TDMS Study 61427-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 07 TIME: 10:12:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#2/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 07 TIME: 10:12:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF VANADIUM PENTOXIDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Hyperplasia
Kidney Nephropathy Chronic
Larynx Inflammation
Inflammation Chronic
Larynx: Respiratory Epithelium, Epiglottis
Degeneration
Hyperplasia
Metaplasia
Liver Hepatodiaphragmatic Nodule
Inflammation Granulomatous
Liver: Portal Inflammation Chronic
Pigmentation
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Metaplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Pigmentation
Lung: Bronchiole Hyperplasia
Metaplasia
Lung: Interstitium Fibrosis
Lymph Node, Bronchial Pigmentation
Lymph Node, Mediastinal Inflammation Granulomatous
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Pancreas: Acinus Hyperplasia
Pancreas: Artery Inflammation
Skin Cyst
Spleen Fibrosis
Hematopoietic Cell Proliferation
Hemorrhage
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Brain Hemorrhage
Kidney Nephropathy Chronic
Larynx Inflammation Chronic
Larynx: Respiratory Epithelium, Epiglottis
Degeneration
Hyperplasia
Metaplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 07 TIME: 10:12:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: RENNE, ROGER MILLER, RODNEY CAS: 1314-62-1
Liver Clear Cell Focus
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Metaplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Pigmentation
Lung: Bronchiole Hyperplasia
Lung: Interstitium Fibrosis
Lymph Node, Bronchial Pigmentation
Lymph Node, Mediastinal Pigmentation
Mammary Gland: Epithelium Hyperplasia
Nose Inflammation
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Ovary Cyst
Pituitary Gland: Pars Distalis Hyperplasia
Spleen Accessory Spleen
Stomach, Forestomach Ulcer
Tongue: Epithelium Hyperplasia
Uterus: Endometrium Hyperplasia
===============================================================
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/40.13 0/42.57 0/42.93 1/41.56 |0/42.75 2/42.98 1/43.54 1/43.19 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 2.4% |0.0% 4.7% 2.3% 2.3% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 652 --- --- 538 |--- 499 139 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.598 P=0.457N P=0.447N P=0.754N |P=0.499 P=0.242 P=0.500 P=0.500 |
|POLY 3 | P=0.592 P=0.488N P=0.487N P=0.753N |P=0.500 P=0.238 P=0.504 P=0.502 |
|POLY 1.5 | P=0.593 P=0.495N P=0.495N P=0.758N |P=0.504 P=0.241 P=0.505 P=0.504 |
|POLY 6 | P=0.590 P=0.475N P=0.474N P=0.744N |P=0.494 P=0.233 P=0.501 P=0.499 |
|LOGISTIC REGRESSION| P=0.598 P=0.503N P=0.524N P=0.752N |P=0.472 P=0.198 (e) P=0.471 |
|COCH-ARM / FISHERS | P=0.594 P=0.500N P=0.505N P=0.753N |P=0.505 P=0.253 P=0.505 P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 7/49 (14%) 5/50 (10%) |9/49 (18%) 7/50 (14%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 9/42.03 5/43.54 7/44.47 5/42.28 |9/43.99 7/42.82 4/43.32 3/43.32 |
|POLY-3 PERCENT (g) | 21.4% 11.5% 15.7% 11.8% |20.5% 16.4% 9.2% 6.9% |
|TERMINAL (d) | 2/20 (10%) 3/29 (10%) 3/26 (12%) 2/27 (7%) |5/33 (15%) 4/24 (17%) 2/29 (7%) 1/30 (3%) |
|FIRST INCIDENCE | 589 493 519 561 |519 499 499 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175N P=0.113N P=0.250N P=0.158N |P=0.045N* P=0.573N P=0.171N P=0.092N |
|POLY 3 | P=0.217N P=0.170N P=0.344N P=0.185N |P=0.032N* P=0.414N P=0.119N P=0.061N |
|POLY 1.5 | P=0.219N P=0.183N P=0.372N P=0.191N |P=0.031N* P=0.394N P=0.115N P=0.058N |
|POLY 6 | P=0.212N P=0.148N P=0.304N P=0.171N |P=0.033N* P=0.447N P=0.128N P=0.068N |
|LOGISTIC REGRESSION| P=0.221N P=0.201N P=0.474N P=0.195N |P=0.031N* P=0.378N P=0.109N P=0.056N |
|COCH-ARM / FISHERS | P=0.219N P=0.194N P=0.410N P=0.194N |P=0.031N* P=0.376N P=0.109N P=0.056N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 8/50 (16%) 12/49 (24%) 10/50 (20%) |2/49 (4%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 16/42.66 8/43.13 12/43.98 10/42.07 |2/42.75 2/41.76 1/42.57 5/42.68 |
|POLY-3 PERCENT (g) | 37.5% 18.6% 27.3% 23.8% |4.7% 4.8% 2.4% 11.7% |
|TERMINAL (d) | 6/20 (30%) 6/29 (21%) 7/26 (27%) 6/27 (22%) |2/33 (6%) 1/24 (4%) 0/29 (0%) 4/30 (13%) |
|FIRST INCIDENCE | 561 584 519 629 |731 (T) 717 725 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120N P=0.012N* P=0.097N P=0.064N |P=0.117 P=0.584 P=0.541N P=0.181 |
|POLY 3 | P=0.200N P=0.039N* P=0.212N P=0.124N |P=0.114 P=0.686 P=0.502N P=0.214 |
|POLY 1.5 | P=0.200N P=0.045N* P=0.238N P=0.127N |P=0.116 P=0.694 P=0.498N P=0.220 |
|POLY 6 | P=0.196N P=0.031N* P=0.181N P=0.114N |P=0.113 P=0.673 P=0.507N P=0.207 |
|LOGISTIC REGRESSION| P=0.187N P=0.039N* P=0.221N P=0.115N |P=0.110 P=0.635 P=0.531N P=0.194 |
|COCH-ARM / FISHERS | P=0.199N P=0.050N P=0.272N P=0.127N |P=0.117 P=0.684N P=0.492N P=0.226 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/49 (4%) 4/50 (8%) |3/50 (6%) 6/50 (12%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/40.90 3/43.72 2/43.38 4/42.33 |3/45.06 6/44.17 3/43.09 0/42.54 |
|POLY-3 PERCENT (g) | 12.2% 6.9% 4.6% 9.5% |6.7% 13.6% 7.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 636 493 655 578 |519 408 661 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.246N P=0.128N P=0.436N |P=0.066N P=0.232 P=0.637 P=0.135N |
|POLY 3 | P=0.458N P=0.319N P=0.192N P=0.478N |P=0.063N P=0.232 P=0.642 P=0.129N |
|POLY 1.5 | P=0.461N P=0.339N P=0.207N P=0.491N |P=0.058N P=0.239 P=0.649 P=0.124N |
|POLY 6 | P=0.453N P=0.286N P=0.170N P=0.451N |P=0.070N P=0.220 P=0.631 P=0.136N |
|LOGISTIC REGRESSION| P=0.464N P=0.366N P=0.236N P=0.501N |P=0.049N* P=0.247 P=0.645N P=0.120N |
|COCH-ARM / FISHERS | P=0.464N P=0.357N P=0.226N P=0.500N |P=0.054N P=0.243 P=0.661N P=0.121N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 3/50 (6%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | |1/43.71 3/42.25 1/42.07 1/42.54 |
|POLY-3 PERCENT (g) | |2.3% 7.1% 2.4% 2.4% |
|TERMINAL (d) | |1/33 (3%) 1/24 (4%) 1/29 (3%) 1/30 (3%) |
|FIRST INCIDENCE | |731 (T) 582 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.453N P=0.229 P=0.733 P=0.741 |
|POLY 3 | |P=0.456N P=0.293 P=0.752 P=0.755 |
|POLY 1.5 | |P=0.451N P=0.300 P=0.753 P=0.758 |
|POLY 6 | |P=0.464N P=0.282 P=0.750 P=0.750 |
|LOGISTIC REGRESSION| |P=0.450N P=0.301 P=0.733 P=0.741 |
|COCH-ARM / FISHERS | |P=0.445N P=0.309 P=0.747 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/50 (6%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |2/43.71 3/42.25 0/42.07 2/42.54 |
|POLY-3 PERCENT (g) | |4.6% 7.1% 0.0% 4.7% |
|TERMINAL (d) | |2/33 (6%) 1/24 (4%) 0/29 (0%) 2/30 (7%) |
|FIRST INCIDENCE | |731 (T) 582 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.482N P=0.388 P=0.267N P=0.661 |
|POLY 3 | |P=0.482N P=0.485 P=0.246N P=0.684 |
|POLY 1.5 | |P=0.479N P=0.493 P=0.244N P=0.689 |
|POLY 6 | |P=0.486N P=0.471 P=0.248N P=0.677 |
|LOGISTIC REGRESSION| |P=0.481N P=0.488 (e) P=0.661 |
|COCH-ARM / FISHERS | |P=0.475N P=0.500 P=0.253N P=0.691N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 2/3 (67%) 1/2 (50%) 2/3 (67%) |3/3 (100%) 0/0 (0%) 0/2 (0%) 3/3 (100%) |
|POLY-3 RATE (b) | 0/1.00 2/3.00 1/1.73 2/3.00 |3/3.00 0/0.00 0/1.01 3/3.00 |
|POLY-3 PERCENT (g) | 0.0% 66.7% 58.0% 66.7% |100.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/1 (0%) 1/2 (50%) 0/0 (0%) 2/3 (67%) |2/2 (100%) 0/0 (0%) 0/1 (0%) 2/2 (100%) |
|FIRST INCIDENCE | --- 709 680 729 (T) |638 --- --- 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.462 P=0.366 P=0.590 P=0.500 |P=0.567 (e) P=0.180N (e) |
|POLY 3 | P=0.432 P=0.500 P=0.601 P=0.500 |(e) (e) P=0.233N (e) |
|POLY 1.5 | P=0.432 P=0.500 P=0.607 P=0.500 |(e) (e) P=0.172N (e) |
|POLY 6 | P=0.430 P=0.500 P=0.587 P=0.500 |(e) (e) P=0.238N (e) |
|LOGISTIC REGRESSION| P=0.429 (e) P=0.985 P=0.500 |P=0.688 (e) P=0.201N (e) |
|COCH-ARM / FISHERS | P=0.418 P=0.500 P=0.667 P=0.500 |P=0.681 (e) P=0.100N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 7/49 (14%) 7/50 (14%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/41.34 7/44.35 7/44.24 7/42.44 |3/43.71 1/42.11 1/43.02 2/42.83 |
|POLY-3 PERCENT (g) | 16.9% 15.8% 15.8% 16.5% |6.9% 2.4% 2.3% 4.7% |
|TERMINAL (d) | 4/20 (20%) 3/29 (10%) 4/26 (15%) 2/27 (7%) |3/33 (9%) 0/24 (0%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 477 485 528 558 |731 (T) 612 589 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470N P=0.444N P=0.462N P=0.485N |P=0.480N P=0.403N P=0.343N P=0.539N |
|POLY 3 | P=0.548N P=0.559N P=0.561N P=0.594N |P=0.473N P=0.318N P=0.311N P=0.509N |
|POLY 1.5 | P=0.555N P=0.589N P=0.593N P=0.608N |P=0.474N P=0.312N P=0.309N P=0.504N |
|POLY 6 | P=0.530N P=0.503N P=0.509N P=0.560N |P=0.471N P=0.329N P=0.314N P=0.516N |
|LOGISTIC REGRESSION| P=0.551 P=0.599 P=0.556 P=0.612 |P=0.474N P=0.316N P=0.309N P=0.519N |
|COCH-ARM / FISHERS | P=0.553 P=0.613N P=0.597 P=0.613N |P=0.474N P=0.309N P=0.309N P=0.500N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.80 0/42.57 2/43.55 0/40.96 |0/43.71 0/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 4.9% 0.0% 4.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 561 --- 528 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.247N P=0.661N P=0.255N |(e) (e) (e) (e) |
|POLY 3 | P=0.253N P=0.227N P=0.671N P=0.236N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.251N P=0.233N P=0.685N P=0.238N |(e) (e) (e) (e) |
|POLY 6 | P=0.257N P=0.216N P=0.648N P=0.230N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.246N P=0.219N P=0.616 P=0.216N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.247N P=0.684 P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 42/50 (84%) 46/49 (94%) 47/50 (94%) |24/50 (48%) 21/50 (42%) 20/49 (41%) 32/50 (64%) |
|POLY-3 RATE (b) | 36/44.96 42/47.06 46/47.81 47/48.29 |24/44.54 21/44.12 20/44.36 32/47.19 |
|POLY-3 PERCENT (g) | 80.1% 89.2% 96.2% 97.3% |53.9% 47.6% 45.1% 67.8% |
|TERMINAL (d) | 17/20 (85%) 27/29 (93%) 26/26 (100%) 27/27 (100%)|20/33 (61%) 13/24 (54%) 13/29 (45%) 17/30 (57%) |
|FIRST INCIDENCE | 561 485 519 332 |638 408 572 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236 P=0.230N P=0.548N P=0.389 |P=0.053 P=0.352 P=0.456N P=0.057 |
|POLY 3 | P<0.001 ** P=0.150 P=0.007 ** P=0.003 ** |P=0.058 P=0.350N P=0.265N P=0.118 |
|POLY 1.5 | P<0.001 ** P=0.117 P=0.004 ** P=0.002 ** |P=0.047 * P=0.338N P=0.283N P=0.099 |
|POLY 6 | P=0.002 ** P=0.238 P=0.019 * P=0.005 ** |P=0.077 P=0.375N P=0.251N P=0.151 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.134 P=0.010 * P=0.002 ** |P=0.034 * P=0.428N P=0.316N P=0.064 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.114 P=0.004 ** P=0.003 ** |P=0.039 * P=0.344N P=0.303N P=0.079 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.85 0/42.57 0/42.93 0/40.96 |0/43.71 0/41.70 0/42.34 0/42.54 |
|POLY-3 PERCENT (g) | 4.9% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 373 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.108N P=0.211N P=0.204N P=0.226N |(e) (e) (e) (e) |
|POLY 3 | P=0.115N P=0.228N P=0.226N P=0.236N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.114N P=0.234N P=0.234N P=0.238N |(e) (e) (e) (e) |
|POLY 6 | P=0.120N P=0.214N P=0.213N P=0.229N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.110N P=0.183N P=0.296N P=0.186N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.253N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 0/40.96 |0/43.71 0/41.70 1/42.52 2/42.73 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.4% 4.7% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 683 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.070 (e) P=0.495 P=0.223 |
|POLY 3 | (e) (e) (e) (e) |P=0.070 (e) P=0.495 P=0.232 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.070 (e) P=0.495 P=0.235 |
|POLY 6 | (e) (e) (e) (e) |P=0.069 (e) P=0.493 P=0.228 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.070 (e) P=0.496 P=0.232 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.070 (e) P=0.495 P=0.247 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/50 (6%) 2/50 (4%) 2/49 (4%) |3/50 (6%) 6/49 (12%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/39.49 3/42.65 2/43.96 2/40.41 |3/45.43 6/42.63 0/42.34 1/43.32 |
|POLY-3 PERCENT (g) | 7.6% 7.0% 4.6% 5.0% |6.6% 14.1% 0.0% 2.3% |
|TERMINAL (d) | 1/20 (5%) 2/29 (7%) 0/26 (0%) 0/27 (0%) |1/33 (3%) 3/24 (13%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 677 709 703 661 |234 571 --- 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.487N P=0.357N P=0.416N |P=0.087N P=0.174 P=0.136N P=0.321N |
|POLY 3 | P=0.366N P=0.627N P=0.451N P=0.489N |P=0.083N P=0.211 P=0.132N P=0.322N |
|POLY 1.5 | P=0.370N P=0.642N P=0.469N P=0.497N |P=0.079N P=0.220 P=0.129N P=0.316N |
|POLY 6 | P=0.356N P=0.598N P=0.423N P=0.472N |P=0.087N P=0.198 P=0.135N P=0.330N |
|LOGISTIC REGRESSION| P=0.361N P=0.574N P=0.421N P=0.491N |P=0.067N P=0.200 P=0.078N P=0.286N |
|COCH-ARM / FISHERS | P=0.373N P=0.651N P=0.490N P=0.500N |P=0.077N P=0.233 P=0.125N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 3/50 (6%) 4/50 (8%) 13/49 (27%) |5/50 (10%) 2/49 (4%) 3/49 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 11/41.44 3/43.95 4/44.95 13/44.41 |5/44.29 2/42.13 3/43.86 2/43.85 |
|POLY-3 PERCENT (g) | 26.5% 6.8% 8.9% 29.3% |11.3% 4.8% 6.8% 4.6% |
|TERMINAL (d) | 2/20 (10%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |3/33 (9%) 0/24 (0%) 1/29 (3%) 0/30 (0%) |
|FIRST INCIDENCE | 589 353 528 332 |638 612 139 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.011N* P=0.022N* P=0.539 |P=0.227N P=0.304N P=0.399N P=0.247N |
|POLY 3 | P=0.157 P=0.013N* P=0.027N* P=0.484 |P=0.206N P=0.236N P=0.361N P=0.220N |
|POLY 1.5 | P=0.152 P=0.015N* P=0.033N* P=0.448 |P=0.208N P=0.229N P=0.360N P=0.217N |
|POLY 6 | P=0.167 P=0.010N* P=0.022N* P=0.543 |P=0.206N P=0.251N P=0.369N P=0.226N |
|LOGISTIC REGRESSION| P=0.151 P=0.021N* P=0.053N P=0.407 |P=0.194N P=0.225N P=0.345N P=0.211N |
|COCH-ARM / FISHERS | P=0.149 P=0.018N* P=0.041N* P=0.407 |P=0.210N P=0.226N P=0.369N P=0.218N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 20/50 (40%) 17/50 (34%) 28/49 (57%) |8/50 (16%) 26/49 (53%) 27/49 (55%) 37/50 (74%) |
|POLY-3 RATE (b) | 3/39.18 20/44.25 17/45.84 28/44.29 |8/44.84 26/45.50 27/45.88 37/46.34 |
|POLY-3 PERCENT (g) | 7.7% 45.2% 37.1% 63.2% |17.8% 57.1% 58.9% 79.8% |
|TERMINAL (d) | 3/20 (15%) 15/29 (52%) 7/26 (27%) 15/27 (56%) |5/33 (15%) 13/24 (54%) 15/29 (52%) 26/30 (87%) |
|FIRST INCIDENCE | 729 (T) 485 633 390 |234 408 139 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.008 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.002 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx: Respiratory Epithelium, Epiglottis |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 22/50 (44%) 23/50 (46%) 33/49 (67%) |2/50 (4%) 33/49 (67%) 26/49 (53%) 40/50 (80%) |
|POLY-3 RATE (b) | 0/39.18 22/42.93 23/45.58 33/45.15 |2/44.35 33/45.30 26/43.88 40/48.75 |
|POLY-3 PERCENT (g) | 0.0% 51.2% 50.5% 73.1% |4.5% 72.9% 59.3% 82.1% |
|TERMINAL (d) | 0/20 (0%) 18/29 (62%) 15/26 (58%) 22/27 (82%) |1/33 (3%) 16/24 (67%) 20/29 (69%) 24/30 (80%) |
|FIRST INCIDENCE | --- 694 519 332 |519 533 572 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx: Respiratory Epithelium, Epiglottis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 18/50 (36%) 34/50 (68%) 32/49 (65%) |0/50 (0%) 25/49 (51%) 26/49 (53%) 33/50 (66%) |
|POLY-3 RATE (b) | 0/39.18 18/45.83 34/49.21 32/46.03 |0/43.71 25/45.25 26/45.42 33/47.79 |
|POLY-3 PERCENT (g) | 0.0% 39.3% 69.1% 69.5% |0.0% 55.3% 57.2% 69.1% |
|TERMINAL (d) | 0/20 (0%) 7/29 (24%) 14/26 (54%) 16/27 (59%) |0/33 (0%) 10/24 (42%) 15/29 (52%) 18/30 (60%) |
|FIRST INCIDENCE | --- 311 392 533 |--- 540 139 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx: Respiratory Epithelium, Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 9/50 (18%) 16/50 (32%) 19/49 (39%) |2/50 (4%) 7/49 (14%) 7/49 (14%) 16/50 (32%) |
|POLY-3 RATE (b) | 0/39.18 9/44.99 16/47.38 19/43.84 |2/43.71 7/43.08 7/43.87 16/44.48 |
|POLY-3 PERCENT (g) | 0.0% 20.0% 33.8% 43.3% |4.6% 16.3% 16.0% 36.0% |
|TERMINAL (d) | 0/20 (0%) 1/29 (3%) 3/26 (12%) 7/27 (26%) |2/33 (6%) 2/24 (8%) 2/29 (7%) 11/30 (37%) |
|FIRST INCIDENCE | --- 311 528 558 |731 (T) 540 139 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.047 * P=0.068 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.074 P=0.079 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.076 P=0.078 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.071 P=0.078 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.077 P=0.079 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.075 P=0.075 P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 0/40.96 |1/44.08 1/41.70 0/42.55 2/42.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 2.4% 0.0% 4.7% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- --- --- --- |625 731 (T) --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.363 P=0.714 P=0.509N P=0.478 |
|POLY 3 | (e) (e) (e) (e) |P=0.363 P=0.748 P=0.507N P=0.489 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.365 P=0.755 P=0.504N P=0.495 |
|POLY 6 | (e) (e) (e) (e) |P=0.360 P=0.738 P=0.512N P=0.482 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.366 P=0.761N P=0.489N P=0.502 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 1/42.57 0/42.93 1/40.96 |2/43.71 2/42.08 2/43.20 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 2.4% |4.6% 4.8% 4.6% 0.0% |
|TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 1/27 (4%) |2/33 (6%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |731 (T) 667 570 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443 P=0.574 (e) P=0.560 |P=0.177N P=0.625 P=0.664 P=0.259N |
|POLY 3 | P=0.415 P=0.513 (e) P=0.506 |P=0.168N P=0.681 P=0.690 P=0.243N |
|POLY 1.5 | P=0.409 P=0.506 (e) P=0.502 |P=0.166N P=0.687 P=0.691 P=0.240N |
|POLY 6 | P=0.427 P=0.527 (e) P=0.514 |P=0.171N P=0.670 P=0.688 P=0.248N |
|LOGISTIC REGRESSION| (e) P=0.574 (e) P=0.560 |P=0.163N P=0.679 P=0.695N (e) |
|COCH-ARM / FISHERS | P=0.405 P=0.500 (e) P=0.500 |P=0.163N P=0.691N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/49 (2%) 7/50 (14%) |1/50 (2%) 4/50 (8%) 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/39.84 2/42.65 1/43.06 7/40.96 |1/44.04 4/41.94 9/42.62 5/42.83 |
|POLY-3 PERCENT (g) | 7.5% 4.7% 2.3% 17.1% |2.3% 9.5% 21.1% 11.7% |
|TERMINAL (d) | 3/20 (15%) 1/29 (3%) 0/26 (0%) 7/27 (26%) |0/33 (0%) 3/24 (13%) 8/29 (28%) 4/30 (13%) |
|FIRST INCIDENCE | 729 (T) 709 694 729 (T) |638 668 712 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 P=0.330N P=0.213N P=0.295 |P=0.102 P=0.124 P=0.006 ** P=0.088 |
|POLY 3 | P=0.053 P=0.469N P=0.277N P=0.165 |P=0.090 P=0.163 P=0.006 ** P=0.094 |
|POLY 1.5 | P=0.053 P=0.487N P=0.294N P=0.160 |P=0.095 P=0.171 P=0.007 ** P=0.098 |
|POLY 6 | P=0.052 P=0.435N P=0.252N P=0.181 |P=0.083 P=0.152 P=0.005 ** P=0.089 |
|LOGISTIC REGRESSION| P=0.067 P=0.348N P=0.210N P=0.295 |P=0.094 P=0.170 P=0.007 ** P=0.099 |
|COCH-ARM / FISHERS | P=0.055 P=0.500N P=0.316N P=0.159 |P=0.103 P=0.181 P=0.008 ** P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 7/49 (14%) 14/50 (28%) |9/50 (18%) 9/50 (18%) 10/50 (20%) 13/50 (26%) |
|POLY-3 RATE (b) | 5/41.10 8/43.56 7/43.50 14/43.44 |9/45.46 9/43.15 10/43.59 13/44.03 |
|POLY-3 PERCENT (g) | 12.2% 18.4% 16.1% 32.2% |19.8% 20.9% 22.9% 29.5% |
|TERMINAL (d) | 1/20 (5%) 5/29 (17%) 4/26 (15%) 7/27 (26%) |5/33 (15%) 4/24 (17%) 8/29 (28%) 9/30 (30%) |
|FIRST INCIDENCE | 477 571 655 542 |458 571 570 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.467 P=0.558 P=0.063 |P=0.166 P=0.411 P=0.408 P=0.185 |
|POLY 3 | P=0.014 * P=0.312 P=0.419 P=0.022 * |P=0.147 P=0.556 P=0.459 P=0.204 |
|POLY 1.5 | P=0.013 * P=0.290 P=0.393 P=0.020 * |P=0.155 P=0.578 P=0.474 P=0.219 |
|POLY 6 | P=0.017 * P=0.358 P=0.464 P=0.031 * |P=0.136 P=0.525 P=0.438 P=0.187 |
|LOGISTIC REGRESSION| P=0.013 * P=0.278 P=0.374 P=0.021 * |P=0.163 P=0.595N P=0.500 P=0.235 |
|COCH-ARM / FISHERS | P=0.013 * P=0.277 P=0.365 P=0.020 * |P=0.164 P=0.602N P=0.500 P=0.235 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 2/41.50 |0/43.71 1/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- --- 561 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * (e) (e) P=0.262 |P=0.568N P=0.436 (e) (e) |
|POLY 3 | P=0.046 * (e) (e) P=0.246 |P=0.575N P=0.491 (e) (e) |
|POLY 1.5 | P=0.046 * (e) (e) P=0.241 |P=0.571N P=0.495 (e) (e) |
|POLY 6 | P=0.047 * (e) (e) P=0.257 |P=0.581N P=0.483 (e) (e) |
|LOGISTIC REGRESSION| P=0.049 * (e) (e) P=0.238 |(e) P=0.436 (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 8/49 (16%) 5/50 (10%) |6/50 (12%) 8/50 (16%) 5/50 (10%) 7/50 (14%) |
|POLY-3 RATE (b) | 5/40.65 4/43.36 8/44.45 5/42.96 |6/44.03 8/43.31 5/44.86 7/43.92 |
|POLY-3 PERCENT (g) | 12.3% 9.2% 18.0% 11.6% |13.6% 18.5% 11.2% 15.9% |
|TERMINAL (d) | 1/20 (5%) 1/29 (3%) 1/26 (4%) 1/27 (4%) |3/33 (9%) 4/24 (17%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 624 608 551 332 |666 499 421 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.532 P=0.349N P=0.477 P=0.547N |P=0.510 P=0.240 P=0.547N P=0.441 |
|POLY 3 | P=0.500 P=0.459N P=0.335 P=0.596N |P=0.532 P=0.373 P=0.487N P=0.498 |
|POLY 1.5 | P=0.487 P=0.482N P=0.301 P=0.612N |P=0.532 P=0.382 P=0.493N P=0.501 |
|POLY 6 | P=0.520 P=0.418N P=0.391 P=0.566N |P=0.531 P=0.354 P=0.482N P=0.492 |
|LOGISTIC REGRESSION| P=0.467 P=0.492N P=0.259 P=0.628N |P=0.533 P=0.381 P=0.483N P=0.497 |
|COCH-ARM / FISHERS | P=0.468 P=0.500N P=0.264 P=0.630N |P=0.528 P=0.387 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 8/49 (16%) 14/50 (28%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 11/40.83 8/43.75 8/43.32 14/41.91 |1/43.71 2/41.99 1/43.02 1/42.54 |
|POLY-3 PERCENT (g) | 26.9% 18.3% 18.5% 33.4% |2.3% 4.8% 2.3% 2.4% |
|TERMINAL (d) | 6/20 (30%) 4/29 (14%) 4/26 (15%) 11/27 (41%) |1/33 (3%) 1/24 (4%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 617 571 680 561 |731 (T) 652 589 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.113N P=0.125N P=0.584N |P=0.534N P=0.424 P=0.744 P=0.741 |
|POLY 3 | P=0.189 P=0.243N P=0.250N P=0.342 |P=0.538N P=0.486 P=0.757 P=0.755 |
|POLY 1.5 | P=0.190 P=0.276N P=0.283N P=0.328 |P=0.534N P=0.493 P=0.758 P=0.758 |
|POLY 6 | P=0.188 P=0.189N P=0.203N P=0.378 |P=0.543N P=0.475 P=0.755 P=0.750 |
|LOGISTIC REGRESSION| P=0.207 P=0.243N P=0.171N P=0.402 |P=0.531N P=0.485 P=0.758N P=0.741 |
|COCH-ARM / FISHERS | P=0.194 P=0.306N P=0.323N P=0.322 |P=0.531N P=0.500 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.84 3/44.35 2/44.19 0/40.96 |0/43.71 0/41.70 0/42.55 1/43.07 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 4.5% 0.0% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- 493 519 --- |--- --- --- 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413N P=0.120 P=0.247 (e) |P=0.202 (e) (e) P=0.504 |
|POLY 3 | P=0.389N P=0.139 P=0.261 (e) |P=0.199 (e) (e) P=0.497 |
|POLY 1.5 | P=0.401N P=0.128 P=0.248 (e) |P=0.199 (e) (e) P=0.499 |
|POLY 6 | P=0.365N P=0.158 P=0.282 (e) |P=0.199 (e) (e) P=0.494 |
|LOGISTIC REGRESSION| P=0.383N P=0.134 P=0.152 (e) |P=0.191 (e) (e) P=0.487 |
|COCH-ARM / FISHERS | P=0.410N P=0.121 P=0.242 (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/40.23 1/43.05 2/43.27 0/40.96 |1/44.04 0/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 2.5% 2.3% 4.6% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 619 584 671 --- |638 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.757N P=0.597 P=0.495N |P=0.312N P=0.519N P=0.505N P=0.514N |
|POLY 3 | P=0.367N P=0.746N P=0.525 P=0.496N |P=0.299N P=0.511N P=0.507N P=0.507N |
|POLY 1.5 | P=0.369N P=0.754N P=0.510 P=0.499N |P=0.303N P=0.505N P=0.504N P=0.503N |
|POLY 6 | P=0.363N P=0.729N P=0.550 P=0.490N |P=0.294N P=0.520N P=0.511N P=0.512N |
|LOGISTIC REGRESSION| P=0.368N P=0.759N P=0.470 P=0.494N |P=0.303N P=0.498N P=0.491N P=0.500N |
|COCH-ARM / FISHERS | P=0.367N P=0.753N P=0.492 P=0.500N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Portal |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/49 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/40.08 0/42.57 1/43.10 4/40.96 |0/43.71 0/41.70 0/42.55 1/42.95 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 2.3% 9.8% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 3/20 (15%) 0/29 (0%) 0/26 (0%) 4/27 (15%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 666 --- 684 729 (T) |--- --- --- 612 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459 P=0.030N* P=0.111N P=0.489N |P=0.198 (e) (e) P=0.491 |
|POLY 3 | P=0.378 P=0.052N P=0.156N P=0.633N |P=0.199 (e) (e) P=0.497 |
|POLY 1.5 | P=0.382 P=0.057N P=0.170N P=0.640N |P=0.199 (e) (e) P=0.498 |
|POLY 6 | P=0.369 P=0.045N* P=0.137N P=0.613N |P=0.199 (e) (e) P=0.494 |
|LOGISTIC REGRESSION| P=0.415 P=0.038N* P=0.133N P=0.540N |P=0.195 (e) (e) P=0.497 |
|COCH-ARM / FISHERS | P=0.386 P=0.059N P=0.187N P=0.643N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver: Portal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 3/41.21 |0/43.71 2/41.99 0/42.55 1/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.3% |0.0% 4.8% 0.0% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 2/27 (7%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- --- --- 661 |--- 652 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.013 * (e) (e) P=0.166 |P=0.532 P=0.202 (e) P=0.481 |
|POLY 3 | P=0.011 * (e) (e) P=0.124 |P=0.527 P=0.228 (e) P=0.495 |
|POLY 1.5 | P=0.011 * (e) (e) P=0.121 |P=0.533 P=0.233 (e) P=0.497 |
|POLY 6 | P=0.011 * (e) (e) P=0.132 |P=0.518 P=0.221 (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.011 * (e) (e) P=0.133 |P=0.536 P=0.234 (e) P=0.481 |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/49 (2%) 2/48 (4%) 1/50 (2%) |1/49 (2%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/40.54 1/42.85 2/42.77 1/41.34 |1/43.71 1/41.17 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 12.3% 2.3% 4.7% 2.4% |2.3% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 2/20 (10%) 0/29 (0%) 2/26 (8%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 638 548 729 (T) 623 |666 633 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.060N P=0.126N P=0.074N |P=0.244N P=0.747 P=0.510N P=0.516N |
|POLY 3 | P=0.095N P=0.088N P=0.193N P=0.095N |P=0.237N P=0.747 P=0.505N P=0.505N |
|POLY 1.5 | P=0.094N P=0.097N P=0.210N P=0.099N |P=0.235N P=0.754 P=0.502N P=0.501N |
|POLY 6 | P=0.097N P=0.074N P=0.171N P=0.087N |P=0.239N P=0.738 P=0.510N P=0.511N |
|LOGISTIC REGRESSION| P=0.094N P=0.111N P=0.172N P=0.101N |P=0.228N P=0.755N P=0.490N P=0.492N |
|COCH-ARM / FISHERS | P=0.093N P=0.107N P=0.235N P=0.102N |P=0.232N P=0.753N P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/48 (0%) 0/50 (0%) |2/49 (4%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.84 2/43.38 0/42.77 0/40.96 |2/43.52 0/40.82 0/42.55 1/43.30 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |4.6% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |1/33 (3%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- 311 --- --- |717 --- --- 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389N P=0.278 (e) (e) |P=0.469N P=0.304N P=0.275N P=0.525N |
|POLY 3 | P=0.378N P=0.256 (e) (e) |P=0.447N P=0.251N P=0.242N P=0.502N |
|POLY 1.5 | P=0.391N P=0.245 (e) (e) |P=0.451N P=0.245N P=0.239N P=0.497N |
|POLY 6 | P=0.356N P=0.277 (e) (e) |P=0.441N P=0.261N P=0.247N P=0.509N |
|LOGISTIC REGRESSION| P=0.383N P=0.273 (e) (e) |P=0.449N P=0.271N P=0.251N P=0.483N |
|COCH-ARM / FISHERS | P=0.405N P=0.242 (e) (e) |P=0.455N P=0.247N P=0.242N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/49 (16%) 24/48 (50%) 42/50 (84%) |10/49 (20%) 10/49 (20%) 14/50 (28%) 40/50 (80%) |
|POLY-3 RATE (b) | 5/40.60 8/42.77 24/46.03 42/48.74 |10/43.51 10/41.35 14/43.57 40/47.41 |
|POLY-3 PERCENT (g) | 12.3% 18.7% 52.1% 86.2% |23.0% 24.2% 32.1% 84.4% |
|TERMINAL (d) | 1/20 (5%) 6/29 (21%) 12/26 (46%) 24/27 (89%) |9/33 (27%) 7/24 (29%) 9/29 (31%) 25/30 (83%) |
|FIRST INCIDENCE | 666 652 519 332 |720 667 589 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.516 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.320 P=0.154 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.308 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.550 P=0.236 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.283 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.573 P=0.242 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.354 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.520 P=0.231 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.340 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.452 P=0.200 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.264 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.599N P=0.259 P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/48 (0%) 1/50 (2%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 2/42.27 0/42.77 1/41.81 |0/43.46 0/40.82 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 2/29 (7%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 390 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572 P=0.323 (e) P=0.500 |(e) (e) (e) (e) |
|POLY 3 | P=0.564 P=0.250 (e) P=0.510 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.552 P=0.241 (e) P=0.505 |(e) (e) (e) (e) |
|POLY 6 | P=0.586 P=0.268 (e) P=0.519 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.544 P=0.323 (e) P=0.662 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.242 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 24/49 (49%) 34/48 (71%) 49/50 (98%) |4/49 (8%) 8/49 (16%) 21/50 (42%) 50/50 (100%) |
|POLY-3 RATE (b) | 7/40.77 24/44.08 34/45.04 49/50.00 |4/43.46 8/42.12 21/44.45 50/50.00 |
|POLY-3 PERCENT (g) | 17.2% 54.5% 75.5% 98.0% |9.2% 19.0% 47.3% 100.0% |
|TERMINAL (d) | 3/20 (15%) 16/29 (55%) 22/26 (85%) 26/27 (96%) |4/33 (12%) 3/24 (13%) 13/29 (45%) 30/30 (100%) |
|FIRST INCIDENCE | 628 571 584 332 |731 (T) 540 589 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.092 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.159 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=0.168 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.160 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=0.178 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/48 (0%) 21/50 (42%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/40.08 0/42.27 0/42.77 21/43.59 |0/43.46 0/40.82 0/42.55 6/44.00 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 48.2% |0.0% 0.0% 0.0% 13.6% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 12/27 (44%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 3/30 (10%) |
|FIRST INCIDENCE | 666 --- --- 390 |--- --- --- 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.461N P=0.461N P<0.001 ** |P<0.001 ** (e) (e) P=0.016 * |
|POLY 3 | P<0.001 ** P=0.489N P=0.487N P<0.001 ** |P<0.001 ** (e) (e) P=0.016 * |
|POLY 1.5 | P<0.001 ** P=0.497N P=0.496N P<0.001 ** |P<0.001 ** (e) (e) P=0.016 * |
|POLY 6 | P<0.001 ** P=0.475N P=0.473N P<0.001 ** |P<0.001 ** (e) (e) P=0.015 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.507N P=0.530N P<0.001 ** |P<0.001 ** (e) (e) P=0.020 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.505N P=0.510N P<0.001 ** |P<0.001 ** (e) (e) P=0.014 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 40/49 (82%) 45/48 (94%) 50/50 (100%)|26/49 (53%) 35/49 (71%) 44/50 (88%) 50/50 (100%) |
|POLY-3 RATE (b) | 22/43.57 40/46.79 45/47.73 50/50.00 |26/44.80 35/43.91 44/46.83 50/50.00 |
|POLY-3 PERCENT (g) | 50.5% 85.5% 94.3% 100.0% |58.0% 79.7% 94.0% 100.0% |
|TERMINAL (d) | 9/20 (45%) 25/29 (86%) 24/26 (92%) 27/27 (100%)|20/33 (61%) 21/24 (88%) 28/29 (97%) 30/30 (100%) |
|FIRST INCIDENCE | 502 353 519 332 |548 540 421 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.101 P=0.020 * P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.018 * 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=0.027 * 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=0.012 * 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=0.047 * P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 2/48 (4%) 28/50 (56%) |1/49 (2%) 1/49 (2%) 8/50 (16%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/40.17 0/42.27 2/43.60 28/44.35 |1/43.46 1/41.34 8/43.02 7/43.81 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 4.6% 63.1% |2.3% 2.4% 18.6% 16.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 20/27 (74%) |1/33 (3%) 0/24 (0%) 7/29 (24%) 3/30 (10%) |
|FIRST INCIDENCE | 638 --- 584 533 |731 (T) 571 589 612 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.468N P=0.549 P<0.001 ** |P=0.009 ** P=0.725 P=0.011 * P=0.029 * |
|POLY 3 | P<0.001 ** P=0.490N P=0.529 P<0.001 ** |P=0.007 ** P=0.750 P=0.014 * P=0.030 * |
|POLY 1.5 | P<0.001 ** P=0.498N P=0.510 P<0.001 ** |P=0.007 ** P=0.755 P=0.015 * P=0.031 * |
|POLY 6 | P<0.001 ** P=0.476N P=0.556 P<0.001 ** |P=0.007 ** P=0.742 P=0.013 * P=0.030 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.510N P=0.348 P<0.001 ** |P=0.008 ** P=0.755N P=0.015 * P=0.035 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.505N P=0.485 P<0.001 ** |P=0.008 ** P=0.753N P=0.017 * P=0.032 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 17/49 (35%) 31/48 (65%) 49/50 (98%) |6/49 (12%) 5/49 (10%) 14/50 (28%) 48/50 (96%) |
|POLY-3 RATE (b) | 3/40.20 17/43.02 31/44.40 49/49.68 |6/44.49 5/41.47 14/43.15 48/50.00 |
|POLY-3 PERCENT (g) | 7.5% 39.5% 69.8% 98.6% |13.5% 12.1% 32.5% 96.0% |
|TERMINAL (d) | 2/20 (10%) 13/29 (45%) 20/26 (77%) 27/27 (100%)|4/33 (12%) 3/24 (13%) 10/29 (35%) 28/30 (93%) |
|FIRST INCIDENCE | 628 652 633 332 |234 540 661 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.581 P=0.024 * P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.549N P=0.029 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.530N P=0.032 * P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.574N P=0.026 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.479N P=0.040 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500N P=0.044 * P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/48 (0%) 7/50 (14%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.84 0/42.27 0/42.77 7/41.72 |0/43.46 0/40.82 0/42.55 1/43.30 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 16.8% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 3/27 (11%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- --- 642 |--- --- --- 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.025 * |P=0.199 (e) (e) P=0.500 |
|POLY 3 | P<0.001 ** (e) (e) P=0.009 ** |P=0.201 (e) (e) P=0.499 |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.008 ** |P=0.202 (e) (e) P=0.502 |
|POLY 6 | P<0.001 ** (e) (e) P=0.010 * |P=0.201 (e) (e) P=0.496 |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.011 * |P=0.176 (e) (e) P=0.460 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.006 ** |P=0.201 (e) (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/49 (14%) 16/48 (33%) 38/50 (76%) |19/49 (39%) 7/49 (14%) 12/50 (24%) 32/50 (64%) |
|POLY-3 RATE (b) | 7/41.02 7/42.68 16/44.30 38/45.78 |19/45.12 7/41.77 12/44.31 32/45.63 |
|POLY-3 PERCENT (g) | 17.1% 16.4% 36.1% 83.0% |42.1% 16.8% 27.1% 70.1% |
|TERMINAL (d) | 2/20 (10%) 5/29 (17%) 7/26 (27%) 24/27 (89%) |14/33 (42%) 3/24 (13%) 5/29 (17%) 22/30 (73%) |
|FIRST INCIDENCE | 624 673 528 332 |463 540 421 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.363N P=0.152 P<0.001 ** |P<0.001 ** P=0.044N* P=0.191N P=0.005 ** |
|POLY 3 | P<0.001 ** P=0.584N P=0.038 * P<0.001 ** |P<0.001 ** P=0.008N** P=0.099N P=0.004 ** |
|POLY 1.5 | P<0.001 ** P=0.609N P=0.029 * P<0.001 ** |P<0.001 ** P=0.006N** P=0.094N P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.538N P=0.055 P<0.001 ** |P<0.001 ** P=0.010N* P=0.104N P=0.003 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.561N P=0.035 * P<0.001 ** |P<0.001 ** P=0.007N** P=0.092N P=0.007 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.597 P=0.021 * P<0.001 ** |P<0.001 ** P=0.006N** P=0.085N P=0.010 * |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/39 (21%) 8/44 (18%) 3/47 (6%) 12/44 (27%) |16/42 (38%) 6/45 (13%) 8/44 (18%) 5/44 (11%) |
|POLY-3 RATE (b) | 8/32.34 8/38.55 3/40.96 12/37.60 |16/38.87 6/38.95 8/38.17 5/38.21 |
|POLY-3 PERCENT (g) | 24.7% 20.8% 7.3% 31.9% |41.2% 15.4% 21.0% 13.1% |
|TERMINAL (d) | 7/17 (41%) 7/27 (26%) 2/24 (8%) 10/25 (40%) |14/29 (48%) 3/22 (14%) 7/27 (26%) 3/28 (11%) |
|FIRST INCIDENCE | 708 608 722 558 |458 408 589 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.328 P=0.241N P=0.024N* P=0.540 |P=0.010N* P=0.051N P=0.062N P=0.008N** |
|POLY 3 | P=0.243 P=0.455N P=0.038N* P=0.344 |P=0.007N** P=0.009N** P=0.044N* P=0.004N** |
|POLY 1.5 | P=0.243 P=0.483N P=0.043N* P=0.330 |P=0.007N** P=0.008N** P=0.041N* P=0.004N** |
|POLY 6 | P=0.247 P=0.399N P=0.029N* P=0.380 |P=0.007N** P=0.011N* P=0.048N* P=0.005N** |
|LOGISTIC REGRESSION| P=0.252 P=0.319N P=0.014N* P=0.390 |P=0.009N** P=0.008N** P=0.044N* P=0.005N** |
|COCH-ARM / FISHERS | P=0.246 P=0.503N P=0.051N P=0.323 |P=0.008N** P=0.008N** P=0.034N* P=0.004N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/47 (0%) 0/46 (0%) 2/44 (5%) |0/48 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/36.59 0/40.55 0/41.44 2/37.46 |0/42.33 0/41.70 0/42.55 0/40.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/28 (0%) 0/26 (0%) 0/25 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- --- --- 542 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.042 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * (e) (e) P=0.256 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.057 (e) (e) P=0.263 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.242 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/45 (38%) 15/47 (32%) 17/46 (37%) 17/44 (39%) |26/48 (54%) 14/50 (28%) 20/50 (40%) 24/48 (50%) |
|POLY-3 RATE (b) | 17/38.78 15/41.09 17/42.09 17/37.41 |26/45.00 14/44.38 20/44.02 24/43.87 |
|POLY-3 PERCENT (g) | 43.8% 36.5% 40.4% 45.4% |57.8% 31.5% 45.4% 54.7% |
|TERMINAL (d) | 8/19 (42%) 11/28 (39%) 11/26 (42%) 13/25 (52%) |19/33 (58%) 6/24 (25%) 17/29 (59%) 15/29 (52%) |
|FIRST INCIDENCE | 617 677 655 661 |463 408 139 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399N P=0.096N P=0.207N P=0.293N |P=0.360 P=0.117N P=0.311N P=0.528 |
|POLY 3 | P=0.405 P=0.327N P=0.464N P=0.537 |P=0.386 P=0.009N** P=0.165N P=0.469N |
|POLY 1.5 | P=0.406 P=0.346N P=0.507N P=0.534 |P=0.395 P=0.007N** P=0.134N P=0.441N |
|POLY 6 | P=0.419 P=0.288N P=0.398N P=0.564 |P=0.375 P=0.013N* P=0.225N P=0.508N |
|LOGISTIC REGRESSION| P=0.500 P=0.220N P=0.328N P=0.536N |P=0.396 P=0.008N** P=0.126N P=0.437N |
|COCH-ARM / FISHERS | P=0.426 P=0.355N P=0.554N P=0.553 |P=0.406 P=0.007N** P=0.115N P=0.419N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/50 (2%) 5/49 (10%) 4/50 (8%) |5/50 (10%) 2/50 (4%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/39.15 1/42.63 5/43.81 4/41.13 |5/43.71 2/41.70 4/42.67 6/42.99 |
|POLY-3 PERCENT (g) | 5.1% 2.4% 11.4% 9.7% |11.4% 4.8% 9.4% 14.0% |
|TERMINAL (d) | 0/19 (0%) 0/29 (0%) 1/26 (4%) 3/27 (11%) |5/33 (15%) 2/24 (8%) 3/29 (10%) 4/30 (13%) |
|FIRST INCIDENCE | 666 714 653 685 |731 (T) 731 (T) 698 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203 P=0.389N P=0.359 P=0.459 |P=0.280 P=0.359N P=0.578N P=0.434 |
|POLY 3 | P=0.161 P=0.470N P=0.263 P=0.359 |P=0.290 P=0.235N P=0.515N P=0.488 |
|POLY 1.5 | P=0.162 P=0.481N P=0.244 P=0.354 |P=0.290 P=0.225N P=0.510N P=0.495 |
|POLY 6 | P=0.164 P=0.448N P=0.300 P=0.376 |P=0.291 P=0.250N P=0.523N P=0.480 |
|LOGISTIC REGRESSION| P=0.165 P=0.480N P=0.218 P=0.380 |P=0.270 P=0.359N P=0.556N P=0.463 |
|COCH-ARM / FISHERS | P=0.167 P=0.485N P=0.226 P=0.359 |P=0.289 P=0.218N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/38.71 0/42.57 0/42.93 0/40.96 |3/43.71 0/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |3/33 (9%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.053N P=0.182N P=0.144N P=0.138N |
|POLY 3 | (e) (e) (e) (e) |P=0.043N* P=0.127N P=0.123N P=0.123N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044N* P=0.123N P=0.122N P=0.121N |
|POLY 6 | (e) (e) (e) (e) |P=0.041N* P=0.134N P=0.126N P=0.127N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.053N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.047N* P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 16/18 (89%) 9/12 (75%) 8/9 (89%) |9/9 (100%) 20/20 (100%) 17/22 (77%) 15/15 (100%) |
|POLY-3 RATE (b) | 7/7.86 16/16.39 9/11.86 8/8.83 |9/9.00 20/20.00 17/20.26 15/15.00 |
|POLY-3 PERCENT (g) | 89.0% 97.6% 75.9% 90.6% |100.0% 100.0% 83.9% 100.0% |
|TERMINAL (d) | 1/1 (100%) 12/12 (100%) 3/4 (75%) 5/5 (100%) |6/6 (100%) 9/9 (100%) 8/9 (89%) 11/11 (100%) |
|FIRST INCIDENCE | 589 584 584 623 |638 408 421 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210N P=0.274N P=0.401N P=0.215N |P=0.460N (e) P=0.109 (e) |
|POLY 3 | P=0.489N P=0.540 P=0.443N P=0.762 |P=0.620N (e) P=0.240N (e) |
|POLY 1.5 | P=0.513N P=0.603 P=0.450N P=0.748 |P=0.601N (e) P=0.212N (e) |
|POLY 6 | P=0.484N P=0.535 P=0.432N P=0.795 |P=0.653N (e) P=0.288N (e) |
|LOGISTIC REGRESSION| P=0.439N P=0.644 P=0.742N P=0.716 |P=0.578N (e) P=0.225N (e) |
|COCH-ARM / FISHERS | P=0.577N P=0.686 P=0.465N P=0.735 |P=0.555N (e) P=0.155N (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 5/50 (10%) 1/49 (2%) 1/48 (2%) |3/50 (6%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/39.80 5/42.90 1/42.93 1/40.02 |3/43.95 4/41.82 1/42.94 2/42.77 |
|POLY-3 PERCENT (g) | 7.5% 11.7% 2.3% 2.5% |6.8% 9.6% 2.3% 4.7% |
|TERMINAL (d) | 1/20 (5%) 2/29 (7%) 1/26 (4%) 0/27 (0%) |2/33 (6%) 3/24 (13%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 617 677 729 (T) 631 |666 701 617 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.086N P=0.527 P=0.240N P=0.277N |P=0.308N P=0.364 P=0.340N P=0.535N |
|POLY 3 | P=0.109N P=0.398 P=0.278N P=0.302N |P=0.299N P=0.473 P=0.313N P=0.512N |
|POLY 1.5 | P=0.114N P=0.380 P=0.290N P=0.309N |P=0.296N P=0.487 P=0.311N P=0.506N |
|POLY 6 | P=0.100N P=0.433 P=0.259N P=0.287N |P=0.304N P=0.451 P=0.318N P=0.522N |
|LOGISTIC REGRESSION| P=0.115N P=0.394 P=0.305N P=0.314N |P=0.297N P=0.449 P=0.306N P=0.510N |
|COCH-ARM / FISHERS | P=0.119N P=0.369 P=0.309N P=0.316N |P=0.292N P=0.500 P=0.309N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 7/50 (14%) 3/49 (6%) 11/48 (23%) |3/50 (6%) 6/50 (12%) 5/50 (10%) 10/50 (20%) |
|POLY-3 RATE (b) | 8/40.41 7/43.39 3/43.39 11/41.65 |3/43.95 6/42.20 5/44.01 10/44.60 |
|POLY-3 PERCENT (g) | 19.8% 16.1% 6.9% 26.4% |6.8% 14.2% 11.4% 22.4% |
|TERMINAL (d) | 3/20 (15%) 3/29 (10%) 1/26 (4%) 4/27 (15%) |2/33 (6%) 3/24 (13%) 1/29 (3%) 3/30 (10%) |
|FIRST INCIDENCE | 617 584 633 542 |666 667 570 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322 P=0.285N P=0.050N P=0.469 |P=0.034 * P=0.157 P=0.324 P=0.035 * |
|POLY 3 | P=0.233 P=0.440N P=0.075N P=0.326 |P=0.029 * P=0.221 P=0.357 P=0.036 * |
|POLY 1.5 | P=0.224 P=0.465N P=0.086N P=0.304 |P=0.028 * P=0.232 P=0.356 P=0.036 * |
|POLY 6 | P=0.248 P=0.394N P=0.062N P=0.374 |P=0.030 * P=0.205 P=0.356 P=0.036 * |
|LOGISTIC REGRESSION| P=0.220 P=0.453N P=0.091N P=0.294 |P=0.028 * P=0.213 P=0.364 P=0.038 * |
|COCH-ARM / FISHERS | P=0.218 P=0.483N P=0.100N P=0.287 |P=0.028 * P=0.243 P=0.357 P=0.036 * |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Goblet Cell, Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 15/50 (30%) 12/49 (24%) 17/48 (35%) |13/50 (26%) 18/50 (36%) 16/50 (32%) 30/50 (60%) |
|POLY-3 RATE (b) | 4/40.05 15/45.12 12/43.84 17/41.96 |13/44.80 18/43.25 16/44.70 30/45.75 |
|POLY-3 PERCENT (g) | 10.0% 33.2% 27.4% 40.5% |29.0% 41.6% 35.8% 65.6% |
|TERMINAL (d) | 1/20 (5%) 4/29 (14%) 8/26 (31%) 10/27 (37%) |8/33 (24%) 10/24 (42%) 8/29 (28%) 20/30 (67%) |
|FIRST INCIDENCE | 612 584 633 542 |625 571 570 589 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * P=0.039 * P=0.092 P=0.010 * |P<0.001 ** P=0.064 P=0.251 P<0.001 ** |
|POLY 3 | P=0.006 ** P=0.008 ** P=0.037 * P<0.001 ** |P<0.001 ** P=0.152 P=0.323 P<0.001 ** |
|POLY 1.5 | P=0.005 ** P=0.006 ** P=0.031 * P<0.001 ** |P<0.001 ** P=0.172 P=0.322 P<0.001 ** |
|POLY 6 | P=0.009 ** P=0.015 * P=0.050 P=0.002 ** |P<0.001 ** P=0.128 P=0.323 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.005 ** P=0.006 ** P=0.039 * P<0.001 ** |P<0.001 ** P=0.147 P=0.311 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.005 ** P=0.005 ** P=0.027 * P<0.001 ** |P<0.001 ** P=0.194 P=0.330 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 0/48 (0%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/39.35 2/43.49 0/42.93 0/39.67 |2/43.71 4/42.23 2/42.94 7/43.09 |
|POLY-3 PERCENT (g) | 2.5% 4.6% 0.0% 0.0% |4.6% 9.5% 4.7% 16.3% |
|TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |2/33 (6%) 2/24 (8%) 1/29 (3%) 5/30 (17%) |
|FIRST INCIDENCE | 652 311 --- --- |731 (T) 652 617 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173N P=0.567 P=0.447N P=0.488N |P=0.059 P=0.245 P=0.654 P=0.065 |
|POLY 3 | P=0.182N P=0.535 P=0.483N P=0.498N |P=0.053 P=0.321 P=0.688 P=0.074 |
|POLY 1.5 | P=0.187N P=0.521 P=0.491N P=0.502N |P=0.054 P=0.330 P=0.689 P=0.077 |
|POLY 6 | P=0.174N P=0.558 P=0.470N P=0.490N |P=0.051 P=0.308 P=0.685 P=0.070 |
|LOGISTIC REGRESSION| P=0.186N P=0.542 P=0.520N P=0.505N |P=0.054 P=0.313 P=0.689 P=0.072 |
|COCH-ARM / FISHERS | P=0.192N P=0.508 P=0.500N P=0.505N |P=0.056 P=0.339 P=0.691N P=0.080 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 3/50 (6%) 1/49 (2%) 4/48 (8%) |16/50 (32%) 20/50 (40%) 6/50 (12%) 4/50 (8%) |
|POLY-3 RATE (b) | 9/41.18 3/42.99 1/43.06 4/40.28 |16/44.97 20/43.64 6/43.52 4/43.58 |
|POLY-3 PERCENT (g) | 21.9% 7.0% 2.3% 9.9% |35.6% 45.8% 13.8% 9.2% |
|TERMINAL (d) | 2/20 (10%) 2/29 (7%) 0/26 (0%) 3/27 (11%) |11/33 (33%) 12/24 (50%) 4/29 (14%) 2/30 (7%) |
|FIRST INCIDENCE | 502 608 694 533 |624 499 421 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071N P=0.031N* P=0.005N** P=0.076N |P<0.001N** P=0.078 P=0.034N* P=0.008N** |
|POLY 3 | P=0.092N P=0.048N* P=0.006N** P=0.119N |P<0.001N** P=0.219 P=0.014N* P=0.002N** |
|POLY 1.5 | P=0.093N P=0.052N P=0.007N** P=0.123N |P<0.001N** P=0.243 P=0.014N* P=0.002N** |
|POLY 6 | P=0.092N P=0.040N* P=0.005N** P=0.110N |P<0.001N** P=0.184 P=0.017N* P=0.003N** |
|LOGISTIC REGRESSION| P=0.099N P=0.059N P=0.012N* P=0.126N |P<0.001N** P=0.212 P=0.016N* P=0.003N** |
|COCH-ARM / FISHERS | P=0.098N P=0.056N P=0.008N** P=0.124N |P<0.001N** P=0.266 P=0.014N* P=0.003N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 1/49 (2%) 3/48 (6%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/39.46 1/43.05 1/43.05 3/40.44 |1/43.71 2/42.46 1/43.07 2/43.46 |
|POLY-3 PERCENT (g) | 5.1% 2.3% 2.3% 7.4% |2.3% 4.7% 2.3% 4.6% |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |1/33 (3%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 617 584 698 542 |731 (T) 571 570 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.460N P=0.421N P=0.571 |P=0.442 P=0.464 P=0.749 P=0.484 |
|POLY 3 | P=0.319 P=0.470N P=0.470N P=0.511 |P=0.444 P=0.490 P=0.758 P=0.498 |
|POLY 1.5 | P=0.317 P=0.483N P=0.484N P=0.499 |P=0.445 P=0.495 P=0.758 P=0.500 |
|POLY 6 | P=0.324 P=0.446N P=0.447N P=0.536 |P=0.443 P=0.481 P=0.756 P=0.496 |
|LOGISTIC REGRESSION| P=0.313 P=0.498N P=0.497N P=0.488 |P=0.445 P=0.506 P=0.756N P=0.501 |
|COCH-ARM / FISHERS | P=0.314 P=0.492N P=0.500N P=0.490 |P=0.444 P=0.500 P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 1/49 (2%) 3/48 (6%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.07 3/43.44 1/43.05 3/40.51 |0/43.71 0/41.70 2/43.09 1/42.56 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 2.3% 7.4% |0.0% 0.0% 4.6% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- 584 698 578 |--- --- 572 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.164 P=0.567 P=0.143 |P=0.255 (e) P=0.229 P=0.488 |
|POLY 3 | P=0.173 P=0.138 P=0.519 P=0.124 |P=0.241 (e) P=0.234 P=0.495 |
|POLY 1.5 | P=0.164 P=0.129 P=0.510 P=0.119 |P=0.243 (e) P=0.235 P=0.497 |
|POLY 6 | P=0.193 P=0.156 P=0.534 P=0.137 |P=0.237 (e) P=0.232 P=0.491 |
|LOGISTIC REGRESSION| P=0.157 P=0.121 P=0.520 P=0.116 |P=0.246 (e) P=0.244 P=0.486 |
|COCH-ARM / FISHERS | P=0.156 P=0.125 P=0.500 P=0.117 |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 10/50 (20%) 7/50 (14%) 12/50 (24%) |
|POLY-3 RATE (b) | |4/43.71 10/43.64 7/43.13 12/44.33 |
|POLY-3 PERCENT (g) | |9.2% 22.9% 16.2% 27.1% |
|TERMINAL (d) | |4/33 (12%) 5/24 (21%) 4/29 (14%) 8/30 (27%) |
|FIRST INCIDENCE | |731 (T) 499 652 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.048 * P=0.031 * P=0.209 P=0.020 * |
|POLY 3 | |P=0.043 * P=0.070 P=0.252 P=0.026 * |
|POLY 1.5 | |P=0.043 * P=0.072 P=0.255 P=0.026 * |
|POLY 6 | |P=0.043 * P=0.066 P=0.248 P=0.026 * |
|LOGISTIC REGRESSION| |P=0.043 * P=0.072 P=0.236 P=0.026 * |
|COCH-ARM / FISHERS | |P=0.044 * P=0.074 P=0.262 P=0.027 * |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | |2/43.71 1/41.94 1/42.55 0/42.54 |
|POLY-3 PERCENT (g) | |4.6% 2.4% 2.4% 0.0% |
|TERMINAL (d) | |2/33 (6%) 0/24 (0%) 1/29 (3%) 0/30 (0%) |
|FIRST INCIDENCE | |731 (T) 667 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.162N P=0.573N P=0.545N P=0.259N |
|POLY 3 | |P=0.155N P=0.514N P=0.509N P=0.243N |
|POLY 1.5 | |P=0.154N P=0.507N P=0.506N P=0.240N |
|POLY 6 | |P=0.156N P=0.526N P=0.515N P=0.248N |
|LOGISTIC REGRESSION| |P=0.158N P=0.521N P=0.545N (e) |
|COCH-ARM / FISHERS | |P=0.153N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 4/49 (8%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.26 0/42.57 4/43.87 1/40.96 |2/43.80 0/41.70 1/42.34 0/42.54 |
|POLY-3 PERCENT (g) | 7.5% 0.0% 9.1% 2.4% |4.6% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 1/26 (4%) 1/27 (4%) |1/33 (3%) 0/24 (0%) 1/29 (3%) 0/30 (0%) |
|FIRST INCIDENCE | 636 --- 633 729 (T) |708 --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.077N P=0.631 P=0.235N |P=0.201N P=0.295N P=0.547N P=0.263N |
|POLY 3 | P=0.411N P=0.108N P=0.547 P=0.298N |P=0.186N P=0.248N P=0.512N P=0.244N |
|POLY 1.5 | P=0.408N P=0.114N P=0.520 P=0.303N |P=0.187N P=0.242N P=0.510N P=0.240N |
|POLY 6 | P=0.415N P=0.098N P=0.590 P=0.286N |P=0.184N P=0.257N P=0.517N P=0.248N |
|LOGISTIC REGRESSION| P=0.404N P=0.111N P=0.480 P=0.284N |P=0.196N P=0.260N P=0.522N P=0.249N |
|COCH-ARM / FISHERS | P=0.405N P=0.121N P=0.489 P=0.309N |P=0.189N P=0.247N P=0.508N P=0.247N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 3/40.96 |0/43.71 0/41.70 0/42.34 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 3/27 (11%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * (e) (e) P=0.177 |(e) (e) (e) (e) |
|POLY 3 | P=0.011 * (e) (e) P=0.123 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.011 * (e) (e) P=0.120 |(e) (e) (e) (e) |
|POLY 6 | P=0.011 * (e) (e) P=0.130 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.177 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pancreas: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/42.93 2/41.13 |0/43.71 0/41.70 0/42.34 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- --- 685 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.051 (e) (e) P=0.297 |(e) (e) (e) (e) |
|POLY 3 | P=0.046 * (e) (e) P=0.244 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.046 * (e) (e) P=0.240 |(e) (e) (e) (e) |
|POLY 6 | P=0.046 * (e) (e) P=0.254 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.045 * (e) (e) P=0.255 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |4/49 (8%) 3/50 (6%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 0/43.82 0/40.96 |4/43.83 3/42.27 1/42.86 3/43.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |9.1% 7.1% 2.3% 6.9% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |2/33 (6%) 1/24 (4%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- --- --- --- |463 608 572 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.412N P=0.591N P=0.203N P=0.536N |
|POLY 3 | (e) (e) (e) (e) |P=0.391N P=0.520N P=0.185N P=0.502N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.390N P=0.505N P=0.183N P=0.495N |
|POLY 6 | (e) (e) (e) (e) |P=0.393N P=0.541N P=0.190N P=0.512N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.388N P=0.480N P=0.168N P=0.488N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.390N P=0.489N P=0.181N P=0.489N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.21 1/43.14 0/43.82 1/41.87 |1/43.51 0/41.70 3/42.75 0/42.54 |
|POLY-3 PERCENT (g) | 7.5% 2.3% 0.0% 2.4% |2.3% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 650 548 --- 332 |458 --- 683 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181N P=0.231N P=0.076N P=0.253N |P=0.518N P=0.504N P=0.285 P=0.508N |
|POLY 3 | P=0.200N P=0.280N P=0.103N P=0.290N |P=0.503N P=0.508N P=0.299 P=0.504N |
|POLY 1.5 | P=0.199N P=0.294N P=0.110N P=0.298N |P=0.500N P=0.502N P=0.301 P=0.501N |
|POLY 6 | P=0.203N P=0.256N P=0.093N P=0.276N |P=0.507N P=0.517N P=0.295 P=0.510N |
|LOGISTIC REGRESSION| P=0.195N P=0.310N P=0.102N P=0.287N |P=0.496N P=0.568N P=0.312 P=0.554N |
|COCH-ARM / FISHERS | P=0.200N P=0.309N P=0.121N P=0.309N |P=0.496N P=0.495N P=0.309 P=0.495N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 5/50 (10%) 4/50 (8%) |12/49 (24%) 6/50 (12%) 16/49 (33%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/40.24 5/43.04 5/44.31 4/42.02 |12/44.86 6/42.35 16/44.13 4/42.99 |
|POLY-3 PERCENT (g) | 5.0% 11.6% 11.3% 9.5% |26.8% 14.2% 36.3% 9.3% |
|TERMINAL (d) | 1/20 (5%) 3/29 (10%) 4/26 (15%) 1/27 (4%) |6/33 (18%) 4/24 (17%) 9/29 (31%) 3/30 (10%) |
|FIRST INCIDENCE | 617 652 584 538 |463 540 570 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433 P=0.353 P=0.305 P=0.410 |P=0.105N P=0.230N P=0.191 P=0.049N* |
|POLY 3 | P=0.388 P=0.243 P=0.256 P=0.356 |P=0.082N P=0.116N P=0.230 P=0.030N* |
|POLY 1.5 | P=0.374 P=0.228 P=0.238 P=0.345 |P=0.076N P=0.101N P=0.236 P=0.027N* |
|POLY 6 | P=0.417 P=0.275 P=0.287 P=0.381 |P=0.091N P=0.141N P=0.221 P=0.036N* |
|LOGISTIC REGRESSION| P=0.364 P=0.239 P=0.239 P=0.336 |P=0.076N P=0.088N P=0.250 P=0.025N* |
|COCH-ARM / FISHERS | P=0.362 P=0.218 P=0.218 P=0.339 |P=0.075N P=0.088N P=0.251 P=0.024N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/1 (0%) |3/3 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/2.00 0/1.00 |3/3.00 0/0.00 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 0/1 (0%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |722 --- --- --- |
|-------------------| | |
|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: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/39.84 1/42.57 0/42.93 2/41.13 | |
|POLY-3 PERCENT (g) | 2.5% 2.4% 0.0% 4.9% | |
|TERMINAL (d) | 1/20 (5%) 1/29 (3%) 0/26 (0%) 1/27 (4%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 684 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.416 P=0.677N P=0.448N P=0.597 | |
|POLY 3 | P=0.372 P=0.746N P=0.485N P=0.511 | |
|POLY 1.5 | P=0.369 P=0.754N P=0.494N P=0.504 | |
|POLY 6 | P=0.377 P=0.730N P=0.471N P=0.528 | |
|LOGISTIC REGRESSION| P=0.385 P=0.677N (e) P=0.545 | |
|COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.505N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/49 (2%) 0/50 (0%) | |
|POLY-3 RATE (b) | 3/40.31 0/42.57 1/43.41 0/40.96 | |
|POLY-3 PERCENT (g) | 7.4% 0.0% 2.3% 0.0% | |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 0/26 (0%) 0/27 (0%) | |
|FIRST INCIDENCE | 628 --- 584 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.082N P=0.246N P=0.096N | |
|POLY 3 | P=0.087N P=0.109N P=0.279N P=0.115N | |
|POLY 1.5 | P=0.086N P=0.114N P=0.294N P=0.118N | |
|POLY 6 | P=0.091N P=0.098N P=0.255N P=0.109N | |
|LOGISTIC REGRESSION| P=0.088N P=0.114N P=0.336N P=0.117N | |
|COCH-ARM / FISHERS | P=0.087N P=0.121N P=0.316N P=0.121N | |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/49 (6%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/39.84 2/42.57 3/42.96 0/40.96 | |
|POLY-3 PERCENT (g) | 2.5% 4.7% 7.0% 0.0% | |
|TERMINAL (d) | 1/20 (5%) 2/29 (7%) 2/26 (8%) 0/27 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 722 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270N P=0.630 P=0.414 P=0.440N | |
|POLY 3 | P=0.329N P=0.523 P=0.332 P=0.494N | |
|POLY 1.5 | P=0.335N P=0.510 P=0.316 P=0.498N | |
|POLY 6 | P=0.316N P=0.548 P=0.359 P=0.486N | |
|LOGISTIC REGRESSION| P=0.270N P=0.630 P=0.432 (e) | |
|COCH-ARM / FISHERS | P=0.338N P=0.500 P=0.301 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) 8/49 (16%) 6/50 (12%) | |
|POLY-3 RATE (b) | 12/42.12 8/43.63 8/44.56 6/42.45 | |
|POLY-3 PERCENT (g) | 28.5% 18.3% 18.0% 14.1% | |
|TERMINAL (d) | 4/20 (20%) 5/29 (17%) 3/26 (12%) 3/27 (11%) | |
|FIRST INCIDENCE | 477 493 528 538 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063N P=0.091N P=0.116N P=0.060N | |
|POLY 3 | P=0.086N P=0.194N P=0.180N P=0.085N | |
|POLY 1.5 | P=0.089N P=0.213N P=0.207N P=0.092N | |
|POLY 6 | P=0.080N P=0.161N P=0.143N P=0.074N | |
|LOGISTIC REGRESSION| P=0.093N P=0.220N P=0.269N P=0.097N | |
|COCH-ARM / FISHERS | P=0.092N P=0.227N P=0.242N P=0.096N | |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/39.84 0/42.57 1/43.18 2/42.11 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 4.8% | |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) | |
|FIRST INCIDENCE | --- --- 661 533 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 (e) P=0.549 P=0.232 | |
|POLY 3 | P=0.073 (e) P=0.516 P=0.249 | |
|POLY 1.5 | P=0.072 (e) P=0.507 P=0.243 | |
|POLY 6 | P=0.076 (e) P=0.531 P=0.263 | |
|LOGISTIC REGRESSION| P=0.076 (e) P=0.482 P=0.264 | |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.495 P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 6/50 (12%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/39.84 1/42.65 2/43.82 6/41.13 |0/43.71 1/41.94 0/42.55 1/42.54 |
|POLY-3 PERCENT (g) | 5.0% 2.3% 4.6% 14.6% |0.0% 2.4% 0.0% 2.4% |
|TERMINAL (d) | 2/20 (10%) 0/29 (0%) 2/26 (8%) 5/27 (19%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | 729 (T) 709 729 (T) 685 |--- 668 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 P=0.367N P=0.599N P=0.241 |P=0.403 P=0.495 (e) P=0.481 |
|POLY 3 | P=0.032 * P=0.476N P=0.660N P=0.141 |P=0.397 P=0.492 (e) P=0.495 |
|POLY 1.5 | P=0.032 * P=0.490N P=0.676N P=0.136 |P=0.402 P=0.496 (e) P=0.497 |
|POLY 6 | P=0.032 * P=0.451N P=0.633N P=0.155 |P=0.391 P=0.485 (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.038 * P=0.395N P=0.599N P=0.204 |P=0.403 P=0.503 (e) P=0.481 |
|COCH-ARM / FISHERS | P=0.033 * P=0.500N P=0.691N P=0.134 |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/41.04 2/42.65 3/44.84 3/40.96 |0/43.71 0/41.70 1/42.63 0/42.54 |
|POLY-3 PERCENT (g) | 9.8% 4.7% 6.7% 7.3% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/20 (5%) 1/29 (3%) 1/26 (4%) 3/27 (11%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 610 709 392 729 (T) |--- --- 710 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.255N P=0.415N P=0.416N |P=0.685 (e) P=0.477 (e) |
|POLY 3 | P=0.503N P=0.319N P=0.452N P=0.501N |P=0.688 (e) P=0.495 (e) |
|POLY 1.5 | P=0.502N P=0.330N P=0.472N P=0.503N |P=0.692 (e) P=0.497 (e) |
|POLY 6 | P=0.504N P=0.296N P=0.422N P=0.492N |P=0.684 (e) P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.501N P=0.340N P=0.597N P=0.495N |P=0.691 (e) P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.339N P=0.500N P=0.500N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/48 (2%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/40.08 0/42.57 1/42.77 0/40.96 |3/44.09 1/41.91 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 2.3% 0.0% |6.8% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 1/26 (4%) 0/27 (0%) |2/33 (6%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 666 --- 729 (T) --- |624 675 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382N P=0.461N P=0.708N P=0.488N |P=0.050N P=0.381N P=0.143N P=0.140N |
|POLY 3 | P=0.410N P=0.488N P=0.746N P=0.496N |P=0.042N* P=0.323N P=0.125N P=0.125N |
|POLY 1.5 | P=0.408N P=0.495N P=0.756N P=0.499N |P=0.043N* P=0.314N P=0.123N P=0.122N |
|POLY 6 | P=0.414N P=0.475N P=0.730N P=0.488N |P=0.042N* P=0.338N P=0.129N P=0.130N |
|LOGISTIC REGRESSION| P=0.402N P=0.502N P=0.753N P=0.500N |P=0.044N* P=0.308N P=0.122N P=0.122N |
|COCH-ARM / FISHERS | P=0.406N P=0.500N P=0.742 P=0.500N |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 16/50 (32%) 12/48 (25%) 11/50 (22%) |2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/40.73 16/44.12 12/44.30 11/41.72 |2/43.71 3/41.97 1/42.67 0/42.54 |
|POLY-3 PERCENT (g) | 17.2% 36.3% 27.1% 26.4% |4.6% 7.2% 2.3% 0.0% |
|TERMINAL (d) | 4/20 (20%) 11/29 (38%) 5/26 (19%) 8/27 (30%) |2/33 (6%) 1/24 (4%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 610 493 528 631 |731 (T) 675 698 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540N P=0.142 P=0.349 P=0.403 |P=0.117N P=0.388 P=0.539N P=0.259N |
|POLY 3 | P=0.406 P=0.038 * P=0.201 P=0.227 |P=0.107N P=0.481 P=0.508N P=0.243N |
|POLY 1.5 | P=0.390 P=0.031 * P=0.167 P=0.219 |P=0.106N P=0.491 P=0.506N P=0.240N |
|POLY 6 | P=0.442 P=0.056 P=0.258 P=0.251 |P=0.110N P=0.467 P=0.513N P=0.248N |
|LOGISTIC REGRESSION| P=0.401 P=0.040 * P=0.165 P=0.259 |P=0.108N P=0.458 P=0.518N (e) |
|COCH-ARM / FISHERS | P=0.384 P=0.028 * P=0.131 P=0.218 |P=0.104N P=0.500 P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/40.67 0/42.57 0/42.77 0/40.96 |1/44.68 0/41.70 0/42.55 2/43.86 |
|POLY-3 PERCENT (g) | 9.8% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 1/20 (5%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 612 --- --- --- |234 --- --- 332 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.016N* P=0.041N* P=0.041N* P=0.052N |P=0.247 P=0.500N P=0.504N P=0.497 |
|POLY 3 | P=0.019N* P=0.054N P=0.053N P=0.058N |P=0.250 P=0.514N P=0.510N P=0.494 |
|POLY 1.5 | P=0.019N* P=0.058N P=0.059N P=0.060N |P=0.248 P=0.508N P=0.507N P=0.496 |
|POLY 6 | P=0.020N* P=0.048N* P=0.047N* P=0.055N |P=0.252 P=0.522N P=0.513N P=0.489 |
|LOGISTIC REGRESSION| P=0.021N* P=0.063N P=0.072N P=0.063N |P=0.185 (e) P=0.335N P=0.457 |
|COCH-ARM / FISHERS | P=0.021N* P=0.059N P=0.064N P=0.059N |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 1/48 (2%) 0/50 (0%) |0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/42.58 4/43.05 1/42.99 0/40.96 |0/43.71 3/42.25 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 18.8% 9.3% 2.3% 0.0% |0.0% 7.1% 0.0% 0.0% |
|TERMINAL (d) | 1/20 (5%) 3/29 (10%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 1/24 (4%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 502 584 671 --- |--- 582 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.123N P=0.013N* P=0.006N** |P=0.321N P=0.090 (e) (e) |
|POLY 3 | P<0.001N** P=0.169N P=0.014N* P=0.004N** |P=0.322N P=0.112 (e) (e) |
|POLY 1.5 | P<0.001N** P=0.176N P=0.016N* P=0.004N** |P=0.315N P=0.116 (e) (e) |
|POLY 6 | P<0.001N** P=0.152N P=0.012N* P=0.004N** |P=0.331N P=0.107 (e) (e) |
|LOGISTIC REGRESSION| P<0.001N** P=0.186N P=0.046N* P=0.004N** |P=0.311N P=0.121 (e) (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.178N P=0.018N* P=0.003N** |P=0.311N P=0.121 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/48 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.84 2/42.94 1/42.78 1/41.32 |0/43.71 0/41.70 1/43.35 1/42.54 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.3% 2.4% |0.0% 0.0% 2.3% 2.4% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 1/30 (3%) |
|FIRST INCIDENCE | --- 677 728 629 |--- --- 421 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.539 P=0.316 P=0.560 P=0.516 |P=0.239 (e) P=0.500 P=0.481 |
|POLY 3 | P=0.517 P=0.254 P=0.514 P=0.507 |P=0.233 (e) P=0.498 P=0.495 |
|POLY 1.5 | P=0.506 P=0.244 P=0.504 P=0.503 |P=0.235 (e) P=0.499 P=0.497 |
|POLY 6 | P=0.539 P=0.273 P=0.529 P=0.517 |P=0.230 (e) P=0.496 P=0.491 |
|LOGISTIC REGRESSION| P=0.499 P=0.239 P=0.569 P=0.503 |P=0.228 (e) P=0.570 P=0.481 |
|COCH-ARM / FISHERS | P=0.499 P=0.247 P=0.490 P=0.500 |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Diverticulum |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/40.32 0/42.57 0/42.93 2/41.34 |0/43.71 0/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 589 --- --- 623 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 P=0.513N P=0.504N P=0.527 |(e) (e) (e) (e) |
|POLY 3 | P=0.244 P=0.489N P=0.487N P=0.509 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.245 P=0.496N P=0.495N P=0.503 |(e) (e) (e) (e) |
|POLY 6 | P=0.242 P=0.477N P=0.475N P=0.523 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.248 P=0.488N P=0.550N P=0.500 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.505N P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.95 1/42.85 0/42.93 1/41.50 |1/44.29 0/41.70 0/42.55 2/43.35 |
|POLY-3 PERCENT (g) | 2.5% 2.3% 0.0% 2.4% |2.3% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 701 652 --- 561 |548 --- --- 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619N P=0.701N P=0.445N P=0.754N |P=0.244 P=0.504N P=0.500N P=0.484 |
|POLY 3 | P=0.610N P=0.745N P=0.486N P=0.753N |P=0.249 P=0.512N P=0.508N P=0.493 |
|POLY 1.5 | P=0.613N P=0.754N P=0.494N P=0.757N |P=0.247 P=0.506N P=0.505N P=0.497 |
|POLY 6 | P=0.608N P=0.728N P=0.472N P=0.742N |P=0.250 P=0.521N P=0.513N P=0.486 |
|LOGISTIC REGRESSION| P=0.614N P=0.762N P=0.480N P=0.760N |P=0.237 P=0.521N P=0.470N P=0.486 |
|COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.505N P=0.753N |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/49 (8%) 3/50 (6%) |5/50 (10%) 5/50 (10%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/41.08 3/43.04 4/44.23 3/42.20 |5/45.34 5/43.23 1/42.84 1/43.30 |
|POLY-3 PERCENT (g) | 7.3% 7.0% 9.0% 7.1% |11.0% 11.6% 2.3% 2.3% |
|TERMINAL (d) | 0/20 (0%) 1/29 (3%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 589 608 528 332 |519 499 652 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565N P=0.597N P=0.582 P=0.636N |P=0.045N* P=0.553 P=0.121N P=0.125N |
|POLY 3 | P=0.568 P=0.641N P=0.540 P=0.651N |P=0.037N* P=0.600 P=0.115N P=0.112N |
|POLY 1.5 | P=0.563 P=0.654N P=0.517 P=0.657N |P=0.036N* P=0.616 P=0.109N P=0.107N |
|POLY 6 | P=0.577 P=0.616N P=0.577 P=0.637N |P=0.040N* P=0.574 P=0.123N P=0.121N |
|LOGISTIC REGRESSION| P=0.561 P=0.656 P=0.391 P=0.640N |P=0.031N* P=0.617N P=0.092N P=0.097N |
|COCH-ARM / FISHERS | P=0.556 P=0.661N P=0.489 P=0.661N |P=0.035N* P=0.630N P=0.102N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/49 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.93 0/42.57 3/43.27 2/41.50 |0/43.71 0/41.70 2/43.61 2/43.35 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 6.9% 4.8% |0.0% 0.0% 4.6% 4.6% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 1/27 (4%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 708 --- 661 561 |--- --- 421 455 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268 P=0.422N P=0.425 P=0.551 |P=0.085 (e) P=0.237 P=0.225 |
|POLY 3 | P=0.244 P=0.487N P=0.334 P=0.514 |P=0.087 (e) P=0.236 P=0.235 |
|POLY 1.5 | P=0.242 P=0.494N P=0.317 P=0.506 |P=0.087 (e) P=0.237 P=0.237 |
|POLY 6 | P=0.249 P=0.473N P=0.363 P=0.530 |P=0.087 (e) P=0.235 P=0.232 |
|LOGISTIC REGRESSION| P=0.242 P=0.471N P=0.339 P=0.500 |P=0.077 (e) P=0.264 P=0.226 |
|COCH-ARM / FISHERS | P=0.242 P=0.500N P=0.301 P=0.500 |P=0.086 (e) P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/40.34 1/42.95 2/43.49 1/41.32 |0/43.71 0/41.70 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 5.0% 2.3% 4.6% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 610 620 633 629 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.447N P=0.601N P=0.470N |(e) (e) (e) (e) |
|POLY 3 | P=0.445N P=0.478N P=0.667N P=0.492N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.445N P=0.491N P=0.683N P=0.497N |(e) (e) (e) (e) |
|POLY 6 | P=0.442N P=0.455N P=0.640N P=0.478N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.445N P=0.506N P=0.658 P=0.500N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.445N P=0.500N P=0.684 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/39.84 0/42.57 2/44.08 0/40.96 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% | |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 1/26 (4%) 0/27 (0%) | |
|FIRST INCIDENCE | --- --- 661 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.621 (e) P=0.297 (e) | |
|POLY 3 | P=0.594 (e) P=0.260 (e) | |
|POLY 1.5 | P=0.593 (e) P=0.249 (e) | |
|POLY 6 | P=0.602 (e) P=0.278 (e) | |
|LOGISTIC REGRESSION| P=0.598 (e) P=0.252 (e) | |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 13/50 (26%) 10/50 (20%) | |
|POLY-3 RATE (b) | 6/40.41 6/43.32 13/45.57 10/41.65 | |
|POLY-3 PERCENT (g) | 14.9% 13.9% 28.5% 24.0% | |
|TERMINAL (d) | 3/20 (15%) 4/29 (14%) 5/26 (19%) 8/27 (30%) | |
|FIRST INCIDENCE | 624 548 519 623 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.191 P=0.402N P=0.204 P=0.381 | |
|POLY 3 | P=0.109 P=0.572N P=0.100 P=0.219 | |
|POLY 1.5 | P=0.108 P=0.599N P=0.080 P=0.210 | |
|POLY 6 | P=0.117 P=0.521N P=0.140 P=0.244 | |
|LOGISTIC REGRESSION| P=0.113 P=0.571N P=0.084 P=0.255 | |
|COCH-ARM / FISHERS | P=0.110 P=0.620N P=0.062 P=0.207 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 5/50 (10%) 3/50 (6%) | |
|POLY-3 RATE (b) | 2/40.13 7/43.89 5/45.27 3/42.64 | |
|POLY-3 PERCENT (g) | 5.0% 16.0% 11.0% 7.0% | |
|TERMINAL (d) | 1/20 (5%) 4/29 (14%) 2/26 (8%) 0/27 (0%) | |
|FIRST INCIDENCE | 652 493 519 542 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.168 P=0.314 P=0.516 | |
|POLY 3 | P=0.470N P=0.100 P=0.267 P=0.528 | |
|POLY 1.5 | P=0.494N P=0.089 P=0.244 P=0.513 | |
|POLY 6 | P=0.429N P=0.124 P=0.305 P=0.555 | |
|LOGISTIC REGRESSION| P=0.516N P=0.080 P=0.174 P=0.517 | |
|COCH-ARM / FISHERS | P=0.517N P=0.080 P=0.218 P=0.500 | |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) 4/49 (8%) 7/50 (14%) |6/50 (12%) 5/50 (10%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 9/41.26 4/42.78 4/43.91 7/41.75 |6/44.29 5/42.83 2/42.91 5/43.08 |
|POLY-3 PERCENT (g) | 21.8% 9.4% 9.1% 16.8% |13.6% 11.7% 4.7% 11.6% |
|TERMINAL (d) | 5/20 (25%) 3/29 (10%) 1/26 (4%) 5/27 (19%) |4/33 (12%) 2/24 (8%) 0/29 (0%) 2/30 (7%) |
|FIRST INCIDENCE | 617 673 528 542 |638 499 652 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346N P=0.044N* P=0.063N P=0.241N |P=0.425N P=0.606 P=0.172N P=0.558N |
|POLY 3 | P=0.438N P=0.098N P=0.090N P=0.380N |P=0.411N P=0.524N P=0.142N P=0.520N |
|POLY 1.5 | P=0.441N P=0.109N P=0.104N P=0.389N |P=0.406N P=0.510N P=0.139N P=0.509N |
|POLY 6 | P=0.435N P=0.080N P=0.071N P=0.356N |P=0.416N P=0.546N P=0.148N P=0.533N |
|LOGISTIC REGRESSION| P=0.439N P=0.094N P=0.129N P=0.373N |P=0.403N P=0.501N P=0.139N P=0.513N |
|COCH-ARM / FISHERS | P=0.443N P=0.117N P=0.125N P=0.393N |P=0.401N P=0.500N P=0.134N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.84 0/42.57 2/42.93 0/40.96 |0/43.71 0/41.70 1/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/20 (0%) 0/29 (0%) 2/26 (8%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 1/29 (3%) 0/30 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.635 (e) P=0.297 (e) |P=0.687 (e) P=0.474 (e) |
|POLY 3 | P=0.594 (e) P=0.254 (e) |P=0.689 (e) P=0.495 (e) |
|POLY 1.5 | P=0.592 (e) P=0.244 (e) |P=0.692 (e) P=0.497 (e) |
|POLY 6 | P=0.602 (e) P=0.271 (e) |P=0.684 (e) P=0.491 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.297 (e) |(e) (e) P=0.474 (e) |
|COCH-ARM / FISHERS | P=0.594 (e) P=0.242 (e) |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Tongue: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/2 (0%) |0/0 (0%) 0/2 (0%) 3/4 (75%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.51 0/1.50 |0/0.00 0/1.86 3/3.81 0/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 78.8% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |0/0 (0%) 0/1 (0%) 1/1 (100%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 707 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.616N (e) P=0.223 (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) |P=0.476N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.567N (e) P=1.000 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Tongue: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 1/1 (100%) 1/2 (50%) |0/0 (0%) 0/2 (0%) 0/4 (0%) 2/2 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 1/1.00 1/1.50 |0/0.00 0/1.86 0/3.69 2/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 66.7% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |0/0 (0%) 0/1 (0%) 0/1 (0%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- 584 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.723 (e) (e) P=1.000 |P=0.159 (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) P=1.000 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.667N (e) (e) P=1.000 |P=0.031 * (e) (e) (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/7 (100%) 1/1 (100%) 2/2 (100%) 4/5 (80%) |3/3 (100%) 1/2 (50%) 1/2 (50%) 1/1 (100%) |
|POLY-3 RATE (b) | 7/7.00 1/1.00 2/2.00 4/4.41 |3/3.00 1/1.48 1/1.48 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 90.7% |100.0% 67.7% 67.6% 100.0% |
|TERMINAL (d) | 3/3 (100%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |2/2 (100%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 589 485 680 533 |638 695 638 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N (e) (e) P=0.451N |P=0.332N P=0.714 P=0.744 (e) |
|POLY 3 | P=0.467N (e) (e) P=0.882N |P=0.813N P=0.774N P=0.771N (e) |
|POLY 1.5 | P=0.321N (e) (e) P=0.640N |P=0.702N P=0.570N P=0.569N (e) |
|POLY 6 | P=0.920N (e) (e) P=1.000N |P=0.983N P=0.997N P=0.997N (e) |
|LOGISTIC REGRESSION| P=0.301N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.219N (e) (e) P=0.417N |P=0.623N P=0.400N P=0.400N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/48 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/39.65 0/42.57 1/42.46 1/41.09 |0/43.71 1/41.76 0/42.55 0/42.54 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 2.4% 2.4% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/19 (0%) 0/29 (0%) 0/26 (0%) 0/27 (0%) |0/33 (0%) 0/24 (0%) 0/29 (0%) 0/30 (0%) |
|FIRST INCIDENCE | 477 --- 661 695 |--- 717 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481N P=0.199N P=0.430N P=0.455N |P=0.575N P=0.450 (e) (e) |
|POLY 3 | P=0.501N P=0.221N P=0.476N P=0.487N |P=0.575N P=0.491 (e) (e) |
|POLY 1.5 | P=0.498N P=0.228N P=0.491N P=0.492N |P=0.571N P=0.496 (e) (e) |
|POLY 6 | P=0.506N P=0.207N P=0.450N P=0.474N |P=0.580N P=0.484 (e) (e) |
|LOGISTIC REGRESSION| P=0.496N P=0.221N P=0.576N P=0.489N |P=0.571N P=0.482 (e) (e) |
|COCH-ARM / FISHERS | P=0.497N P=0.242N P=0.508N P=0.492N |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 07 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 0.5 1.0 2.0 |CONTROL 0.5 1.0 2.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | |0/43.71 1/41.70 4/42.55 4/42.54 |
|POLY-3 PERCENT (g) | |0.0% 2.4% 9.4% 9.4% |
|TERMINAL (d) | |0/33 (0%) 1/24 (4%) 4/29 (14%) 4/30 (13%) |
|FIRST INCIDENCE | |--- 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.029 * P=0.436 P=0.047 * P=0.051 |
|POLY 3 | |P=0.026 * P=0.491 P=0.056 P=0.056 |
|POLY 1.5 | |P=0.027 * P=0.495 P=0.058 P=0.059 |
|POLY 6 | |P=0.024 * P=0.483 P=0.054 P=0.054 |
|LOGISTIC REGRESSION| |(e) P=0.436 P=0.047 * P=0.051 |
|COCH-ARM / FISHERS | |P=0.029 * P=0.500 P=0.059 P=0.059 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(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.
(g) Poly-3 adjusted lifetime tumor incidence.
(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).