TDMS Study 61427-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 08 TIME: 10:29:16
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: MILLER, RODNEY CAS: 1314-62-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#2/MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 08 TIME: 10:29:16
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: MILLER, RODNEY CAS: 1314-62-1
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01
EXPERIMENT: 61427 TEST: 08 TIME: 10:29:16
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 61427B
PATHOLOGIST: MILLER, RODNEY CAS: 1314-62-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF VANADIUM PENTOXIDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Spleen Hemangiosarcoma
Thyroid Gland: Follicular Cell Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 1/50 (2%) |2/49 (4%) 0/50 (0%) 0/48 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/46.78 0/43.43 1/45.18 1/40.58 |2/45.22 0/41.52 0/39.39 3/42.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 2.5% |4.4% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/35 (0%) 0/27 (0%) |2/38 (5%) 0/32 (0%) 0/30 (0%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- 639 667 |731 (T) --- --- 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.204 (e) P=0.500 P=0.450 |P=0.206 P=0.277N P=0.292N P=0.414 |
|POLY 3 | P=0.203 (e) P=0.493 P=0.472 |P=0.244 P=0.257N P=0.269N P=0.472 |
|POLY 1.5 | P=0.217 (e) P=0.494 P=0.483 |P=0.247 P=0.249N P=0.258N P=0.488 |
|POLY 6 | P=0.185 (e) P=0.491 P=0.457 |P=0.242 P=0.266N P=0.278N P=0.454 |
|LOGISTIC REGRESSION| P=0.285 (e) P=0.530 P=0.533 |P=0.216 (e) (e) P=0.435 |
|COCH-ARM / FISHERS | P=0.237 (e) P=0.495 P=0.500 |P=0.243 P=0.242N P=0.253N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/46.90 5/44.10 4/46.66 1/40.58 |2/45.55 1/41.52 1/39.96 0/43.48 |
|POLY-3 PERCENT (g) | 17.1% 11.3% 8.6% 2.5% |4.4% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 7/39 (18%) 5/33 (15%) 1/36 (3%) 0/27 (0%) |2/38 (5%) 1/32 (3%) 1/30 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 698 729 (T) 617 667 |731 (T) 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035N* P=0.390N P=0.220N P=0.061N |P=0.184N P=0.560N P=0.583N P=0.277N |
|POLY 3 | P=0.018N* P=0.316N P=0.179N P=0.028N* |P=0.157N P=0.532N P=0.545N P=0.248N |
|POLY 1.5 | P=0.015N* P=0.300N P=0.179N P=0.022N* |P=0.154N P=0.523N P=0.529N P=0.241N |
|POLY 6 | P=0.021N* P=0.338N P=0.179N P=0.037N* |P=0.161N P=0.544N P=0.559N P=0.255N |
|LOGISTIC REGRESSION| P=0.019N* P=0.357N P=0.179N P=0.040N* |P=0.184N P=0.560N P=0.583N (e) |
|COCH-ARM / FISHERS | P=0.012N* P=0.277N P=0.178N P=0.015N* |P=0.153N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/46.90 5/44.10 5/46.66 2/40.58 |2/45.55 1/41.52 1/39.96 0/43.48 |
|POLY-3 PERCENT (g) | 17.1% 11.3% 10.7% 4.9% |4.4% 2.4% 2.5% 0.0% |
|TERMINAL (d) | 7/39 (18%) 5/33 (15%) 2/36 (6%) 1/27 (4%) |2/38 (5%) 1/32 (3%) 1/30 (3%) 0/32 (0%) |
|FIRST INCIDENCE | 698 729 (T) 617 667 |731 (T) 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103N P=0.390N P=0.328N P=0.140N |P=0.184N P=0.560N P=0.583N P=0.277N |
|POLY 3 | P=0.058N P=0.316N P=0.279N P=0.074N |P=0.157N P=0.532N P=0.545N P=0.248N |
|POLY 1.5 | P=0.050N P=0.300N P=0.279N P=0.061N |P=0.154N P=0.523N P=0.529N P=0.241N |
|POLY 6 | P=0.069N P=0.338N P=0.279N P=0.094N |P=0.161N P=0.544N P=0.559N P=0.255N |
|LOGISTIC REGRESSION| P=0.064N P=0.357N P=0.279N P=0.103N |P=0.184N P=0.560N P=0.583N (e) |
|COCH-ARM / FISHERS | P=0.040N* P=0.277N P=0.277N P=0.046N* |P=0.153N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 17/50 (34%) 10/50 (20%) 7/50 (14%) |6/50 (12%) 7/50 (14%) 9/50 (18%) 2/50 (4%) |
|POLY-3 RATE (b) | 15/46.92 17/45.91 10/46.26 7/41.42 |6/46.22 7/42.06 9/42.16 2/43.59 |
|POLY-3 PERCENT (g) | 32.0% 37.0% 21.6% 16.9% |13.0% 16.6% 21.4% 4.6% |
|TERMINAL (d) | 14/39 (36%) 14/33 (42%) 8/36 (22%) 4/27 (15%) |5/38 (13%) 6/32 (19%) 4/30 (13%) 1/32 (3%) |
|FIRST INCIDENCE | 692 514 639 541 |505 564 416 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084N P=0.228 P=0.239N P=0.216N |P=0.179N P=0.384 P=0.175 P=0.186N |
|POLY 3 | P=0.028N* P=0.384 P=0.185N P=0.080N |P=0.137N P=0.427 P=0.223 P=0.152N |
|POLY 1.5 | P=0.021N* P=0.397 P=0.182N P=0.063N |P=0.123N P=0.448 P=0.245 P=0.141N |
|POLY 6 | P=0.040N* P=0.366 P=0.189N P=0.108N |P=0.154N P=0.403 P=0.212 P=0.165N |
|LOGISTIC REGRESSION| P=0.027N* P=0.362 P=0.205N P=0.111N |P=0.120N P=0.462 P=0.294 P=0.136N |
|COCH-ARM / FISHERS | P=0.014N* P=0.415 P=0.178N P=0.045N* |P=0.120N P=0.500 P=0.288 P=0.134N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 18/50 (36%) 14/50 (28%) 12/50 (24%) |6/50 (12%) 4/50 (8%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 14/49.21 18/45.68 14/46.81 12/43.14 |6/45.73 4/41.80 4/40.29 6/43.66 |
|POLY-3 PERCENT (g) | 28.5% 39.4% 29.9% 27.8% |13.1% 9.6% 9.9% 13.7% |
|TERMINAL (d) | 5/39 (13%) 13/33 (39%) 9/36 (25%) 5/27 (19%) |5/38 (13%) 2/32 (6%) 3/30 (10%) 3/32 (9%) |
|FIRST INCIDENCE | 523 590 611 541 |686 660 639 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493 P=0.162 P=0.511 P=0.435 |P=0.414 P=0.480N P=0.515N P=0.514 |
|POLY 3 | P=0.391N P=0.181 P=0.527 P=0.565N |P=0.482 P=0.427N P=0.451N P=0.588 |
|POLY 1.5 | P=0.329N P=0.211 P=0.552 P=0.502N |P=0.499 P=0.410N P=0.421N P=0.608 |
|POLY 6 | P=0.477N P=0.149 P=0.491 P=0.539 |P=0.464 P=0.448N P=0.474N P=0.565 |
|LOGISTIC REGRESSION| P=0.217N P=0.299 P=0.560N P=0.250N |P=0.464 P=0.440N P=0.462N P=0.559 |
|COCH-ARM / FISHERS | P=0.247N P=0.260 P=0.588N P=0.410N |P=0.500 P=0.370N P=0.370N P=0.620N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 30/50 (60%) 22/50 (44%) 17/50 (34%) |12/50 (24%) 10/50 (20%) 13/50 (26%) 8/50 (16%) |
|POLY-3 RATE (b) | 26/49.21 30/47.49 22/47.22 17/43.41 |12/46.40 10/42.34 13/42.49 8/43.76 |
|POLY-3 PERCENT (g) | 52.8% 63.2% 46.6% 39.2% |25.9% 23.6% 30.6% 18.3% |
|TERMINAL (d) | 17/39 (44%) 22/33 (67%) 15/36 (42%) 9/27 (33%) |10/38 (26%) 7/32 (22%) 7/30 (23%) 4/32 (13%) |
|FIRST INCIDENCE | 523 514 611 541 |505 564 416 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N P=0.119 P=0.406N P=0.417N |P=0.355N P=0.571N P=0.285 P=0.354N |
|POLY 3 | P=0.045N* P=0.204 P=0.341N P=0.131N |P=0.265N P=0.501N P=0.398 P=0.270N |
|POLY 1.5 | P=0.027N* P=0.231 P=0.313N P=0.092N |P=0.238N P=0.473N P=0.433 P=0.244N |
|POLY 6 | P=0.080N P=0.172 P=0.380N P=0.198N |P=0.293N P=0.533N P=0.381 P=0.300N |
|LOGISTIC REGRESSION| P=0.017N* P=0.296 P=0.273N P=0.056N |P=0.240N P=0.472N P=0.461 P=0.255N |
|COCH-ARM / FISHERS | P=0.013N* P=0.273 P=0.274N P=0.053N |P=0.234N P=0.405N P=0.500 P=0.227N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 30/50 (60%) 22/50 (44%) 17/50 (34%) |12/50 (24%) 10/50 (20%) 13/50 (26%) 8/50 (16%) |
|POLY-3 RATE (b) | 26/49.21 30/47.49 22/47.22 17/43.41 |12/46.40 10/42.34 13/42.49 8/43.76 |
|POLY-3 PERCENT (g) | 52.8% 63.2% 46.6% 39.2% |25.9% 23.6% 30.6% 18.3% |
|TERMINAL (d) | 17/39 (44%) 22/33 (67%) 15/36 (42%) 9/27 (33%) |10/38 (26%) 7/32 (22%) 7/30 (23%) 4/32 (13%) |
|FIRST INCIDENCE | 523 514 611 541 |505 564 416 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N P=0.119 P=0.406N P=0.417N |P=0.355N P=0.571N P=0.285 P=0.354N |
|POLY 3 | P=0.045N* P=0.204 P=0.341N P=0.131N |P=0.265N P=0.501N P=0.398 P=0.270N |
|POLY 1.5 | P=0.027N* P=0.231 P=0.313N P=0.092N |P=0.238N P=0.473N P=0.433 P=0.244N |
|POLY 6 | P=0.080N P=0.172 P=0.380N P=0.198N |P=0.293N P=0.533N P=0.381 P=0.300N |
|LOGISTIC REGRESSION| P=0.017N* P=0.296 P=0.273N P=0.056N |P=0.240N P=0.472N P=0.461 P=0.255N |
|COCH-ARM / FISHERS | P=0.013N* P=0.273 P=0.274N P=0.053N |P=0.234N P=0.405N P=0.500 P=0.227N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 16/50 (32%) 26/50 (52%) 15/50 (30%) |1/50 (2%) 17/50 (34%) 23/50 (46%) 19/50 (38%) |
|POLY-3 RATE (b) | 13/48.11 16/45.97 26/46.55 15/42.34 |1/45.55 17/43.94 23/44.66 19/45.06 |
|POLY-3 PERCENT (g) | 27.0% 34.8% 55.9% 35.4% |2.2% 38.7% 51.5% 42.2% |
|TERMINAL (d) | 6/39 (15%) 11/33 (33%) 24/36 (67%) 10/27 (37%) |1/38 (3%) 9/32 (28%) 13/30 (43%) 14/32 (44%) |
|FIRST INCIDENCE | 620 405 611 562 |731 (T) 530 281 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.064 P=0.212 P=0.005 ** P=0.127 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.143 P=0.276 P=0.003 ** P=0.263 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.207 P=0.301 P=0.004 ** P=0.322 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.082 P=0.240 P=0.002 ** P=0.196 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.221 P=0.363 P=0.005 ** P=0.350 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.326 P=0.330 P=0.007 ** P=0.412 |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 29/50 (58%) 30/50 (60%) 35/50 (70%) |0/50 (0%) 23/50 (46%) 18/50 (36%) 22/50 (44%) |
|POLY-3 RATE (b) | 12/47.01 29/48.14 30/48.13 35/48.09 |0/45.55 23/44.00 18/40.29 22/45.95 |
|POLY-3 PERCENT (g) | 25.5% 60.3% 62.3% 72.8% |0.0% 52.3% 44.7% 47.9% |
|TERMINAL (d) | 11/39 (28%) 17/33 (52%) 21/36 (58%) 15/27 (56%) |0/38 (0%) 15/32 (47%) 15/30 (50%) 12/32 (38%) |
|FIRST INCIDENCE | 667 530 534 394 |--- 522 695 542 |
|-------------------| | |
|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 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 42/50 (84%) 43/50 (86%) 43/50 (86%) |1/50 (2%) 32/50 (64%) 35/50 (70%) 32/50 (64%) |
|POLY-3 RATE (b) | 22/48.11 42/49.67 43/48.82 43/48.57 |1/45.55 32/45.55 35/44.85 32/46.96 |
|POLY-3 PERCENT (g) | 45.7% 84.6% 88.1% 88.5% |2.2% 70.3% 78.0% 68.1% |
|TERMINAL (d) | 15/39 (39%) 26/33 (79%) 32/36 (89%) 22/27 (82%) |1/38 (3%) 20/32 (63%) 23/30 (77%) 20/32 (63%) |
|FIRST INCIDENCE | 620 405 534 394 |731 (T) 522 281 478 |
|-------------------| | |
|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: 08 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/48 (2%) 0/50 (0%) 1/49 (2%) 2/47 (4%) |
|POLY-3 RATE (b) | |1/43.92 0/41.52 1/39.90 2/40.59 |
|POLY-3 PERCENT (g) | |2.3% 0.0% 2.5% 4.9% |
|TERMINAL (d) | |1/37 (3%) 0/32 (0%) 1/30 (3%) 1/29 (3%) |
|FIRST INCIDENCE | |731 (T) --- 731 (T) 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.207 P=0.529N P=0.715 P=0.435 |
|POLY 3 | |P=0.236 P=0.511N P=0.739 P=0.472 |
|POLY 1.5 | |P=0.241 P=0.505N P=0.750 P=0.484 |
|POLY 6 | |P=0.230 P=0.519N P=0.729 P=0.459 |
|LOGISTIC REGRESSION| |P=0.218 (e) P=0.715 P=0.455 |
|COCH-ARM / FISHERS | |P=0.237 P=0.490N P=0.747N P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |8/49 (16%) 6/50 (12%) 7/50 (14%) 3/47 (6%) |
|POLY-3 RATE (b) | 1/46.78 0/42.11 0/44.85 0/39.35 |8/45.76 6/42.22 7/40.06 3/41.63 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |17.5% 14.2% 17.5% 7.2% |
|TERMINAL (d) | 1/39 (3%) 0/32 (0%) 0/35 (0%) 0/26 (0%) |6/38 (16%) 2/32 (6%) 6/30 (20%) 2/30 (7%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |695 654 705 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.539N P=0.522N P=0.581N |P=0.168N P=0.514N P=0.537 P=0.177N |
|POLY 3 | P=0.286N P=0.521N P=0.508N P=0.534N |P=0.117N P=0.450N P=0.611N P=0.130N |
|POLY 1.5 | P=0.295N P=0.516N P=0.507N P=0.522N |P=0.108N P=0.431N P=0.568N P=0.121N |
|POLY 6 | P=0.272N P=0.527N P=0.511N P=0.550N |P=0.127N P=0.469N P=0.579 P=0.141N |
|LOGISTIC REGRESSION| P=0.347N (e) (e) (e) |P=0.124N P=0.449N P=0.569 P=0.122N |
|COCH-ARM / FISHERS | P=0.307N P=0.510N P=0.505N P=0.505N |P=0.106N P=0.371N P=0.483N P=0.113N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |8/49 (16%) 6/50 (12%) 7/50 (14%) 3/47 (6%) |
|POLY-3 RATE (b) | 2/46.78 0/42.11 0/44.85 0/39.35 |8/45.76 6/42.22 7/40.06 3/41.63 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |17.5% 14.2% 17.5% 7.2% |
|TERMINAL (d) | 2/39 (5%) 0/32 (0%) 0/35 (0%) 0/26 (0%) |6/38 (16%) 2/32 (6%) 6/30 (20%) 2/30 (7%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |695 654 705 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145N P=0.283N P=0.262N P=0.331N |P=0.168N P=0.514N P=0.537 P=0.177N |
|POLY 3 | P=0.106N P=0.261N P=0.247N P=0.278N |P=0.117N P=0.450N P=0.611N P=0.130N |
|POLY 1.5 | P=0.110N P=0.255N P=0.245N P=0.262N |P=0.108N P=0.431N P=0.568N P=0.121N |
|POLY 6 | P=0.100N P=0.269N P=0.250N P=0.298N |P=0.127N P=0.469N P=0.579 P=0.141N |
|LOGISTIC REGRESSION| P=0.145N (e) (e) (e) |P=0.124N P=0.449N P=0.569 P=0.122N |
|COCH-ARM / FISHERS | P=0.116N P=0.258N P=0.253N P=0.253N |P=0.106N P=0.371N P=0.483N P=0.113N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.78 0/44.10 0/45.85 0/40.35 |2/46.00 0/41.52 2/41.28 2/43.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 4.9% 4.6% |
|TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- --- |662 --- 416 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.416 P=0.291N P=0.635 P=0.639 |
|POLY 3 | (e) (e) (e) (e) |P=0.443 P=0.261N P=0.654 P=0.674 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.451 P=0.253N P=0.669 P=0.686 |
|POLY 6 | (e) (e) (e) (e) |P=0.434 P=0.271N P=0.642 P=0.659 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.434 P=0.235N P=0.659N P=0.692 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.247N P=0.691N P=0.691N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |2/50 (4%) 0/48 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.78 0/44.10 0/45.85 3/40.58 |2/45.92 0/41.52 1/39.90 2/43.77 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.4% |4.4% 0.0% 2.5% 4.6% |
|TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 2/27 (7%) |1/38 (3%) 0/32 (0%) 1/30 (3%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- 667 |626 --- 731 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.072 |P=0.427 P=0.277N P=0.576N P=0.638 |
|POLY 3 | P=0.010 * (e) (e) P=0.095 |P=0.468 P=0.260N P=0.549N P=0.677 |
|POLY 1.5 | P=0.010 * (e) (e) P=0.105 |P=0.472 P=0.253N P=0.532N P=0.687 |
|POLY 6 | P=0.009 ** (e) (e) P=0.085 |P=0.464 P=0.269N P=0.563N P=0.665 |
|LOGISTIC REGRESSION| P=0.008 ** (e) (e) P=0.089 |P=0.471 P=0.245N P=0.523N P=0.695N |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.474 P=0.258N P=0.508N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.78 1/44.10 0/45.85 0/40.35 |2/45.69 0/41.52 1/40.21 0/43.48 |
|POLY-3 PERCENT (g) | 4.3% 2.3% 0.0% 0.0% |4.4% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/33 (3%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |695 --- 662 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.558N P=0.256N P=0.322N |P=0.212N P=0.277N P=0.568N P=0.267N |
|POLY 3 | P=0.102N P=0.521N P=0.242N P=0.272N |P=0.184N P=0.259N P=0.544N P=0.248N |
|POLY 1.5 | P=0.101N P=0.512N P=0.240N P=0.257N |P=0.183N P=0.252N P=0.528N P=0.241N |
|POLY 6 | P=0.102N P=0.531N P=0.244N P=0.292N |P=0.185N P=0.268N P=0.556N P=0.257N |
|LOGISTIC REGRESSION| P=0.132N P=0.558N (e) (e) |P=0.191N P=0.255N P=0.521N P=0.245N |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.188N P=0.247N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.78 1/44.10 0/45.85 0/40.35 |2/45.69 0/41.52 0/39.96 0/43.48 |
|POLY-3 PERCENT (g) | 4.3% 2.3% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/33 (3%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |695 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.558N P=0.256N P=0.322N |P=0.131N P=0.277N P=0.284N P=0.267N |
|POLY 3 | P=0.102N P=0.521N P=0.242N P=0.272N |P=0.109N P=0.259N P=0.268N P=0.248N |
|POLY 1.5 | P=0.101N P=0.512N P=0.240N P=0.257N |P=0.110N P=0.252N P=0.257N P=0.241N |
|POLY 6 | P=0.102N P=0.531N P=0.244N P=0.292N |P=0.108N P=0.268N P=0.278N P=0.257N |
|LOGISTIC REGRESSION| P=0.132N P=0.558N (e) (e) |P=0.122N P=0.255N P=0.263N P=0.245N |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/48 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.78 0/44.10 0/45.85 2/40.35 |0/45.55 1/41.80 0/39.85 0/43.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/33 (0%) 0/36 (0%) 2/27 (7%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 654 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * (e) (e) P=0.172 |P=0.584N P=0.471 (e) (e) |
|POLY 3 | P=0.042 * (e) (e) P=0.215 |P=0.584N P=0.483 (e) (e) |
|POLY 1.5 | P=0.044 * (e) (e) P=0.228 |P=0.578N P=0.488 (e) (e) |
|POLY 6 | P=0.041 * (e) (e) P=0.199 |P=0.591N P=0.477 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.172 |P=0.570N P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.048 * (e) (e) P=0.258 |P=0.568N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/45.74 2/41.52 3/39.96 1/43.48 |
|POLY-3 PERCENT (g) | |4.4% 4.8% 7.5% 2.3% |
|TERMINAL (d) | |1/38 (3%) 2/32 (6%) 3/30 (10%) 1/32 (3%) |
|FIRST INCIDENCE | |683 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.463N P=0.627 P=0.396 P=0.551N |
|POLY 3 | |P=0.420N P=0.659 P=0.439 P=0.518N |
|POLY 1.5 | |P=0.407N P=0.669 P=0.461 P=0.507N |
|POLY 6 | |P=0.435N P=0.645 P=0.420 P=0.530N |
|LOGISTIC REGRESSION| |P=0.436N P=0.656 P=0.424 P=0.516N |
|COCH-ARM / FISHERS | |P=0.404N P=0.691N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/45.74 2/41.52 4/40.77 1/43.48 |
|POLY-3 PERCENT (g) | |4.4% 4.8% 9.8% 2.3% |
|TERMINAL (d) | |1/38 (3%) 2/32 (6%) 3/30 (10%) 1/32 (3%) |
|FIRST INCIDENCE | |683 731 (T) 416 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.487N P=0.627 P=0.252 P=0.551N |
|POLY 3 | |P=0.448N P=0.659 P=0.286 P=0.518N |
|POLY 1.5 | |P=0.433N P=0.669 P=0.305 P=0.507N |
|POLY 6 | |P=0.465N P=0.645 P=0.270 P=0.530N |
|LOGISTIC REGRESSION| |P=0.433N P=0.656 P=0.337 P=0.516N |
|COCH-ARM / FISHERS | |P=0.431N P=0.691N P=0.339 P=0.500N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.78 1/44.10 1/45.90 0/40.35 |0/45.55 0/41.52 2/40.21 0/43.48 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.2% 0.0% |0.0% 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/33 (3%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 1/30 (3%) 0/32 (0%) |
|FIRST INCIDENCE | --- 729 (T) 718 --- |--- --- 662 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.666N P=0.467 P=0.490 (e) |P=0.567 (e) P=0.194 (e) |
|POLY 3 | P=0.632N P=0.488 P=0.496 (e) |P=0.591 (e) P=0.210 (e) |
|POLY 1.5 | P=0.617N P=0.493 P=0.498 (e) |P=0.600 (e) P=0.220 (e) |
|POLY 6 | P=0.651N P=0.483 P=0.494 (e) |P=0.579 (e) P=0.204 (e) |
|LOGISTIC REGRESSION| P=0.655N P=0.467 P=0.495 (e) |P=0.593 (e) P=0.221 (e) |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/46.78 1/44.10 1/45.85 3/40.58 |2/45.92 0/41.52 1/39.96 3/44.19 |
|POLY-3 PERCENT (g) | 2.1% 2.3% 2.2% 7.4% |4.4% 0.0% 2.5% 6.8% |
|TERMINAL (d) | 1/39 (3%) 1/33 (3%) 1/36 (3%) 2/27 (7%) |1/38 (3%) 0/32 (0%) 1/30 (3%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 667 |626 --- 731 (T) 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 P=0.724 P=0.744 P=0.196 |P=0.215 P=0.277N P=0.576N P=0.439 |
|POLY 3 | P=0.140 P=0.747 P=0.756 P=0.256 |P=0.245 P=0.260N P=0.548N P=0.482 |
|POLY 1.5 | P=0.150 P=0.753 P=0.758 P=0.276 |P=0.248 P=0.253N P=0.530N P=0.494 |
|POLY 6 | P=0.129 P=0.741 P=0.754 P=0.233 |P=0.243 P=0.270N P=0.563N P=0.470 |
|LOGISTIC REGRESSION| P=0.110 P=0.724 P=0.744 P=0.230 |P=0.243 P=0.238N P=0.521N P=0.499 |
|COCH-ARM / FISHERS | P=0.163 P=0.753N P=0.753N P=0.309 |P=0.242 P=0.247N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/46.78 2/44.10 2/45.90 3/40.58 |2/45.92 0/41.52 3/40.21 3/44.19 |
|POLY-3 PERCENT (g) | 2.1% 4.5% 4.4% 7.4% |4.4% 0.0% 7.5% 6.8% |
|TERMINAL (d) | 1/39 (3%) 2/33 (6%) 1/36 (3%) 2/27 (7%) |1/38 (3%) 0/32 (0%) 2/30 (7%) 1/32 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 718 667 |626 --- 662 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137 P=0.442 P=0.476 P=0.196 |P=0.201 P=0.277N P=0.403 P=0.439 |
|POLY 3 | P=0.188 P=0.479 P=0.493 P=0.256 |P=0.235 P=0.260N P=0.440 P=0.482 |
|POLY 1.5 | P=0.206 P=0.488 P=0.496 P=0.276 |P=0.240 P=0.253N P=0.462 P=0.494 |
|POLY 6 | P=0.168 P=0.469 P=0.489 P=0.233 |P=0.231 P=0.270N P=0.423 P=0.470 |
|LOGISTIC REGRESSION| P=0.155 P=0.442 P=0.482 P=0.230 |P=0.233 P=0.238N P=0.472 P=0.499 |
|COCH-ARM / FISHERS | P=0.232 P=0.500 P=0.500 P=0.309 |P=0.232 P=0.247N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.78 1/44.43 0/45.85 0/40.35 |3/45.76 1/42.13 1/39.98 1/43.48 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |6.6% 2.4% 2.5% 2.3% |
|TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 639 --- --- |695 530 725 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590N P=0.486 (e) (e) |P=0.272N P=0.354N P=0.384N P=0.356N |
|POLY 3 | P=0.577N P=0.490 (e) (e) |P=0.247N P=0.335N P=0.355N P=0.324N |
|POLY 1.5 | P=0.574N P=0.494 (e) (e) |P=0.242N P=0.327N P=0.336N P=0.312N |
|POLY 6 | P=0.580N P=0.485 (e) (e) |P=0.253N P=0.347N P=0.371N P=0.337N |
|LOGISTIC REGRESSION| P=0.511N P=0.559 (e) (e) |P=0.243N P=0.301N P=0.355N P=0.325N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.242N P=0.309N P=0.309N P=0.309N |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |7/50 (14%) 4/50 (8%) 12/50 (24%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/46.78 2/44.10 1/45.90 1/40.83 |7/45.55 4/42.19 12/42.05 5/44.20 |
|POLY-3 PERCENT (g) | 4.3% 4.5% 2.2% 2.5% |15.4% 9.5% 28.5% 11.3% |
|TERMINAL (d) | 2/39 (5%) 2/33 (6%) 0/36 (0%) 0/27 (0%) |7/38 (18%) 2/32 (6%) 7/30 (23%) 2/32 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 718 586 |731 (T) 603 270 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437N P=0.634 P=0.524N P=0.602N |P=0.504 P=0.367N P=0.068 P=0.493N |
|POLY 3 | P=0.367N P=0.673 P=0.507N P=0.547N |P=0.505N P=0.306N P=0.107 P=0.400N |
|POLY 1.5 | P=0.356N P=0.681 P=0.504N P=0.528N |P=0.488N P=0.295N P=0.123 P=0.385N |
|POLY 6 | P=0.382N P=0.662 P=0.511N P=0.572N |P=0.520N P=0.319N P=0.099 P=0.415N |
|LOGISTIC REGRESSION| P=0.360N P=0.634 P=0.518N P=0.480N |P=0.501N P=0.311N P=0.128 P=0.408N |
|COCH-ARM / FISHERS | P=0.337N P=0.691N P=0.500N P=0.500N |P=0.500N P=0.262N P=0.154 P=0.380N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 31/50 (62%) 36/50 (72%) 21/50 (42%) |19/50 (38%) 23/50 (46%) 35/50 (70%) 27/50 (54%) |
|POLY-3 RATE (b) | 31/48.94 31/47.26 36/47.85 21/43.65 |19/46.63 23/44.48 35/45.58 27/45.84 |
|POLY-3 PERCENT (g) | 63.4% 65.6% 75.2% 48.1% |40.7% 51.7% 76.8% 58.9% |
|TERMINAL (d) | 22/39 (56%) 23/33 (70%) 28/36 (78%) 12/27 (44%) |15/38 (40%) 14/32 (44%) 23/30 (77%) 19/32 (59%) |
|FIRST INCIDENCE | 499 405 611 541 |505 530 281 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.273 P=0.136 P=0.464N |P=0.021 * P=0.125 P<0.001 ** P=0.029 * |
|POLY 3 | P=0.090N P=0.493 P=0.144 P=0.098N |P=0.027 * P=0.199 P<0.001 ** P=0.058 |
|POLY 1.5 | P=0.054N P=0.535 P=0.163 P=0.065N |P=0.037 * P=0.210 P<0.001 ** P=0.072 |
|POLY 6 | P=0.154N P=0.425 P=0.125 P=0.155N |P=0.018 * P=0.193 P<0.001 ** P=0.046 * |
|LOGISTIC REGRESSION| P=0.055N P=0.571 P=0.178 P=0.067N |P=0.041 * P=0.201 P<0.001 ** P=0.066 |
|COCH-ARM / FISHERS | P=0.024N* P=0.582N P=0.198 P=0.036N* |P=0.042 * P=0.272 P<0.001 ** P=0.080 |
|=================================================================================================================================|
Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - VANADIUM PENTOXIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 40/50 (80%) 38/50 (76%) 41/50 (82%) |17/50 (34%) 29/50 (58%) 32/50 (64%) 33/50 (66%) |
|POLY-3 RATE (b) | 27/49.21 40/49.35 38/49.19 41/49.15 |17/46.75 29/45.63 32/43.73 33/48.50 |
|POLY-3 PERCENT (g) | 54.9% 81.1% 77.3% 83.4% |36.4% 63.6% 73.2% 68.0% |
|TERMINAL (d) | 18/39 (46%) 25/33 (76%) 25/36 (69%) 19/27 (70%) |11/38 (29%) 17/32 (53%) 21/30 (70%) 17/32 (53%) |
|FIRST INCIDENCE | 523 405 534 394 |626 522 270 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.005 ** P=0.029 * P<0.001 ** |P=0.003 ** P=0.006 ** P<0.001 ** P=0.002 ** |
|POLY 3 | P=0.004 ** P=0.004 ** P=0.015 * P<0.001 ** |P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.004 ** P=0.004 ** P=0.015 * P<0.001 ** |P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.004 ** P=0.004 ** P=0.015 * P=0.002 ** |P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.013 * P=0.009 ** P=0.020 * P=0.010 * |P=0.002 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.006 ** P=0.005 ** P=0.018 * P=0.002 ** |P=0.002 ** P=0.013 * P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 1.0 2.0 4.0 |CONTROL 1.0 2.0 4.0 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 49/50 (98%) 47/50 (94%) 47/50 (94%) |32/50 (64%) 37/50 (74%) 44/50 (88%) 40/50 (80%) |
|POLY-3 RATE (b) | 42/50.00 49/50.00 47/49.19 47/49.15 |32/47.69 37/46.23 44/47.37 40/48.50 |
|POLY-3 PERCENT (g) | 84.0% 98.0% 95.5% 95.6% |67.1% 80.0% 92.9% 82.5% |
|TERMINAL (d) | 31/39 (80%) 32/33 (97%) 34/36 (94%) 25/27 (93%) |23/38 (61%) 23/32 (72%) 28/30 (93%) 24/32 (75%) |
|FIRST INCIDENCE | 499 405 534 394 |505 522 270 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.019 * P=0.110 P=0.003 ** |P=0.026 * P=0.063 P<0.001 ** P=0.030 * |
|POLY 3 | P=0.052 P=0.016 * P=0.056 P=0.055 |P=0.038 * P=0.116 P<0.001 ** P=0.064 |
|POLY 1.5 | P=0.067 P=0.016 * P=0.067 P=0.065 |P=0.044 * P=0.118 P=0.002 ** P=0.068 |
|POLY 6 | P=0.045 * P=0.016 * P=0.051 P=0.050 |P=0.035 * P=0.117 P<0.001 ** P=0.061 |
|LOGISTIC REGRESSION| P=0.107 (e) P=0.097 P=0.115 |P=0.033 * P=0.105 P=0.002 ** P=0.055 |
|COCH-ARM / FISHERS | P=0.128 P=0.015 * P=0.100 P=0.100 |P=0.033 * P=0.194 P=0.005 ** 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).