TDMS Study 89002-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:47:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 Rats(FISCHER344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PENTACHLOROPHENOL DATE: 09/15/97 EXPERIMENT: 89002 TEST: 02 TIME: 16:47:38 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15322 ROUTE: DOSED FEED NTP C#: C89002 PATHOLOGIST: TOFT, J. CAS: 87-86-5 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PENTACHLOROPHENOL =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Degeneration Fatty Hypertrophy Adrenal Medulla Hyperplasia Bone Marrow Hyperplasia Heart Cardiomyopathy Chronic Heart: Atrium Thrombosis Kidney Nephropathy Chronic Kidney: Renal Tubule Pigmentation Liver Basophilic Focus Clear Cell Focus Eosinophilic Focus Hepatodiaphragmatic Nodule Inflammation Chronic Liver: Bile Duct Hyperplasia Liver: Hepatocyte Degeneration Cystic Vacuolization Cytoplasmic Lung: Alveolus Infiltration Cellular Histiocyte Lymph Node, Mediastinal Pigmentation Hemosiderin Mammary Gland Hyperplasia Cystic Mesentery: Fat Necrosis Nose Fungus Inflammation Chronic Nose: Respiratory Epithelium Hyperplasia Metaplasia Pancreas: Acinus Atrophy Parathyroid Gland Hyperplasia Pituitary Gland: Pars Distalis Cyst Hyperplasia Preputial Gland Hyperplasia Inflammation Chronic Prostate Inflammation Chronic Skin: Epidermis Hyperkeratosis Spleen Fibrosis Hematopoietic Cell Proliferation Stomach, Forestomach Inflammation Chronic Stomach, Forestomach: Epithelium Hyperplasia Ulcer Testes: Interstitial Cell Hyperplasia Thyroid Gland: C-Cell Hyperplasia =============================================================== Female Rats ------------ Organ Morphology 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 ----- ---------- Adrenal Cortex Degeneration Fatty Hyperplasia Hypertrophy Bone Osteopetrosis Bone Marrow Hyperplasia Clitoral Gland Inflammation Chronic Eye: Lens Cataract Eye: Retina Atrophy Heart Cardiomyopathy Chronic Intestine Large, Colon Parasite Metazoan Intestine Large, Rectum Parasite Metazoan Liver Clear Cell Focus Mixed Cell Focus Liver: Hepatocyte Vacuolization Cytoplasmic Lymph Node, Mediastinal Pigmentation Hemosiderin Nose Fungus Inflammation Chronic Nose: Respiratory Epithelium Hyperplasia Pituitary Gland: Pars Distalis Cyst Thyroid Gland: C-Cell Hyperplasia =============================================================== Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Accessory Adrenal Cortical Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.6% |2.4% 4.7% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 2/31 (7%) |1/28 (4%) 2/33 (6%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 736 (T) 736 (T) |738 (T) 738 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.161 (e) P=0.612 P=0.463 |P=0.138N P=0.558 P=0.461N P=0.500N | |POLY 3 | P=0.076 (e) P=0.504 P=0.272 |P=0.148N P=0.514 P=0.491N P=0.502N | |POLY 1.5 | P=0.068 (e) P=0.502 P=0.256 |P=0.148N P=0.505 P=0.495N P=0.501N | |POLY 6 | P=0.091 (e) P=0.509 P=0.299 |P=0.150N P=0.529 P=0.485N P=0.505N | |LOGISTIC REGRESSION| (e) (e) P=0.612 P=0.463 |P=0.138N P=0.558 (e) (e) | |COCH-ARM / FISHERS | P=0.059 (e) P=0.500 P=0.247 |P=0.149N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 4/50 (8%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 2.8% 2.6% 0.0% |0.0% 9.3% 7.0% 0.0% | |TERMINAL (d) | 1/12 (8%) 1/16 (6%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 4/33 (12%) 3/34 (9%) 0/28 (0%) | |FIRST INCIDENCE | 736 (T) 736 (T) 624 --- |--- 738 (T) 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.168N P=0.698N P=0.704N P=0.311N |P=0.496N P=0.085 P=0.157 (e) | |POLY 3 | P=0.268N P=0.754 P=0.755N P=0.470N |P=0.506N P=0.065 P=0.126 (e) | |POLY 1.5 | P=0.284N P=0.756 P=0.757N P=0.484N |P=0.502N P=0.062 P=0.123 (e) | |POLY 6 | P=0.245N P=0.753 P=0.748N P=0.449N |P=0.518N P=0.071 P=0.132 (e) | |LOGISTIC REGRESSION| P=0.259N P=0.698N P=0.759N (e) |(e) P=0.085 P=0.157 (e) | |COCH-ARM / FISHERS | P=0.301N P=0.753N P=0.753N P=0.500N |P=0.500N P=0.059 P=0.121 (e) | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Degeneration Fatty | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 19/50 (38%) 16/50 (32%) 20/50 (40%) |9/50 (18%) 11/50 (22%) 17/50 (34%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 63.2% 46.9% 38.1% 43.5% |21.2% 25.5% 37.7% 35.6% | |TERMINAL (d) | 8/12 (67%) 6/16 (38%) 6/21 (29%) 12/31 (39%) |4/28 (14%) 10/33 (30%) 10/34 (29%) 11/28 (39%) | |FIRST INCIDENCE | 396 507 443 518 |585 620 451 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.064N P=0.005N** P<0.001N** |P=0.049 * P=0.545 P=0.139 P=0.122 | |POLY 3 | P=0.020N* P=0.087N P=0.012N* P=0.041N* |P=0.044 * P=0.417 P=0.071 P=0.107 | |POLY 1.5 | P=0.030N* P=0.072N P=0.012N* P=0.059N |P=0.046 * P=0.403 P=0.062 P=0.114 | |POLY 6 | P=0.011N* P=0.100N P=0.012N* P=0.023N* |P=0.038 * P=0.441 P=0.084 P=0.096 | |LOGISTIC REGRESSION| P=0.037N* P=0.058N P=0.013N* P=0.080N |P=0.045 * P=0.442 P=0.060 P=0.112 | |COCH-ARM / FISHERS | P=0.048N* P=0.054N P=0.013N* P=0.080N |P=0.049 * P=0.402 P=0.055 P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 13/50 (26%) 11/50 (22%) 13/50 (26%) 15/50 (30%) |7/50 (14%) 12/50 (24%) 23/50 (46%) 12/50 (24%) | |POLY-3 ADJUSTED (b)| 32.2% 29.3% 33.1% 34.0% |17.0% 28.0% 51.6% 29.1% | |TERMINAL (d) | 4/12 (33%) 7/16 (44%) 8/21 (38%) 12/31 (39%) |6/28 (21%) 12/33 (36%) 19/34 (56%) 10/28 (36%) | |FIRST INCIDENCE | 564 524 605 619 |698 738 (T) 451 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.067N P=0.313N P=0.291N P=0.088N |P=0.027 * P=0.255 P=0.003 ** P=0.141 | |POLY 3 | P=0.417 P=0.488N P=0.562 P=0.521 |P=0.027 * P=0.168 P<0.001 ** P=0.144 | |POLY 1.5 | P=0.363 P=0.450N P=0.576 P=0.471 |P=0.031 * P=0.156 P<0.001 ** P=0.149 | |POLY 6 | P=0.500 P=0.541N P=0.544 P=0.590 |P=0.022 * P=0.192 P<0.001 ** P=0.135 | |LOGISTIC REGRESSION| P=0.499N P=0.441N P=0.567N P=0.582 |P=0.024 * P=0.255 P<0.001 ** P=0.120 | |COCH-ARM / FISHERS | P=0.307 P=0.408N P=0.590N P=0.412 |P=0.037 * P=0.154 P<0.001 ** P=0.154 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 6/50 (12%) 8/50 (16%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 0.0% 2.7% 5.1% 9.2% |2.4% 14.0% 18.6% 17.2% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 4/31 (13%) |1/28 (4%) 6/33 (18%) 8/34 (24%) 7/28 (25%) | |FIRST INCIDENCE | --- 619 443 736 (T) |738 (T) 738 (T) 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.068 P=0.489 P=0.244 P=0.238 |P=0.020 * P=0.085 P=0.033 * P=0.029 * | |POLY 3 | P=0.028 * P=0.495 P=0.249 P=0.082 |P=0.024 * P=0.061 P=0.018 * P=0.028 * | |POLY 1.5 | P=0.024 * P=0.497 P=0.244 P=0.071 |P=0.025 * P=0.058 P=0.017 * P=0.029 * | |POLY 6 | P=0.038 * P=0.496 P=0.258 P=0.100 |P=0.022 * P=0.069 P=0.020 * P=0.025 * | |LOGISTIC REGRESSION| P=0.016 * P=0.506 P=0.198 P=0.238 |P=0.020 * P=0.085 P=0.033 * P=0.029 * | |COCH-ARM / FISHERS | P=0.019 * P=0.500 P=0.247 P=0.059 |P=0.027 * P=0.056 P=0.015 * P=0.030 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 27/50 (54%) 22/50 (44%) 25/50 (50%) |3/50 (6%) 7/50 (14%) 6/50 (12%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 46.2% 65.0% 51.8% 53.9% |7.3% 16.0% 13.6% 16.3% | |TERMINAL (d) | 6/12 (50%) 9/16 (56%) 9/21 (43%) 17/31 (55%) |3/28 (11%) 5/33 (15%) 4/34 (12%) 2/28 (7%) | |FIRST INCIDENCE | 647 563 521 544 |738 (T) 430 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.056N P=0.167 P=0.477N P=0.118N |P=0.158 P=0.223 P=0.327 P=0.163 | |POLY 3 | P=0.456 P=0.056 P=0.383 P=0.307 |P=0.183 P=0.182 P=0.276 P=0.173 | |POLY 1.5 | P=0.303 P=0.050 P=0.325 P=0.199 |P=0.175 P=0.168 P=0.261 P=0.168 | |POLY 6 | P=0.386N P=0.087 P=0.491 P=0.495 |P=0.191 P=0.205 P=0.296 P=0.180 | |LOGISTIC REGRESSION| P=0.377 P=0.024 * P=0.288 P=0.334 |P=0.160 P=0.166 P=0.248 P=0.158 | |COCH-ARM / FISHERS | P=0.171 P=0.054 P=0.270 P=0.113 |P=0.161 P=0.159 P=0.243 P=0.159 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |6/50 (12%) 1/50 (2%) 4/50 (8%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% 0.0% |14.5% 2.3% 9.3% 4.9% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |3/28 (11%) 0/33 (0%) 4/34 (12%) 1/28 (4%) | |FIRST INCIDENCE | --- 614 --- --- |698 698 738 (T) 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.474N P=0.489 (e) (e) |P=0.157N P=0.040N* P=0.273N P=0.154N | |POLY 3 | P=0.497N P=0.495 (e) (e) |P=0.157N P=0.050N P=0.347N P=0.134N | |POLY 1.5 | P=0.499N P=0.497 (e) (e) |P=0.152N P=0.054N P=0.357N P=0.133N | |POLY 6 | P=0.490N P=0.496 (e) (e) |P=0.168N P=0.044N* P=0.333N P=0.139N | |LOGISTIC REGRESSION| P=0.520N P=0.507 (e) (e) |P=0.153N P=0.049N* P=0.312N P=0.138N | |COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.152N P=0.056N P=0.370N P=0.134N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 30/50 (60%) 33/50 (66%) 36/50 (72%) 32/50 (64%) |11/50 (22%) 14/50 (28%) 17/50 (34%) 21/50 (42%) | |POLY-3 ADJUSTED (b)| 67.6% 74.9% 77.7% 67.1% |25.3% 31.4% 38.2% 45.1% | |TERMINAL (d) | 5/12 (42%) 11/16 (69%) 16/21 (76%) 19/31 (61%) |3/28 (11%) 6/33 (18%) 12/34 (35%) 9/28 (32%) | |FIRST INCIDENCE | 396 435 360 518 |475 535 535 444 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.013N* P=0.477 P=0.505N P=0.019N* |P=0.023 * P=0.474 P=0.273 P=0.046 * | |POLY 3 | P=0.528N P=0.291 P=0.188 P=0.569N |P=0.020 * P=0.346 P=0.140 P=0.037 * | |POLY 1.5 | P=0.423 P=0.309 P=0.170 P=0.524 |P=0.018 * P=0.326 P=0.135 P=0.032 * | |POLY 6 | P=0.401N P=0.280 P=0.206 P=0.475N |P=0.022 * P=0.383 P=0.146 P=0.042 * | |LOGISTIC REGRESSION| P=0.385 P=0.304 P=0.151 P=0.504 |P=0.015 * P=0.324 P=0.140 P=0.025 * | |COCH-ARM / FISHERS | P=0.297 P=0.339 P=0.146 P=0.418 |P=0.015 * P=0.322 P=0.133 P=0.026 * | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Myelofibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 5.5% 0.0% 2.3% |2.4% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 698 --- 708 |705 698 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.265N P=0.516 P=0.500N P=0.645N |P=0.176N P=0.722N P=0.470N P=0.513N | |POLY 3 | P=0.390N P=0.488 P=0.497N P=0.726N |P=0.174N P=0.752N P=0.492N P=0.502N | |POLY 1.5 | P=0.401N P=0.493 P=0.498N P=0.743N |P=0.172N P=0.757N P=0.496N P=0.501N | |POLY 6 | P=0.371N P=0.485 P=0.494N P=0.701N |P=0.177N P=0.742N P=0.486N P=0.506N | |LOGISTIC REGRESSION| P=0.346N P=0.487 P=0.496N P=0.742N |P=0.169N P=0.759N P=0.494N P=0.502N | |COCH-ARM / FISHERS | P=0.411N P=0.500 P=0.500N P=0.753N |P=0.170N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 6/50 (12%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 10.3% 0.0% 14.7% 4.5% |0.0% 2.3% 0.0% 4.7% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 564 --- 527 518 |--- 392 --- 444 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.428N P=0.080N P=0.388 P=0.235N |P=0.154 P=0.496 (e) P=0.237 | |POLY 3 | P=0.447N P=0.069N P=0.397 P=0.278N |P=0.156 P=0.512 (e) P=0.243 | |POLY 1.5 | P=0.496N P=0.065N P=0.385 P=0.305N |P=0.153 P=0.506 (e) P=0.242 | |POLY 6 | P=0.377N P=0.074N P=0.419 P=0.244N |P=0.160 P=0.521 (e) P=0.242 | |LOGISTIC REGRESSION| P=0.470 P=0.059N P=0.350 P=0.404N |P=0.054 P=0.735 (e) P=0.166 | |COCH-ARM / FISHERS | P=0.553N P=0.059N P=0.370 P=0.339N |P=0.149 P=0.500 (e) P=0.247 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |10/50 (20%) 12/50 (24%) 14/48 (29%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| |23.7% 27.4% 33.5% 25.7% | |TERMINAL (d) | |6/28 (21%) 10/33 (30%) 13/34 (38%) 6/28 (21%) | |FIRST INCIDENCE | |523 535 600 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.381 P=0.554 P=0.409 P=0.487 | |POLY 3 | |P=0.377 P=0.438 P=0.223 P=0.512 | |POLY 1.5 | |P=0.377 P=0.415 P=0.214 P=0.508 | |POLY 6 | |P=0.371 P=0.477 P=0.241 P=0.515 | |LOGISTIC REGRESSION| |P=0.362 P=0.435 P=0.253 P=0.497 | |COCH-ARM / FISHERS | |P=0.370 P=0.405 P=0.206 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/50 (8%) 11/50 (22%) 4/48 (8%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| |9.4% 24.1% 9.3% 12.0% | |TERMINAL (d) | |1/28 (4%) 6/33 (18%) 2/34 (6%) 3/28 (11%) | |FIRST INCIDENCE | |544 337 417 572 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.383N P=0.080 P=0.590N P=0.502 | |POLY 3 | |P=0.398N P=0.059 P=0.638N P=0.487 | |POLY 1.5 | |P=0.394N P=0.051 P=0.638 P=0.494 | |POLY 6 | |P=0.410N P=0.071 P=0.624N P=0.474 | |LOGISTIC REGRESSION| |P=0.408N P=0.045 * P=0.587 P=0.500 | |COCH-ARM / FISHERS | |P=0.395N P=0.045 * P=0.619 P=0.500 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Coagulating Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 715 736 (T) --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Granuloma Sperm | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% 0.0% | | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) | | |FIRST INCIDENCE | --- 507 --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.334N P=0.229 (e) (e) | | |POLY 3 | P=0.352N P=0.234 (e) (e) | | |POLY 1.5 | P=0.363N P=0.235 (e) (e) | | |POLY 6 | P=0.331N P=0.235 (e) (e) | | |LOGISTIC REGRESSION| P=0.403N P=0.247 (e) (e) | | |COCH-ARM / FISHERS | P=0.375N P=0.247 (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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Eye | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) |2/3 (67%) 0/3 (0%) 0/2 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |70.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/1 (0%) 0/3 (0%) |2/2 (100%) 0/2 (0%) 0/0 (0%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- |738 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.132N P=0.193N P=1.000N P=0.362N | |POLY 3 | (e) (e) (e) (e) |P=0.059N P=0.146N P=0.485N P=0.350N | |POLY 1.5 | (e) (e) (e) (e) |P=0.050N P=0.152N P=0.404N P=0.318N | |POLY 6 | (e) (e) (e) (e) |P=0.066N P=0.134N P=0.572N P=0.393N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.132N (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.066N P=0.200N P=0.300N P=0.300N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Cataract | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 3/4 (75%) 0/1 (0%) 3/3 (100%) |0/3 (0%) 2/3 (67%) 2/2 (100%) 2/2 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 77.1% 0.0% 100.0% |0.0% 70.3% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/1 (0%) 3/3 (100%) |0/2 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | 396 592 --- 736 (T) |--- 738 (T) 417 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.186N P=0.759N P=0.510N (e) |P=0.041 * P=0.193 P=0.262 P=0.161 | |POLY 3 | P=0.584 P=0.783N P=1.000N (e) |P<0.001 ** P=0.146 P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.569 P=0.766N P=1.000N (e) |P<0.001 ** P=0.152 P<0.001 ** P<0.001 ** | |POLY 6 | P=0.615 P=0.817N P=1.000N (e) |P<0.001 ** P=0.134 P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.351 (e) (e) (e) |P=0.028 * P=0.193 (e) P=0.174 | |COCH-ARM / FISHERS | P=0.550 P=0.800N P=0.500N (e) |P=0.015 * P=0.200 P=0.100 P=0.100 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Eye: Lens | | Synechia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/1 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) |0/3 (0%) 2/3 (67%) 0/2 (0%) 0/2 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 66.7% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/1 (0%) 0/3 (0%) |0/2 (0%) 1/2 (50%) 0/0 (0%) 0/1 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 698 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.503N P=0.257 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.698N P=0.172 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.606N P=0.165 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.626 P=0.185 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.610N P=0.186 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.471N P=0.200 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Eye: Retina | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/1 (100%) 4/4 (100%) 0/1 (0%) 3/3 (100%) |0/3 (0%) 3/3 (100%) 2/2 (100%) 2/2 (100%) | |POLY-3 ADJUSTED (b)| 100.0% 100.0% 0.0% 100.0% |0.0% 100.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 0/1 (0%) 3/3 (100%) |0/2 (0%) 2/2 (100%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | 396 592 --- 736 (T) |--- 698 417 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.119N (e) P=0.510N (e) |P=0.083 P=0.104 P=0.262 P=0.161 | |POLY 3 | P=1.000N (e) P=1.000N (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=1.000N (e) P=1.000N (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=1.000 (e) P=1.000N (e) |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.032 * P=0.051 (e) P=0.174 | |COCH-ARM / FISHERS | P=0.567N (e) P=0.500N (e) |P=0.016 * P=0.050 P=0.100 P=0.100 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 41/50 (82%) 41/50 (82%) 41/50 (82%) 44/50 (88%) |27/50 (54%) 31/50 (62%) 36/50 (72%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 87.8% 87.0% 89.0% 89.3% |58.9% 66.8% 79.6% 77.2% | |TERMINAL (d) | 12/12 (100%) 15/16 (94%) 21/21 (100%) 27/31 (87%) |15/28 (54%) 22/33 (67%) 29/34 (85%) 22/28 (79%) | |FIRST INCIDENCE | 396 410 360 213 |461 284 535 459 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.391N P=0.094N P<0.001N** |P=0.055 P=0.554 P=0.290 P=0.114 | |POLY 3 | P=0.411 P=0.588N P=0.565 P=0.541 |P=0.011 * P=0.280 P=0.021 * P=0.041 * | |POLY 1.5 | P=0.336 P=0.579N P=0.600 P=0.433 |P=0.017 * P=0.266 P=0.028 * P=0.053 | |POLY 6 | P=0.531 P=0.633N P=0.480 P=0.620N |P=0.006 ** P=0.313 P=0.017 * P=0.030 * | |LOGISTIC REGRESSION| P=0.334 P=0.580 P=0.580N P=0.356 |P=0.030 * P=0.278 P=0.060 P=0.071 | |COCH-ARM / FISHERS | P=0.248 P=0.602N P=0.602N P=0.288 |P=0.032 * P=0.272 P=0.048 * P=0.074 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Heart: Atrium | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 7/50 (14%) 4/50 (8%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 18.5% 18.4% 10.4% 4.6% |0.0% 2.3% 0.0% 0.0% | |TERMINAL (d) | 3/12 (25%) 1/16 (6%) 2/21 (10%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 684 507 640 708 |--- 620 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003N** P=0.532N P=0.109N P=0.004N** |P=0.509N P=0.514 (e) (e) | |POLY 3 | P=0.018N* P=0.611N P=0.242N P=0.048N* |P=0.502N P=0.510 (e) (e) | |POLY 1.5 | P=0.025N* P=0.613N P=0.251N P=0.061N |P=0.501N P=0.504 (e) (e) | |POLY 6 | P=0.011N* P=0.596N P=0.225N P=0.033N* |P=0.507N P=0.520 (e) (e) | |LOGISTIC REGRESSION| P=0.019N* P=0.588 P=0.210N P=0.017N* |P=0.507N P=0.508 (e) (e) | |COCH-ARM / FISHERS | P=0.037N* P=0.613N P=0.262N P=0.080N |P=0.500N P=0.500 (e) (e) | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 3/49 (6%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.7% 7.9% 2.6% 7.0% |0.0% 4.7% 2.3% 12.3% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 1/21 (5%) 1/30 (3%) |0/28 (0%) 2/33 (6%) 0/34 (0%) 5/28 (18%) | |FIRST INCIDENCE | 736 (T) 410 736 (T) 708 |--- 738 (T) 417 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.532 P=0.330 P=0.633N P=0.596 |P=0.016 * P=0.275 P=0.500 P=0.032 * | |POLY 3 | P=0.365 P=0.310 P=0.757N P=0.355 |P=0.018 * P=0.246 P=0.513 P=0.029 * | |POLY 1.5 | P=0.337 P=0.308 P=0.759N P=0.328 |P=0.018 * P=0.240 P=0.507 P=0.030 * | |POLY 6 | P=0.414 P=0.317 P=0.753N P=0.398 |P=0.019 * P=0.256 P=0.520 P=0.027 * | |LOGISTIC REGRESSION| P=0.279 P=0.325 P=0.633N P=0.439 |P=0.018 * P=0.275 P=0.541 P=0.032 * | |COCH-ARM / FISHERS | P=0.307 P=0.309 P=0.753N P=0.301 |P=0.018 * P=0.247 P=0.500 P=0.028 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 3/49 (6%) |2/50 (4%) 5/50 (10%) 8/50 (16%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.7% 13.1% 7.7% 7.0% |4.9% 11.7% 18.3% 12.1% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 3/30 (10%) |2/28 (7%) 5/33 (15%) 7/34 (21%) 2/28 (7%) | |FIRST INCIDENCE | 643 507 583 736 (T) |738 (T) 738 (T) 451 605 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.511N P=0.098 P=0.373 P=0.577 |P=0.116 P=0.284 P=0.081 P=0.216 | |POLY 3 | P=0.424 P=0.102 P=0.313 P=0.349 |P=0.124 P=0.231 P=0.055 P=0.218 | |POLY 1.5 | P=0.381 P=0.101 P=0.310 P=0.325 |P=0.125 P=0.222 P=0.051 P=0.218 | |POLY 6 | P=0.491 P=0.105 P=0.322 P=0.387 |P=0.121 P=0.250 P=0.061 P=0.216 | |LOGISTIC REGRESSION| P=0.321 P=0.111 P=0.308 P=0.391 |P=0.116 P=0.284 P=0.054 P=0.210 | |COCH-ARM / FISHERS | P=0.336 P=0.102 P=0.309 P=0.301 |P=0.123 P=0.218 P=0.046 * P=0.218 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/48 (2%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 2.5% | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 1/30 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) --- --- 736 (T) |--- --- --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.126N P=0.175N P=0.124N P=0.200N |P=0.178 (e) (e) P=0.500 | |POLY 3 | P=0.309N P=0.244N P=0.232N P=0.462N |P=0.194 (e) (e) P=0.498 | |POLY 1.5 | P=0.310N P=0.241N P=0.234N P=0.487N |P=0.190 (e) (e) P=0.499 | |POLY 6 | P=0.305N P=0.245N P=0.226N P=0.426N |P=0.200 (e) (e) P=0.495 | |LOGISTIC REGRESSION| P=0.126N (e) (e) P=0.200N |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P=0.309N P=0.247N P=0.247N P=0.515N |P=0.186 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 10.8% 2.6% 2.3% |2.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 1/31 (3%) |1/28 (4%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 681 507 736 (T) 736 (T) |738 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176N P=0.198 P=0.704N P=0.616N |P=0.176N P=0.467N P=0.461N P=0.500N | |POLY 3 | P=0.312N P=0.172 P=0.758N P=0.727N |P=0.192N P=0.492N P=0.491N P=0.502N | |POLY 1.5 | P=0.337N P=0.175 P=0.759N P=0.743N |P=0.188N P=0.497N P=0.495N P=0.501N | |POLY 6 | P=0.273N P=0.172 P=0.755N P=0.702N |P=0.199N P=0.483N P=0.485N P=0.505N | |LOGISTIC REGRESSION| P=0.330N P=0.176 P=0.751N P=0.719N |P=0.176N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.365N P=0.181 P=0.753N P=0.753N |P=0.185N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 50/50 (100%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |44/50 (88%) 46/50 (92%) 44/50 (88%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 100.0% 99.3% 100.0% 100.0% |95.7% 96.2% 92.8% 97.9% | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%)|28/28 (100%) 33/33 (100%) 34/34 (100%) 28/28 (100%) | |FIRST INCIDENCE | 396 410 360 518 |507 284 451 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.359N (e) P<0.001N** |P=0.293 P=0.267N P=0.126N P=0.279 | |POLY 3 | P=0.856 P=0.981N (e) P=1.000N |P=0.442 P=0.705 P=0.420N P=0.478 | |POLY 1.5 | P=0.757 P=0.774N (e) P=1.000N |P=0.284 P=0.504 P=0.526N P=0.256 | |POLY 6 | P=1.000 P=1.000N (e) P=1.000N |P=0.544N P=0.678N P=0.292N P=0.883 | |LOGISTIC REGRESSION| P=0.538N P=0.506N (e) (e) |P=0.182 P=0.259 P=0.522N P=0.118 | |COCH-ARM / FISHERS | P=0.375N P=0.500N (e) P=0.500N |P=0.160 P=0.370 P=0.620N P=0.134 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 48/50 (96%) 49/50 (98%) 50/50 (100%)|48/50 (96%) 48/50 (96%) 50/50 (100%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 98.7% 98.4% 99.8% 100.0% |98.4% 99.6% 100.0% 100.0% | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 21/21 (100%) 31/31 (100%)|28/28 (100%) 33/33 (100%) 34/34 (100%) 28/28 (100%) | |FIRST INCIDENCE | 396 410 443 213 |391 337 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.353N P=0.114N P<0.001N** |P=0.350 P=0.179N P=0.246N P=0.408 | |POLY 3 | P=0.207 P=0.832N P=0.748 P=0.690 |P=0.114 P=0.759 P=0.636 P=0.636 | |POLY 1.5 | P=0.204 P=0.685N P=0.725 P=0.588 |P=0.063 P=0.649 P=0.384 P=0.384 | |POLY 6 | P=0.292 P=0.953 P=0.899 P=0.892 |P=0.508 P=0.998 P=0.997 P=0.997 | |LOGISTIC REGRESSION| P=0.261 P=0.522N P=0.744N P=0.520 |P=0.057 P=0.493 P=0.243 P=0.249 | |COCH-ARM / FISHERS | P=0.249 P=0.500N P=0.753N P=0.500 |P=0.057 P=0.691N P=0.247 P=0.247 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% 2.3% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 647 --- 736 (T) 736 (T) |--- --- --- 613 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.237N P=0.241N P=0.422N P=0.312N |P=0.179 (e) (e) P=0.495 | |POLY 3 | P=0.384N P=0.246N P=0.497N P=0.451N |P=0.192 (e) (e) P=0.500 | |POLY 1.5 | P=0.397N P=0.243N P=0.498N P=0.473N |P=0.189 (e) (e) P=0.501 | |POLY 6 | P=0.362N P=0.250N P=0.493N P=0.418N |P=0.197 (e) (e) P=0.499 | |LOGISTIC REGRESSION| P=0.334N P=0.244N P=0.487N P=0.449N |P=0.177 (e) (e) P=0.495 | |COCH-ARM / FISHERS | P=0.411N P=0.247N P=0.500N P=0.500N |P=0.185 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 17/50 (34%) 14/50 (28%) 20/50 (40%) 16/50 (32%) |41/50 (82%) 42/50 (84%) 44/50 (88%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 42.0% 37.9% 49.6% 36.2% |86.2% 92.9% 93.8% 79.0% | |TERMINAL (d) | 10/12 (83%) 12/16 (75%) 16/21 (76%) 14/31 (45%) |27/28 (96%) 33/33 (100%) 34/34 (100%) 25/28 (89%) | |FIRST INCIDENCE | 396 563 360 544 |391 522 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.091N P=0.197N P=0.002N** |P=0.159N P=0.220N P=0.302N P=0.186N | |POLY 3 | P=0.424N P=0.442N P=0.314 P=0.368N |P=0.195N P=0.213 P=0.154 P=0.237N | |POLY 1.5 | P=0.517N P=0.396N P=0.325 P=0.436N |P=0.138N P=0.286 P=0.203 P=0.175N | |POLY 6 | P=0.272N P=0.488N P=0.310 P=0.261N |P=0.319N P=0.191 P=0.119 P=0.345N | |LOGISTIC REGRESSION| P=0.309N P=0.381N P=0.358 P=0.339N |P=0.076N P=0.501 P=0.332 P=0.107N | |COCH-ARM / FISHERS | P=0.447 P=0.333N P=0.339 P=0.500N |P=0.113N P=0.500 P=0.288 P=0.121N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 7/50 (14%) 5/50 (10%) |11/50 (22%) 10/50 (20%) 8/50 (16%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 16.0% 5.5% 18.3% 11.5% |26.8% 23.4% 18.6% 7.4% | |TERMINAL (d) | 6/12 (50%) 2/16 (13%) 7/21 (33%) 5/31 (16%) |11/28 (39%) 10/33 (30%) 8/34 (24%) 3/28 (11%) | |FIRST INCIDENCE | 736 (T) 736 (T) 736 (T) 736 (T) |738 (T) 738 (T) 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.070N P=0.043N* P=0.287N P=0.031N* |P=0.008N** P=0.322N P=0.146N P=0.016N* | |POLY 3 | P=0.509N P=0.139N P=0.516 P=0.393N |P=0.014N* P=0.458N P=0.262N P=0.018N* | |POLY 1.5 | P=0.527 P=0.137N P=0.509 P=0.443N |P=0.014N* P=0.485N P=0.282N P=0.019N* | |POLY 6 | P=0.420N P=0.138N P=0.535 P=0.320N |P=0.015N* P=0.411N P=0.235N P=0.018N* | |LOGISTIC REGRESSION| P=0.070N P=0.043N* P=0.287N P=0.031N* |P=0.008N** P=0.322N P=0.146N P=0.016N* | |COCH-ARM / FISHERS | P=0.458 P=0.134N P=0.500 P=0.500N |P=0.016N* P=0.500N P=0.306N P=0.020N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 9/50 (18%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 5.3% 5.5% 2.6% 20.4% |4.8% 2.3% 2.3% 7.3% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 1/21 (5%) 7/31 (23%) |1/28 (4%) 1/33 (3%) 1/34 (3%) 2/28 (7%) | |FIRST INCIDENCE | 619 649 736 (T) 605 |620 738 (T) 738 (T) 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.099 P=0.672N P=0.393N P=0.243 |P=0.359 P=0.454N P=0.452N P=0.491 | |POLY 3 | P=0.011 * P=0.682 P=0.497N P=0.045 * |P=0.367 P=0.489N P=0.488N P=0.495 | |POLY 1.5 | P=0.009 ** P=0.687 P=0.498N P=0.035 * |P=0.368 P=0.497N P=0.493N P=0.499 | |POLY 6 | P=0.014 * P=0.679 P=0.493N P=0.065 |P=0.366 P=0.477N P=0.480N P=0.488 | |LOGISTIC REGRESSION| P=0.025 * P=0.684 P=0.489N P=0.057 |P=0.363 P=0.495N P=0.493N P=0.498 | |COCH-ARM / FISHERS | P=0.009 ** P=0.691N P=0.500N P=0.026 * |P=0.365 P=0.500N P=0.500N P=0.500 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 7/50 (14%) 6/50 (12%) 8/50 (16%) |9/50 (18%) 4/50 (8%) 7/50 (14%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 18.6% 15.1% 17.7% |21.1% 9.0% 15.8% 7.3% | |TERMINAL (d) | 0/12 (0%) 3/16 (19%) 3/21 (14%) 5/31 (16%) |6/28 (21%) 2/33 (6%) 5/34 (15%) 2/28 (7%) | |FIRST INCIDENCE | --- 505 521 213 |475 337 417 704 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.121 P=0.015 * P=0.039 * P=0.043 * |P=0.080N P=0.089N P=0.285N P=0.068N | |POLY 3 | P=0.028 * P=0.007 ** P=0.018 * P=0.008 ** |P=0.096N P=0.097N P=0.360N P=0.067N | |POLY 1.5 | P=0.019 * P=0.007 ** P=0.017 * P=0.006 ** |P=0.089N P=0.106N P=0.374N P=0.063N | |POLY 6 | P=0.050 P=0.007 ** P=0.020 * P=0.014 * |P=0.108N P=0.086N P=0.341N P=0.073N | |LOGISTIC REGRESSION| P=0.009 ** P=0.008 ** P=0.017 * P=0.003 ** |P=0.085N P=0.112N P=0.402N P=0.062N | |COCH-ARM / FISHERS | P=0.012 * P=0.006 ** P=0.013 * P=0.003 ** |P=0.083N P=0.117N P=0.393N P=0.061N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 16/50 (32%) 22/50 (44%) 22/50 (44%) |31/50 (62%) 36/50 (72%) 33/50 (66%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 51.3% 40.0% 52.0% 48.9% |69.4% 78.5% 73.5% 62.9% | |TERMINAL (d) | 9/12 (75%) 9/16 (56%) 13/21 (62%) 19/31 (61%) |22/28 (79%) 29/33 (88%) 28/34 (82%) 19/28 (68%) | |FIRST INCIDENCE | 396 428 360 544 |507 284 399 592 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010N* P=0.080N P=0.156N P=0.003N** |P=0.180N P=0.557 P=0.323N P=0.306N | |POLY 3 | P=0.485 P=0.197N P=0.564 P=0.494N |P=0.230N P=0.217 P=0.421 P=0.329N | |POLY 1.5 | P=0.423 P=0.178N P=0.567 P=0.545N |P=0.197N P=0.197 P=0.420 P=0.298N | |POLY 6 | P=0.468N P=0.215N P=0.579 P=0.401N |P=0.290N P=0.263 P=0.428 P=0.382N | |LOGISTIC REGRESSION| P=0.457 P=0.152N P=0.576N P=0.507N |P=0.164N P=0.211 P=0.515 P=0.270N | |COCH-ARM / FISHERS | P=0.374 P=0.151N P=0.580N P=0.580N |P=0.179N P=0.198 P=0.418 P=0.272N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |7/50 (14%) 7/50 (14%) 5/50 (10%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 2.6% 2.3% |17.0% 16.4% 11.6% 4.9% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |7/28 (25%) 7/33 (21%) 5/34 (15%) 2/28 (7%) | |FIRST INCIDENCE | 736 (T) --- 645 736 (T) |738 (T) 738 (T) 738 (T) 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.532N P=0.443N P=0.711N P=0.537N |P=0.037N* P=0.482N P=0.244N P=0.075N | |POLY 3 | P=0.555 P=0.507N P=0.755N P=0.726N |P=0.048N* P=0.583N P=0.346N P=0.078N | |POLY 1.5 | P=0.529 P=0.504N P=0.758N P=0.742N |P=0.048N* P=0.603N P=0.362N P=0.078N | |POLY 6 | P=0.593 P=0.509N P=0.749N P=0.699N |P=0.051N P=0.549N P=0.324N P=0.080N | |LOGISTIC REGRESSION| P=0.564 (e) P=0.757N P=0.537N |P=0.037N* P=0.482N P=0.244N P=0.075N | |COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.753N P=0.753N |P=0.049N* P=0.613N P=0.380N P=0.080N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation Bile | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 2.3% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 620 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.508N P=0.271 P=0.539 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.504N P=0.249 P=0.509 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.501N P=0.242 P=0.505 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.512N P=0.261 P=0.515 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.500N P=0.237 P=0.539 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.247 P=0.500 (e) | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.8% 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- --- --- |391 698 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.060N P=0.462N P=0.220N P=0.243N | |POLY 3 | (e) (e) (e) (e) |P=0.061N P=0.493N P=0.232N P=0.244N | |POLY 1.5 | (e) (e) (e) (e) |P=0.060N P=0.499N P=0.235N P=0.241N | |POLY 6 | (e) (e) (e) (e) |P=0.063N P=0.479N P=0.227N P=0.249N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.062N P=0.476N P=0.246N P=0.248N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.059N P=0.500N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 49/50 (98%) 47/50 (94%) 46/50 (92%) 48/50 (96%) |24/50 (48%) 18/50 (36%) 22/50 (44%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 99.1% 95.4% 94.6% 99.1% |56.1% 39.5% 46.8% 44.3% | |TERMINAL (d) | 12/12 (100%) 16/16 (100%) 20/21 (95%) 31/31 (100%)|16/28 (57%) 10/33 (30%) 13/34 (38%) 14/28 (50%) | |FIRST INCIDENCE | 396 410 443 518 |585 430 535 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.313N P=0.062N P<0.001N** |P=0.280N P=0.073N P=0.218N P=0.238N | |POLY 3 | P=0.546N P=0.286N P=0.217N P=0.949 |P=0.240N P=0.083N P=0.249N P=0.183N | |POLY 1.5 | P=0.498N P=0.291N P=0.205N P=0.820N |P=0.242N P=0.113N P=0.320N P=0.190N | |POLY 6 | P=0.565N P=0.292N P=0.227N P=1.000 |P=0.250N P=0.054N P=0.175N P=0.189N | |LOGISTIC REGRESSION| P=0.229N P=0.311N P=0.165N P=0.407N |P=0.258N P=0.131N P=0.377N P=0.214N | |COCH-ARM / FISHERS | P=0.332N P=0.309N P=0.181N P=0.500N |P=0.261N P=0.156N P=0.421N P=0.210N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 22/50 (44%) 28/50 (56%) 39/50 (78%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 40.1% 55.6% 65.2% 81.7% |0.0% 0.0% 0.0% 2.5% | |TERMINAL (d) | 4/12 (33%) 11/16 (69%) 14/21 (67%) 24/31 (77%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | 576 507 527 561 |--- --- --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176 P=0.289 P=0.182 P=0.218 |P=0.178 (e) (e) P=0.500 | |POLY 3 | P<0.001 ** P=0.111 P=0.013 * P<0.001 ** |P=0.193 (e) (e) P=0.498 | |POLY 1.5 | P<0.001 ** P=0.127 P=0.012 * P<0.001 ** |P=0.189 (e) (e) P=0.499 | |POLY 6 | P<0.001 ** P=0.097 P=0.018 * P<0.001 ** |P=0.199 (e) (e) P=0.495 | |LOGISTIC REGRESSION| P<0.001 ** P=0.102 P=0.013 * P<0.001 ** |(e) (e) (e) P=0.500 | |COCH-ARM / FISHERS | P<0.001 ** P=0.151 P=0.013 * P<0.001 ** |P=0.185 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.8% 0.0% 5.2% 2.3% |0.0% 2.3% 4.7% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 2/34 (6%) 0/28 (0%) | |FIRST INCIDENCE | 535 --- 521 736 (T) |--- 337 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176N P=0.139N P=0.451N P=0.188N |P=0.502 P=0.496 P=0.282 (e) | |POLY 3 | P=0.248N P=0.130N P=0.498N P=0.263N |P=0.496 P=0.512 P=0.247 (e) | |POLY 1.5 | P=0.267N P=0.125N P=0.498N P=0.282N |P=0.499 P=0.506 P=0.242 (e) | |POLY 6 | P=0.221N P=0.135N P=0.495N P=0.236N |P=0.488 P=0.521 P=0.254 (e) | |LOGISTIC REGRESSION| P=0.315N P=0.113N P=0.511N P=0.339N |P=0.483 P=0.905 P=0.282 (e) | |COCH-ARM / FISHERS | P=0.289N P=0.121N P=0.500N P=0.309N |P=0.500 P=0.500 P=0.247 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 3/50 (6%) 5/50 (10%) 7/50 (14%) |7/50 (14%) 2/50 (4%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 24.6% 8.0% 13.0% 15.7% |16.8% 4.5% 2.3% 7.3% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 4/21 (19%) 6/31 (19%) |3/28 (11%) 0/33 (0%) 1/34 (3%) 1/28 (4%) | |FIRST INCIDENCE | 396 450 676 213 |645 337 738 (T) 613 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.053N P=0.050N P=0.071N P=0.051N |P=0.067N P=0.065N P=0.022N* P=0.188N | |POLY 3 | P=0.224N P=0.044N* P=0.149N P=0.224N |P=0.063N P=0.064N P=0.026N* P=0.158N | |POLY 1.5 | P=0.250N P=0.040N* P=0.141N P=0.254N |P=0.061N P=0.071N P=0.028N* P=0.157N | |POLY 6 | P=0.189N P=0.050N P=0.160N P=0.187N |P=0.066N P=0.056N P=0.024N* P=0.163N | |LOGISTIC REGRESSION| P=0.315N P=0.031N* P=0.130N P=0.385N |P=0.063N P=0.080N P=0.026N* P=0.161N | |COCH-ARM / FISHERS | P=0.283N P=0.036N* P=0.131N P=0.298N |P=0.062N P=0.080N P=0.030N* P=0.159N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 2.8% 2.6% 2.3% |0.0% 0.0% 2.3% 2.5% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | 617 726 593 621 |--- --- 733 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.235N P=0.488N P=0.466N P=0.387N |P=0.164 (e) P=0.545 P=0.500 | |POLY 3 | P=0.308N P=0.516N P=0.493N P=0.448N |P=0.171 (e) P=0.509 P=0.498 | |POLY 1.5 | P=0.325N P=0.509N P=0.496N P=0.472N |P=0.172 (e) P=0.505 P=0.499 | |POLY 6 | P=0.283N P=0.522N P=0.486N P=0.413N |P=0.170 (e) P=0.515 P=0.495 | |LOGISTIC REGRESSION| P=0.351N P=0.512N P=0.503N P=0.526N |P=0.156 (e) P=0.524 P=0.500 | |COCH-ARM / FISHERS | P=0.343N P=0.500N P=0.500N P=0.500N |P=0.170 (e) P=0.500 P=0.500 | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Liver: Hepatocyte, Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 5.3% 10.7% 2.6% 4.6% |4.7% 0.0% 4.6% 0.0% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 729 410 640 708 |391 --- 399 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.181N P=0.390 P=0.400N P=0.381N |P=0.241N P=0.244N P=0.668N P=0.230N | |POLY 3 | P=0.325N P=0.335 P=0.490N P=0.637N |P=0.265N P=0.235N P=0.683N P=0.246N | |POLY 1.5 | P=0.351N P=0.336 P=0.495N P=0.664N |P=0.256N P=0.239N P=0.688N P=0.242N | |POLY 6 | P=0.283N P=0.340 P=0.480N P=0.595N |P=0.282N P=0.229N P=0.675N P=0.253N | |LOGISTIC REGRESSION| P=0.367N P=0.333 P=0.485N P=0.515N |P=0.283N P=0.125N P=0.687 P=0.250N | |COCH-ARM / FISHERS | P=0.380N P=0.339 P=0.500N P=0.691N |P=0.249N P=0.247N P=0.691N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 4/50 (8%) |12/50 (24%) 12/50 (24%) 17/50 (34%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 7.7% 0.0% 13.0% 9.2% |27.9% 27.4% 39.6% 36.1% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 4/21 (19%) 4/31 (13%) |7/28 (25%) 10/33 (30%) 17/34 (50%) 13/28 (46%) | |FIRST INCIDENCE | 396 --- 676 736 (T) |523 522 738 (T) 605 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.510 P=0.126N P=0.533 P=0.478N |P=0.168 P=0.447N P=0.362 P=0.315 | |POLY 3 | P=0.238 P=0.131N P=0.348 P=0.563 |P=0.137 P=0.575N P=0.176 P=0.279 | |POLY 1.5 | P=0.206 P=0.126N P=0.351 P=0.533 |P=0.158 P=0.590N P=0.181 P=0.303 | |POLY 6 | P=0.292 P=0.135N P=0.351 P=0.610 |P=0.106 P=0.547N P=0.170 P=0.241 | |LOGISTIC REGRESSION| P=0.221 P=0.106N P=0.358 P=0.476 |P=0.160 P=0.577N P=0.235 P=0.311 | |COCH-ARM / FISHERS | P=0.176 P=0.121N P=0.357 P=0.500 |P=0.180 P=0.592N P=0.189 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 2/50 (4%) |5/50 (10%) 2/50 (4%) 5/50 (10%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.7% 13.5% 7.8% 4.6% |12.1% 4.7% 11.6% 7.2% | |TERMINAL (d) | 1/12 (8%) 3/16 (19%) 2/21 (10%) 2/31 (7%) |4/28 (14%) 1/33 (3%) 4/34 (12%) 1/28 (4%) | |FIRST INCIDENCE | 736 (T) 435 593 736 (T) |645 731 690 588 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.249N P=0.153 P=0.459 P=0.672N |P=0.404N P=0.164N P=0.525N P=0.360N | |POLY 3 | P=0.519N P=0.096 P=0.316 P=0.553 |P=0.406N P=0.202N P=0.605N P=0.352N | |POLY 1.5 | P=0.557 P=0.099 P=0.311 P=0.528 |P=0.402N P=0.211N P=0.617N P=0.353N | |POLY 6 | P=0.449N P=0.095 P=0.327 P=0.589 |P=0.418N P=0.187N P=0.587N P=0.354N | |LOGISTIC REGRESSION| P=0.536N P=0.096 P=0.318 P=0.672N |P=0.408N P=0.182N P=0.582N P=0.357N | |COCH-ARM / FISHERS | P=0.500 P=0.102 P=0.309 P=0.500 |P=0.405N P=0.218N P=0.630N P=0.357N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 39/50 (78%) 37/50 (74%) 39/50 (78%) 40/50 (80%) |41/50 (82%) 42/50 (84%) 45/50 (90%) 46/50 (92%) | |POLY-3 ADJUSTED (b)| 84.4% 81.9% 84.1% 86.4% |89.0% 90.5% 93.8% 96.0% | |TERMINAL (d) | 10/12 (83%) 11/16 (69%) 18/21 (86%) 28/31 (90%) |28/28 (100%) 32/33 (97%) 33/34 (97%) 28/28 (100%) | |FIRST INCIDENCE | 396 435 443 544 |461 430 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.344N P=0.143N P<0.001N** |P=0.150 P=0.221N P=0.365N P=0.218 | |POLY 3 | P=0.391 P=0.481N P=0.608N P=0.508 |P=0.071 P=0.548 P=0.301 P=0.138 | |POLY 1.5 | P=0.378 P=0.459N P=0.604N P=0.492 |P=0.065 P=0.489 P=0.248 P=0.128 | |POLY 6 | P=0.392 P=0.474N P=0.616N P=0.524 |P=0.072 P=0.668N P=0.386 P=0.151 | |LOGISTIC REGRESSION| P=0.449N P=0.452N P=0.577N P=0.427N |P=0.055 P=0.510 P=0.228 P=0.106 | |COCH-ARM / FISHERS | P=0.381 P=0.408N P=0.595N P=0.500 |P=0.055 P=0.500 P=0.194 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.2% 2.3% |2.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 666 736 (T) |698 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.285 (e) P=0.300 P=0.689 |P=0.191N P=0.468N P=0.489N P=0.525N | |POLY 3 | P=0.200 (e) P=0.242 P=0.530 |P=0.191N P=0.497N P=0.492N P=0.503N | |POLY 1.5 | P=0.175 (e) P=0.240 P=0.516 |P=0.187N P=0.502N P=0.496N P=0.501N | |POLY 6 | P=0.241 (e) P=0.248 P=0.551 |P=0.198N P=0.490N P=0.486N P=0.506N | |LOGISTIC REGRESSION| P=0.202 (e) P=0.246 P=0.689 |P=0.184N P=0.502N P=0.496N P=0.501N | |COCH-ARM / FISHERS | P=0.149 (e) P=0.247 P=0.500 |P=0.185N P=0.505N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.9% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 3/21 (14%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) 736 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.491N P=0.557 P=0.232 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.519 P=0.493 P=0.121 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.468 P=0.496 P=0.120 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.592 P=0.491 P=0.124 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.557 P=0.232 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.411 P=0.500 P=0.121 (e) |(e) (e) (e) (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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/50 (50%) 19/50 (38%) 23/50 (46%) 36/50 (72%) |30/50 (60%) 22/50 (44%) 21/50 (42%) 24/50 (48%) | |POLY-3 ADJUSTED (b)| 58.0% 46.6% 55.8% 77.6% |66.1% 48.4% 43.9% 52.9% | |TERMINAL (d) | 5/12 (42%) 7/16 (44%) 11/21 (52%) 25/31 (81%) |18/28 (64%) 14/33 (42%) 11/34 (32%) 13/28 (46%) | |FIRST INCIDENCE | 396 507 593 605 |507 337 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211N P=0.156N P=0.147N P=0.127N |P=0.172N P=0.038N* P=0.032N* P=0.223N | |POLY 3 | P=0.011 * P=0.194N P=0.507N P=0.029 * |P=0.096N P=0.064N P=0.022N* P=0.137N | |POLY 1.5 | P=0.009 ** P=0.177N P=0.470N P=0.021 * |P=0.102N P=0.071N P=0.031N* P=0.140N | |POLY 6 | P=0.018 * P=0.215N P=0.545N P=0.052 |P=0.097N P=0.055N P=0.017N* P=0.146N | |LOGISTIC REGRESSION| P=0.042 * P=0.169N P=0.394N P=0.057 |P=0.127N P=0.073N P=0.059N P=0.158N | |COCH-ARM / FISHERS | P=0.011 * P=0.157N P=0.421N P=0.020 * |P=0.127N P=0.080N P=0.055N P=0.158N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 4.7% |0.0% 0.0% 7.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/30 (3%) |0/28 (0%) 0/33 (0%) 3/34 (9%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 666 684 |--- --- 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.118 (e) P=0.500 P=0.385 |P=0.297 (e) P=0.157 (e) | |POLY 3 | P=0.074 (e) P=0.505 P=0.268 |P=0.287 (e) P=0.126 (e) | |POLY 1.5 | P=0.066 (e) P=0.503 P=0.251 |P=0.294 (e) P=0.123 (e) | |POLY 6 | P=0.088 (e) P=0.511 P=0.295 |P=0.274 (e) P=0.132 (e) | |LOGISTIC REGRESSION| P=0.071 (e) P=0.501 P=0.280 |(e) (e) P=0.157 (e) | |COCH-ARM / FISHERS | P=0.058 (e) P=0.500 P=0.242 |P=0.301 (e) P=0.121 (e) | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/47 (0%) 1/50 (2%) 1/49 (2%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 2.3% |4.9% 4.7% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |2/28 (7%) 1/33 (3%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 722 736 (T) |738 (T) 731 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.292 (e) P=0.560 P=0.689 |P=0.051N P=0.634N P=0.196N P=0.238N | |POLY 3 | P=0.213 (e) P=0.508 P=0.531 |P=0.057N P=0.680N P=0.227N P=0.239N | |POLY 1.5 | P=0.194 (e) P=0.506 P=0.517 |P=0.056N P=0.689N P=0.232N P=0.238N | |POLY 6 | P=0.244 (e) P=0.513 P=0.553 |P=0.057N P=0.664N P=0.220N P=0.242N | |LOGISTIC REGRESSION| P=0.253 (e) P=0.527 P=0.689 |P=0.052N P=0.635N (e) (e) | |COCH-ARM / FISHERS | P=0.173 (e) P=0.505 P=0.500 |P=0.057N P=0.691N P=0.247N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 36/49 (73%) 34/47 (72%) 24/50 (48%) 28/49 (57%) |43/50 (86%) 44/50 (88%) 45/50 (90%) 42/50 (84%) | |POLY-3 ADJUSTED (b)| 79.7% 79.9% 56.7% 62.6% |88.2% 93.4% 94.3% 86.4% | |TERMINAL (d) | 8/12 (67%) 11/16 (69%) 11/21 (52%) 20/31 (65%) |24/28 (86%) 32/33 (97%) 32/34 (94%) 24/28 (86%) | |FIRST INCIDENCE | 396 524 443 561 |461 392 451 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.346N P=0.005N** P<0.001N** |P=0.476N P=0.267N P=0.288N P=0.513N | |POLY 3 | P=0.006N** P=0.602 P=0.011N* P=0.049N* |P=0.448N P=0.292 P=0.232 P=0.516N | |POLY 1.5 | P=0.007N** P=0.592N P=0.008N** P=0.057N |P=0.429N P=0.342 P=0.276 P=0.495N | |POLY 6 | P=0.006N** P=0.610 P=0.020N* P=0.043N* |P=0.512N P=0.272 P=0.213 P=0.574N | |LOGISTIC REGRESSION| P=0.002N** P=0.537N P=0.007N** P=0.029N* |P=0.437N P=0.481 P=0.420 P=0.500N | |COCH-ARM / FISHERS | P=0.011N* P=0.542N P=0.008N** P=0.068N |P=0.463N P=0.500 P=0.380 P=0.500N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/15 (80%) 8/12 (67%) 8/15 (53%) 8/11 (73%) |3/8 (38%) 0/1 (0%) 3/5 (60%) 1/5 (20%) | |POLY-3 ADJUSTED (b)| 83.4% 73.2% 60.3% 77.5% |42.2% 0.0% 71.7% 25.2% | |TERMINAL (d) | 3/3 (100%) 0/1 (0%) 3/6 (50%) 5/5 (100%) |2/5 (40%) 0/1 (0%) 2/2 (100%) 1/2 (50%) | |FIRST INCIDENCE | 593 534 563 610 |391 --- 684 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016N* P=0.393N P=0.091N P=0.025N* |P=0.491 P=0.322N P=0.358 P=0.575N | |POLY 3 | P=0.285N P=0.443N P=0.158N P=0.560N |P=0.571N P=0.611N P=0.367 P=0.532N | |POLY 1.5 | P=0.275N P=0.408N P=0.140N P=0.542N |P=0.525N P=0.620N P=0.396 P=0.503N | |POLY 6 | P=0.293N P=0.495N P=0.188N P=0.574N |P=0.515 P=0.599N P=0.308 P=0.591N | |LOGISTIC REGRESSION| P=0.243N P=0.302N P=0.119N P=0.497N |P=0.479N P=0.714N P=0.419 P=0.495N | |COCH-ARM / FISHERS | P=0.258N P=0.364N P=0.123N P=0.509N |P=0.488N P=0.667N P=0.413 P=0.490N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose | | Fungus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 21/50 (42%) 15/50 (30%) 10/50 (20%) 11/50 (22%) |6/50 (12%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 49.1% 36.9% 24.9% 24.2% |13.9% 4.6% 2.3% 0.0% | |TERMINAL (d) | 6/12 (50%) 3/16 (19%) 5/21 (24%) 6/31 (19%) |1/28 (4%) 0/33 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE | 396 450 557 544 |461 337 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.157N P=0.004N** P<0.001N** |P=0.003N** P=0.123N P=0.051N P=0.021N* | |POLY 3 | P=0.003N** P=0.174N P=0.016N* P=0.011N* |P=0.003N** P=0.127N P=0.056N P=0.018N* | |POLY 1.5 | P=0.005N** P=0.164N P=0.015N* P=0.016N* |P=0.003N** P=0.132N P=0.056N P=0.017N* | |POLY 6 | P=0.002N** P=0.175N P=0.017N* P=0.006N** |P=0.003N** P=0.119N P=0.054N P=0.020N* | |LOGISTIC REGRESSION| P=0.009N** P=0.146N P=0.015N* P=0.033N* |P=0.003N** P=0.109N P=0.064N P=0.017N* | |COCH-ARM / FISHERS | P=0.009N** P=0.149N P=0.015N* P=0.026N* |P=0.003N** P=0.134N P=0.056N P=0.013N* | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 25/50 (50%) 19/50 (38%) 22/50 (44%) 18/50 (36%) |13/50 (26%) 13/50 (26%) 7/50 (14%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 57.5% 46.7% 52.8% 39.5% |29.9% 28.9% 16.1% 14.4% | |TERMINAL (d) | 7/12 (58%) 7/16 (44%) 13/21 (62%) 11/31 (36%) |7/28 (25%) 8/33 (24%) 6/34 (18%) 4/28 (14%) | |FIRST INCIDENCE | 396 450 521 544 |461 337 544 571 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.142N P=0.075N P<0.001N** |P=0.020N* P=0.450N P=0.062N P=0.072N | |POLY 3 | P=0.068N P=0.208N P=0.408N P=0.061N |P=0.021N* P=0.555N P=0.098N P=0.069N | |POLY 1.5 | P=0.097N P=0.185N P=0.379N P=0.083N |P=0.020N* P=0.577N P=0.101N P=0.065N | |POLY 6 | P=0.038N* P=0.230N P=0.443N P=0.037N* |P=0.025N* P=0.517N P=0.093N P=0.077N | |LOGISTIC REGRESSION| P=0.087N P=0.166N P=0.328N P=0.097N |P=0.019N* P=0.588 P=0.103N P=0.063N | |COCH-ARM / FISHERS | P=0.138N P=0.157N P=0.344N P=0.113N |P=0.019N* P=0.590N P=0.105N P=0.062N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 6/50 (12%) 5/50 (10%) |9/50 (18%) 6/50 (12%) 10/50 (20%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 15.7% 16.3% 14.9% 11.5% |21.2% 13.9% 22.6% 14.2% | |TERMINAL (d) | 1/12 (8%) 2/16 (13%) 2/21 (10%) 4/31 (13%) |5/28 (18%) 4/33 (12%) 6/34 (18%) 3/28 (11%) | |FIRST INCIDENCE | 617 631 482 712 |523 701 600 459 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.093N P=0.544N P=0.469N P=0.118N |P=0.368N P=0.200N P=0.554N P=0.301N | |POLY 3 | P=0.311N P=0.595 P=0.586N P=0.406N |P=0.361N P=0.276N P=0.538 P=0.286N | |POLY 1.5 | P=0.361N P=0.606 P=0.600N P=0.449N |P=0.357N P=0.287N P=0.520 P=0.285N | |POLY 6 | P=0.243N P=0.588 P=0.563N P=0.346N |P=0.377N P=0.255N P=0.567 P=0.295N | |LOGISTIC REGRESSION| P=0.328N P=0.595 P=0.620N P=0.308N |P=0.363N P=0.269N P=0.516 P=0.287N | |COCH-ARM / FISHERS | P=0.421N P=0.620N P=0.620N P=0.500N |P=0.363N P=0.288N P=0.500 P=0.288N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 24/50 (48%) 16/50 (32%) 17/50 (34%) 13/50 (26%) |10/50 (20%) 3/50 (6%) 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 56.1% 40.1% 41.9% 28.9% |23.2% 7.0% 4.7% 9.7% | |TERMINAL (d) | 7/12 (58%) 5/16 (31%) 10/21 (48%) 8/31 (26%) |5/28 (18%) 2/33 (6%) 2/34 (6%) 2/28 (7%) | |FIRST INCIDENCE | 396 507 527 610 |461 700 738 (T) 586 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.080N P=0.019N* P<0.001N** |P=0.026N* P=0.026N* P=0.010N* P=0.086N | |POLY 3 | P=0.006N** P=0.097N P=0.128N P=0.007N** |P=0.025N* P=0.034N* P=0.013N* P=0.082N | |POLY 1.5 | P=0.011N* P=0.088N P=0.119N P=0.010N* |P=0.024N* P=0.036N* P=0.013N* P=0.077N | |POLY 6 | P=0.003N** P=0.102N P=0.139N P=0.003N** |P=0.027N* P=0.030N* P=0.012N* P=0.089N | |LOGISTIC REGRESSION| P=0.009N** P=0.084N P=0.100N P=0.013N* |P=0.026N* P=0.037N* P=0.016N* P=0.075N | |COCH-ARM / FISHERS | P=0.020N* P=0.076N P=0.111N P=0.019N* |P=0.026N* P=0.036N* P=0.014N* P=0.074N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 9/50 (18%) 8/50 (16%) 7/50 (14%) |3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 28.8% 23.0% 20.0% 15.6% |7.2% 7.0% 0.0% 2.4% | |TERMINAL (d) | 1/12 (8%) 2/16 (13%) 4/21 (19%) 3/31 (10%) |1/28 (4%) 2/33 (6%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 396 450 527 544 |543 700 --- 571 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017N* P=0.338N P=0.144N P=0.032N* |P=0.080N P=0.598N P=0.101N P=0.298N | |POLY 3 | P=0.071N P=0.365N P=0.249N P=0.107N |P=0.083N P=0.650N P=0.113N P=0.309N | |POLY 1.5 | P=0.088N P=0.343N P=0.239N P=0.128N |P=0.083N P=0.659N P=0.116N P=0.306N | |POLY 6 | P=0.050N P=0.387N P=0.259N P=0.081N |P=0.084N P=0.632N P=0.109N P=0.314N | |LOGISTIC REGRESSION| P=0.143N P=0.286N P=0.234N P=0.224N |P=0.085N P=0.657N P=0.123N P=0.306N | |COCH-ARM / FISHERS | P=0.108N P=0.312N P=0.227N P=0.154N |P=0.084N P=0.661N P=0.121N P=0.309N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/50 (8%) 6/50 (12%) 4/50 (8%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| |9.6% 13.8% 9.2% 18.8% | |TERMINAL (d) | |3/28 (11%) 5/33 (15%) 2/34 (6%) 5/28 (18%) | |FIRST INCIDENCE | |573 535 647 444 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.188 P=0.456 P=0.551N P=0.194 | |POLY 3 | |P=0.190 P=0.395 P=0.622N P=0.184 | |POLY 1.5 | |P=0.188 P=0.379 P=0.632N P=0.183 | |POLY 6 | |P=0.190 P=0.422 P=0.606N P=0.182 | |LOGISTIC REGRESSION| |P=0.181 P=0.380 P=0.627N P=0.178 | |COCH-ARM / FISHERS | |P=0.182 P=0.370 P=0.643N P=0.178 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 27/50 (54%) 16/50 (32%) 27/48 (56%) |10/50 (20%) 14/49 (29%) 14/50 (28%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 30.6% 62.4% 41.5% 61.2% |23.7% 32.8% 31.9% 21.6% | |TERMINAL (d) | 4/12 (33%) 7/16 (44%) 13/21 (62%) 18/30 (60%) |6/28 (21%) 12/33 (36%) 12/34 (35%) 6/28 (21%) | |FIRST INCIDENCE | 600 428 666 605 |585 535 544 605 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.014 * P=0.479N P=0.390 |P=0.438N P=0.391 P=0.412 P=0.512N | |POLY 3 | P=0.021 * P=0.002 ** P=0.217 P=0.003 ** |P=0.442N P=0.245 P=0.270 P=0.509N | |POLY 1.5 | P=0.013 * P=0.002 ** P=0.235 P<0.001 ** |P=0.433N P=0.228 P=0.257 P=0.503N | |POLY 6 | P=0.046 * P=0.004 ** P=0.192 P=0.010 * |P=0.465N P=0.277 P=0.290 P=0.524N | |LOGISTIC REGRESSION| P=0.039 * P=0.002 ** P=0.296 P=0.006 ** |P=0.445N P=0.260 P=0.283 P=0.511N | |COCH-ARM / FISHERS | P=0.011 * P=0.002 ** P=0.252 P<0.001 ** |P=0.434N P=0.224 P=0.241 P=0.500N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/47 (19%) 3/45 (7%) 0/47 (0%) 0/46 (0%) |1/46 (2%) 0/44 (0%) 0/41 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 24.8% 9.1% 0.0% 0.0% |2.6% 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/12 (25%) 1/14 (7%) 0/20 (0%) 0/28 (0%) |0/25 (0%) 0/29 (0%) 0/26 (0%) 0/26 (0%) | |FIRST INCIDENCE | 681 544 --- --- |704 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.059N P<0.001N** P<0.001N** |P=0.184N P=0.471N P=0.477N P=0.513N | |POLY 3 | P<0.001N** P=0.076N P<0.001N** P<0.001N** |P=0.199N P=0.498N P=0.518N P=0.499N | |POLY 1.5 | P<0.001N** P=0.072N P<0.001N** P<0.001N** |P=0.194N P=0.504N P=0.521N P=0.498N | |POLY 6 | P<0.001N** P=0.082N P<0.001N** P<0.001N** |P=0.206N P=0.489N P=0.514N P=0.502N | |LOGISTIC REGRESSION| P<0.001N** P=0.084N P=0.002N** P<0.001N** |P=0.189N P=0.503N P=0.519N P=0.498N | |COCH-ARM / FISHERS | P<0.001N** P=0.070N P<0.001N** P<0.001N** |P=0.189N P=0.511N P=0.529N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 8/50 (16%) 3/49 (6%) 6/50 (12%) |35/50 (70%) 28/50 (56%) 34/50 (68%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 18.3% 21.7% 7.8% 13.5% |76.0% 61.5% 75.4% 68.9% | |TERMINAL (d) | 3/12 (25%) 6/16 (38%) 1/21 (5%) 3/31 (10%) |23/28 (82%) 19/33 (58%) 27/34 (79%) 19/28 (68%) | |FIRST INCIDENCE | 579 563 583 614 |475 392 563 444 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.027N* P=0.587N P=0.080N P=0.117N |P=0.456N P=0.040N* P=0.151N P=0.385N | |POLY 3 | P=0.171N P=0.467 P=0.149N P=0.384N |P=0.425N P=0.093N P=0.576N P=0.291N | |POLY 1.5 | P=0.207N P=0.481 P=0.157N P=0.437N |P=0.424N P=0.104N P=0.548N P=0.304N | |POLY 6 | P=0.122N P=0.454 P=0.135N P=0.308N |P=0.443N P=0.073N P=0.594N P=0.286N | |LOGISTIC REGRESSION| P=0.155N P=0.465 P=0.154N P=0.403N |P=0.440N P=0.092N P=0.410N P=0.335N | |COCH-ARM / FISHERS | P=0.252N P=0.500 P=0.167N P=0.500N |P=0.447N P=0.107N P=0.500N P=0.335N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 13/50 (26%) 15/49 (31%) 21/50 (42%) |24/50 (48%) 21/50 (42%) 26/50 (52%) 27/50 (54%) | |POLY-3 ADJUSTED (b)| 53.8% 33.2% 36.0% 45.9% |53.9% 47.5% 56.8% 58.7% | |TERMINAL (d) | 6/12 (50%) 3/16 (19%) 8/21 (38%) 13/31 (42%) |16/28 (57%) 15/33 (46%) 19/34 (56%) 16/28 (57%) | |FIRST INCIDENCE | 593 534 360 544 |475 620 451 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.021N* P=0.054N P=0.029N* P=0.010N* |P=0.224 P=0.172N P=0.442N P=0.356 | |POLY 3 | P=0.321N P=0.043N* P=0.071N P=0.299N |P=0.251 P=0.348N P=0.472 P=0.397 | |POLY 1.5 | P=0.402N P=0.043N* P=0.086N P=0.386N |P=0.240 P=0.362N P=0.447 P=0.381 | |POLY 6 | P=0.227N P=0.045N* P=0.061N P=0.203N |P=0.251 P=0.305N P=0.515 P=0.406 | |LOGISTIC REGRESSION| P=0.384N P=0.054N P=0.110N P=0.278N |P=0.205 P=0.309N P=0.455 P=0.344 | |COCH-ARM / FISHERS | P=0.509N P=0.046N* P=0.121N P=0.500N |P=0.205 P=0.344N P=0.421 P=0.345 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Intermedia | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/49 (6%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.7% 2.3% |2.4% 4.7% 0.0% 2.5% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 2/33 (6%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | --- 708 572 736 (T) |698 738 (T) --- 738 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.339 P=0.520 P=0.127 P=0.689 |P=0.416N P=0.557 P=0.489N P=0.747 | |POLY 3 | P=0.284 P=0.494 P=0.124 P=0.530 |P=0.410N P=0.513 P=0.492N P=0.758 | |POLY 1.5 | P=0.247 P=0.496 P=0.120 P=0.516 |P=0.410N P=0.504 P=0.496N P=0.760 | |POLY 6 | P=0.344 P=0.493 P=0.133 P=0.551 |P=0.412N P=0.527 P=0.486N P=0.754 | |LOGISTIC REGRESSION| P=0.204 P=0.493 P=0.111 P=0.689 |P=0.418N P=0.530 P=0.496N P=0.758 | |COCH-ARM / FISHERS | P=0.208 P=0.500 P=0.117 P=0.500 |P=0.411N P=0.500 P=0.500N P=0.753N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 7/50 (14%) 7/50 (14%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 18.2% 18.5% 17.9% 9.1% | | |TERMINAL (d) | 5/12 (42%) 3/16 (19%) 4/21 (19%) 3/31 (10%) | | |FIRST INCIDENCE | 396 435 572 660 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020N* P=0.497N P=0.337N P=0.022N* | | |POLY 3 | P=0.141N P=0.606 P=0.602N P=0.188N | | |POLY 1.5 | P=0.178N P=0.606 P=0.609N P=0.222N | | |POLY 6 | P=0.093N P=0.617 P=0.580N P=0.142N | | |LOGISTIC REGRESSION| P=0.175N P=0.603 P=0.599N P=0.203N | | |COCH-ARM / FISHERS | P=0.222N P=0.613N P=0.613N P=0.262N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 42/50 (84%) 40/50 (80%) 47/50 (94%) 47/50 (94%) | | |POLY-3 ADJUSTED (b)| 92.0% 86.0% 96.8% 97.0% | | |TERMINAL (d) | 12/12 (100%) 13/16 (81%) 20/21 (95%) 30/31 (97%) | | |FIRST INCIDENCE | 396 410 443 518 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** P=0.306N P=0.279N P<0.001N** | | |POLY 3 | P=0.045 * P=0.245N P=0.238 P=0.224 | | |POLY 1.5 | P=0.021 * P=0.313N P=0.140 P=0.122 | | |POLY 6 | P=0.144 P=0.155N P=0.543 P=0.541 | | |LOGISTIC REGRESSION| P=0.048 * P=0.456N P=0.098 P=0.290 | | |COCH-ARM / FISHERS | P=0.020 * P=0.398N P=0.100 P=0.100 | | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 5.2% 0.0% | | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 1/21 (5%) 0/31 (0%) | | |FIRST INCIDENCE | 561 --- 666 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143N P=0.238N P=0.608N P=0.152N | | |POLY 3 | P=0.209N P=0.247N P=0.691N P=0.208N | | |POLY 1.5 | P=0.227N P=0.243N P=0.692N P=0.221N | | |POLY 6 | P=0.183N P=0.251N P=0.685N P=0.189N | | |LOGISTIC REGRESSION| P=0.237N P=0.236N P=0.692N P=0.255N | | |COCH-ARM / FISHERS | P=0.249N P=0.247N P=0.691N P=0.247N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 38/50 (76%) 34/50 (68%) 32/50 (64%) 26/49 (53%) | | |POLY-3 ADJUSTED (b)| 79.2% 73.1% 67.9% 54.9% | | |TERMINAL (d) | 8/12 (67%) 10/16 (63%) 10/21 (48%) 15/30 (50%) | | |FIRST INCIDENCE | 396 410 360 213 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.260N P=0.072N P<0.001N** | | |POLY 3 | P=0.004N** P=0.316N P=0.144N P=0.008N** | | |POLY 1.5 | P=0.006N** P=0.288N P=0.141N P=0.010N* | | |POLY 6 | P=0.002N** P=0.351N P=0.147N P=0.005N** | | |LOGISTIC REGRESSION| P=0.033N* P=0.221N P=0.146N P=0.055N | | |COCH-ARM / FISHERS | P=0.010N* P=0.252N P=0.138N P=0.014N* | | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 0.0% 4.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 736 (T) --- 707 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.310 P=0.557 (e) P=0.428 |(e) (e) (e) (e) | |POLY 3 | P=0.171 P=0.493 (e) P=0.273 |(e) (e) (e) (e) | |POLY 1.5 | P=0.160 P=0.496 (e) P=0.256 |(e) (e) (e) (e) | |POLY 6 | P=0.190 P=0.491 (e) P=0.301 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.235 P=0.557 (e) P=0.318 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.149 P=0.500 (e) P=0.247 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.8% 7.9% 6.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 3/21 (14%) 3/31 (10%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- 726 736 (T) 736 (T) |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.201 P=0.525 P=0.232 P=0.328 |(e) (e) (e) (e) | |POLY 3 | P=0.065 P=0.493 P=0.121 P=0.148 |(e) (e) (e) (e) | |POLY 1.5 | P=0.054 P=0.496 P=0.120 P=0.134 |(e) (e) (e) (e) | |POLY 6 | P=0.088 P=0.492 P=0.124 P=0.172 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.155 P=0.506 P=0.232 P=0.328 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.043 * P=0.500 P=0.121 P=0.121 |(e) (e) (e) (e) | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.7% 0.0% 0.0% 0.0% |2.4% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |1/28 (4%) 0/33 (0%) 1/34 (3%) 0/28 (0%) | |FIRST INCIDENCE | 663 --- --- --- |738 (T) --- 600 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.168N P=0.521N P=0.507N P=0.448N |P=0.496N P=0.467N P=0.553 P=0.500N | |POLY 3 | P=0.194N P=0.508N P=0.497N P=0.471N |P=0.518N P=0.492N P=0.519 P=0.502N | |POLY 1.5 | P=0.191N P=0.505N P=0.499N P=0.484N |P=0.507N P=0.497N P=0.510 P=0.501N | |POLY 6 | P=0.198N P=0.511N P=0.494N P=0.451N |P=0.539N P=0.483N P=0.532 P=0.505N | |LOGISTIC REGRESSION| P=0.183N P=0.502N P=0.499N P=0.509N |P=0.500N (e) P=0.503 (e) | |COCH-ARM / FISHERS | P=0.185N P=0.500N P=0.500N P=0.500N |P=0.500N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 13.2% 8.3% 7.8% 2.3% |2.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/12 (33%) 2/16 (13%) 2/21 (10%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 723 645 736 (T) |696 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.005N** P=0.231N P=0.158N P=0.007N** |P=0.194N P=0.473N P=0.494N P=0.531N | |POLY 3 | P=0.046N* P=0.379N P=0.345N P=0.071N |P=0.192N P=0.493N P=0.492N P=0.503N | |POLY 1.5 | P=0.057N P=0.370N P=0.350N P=0.084N |P=0.188N P=0.497N P=0.496N P=0.501N | |POLY 6 | P=0.033N* P=0.387N P=0.331N P=0.055N |P=0.199N P=0.485N P=0.487N P=0.506N | |LOGISTIC REGRESSION| P=0.027N* P=0.361N P=0.324N P=0.046N* |P=0.184N P=0.498N P=0.497N P=0.501N | |COCH-ARM / FISHERS | P=0.071N P=0.357N P=0.357N P=0.102N |P=0.185N P=0.500N P=0.500N 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |9/50 (18%) 12/50 (24%) 6/50 (12%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 10.3% 0.0% 2.6% 0.0% |21.1% 27.6% 13.6% 23.3% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 0/31 (0%) |5/28 (18%) 10/33 (30%) 3/34 (9%) 6/28 (21%) | |FIRST INCIDENCE | 396 --- 593 --- |391 535 399 417 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010N* P=0.058N P=0.138N P=0.023N* |P=0.430N P=0.450 P=0.200N P=0.499 | |POLY 3 | P=0.016N* P=0.068N P=0.177N P=0.046N* |P=0.419N P=0.328 P=0.261N P=0.508 | |POLY 1.5 | P=0.018N* P=0.065N P=0.179N P=0.053N |P=0.422N P=0.311 P=0.274N P=0.507 | |POLY 6 | P=0.013N* P=0.070N P=0.171N P=0.037N* |P=0.422N P=0.362 P=0.242N P=0.502 | |LOGISTIC REGRESSION| P=0.025N* P=0.058N P=0.186N P=0.080N |P=0.435N P=0.325 P=0.298N P=0.500 | |COCH-ARM / FISHERS | P=0.021N* P=0.059N P=0.181N P=0.059N |P=0.435N P=0.312 P=0.288N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 5.3% 0.0% 5.2% 4.6% |2.4% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 690 --- 617 709 |573 --- --- 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.504N P=0.229N P=0.631N P=0.435N |P=0.623N P=0.495N P=0.491N P=0.759N | |POLY 3 | P=0.495 P=0.245N P=0.685N P=0.639N |P=0.627N P=0.495N P=0.494N P=0.758 | |POLY 1.5 | P=0.462 P=0.242N P=0.689N P=0.665N |P=0.625N P=0.499N P=0.497N P=0.760 | |POLY 6 | P=0.544 P=0.248N P=0.675N P=0.599N |P=0.632 P=0.487N P=0.489N P=0.755 | |LOGISTIC REGRESSION| P=0.499 P=0.243N P=0.688N P=0.581N |P=0.613 P=0.472N P=0.513N P=0.758 | |COCH-ARM / FISHERS | P=0.426 P=0.247N P=0.691N P=0.691N |P=0.625N P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 25.6% 10.7% 7.6% 4.5% |2.4% 0.0% 6.8% 2.4% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 579 544 360 561 |731 --- 451 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.084N P=0.028N* P=0.002N** |P=0.330 P=0.468N P=0.335 P=0.750 | |POLY 3 | P=0.002N** P=0.079N P=0.029N* P=0.006N** |P=0.336 P=0.492N P=0.332 P=0.760 | |POLY 1.5 | P=0.003N** P=0.076N P=0.031N* P=0.009N** |P=0.341 P=0.497N P=0.320 P=0.761 | |POLY 6 | P<0.001N** P=0.082N P=0.026N* P=0.004N** |P=0.326 P=0.484N P=0.350 P=0.758 | |LOGISTIC REGRESSION| P=0.006N** P=0.081N P=0.037N* P=0.013N* |P=0.333 P=0.475N P=0.282 P=0.760 | |COCH-ARM / FISHERS | P=0.005N** P=0.074N P=0.036N* P=0.014N* |P=0.343 P=0.500N P=0.309 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 8/50 (16%) 4/50 (8%) 3/50 (6%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 20.5% 21.1% 9.9% 6.8% |7.2% 2.3% 6.8% 7.2% | |TERMINAL (d) | 0/12 (0%) 2/16 (13%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 579 544 360 561 |543 620 451 605 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008N** P=0.579N P=0.156N P=0.022N* |P=0.427 P=0.280N P=0.625N P=0.644 | |POLY 3 | P=0.019N* P=0.586 P=0.156N P=0.062N |P=0.444 P=0.294N P=0.636N P=0.662 | |POLY 1.5 | P=0.026N* P=0.594 P=0.164N P=0.077N |P=0.445 P=0.302N P=0.647N P=0.662 | |POLY 6 | P=0.012N* P=0.583 P=0.147N P=0.045N* |P=0.439 P=0.280N P=0.619N P=0.659 | |LOGISTIC REGRESSION| P=0.044N* P=0.589 P=0.184N P=0.097N |P=0.426 P=0.302N P=0.638 P=0.662 | |COCH-ARM / FISHERS | P=0.037N* P=0.607N P=0.178N P=0.100N |P=0.442 P=0.309N P=0.661N P=0.661N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia Basal Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.2% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/16 (0%) 2/21 (10%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | --- --- 736 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.572 (e) P=0.367 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.468 (e) P=0.241 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.425 (e) P=0.239 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.531 (e) P=0.245 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.367 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.375 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 20.8% 8.1% 10.0% 2.3% |4.8% 0.0% 6.8% 2.4% | |TERMINAL (d) | 0/12 (0%) 1/16 (6%) 0/21 (0%) 0/31 (0%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 600 544 527 561 |475 --- 451 684 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004N** P=0.101N P=0.138N P=0.003N** |P=0.562 P=0.227N P=0.525 P=0.513N | |POLY 3 | P=0.006N** P=0.104N P=0.153N P=0.008N** |P=0.563 P=0.232N P=0.526 P=0.508N | |POLY 1.5 | P=0.009N** P=0.102N P=0.164N P=0.011N* |P=0.570 P=0.236N P=0.514 P=0.504N | |POLY 6 | P=0.004N** P=0.105N P=0.137N P=0.005N** |P=0.551 P=0.224N P=0.544 P=0.514N | |LOGISTIC REGRESSION| P=0.015N* P=0.109N P=0.176N P=0.013N* |P=0.553 P=0.219N P=0.466 P=0.504N | |COCH-ARM / FISHERS | P=0.013N* P=0.100N P=0.178N P=0.015N* |P=0.574N P=0.247N P=0.500 P=0.500N | |=================================================================================================================================| 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 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular: Epithelium | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 5.3% 2.7% 0.0% 4.5% |2.4% 4.6% 2.3% 4.8% | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 0/21 (0%) 1/31 (3%) |0/28 (0%) 0/33 (0%) 0/34 (0%) 0/28 (0%) | |FIRST INCIDENCE | 603 614 --- 518 |696 620 733 572 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.349N P=0.480N P=0.180N P=0.498N |P=0.405 P=0.542 P=0.733N P=0.480 | |POLY 3 | P=0.486N P=0.512N P=0.234N P=0.637N |P=0.435 P=0.517 P=0.752N P=0.503 | |POLY 1.5 | P=0.494N P=0.507N P=0.236N P=0.663N |P=0.432 P=0.507 P=0.756N P=0.502 | |POLY 6 | P=0.471N P=0.515N P=0.231N P=0.597N |P=0.437 P=0.534 P=0.746N P=0.502 | |LOGISTIC REGRESSION| P=0.528N P=0.500N P=0.236N P=0.665 |P=0.423 P=0.499 P=0.752N P=0.497 | |COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.247N P=0.691N |P=0.426 P=0.500 P=0.753N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Testes: Germinal Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 4/50 (8%) | | |POLY-3 ADJUSTED (b)| 5.3% 5.3% 10.4% 9.1% | | |TERMINAL (d) | 1/12 (8%) 0/16 (0%) 2/21 (10%) 2/31 (7%) | | |FIRST INCIDENCE | 733 507 702 621 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.467 P=0.663N P=0.537 P=0.655N | | |POLY 3 | P=0.247 P=0.695 P=0.347 P=0.415 | | |POLY 1.5 | P=0.212 P=0.694 P=0.343 P=0.378 | | |POLY 6 | P=0.309 P=0.692N P=0.360 P=0.473 | | |LOGISTIC REGRESSION| P=0.209 P=0.688N P=0.406 P=0.455 | | |COCH-ARM / FISHERS | P=0.176 P=0.691N P=0.339 P=0.339 | | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 10/50 (20%) 6/50 (12%) 5/50 (10%) | | |POLY-3 ADJUSTED (b)| 24.7% 24.1% 14.6% 11.1% | | |TERMINAL (d) | 2/12 (17%) 0/16 (0%) 0/21 (0%) 1/31 (3%) | | |FIRST INCIDENCE | 435 435 360 518 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024N* P=0.571 P=0.166N P=0.033N* | | |POLY 3 | P=0.033N* P=0.581N P=0.192N P=0.084N | | |POLY 1.5 | P=0.043N* P=0.590N P=0.197N P=0.104N | | |POLY 6 | P=0.022N* P=0.559N P=0.183N P=0.060N | | |LOGISTIC REGRESSION| P=0.124N P=0.545N P=0.217N P=0.192N | | |COCH-ARM / FISHERS | P=0.058N P=0.598N P=0.207N P=0.131N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/46 (0%) 0/49 (0%) 0/47 (0%) |0/48 (0%) 1/44 (2%) 3/48 (6%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.5% 7.3% 0.0% | |TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/20 (0%) 0/28 (0%) |0/26 (0%) 0/31 (0%) 3/33 (9%) 0/27 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 392 738 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.422 P=0.496 P=0.165 (e) | |POLY 3 | (e) (e) (e) (e) |P=0.413 P=0.501 P=0.128 (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.414 P=0.492 P=0.124 (e) | |POLY 6 | (e) (e) (e) (e) |P=0.407 P=0.514 P=0.136 (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.406 P=0.710 P=0.165 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.413 P=0.478 P=0.121 (e) | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Ectopic Parathyroid Gland | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/46 (2%) 0/49 (0%) 0/47 (0%) |0/48 (0%) 0/44 (0%) 0/48 (0%) 2/47 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 3.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.1% | |TERMINAL (d) | 0/12 (0%) 0/15 (0%) 0/20 (0%) 0/28 (0%) |0/26 (0%) 0/31 (0%) 0/33 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 708 --- --- |--- --- --- 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.406N P=0.520 (e) (e) |P=0.050 (e) (e) P=0.222 | |POLY 3 | P=0.506N P=0.477 (e) (e) |P=0.058 (e) (e) P=0.238 | |POLY 1.5 | P=0.505N P=0.481 (e) (e) |P=0.058 (e) (e) P=0.236 | |POLY 6 | P=0.502N P=0.474 (e) (e) |P=0.060 (e) (e) P=0.241 | |LOGISTIC REGRESSION| P=0.467N P=0.475 (e) (e) |P=0.055 (e) (e) P=0.226 | |COCH-ARM / FISHERS | P=0.503N P=0.484 (e) (e) |P=0.057 (e) (e) P=0.242 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 8/50 (16%) 21/50 (42%) 19/50 (38%) |16/50 (32%) 23/50 (46%) 27/50 (54%) 20/50 (40%) | |POLY-3 ADJUSTED (b)| 39.8% 21.1% 50.5% 42.8% |37.8% 51.6% 60.3% 47.1% | |TERMINAL (d) | 5/12 (42%) 3/16 (19%) 11/21 (52%) 16/31 (52%) |9/28 (32%) 19/33 (58%) 21/34 (62%) 15/28 (54%) | |FIRST INCIDENCE | 579 507 521 619 |620 430 544 572 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.213N P=0.042N* P=0.567N P=0.049N* |P=0.168 P=0.272 P=0.113 P=0.259 | |POLY 3 | P=0.147 P=0.055N P=0.220 P=0.477 |P=0.151 P=0.135 P=0.025 * P=0.254 | |POLY 1.5 | P=0.107 P=0.051N P=0.213 P=0.411 |P=0.162 P=0.117 P=0.021 * P=0.263 | |POLY 6 | P=0.223 P=0.061N P=0.234 P=0.569 |P=0.130 P=0.163 P=0.031 * P=0.233 | |LOGISTIC REGRESSION| P=0.196 P=0.057N P=0.216 P=0.551N |P=0.148 P=0.133 P=0.030 * P=0.235 | |COCH-ARM / FISHERS | P=0.077 P=0.050N P=0.204 P=0.338 |P=0.169 P=0.109 P=0.021 * P=0.266 | |=================================================================================================================================| Date: 09/15/97 EXPERIMENT: 89002 TEST: 02 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PENTACHLOROPHENOL Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 200 PPM 400 PPM 600 PPM |0 PPM 200 PPM 400 PPM 600 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 4.7% 0.0% 4.9% | |TERMINAL (d) | |0/28 (0%) 2/33 (6%) 0/34 (0%) 1/28 (4%) | |FIRST INCIDENCE | |--- 738 (T) --- 692 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.236 P=0.275 (e) P=0.226 | |POLY 3 | |P=0.259 P=0.246 (e) P=0.236 | |POLY 1.5 | |P=0.254 P=0.240 (e) P=0.237 | |POLY 6 | |P=0.266 P=0.256 (e) P=0.233 | |LOGISTIC REGRESSION| |P=0.236 P=0.275 (e) P=0.233 | |COCH-ARM / FISHERS | |P=0.249 P=0.247 (e) P=0.247 | |=================================================================================================================================| (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).