TDMS Study 55301-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research PYRIDINE DATE: 09/29/97 EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1 Rats(FISCHER344) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research PYRIDINE DATE: 09/29/97 EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PYRIDINE =============================================================== Male Rats ------------ Organ Morphology ----- ---------- Adrenal Cortex Hyperplasia Bone Fibrous Osteodystrophy Heart Cardiomyopathy Kidney Cyst Nephropathy Kidney: Renal Tubule Hyperplasia Liver Basophilic Focus Clear Cell Focus Degeneration Cystic Eosinophilic Focus Fibrosis Hepatodiaphragmatic Nodule Mitotic Alteration Pigmentation Vacuolization Cytoplasmic Liver: Bile Duct Hyperplasia Liver: Centrilobular Cytomegaly Degeneration Necrosis Liver: Periportal Fibrosis Lung Infiltration Cellular Histiocyte Lymph Node, Mediastinal Congestion Lymph Node: Renal Pigmentation Parathyroid Gland Hyperplasia Pituitary Gland: Pars Distalis Cyst Hyperplasia Preputial Gland Inflammation Chronic Spleen Necrosis Pigmentation Stomach, Forestomach Hyperkeratosis Inflammation Chronic Ulcer Stomach, Forestomach: Epithelium Hyperplasia Stomach, Glandular Mineralization Testes: Interstitial Cell Hyperplasia =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Heart Cardiomyopathy Kidney Mineralization Liver Basophilic Focus NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: TSI Mason Research PYRIDINE DATE: 09/29/97 EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1 Clear Cell Focus Hepatodiaphragmatic Nodule Inflammation Chronic Necrosis Pigmentation Tension Lipidosis Vacuolization Cytoplasmic Liver: Bile Duct Hyperplasia Liver: Capsule Inflammation Chronic Liver: Centrilobular Cytomegaly Degeneration Lymph Node, Mandibular Ectasia Lymph Node: Iliac Congestion Mammary Gland Galactocele Mesentery: Fat Necrosis Pancreas Atrophy Pituitary Gland: Pars Distalis Angiectasis Cyst Uterus Hyperplasia Cystic =============================================================== Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 7/49 (14%) 7/50 (14%) 2/50 (4%) |11/50 (22%) 12/50 (24%) 9/50 (18%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 19.3% 17.6% 17.0% 5.2% |24.8% 26.2% 20.3% 14.7% | |TERMINAL (d) | 6/25 (24%) 7/20 (35%) 5/25 (20%) 0/16 (0%) |11/32 (34%) 11/37 (30%) 8/29 (28%) 6/26 (23%) | |FIRST INCIDENCE | 625 722 (T) 644 681 |729 (T) 728 605 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.111N P=0.548 P=0.515N P=0.148N |P=0.208N P=0.532N P=0.495N P=0.260N | |POLY 3 | P=0.047N* P=0.538N P=0.507N P=0.056N |P=0.118N P=0.534 P=0.401N P=0.186N | |POLY 1.5 | P=0.043N* P=0.519N P=0.499N P=0.051N |P=0.100N P=0.520 P=0.400N P=0.166N | |POLY 6 | P=0.057N P=0.583N P=0.529N P=0.069N |P=0.147N P=0.555 P=0.403N P=0.220N | |LOGISTIC REGRESSION| P=0.071N P=0.574 P=0.539N P=0.075N |P=0.208N (e) P=0.429N P=0.260N | |COCH-ARM / FISHERS | P=0.038N* P=0.517N P=0.500N P=0.046N* |P=0.081N P=0.500 P=0.402N P=0.143N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 5.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) --- --- 717 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.170 P=0.545N P=0.500N P=0.350 |(e) (e) (e) (e) | |POLY 3 | P=0.240 P=0.507N P=0.501N P=0.475 |(e) (e) (e) (e) | |POLY 1.5 | P=0.242 P=0.504N P=0.500N P=0.487 |(e) (e) (e) (e) | |POLY 6 | P=0.237 P=0.515N P=0.506N P=0.453 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.356 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.247 P=0.505N P=0.500N P=0.500 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Cortex | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 5/49 (10%) 9/50 (18%) 7/50 (14%) |6/50 (12%) 8/50 (16%) 6/50 (12%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 21.0% 12.4% 21.5% 17.5% |13.2% 17.2% 13.5% 7.4% | |TERMINAL (d) | 5/25 (20%) 3/20 (15%) 5/25 (20%) 3/16 (19%) |3/32 (9%) 5/37 (14%) 3/29 (10%) 2/26 (8%) | |FIRST INCIDENCE | 473 620 589 444 |503 611 624 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.420 P=0.298N P=0.595 P=0.580 |P=0.264N P=0.472 P=0.587 P=0.349N | |POLY 3 | P=0.513N P=0.225N P=0.585 P=0.449N |P=0.195N P=0.404 P=0.606 P=0.297N | |POLY 1.5 | P=0.493N P=0.211N P=0.596 P=0.422N |P=0.169N P=0.397 P=0.613 P=0.272N | |POLY 6 | P=0.548N P=0.256N P=0.563 P=0.500N |P=0.235N P=0.416 P=0.597 P=0.335N | |LOGISTIC REGRESSION| P=0.486N P=0.204N P=0.602N P=0.388N |P=0.156N P=0.374 P=0.620N P=0.257N | |COCH-ARM / FISHERS | P=0.467N P=0.205N P=0.602N P=0.393N |P=0.139N P=0.387 P=0.620N P=0.243N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Adrenal Medulla | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 23/49 (47%) 19/50 (38%) 16/49 (33%) |5/50 (10%) 7/50 (14%) 8/50 (16%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| 42.2% 54.5% 45.4% 40.0% |11.2% 15.1% 17.4% 5.0% | |TERMINAL (d) | 13/25 (52%) 13/20 (65%) 14/25 (56%) 9/16 (56%) |4/32 (13%) 3/37 (8%) 3/29 (10%) 0/25 (0%) | |FIRST INCIDENCE | 571 598 627 465 |671 650 521 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.398 P=0.069 P=0.485 P=0.279 |P=0.289N P=0.461 P=0.255 P=0.320N | |POLY 3 | P=0.321N P=0.172 P=0.467 P=0.509N |P=0.222N P=0.408 P=0.297 P=0.259N | |POLY 1.5 | P=0.290N P=0.185 P=0.490 P=0.475N |P=0.198N P=0.396 P=0.290 P=0.244N | |POLY 6 | P=0.397N P=0.142 P=0.417 P=0.584N |P=0.260N P=0.427 P=0.306 P=0.281N | |LOGISTIC REGRESSION| P=0.388N P=0.149 P=0.456 P=0.538N |P=0.142N P=0.395 P=0.275 P=0.254N | |COCH-ARM / FISHERS | P=0.262N P=0.184 P=0.500 P=0.445N |P=0.169N P=0.380 P=0.277 P=0.226N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 2.5% 9.6% 15.4% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 574 722 (T) 585 622 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.557N P=0.318 P=0.066 |(e) (e) (e) (e) | |POLY 3 | P=0.028 * P=0.510N P=0.335 P=0.109 |(e) (e) (e) (e) | |POLY 1.5 | P=0.031 * P=0.502N P=0.338 P=0.120 |(e) (e) (e) (e) | |POLY 6 | P=0.024 * P=0.529N P=0.325 P=0.092 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.029 * P=0.500N P=0.337 P=0.115 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.036 * P=0.500N P=0.339 P=0.134 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Bone | | Osteopetrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |9/50 (18%) 12/50 (24%) 10/50 (20%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.9% 0.0% |19.6% 25.8% 22.0% 12.0% | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 2/25 (8%) 0/16 (0%) |5/32 (16%) 10/37 (27%) 4/29 (14%) 2/26 (8%) | |FIRST INCIDENCE | 722 (T) --- 722 (T) --- |493 546 580 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.554N P=0.545N P=0.500 P=0.589N |P=0.249N P=0.420 P=0.445 P=0.318N | |POLY 3 | P=0.482N P=0.503N P=0.498 P=0.514N |P=0.158N P=0.325 P=0.490 P=0.245N | |POLY 1.5 | P=0.473N P=0.500N P=0.501 P=0.507N |P=0.134N P=0.320 P=0.495 P=0.222N | |POLY 6 | P=0.495N P=0.512N P=0.489 P=0.527N |P=0.196N P=0.331 P=0.484 P=0.280N | |LOGISTIC REGRESSION| P=0.554N (e) P=0.500 (e) |P=0.100N P=0.305 P=0.502 P=0.172N | |COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |P=0.107N P=0.312 P=0.500 P=0.194N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Depletion Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.8% 9.7% 7.1% 2.6% |2.3% 0.0% 4.6% 4.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 644 665 269 722 (T) |717 --- 707 589 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.384N P=0.275 P=0.488 P=0.616N |P=0.185 P=0.478N P=0.471 P=0.441 | |POLY 3 | P=0.329N P=0.333 P=0.508 P=0.528N |P=0.219 P=0.494N P=0.497 P=0.476 | |POLY 1.5 | P=0.311N P=0.340 P=0.509 P=0.515N |P=0.231 P=0.496N P=0.499 P=0.487 | |POLY 6 | P=0.363N P=0.316 P=0.498 P=0.553N |P=0.204 P=0.491N P=0.493 P=0.462 | |LOGISTIC REGRESSION| P=0.274N P=0.336 P=0.475 P=0.530N |P=0.267 P=0.491N P=0.491 P=0.542 | |COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |P=0.245 P=0.500N P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.7% 8.4% 0.0% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- --- |687 488 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.152N P=0.535 P=0.123N P=0.388N | |POLY 3 | (e) (e) (e) (e) |P=0.124N P=0.534 P=0.122N P=0.339N | |POLY 1.5 | (e) (e) (e) (e) |P=0.118N P=0.520 P=0.120N P=0.324N | |POLY 6 | (e) (e) (e) (e) |P=0.133N P=0.551 P=0.124N P=0.362N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.078N P=0.417 P=0.122N P=0.352N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111N P=0.500 P=0.121N P=0.309N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Brain | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |2.2% 2.2% 0.0% 4.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/23 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 525 --- |681 729 (T) --- 503 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.691 (e) P=0.513 (e) |P=0.308 P=0.736N P=0.495N P=0.449 | |POLY 3 | P=0.661 (e) P=0.492 (e) |P=0.348 P=0.755N P=0.503N P=0.474 | |POLY 1.5 | P=0.675 (e) P=0.493 (e) |P=0.357 P=0.757N P=0.501N P=0.486 | |POLY 6 | P=0.637 (e) P=0.487 (e) |P=0.337 P=0.752N P=0.506N P=0.456 | |LOGISTIC REGRESSION| P=0.727 (e) P=0.477 (e) |P=0.409 P=0.760N P=0.500N P=0.550 | |COCH-ARM / FISHERS | P=0.693 (e) P=0.490 (e) |P=0.366 P=0.753N P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/47 (2%) 2/48 (4%) 1/50 (2%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| |2.4% 4.5% 2.3% 5.0% | |TERMINAL (d) | |1/32 (3%) 2/36 (6%) 1/29 (3%) 2/25 (8%) | |FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.333 P=0.541 P=0.740 P=0.414 | |POLY 3 | |P=0.420 P=0.519 P=0.750N P=0.481 | |POLY 1.5 | |P=0.438 P=0.515 P=0.748N P=0.497 | |POLY 6 | |P=0.393 P=0.525 P=0.754N P=0.459 | |LOGISTIC REGRESSION| |P=0.333 P=0.541 P=0.740 P=0.414 | |COCH-ARM / FISHERS | |P=0.460 P=0.508 P=0.737N P=0.516 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |1/47 (2%) 2/48 (4%) 1/50 (2%) 0/49 (0%) | |POLY-3 ADJUSTED (b)| |2.4% 4.5% 2.3% 0.0% | |TERMINAL (d) | |1/32 (3%) 1/36 (3%) 1/29 (3%) 0/25 (0%) | |FIRST INCIDENCE | |729 (T) 728 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.313N P=0.547 P=0.740 P=0.549N | |POLY 3 | |P=0.261N P=0.520 P=0.750N P=0.511N | |POLY 1.5 | |P=0.250N P=0.515 P=0.748N P=0.502N | |POLY 6 | |P=0.277N P=0.525 P=0.754N P=0.524N | |LOGISTIC REGRESSION| |P=0.317N P=0.540 P=0.740 (e) | |COCH-ARM / FISHERS | |P=0.237N P=0.508 P=0.737N P=0.490N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |4/47 (9%) 2/48 (4%) 7/50 (14%) 3/49 (6%) | |POLY-3 ADJUSTED (b)| |9.6% 4.5% 15.9% 7.3% | |TERMINAL (d) | |4/32 (13%) 2/36 (6%) 5/29 (17%) 0/25 (0%) | |FIRST INCIDENCE | |729 (T) 729 (T) 707 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.408 P=0.283N P=0.213 P=0.600N | |POLY 3 | |P=0.533 P=0.311N P=0.289 P=0.513N | |POLY 1.5 | |P=0.561 P=0.318N P=0.295 P=0.497N | |POLY 6 | |P=0.491 P=0.304N P=0.279 P=0.538N | |LOGISTIC REGRESSION| |P=0.544 P=0.283N P=0.246 P=0.464N | |COCH-ARM / FISHERS | |P=0.544N P=0.329N P=0.299 P=0.476N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Clitoral Gland: Duct | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/47 (6%) 5/48 (10%) 4/50 (8%) 2/49 (4%) | |POLY-3 ADJUSTED (b)| |7.1% 11.3% 9.1% 5.0% | |TERMINAL (d) | |1/32 (3%) 5/36 (14%) 3/29 (10%) 2/25 (8%) | |FIRST INCIDENCE | |671 729 (T) 707 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.474N P=0.414 P=0.470 P=0.607N | |POLY 3 | |P=0.361N P=0.382 P=0.522 P=0.529N | |POLY 1.5 | |P=0.332N P=0.377 P=0.528 P=0.507N | |POLY 6 | |P=0.407N P=0.385 P=0.509 P=0.562N | |LOGISTIC REGRESSION| |P=0.417N P=0.390 P=0.523 P=0.541N | |COCH-ARM / FISHERS | |P=0.298N P=0.369 P=0.535 P=0.480N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Epididymis | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/49 (4%) 0/48 (0%) | | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% | | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | | |FIRST INCIDENCE | --- --- 679 --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.537 (e) P=0.222 (e) | | |POLY 3 | P=0.552 (e) P=0.238 (e) | | |POLY 1.5 | P=0.569 (e) P=0.239 (e) | | |POLY 6 | P=0.522 (e) P=0.235 (e) | | |LOGISTIC REGRESSION| P=0.577 (e) P=0.237 (e) | | |COCH-ARM / FISHERS | P=0.591 (e) P=0.247 (e) | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Eye | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 2/2 (100%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 100.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 2/2 (100%) | |FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (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 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 45/50 (90%) 43/50 (86%) 43/50 (86%) 46/50 (92%) |42/49 (86%) 43/50 (86%) 43/50 (86%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 92.3% 88.5% 90.4% 96.6% |89.8% 88.7% 87.2% 78.3% | |TERMINAL (d) | 25/25 (100%) 17/20 (85%) 23/25 (92%) 16/16 (100%)|28/31 (90%) 34/37 (92%) 24/29 (83%) 21/26 (81%) | |FIRST INCIDENCE | 309 444 269 428 |493 533 496 503 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.044 * P=0.308 P=0.478N P=0.032 * |P=0.343 P=0.220N P=0.372 P=0.509 | |POLY 3 | P=0.175 P=0.374N P=0.511N P=0.294 |P=0.051N P=0.569N P=0.467N P=0.091N | |POLY 1.5 | P=0.210 P=0.377N P=0.457N P=0.329 |P=0.041N* P=0.587N P=0.531N P=0.079N | |POLY 6 | P=0.180 P=0.369N P=0.557N P=0.323 |P=0.073N P=0.565N P=0.397N P=0.122N | |LOGISTIC REGRESSION| P=0.306 P=0.377N P=0.365N P=0.445 |P=0.083N P=0.534N P=0.604 P=0.148N | |COCH-ARM / FISHERS | P=0.368 P=0.380N P=0.380N P=0.500 |P=0.034N* P=0.597 P=0.597 P=0.077N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 9 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 7.2% 5.2% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/31 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 574 --- 585 685 |503 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.186 P=0.496N P=0.293 P=0.412 |P=0.306N P=0.496N P=0.496N P=0.500N | |POLY 3 | P=0.213 P=0.505N P=0.304 P=0.472 |P=0.296N P=0.492N P=0.501N P=0.516N | |POLY 1.5 | P=0.225 P=0.501N P=0.307 P=0.485 |P=0.299N P=0.494N P=0.498N P=0.507N | |POLY 6 | P=0.195 P=0.516N P=0.297 P=0.449 |P=0.290N P=0.490N P=0.504N P=0.528N | |LOGISTIC REGRESSION| P=0.243 P=0.545N P=0.300 P=0.498 |P=0.239N P=0.681N P=0.652N P=0.423N | |COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.309 P=0.500 |P=0.303N P=0.495N P=0.495N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Heart | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.9% 14.4% 7.3% 10.2% |0.0% 0.0% 4.5% 2.4% | |TERMINAL (d) | 2/25 (8%) 0/20 (0%) 2/25 (8%) 0/16 (0%) |0/31 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) 618 700 601 |--- --- 561 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311 P=0.102 P=0.494 P=0.215 |P=0.209 (e) P=0.249 P=0.461 | |POLY 3 | P=0.411 P=0.136 P=0.498 P=0.314 |P=0.214 (e) P=0.243 P=0.488 | |POLY 1.5 | P=0.427 P=0.138 P=0.501 P=0.325 |P=0.229 (e) P=0.243 P=0.495 | |POLY 6 | P=0.382 P=0.128 P=0.488 P=0.294 |P=0.194 (e) P=0.243 P=0.479 | |LOGISTIC REGRESSION| P=0.411 P=0.132 P=0.461 P=0.311 |P=0.298 (e) P=0.222 P=0.512 | |COCH-ARM / FISHERS | P=0.446 P=0.134 P=0.500 P=0.339 |P=0.249 (e) P=0.253 P=0.505 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 10 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Colon | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 4/48 (8%) 3/50 (6%) 2/49 (4%) |3/50 (6%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 9.7% 10.1% 7.3% 5.3% |6.7% 6.6% 6.8% 2.5% | |TERMINAL (d) | 2/25 (8%) 2/20 (10%) 3/25 (12%) 1/16 (6%) |2/32 (6%) 3/37 (8%) 3/29 (10%) 1/26 (4%) | |FIRST INCIDENCE | 718 604 722 (T) 598 |667 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.364N P=0.546 P=0.511N P=0.518N |P=0.318N P=0.605N P=0.622 P=0.386N | |POLY 3 | P=0.263N P=0.625 P=0.504N P=0.376N |P=0.261N P=0.651N P=0.655 P=0.338N | |POLY 1.5 | P=0.252N P=0.628 P=0.499N P=0.362N |P=0.244N P=0.655N P=0.659 P=0.323N | |POLY 6 | P=0.284N P=0.611 P=0.518N P=0.403N |P=0.287N P=0.645N P=0.649 P=0.361N | |LOGISTIC REGRESSION| P=0.280N P=0.606 P=0.552N P=0.415N |P=0.303N P=0.640N P=0.652 P=0.360N | |COCH-ARM / FISHERS | P=0.236N P=0.619 P=0.500N P=0.349N |P=0.221N P=0.661N P=0.661N P=0.309N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Intestine Large, Rectum | | Parasite Metazoan | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/48 (4%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.6% 5.1% 0.0% 2.6% |2.2% 4.4% 2.3% 4.9% | |TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | 604 718 --- 515 |493 729 (T) 703 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.122N P=0.411N P=0.067N P=0.249N |P=0.361 P=0.534 P=0.758N P=0.450 | |POLY 3 | P=0.089N P=0.370N P=0.063N P=0.206N |P=0.403 P=0.505 P=0.755 P=0.465 | |POLY 1.5 | P=0.088N P=0.359N P=0.061N P=0.196N |P=0.421 P=0.503 P=0.758 P=0.480 | |POLY 6 | P=0.091N P=0.396N P=0.067N P=0.228N |P=0.378 P=0.509 P=0.752 P=0.443 | |LOGISTIC REGRESSION| P=0.087N P=0.362N P=0.063N P=0.179N |P=0.454 P=0.455 P=0.738 P=0.538 | |COCH-ARM / FISHERS | P=0.087N P=0.359N P=0.059N P=0.187N |P=0.444 P=0.500 P=0.753N P=0.500 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 11 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Intestine Small, Ileum | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 9/47 (19%) 3/50 (6%) 4/47 (9%) |3/50 (6%) 2/49 (4%) 2/50 (4%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 14.3% 23.1% 7.3% 10.8% |6.8% 4.4% 4.6% 12.2% | |TERMINAL (d) | 5/25 (20%) 8/20 (40%) 3/25 (12%) 2/16 (13%) |3/32 (9%) 2/37 (5%) 2/29 (7%) 4/26 (15%) | |FIRST INCIDENCE | 473 538 722 (T) 444 |729 (T) 729 (T) 729 (T) 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311N P=0.155 P=0.234N P=0.574N |P=0.114 P=0.434N P=0.545N P=0.250 | |POLY 3 | P=0.199N P=0.232 P=0.252N P=0.445N |P=0.183 P=0.492N P=0.505N P=0.314 | |POLY 1.5 | P=0.189N P=0.243 P=0.245N P=0.428N |P=0.196 P=0.499N P=0.502N P=0.333 | |POLY 6 | P=0.220N P=0.205 P=0.266N P=0.476N |P=0.165 P=0.481N P=0.510N P=0.288 | |LOGISTIC REGRESSION| P=0.203N P=0.230 P=0.248N P=0.408N |P=0.127 P=0.434N P=0.545N P=0.260 | |COCH-ARM / FISHERS | P=0.178N P=0.245 P=0.243N P=0.410N |P=0.213 P=0.510N P=0.500N P=0.357 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 2/48 (4%) 1/50 (2%) 1/49 (2%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 11.9% 5.1% 2.4% 2.7% |0.0% 0.0% 2.3% 2.4% | |TERMINAL (d) | 2/25 (8%) 2/20 (10%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 574 722 (T) 662 722 (T) |--- --- 729 (T) 641 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.098N P=0.290N P=0.115N P=0.195N |P=0.187 (e) P=0.480 P=0.453 | |POLY 3 | P=0.065N P=0.245N P=0.106N P=0.130N |P=0.213 (e) P=0.501 P=0.487 | |POLY 1.5 | P=0.063N P=0.236N P=0.103N P=0.118N |P=0.224 (e) P=0.503 P=0.495 | |POLY 6 | P=0.069N P=0.268N P=0.113N P=0.152N |P=0.198 (e) P=0.498 P=0.477 | |LOGISTIC REGRESSION| P=0.067N P=0.233N P=0.103N P=0.115N |P=0.242 (e) P=0.480 P=0.532 | |COCH-ARM / FISHERS | P=0.061N P=0.235N P=0.102N P=0.107N |P=0.238 (e) P=0.505 P=0.505 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 12 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- --- |596 --- 703 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.217N P=0.231N P=0.505N P=0.273N | |POLY 3 | (e) (e) (e) (e) |P=0.200N P=0.233N P=0.508N P=0.260N | |POLY 1.5 | (e) (e) (e) (e) |P=0.195N P=0.235N P=0.504N P=0.250N | |POLY 6 | (e) (e) (e) (e) |P=0.207N P=0.232N P=0.514N P=0.276N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.166N P=0.269N P=0.505N P=0.205N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.188N P=0.247N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/48 (6%) 13/50 (26%) 10/49 (20%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.3% 7.6% 30.7% 26.2% |0.0% 0.0% 2.3% 0.0% | |TERMINAL (d) | 3/25 (12%) 2/20 (10%) 8/25 (32%) 3/16 (19%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) 665 534 622 |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.573 P=0.007 ** P=0.007 ** |P=0.665 (e) P=0.480 (e) | |POLY 3 | P=0.004 ** P=0.643 P=0.006 ** P=0.022 * |P=0.653 (e) P=0.498 (e) | |POLY 1.5 | P=0.005 ** P=0.647 P=0.006 ** P=0.026 * |P=0.671 (e) P=0.499 (e) | |POLY 6 | P=0.003 ** P=0.628 P=0.005 ** P=0.016 * |P=0.625 (e) P=0.496 (e) | |LOGISTIC REGRESSION| P=0.003 ** P=0.584 P=0.006 ** P=0.012 * |(e) (e) P=0.480 (e) | |COCH-ARM / FISHERS | P=0.009 ** P=0.641 P=0.006 ** P=0.033 * |P=0.694 (e) P=0.500 (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 13 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Developmental Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.140N P=0.288N P=0.237N P=0.340N |(e) (e) (e) (e) | |POLY 3 | P=0.111N P=0.248N P=0.238N P=0.259N |(e) (e) (e) (e) | |POLY 1.5 | P=0.113N P=0.245N P=0.237N P=0.250N |(e) (e) (e) (e) | |POLY 6 | P=0.106N P=0.256N P=0.243N P=0.274N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.140N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.116N P=0.258N P=0.247N P=0.253N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/48 (2%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 7.3% 2.6% 0.0% 5.2% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 692 722 (T) --- 194 |--- 488 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.552N P=0.393N P=0.130N P=0.654N |P=0.410N P=0.242 (e) (e) | |POLY 3 | P=0.450N P=0.323N P=0.120N P=0.534N |P=0.412N P=0.250 (e) (e) | |POLY 1.5 | P=0.449N P=0.318N P=0.118N P=0.519N |P=0.408N P=0.245 (e) (e) | |POLY 6 | P=0.451N P=0.338N P=0.124N P=0.562N |P=0.418N P=0.257 (e) (e) | |LOGISTIC REGRESSION| P=0.424N P=0.373N P=0.130N P=0.482N |P=0.295N P=0.095 (e) (e) | |COCH-ARM / FISHERS | P=0.447N P=0.324N P=0.121N P=0.510N |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 14 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |3/50 (6%) 0/50 (0%) 4/50 (8%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.6% 0.0% 9.0% 14.3% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 2/29 (7%) 3/26 (12%) | |FIRST INCIDENCE | --- --- --- --- |493 --- 561 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.030 * P=0.111N P=0.478 P=0.181 | |POLY 3 | (e) (e) (e) (e) |P=0.042 * P=0.117N P=0.491 P=0.207 | |POLY 1.5 | (e) (e) (e) (e) |P=0.047 * P=0.118N P=0.496 P=0.222 | |POLY 6 | (e) (e) (e) (e) |P=0.036 * P=0.115N P=0.484 P=0.187 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.082 P=0.144N P=0.497 P=0.295 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.055 P=0.121N P=0.500 P=0.243 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 47/50 (94%) 47/48 (98%) 49/50 (98%) 49/49 (100%)|41/50 (82%) 42/50 (84%) 35/50 (70%) 37/50 (74%) | |POLY-3 ADJUSTED (b)| 95.2% 98.7% 98.7% 100.0% |83.7% 87.6% 73.8% 80.0% | |TERMINAL (d) | 25/25 (100%) 20/20 (100%) 25/25 (100%) 16/16 (100%)|28/32 (88%) 35/37 (95%) 22/29 (76%) 22/26 (85%) | |FIRST INCIDENCE | 309 444 269 194 |399 533 549 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.029 * P=0.195 P=0.407 P=0.027 * |P=0.246 P=0.276N P=0.356N P=0.348 | |POLY 3 | P=0.080 P=0.331 P=0.322 P=0.163 |P=0.226N P=0.391 P=0.164N P=0.416N | |POLY 1.5 | P=0.076 P=0.324 P=0.313 P=0.141 |P=0.177N P=0.437 P=0.146N P=0.336N | |POLY 6 | P=0.096 P=0.352 P=0.347 P=0.218 |P=0.292N P=0.337 P=0.185N P=0.518N | |LOGISTIC REGRESSION| P=0.071 P=0.324 P=0.306 P=0.126 |P=0.209N P=0.547 P=0.121N P=0.297N | |COCH-ARM / FISHERS | P=0.074 P=0.324 P=0.309 P=0.125 |P=0.120N P=0.500 P=0.121N P=0.235N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 15 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |0.0% 0.0% 4.6% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- 444 |--- --- 707 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.199 (e) (e) P=0.508 |P=0.184 (e) P=0.226 P=0.459 | |POLY 3 | P=0.191 (e) (e) P=0.485 |P=0.209 (e) P=0.235 P=0.483 | |POLY 1.5 | P=0.194 (e) (e) P=0.490 |P=0.225 (e) P=0.236 P=0.490 | |POLY 6 | P=0.186 (e) (e) P=0.474 |P=0.187 (e) P=0.233 P=0.472 | |LOGISTIC REGRESSION| P=0.272 (e) (e) P=0.555 |P=0.192 (e) P=0.232 P=0.459 | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.495 |P=0.246 (e) P=0.247 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/48 (0%) 4/50 (8%) 7/49 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 9.7% 18.4% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 3/25 (12%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) --- 648 644 |--- --- --- 503 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.545N P=0.178 P=0.012 * |P=0.197 (e) (e) P=0.500 | |POLY 3 | P<0.001 ** P=0.510N P=0.177 P=0.021 * |P=0.188 (e) (e) P=0.486 | |POLY 1.5 | P=0.002 ** P=0.507N P=0.180 P=0.024 * |P=0.193 (e) (e) P=0.492 | |POLY 6 | P<0.001 ** P=0.518N P=0.171 P=0.017 * |P=0.181 (e) (e) P=0.477 | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.164 P=0.018 * |P=0.299 (e) (e) P=0.576 | |COCH-ARM / FISHERS | P=0.002 ** P=0.510N P=0.181 P=0.028 * |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 16 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 2.4% 2.6% |4.5% 4.4% 6.8% 4.9% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 2/29 (7%) 1/26 (4%) | |FIRST INCIDENCE | --- 708 679 717 |717 728 671 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.311 P=0.438 P=0.481 P=0.416 |P=0.457 P=0.641N P=0.463 P=0.624 | |POLY 3 | P=0.359 P=0.494 P=0.500 P=0.486 |P=0.520 P=0.683N P=0.497 P=0.667 | |POLY 1.5 | P=0.372 P=0.497 P=0.501 P=0.493 |P=0.541 P=0.687N P=0.499 P=0.679 | |POLY 6 | P=0.336 P=0.485 P=0.496 P=0.473 |P=0.490 P=0.677N P=0.494 P=0.649 | |LOGISTIC REGRESSION| P=0.350 P=0.474 P=0.500 P=0.434 |P=0.529 P=0.662N P=0.491 P=0.687 | |COCH-ARM / FISHERS | P=0.386 P=0.495 P=0.500 P=0.500 |P=0.569 P=0.691N P=0.500 P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/50 (24%) 5/49 (10%) 0/50 (0%) 1/50 (2%) |38/50 (76%) 28/50 (56%) 11/50 (22%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 29.0% 12.6% 0.0% 2.6% |81.3% 60.9% 25.1% 0.0% | |TERMINAL (d) | 11/25 (44%) 5/20 (25%) 0/25 (0%) 1/16 (6%) |30/32 (94%) 26/37 (70%) 11/29 (38%) 0/26 (0%) | |FIRST INCIDENCE | 644 722 (T) --- 722 (T) |493 666 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001N** P=0.107N P<0.001N** P=0.008N** |P<0.001N** P=0.002N** P<0.001N** P<0.001N** | |POLY 3 | P<0.001N** P=0.057N P<0.001N** P<0.001N** |P<0.001N** P=0.019N* P<0.001N** P<0.001N** | |POLY 1.5 | P<0.001N** P=0.055N P<0.001N** P<0.001N** |P<0.001N** P=0.021N* P<0.001N** P<0.001N** | |POLY 6 | P<0.001N** P=0.068N P<0.001N** P=0.002N** |P<0.001N** P=0.017N* P<0.001N** P<0.001N** | |LOGISTIC REGRESSION| P<0.001N** P=0.120N P<0.001N** P=0.005N** |P<0.001N** P=0.009N** P<0.001N** P<0.001N** | |COCH-ARM / FISHERS | P<0.001N** P=0.059N P<0.001N** P<0.001N** |P<0.001N** P=0.028N* P<0.001N** P<0.001N** | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 17 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 1/49 (2%) 7/50 (14%) 4/50 (8%) |4/50 (8%) 9/50 (18%) 11/50 (22%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 17.0% 2.5% 17.1% 10.3% |9.0% 19.7% 25.1% 39.3% | |TERMINAL (d) | 7/25 (28%) 1/20 (5%) 7/25 (28%) 3/16 (19%) |4/32 (13%) 9/37 (24%) 11/29 (38%) 16/26 (62%) | |FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 562 |729 (T) 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.482 P=0.055N P=0.622 P=0.532N |P<0.001 ** P=0.174 P=0.023 * P<0.001 ** | |POLY 3 | P=0.447N P=0.032N* P=0.610 P=0.292N |P<0.001 ** P=0.126 P=0.040 * P<0.001 ** | |POLY 1.5 | P=0.435N P=0.031N* P=0.613N P=0.277N |P<0.001 ** P=0.122 P=0.042 * P<0.001 ** | |POLY 6 | P=0.468N P=0.036N* P=0.593 P=0.324N |P<0.001 ** P=0.132 P=0.036 * P<0.001 ** | |LOGISTIC REGRESSION| P=0.566 P=0.055N P=0.622 P=0.379N |P<0.001 ** P=0.174 P=0.023 * P<0.001 ** | |COCH-ARM / FISHERS | P=0.415N P=0.032N* P=0.613N P=0.262N |P=0.002 ** P=0.117 P=0.045 * P=0.003 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% |8.8% 2.2% 6.7% 4.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 434 --- --- --- |588 728 624 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.304N P=0.488N P=0.492N P=0.496N |P=0.445N P=0.164N P=0.521N P=0.388N | |POLY 3 | P=0.294N P=0.510N P=0.505N P=0.518N |P=0.403N P=0.177N P=0.511N P=0.373N | |POLY 1.5 | P=0.300N P=0.506N P=0.502N P=0.510N |P=0.389N P=0.177N P=0.505N P=0.356N | |POLY 6 | P=0.284N P=0.520N P=0.511N P=0.532N |P=0.425N P=0.176N P=0.519N P=0.401N | |LOGISTIC REGRESSION| P=0.233N P=0.733N P=0.529N P=0.439N |P=0.250N P=0.203N P=0.507N P=0.215N | |COCH-ARM / FISHERS | P=0.305N P=0.505N P=0.500N P=0.500N |P=0.371N P=0.181N P=0.500N P=0.339N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 18 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 12/49 (24%) 11/50 (22%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 9.6% 29.4% 26.0% 7.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 7/20 (35%) 7/25 (28%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 574 604 525 520 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.435N P=0.012 * P=0.049 * P=0.645N |(e) (e) (e) (e) | |POLY 3 | P=0.275N P=0.020 * P=0.044 * P=0.534N |(e) (e) (e) (e) | |POLY 1.5 | P=0.249N P=0.022 * P=0.045 * P=0.517N |(e) (e) (e) (e) | |POLY 6 | P=0.330N P=0.015 * P=0.040 * P=0.564N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.262N P=0.020 * P=0.046 * P=0.501N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.226N P=0.024 * P=0.045 * P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Developmental Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 2.6% |2.2% 4.4% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 722 (T) 428 |696 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.204 (e) P=0.500 P=0.508 |P=0.306N P=0.543 P=0.756 P=0.550N | |POLY 3 | P=0.224 (e) P=0.499 P=0.490 |P=0.270N P=0.510 P=0.758 P=0.518N | |POLY 1.5 | P=0.230 (e) P=0.500 P=0.495 |P=0.260N P=0.506 P=0.759 P=0.510N | |POLY 6 | P=0.212 (e) P=0.494 P=0.479 |P=0.286N P=0.515 P=0.755 P=0.529N | |LOGISTIC REGRESSION| P=0.270 (e) P=0.500 P=0.563 |P=0.292N P=0.517 P=0.759 P=0.511N | |COCH-ARM / FISHERS | P=0.237 (e) P=0.500 P=0.500 |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 19 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 23/49 (47%) 23/50 (46%) 13/50 (26%) |19/50 (38%) 24/50 (48%) 22/50 (44%) 15/50 (30%) | |POLY-3 ADJUSTED (b)| 33.6% 54.8% 52.5% 31.7% |41.0% 51.9% 49.9% 36.3% | |TERMINAL (d) | 13/25 (52%) 15/20 (75%) 15/25 (60%) 5/16 (31%) |13/32 (41%) 22/37 (60%) 21/29 (72%) 12/26 (46%) | |FIRST INCIDENCE | 574 455 525 428 |588 666 671 649 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.369 P=0.005 ** P=0.042 * P=0.288 |P=0.512N P=0.393 P=0.211 P=0.539N | |POLY 3 | P=0.283N P=0.035 * P=0.055 P=0.518N |P=0.289N P=0.196 P=0.259 P=0.407N | |POLY 1.5 | P=0.277N P=0.040 * P=0.052 P=0.508N |P=0.213N P=0.204 P=0.299 P=0.338N | |POLY 6 | P=0.304N P=0.025 * P=0.057 P=0.546N |P=0.422N P=0.185 P=0.201 P=0.513N | |LOGISTIC REGRESSION| P=0.368N P=0.021 * P=0.039 * P=0.582N |P=0.373N P=0.247 P=0.307 P=0.407N | |COCH-ARM / FISHERS | P=0.275N P=0.041 * P=0.048 * P=0.500N |P=0.142N P=0.210 P=0.342 P=0.263N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/50 (2%) 10/50 (20%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 2.4% 24.7% |2.2% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 574 722 (T) 679 523 |681 570 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.738 P=0.750 P=0.003 ** |P=0.254N P=0.752N P=0.495N P=0.547N | |POLY 3 | P<0.001 ** P=0.751 P=0.758 P=0.003 ** |P=0.241N P=0.752N P=0.503N P=0.518N | |POLY 1.5 | P<0.001 ** P=0.755 P=0.760 P=0.003 ** |P=0.239N P=0.755N P=0.501N P=0.510N | |POLY 6 | P<0.001 ** P=0.740 P=0.752 P=0.002 ** |P=0.243N P=0.748N P=0.506N P=0.530N | |LOGISTIC REGRESSION| P<0.001 ** P=0.755 P=0.759 P=0.005 ** |P=0.199N P=0.722 P=0.500N P=0.499N | |COCH-ARM / FISHERS | P<0.001 ** P=0.747 P=0.753N P=0.004 ** |P=0.236N P=0.753N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 20 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.9% 2.5% 0.0% 0.0% |0.0% 2.2% 2.3% 4.9% | |TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | 722 (T) 722 (T) --- --- |--- 488 707 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.131N P=0.579N P=0.237N P=0.340N |P=0.112 P=0.504 P=0.494 P=0.193 | |POLY 3 | P=0.101N P=0.512N P=0.238N P=0.253N |P=0.133 P=0.509 P=0.498 P=0.218 | |POLY 1.5 | P=0.101N P=0.506N P=0.237N P=0.245N |P=0.142 P=0.506 P=0.499 P=0.227 | |POLY 6 | P=0.101N P=0.527N P=0.243N P=0.268N |P=0.121 P=0.514 P=0.497 P=0.207 | |LOGISTIC REGRESSION| P=0.131N P=0.579N (e) (e) |P=0.180 P=0.289 P=0.498 P=0.193 | |COCH-ARM / FISHERS | P=0.100N P=0.508N P=0.247N P=0.247N |P=0.153 P=0.500 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 8/50 (16%) 3/50 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 7.3% 2.5% 0.0% 0.0% |19.7% 16.8% 6.8% 7.3% | |TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |6/32 (19%) 4/37 (11%) 3/29 (10%) 2/26 (8%) | |FIRST INCIDENCE | 695 708 --- --- |399 533 729 (T) 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.066N P=0.400N P=0.128N P=0.206N |P=0.054N P=0.415N P=0.083N P=0.119N | |POLY 3 | P=0.043N* P=0.317N P=0.120N P=0.132N |P=0.034N* P=0.462N P=0.067N P=0.084N | |POLY 1.5 | P=0.043N* P=0.312N P=0.118N P=0.125N |P=0.029N* P=0.478N P=0.064N P=0.073N | |POLY 6 | P=0.043N* P=0.333N P=0.124N P=0.145N |P=0.043N* P=0.438N P=0.072N P=0.102N | |LOGISTIC REGRESSION| P=0.055N P=0.361N P=0.130N P=0.166N |P=0.017N* P=0.560N P=0.062N P=0.058N | |COCH-ARM / FISHERS | P=0.044N* P=0.316N P=0.121N P=0.121N |P=0.024N* P=0.500N P=0.061N P=0.061N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 21 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 1/50 (2%) 2/50 (4%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |19.6% 2.2% 4.6% 9.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |6/32 (19%) 1/37 (3%) 2/29 (7%) 3/26 (12%) | |FIRST INCIDENCE | --- --- --- --- |399 729 (T) 729 (T) 673 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.240N P=0.007N** P=0.040N* P=0.211N | |POLY 3 | (e) (e) (e) (e) |P=0.161N P=0.008N** P=0.030N* P=0.163N | |POLY 1.5 | (e) (e) (e) (e) |P=0.152N P=0.008N** P=0.028N* P=0.142N | |POLY 6 | (e) (e) (e) (e) |P=0.173N P=0.008N** P=0.032N* P=0.195N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.148N P=0.011N* P=0.027N* P=0.118N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.145N P=0.008N** P=0.026N* P=0.117N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mitotic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.2% |2.3% 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 2/16 (13%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- 722 (T) |729 (T) --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.024 * (e) (e) P=0.145 |P=0.542 P=0.471N P=0.520N P=0.715 | |POLY 3 | P=0.043 * (e) (e) P=0.221 |P=0.577 P=0.494N P=0.502N P=0.741 | |POLY 1.5 | P=0.044 * (e) (e) P=0.229 |P=0.585 P=0.496N P=0.501N P=0.750 | |POLY 6 | P=0.042 * (e) (e) P=0.207 |P=0.567 P=0.490N P=0.504N P=0.728 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.145 |P=0.542 (e) (e) P=0.715 | |COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.595 P=0.500N P=0.500N P=0.753N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 22 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 4/50 (8%) 1/50 (2%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 4.9% 2.5% 7.3% 2.6% |4.5% 8.6% 2.3% 12.2% | |TERMINAL (d) | 1/25 (4%) 1/20 (5%) 3/25 (12%) 0/16 (0%) |2/32 (6%) 2/37 (5%) 1/29 (3%) 4/26 (15%) | |FIRST INCIDENCE | 695 722 (T) 722 (T) 647 |729 (T) 533 729 (T) 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.599N P=0.580N P=0.491 P=0.604N |P=0.125 P=0.391 P=0.535N P=0.145 | |POLY 3 | P=0.499N P=0.513N P=0.496 P=0.524N |P=0.181 P=0.361 P=0.504N P=0.185 | |POLY 1.5 | P=0.487N P=0.507N P=0.500 P=0.512N |P=0.194 P=0.351 P=0.501N P=0.199 | |POLY 6 | P=0.518N P=0.529N P=0.484 P=0.544N |P=0.165 P=0.375 P=0.508N P=0.167 | |LOGISTIC REGRESSION| P=0.542N P=0.561N P=0.463 P=0.529N |P=0.195 P=0.317 P=0.535N P=0.157 | |COCH-ARM / FISHERS | P=0.471N P=0.508N P=0.500 P=0.500N |P=0.210 P=0.339 P=0.500N P=0.218 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 2/50 (4%) |6/50 (12%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.7% 2.5% 2.4% 5.2% |13.0% 2.2% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 388 722 (T) 538 627 |399 488 707 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.505 P=0.521N P=0.500N P=0.650 |P=0.012N* P=0.056N P=0.074N P=0.033N* | |POLY 3 | P=0.533 P=0.523N P=0.508N P=0.661 |P=0.008N** P=0.055N P=0.064N P=0.023N* | |POLY 1.5 | P=0.543 P=0.513N P=0.503N P=0.675 |P=0.007N** P=0.055N P=0.060N P=0.019N* | |POLY 6 | P=0.518 P=0.542N P=0.518N P=0.636 |P=0.009N** P=0.054N P=0.068N P=0.029N* | |LOGISTIC REGRESSION| P=0.604 P=0.598N P=0.556N P=0.665N |P=0.003N** P=0.079N P=0.058N P=0.009N** | |COCH-ARM / FISHERS | P=0.558 P=0.508N P=0.500N P=0.691N |P=0.007N** P=0.056N P=0.056N P=0.013N* | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 23 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 11/49 (22%) 20/50 (40%) 25/50 (50%) |6/50 (12%) 2/50 (4%) 6/50 (12%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 9.6% 27.1% 45.2% 59.5% |13.2% 4.3% 13.3% 40.9% | |TERMINAL (d) | 1/25 (4%) 6/20 (30%) 10/25 (40%) 11/16 (69%) |2/32 (6%) 1/37 (3%) 1/29 (3%) 15/26 (58%) | |FIRST INCIDENCE | 644 665 525 523 |596 570 561 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.119N P=0.580 P=0.002 ** | |POLY 3 | P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.126N P=0.619 P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.129N P=0.620N P=0.004 ** | |POLY 6 | P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.123N P=0.615 P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.150N P=0.621N P=0.003 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.134N P=0.620N P=0.008 ** | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.6% 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- --- |399 533 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.051N P=0.298N P=0.127N P=0.148N | |POLY 3 | (e) (e) (e) (e) |P=0.046N* P=0.301N P=0.126N P=0.141N | |POLY 1.5 | (e) (e) (e) (e) |P=0.045N* P=0.303N P=0.123N P=0.131N | |POLY 6 | (e) (e) (e) (e) |P=0.047N* P=0.297N P=0.131N P=0.156N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.019N* P=0.436N P=0.139N P=0.066N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044N* P=0.309N P=0.121N P=0.121N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 24 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver | | Vacuolization Cytoplasmic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 6/49 (12%) 13/50 (26%) 17/50 (34%) |10/50 (20%) 7/50 (14%) 9/50 (18%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 9.6% 14.9% 30.6% 42.8% |22.2% 15.3% 20.3% 43.3% | |TERMINAL (d) | 2/25 (8%) 3/20 (15%) 9/25 (36%) 9/16 (56%) |6/32 (19%) 7/37 (19%) 7/29 (24%) 15/26 (58%) | |FIRST INCIDENCE | 644 666 534 622 |661 729 (T) 624 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.256 P=0.018 * P<0.001 ** |P<0.001 ** P=0.211N P=0.571N P=0.013 * | |POLY 3 | P<0.001 ** P=0.348 P=0.014 * P<0.001 ** |P=0.006 ** P=0.283N P=0.514N P=0.027 * | |POLY 1.5 | P<0.001 ** P=0.358 P=0.015 * P<0.001 ** |P=0.008 ** P=0.288N P=0.506N P=0.039 * | |POLY 6 | P<0.001 ** P=0.322 P=0.013 * P<0.001 ** |P=0.004 ** P=0.277N P=0.530N P=0.016 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.322 P=0.016 * P<0.001 ** |P=0.002 ** P=0.255N P=0.518N P=0.016 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.357 P=0.016 * P<0.001 ** |P=0.014 * P=0.298N P=0.500N P=0.059 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Bile Duct | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 46/50 (92%) 43/49 (88%) 44/50 (88%) 49/50 (98%) |20/50 (40%) 29/50 (58%) 34/50 (68%) 29/50 (58%) | |POLY-3 ADJUSTED (b)| 97.3% 91.5% 92.1% 100.0% |43.3% 62.1% 72.4% 64.3% | |TERMINAL (d) | 25/25 (100%) 19/20 (95%) 23/25 (92%) 16/16 (100%)|12/32 (38%) 25/37 (68%) 22/29 (76%) 17/26 (65%) | |FIRST INCIDENCE | 434 455 486 428 |622 546 496 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.017 * P=0.343 P=0.478N P=0.017 * |P=0.004 ** P=0.179 P=0.006 ** P=0.015 * | |POLY 3 | P=0.178 P=0.189N P=0.227N P=0.378 |P=0.029 * P=0.049 * P=0.003 ** P=0.030 * | |POLY 1.5 | P=0.130 P=0.218N P=0.258N P=0.214 |P=0.039 * P=0.052 P=0.003 ** P=0.039 * | |POLY 6 | P=0.238 P=0.208N P=0.251N P=0.565 |P=0.019 * P=0.044 * P=0.002 ** P=0.022 * | |LOGISTIC REGRESSION| P=0.064 P=0.199N P=0.242N P=0.120 |P=0.023 * P=0.068 P=0.004 ** P=0.034 * | |COCH-ARM / FISHERS | P=0.122 P=0.357N P=0.370N P=0.181 |P=0.062 P=0.055 P=0.004 ** P=0.055 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 25 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Capsule | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.212 | |POLY 3 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.221 | |POLY 1.5 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.228 | |POLY 6 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.212 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.065 (e) (e) P=0.266 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Cytomegaly | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/49 (8%) 8/50 (16%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 4/50 (8%) 20/50 (40%) | |POLY-3 ADJUSTED (b)| 0.0% 10.0% 19.4% 15.6% |0.0% 2.2% 9.1% 48.6% | |TERMINAL (d) | 0/25 (0%) 3/20 (15%) 7/25 (28%) 5/16 (31%) |0/32 (0%) 1/37 (3%) 4/29 (14%) 18/26 (69%) | |FIRST INCIDENCE | --- 666 609 644 |--- 729 (T) 729 (T) 649 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** P=0.042 * P=0.004 ** P=0.004 ** |P<0.001 ** P=0.529 P=0.050 P<0.001 ** | |POLY 3 | P=0.017 * P=0.056 P=0.003 ** P=0.012 * |P<0.001 ** P=0.506 P=0.059 P<0.001 ** | |POLY 1.5 | P=0.021 * P=0.058 P=0.004 ** P=0.013 * |P<0.001 ** P=0.504 P=0.060 P<0.001 ** | |POLY 6 | P=0.012 * P=0.051 P=0.003 ** P=0.009 ** |P<0.001 ** P=0.510 P=0.057 P<0.001 ** | |LOGISTIC REGRESSION| P=0.011 * P=0.046 * P=0.004 ** P=0.007 ** |P<0.001 ** P=0.529 P=0.050 P<0.001 ** | |COCH-ARM / FISHERS | P=0.028 * P=0.056 P=0.003 ** P=0.013 * |P<0.001 ** P=0.500 P=0.059 P<0.001 ** | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 26 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/49 (6%) 2/50 (4%) 8/50 (16%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 2.4% 7.4% 4.9% 19.8% |2.2% 4.3% 4.6% 17.2% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 7/26 (27%) | |FIRST INCIDENCE | 388 444 679 428 |661 488 707 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003 ** P=0.273 P=0.489 P=0.010 * |P=0.002 ** P=0.510 P=0.483 P=0.014 * | |POLY 3 | P=0.004 ** P=0.294 P=0.492 P=0.012 * |P=0.005 ** P=0.516 P=0.495 P=0.021 * | |POLY 1.5 | P=0.005 ** P=0.299 P=0.497 P=0.014 * |P=0.006 ** P=0.510 P=0.498 P=0.025 * | |POLY 6 | P=0.004 ** P=0.281 P=0.483 P=0.010 * |P=0.004 ** P=0.524 P=0.490 P=0.016 * | |LOGISTIC REGRESSION| P=0.008 ** P=0.194 P=0.484 P=0.021 * |P=0.007 ** P=0.397 P=0.499 P=0.014 * | |COCH-ARM / FISHERS | P=0.006 ** P=0.301 P=0.500 P=0.015 * |P=0.008 ** P=0.500 P=0.500 P=0.030 * | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/50 (0%) 5/50 (10%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.4% 0.0% 12.3% |2.2% 4.3% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 618 --- 194 |503 570 687 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.020 * P=0.098 (e) P=0.029 * |P=0.275N P=0.508 P=0.752N P=0.500N | |POLY 3 | P=0.023 * P=0.115 (e) P=0.029 * |P=0.274N P=0.511 P=0.756 P=0.520N | |POLY 1.5 | P=0.024 * P=0.117 (e) P=0.030 * |P=0.263N P=0.506 P=0.758 P=0.511N | |POLY 6 | P=0.021 * P=0.109 (e) P=0.026 * |P=0.290N P=0.519 P=0.753 P=0.532N | |LOGISTIC REGRESSION| P=0.037 * P=0.117 (e) P=0.037 * |P=0.177N P=0.371 P=0.737 P=0.424N | |COCH-ARM / FISHERS | P=0.026 * P=0.117 (e) P=0.028 * |P=0.247N P=0.500 P=0.753N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 27 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Liver: Periportal | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 29/50 (58%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 69.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 12/16 (75%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 673 523 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** (e) P=0.233 P<0.001 ** |(e) (e) (e) (e) | |POLY 3 | P<0.001 ** (e) P=0.236 P<0.001 ** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001 ** (e) P=0.238 P<0.001 ** |(e) (e) (e) (e) | |POLY 6 | P<0.001 ** (e) P=0.232 P<0.001 ** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P<0.001 ** (e) P=0.233 P<0.001 ** |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 P<0.001 ** |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% 5.2% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 664 --- 647 |649 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123 P=0.500 (e) P=0.213 |P=0.335N P=0.495N P=0.510N P=0.553N | |POLY 3 | P=0.131 P=0.498 (e) P=0.223 |P=0.299N P=0.495N P=0.503N P=0.518N | |POLY 1.5 | P=0.135 P=0.501 (e) P=0.230 |P=0.302N P=0.497N P=0.502N P=0.510N | |POLY 6 | P=0.125 P=0.490 (e) P=0.212 |P=0.293N P=0.493N P=0.507N P=0.531N | |LOGISTIC REGRESSION| P=0.138 P=0.500 (e) P=0.234 |P=0.285N P=0.527N P=0.506N P=0.478N | |COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 28 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 5.1% |0.0% 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 648 520 |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.058 (e) P=0.237 P=0.191 |P=0.163 (e) (e) P=0.459 | |POLY 3 | P=0.076 (e) P=0.237 P=0.224 |P=0.186 (e) (e) P=0.483 | |POLY 1.5 | P=0.080 (e) P=0.238 P=0.231 |P=0.192 (e) (e) P=0.490 | |POLY 6 | P=0.070 (e) P=0.233 P=0.213 |P=0.179 (e) (e) P=0.472 | |LOGISTIC REGRESSION| P=0.088 (e) P=0.236 P=0.246 |(e) (e) (e) P=0.459 | |COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 4/50 (8%) 9/50 (18%) 9/50 (18%) |13/50 (26%) 10/50 (20%) 9/50 (18%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 14.6% 9.8% 21.1% 23.2% |28.2% 21.9% 19.9% 26.2% | |TERMINAL (d) | 6/25 (24%) 3/20 (15%) 5/25 (20%) 7/16 (44%) |9/32 (28%) 10/37 (27%) 5/29 (17%) 8/26 (31%) | |FIRST INCIDENCE | 722 (T) 607 269 622 |399 729 (T) 561 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * P=0.495N P=0.281 P=0.062 |P=0.445 P=0.210N P=0.300N P=0.576 | |POLY 3 | P=0.104 P=0.371N P=0.313 P=0.240 |P=0.483N P=0.322N P=0.246N P=0.511N | |POLY 1.5 | P=0.116 P=0.364N P=0.309 P=0.263 |P=0.447N P=0.321N P=0.242N P=0.467N | |POLY 6 | P=0.087 P=0.393N P=0.307 P=0.203 |P=0.531N P=0.322N P=0.251N P=0.571N | |LOGISTIC REGRESSION| P=0.101 P=0.456N P=0.288 P=0.122 |P=0.440N P=0.305N P=0.232N P=0.434N | |COCH-ARM / FISHERS | P=0.135 P=0.370N P=0.288 P=0.288 |P=0.397N P=0.318N P=0.235N P=0.408N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 29 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 10/50 (20%) 12/50 (24%) 9/50 (18%) |9/50 (18%) 8/50 (16%) 6/50 (12%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 19.0% 23.9% 28.3% 23.5% |20.2% 17.4% 13.6% 19.3% | |TERMINAL (d) | 6/25 (24%) 4/20 (20%) 6/25 (24%) 8/16 (50%) |8/32 (25%) 6/37 (16%) 4/29 (14%) 6/26 (23%) | |FIRST INCIDENCE | 388 444 596 717 |687 666 700 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.188 P=0.240 P=0.223 P=0.154 |P=0.440 P=0.382N P=0.344N P=0.536 | |POLY 3 | P=0.355 P=0.389 P=0.227 P=0.413 |P=0.499N P=0.470N P=0.293N P=0.564N | |POLY 1.5 | P=0.401 P=0.401 P=0.228 P=0.453 |P=0.471N P=0.482N P=0.290N P=0.535N | |POLY 6 | P=0.287 P=0.358 P=0.225 P=0.348 |P=0.539N P=0.451N P=0.298N P=0.605N | |LOGISTIC REGRESSION| P=0.374 P=0.395 P=0.225 P=0.369 |P=0.520 P=0.440N P=0.307N P=0.581 | |COCH-ARM / FISHERS | P=0.464 P=0.398 P=0.227 P=0.500 |P=0.434N P=0.500N P=0.288N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.3% 0.0% 7.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 607 --- 717 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.104 P=0.106 (e) P=0.057 |(e) (e) (e) (e) | |POLY 3 | P=0.146 P=0.119 (e) P=0.105 |(e) (e) (e) (e) | |POLY 1.5 | P=0.154 P=0.120 (e) P=0.112 |(e) (e) (e) (e) | |POLY 6 | P=0.132 P=0.113 (e) P=0.095 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.142 P=0.120 (e) P=0.056 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.163 P=0.121 (e) P=0.121 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 30 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |3/49 (6%) 4/50 (8%) 9/50 (18%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.7% 7.4% 4.9% 7.8% |6.8% 8.6% 20.3% 4.9% | |TERMINAL (d) | 3/25 (12%) 2/20 (10%) 2/25 (8%) 2/16 (13%) |3/32 (9%) 3/37 (8%) 7/29 (24%) 2/26 (8%) | |FIRST INCIDENCE | 692 708 722 (T) 598 |729 (T) 533 573 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.573 P=0.631N P=0.346N P=0.609 |P=0.509 P=0.571 P=0.043 * P=0.595N | |POLY 3 | P=0.443N P=0.509N P=0.340N P=0.535N |P=0.555N P=0.530 P=0.061 P=0.534N | |POLY 1.5 | P=0.433N P=0.499N P=0.337N P=0.518N |P=0.511N P=0.523 P=0.063 P=0.515N | |POLY 6 | P=0.459N P=0.534N P=0.352N P=0.567N |P=0.506 P=0.541 P=0.058 P=0.562N | |LOGISTIC REGRESSION| P=0.514N P=0.611N P=0.373N P=0.578N |P=0.537N P=0.512 P=0.057 P=0.595N | |COCH-ARM / FISHERS | P=0.420N P=0.500N P=0.339N P=0.500N |P=0.456N P=0.511 P=0.065 P=0.490N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 5/50 (10%) 0/50 (0%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 12.1% 0.0% 10.3% |6.6% 2.2% 8.8% 2.4% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |1/32 (3%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- 625 --- 598 |493 570 561 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.099 P=0.023 * (e) P=0.033 * |P=0.403N P=0.294N P=0.480 P=0.367N | |POLY 3 | P=0.143 P=0.030 * (e) P=0.052 |P=0.397N P=0.297N P=0.500 P=0.342N | |POLY 1.5 | P=0.151 P=0.031 * (e) P=0.056 |P=0.374N P=0.301N P=0.500 P=0.326N | |POLY 6 | P=0.128 P=0.027 * (e) P=0.046 * |P=0.429N P=0.292N P=0.499 P=0.365N | |LOGISTIC REGRESSION| P=0.145 P=0.032 * (e) P=0.053 |P=0.236N P=0.381N P=0.481 P=0.256N | |COCH-ARM / FISHERS | P=0.164 P=0.028 * (e) P=0.059 |P=0.343N P=0.309N P=0.500 P=0.309N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 31 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.4% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 574 607 585 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.405N P=0.750N P=0.491 P=0.514N |(e) (e) (e) (e) | |POLY 3 | P=0.395N P=0.757 P=0.498 P=0.517N |(e) (e) (e) (e) | |POLY 1.5 | P=0.382N P=0.760N P=0.501 P=0.509N |(e) (e) (e) (e) | |POLY 6 | P=0.417N P=0.748 P=0.490 P=0.531N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.345N P=0.734 P=0.492 P=0.481N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/47 (4%) 0/50 (0%) 1/48 (2%) |2/49 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 2.7% |4.5% 0.0% 6.6% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 708 --- 681 |622 --- 561 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.459 P=0.173 (e) P=0.452 |P=0.333N P=0.231N P=0.488 P=0.282N | |POLY 3 | P=0.516 P=0.221 (e) P=0.482 |P=0.332N P=0.231N P=0.506 P=0.258N | |POLY 1.5 | P=0.528 P=0.224 (e) P=0.488 |P=0.314N P=0.232N P=0.508 P=0.247N | |POLY 6 | P=0.494 P=0.213 (e) P=0.470 |P=0.359N P=0.231N P=0.504 P=0.275N | |LOGISTIC REGRESSION| P=0.500 P=0.195 (e) P=0.483 |P=0.195N P=0.250N P=0.514 P=0.200N | |COCH-ARM / FISHERS | P=0.534 P=0.232 (e) P=0.490 |P=0.291N P=0.242N P=0.510 P=0.242N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 32 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/47 (6%) 2/50 (4%) 1/48 (2%) |0/49 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 7.8% 4.9% 2.7% |0.0% 0.0% 9.1% 0.0% | |TERMINAL (d) | 2/25 (8%) 3/20 (15%) 2/25 (8%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 4/29 (14%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 722 (T) |--- --- 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.451N P=0.397 P=0.697 P=0.655N |P=0.418 (e) P=0.050 (e) | |POLY 3 | P=0.342N P=0.468 P=0.692 P=0.534N |P=0.426 (e) P=0.059 (e) | |POLY 1.5 | P=0.330N P=0.474 P=0.693N P=0.522N |P=0.460 (e) P=0.061 (e) | |POLY 6 | P=0.366N P=0.450 P=0.684 P=0.556N |P=0.378 (e) P=0.057 (e) | |LOGISTIC REGRESSION| P=0.451N P=0.397 P=0.697 P=0.655N |(e) (e) P=0.050 (e) | |COCH-ARM / FISHERS | P=0.321N P=0.470 P=0.691N P=0.515N |P=0.505 (e) P=0.061 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/47 (0%) 2/50 (4%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 632 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.553 (e) P=0.240 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.559 (e) P=0.237 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.577 (e) P=0.238 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.526 (e) P=0.233 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.586 (e) P=0.237 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.591 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 33 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 4.9% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | --- --- --- --- |--- 488 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.211 P=0.242 (e) P=0.193 | |POLY 3 | (e) (e) (e) (e) |P=0.226 P=0.252 (e) P=0.220 | |POLY 1.5 | (e) (e) (e) (e) |P=0.237 P=0.248 (e) P=0.229 | |POLY 6 | (e) (e) (e) (e) |P=0.213 P=0.257 (e) P=0.207 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.339 P=0.117 (e) P=0.193 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.251 P=0.253 (e) P=0.253 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/47 (6%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 7.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 604 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.348N P=0.121 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.324N P=0.109 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.316N P=0.110 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.342N P=0.105 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.314N P=0.105 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.316N P=0.110 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 34 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/23 (0%) |2/7 (29%) 0/9 (0%) 0/15 (0%) 0/19 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |31.8% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- --- --- |493 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.124N P=0.240N P=0.240N P=0.269N | |POLY 3 | (e) (e) (e) (e) |P=0.019N* P=0.170N P=0.091N P=0.057N | |POLY 1.5 | (e) (e) (e) (e) |P=0.021N* P=0.167N P=0.081N P=0.049N* | |POLY 6 | (e) (e) (e) (e) |P=0.018N* P=0.173N P=0.106N P=0.072N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.019N* P=0.249N P=0.060N P=0.035N* | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.039N* P=0.175N P=0.091N P=0.065N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Iliac | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/23 (0%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 2/19 (11%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 14.7% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 2/4 (50%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.059 (e) (e) P=0.390 | |POLY 3 | (e) (e) (e) (e) |P=0.105 (e) (e) P=0.457 | |POLY 1.5 | (e) (e) (e) (e) |P=0.112 (e) (e) P=0.465 | |POLY 6 | (e) (e) (e) (e) |P=0.094 (e) (e) P=0.443 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.390 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.120 (e) (e) P=0.526 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 35 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Pancreatic | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/20 (0%) 0/25 (0%) 1/20 (5%) 2/23 (9%) |0/7 (0%) 0/9 (0%) 1/15 (7%) 0/19 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 10.9% |0.0% 0.0% 8.8% 0.0% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- 708 598 |--- --- 624 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.056 (e) P=0.479 P=0.231 |P=0.677 (e) P=0.491 (e) | |POLY 3 | P=0.078 (e) P=0.499 P=0.275 |P=0.704N (e) P=0.651 (e) | |POLY 1.5 | P=0.077 (e) P=0.502 P=0.273 |P=0.694N (e) P=0.650 (e) | |POLY 6 | P=0.081 (e) P=0.490 P=0.277 |P=0.719N (e) P=0.655 (e) | |LOGISTIC REGRESSION| P=0.073 (e) P=0.469 P=0.248 |P=0.667N (e) P=0.665 (e) | |COCH-ARM / FISHERS | P=0.074 (e) P=0.500 P=0.280 |P=0.684N (e) P=0.682 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/20 (5%) 0/25 (0%) 1/20 (5%) 3/23 (13%) |1/7 (14%) 1/9 (11%) 1/15 (7%) 0/19 (0%) | |POLY-3 ADJUSTED (b)| 6.4% 0.0% 6.5% 16.2% |16.5% 12.3% 8.7% 0.0% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) | |FIRST INCIDENCE | 571 --- 609 598 |493 570 605 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.086 P=0.500N P=0.760N P=0.273 |P=0.322N P=0.760 P=0.758 P=0.504N | |POLY 3 | P=0.106 P=0.461N P=0.760 P=0.359 |P=0.147N P=0.696N P=0.617N P=0.326N | |POLY 1.5 | P=0.104 P=0.456N P=0.761N P=0.360 |P=0.136N P=0.700N P=0.603N P=0.312N | |POLY 6 | P=0.110 P=0.473N P=0.751 P=0.357 |P=0.165N P=0.687N P=0.630N P=0.347N | |LOGISTIC REGRESSION| P=0.093 P=0.508N P=0.739 P=0.334 |P=0.050N (e) P=0.580N P=0.197N | |COCH-ARM / FISHERS | P=0.102 P=0.444N P=0.756N P=0.359 |P=0.121N P=0.700N P=0.545N P=0.269N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 36 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/20 (0%) 0/25 (0%) 2/20 (10%) 0/23 (0%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 1/19 (5%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 12.8% 0.0% |0.0% 0.0% 0.0% 7.2% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 1/5 (20%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- 534 --- |--- --- --- 673 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.595 (e) P=0.242 (e) |P=0.169 (e) (e) P=0.465 | |POLY 3 | P=0.609 (e) P=0.238 (e) |P=0.300 (e) (e) P=0.690 | |POLY 1.5 | P=0.612 (e) P=0.239 (e) |P=0.309 (e) (e) P=0.693 | |POLY 6 | P=0.601 (e) P=0.231 (e) |P=0.288 (e) (e) P=0.688 | |LOGISTIC REGRESSION| P=0.602 (e) P=0.225 (e) |P=0.301 (e) (e) P=0.689 | |COCH-ARM / FISHERS | P=0.608 (e) P=0.244 (e) |P=0.316 (e) (e) P=0.731 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Lymph Node: Renal | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/20 (0%) 0/25 (0%) 1/20 (5%) 4/23 (17%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 0/19 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 22.6% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/5 (0%) 0/7 (0%) 1/5 (20%) 2/6 (33%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) | |FIRST INCIDENCE | --- --- 722 (T) 685 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.004 ** (e) P=0.500 P=0.050 |(e) (e) (e) (e) | |POLY 3 | P=0.004 ** (e) P=0.498 P=0.067 |(e) (e) (e) (e) | |POLY 1.5 | P=0.005 ** (e) P=0.502 P=0.070 |(e) (e) (e) (e) | |POLY 6 | P=0.004 ** (e) P=0.489 P=0.061 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.004 ** (e) P=0.500 P=0.050 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.006 ** (e) P=0.500 P=0.072 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 37 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) |3/50 (6%) 5/50 (10%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 0.0% |6.7% 10.8% 2.3% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 4/37 (11%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 700 --- |661 611 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.653 (e) P=0.487 (e) |P=0.062N P=0.420 P=0.338N P=0.174N | |POLY 3 | P=0.664 (e) P=0.503 (e) |P=0.044N* P=0.375 P=0.311N P=0.136N | |POLY 1.5 | P=0.678 (e) P=0.505 (e) |P=0.040N* P=0.368 P=0.308N P=0.128N | |POLY 6 | P=0.640 (e) P=0.498 (e) |P=0.051N P=0.384 P=0.317N P=0.148N | |LOGISTIC REGRESSION| P=0.682 (e) P=0.499 (e) |P=0.043N* P=0.363 P=0.309N P=0.134N | |COCH-ARM / FISHERS | P=0.696 (e) P=0.505 (e) |P=0.037N* P=0.357 P=0.309N P=0.121N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 3/48 (6%) 2/50 (4%) 3/49 (6%) |5/50 (10%) 2/50 (4%) 6/50 (12%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 2.5% 7.7% 4.9% 7.9% |11.3% 4.4% 13.5% 12.0% | |TERMINAL (d) | 1/25 (4%) 3/20 (15%) 2/25 (8%) 2/16 (13%) |5/32 (16%) 2/37 (5%) 5/29 (17%) 2/26 (8%) | |FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 465 |729 (T) 729 (T) 561 634 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176 P=0.226 P=0.500 P=0.196 |P=0.250 P=0.160N P=0.437 P=0.496 | |POLY 3 | P=0.281 P=0.291 P=0.505 P=0.285 |P=0.348 P=0.203N P=0.501 P=0.591 | |POLY 1.5 | P=0.293 P=0.298 P=0.508 P=0.295 |P=0.370 P=0.209N P=0.502 P=0.608 | |POLY 6 | P=0.258 P=0.274 P=0.495 P=0.265 |P=0.320 P=0.196N P=0.499 P=0.569 | |LOGISTIC REGRESSION| P=0.264 P=0.226 P=0.500 P=0.302 |P=0.344 P=0.160N P=0.487 P=0.578 | |COCH-ARM / FISHERS | P=0.305 P=0.301 P=0.508 P=0.309 |P=0.401 P=0.218N P=0.500 P=0.630N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 38 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mammary Gland: Duct | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 16/48 (33%) 12/50 (24%) 15/49 (31%) |13/50 (26%) 9/50 (18%) 13/50 (26%) 13/50 (26%) | |POLY-3 ADJUSTED (b)| 32.8% 39.7% 27.5% 36.0% |28.4% 19.0% 28.4% 29.5% | |TERMINAL (d) | 7/25 (28%) 7/20 (35%) 7/25 (28%) 3/16 (19%) |8/32 (25%) 6/37 (16%) 7/29 (24%) 4/26 (15%) | |FIRST INCIDENCE | 434 641 269 523 |588 488 496 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263 P=0.232 P=0.433N P=0.243 |P=0.208 P=0.172N P=0.503 P=0.391 | |POLY 3 | P=0.528 P=0.335 P=0.381N P=0.468 |P=0.349 P=0.204N P=0.588N P=0.546 | |POLY 1.5 | P=0.533 P=0.368 P=0.373N P=0.481 |P=0.375 P=0.215N P=0.585N P=0.565 | |POLY 6 | P=0.514 P=0.278 P=0.415N P=0.445 |P=0.317 P=0.194N P=0.584 P=0.521 | |LOGISTIC REGRESSION| P=0.532 P=0.375 P=0.389N P=0.497 |P=0.495 P=0.253N P=0.589N P=0.564N | |COCH-ARM / FISHERS | P=0.541N P=0.387 P=0.387N P=0.500 |P=0.411 P=0.235N P=0.590N P=0.590N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 10/11 (91%) 13/14 (93%) 6/7 (86%) 8/8 (100%) |8/9 (89%) 9/11 (82%) 6/7 (86%) 11/12 (92%) | |POLY-3 ADJUSTED (b)| 91.0% 95.2% 87.8% 100.0% |88.9% 92.0% 87.2% 91.7% | |TERMINAL (d) | 4/4 (100%) 6/6 (100%) 3/3 (100%) 2/2 (100%) |6/7 (86%) 6/6 (100%) 3/3 (100%) 4/5 (80%) | |FIRST INCIDENCE | 388 604 640 523 |671 642 496 380 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.534 P=0.430 P=0.264N P=0.511 |P=0.042 * P=0.380 P=0.406 P=0.084 | |POLY 3 | P=0.423 P=0.659 P=0.718N P=0.568 |P=0.583 P=0.727 P=0.744N P=0.695 | |POLY 1.5 | P=0.421 P=0.683 P=0.688N P=0.565 |P=0.531 P=0.751N P=0.724N P=0.695 | |POLY 6 | P=0.426 P=0.613 P=0.771N P=0.572 |P=0.638 P=0.612 P=0.780N P=0.695 | |LOGISTIC REGRESSION| P=0.415 P=0.701 P=0.705N P=0.704 |P=0.368 P=0.525 P=0.624N (e) | |COCH-ARM / FISHERS | P=0.416 P=0.697 P=0.641N P=0.579 |P=0.456 P=0.579N P=0.700N P=0.686 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 39 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 26/50 (52%) 18/50 (36%) 22/49 (45%) 25/50 (50%) |17/50 (34%) 15/50 (30%) 19/50 (38%) 19/50 (38%) | |POLY-3 ADJUSTED (b)| 58.3% 40.9% 52.6% 56.2% |38.0% 32.8% 41.7% 43.7% | |TERMINAL (d) | 13/25 (52%) 8/20 (40%) 14/24 (58%) 8/16 (50%) |16/32 (50%) 15/37 (41%) 11/29 (38%) 11/26 (42%) | |FIRST INCIDENCE | 388 466 529 194 |622 729 (T) 496 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.121 P=0.264N P=0.366N P=0.211 |P=0.065 P=0.224N P=0.314 P=0.180 | |POLY 3 | P=0.419 P=0.069N P=0.372N P=0.504N |P=0.237 P=0.382N P=0.443 P=0.371 | |POLY 1.5 | P=0.429 P=0.066N P=0.333N P=0.488N |P=0.259 P=0.395N P=0.434 P=0.391 | |POLY 6 | P=0.393 P=0.089N P=0.451N P=0.553N |P=0.212 P=0.364N P=0.457 P=0.347 | |LOGISTIC REGRESSION| P=0.387 P=0.077N P=0.309N P=0.519N |P=0.156 P=0.290N P=0.391 P=0.288 | |COCH-ARM / FISHERS | P=0.429 P=0.079N P=0.307N P=0.500N |P=0.291 P=0.415N P=0.418 P=0.418 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Nose: Nasolacrimal Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 2.6% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/24 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 722 (T) 651 |--- 533 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.190 (e) P=0.492 P=0.470 |P=0.435N P=0.249 (e) (e) | |POLY 3 | P=0.219 (e) P=0.494 P=0.487 |P=0.412N P=0.249 (e) (e) | |POLY 1.5 | P=0.226 (e) P=0.496 P=0.493 |P=0.408N P=0.244 (e) (e) | |POLY 6 | P=0.207 (e) P=0.488 P=0.476 |P=0.419N P=0.255 (e) (e) | |LOGISTIC REGRESSION| P=0.221 (e) P=0.492 P=0.501 |P=0.328N P=0.152 (e) (e) | |COCH-ARM / FISHERS | P=0.236 (e) P=0.495 P=0.500 |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 40 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |3/50 (6%) 8/50 (16%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| |6.7% 17.2% 8.9% 9.6% | |TERMINAL (d) | |2/32 (6%) 6/37 (16%) 2/29 (7%) 1/26 (4%) | |FIRST INCIDENCE | |503 546 521 616 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.510 P=0.146 P=0.473 P=0.409 | |POLY 3 | |P=0.540N P=0.108 P=0.500 P=0.458 | |POLY 1.5 | |P=0.516N P=0.105 P=0.501 P=0.476 | |POLY 6 | |P=0.551 P=0.115 P=0.498 P=0.436 | |LOGISTIC REGRESSION| |P=0.416N P=0.092 P=0.488 P=0.550 | |COCH-ARM / FISHERS | |P=0.484N P=0.100 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 15/48 (31%) 17/50 (34%) 12/49 (24%) |22/49 (45%) 14/50 (28%) 13/50 (26%) 14/50 (28%) | |POLY-3 ADJUSTED (b)| 40.7% 36.8% 39.0% 30.6% |47.9% 30.2% 28.8% 33.3% | |TERMINAL (d) | 9/25 (36%) 11/20 (55%) 9/25 (36%) 8/16 (50%) |15/32 (47%) 13/37 (35%) 8/29 (28%) 9/26 (35%) | |FIRST INCIDENCE | 388 444 529 465 |399 533 605 608 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.428N P=0.548N P=0.521N P=0.473N |P=0.311N P=0.032N* P=0.096N P=0.253N | |POLY 3 | P=0.212N P=0.440N P=0.521N P=0.227N |P=0.127N P=0.059N P=0.045N* P=0.114N | |POLY 1.5 | P=0.180N P=0.404N P=0.506N P=0.188N |P=0.103N P=0.059N P=0.041N* P=0.088N | |POLY 6 | P=0.277N P=0.520N P=0.553N P=0.308N |P=0.164N P=0.061N P=0.051N P=0.161N | |LOGISTIC REGRESSION| P=0.173N P=0.384N P=0.498N P=0.174N |P=0.118N P=0.057N P=0.040N* P=0.094N | |COCH-ARM / FISHERS | P=0.144N P=0.389N P=0.500N P=0.152N |P=0.077N P=0.062N P=0.039N* P=0.062N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 41 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) --- --- --- |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.140N P=0.288N P=0.237N P=0.340N |P=0.335N P=0.471N P=0.520N P=0.541N | |POLY 3 | P=0.111N P=0.248N P=0.238N P=0.259N |P=0.297N P=0.491N P=0.499N P=0.514N | |POLY 1.5 | P=0.113N P=0.245N P=0.237N P=0.250N |P=0.300N P=0.493N P=0.497N P=0.506N | |POLY 6 | P=0.106N P=0.256N P=0.243N P=0.274N |P=0.291N P=0.488N P=0.502N P=0.526N | |LOGISTIC REGRESSION| P=0.140N (e) (e) (e) |P=0.335N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.116N P=0.258N P=0.247N P=0.253N |P=0.303N P=0.495N P=0.495N P=0.495N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Ectopic Liver | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 4.6% 7.3% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 2/29 (7%) 2/26 (8%) | |FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 641 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.059 P=0.271 P=0.216 P=0.087 | |POLY 3 | (e) (e) (e) (e) |P=0.091 P=0.247 P=0.238 P=0.107 | |POLY 1.5 | (e) (e) (e) (e) |P=0.100 P=0.245 P=0.240 P=0.114 | |POLY 6 | (e) (e) (e) (e) |P=0.079 P=0.250 P=0.234 P=0.099 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.073 P=0.271 P=0.216 P=0.108 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111 P=0.253 P=0.253 P=0.125 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 42 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/48 (8%) 2/50 (4%) 3/49 (6%) |0/49 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 10.1% 4.9% 7.8% |0.0% 6.5% 4.6% 0.0% | |TERMINAL (d) | 1/25 (4%) 2/20 (10%) 2/25 (8%) 1/16 (6%) |0/32 (0%) 2/37 (5%) 2/29 (7%) 0/26 (0%) | |FIRST INCIDENCE | 571 665 722 (T) 428 |--- 570 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.392 P=0.270 P=0.692 P=0.412 |P=0.480N P=0.140 P=0.216 (e) | |POLY 3 | P=0.485 P=0.311 P=0.688 P=0.464 |P=0.447N P=0.129 P=0.238 (e) | |POLY 1.5 | P=0.501 P=0.319 P=0.692 P=0.478 |P=0.427N P=0.127 P=0.240 (e) | |POLY 6 | P=0.456 P=0.294 P=0.677 P=0.438 |P=0.477N P=0.133 P=0.234 (e) | |LOGISTIC REGRESSION| P=0.511 P=0.316 P=0.694 P=0.516 |P=0.415N P=0.113 P=0.216 (e) | |COCH-ARM / FISHERS | P=0.517 P=0.319 P=0.691N P=0.490 |P=0.404N P=0.125 P=0.253 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pancreas | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/48 (0%) 3/50 (6%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.4% 0.0% 7.3% 0.0% |0.0% 0.0% 2.3% 4.9% | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 3/25 (12%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | 722 (T) --- 722 (T) --- |--- --- 707 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.610N P=0.545N P=0.303 P=0.589N |P=0.050 (e) P=0.494 P=0.212 | |POLY 3 | P=0.535N P=0.510N P=0.302 P=0.519N |P=0.061 (e) P=0.501 P=0.224 | |POLY 1.5 | P=0.521N P=0.507N P=0.306 P=0.512N |P=0.066 (e) P=0.503 P=0.232 | |POLY 6 | P=0.557N P=0.518N P=0.293 P=0.532N |P=0.056 (e) P=0.499 P=0.213 | |LOGISTIC REGRESSION| P=0.610N (e) P=0.303 (e) |P=0.080 (e) P=0.501 P=0.260 | |COCH-ARM / FISHERS | P=0.502N P=0.510N P=0.309 P=0.505N |P=0.071 (e) P=0.505 P=0.253 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 43 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/48 (6%) |1/48 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 7.3% 8.0% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 2/25 (8%) 2/16 (13%) |0/31 (0%) 0/37 (0%) 0/28 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 722 (T) 679 670 |503 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.032 * P=0.455 P=0.117 P=0.071 |P=0.306N P=0.496N P=0.496N P=0.500N | |POLY 3 | P=0.052 P=0.497 P=0.118 P=0.102 |P=0.295N P=0.488N P=0.505N P=0.511N | |POLY 1.5 | P=0.057 P=0.500 P=0.119 P=0.108 |P=0.299N P=0.490N P=0.503N P=0.503N | |POLY 6 | P=0.045 * P=0.488 P=0.113 P=0.093 |P=0.290N P=0.485N P=0.508N P=0.523N | |LOGISTIC REGRESSION| P=0.040 * P=0.455 P=0.111 P=0.086 |P=0.239N P=0.680N P=0.651N P=0.422N | |COCH-ARM / FISHERS | P=0.061 P=0.500 P=0.121 P=0.114 |P=0.302N P=0.490N P=0.500N P=0.490N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |11/49 (22%) 9/50 (18%) 12/50 (24%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 0.0% 4.9% 4.9% 5.2% |24.9% 19.0% 27.0% 9.5% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 2/25 (8%) 0/16 (0%) |8/31 (26%) 5/37 (14%) 10/29 (35%) 0/26 (0%) | |FIRST INCIDENCE | --- 698 722 (T) 676 |622 546 549 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.156 P=0.193 P=0.237 P=0.185 |P=0.139N P=0.295N P=0.437 P=0.107N | |POLY 3 | P=0.216 P=0.234 P=0.235 P=0.223 |P=0.075N P=0.335N P=0.509 P=0.053N | |POLY 1.5 | P=0.228 P=0.238 P=0.237 P=0.229 |P=0.062N P=0.354N P=0.518 P=0.047N* | |POLY 6 | P=0.196 P=0.224 P=0.230 P=0.211 |P=0.096N P=0.312N P=0.492 P=0.062N | |LOGISTIC REGRESSION| P=0.193 P=0.206 P=0.237 P=0.221 |P=0.053N P=0.390N P=0.509 P=0.047N* | |COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.247 P=0.247 |P=0.048N* P=0.382N P=0.522 P=0.041N* | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 44 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 8/50 (16%) 3/50 (6%) 1/50 (2%) |16/49 (33%) 18/50 (36%) 20/50 (40%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 4.9% 19.2% 7.3% 2.6% |36.1% 38.4% 42.4% 19.1% | |TERMINAL (d) | 1/25 (4%) 4/20 (20%) 3/25 (12%) 0/16 (0%) |13/31 (42%) 16/37 (43%) 11/29 (38%) 5/26 (19%) | |FIRST INCIDENCE | 718 598 722 (T) 691 |493 488 549 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.265N P=0.029 * P=0.490 P=0.641N |P=0.142N P=0.530N P=0.228 P=0.122N | |POLY 3 | P=0.175N P=0.045 * P=0.497 P=0.524N |P=0.055N P=0.493 P=0.340 P=0.061N | |POLY 1.5 | P=0.161N P=0.047 * P=0.501 P=0.513N |P=0.043N* P=0.474 P=0.319 P=0.052N | |POLY 6 | P=0.203N P=0.039 * P=0.486 P=0.545N |P=0.076N P=0.519 P=0.370 P=0.075N | |LOGISTIC REGRESSION| P=0.190N P=0.042 * P=0.458 P=0.581N |P=0.039N* P=0.481 P=0.291 P=0.066N | |COCH-ARM / FISHERS | P=0.151N P=0.046 * P=0.500 P=0.500N |P=0.031N* P=0.445 P=0.291 P=0.044N* | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 16/50 (32%) 18/50 (36%) 12/50 (24%) |22/49 (45%) 29/50 (58%) 21/50 (42%) 18/50 (36%) | |POLY-3 ADJUSTED (b)| 50.9% 37.2% 40.9% 29.1% |48.3% 60.7% 45.2% 41.2% | |TERMINAL (d) | 15/25 (60%) 7/20 (35%) 10/25 (40%) 5/16 (31%) |17/31 (55%) 23/37 (62%) 15/29 (52%) 11/26 (42%) | |FIRST INCIDENCE | 388 466 486 520 |399 533 561 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.200N P=0.371N P=0.296N P=0.232N |P=0.387N P=0.333 P=0.564 P=0.518N | |POLY 3 | P=0.037N* P=0.137N P=0.229N P=0.029N* |P=0.135N P=0.156 P=0.465N P=0.320N | |POLY 1.5 | P=0.036N* P=0.136N P=0.242N P=0.027N* |P=0.112N P=0.144 P=0.467N P=0.289N | |POLY 6 | P=0.041N* P=0.154N P=0.222N P=0.035N* |P=0.169N P=0.181 P=0.461N P=0.361N | |LOGISTIC REGRESSION| P=0.043N* P=0.151N P=0.266N P=0.037N* |P=0.106N P=0.145 P=0.465N P=0.271N | |COCH-ARM / FISHERS | P=0.035N* P=0.151N P=0.270N P=0.028N* |P=0.084N P=0.135 P=0.465N P=0.243N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 45 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/47 (6%) 5/49 (10%) 4/48 (8%) | | |POLY-3 ADJUSTED (b)| 9.6% 7.8% 12.4% 10.7% | | |TERMINAL (d) | 3/25 (12%) 1/19 (5%) 5/25 (20%) 3/16 (19%) | | |FIRST INCIDENCE | 604 607 722 (T) 444 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.331 P=0.578N P=0.500 P=0.452 | | |POLY 3 | P=0.443 P=0.539N P=0.479 P=0.587 | | |POLY 1.5 | P=0.463 P=0.531N P=0.486 P=0.604 | | |POLY 6 | P=0.409 P=0.559N P=0.462 P=0.553 | | |LOGISTIC REGRESSION| P=0.443 P=0.537N P=0.464 P=0.602 | | |COCH-ARM / FISHERS | P=0.486 P=0.535N P=0.487 P=0.619 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/47 (0%) 0/49 (0%) 2/48 (4%) | | |POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 5.4% | | |TERMINAL (d) | 1/25 (4%) 0/19 (0%) 0/25 (0%) 1/16 (6%) | | |FIRST INCIDENCE | 604 --- --- 719 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.418 P=0.259N P=0.240N P=0.568 | | |POLY 3 | P=0.485 P=0.256N P=0.244N P=0.650 | | |POLY 1.5 | P=0.487 P=0.252N P=0.242N P=0.664 | | |POLY 6 | P=0.484 P=0.268N P=0.250N P=0.624 | | |LOGISTIC REGRESSION| P=0.467 P=0.251N P=0.242N P=0.647 | | |COCH-ARM / FISHERS | P=0.493 P=0.263N P=0.253N P=0.676 | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 46 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 22/50 (44%) 39/47 (83%) 31/49 (63%) 28/48 (58%) | | |POLY-3 ADJUSTED (b)| 50.0% 86.9% 69.9% 65.2% | | |TERMINAL (d) | 14/25 (56%) 16/19 (84%) 18/25 (72%) 10/16 (63%) | | |FIRST INCIDENCE | 309 444 525 444 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.091 P<0.001 ** P=0.072 P=0.020 * | | |POLY 3 | P=0.345 P<0.001 ** P=0.037 * P=0.103 | | |POLY 1.5 | P=0.345 P<0.001 ** P=0.038 * P=0.104 | | |POLY 6 | P=0.323 P<0.001 ** P=0.038 * P=0.096 | | |LOGISTIC REGRESSION| P=0.302 P<0.001 ** P=0.042 * P=0.096 | | |COCH-ARM / FISHERS | P=0.362 P<0.001 ** P=0.042 * P=0.112 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Preputial Gland: Duct | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/47 (4%) 0/49 (0%) 2/48 (4%) | | |POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 5.4% | | |TERMINAL (d) | 0/25 (0%) 1/19 (5%) 0/25 (0%) 1/16 (6%) | | |FIRST INCIDENCE | --- 666 --- 644 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.193 P=0.201 (e) P=0.183 | | |POLY 3 | P=0.226 P=0.221 (e) P=0.214 | | |POLY 1.5 | P=0.233 P=0.224 (e) P=0.220 | | |POLY 6 | P=0.212 P=0.213 (e) P=0.202 | | |LOGISTIC REGRESSION| P=0.222 P=0.216 (e) P=0.213 | | |COCH-ARM / FISHERS | P=0.242 P=0.232 (e) P=0.237 | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 47 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/48 (2%) 4/50 (8%) 2/49 (4%) | | |POLY-3 ADJUSTED (b)| 2.4% 2.6% 9.8% 5.4% | | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 4/25 (16%) 2/16 (13%) | | |FIRST INCIDENCE | 579 722 (T) 722 (T) 722 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.190 P=0.741 P=0.181 P=0.392 | | |POLY 3 | P=0.264 P=0.746 P=0.172 P=0.462 | | |POLY 1.5 | P=0.284 P=0.751 P=0.177 P=0.477 | | |POLY 6 | P=0.233 P=0.735 P=0.162 P=0.437 | | |LOGISTIC REGRESSION| P=0.247 P=0.751 P=0.175 P=0.478 | | |COCH-ARM / FISHERS | P=0.310 P=0.742 P=0.181 P=0.492 | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Acute | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/48 (4%) 0/50 (0%) 1/49 (2%) | | |POLY-3 ADJUSTED (b)| 4.8% 5.0% 0.0% 2.6% | | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | | |FIRST INCIDENCE | 571 466 --- 520 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.324N P=0.682 P=0.253N P=0.554N | | |POLY 3 | P=0.309N P=0.680 P=0.241N P=0.533N | | |POLY 1.5 | P=0.304N P=0.683 P=0.238N P=0.520N | | |POLY 6 | P=0.318N P=0.668 P=0.249N P=0.556N | | |LOGISTIC REGRESSION| P=0.251N P=0.624 P=0.240N P=0.481N | | |COCH-ARM / FISHERS | P=0.298N P=0.676 P=0.247N P=0.508N | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 48 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Prostate | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 33/50 (66%) 30/48 (63%) 28/50 (56%) 25/49 (51%) | | |POLY-3 ADJUSTED (b)| 72.4% 70.5% 61.1% 57.8% | | |TERMINAL (d) | 18/25 (72%) 14/20 (70%) 15/25 (60%) 8/16 (50%) | | |FIRST INCIDENCE | 388 538 269 194 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.496N P=0.409 P=0.293N P=0.529 | | |POLY 3 | P=0.057N P=0.518N P=0.167N P=0.101N | | |POLY 1.5 | P=0.056N P=0.470N P=0.170N P=0.092N | | |POLY 6 | P=0.064N P=0.599N P=0.187N P=0.123N | | |LOGISTIC REGRESSION| P=0.081N P=0.422N P=0.202N P=0.110N | | |COCH-ARM / FISHERS | P=0.064N P=0.440N P=0.206N P=0.095N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Salivary Glands | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 6.8% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 3/29 (10%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- 546 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.360 P=0.258 P=0.103 P=0.459 | |POLY 3 | (e) (e) (e) (e) |P=0.385 P=0.247 P=0.116 P=0.483 | |POLY 1.5 | (e) (e) (e) (e) |P=0.411 P=0.243 P=0.118 P=0.490 | |POLY 6 | (e) (e) (e) (e) |P=0.348 P=0.252 P=0.114 P=0.472 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.426 P=0.196 P=0.103 P=0.459 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.247 P=0.121 P=0.500 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 49 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Salivary Glands | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 701 --- --- |--- 546 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.630N P=0.440 (e) (e) |P=0.434N P=0.258 (e) (e) | |POLY 3 | P=0.571N P=0.498 (e) (e) |P=0.413N P=0.247 (e) (e) | |POLY 1.5 | P=0.568N P=0.501 (e) (e) |P=0.409N P=0.243 (e) (e) | |POLY 6 | P=0.578N P=0.489 (e) (e) |P=0.420N P=0.252 (e) (e) | |LOGISTIC REGRESSION| P=0.588N P=0.487 (e) (e) |P=0.360N P=0.196 (e) (e) | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Seminal Vesicle | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 1/47 (2%) 2/50 (4%) 2/48 (4%) | | |POLY-3 ADJUSTED (b)| 4.9% 2.6% 4.9% 5.4% | | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) | | |FIRST INCIDENCE | 695 722 (T) 662 672 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.415 P=0.591N P=0.664 P=0.560 | | |POLY 3 | P=0.492 P=0.526N P=0.693 P=0.657 | | |POLY 1.5 | P=0.503 P=0.521N P=0.693N P=0.668 | | |POLY 6 | P=0.473 P=0.540N P=0.686 P=0.636 | | |LOGISTIC REGRESSION| P=0.467 P=0.562N P=0.688 P=0.630 | | |COCH-ARM / FISHERS | P=0.518 P=0.523N P=0.691N P=0.676 | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 50 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |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% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 580 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.556 (e) P=0.237 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.554 (e) P=0.238 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.572 (e) P=0.239 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.522 (e) P=0.235 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.603 (e) P=0.235 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 0.0% |0.0% 0.0% 4.6% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 722 (T) --- |--- --- 707 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.656 (e) P=0.500 (e) |P=0.539 (e) P=0.226 (e) | |POLY 3 | P=0.664 (e) P=0.499 (e) |P=0.541 (e) P=0.235 (e) | |POLY 1.5 | P=0.677 (e) P=0.500 (e) |P=0.565 (e) P=0.236 (e) | |POLY 6 | P=0.640 (e) P=0.494 (e) |P=0.505 (e) P=0.233 (e) | |LOGISTIC REGRESSION| (e) (e) P=0.500 (e) |P=0.558 (e) P=0.232 (e) | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.595 (e) P=0.247 (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 51 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 2.5% 2.4% 0.0% |4.5% 2.2% 2.3% 2.5% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- 722 (T) 722 (T) --- |717 729 (T) 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.674N P=0.455 P=0.500 (e) |P=0.502N P=0.454N P=0.537N P=0.582N | |POLY 3 | P=0.613N P=0.497 P=0.499 (e) |P=0.432N P=0.490N P=0.504N P=0.530N | |POLY 1.5 | P=0.604N P=0.500 P=0.500 (e) |P=0.422N P=0.494N P=0.502N P=0.517N | |POLY 6 | P=0.630N P=0.488 P=0.494 (e) |P=0.445N P=0.484N P=0.508N P=0.550N | |LOGISTIC REGRESSION| (e) P=0.455 P=0.500 (e) |P=0.498N P=0.470N P=0.514N P=0.580N | |COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.409N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Skin | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.8% 2.2% 0.0% 2.4% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |2/32 (6%) 1/37 (3%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- --- |717 729 (T) --- 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.254N P=0.260N P=0.142N P=0.376N | |POLY 3 | (e) (e) (e) (e) |P=0.207N P=0.295N P=0.121N P=0.332N | |POLY 1.5 | (e) (e) (e) (e) |P=0.204N P=0.299N P=0.120N P=0.320N | |POLY 6 | (e) (e) (e) (e) |P=0.211N P=0.288N P=0.122N P=0.350N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.206N P=0.270N P=0.126N P=0.313N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.200N P=0.309N P=0.121N P=0.309N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 52 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Congestion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 1/48 (2%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 2.7% |2.3% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- 722 (T) --- 722 (T) |729 (T) --- 624 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.326 P=0.455 (e) P=0.411 |P=0.517N P=0.471N P=0.487 P=0.541N | |POLY 3 | P=0.387 P=0.494 (e) P=0.485 |P=0.494N P=0.494N P=0.500 P=0.517N | |POLY 1.5 | P=0.397 P=0.497 (e) P=0.492 |P=0.480N P=0.496N P=0.501 P=0.509N | |POLY 6 | P=0.369 P=0.486 (e) P=0.471 |P=0.514N P=0.490N P=0.500 P=0.528N | |LOGISTIC REGRESSION| (e) P=0.455 (e) P=0.411 |P=0.452N (e) P=0.500 (e) | |COCH-ARM / FISHERS | P=0.407 P=0.495 (e) P=0.500 |P=0.461N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/49 (29%) 11/48 (23%) 9/50 (18%) 12/49 (24%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 33.8% 27.3% 21.8% 30.6% |4.5% 6.5% 6.7% 9.8% | |TERMINAL (d) | 9/25 (36%) 5/20 (25%) 7/25 (28%) 4/16 (25%) |1/32 (3%) 2/37 (5%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | 574 642 632 444 |667 546 573 672 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.406 P=0.534N P=0.183N P=0.399 |P=0.181 P=0.541 P=0.479 P=0.246 | |POLY 3 | P=0.430N P=0.346N P=0.162N P=0.476N |P=0.230 P=0.517 P=0.499 P=0.299 | |POLY 1.5 | P=0.406N P=0.335N P=0.155N P=0.442N |P=0.249 P=0.511 P=0.500 P=0.316 | |POLY 6 | P=0.475N P=0.381N P=0.184N P=0.540N |P=0.205 P=0.526 P=0.497 P=0.275 | |LOGISTIC REGRESSION| P=0.490N P=0.370N P=0.169N P=0.507N |P=0.281 P=0.480 P=0.500 P=0.286 | |COCH-ARM / FISHERS | P=0.378N P=0.343N P=0.157N P=0.410N |P=0.273 P=0.500 P=0.500 P=0.339 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 53 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/49 (2%) 1/48 (2%) 0/50 (0%) 1/49 (2%) |2/50 (4%) 4/50 (8%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 2.5% 2.5% 0.0% 2.7% |4.4% 8.4% 0.0% 4.9% | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) | |FIRST INCIDENCE | 722 (T) 444 --- 685 |493 488 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.649 P=0.745 P=0.500N P=0.678 |P=0.475N P=0.356 P=0.232N P=0.630 | |POLY 3 | P=0.618N P=0.759 P=0.497N P=0.745 |P=0.434N P=0.360 P=0.244N P=0.656 | |POLY 1.5 | P=0.616N P=0.760 P=0.496N P=0.752 |P=0.421N P=0.351 P=0.241N P=0.673 | |POLY 6 | P=0.621N P=0.752 P=0.503N P=0.730 |P=0.453N P=0.374 P=0.248N P=0.632 | |LOGISTIC REGRESSION| P=0.591N P=0.724 (e) P=0.726 |P=0.297N P=0.210 P=0.263N P=0.670N | |COCH-ARM / FISHERS | P=0.614N P=0.747 P=0.495N P=0.753N |P=0.404N P=0.339 P=0.247N P=0.691N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- --- |--- 666 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.457N P=0.261 (e) (e) | |POLY 3 | (e) (e) (e) (e) |P=0.414N P=0.245 (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |P=0.409N P=0.242 (e) (e) | |POLY 6 | (e) (e) (e) (e) |P=0.421N P=0.250 (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.412N P=0.236 (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 54 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/49 (8%) 2/48 (4%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 9.5% 5.0% 2.4% 0.0% |0.0% 2.2% 4.5% 2.5% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 309 604 589 --- |--- 546 549 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.039N* P=0.378N P=0.195N P=0.087N |P=0.336 P=0.504 P=0.237 P=0.448 | |POLY 3 | P=0.033N* P=0.364N P=0.184N P=0.077N |P=0.321 P=0.509 P=0.240 P=0.483 | |POLY 1.5 | P=0.031N* P=0.354N P=0.179N P=0.069N |P=0.341 P=0.505 P=0.239 P=0.491 | |POLY 6 | P=0.036N* P=0.385N P=0.194N P=0.090N |P=0.294 P=0.513 P=0.240 P=0.472 | |LOGISTIC REGRESSION| P=0.020N* P=0.438N P=0.193N P=0.044N* |P=0.477 P=0.381 P=0.178 P=0.472 | |COCH-ARM / FISHERS | P=0.029N* P=0.349N P=0.175N P=0.059N |P=0.366 P=0.500 P=0.247 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Spleen | | Pigmentation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.3% |0.0% 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- 685 |--- --- --- 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.032 * (e) (e) P=0.167 |P=0.195 (e) (e) P=0.491 | |POLY 3 | P=0.043 * (e) (e) P=0.221 |P=0.188 (e) (e) P=0.485 | |POLY 1.5 | P=0.044 * (e) (e) P=0.229 |P=0.192 (e) (e) P=0.492 | |POLY 6 | P=0.041 * (e) (e) P=0.207 |P=0.181 (e) (e) P=0.476 | |LOGISTIC REGRESSION| P=0.036 * (e) (e) P=0.200 |P=0.261 (e) (e) P=0.551 | |COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 55 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.3% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- 523 |503 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * (e) (e) P=0.189 |P=0.306N P=0.496N P=0.496N P=0.500N | |POLY 3 | P=0.042 * (e) (e) P=0.219 |P=0.298N P=0.497N P=0.505N P=0.520N | |POLY 1.5 | P=0.043 * (e) (e) P=0.226 |P=0.302N P=0.498N P=0.503N P=0.511N | |POLY 6 | P=0.041 * (e) (e) P=0.207 |P=0.292N P=0.495N P=0.509N P=0.532N | |LOGISTIC REGRESSION| P=0.051 (e) (e) P=0.242 |P=0.239N P=0.682N P=0.653N P=0.424N | |COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 8/49 (16%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 20.0% |4.4% 2.2% 6.7% 4.8% | |TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 595 --- --- 194 |503 729 (T) 496 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.259N P=0.253N P=0.032 * |P=0.430 P=0.475N P=0.505 P=0.648 | |POLY 3 | P<0.001 ** P=0.247N P=0.241N P=0.037 * |P=0.450 P=0.496N P=0.495 P=0.661 | |POLY 1.5 | P<0.001 ** P=0.242N P=0.238N P=0.040 * |P=0.471 P=0.498N P=0.498 P=0.675 | |POLY 6 | P<0.001 ** P=0.259N P=0.249N P=0.031 * |P=0.420 P=0.494N P=0.490 P=0.641 | |LOGISTIC REGRESSION| P=0.002 ** P=0.246N P=0.239N P=0.052 |P=0.586N P=0.561N P=0.470 P=0.623N | |COCH-ARM / FISHERS | P<0.001 ** P=0.253N P=0.247N P=0.043 * |P=0.500 P=0.500N P=0.500 P=0.691N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 56 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 10/49 (20%) 3/50 (6%) 4/49 (8%) |3/50 (6%) 3/50 (6%) 4/50 (8%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 4.8% 24.0% 7.2% 10.3% |6.7% 6.4% 8.9% 9.6% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | 595 538 609 194 |667 488 605 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.522 P=0.013 * P=0.497 P=0.266 |P=0.286 P=0.640N P=0.481 P=0.387 | |POLY 3 | P=0.536N P=0.012 * P=0.499 P=0.300 |P=0.336 P=0.639N P=0.499 P=0.461 | |POLY 1.5 | P=0.510N P=0.013 * P=0.502 P=0.316 |P=0.359 P=0.648N P=0.501 P=0.478 | |POLY 6 | P=0.540 P=0.010 * P=0.490 P=0.271 |P=0.307 P=0.628N P=0.497 P=0.436 | |LOGISTIC REGRESSION| P=0.460N P=0.014 * P=0.491 P=0.366 |P=0.502 P=0.591 P=0.499 P=0.529 | |COCH-ARM / FISHERS | P=0.493N P=0.013 * P=0.500 P=0.329 |P=0.389 P=0.661N P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 7/49 (14%) 7/50 (14%) 11/49 (22%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 17.1% 16.3% 28.0% |4.5% 4.3% 4.5% 2.5% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 625 604 538 598 |588 546 586 711 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.025 * P=0.037 * P<0.001 ** |P=0.448N P=0.673N P=0.672 P=0.571N | |POLY 3 | P=0.002 ** P=0.027 * P=0.033 * P<0.001 ** |P=0.412N P=0.682N P=0.691 P=0.533N | |POLY 1.5 | P=0.003 ** P=0.029 * P=0.032 * P<0.001 ** |P=0.395N P=0.687N P=0.693 P=0.519N | |POLY 6 | P=0.002 ** P=0.024 * P=0.033 * P<0.001 ** |P=0.436N P=0.676N P=0.688 P=0.555N | |LOGISTIC REGRESSION| P=0.004 ** P=0.031 * P=0.030 * P=0.002 ** |P=0.307N P=0.645 P=0.688 P=0.486N | |COCH-ARM / FISHERS | P=0.004 ** P=0.028 * P=0.030 * P=0.002 ** |P=0.373N P=0.691N P=0.691N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 57 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Erosion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 17/49 (35%) 12/50 (24%) 12/49 (24%) |6/50 (12%) 9/50 (18%) 9/50 (18%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 33.2% 37.8% 27.1% 28.8% |13.2% 18.7% 19.6% 16.3% | |TERMINAL (d) | 1/25 (4%) 1/20 (5%) 1/25 (4%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | 473 444 585 444 |636 488 580 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374N P=0.326 P=0.383N P=0.534N |P=0.340 P=0.351 P=0.282 P=0.369 | |POLY 3 | P=0.270N P=0.407 P=0.344N P=0.416N |P=0.442 P=0.332 P=0.295 P=0.458 | |POLY 1.5 | P=0.242N P=0.412 P=0.332N P=0.383N |P=0.473 P=0.314 P=0.293 P=0.477 | |POLY 6 | P=0.318N P=0.378 P=0.366N P=0.477N |P=0.398 P=0.355 P=0.298 P=0.430 | |LOGISTIC REGRESSION| P=0.155N P=0.363 P=0.333N P=0.304N |P=0.450N P=0.231 P=0.288 P=0.565 | |COCH-ARM / FISHERS | P=0.209N P=0.388 P=0.326N P=0.349N |P=0.513 P=0.288 P=0.288 P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 2/50 (4%) 8/49 (16%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 5.0% 4.9% 21.0% |0.0% 0.0% 4.5% 0.0% | |TERMINAL (d) | 0/25 (0%) 2/20 (10%) 0/25 (0%) 3/16 (19%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- 722 (T) 679 622 |--- --- 561 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.190 P=0.218 P<0.001 ** |P=0.567 (e) P=0.229 (e) | |POLY 3 | P<0.001 ** P=0.229 P=0.237 P=0.002 ** |P=0.539 (e) P=0.237 (e) | |POLY 1.5 | P<0.001 ** P=0.233 P=0.238 P=0.003 ** |P=0.565 (e) P=0.238 (e) | |POLY 6 | P<0.001 ** P=0.219 P=0.232 P=0.002 ** |P=0.503 (e) P=0.236 (e) | |LOGISTIC REGRESSION| P<0.001 ** P=0.190 P=0.234 P=0.002 ** |P=0.635 (e) P=0.228 (e) | |COCH-ARM / FISHERS | P<0.001 ** P=0.242 P=0.247 P=0.003 ** |P=0.595 (e) P=0.247 (e) | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 58 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Stomach, Glandular | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/49 (10%) 1/50 (2%) 1/49 (2%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.8% 12.3% 2.4% 2.7% |2.2% 2.2% 6.7% 0.0% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 692 607 700 697 |503 546 573 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.275N P=0.176 P=0.534N P=0.628N |P=0.450N P=0.756N P=0.303 P=0.500N | |POLY 3 | P=0.219N P=0.209 P=0.503N P=0.535N |P=0.462N P=0.754N P=0.301 P=0.520N | |POLY 1.5 | P=0.207N P=0.212 P=0.500N P=0.521N |P=0.439N P=0.757N P=0.304 P=0.511N | |POLY 6 | P=0.241N P=0.198 P=0.513N P=0.558N |P=0.494N P=0.750N P=0.299 P=0.532N | |LOGISTIC REGRESSION| P=0.211N P=0.208 P=0.506N P=0.549N |P=0.302N P=0.639 P=0.276 P=0.424N | |COCH-ARM / FISHERS | P=0.198N P=0.210 P=0.500N P=0.508N |P=0.409N P=0.753N P=0.309 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | | |POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 0.0% | | |TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | | |FIRST INCIDENCE | 695 --- --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142N P=0.293N P=0.251N P=0.334N | | |POLY 3 | P=0.111N P=0.240N P=0.237N P=0.258N | | |POLY 1.5 | P=0.113N P=0.236N P=0.236N P=0.250N | | |POLY 6 | P=0.106N P=0.250N P=0.241N P=0.272N | | |LOGISTIC REGRESSION| P=0.128N P=0.259N P=0.243N P=0.283N | | |COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N | | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 59 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Testes: Interstitial Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 12/49 (24%) 8/49 (16%) 9/49 (18%) 5/48 (10%) | | |POLY-3 ADJUSTED (b)| 26.5% 19.4% 20.6% 12.9% | | |TERMINAL (d) | 4/25 (16%) 3/20 (15%) 1/25 (4%) 0/16 (0%) | | |FIRST INCIDENCE | 309 553 486 520 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.117N P=0.309N P=0.326N P=0.117N | | |POLY 3 | P=0.089N P=0.295N P=0.340N P=0.098N | | |POLY 1.5 | P=0.078N P=0.264N P=0.331N P=0.081N | | |POLY 6 | P=0.105N P=0.344N P=0.352N P=0.123N | | |LOGISTIC REGRESSION| P=0.034N* P=0.264N P=0.351N P=0.032N* | | |COCH-ARM / FISHERS | P=0.061N P=0.226N P=0.312N P=0.059N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thymus | | Ectopic Parathyroid Gland | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |4.5% 2.2% 2.3% 4.9% | |TERMINAL (d) | 0/25 (0%) 0/19 (0%) 0/23 (0%) 0/16 (0%) |2/32 (6%) 1/37 (3%) 1/29 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- 562 |729 (T) 729 (T) 729 (T) 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.189 (e) (e) P=0.486 |P=0.463 P=0.449N P=0.535N P=0.617 | |POLY 3 | P=0.194 (e) (e) P=0.488 |P=0.526 P=0.489N P=0.504N P=0.668 | |POLY 1.5 | P=0.197 (e) (e) P=0.494 |P=0.538 P=0.494N P=0.501N P=0.679 | |POLY 6 | P=0.189 (e) (e) P=0.478 |P=0.509 P=0.483N P=0.508N P=0.652 | |LOGISTIC REGRESSION| P=0.228 (e) (e) P=0.522 |P=0.525 P=0.449N P=0.535N P=0.683 | |COCH-ARM / FISHERS | P=0.200 (e) (e) P=0.500 |P=0.556 P=0.500N P=0.500N P=0.691N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 60 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland | | Ultimobranchial Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 0.0% 2.6% |0.0% 6.5% 0.0% 2.4% | |TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 309 722 (T) --- 523 |--- 695 --- 511 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.651N P=0.736 P=0.504N P=0.756 |P=0.578 P=0.147 (e) P=0.500 | |POLY 3 | P=0.625N P=0.753 P=0.506N P=0.743 |P=0.611 P=0.125 (e) P=0.486 | |POLY 1.5 | P=0.623N P=0.758 P=0.503N P=0.750 |P=0.622 P=0.122 (e) P=0.492 | |POLY 6 | P=0.628N P=0.742 P=0.511N P=0.730 |P=0.594 P=0.128 (e) P=0.477 | |LOGISTIC REGRESSION| P=0.643 P=0.669 P=0.455N P=0.556 |P=0.598N P=0.128 (e) P=0.574 | |COCH-ARM / FISHERS | P=0.621N P=0.753N P=0.500N P=0.747 |P=0.634 P=0.121 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 5/50 (10%) 3/50 (6%) 3/49 (6%) |16/50 (32%) 17/50 (34%) 13/50 (26%) 10/50 (20%) | |POLY-3 ADJUSTED (b)| 16.5% 12.1% 7.2% 7.8% |35.6% 36.8% 28.6% 24.3% | |TERMINAL (d) | 2/25 (8%) 3/20 (15%) 1/25 (4%) 2/16 (13%) |14/32 (44%) 15/37 (41%) 9/29 (31%) 9/26 (35%) | |FIRST INCIDENCE | 388 598 596 598 |622 650 521 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.195N P=0.492N P=0.185N P=0.323N |P=0.236N P=0.486N P=0.423N P=0.280N | |POLY 3 | P=0.125N P=0.398N P=0.164N P=0.196N |P=0.110N P=0.540 P=0.312N P=0.180N | |POLY 1.5 | P=0.118N P=0.384N P=0.160N P=0.179N |P=0.089N P=0.524 P=0.317N P=0.153N | |POLY 6 | P=0.139N P=0.432N P=0.174N P=0.229N |P=0.147N P=0.565 P=0.309N P=0.226N | |LOGISTIC REGRESSION| P=0.111N P=0.379N P=0.160N P=0.167N |P=0.137N P=0.573 P=0.339N P=0.255N | |COCH-ARM / FISHERS | P=0.111N P=0.380N P=0.159N P=0.167N |P=0.068N P=0.500 P=0.330N P=0.127N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 61 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicle | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 2.5% 2.4% 5.2% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) 722 (T) 662 651 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263 P=0.712 P=0.754 P=0.380 |(e) (e) (e) (e) | |POLY 3 | P=0.331 P=0.758 P=0.761 P=0.477 |(e) (e) (e) (e) | |POLY 1.5 | P=0.339 P=0.760N P=0.760N P=0.487 |(e) (e) (e) (e) | |POLY 6 | P=0.318 P=0.748 P=0.757 P=0.457 |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.315 P=0.712 P=0.760 P=0.453 |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.344 P=0.753N P=0.753N P=0.492 |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 5/50 (10%) 1/50 (2%) 2/49 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.4% 12.3% 2.4% 5.2% |2.3% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/25 (4%) 4/20 (20%) 0/25 (0%) 2/16 (13%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | 722 (T) 700 640 722 (T) |729 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.515 P=0.058 P=0.757 P=0.345 |P=0.335N P=0.471N P=0.520N P=0.541N | |POLY 3 | P=0.555N P=0.097 P=0.761N P=0.475 |P=0.300N P=0.494N P=0.502N P=0.517N | |POLY 1.5 | P=0.541N P=0.101 P=0.759N P=0.486 |P=0.303N P=0.496N P=0.501N P=0.509N | |POLY 6 | P=0.583N P=0.086 P=0.758 P=0.453 |P=0.294N P=0.490N P=0.504N P=0.528N | |LOGISTIC REGRESSION| P=0.574 P=0.052 P=0.762 P=0.345 |P=0.335N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.532N P=0.102 P=0.753N P=0.492 |P=0.306N P=0.500N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 62 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Urinary Bladder | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 0/47 (0%) 1/50 (2%) 1/49 (2%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 9.7% 0.0% 2.4% 2.7% |0.0% 6.6% 2.3% 4.9% | |TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 3/37 (8%) 1/29 (3%) 1/26 (4%) | |FIRST INCIDENCE | 692 --- 529 722 (T) |--- 729 (T) 729 (T) 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.230N P=0.101N P=0.196N P=0.329N |P=0.257 P=0.147 P=0.480 P=0.212 | |POLY 3 | P=0.165N P=0.069N P=0.177N P=0.210N |P=0.305 P=0.124 P=0.498 P=0.221 | |POLY 1.5 | P=0.165N P=0.068N P=0.176N P=0.198N |P=0.319 P=0.122 P=0.499 P=0.228 | |POLY 6 | P=0.165N P=0.075N P=0.182N P=0.233N |P=0.285 P=0.127 P=0.496 P=0.211 | |LOGISTIC REGRESSION| P=0.173N P=0.080N P=0.179N P=0.259N |P=0.304 P=0.147 P=0.480 P=0.255 | |COCH-ARM / FISHERS | P=0.164N P=0.066N P=0.181N P=0.187N |P=0.337 P=0.121 P=0.500 P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Dilatation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| |0.0% 2.2% 2.3% 4.8% | |TERMINAL (d) | |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) | |FIRST INCIDENCE | |--- 488 699 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.126 P=0.504 P=0.511 P=0.217 | |POLY 3 | |P=0.137 P=0.509 P=0.498 P=0.222 | |POLY 1.5 | |P=0.144 P=0.506 P=0.499 P=0.229 | |POLY 6 | |P=0.126 P=0.514 P=0.497 P=0.212 | |LOGISTIC REGRESSION| |P=0.242 P=0.289 P=0.499 P=0.287 | |COCH-ARM / FISHERS | |P=0.153 P=0.500 P=0.500 P=0.247 | |=================================================================================================================================| Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 63 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |6/50 (12%) 0/50 (0%) 5/50 (10%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| |13.4% 0.0% 11.2% 16.9% | |TERMINAL (d) | |4/32 (13%) 0/37 (0%) 1/29 (3%) 5/26 (19%) | |FIRST INCIDENCE | |671 --- 665 608 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.091 P=0.013N* P=0.526N P=0.355 | |POLY 3 | |P=0.142 P=0.014N* P=0.504N P=0.442 | |POLY 1.5 | |P=0.156 P=0.015N* P=0.501N P=0.468 | |POLY 6 | |P=0.125 P=0.013N* P=0.509N P=0.404 | |LOGISTIC REGRESSION| |P=0.147 P=0.016N* P=0.506N P=0.430 | |COCH-ARM / FISHERS | |P=0.179 P=0.013N* P=0.500N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM | | | | | |=================================================================================================================================| | | |Uterus | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| |0.0% 4.4% 0.0% 2.4% | |TERMINAL (d) | |0/32 (0%) 2/37 (5%) 0/29 (0%) 0/26 (0%) | |FIRST INCIDENCE | |--- 729 (T) --- 584 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.490 P=0.271 (e) P=0.491 | |POLY 3 | |P=0.516 P=0.244 (e) P=0.485 | |POLY 1.5 | |P=0.526 P=0.241 (e) P=0.492 | |POLY 6 | |P=0.501 P=0.248 (e) P=0.476 | |LOGISTIC REGRESSION| |P=0.553 P=0.271 (e) P=0.551 | |COCH-ARM / FISHERS | |P=0.539 P=0.247 (e) P=0.500 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (d) Observed incidence at terminal kill. (f) Beneath the control incidence are the P-values associated with the trend test. Beneath the dosed group incidence are the P-values corresponding to pairwise comparisons between the controls and that dosed group. The life table analysis regards tumors in animals dying prior to terminal kill as being (directly or indirectly) the cause of death. Logistic regression is an alternative method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage and Fishers exact tests compare directly the overall incidence rates For all tests a negative trend is indicated by N (e) Value of Statistic cannot be computed. (I) Interim sacrifice (T) Terminal sacrifice # Tumor rates based on number of animals necropsied. * To the right of any statistical result, indicates significance at (P<=0.05). ** To the right of any statistical result, indicates significance at (P<=0.01).