TDMS Study 55301-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 06 TIME: 09:12:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: D. SAUER CAS: 110-86-1
Rats(WISTAR OUTBRED)
-----------------------------
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: 06 TIME: 09:12:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: D. SAUER CAS: 110-86-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PYRIDINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hemorrhage
Necrosis
Vacuolization Cytoplasmic
Blood Vessel Mineralization
Blood Vessel: Aorta Mineralization
Bone Fibrous Osteodystrophy
Bone: Cranium Fibrous Osteodystrophy
Bone: Vertebra Fibrous Osteodystrophy
Heart Cardiomyopathy
Mineralization
Heart: Artery Mineralization
Kidney Congestion
Cyst
Hydronephrosis
Mineralization
Kidney: Artery Mineralization
Kidney: Renal Tubule Hyperplasia
Kidney: Vein Thrombosis
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Congestion
Degeneration Cystic
Eosinophilic Focus
Fibrosis
Hemorrhage
Mineralization
Pigmentation
Regeneration
Liver: Bile Duct Cyst
Hyperplasia
Liver: Centrilobular Degeneration
Necrosis
Liver: Periportal Fibrosis
Lung Congestion
Hemorrhage
Lung: Alveolus Infiltration Cellular Histiocyte
Lung: Artery Mineralization
Lymph Node, Mandibular Congestion
Lymph Node, Mediastinal Ectasia
Hemorrhage
Lymph Node, Mesenteric Atrophy
Hyperplasia Lymphoid
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 06 TIME: 09:12:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: D. SAUER CAS: 110-86-1
Lymph Node: Iliac Hemorrhage
Hyperplasia
Lymph Node: Pancreatic Hemorrhage
Lymph Node: Renal Hemorrhage
Hyperplasia
Hyperplasia Lymphoid
Mammary Gland: Artery Mineralization
Mesentery: Artery Inflammation
Mesentery: Vein Thrombosis
Nose Foreign Body
Inflammation Acute
Nose: Respiratory Epithelium Hyperplasia
Pancreas Hyperplasia
Parathyroid Gland Hyperplasia
Peripheral Nerve Radicular Neuropathy
Pituitary Gland Congestion
Hyperplasia
Preputial Gland Inflammation
Preputial Gland: Duct Cyst
Prostate Inflammation Acute
Skin Hyperplasia
Stomach, Forestomach Cyst
Foreign Body
Hyperplasia
Inflammation Chronic
Stomach, Glandular Mineralization
Testes Atrophy
Testes: Artery Inflammation
Testes: Interstitial Cell Hyperplasia
Thymus Atrophy
Hemorrhage
Hyperplasia
Thyroid Gland: Follicle Cyst
===============================================================
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 642 --- 595 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326 P=0.181 (e) P=0.372 |
|POLY 3 | P=0.414 P=0.210 (e) P=0.434 |
|POLY 1.5 | P=0.469 P=0.221 (e) P=0.462 |
|POLY 6 | P=0.346 P=0.198 (e) P=0.395 |
|LOGISTIC REGRESSION| P=0.477 P=0.205 (e) P=0.534 |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 642 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.553N P=0.193 (e) (e) |
|POLY 3 | P=0.489N P=0.211 (e) (e) |
|POLY 1.5 | P=0.452N P=0.221 (e) (e) |
|POLY 6 | P=0.552N P=0.201 (e) (e) |
|LOGISTIC REGRESSION| P=0.444N P=0.231 (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 616 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.113N P=0.199N P=0.227N P=0.343N |
|POLY 3 | P=0.039N* P=0.145N P=0.154N P=0.197N |
|POLY 1.5 | P=0.041N* P=0.134N P=0.138N P=0.159N |
|POLY 6 | P=0.039N* P=0.161N P=0.176N P=0.263N |
|LOGISTIC REGRESSION| P=0.075N P=0.149N P=0.161N P=0.237N |
|COCH-ARM / FISHERS | P=0.047N* P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 5.5% 2.9% 3.5% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 470 588 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.520 P=0.424 P=0.655 P=0.571 |
|POLY 3 | P=0.572 P=0.463 P=0.725 P=0.680 |
|POLY 1.5 | P=0.586N P=0.478 P=0.740 P=0.717 |
|POLY 6 | P=0.488 P=0.447 P=0.706 P=0.625 |
|LOGISTIC REGRESSION| P=0.480N P=0.539 P=0.751 P=0.738 |
|COCH-ARM / FISHERS | P=0.531N P=0.500 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 5.7% 5.9% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/14 (7%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 705 690 632 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.463N P=0.544 P=0.484 P=0.511N |
|POLY 3 | P=0.261N P=0.646 P=0.634 P=0.324N |
|POLY 1.5 | P=0.214N P=0.666 P=0.660 P=0.283N |
|POLY 6 | P=0.347N P=0.623 P=0.602 P=0.386N |
|LOGISTIC REGRESSION| P=0.351N P=0.591 P=0.589 P=0.470N |
|COCH-ARM / FISHERS | P=0.163N P=0.691N P=0.691N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.010 * (e) (e) P=0.074 |
|POLY 3 | P=0.036 * (e) (e) P=0.170 |
|POLY 1.5 | P=0.039 * (e) (e) P=0.197 |
|POLY 6 | P=0.034 * (e) (e) P=0.139 |
|LOGISTIC REGRESSION| P=0.019 * (e) (e) P=0.122 |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/50 (34%) 13/50 (26%) 12/50 (24%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 39.7% 34.6% 33.7% 23.1% |
|TERMINAL (d) | 9/22 (41%) 6/14 (43%) 4/11 (36%) 2/7 (29%) |
|FIRST INCIDENCE | 572 486 404 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.497 P=0.502 P=0.432 P=0.588N |
|POLY 3 | P=0.088N P=0.403N P=0.376N P=0.106N |
|POLY 1.5 | P=0.040N* P=0.337N P=0.283N P=0.049N* |
|POLY 6 | P=0.225N P=0.492N P=0.509N P=0.259N |
|LOGISTIC REGRESSION| P=0.107N P=0.377N P=0.372N P=0.108N |
|COCH-ARM / FISHERS | P=0.014N* P=0.257N P=0.189N P=0.017N* |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.4% 11.2% 5.9% 3.6% |
|TERMINAL (d) | 2/22 (9%) 1/14 (7%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 576 660 682 722 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.531N P=0.319 P=0.631 P=0.689N |
|POLY 3 | P=0.286N P=0.428 P=0.581N P=0.445N |
|POLY 1.5 | P=0.226N P=0.457 P=0.547N P=0.381N |
|POLY 6 | P=0.393N P=0.397 P=0.623N P=0.538N |
|LOGISTIC REGRESSION| P=0.383N P=0.416 P=0.607N P=0.548N |
|COCH-ARM / FISHERS | P=0.162N P=0.500 P=0.500N P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/8 (75%) 6/23 (26%) 1/12 (8%) 0/3 (0%) |
|POLY-3 ADJUSTED (b)| 80.7% 35.2% 13.8% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 468 445 500 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023N* P=0.490 P=0.109N P=0.088N |
|POLY 3 | P=0.002N** P=0.027N* P=0.004N** P=0.255N |
|POLY 1.5 | P=0.002N** P=0.020N* P<0.001N** P=0.107N |
|POLY 6 | P=0.006N** P=0.048N* P=0.019N* P=0.556N |
|LOGISTIC REGRESSION| P=0.003N** P=0.021N* P=0.004N** P=0.059N |
|COCH-ARM / FISHERS | P=0.005N** P=0.022N* P=0.004N** P=0.061N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/8 (88%) 21/23 (91%) 10/12 (83%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 96.3% 94.4% 88.5% 100.0% |
|TERMINAL (d) | 0/0 (0%) 1/2 (50%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 557 352 354 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309N P=0.002 ** P=0.150 P=0.518N |
|POLY 3 | P=0.744N P=0.802N P=0.626N P=0.999 |
|POLY 1.5 | P=0.736N P=0.812 P=0.616N P=0.919 |
|POLY 6 | P=0.794N P=0.750N P=0.751N P=1.000 |
|LOGISTIC REGRESSION| P=0.591 P=0.636 P=0.663N (e) |
|COCH-ARM / FISHERS | P=0.613 P=0.606 P=0.656N P=0.727 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Pulmonary Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/8 (38%) 3/23 (13%) 5/12 (42%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 52.1% 20.1% 60.2% 86.8% |
|TERMINAL (d) | 0/0 (0%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 559 634 501 499 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.326 P=0.532 P=0.215 P=0.586 |
|POLY 3 | P=0.109 P=0.167N P=0.604 P=0.449 |
|POLY 1.5 | P=0.112 P=0.165N P=0.594 P=0.432 |
|POLY 6 | P=0.123 P=0.170N P=0.655 P=0.531 |
|LOGISTIC REGRESSION| P=0.062 P=0.125N P=0.554 P=0.309 |
|COCH-ARM / FISHERS | P=0.131 P=0.161N P=0.612 P=0.424 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 21/50 (42%) 16/50 (32%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 23.4% 48.4% 38.7% 18.9% |
|TERMINAL (d) | 1/22 (5%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 352 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.527 P=0.007 ** P=0.041 * P=0.491 |
|POLY 3 | P=0.304N P=0.011 * P=0.095 P=0.429N |
|POLY 1.5 | P=0.158N P=0.012 * P=0.107 P=0.323N |
|POLY 6 | P=0.510 P=0.012 * P=0.085 P=0.584N |
|LOGISTIC REGRESSION| P=0.009N** P=0.033 * P=0.276 P=0.118N |
|COCH-ARM / FISHERS | P=0.055N P=0.015 * P=0.127 P=0.207N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.9% 2.9% 0.0% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 624 722 (T) 494 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.278N P=0.598N P=0.566N P=0.413N |
|POLY 3 | P=0.200N P=0.552N P=0.558N P=0.327N |
|POLY 1.5 | P=0.178N P=0.530N P=0.533N P=0.285N |
|POLY 6 | P=0.248N P=0.579N P=0.589N P=0.392N |
|LOGISTIC REGRESSION| P=0.149N P=0.536N P=0.431N P=0.262N |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone: Cranium |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/50 (20%) 15/50 (30%) 13/50 (26%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 23.4% 36.2% 32.8% 6.8% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 352 354 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N P=0.085 P=0.119 P=0.216N |
|POLY 3 | P=0.101N P=0.143 P=0.237 P=0.065N |
|POLY 1.5 | P=0.036N* P=0.154 P=0.270 P=0.034N* |
|POLY 6 | P=0.299N P=0.137 P=0.204 P=0.145N |
|LOGISTIC REGRESSION| P=0.002N** P=0.273 P=0.478 P=0.014N* |
|COCH-ARM / FISHERS | P=0.008N** P=0.178 P=0.318 P=0.014N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone: Vertebra |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.9% 5.8% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 506 501 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.537N P=0.047 * P=0.158 (e) |
|POLY 3 | P=0.535N P=0.049 * P=0.204 (e) |
|POLY 1.5 | P=0.444N P=0.053 P=0.218 (e) |
|POLY 6 | P=0.492 P=0.045 * P=0.189 (e) |
|LOGISTIC REGRESSION| P=0.283N P=0.082 P=0.260 (e) |
|COCH-ARM / FISHERS | P=0.337N P=0.059 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 49/50 (98%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 98.0% 99.8% 99.4% 98.9% |
|TERMINAL (d) | 21/22 (96%) 14/14 (100%) 11/11 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 283 352 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.048 * P=0.011 * P<0.001 ** |
|POLY 3 | P=0.612 P=0.544 P=0.623 P=0.706 |
|POLY 1.5 | P=0.565N P=0.622 P=0.690 P=0.758N |
|POLY 6 | P=0.388 P=0.508 P=0.545 P=0.571 |
|LOGISTIC REGRESSION| P=0.416N P=0.690 P=0.737 P=0.634N |
|COCH-ARM / FISHERS | P=0.163N P=0.753N P=0.753N P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 17/50 (34%) 12/50 (24%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 14.3% 40.8% 30.7% 10.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 445 479 550 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.470N P=0.005 ** P=0.040 * P=0.636N |
|POLY 3 | P=0.344N P=0.005 ** P=0.061 P=0.439N |
|POLY 1.5 | P=0.180N P=0.005 ** P=0.073 P=0.348N |
|POLY 6 | P=0.455 P=0.005 ** P=0.051 P=0.568N |
|LOGISTIC REGRESSION| P=0.023N* P=0.018 * P=0.184 P=0.181N |
|COCH-ARM / FISHERS | P=0.064N P=0.008 ** P=0.096 P=0.243N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 15/50 (30%) 9/50 (18%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.7% 36.5% 24.1% 6.8% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 559 352 479 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.444N P=0.003 ** P=0.047 * P=0.656N |
|POLY 3 | P=0.333N P=0.003 ** P=0.076 P=0.502N |
|POLY 1.5 | P=0.188N P=0.003 ** P=0.091 P=0.428N |
|POLY 6 | P=0.494 P=0.003 ** P=0.062 P=0.604N |
|LOGISTIC REGRESSION| P=0.033N* P=0.011 * P=0.168 P=0.257N |
|COCH-ARM / FISHERS | P=0.080N P=0.005 ** P=0.117 P=0.339N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 9.8% 5.6% 14.2% 10.3% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 616 642 486 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.193 P=0.493N P=0.282 P=0.358 |
|POLY 3 | P=0.413 P=0.403N P=0.406 P=0.626 |
|POLY 1.5 | P=0.501 P=0.375N P=0.445 P=0.603N |
|POLY 6 | P=0.300 P=0.436N P=0.360 P=0.517 |
|LOGISTIC REGRESSION| P=0.462 P=0.392N P=0.450 P=0.644 |
|COCH-ARM / FISHERS | P=0.537N P=0.339N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/32 (3%) 2/37 (5%) 1/29 (3%) 0/27 (0%) |
|POLY-3 ADJUSTED (b)| 3.5% 7.2% 5.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 701 561 575 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.453N P=0.391 P=0.676 P=0.734N |
|POLY 3 | P=0.428N P=0.488 P=0.676 P=0.614N |
|POLY 1.5 | P=0.373N P=0.513 P=0.701 P=0.583N |
|POLY 6 | P=0.517N P=0.458 P=0.652 P=0.650N |
|LOGISTIC REGRESSION| P=0.300N P=0.562 P=0.782N P=0.685N |
|COCH-ARM / FISHERS | P=0.297N P=0.555 P=0.729 P=0.542N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/32 (0%) 2/37 (5%) 2/29 (7%) 1/27 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.3% 9.8% 6.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 679 473 499 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.261 P=0.176 P=0.173 P=0.453 |
|POLY 3 | P=0.210 P=0.225 P=0.166 P=0.392 |
|POLY 1.5 | P=0.276 P=0.242 P=0.183 P=0.420 |
|POLY 6 | P=0.144 P=0.207 P=0.151 P=0.359 |
|LOGISTIC REGRESSION| P=0.422 P=0.209 P=0.292 P=0.668 |
|COCH-ARM / FISHERS | P=0.389 P=0.284 P=0.222 P=0.458 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/32 (0%) 2/37 (5%) 0/29 (0%) 2/27 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.1% 0.0% 11.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 573 --- 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.148 P=0.202 (e) P=0.165 |
|POLY 3 | P=0.112 P=0.232 (e) P=0.135 |
|POLY 1.5 | P=0.138 P=0.246 (e) P=0.157 |
|POLY 6 | P=0.087 P=0.216 (e) P=0.113 |
|LOGISTIC REGRESSION| P=0.324 P=0.394 (e) P=0.355 |
|COCH-ARM / FISHERS | P=0.187 P=0.284 (e) P=0.205 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/47 (2%) 1/50 (2%) 2/49 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.8% 6.0% 3.6% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 593 704 616 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.304 P=0.695 P=0.321 P=0.547 |
|POLY 3 | P=0.452 P=0.747 P=0.454 P=0.690 |
|POLY 1.5 | P=0.518 P=0.758 P=0.480 P=0.727 |
|POLY 6 | P=0.363 P=0.733 P=0.424 P=0.633 |
|LOGISTIC REGRESSION| P=0.471 P=0.765N P=0.376 P=0.684 |
|COCH-ARM / FISHERS | P=0.600 P=0.737N P=0.516 P=0.742N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.6% 0.0% 0.0% 6.9% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 283 --- --- 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.519N P=0.099N P=0.112N P=0.604N |
|POLY 3 | P=0.326N P=0.085N P=0.091N P=0.513N |
|POLY 1.5 | P=0.328N P=0.074N P=0.077N P=0.436N |
|POLY 6 | P=0.326N P=0.099N P=0.112N P=0.618N |
|LOGISTIC REGRESSION| P=0.220N P=0.030N* P=0.028N* P=0.177N |
|COCH-ARM / FISHERS | P=0.337N P=0.059N P=0.059N P=0.339N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 21/50 (42%) 31/50 (62%) 19/50 (38%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 48.8% 71.0% 48.2% 47.6% |
|TERMINAL (d) | 11/22 (50%) 7/14 (50%) 6/11 (55%) 4/7 (57%) |
|FIRST INCIDENCE | 557 445 354 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.105 P=0.005 ** P=0.134 P=0.042 * |
|POLY 3 | P=0.255N P=0.022 * P=0.570N P=0.550N |
|POLY 1.5 | P=0.121N P=0.023 * P=0.503N P=0.383N |
|POLY 6 | P=0.519N P=0.030 * P=0.543 P=0.421 |
|LOGISTIC REGRESSION| P=0.141N P=0.017 * P=0.548N P=0.581 |
|COCH-ARM / FISHERS | P=0.039N* P=0.036 * P=0.419N P=0.204N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 19/50 (38%) 20/50 (40%) 30/50 (60%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 43.9% 51.3% 66.4% 43.5% |
|TERMINAL (d) | 9/22 (41%) 7/14 (50%) 3/11 (27%) 2/7 (29%) |
|FIRST INCIDENCE | 536 336 354 450 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * P=0.134 P=0.002 ** P=0.071 |
|POLY 3 | P=0.387 P=0.320 P=0.022 * P=0.582N |
|POLY 1.5 | P=0.511N P=0.396 P=0.021 * P=0.437N |
|POLY 6 | P=0.194 P=0.237 P=0.026 * P=0.421 |
|LOGISTIC REGRESSION| P=0.366N P=0.356 P=0.037 * P=0.426N |
|COCH-ARM / FISHERS | P=0.281N P=0.500 P=0.022 * P=0.263N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 611 --- 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.327 P=0.177 (e) P=0.342 |
|POLY 3 | P=0.412 P=0.210 (e) P=0.432 |
|POLY 1.5 | P=0.468 P=0.221 (e) P=0.462 |
|POLY 6 | P=0.345 P=0.199 (e) P=0.393 |
|LOGISTIC REGRESSION| P=0.448 P=0.217 (e) P=0.423 |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 17/50 (34%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 18.8% 40.7% 21.4% 16.5% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 557 352 404 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.482N P=0.015 * P=0.372 P=0.455 |
|POLY 3 | P=0.278N P=0.021 * P=0.495 P=0.524N |
|POLY 1.5 | P=0.155N P=0.024 * P=0.544 P=0.410N |
|POLY 6 | P=0.503N P=0.019 * P=0.435 P=0.560 |
|LOGISTIC REGRESSION| P=0.023N* P=0.063 P=0.457N P=0.230N |
|COCH-ARM / FISHERS | P=0.064N P=0.032 * P=0.607N P=0.277N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 22/22 (100%) 14/14 (100%) 11/11 (100%) 7/7 (100%) |
|FIRST INCIDENCE | 283 336 354 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.9% 20.9% 8.6% 0.0% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 479 500 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.079N P=0.169 P=0.522N P=0.134N |
|POLY 3 | P=0.051N P=0.211 P=0.462N P=0.083N |
|POLY 1.5 | P=0.025N* P=0.236 P=0.416N P=0.054N |
|POLY 6 | P=0.125N P=0.187 P=0.518N P=0.143N |
|LOGISTIC REGRESSION| P=0.005N** P=0.376 P=0.264N P=0.016N* |
|COCH-ARM / FISHERS | P=0.011N* P=0.277 P=0.357N P=0.028N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 17/50 (34%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 14.5% 41.6% 22.0% 16.2% |
|TERMINAL (d) | 4/22 (18%) 3/14 (21%) 3/11 (27%) 0/7 (0%) |
|FIRST INCIDENCE | 468 445 354 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.430 P=0.003 ** P=0.122 P=0.315 |
|POLY 3 | P=0.390N P=0.004 ** P=0.288 P=0.552 |
|POLY 1.5 | P=0.255N P=0.005 ** P=0.330 P=0.617N |
|POLY 6 | P=0.489 P=0.005 ** P=0.239 P=0.438 |
|LOGISTIC REGRESSION| P=0.093N P=0.012 * P=0.430 P=0.434N |
|COCH-ARM / FISHERS | P=0.131N P=0.008 ** P=0.387 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Vein |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.7% 2.9% 10.3% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 668 561 616 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * P=0.173 P=0.450 P=0.033 * |
|POLY 3 | P=0.055 P=0.210 P=0.469 P=0.071 |
|POLY 1.5 | P=0.073 P=0.221 P=0.482 P=0.089 |
|POLY 6 | P=0.038 * P=0.198 P=0.453 P=0.053 |
|LOGISTIC REGRESSION| P=0.073 P=0.200 P=0.557 P=0.082 |
|COCH-ARM / FISHERS | P=0.104 P=0.247 P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.4% 24.2% 5.7% 0.0% |
|TERMINAL (d) | 3/22 (14%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 695 561 354 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.089N P=0.080 P=0.434N P=0.230N |
|POLY 3 | P=0.025N* P=0.144 P=0.276N P=0.074N |
|POLY 1.5 | P=0.013N* P=0.161 P=0.249N P=0.051N |
|POLY 6 | P=0.060N P=0.133 P=0.312N P=0.123N |
|LOGISTIC REGRESSION| P=0.014N* P=0.123 P=0.237N P=0.171N |
|COCH-ARM / FISHERS | P=0.007N** P=0.194 P=0.218N P=0.028N* |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 550 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.019 * (e) (e) P=0.119 |
|POLY 3 | P=0.036 * (e) (e) P=0.172 |
|POLY 1.5 | P=0.039 * (e) (e) P=0.198 |
|POLY 6 | P=0.033 * (e) (e) P=0.142 |
|LOGISTIC REGRESSION| P=0.043 * (e) (e) P=0.231 |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 7/50 (14%) 8/50 (16%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 36.5% 19.6% 23.7% 28.1% |
|TERMINAL (d) | 12/22 (55%) 6/14 (43%) 8/11 (73%) 7/7 (100%) |
|FIRST INCIDENCE | 592 470 722 (T) 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.088 P=0.228N P=0.613 P=0.129 |
|POLY 3 | P=0.260N P=0.077N P=0.167N P=0.318N |
|POLY 1.5 | P=0.173N P=0.061N P=0.119N P=0.178N |
|POLY 6 | P=0.432N P=0.104N P=0.254N P=0.590N |
|LOGISTIC REGRESSION| P=0.305 P=0.118N P=0.306N P=0.343 |
|COCH-ARM / FISHERS | P=0.100N P=0.045N* P=0.077N P=0.077N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 19/50 (38%) 12/50 (24%) 6/50 (12%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 42.4% 31.3% 17.1% 46.6% |
|TERMINAL (d) | 2/22 (9%) 2/14 (14%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 536 470 631 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.055 P=0.371N P=0.066N P=0.063 |
|POLY 3 | P=0.449 P=0.204N P=0.013N* P=0.437 |
|POLY 1.5 | P=0.542N P=0.151N P=0.006N** P=0.573 |
|POLY 6 | P=0.303 P=0.290N P=0.033N* P=0.260 |
|LOGISTIC REGRESSION| P=0.462N P=0.105N P=0.004N** P=0.310N |
|COCH-ARM / FISHERS | P=0.436N P=0.097N P=0.002N** P=0.418N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 13/50 (26%) 9/50 (18%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 17.2% 34.0% 25.2% 17.5% |
|TERMINAL (d) | 5/22 (23%) 2/14 (14%) 2/11 (18%) 3/7 (43%) |
|FIRST INCIDENCE | 618 541 515 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.212 P=0.032 * P=0.103 P=0.162 |
|POLY 3 | P=0.500N P=0.067 P=0.279 P=0.609 |
|POLY 1.5 | P=0.333N P=0.079 P=0.325 P=0.524N |
|POLY 6 | P=0.339 P=0.060 P=0.232 P=0.443 |
|LOGISTIC REGRESSION| P=0.510N P=0.063 P=0.246 P=0.310 |
|COCH-ARM / FISHERS | P=0.170N P=0.105 P=0.393 P=0.380N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 14/50 (28%) 12/50 (24%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 34.3% 33.0% 11.7% 7.0% |
|TERMINAL (d) | 11/22 (50%) 7/14 (50%) 2/11 (18%) 0/7 (0%) |
|FIRST INCIDENCE | 644 634 631 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.051N P=0.320 P=0.130N P=0.138N |
|POLY 3 | P<0.001N** P=0.550N P=0.019N* P=0.008N** |
|POLY 1.5 | P<0.001N** P=0.493N P=0.013N* P=0.003N** |
|POLY 6 | P=0.004N** P=0.592 P=0.029N* P=0.029N* |
|LOGISTIC REGRESSION| P=0.011N* P=0.495 P=0.044N* P=0.063N |
|COCH-ARM / FISHERS | P<0.001N** P=0.410N P=0.009N** P<0.001N** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 26/50 (52%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 2.5% 13.8% 61.3% 76.7% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 4/11 (36%) 5/7 (71%) |
|FIRST INCIDENCE | 707 581 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.077 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.086 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.068 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.077 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.102 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.8% 14.2% 10.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 616 638 447 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.042 * P=0.720 P=0.051 P=0.160 |
|POLY 3 | P=0.069 P=0.730 P=0.071 P=0.205 |
|POLY 1.5 | P=0.103 P=0.743 P=0.083 P=0.246 |
|POLY 6 | P=0.037 * P=0.715 P=0.058 P=0.158 |
|LOGISTIC REGRESSION| P=0.197 P=0.753N P=0.116 P=0.427 |
|COCH-ARM / FISHERS | P=0.162 P=0.753N P=0.102 P=0.309 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.8% 5.8% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 701 372 487 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.353N P=0.602N P=0.549 P=0.515N |
|POLY 3 | P=0.287N P=0.539N P=0.641 P=0.324N |
|POLY 1.5 | P=0.246N P=0.522N P=0.663 P=0.283N |
|POLY 6 | P=0.361N P=0.560N P=0.613 P=0.386N |
|LOGISTIC REGRESSION| P=0.148N P=0.444N P=0.693 P=0.462N |
|COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.691N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.8% 5.8% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 595 561 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.551 P=0.468 P=0.193 (e) |
|POLY 3 | P=0.496 P=0.476 P=0.205 (e) |
|POLY 1.5 | P=0.587 P=0.485 P=0.218 (e) |
|POLY 6 | P=0.372 P=0.465 P=0.191 (e) |
|LOGISTIC REGRESSION| P=0.577N P=0.534 P=0.274 (e) |
|COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.9% 8.6% 3.6% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 639 722 (T) 404 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287 P=0.688 P=0.221 P=0.537 |
|POLY 3 | P=0.368 P=0.729 P=0.254 P=0.674 |
|POLY 1.5 | P=0.452 P=0.742 P=0.276 P=0.714 |
|POLY 6 | P=0.265 P=0.711 P=0.229 P=0.612 |
|LOGISTIC REGRESSION| P=0.513 P=0.731 P=0.368 P=0.657 |
|COCH-ARM / FISHERS | P=0.556 P=0.753N P=0.309 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.8% 8.5% 10.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 581 473 483 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * P=0.465 P=0.100 P=0.087 |
|POLY 3 | P=0.030 * P=0.476 P=0.096 P=0.075 |
|POLY 1.5 | P=0.043 * P=0.486 P=0.105 P=0.092 |
|POLY 6 | P=0.018 * P=0.465 P=0.086 P=0.056 |
|LOGISTIC REGRESSION| P=0.135 P=0.542 P=0.158 P=0.225 |
|COCH-ARM / FISHERS | P=0.067 P=0.500 P=0.121 P=0.121 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 6/50 (12%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 14.6% 19.0% 16.0% 6.9% |
|TERMINAL (d) | 2/22 (9%) 3/14 (21%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 598 470 447 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.387N P=0.291 P=0.418 P=0.504N |
|POLY 3 | P=0.226N P=0.413 P=0.554 P=0.271N |
|POLY 1.5 | P=0.153N P=0.448 P=0.582 P=0.203N |
|POLY 6 | P=0.361N P=0.372 P=0.518 P=0.386N |
|LOGISTIC REGRESSION| P=0.060N P=0.454 P=0.486N P=0.188N |
|COCH-ARM / FISHERS | P=0.086N P=0.500 P=0.620N P=0.134N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 15/50 (30%) 34/50 (68%) 42/50 (84%) |
|POLY-3 ADJUSTED (b)| 14.6% 38.0% 75.3% 92.5% |
|TERMINAL (d) | 2/22 (9%) 3/14 (21%) 6/11 (55%) 7/7 (100%) |
|FIRST INCIDENCE | 557 372 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- --- 556 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.013 * (e) (e) P=0.088 |
|POLY 3 | P=0.036 * (e) (e) P=0.172 |
|POLY 1.5 | P=0.039 * (e) (e) P=0.198 |
|POLY 6 | P=0.033 * (e) (e) P=0.141 |
|LOGISTIC REGRESSION| P=0.039 * (e) (e) P=0.214 |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/50 (36%) 18/50 (36%) 12/50 (24%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 42.0% 46.1% 32.5% 43.2% |
|TERMINAL (d) | 8/22 (36%) 6/14 (43%) 3/11 (27%) 1/7 (14%) |
|FIRST INCIDENCE | 468 470 473 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.065 P=0.200 P=0.559 P=0.059 |
|POLY 3 | P=0.472N P=0.439 P=0.258N P=0.550 |
|POLY 1.5 | P=0.357N P=0.495 P=0.200N P=0.508N |
|POLY 6 | P=0.454 P=0.380 P=0.337N P=0.393 |
|LOGISTIC REGRESSION| P=0.431N P=0.447 P=0.233N P=0.498N |
|COCH-ARM / FISHERS | P=0.228N P=0.582N P=0.138N P=0.335N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.9% 10.3% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 645 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** (e) P=0.147 P=0.043 * |
|POLY 3 | P=0.013 * (e) P=0.202 P=0.072 |
|POLY 1.5 | P=0.018 * (e) P=0.216 P=0.090 |
|POLY 6 | P=0.009 ** (e) P=0.186 P=0.053 |
|LOGISTIC REGRESSION| P=0.017 * (e) P=0.186 P=0.118 |
|COCH-ARM / FISHERS | P=0.028 * (e) P=0.247 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.7% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 679 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.594N P=0.176 (e) (e) |
|POLY 3 | P=0.490N P=0.209 (e) (e) |
|POLY 1.5 | P=0.453N P=0.220 (e) (e) |
|POLY 6 | P=0.553N P=0.198 (e) (e) |
|LOGISTIC REGRESSION| P=0.531N P=0.196 (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 31/50 (62%) 33/50 (66%) 30/50 (60%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 71.7% 76.0% 72.4% 73.1% |
|TERMINAL (d) | 21/22 (96%) 11/14 (79%) 9/11 (82%) 7/7 (100%) |
|FIRST INCIDENCE | 536 372 354 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.026 * P=0.015 * P<0.001 ** |
|POLY 3 | P=0.542 P=0.407 P=0.573 P=0.550 |
|POLY 1.5 | P=0.365N P=0.394 P=0.576N P=0.489N |
|POLY 6 | P=0.305 P=0.490 P=0.557 P=0.338 |
|LOGISTIC REGRESSION| P=0.381 P=0.180 P=0.317 P=0.118 |
|COCH-ARM / FISHERS | P=0.170N P=0.418 P=0.500N P=0.272N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 15/50 (30%) 25/50 (50%) 33/50 (66%) |
|POLY-3 ADJUSTED (b)| 2.5% 36.3% 58.9% 77.4% |
|TERMINAL (d) | 1/22 (5%) 1/14 (7%) 6/11 (55%) 6/7 (86%) |
|FIRST INCIDENCE | 722 (T) 445 481 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 4/50 (8%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 12.1% 15.9% 11.2% 58.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 572 486 481 450 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.349 P=0.592 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.437 P=0.594N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.461 P=0.554N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.412 P=0.637 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.580 P=0.434N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500N P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 3.0% 3.5% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) --- 722 (T) 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.498 P=0.341N P=0.736 P=0.664 |
|POLY 3 | P=0.531N P=0.267N P=0.560N P=0.616N |
|POLY 1.5 | P=0.518N P=0.255N P=0.534N P=0.566N |
|POLY 6 | P=0.552N P=0.283N P=0.591N P=0.681N |
|LOGISTIC REGRESSION| P=0.574 (e) P=0.736 P=0.740N |
|COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/50 (10%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 14.1% 22.6% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 473 531 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.021 * P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.021 * P=0.002 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.024 * P=0.004 ** |
|POLY 6 | P<0.001 ** (e) P=0.017 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.040 * P=0.009 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.028 * P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 11.0% 5.7% 13.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 549 404 553 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.025 * P=0.044 * P=0.211 P=0.010 * |
|POLY 3 | P=0.047 * P=0.048 * P=0.208 P=0.030 * |
|POLY 1.5 | P=0.070 P=0.053 P=0.220 P=0.041 * |
|POLY 6 | P=0.027 * P=0.044 * P=0.194 P=0.020 * |
|LOGISTIC REGRESSION| P=0.163 P=0.071 P=0.315 P=0.053 |
|COCH-ARM / FISHERS | P=0.114 P=0.059 P=0.247 P=0.059 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 611 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.551N P=0.201 (e) (e) |
|POLY 3 | P=0.489N P=0.212 (e) (e) |
|POLY 1.5 | P=0.452N P=0.222 (e) (e) |
|POLY 6 | P=0.552N P=0.202 (e) (e) |
|LOGISTIC REGRESSION| P=0.408N P=0.248 (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.8% 26.4% 22.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 618 647 473 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.557N P=0.007 ** P=0.014 * |
|POLY 3 | P=0.003 ** P=0.550N P=0.008 ** P=0.031 * |
|POLY 1.5 | P=0.007 ** P=0.529N P=0.010 * P=0.047 * |
|POLY 6 | P<0.001 ** P=0.575N P=0.006 ** P=0.017 * |
|LOGISTIC REGRESSION| P=0.039 * P=0.482N P=0.029 * P=0.141 |
|COCH-ARM / FISHERS | P=0.019 * P=0.500N P=0.014 * P=0.080 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 8.2% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 598 549 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.255N P=0.250 P=0.545N P=0.638N |
|POLY 3 | P=0.224N P=0.267 P=0.536N P=0.571N |
|POLY 1.5 | P=0.189N P=0.282 P=0.521N P=0.540N |
|POLY 6 | P=0.288N P=0.252 P=0.556N P=0.613N |
|LOGISTIC REGRESSION| P=0.112N P=0.371 P=0.465N P=0.470N |
|COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 10.0% 2.9% 14.5% 7.0% |
|TERMINAL (d) | 3/22 (14%) 1/14 (7%) 3/11 (27%) 1/7 (14%) |
|FIRST INCIDENCE | 701 722 (T) 501 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.240 P=0.334N P=0.174 P=0.506 |
|POLY 3 | P=0.550 P=0.221N P=0.404 P=0.504N |
|POLY 1.5 | P=0.510N P=0.203N P=0.445 P=0.429N |
|POLY 6 | P=0.429 P=0.244N P=0.355 P=0.609N |
|LOGISTIC REGRESSION| P=0.397 P=0.291N P=0.328 P=0.619 |
|COCH-ARM / FISHERS | P=0.420N P=0.181N P=0.500 P=0.339N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 5.9% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) --- 700 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.604 P=0.590N P=0.296 P=0.727N |
|POLY 3 | P=0.553N P=0.527N P=0.441 P=0.569N |
|POLY 1.5 | P=0.511N P=0.516N P=0.466 P=0.539N |
|POLY 6 | P=0.608 P=0.540N P=0.411 P=0.610N |
|LOGISTIC REGRESSION| P=0.641 (e) P=0.348 (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 19.0% 13.8% 11.5% 0.0% |
|TERMINAL (d) | 2/22 (9%) 1/14 (7%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 557 549 486 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.059N P=0.496N P=0.433N P=0.069N |
|POLY 3 | P=0.014N* P=0.376N P=0.279N P=0.020N* |
|POLY 1.5 | P=0.007N** P=0.333N P=0.231N P=0.010N* |
|POLY 6 | P=0.038N* P=0.430N P=0.345N P=0.051N |
|LOGISTIC REGRESSION| P=0.006N** P=0.292N P=0.192N P=0.008N** |
|COCH-ARM / FISHERS | P=0.003N** P=0.277N P=0.178N P=0.003N** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.164N P=0.285N P=0.304N P=0.365N |
|POLY 3 | P=0.098N P=0.274N P=0.283N P=0.330N |
|POLY 1.5 | P=0.104N P=0.258N P=0.263N P=0.287N |
|POLY 6 | P=0.099N P=0.295N P=0.311N P=0.396N |
|LOGISTIC REGRESSION| P=0.075N P=0.175N P=0.170N P=0.147N |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 8.1% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 479 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.142N P=0.417 P=0.326N P=0.442N |
|POLY 3 | P=0.113N P=0.454 P=0.281N P=0.328N |
|POLY 1.5 | P=0.093N P=0.472 P=0.261N P=0.285N |
|POLY 6 | P=0.154N P=0.433 P=0.307N P=0.392N |
|LOGISTIC REGRESSION| P=0.038N* P=0.616 P=0.218N P=0.231N |
|COCH-ARM / FISHERS | P=0.073N P=0.500 P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.8% 16.1% 11.6% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 618 352 664 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.389N P=0.238 P=0.432 P=0.470N |
|POLY 3 | P=0.230N P=0.310 P=0.548 P=0.301N |
|POLY 1.5 | P=0.159N P=0.335 P=0.589 P=0.242N |
|POLY 6 | P=0.363N P=0.280 P=0.499 P=0.396N |
|LOGISTIC REGRESSION| P=0.103N P=0.408 P=0.545 P=0.197N |
|COCH-ARM / FISHERS | P=0.094N P=0.370 P=0.643N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 642 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.553N P=0.193 (e) (e) |
|POLY 3 | P=0.489N P=0.211 (e) (e) |
|POLY 1.5 | P=0.452N P=0.221 (e) (e) |
|POLY 6 | P=0.552N P=0.201 (e) (e) |
|LOGISTIC REGRESSION| P=0.444N P=0.231 (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/31 (6%) 1/44 (2%) 0/38 (0%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 8.2% 3.2% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 1/12 (8%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 717 722 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.235N P=0.576N P=0.371N P=0.521N |
|POLY 3 | P=0.095N P=0.416N P=0.226N P=0.324N |
|POLY 1.5 | P=0.095N P=0.398N P=0.209N P=0.279N |
|POLY 6 | P=0.104N P=0.441N P=0.249N P=0.394N |
|LOGISTIC REGRESSION| P=0.212N P=0.509N P=0.304N P=0.528N |
|COCH-ARM / FISHERS | P=0.096N P=0.370N P=0.198N P=0.238N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/31 (6%) 1/44 (2%) 0/38 (0%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 8.2% 3.2% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 1/12 (8%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 717 722 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.235N P=0.576N P=0.371N P=0.521N |
|POLY 3 | P=0.095N P=0.416N P=0.226N P=0.324N |
|POLY 1.5 | P=0.095N P=0.398N P=0.209N P=0.279N |
|POLY 6 | P=0.104N P=0.441N P=0.249N P=0.394N |
|LOGISTIC REGRESSION| P=0.212N P=0.509N P=0.304N P=0.528N |
|COCH-ARM / FISHERS | P=0.096N P=0.370N P=0.198N P=0.238N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/31 (6%) 0/44 (0%) 0/38 (0%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 8.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/12 (0%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 681 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.199N P=0.281N P=0.334N P=0.477N |
|POLY 3 | P=0.081N P=0.183N P=0.227N P=0.326N |
|POLY 1.5 | P=0.092N P=0.173N P=0.210N P=0.280N |
|POLY 6 | P=0.077N P=0.198N P=0.252N P=0.397N |
|LOGISTIC REGRESSION| P=0.167N P=0.209N P=0.263N P=0.441N |
|COCH-ARM / FISHERS | P=0.109N P=0.168N P=0.198N P=0.238N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 5/49 (10%) 1/47 (2%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 13.6% 3.0% 13.3% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 536 447 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.098 P=0.025 * P=0.496 P=0.061 |
|POLY 3 | P=0.084 P=0.026 * P=0.471 P=0.034 * |
|POLY 1.5 | P=0.111 P=0.028 * P=0.481 P=0.044 * |
|POLY 6 | P=0.055 P=0.024 * P=0.459 P=0.023 * |
|LOGISTIC REGRESSION| P=0.380 P=0.053 P=0.551 P=0.178 |
|COCH-ARM / FISHERS | P=0.159 P=0.030 * P=0.495 P=0.059 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/48 (31%) 8/49 (16%) 10/47 (21%) 10/48 (21%) |
|POLY-3 ADJUSTED (b)| 37.3% 22.6% 27.9% 33.8% |
|TERMINAL (d) | 10/22 (46%) 5/14 (36%) 1/11 (9%) 3/7 (43%) |
|FIRST INCIDENCE | 592 372 404 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115 P=0.321N P=0.560 P=0.129 |
|POLY 3 | P=0.449N P=0.122N P=0.262N P=0.480N |
|POLY 1.5 | P=0.353N P=0.094N P=0.229N P=0.328N |
|POLY 6 | P=0.495 P=0.172N P=0.303N P=0.513 |
|LOGISTIC REGRESSION| P=0.501N P=0.133N P=0.239N P=0.567 |
|COCH-ARM / FISHERS | P=0.240N P=0.068N P=0.192N P=0.176N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 1/49 (2%) 3/47 (6%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| 7.8% 2.9% 9.0% 3.7% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 644 647 575 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.564 P=0.428N P=0.453 P=0.662N |
|POLY 3 | P=0.431N P=0.346N P=0.593 P=0.436N |
|POLY 1.5 | P=0.379N P=0.326N P=0.618 P=0.377N |
|POLY 6 | P=0.509N P=0.370N P=0.566 P=0.520N |
|LOGISTIC REGRESSION| P=0.430N P=0.356N P=0.604 P=0.509N |
|COCH-ARM / FISHERS | P=0.316N P=0.301N P=0.651 P=0.308N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/48 (8%) 8/49 (16%) 6/47 (13%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 10.0% 21.8% 17.4% 13.8% |
|TERMINAL (d) | 0/22 (0%) 3/14 (21%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 283 372 494 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.284 P=0.099 P=0.245 P=0.337 |
|POLY 3 | P=0.425 P=0.130 P=0.276 P=0.459 |
|POLY 1.5 | P=0.552 P=0.151 P=0.305 P=0.543 |
|POLY 6 | P=0.271 P=0.110 P=0.251 P=0.349 |
|LOGISTIC REGRESSION| P=0.252N P=0.261 P=0.471 P=0.310N |
|COCH-ARM / FISHERS | P=0.416N P=0.188 P=0.356 P=0.643N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 8.3% 5.7% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 601 552 487 568 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.537 P=0.237 P=0.436 P=0.619 |
|POLY 3 | P=0.540 P=0.264 P=0.449 P=0.677 |
|POLY 1.5 | P=0.562N P=0.280 P=0.470 P=0.716 |
|POLY 6 | P=0.425 P=0.248 P=0.423 P=0.620 |
|LOGISTIC REGRESSION| P=0.376N P=0.338 P=0.615 P=0.728N |
|COCH-ARM / FISHERS | P=0.474N P=0.309 P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 12/50 (24%) 9/50 (18%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 14.4% 33.3% 24.5% 18.9% |
|TERMINAL (d) | 2/22 (9%) 8/14 (57%) 3/11 (27%) 0/7 (0%) |
|FIRST INCIDENCE | 559 573 486 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.149 P=0.017 * P=0.094 P=0.255 |
|POLY 3 | P=0.448 P=0.040 * P=0.196 P=0.422 |
|POLY 1.5 | P=0.519N P=0.059 P=0.234 P=0.508 |
|POLY 6 | P=0.270 P=0.023 * P=0.154 P=0.308 |
|LOGISTIC REGRESSION| P=0.437N P=0.044 * P=0.340 P=0.429N |
|COCH-ARM / FISHERS | P=0.362N P=0.096 P=0.288 P=0.620N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 15/50 (30%) 10/50 (20%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 18.9% 38.5% 26.4% 28.2% |
|TERMINAL (d) | 1/22 (5%) 3/14 (21%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 559 541 486 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.097 P=0.026 * P=0.174 P=0.071 |
|POLY 3 | P=0.327 P=0.040 * P=0.296 P=0.254 |
|POLY 1.5 | P=0.473 P=0.051 P=0.337 P=0.355 |
|POLY 6 | P=0.166 P=0.031 * P=0.250 P=0.144 |
|LOGISTIC REGRESSION| P=0.430N P=0.070 P=0.492 P=0.536 |
|COCH-ARM / FISHERS | P=0.430N P=0.077 P=0.398 P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 3.0% 3.5% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | --- 593 722 (T) 552 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.270 P=0.178 P=0.362 P=0.417 |
|POLY 3 | P=0.347 P=0.210 P=0.466 P=0.434 |
|POLY 1.5 | P=0.413 P=0.221 P=0.480 P=0.463 |
|POLY 6 | P=0.264 P=0.199 P=0.448 P=0.396 |
|LOGISTIC REGRESSION| P=0.434 P=0.222 P=0.362 P=0.581 |
|COCH-ARM / FISHERS | P=0.500 P=0.247 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/46 (0%) 6/50 (12%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 15.8% 2.9% 6.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 445 500 595 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.356 P=0.013 * P=0.469 P=0.107 |
|POLY 3 | P=0.363 P=0.014 * P=0.479 P=0.181 |
|POLY 1.5 | P=0.466 P=0.016 * P=0.495 P=0.211 |
|POLY 6 | P=0.242 P=0.012 * P=0.459 P=0.147 |
|LOGISTIC REGRESSION| P=0.428N P=0.044 * P=0.605 P=0.224 |
|COCH-ARM / FISHERS | P=0.585N P=0.017 * P=0.521 P=0.269 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/46 (11%) 6/50 (12%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 13.0% 16.1% 17.2% 16.3% |
|TERMINAL (d) | 5/22 (23%) 1/14 (7%) 2/11 (18%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 470 515 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.133 P=0.286 P=0.159 P=0.167 |
|POLY 3 | P=0.404 P=0.480 P=0.435 P=0.487 |
|POLY 1.5 | P=0.506 P=0.511 P=0.487 P=0.572 |
|POLY 6 | P=0.279 P=0.447 P=0.375 P=0.376 |
|LOGISTIC REGRESSION| P=0.555 P=0.520 P=0.347 P=0.589 |
|COCH-ARM / FISHERS | P=0.482N P=0.559 P=0.559 P=0.575N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/46 (26%) 14/50 (28%) 12/50 (24%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 29.7% 35.4% 31.7% 35.3% |
|TERMINAL (d) | 2/22 (9%) 2/14 (14%) 2/11 (18%) 1/7 (14%) |
|FIRST INCIDENCE | 616 445 515 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.058 P=0.181 P=0.244 P=0.060 |
|POLY 3 | P=0.384 P=0.377 P=0.521 P=0.395 |
|POLY 1.5 | P=0.518 P=0.429 P=0.589 P=0.522 |
|POLY 6 | P=0.223 P=0.322 P=0.443 P=0.240 |
|LOGISTIC REGRESSION| P=0.393N P=0.499 P=0.537N P=0.471N |
|COCH-ARM / FISHERS | P=0.400N P=0.508 P=0.499N P=0.499N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/46 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.5% 0.0% 3.6% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 536 --- 722 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.365 P=0.211 (e) P=0.273 |
|POLY 3 | P=0.413 P=0.224 (e) P=0.440 |
|POLY 1.5 | P=0.476 P=0.236 (e) P=0.473 |
|POLY 6 | P=0.345 P=0.210 (e) P=0.395 |
|LOGISTIC REGRESSION| P=0.568 P=0.326 (e) P=0.273 |
|COCH-ARM / FISHERS | P=0.556 P=0.269 (e) P=0.521 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/46 (2%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.9% 5.8% 16.1% |
|TERMINAL (d) | 1/22 (5%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 515 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.659 P=0.360 P=0.025 * |
|POLY 3 | P=0.016 * P=0.741 P=0.464 P=0.059 |
|POLY 1.5 | P=0.023 * P=0.757 P=0.492 P=0.083 |
|POLY 6 | P=0.011 * P=0.720 P=0.432 P=0.037 * |
|LOGISTIC REGRESSION| P=0.077 P=0.659 P=0.544 P=0.313 |
|COCH-ARM / FISHERS | P=0.033 * P=0.731N P=0.532 P=0.122 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/31 (16%) 3/44 (7%) 3/38 (8%) 1/32 (3%) |
|POLY-3 ADJUSTED (b)| 19.9% 9.6% 11.8% 5.6% |
|TERMINAL (d) | 2/13 (15%) 1/12 (8%) 1/8 (13%) 0/4 (0%) |
|FIRST INCIDENCE | 576 649 705 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.383N P=0.484N P=0.630N P=0.386N |
|POLY 3 | P=0.137N P=0.232N P=0.342N P=0.195N |
|POLY 1.5 | P=0.109N P=0.208N P=0.296N P=0.141N |
|POLY 6 | P=0.196N P=0.270N P=0.411N P=0.295N |
|LOGISTIC REGRESSION| P=0.210N P=0.254N P=0.404N P=0.158N |
|COCH-ARM / FISHERS | P=0.080N P=0.182N P=0.246N P=0.091N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/31 (3%) 2/44 (5%) 2/38 (5%) 3/32 (9%) |
|POLY-3 ADJUSTED (b)| 4.1% 6.4% 7.7% 16.6% |
|TERMINAL (d) | 0/13 (0%) 1/12 (8%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 717 714 622 468 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.039 * P=0.393 P=0.349 P=0.090 |
|POLY 3 | P=0.114 P=0.584 P=0.519 P=0.201 |
|POLY 1.5 | P=0.145 P=0.601 P=0.542 P=0.247 |
|POLY 6 | P=0.082 P=0.560 P=0.489 P=0.148 |
|LOGISTIC REGRESSION| P=0.082 P=0.502 P=0.493 P=0.221 |
|COCH-ARM / FISHERS | P=0.194 P=0.630 P=0.577 P=0.319 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 4/44 (9%) 2/38 (5%) 2/32 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 12.1% 7.7% 10.8% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 1/8 (13%) 0/4 (0%) |
|FIRST INCIDENCE | --- 352 515 468 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.221 P=0.045 * P=0.165 P=0.209 |
|POLY 3 | P=0.211 P=0.099 P=0.248 P=0.177 |
|POLY 1.5 | P=0.274 P=0.106 P=0.264 P=0.204 |
|POLY 6 | P=0.139 P=0.091 P=0.229 P=0.145 |
|LOGISTIC REGRESSION| P=0.541 P=0.133 P=0.292 P=0.375 |
|COCH-ARM / FISHERS | P=0.366 P=0.112 P=0.300 P=0.254 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 1/44 (2%) 2/38 (5%) 1/32 (3%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.2% 7.7% 5.7% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- 552 588 568 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.195 P=0.463 P=0.152 P=0.395 |
|POLY 3 | P=0.198 P=0.552 P=0.246 P=0.435 |
|POLY 1.5 | P=0.254 P=0.560 P=0.263 P=0.466 |
|POLY 6 | P=0.140 P=0.540 P=0.227 P=0.394 |
|LOGISTIC REGRESSION| P=0.350 P=0.595 P=0.258 P=0.555 |
|COCH-ARM / FISHERS | P=0.337 P=0.587 P=0.300 P=0.508 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/31 (6%) 5/44 (11%) 0/38 (0%) 1/32 (3%) |
|POLY-3 ADJUSTED (b)| 8.2% 15.5% 0.0% 5.7% |
|TERMINAL (d) | 2/13 (15%) 1/12 (8%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 722 (T) 479 --- 545 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439N P=0.153 P=0.348N P=0.693 |
|POLY 3 | P=0.245N P=0.333 P=0.225N P=0.613N |
|POLY 1.5 | P=0.208N P=0.353 P=0.209N P=0.560N |
|POLY 6 | P=0.306N P=0.308 P=0.249N P=0.683N |
|LOGISTIC REGRESSION| P=0.256N P=0.317 (e) P=0.661N |
|COCH-ARM / FISHERS | P=0.169N P=0.384 P=0.198N P=0.488N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/31 (13%) 5/44 (11%) 4/38 (11%) 7/32 (22%) |
|POLY-3 ADJUSTED (b)| 16.1% 15.6% 15.5% 34.0% |
|TERMINAL (d) | 1/13 (8%) 0/12 (0%) 2/8 (25%) 0/4 (0%) |
|FIRST INCIDENCE | 674 610 622 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.016 * P=0.327 P=0.389 P=0.038 * |
|POLY 3 | P=0.085 P=0.623N P=0.626N P=0.143 |
|POLY 1.5 | P=0.113 P=0.596N P=0.581N P=0.192 |
|POLY 6 | P=0.056 P=0.634 P=0.621 P=0.093 |
|LOGISTIC REGRESSION| P=0.075 P=0.622 P=0.588 P=0.248 |
|COCH-ARM / FISHERS | P=0.159 P=0.556N P=0.524N P=0.273 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/31 (3%) 0/44 (0%) 2/38 (5%) 2/32 (6%) |
|POLY-3 ADJUSTED (b)| 4.1% 0.0% 7.8% 10.9% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 1/8 (13%) 0/4 (0%) |
|FIRST INCIDENCE | 674 --- 630 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.103 P=0.562N P=0.388 P=0.346 |
|POLY 3 | P=0.147 P=0.453N P=0.515 P=0.396 |
|POLY 1.5 | P=0.173 P=0.442N P=0.541 P=0.445 |
|POLY 6 | P=0.118 P=0.469N P=0.481 P=0.332 |
|LOGISTIC REGRESSION| P=0.210 P=0.452N P=0.505 P=0.593 |
|COCH-ARM / FISHERS | P=0.213 P=0.413N P=0.577 P=0.512 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/31 (6%) 1/44 (2%) 0/38 (0%) 4/32 (13%) |
|POLY-3 ADJUSTED (b)| 8.2% 3.2% 0.0% 20.4% |
|TERMINAL (d) | 2/13 (15%) 1/12 (8%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) --- 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.050 P=0.529N P=0.348N P=0.137 |
|POLY 3 | P=0.109 P=0.415N P=0.225N P=0.233 |
|POLY 1.5 | P=0.117 P=0.398N P=0.209N P=0.280 |
|POLY 6 | P=0.098 P=0.440N P=0.249N P=0.177 |
|LOGISTIC REGRESSION| P=0.157 P=0.529N (e) P=0.438 |
|COCH-ARM / FISHERS | P=0.132 P=0.370N P=0.198N P=0.351 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/31 (48%) 20/44 (45%) 16/38 (42%) 10/32 (31%) |
|POLY-3 ADJUSTED (b)| 53.0% 52.9% 52.8% 44.5% |
|TERMINAL (d) | 4/13 (31%) 1/12 (8%) 4/8 (50%) 1/4 (25%) |
|FIRST INCIDENCE | 468 352 354 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.297 P=0.101 P=0.151 P=0.335 |
|POLY 3 | P=0.314N P=0.596N P=0.600N P=0.371N |
|POLY 1.5 | P=0.193N P=0.551N P=0.498N P=0.248N |
|POLY 6 | P=0.531N P=0.567 P=0.484 P=0.567N |
|LOGISTIC REGRESSION| P=0.064N P=0.450N P=0.383N P=0.093N |
|COCH-ARM / FISHERS | P=0.087N P=0.493N P=0.390N P=0.129N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 2/44 (5%) 0/38 (0%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.3% 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- 610 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.579N P=0.186 (e) (e) |
|POLY 3 | P=0.488N P=0.293 (e) (e) |
|POLY 1.5 | P=0.455N P=0.304 (e) (e) |
|POLY 6 | P=0.563N P=0.279 (e) (e) |
|LOGISTIC REGRESSION| P=0.475N P=0.305 (e) (e) |
|COCH-ARM / FISHERS | P=0.415N P=0.341 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 10/31 (32%) 17/44 (39%) 19/38 (50%) 12/32 (38%) |
|POLY-3 ADJUSTED (b)| 36.1% 46.0% 60.4% 54.8% |
|TERMINAL (d) | 1/13 (8%) 1/12 (8%) 3/8 (38%) 2/4 (50%) |
|FIRST INCIDENCE | 468 352 354 464 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.022 * P=0.046 * P=0.009 ** P=0.032 * |
|POLY 3 | P=0.066 P=0.288 P=0.045 * P=0.145 |
|POLY 1.5 | P=0.153 P=0.324 P=0.067 P=0.247 |
|POLY 6 | P=0.018 * P=0.253 P=0.028 * P=0.063 |
|LOGISTIC REGRESSION| P=0.387 P=0.442 P=0.134 P=0.435 |
|COCH-ARM / FISHERS | P=0.367 P=0.375 P=0.107 P=0.432 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 1/44 (2%) 6/38 (16%) 2/32 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.2% 22.6% 11.3% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 3/8 (38%) 1/4 (25%) |
|FIRST INCIDENCE | --- 595 515 468 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.023 * P=0.473 P=0.005 ** P=0.112 |
|POLY 3 | P=0.032 * P=0.551 P=0.015 * P=0.170 |
|POLY 1.5 | P=0.061 P=0.559 P=0.019 * P=0.200 |
|POLY 6 | P=0.012 * P=0.539 P=0.011 * P=0.136 |
|LOGISTIC REGRESSION| P=0.075 P=0.589 P=0.018 * P=0.245 |
|COCH-ARM / FISHERS | P=0.129 P=0.587 P=0.023 * P=0.254 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 0/44 (0%) 1/38 (3%) 2/32 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 3.9% 11.1% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 0/8 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- 588 553 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.028 * (e) P=0.452 P=0.136 |
|POLY 3 | P=0.034 * (e) P=0.511 P=0.173 |
|POLY 1.5 | P=0.040 * (e) P=0.524 P=0.201 |
|POLY 6 | P=0.027 * (e) P=0.494 P=0.142 |
|LOGISTIC REGRESSION| P=0.073 (e) P=0.569 P=0.287 |
|COCH-ARM / FISHERS | P=0.053 (e) P=0.551 P=0.254 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/31 (0%) 0/44 (0%) 3/38 (8%) 0/32 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 11.7% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/12 (0%) 2/8 (25%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- 632 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277 (e) P=0.059 (e) |
|POLY 3 | P=0.293 (e) P=0.122 (e) |
|POLY 1.5 | P=0.392 (e) P=0.137 (e) |
|POLY 6 | P=0.186 (e) P=0.105 (e) |
|LOGISTIC REGRESSION| P=0.340 (e) P=0.101 (e) |
|COCH-ARM / FISHERS | P=0.522 (e) P=0.161 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/46 (4%) 0/44 (0%) 1/46 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.0% 0.0% 3.8% |
|TERMINAL (d) | 0/21 (0%) 0/14 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 506 --- 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.389 P=0.208 (e) P=0.342 |
|POLY 3 | P=0.406 P=0.207 (e) P=0.428 |
|POLY 1.5 | P=0.460 P=0.215 (e) P=0.456 |
|POLY 6 | P=0.334 P=0.197 (e) P=0.390 |
|LOGISTIC REGRESSION| P=0.563 P=0.269 (e) P=0.418 |
|COCH-ARM / FISHERS | P=0.529 P=0.237 (e) P=0.489 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/48 (8%) 0/46 (0%) 2/44 (5%) 4/46 (9%) |
|POLY-3 ADJUSTED (b)| 10.2% 0.0% 6.7% 14.1% |
|TERMINAL (d) | 1/21 (5%) 0/14 (0%) 1/10 (10%) 0/7 (0%) |
|FIRST INCIDENCE | 536 --- 494 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.145 P=0.107N P=0.555N P=0.307 |
|POLY 3 | P=0.282 P=0.088N P=0.469N P=0.456 |
|POLY 1.5 | P=0.316 P=0.078N P=0.430N P=0.533 |
|POLY 6 | P=0.238 P=0.103N P=0.517N P=0.354 |
|LOGISTIC REGRESSION| P=0.528 P=0.059N P=0.341N P=0.437N |
|COCH-ARM / FISHERS | P=0.354 P=0.064N P=0.381N P=0.619 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 5/46 (11%) 0/44 (0%) 0/46 (0%) |
|POLY-3 ADJUSTED (b)| 7.6% 14.5% 0.0% 0.0% |
|TERMINAL (d) | 0/21 (0%) 0/14 (0%) 0/10 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 479 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.079N P=0.271 P=0.186N P=0.293N |
|POLY 3 | P=0.061N P=0.287 P=0.178N P=0.207N |
|POLY 1.5 | P=0.042N* P=0.305 P=0.158N P=0.167N |
|POLY 6 | P=0.102N P=0.267 P=0.205N P=0.274N |
|LOGISTIC REGRESSION| P=0.016N* P=0.417 P=0.113N P=0.108N |
|COCH-ARM / FISHERS | P=0.029N* P=0.333 P=0.138N P=0.129N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland: Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/48 (13%) 7/46 (15%) 5/44 (11%) 4/46 (9%) |
|POLY-3 ADJUSTED (b)| 15.1% 20.7% 16.4% 14.6% |
|TERMINAL (d) | 2/21 (10%) 3/14 (21%) 0/10 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 468 486 520 562 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.360 P=0.295 P=0.489 P=0.423 |
|POLY 3 | P=0.495N P=0.375 P=0.573 P=0.610N |
|POLY 1.5 | P=0.392N P=0.414 P=0.622 P=0.518N |
|POLY 6 | P=0.455 P=0.328 P=0.519 P=0.533 |
|LOGISTIC REGRESSION| P=0.392N P=0.447 P=0.595N P=0.482N |
|COCH-ARM / FISHERS | P=0.270N P=0.467 P=0.562N P=0.398N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/7 (71%) 1/1 (100%) 0/2 (0%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 72.3% 100.0% 0.0% 60.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 468 573 --- 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.167N P=0.200N P=0.098N P=0.384N |
|POLY 3 | P=0.307N P=0.720 P=0.157N P=0.710N |
|POLY 1.5 | P=0.287N P=0.714 P=0.148N P=0.659N |
|POLY 6 | P=0.342N P=0.732 P=0.176N P=0.786N |
|LOGISTIC REGRESSION| P=0.049N* (e) P=0.228N P=0.342N |
|COCH-ARM / FISHERS | P=0.268N P=0.750 P=0.167N P=0.583N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/7 (29%) 0/1 (0%) 0/2 (0%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 35.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 701 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.233N P=0.341N P=0.402N P=0.516N |
|POLY 3 | P=0.278N P=0.785N P=0.507N P=0.658N |
|POLY 1.5 | P=0.252N P=0.750N P=0.520N P=0.606N |
|POLY 6 | P=0.323N P=0.834N P=0.496N P=0.724N |
|LOGISTIC REGRESSION| P=0.442N (e) P=0.474N (e) |
|COCH-ARM / FISHERS | P=0.273N P=0.750N P=0.583N P=0.583N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Vein |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/7 (0%) 0/1 (0%) 2/2 (100%) 0/2 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- 683 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.311 (e) P=0.196 (e) |
|POLY 3 | P<0.001 ** (e) P<0.001 ** (e) |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** (e) |
|POLY 6 | P<0.001 ** (e) P<0.001 ** (e) |
|LOGISTIC REGRESSION| P=0.097 (e) P=0.033 * (e) |
|COCH-ARM / FISHERS | P=0.333 (e) P=0.028 * (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 4/50 (8%) 6/50 (12%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 26.1% 11.0% 15.7% 3.5% |
|TERMINAL (d) | 4/22 (18%) 2/14 (14%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 592 336 354 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.049N* P=0.156N P=0.363N P=0.086N |
|POLY 3 | P=0.012N* P=0.077N P=0.191N P=0.014N* |
|POLY 1.5 | P=0.007N** P=0.060N P=0.166N P=0.006N** |
|POLY 6 | P=0.028N* P=0.106N P=0.233N P=0.045N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.053N P=0.056N P=0.007N** |
|COCH-ARM / FISHERS | P=0.004N** P=0.045N* P=0.143N P=0.002N** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.5% 0.0% 2.9% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 717 --- 487 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N P=0.216N P=0.508N P=0.384N |
|POLY 3 | P=0.096N P=0.143N P=0.361N P=0.195N |
|POLY 1.5 | P=0.090N P=0.133N P=0.337N P=0.157N |
|POLY 6 | P=0.109N P=0.157N P=0.391N P=0.258N |
|LOGISTIC REGRESSION| P=0.116N P=0.191N P=0.342N P=0.370N |
|COCH-ARM / FISHERS | P=0.086N P=0.121N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 16.7% 18.6% 11.1% 6.8% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 589 352 473 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.208N P=0.433 P=0.421N P=0.364N |
|POLY 3 | P=0.112N P=0.529 P=0.350N P=0.196N |
|POLY 1.5 | P=0.072N P=0.565 P=0.310N P=0.134N |
|POLY 6 | P=0.199N P=0.481 P=0.408N P=0.310N |
|LOGISTIC REGRESSION| P=0.014N* P=0.549N P=0.164N P=0.056N |
|COCH-ARM / FISHERS | P=0.040N* P=0.613N P=0.262N P=0.080N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 7/50 (14%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 26.5% 18.6% 19.4% 22.9% |
|TERMINAL (d) | 8/22 (36%) 3/14 (21%) 2/11 (18%) 2/7 (29%) |
|FIRST INCIDENCE | 468 336 354 464 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.286 P=0.490N P=0.581 P=0.291 |
|POLY 3 | P=0.405N P=0.285N P=0.317N P=0.469N |
|POLY 1.5 | P=0.317N P=0.254N P=0.270N P=0.349N |
|POLY 6 | P=0.533N P=0.328N P=0.383N P=0.582 |
|LOGISTIC REGRESSION| P=0.234N P=0.217N P=0.242N P=0.433N |
|COCH-ARM / FISHERS | P=0.217N P=0.218N P=0.218N P=0.218N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.8% 3.0% 6.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 639 721 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.052 P=0.462 P=0.379 P=0.137 |
|POLY 3 | P=0.094 P=0.475 P=0.466 P=0.173 |
|POLY 1.5 | P=0.117 P=0.485 P=0.480 P=0.199 |
|POLY 6 | P=0.068 P=0.464 P=0.448 P=0.142 |
|LOGISTIC REGRESSION| P=0.133 P=0.503 P=0.383 P=0.285 |
|COCH-ARM / FISHERS | P=0.153 P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.7% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 479 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.561 (e) P=0.221 (e) |
|POLY 3 | P=0.409 (e) P=0.208 (e) |
|POLY 1.5 | P=0.495 (e) P=0.220 (e) |
|POLY 6 | P=0.300 (e) P=0.195 (e) |
|LOGISTIC REGRESSION| P=0.631N (e) P=0.318 (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 20/50 (40%) 9/50 (18%) 12/50 (24%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 46.4% 24.0% 32.1% 43.0% |
|TERMINAL (d) | 11/22 (50%) 2/14 (14%) 2/11 (18%) 2/7 (29%) |
|FIRST INCIDENCE | 557 336 486 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.054 P=0.138N P=0.492N P=0.084 |
|POLY 3 | P=0.515N P=0.027N* P=0.134N P=0.469N |
|POLY 1.5 | P=0.427N P=0.019N* P=0.099N P=0.333N |
|POLY 6 | P=0.453 P=0.041N* P=0.184N P=0.546 |
|LOGISTIC REGRESSION| P=0.419N P=0.023N* P=0.120N P=0.269N |
|COCH-ARM / FISHERS | P=0.335N P=0.013N* P=0.066N P=0.201N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/5 (60%) 0/1 (0%) 0/1 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 66.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/2 (50%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 654 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.185N P=0.236N P=0.378N P=0.525N |
|POLY 3 | P=1.000 P=0.463N P=0.499N P=1.000N |
|POLY 1.5 | P=1.000 P=0.480N P=0.497N P=1.000N |
|POLY 6 | P=1.000 P=0.437N P=0.513N P=1.000N |
|LOGISTIC REGRESSION| P=0.353N P=0.448N P=0.459N (e) |
|COCH-ARM / FISHERS | P=0.382N P=0.500N P=0.500N P=1.000 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/46 (4%) 3/50 (6%) 3/50 (6%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.3% 8.5% 8.7% 3.6% |
|TERMINAL (d) | 1/22 (5%) 2/14 (14%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 468 638 630 595 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.495 P=0.360 P=0.338 P=0.709N |
|POLY 3 | P=0.491N P=0.471 P=0.457 P=0.599N |
|POLY 1.5 | P=0.415N P=0.498 P=0.491 P=0.547N |
|POLY 6 | P=0.537 P=0.438 P=0.417 P=0.668N |
|LOGISTIC REGRESSION| P=0.428N P=0.518 P=0.535 P=0.421N |
|COCH-ARM / FISHERS | P=0.324N P=0.540 P=0.540 P=0.476N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 18/46 (39%) 18/50 (36%) 8/50 (16%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| 46.2% 45.4% 22.7% 26.7% |
|TERMINAL (d) | 12/22 (55%) 8/14 (57%) 5/11 (46%) 2/7 (29%) |
|FIRST INCIDENCE | 572 352 501 483 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.452N P=0.158 P=0.298N P=0.467 |
|POLY 3 | P=0.017N* P=0.565N P=0.025N* P=0.073N |
|POLY 1.5 | P=0.007N** P=0.517N P=0.015N* P=0.032N* |
|POLY 6 | P=0.053N P=0.566 P=0.046N* P=0.192N |
|LOGISTIC REGRESSION| P=0.023N* P=0.585 P=0.039N* P=0.169N |
|COCH-ARM / FISHERS | P=0.003N** P=0.458N P=0.010N* P=0.012N* |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/46 (7%) 5/50 (10%) 3/50 (6%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 8.0% 13.7% 8.7% 0.0% |
|TERMINAL (d) | 2/22 (9%) 2/14 (14%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 639 506 630 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.277N P=0.209 P=0.466 P=0.353N |
|POLY 3 | P=0.139N P=0.342 P=0.628 P=0.181N |
|POLY 1.5 | P=0.094N P=0.367 P=0.659 P=0.144N |
|POLY 6 | P=0.237N P=0.314 P=0.589 P=0.245N |
|LOGISTIC REGRESSION| P=0.094N P=0.370 P=0.619 P=0.246N |
|COCH-ARM / FISHERS | P=0.056N P=0.405 P=0.621N P=0.110N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/46 (4%) 6/50 (12%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.3% 16.3% 2.9% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 576 561 675 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.227N P=0.076 P=0.643N P=0.446N |
|POLY 3 | P=0.122N P=0.123 P=0.535N P=0.310N |
|POLY 1.5 | P=0.083N P=0.137 P=0.507N P=0.269N |
|POLY 6 | P=0.206N P=0.109 P=0.570N P=0.375N |
|LOGISTIC REGRESSION| P=0.068N P=0.161 P=0.500N P=0.257N |
|COCH-ARM / FISHERS | P=0.053N P=0.163 P=0.468N P=0.232N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 16/48 (33%) 32/47 (68%) 29/48 (60%) 12/47 (26%) |
|POLY-3 ADJUSTED (b)| 38.0% 75.7% 67.1% 36.6% |
|TERMINAL (d) | 5/22 (23%) 7/13 (54%) 2/11 (18%) 0/7 (0%) |
|FIRST INCIDENCE | 536 372 354 483 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159 P<0.001 ** P<0.001 ** P=0.184 |
|POLY 3 | P=0.376N P<0.001 ** P=0.004 ** P=0.547N |
|POLY 1.5 | P=0.186N P<0.001 ** P=0.004 ** P=0.425N |
|POLY 6 | P=0.419 P<0.001 ** P=0.005 ** P=0.492 |
|LOGISTIC REGRESSION| P=0.044N* P<0.001 ** P=0.013 * P=0.222N |
|COCH-ARM / FISHERS | P=0.057N P<0.001 ** P=0.007 ** P=0.272N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 59
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Peripheral Nerve |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 2/4 (50%) 2/2 (100%) 0/5 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 63.0% 100.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- 541 501 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.585 P=0.200 P=0.158 (e) |
|POLY 3 | P=0.367N P=0.520 P=1.000N (e) |
|POLY 1.5 | P=0.197N P=0.548 P=1.000N (e) |
|POLY 6 | P=0.744 P=0.474 P=1.000N (e) |
|LOGISTIC REGRESSION| P=0.159N P=0.797 (e) (e) |
|COCH-ARM / FISHERS | P=0.169N P=0.600 P=0.333 (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Peripheral Nerve |
| Radicular Neuropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 4/4 (100%) 1/2 (50%) 2/5 (40%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 75.0% 54.6% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- 506 721 582 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.166 P=0.042 * P=0.379 P=0.099 |
|POLY 3 | P=0.532N P=1.000N P=0.568 P=0.567 |
|POLY 1.5 | P=0.400N P=1.000N P=0.591 P=0.598 |
|POLY 6 | P=0.699N P=1.000N P=0.530 P=0.527 |
|LOGISTIC REGRESSION| P=0.334N (e) P=0.497 P=0.687 |
|COCH-ARM / FISHERS | P=0.300N P=0.200 P=0.667 P=0.667 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 60
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- --- --- 682 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.009 ** (e) (e) P=0.065 |
|POLY 3 | P=0.037 * (e) (e) P=0.172 |
|POLY 1.5 | P=0.040 * (e) (e) P=0.200 |
|POLY 6 | P=0.036 * (e) (e) P=0.139 |
|LOGISTIC REGRESSION| P=0.011 * (e) (e) P=0.078 |
|COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.253 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 17/49 (35%) 13/49 (27%) 18/50 (36%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 40.3% 33.9% 44.8% 34.8% |
|TERMINAL (d) | 8/22 (36%) 5/14 (36%) 3/11 (27%) 2/7 (29%) |
|FIRST INCIDENCE | 536 336 354 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.129 P=0.533 P=0.109 P=0.172 |
|POLY 3 | P=0.465N P=0.355N P=0.424 P=0.403N |
|POLY 1.5 | P=0.308N P=0.307N P=0.470 P=0.253N |
|POLY 6 | P=0.389 P=0.427N P=0.374 P=0.570 |
|LOGISTIC REGRESSION| P=0.208N P=0.272N P=0.525 P=0.405N |
|COCH-ARM / FISHERS | P=0.147N P=0.256N P=0.530 P=0.119N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 61
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 13/49 (27%) 10/49 (20%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 31.2% 28.0% 19.9% 10.4% |
|TERMINAL (d) | 6/22 (27%) 6/14 (43%) 4/11 (36%) 1/7 (14%) |
|FIRST INCIDENCE | 589 536 479 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N P=0.520 P=0.458N P=0.261N |
|POLY 3 | P=0.020N* P=0.476N P=0.190N P=0.039N* |
|POLY 1.5 | P=0.008N** P=0.406N P=0.142N P=0.016N* |
|POLY 6 | P=0.067N P=0.567N P=0.271N P=0.117N |
|LOGISTIC REGRESSION| P=0.024N* P=0.455N P=0.162N P=0.037N* |
|COCH-ARM / FISHERS | P=0.003N** P=0.317N P=0.096N P=0.005N** |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 2.8% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 372 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.185N P=0.606N P=0.400N P=0.512N |
|POLY 3 | P=0.109N P=0.540N P=0.273N P=0.319N |
|POLY 1.5 | P=0.104N P=0.523N P=0.255N P=0.279N |
|POLY 6 | P=0.122N P=0.562N P=0.296N P=0.382N |
|LOGISTIC REGRESSION| P=0.080N P=0.451N (e) (e) |
|COCH-ARM / FISHERS | P=0.098N P=0.500N P=0.242N P=0.242N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 62
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 12/50 (24%) 9/48 (19%) 10/50 (20%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 27.9% 24.6% 27.0% 10.3% |
|TERMINAL (d) | 6/22 (27%) 1/13 (8%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 468 479 473 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.265N P=0.579 P=0.378 P=0.260N |
|POLY 3 | P=0.080N P=0.467N P=0.565N P=0.067N |
|POLY 1.5 | P=0.036N* P=0.420N P=0.497N P=0.032N* |
|POLY 6 | P=0.200N P=0.518N P=0.564 P=0.160N |
|LOGISTIC REGRESSION| P=0.013N* P=0.295N P=0.379N P=0.022N* |
|COCH-ARM / FISHERS | P=0.012N* P=0.350N P=0.405N P=0.011N* |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/48 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.5% 5.9% 11.3% 3.5% |
|TERMINAL (d) | 2/22 (9%) 0/13 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 707 470 354 511 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.588 P=0.653N P=0.269 P=0.646N |
|POLY 3 | P=0.440N P=0.576N P=0.432 P=0.432N |
|POLY 1.5 | P=0.369N P=0.553N P=0.462 P=0.374N |
|POLY 6 | P=0.549N P=0.604N P=0.396 P=0.516N |
|LOGISTIC REGRESSION| P=0.255N P=0.567N P=0.522 P=0.457N |
|COCH-ARM / FISHERS | P=0.287N P=0.520N P=0.500 P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 63
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 49/50 (98%) 43/48 (90%) 46/50 (92%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 98.4% 91.4% 93.2% 98.7% |
|TERMINAL (d) | 22/22 (100%) 12/13 (92%) 8/11 (73%) 7/7 (100%) |
|FIRST INCIDENCE | 283 336 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.164 P=0.037 * P<0.001 ** |
|POLY 3 | P=0.389 P=0.115N P=0.207N P=0.786 |
|POLY 1.5 | P=0.401 P=0.103N P=0.197N P=0.784 |
|POLY 6 | P=0.396 P=0.141N P=0.210N P=0.823 |
|LOGISTIC REGRESSION| P=0.570 P=0.066N P=0.130N P=0.736 |
|COCH-ARM / FISHERS | P=0.572 P=0.093N P=0.181N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.8% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 354 631 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.130 (e) P=0.177 P=0.344 |
|POLY 3 | P=0.145 (e) P=0.205 P=0.433 |
|POLY 1.5 | P=0.187 (e) P=0.219 P=0.462 |
|POLY 6 | P=0.102 (e) P=0.189 P=0.394 |
|LOGISTIC REGRESSION| P=0.312 (e) P=0.311 P=0.480 |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 64
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/50 (8%) 4/49 (8%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 10.0% 11.7% 3.0% 7.1% |
|TERMINAL (d) | 4/22 (18%) 3/14 (21%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 722 (T) 710 722 (T) 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.525 P=0.391 P=0.433N P=0.513 |
|POLY 3 | P=0.278N P=0.555 P=0.233N P=0.505N |
|POLY 1.5 | P=0.234N P=0.587 P=0.209N P=0.429N |
|POLY 6 | P=0.348N P=0.516 P=0.266N P=0.610N |
|LOGISTIC REGRESSION| P=0.591 P=0.415 P=0.433N P=0.570 |
|COCH-ARM / FISHERS | P=0.184N P=0.631 P=0.181N P=0.339N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.4% 2.9% 0.0% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 486 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.101N P=0.418N P=0.235N P=0.325N |
|POLY 3 | P=0.048N* P=0.361N P=0.154N P=0.198N |
|POLY 1.5 | P=0.045N* P=0.341N P=0.138N P=0.159N |
|POLY 6 | P=0.056N P=0.386N P=0.177N P=0.264N |
|LOGISTIC REGRESSION| P=0.038N* P=0.280N P=0.141N P=0.187N |
|COCH-ARM / FISHERS | P=0.044N* P=0.316N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 65
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/50 (16%) 9/49 (18%) 7/50 (14%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 19.3% 24.1% 20.1% 13.3% |
|TERMINAL (d) | 3/22 (14%) 0/14 (0%) 3/11 (27%) 0/7 (0%) |
|FIRST INCIDENCE | 468 352 561 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.500 P=0.278 P=0.345 P=0.591 |
|POLY 3 | P=0.284N P=0.401 P=0.580 P=0.365N |
|POLY 1.5 | P=0.191N P=0.433 P=0.586N P=0.274N |
|POLY 6 | P=0.442N P=0.372 P=0.509 P=0.503N |
|LOGISTIC REGRESSION| P=0.150N P=0.498 P=0.584 P=0.212N |
|COCH-ARM / FISHERS | P=0.105N P=0.482 P=0.500N P=0.178N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 3/49 (6%) 0/47 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 5.1% 8.6% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 601 639 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196N P=0.384 P=0.314N P=0.457N |
|POLY 3 | P=0.111N P=0.450 P=0.279N P=0.326N |
|POLY 1.5 | P=0.093N P=0.474 P=0.263N P=0.284N |
|POLY 6 | P=0.147N P=0.423 P=0.300N P=0.388N |
|LOGISTIC REGRESSION| P=0.101N P=0.477 P=0.244N P=0.276N |
|COCH-ARM / FISHERS | P=0.074N P=0.510 P=0.253N P=0.247N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 66
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 5.5% 2.9% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 506 674 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.429N P=0.422 P=0.646 P=0.727N |
|POLY 3 | P=0.345N P=0.463 P=0.723 P=0.569N |
|POLY 1.5 | P=0.300N P=0.478 P=0.739 P=0.539N |
|POLY 6 | P=0.423N P=0.447 P=0.702 P=0.610N |
|LOGISTIC REGRESSION| P=0.262N P=0.529 P=0.695 (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.7% 2.9% 7.1% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | --- 710 548 687 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.058 P=0.162 P=0.447 P=0.049 * |
|POLY 3 | P=0.144 P=0.208 P=0.469 P=0.169 |
|POLY 1.5 | P=0.184 P=0.220 P=0.482 P=0.196 |
|POLY 6 | P=0.103 P=0.195 P=0.454 P=0.136 |
|LOGISTIC REGRESSION| P=0.116 P=0.166 P=0.562 P=0.072 |
|COCH-ARM / FISHERS | P=0.245 P=0.247 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 67
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 5.7% 0.0% 3.6% |
|TERMINAL (d) | 1/22 (5%) 1/14 (7%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 722 (T) 710 --- 722 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.460 P=0.362 P=0.638N P=0.488 |
|POLY 3 | P=0.565N P=0.454 P=0.534N P=0.676 |
|POLY 1.5 | P=0.537N P=0.473 P=0.520N P=0.715 |
|POLY 6 | P=0.596 P=0.431 P=0.552N P=0.615 |
|LOGISTIC REGRESSION| P=0.485 P=0.377 (e) P=0.488 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.8% 0.0% 6.9% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 552 --- 468 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.212 P=0.688 P=0.638N P=0.276 |
|POLY 3 | P=0.303 P=0.734 P=0.534N P=0.391 |
|POLY 1.5 | P=0.330 P=0.745 P=0.520N P=0.438 |
|POLY 6 | P=0.270 P=0.722 P=0.552N P=0.330 |
|LOGISTIC REGRESSION| P=0.415 P=0.761N (e) P=0.531 |
|COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 68
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.8% 3.0% 3.6% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 541 628 660 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.597N P=0.559N P=0.574N P=0.723N |
|POLY 3 | P=0.479N P=0.541N P=0.563N P=0.622N |
|POLY 1.5 | P=0.449N P=0.521N P=0.536N P=0.569N |
|POLY 6 | P=0.525N P=0.565N P=0.594N P=0.689N |
|LOGISTIC REGRESSION| P=0.360N P=0.406N P=0.436N P=0.467N |
|COCH-ARM / FISHERS | P=0.411N P=0.492N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 5.6% 0.0% 7.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 572 552 --- 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.291 P=0.427 P=0.556N P=0.305 |
|POLY 3 | P=0.369 P=0.464 P=0.536N P=0.387 |
|POLY 1.5 | P=0.411 P=0.481 P=0.520N P=0.436 |
|POLY 6 | P=0.315 P=0.444 P=0.554N P=0.325 |
|LOGISTIC REGRESSION| P=0.503 P=0.557 P=0.450N P=0.558 |
|COCH-ARM / FISHERS | P=0.467 P=0.508 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 69
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% 7.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 683 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.021 * (e) P=0.430 P=0.119 |
|POLY 3 | P=0.043 * (e) P=0.467 P=0.171 |
|POLY 1.5 | P=0.053 (e) P=0.482 P=0.196 |
|POLY 6 | P=0.034 * (e) P=0.450 P=0.142 |
|LOGISTIC REGRESSION| P=0.059 (e) P=0.455 P=0.269 |
|COCH-ARM / FISHERS | P=0.069 (e) P=0.505 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% 6.9% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 479 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 (e) P=0.492 P=0.216 |
|POLY 3 | P=0.045 * (e) P=0.470 P=0.174 |
|POLY 1.5 | P=0.054 (e) P=0.484 P=0.199 |
|POLY 6 | P=0.035 * (e) P=0.454 P=0.145 |
|LOGISTIC REGRESSION| P=0.181 (e) P=0.822 P=0.470 |
|COCH-ARM / FISHERS | P=0.069 (e) P=0.505 P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 70
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 13/50 (26%) 11/50 (22%) 10/49 (20%) |
|POLY-3 ADJUSTED (b)| 4.9% 33.2% 28.8% 31.1% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 2/11 (18%) 0/7 (0%) |
|FIRST INCIDENCE | 468 372 354 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P<0.001 ** P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.011 * P<0.001 ** P=0.004 ** P=0.003 ** |
|POLY 1.5 | P=0.026 * P<0.001 ** P=0.005 ** P=0.005 ** |
|POLY 6 | P=0.003 ** P<0.001 ** P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.177 P=0.006 ** P=0.040 * P=0.040 * |
|COCH-ARM / FISHERS | P=0.083 P=0.002 ** P=0.008 ** P=0.014 * |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% 7.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 630 468 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.029 * (e) P=0.462 P=0.157 |
|POLY 3 | P=0.044 * (e) P=0.468 P=0.172 |
|POLY 1.5 | P=0.053 (e) P=0.482 P=0.197 |
|POLY 6 | P=0.034 * (e) P=0.452 P=0.143 |
|LOGISTIC REGRESSION| P=0.093 (e) P=0.522 P=0.344 |
|COCH-ARM / FISHERS | P=0.069 (e) P=0.505 P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 71
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 5/50 (10%) 3/50 (6%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 7.3% 13.5% 8.6% 3.5% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 576 479 500 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.397N P=0.255 P=0.528 P=0.543N |
|POLY 3 | P=0.317N P=0.300 P=0.586 P=0.445N |
|POLY 1.5 | P=0.240N P=0.324 P=0.621 P=0.383N |
|POLY 6 | P=0.444N P=0.274 P=0.544 P=0.532N |
|LOGISTIC REGRESSION| P=0.100N P=0.475 P=0.591N P=0.186N |
|COCH-ARM / FISHERS | P=0.157N P=0.369 P=0.651N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 4/50 (8%) 3/50 (6%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 4.9% 10.8% 8.6% 13.4% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 644 372 404 466 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128 P=0.255 P=0.399 P=0.132 |
|POLY 3 | P=0.180 P=0.296 P=0.434 P=0.207 |
|POLY 1.5 | P=0.237 P=0.315 P=0.464 P=0.258 |
|POLY 6 | P=0.119 P=0.273 P=0.397 P=0.151 |
|LOGISTIC REGRESSION| P=0.538 P=0.548 P=0.638 P=0.471 |
|COCH-ARM / FISHERS | P=0.328 P=0.349 P=0.510 P=0.339 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 72
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/49 (6%) 3/50 (6%) 2/48 (4%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 7.4% 8.5% 6.1% 13.8% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 634 447 539 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.124 P=0.515 P=0.644N P=0.179 |
|POLY 3 | P=0.272 P=0.600 P=0.593N P=0.323 |
|POLY 1.5 | P=0.328 P=0.630 P=0.557N P=0.392 |
|POLY 6 | P=0.204 P=0.561 P=0.636N P=0.241 |
|LOGISTIC REGRESSION| P=0.387 P=0.662 P=0.426N P=0.535 |
|COCH-ARM / FISHERS | P=0.404 P=0.651N P=0.510N P=0.488 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/48 (4%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.1% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.418 (e) P=0.171 (e) |
|POLY 3 | P=0.418 (e) P=0.197 (e) |
|POLY 1.5 | P=0.496 (e) P=0.211 (e) |
|POLY 6 | P=0.310 (e) P=0.181 (e) |
|LOGISTIC REGRESSION| P=0.499 (e) P=0.189 (e) |
|COCH-ARM / FISHERS | P=0.589 (e) P=0.242 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 73
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/49 (16%) 25/50 (50%) 16/48 (33%) 6/48 (13%) |
|POLY-3 ADJUSTED (b)| 19.1% 56.0% 40.0% 19.9% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 557 352 354 463 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.475 P<0.001 ** P=0.018 * P=0.319 |
|POLY 3 | P=0.416N P<0.001 ** P=0.029 * P=0.583 |
|POLY 1.5 | P=0.217N P<0.001 ** P=0.034 * P=0.542N |
|POLY 6 | P=0.348 P<0.001 ** P=0.025 * P=0.432 |
|LOGISTIC REGRESSION| P=0.015N* P<0.001 ** P=0.144 P=0.314N |
|COCH-ARM / FISHERS | P=0.075N P<0.001 ** P=0.044 * P=0.403N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 20/50 (40%) 20/49 (41%) 18/49 (37%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 44.9% 49.3% 45.7% 28.9% |
|TERMINAL (d) | 7/22 (32%) 4/14 (29%) 2/11 (18%) 2/7 (29%) |
|FIRST INCIDENCE | 468 445 486 499 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.527N P=0.223 P=0.243 P=0.560 |
|POLY 3 | P=0.104N P=0.424 P=0.563 P=0.118N |
|POLY 1.5 | P=0.036N* P=0.472 P=0.548N P=0.048N* |
|POLY 6 | P=0.296N P=0.376 P=0.500 P=0.299N |
|LOGISTIC REGRESSION| P=0.011N* P=0.568 P=0.423N P=0.047N* |
|COCH-ARM / FISHERS | P=0.007N** P=0.548 P=0.449N P=0.013N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 74
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 2/49 (4%) 9/49 (18%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 14.5% 5.7% 24.6% 13.7% |
|TERMINAL (d) | 3/22 (14%) 0/14 (0%) 0/11 (0%) 1/7 (14%) |
|FIRST INCIDENCE | 557 541 494 550 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.189 P=0.250N P=0.114 P=0.361 |
|POLY 3 | P=0.349 P=0.186N P=0.200 P=0.593N |
|POLY 1.5 | P=0.464 P=0.166N P=0.228 P=0.495N |
|POLY 6 | P=0.215 P=0.212N P=0.175 P=0.539 |
|LOGISTIC REGRESSION| P=0.511N P=0.126N P=0.314 P=0.553N |
|COCH-ARM / FISHERS | P=0.512N P=0.141N P=0.274 P=0.370N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 24/50 (48%) 24/49 (49%) 14/49 (29%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 53.3% 61.6% 39.6% 34.4% |
|TERMINAL (d) | 9/22 (41%) 9/14 (64%) 4/11 (36%) 2/7 (29%) |
|FIRST INCIDENCE | 468 506 575 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.533N P=0.151 P=0.452N P=0.513 |
|POLY 3 | P=0.022N* P=0.283 P=0.153N P=0.074N |
|POLY 1.5 | P=0.005N** P=0.380 P=0.085N P=0.025N* |
|POLY 6 | P=0.110N P=0.201 P=0.272N P=0.233N |
|LOGISTIC REGRESSION| P=0.021N* P=0.379 P=0.095N P=0.029N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.541 P=0.037N* P=0.006N** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 75
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 2/49 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.4% 5.8% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 506 486 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.560N P=0.094 P=0.212 (e) |
|POLY 3 | P=0.592N P=0.098 P=0.203 (e) |
|POLY 1.5 | P=0.510N P=0.104 P=0.215 (e) |
|POLY 6 | P=0.460 P=0.091 P=0.190 (e) |
|LOGISTIC REGRESSION| P=0.300N P=0.152 P=0.303 (e) |
|COCH-ARM / FISHERS | P=0.408N P=0.117 P=0.242 (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/49 (8%) 7/49 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 7.4% 11.6% 20.5% 22.0% |
|TERMINAL (d) | 2/22 (9%) 2/14 (14%) 3/11 (27%) 1/7 (14%) |
|FIRST INCIDENCE | 676 651 548 467 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.300 P=0.029 * P=0.023 * |
|POLY 3 | P=0.037 * P=0.415 P=0.093 P=0.075 |
|POLY 1.5 | P=0.059 P=0.445 P=0.115 P=0.105 |
|POLY 6 | P=0.018 * P=0.381 P=0.073 P=0.045 * |
|LOGISTIC REGRESSION| P=0.043 * P=0.347 P=0.067 P=0.207 |
|COCH-ARM / FISHERS | P=0.101 P=0.489 P=0.151 P=0.159 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 76
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 15/48 (31%) 29/49 (59%) 28/49 (57%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 34.9% 64.1% 62.5% 60.4% |
|TERMINAL (d) | 1/22 (5%) 2/14 (14%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 557 352 354 443 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.003 ** P=0.002 ** P<0.001 ** |
|POLY 3 | P=0.028 * P=0.004 ** P=0.006 ** P=0.013 * |
|POLY 1.5 | P=0.062 P=0.004 ** P=0.007 ** P=0.027 * |
|POLY 6 | P=0.009 ** P=0.004 ** P=0.005 ** P=0.005 ** |
|LOGISTIC REGRESSION| P=0.506 P=0.015 * P=0.047 * P=0.181 |
|COCH-ARM / FISHERS | P=0.167 P=0.005 ** P=0.009 ** P=0.068 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/48 (10%) 6/49 (12%) 4/49 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 12.6% 16.3% 11.7% 19.7% |
|TERMINAL (d) | 2/22 (9%) 1/14 (7%) 1/11 (9%) 1/7 (14%) |
|FIRST INCIDENCE | 572 479 481 489 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.111 P=0.330 P=0.516 P=0.089 |
|POLY 3 | P=0.302 P=0.446 P=0.594N P=0.315 |
|POLY 1.5 | P=0.390 P=0.473 P=0.548N P=0.405 |
|POLY 6 | P=0.198 P=0.417 P=0.625 P=0.210 |
|LOGISTIC REGRESSION| P=0.533 P=0.561 P=0.488N P=0.438 |
|COCH-ARM / FISHERS | P=0.511 P=0.515 P=0.487N P=0.529 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 77
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 5/49 (10%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.7% 13.8% 3.0% 3.5% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 717 479 700 486 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.353N P=0.225 P=0.540N P=0.643N |
|POLY 3 | P=0.193N P=0.314 P=0.367N P=0.419N |
|POLY 1.5 | P=0.149N P=0.334 P=0.336N P=0.360N |
|POLY 6 | P=0.273N P=0.296 P=0.407N P=0.506N |
|LOGISTIC REGRESSION| P=0.134N P=0.344 P=0.488N P=0.424N |
|COCH-ARM / FISHERS | P=0.106N P=0.369 P=0.301N P=0.293N |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 8/48 (17%) 6/49 (12%) 8/49 (16%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 19.1% 17.0% 21.5% 38.1% |
|TERMINAL (d) | 1/22 (5%) 2/14 (14%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | 283 593 404 94 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.584N P=0.419 P=0.015 * |
|POLY 3 | P=0.021 * P=0.524N P=0.506 P=0.048 * |
|POLY 1.5 | P=0.031 * P=0.462N P=0.555 P=0.078 |
|POLY 6 | P=0.011 * P=0.597N P=0.444 P=0.024 * |
|LOGISTIC REGRESSION| P=0.237 P=0.321N P=0.259N P=0.464N |
|COCH-ARM / FISHERS | P=0.049 * P=0.371N P=0.590N P=0.135 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 78
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/22 (0%) 0/14 (0%) 0/11 (0%) 2/7 (29%) |
|FIRST INCIDENCE | --- --- --- 722 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.043 * |
|POLY 3 | P=0.037 * (e) (e) P=0.173 |
|POLY 1.5 | P=0.041 * (e) (e) P=0.203 |
|POLY 6 | P=0.037 * (e) (e) P=0.138 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.043 * |
|COCH-ARM / FISHERS | P=0.049 * (e) (e) P=0.258 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/49 (4%) 4/50 (8%) 5/48 (10%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.1% 11.0% 15.2% 3.6% |
|TERMINAL (d) | 2/22 (9%) 0/14 (0%) 3/11 (27%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 506 700 658 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.350 P=0.214 P=0.044 * P=0.658 |
|POLY 3 | P=0.551 P=0.301 P=0.148 P=0.617N |
|POLY 1.5 | P=0.477N P=0.318 P=0.172 P=0.566N |
|POLY 6 | P=0.384 P=0.283 P=0.124 P=0.681N |
|LOGISTIC REGRESSION| P=0.547 P=0.311 P=0.071 P=0.718 |
|COCH-ARM / FISHERS | P=0.348N P=0.349 P=0.209 P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 79
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/48 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 3.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 1/14 (7%) 0/11 (0%) 0/7 (0%) |
|FIRST INCIDENCE | --- 593 628 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.664N P=0.178 P=0.469 (e) |
|POLY 3 | P=0.590N P=0.215 P=0.467 (e) |
|POLY 1.5 | P=0.535N P=0.226 P=0.479 (e) |
|POLY 6 | P=0.553 P=0.204 P=0.453 (e) |
|LOGISTIC REGRESSION| P=0.518N P=0.226 P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.463N P=0.253 P=0.495 (e) |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/2 (50%) 1/2 (50%) 4/4 (100%) 1/3 (33%) |
|POLY-3 ADJUSTED (b)| 50.0% 50.0% 100.0% 37.7% |
|TERMINAL (d) | 1/2 (50%) 1/2 (50%) 1/1 (100%) 0/1 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 354 709 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.188 P=0.807 P=0.052 P=0.561 |
|POLY 3 | P=0.598N P=0.760 P=0.342 P=0.707N |
|POLY 1.5 | P=0.553N P=0.760 P=0.342 P=0.690N |
|POLY 6 | P=0.652 P=0.760 P=0.342 P=0.733N |
|LOGISTIC REGRESSION| P=0.447N P=0.807 (e) P=0.851 |
|COCH-ARM / FISHERS | P=0.500N P=0.833N P=0.333 P=0.700N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 06 Page 80
Statistical Analysis of Non-neoplastic Lesions in Rats(WISTAR OUTBRED) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/2 (50%) 0/2 (0%) 0/4 (0%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 50.0% 0.0% 0.0% 67.9% |
|TERMINAL (d) | 1/2 (50%) 0/2 (0%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 722 (T) --- --- 627 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.087 P=0.500N P=0.638N P=0.216 |
|POLY 3 | P=0.298 P=0.500N P=0.429N P=0.666 |
|POLY 1.5 | P=0.300 P=0.500N P=0.396N P=0.668 |
|POLY 6 | P=0.293 P=0.500N P=0.466N P=0.662 |
|LOGISTIC REGRESSION| P=0.292 (e) (e) P=0.851N |
|COCH-ARM / FISHERS | P=0.316 P=0.500N P=0.333N P=0.700 |
|=================================================================================================================================|
| | | |
| | Males |
|Dose | 0 PPM 100 PPM | 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/47 (2%) 3/49 (6%) 1/47 (2%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 8.5% 3.2% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/14 (0%) 1/11 (9%) 0/7 (0%) |
|FIRST INCIDENCE | 722 (T) 352 722 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.438N P=0.206 P=0.600 P=0.727N |
|POLY 3 | P=0.337N P=0.271 P=0.714 P=0.584N |
|POLY 1.5 | P=0.281N P=0.290 P=0.733 P=0.555N |
|POLY 6 | P=0.425N P=0.249 P=0.690 P=0.621N |
|LOGISTIC REGRESSION| P=0.251N P=0.358 P=0.600 (e) |
|COCH-ARM / FISHERS | P=0.216N P=0.324 P=0.753N P=0.516N |
|=================================================================================================================================|
(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).