TDMS Study 55301-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: TSI Mason Research PYRIDINE DATE: 09/26/97
EXPERIMENT: 55301 TEST: 04 TIME: 13:39:39
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: TSI Mason Research PYRIDINE DATE: 09/26/97
EXPERIMENT: 55301 TEST: 04 TIME: 13:39:39
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
----- ----------
Harderian Gland Carcinoma or Adenoma
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Ovary Cystadenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Hemangioma
Hemangiosarcoma or Hemangioma
Mesothelioma: Benign, Malignant, NOS
Benign Tumors
Malignant Tumors
===============================================================
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 1
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |1/49 (2%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.8% 0.0% 0.0% 2.4% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/27 (0%) 0/34 (0%) 1/34 (3%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 598 --- --- 722 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244N P=0.164N P=0.129N P=0.318N |P=0.327N P=0.513N P=0.575N P=0.520N |
|POLY 3 | P=0.234N P=0.134N P=0.126N P=0.321N |P=0.294N P=0.506N P=0.517N P=0.516N |
|POLY 1.5 | P=0.239N P=0.128N P=0.124N P=0.322N |P=0.296N P=0.506N P=0.515N P=0.512N |
|POLY 6 | P=0.229N P=0.142N P=0.127N P=0.318N |P=0.294N P=0.507N P=0.522N P=0.519N |
|LOGISTIC REGRESSION| P=0.252N P=0.123N P=0.121N P=0.314N |P=0.327N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.121N P=0.121N P=0.309N |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 |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.7% 0.0% 0.0% 2.3% |0.0% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/28 (0%) 0/35 (0%) 1/35 (3%) |0/32 (0%) 1/30 (3%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 633 --- --- 722 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242N P=0.159N P=0.129N P=0.312N |P=0.583N P=0.487 (e) (e) |
|POLY 3 | P=0.235N P=0.133N P=0.125N P=0.320N |P=0.582N P=0.489 (e) (e) |
|POLY 1.5 | P=0.239N P=0.128N P=0.124N P=0.322N |P=0.579N P=0.490 (e) (e) |
|POLY 6 | P=0.229N P=0.141N P=0.127N P=0.316N |P=0.586N P=0.488 (e) (e) |
|LOGISTIC REGRESSION| P=0.252N P=0.126N P=0.123N P=0.316N |(e) P=0.487 (e) (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.121N P=0.121N P=0.309N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 2
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |2.3% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 0/35 (0%) 0/35 (0%) |1/32 (3%) 0/30 (0%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | 722 (T) --- --- --- |729 (T) --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112N P=0.288N P=0.238N P=0.238N |P=0.567 P=0.513N P=0.575N P=0.740 |
|POLY 3 | P=0.108N P=0.253N P=0.244N P=0.244N |P=0.585 P=0.511N P=0.515N P=0.738 |
|POLY 1.5 | P=0.109N P=0.248N P=0.243N P=0.246N |P=0.587 P=0.510N P=0.511N P=0.742 |
|POLY 6 | P=0.106N P=0.261N P=0.244N P=0.241N |P=0.582 P=0.512N P=0.521N P=0.735 |
|LOGISTIC REGRESSION| P=0.112N (e) (e) (e) |P=0.567 (e) (e) P=0.740 |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.1% 0.0% 0.0% 2.3% |2.3% 2.5% 0.0% 2.6% |
|TERMINAL (d) | 3/35 (9%) 0/28 (0%) 0/35 (0%) 1/35 (3%) |1/32 (3%) 1/30 (3%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | 633 --- --- 722 (T) |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060N P=0.056N P=0.037N* P=0.109N |P=0.643N P=0.748 P=0.575N P=0.740 |
|POLY 3 | P=0.052N P=0.038N* P=0.034N* P=0.111N |P=0.625N P=0.749 P=0.515N P=0.738 |
|POLY 1.5 | P=0.055N P=0.035N* P=0.033N* P=0.112N |P=0.623N P=0.750 P=0.511N P=0.742 |
|POLY 6 | P=0.050N P=0.041N* P=0.034N* P=0.108N |P=0.629N P=0.748 P=0.521N P=0.735 |
|LOGISTIC REGRESSION| P=0.063N P=0.040N* P=0.035N* P=0.110N |P=0.643N P=0.748 (e) P=0.740 |
|COCH-ARM / FISHERS | P=0.062N P=0.028N* P=0.028N* P=0.102N |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 3
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/48 (4%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 0/47 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 4.7% 2.3% |2.4% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 0/34 (0%) 1/35 (3%) |0/32 (0%) 1/30 (3%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 722 (T) 513 722 (T) |554 696 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376 P=0.455 P=0.235 P=0.500 |P=0.215N P=0.481 P=0.509N P=0.528N |
|POLY 3 | P=0.361 P=0.490 P=0.231 P=0.498 |P=0.208N P=0.485 P=0.521N P=0.523N |
|POLY 1.5 | P=0.354 P=0.495 P=0.230 P=0.496 |P=0.204N P=0.488 P=0.517N P=0.518N |
|POLY 6 | P=0.371 P=0.484 P=0.234 P=0.501 |P=0.213N P=0.482 P=0.528N P=0.527N |
|LOGISTIC REGRESSION| P=0.377 P=0.455 P=0.256 P=0.500 |P=0.193N P=0.505 P=0.489N P=0.469N |
|COCH-ARM / FISHERS | P=0.370 P=0.505 P=0.242 P=0.505 |P=0.191N P=0.508 P=0.510N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 4.7% 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 | 706 532 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.192N P=0.458 P=0.505N P=0.505N |(e) (e) (e) (e) |
|POLY 3 | P=0.196N P=0.482 P=0.511N P=0.507N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.196N P=0.487 P=0.509N P=0.508N |(e) (e) (e) (e) |
|POLY 6 | P=0.195N P=0.474 P=0.512N P=0.504N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.177N P=0.526 P=0.510N P=0.506N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.189N P=0.500 P=0.505N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 4
Statistical Analysis of Primary Tumors 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 |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 18/50 (36%) 22/49 (45%) 15/50 (30%) |1/49 (2%) 2/50 (4%) 9/50 (18%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 4.5% 41.2% 49.8% 34.4% |2.4% 4.9% 21.6% 39.6% |
|TERMINAL (d) | 2/35 (6%) 11/28 (39%) 17/34 (50%) 13/35 (37%) |1/32 (3%) 1/30 (3%) 3/22 (14%) 12/29 (41%) |
|FIRST INCIDENCE | 722 (T) 549 514 624 |729 (T) 599 564 510 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.482 P=0.005 ** P<0.001 ** |
|POLY 3 | P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.493 P=0.007 ** P<0.001 ** |
|POLY 1.5 | P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.492 P=0.007 ** P<0.001 ** |
|POLY 6 | P=0.006 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.494 P=0.007 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.010 * P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.496 P=0.009 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.508 P=0.009 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 40/50 (80%) 34/49 (69%) 39/50 (78%) |37/49 (76%) 39/50 (78%) 43/50 (86%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 63.2% 88.0% 75.7% 84.9% |82.5% 87.9% 97.3% 79.1% |
|TERMINAL (d) | 24/35 (69%) 27/28 (96%) 27/34 (79%) 31/35 (89%) |27/32 (84%) 27/30 (90%) 22/22 (100%) 23/29 (79%) |
|FIRST INCIDENCE | 520 522 513 406 |554 419 509 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179 P<0.001 ** P=0.165 P=0.035 * |P=0.417 P=0.267 P=0.003 ** P=0.520 |
|POLY 3 | P=0.031 * P=0.003 ** P=0.134 P=0.011 * |P=0.372N P=0.336 P=0.015 * P=0.442N |
|POLY 1.5 | P=0.025 * P=0.005 ** P=0.133 P=0.009 ** |P=0.350N P=0.326 P=0.022 * P=0.428N |
|POLY 6 | P=0.044 * P=0.002 ** P=0.143 P=0.016 * |P=0.380N P=0.344 P=0.011 * P=0.448N |
|LOGISTIC REGRESSION| P=0.025 * P=0.002 ** P=0.105 P=0.009 ** |P=0.450N P=0.288 P=0.023 * P=0.512N |
|COCH-ARM / FISHERS | P=0.060 P=0.015 * P=0.166 P=0.026 * |P=0.210N P=0.478 P=0.142 P=0.272N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 5
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 35/50 (70%) 41/49 (84%) 40/50 (80%) |13/49 (27%) 23/50 (46%) 33/50 (66%) 41/50 (82%) |
|POLY-3 ADJUSTED (b)| 32.3% 78.7% 89.9% 85.1% |29.8% 55.0% 78.1% 97.1% |
|TERMINAL (d) | 9/35 (26%) 23/28 (82%) 32/34 (94%) 28/35 (80%) |8/32 (25%) 18/30 (60%) 20/22 (91%) 29/29 (100%) |
|FIRST INCIDENCE | 574 522 513 406 |476 573 556 479 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 42/50 (84%) 45/49 (92%) 42/50 (84%) |13/49 (27%) 23/50 (46%) 36/50 (72%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 36.7% 91.3% 96.8% 89.4% |29.8% 55.0% 82.8% 99.0% |
|TERMINAL (d) | 11/35 (31%) 26/28 (93%) 34/34 (100%) 30/35 (86%) |8/32 (25%) 18/30 (60%) 20/22 (91%) 29/29 (100%) |
|FIRST INCIDENCE | 574 522 513 406 |476 573 556 479 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 6
Statistical Analysis of Primary Tumors 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 |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 45/50 (90%) 45/49 (92%) 47/50 (94%) |41/49 (84%) 42/50 (84%) 44/50 (88%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 78.0% 96.5% 96.8% 100.0% |89.9% 94.6% 98.4% 99.5% |
|TERMINAL (d) | 28/35 (80%) 28/28 (100%) 34/34 (100%) 35/35 (100%)|29/32 (91%) 29/30 (97%) 22/22 (100%) 29/29 (100%) |
|FIRST INCIDENCE | 520 522 513 406 |476 419 509 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.138 P=0.005 ** P=0.055 P=0.042 * |P=0.077 P=0.317 P=0.012 * P=0.120 |
|POLY 3 | P<0.001 ** P=0.004 ** P=0.004 ** P<0.001 ** |P=0.011 * P=0.323 P=0.081 P=0.045 * |
|POLY 1.5 | P<0.001 ** P=0.008 ** P=0.005 ** P<0.001 ** |P=0.020 * P=0.347 P=0.101 P=0.057 |
|POLY 6 | P<0.001 ** P=0.003 ** P=0.004 ** P<0.001 ** |P=0.011 * P=0.297 P=0.070 P=0.050 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P=0.005 ** P<0.001 ** |P=0.012 * P=0.349 P=0.120 P=0.038 * |
|COCH-ARM / FISHERS | P=0.005 ** P=0.033 * P=0.017 * P=0.006 ** |P=0.279 P=0.590 P=0.371 P=0.371 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 47/50 (94%) 46/49 (94%) 47/50 (94%) |41/49 (84%) 42/50 (84%) 45/50 (90%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 80.1% 98.9% 98.5% 100.0% |89.9% 94.6% 99.6% 99.5% |
|TERMINAL (d) | 29/35 (83%) 28/28 (100%) 34/34 (100%) 35/35 (100%)|29/32 (91%) 29/30 (97%) 22/22 (100%) 29/29 (100%) |
|FIRST INCIDENCE | 520 522 513 406 |476 419 509 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213 P=0.003 ** P=0.055 P=0.059 |P=0.075 P=0.317 P=0.008 ** P=0.120 |
|POLY 3 | P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |P=0.009 ** P=0.323 P=0.042 * P=0.045 * |
|POLY 1.5 | P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |P=0.015 * P=0.347 P=0.045 * P=0.057 |
|POLY 6 | P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |P=0.009 ** P=0.297 P=0.049 * P=0.050 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P=0.003 ** P<0.001 ** |P=0.010 * P=0.349 P=0.051 P=0.038 * |
|COCH-ARM / FISHERS | P=0.011 * P=0.011 * P=0.013 * P=0.011 * |P=0.265 P=0.590 P=0.264 P=0.371 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 7
Statistical Analysis of Primary Tumors 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/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 5/50 (10%) 8/49 (16%) 8/50 (16%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 27.0% 11.9% 18.5% 18.3% |4.7% 7.2% 0.0% 7.8% |
|TERMINAL (d) | 9/35 (26%) 4/28 (14%) 6/34 (18%) 6/35 (17%) |2/32 (6%) 1/30 (3%) 0/22 (0%) 2/29 (7%) |
|FIRST INCIDENCE | 520 546 526 639 |729 (T) 555 --- 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278N P=0.124N P=0.258N P=0.235N |P=0.447 P=0.476 P=0.324N P=0.450 |
|POLY 3 | P=0.303N P=0.065N P=0.245N P=0.239N |P=0.463 P=0.486 P=0.254N P=0.455 |
|POLY 1.5 | P=0.317N P=0.059N P=0.243N P=0.244N |P=0.471 P=0.483 P=0.250N P=0.463 |
|POLY 6 | P=0.279N P=0.075N P=0.245N P=0.227N |P=0.455 P=0.491 P=0.261N P=0.450 |
|LOGISTIC REGRESSION| P=0.317N P=0.062N P=0.241N P=0.233N |P=0.473 P=0.493 (e) P=0.444 |
|COCH-ARM / FISHERS | P=0.303N P=0.049N* P=0.226N P=0.212N |P=0.500 P=0.500 P=0.247N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.8% 2.4% 2.3% |4.7% 2.5% 5.0% 7.6% |
|TERMINAL (d) | 0/35 (0%) 2/28 (7%) 1/34 (3%) 1/35 (3%) |1/32 (3%) 1/30 (3%) 1/22 (5%) 0/29 (0%) |
|FIRST INCIDENCE | 672 722 (T) 722 (T) 722 (T) |662 729 (T) 727 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N P=0.442 P=0.751 P=0.755N |P=0.278 P=0.524N P=0.580 P=0.455 |
|POLY 3 | P=0.535N P=0.481 P=0.753 P=0.757 |P=0.287 P=0.521N P=0.665 P=0.460 |
|POLY 1.5 | P=0.538N P=0.490 P=0.755 P=0.756 |P=0.291 P=0.518N P=0.672 P=0.466 |
|POLY 6 | P=0.531N P=0.468 P=0.752 P=0.760 |P=0.285 P=0.524N P=0.652 P=0.458 |
|LOGISTIC REGRESSION| P=0.518N P=0.475 P=0.758 P=0.761 |P=0.285 P=0.518N P=0.661 P=0.481 |
|COCH-ARM / FISHERS | P=0.526N P=0.508 P=0.753N P=0.747N |P=0.313 P=0.500N P=0.691N P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 8
Statistical Analysis of Primary Tumors 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/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 7/50 (14%) 9/49 (18%) 8/50 (16%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 29.1% 16.6% 20.8% 18.3% |9.3% 9.6% 5.0% 12.7% |
|TERMINAL (d) | 9/35 (26%) 6/28 (21%) 7/34 (21%) 6/35 (17%) |3/32 (9%) 2/30 (7%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | 520 546 526 639 |662 555 727 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175N P=0.221N P=0.270N P=0.172N |P=0.382 P=0.609 P=0.495N P=0.439 |
|POLY 3 | P=0.197N P=0.130N P=0.258N P=0.174N |P=0.399 P=0.624 P=0.374N P=0.445 |
|POLY 1.5 | P=0.208N P=0.116N P=0.254N P=0.178N |P=0.408 P=0.622 P=0.365N P=0.453 |
|POLY 6 | P=0.179N P=0.151N P=0.262N P=0.167N |P=0.392 P=0.627 P=0.391N P=0.442 |
|LOGISTIC REGRESSION| P=0.204N P=0.121N P=0.250N P=0.168N |P=0.407 P=0.627 P=0.395N P=0.448 |
|COCH-ARM / FISHERS | P=0.193N P=0.096N P=0.234N P=0.150N |P=0.446 P=0.643N P=0.339N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.4% 2.3% 0.0% |0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/35 (0%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 561 637 --- |--- 599 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.593N P=0.487 P=0.495 (e) |P=0.423N P=0.231 (e) (e) |
|POLY 3 | P=0.604N P=0.488 P=0.496 (e) |P=0.431N P=0.228 (e) (e) |
|POLY 1.5 | P=0.606N P=0.492 P=0.496 (e) |P=0.427N P=0.228 (e) (e) |
|POLY 6 | P=0.601N P=0.483 P=0.496 (e) |P=0.436N P=0.230 (e) (e) |
|LOGISTIC REGRESSION| P=0.571N P=0.535 P=0.510 (e) |P=0.403N P=0.241 (e) (e) |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 9
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |4/47 (9%) 3/49 (6%) 1/46 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |9.9% 7.6% 2.7% 0.0% |
|TERMINAL (d) | |4/32 (13%) 2/29 (7%) 1/21 (5%) 0/29 (0%) |
|FIRST INCIDENCE | |729 (T) 696 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.038N* P=0.551N P=0.324N P=0.075N |
|POLY 3 | |P=0.029N* P=0.513N P=0.210N P=0.069N |
|POLY 1.5 | |P=0.028N* P=0.508N P=0.204N P=0.066N |
|POLY 6 | |P=0.030N* P=0.520N P=0.220N P=0.072N |
|LOGISTIC REGRESSION| |P=0.034N* P=0.535N P=0.324N (e) |
|COCH-ARM / FISHERS | |P=0.024N* P=0.476N P=0.187N P=0.054N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/47 (0%) 0/45 (0%) 0/49 (0%) |8/47 (17%) 9/44 (20%) 6/42 (14%) 2/46 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |19.7% 25.0% 17.1% 5.7% |
|TERMINAL (d) | 0/34 (0%) 0/26 (0%) 0/32 (0%) 0/34 (0%) |8/31 (26%) 6/26 (23%) 5/21 (24%) 2/27 (7%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 608 700 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.044N* P=0.362 P=0.545 P=0.068N |
|POLY 3 | (e) (e) (e) (e) |P=0.041N* P=0.391 P=0.502N P=0.071N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.037N* P=0.391 P=0.490N P=0.066N |
|POLY 6 | (e) (e) (e) (e) |P=0.045N* P=0.395 P=0.520N P=0.075N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.041N* P=0.364 P=0.608N P=0.068N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.026N* P=0.440 P=0.477N P=0.049N* |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 10
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.7% 4.9% 7.4% 9.9% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 0/35 (0%) 0/35 (0%) |2/32 (6%) 1/30 (3%) 0/22 (0%) 1/29 (3%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 573 556 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.185 P=0.676 P=0.402 P=0.302 |
|POLY 3 | (e) (e) (e) (e) |P=0.197 P=0.679 P=0.477 P=0.311 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.200 P=0.679 P=0.480 P=0.313 |
|POLY 6 | (e) (e) (e) (e) |P=0.196 P=0.681 P=0.470 P=0.310 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.224 P=0.682 P=0.488 P=0.364 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.216 P=0.691N P=0.500 P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/50 (6%) 1/47 (2%) 1/49 (2%) |0/49 (0%) 0/50 (0%) 0/48 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 7.1% 2.4% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 2/28 (7%) 1/34 (3%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 722 (T) 532 722 (T) 722 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429N P=0.247 P=0.755 P=0.762 |(e) (e) (e) (e) |
|POLY 3 | P=0.459N P=0.292 P=0.748 P=0.755 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.463N P=0.299 P=0.748 P=0.752 |(e) (e) (e) (e) |
|POLY 6 | P=0.451N P=0.283 P=0.750 P=0.759 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.454N P=0.309 P=0.755 P=0.762 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.449N P=0.316 P=0.742 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 11
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 4.6% 4.8% 4.7% 4.6% |7.0% 4.9% 7.6% 7.8% |
|TERMINAL (d) | 2/35 (6%) 1/28 (4%) 2/34 (6%) 2/35 (6%) |3/32 (9%) 1/30 (3%) 3/22 (14%) 3/29 (10%) |
|FIRST INCIDENCE | 722 (T) 677 722 (T) 722 (T) |729 (T) 674 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565N P=0.625 P=0.685 P=0.695 |P=0.462 P=0.526N P=0.481 P=0.618 |
|POLY 3 | P=0.595N P=0.678 P=0.683 P=0.690 |P=0.472 P=0.522N P=0.628 P=0.615 |
|POLY 1.5 | P=0.588 P=0.686 P=0.685 P=0.687 |P=0.483 P=0.522N P=0.636 P=0.624 |
|POLY 6 | P=0.586N P=0.667 P=0.682 P=0.693N |P=0.463 P=0.522N P=0.614 P=0.609 |
|LOGISTIC REGRESSION| P=0.572N P=0.662 P=0.685 P=0.695 |P=0.456 P=0.527N P=0.481 P=0.618 |
|COCH-ARM / FISHERS | P=0.591N P=0.684N P=0.691N P=0.684N |P=0.521 P=0.500N P=0.661N P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.6% 2.5% 0.0% 0.0% |
|TERMINAL (d) | |0/32 (0%) 1/30 (3%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | |151 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.118N P=0.519N P=0.275N P=0.259N |
|POLY 3 | |P=0.105N P=0.527N P=0.259N P=0.266N |
|POLY 1.5 | |P=0.103N P=0.524N P=0.255N P=0.261N |
|POLY 6 | |P=0.106N P=0.530N P=0.267N P=0.270N |
|LOGISTIC REGRESSION| |P=0.084N P=0.443N P=0.165N P=0.154N |
|COCH-ARM / FISHERS | |P=0.101N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 12
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.2% 4.6% 2.3% |0.0% 0.0% 2.5% 7.7% |
|TERMINAL (d) | 0/35 (0%) 1/28 (4%) 2/35 (6%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | --- 680 722 (T) 722 (T) |--- --- 729 (T) 615 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.580 P=0.095 P=0.238 P=0.500 |P=0.018 * (e) P=0.425 P=0.105 |
|POLY 3 | P=0.536 P=0.107 P=0.231 P=0.493 |P=0.017 * (e) P=0.485 P=0.103 |
|POLY 1.5 | P=0.531 P=0.111 P=0.232 P=0.492 |P=0.017 * (e) P=0.489 P=0.105 |
|POLY 6 | P=0.545 P=0.102 P=0.230 P=0.497 |P=0.016 * (e) P=0.479 P=0.101 |
|LOGISTIC REGRESSION| P=0.566 P=0.103 P=0.238 P=0.500 |P=0.017 * (e) P=0.425 P=0.107 |
|COCH-ARM / FISHERS | P=0.556 P=0.121 P=0.247 P=0.500 |P=0.020 * (e) P=0.500 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 9.4% 4.6% 2.3% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 1/35 (3%) 2/28 (7%) 1/35 (3%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 706 532 630 722 (T) |--- --- 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254N P=0.265 P=0.688 P=0.503N |P=0.674 (e) P=0.443 (e) |
|POLY 3 | P=0.276N P=0.313 P=0.686 P=0.512N |P=0.659 (e) P=0.485 (e) |
|POLY 1.5 | P=0.279N P=0.321 P=0.686 P=0.514N |P=0.666 (e) P=0.489 (e) |
|POLY 6 | P=0.269N P=0.303 P=0.687 P=0.507N |P=0.656 (e) P=0.479 (e) |
|LOGISTIC REGRESSION| P=0.268N P=0.333 P=0.688 P=0.501N |P=0.677 (e) P=0.464 (e) |
|COCH-ARM / FISHERS | P=0.263N P=0.339 P=0.691N P=0.500N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 13
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 4.5% 16.4% 9.2% 2.3% |0.0% 0.0% 5.0% 7.7% |
|TERMINAL (d) | 1/35 (3%) 3/28 (11%) 3/35 (9%) 1/35 (3%) |0/32 (0%) 0/30 (0%) 1/22 (5%) 2/29 (7%) |
|FIRST INCIDENCE | 706 532 630 722 (T) |--- --- 723 615 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188N P=0.053 P=0.336 P=0.503N |P=0.025 * (e) P=0.171 P=0.105 |
|POLY 3 | P=0.215N P=0.067 P=0.327 P=0.512N |P=0.022 * (e) P=0.221 P=0.103 |
|POLY 1.5 | P=0.219N P=0.071 P=0.328 P=0.514N |P=0.023 * (e) P=0.225 P=0.105 |
|POLY 6 | P=0.206N P=0.062 P=0.327 P=0.507N |P=0.022 * (e) P=0.214 P=0.101 |
|LOGISTIC REGRESSION| P=0.207N P=0.073 P=0.324 P=0.501N |P=0.023 * (e) P=0.187 P=0.107 |
|COCH-ARM / FISHERS | P=0.200N P=0.080 P=0.339 P=0.500N |P=0.028 * (e) P=0.247 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 4.7% 2.3% 0.0% |4.5% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/35 (3%) 0/35 (0%) |0/32 (0%) 2/30 (7%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | 653 237 722 (T) --- |375 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245N P=0.477 P=0.755 P=0.500N |P=0.105N P=0.666 P=0.252N P=0.266N |
|POLY 3 | P=0.258N P=0.483 P=0.753 P=0.508N |P=0.096N P=0.664 P=0.260N P=0.267N |
|POLY 1.5 | P=0.259N P=0.490 P=0.755 P=0.509N |P=0.094N P=0.669 P=0.254N P=0.260N |
|POLY 6 | P=0.255N P=0.473 P=0.752 P=0.506N |P=0.100N P=0.659 P=0.270N P=0.273N |
|LOGISTIC REGRESSION| P=0.200N P=0.588 P=0.760 P=0.495N |P=0.081N P=0.679N P=0.187N P=0.179N |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |P=0.086N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 14
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 4/50 (8%) 1/50 (2%) |8/50 (16%) 9/50 (18%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 8.8% 11.5% 9.0% 2.3% |18.0% 22.0% 9.8% 15.3% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 3/35 (9%) 1/35 (3%) |2/32 (6%) 7/30 (23%) 0/22 (0%) 5/29 (17%) |
|FIRST INCIDENCE | 542 237 226 722 (T) |375 599 624 510 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.437 P=0.633 P=0.187N |P=0.328N P=0.441 P=0.285N P=0.481N |
|POLY 3 | P=0.125N P=0.474 P=0.629 P=0.194N |P=0.298N P=0.428 P=0.221N P=0.483N |
|POLY 1.5 | P=0.126N P=0.484 P=0.634 P=0.195N |P=0.282N P=0.440 P=0.211N P=0.462N |
|POLY 6 | P=0.122N P=0.461 P=0.623 P=0.193N |P=0.316N P=0.413 P=0.237N P=0.505N |
|LOGISTIC REGRESSION| P=0.086N P=0.568 P=0.613N P=0.179N |P=0.267N P=0.469 P=0.181N P=0.418N |
|COCH-ARM / FISHERS | P=0.112N P=0.500 P=0.643N P=0.181N |P=0.231N P=0.500 P=0.178N P=0.387N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |6/50 (12%) 7/50 (14%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 6.6% 7.1% 6.8% 2.3% |13.9% 17.1% 9.8% 15.3% |
|TERMINAL (d) | 2/35 (6%) 0/28 (0%) 2/35 (6%) 1/35 (3%) |2/32 (6%) 5/30 (17%) 0/22 (0%) 5/29 (17%) |
|FIRST INCIDENCE | 542 595 226 722 (T) |687 599 624 510 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.602 P=0.656 P=0.312N |P=0.535 P=0.450 P=0.499N P=0.535 |
|POLY 3 | P=0.233N P=0.632 P=0.653 P=0.322N |P=0.546N P=0.460 P=0.407N P=0.554 |
|POLY 1.5 | P=0.236N P=0.642 P=0.656 P=0.323N |P=0.533N P=0.463 P=0.401N P=0.566 |
|POLY 6 | P=0.227N P=0.621 P=0.651 P=0.318N |P=0.557 P=0.455 P=0.420N P=0.542 |
|LOGISTIC REGRESSION| P=0.201N P=0.650N P=0.627N P=0.308N |P=0.543N P=0.458 P=0.401N P=0.557 |
|COCH-ARM / FISHERS | P=0.221N P=0.661N P=0.661N P=0.309N |P=0.485N P=0.500 P=0.370N P=0.620N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 15
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% 2.3% |0.0% 0.0% 0.0% 5.1% |
|TERMINAL (d) | 0/35 (0%) 0/28 (0%) 1/35 (3%) 0/35 (0%) |0/32 (0%) 0/30 (0%) 0/22 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- 722 (T) 699 |--- --- --- 615 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252 (e) P=0.500 P=0.500 |P=0.043 * (e) (e) P=0.220 |
|POLY 3 | P=0.234 (e) P=0.494 P=0.494 |P=0.042 * (e) (e) P=0.218 |
|POLY 1.5 | P=0.230 (e) P=0.495 P=0.492 |P=0.043 * (e) (e) P=0.221 |
|POLY 6 | P=0.243 (e) P=0.494 P=0.497 |P=0.042 * (e) (e) P=0.218 |
|LOGISTIC REGRESSION| P=0.240 (e) P=0.500 P=0.494 |P=0.046 * (e) (e) P=0.236 |
|COCH-ARM / FISHERS | P=0.236 (e) P=0.500 P=0.500 |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 42/50 (84%) 36/50 (72%) 39/50 (78%) |40/50 (80%) 41/50 (82%) 43/50 (86%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 74.7% 91.2% 77.4% 84.9% |85.5% 91.5% 97.3% 83.7% |
|TERMINAL (d) | 27/35 (77%) 27/28 (96%) 28/35 (80%) 31/35 (89%) |28/32 (88%) 28/30 (93%) 22/22 (100%) 25/29 (86%) |
|FIRST INCIDENCE | 520 522 513 406 |151 419 509 430 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504N P=0.009 ** P=0.479 P=0.276 |P=0.476 P=0.325 P=0.013 * P=0.569N |
|POLY 3 | P=0.275 P=0.023 * P=0.476 P=0.157 |P=0.445N P=0.275 P=0.035 * P=0.527N |
|POLY 1.5 | P=0.248 P=0.033 * P=0.465 P=0.145 |P=0.397N P=0.259 P=0.052 P=0.495N |
|POLY 6 | P=0.313 P=0.016 * P=0.492 P=0.175 |P=0.473N P=0.307 P=0.026 * P=0.540N |
|LOGISTIC REGRESSION| P=0.240 P=0.018 * P=0.418 P=0.131 |P=0.385N P=0.303 P=0.105 P=0.467N |
|COCH-ARM / FISHERS | P=0.368 P=0.077 P=0.500 P=0.247 |P=0.169N P=0.500 P=0.298 P=0.241N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55301 TEST: 04 Page 16
Statistical Analysis of Primary Tumors 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 |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 46/50 (92%) 47/50 (94%) 42/50 (84%) |26/50 (52%) 30/50 (60%) 40/50 (80%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 46.5% 94.8% 96.4% 89.4% |56.0% 69.7% 90.1% 99.2% |
|TERMINAL (d) | 13/35 (37%) 26/28 (93%) 34/35 (97%) 30/35 (86%) |14/32 (44%) 20/30 (67%) 20/22 (91%) 29/29 (100%) |
|FIRST INCIDENCE | 542 237 226 406 |375 573 556 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.217 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.128 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.145 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.117 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.190 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.273 P=0.003 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 250 PPM 500 PPM 1000 PPM |0 PPM 125 PPM 250 PPM 500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 49/50 (98%) 48/50 (96%) 47/50 (94%) |47/50 (94%) 45/50 (90%) 45/50 (90%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 88.7% 100.0% 98.0% 100.0% |96.5% 99.7% 99.6% 99.7% |
|TERMINAL (d) | 31/35 (89%) 28/28 (100%) 34/35 (97%) 35/35 (100%)|31/32 (97%) 30/30 (100%) 22/22 (100%) 29/29 (100%) |
|FIRST INCIDENCE | 520 237 226 406 |151 419 509 299 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.531 P=0.015 * P=0.212 P=0.280 |P=0.273 P=0.509 P=0.069 P=0.382 |
|POLY 3 | P=0.009 ** P=0.018 * P=0.069 P=0.021 * |P=0.174 P=0.348 P=0.366 P=0.347 |
|POLY 1.5 | P=0.008 ** P=0.015 * P=0.060 P=0.018 * |P=0.270 P=0.416 P=0.442 P=0.418 |
|POLY 6 | P=0.012 * P=0.022 * P=0.084 P=0.025 * |P=0.164 P=0.358 P=0.364 P=0.357 |
|LOGISTIC REGRESSION| P=0.023 * P=0.010 * P=0.043 * P=0.022 * |P=0.427 P=0.691N P=0.657N P=0.637 |
|COCH-ARM / FISHERS | P=0.178 P=0.030 * P=0.080 P=0.159 |P=0.338N P=0.357N P=0.357N P=0.357N |
|=================================================================================================================================|
(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).