TDMS Study 55301-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: TSI Mason Research PYRIDINE DATE: 09/29/97
EXPERIMENT: 55301 TEST: 04 TIME: 09:11:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: F. VOELKER STEDHAM, MICHAEL CAS: 110-86-1
Mice(B6C3F1)
-----------------------------
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: 04 TIME: 09:11:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-95268 ROUTE: DOSED WATER NTP C#: 55301B
PATHOLOGIST: F. VOELKER STEDHAM, MICHAEL CAS: 110-86-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PYRIDINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Cytoplasmic Alteration
Adrenal Cortex: Capsule Hyperplasia
Brain Mineralization
Islets, Pancreatic Hyperplasia
Kidney Infarct
Kidney: Renal Tubule Dilatation
Pigmentation
Liver Basophilic Focus
Liver: Centrilobular Vacuolization Cytoplasmic
Lung Infiltration Cellular Lymphocyte
Nose: Olfactory Epithelium Degeneration Hyaline
Nose: Respiratory Epithelium Degeneration Hyaline
Hyperplasia
Spleen Hematopoietic Cell Proliferation
Thymus Atrophy
Thyroid Gland: Follicular Cell Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Fibrous Osteodystrophy
Clitoral Gland Cyst
Islets, Pancreatic Hyperplasia
Liver Eosinophilic Focus
Infiltration Cellular Lymphocyte
Mixed Cell Focus
Lung: Alveolar Epithelium Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Nose: Respiratory Epithelium Degeneration Hyaline
Hyperplasia
Salivary Glands Infiltration Cellular Lymphocyte
Spleen Hematopoietic Cell Proliferation
Thyroid Gland: Follicle Cyst
Thyroid Gland: Follicular Cell Hyperplasia
Urinary Bladder Infiltration Cellular Lymphocyte
Uterus Hyperplasia Cystic
===============================================================
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/49 (37%) 13/49 (27%) 9/49 (18%) 11/49 (22%) |2/49 (4%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 40.5% 30.9% 21.3% 26.1% |4.8% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 16/35 (46%) 9/27 (33%) 9/34 (27%) 11/34 (32%) |2/32 (6%) 0/30 (0%) 0/22 (0%) 2/29 (7%) |
|FIRST INCIDENCE | 598 522 722 (T) 722 (T) |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.461N P=0.037N* P=0.098N |P=0.464 P=0.252N P=0.324N P=0.660 |
|POLY 3 | P=0.079N P=0.236N P=0.041N* P=0.114N |P=0.495 P=0.244N P=0.256N P=0.666 |
|POLY 1.5 | P=0.083N P=0.222N P=0.039N* P=0.116N |P=0.498 P=0.243N P=0.254N P=0.672 |
|POLY 6 | P=0.073N P=0.257N P=0.043N* P=0.108N |P=0.492 P=0.245N P=0.262N P=0.660 |
|LOGISTIC REGRESSION| P=0.067N P=0.258N P=0.039N* P=0.090N |P=0.464 (e) (e) P=0.660 |
|COCH-ARM / FISHERS | P=0.072N P=0.193N P=0.035N* P=0.092N |P=0.503 P=0.242N P=0.253N P=0.684N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 0/50 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.4% 0.0% 0.0% 5.1% |
|TERMINAL (d) | 0/35 (0%) 0/27 (0%) 0/34 (0%) 0/34 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- --- --- |476 --- --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.228 P=0.513N P=0.509N P=0.463 |
|POLY 3 | (e) (e) (e) (e) |P=0.240 P=0.510N P=0.521N P=0.469 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.242 P=0.508N P=0.517N P=0.476 |
|POLY 6 | (e) (e) (e) (e) |P=0.238 P=0.512N P=0.526N P=0.464 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.253 P=0.447N P=0.455N P=0.521 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.249 P=0.495N P=0.505N P=0.508 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/49 (2%) 2/49 (4%) 0/49 (0%) |1/49 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.5% 4.7% 0.0% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 1/27 (4%) 2/34 (6%) 0/34 (0%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193N P=0.591N P=0.685 P=0.245N |P=0.327N P=0.513N P=0.575N P=0.520N |
|POLY 3 | P=0.202N P=0.526N P=0.683 P=0.245N |P=0.294N P=0.506N P=0.517N P=0.516N |
|POLY 1.5 | P=0.206N P=0.517N P=0.685 P=0.247N |P=0.296N P=0.506N P=0.515N P=0.512N |
|POLY 6 | P=0.194N P=0.538N P=0.682 P=0.241N |P=0.294N P=0.507N P=0.522N P=0.519N |
|LOGISTIC REGRESSION| P=0.193N P=0.591N P=0.685 (e) |P=0.327N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.691N P=0.247N |P=0.305N P=0.495N P=0.505N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/27 (0%) 0/34 (0%) 0/34 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 663 --- --- 709 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.280N P=0.252N P=0.497N |(e) (e) (e) (e) |
|POLY 3 | P=0.449N P=0.255N P=0.245N P=0.513N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.453N P=0.249N P=0.243N P=0.515N |(e) (e) (e) (e) |
|POLY 6 | P=0.444N P=0.264N P=0.247N P=0.509N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.465N P=0.247N P=0.241N P=0.511N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/49 (86%) 29/49 (59%) 30/49 (61%) 29/49 (59%) |41/49 (84%) 35/50 (70%) 39/48 (81%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 89.3% 65.7% 67.7% 67.2% |90.7% 81.3% 92.7% 87.8% |
|TERMINAL (d) | 32/35 (91%) 19/27 (70%) 24/34 (71%) 25/34 (74%) |30/32 (94%) 27/30 (90%) 22/22 (100%) 27/29 (93%) |
|FIRST INCIDENCE | 520 522 513 624 |554 573 417 510 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013N* P=0.201N P=0.028N* P=0.012N* |P=0.346 P=0.299N P=0.059 P=0.574 |
|POLY 3 | P=0.021N* P=0.004N** P=0.007N** P=0.007N** |P=0.554 P=0.152N P=0.520 P=0.458N |
|POLY 1.5 | P=0.022N* P=0.003N** P=0.006N** P=0.006N** |P=0.508N P=0.137N P=0.554 P=0.383N |
|POLY 6 | P=0.020N* P=0.005N** P=0.009N** P=0.007N** |P=0.500 P=0.183N P=0.447 P=0.531N |
|LOGISTIC REGRESSION| P=0.015N* P=0.006N** P=0.007N** P=0.004N** |P=0.492 P=0.127N P=0.539 P=0.470N |
|COCH-ARM / FISHERS | P=0.014N* P=0.003N** P=0.006N** P=0.003N** |P=0.285N P=0.084N P=0.481N P=0.176N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 2/49 (4%) 0/45 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.4% 5.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/27 (0%) 0/34 (0%) 0/34 (0%) |1/32 (3%) 2/30 (7%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.217N P=0.477 P=0.575N P=0.520N |
|POLY 3 | (e) (e) (e) (e) |P=0.208N P=0.482 P=0.531N P=0.520N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.206N P=0.483 P=0.529N P=0.517N |
|POLY 6 | (e) (e) (e) (e) |P=0.211N P=0.481 P=0.534N P=0.523N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.217N P=0.477 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.192N P=0.500 P=0.521N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 5/50 (10%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 12.3% 5.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 4/30 (13%) 1/22 (5%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 680 696 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.325N P=0.028 * P=0.187 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.334N P=0.026 * P=0.221 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.324N P=0.027 * P=0.225 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.344N P=0.026 * P=0.215 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.318N P=0.028 * P=0.215 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.279N P=0.028 * P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 0.0% |2.4% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |1/32 (3%) 1/30 (3%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.288N P=0.245N P=0.238N |P=0.263N P=0.748 P=0.575N P=0.520N |
|POLY 3 | P=0.107N P=0.248N P=0.244N P=0.239N |P=0.241N P=0.754 P=0.511N P=0.516N |
|POLY 1.5 | P=0.108N P=0.243N P=0.243N P=0.242N |P=0.239N P=0.754 P=0.509N P=0.512N |
|POLY 6 | P=0.105N P=0.256N P=0.244N P=0.236N |P=0.243N P=0.753 P=0.517N P=0.519N |
|LOGISTIC REGRESSION| P=0.113N (e) (e) (e) |P=0.263N P=0.748 (e) (e) |
|COCH-ARM / FISHERS | P=0.114N P=0.242N P=0.247N P=0.242N |P=0.234N P=0.747N P=0.500N P=0.495N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.4% 0.0% 2.3% |2.4% 0.0% 0.0% 5.1% |
|TERMINAL (d) | 1/35 (3%) 1/28 (4%) 0/34 (0%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) --- 722 (T) |568 --- --- 510 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.712 P=0.506N P=0.762 |P=0.232 P=0.505N P=0.509N P=0.472 |
|POLY 3 | P=0.613N P=0.750 P=0.506N P=0.758 |P=0.243 P=0.509N P=0.514N P=0.476 |
|POLY 1.5 | P=0.614N P=0.755 P=0.505N P=0.756 |P=0.244 P=0.507N P=0.510N P=0.481 |
|POLY 6 | P=0.611N P=0.742 P=0.507N P=0.760N |P=0.241 P=0.511N P=0.521N P=0.472 |
|LOGISTIC REGRESSION| P=0.597N P=0.712 (e) P=0.762 |P=0.262 P=0.474N P=0.479N P=0.542 |
|COCH-ARM / FISHERS | P=0.612N P=0.747N P=0.500N P=0.747N |P=0.249 P=0.495N P=0.500N P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 27/50 (54%) 30/49 (61%) 35/50 (70%) |25/50 (50%) 27/50 (54%) 18/50 (36%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 84.7% 58.5% 65.8% 77.8% |55.2% 62.5% 41.9% 45.1% |
|TERMINAL (d) | 30/35 (86%) 16/28 (57%) 20/34 (59%) 27/35 (77%) |17/32 (53%) 18/30 (60%) 7/22 (32%) 11/29 (38%) |
|FIRST INCIDENCE | 520 237 514 594 |476 372 417 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239N P=0.119N P=0.067N P=0.182N |P=0.204N P=0.321 P=0.467N P=0.311N |
|POLY 3 | P=0.469N P=0.003N** P=0.025N* P=0.273N |P=0.094N P=0.313 P=0.147N P=0.232N |
|POLY 1.5 | P=0.464N P=0.002N** P=0.023N* P=0.250N |P=0.089N P=0.322 P=0.142N P=0.219N |
|POLY 6 | P=0.453N P=0.004N** P=0.027N* P=0.286N |P=0.102N P=0.300 P=0.161N P=0.248N |
|LOGISTIC REGRESSION| P=0.394N P=0.004N** P=0.024N* P=0.195N |P=0.100N P=0.327 P=0.147N P=0.222N |
|COCH-ARM / FISHERS | P=0.321N P=0.002N** P=0.019N* P=0.121N |P=0.065N P=0.421 P=0.113N P=0.157N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |45/47 (96%) 43/48 (90%) 45/48 (94%) 43/45 (96%) |
|POLY-3 ADJUSTED (b)| |97.5% 97.7% 100.0% 99.7% |
|TERMINAL (d) | |29/30 (97%) 28/29 (97%) 21/21 (100%) 27/27 (100%) |
|FIRST INCIDENCE | |64 372 417 188 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.253 P=0.562N P=0.053 P=0.385 |
|POLY 3 | |P=0.253 P=0.743 P=0.457 P=0.513 |
|POLY 1.5 | |P=0.277 P=0.711 P=0.419 P=0.517 |
|POLY 6 | |P=0.245 P=0.754N P=0.497 P=0.513 |
|LOGISTIC REGRESSION| |P=0.401 P=0.413N P=0.677N P=0.661 |
|COCH-ARM / FISHERS | |P=0.445 P=0.226N P=0.510N P=0.675N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/47 (6%) 0/48 (0%) 0/48 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| |7.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |3/30 (10%) 0/29 (0%) 0/21 (0%) 0/27 (0%) |
|FIRST INCIDENCE | |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.061N P=0.126N P=0.189N P=0.139N |
|POLY 3 | |P=0.044N* P=0.122N P=0.123N P=0.137N |
|POLY 1.5 | |P=0.044N* P=0.122N P=0.121N P=0.134N |
|POLY 6 | |P=0.045N* P=0.121N P=0.129N P=0.139N |
|LOGISTIC REGRESSION| |P=0.061N (e) (e) (e) |
|COCH-ARM / FISHERS | |P=0.048N* P=0.117N P=0.117N P=0.129N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |4/47 (9%) 2/48 (4%) 4/48 (8%) 4/45 (9%) |
|POLY-3 ADJUSTED (b)| |10.0% 5.1% 10.0% 11.1% |
|TERMINAL (d) | |4/30 (13%) 2/29 (7%) 1/21 (5%) 4/27 (15%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 417 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.388 P=0.351N P=0.500 P=0.587 |
|POLY 3 | |P=0.410 P=0.346N P=0.643N P=0.587 |
|POLY 1.5 | |P=0.421 P=0.347N P=0.640N P=0.596 |
|POLY 6 | |P=0.402 P=0.345N P=0.638 P=0.580 |
|LOGISTIC REGRESSION| |P=0.412 P=0.351N P=0.641N P=0.587 |
|COCH-ARM / FISHERS | |P=0.434 P=0.329N P=0.631N P=0.618 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/47 (4%) 0/48 (0%) 1/48 (2%) 3/45 (7%) |
|POLY-3 ADJUSTED (b)| |5.0% 0.0% 2.6% 8.2% |
|TERMINAL (d) | |2/30 (7%) 0/29 (0%) 1/21 (5%) 2/27 (7%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) 615 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.209 P=0.245N P=0.624N P=0.450 |
|POLY 3 | |P=0.219 P=0.241N P=0.510N P=0.458 |
|POLY 1.5 | |P=0.223 P=0.242N P=0.505N P=0.464 |
|POLY 6 | |P=0.217 P=0.241N P=0.522N P=0.457 |
|LOGISTIC REGRESSION| |P=0.209 (e) P=0.624N P=0.454 |
|COCH-ARM / FISHERS | |P=0.225 P=0.242N P=0.492N P=0.479 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 4/49 (8%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 2.2% 9.6% 9.5% 9.1% | |
|TERMINAL (d) | 1/35 (3%) 3/28 (11%) 4/34 (12%) 2/35 (6%) | |
|FIRST INCIDENCE | 722 (T) 692 722 (T) 624 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238 P=0.124 P=0.170 P=0.186 | |
|POLY 3 | P=0.198 P=0.158 P=0.163 P=0.172 | |
|POLY 1.5 | P=0.190 P=0.165 P=0.165 P=0.169 | |
|POLY 6 | P=0.213 P=0.149 P=0.161 P=0.180 | |
|LOGISTIC REGRESSION| P=0.207 P=0.136 P=0.170 P=0.171 | |
|COCH-ARM / FISHERS | P=0.205 P=0.181 P=0.175 P=0.181 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 2.2% 2.4% 0.0% 7.0% | |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 0/34 (0%) 3/35 (9%) | |
|FIRST INCIDENCE | 706 722 (T) --- 722 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 P=0.708 P=0.505N P=0.304 | |
|POLY 3 | P=0.158 P=0.744 P=0.511N P=0.293 | |
|POLY 1.5 | P=0.156 P=0.750 P=0.509N P=0.291 | |
|POLY 6 | P=0.161 P=0.736 P=0.512N P=0.297 | |
|LOGISTIC REGRESSION| P=0.174 P=0.733 P=0.510N P=0.304 | |
|COCH-ARM / FISHERS | P=0.160 P=0.753N P=0.505N P=0.309 | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.0% 0.0% 0.0% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 546 --- --- |--- --- 692 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.110 (e) (e) |P=0.677 (e) P=0.483 (e) |
|POLY 3 | P=0.325N P=0.111 (e) (e) |P=0.659 (e) P=0.486 (e) |
|POLY 1.5 | P=0.325N P=0.113 (e) (e) |P=0.666 (e) P=0.489 (e) |
|POLY 6 | P=0.324N P=0.109 (e) (e) |P=0.656 (e) P=0.480 (e) |
|LOGISTIC REGRESSION| P=0.283N P=0.138 (e) (e) |P=0.686 (e) P=0.490 (e) |
|COCH-ARM / FISHERS | P=0.312N P=0.121 (e) (e) |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 598 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.280N P=0.248N P=0.245N |(e) (e) (e) (e) |
|POLY 3 | P=0.108N P=0.256N P=0.251N P=0.247N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.110N P=0.249N P=0.249N P=0.248N |(e) (e) (e) (e) |
|POLY 6 | P=0.106N P=0.265N P=0.253N P=0.244N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.114N P=0.231N P=0.236N P=0.232N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.253N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum: Lymphoid Tissue |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/44 (0%) 2/42 (5%) 1/45 (2%) |0/44 (0%) 0/49 (0%) 0/40 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.3% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 2/34 (6%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) 722 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265 (e) P=0.232 P=0.500 |(e) (e) (e) (e) |
|POLY 3 | P=0.244 (e) P=0.212 P=0.490 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.234 (e) P=0.210 P=0.486 |(e) (e) (e) (e) |
|POLY 6 | P=0.258 (e) P=0.216 P=0.496 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.232 P=0.500 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.241 (e) P=0.220 P=0.489 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/40 (3%) 1/46 (2%) 3/42 (7%) 1/44 (2%) |1/42 (2%) 0/47 (0%) 0/38 (0%) 0/43 (0%) |
|POLY-3 ADJUSTED (b)| 2.7% 2.6% 8.0% 2.5% |2.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 1/28 (4%) 3/33 (9%) 1/35 (3%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 722 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.712 P=0.284 P=0.762 |P=0.327N P=0.513N P=0.575N P=0.520N |
|POLY 3 | P=0.580 P=0.757N P=0.304 P=0.746N |P=0.289N P=0.497N P=0.527N P=0.522N |
|POLY 1.5 | P=0.570 P=0.748N P=0.306 P=0.747N |P=0.294N P=0.493N P=0.524N P=0.514N |
|POLY 6 | P=0.589 P=0.753 P=0.301 P=0.746N |P=0.285N P=0.503N P=0.534N P=0.528N |
|LOGISTIC REGRESSION| P=0.578 P=0.712 P=0.284 P=0.762 |P=0.327N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.575 P=0.717N P=0.327 P=0.729N |P=0.310N P=0.472N P=0.525N P=0.494N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 5/50 (10%) 2/48 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 2/47 (4%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 11.7% 4.8% 0.0% |0.0% 0.0% 5.2% 7.8% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 2/34 (6%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 2/22 (9%) 1/29 (3%) |
|FIRST INCIDENCE | --- 561 722 (T) --- |--- --- 729 (T) 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.272N P=0.027 * P=0.232 (e) |P=0.025 * (e) P=0.160 P=0.106 |
|POLY 3 | P=0.292N P=0.028 * P=0.227 (e) |P=0.022 * (e) P=0.217 P=0.103 |
|POLY 1.5 | P=0.295N P=0.030 * P=0.227 (e) |P=0.023 * (e) P=0.220 P=0.105 |
|POLY 6 | P=0.285N P=0.027 * P=0.227 (e) |P=0.022 * (e) P=0.211 P=0.103 |
|LOGISTIC REGRESSION| P=0.277N P=0.037 * P=0.232 (e) |P=0.023 * (e) P=0.160 P=0.112 |
|COCH-ARM / FISHERS | P=0.276N P=0.030 * P=0.242 (e) |P=0.028 * (e) P=0.237 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/50 (4%) 4/48 (8%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 9.1% 4.8% 9.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/35 (9%) 2/28 (7%) 4/34 (12%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 542 722 (T) 722 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071N P=0.429N P=0.625 P=0.067N |(e) (e) (e) (e) |
|POLY 3 | P=0.077N P=0.366N P=0.610 P=0.063N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.080N P=0.353N P=0.615 P=0.064N |(e) (e) (e) (e) |
|POLY 6 | P=0.072N P=0.385N P=0.607 P=0.062N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.077N P=0.347N P=0.621 P=0.061N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.076N P=0.329N P=0.631 P=0.056N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 2/48 (4%) 6/50 (12%) |1/49 (2%) 2/50 (4%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 2.4% 4.8% 13.9% |2.4% 4.9% 2.6% 0.0% |
|TERMINAL (d) | 2/35 (6%) 1/28 (4%) 2/34 (6%) 5/35 (14%) |1/32 (3%) 2/30 (7%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 699 |729 (T) 729 (T) 699 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.578N P=0.685 P=0.135 |P=0.283N P=0.477 P=0.701 P=0.520N |
|POLY 3 | P=0.034 * P=0.517N P=0.677 P=0.129 |P=0.271N P=0.489 P=0.745 P=0.516N |
|POLY 1.5 | P=0.032 * P=0.509N P=0.678 P=0.127 |P=0.266N P=0.490 P=0.748 P=0.512N |
|POLY 6 | P=0.036 * P=0.529N P=0.678 P=0.134 |P=0.276N P=0.487 P=0.738 P=0.519N |
|LOGISTIC REGRESSION| P=0.042 * P=0.578N P=0.685 P=0.139 |P=0.274N P=0.477 P=0.740 (e) |
|COCH-ARM / FISHERS | P=0.035 * P=0.492N P=0.684 P=0.141 |P=0.249N P=0.508 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 2/48 (4%) 6/50 (12%) |4/49 (8%) 2/50 (4%) 5/49 (10%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.4% 4.8% 13.6% |9.5% 4.9% 12.6% 5.2% |
|TERMINAL (d) | 3/35 (9%) 1/28 (4%) 2/34 (6%) 5/35 (14%) |3/32 (9%) 1/30 (3%) 4/22 (18%) 1/29 (3%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 406 |670 642 417 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.387N P=0.513N P=0.240 |P=0.434N P=0.369N P=0.315 P=0.388N |
|POLY 3 | P=0.085 P=0.323N P=0.521N P=0.245 |P=0.408N P=0.350N P=0.463 P=0.375N |
|POLY 1.5 | P=0.080 P=0.314N P=0.520N P=0.239 |P=0.397N P=0.349N P=0.471 P=0.366N |
|POLY 6 | P=0.091 P=0.335N P=0.521N P=0.255 |P=0.418N P=0.351N P=0.443 P=0.383N |
|LOGISTIC REGRESSION| P=0.079 P=0.387N P=0.513N P=0.241 |P=0.396N P=0.349N P=0.471 P=0.378N |
|COCH-ARM / FISHERS | P=0.082 P=0.301N P=0.510N P=0.254 |P=0.370N P=0.329N P=0.500 P=0.339N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 633 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.116N P=0.259N P=0.251N P=0.237N |(e) (e) (e) (e) |
|POLY 3 | P=0.107N P=0.251N P=0.250N P=0.242N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.109N P=0.244N P=0.248N P=0.243N |(e) (e) (e) (e) |
|POLY 6 | P=0.104N P=0.261N P=0.252N P=0.241N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.112N P=0.224N P=0.235N P=0.225N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.242N P=0.253N P=0.242N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 3/50 (6%) 0/48 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 7.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 542 546 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.449 P=0.256N P=0.244N |(e) (e) (e) (e) |
|POLY 3 | P=0.076N P=0.476 P=0.252N P=0.243N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.076N P=0.488 P=0.249N P=0.244N |(e) (e) (e) (e) |
|POLY 6 | P=0.076N P=0.461 P=0.254N P=0.242N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.066N P=0.536 P=0.220N P=0.204N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.072N P=0.510 P=0.253N P=0.242N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/49 (69%) 27/50 (54%) 25/48 (52%) 32/50 (64%) |5/49 (10%) 10/50 (20%) 7/49 (14%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| 73.8% 61.7% 59.5% 73.2% |11.9% 24.6% 17.8% 20.5% |
|TERMINAL (d) | 28/35 (80%) 20/28 (71%) 23/34 (68%) 29/35 (83%) |4/32 (13%) 9/30 (30%) 4/22 (18%) 7/29 (24%) |
|FIRST INCIDENCE | 520 532 630 594 |691 680 659 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.496N P=0.063N P=0.418N |P=0.277 P=0.101 P=0.196 P=0.210 |
|POLY 3 | P=0.493 P=0.149N P=0.107N P=0.570N |P=0.295 P=0.112 P=0.331 P=0.227 |
|POLY 1.5 | P=0.504 P=0.122N P=0.089N P=0.539N |P=0.311 P=0.115 P=0.341 P=0.237 |
|POLY 6 | P=0.486 P=0.190N P=0.131N P=0.603N |P=0.282 P=0.108 P=0.314 P=0.219 |
|LOGISTIC REGRESSION| P=0.432N P=0.154N P=0.070N P=0.432N |P=0.284 P=0.107 P=0.299 P=0.214 |
|COCH-ARM / FISHERS | P=0.451N P=0.086N P=0.062N P=0.361N |P=0.363 P=0.140 P=0.380 P=0.276 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.6% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.288N P=0.245N P=0.238N |(e) (e) (e) (e) |
|POLY 3 | P=0.107N P=0.248N P=0.248N P=0.239N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.109N P=0.243N P=0.247N P=0.242N |(e) (e) (e) (e) |
|POLY 6 | P=0.105N P=0.256N P=0.247N P=0.236N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.113N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.242N P=0.253N P=0.242N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/48 (4%) 5/50 (10%) |0/49 (0%) 1/50 (2%) 2/49 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 4.7% 10.8% |0.0% 2.4% 4.9% 5.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 645 3 3 |--- 4 3 15 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.485 P=0.240 P=0.036 * |P=0.158 P=0.500 P=0.237 P=0.228 |
|POLY 3 | P=0.009 ** P=0.491 P=0.234 P=0.036 * |P=0.150 P=0.499 P=0.231 P=0.229 |
|POLY 1.5 | P=0.008 ** P=0.496 P=0.233 P=0.035 * |P=0.153 P=0.499 P=0.234 P=0.232 |
|POLY 6 | P=0.010 * P=0.486 P=0.235 P=0.038 * |P=0.148 P=0.498 P=0.225 P=0.228 |
|LOGISTIC REGRESSION| P=0.020 * P=0.513 P=0.314 P=0.082 |P=0.168 (e) P=0.452 P=0.345 |
|COCH-ARM / FISHERS | P=0.008 ** P=0.505 P=0.242 P=0.030 * |P=0.158 P=0.505 P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 1/48 (2%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 6.9% 0.0% 2.4% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/35 (9%) 0/28 (0%) 0/34 (0%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) --- 657 722 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N P=0.162N P=0.317N P=0.305N |(e) (e) (e) (e) |
|POLY 3 | P=0.284N P=0.128N P=0.320N P=0.309N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.290N P=0.123N P=0.320N P=0.312N |(e) (e) (e) (e) |
|POLY 6 | P=0.275N P=0.134N P=0.317N P=0.303N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.291N (e) P=0.321N P=0.305N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.117N P=0.316N P=0.301N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 5/50 (10%) 3/48 (6%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 3/49 (6%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 12.0% 7.1% 4.6% |0.0% 0.0% 7.6% 5.2% |
|TERMINAL (d) | 0/35 (0%) 4/28 (14%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 1/22 (5%) 1/29 (3%) |
|FIRST INCIDENCE | --- 692 526 624 |--- --- 583 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 P=0.019 * P=0.117 P=0.243 |P=0.086 (e) P=0.097 P=0.220 |
|POLY 3 | P=0.445 P=0.026 * P=0.113 P=0.237 |P=0.081 (e) P=0.109 P=0.221 |
|POLY 1.5 | P=0.436 P=0.028 * P=0.113 P=0.234 |P=0.084 (e) P=0.110 P=0.224 |
|POLY 6 | P=0.461 P=0.024 * P=0.115 P=0.242 |P=0.079 (e) P=0.106 P=0.218 |
|LOGISTIC REGRESSION| P=0.455 P=0.023 * P=0.123 P=0.242 |P=0.091 (e) P=0.120 P=0.221 |
|COCH-ARM / FISHERS | P=0.462 P=0.030 * P=0.117 P=0.253 |P=0.095 (e) P=0.121 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.7% 2.4% 0.0% 0.0% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 663 680 --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044N* P=0.368N P=0.131N P=0.122N |P=0.327N P=0.513N P=0.575N P=0.520N |
|POLY 3 | P=0.042N* P=0.332N P=0.129N P=0.125N |P=0.293N P=0.506N P=0.510N P=0.516N |
|POLY 1.5 | P=0.043N* P=0.322N P=0.128N P=0.127N |P=0.294N P=0.506N P=0.507N P=0.512N |
|POLY 6 | P=0.041N* P=0.344N P=0.130N P=0.123N |P=0.293N P=0.507N P=0.517N P=0.519N |
|LOGISTIC REGRESSION| P=0.046N* P=0.325N P=0.129N P=0.126N |P=0.327N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.044N* P=0.309N P=0.125N P=0.121N |P=0.303N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/49 (2%) 2/50 (4%) |1/49 (2%) 5/50 (10%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.2% 7.1% 2.4% 4.6% |2.4% 12.4% 2.5% 5.2% |
|TERMINAL (d) | 1/35 (3%) 1/28 (4%) 1/34 (3%) 2/35 (6%) |1/32 (3%) 5/30 (17%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | 722 (T) 587 722 (T) 722 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544 P=0.256 P=0.755 P=0.500 |P=0.578N P=0.087 P=0.676 P=0.465 |
|POLY 3 | P=0.510 P=0.287 P=0.749 P=0.489 |P=0.567N P=0.093 P=0.749 P=0.472 |
|POLY 1.5 | P=0.506 P=0.293 P=0.750 P=0.486 |P=0.557N P=0.094 P=0.753 P=0.479 |
|POLY 6 | P=0.518 P=0.280 P=0.748 P=0.494 |P=0.578N P=0.091 P=0.742 P=0.467 |
|LOGISTIC REGRESSION| P=0.518 P=0.314 P=0.755 P=0.500 |P=0.578N P=0.087 P=0.676 P=0.465 |
|COCH-ARM / FISHERS | P=0.525 P=0.309 P=0.747 P=0.500 |P=0.516N P=0.107 P=0.747N P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 22/50 (44%) 18/49 (37%) 15/50 (30%) |17/49 (35%) 12/50 (24%) 14/50 (28%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 41.7% 49.1% 40.3% 34.5% |38.4% 29.0% 34.6% 22.0% |
|TERMINAL (d) | 15/35 (43%) 12/28 (43%) 13/34 (38%) 13/35 (37%) |12/32 (38%) 9/30 (30%) 8/22 (36%) 5/29 (17%) |
|FIRST INCIDENCE | 633 522 513 649 |375 599 678 479 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.147 P=0.545N P=0.266N |P=0.139N P=0.256N P=0.471 P=0.109N |
|POLY 3 | P=0.185N P=0.309 P=0.531N P=0.313N |P=0.082N P=0.244N P=0.445N P=0.076N |
|POLY 1.5 | P=0.192N P=0.313 P=0.541N P=0.318N |P=0.077N P=0.231N P=0.407N P=0.071N |
|POLY 6 | P=0.174N P=0.309 P=0.517N P=0.304N |P=0.084N P=0.254N P=0.494N P=0.078N |
|LOGISTIC REGRESSION| P=0.170N P=0.273 P=0.566N P=0.277N |P=0.079N P=0.201N P=0.369N P=0.056N |
|COCH-ARM / FISHERS | P=0.152N P=0.342 P=0.531N P=0.263N |P=0.057N P=0.172N P=0.308N P=0.048N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.4% 0.0% |4.7% 2.5% 2.5% 2.6% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 1/34 (3%) 0/35 (0%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | --- 722 (T) 722 (T) --- |568 680 708 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579N P=0.455 P=0.494 (e) |P=0.451N P=0.520N P=0.578N P=0.534N |
|POLY 3 | P=0.605N P=0.486 P=0.490 (e) |P=0.425N P=0.514N P=0.522N P=0.532N |
|POLY 1.5 | P=0.606N P=0.491 P=0.491 (e) |P=0.420N P=0.511N P=0.514N P=0.524N |
|POLY 6 | P=0.601N P=0.479 P=0.489 (e) |P=0.432N P=0.517N P=0.534N P=0.539N |
|LOGISTIC REGRESSION| (e) P=0.455 P=0.494 (e) |P=0.421N P=0.495N P=0.499N P=0.509N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.495 (e) |P=0.404N P=0.492N P=0.492N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |4/49 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |9.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |2/32 (6%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- --- --- |375 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.027N* P=0.074N P=0.098N P=0.078N |
|POLY 3 | (e) (e) (e) (e) |P=0.016N* P=0.067N P=0.070N P=0.074N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.016N* P=0.066N P=0.067N P=0.071N |
|POLY 6 | (e) (e) (e) (e) |P=0.016N* P=0.069N P=0.076N P=0.078N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.018N* P=0.055N P=0.055N P=0.054N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.020N* P=0.056N P=0.056N P=0.056N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |5/49 (10%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.0% 4.8% 2.4% 2.3% |11.8% 9.9% 7.5% 0.0% |
|TERMINAL (d) | 4/35 (11%) 1/28 (4%) 1/34 (3%) 1/35 (3%) |3/32 (9%) 4/30 (13%) 2/22 (9%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 587 722 (T) 722 (T) |644 729 (T) 700 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.104N P=0.431N P=0.187N P=0.178N |P=0.036N* P=0.546N P=0.522N P=0.047N* |
|POLY 3 | P=0.112N P=0.365N P=0.194N P=0.188N |P=0.027N* P=0.527N P=0.389N P=0.038N* |
|POLY 1.5 | P=0.115N P=0.356N P=0.193N P=0.191N |P=0.025N* P=0.521N P=0.378N P=0.036N* |
|POLY 6 | P=0.108N P=0.377N P=0.195N P=0.183N |P=0.029N* P=0.536N P=0.410N P=0.041N* |
|LOGISTIC REGRESSION| P=0.114N P=0.368N P=0.187N P=0.178N |P=0.028N* P=0.522N P=0.391N P=0.039N* |
|COCH-ARM / FISHERS | P=0.112N P=0.339N P=0.187N P=0.181N |P=0.021N* P=0.487N P=0.346N P=0.027N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 7/49 (14%) 6/50 (12%) |5/49 (10%) 2/50 (4%) 5/50 (10%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 6.6% 11.6% 15.8% 13.4% |11.7% 4.9% 12.3% 17.3% |
|TERMINAL (d) | 1/35 (3%) 1/28 (4%) 2/34 (6%) 2/35 (6%) |2/32 (6%) 2/30 (7%) 1/22 (5%) 4/29 (14%) |
|FIRST INCIDENCE | 574 532 514 432 |568 729 (T) 632 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 P=0.305 P=0.157 P=0.245 |P=0.139 P=0.251N P=0.512 P=0.317 |
|POLY 3 | P=0.201 P=0.327 P=0.146 P=0.232 |P=0.158 P=0.238N P=0.601 P=0.337 |
|POLY 1.5 | P=0.191 P=0.336 P=0.145 P=0.227 |P=0.162 P=0.233N P=0.609 P=0.347 |
|POLY 6 | P=0.216 P=0.315 P=0.150 P=0.241 |P=0.153 P=0.247N P=0.585 P=0.326 |
|LOGISTIC REGRESSION| P=0.231 P=0.397 P=0.169 P=0.266 |P=0.168 P=0.221N P=0.631N P=0.389 |
|COCH-ARM / FISHERS | P=0.206 P=0.357 P=0.151 P=0.243 |P=0.181 P=0.210N P=0.617N P=0.394 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/49 (0%) 6/50 (12%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 4.7% 0.0% 13.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 6/35 (17%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 118 591 --- 722 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021 * P=0.478 P=0.504N P=0.058 |(e) (e) (e) (e) |
|POLY 3 | P=0.014 * P=0.473 P=0.515N P=0.047 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.014 * P=0.480 P=0.513N P=0.047 * |(e) (e) (e) (e) |
|POLY 6 | P=0.014 * P=0.466 P=0.516N P=0.049 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.019 * P=0.616 P=0.305N P=0.065 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.017 * P=0.500 P=0.505N P=0.056 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Periportal |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/49 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 4.5% |0.0% 4.7% 2.5% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 520 --- --- 59 |--- 372 175 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245 P=0.504N P=0.513N P=0.485 |P=0.474N P=0.230 P=0.496 (e) |
|POLY 3 | P=0.251 P=0.517N P=0.513N P=0.492 |P=0.492N P=0.239 P=0.495 (e) |
|POLY 1.5 | P=0.248 P=0.511N P=0.511N P=0.490 |P=0.486N P=0.237 P=0.497 (e) |
|POLY 6 | P=0.257 P=0.525N P=0.515N P=0.495 |P=0.498N P=0.240 P=0.489 (e) |
|LOGISTIC REGRESSION| P=0.349 P=0.453N P=0.461N P=0.674 |P=0.361N P=0.314 P=0.664 (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.505N P=0.500 |P=0.457N P=0.253 P=0.505 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.4% 2.3% 4.4% |0.0% 4.7% 9.2% 7.2% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 598 8 3 9 |--- 4 3 12 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.745 P=0.755 P=0.488 |P=0.115 P=0.237 P=0.064 P=0.122 |
|POLY 3 | P=0.364 P=0.753 P=0.757 P=0.509 |P=0.103 P=0.236 P=0.063 P=0.113 |
|POLY 1.5 | P=0.359 P=0.759 P=0.759 P=0.506 |P=0.108 P=0.236 P=0.064 P=0.116 |
|POLY 6 | P=0.372 P=0.744 P=0.755 P=0.513 |P=0.100 P=0.235 P=0.059 P=0.112 |
|LOGISTIC REGRESSION| P=0.490N P=0.673N P=0.680N P=0.701N |P=0.189 P=0.468 P=0.096 P=0.299 |
|COCH-ARM / FISHERS | P=0.355 P=0.747N P=0.753N P=0.508 |P=0.113 P=0.247 P=0.059 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 4/50 (8%) 2/49 (4%) 0/50 (0%) |4/50 (8%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.6% 4.7% 0.0% |9.3% 4.9% 0.0% 2.6% |
|TERMINAL (d) | 0/35 (0%) 4/28 (14%) 2/34 (6%) 0/35 (0%) |3/32 (9%) 1/30 (3%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | --- 722 (T) 722 (T) --- |670 599 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317N P=0.038 * P=0.232 (e) |P=0.112N P=0.365N P=0.110N P=0.210N |
|POLY 3 | P=0.352N P=0.054 P=0.230 (e) |P=0.092N P=0.359N P=0.070N P=0.212N |
|POLY 1.5 | P=0.354N P=0.057 P=0.232 (e) |P=0.090N P=0.359N P=0.068N P=0.205N |
|POLY 6 | P=0.347N P=0.050 P=0.229 (e) |P=0.095N P=0.360N P=0.075N P=0.218N |
|LOGISTIC REGRESSION| (e) P=0.038 * P=0.232 (e) |P=0.099N P=0.357N P=0.076N P=0.214N |
|COCH-ARM / FISHERS | P=0.333N P=0.061 P=0.247 (e) |P=0.086N P=0.339N P=0.059N P=0.181N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 8/50 (16%) 1/49 (2%) 2/50 (4%) |5/50 (10%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.2% 18.7% 2.4% 4.6% |11.3% 7.4% 2.5% 0.0% |
|TERMINAL (d) | 4/35 (11%) 5/28 (18%) 1/34 (3%) 2/35 (6%) |2/32 (6%) 3/30 (10%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 522 722 (T) 722 (T) |554 729 (T) 648 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087N P=0.104 P=0.187N P=0.336N |P=0.020N* P=0.394N P=0.154N P=0.048N* |
|POLY 3 | P=0.095N P=0.165 P=0.187N P=0.342N |P=0.015N* P=0.405N P=0.125N P=0.043N* |
|POLY 1.5 | P=0.097N P=0.172 P=0.186N P=0.346N |P=0.014N* P=0.394N P=0.118N P=0.040N* |
|POLY 6 | P=0.090N P=0.156 P=0.188N P=0.334N |P=0.016N* P=0.418N P=0.137N P=0.047N* |
|LOGISTIC REGRESSION| P=0.095N P=0.168 P=0.187N P=0.336N |P=0.013N* P=0.368N P=0.099N P=0.031N* |
|COCH-ARM / FISHERS | P=0.091N P=0.188 P=0.181N P=0.329N |P=0.012N* P=0.357N P=0.102N P=0.028N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 4/49 (8%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.8% 9.5% 2.3% |4.7% 0.0% 0.0% 5.1% |
|TERMINAL (d) | 1/35 (3%) 2/28 (7%) 4/34 (12%) 1/35 (3%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | 722 (T) 722 (T) 722 (T) 722 (T) |691 --- --- 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.566N P=0.422 P=0.170 P=0.762 |P=0.462 P=0.256N P=0.294N P=0.647 |
|POLY 3 | P=0.591 P=0.483 P=0.169 P=0.758 |P=0.492 P=0.250N P=0.255N P=0.659 |
|POLY 1.5 | P=0.582 P=0.491 P=0.171 P=0.756 |P=0.495 P=0.249N P=0.250N P=0.665 |
|POLY 6 | P=0.587N P=0.471 P=0.167 P=0.760N |P=0.490 P=0.252N P=0.263N P=0.656 |
|LOGISTIC REGRESSION| P=0.566N P=0.422 P=0.170 P=0.762 |P=0.479 P=0.249N P=0.256N P=0.668 |
|COCH-ARM / FISHERS | P=0.591N P=0.508 P=0.181 P=0.747N |P=0.500 P=0.247N P=0.247N P=0.691N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/50 (0%) |3/48 (6%) 0/50 (0%) 1/49 (2%) 1/47 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.2% 0.0% 2.5% 2.8% |
|TERMINAL (d) | 0/35 (0%) 0/27 (0%) 0/33 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 1/27 (4%) |
|FIRST INCIDENCE | --- --- --- --- |565 --- 556 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.346N P=0.135N P=0.353N P=0.368N |
|POLY 3 | (e) (e) (e) (e) |P=0.306N P=0.124N P=0.318N P=0.358N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.305N P=0.122N P=0.311N P=0.348N |
|POLY 6 | (e) (e) (e) (e) |P=0.309N P=0.128N P=0.333N P=0.369N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.305N P=0.113N P=0.288N P=0.327N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.304N P=0.114N P=0.301N P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/47 (0%) 0/48 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 4.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/27 (0%) 0/33 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 706 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.297N P=0.249N P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.105N P=0.256N P=0.245N P=0.236N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.107N P=0.251N P=0.243N P=0.237N |(e) (e) (e) (e) |
|POLY 6 | P=0.104N P=0.263N P=0.247N P=0.233N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.113N P=0.267N P=0.247N P=0.232N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.112N P=0.253N P=0.247N P=0.237N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 0/47 (0%) 1/48 (2%) 1/50 (2%) |2/48 (4%) 2/50 (4%) 0/49 (0%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 7.0% 0.0% 2.4% 2.3% |4.8% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 3/35 (9%) 0/27 (0%) 1/33 (3%) 1/35 (3%) |1/32 (3%) 2/30 (7%) 0/22 (0%) 0/27 (0%) |
|FIRST INCIDENCE | 722 (T) --- 722 (T) 722 (T) |644 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.170N P=0.326N P=0.305N |P=0.114N P=0.667 P=0.296N P=0.276N |
|POLY 3 | P=0.277N P=0.134N P=0.318N P=0.302N |P=0.095N P=0.687 P=0.246N P=0.267N |
|POLY 1.5 | P=0.282N P=0.130N P=0.315N P=0.305N |P=0.093N P=0.690 P=0.241N P=0.262N |
|POLY 6 | P=0.270N P=0.139N P=0.320N P=0.297N |P=0.098N P=0.682 P=0.255N P=0.273N |
|LOGISTIC REGRESSION| P=0.279N (e) P=0.326N P=0.305N |P=0.098N P=0.691 P=0.238N P=0.256N |
|COCH-ARM / FISHERS | P=0.283N P=0.125N P=0.308N P=0.293N |P=0.088N P=0.676N P=0.242N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 2/47 (4%) 0/44 (0%) 0/50 (0%) |0/48 (0%) 0/47 (0%) 1/43 (2%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.0% 0.0% 0.0% |0.0% 0.0% 2.8% 5.5% |
|TERMINAL (d) | 0/33 (0%) 1/27 (4%) 0/31 (0%) 0/35 (0%) |0/32 (0%) 0/28 (0%) 1/21 (5%) 2/29 (7%) |
|FIRST INCIDENCE | --- 680 --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.206 (e) (e) |P=0.069 (e) P=0.416 P=0.216 |
|POLY 3 | P=0.395N P=0.244 (e) (e) |P=0.060 (e) P=0.472 P=0.209 |
|POLY 1.5 | P=0.393N P=0.249 (e) (e) |P=0.062 (e) P=0.475 P=0.213 |
|POLY 6 | P=0.398N P=0.237 (e) (e) |P=0.059 (e) P=0.467 P=0.206 |
|LOGISTIC REGRESSION| P=0.385N P=0.243 (e) (e) |(e) (e) P=0.416 P=0.216 |
|COCH-ARM / FISHERS | P=0.380N P=0.270 (e) (e) |P=0.065 (e) P=0.473 P=0.231 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 3/47 (6%) 6/44 (14%) 1/50 (2%) |1/48 (2%) 0/47 (0%) 0/43 (0%) 1/45 (2%) |
|POLY-3 ADJUSTED (b)| 5.2% 7.5% 15.7% 2.3% |2.4% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 2/33 (6%) 2/27 (7%) 6/31 (19%) 1/35 (3%) |0/32 (0%) 0/28 (0%) 0/21 (0%) 1/29 (3%) |
|FIRST INCIDENCE | 722 (T) 561 722 (T) 722 (T) |375 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367N P=0.421 P=0.111 P=0.479N |P=0.575 P=0.513N P=0.508N P=0.740 |
|POLY 3 | P=0.374N P=0.520 P=0.128 P=0.460N |P=0.576 P=0.521N P=0.532N P=0.727 |
|POLY 1.5 | P=0.380N P=0.527 P=0.130 P=0.462N |P=0.579 P=0.518N P=0.528N P=0.733 |
|POLY 6 | P=0.364N P=0.508 P=0.124 P=0.458N |P=0.574 P=0.524N P=0.538N P=0.723 |
|LOGISTIC REGRESSION| P=0.361N P=0.528 P=0.111 P=0.479N |P=0.585 P=0.418N P=0.509N P=0.759N |
|COCH-ARM / FISHERS | P=0.356N P=0.543 P=0.140 P=0.443N |P=0.580 P=0.505N P=0.527N P=0.736 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/43 (30%) 10/47 (21%) 10/44 (23%) 12/50 (24%) |4/48 (8%) 2/47 (4%) 3/43 (7%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 33.1% 24.3% 25.6% 27.4% |9.6% 5.3% 8.3% 5.5% |
|TERMINAL (d) | 10/33 (30%) 5/27 (19%) 6/31 (19%) 8/35 (23%) |1/32 (3%) 1/28 (4%) 0/21 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 637 561 642 649 |568 649 692 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.408N P=0.489N P=0.376N P=0.444N |P=0.384N P=0.380N P=0.606N P=0.403N |
|POLY 3 | P=0.393N P=0.267N P=0.316N P=0.371N |P=0.370N P=0.382N P=0.582N P=0.400N |
|POLY 1.5 | P=0.402N P=0.256N P=0.312N P=0.375N |P=0.362N P=0.376N P=0.572N P=0.390N |
|POLY 6 | P=0.378N P=0.287N P=0.320N P=0.366N |P=0.376N P=0.389N P=0.598N P=0.407N |
|LOGISTIC REGRESSION| P=0.393N P=0.266N P=0.316N P=0.367N |P=0.361N P=0.360N P=0.566N P=0.372N |
|COCH-ARM / FISHERS | P=0.369N P=0.232N P=0.291N P=0.329N |P=0.352N P=0.349N P=0.562N P=0.370N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/43 (7%) 1/47 (2%) 1/44 (2%) 0/50 (0%) |0/48 (0%) 0/47 (0%) 0/43 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 7.7% 2.5% 2.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/33 (6%) 1/27 (4%) 1/31 (3%) 0/35 (0%) |0/32 (0%) 0/28 (0%) 0/21 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 598 722 (T) 722 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.068N P=0.374N P=0.327N P=0.119N |(e) (e) (e) (e) |
|POLY 3 | P=0.060N P=0.298N P=0.311N P=0.100N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.062N P=0.289N P=0.308N P=0.100N |(e) (e) (e) (e) |
|POLY 6 | P=0.058N P=0.312N P=0.316N P=0.100N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.064N P=0.283N P=0.301N P=0.097N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.061N P=0.275N P=0.299N P=0.095N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/43 (2%) 5/47 (11%) 3/44 (7%) 4/50 (8%) |1/48 (2%) 1/47 (2%) 0/43 (0%) 0/45 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 12.3% 7.8% 9.2% |2.4% 2.7% 0.0% 0.0% |
|TERMINAL (d) | 1/33 (3%) 3/27 (11%) 3/31 (10%) 3/35 (9%) |1/32 (3%) 1/28 (4%) 0/21 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 532 722 (T) 672 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315 P=0.074 P=0.282 P=0.199 |P=0.262N P=0.732 P=0.584N P=0.520N |
|POLY 3 | P=0.308 P=0.113 P=0.302 P=0.215 |P=0.253N P=0.742 P=0.528N P=0.526N |
|POLY 1.5 | P=0.304 P=0.116 P=0.304 P=0.213 |P=0.251N P=0.743 P=0.525N P=0.522N |
|POLY 6 | P=0.314 P=0.107 P=0.299 P=0.218 |P=0.255N P=0.740 P=0.533N P=0.528N |
|LOGISTIC REGRESSION| P=0.316 P=0.124 P=0.282 P=0.215 |P=0.262N P=0.732 (e) (e) |
|COCH-ARM / FISHERS | P=0.327 P=0.123 P=0.317 P=0.231 |P=0.248N P=0.747 P=0.527N P=0.516N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 0/4 (0%) 0/4 (0%) 0/2 (0%) |3/10 (30%) 0/10 (0%) 2/7 (29%) 0/7 (0%) |
|POLY-3 ADJUSTED (b)| 59.1% 0.0% 0.0% 0.0% |36.7% 0.0% 37.5% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |2/4 (50%) 0/4 (0%) 2/2 (100%) 0/5 (0%) |
|FIRST INCIDENCE | 542 --- --- --- |644 --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.517N P=0.513N P=0.513N |P=0.099N P=0.115N P=0.653 P=0.093N |
|POLY 3 | P=0.253N P=0.370N P=0.329N P=0.482N |P=0.166N P=0.081N P=0.702 P=0.147N |
|POLY 1.5 | P=0.261N P=0.356N P=0.335N P=0.491N |P=0.173N P=0.085N P=0.694N P=0.155N |
|POLY 6 | P=0.241N P=0.392N P=0.319N P=0.468N |P=0.150N P=0.079N P=0.661 P=0.135N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.150N P=0.088N P=0.630 P=0.144N |
|COCH-ARM / FISHERS | P=0.288N P=0.333N P=0.333N P=0.500N |P=0.187N P=0.105N P=0.686N P=0.176N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/4 (0%) 2/4 (50%) 1/2 (50%) |0/10 (0%) 0/10 (0%) 1/7 (14%) 0/7 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 54.2% 54.5% |0.0% 0.0% 17.5% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/1 (0%) 1/2 (50%) 1/1 (100%) |0/4 (0%) 0/4 (0%) 0/2 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 657 722 (T) |--- --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361 (e) P=0.500 P=1.000 |P=0.679 (e) P=0.490 (e) |
|POLY 3 | P=0.261 (e) P=0.525 P=0.599 |P=0.672 (e) P=0.434 (e) |
|POLY 1.5 | P=0.197 (e) P=0.459 P=0.551 |P=0.658 (e) P=0.432 (e) |
|POLY 6 | P=0.386 (e) P=0.628 P=0.676 |P=0.702 (e) P=0.432 (e) |
|LOGISTIC REGRESSION| P=0.358 (e) P=0.751 P=1.000 |P=0.633 (e) P=0.408 (e) |
|COCH-ARM / FISHERS | P=0.143 (e) P=0.400 P=0.500 |P=0.646 (e) P=0.412 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) |2/47 (4%) 1/50 (2%) 0/49 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |5.0% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 0/5 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |1/31 (3%) 0/30 (0%) 0/22 (0%) 0/28 (0%) |
|FIRST INCIDENCE | --- --- --- --- |714 674 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.120N P=0.517N P=0.314N P=0.269N |
|POLY 3 | (e) (e) (e) (e) |P=0.101N P=0.496N P=0.244N P=0.258N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.100N P=0.494N P=0.240N P=0.252N |
|POLY 6 | (e) (e) (e) (e) |P=0.103N P=0.498N P=0.251N P=0.262N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.108N P=0.496N P=0.260N P=0.263N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.098N P=0.477N P=0.237N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/7 (0%) 0/6 (0%) 0/4 (0%) |2/17 (12%) 0/18 (0%) 0/13 (0%) 0/13 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |12.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/2 (0%) 0/3 (0%) 0/4 (0%) 0/1 (0%) |1/9 (11%) 0/10 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |568 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.130N P=0.231N P=0.273N P=0.266N |
|POLY 3 | (e) (e) (e) (e) |P=0.136N P=0.229N P=0.305N P=0.301N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.137N P=0.225N P=0.301N P=0.299N |
|POLY 6 | (e) (e) (e) (e) |P=0.135N P=0.235N P=0.312N P=0.304N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.137N P=0.201N P=0.294N P=0.282N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.142N P=0.229N P=0.313N P=0.313N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 3/7 (43%) 1/6 (17%) 2/4 (50%) |12/17 (71%) 13/18 (72%) 11/13 (85%) 9/13 (69%) |
|POLY-3 ADJUSTED (b)| 100.0% 56.2% 19.2% 53.4% |73.7% 76.8% 89.6% 73.7% |
|TERMINAL (d) | 2/2 (100%) 2/3 (67%) 1/4 (25%) 1/1 (100%) |7/9 (78%) 8/10 (80%) 7/7 (100%) 7/8 (88%) |
|FIRST INCIDENCE | 722 (T) 522 722 (T) 639 |565 555 583 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.711 P=0.215N P=0.516 |P=0.348N P=0.557 P=0.453 P=0.409N |
|POLY 3 | P=0.314N P=0.393N P=0.063N P=0.419N |P=0.540 P=0.581 P=0.270 P=0.668N |
|POLY 1.5 | P=0.332N P=0.343N P=0.056N P=0.402N |P=0.555 P=0.593 P=0.297 P=0.644N |
|POLY 6 | P=0.307N P=0.454N P=0.081N P=0.458N |P=0.498 P=0.560 P=0.226 P=0.647 |
|LOGISTIC REGRESSION| P=0.348N P=0.429N P=0.215N P=0.471N |P=0.576 P=0.592 P=0.310 P=0.626N |
|COCH-ARM / FISHERS | P=0.394N P=0.278N P=0.107N P=0.400N |P=0.566 P=0.604 P=0.326 P=0.623N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 31/49 (63%) 35/49 (71%) 7/50 (14%) |19/50 (38%) 27/50 (54%) 35/47 (74%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 32.1% 70.9% 79.0% 16.2% |42.5% 64.6% 85.1% 87.7% |
|TERMINAL (d) | 10/35 (29%) 20/28 (71%) 28/34 (82%) 7/35 (20%) |13/32 (41%) 20/30 (67%) 20/22 (91%) 27/29 (93%) |
|FIRST INCIDENCE | 520 522 623 722 (T) |476 573 556 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009N** P<0.001 ** P<0.001 ** P=0.052N |P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.012N* P<0.001 ** P<0.001 ** P=0.064N |P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.011N* P<0.001 ** P<0.001 ** P=0.061N |P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.014N* P<0.001 ** P<0.001 ** P=0.068N |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.011N* P<0.001 ** P<0.001 ** P=0.053N |P<0.001 ** P=0.042 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.010N* P<0.001 ** P<0.001 ** P=0.045N* |P<0.001 ** P=0.080 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 10/49 (20%) 15/49 (31%) 2/50 (4%) |26/50 (52%) 16/50 (32%) 12/47 (26%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 43.0% 23.8% 34.2% 4.6% |57.2% 38.4% 30.4% 32.5% |
|TERMINAL (d) | 13/35 (37%) 6/28 (21%) 10/34 (29%) 1/35 (3%) |18/32 (56%) 12/30 (40%) 7/22 (32%) 9/29 (31%) |
|FIRST INCIDENCE | 542 532 513 672 |476 605 632 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.102N P=0.254N P<0.001N** |P=0.030N* P=0.074N P=0.071N P=0.028N* |
|POLY 3 | P<0.001N** P=0.044N* P=0.259N P<0.001N** |P=0.012N* P=0.058N P=0.009N** P=0.016N* |
|POLY 1.5 | P<0.001N** P=0.037N* P=0.251N P<0.001N** |P=0.010N* P=0.052N P=0.008N** P=0.013N* |
|POLY 6 | P<0.001N** P=0.056N P=0.266N P<0.001N** |P=0.014N* P=0.066N P=0.013N* P=0.020N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.037N* P=0.241N P<0.001N** |P=0.014N* P=0.047N* P=0.008N** P=0.014N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.028N* P=0.222N P<0.001N** |P=0.008N** P=0.034N* P=0.007N** P=0.007N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 22/49 (45%) 11/49 (22%) 15/50 (30%) |12/50 (24%) 8/50 (16%) 12/47 (26%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 43.1% 51.1% 26.0% 34.6% |27.8% 19.6% 29.7% 10.4% |
|TERMINAL (d) | 14/35 (40%) 15/28 (54%) 11/34 (32%) 14/35 (40%) |10/32 (31%) 6/30 (20%) 6/22 (27%) 4/29 (14%) |
|FIRST INCIDENCE | 542 532 722 (T) 680 |644 680 556 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.057N P=0.184 P=0.056N P=0.208N |P=0.082N P=0.281N P=0.293 P=0.043N* |
|POLY 3 | P=0.103N P=0.289 P=0.069N P=0.273N |P=0.065N P=0.266N P=0.518 P=0.042N* |
|POLY 1.5 | P=0.101N P=0.319 P=0.060N P=0.265N |P=0.059N P=0.263N P=0.511 P=0.038N* |
|POLY 6 | P=0.106N P=0.254 P=0.081N P=0.281N |P=0.071N P=0.269N P=0.522 P=0.045N* |
|LOGISTIC REGRESSION| P=0.079N P=0.312 P=0.056N P=0.232N |P=0.064N P=0.269N P=0.485 P=0.045N* |
|COCH-ARM / FISHERS | P=0.077N P=0.386 P=0.047N* P=0.201N |P=0.043N* P=0.227N P=0.524 P=0.027N* |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/49 (0%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 0/47 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.5% 2.4% 0.0% 2.3% |6.9% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 1/35 (3%) 0/28 (0%) 0/34 (0%) 1/35 (3%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | 653 645 --- 722 (T) |644 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.549N P=0.248N P=0.500N |P=0.282N P=0.139N P=0.165N P=0.349N |
|POLY 3 | P=0.365N P=0.532N P=0.250N P=0.513N |P=0.241N P=0.131N P=0.140N P=0.347N |
|POLY 1.5 | P=0.367N P=0.524N P=0.248N P=0.515N |P=0.242N P=0.129N P=0.137N P=0.338N |
|POLY 6 | P=0.362N P=0.543N P=0.252N P=0.510N |P=0.242N P=0.134N P=0.146N P=0.356N |
|LOGISTIC REGRESSION| P=0.371N P=0.508N P=0.244N P=0.511N |P=0.264N P=0.124N P=0.134N P=0.330N |
|COCH-ARM / FISHERS | P=0.366N P=0.508N P=0.253N P=0.500N |P=0.250N P=0.121N P=0.133N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |14/47 (30%) 9/49 (18%) 11/46 (24%) 11/49 (22%) |
|POLY-3 ADJUSTED (b)| |34.0% 22.1% 29.1% 28.8% |
|TERMINAL (d) | |12/32 (38%) 7/29 (24%) 6/21 (29%) 9/29 (31%) |
|FIRST INCIDENCE | |565 372 509 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.507N P=0.238N P=0.478 P=0.432N |
|POLY 3 | |P=0.452N P=0.171N P=0.414N P=0.399N |
|POLY 1.5 | |P=0.427N P=0.168N P=0.401N P=0.371N |
|POLY 6 | |P=0.472N P=0.180N P=0.440N P=0.423N |
|LOGISTIC REGRESSION| |P=0.451N P=0.176N P=0.428N P=0.413N |
|COCH-ARM / FISHERS | |P=0.348N P=0.142N P=0.343N P=0.279N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |1/49 (2%) 0/49 (0%) 0/47 (0%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.4% 0.0% 0.0% 5.4% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 2/29 (7%) |
|FIRST INCIDENCE | --- --- --- --- |568 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.228 P=0.505N P=0.509N P=0.466 |
|POLY 3 | (e) (e) (e) (e) |P=0.231 P=0.512N P=0.521N P=0.452 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.234 P=0.511N P=0.517N P=0.460 |
|POLY 6 | (e) (e) (e) (e) |P=0.228 P=0.513N P=0.527N P=0.445 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.231 P=0.478N P=0.492N P=0.476 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.241 P=0.500N P=0.510N P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/50 (4%) 1/48 (2%) 1/50 (2%) |0/49 (0%) 2/49 (4%) 1/47 (2%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 6.8% 4.8% 2.4% 2.3% |0.0% 5.0% 2.6% 5.4% |
|TERMINAL (d) | 1/35 (3%) 0/28 (0%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 1/30 (3%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | 574 638 722 (T) 709 |--- 680 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193N P=0.558N P=0.322N P=0.305N |P=0.223 P=0.224 P=0.425 P=0.216 |
|POLY 3 | P=0.201N P=0.526N P=0.328N P=0.314N |P=0.205 P=0.228 P=0.482 P=0.210 |
|POLY 1.5 | P=0.204N P=0.513N P=0.324N P=0.315N |P=0.211 P=0.227 P=0.484 P=0.214 |
|POLY 6 | P=0.197N P=0.542N P=0.331N P=0.312N |P=0.200 P=0.229 P=0.476 P=0.207 |
|LOGISTIC REGRESSION| P=0.199N P=0.482N P=0.310N P=0.296N |P=0.208 P=0.228 P=0.425 P=0.216 |
|COCH-ARM / FISHERS | P=0.197N P=0.490N P=0.316N P=0.301N |P=0.239 P=0.247 P=0.490 P=0.242 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 1/48 (2%) 1/50 (2%) |0/49 (0%) 1/49 (2%) 2/47 (4%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.4% 2.3% |0.0% 2.5% 5.2% 5.4% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/34 (3%) 1/35 (3%) |0/32 (0%) 1/30 (3%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | --- --- 722 (T) 722 (T) |--- 729 (T) 678 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252 (e) P=0.494 P=0.500 |P=0.144 P=0.487 P=0.191 P=0.216 |
|POLY 3 | P=0.237 (e) P=0.491 P=0.498 |P=0.128 P=0.491 P=0.218 P=0.210 |
|POLY 1.5 | P=0.232 (e) P=0.491 P=0.496 |P=0.133 P=0.491 P=0.220 P=0.214 |
|POLY 6 | P=0.245 (e) P=0.491 P=0.501 |P=0.125 P=0.491 P=0.213 P=0.207 |
|LOGISTIC REGRESSION| (e) (e) P=0.494 P=0.500 |P=0.131 P=0.487 P=0.217 P=0.216 |
|COCH-ARM / FISHERS | P=0.238 (e) P=0.495 P=0.505 |P=0.155 P=0.500 P=0.237 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/47 (0%) 1/45 (2%) 0/49 (0%) |5/47 (11%) 4/44 (9%) 6/42 (14%) 8/46 (17%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 0.0% |12.3% 11.2% 16.8% 22.8% |
|TERMINAL (d) | 0/34 (0%) 0/26 (0%) 1/32 (3%) 0/34 (0%) |3/31 (10%) 3/26 (12%) 3/21 (14%) 8/27 (30%) |
|FIRST INCIDENCE | --- --- 722 (T) --- |687 605 583 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.699 (e) P=0.488 (e) |P=0.111 P=0.587N P=0.315 P=0.192 |
|POLY 3 | P=0.694 (e) P=0.490 (e) |P=0.104 P=0.583N P=0.406 P=0.182 |
|POLY 1.5 | P=0.688 (e) P=0.491 (e) |P=0.115 P=0.579N P=0.413 P=0.199 |
|POLY 6 | P=0.703 (e) P=0.490 (e) |P=0.094 P=0.589N P=0.395 P=0.168 |
|LOGISTIC REGRESSION| (e) (e) P=0.488 (e) |P=0.101 P=0.587N P=0.398 P=0.166 |
|COCH-ARM / FISHERS | P=0.700 (e) P=0.495 (e) |P=0.152 P=0.542N P=0.420 P=0.262 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 45/50 (90%) 47/49 (96%) 42/49 (86%) | |
|POLY-3 ADJUSTED (b)| 95.9% 93.4% 97.9% 91.3% | |
|TERMINAL (d) | 33/35 (94%) 26/28 (93%) 33/34 (97%) 31/35 (89%) | |
|FIRST INCIDENCE | 520 237 226 406 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.195 P=0.468 P=0.239N | |
|POLY 3 | P=0.279N P=0.456N P=0.506 P=0.310N | |
|POLY 1.5 | P=0.302N P=0.414N P=0.493 P=0.314N | |
|POLY 6 | P=0.256N P=0.523N P=0.507 P=0.309N | |
|LOGISTIC REGRESSION| P=0.272N P=0.478N P=0.376 P=0.315N | |
|COCH-ARM / FISHERS | P=0.134N P=0.357N P=0.510 P=0.151N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 25/50 (50%) 32/49 (65%) 28/49 (57%) | |
|POLY-3 ADJUSTED (b)| 61.7% 57.8% 71.1% 65.4% | |
|TERMINAL (d) | 22/35 (63%) 17/28 (61%) 25/34 (74%) 26/35 (74%) | |
|FIRST INCIDENCE | 520 561 513 639 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.482 P=0.293 P=0.506N | |
|POLY 3 | P=0.288 P=0.436N P=0.227 P=0.440 | |
|POLY 1.5 | P=0.294 P=0.374N P=0.238 P=0.463 | |
|POLY 6 | P=0.292 P=0.515N P=0.219 P=0.424 | |
|LOGISTIC REGRESSION| P=0.376 P=0.399N P=0.239 P=0.537 | |
|COCH-ARM / FISHERS | P=0.425 P=0.274N P=0.295 P=0.547N | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 24/50 (48%) 16/49 (33%) 18/49 (37%) | |
|POLY-3 ADJUSTED (b)| 47.7% 53.5% 37.0% 40.9% | |
|TERMINAL (d) | 19/35 (54%) 12/28 (43%) 13/34 (38%) 14/35 (40%) | |
|FIRST INCIDENCE | 520 546 630 406 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.173 P=0.179N P=0.278N | |
|POLY 3 | P=0.180N P=0.364 P=0.207N P=0.332N | |
|POLY 1.5 | P=0.194N P=0.373 P=0.200N P=0.349N | |
|POLY 6 | P=0.156N P=0.368 P=0.208N P=0.300N | |
|LOGISTIC REGRESSION| P=0.187N P=0.350 P=0.197N P=0.344N | |
|COCH-ARM / FISHERS | P=0.164N P=0.421 P=0.170N P=0.298N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 3/48 (6%) 10/48 (21%) 9/49 (18%) | |
|POLY-3 ADJUSTED (b)| 17.5% 7.6% 24.2% 21.0% | |
|TERMINAL (d) | 4/35 (11%) 3/27 (11%) 10/33 (30%) 7/35 (20%) | |
|FIRST INCIDENCE | 520 722 (T) 722 (T) 594 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.283 P=0.185N P=0.351 P=0.497 | |
|POLY 3 | P=0.217 P=0.151N P=0.305 P=0.442 | |
|POLY 1.5 | P=0.205 P=0.136N P=0.322 P=0.438 | |
|POLY 6 | P=0.239 P=0.173N P=0.285 P=0.452 | |
|LOGISTIC REGRESSION| P=0.219 P=0.127N P=0.332 P=0.458 | |
|COCH-ARM / FISHERS | P=0.224 P=0.113N P=0.361 P=0.482 | |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 31/48 (65%) 33/50 (66%) 26/49 (53%) 34/50 (68%) |33/50 (66%) 35/50 (70%) 36/49 (73%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 68.1% 72.8% 58.2% 74.7% |72.3% 80.6% 82.8% 68.9% |
|TERMINAL (d) | 25/35 (71%) 22/28 (79%) 19/34 (56%) 26/35 (74%) |24/32 (75%) 26/30 (87%) 20/22 (91%) 21/29 (72%) |
|FIRST INCIDENCE | 520 522 514 406 |476 419 556 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528 P=0.096 P=0.282N P=0.351 |P=0.509N P=0.277 P=0.020 * P=0.514N |
|POLY 3 | P=0.368 P=0.391 P=0.220N P=0.317 |P=0.342N P=0.244 P=0.168 P=0.450N |
|POLY 1.5 | P=0.355 P=0.433 P=0.210N P=0.313 |P=0.305N P=0.262 P=0.184 P=0.412N |
|POLY 6 | P=0.402 P=0.341 P=0.224N P=0.339 |P=0.374N P=0.218 P=0.152 P=0.485N |
|LOGISTIC REGRESSION| P=0.385 P=0.419 P=0.202N P=0.336 |P=0.357N P=0.265 P=0.177 P=0.446N |
|COCH-ARM / FISHERS | P=0.462 P=0.526 P=0.172N P=0.443 |P=0.192N P=0.415 P=0.278 P=0.268N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 3/47 (6%) 0/49 (0%) |0/49 (0%) 1/50 (2%) 1/48 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% 7.2% 0.0% |0.0% 2.5% 2.6% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 549 657 --- |--- 696 722 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515N P=0.226 P=0.118 (e) |P=0.621N P=0.489 P=0.451 (e) |
|POLY 3 | P=0.548N P=0.230 P=0.110 (e) |P=0.620N P=0.493 P=0.481 (e) |
|POLY 1.5 | P=0.555N P=0.234 P=0.109 (e) |P=0.615N P=0.494 P=0.484 (e) |
|POLY 6 | P=0.535N P=0.225 P=0.113 (e) |P=0.626N P=0.492 P=0.475 (e) |
|LOGISTIC REGRESSION| P=0.528N P=0.260 P=0.113 (e) |P=0.613N P=0.495 P=0.465 (e) |
|COCH-ARM / FISHERS | P=0.534N P=0.253 P=0.113 (e) |P=0.597N P=0.505 P=0.495 (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 30/50 (60%) 26/47 (55%) 23/49 (47%) |29/49 (59%) 27/50 (54%) 32/48 (67%) 39/49 (80%) |
|POLY-3 ADJUSTED (b)| 28.1% 64.5% 61.5% 52.9% |62.4% 63.1% 76.3% 90.2% |
|TERMINAL (d) | 5/35 (14%) 16/28 (57%) 22/34 (65%) 17/35 (49%) |18/32 (56%) 18/30 (60%) 19/22 (86%) 26/29 (90%) |
|FIRST INCIDENCE | 520 237 623 624 |375 573 417 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224 P<0.001 ** P=0.009 ** P=0.048 * |P=0.005 ** P=0.550N P=0.042 * P=0.019 * |
|POLY 3 | P=0.042 * P<0.001 ** P<0.001 ** P=0.013 * |P<0.001 ** P=0.561 P=0.115 P<0.001 ** |
|POLY 1.5 | P=0.046 * P<0.001 ** P<0.001 ** P=0.014 * |P<0.001 ** P=0.562N P=0.146 P=0.003 ** |
|POLY 6 | P=0.040 * P<0.001 ** P<0.001 ** P=0.012 * |P<0.001 ** P=0.519 P=0.078 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.091 P<0.001 ** P=0.003 ** P=0.022 * |P=0.002 ** P=0.462N P=0.202 P=0.008 ** |
|COCH-ARM / FISHERS | P=0.112 P<0.001 ** P=0.004 ** P=0.029 * |P=0.007 ** P=0.376N P=0.290 P=0.024 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/47 (2%) 1/49 (2%) |2/49 (4%) 5/50 (10%) 4/48 (8%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.4% 2.4% |4.8% 12.4% 10.4% 5.2% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 0/34 (0%) 1/35 (3%) |2/32 (6%) 5/30 (17%) 3/22 (14%) 2/29 (7%) |
|FIRST INCIDENCE | --- 722 (T) 664 722 (T) |729 (T) 729 (T) 642 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404 P=0.455 P=0.489 P=0.500 |P=0.512N P=0.188 P=0.199 P=0.660 |
|POLY 3 | P=0.375 P=0.490 P=0.490 P=0.495 |P=0.502N P=0.200 P=0.296 P=0.664 |
|POLY 1.5 | P=0.369 P=0.495 P=0.489 P=0.492 |P=0.488N P=0.203 P=0.302 P=0.671 |
|POLY 6 | P=0.384 P=0.484 P=0.492 P=0.499 |P=0.515N P=0.196 P=0.286 P=0.657 |
|LOGISTIC REGRESSION| P=0.381 P=0.455 P=0.494 P=0.500 |P=0.508N P=0.188 P=0.279 P=0.660 |
|COCH-ARM / FISHERS | P=0.381 P=0.505 P=0.490 P=0.500 |P=0.447N P=0.226 P=0.329 P=0.691N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 2/48 (4%) 3/49 (6%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.4% 4.7% 6.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 706 546 226 624 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.731 P=0.494 P=0.313 |(e) (e) (e) (e) |
|POLY 3 | P=0.168 P=0.752 P=0.491 P=0.304 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.161 P=0.756 P=0.491 P=0.297 |(e) (e) (e) (e) |
|POLY 6 | P=0.180 P=0.746 P=0.492 P=0.315 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.187 P=0.744N P=0.549 P=0.304 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.162 P=0.747N P=0.492 P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/48 (4%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 4.7% 4.6% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 680 226 594 |644 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 P=0.477 P=0.237 P=0.237 |P=0.325N P=0.520N P=0.531N P=0.531N |
|POLY 3 | P=0.164 P=0.491 P=0.232 P=0.238 |P=0.296N P=0.508N P=0.515N P=0.522N |
|POLY 1.5 | P=0.155 P=0.495 P=0.232 P=0.233 |P=0.298N P=0.506N P=0.512N P=0.517N |
|POLY 6 | P=0.176 P=0.485 P=0.232 P=0.245 |P=0.295N P=0.510N P=0.522N P=0.526N |
|LOGISTIC REGRESSION| P=0.190 P=0.501 P=0.282 P=0.255 |P=0.304N P=0.497N P=0.498N P=0.499N |
|COCH-ARM / FISHERS | P=0.158 P=0.505 P=0.242 P=0.247 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 4/48 (8%) 1/47 (2%) |3/48 (6%) 3/49 (6%) 4/48 (8%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 4.5% 4.7% 9.3% 2.4% |7.0% 7.2% 9.8% 7.7% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 574 549 514 59 |64 172 417 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432N P=0.664 P=0.328 P=0.512N |P=0.501 P=0.635 P=0.463 P=0.609 |
|POLY 3 | P=0.444N P=0.676 P=0.322 P=0.515N |P=0.501 P=0.649 P=0.474 P=0.620 |
|POLY 1.5 | P=0.455N P=0.684 P=0.321 P=0.519N |P=0.509 P=0.654 P=0.478 P=0.628 |
|POLY 6 | P=0.429N P=0.664 P=0.325 P=0.510N |P=0.494 P=0.643 P=0.463 P=0.614 |
|LOGISTIC REGRESSION| P=0.363N P=0.653N P=0.361 P=0.336N |P=0.488N P=0.587N P=0.569 P=0.540N |
|COCH-ARM / FISHERS | P=0.454N P=0.684N P=0.329 P=0.516N |P=0.565 P=0.651N P=0.500 P=0.651N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Dysplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/48 (4%) 0/47 (0%) |0/48 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/34 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- 514 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.592 (e) P=0.232 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.592 (e) P=0.230 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.577 (e) P=0.229 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.612 (e) P=0.231 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.600 (e) P=0.246 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.585 (e) P=0.242 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/49 (2%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 4.5% 2.4% 2.3% 2.3% | |
|TERMINAL (d) | 2/35 (6%) 1/28 (4%) 0/34 (0%) 0/35 (0%) | |
|FIRST INCIDENCE | 722 (T) 722 (T) 637 709 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.578N P=0.509N P=0.500N | |
|POLY 3 | P=0.410N P=0.525N P=0.516N P=0.511N | |
|POLY 1.5 | P=0.415N P=0.516N P=0.515N P=0.514N | |
|POLY 6 | P=0.402N P=0.537N P=0.515N P=0.505N | |
|LOGISTIC REGRESSION| P=0.414N P=0.578N P=0.514N P=0.501N | |
|COCH-ARM / FISHERS | P=0.410N P=0.500N P=0.508N P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/46 (57%) 21/46 (46%) 16/39 (41%) 16/47 (34%) |11/45 (24%) 11/44 (25%) 13/46 (28%) 10/39 (26%) |
|POLY-3 ADJUSTED (b)| 57.9% 49.0% 44.4% 38.5% |27.2% 29.1% 32.1% 28.9% |
|TERMINAL (d) | 16/34 (47%) 8/27 (30%) 10/28 (36%) 12/34 (35%) |5/30 (17%) 3/28 (11%) 1/22 (5%) 3/26 (12%) |
|FIRST INCIDENCE | 118 237 514 624 |476 555 417 12 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033N* P=0.486N P=0.136N P=0.052N |P=0.489 P=0.529 P=0.261 P=0.574 |
|POLY 3 | P=0.044N* P=0.267N P=0.164N P=0.055N |P=0.475 P=0.527 P=0.406 P=0.539 |
|POLY 1.5 | P=0.041N* P=0.252N P=0.159N P=0.050N |P=0.470 P=0.521 P=0.411 P=0.532 |
|POLY 6 | P=0.047N* P=0.288N P=0.167N P=0.060N |P=0.475 P=0.539 P=0.389 P=0.544 |
|LOGISTIC REGRESSION| P=0.022N* P=0.169N P=0.108N P=0.029N* |P=0.504 P=0.552 P=0.429 P=0.554N |
|COCH-ARM / FISHERS | P=0.021N* P=0.202N P=0.114N P=0.024N* |P=0.477 P=0.573 P=0.431 P=0.549 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/46 (0%) 0/39 (0%) 0/47 (0%) |1/45 (2%) 0/44 (0%) 2/46 (4%) 0/39 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.6% 0.0% 5.3% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) |1/30 (3%) 0/28 (0%) 0/22 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- 659 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.493N P=0.514N P=0.419 P=0.529N |
|POLY 3 | (e) (e) (e) (e) |P=0.523N P=0.516N P=0.492 P=0.552N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.519N P=0.515N P=0.496 P=0.549N |
|POLY 6 | (e) (e) (e) (e) |P=0.524N P=0.516N P=0.483 P=0.553N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.520N (e) P=0.490 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.494N P=0.506N P=0.508 P=0.536N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/46 (0%) 1/39 (3%) 1/47 (2%) |2/45 (4%) 4/44 (9%) 3/46 (7%) 3/39 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% 2.4% |5.0% 10.2% 7.6% 9.3% |
|TERMINAL (d) | 0/34 (0%) 0/27 (0%) 0/28 (0%) 0/34 (0%) |0/30 (0%) 0/28 (0%) 0/22 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 514 9 |64 4 40 14 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228 (e) P=0.492 P=0.496 |P=0.478 P=0.328 P=0.481 P=0.479 |
|POLY 3 | P=0.247 (e) P=0.463 P=0.503 |P=0.380 P=0.323 P=0.490 P=0.398 |
|POLY 1.5 | P=0.242 (e) P=0.463 P=0.501 |P=0.386 P=0.321 P=0.496 P=0.402 |
|POLY 6 | P=0.255 (e) P=0.465 P=0.506 |P=0.381 P=0.326 P=0.479 P=0.401 |
|LOGISTIC REGRESSION| P=0.401 (e) P=0.518 (e) |P=0.371N P=0.756 P=0.711 P=0.544N |
|COCH-ARM / FISHERS | P=0.241 (e) P=0.459 P=0.505 |P=0.429 P=0.328 P=0.511 P=0.432 |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 0.0% 0.0% |0.0% 7.4% 0.0% 7.8% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 0/34 (0%) 0/35 (0%) |0/32 (0%) 3/30 (10%) 0/22 (0%) 3/29 (10%) |
|FIRST INCIDENCE | --- 722 (T) --- --- |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.455 (e) (e) |P=0.142 P=0.109 (e) P=0.103 |
|POLY 3 | P=0.576N P=0.490 (e) (e) |P=0.136 P=0.109 (e) P=0.101 |
|POLY 1.5 | P=0.573N P=0.495 (e) (e) |P=0.141 P=0.110 (e) P=0.104 |
|POLY 6 | P=0.579N P=0.484 (e) (e) |P=0.131 P=0.108 (e) P=0.099 |
|LOGISTIC REGRESSION| (e) P=0.455 (e) (e) |(e) P=0.109 (e) P=0.103 |
|COCH-ARM / FISHERS | P=0.565N P=0.505 (e) (e) |P=0.163 P=0.121 (e) P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 0.0% 0.0% |9.3% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/28 (0%) 0/34 (0%) 0/35 (0%) |3/32 (9%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |711 --- 692 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301N P=0.545N P=0.506N P=0.500N |P=0.055N P=0.073N P=0.283N P=0.081N |
|POLY 3 | P=0.296N P=0.510N P=0.506N P=0.502N |P=0.038N* P=0.067N P=0.200N P=0.074N |
|POLY 1.5 | P=0.297N P=0.505N P=0.505N P=0.504N |P=0.037N* P=0.067N P=0.196N P=0.071N |
|POLY 6 | P=0.295N P=0.516N P=0.507N P=0.499N |P=0.038N* P=0.068N P=0.210N P=0.076N |
|LOGISTIC REGRESSION| P=0.301N (e) (e) (e) |P=0.048N* P=0.070N P=0.218N P=0.078N |
|COCH-ARM / FISHERS | P=0.304N P=0.495N P=0.500N P=0.495N |P=0.039N* P=0.059N P=0.181N P=0.059N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 14/50 (28%) 20/49 (41%) 12/50 (24%) |14/50 (28%) 21/50 (42%) 22/50 (44%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 18.3% 33.6% 47.0% 27.8% |32.6% 51.5% 54.1% 59.1% |
|TERMINAL (d) | 8/35 (23%) 13/28 (46%) 19/34 (56%) 12/35 (34%) |13/32 (41%) 19/30 (63%) 16/22 (73%) 21/29 (72%) |
|FIRST INCIDENCE | 722 (T) 692 664 722 (T) |670 674 659 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.306 P=0.028 * P=0.003 ** P=0.215 |P=0.011 * P=0.050 P=0.002 ** P=0.011 * |
|POLY 3 | P=0.221 P=0.083 P=0.003 ** P=0.213 |P=0.012 * P=0.057 P=0.034 * P=0.011 * |
|POLY 1.5 | P=0.207 P=0.096 P=0.004 ** P=0.209 |P=0.019 * P=0.063 P=0.040 * P=0.016 * |
|POLY 6 | P=0.247 P=0.067 P=0.003 ** P=0.223 |P=0.008 ** P=0.051 P=0.026 * P=0.008 ** |
|LOGISTIC REGRESSION| P=0.308 P=0.038 * P=0.003 ** P=0.215 |P=0.008 ** P=0.048 * P=0.015 * P=0.007 ** |
|COCH-ARM / FISHERS | P=0.256 P=0.124 P=0.007 ** P=0.242 |P=0.059 P=0.104 P=0.072 P=0.048 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Developmental Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/42 (100%) 10/10 (100%) 1/1 (100%) 3/3 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 30/30 (100%) 7/7 (100%) 1/1 (100%) 3/3 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 520 522 722 (T) 722 (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) |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/48 (17%) 7/49 (14%) 9/44 (20%) 8/50 (16%) |16/45 (36%) 16/49 (33%) 17/44 (39%) 22/43 (51%) |
|POLY-3 ADJUSTED (b)| 18.6% 17.2% 23.0% 18.5% |40.6% 37.4% 45.7% 61.1% |
|TERMINAL (d) | 8/35 (23%) 6/27 (22%) 9/33 (27%) 7/35 (20%) |14/32 (44%) 9/30 (30%) 14/22 (64%) 16/29 (55%) |
|FIRST INCIDENCE | 722 (T) 676 722 (T) 699 |644 555 633 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N P=0.519 P=0.445 P=0.609 |P=0.044 * P=0.505 P=0.095 P=0.078 |
|POLY 3 | P=0.514 P=0.546N P=0.417 P=0.602N |P=0.024 * P=0.470N P=0.411 P=0.057 |
|POLY 1.5 | P=0.497 P=0.523N P=0.411 P=0.608N |P=0.025 * P=0.481N P=0.428 P=0.056 |
|POLY 6 | P=0.541 P=0.576N P=0.426 P=0.591N |P=0.025 * P=0.458N P=0.371 P=0.065 |
|LOGISTIC REGRESSION| P=0.533N P=0.582 P=0.445 P=0.592N |P=0.017 * P=0.523N P=0.313 P=0.041 * |
|COCH-ARM / FISHERS | P=0.524 P=0.482N P=0.421 P=0.572N |P=0.050 P=0.468N P=0.468 P=0.103 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/48 (6%) 3/50 (6%) 5/47 (11%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |7.3% 7.4% 13.0% 5.2% |
|TERMINAL (d) | |3/32 (9%) 1/30 (3%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | |729 (T) 674 642 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.511N P=0.637 P=0.209 P=0.545N |
|POLY 3 | |P=0.488N P=0.659 P=0.321 P=0.528N |
|POLY 1.5 | |P=0.474N P=0.660 P=0.327 P=0.519N |
|POLY 6 | |P=0.500N P=0.658 P=0.309 P=0.536N |
|LOGISTIC REGRESSION| |P=0.489N P=0.653 P=0.298 P=0.545N |
|COCH-ARM / FISHERS | |P=0.428N P=0.641N P=0.345 P=0.480N |
|=================================================================================================================================|
Date: 09/29/97 EXPERIMENT: 55301 TEST: 04 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PYRIDINE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |44/48 (92%) 43/50 (86%) 38/47 (81%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| |98.6% 95.5% 90.6% 86.7% |
|TERMINAL (d) | |32/32 (100%) 29/30 (97%) 22/22 (100%) 26/29 (90%) |
|FIRST INCIDENCE | |476 372 556 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.495N P=0.442 P=0.181 P=0.518N |
|POLY 3 | |P=0.009N** P=0.387N P=0.084N P=0.027N* |
|POLY 1.5 | |P=0.015N* P=0.416N P=0.088N P=0.038N* |
|POLY 6 | |P=0.006N** P=0.407N P=0.098N P=0.023N* |
|LOGISTIC REGRESSION| |P=0.091N P=0.541N P=0.089N P=0.142N |
|COCH-ARM / FISHERS | |P=0.040N* P=0.286N P=0.108N P=0.054N |
|=================================================================================================================================|
(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).