=0.358N | P=0.122N | |POLY 1.5 | P=0.272N | P=0.140N | |POLY 6 | P=0.473N | P=0.111N | |LOGISTIC REGRESSION| P=0.149N | P=0.085N | |COCH-ARM / FISHERS | P=0.181N | P=0.156N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 28/50 (56%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 40.1% 63.0% | 0.0% 0.0% | |TERMINAL (d) | 4/12 (33%) 16/27 (59%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 576 550 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.532 | (e) | |POLY 3 | P=0.023 * | (e) | |POLY 1.5 | P=0.015 * | (e) | |POLY 6 | P=0.047 * | (e) | |LOGISTIC REGRESSION| P=0.035 * | (e) | |COCH-ARM / FISHERS | P=0.013 * | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 7.8% 4.7% | 0.0% 2.3% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 535 536 | --- 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.423N | P=0.522 | |POLY 3 | P=0.450N | P=0.500 | |POLY 1.5 | P=0.475N | P=0.500 | |POLY 6 | P=0.411N | P=0.501 | |LOGISTIC REGRESSION| P=0.530N | P=0.500 | |COCH-ARM / FISHERS | P=0.500N | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 13/50 (26%) | 7/50 (14%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 24.6% 30.2% | 16.8% 20.9% | |TERMINAL (d) | 1/12 (8%) 10/27 (37%) | 3/28 (11%) 6/28 (21%) | |FIRST INCIDENCE | 396 536 | 645 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384N | P=0.417 | |POLY 3 | P=0.369 | P=0.415 | |POLY 1.5 | P=0.340 | P=0.400 | |POLY 6 | P=0.422 | P=0.428 | |LOGISTIC REGRESSION| P=0.325 | P=0.436 | |COCH-ARM / FISHERS | P=0.318 | P=0.393 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.3% 4.7% | 0.0% 4.7% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 617 502 | --- 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.588N | P=0.257 | |POLY 3 | P=0.643N | P=0.242 | |POLY 1.5 | P=0.668N | P=0.239 | |POLY 6 | P=0.603N | P=0.245 | |LOGISTIC REGRESSION| P=0.678 | P=0.243 | |COCH-ARM / FISHERS | P=0.691N | P=0.247 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 4.7% | 4.7% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 729 502 | 391 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.520N | P=0.237N | |POLY 3 | P=0.638N | P=0.237N | |POLY 1.5 | P=0.665N | P=0.240N | |POLY 6 | P=0.592N | P=0.234N | |LOGISTIC REGRESSION| P=0.696 | P=0.142N | |COCH-ARM / FISHERS | P=0.691N | P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 6/50 (12%) | 12/50 (24%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 7.7% 14.3% | 27.9% 34.3% | |TERMINAL (d) | 0/12 (0%) 5/27 (19%) | 7/28 (25%) 12/28 (43%) | |FIRST INCIDENCE | 396 684 | 523 516 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.547 | P=0.352 | |POLY 3 | P=0.274 | P=0.338 | |POLY 1.5 | P=0.256 | P=0.326 | |POLY 6 | P=0.310 | P=0.341 | |LOGISTIC REGRESSION| P=0.248 | P=0.342 | |COCH-ARM / FISHERS | P=0.243 | P=0.326 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) | 5/50 (10%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.7% 7.1% | 12.1% 11.7% | |TERMINAL (d) | 1/12 (8%) 2/27 (7%) | 4/28 (14%) 4/28 (14%) | |FIRST INCIDENCE | 736 (T) 460 | 645 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.538 | P=0.619N | |POLY 3 | P=0.341 | P=0.610N | |POLY 1.5 | P=0.323 | P=0.623N | |POLY 6 | P=0.371 | P=0.597N | |LOGISTIC REGRESSION| P=0.303 | P=0.596N | |COCH-ARM / FISHERS | P=0.309 | P=0.630N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/50 (78%) 44/50 (88%) | 41/50 (82%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 84.4% 90.3% | 89.0% 96.5% | |TERMINAL (d) | 10/12 (83%) 24/27 (89%) | 28/28 (100%) 28/28 (100%) | |FIRST INCIDENCE | 396 360 | 461 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.034N* | P=0.298 | |POLY 3 | P=0.272 | P=0.116 | |POLY 1.5 | P=0.194 | P=0.086 | |POLY 6 | P=0.401 | P=0.177 | |LOGISTIC REGRESSION| P=0.176 | P=0.108 | |COCH-ARM / FISHERS | P=0.143 | P=0.117 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/50 (50%) 24/50 (48%) | 30/50 (60%) 26/50 (52%) | |POLY-3 ADJUSTED (b)| 58.0% 53.6% | 66.1% 56.8% | |TERMINAL (d) | 5/12 (42%) 13/27 (48%) | 18/28 (64%) 13/28 (46%) | |FIRST INCIDENCE | 396 502 | 507 571 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.035N* | P=0.261N | |POLY 3 | P=0.417N | P=0.241N | |POLY 1.5 | P=0.467N | P=0.267N | |POLY 6 | P=0.334N | P=0.217N | |LOGISTIC REGRESSION| P=0.432N | P=0.252N | |COCH-ARM / FISHERS | P=0.500N | P=0.273N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 14.3% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 5/27 (19%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 614 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.084 | (e) | |POLY 3 | P=0.021 * | (e) | |POLY 1.5 | P=0.018 * | (e) | |POLY 6 | P=0.027 * | (e) | |LOGISTIC REGRESSION| P=0.031 * | (e) | |COCH-ARM / FISHERS | P=0.013 * | (e) | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.0% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 360 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201 | (e) | |POLY 3 | P=0.136 | (e) | |POLY 1.5 | P=0.127 | (e) | |POLY 6 | P=0.152 | (e) | |LOGISTIC REGRESSION| P=0.108 | (e) | |COCH-ARM / FISHERS | P=0.121 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/49 (4%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.9% | 4.9% 0.0% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 2/28 (7%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) | 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.429 | P=0.238N | |POLY 3 | P=0.252 | P=0.226N | |POLY 1.5 | P=0.244 | P=0.233N | |POLY 6 | P=0.266 | P=0.219N | |LOGISTIC REGRESSION| P=0.429 | (e) | |COCH-ARM / FISHERS | P=0.247 | P=0.247N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/49 (73%) 26/49 (53%) | 43/50 (86%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 79.7% 60.9% | 88.2% 94.2% | |TERMINAL (d) | 8/12 (67%) 18/27 (67%) | 24/28 (86%) 27/28 (96%) | |FIRST INCIDENCE | 396 613 | 461 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.509 | |POLY 3 | P=0.036N* | P=0.240 | |POLY 1.5 | P=0.033N* | P=0.260 | |POLY 6 | P=0.039N* | P=0.215 | |LOGISTIC REGRESSION| P=0.011N* | P=0.353 | |COCH-ARM / FISHERS | P=0.029N* | P=0.380 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/15 (80%) 11/15 (73%) | 3/8 (38%) 3/6 (50%) | |POLY-3 ADJUSTED (b)| 83.4% 87.8% | 42.2% 60.9% | |TERMINAL (d) | 3/3 (100%) 9/9 (100%) | 2/5 (40%) 1/1 (100%) | |FIRST INCIDENCE | 593 680 | 391 600 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.011N* | P=0.322 | |POLY 3 | P=0.622 | P=0.524 | |POLY 1.5 | P=0.701 | P=0.540 | |POLY 6 | P=0.539 | P=0.499 | |LOGISTIC REGRESSION| P=0.542N | P=0.531 | |COCH-ARM / FISHERS | P=0.500N | P=0.529 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Fungus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 7/50 (14%) | 6/50 (12%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 49.1% 16.4% | 13.9% 4.7% | |TERMINAL (d) | 6/12 (50%) 2/27 (7%) | 1/28 (4%) 1/28 (4%) | |FIRST INCIDENCE | 396 565 | 461 652 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.135N | |POLY 3 | P<0.001N** | P=0.134N | |POLY 1.5 | P<0.001N** | P=0.137N | |POLY 6 | P<0.001N** | P=0.133N | |LOGISTIC REGRESSION| P=0.002N** | P=0.126N | |COCH-ARM / FISHERS | P=0.002N** | P=0.134N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/50 (50%) 21/50 (42%) | 13/50 (26%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 57.5% 48.7% | 29.9% 15.9% | |TERMINAL (d) | 7/12 (58%) 13/27 (48%) | 7/28 (25%) 3/28 (11%) | |FIRST INCIDENCE | 396 565 | 461 11 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007N** | P=0.112N | |POLY 3 | P=0.266N | P=0.092N | |POLY 1.5 | P=0.279N | P=0.097N | |POLY 6 | P=0.227N | P=0.089N | |LOGISTIC REGRESSION| P=0.197N | P=0.103N | |COCH-ARM / FISHERS | P=0.274N | P=0.105N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) | 9/50 (18%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 15.7% 9.4% | 21.2% 22.7% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 5/28 (18%) 5/28 (18%) | |FIRST INCIDENCE | 617 613 | 523 11 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.157N | P=0.528 | |POLY 3 | P=0.297N | P=0.535 | |POLY 1.5 | P=0.333N | P=0.521 | |POLY 6 | P=0.244N | P=0.549 | |LOGISTIC REGRESSION| P=0.321N | P=0.500 | |COCH-ARM / FISHERS | P=0.370N | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/50 (48%) 11/50 (22%) | 10/50 (20%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 56.1% 25.8% | 23.2% 4.7% | |TERMINAL (d) | 7/12 (58%) 5/27 (19%) | 5/28 (18%) 1/28 (4%) | |FIRST INCIDENCE | 396 565 | 461 652 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** | P=0.018N* | |POLY 3 | P=0.003N** | P=0.013N* | |POLY 1.5 | P=0.004N** | P=0.014N* | |POLY 6 | P<0.001N** | P=0.012N* | |LOGISTIC REGRESSION| P=0.004N** | P=0.016N* | |COCH-ARM / FISHERS | P=0.006N** | P=0.014N* | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 5/50 (10%) | 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 28.8% 11.8% | 7.2% 0.0% | |TERMINAL (d) | 1/12 (8%) 1/27 (4%) | 1/28 (4%) 0/28 (0%) | |FIRST INCIDENCE | 396 565 | 543 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017N* | P=0.125N | |POLY 3 | P=0.043N* | P=0.114N | |POLY 1.5 | P=0.049N* | P=0.118N | |POLY 6 | P=0.034N* | P=0.110N | |LOGISTIC REGRESSION| P=0.067N | P=0.120N | |COCH-ARM / FISHERS | P=0.054N | P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 4/50 (8%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| | 9.6% 16.2% | |TERMINAL (d) | | 3/28 (11%) 4/28 (14%) | |FIRST INCIDENCE | | 573 571 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.282 | |POLY 3 | | P=0.281 | |POLY 1.5 | | P=0.268 | |POLY 6 | | P=0.294 | |LOGISTIC REGRESSION| | P=0.270 | |COCH-ARM / FISHERS | | P=0.262 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 19/50 (38%) | 10/50 (20%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 30.6% 43.3% | 23.7% 29.6% | |TERMINAL (d) | 4/12 (33%) 12/27 (44%) | 6/28 (21%) 8/28 (29%) | |FIRST INCIDENCE | 600 502 | 585 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.477N | P=0.351 | |POLY 3 | P=0.160 | P=0.354 | |POLY 1.5 | P=0.124 | P=0.332 | |POLY 6 | P=0.231 | P=0.375 | |LOGISTIC REGRESSION| P=0.163 | P=0.337 | |COCH-ARM / FISHERS | P=0.097 | P=0.318 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/47 (19%) 7/47 (15%) | 1/46 (2%) 1/45 (2%) | |POLY-3 ADJUSTED (b)| 24.8% 17.2% | 2.6% 2.6% | |TERMINAL (d) | 3/12 (25%) 1/26 (4%) | 0/25 (0%) 0/26 (0%) | |FIRST INCIDENCE | 681 680 | 704 708 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.110N | P=0.743N | |POLY 3 | P=0.293N | P=0.756N | |POLY 1.5 | P=0.338N | P=0.759 | |POLY 6 | P=0.232N | P=0.746N | |LOGISTIC REGRESSION| P=0.258N | P=0.763N | |COCH-ARM / FISHERS | P=0.392N | P=0.747 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 6/50 (12%) | 35/50 (70%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 18.3% 14.2% | 76.0% 52.4% | |TERMINAL (d) | 3/12 (25%) 4/27 (15%) | 23/28 (82%) 13/28 (46%) | |FIRST INCIDENCE | 579 614 | 475 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.137N | P=0.037N* | |POLY 3 | P=0.418N | P=0.012N* | |POLY 1.5 | P=0.459N | P=0.016N* | |POLY 6 | P=0.352N | P=0.009N** | |LOGISTIC REGRESSION| P=0.378N | P=0.018N* | |COCH-ARM / FISHERS | P=0.500N | P=0.021N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 26/50 (52%) | 24/50 (48%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 53.8% 59.1% | 53.9% 52.7% | |TERMINAL (d) | 6/12 (50%) 17/27 (63%) | 16/28 (57%) 13/28 (46%) | |FIRST INCIDENCE | 593 565 | 475 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.088N | P=0.524N | |POLY 3 | P=0.384 | P=0.540N | |POLY 1.5 | P=0.324 | P=0.571N | |POLY 6 | P=0.484 | P=0.505N | |LOGISTIC REGRESSION| P=0.483 | P=0.569N | |COCH-ARM / FISHERS | P=0.274 | P=0.579N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% | 2.4% 4.7% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 2/28 (7%) | |FIRST INCIDENCE | --- --- | 698 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) | P=0.510 | |POLY 3 | (e) | P=0.507 | |POLY 1.5 | (e) | P=0.502 | |POLY 6 | (e) | P=0.511 | |LOGISTIC REGRESSION| (e) | P=0.520 | |COCH-ARM / FISHERS | (e) | P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/49 (16%) | | |POLY-3 ADJUSTED (b)| 18.2% 19.4% | | |TERMINAL (d) | 5/12 (42%) 6/27 (22%) | | |FIRST INCIDENCE | 396 613 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211N | | |POLY 3 | P=0.557 | | |POLY 1.5 | P=0.517 | | |POLY 6 | P=0.588N | | |LOGISTIC REGRESSION| P=0.580 | | |COCH-ARM / FISHERS | P=0.483 | | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 44/49 (90%) | | |POLY-3 ADJUSTED (b)| 92.0% 94.5% | | |TERMINAL (d) | 12/12 (100%) 26/27 (96%) | | |FIRST INCIDENCE | 396 360 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** | | |POLY 3 | P=0.465 | | |POLY 1.5 | P=0.343 | | |POLY 6 | P=0.723 | | |LOGISTIC REGRESSION| P=0.377 | | |COCH-ARM / FISHERS | P=0.290 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) | | |POLY-3 ADJUSTED (b)| 5.3% 0.0% | | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | | |FIRST INCIDENCE | 561 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.172N | | |POLY 3 | P=0.215N | | |POLY 1.5 | P=0.229N | | |POLY 6 | P=0.192N | | |LOGISTIC REGRESSION| P=0.249N | | |COCH-ARM / FISHERS | P=0.253N | | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 37/50 (74%) | | |POLY-3 ADJUSTED (b)| 79.2% 79.7% | | |TERMINAL (d) | 8/12 (67%) 24/27 (89%) | | |FIRST INCIDENCE | 396 360 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.007N** | | |POLY 3 | P=0.584 | | |POLY 1.5 | P=0.592N | | |POLY 6 | P=0.571 | | |LOGISTIC REGRESSION| P=0.485N | | |COCH-ARM / FISHERS | P=0.500N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.8% | 0.0% 2.4% | |TERMINAL (d) | 0/12 (0%) 2/27 (7%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- 736 (T) | --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.429 | P=0.500 | |POLY 3 | P=0.250 | P=0.500 | |POLY 1.5 | P=0.243 | P=0.500 | |POLY 6 | P=0.264 | P=0.501 | |LOGISTIC REGRESSION| P=0.429 | P=0.500 | |COCH-ARM / FISHERS | P=0.247 | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 9.6% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 3/27 (11%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 715 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.186 | (e) | |POLY 3 | P=0.071 | (e) | |POLY 1.5 | P=0.065 | (e) | |POLY 6 | P=0.082 | (e) | |LOGISTIC REGRESSION| P=0.132 | (e) | |COCH-ARM / FISHERS | P=0.059 | (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 6/50 (12%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 13.2% 14.4% | 2.4% 0.0% | |TERMINAL (d) | 4/12 (33%) 6/27 (22%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 736 (T) | 696 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.244N | P=0.489N | |POLY 3 | P=0.562 | P=0.488N | |POLY 1.5 | P=0.530 | P=0.496N | |POLY 6 | P=0.616 | P=0.481N | |LOGISTIC REGRESSION| P=0.515N | P=0.498N | |COCH-ARM / FISHERS | P=0.500 | P=0.500N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) | 9/50 (18%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 10.3% 7.1% | 21.1% 15.5% | |TERMINAL (d) | 1/12 (8%) 0/27 (0%) | 5/28 (18%) 0/28 (0%) | |FIRST INCIDENCE | 396 614 | 391 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.327N | P=0.378N | |POLY 3 | P=0.444N | P=0.340N | |POLY 1.5 | P=0.474N | P=0.369N | |POLY 6 | P=0.393N | P=0.309N | |LOGISTIC REGRESSION| P=0.526N | P=0.385N | |COCH-ARM / FISHERS | P=0.500N | P=0.393N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% | 2.4% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 690 --- | 573 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.139N | P=0.486N | |POLY 3 | P=0.205N | P=0.492N | |POLY 1.5 | P=0.221N | P=0.498N | |POLY 6 | P=0.182N | P=0.486N | |LOGISTIC REGRESSION| P=0.188N | P=0.469N | |COCH-ARM / FISHERS | P=0.247N | P=0.500N | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 25.6% 4.7% | 2.4% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 579 265 | 731 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** | P=0.507N | |POLY 3 | P=0.007N** | P=0.487N | |POLY 1.5 | P=0.010N* | P=0.495N | |POLY 6 | P=0.005N** | P=0.479N | |LOGISTIC REGRESSION| P=0.017N* | P=0.489N | |COCH-ARM / FISHERS | P=0.014N* | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 4/50 (8%) | 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 20.5% 9.2% | 7.2% 9.2% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 1/28 (4%) | |FIRST INCIDENCE | 579 265 | 543 472 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.074N | P=0.520 | |POLY 3 | P=0.122N | P=0.518 | |POLY 1.5 | P=0.143N | P=0.507 | |POLY 6 | P=0.096N | P=0.528 | |LOGISTIC REGRESSION| P=0.209N | P=0.504 | |COCH-ARM / FISHERS | P=0.178N | P=0.500 | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 20.8% 2.4% | 4.8% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 600 715 | 475 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003N** | P=0.246N | |POLY 3 | P=0.010N* | P=0.232N | |POLY 1.5 | P=0.012N* | P=0.237N | |POLY 6 | P=0.007N** | P=0.227N | |LOGISTIC REGRESSION| P=0.009N** | P=0.214N | |COCH-ARM / FISHERS | P=0.015N* | P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 4.8% | 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/27 (4%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 715 684 | --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.670 | (e) | |POLY 3 | P=0.527 | (e) | |POLY 1.5 | P=0.513 | (e) | |POLY 6 | P=0.551 | (e) | |LOGISTIC REGRESSION| P=0.575 | (e) | |COCH-ARM / FISHERS | P=0.500 | (e) | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 2.4% | 2.4% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/27 (0%) | 0/28 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 708 | 696 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.343N | P=0.489N | |POLY 3 | P=0.455N | P=0.488N | |POLY 1.5 | P=0.478N | P=0.496N | |POLY 6 | P=0.419N | P=0.481N | |LOGISTIC REGRESSION| P=0.485N | P=0.498N | |COCH-ARM / FISHERS | P=0.500N | P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 5.3% 9.3% | | |TERMINAL (d) | 1/12 (8%) 0/27 (0%) | | |FIRST INCIDENCE | 733 502 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.550 | | |POLY 3 | P=0.392 | | |POLY 1.5 | P=0.364 | | |POLY 6 | P=0.439 | | |LOGISTIC REGRESSION| P=0.341 | | |COCH-ARM / FISHERS | P=0.339 | | |=================================================================================================================================| 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 | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 8/50 (16%) | | |POLY-3 ADJUSTED (b)| 24.7% 17.9% | | |TERMINAL (d) | 2/12 (17%) 3/27 (11%) | | |FIRST INCIDENCE | 435 360 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.166N | | |POLY 3 | P=0.306N | | |POLY 1.5 | P=0.347N | | |POLY 6 | P=0.251N | | |LOGISTIC REGRESSION| P=0.474N | | |COCH-ARM / FISHERS | P=0.398N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 1000 PPM | 0 PPM 1000 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 17/50 (34%) | 16/50 (32%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 39.8% 38.5% | 37.8% 38.4% | |TERMINAL (d) | 5/12 (42%) 11/27 (41%) | 9/28 (32%) 12/28 (43%) | |FIRST INCIDENCE | 579 360 | 620 365 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.105N | P=0.529 | |POLY 3 | P=0.536N | P=0.563 | |POLY 1.5 | P=0.573 | P=0.531 | |POLY 6 | P=0.448N | P=0.584 | |LOGISTIC REGRESSION| P=0.580 | P=0.543 | |COCH-ARM / FISHERS | P=0.500 | P=0.500 | |=================================================================================================================================| (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).