TDMS Study 55301-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1
Rats(FISCHER344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PYRIDINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Bone Fibrous Osteodystrophy
Heart Cardiomyopathy
Kidney Cyst
Nephropathy
Kidney: Renal Tubule Hyperplasia
Liver Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Eosinophilic Focus
Fibrosis
Hepatodiaphragmatic Nodule
Mitotic Alteration
Pigmentation
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Cytomegaly
Degeneration
Necrosis
Liver: Periportal Fibrosis
Lung Infiltration Cellular Histiocyte
Lymph Node, Mediastinal Congestion
Lymph Node: Renal Pigmentation
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Cyst
Hyperplasia
Preputial Gland Inflammation Chronic
Spleen Necrosis
Pigmentation
Stomach, Forestomach Hyperkeratosis
Inflammation Chronic
Ulcer
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Mineralization
Testes: Interstitial Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy
Kidney Mineralization
Liver Basophilic Focus
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 05 TIME: 09:11:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01ES95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: P. HILDEBRANDT CAS: 110-86-1
Clear Cell Focus
Hepatodiaphragmatic Nodule
Inflammation Chronic
Necrosis
Pigmentation
Tension Lipidosis
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Liver: Capsule Inflammation Chronic
Liver: Centrilobular Cytomegaly
Degeneration
Lymph Node, Mandibular Ectasia
Lymph Node: Iliac Congestion
Mammary Gland Galactocele
Mesentery: Fat Necrosis
Pancreas Atrophy
Pituitary Gland: Pars Distalis Angiectasis
Cyst
Uterus Hyperplasia Cystic
===============================================================
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 7/49 (14%) 7/50 (14%) 2/50 (4%) |11/50 (22%) 12/50 (24%) 9/50 (18%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 19.3% 17.6% 17.0% 5.2% |24.8% 26.2% 20.3% 14.7% |
|TERMINAL (d) | 6/25 (24%) 7/20 (35%) 5/25 (20%) 0/16 (0%) |11/32 (34%) 11/37 (30%) 8/29 (28%) 6/26 (23%) |
|FIRST INCIDENCE | 625 722 (T) 644 681 |729 (T) 728 605 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.548 P=0.515N P=0.148N |P=0.208N P=0.532N P=0.495N P=0.260N |
|POLY 3 | P=0.047N* P=0.538N P=0.507N P=0.056N |P=0.118N P=0.534 P=0.401N P=0.186N |
|POLY 1.5 | P=0.043N* P=0.519N P=0.499N P=0.051N |P=0.100N P=0.520 P=0.400N P=0.166N |
|POLY 6 | P=0.057N P=0.583N P=0.529N P=0.069N |P=0.147N P=0.555 P=0.403N P=0.220N |
|LOGISTIC REGRESSION| P=0.071N P=0.574 P=0.539N P=0.075N |P=0.208N (e) P=0.429N P=0.260N |
|COCH-ARM / FISHERS | P=0.038N* P=0.517N P=0.500N P=0.046N* |P=0.081N P=0.500 P=0.402N P=0.143N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 5.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- 717 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170 P=0.545N P=0.500N P=0.350 |(e) (e) (e) (e) |
|POLY 3 | P=0.240 P=0.507N P=0.501N P=0.475 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.242 P=0.504N P=0.500N P=0.487 |(e) (e) (e) (e) |
|POLY 6 | P=0.237 P=0.515N P=0.506N P=0.453 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.356 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247 P=0.505N P=0.500N P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/49 (10%) 9/50 (18%) 7/50 (14%) |6/50 (12%) 8/50 (16%) 6/50 (12%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 21.0% 12.4% 21.5% 17.5% |13.2% 17.2% 13.5% 7.4% |
|TERMINAL (d) | 5/25 (20%) 3/20 (15%) 5/25 (20%) 3/16 (19%) |3/32 (9%) 5/37 (14%) 3/29 (10%) 2/26 (8%) |
|FIRST INCIDENCE | 473 620 589 444 |503 611 624 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420 P=0.298N P=0.595 P=0.580 |P=0.264N P=0.472 P=0.587 P=0.349N |
|POLY 3 | P=0.513N P=0.225N P=0.585 P=0.449N |P=0.195N P=0.404 P=0.606 P=0.297N |
|POLY 1.5 | P=0.493N P=0.211N P=0.596 P=0.422N |P=0.169N P=0.397 P=0.613 P=0.272N |
|POLY 6 | P=0.548N P=0.256N P=0.563 P=0.500N |P=0.235N P=0.416 P=0.597 P=0.335N |
|LOGISTIC REGRESSION| P=0.486N P=0.204N P=0.602N P=0.388N |P=0.156N P=0.374 P=0.620N P=0.257N |
|COCH-ARM / FISHERS | P=0.467N P=0.205N P=0.602N P=0.393N |P=0.139N P=0.387 P=0.620N P=0.243N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 23/49 (47%) 19/50 (38%) 16/49 (33%) |5/50 (10%) 7/50 (14%) 8/50 (16%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 42.2% 54.5% 45.4% 40.0% |11.2% 15.1% 17.4% 5.0% |
|TERMINAL (d) | 13/25 (52%) 13/20 (65%) 14/25 (56%) 9/16 (56%) |4/32 (13%) 3/37 (8%) 3/29 (10%) 0/25 (0%) |
|FIRST INCIDENCE | 571 598 627 465 |671 650 521 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398 P=0.069 P=0.485 P=0.279 |P=0.289N P=0.461 P=0.255 P=0.320N |
|POLY 3 | P=0.321N P=0.172 P=0.467 P=0.509N |P=0.222N P=0.408 P=0.297 P=0.259N |
|POLY 1.5 | P=0.290N P=0.185 P=0.490 P=0.475N |P=0.198N P=0.396 P=0.290 P=0.244N |
|POLY 6 | P=0.397N P=0.142 P=0.417 P=0.584N |P=0.260N P=0.427 P=0.306 P=0.281N |
|LOGISTIC REGRESSION| P=0.388N P=0.149 P=0.456 P=0.538N |P=0.142N P=0.395 P=0.275 P=0.254N |
|COCH-ARM / FISHERS | P=0.262N P=0.184 P=0.500 P=0.445N |P=0.169N P=0.380 P=0.277 P=0.226N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 2.5% 9.6% 15.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 574 722 (T) 585 622 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016 * P=0.557N P=0.318 P=0.066 |(e) (e) (e) (e) |
|POLY 3 | P=0.028 * P=0.510N P=0.335 P=0.109 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.031 * P=0.502N P=0.338 P=0.120 |(e) (e) (e) (e) |
|POLY 6 | P=0.024 * P=0.529N P=0.325 P=0.092 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.029 * P=0.500N P=0.337 P=0.115 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.036 * P=0.500N P=0.339 P=0.134 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |9/50 (18%) 12/50 (24%) 10/50 (20%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.9% 0.0% |19.6% 25.8% 22.0% 12.0% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 2/25 (8%) 0/16 (0%) |5/32 (16%) 10/37 (27%) 4/29 (14%) 2/26 (8%) |
|FIRST INCIDENCE | 722 (T) --- 722 (T) --- |493 546 580 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.554N P=0.545N P=0.500 P=0.589N |P=0.249N P=0.420 P=0.445 P=0.318N |
|POLY 3 | P=0.482N P=0.503N P=0.498 P=0.514N |P=0.158N P=0.325 P=0.490 P=0.245N |
|POLY 1.5 | P=0.473N P=0.500N P=0.501 P=0.507N |P=0.134N P=0.320 P=0.495 P=0.222N |
|POLY 6 | P=0.495N P=0.512N P=0.489 P=0.527N |P=0.196N P=0.331 P=0.484 P=0.280N |
|LOGISTIC REGRESSION| P=0.554N (e) P=0.500 (e) |P=0.100N P=0.305 P=0.502 P=0.172N |
|COCH-ARM / FISHERS | P=0.461N P=0.500N P=0.500 P=0.500N |P=0.107N P=0.312 P=0.500 P=0.194N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 9.7% 7.1% 2.6% |2.3% 0.0% 4.6% 4.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 644 665 269 722 (T) |717 --- 707 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.384N P=0.275 P=0.488 P=0.616N |P=0.185 P=0.478N P=0.471 P=0.441 |
|POLY 3 | P=0.329N P=0.333 P=0.508 P=0.528N |P=0.219 P=0.494N P=0.497 P=0.476 |
|POLY 1.5 | P=0.311N P=0.340 P=0.509 P=0.515N |P=0.231 P=0.496N P=0.499 P=0.487 |
|POLY 6 | P=0.363N P=0.316 P=0.498 P=0.553N |P=0.204 P=0.491N P=0.493 P=0.462 |
|LOGISTIC REGRESSION| P=0.274N P=0.336 P=0.475 P=0.530N |P=0.267 P=0.491N P=0.491 P=0.542 |
|COCH-ARM / FISHERS | P=0.292N P=0.339 P=0.500 P=0.500N |P=0.245 P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.7% 8.4% 0.0% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- --- |687 488 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.152N P=0.535 P=0.123N P=0.388N |
|POLY 3 | (e) (e) (e) (e) |P=0.124N P=0.534 P=0.122N P=0.339N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.118N P=0.520 P=0.120N P=0.324N |
|POLY 6 | (e) (e) (e) (e) |P=0.133N P=0.551 P=0.124N P=0.362N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.078N P=0.417 P=0.122N P=0.352N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111N P=0.500 P=0.121N P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/48 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 0.0% |2.2% 2.2% 0.0% 4.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/23 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- 525 --- |681 729 (T) --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.691 (e) P=0.513 (e) |P=0.308 P=0.736N P=0.495N P=0.449 |
|POLY 3 | P=0.661 (e) P=0.492 (e) |P=0.348 P=0.755N P=0.503N P=0.474 |
|POLY 1.5 | P=0.675 (e) P=0.493 (e) |P=0.357 P=0.757N P=0.501N P=0.486 |
|POLY 6 | P=0.637 (e) P=0.487 (e) |P=0.337 P=0.752N P=0.506N P=0.456 |
|LOGISTIC REGRESSION| P=0.727 (e) P=0.477 (e) |P=0.409 P=0.760N P=0.500N P=0.550 |
|COCH-ARM / FISHERS | P=0.693 (e) P=0.490 (e) |P=0.366 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/47 (2%) 2/48 (4%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| |2.4% 4.5% 2.3% 5.0% |
|TERMINAL (d) | |1/32 (3%) 2/36 (6%) 1/29 (3%) 2/25 (8%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.333 P=0.541 P=0.740 P=0.414 |
|POLY 3 | |P=0.420 P=0.519 P=0.750N P=0.481 |
|POLY 1.5 | |P=0.438 P=0.515 P=0.748N P=0.497 |
|POLY 6 | |P=0.393 P=0.525 P=0.754N P=0.459 |
|LOGISTIC REGRESSION| |P=0.333 P=0.541 P=0.740 P=0.414 |
|COCH-ARM / FISHERS | |P=0.460 P=0.508 P=0.737N P=0.516 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/47 (2%) 2/48 (4%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |2.4% 4.5% 2.3% 0.0% |
|TERMINAL (d) | |1/32 (3%) 1/36 (3%) 1/29 (3%) 0/25 (0%) |
|FIRST INCIDENCE | |729 (T) 728 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.313N P=0.547 P=0.740 P=0.549N |
|POLY 3 | |P=0.261N P=0.520 P=0.750N P=0.511N |
|POLY 1.5 | |P=0.250N P=0.515 P=0.748N P=0.502N |
|POLY 6 | |P=0.277N P=0.525 P=0.754N P=0.524N |
|LOGISTIC REGRESSION| |P=0.317N P=0.540 P=0.740 (e) |
|COCH-ARM / FISHERS | |P=0.237N P=0.508 P=0.737N P=0.490N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |4/47 (9%) 2/48 (4%) 7/50 (14%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| |9.6% 4.5% 15.9% 7.3% |
|TERMINAL (d) | |4/32 (13%) 2/36 (6%) 5/29 (17%) 0/25 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 707 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.408 P=0.283N P=0.213 P=0.600N |
|POLY 3 | |P=0.533 P=0.311N P=0.289 P=0.513N |
|POLY 1.5 | |P=0.561 P=0.318N P=0.295 P=0.497N |
|POLY 6 | |P=0.491 P=0.304N P=0.279 P=0.538N |
|LOGISTIC REGRESSION| |P=0.544 P=0.283N P=0.246 P=0.464N |
|COCH-ARM / FISHERS | |P=0.544N P=0.329N P=0.299 P=0.476N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/47 (6%) 5/48 (10%) 4/50 (8%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| |7.1% 11.3% 9.1% 5.0% |
|TERMINAL (d) | |1/32 (3%) 5/36 (14%) 3/29 (10%) 2/25 (8%) |
|FIRST INCIDENCE | |671 729 (T) 707 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.474N P=0.414 P=0.470 P=0.607N |
|POLY 3 | |P=0.361N P=0.382 P=0.522 P=0.529N |
|POLY 1.5 | |P=0.332N P=0.377 P=0.528 P=0.507N |
|POLY 6 | |P=0.407N P=0.385 P=0.509 P=0.562N |
|LOGISTIC REGRESSION| |P=0.417N P=0.390 P=0.523 P=0.541N |
|COCH-ARM / FISHERS | |P=0.298N P=0.369 P=0.535 P=0.480N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/49 (4%) 0/48 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% | |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | |
|FIRST INCIDENCE | --- --- 679 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.537 (e) P=0.222 (e) | |
|POLY 3 | P=0.552 (e) P=0.238 (e) | |
|POLY 1.5 | P=0.569 (e) P=0.239 (e) | |
|POLY 6 | P=0.522 (e) P=0.235 (e) | |
|LOGISTIC REGRESSION| P=0.577 (e) P=0.237 (e) | |
|COCH-ARM / FISHERS | P=0.591 (e) P=0.247 (e) | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 2/2 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 43/50 (86%) 43/50 (86%) 46/50 (92%) |42/49 (86%) 43/50 (86%) 43/50 (86%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 92.3% 88.5% 90.4% 96.6% |89.8% 88.7% 87.2% 78.3% |
|TERMINAL (d) | 25/25 (100%) 17/20 (85%) 23/25 (92%) 16/16 (100%)|28/31 (90%) 34/37 (92%) 24/29 (83%) 21/26 (81%) |
|FIRST INCIDENCE | 309 444 269 428 |493 533 496 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * P=0.308 P=0.478N P=0.032 * |P=0.343 P=0.220N P=0.372 P=0.509 |
|POLY 3 | P=0.175 P=0.374N P=0.511N P=0.294 |P=0.051N P=0.569N P=0.467N P=0.091N |
|POLY 1.5 | P=0.210 P=0.377N P=0.457N P=0.329 |P=0.041N* P=0.587N P=0.531N P=0.079N |
|POLY 6 | P=0.180 P=0.369N P=0.557N P=0.323 |P=0.073N P=0.565N P=0.397N P=0.122N |
|LOGISTIC REGRESSION| P=0.306 P=0.377N P=0.365N P=0.445 |P=0.083N P=0.534N P=0.604 P=0.148N |
|COCH-ARM / FISHERS | P=0.368 P=0.380N P=0.380N P=0.500 |P=0.034N* P=0.597 P=0.597 P=0.077N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 7.2% 5.2% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/31 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 574 --- 585 685 |503 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186 P=0.496N P=0.293 P=0.412 |P=0.306N P=0.496N P=0.496N P=0.500N |
|POLY 3 | P=0.213 P=0.505N P=0.304 P=0.472 |P=0.296N P=0.492N P=0.501N P=0.516N |
|POLY 1.5 | P=0.225 P=0.501N P=0.307 P=0.485 |P=0.299N P=0.494N P=0.498N P=0.507N |
|POLY 6 | P=0.195 P=0.516N P=0.297 P=0.449 |P=0.290N P=0.490N P=0.504N P=0.528N |
|LOGISTIC REGRESSION| P=0.243 P=0.545N P=0.300 P=0.498 |P=0.239N P=0.681N P=0.652N P=0.423N |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.309 P=0.500 |P=0.303N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 14.4% 7.3% 10.2% |0.0% 0.0% 4.5% 2.4% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 2/25 (8%) 0/16 (0%) |0/31 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 618 700 601 |--- --- 561 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 P=0.102 P=0.494 P=0.215 |P=0.209 (e) P=0.249 P=0.461 |
|POLY 3 | P=0.411 P=0.136 P=0.498 P=0.314 |P=0.214 (e) P=0.243 P=0.488 |
|POLY 1.5 | P=0.427 P=0.138 P=0.501 P=0.325 |P=0.229 (e) P=0.243 P=0.495 |
|POLY 6 | P=0.382 P=0.128 P=0.488 P=0.294 |P=0.194 (e) P=0.243 P=0.479 |
|LOGISTIC REGRESSION| P=0.411 P=0.132 P=0.461 P=0.311 |P=0.298 (e) P=0.222 P=0.512 |
|COCH-ARM / FISHERS | P=0.446 P=0.134 P=0.500 P=0.339 |P=0.249 (e) P=0.253 P=0.505 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/48 (8%) 3/50 (6%) 2/49 (4%) |3/50 (6%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.7% 10.1% 7.3% 5.3% |6.7% 6.6% 6.8% 2.5% |
|TERMINAL (d) | 2/25 (8%) 2/20 (10%) 3/25 (12%) 1/16 (6%) |2/32 (6%) 3/37 (8%) 3/29 (10%) 1/26 (4%) |
|FIRST INCIDENCE | 718 604 722 (T) 598 |667 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.546 P=0.511N P=0.518N |P=0.318N P=0.605N P=0.622 P=0.386N |
|POLY 3 | P=0.263N P=0.625 P=0.504N P=0.376N |P=0.261N P=0.651N P=0.655 P=0.338N |
|POLY 1.5 | P=0.252N P=0.628 P=0.499N P=0.362N |P=0.244N P=0.655N P=0.659 P=0.323N |
|POLY 6 | P=0.284N P=0.611 P=0.518N P=0.403N |P=0.287N P=0.645N P=0.649 P=0.361N |
|LOGISTIC REGRESSION| P=0.280N P=0.606 P=0.552N P=0.415N |P=0.303N P=0.640N P=0.652 P=0.360N |
|COCH-ARM / FISHERS | P=0.236N P=0.619 P=0.500N P=0.349N |P=0.221N P=0.661N P=0.661N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/48 (4%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.6% 5.1% 0.0% 2.6% |2.2% 4.4% 2.3% 4.9% |
|TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 0/29 (0%) 2/26 (8%) |
|FIRST INCIDENCE | 604 718 --- 515 |493 729 (T) 703 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122N P=0.411N P=0.067N P=0.249N |P=0.361 P=0.534 P=0.758N P=0.450 |
|POLY 3 | P=0.089N P=0.370N P=0.063N P=0.206N |P=0.403 P=0.505 P=0.755 P=0.465 |
|POLY 1.5 | P=0.088N P=0.359N P=0.061N P=0.196N |P=0.421 P=0.503 P=0.758 P=0.480 |
|POLY 6 | P=0.091N P=0.396N P=0.067N P=0.228N |P=0.378 P=0.509 P=0.752 P=0.443 |
|LOGISTIC REGRESSION| P=0.087N P=0.362N P=0.063N P=0.179N |P=0.454 P=0.455 P=0.738 P=0.538 |
|COCH-ARM / FISHERS | P=0.087N P=0.359N P=0.059N P=0.187N |P=0.444 P=0.500 P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/47 (19%) 3/50 (6%) 4/47 (9%) |3/50 (6%) 2/49 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 14.3% 23.1% 7.3% 10.8% |6.8% 4.4% 4.6% 12.2% |
|TERMINAL (d) | 5/25 (20%) 8/20 (40%) 3/25 (12%) 2/16 (13%) |3/32 (9%) 2/37 (5%) 2/29 (7%) 4/26 (15%) |
|FIRST INCIDENCE | 473 538 722 (T) 444 |729 (T) 729 (T) 729 (T) 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.155 P=0.234N P=0.574N |P=0.114 P=0.434N P=0.545N P=0.250 |
|POLY 3 | P=0.199N P=0.232 P=0.252N P=0.445N |P=0.183 P=0.492N P=0.505N P=0.314 |
|POLY 1.5 | P=0.189N P=0.243 P=0.245N P=0.428N |P=0.196 P=0.499N P=0.502N P=0.333 |
|POLY 6 | P=0.220N P=0.205 P=0.266N P=0.476N |P=0.165 P=0.481N P=0.510N P=0.288 |
|LOGISTIC REGRESSION| P=0.203N P=0.230 P=0.248N P=0.408N |P=0.127 P=0.434N P=0.545N P=0.260 |
|COCH-ARM / FISHERS | P=0.178N P=0.245 P=0.243N P=0.410N |P=0.213 P=0.510N P=0.500N P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/48 (4%) 1/50 (2%) 1/49 (2%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.9% 5.1% 2.4% 2.7% |0.0% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 2/25 (8%) 2/20 (10%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 574 722 (T) 662 722 (T) |--- --- 729 (T) 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.098N P=0.290N P=0.115N P=0.195N |P=0.187 (e) P=0.480 P=0.453 |
|POLY 3 | P=0.065N P=0.245N P=0.106N P=0.130N |P=0.213 (e) P=0.501 P=0.487 |
|POLY 1.5 | P=0.063N P=0.236N P=0.103N P=0.118N |P=0.224 (e) P=0.503 P=0.495 |
|POLY 6 | P=0.069N P=0.268N P=0.113N P=0.152N |P=0.198 (e) P=0.498 P=0.477 |
|LOGISTIC REGRESSION| P=0.067N P=0.233N P=0.103N P=0.115N |P=0.242 (e) P=0.480 P=0.532 |
|COCH-ARM / FISHERS | P=0.061N P=0.235N P=0.102N P=0.107N |P=0.238 (e) P=0.505 P=0.505 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |596 --- 703 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.217N P=0.231N P=0.505N P=0.273N |
|POLY 3 | (e) (e) (e) (e) |P=0.200N P=0.233N P=0.508N P=0.260N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.195N P=0.235N P=0.504N P=0.250N |
|POLY 6 | (e) (e) (e) (e) |P=0.207N P=0.232N P=0.514N P=0.276N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.166N P=0.269N P=0.505N P=0.205N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.188N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/48 (6%) 13/50 (26%) 10/49 (20%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 7.6% 30.7% 26.2% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 3/25 (12%) 2/20 (10%) 8/25 (32%) 3/16 (19%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 665 534 622 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.573 P=0.007 ** P=0.007 ** |P=0.665 (e) P=0.480 (e) |
|POLY 3 | P=0.004 ** P=0.643 P=0.006 ** P=0.022 * |P=0.653 (e) P=0.498 (e) |
|POLY 1.5 | P=0.005 ** P=0.647 P=0.006 ** P=0.026 * |P=0.671 (e) P=0.499 (e) |
|POLY 6 | P=0.003 ** P=0.628 P=0.005 ** P=0.016 * |P=0.625 (e) P=0.496 (e) |
|LOGISTIC REGRESSION| P=0.003 ** P=0.584 P=0.006 ** P=0.012 * |(e) (e) P=0.480 (e) |
|COCH-ARM / FISHERS | P=0.009 ** P=0.641 P=0.006 ** P=0.033 * |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Developmental Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.288N P=0.237N P=0.340N |(e) (e) (e) (e) |
|POLY 3 | P=0.111N P=0.248N P=0.238N P=0.259N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.113N P=0.245N P=0.237N P=0.250N |(e) (e) (e) (e) |
|POLY 6 | P=0.106N P=0.256N P=0.243N P=0.274N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.140N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.258N P=0.247N P=0.253N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/48 (2%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 2.6% 0.0% 5.2% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 692 722 (T) --- 194 |--- 488 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552N P=0.393N P=0.130N P=0.654N |P=0.410N P=0.242 (e) (e) |
|POLY 3 | P=0.450N P=0.323N P=0.120N P=0.534N |P=0.412N P=0.250 (e) (e) |
|POLY 1.5 | P=0.449N P=0.318N P=0.118N P=0.519N |P=0.408N P=0.245 (e) (e) |
|POLY 6 | P=0.451N P=0.338N P=0.124N P=0.562N |P=0.418N P=0.257 (e) (e) |
|LOGISTIC REGRESSION| P=0.424N P=0.373N P=0.130N P=0.482N |P=0.295N P=0.095 (e) (e) |
|COCH-ARM / FISHERS | P=0.447N P=0.324N P=0.121N P=0.510N |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |3/50 (6%) 0/50 (0%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.6% 0.0% 9.0% 14.3% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 2/29 (7%) 3/26 (12%) |
|FIRST INCIDENCE | --- --- --- --- |493 --- 561 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.030 * P=0.111N P=0.478 P=0.181 |
|POLY 3 | (e) (e) (e) (e) |P=0.042 * P=0.117N P=0.491 P=0.207 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.047 * P=0.118N P=0.496 P=0.222 |
|POLY 6 | (e) (e) (e) (e) |P=0.036 * P=0.115N P=0.484 P=0.187 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.082 P=0.144N P=0.497 P=0.295 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.055 P=0.121N P=0.500 P=0.243 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 47/48 (98%) 49/50 (98%) 49/49 (100%)|41/50 (82%) 42/50 (84%) 35/50 (70%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 95.2% 98.7% 98.7% 100.0% |83.7% 87.6% 73.8% 80.0% |
|TERMINAL (d) | 25/25 (100%) 20/20 (100%) 25/25 (100%) 16/16 (100%)|28/32 (88%) 35/37 (95%) 22/29 (76%) 22/26 (85%) |
|FIRST INCIDENCE | 309 444 269 194 |399 533 549 457 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.195 P=0.407 P=0.027 * |P=0.246 P=0.276N P=0.356N P=0.348 |
|POLY 3 | P=0.080 P=0.331 P=0.322 P=0.163 |P=0.226N P=0.391 P=0.164N P=0.416N |
|POLY 1.5 | P=0.076 P=0.324 P=0.313 P=0.141 |P=0.177N P=0.437 P=0.146N P=0.336N |
|POLY 6 | P=0.096 P=0.352 P=0.347 P=0.218 |P=0.292N P=0.337 P=0.185N P=0.518N |
|LOGISTIC REGRESSION| P=0.071 P=0.324 P=0.306 P=0.126 |P=0.209N P=0.547 P=0.121N P=0.297N |
|COCH-ARM / FISHERS | P=0.074 P=0.324 P=0.309 P=0.125 |P=0.120N P=0.500 P=0.121N P=0.235N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |0.0% 0.0% 4.6% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- 444 |--- --- 707 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 (e) (e) P=0.508 |P=0.184 (e) P=0.226 P=0.459 |
|POLY 3 | P=0.191 (e) (e) P=0.485 |P=0.209 (e) P=0.235 P=0.483 |
|POLY 1.5 | P=0.194 (e) (e) P=0.490 |P=0.225 (e) P=0.236 P=0.490 |
|POLY 6 | P=0.186 (e) (e) P=0.474 |P=0.187 (e) P=0.233 P=0.472 |
|LOGISTIC REGRESSION| P=0.272 (e) (e) P=0.555 |P=0.192 (e) P=0.232 P=0.459 |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.495 |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 4/50 (8%) 7/49 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 9.7% 18.4% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 3/25 (12%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- 648 644 |--- --- --- 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.545N P=0.178 P=0.012 * |P=0.197 (e) (e) P=0.500 |
|POLY 3 | P<0.001 ** P=0.510N P=0.177 P=0.021 * |P=0.188 (e) (e) P=0.486 |
|POLY 1.5 | P=0.002 ** P=0.507N P=0.180 P=0.024 * |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P<0.001 ** P=0.518N P=0.171 P=0.017 * |P=0.181 (e) (e) P=0.477 |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.164 P=0.018 * |P=0.299 (e) (e) P=0.576 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.510N P=0.181 P=0.028 * |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 2.4% 2.6% |4.5% 4.4% 6.8% 4.9% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 2/29 (7%) 1/26 (4%) |
|FIRST INCIDENCE | --- 708 679 717 |717 728 671 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 P=0.438 P=0.481 P=0.416 |P=0.457 P=0.641N P=0.463 P=0.624 |
|POLY 3 | P=0.359 P=0.494 P=0.500 P=0.486 |P=0.520 P=0.683N P=0.497 P=0.667 |
|POLY 1.5 | P=0.372 P=0.497 P=0.501 P=0.493 |P=0.541 P=0.687N P=0.499 P=0.679 |
|POLY 6 | P=0.336 P=0.485 P=0.496 P=0.473 |P=0.490 P=0.677N P=0.494 P=0.649 |
|LOGISTIC REGRESSION| P=0.350 P=0.474 P=0.500 P=0.434 |P=0.529 P=0.662N P=0.491 P=0.687 |
|COCH-ARM / FISHERS | P=0.386 P=0.495 P=0.500 P=0.500 |P=0.569 P=0.691N P=0.500 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 5/49 (10%) 0/50 (0%) 1/50 (2%) |38/50 (76%) 28/50 (56%) 11/50 (22%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 29.0% 12.6% 0.0% 2.6% |81.3% 60.9% 25.1% 0.0% |
|TERMINAL (d) | 11/25 (44%) 5/20 (25%) 0/25 (0%) 1/16 (6%) |30/32 (94%) 26/37 (70%) 11/29 (38%) 0/26 (0%) |
|FIRST INCIDENCE | 644 722 (T) --- 722 (T) |493 666 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.107N P<0.001N** P=0.008N** |P<0.001N** P=0.002N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.057N P<0.001N** P<0.001N** |P<0.001N** P=0.019N* P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.055N P<0.001N** P<0.001N** |P<0.001N** P=0.021N* P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.068N P<0.001N** P=0.002N** |P<0.001N** P=0.017N* P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.120N P<0.001N** P=0.005N** |P<0.001N** P=0.009N** P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.059N P<0.001N** P<0.001N** |P<0.001N** P=0.028N* P<0.001N** P<0.001N** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/49 (2%) 7/50 (14%) 4/50 (8%) |4/50 (8%) 9/50 (18%) 11/50 (22%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 17.0% 2.5% 17.1% 10.3% |9.0% 19.7% 25.1% 39.3% |
|TERMINAL (d) | 7/25 (28%) 1/20 (5%) 7/25 (28%) 3/16 (19%) |4/32 (13%) 9/37 (24%) 11/29 (38%) 16/26 (62%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 562 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.055N P=0.622 P=0.532N |P<0.001 ** P=0.174 P=0.023 * P<0.001 ** |
|POLY 3 | P=0.447N P=0.032N* P=0.610 P=0.292N |P<0.001 ** P=0.126 P=0.040 * P<0.001 ** |
|POLY 1.5 | P=0.435N P=0.031N* P=0.613N P=0.277N |P<0.001 ** P=0.122 P=0.042 * P<0.001 ** |
|POLY 6 | P=0.468N P=0.036N* P=0.593 P=0.324N |P<0.001 ** P=0.132 P=0.036 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.566 P=0.055N P=0.622 P=0.379N |P<0.001 ** P=0.174 P=0.023 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.415N P=0.032N* P=0.613N P=0.262N |P=0.002 ** P=0.117 P=0.045 * P=0.003 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 0.0% |8.8% 2.2% 6.7% 4.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 434 --- --- --- |588 728 624 457 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304N P=0.488N P=0.492N P=0.496N |P=0.445N P=0.164N P=0.521N P=0.388N |
|POLY 3 | P=0.294N P=0.510N P=0.505N P=0.518N |P=0.403N P=0.177N P=0.511N P=0.373N |
|POLY 1.5 | P=0.300N P=0.506N P=0.502N P=0.510N |P=0.389N P=0.177N P=0.505N P=0.356N |
|POLY 6 | P=0.284N P=0.520N P=0.511N P=0.532N |P=0.425N P=0.176N P=0.519N P=0.401N |
|LOGISTIC REGRESSION| P=0.233N P=0.733N P=0.529N P=0.439N |P=0.250N P=0.203N P=0.507N P=0.215N |
|COCH-ARM / FISHERS | P=0.305N P=0.505N P=0.500N P=0.500N |P=0.371N P=0.181N P=0.500N P=0.339N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 12/49 (24%) 11/50 (22%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.6% 29.4% 26.0% 7.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 7/20 (35%) 7/25 (28%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 574 604 525 520 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.435N P=0.012 * P=0.049 * P=0.645N |(e) (e) (e) (e) |
|POLY 3 | P=0.275N P=0.020 * P=0.044 * P=0.534N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.249N P=0.022 * P=0.045 * P=0.517N |(e) (e) (e) (e) |
|POLY 6 | P=0.330N P=0.015 * P=0.040 * P=0.564N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.262N P=0.020 * P=0.046 * P=0.501N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.226N P=0.024 * P=0.045 * P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Developmental Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 2.6% |2.2% 4.4% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) 428 |696 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.204 (e) P=0.500 P=0.508 |P=0.306N P=0.543 P=0.756 P=0.550N |
|POLY 3 | P=0.224 (e) P=0.499 P=0.490 |P=0.270N P=0.510 P=0.758 P=0.518N |
|POLY 1.5 | P=0.230 (e) P=0.500 P=0.495 |P=0.260N P=0.506 P=0.759 P=0.510N |
|POLY 6 | P=0.212 (e) P=0.494 P=0.479 |P=0.286N P=0.515 P=0.755 P=0.529N |
|LOGISTIC REGRESSION| P=0.270 (e) P=0.500 P=0.563 |P=0.292N P=0.517 P=0.759 P=0.511N |
|COCH-ARM / FISHERS | P=0.237 (e) P=0.500 P=0.500 |P=0.247N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 23/49 (47%) 23/50 (46%) 13/50 (26%) |19/50 (38%) 24/50 (48%) 22/50 (44%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 33.6% 54.8% 52.5% 31.7% |41.0% 51.9% 49.9% 36.3% |
|TERMINAL (d) | 13/25 (52%) 15/20 (75%) 15/25 (60%) 5/16 (31%) |13/32 (41%) 22/37 (60%) 21/29 (72%) 12/26 (46%) |
|FIRST INCIDENCE | 574 455 525 428 |588 666 671 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369 P=0.005 ** P=0.042 * P=0.288 |P=0.512N P=0.393 P=0.211 P=0.539N |
|POLY 3 | P=0.283N P=0.035 * P=0.055 P=0.518N |P=0.289N P=0.196 P=0.259 P=0.407N |
|POLY 1.5 | P=0.277N P=0.040 * P=0.052 P=0.508N |P=0.213N P=0.204 P=0.299 P=0.338N |
|POLY 6 | P=0.304N P=0.025 * P=0.057 P=0.546N |P=0.422N P=0.185 P=0.201 P=0.513N |
|LOGISTIC REGRESSION| P=0.368N P=0.021 * P=0.039 * P=0.582N |P=0.373N P=0.247 P=0.307 P=0.407N |
|COCH-ARM / FISHERS | P=0.275N P=0.041 * P=0.048 * P=0.500N |P=0.142N P=0.210 P=0.342 P=0.263N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/50 (2%) 10/50 (20%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.5% 2.4% 24.7% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 574 722 (T) 679 523 |681 570 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.738 P=0.750 P=0.003 ** |P=0.254N P=0.752N P=0.495N P=0.547N |
|POLY 3 | P<0.001 ** P=0.751 P=0.758 P=0.003 ** |P=0.241N P=0.752N P=0.503N P=0.518N |
|POLY 1.5 | P<0.001 ** P=0.755 P=0.760 P=0.003 ** |P=0.239N P=0.755N P=0.501N P=0.510N |
|POLY 6 | P<0.001 ** P=0.740 P=0.752 P=0.002 ** |P=0.243N P=0.748N P=0.506N P=0.530N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.755 P=0.759 P=0.005 ** |P=0.199N P=0.722 P=0.500N P=0.499N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.747 P=0.753N P=0.004 ** |P=0.236N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.5% 0.0% 0.0% |0.0% 2.2% 2.3% 4.9% |
|TERMINAL (d) | 2/25 (8%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) |
|FIRST INCIDENCE | 722 (T) 722 (T) --- --- |--- 488 707 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.579N P=0.237N P=0.340N |P=0.112 P=0.504 P=0.494 P=0.193 |
|POLY 3 | P=0.101N P=0.512N P=0.238N P=0.253N |P=0.133 P=0.509 P=0.498 P=0.218 |
|POLY 1.5 | P=0.101N P=0.506N P=0.237N P=0.245N |P=0.142 P=0.506 P=0.499 P=0.227 |
|POLY 6 | P=0.101N P=0.527N P=0.243N P=0.268N |P=0.121 P=0.514 P=0.497 P=0.207 |
|LOGISTIC REGRESSION| P=0.131N P=0.579N (e) (e) |P=0.180 P=0.289 P=0.498 P=0.193 |
|COCH-ARM / FISHERS | P=0.100N P=0.508N P=0.247N P=0.247N |P=0.153 P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 8/50 (16%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 2.5% 0.0% 0.0% |19.7% 16.8% 6.8% 7.3% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |6/32 (19%) 4/37 (11%) 3/29 (10%) 2/26 (8%) |
|FIRST INCIDENCE | 695 708 --- --- |399 533 729 (T) 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.400N P=0.128N P=0.206N |P=0.054N P=0.415N P=0.083N P=0.119N |
|POLY 3 | P=0.043N* P=0.317N P=0.120N P=0.132N |P=0.034N* P=0.462N P=0.067N P=0.084N |
|POLY 1.5 | P=0.043N* P=0.312N P=0.118N P=0.125N |P=0.029N* P=0.478N P=0.064N P=0.073N |
|POLY 6 | P=0.043N* P=0.333N P=0.124N P=0.145N |P=0.043N* P=0.438N P=0.072N P=0.102N |
|LOGISTIC REGRESSION| P=0.055N P=0.361N P=0.130N P=0.166N |P=0.017N* P=0.560N P=0.062N P=0.058N |
|COCH-ARM / FISHERS | P=0.044N* P=0.316N P=0.121N P=0.121N |P=0.024N* P=0.500N P=0.061N P=0.061N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |9/50 (18%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |19.6% 2.2% 4.6% 9.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |6/32 (19%) 1/37 (3%) 2/29 (7%) 3/26 (12%) |
|FIRST INCIDENCE | --- --- --- --- |399 729 (T) 729 (T) 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.240N P=0.007N** P=0.040N* P=0.211N |
|POLY 3 | (e) (e) (e) (e) |P=0.161N P=0.008N** P=0.030N* P=0.163N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.152N P=0.008N** P=0.028N* P=0.142N |
|POLY 6 | (e) (e) (e) (e) |P=0.173N P=0.008N** P=0.032N* P=0.195N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.148N P=0.011N* P=0.027N* P=0.118N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.145N P=0.008N** P=0.026N* P=0.117N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mitotic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.2% |2.3% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 2/16 (13%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- 722 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * (e) (e) P=0.145 |P=0.542 P=0.471N P=0.520N P=0.715 |
|POLY 3 | P=0.043 * (e) (e) P=0.221 |P=0.577 P=0.494N P=0.502N P=0.741 |
|POLY 1.5 | P=0.044 * (e) (e) P=0.229 |P=0.585 P=0.496N P=0.501N P=0.750 |
|POLY 6 | P=0.042 * (e) (e) P=0.207 |P=0.567 P=0.490N P=0.504N P=0.728 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.145 |P=0.542 (e) (e) P=0.715 |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 4/50 (8%) 1/50 (2%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.5% 7.3% 2.6% |4.5% 8.6% 2.3% 12.2% |
|TERMINAL (d) | 1/25 (4%) 1/20 (5%) 3/25 (12%) 0/16 (0%) |2/32 (6%) 2/37 (5%) 1/29 (3%) 4/26 (15%) |
|FIRST INCIDENCE | 695 722 (T) 722 (T) 647 |729 (T) 533 729 (T) 616 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.599N P=0.580N P=0.491 P=0.604N |P=0.125 P=0.391 P=0.535N P=0.145 |
|POLY 3 | P=0.499N P=0.513N P=0.496 P=0.524N |P=0.181 P=0.361 P=0.504N P=0.185 |
|POLY 1.5 | P=0.487N P=0.507N P=0.500 P=0.512N |P=0.194 P=0.351 P=0.501N P=0.199 |
|POLY 6 | P=0.518N P=0.529N P=0.484 P=0.544N |P=0.165 P=0.375 P=0.508N P=0.167 |
|LOGISTIC REGRESSION| P=0.542N P=0.561N P=0.463 P=0.529N |P=0.195 P=0.317 P=0.535N P=0.157 |
|COCH-ARM / FISHERS | P=0.471N P=0.508N P=0.500 P=0.500N |P=0.210 P=0.339 P=0.500N P=0.218 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 2/50 (4%) |6/50 (12%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 2.5% 2.4% 5.2% |13.0% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 388 722 (T) 538 627 |399 488 707 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.505 P=0.521N P=0.500N P=0.650 |P=0.012N* P=0.056N P=0.074N P=0.033N* |
|POLY 3 | P=0.533 P=0.523N P=0.508N P=0.661 |P=0.008N** P=0.055N P=0.064N P=0.023N* |
|POLY 1.5 | P=0.543 P=0.513N P=0.503N P=0.675 |P=0.007N** P=0.055N P=0.060N P=0.019N* |
|POLY 6 | P=0.518 P=0.542N P=0.518N P=0.636 |P=0.009N** P=0.054N P=0.068N P=0.029N* |
|LOGISTIC REGRESSION| P=0.604 P=0.598N P=0.556N P=0.665N |P=0.003N** P=0.079N P=0.058N P=0.009N** |
|COCH-ARM / FISHERS | P=0.558 P=0.508N P=0.500N P=0.691N |P=0.007N** P=0.056N P=0.056N P=0.013N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 11/49 (22%) 20/50 (40%) 25/50 (50%) |6/50 (12%) 2/50 (4%) 6/50 (12%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 9.6% 27.1% 45.2% 59.5% |13.2% 4.3% 13.3% 40.9% |
|TERMINAL (d) | 1/25 (4%) 6/20 (30%) 10/25 (40%) 11/16 (69%) |2/32 (6%) 1/37 (3%) 1/29 (3%) 15/26 (58%) |
|FIRST INCIDENCE | 644 665 525 523 |596 570 561 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.119N P=0.580 P=0.002 ** |
|POLY 3 | P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.126N P=0.619 P=0.003 ** |
|POLY 1.5 | P<0.001 ** P=0.039 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.129N P=0.620N P=0.004 ** |
|POLY 6 | P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.123N P=0.615 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.150N P=0.621N P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.134N P=0.620N P=0.008 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.6% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |399 533 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.051N P=0.298N P=0.127N P=0.148N |
|POLY 3 | (e) (e) (e) (e) |P=0.046N* P=0.301N P=0.126N P=0.141N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.045N* P=0.303N P=0.123N P=0.131N |
|POLY 6 | (e) (e) (e) (e) |P=0.047N* P=0.297N P=0.131N P=0.156N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.019N* P=0.436N P=0.139N P=0.066N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/49 (12%) 13/50 (26%) 17/50 (34%) |10/50 (20%) 7/50 (14%) 9/50 (18%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 9.6% 14.9% 30.6% 42.8% |22.2% 15.3% 20.3% 43.3% |
|TERMINAL (d) | 2/25 (8%) 3/20 (15%) 9/25 (36%) 9/16 (56%) |6/32 (19%) 7/37 (19%) 7/29 (24%) 15/26 (58%) |
|FIRST INCIDENCE | 644 666 534 622 |661 729 (T) 624 616 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.256 P=0.018 * P<0.001 ** |P<0.001 ** P=0.211N P=0.571N P=0.013 * |
|POLY 3 | P<0.001 ** P=0.348 P=0.014 * P<0.001 ** |P=0.006 ** P=0.283N P=0.514N P=0.027 * |
|POLY 1.5 | P<0.001 ** P=0.358 P=0.015 * P<0.001 ** |P=0.008 ** P=0.288N P=0.506N P=0.039 * |
|POLY 6 | P<0.001 ** P=0.322 P=0.013 * P<0.001 ** |P=0.004 ** P=0.277N P=0.530N P=0.016 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.322 P=0.016 * P<0.001 ** |P=0.002 ** P=0.255N P=0.518N P=0.016 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.357 P=0.016 * P<0.001 ** |P=0.014 * P=0.298N P=0.500N P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 43/49 (88%) 44/50 (88%) 49/50 (98%) |20/50 (40%) 29/50 (58%) 34/50 (68%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 97.3% 91.5% 92.1% 100.0% |43.3% 62.1% 72.4% 64.3% |
|TERMINAL (d) | 25/25 (100%) 19/20 (95%) 23/25 (92%) 16/16 (100%)|12/32 (38%) 25/37 (68%) 22/29 (76%) 17/26 (65%) |
|FIRST INCIDENCE | 434 455 486 428 |622 546 496 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.343 P=0.478N P=0.017 * |P=0.004 ** P=0.179 P=0.006 ** P=0.015 * |
|POLY 3 | P=0.178 P=0.189N P=0.227N P=0.378 |P=0.029 * P=0.049 * P=0.003 ** P=0.030 * |
|POLY 1.5 | P=0.130 P=0.218N P=0.258N P=0.214 |P=0.039 * P=0.052 P=0.003 ** P=0.039 * |
|POLY 6 | P=0.238 P=0.208N P=0.251N P=0.565 |P=0.019 * P=0.044 * P=0.002 ** P=0.022 * |
|LOGISTIC REGRESSION| P=0.064 P=0.199N P=0.242N P=0.120 |P=0.023 * P=0.068 P=0.004 ** P=0.034 * |
|COCH-ARM / FISHERS | P=0.122 P=0.357N P=0.370N P=0.181 |P=0.062 P=0.055 P=0.004 ** P=0.055 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Capsule |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.212 |
|POLY 3 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.221 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.228 |
|POLY 6 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.212 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.065 (e) (e) P=0.266 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Cytomegaly |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/49 (8%) 8/50 (16%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 4/50 (8%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.0% 19.4% 15.6% |0.0% 2.2% 9.1% 48.6% |
|TERMINAL (d) | 0/25 (0%) 3/20 (15%) 7/25 (28%) 5/16 (31%) |0/32 (0%) 1/37 (3%) 4/29 (14%) 18/26 (69%) |
|FIRST INCIDENCE | --- 666 609 644 |--- 729 (T) 729 (T) 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.042 * P=0.004 ** P=0.004 ** |P<0.001 ** P=0.529 P=0.050 P<0.001 ** |
|POLY 3 | P=0.017 * P=0.056 P=0.003 ** P=0.012 * |P<0.001 ** P=0.506 P=0.059 P<0.001 ** |
|POLY 1.5 | P=0.021 * P=0.058 P=0.004 ** P=0.013 * |P<0.001 ** P=0.504 P=0.060 P<0.001 ** |
|POLY 6 | P=0.012 * P=0.051 P=0.003 ** P=0.009 ** |P<0.001 ** P=0.510 P=0.057 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.011 * P=0.046 * P=0.004 ** P=0.007 ** |P<0.001 ** P=0.529 P=0.050 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.028 * P=0.056 P=0.003 ** P=0.013 * |P<0.001 ** P=0.500 P=0.059 P<0.001 ** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 2/50 (4%) 8/50 (16%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.4% 4.9% 19.8% |2.2% 4.3% 4.6% 17.2% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 7/26 (27%) |
|FIRST INCIDENCE | 388 444 679 428 |661 488 707 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.273 P=0.489 P=0.010 * |P=0.002 ** P=0.510 P=0.483 P=0.014 * |
|POLY 3 | P=0.004 ** P=0.294 P=0.492 P=0.012 * |P=0.005 ** P=0.516 P=0.495 P=0.021 * |
|POLY 1.5 | P=0.005 ** P=0.299 P=0.497 P=0.014 * |P=0.006 ** P=0.510 P=0.498 P=0.025 * |
|POLY 6 | P=0.004 ** P=0.281 P=0.483 P=0.010 * |P=0.004 ** P=0.524 P=0.490 P=0.016 * |
|LOGISTIC REGRESSION| P=0.008 ** P=0.194 P=0.484 P=0.021 * |P=0.007 ** P=0.397 P=0.499 P=0.014 * |
|COCH-ARM / FISHERS | P=0.006 ** P=0.301 P=0.500 P=0.015 * |P=0.008 ** P=0.500 P=0.500 P=0.030 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/50 (0%) 5/50 (10%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.4% 0.0% 12.3% |2.2% 4.3% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 618 --- 194 |503 570 687 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * P=0.098 (e) P=0.029 * |P=0.275N P=0.508 P=0.752N P=0.500N |
|POLY 3 | P=0.023 * P=0.115 (e) P=0.029 * |P=0.274N P=0.511 P=0.756 P=0.520N |
|POLY 1.5 | P=0.024 * P=0.117 (e) P=0.030 * |P=0.263N P=0.506 P=0.758 P=0.511N |
|POLY 6 | P=0.021 * P=0.109 (e) P=0.026 * |P=0.290N P=0.519 P=0.753 P=0.532N |
|LOGISTIC REGRESSION| P=0.037 * P=0.117 (e) P=0.037 * |P=0.177N P=0.371 P=0.737 P=0.424N |
|COCH-ARM / FISHERS | P=0.026 * P=0.117 (e) P=0.028 * |P=0.247N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 29/50 (58%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 69.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 12/16 (75%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 673 523 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.233 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P=0.236 P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.238 P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P=0.232 P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.233 P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% 5.2% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 664 --- 647 |649 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.500 (e) P=0.213 |P=0.335N P=0.495N P=0.510N P=0.553N |
|POLY 3 | P=0.131 P=0.498 (e) P=0.223 |P=0.299N P=0.495N P=0.503N P=0.518N |
|POLY 1.5 | P=0.135 P=0.501 (e) P=0.230 |P=0.302N P=0.497N P=0.502N P=0.510N |
|POLY 6 | P=0.125 P=0.490 (e) P=0.212 |P=0.293N P=0.493N P=0.507N P=0.531N |
|LOGISTIC REGRESSION| P=0.138 P=0.500 (e) P=0.234 |P=0.285N P=0.527N P=0.506N P=0.478N |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 5.1% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- 648 520 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058 (e) P=0.237 P=0.191 |P=0.163 (e) (e) P=0.459 |
|POLY 3 | P=0.076 (e) P=0.237 P=0.224 |P=0.186 (e) (e) P=0.483 |
|POLY 1.5 | P=0.080 (e) P=0.238 P=0.231 |P=0.192 (e) (e) P=0.490 |
|POLY 6 | P=0.070 (e) P=0.233 P=0.213 |P=0.179 (e) (e) P=0.472 |
|LOGISTIC REGRESSION| P=0.088 (e) P=0.236 P=0.246 |(e) (e) (e) P=0.459 |
|COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 9/50 (18%) 9/50 (18%) |13/50 (26%) 10/50 (20%) 9/50 (18%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 14.6% 9.8% 21.1% 23.2% |28.2% 21.9% 19.9% 26.2% |
|TERMINAL (d) | 6/25 (24%) 3/20 (15%) 5/25 (20%) 7/16 (44%) |9/32 (28%) 10/37 (27%) 5/29 (17%) 8/26 (31%) |
|FIRST INCIDENCE | 722 (T) 607 269 622 |399 729 (T) 561 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * P=0.495N P=0.281 P=0.062 |P=0.445 P=0.210N P=0.300N P=0.576 |
|POLY 3 | P=0.104 P=0.371N P=0.313 P=0.240 |P=0.483N P=0.322N P=0.246N P=0.511N |
|POLY 1.5 | P=0.116 P=0.364N P=0.309 P=0.263 |P=0.447N P=0.321N P=0.242N P=0.467N |
|POLY 6 | P=0.087 P=0.393N P=0.307 P=0.203 |P=0.531N P=0.322N P=0.251N P=0.571N |
|LOGISTIC REGRESSION| P=0.101 P=0.456N P=0.288 P=0.122 |P=0.440N P=0.305N P=0.232N P=0.434N |
|COCH-ARM / FISHERS | P=0.135 P=0.370N P=0.288 P=0.288 |P=0.397N P=0.318N P=0.235N P=0.408N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 10/50 (20%) 12/50 (24%) 9/50 (18%) |9/50 (18%) 8/50 (16%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 19.0% 23.9% 28.3% 23.5% |20.2% 17.4% 13.6% 19.3% |
|TERMINAL (d) | 6/25 (24%) 4/20 (20%) 6/25 (24%) 8/16 (50%) |8/32 (25%) 6/37 (16%) 4/29 (14%) 6/26 (23%) |
|FIRST INCIDENCE | 388 444 596 717 |687 666 700 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.240 P=0.223 P=0.154 |P=0.440 P=0.382N P=0.344N P=0.536 |
|POLY 3 | P=0.355 P=0.389 P=0.227 P=0.413 |P=0.499N P=0.470N P=0.293N P=0.564N |
|POLY 1.5 | P=0.401 P=0.401 P=0.228 P=0.453 |P=0.471N P=0.482N P=0.290N P=0.535N |
|POLY 6 | P=0.287 P=0.358 P=0.225 P=0.348 |P=0.539N P=0.451N P=0.298N P=0.605N |
|LOGISTIC REGRESSION| P=0.374 P=0.395 P=0.225 P=0.369 |P=0.520 P=0.440N P=0.307N P=0.581 |
|COCH-ARM / FISHERS | P=0.464 P=0.398 P=0.227 P=0.500 |P=0.434N P=0.500N P=0.288N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.3% 0.0% 7.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 2/16 (13%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 607 --- 717 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.104 P=0.106 (e) P=0.057 |(e) (e) (e) (e) |
|POLY 3 | P=0.146 P=0.119 (e) P=0.105 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.154 P=0.120 (e) P=0.112 |(e) (e) (e) (e) |
|POLY 6 | P=0.132 P=0.113 (e) P=0.095 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.142 P=0.120 (e) P=0.056 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.121 (e) P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |3/49 (6%) 4/50 (8%) 9/50 (18%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.7% 7.4% 4.9% 7.8% |6.8% 8.6% 20.3% 4.9% |
|TERMINAL (d) | 3/25 (12%) 2/20 (10%) 2/25 (8%) 2/16 (13%) |3/32 (9%) 3/37 (8%) 7/29 (24%) 2/26 (8%) |
|FIRST INCIDENCE | 692 708 722 (T) 598 |729 (T) 533 573 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 P=0.631N P=0.346N P=0.609 |P=0.509 P=0.571 P=0.043 * P=0.595N |
|POLY 3 | P=0.443N P=0.509N P=0.340N P=0.535N |P=0.555N P=0.530 P=0.061 P=0.534N |
|POLY 1.5 | P=0.433N P=0.499N P=0.337N P=0.518N |P=0.511N P=0.523 P=0.063 P=0.515N |
|POLY 6 | P=0.459N P=0.534N P=0.352N P=0.567N |P=0.506 P=0.541 P=0.058 P=0.562N |
|LOGISTIC REGRESSION| P=0.514N P=0.611N P=0.373N P=0.578N |P=0.537N P=0.512 P=0.057 P=0.595N |
|COCH-ARM / FISHERS | P=0.420N P=0.500N P=0.339N P=0.500N |P=0.456N P=0.511 P=0.065 P=0.490N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 0/50 (0%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 12.1% 0.0% 10.3% |6.6% 2.2% 8.8% 2.4% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |1/32 (3%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- 625 --- 598 |493 570 561 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 P=0.023 * (e) P=0.033 * |P=0.403N P=0.294N P=0.480 P=0.367N |
|POLY 3 | P=0.143 P=0.030 * (e) P=0.052 |P=0.397N P=0.297N P=0.500 P=0.342N |
|POLY 1.5 | P=0.151 P=0.031 * (e) P=0.056 |P=0.374N P=0.301N P=0.500 P=0.326N |
|POLY 6 | P=0.128 P=0.027 * (e) P=0.046 * |P=0.429N P=0.292N P=0.499 P=0.365N |
|LOGISTIC REGRESSION| P=0.145 P=0.032 * (e) P=0.053 |P=0.236N P=0.381N P=0.481 P=0.256N |
|COCH-ARM / FISHERS | P=0.164 P=0.028 * (e) P=0.059 |P=0.343N P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.4% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 574 607 585 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.750N P=0.491 P=0.514N |(e) (e) (e) (e) |
|POLY 3 | P=0.395N P=0.757 P=0.498 P=0.517N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.382N P=0.760N P=0.501 P=0.509N |(e) (e) (e) (e) |
|POLY 6 | P=0.417N P=0.748 P=0.490 P=0.531N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.345N P=0.734 P=0.492 P=0.481N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.753N P=0.500 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/47 (4%) 0/50 (0%) 1/48 (2%) |2/49 (4%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 2.7% |4.5% 0.0% 6.6% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 708 --- 681 |622 --- 561 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459 P=0.173 (e) P=0.452 |P=0.333N P=0.231N P=0.488 P=0.282N |
|POLY 3 | P=0.516 P=0.221 (e) P=0.482 |P=0.332N P=0.231N P=0.506 P=0.258N |
|POLY 1.5 | P=0.528 P=0.224 (e) P=0.488 |P=0.314N P=0.232N P=0.508 P=0.247N |
|POLY 6 | P=0.494 P=0.213 (e) P=0.470 |P=0.359N P=0.231N P=0.504 P=0.275N |
|LOGISTIC REGRESSION| P=0.500 P=0.195 (e) P=0.483 |P=0.195N P=0.250N P=0.514 P=0.200N |
|COCH-ARM / FISHERS | P=0.534 P=0.232 (e) P=0.490 |P=0.291N P=0.242N P=0.510 P=0.242N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/47 (6%) 2/50 (4%) 1/48 (2%) |0/49 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 7.8% 4.9% 2.7% |0.0% 0.0% 9.1% 0.0% |
|TERMINAL (d) | 2/25 (8%) 3/20 (15%) 2/25 (8%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 4/29 (14%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 722 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.451N P=0.397 P=0.697 P=0.655N |P=0.418 (e) P=0.050 (e) |
|POLY 3 | P=0.342N P=0.468 P=0.692 P=0.534N |P=0.426 (e) P=0.059 (e) |
|POLY 1.5 | P=0.330N P=0.474 P=0.693N P=0.522N |P=0.460 (e) P=0.061 (e) |
|POLY 6 | P=0.366N P=0.450 P=0.684 P=0.556N |P=0.378 (e) P=0.057 (e) |
|LOGISTIC REGRESSION| P=0.451N P=0.397 P=0.697 P=0.655N |(e) (e) P=0.050 (e) |
|COCH-ARM / FISHERS | P=0.321N P=0.470 P=0.691N P=0.515N |P=0.505 (e) P=0.061 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 2/50 (4%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.9% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 632 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553 (e) P=0.240 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.559 (e) P=0.237 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.577 (e) P=0.238 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.526 (e) P=0.233 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.586 (e) P=0.237 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 4.9% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) |
|FIRST INCIDENCE | --- --- --- --- |--- 488 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.211 P=0.242 (e) P=0.193 |
|POLY 3 | (e) (e) (e) (e) |P=0.226 P=0.252 (e) P=0.220 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.237 P=0.248 (e) P=0.229 |
|POLY 6 | (e) (e) (e) (e) |P=0.213 P=0.257 (e) P=0.207 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.339 P=0.117 (e) P=0.193 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.251 P=0.253 (e) P=0.253 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/47 (6%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 604 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N P=0.121 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.324N P=0.109 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.316N P=0.110 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.342N P=0.105 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.314N P=0.105 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.316N P=0.110 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/23 (0%) |2/7 (29%) 0/9 (0%) 0/15 (0%) 0/19 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |31.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- --- --- |493 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.124N P=0.240N P=0.240N P=0.269N |
|POLY 3 | (e) (e) (e) (e) |P=0.019N* P=0.170N P=0.091N P=0.057N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.021N* P=0.167N P=0.081N P=0.049N* |
|POLY 6 | (e) (e) (e) (e) |P=0.018N* P=0.173N P=0.106N P=0.072N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.019N* P=0.249N P=0.060N P=0.035N* |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.039N* P=0.175N P=0.091N P=0.065N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/20 (0%) 0/25 (0%) 0/20 (0%) 0/23 (0%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 2/19 (11%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 14.7% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 2/4 (50%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.059 (e) (e) P=0.390 |
|POLY 3 | (e) (e) (e) (e) |P=0.105 (e) (e) P=0.457 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.112 (e) (e) P=0.465 |
|POLY 6 | (e) (e) (e) (e) |P=0.094 (e) (e) P=0.443 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.390 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.120 (e) (e) P=0.526 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Pancreatic |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/20 (0%) 0/25 (0%) 1/20 (5%) 2/23 (9%) |0/7 (0%) 0/9 (0%) 1/15 (7%) 0/19 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 10.9% |0.0% 0.0% 8.8% 0.0% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- 708 598 |--- --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 (e) P=0.479 P=0.231 |P=0.677 (e) P=0.491 (e) |
|POLY 3 | P=0.078 (e) P=0.499 P=0.275 |P=0.704N (e) P=0.651 (e) |
|POLY 1.5 | P=0.077 (e) P=0.502 P=0.273 |P=0.694N (e) P=0.650 (e) |
|POLY 6 | P=0.081 (e) P=0.490 P=0.277 |P=0.719N (e) P=0.655 (e) |
|LOGISTIC REGRESSION| P=0.073 (e) P=0.469 P=0.248 |P=0.667N (e) P=0.665 (e) |
|COCH-ARM / FISHERS | P=0.074 (e) P=0.500 P=0.280 |P=0.684N (e) P=0.682 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/20 (5%) 0/25 (0%) 1/20 (5%) 3/23 (13%) |1/7 (14%) 1/9 (11%) 1/15 (7%) 0/19 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 6.5% 16.2% |16.5% 12.3% 8.7% 0.0% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 0/5 (0%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | 571 --- 609 598 |493 570 605 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.086 P=0.500N P=0.760N P=0.273 |P=0.322N P=0.760 P=0.758 P=0.504N |
|POLY 3 | P=0.106 P=0.461N P=0.760 P=0.359 |P=0.147N P=0.696N P=0.617N P=0.326N |
|POLY 1.5 | P=0.104 P=0.456N P=0.761N P=0.360 |P=0.136N P=0.700N P=0.603N P=0.312N |
|POLY 6 | P=0.110 P=0.473N P=0.751 P=0.357 |P=0.165N P=0.687N P=0.630N P=0.347N |
|LOGISTIC REGRESSION| P=0.093 P=0.508N P=0.739 P=0.334 |P=0.050N (e) P=0.580N P=0.197N |
|COCH-ARM / FISHERS | P=0.102 P=0.444N P=0.756N P=0.359 |P=0.121N P=0.700N P=0.545N P=0.269N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/20 (0%) 0/25 (0%) 2/20 (10%) 0/23 (0%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 1/19 (5%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 12.8% 0.0% |0.0% 0.0% 0.0% 7.2% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 1/5 (20%) 0/6 (0%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- 534 --- |--- --- --- 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595 (e) P=0.242 (e) |P=0.169 (e) (e) P=0.465 |
|POLY 3 | P=0.609 (e) P=0.238 (e) |P=0.300 (e) (e) P=0.690 |
|POLY 1.5 | P=0.612 (e) P=0.239 (e) |P=0.309 (e) (e) P=0.693 |
|POLY 6 | P=0.601 (e) P=0.231 (e) |P=0.288 (e) (e) P=0.688 |
|LOGISTIC REGRESSION| P=0.602 (e) P=0.225 (e) |P=0.301 (e) (e) P=0.689 |
|COCH-ARM / FISHERS | P=0.608 (e) P=0.244 (e) |P=0.316 (e) (e) P=0.731 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/20 (0%) 0/25 (0%) 1/20 (5%) 4/23 (17%) |0/7 (0%) 0/9 (0%) 0/15 (0%) 0/19 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 22.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/5 (0%) 0/7 (0%) 1/5 (20%) 2/6 (33%) |0/2 (0%) 0/4 (0%) 0/4 (0%) 0/4 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) 685 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) P=0.500 P=0.050 |(e) (e) (e) (e) |
|POLY 3 | P=0.004 ** (e) P=0.498 P=0.067 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.005 ** (e) P=0.502 P=0.070 |(e) (e) (e) (e) |
|POLY 6 | P=0.004 ** (e) P=0.489 P=0.061 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.004 ** (e) P=0.500 P=0.050 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.006 ** (e) P=0.500 P=0.072 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 1/50 (2%) 0/49 (0%) |3/50 (6%) 5/50 (10%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 0.0% |6.7% 10.8% 2.3% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 4/37 (11%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 700 --- |661 611 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.653 (e) P=0.487 (e) |P=0.062N P=0.420 P=0.338N P=0.174N |
|POLY 3 | P=0.664 (e) P=0.503 (e) |P=0.044N* P=0.375 P=0.311N P=0.136N |
|POLY 1.5 | P=0.678 (e) P=0.505 (e) |P=0.040N* P=0.368 P=0.308N P=0.128N |
|POLY 6 | P=0.640 (e) P=0.498 (e) |P=0.051N P=0.384 P=0.317N P=0.148N |
|LOGISTIC REGRESSION| P=0.682 (e) P=0.499 (e) |P=0.043N* P=0.363 P=0.309N P=0.134N |
|COCH-ARM / FISHERS | P=0.696 (e) P=0.505 (e) |P=0.037N* P=0.357 P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/48 (6%) 2/50 (4%) 3/49 (6%) |5/50 (10%) 2/50 (4%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.5% 7.7% 4.9% 7.9% |11.3% 4.4% 13.5% 12.0% |
|TERMINAL (d) | 1/25 (4%) 3/20 (15%) 2/25 (8%) 2/16 (13%) |5/32 (16%) 2/37 (5%) 5/29 (17%) 2/26 (8%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 465 |729 (T) 729 (T) 561 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.226 P=0.500 P=0.196 |P=0.250 P=0.160N P=0.437 P=0.496 |
|POLY 3 | P=0.281 P=0.291 P=0.505 P=0.285 |P=0.348 P=0.203N P=0.501 P=0.591 |
|POLY 1.5 | P=0.293 P=0.298 P=0.508 P=0.295 |P=0.370 P=0.209N P=0.502 P=0.608 |
|POLY 6 | P=0.258 P=0.274 P=0.495 P=0.265 |P=0.320 P=0.196N P=0.499 P=0.569 |
|LOGISTIC REGRESSION| P=0.264 P=0.226 P=0.500 P=0.302 |P=0.344 P=0.160N P=0.487 P=0.578 |
|COCH-ARM / FISHERS | P=0.305 P=0.301 P=0.508 P=0.309 |P=0.401 P=0.218N P=0.500 P=0.630N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland: Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 16/48 (33%) 12/50 (24%) 15/49 (31%) |13/50 (26%) 9/50 (18%) 13/50 (26%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 32.8% 39.7% 27.5% 36.0% |28.4% 19.0% 28.4% 29.5% |
|TERMINAL (d) | 7/25 (28%) 7/20 (35%) 7/25 (28%) 3/16 (19%) |8/32 (25%) 6/37 (16%) 7/29 (24%) 4/26 (15%) |
|FIRST INCIDENCE | 434 641 269 523 |588 488 496 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263 P=0.232 P=0.433N P=0.243 |P=0.208 P=0.172N P=0.503 P=0.391 |
|POLY 3 | P=0.528 P=0.335 P=0.381N P=0.468 |P=0.349 P=0.204N P=0.588N P=0.546 |
|POLY 1.5 | P=0.533 P=0.368 P=0.373N P=0.481 |P=0.375 P=0.215N P=0.585N P=0.565 |
|POLY 6 | P=0.514 P=0.278 P=0.415N P=0.445 |P=0.317 P=0.194N P=0.584 P=0.521 |
|LOGISTIC REGRESSION| P=0.532 P=0.375 P=0.389N P=0.497 |P=0.495 P=0.253N P=0.589N P=0.564N |
|COCH-ARM / FISHERS | P=0.541N P=0.387 P=0.387N P=0.500 |P=0.411 P=0.235N P=0.590N P=0.590N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/11 (91%) 13/14 (93%) 6/7 (86%) 8/8 (100%) |8/9 (89%) 9/11 (82%) 6/7 (86%) 11/12 (92%) |
|POLY-3 ADJUSTED (b)| 91.0% 95.2% 87.8% 100.0% |88.9% 92.0% 87.2% 91.7% |
|TERMINAL (d) | 4/4 (100%) 6/6 (100%) 3/3 (100%) 2/2 (100%) |6/7 (86%) 6/6 (100%) 3/3 (100%) 4/5 (80%) |
|FIRST INCIDENCE | 388 604 640 523 |671 642 496 380 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534 P=0.430 P=0.264N P=0.511 |P=0.042 * P=0.380 P=0.406 P=0.084 |
|POLY 3 | P=0.423 P=0.659 P=0.718N P=0.568 |P=0.583 P=0.727 P=0.744N P=0.695 |
|POLY 1.5 | P=0.421 P=0.683 P=0.688N P=0.565 |P=0.531 P=0.751N P=0.724N P=0.695 |
|POLY 6 | P=0.426 P=0.613 P=0.771N P=0.572 |P=0.638 P=0.612 P=0.780N P=0.695 |
|LOGISTIC REGRESSION| P=0.415 P=0.701 P=0.705N P=0.704 |P=0.368 P=0.525 P=0.624N (e) |
|COCH-ARM / FISHERS | P=0.416 P=0.697 P=0.641N P=0.579 |P=0.456 P=0.579N P=0.700N P=0.686 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 18/50 (36%) 22/49 (45%) 25/50 (50%) |17/50 (34%) 15/50 (30%) 19/50 (38%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 58.3% 40.9% 52.6% 56.2% |38.0% 32.8% 41.7% 43.7% |
|TERMINAL (d) | 13/25 (52%) 8/20 (40%) 14/24 (58%) 8/16 (50%) |16/32 (50%) 15/37 (41%) 11/29 (38%) 11/26 (42%) |
|FIRST INCIDENCE | 388 466 529 194 |622 729 (T) 496 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121 P=0.264N P=0.366N P=0.211 |P=0.065 P=0.224N P=0.314 P=0.180 |
|POLY 3 | P=0.419 P=0.069N P=0.372N P=0.504N |P=0.237 P=0.382N P=0.443 P=0.371 |
|POLY 1.5 | P=0.429 P=0.066N P=0.333N P=0.488N |P=0.259 P=0.395N P=0.434 P=0.391 |
|POLY 6 | P=0.393 P=0.089N P=0.451N P=0.553N |P=0.212 P=0.364N P=0.457 P=0.347 |
|LOGISTIC REGRESSION| P=0.387 P=0.077N P=0.309N P=0.519N |P=0.156 P=0.290N P=0.391 P=0.288 |
|COCH-ARM / FISHERS | P=0.429 P=0.079N P=0.307N P=0.500N |P=0.291 P=0.415N P=0.418 P=0.418 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.5% 2.6% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/24 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) 651 |--- 533 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 (e) P=0.492 P=0.470 |P=0.435N P=0.249 (e) (e) |
|POLY 3 | P=0.219 (e) P=0.494 P=0.487 |P=0.412N P=0.249 (e) (e) |
|POLY 1.5 | P=0.226 (e) P=0.496 P=0.493 |P=0.408N P=0.244 (e) (e) |
|POLY 6 | P=0.207 (e) P=0.488 P=0.476 |P=0.419N P=0.255 (e) (e) |
|LOGISTIC REGRESSION| P=0.221 (e) P=0.492 P=0.501 |P=0.328N P=0.152 (e) (e) |
|COCH-ARM / FISHERS | P=0.236 (e) P=0.495 P=0.500 |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 8/50 (16%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| |6.7% 17.2% 8.9% 9.6% |
|TERMINAL (d) | |2/32 (6%) 6/37 (16%) 2/29 (7%) 1/26 (4%) |
|FIRST INCIDENCE | |503 546 521 616 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.510 P=0.146 P=0.473 P=0.409 |
|POLY 3 | |P=0.540N P=0.108 P=0.500 P=0.458 |
|POLY 1.5 | |P=0.516N P=0.105 P=0.501 P=0.476 |
|POLY 6 | |P=0.551 P=0.115 P=0.498 P=0.436 |
|LOGISTIC REGRESSION| |P=0.416N P=0.092 P=0.488 P=0.550 |
|COCH-ARM / FISHERS | |P=0.484N P=0.100 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 15/48 (31%) 17/50 (34%) 12/49 (24%) |22/49 (45%) 14/50 (28%) 13/50 (26%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 40.7% 36.8% 39.0% 30.6% |47.9% 30.2% 28.8% 33.3% |
|TERMINAL (d) | 9/25 (36%) 11/20 (55%) 9/25 (36%) 8/16 (50%) |15/32 (47%) 13/37 (35%) 8/29 (28%) 9/26 (35%) |
|FIRST INCIDENCE | 388 444 529 465 |399 533 605 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.548N P=0.521N P=0.473N |P=0.311N P=0.032N* P=0.096N P=0.253N |
|POLY 3 | P=0.212N P=0.440N P=0.521N P=0.227N |P=0.127N P=0.059N P=0.045N* P=0.114N |
|POLY 1.5 | P=0.180N P=0.404N P=0.506N P=0.188N |P=0.103N P=0.059N P=0.041N* P=0.088N |
|POLY 6 | P=0.277N P=0.520N P=0.553N P=0.308N |P=0.164N P=0.061N P=0.051N P=0.161N |
|LOGISTIC REGRESSION| P=0.173N P=0.384N P=0.498N P=0.174N |P=0.118N P=0.057N P=0.040N* P=0.094N |
|COCH-ARM / FISHERS | P=0.144N P=0.389N P=0.500N P=0.152N |P=0.077N P=0.062N P=0.039N* P=0.062N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.288N P=0.237N P=0.340N |P=0.335N P=0.471N P=0.520N P=0.541N |
|POLY 3 | P=0.111N P=0.248N P=0.238N P=0.259N |P=0.297N P=0.491N P=0.499N P=0.514N |
|POLY 1.5 | P=0.113N P=0.245N P=0.237N P=0.250N |P=0.300N P=0.493N P=0.497N P=0.506N |
|POLY 6 | P=0.106N P=0.256N P=0.243N P=0.274N |P=0.291N P=0.488N P=0.502N P=0.526N |
|LOGISTIC REGRESSION| P=0.140N (e) (e) (e) |P=0.335N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.258N P=0.247N P=0.253N |P=0.303N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Ectopic Liver |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 4.6% 7.3% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 2/29 (7%) 2/26 (8%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.059 P=0.271 P=0.216 P=0.087 |
|POLY 3 | (e) (e) (e) (e) |P=0.091 P=0.247 P=0.238 P=0.107 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.100 P=0.245 P=0.240 P=0.114 |
|POLY 6 | (e) (e) (e) (e) |P=0.079 P=0.250 P=0.234 P=0.099 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.073 P=0.271 P=0.216 P=0.108 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111 P=0.253 P=0.253 P=0.125 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/48 (8%) 2/50 (4%) 3/49 (6%) |0/49 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 10.1% 4.9% 7.8% |0.0% 6.5% 4.6% 0.0% |
|TERMINAL (d) | 1/25 (4%) 2/20 (10%) 2/25 (8%) 1/16 (6%) |0/32 (0%) 2/37 (5%) 2/29 (7%) 0/26 (0%) |
|FIRST INCIDENCE | 571 665 722 (T) 428 |--- 570 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392 P=0.270 P=0.692 P=0.412 |P=0.480N P=0.140 P=0.216 (e) |
|POLY 3 | P=0.485 P=0.311 P=0.688 P=0.464 |P=0.447N P=0.129 P=0.238 (e) |
|POLY 1.5 | P=0.501 P=0.319 P=0.692 P=0.478 |P=0.427N P=0.127 P=0.240 (e) |
|POLY 6 | P=0.456 P=0.294 P=0.677 P=0.438 |P=0.477N P=0.133 P=0.234 (e) |
|LOGISTIC REGRESSION| P=0.511 P=0.316 P=0.694 P=0.516 |P=0.415N P=0.113 P=0.216 (e) |
|COCH-ARM / FISHERS | P=0.517 P=0.319 P=0.691N P=0.490 |P=0.404N P=0.125 P=0.253 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 3/50 (6%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 7.3% 0.0% |0.0% 0.0% 2.3% 4.9% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 3/25 (12%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | 722 (T) --- 722 (T) --- |--- --- 707 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610N P=0.545N P=0.303 P=0.589N |P=0.050 (e) P=0.494 P=0.212 |
|POLY 3 | P=0.535N P=0.510N P=0.302 P=0.519N |P=0.061 (e) P=0.501 P=0.224 |
|POLY 1.5 | P=0.521N P=0.507N P=0.306 P=0.512N |P=0.066 (e) P=0.503 P=0.232 |
|POLY 6 | P=0.557N P=0.518N P=0.293 P=0.532N |P=0.056 (e) P=0.499 P=0.213 |
|LOGISTIC REGRESSION| P=0.610N (e) P=0.303 (e) |P=0.080 (e) P=0.501 P=0.260 |
|COCH-ARM / FISHERS | P=0.502N P=0.510N P=0.309 P=0.505N |P=0.071 (e) P=0.505 P=0.253 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 3/48 (6%) |1/48 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 7.3% 8.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 2/25 (8%) 2/16 (13%) |0/31 (0%) 0/37 (0%) 0/28 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 722 (T) 679 670 |503 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.455 P=0.117 P=0.071 |P=0.306N P=0.496N P=0.496N P=0.500N |
|POLY 3 | P=0.052 P=0.497 P=0.118 P=0.102 |P=0.295N P=0.488N P=0.505N P=0.511N |
|POLY 1.5 | P=0.057 P=0.500 P=0.119 P=0.108 |P=0.299N P=0.490N P=0.503N P=0.503N |
|POLY 6 | P=0.045 * P=0.488 P=0.113 P=0.093 |P=0.290N P=0.485N P=0.508N P=0.523N |
|LOGISTIC REGRESSION| P=0.040 * P=0.455 P=0.111 P=0.086 |P=0.239N P=0.680N P=0.651N P=0.422N |
|COCH-ARM / FISHERS | P=0.061 P=0.500 P=0.121 P=0.114 |P=0.302N P=0.490N P=0.500N P=0.490N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |11/49 (22%) 9/50 (18%) 12/50 (24%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.9% 4.9% 5.2% |24.9% 19.0% 27.0% 9.5% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 2/25 (8%) 0/16 (0%) |8/31 (26%) 5/37 (14%) 10/29 (35%) 0/26 (0%) |
|FIRST INCIDENCE | --- 698 722 (T) 676 |622 546 549 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156 P=0.193 P=0.237 P=0.185 |P=0.139N P=0.295N P=0.437 P=0.107N |
|POLY 3 | P=0.216 P=0.234 P=0.235 P=0.223 |P=0.075N P=0.335N P=0.509 P=0.053N |
|POLY 1.5 | P=0.228 P=0.238 P=0.237 P=0.229 |P=0.062N P=0.354N P=0.518 P=0.047N* |
|POLY 6 | P=0.196 P=0.224 P=0.230 P=0.211 |P=0.096N P=0.312N P=0.492 P=0.062N |
|LOGISTIC REGRESSION| P=0.193 P=0.206 P=0.237 P=0.221 |P=0.053N P=0.390N P=0.509 P=0.047N* |
|COCH-ARM / FISHERS | P=0.242 P=0.247 P=0.247 P=0.247 |P=0.048N* P=0.382N P=0.522 P=0.041N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 3/50 (6%) 1/50 (2%) |16/49 (33%) 18/50 (36%) 20/50 (40%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 4.9% 19.2% 7.3% 2.6% |36.1% 38.4% 42.4% 19.1% |
|TERMINAL (d) | 1/25 (4%) 4/20 (20%) 3/25 (12%) 0/16 (0%) |13/31 (42%) 16/37 (43%) 11/29 (38%) 5/26 (19%) |
|FIRST INCIDENCE | 718 598 722 (T) 691 |493 488 549 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265N P=0.029 * P=0.490 P=0.641N |P=0.142N P=0.530N P=0.228 P=0.122N |
|POLY 3 | P=0.175N P=0.045 * P=0.497 P=0.524N |P=0.055N P=0.493 P=0.340 P=0.061N |
|POLY 1.5 | P=0.161N P=0.047 * P=0.501 P=0.513N |P=0.043N* P=0.474 P=0.319 P=0.052N |
|POLY 6 | P=0.203N P=0.039 * P=0.486 P=0.545N |P=0.076N P=0.519 P=0.370 P=0.075N |
|LOGISTIC REGRESSION| P=0.190N P=0.042 * P=0.458 P=0.581N |P=0.039N* P=0.481 P=0.291 P=0.066N |
|COCH-ARM / FISHERS | P=0.151N P=0.046 * P=0.500 P=0.500N |P=0.031N* P=0.445 P=0.291 P=0.044N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 16/50 (32%) 18/50 (36%) 12/50 (24%) |22/49 (45%) 29/50 (58%) 21/50 (42%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 50.9% 37.2% 40.9% 29.1% |48.3% 60.7% 45.2% 41.2% |
|TERMINAL (d) | 15/25 (60%) 7/20 (35%) 10/25 (40%) 5/16 (31%) |17/31 (55%) 23/37 (62%) 15/29 (52%) 11/26 (42%) |
|FIRST INCIDENCE | 388 466 486 520 |399 533 561 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.371N P=0.296N P=0.232N |P=0.387N P=0.333 P=0.564 P=0.518N |
|POLY 3 | P=0.037N* P=0.137N P=0.229N P=0.029N* |P=0.135N P=0.156 P=0.465N P=0.320N |
|POLY 1.5 | P=0.036N* P=0.136N P=0.242N P=0.027N* |P=0.112N P=0.144 P=0.467N P=0.289N |
|POLY 6 | P=0.041N* P=0.154N P=0.222N P=0.035N* |P=0.169N P=0.181 P=0.461N P=0.361N |
|LOGISTIC REGRESSION| P=0.043N* P=0.151N P=0.266N P=0.037N* |P=0.106N P=0.145 P=0.465N P=0.271N |
|COCH-ARM / FISHERS | P=0.035N* P=0.151N P=0.270N P=0.028N* |P=0.084N P=0.135 P=0.465N P=0.243N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/47 (6%) 5/49 (10%) 4/48 (8%) | |
|POLY-3 ADJUSTED (b)| 9.6% 7.8% 12.4% 10.7% | |
|TERMINAL (d) | 3/25 (12%) 1/19 (5%) 5/25 (20%) 3/16 (19%) | |
|FIRST INCIDENCE | 604 607 722 (T) 444 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.578N P=0.500 P=0.452 | |
|POLY 3 | P=0.443 P=0.539N P=0.479 P=0.587 | |
|POLY 1.5 | P=0.463 P=0.531N P=0.486 P=0.604 | |
|POLY 6 | P=0.409 P=0.559N P=0.462 P=0.553 | |
|LOGISTIC REGRESSION| P=0.443 P=0.537N P=0.464 P=0.602 | |
|COCH-ARM / FISHERS | P=0.486 P=0.535N P=0.487 P=0.619 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/47 (0%) 0/49 (0%) 2/48 (4%) | |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 5.4% | |
|TERMINAL (d) | 1/25 (4%) 0/19 (0%) 0/25 (0%) 1/16 (6%) | |
|FIRST INCIDENCE | 604 --- --- 719 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.418 P=0.259N P=0.240N P=0.568 | |
|POLY 3 | P=0.485 P=0.256N P=0.244N P=0.650 | |
|POLY 1.5 | P=0.487 P=0.252N P=0.242N P=0.664 | |
|POLY 6 | P=0.484 P=0.268N P=0.250N P=0.624 | |
|LOGISTIC REGRESSION| P=0.467 P=0.251N P=0.242N P=0.647 | |
|COCH-ARM / FISHERS | P=0.493 P=0.263N P=0.253N P=0.676 | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 39/47 (83%) 31/49 (63%) 28/48 (58%) | |
|POLY-3 ADJUSTED (b)| 50.0% 86.9% 69.9% 65.2% | |
|TERMINAL (d) | 14/25 (56%) 16/19 (84%) 18/25 (72%) 10/16 (63%) | |
|FIRST INCIDENCE | 309 444 525 444 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091 P<0.001 ** P=0.072 P=0.020 * | |
|POLY 3 | P=0.345 P<0.001 ** P=0.037 * P=0.103 | |
|POLY 1.5 | P=0.345 P<0.001 ** P=0.038 * P=0.104 | |
|POLY 6 | P=0.323 P<0.001 ** P=0.038 * P=0.096 | |
|LOGISTIC REGRESSION| P=0.302 P<0.001 ** P=0.042 * P=0.096 | |
|COCH-ARM / FISHERS | P=0.362 P<0.001 ** P=0.042 * P=0.112 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/47 (4%) 0/49 (0%) 2/48 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 5.4% | |
|TERMINAL (d) | 0/25 (0%) 1/19 (5%) 0/25 (0%) 1/16 (6%) | |
|FIRST INCIDENCE | --- 666 --- 644 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193 P=0.201 (e) P=0.183 | |
|POLY 3 | P=0.226 P=0.221 (e) P=0.214 | |
|POLY 1.5 | P=0.233 P=0.224 (e) P=0.220 | |
|POLY 6 | P=0.212 P=0.213 (e) P=0.202 | |
|LOGISTIC REGRESSION| P=0.222 P=0.216 (e) P=0.213 | |
|COCH-ARM / FISHERS | P=0.242 P=0.232 (e) P=0.237 | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 4/50 (8%) 2/49 (4%) | |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 9.8% 5.4% | |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 4/25 (16%) 2/16 (13%) | |
|FIRST INCIDENCE | 579 722 (T) 722 (T) 722 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.741 P=0.181 P=0.392 | |
|POLY 3 | P=0.264 P=0.746 P=0.172 P=0.462 | |
|POLY 1.5 | P=0.284 P=0.751 P=0.177 P=0.477 | |
|POLY 6 | P=0.233 P=0.735 P=0.162 P=0.437 | |
|LOGISTIC REGRESSION| P=0.247 P=0.751 P=0.175 P=0.478 | |
|COCH-ARM / FISHERS | P=0.310 P=0.742 P=0.181 P=0.492 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/48 (4%) 0/50 (0%) 1/49 (2%) | |
|POLY-3 ADJUSTED (b)| 4.8% 5.0% 0.0% 2.6% | |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | |
|FIRST INCIDENCE | 571 466 --- 520 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.324N P=0.682 P=0.253N P=0.554N | |
|POLY 3 | P=0.309N P=0.680 P=0.241N P=0.533N | |
|POLY 1.5 | P=0.304N P=0.683 P=0.238N P=0.520N | |
|POLY 6 | P=0.318N P=0.668 P=0.249N P=0.556N | |
|LOGISTIC REGRESSION| P=0.251N P=0.624 P=0.240N P=0.481N | |
|COCH-ARM / FISHERS | P=0.298N P=0.676 P=0.247N P=0.508N | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 30/48 (63%) 28/50 (56%) 25/49 (51%) | |
|POLY-3 ADJUSTED (b)| 72.4% 70.5% 61.1% 57.8% | |
|TERMINAL (d) | 18/25 (72%) 14/20 (70%) 15/25 (60%) 8/16 (50%) | |
|FIRST INCIDENCE | 388 538 269 194 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496N P=0.409 P=0.293N P=0.529 | |
|POLY 3 | P=0.057N P=0.518N P=0.167N P=0.101N | |
|POLY 1.5 | P=0.056N P=0.470N P=0.170N P=0.092N | |
|POLY 6 | P=0.064N P=0.599N P=0.187N P=0.123N | |
|LOGISTIC REGRESSION| P=0.081N P=0.422N P=0.202N P=0.110N | |
|COCH-ARM / FISHERS | P=0.064N P=0.440N P=0.206N P=0.095N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 6.8% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 3/29 (10%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- --- |--- 546 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.360 P=0.258 P=0.103 P=0.459 |
|POLY 3 | (e) (e) (e) (e) |P=0.385 P=0.247 P=0.116 P=0.483 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.411 P=0.243 P=0.118 P=0.490 |
|POLY 6 | (e) (e) (e) (e) |P=0.348 P=0.252 P=0.114 P=0.472 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.426 P=0.196 P=0.103 P=0.459 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.247 P=0.121 P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 49
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 701 --- --- |--- 546 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.630N P=0.440 (e) (e) |P=0.434N P=0.258 (e) (e) |
|POLY 3 | P=0.571N P=0.498 (e) (e) |P=0.413N P=0.247 (e) (e) |
|POLY 1.5 | P=0.568N P=0.501 (e) (e) |P=0.409N P=0.243 (e) (e) |
|POLY 6 | P=0.578N P=0.489 (e) (e) |P=0.420N P=0.252 (e) (e) |
|LOGISTIC REGRESSION| P=0.588N P=0.487 (e) (e) |P=0.360N P=0.196 (e) (e) |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/47 (2%) 2/50 (4%) 2/48 (4%) | |
|POLY-3 ADJUSTED (b)| 4.9% 2.6% 4.9% 5.4% | |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) | |
|FIRST INCIDENCE | 695 722 (T) 662 672 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415 P=0.591N P=0.664 P=0.560 | |
|POLY 3 | P=0.492 P=0.526N P=0.693 P=0.657 | |
|POLY 1.5 | P=0.503 P=0.521N P=0.693N P=0.668 | |
|POLY 6 | P=0.473 P=0.540N P=0.686 P=0.636 | |
|LOGISTIC REGRESSION| P=0.467 P=0.562N P=0.688 P=0.630 | |
|COCH-ARM / FISHERS | P=0.518 P=0.523N P=0.691N P=0.676 | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 50
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 580 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556 (e) P=0.237 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.554 (e) P=0.238 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.572 (e) P=0.239 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.522 (e) P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.603 (e) P=0.235 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 1/25 (4%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) --- |--- --- 707 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.656 (e) P=0.500 (e) |P=0.539 (e) P=0.226 (e) |
|POLY 3 | P=0.664 (e) P=0.499 (e) |P=0.541 (e) P=0.235 (e) |
|POLY 1.5 | P=0.677 (e) P=0.500 (e) |P=0.565 (e) P=0.236 (e) |
|POLY 6 | P=0.640 (e) P=0.494 (e) |P=0.505 (e) P=0.233 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.500 (e) |P=0.558 (e) P=0.232 (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 51
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 2.4% 0.0% |4.5% 2.2% 2.3% 2.5% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | --- 722 (T) 722 (T) --- |717 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.674N P=0.455 P=0.500 (e) |P=0.502N P=0.454N P=0.537N P=0.582N |
|POLY 3 | P=0.613N P=0.497 P=0.499 (e) |P=0.432N P=0.490N P=0.504N P=0.530N |
|POLY 1.5 | P=0.604N P=0.500 P=0.500 (e) |P=0.422N P=0.494N P=0.502N P=0.517N |
|POLY 6 | P=0.630N P=0.488 P=0.494 (e) |P=0.445N P=0.484N P=0.508N P=0.550N |
|LOGISTIC REGRESSION| (e) P=0.455 P=0.500 (e) |P=0.498N P=0.470N P=0.514N P=0.580N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.409N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.8% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |2/32 (6%) 1/37 (3%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |717 729 (T) --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.254N P=0.260N P=0.142N P=0.376N |
|POLY 3 | (e) (e) (e) (e) |P=0.207N P=0.295N P=0.121N P=0.332N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.204N P=0.299N P=0.120N P=0.320N |
|POLY 6 | (e) (e) (e) (e) |P=0.211N P=0.288N P=0.122N P=0.350N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.206N P=0.270N P=0.126N P=0.313N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.200N P=0.309N P=0.121N P=0.309N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 52
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/48 (2%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 2.7% |2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 722 (T) --- 722 (T) |729 (T) --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.455 (e) P=0.411 |P=0.517N P=0.471N P=0.487 P=0.541N |
|POLY 3 | P=0.387 P=0.494 (e) P=0.485 |P=0.494N P=0.494N P=0.500 P=0.517N |
|POLY 1.5 | P=0.397 P=0.497 (e) P=0.492 |P=0.480N P=0.496N P=0.501 P=0.509N |
|POLY 6 | P=0.369 P=0.486 (e) P=0.471 |P=0.514N P=0.490N P=0.500 P=0.528N |
|LOGISTIC REGRESSION| (e) P=0.455 (e) P=0.411 |P=0.452N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.407 P=0.495 (e) P=0.500 |P=0.461N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 11/48 (23%) 9/50 (18%) 12/49 (24%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 33.8% 27.3% 21.8% 30.6% |4.5% 6.5% 6.7% 9.8% |
|TERMINAL (d) | 9/25 (36%) 5/20 (25%) 7/25 (28%) 4/16 (25%) |1/32 (3%) 2/37 (5%) 0/29 (0%) 2/26 (8%) |
|FIRST INCIDENCE | 574 642 632 444 |667 546 573 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.406 P=0.534N P=0.183N P=0.399 |P=0.181 P=0.541 P=0.479 P=0.246 |
|POLY 3 | P=0.430N P=0.346N P=0.162N P=0.476N |P=0.230 P=0.517 P=0.499 P=0.299 |
|POLY 1.5 | P=0.406N P=0.335N P=0.155N P=0.442N |P=0.249 P=0.511 P=0.500 P=0.316 |
|POLY 6 | P=0.475N P=0.381N P=0.184N P=0.540N |P=0.205 P=0.526 P=0.497 P=0.275 |
|LOGISTIC REGRESSION| P=0.490N P=0.370N P=0.169N P=0.507N |P=0.281 P=0.480 P=0.500 P=0.286 |
|COCH-ARM / FISHERS | P=0.378N P=0.343N P=0.157N P=0.410N |P=0.273 P=0.500 P=0.500 P=0.339 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 53
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/48 (2%) 0/50 (0%) 1/49 (2%) |2/50 (4%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.5% 0.0% 2.7% |4.4% 8.4% 0.0% 4.9% |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 2/26 (8%) |
|FIRST INCIDENCE | 722 (T) 444 --- 685 |493 488 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.649 P=0.745 P=0.500N P=0.678 |P=0.475N P=0.356 P=0.232N P=0.630 |
|POLY 3 | P=0.618N P=0.759 P=0.497N P=0.745 |P=0.434N P=0.360 P=0.244N P=0.656 |
|POLY 1.5 | P=0.616N P=0.760 P=0.496N P=0.752 |P=0.421N P=0.351 P=0.241N P=0.673 |
|POLY 6 | P=0.621N P=0.752 P=0.503N P=0.730 |P=0.453N P=0.374 P=0.248N P=0.632 |
|LOGISTIC REGRESSION| P=0.591N P=0.724 (e) P=0.726 |P=0.297N P=0.210 P=0.263N P=0.670N |
|COCH-ARM / FISHERS | P=0.614N P=0.747 P=0.495N P=0.753N |P=0.404N P=0.339 P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 666 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.457N P=0.261 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.414N P=0.245 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.409N P=0.242 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.421N P=0.250 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.412N P=0.236 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 54
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/48 (4%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.5% 5.0% 2.4% 0.0% |0.0% 2.2% 4.5% 2.5% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 309 604 589 --- |--- 546 549 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039N* P=0.378N P=0.195N P=0.087N |P=0.336 P=0.504 P=0.237 P=0.448 |
|POLY 3 | P=0.033N* P=0.364N P=0.184N P=0.077N |P=0.321 P=0.509 P=0.240 P=0.483 |
|POLY 1.5 | P=0.031N* P=0.354N P=0.179N P=0.069N |P=0.341 P=0.505 P=0.239 P=0.491 |
|POLY 6 | P=0.036N* P=0.385N P=0.194N P=0.090N |P=0.294 P=0.513 P=0.240 P=0.472 |
|LOGISTIC REGRESSION| P=0.020N* P=0.438N P=0.193N P=0.044N* |P=0.477 P=0.381 P=0.178 P=0.472 |
|COCH-ARM / FISHERS | P=0.029N* P=0.349N P=0.175N P=0.059N |P=0.366 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.3% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- 685 |--- --- --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * (e) (e) P=0.167 |P=0.195 (e) (e) P=0.491 |
|POLY 3 | P=0.043 * (e) (e) P=0.221 |P=0.188 (e) (e) P=0.485 |
|POLY 1.5 | P=0.044 * (e) (e) P=0.229 |P=0.192 (e) (e) P=0.492 |
|POLY 6 | P=0.041 * (e) (e) P=0.207 |P=0.181 (e) (e) P=0.476 |
|LOGISTIC REGRESSION| P=0.036 * (e) (e) P=0.200 |P=0.261 (e) (e) P=0.551 |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 55
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/49 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.3% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- 523 |503 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * (e) (e) P=0.189 |P=0.306N P=0.496N P=0.496N P=0.500N |
|POLY 3 | P=0.042 * (e) (e) P=0.219 |P=0.298N P=0.497N P=0.505N P=0.520N |
|POLY 1.5 | P=0.043 * (e) (e) P=0.226 |P=0.302N P=0.498N P=0.503N P=0.511N |
|POLY 6 | P=0.041 * (e) (e) P=0.207 |P=0.292N P=0.495N P=0.509N P=0.532N |
|LOGISTIC REGRESSION| P=0.051 (e) (e) P=0.242 |P=0.239N P=0.682N P=0.653N P=0.424N |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 8/49 (16%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 0.0% 20.0% |4.4% 2.2% 6.7% 4.8% |
|TERMINAL (d) | 0/25 (0%) 0/20 (0%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 1/37 (3%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 595 --- --- 194 |503 729 (T) 496 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.259N P=0.253N P=0.032 * |P=0.430 P=0.475N P=0.505 P=0.648 |
|POLY 3 | P<0.001 ** P=0.247N P=0.241N P=0.037 * |P=0.450 P=0.496N P=0.495 P=0.661 |
|POLY 1.5 | P<0.001 ** P=0.242N P=0.238N P=0.040 * |P=0.471 P=0.498N P=0.498 P=0.675 |
|POLY 6 | P<0.001 ** P=0.259N P=0.249N P=0.031 * |P=0.420 P=0.494N P=0.490 P=0.641 |
|LOGISTIC REGRESSION| P=0.002 ** P=0.246N P=0.239N P=0.052 |P=0.586N P=0.561N P=0.470 P=0.623N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.253N P=0.247N P=0.043 * |P=0.500 P=0.500N P=0.500 P=0.691N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 56
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 10/49 (20%) 3/50 (6%) 4/49 (8%) |3/50 (6%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 4.8% 24.0% 7.2% 10.3% |6.7% 6.4% 8.9% 9.6% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 595 538 609 194 |667 488 605 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522 P=0.013 * P=0.497 P=0.266 |P=0.286 P=0.640N P=0.481 P=0.387 |
|POLY 3 | P=0.536N P=0.012 * P=0.499 P=0.300 |P=0.336 P=0.639N P=0.499 P=0.461 |
|POLY 1.5 | P=0.510N P=0.013 * P=0.502 P=0.316 |P=0.359 P=0.648N P=0.501 P=0.478 |
|POLY 6 | P=0.540 P=0.010 * P=0.490 P=0.271 |P=0.307 P=0.628N P=0.497 P=0.436 |
|LOGISTIC REGRESSION| P=0.460N P=0.014 * P=0.491 P=0.366 |P=0.502 P=0.591 P=0.499 P=0.529 |
|COCH-ARM / FISHERS | P=0.493N P=0.013 * P=0.500 P=0.329 |P=0.389 P=0.661N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/49 (14%) 7/50 (14%) 11/49 (22%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 17.1% 16.3% 28.0% |4.5% 4.3% 4.5% 2.5% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 1/25 (4%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 625 604 538 598 |588 546 586 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.025 * P=0.037 * P<0.001 ** |P=0.448N P=0.673N P=0.672 P=0.571N |
|POLY 3 | P=0.002 ** P=0.027 * P=0.033 * P<0.001 ** |P=0.412N P=0.682N P=0.691 P=0.533N |
|POLY 1.5 | P=0.003 ** P=0.029 * P=0.032 * P<0.001 ** |P=0.395N P=0.687N P=0.693 P=0.519N |
|POLY 6 | P=0.002 ** P=0.024 * P=0.033 * P<0.001 ** |P=0.436N P=0.676N P=0.688 P=0.555N |
|LOGISTIC REGRESSION| P=0.004 ** P=0.031 * P=0.030 * P=0.002 ** |P=0.307N P=0.645 P=0.688 P=0.486N |
|COCH-ARM / FISHERS | P=0.004 ** P=0.028 * P=0.030 * P=0.002 ** |P=0.373N P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 57
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 17/49 (35%) 12/50 (24%) 12/49 (24%) |6/50 (12%) 9/50 (18%) 9/50 (18%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 33.2% 37.8% 27.1% 28.8% |13.2% 18.7% 19.6% 16.3% |
|TERMINAL (d) | 1/25 (4%) 1/20 (5%) 1/25 (4%) 0/16 (0%) |1/32 (3%) 1/37 (3%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 473 444 585 444 |636 488 580 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374N P=0.326 P=0.383N P=0.534N |P=0.340 P=0.351 P=0.282 P=0.369 |
|POLY 3 | P=0.270N P=0.407 P=0.344N P=0.416N |P=0.442 P=0.332 P=0.295 P=0.458 |
|POLY 1.5 | P=0.242N P=0.412 P=0.332N P=0.383N |P=0.473 P=0.314 P=0.293 P=0.477 |
|POLY 6 | P=0.318N P=0.378 P=0.366N P=0.477N |P=0.398 P=0.355 P=0.298 P=0.430 |
|LOGISTIC REGRESSION| P=0.155N P=0.363 P=0.333N P=0.304N |P=0.450N P=0.231 P=0.288 P=0.565 |
|COCH-ARM / FISHERS | P=0.209N P=0.388 P=0.326N P=0.349N |P=0.513 P=0.288 P=0.288 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 2/50 (4%) 8/49 (16%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.0% 4.9% 21.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/25 (0%) 2/20 (10%) 0/25 (0%) 3/16 (19%) |0/32 (0%) 0/37 (0%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- 722 (T) 679 622 |--- --- 561 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.190 P=0.218 P<0.001 ** |P=0.567 (e) P=0.229 (e) |
|POLY 3 | P<0.001 ** P=0.229 P=0.237 P=0.002 ** |P=0.539 (e) P=0.237 (e) |
|POLY 1.5 | P<0.001 ** P=0.233 P=0.238 P=0.003 ** |P=0.565 (e) P=0.238 (e) |
|POLY 6 | P<0.001 ** P=0.219 P=0.232 P=0.002 ** |P=0.503 (e) P=0.236 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.190 P=0.234 P=0.002 ** |P=0.635 (e) P=0.228 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.242 P=0.247 P=0.003 ** |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 58
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/49 (10%) 1/50 (2%) 1/49 (2%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 12.3% 2.4% 2.7% |2.2% 2.2% 6.7% 0.0% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 692 607 700 697 |503 546 573 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275N P=0.176 P=0.534N P=0.628N |P=0.450N P=0.756N P=0.303 P=0.500N |
|POLY 3 | P=0.219N P=0.209 P=0.503N P=0.535N |P=0.462N P=0.754N P=0.301 P=0.520N |
|POLY 1.5 | P=0.207N P=0.212 P=0.500N P=0.521N |P=0.439N P=0.757N P=0.304 P=0.511N |
|POLY 6 | P=0.241N P=0.198 P=0.513N P=0.558N |P=0.494N P=0.750N P=0.299 P=0.532N |
|LOGISTIC REGRESSION| P=0.211N P=0.208 P=0.506N P=0.549N |P=0.302N P=0.639 P=0.276 P=0.424N |
|COCH-ARM / FISHERS | P=0.198N P=0.210 P=0.500N P=0.508N |P=0.409N P=0.753N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/49 (0%) 0/48 (0%) | |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 1/25 (4%) 0/20 (0%) 0/25 (0%) 0/16 (0%) | |
|FIRST INCIDENCE | 695 --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142N P=0.293N P=0.251N P=0.334N | |
|POLY 3 | P=0.111N P=0.240N P=0.237N P=0.258N | |
|POLY 1.5 | P=0.113N P=0.236N P=0.236N P=0.250N | |
|POLY 6 | P=0.106N P=0.250N P=0.241N P=0.272N | |
|LOGISTIC REGRESSION| P=0.128N P=0.259N P=0.243N P=0.283N | |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 59
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 8/49 (16%) 9/49 (18%) 5/48 (10%) | |
|POLY-3 ADJUSTED (b)| 26.5% 19.4% 20.6% 12.9% | |
|TERMINAL (d) | 4/25 (16%) 3/20 (15%) 1/25 (4%) 0/16 (0%) | |
|FIRST INCIDENCE | 309 553 486 520 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.309N P=0.326N P=0.117N | |
|POLY 3 | P=0.089N P=0.295N P=0.340N P=0.098N | |
|POLY 1.5 | P=0.078N P=0.264N P=0.331N P=0.081N | |
|POLY 6 | P=0.105N P=0.344N P=0.352N P=0.123N | |
|LOGISTIC REGRESSION| P=0.034N* P=0.264N P=0.351N P=0.032N* | |
|COCH-ARM / FISHERS | P=0.061N P=0.226N P=0.312N P=0.059N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.6% |4.5% 2.2% 2.3% 4.9% |
|TERMINAL (d) | 0/25 (0%) 0/19 (0%) 0/23 (0%) 0/16 (0%) |2/32 (6%) 1/37 (3%) 1/29 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- 562 |729 (T) 729 (T) 729 (T) 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189 (e) (e) P=0.486 |P=0.463 P=0.449N P=0.535N P=0.617 |
|POLY 3 | P=0.194 (e) (e) P=0.488 |P=0.526 P=0.489N P=0.504N P=0.668 |
|POLY 1.5 | P=0.197 (e) (e) P=0.494 |P=0.538 P=0.494N P=0.501N P=0.679 |
|POLY 6 | P=0.189 (e) (e) P=0.478 |P=0.509 P=0.483N P=0.508N P=0.652 |
|LOGISTIC REGRESSION| P=0.228 (e) (e) P=0.522 |P=0.525 P=0.449N P=0.535N P=0.683 |
|COCH-ARM / FISHERS | P=0.200 (e) (e) P=0.500 |P=0.556 P=0.500N P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 60
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.5% 0.0% 2.6% |0.0% 6.5% 0.0% 2.4% |
|TERMINAL (d) | 0/25 (0%) 1/20 (5%) 0/25 (0%) 0/16 (0%) |0/32 (0%) 2/37 (5%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 309 722 (T) --- 523 |--- 695 --- 511 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.651N P=0.736 P=0.504N P=0.756 |P=0.578 P=0.147 (e) P=0.500 |
|POLY 3 | P=0.625N P=0.753 P=0.506N P=0.743 |P=0.611 P=0.125 (e) P=0.486 |
|POLY 1.5 | P=0.623N P=0.758 P=0.503N P=0.750 |P=0.622 P=0.122 (e) P=0.492 |
|POLY 6 | P=0.628N P=0.742 P=0.511N P=0.730 |P=0.594 P=0.128 (e) P=0.477 |
|LOGISTIC REGRESSION| P=0.643 P=0.669 P=0.455N P=0.556 |P=0.598N P=0.128 (e) P=0.574 |
|COCH-ARM / FISHERS | P=0.621N P=0.753N P=0.500N P=0.747 |P=0.634 P=0.121 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 3/50 (6%) 3/49 (6%) |16/50 (32%) 17/50 (34%) 13/50 (26%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 16.5% 12.1% 7.2% 7.8% |35.6% 36.8% 28.6% 24.3% |
|TERMINAL (d) | 2/25 (8%) 3/20 (15%) 1/25 (4%) 2/16 (13%) |14/32 (44%) 15/37 (41%) 9/29 (31%) 9/26 (35%) |
|FIRST INCIDENCE | 388 598 596 598 |622 650 521 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195N P=0.492N P=0.185N P=0.323N |P=0.236N P=0.486N P=0.423N P=0.280N |
|POLY 3 | P=0.125N P=0.398N P=0.164N P=0.196N |P=0.110N P=0.540 P=0.312N P=0.180N |
|POLY 1.5 | P=0.118N P=0.384N P=0.160N P=0.179N |P=0.089N P=0.524 P=0.317N P=0.153N |
|POLY 6 | P=0.139N P=0.432N P=0.174N P=0.229N |P=0.147N P=0.565 P=0.309N P=0.226N |
|LOGISTIC REGRESSION| P=0.111N P=0.379N P=0.160N P=0.167N |P=0.137N P=0.573 P=0.339N P=0.255N |
|COCH-ARM / FISHERS | P=0.111N P=0.380N P=0.159N P=0.167N |P=0.068N P=0.500 P=0.330N P=0.127N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 61
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.5% 2.4% 5.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 1/20 (5%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 662 651 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263 P=0.712 P=0.754 P=0.380 |(e) (e) (e) (e) |
|POLY 3 | P=0.331 P=0.758 P=0.761 P=0.477 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.339 P=0.760N P=0.760N P=0.487 |(e) (e) (e) (e) |
|POLY 6 | P=0.318 P=0.748 P=0.757 P=0.457 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.315 P=0.712 P=0.760 P=0.453 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.344 P=0.753N P=0.753N P=0.492 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 1/50 (2%) 2/49 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 12.3% 2.4% 5.2% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/25 (4%) 4/20 (20%) 0/25 (0%) 2/16 (13%) |1/32 (3%) 0/37 (0%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 722 (T) 700 640 722 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.058 P=0.757 P=0.345 |P=0.335N P=0.471N P=0.520N P=0.541N |
|POLY 3 | P=0.555N P=0.097 P=0.761N P=0.475 |P=0.300N P=0.494N P=0.502N P=0.517N |
|POLY 1.5 | P=0.541N P=0.101 P=0.759N P=0.486 |P=0.303N P=0.496N P=0.501N P=0.509N |
|POLY 6 | P=0.583N P=0.086 P=0.758 P=0.453 |P=0.294N P=0.490N P=0.504N P=0.528N |
|LOGISTIC REGRESSION| P=0.574 P=0.052 P=0.762 P=0.345 |P=0.335N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.532N P=0.102 P=0.753N P=0.492 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 62
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/47 (0%) 1/50 (2%) 1/49 (2%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.7% 0.0% 2.4% 2.7% |0.0% 6.6% 2.3% 4.9% |
|TERMINAL (d) | 2/25 (8%) 0/20 (0%) 0/25 (0%) 1/16 (6%) |0/32 (0%) 3/37 (8%) 1/29 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 692 --- 529 722 (T) |--- 729 (T) 729 (T) 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230N P=0.101N P=0.196N P=0.329N |P=0.257 P=0.147 P=0.480 P=0.212 |
|POLY 3 | P=0.165N P=0.069N P=0.177N P=0.210N |P=0.305 P=0.124 P=0.498 P=0.221 |
|POLY 1.5 | P=0.165N P=0.068N P=0.176N P=0.198N |P=0.319 P=0.122 P=0.499 P=0.228 |
|POLY 6 | P=0.165N P=0.075N P=0.182N P=0.233N |P=0.285 P=0.127 P=0.496 P=0.211 |
|LOGISTIC REGRESSION| P=0.173N P=0.080N P=0.179N P=0.259N |P=0.304 P=0.147 P=0.480 P=0.255 |
|COCH-ARM / FISHERS | P=0.164N P=0.066N P=0.181N P=0.187N |P=0.337 P=0.121 P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |0.0% 2.2% 2.3% 4.8% |
|TERMINAL (d) | |0/32 (0%) 0/37 (0%) 0/29 (0%) 1/26 (4%) |
|FIRST INCIDENCE | |--- 488 699 457 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.126 P=0.504 P=0.511 P=0.217 |
|POLY 3 | |P=0.137 P=0.509 P=0.498 P=0.222 |
|POLY 1.5 | |P=0.144 P=0.506 P=0.499 P=0.229 |
|POLY 6 | |P=0.126 P=0.514 P=0.497 P=0.212 |
|LOGISTIC REGRESSION| |P=0.242 P=0.289 P=0.499 P=0.287 |
|COCH-ARM / FISHERS | |P=0.153 P=0.500 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 05 Page 63
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 0/50 (0%) 5/50 (10%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| |13.4% 0.0% 11.2% 16.9% |
|TERMINAL (d) | |4/32 (13%) 0/37 (0%) 1/29 (3%) 5/26 (19%) |
|FIRST INCIDENCE | |671 --- 665 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.091 P=0.013N* P=0.526N P=0.355 |
|POLY 3 | |P=0.142 P=0.014N* P=0.504N P=0.442 |
|POLY 1.5 | |P=0.156 P=0.015N* P=0.501N P=0.468 |
|POLY 6 | |P=0.125 P=0.013N* P=0.509N P=0.404 |
|LOGISTIC REGRESSION| |P=0.147 P=0.016N* P=0.506N P=0.430 |
|COCH-ARM / FISHERS | |P=0.179 P=0.013N* P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 100 PPM 200 PPM 400 PPM |0 PPM 100 PPM 200 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.4% 0.0% 2.4% |
|TERMINAL (d) | |0/32 (0%) 2/37 (5%) 0/29 (0%) 0/26 (0%) |
|FIRST INCIDENCE | |--- 729 (T) --- 584 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.490 P=0.271 (e) P=0.491 |
|POLY 3 | |P=0.516 P=0.244 (e) P=0.485 |
|POLY 1.5 | |P=0.526 P=0.241 (e) P=0.492 |
|POLY 6 | |P=0.501 P=0.248 (e) P=0.476 |
|LOGISTIC REGRESSION| |P=0.553 P=0.271 (e) P=0.551 |
|COCH-ARM / FISHERS | |P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).