TDMS Study 61427-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 08 TIME: 10:33:42 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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 08 TIME: 10:33:42 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 ----- ---------- Adrenal Cortex Hyperplasia Hypertrophy Heart Cardiomyopathy Islets, Pancreatic Hyperplasia Kidney Nephropathy Larynx: Respiratory Epithelium, Epiglottis Metaplasia Liver Clear Cell Focus Lung Inflammation Chronic Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Infiltration Cellular Histiocyte Lung: Bronchiole, Epithelium Hyperplasia Lung: Interstitium Fibrosis Lymph Node, Bronchial Hyperplasia Lymph Node, Mediastinal Hyperplasia Nose Inflammation Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia Necrosis Preputial Gland Ectasia Prostate Inflammation Skin: Prepuce Inflammation Chronic Stomach, Forestomach: Epithelium Hyperplasia =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Adrenal Medulla Hyperplasia Bone Fibrous Osteodystrophy Kidney Nephropathy Larynx: Respiratory Epithelium, Epiglottis Metaplasia Liver Eosinophilic Focus Inflammation Focal Granulomatous Necrosis Focal Lung Inflammation Chronic Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Infiltration Cellular Histiocyte Lung: Bronchiole, Epithelium Hyperplasia Lung: Interstitium Fibrosis Lymph Node Angiectasis Lymph Node, Bronchial Hyperplasia Nose Inflammation NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest VANADIUM PENTOXIDE DATE: 11/19/01 EXPERIMENT: 61427 TEST: 08 TIME: 10:33:42 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 Nose: Olfactory Epithelium Atrophy Degeneration Hyaline Nose: Respiratory Epithelium Degeneration Hyaline Metaplasia Necrosis Spleen Hematopoietic Cell Proliferation Stomach, Forestomach Cyst Thyroid Gland Inflammation Uterus Angiectasis =============================================================== Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 1 Statistical Analysis of Non-neoplastic Lesions 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 Cortex | | Degeneration Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/49 (4%) 2/49 (4%) | |POLY-3 RATE (b) | 0/46.78 1/43.43 0/45.85 0/40.35 |0/45.55 0/41.52 2/40.00 2/42.50 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 0.0% 5.0% 4.7% | |TERMINAL (d) | 0/39 (0%) 1/33 (3%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 1/30 (3%) 1/31 (3%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- --- 705 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.617N P=0.467 (e) (e) |P=0.076 (e) P=0.197 P=0.206 | |POLY 3 | P=0.576N P=0.485 (e) (e) |P=0.080 (e) P=0.209 P=0.222 | |POLY 1.5 | P=0.573N P=0.489 (e) (e) |P=0.084 (e) P=0.218 P=0.229 | |POLY 6 | P=0.579N P=0.480 (e) (e) |P=0.076 (e) P=0.202 P=0.215 | |LOGISTIC REGRESSION| (e) P=0.467 (e) (e) |P=0.078 (e) P=0.204 P=0.208 | |COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.083 (e) P=0.242 P=0.242 | |=================================================================================================================================| | | | | | | 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 Cortex | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 9/46.78 0/43.43 2/45.90 0/40.35 |0/45.55 0/41.52 0/39.90 0/42.48 | |POLY-3 PERCENT (g) | 19.2% 0.0% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 9/39 (23%) 0/33 (0%) 1/36 (3%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | 729 (T) --- 718 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.003N** P=0.005N** P=0.037N* P=0.011N* |(e) (e) (e) (e) | |POLY 3 | P<0.001N** P=0.002N** P=0.027N* P=0.004N** |(e) (e) (e) (e) | |POLY 1.5 | P<0.001N** P=0.002N** P=0.026N* P=0.003N** |(e) (e) (e) (e) | |POLY 6 | P<0.001N** P=0.003N** P=0.028N* P=0.006N** |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.003N** (e) P=0.034N* (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P<0.001N** P<0.001N** P=0.026N* P<0.001N** |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 2 Statistical Analysis of Non-neoplastic Lesions 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 Cortex | | Hypertrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 40/50 (80%) 36/49 (73%) 31/50 (62%) 31/50 (62%) |5/50 (10%) 5/50 (10%) 3/49 (6%) 7/49 (14%) | |POLY-3 RATE (b) | 40/47.73 36/46.09 31/47.94 31/45.10 |5/45.73 5/41.95 3/40.16 7/43.39 | |POLY-3 PERCENT (g) | 83.8% 78.1% 64.7% 68.7% |10.9% 11.9% 7.5% 16.1% | |TERMINAL (d) | 34/39 (87%) 29/33 (88%) 25/36 (69%) 19/27 (70%) |4/38 (11%) 4/32 (13%) 2/30 (7%) 5/31 (16%) | |FIRST INCIDENCE | 620 514 422 387 |686 603 662 550 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.450 P=0.423 P=0.140N P=0.360 |P=0.233 P=0.522 P=0.485N P=0.271 | |POLY 3 | P=0.035N* P=0.321N P=0.022N* P=0.058N |P=0.289 P=0.575 P=0.430N P=0.342 | |POLY 1.5 | P=0.028N* P=0.312N P=0.027N* P=0.046N* |P=0.302 P=0.591 P=0.405N P=0.358 | |POLY 6 | P=0.049N* P=0.336N P=0.020N* P=0.087N |P=0.276 P=0.556 P=0.450N P=0.325 | |LOGISTIC REGRESSION| P=0.088N P=0.486N P=0.045N* P=0.157N |P=0.292 P=0.576 P=0.435N P=0.353 | |COCH-ARM / FISHERS | P=0.024N* P=0.298N P=0.038N* P=0.038N* |P=0.302 P=0.630N P=0.369N P=0.365 | |=================================================================================================================================| | | | | | | 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/49 (2%) 1/50 (2%) |4/49 (8%) 0/50 (0%) 0/48 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 0/46.78 2/44.04 1/44.85 1/40.35 |4/45.58 0/41.52 0/39.39 0/42.48 | |POLY-3 PERCENT (g) | 0.0% 4.5% 2.2% 2.5% |8.8% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/33 (3%) 1/35 (3%) 1/27 (4%) |2/38 (5%) 0/32 (0%) 0/30 (0%) 0/31 (0%) | |FIRST INCIDENCE | --- 530 729 (T) 729 (T) |683 --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.221 P=0.478 P=0.427 |P=0.028N* P=0.092N P=0.097N P=0.086N | |POLY 3 | P=0.434 P=0.224 P=0.492 P=0.471 |P=0.017N* P=0.073N P=0.081N P=0.070N | |POLY 1.5 | P=0.462 P=0.227 P=0.493 P=0.483 |P=0.017N* P=0.068N P=0.074N P=0.064N | |POLY 6 | P=0.398 P=0.220 P=0.489 P=0.455 |P=0.016N* P=0.080N P=0.088N P=0.076N | |LOGISTIC REGRESSION| P=0.533 P=0.298 P=0.478 P=0.427 |P=0.023N* P=0.068N P=0.074N P=0.065N | |COCH-ARM / FISHERS | P=0.501 P=0.242 P=0.495 P=0.500 |P=0.021N* P=0.056N P=0.061N P=0.059N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 3 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Bone | | Fibrous Osteodystrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |28/50 (56%) 21/50 (42%) 22/50 (44%) 32/50 (64%) | |POLY-3 RATE (b) | 1/46.78 3/44.23 2/45.85 2/40.35 |28/46.13 21/42.32 22/41.17 32/45.20 | |POLY-3 PERCENT (g) | 2.1% 6.8% 4.4% 5.0% |60.7% 49.6% 53.4% 70.8% | |TERMINAL (d) | 1/39 (3%) 2/33 (6%) 2/36 (6%) 2/27 (7%) |25/38 (66%) 19/32 (59%) 16/30 (53%) 25/32 (78%) | |FIRST INCIDENCE | 729 (T) 695 729 (T) 729 (T) |626 564 584 550 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.362 P=0.253 P=0.472 P=0.372 |P=0.031 * P=0.342N P=0.550N P=0.059 | |POLY 3 | P=0.425 P=0.286 P=0.493 P=0.449 |P=0.102 P=0.198N P=0.317N P=0.206 | |POLY 1.5 | P=0.456 P=0.293 P=0.496 P=0.470 |P=0.125 P=0.169N P=0.249N P=0.251 | |POLY 6 | P=0.386 P=0.276 P=0.489 P=0.421 |P=0.082 P=0.241N P=0.363N P=0.160 | |LOGISTIC REGRESSION| P=0.374 P=0.272 P=0.472 P=0.372 |P=0.063 P=0.282N P=0.423N P=0.129 | |COCH-ARM / FISHERS | P=0.500 P=0.309 P=0.500 P=0.500 |P=0.131 P=0.115N P=0.159N P=0.270 | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Bone | | Fracture | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 1/46.66 0/40.35 |0/45.55 0/41.52 3/42.44 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.1% 0.0% |0.0% 0.0% 7.1% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 422 --- |--- --- 251 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.690 (e) P=0.500 (e) |P=0.548 (e) P=0.119 (e) | |POLY 3 | P=0.631 (e) P=0.499 (e) |P=0.529 (e) P=0.106 (e) | |POLY 1.5 | P=0.658 (e) P=0.500 (e) |P=0.542 (e) P=0.112 (e) | |POLY 6 | P=0.592 (e) P=0.498 (e) |P=0.514 (e) P=0.102 (e) | |LOGISTIC REGRESSION| P=0.546N (e) (e) (e) |P=0.380 (e) P=0.103 (e) | |COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.539 (e) P=0.121 (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 4 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Bone Marrow | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 4/50 (8%) |5/50 (10%) 1/50 (2%) 6/50 (12%) 6/50 (12%) | |POLY-3 RATE (b) | 8/47.53 5/45.98 4/46.18 4/41.19 |5/45.74 1/41.78 6/41.62 6/44.25 | |POLY-3 PERCENT (g) | 16.8% 10.9% 8.7% 9.7% |10.9% 2.4% 14.4% 13.6% | |TERMINAL (d) | 6/39 (15%) 2/33 (6%) 2/36 (6%) 3/27 (11%) |4/38 (11%) 0/32 (0%) 3/30 (10%) 4/32 (13%) | |FIRST INCIDENCE | 499 405 653 394 |681 660 318 542 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.274N P=0.361N P=0.220N P=0.366N |P=0.184 P=0.153N P=0.363 P=0.406 | |POLY 3 | P=0.193N P=0.298N P=0.191N P=0.254N |P=0.227 P=0.123N P=0.434 P=0.477 | |POLY 1.5 | P=0.173N P=0.289N P=0.186N P=0.219N |P=0.235 P=0.117N P=0.459 P=0.493 | |POLY 6 | P=0.219N P=0.310N P=0.197N P=0.304N |P=0.219 P=0.132N P=0.416 P=0.458 | |LOGISTIC REGRESSION| P=0.075N P=0.159N P=0.172N P=0.138N |P=0.227 P=0.120N P=0.505 P=0.489 | |COCH-ARM / FISHERS | P=0.146N P=0.277N P=0.178N P=0.178N |P=0.226 P=0.102N 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 | |=================================================================================================================================| | | |Brain | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 0/43.10 0/45.85 0/40.35 |2/46.22 0/41.52 2/41.48 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 4.8% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/32 (0%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |505 --- 318 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.258N P=0.263N P=0.646 P=0.259N | |POLY 3 | (e) (e) (e) (e) |P=0.246N P=0.262N P=0.654 P=0.251N | |POLY 1.5 | (e) (e) (e) (e) |P=0.242N P=0.254N P=0.670 P=0.243N | |POLY 6 | (e) (e) (e) (e) |P=0.250N P=0.271N P=0.642 P=0.260N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.278N P=0.218N P=0.653N P=0.248N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247N P=0.247N P=0.691N P=0.247N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 5 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Brain: Meninges | | Infiltration Cellular Mononuclear Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 1/43.10 0/45.85 0/40.35 |0/45.55 2/41.52 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 4.8% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 1/32 (3%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 2/32 (6%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 729 (T) --- --- |--- 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.615N P=0.461 (e) (e) |P=0.437N P=0.201 (e) (e) | |POLY 3 | P=0.577N P=0.484 (e) (e) |P=0.434N P=0.217 (e) (e) | |POLY 1.5 | P=0.573N P=0.489 (e) (e) |P=0.422N P=0.223 (e) (e) | |POLY 6 | P=0.580N P=0.478 (e) (e) |P=0.447N P=0.210 (e) (e) | |LOGISTIC REGRESSION| (e) P=0.461 (e) (e) |(e) P=0.201 (e) (e) | |COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.405N P=0.247 (e) (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 | |=================================================================================================================================| | | |Epididymis | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) | | |POLY-3 RATE (b) | 3/46.78 0/44.10 1/45.85 0/40.35 | | |POLY-3 PERCENT (g) | 6.4% 0.0% 2.2% 0.0% | | |TERMINAL (d) | 3/39 (8%) 0/33 (0%) 1/36 (3%) 0/27 (0%) | | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.119N P=0.152N P=0.334N P=0.193N | | |POLY 3 | P=0.087N P=0.130N P=0.313N P=0.148N | | |POLY 1.5 | P=0.086N P=0.125N P=0.310N P=0.135N | | |POLY 6 | P=0.089N P=0.135N P=0.317N P=0.165N | | |LOGISTIC REGRESSION| P=0.119N (e) P=0.334N (e) | | |COCH-ARM / FISHERS | P=0.086N P=0.121N P=0.309N P=0.121N | | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 6 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Esophagus | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) | |POLY-3 RATE (b) | 2/47.55 0/44.10 0/45.85 0/40.20 |0/45.55 0/41.52 0/39.96 0/43.06 | |POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 523 --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.130N P=0.258N P=0.245N P=0.290N |(e) (e) (e) (e) | |POLY 3 | P=0.105N P=0.254N P=0.245N P=0.276N |(e) (e) (e) (e) | |POLY 1.5 | P=0.109N P=0.247N P=0.242N P=0.261N |(e) (e) (e) (e) | |POLY 6 | P=0.100N P=0.263N P=0.250N P=0.298N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.074N P=0.135N P=0.175N P=0.110N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N |(e) (e) (e) (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 | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 48/50 (96%) 48/50 (96%) 47/50 (94%) |47/50 (94%) 45/50 (90%) 46/50 (92%) 49/50 (98%) | |POLY-3 RATE (b) | 48/48.69 48/49.23 48/49.16 47/48.88 |47/47.35 45/45.94 46/46.87 49/49.04 | |POLY-3 PERCENT (g) | 98.6% 97.5% 97.6% 96.2% |99.3% 98.0% 98.1% 99.9% | |TERMINAL (d) | 39/39 (100%) 33/33 (100%) 36/36 (100%) 26/27 (96%) |38/38 (100%) 32/32 (100%) 30/30 (100%) 32/32 (100%) | |FIRST INCIDENCE | 603 405 422 387 |626 446 270 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** P=0.106 P=0.299 P=0.008 ** |P=0.058 P=0.164 P=0.055 P=0.056 | |POLY 3 | P=0.297N P=0.680N P=0.710N P=0.443N |P=0.488 P=0.693N P=0.727N P=0.980 | |POLY 1.5 | P=0.338N P=0.671N P=0.685N P=0.464N |P=0.410 P=0.600N P=0.550N P=0.783 | |POLY 6 | P=0.246N P=0.803N P=0.864N P=0.445N |P=0.740 P=0.959N P=0.895N P=1.000 | |LOGISTIC REGRESSION| P=0.482 P=0.462 P=0.657 P=0.520 |P=0.163 P=0.685 P=0.488 P=0.257 | |COCH-ARM / FISHERS | P=0.387N P=0.691N P=0.691N P=0.500N |P=0.178 P=0.357N P=0.500N P=0.309 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 7 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Heart | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 1/44.43 0/45.85 0/40.35 |2/47.21 1/42.52 1/39.96 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |4.2% 2.4% 2.5% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 1/30 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- 639 --- --- |181 23 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.590N P=0.486 (e) (e) |P=0.162N P=0.507N P=0.540N P=0.238N | |POLY 3 | P=0.577N P=0.490 (e) (e) |P=0.163N P=0.536N P=0.558N P=0.256N | |POLY 1.5 | P=0.574N P=0.494 (e) (e) |P=0.158N P=0.525N P=0.538N P=0.247N | |POLY 6 | P=0.580N P=0.485 (e) (e) |P=0.168N P=0.550N P=0.573N P=0.265N | |LOGISTIC REGRESSION| P=0.511N P=0.559 (e) (e) |P=0.215N P=0.291N P=0.460N P=0.369N | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |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 | |=================================================================================================================================| | | |Heart: Capillary | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/46.78 0/44.10 0/45.85 0/40.35 |2/45.55 0/41.52 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |2/38 (5%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.342N P=0.533N P=0.516N P=0.573N |P=0.135N P=0.277N P=0.292N P=0.277N | |POLY 3 | P=0.284N P=0.512N P=0.504N P=0.529N |P=0.109N P=0.258N P=0.268N P=0.248N | |POLY 1.5 | P=0.294N P=0.507N P=0.502N P=0.517N |P=0.110N P=0.252N P=0.256N P=0.241N | |POLY 6 | P=0.272N P=0.517N P=0.506N P=0.545N |P=0.108N P=0.266N P=0.277N P=0.255N | |LOGISTIC REGRESSION| P=0.342N (e) (e) (e) |P=0.135N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.115N P=0.247N P=0.247N P=0.247N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 8 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 6/50 (12%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 11/47.03 6/45.73 1/45.85 2/40.69 |0/45.55 1/41.54 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 23.4% 13.1% 2.2% 4.9% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 9/39 (23%) 3/33 (9%) 1/36 (3%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 667 530 729 (T) 676 |--- 726 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008N** P=0.235N P=0.005N** P=0.047N* |P=0.580N P=0.472 (e) (e) | |POLY 3 | P=0.002N** P=0.156N P=0.002N** P=0.015N* |P=0.586N P=0.482 (e) (e) | |POLY 1.5 | P=0.002N** P=0.151N P=0.002N** P=0.011N* |P=0.579N P=0.487 (e) (e) | |POLY 6 | P=0.003N** P=0.163N P=0.002N** P=0.022N* |P=0.594N P=0.475 (e) (e) | |LOGISTIC REGRESSION| P=0.002N** P=0.127N P=0.003N** P=0.023N* |P=0.577N P=0.470 (e) (e) | |COCH-ARM / FISHERS | P=0.002N** P=0.143N P=0.002N** P=0.007N** |P=0.567N P=0.500 (e) (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 | |=================================================================================================================================| | | |Kidney | | Accumulation, Hyaline Droplet | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 0/45.85 1/40.83 |2/45.76 1/42.13 0/39.90 1/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.5% |4.4% 2.4% 0.0% 2.3% | |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 | --- --- --- 586 |695 530 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.180 (e) (e) P=0.469 |P=0.389N P=0.539N P=0.283N P=0.541N | |POLY 3 | P=0.184 (e) (e) P=0.473 |P=0.373N P=0.529N P=0.269N P=0.518N | |POLY 1.5 | P=0.190 (e) (e) P=0.484 |P=0.369N P=0.521N P=0.258N P=0.507N | |POLY 6 | P=0.177 (e) (e) P=0.459 |P=0.378N P=0.540N P=0.279N P=0.531N | |LOGISTIC REGRESSION| P=0.282 (e) (e) P=0.656 |P=0.368N P=0.486N P=0.256N P=0.514N | |COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.367N P=0.500N P=0.253N P=0.500N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 9 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Kidney | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 7/50 (14%) 6/50 (12%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 5/46.78 3/44.10 7/45.85 6/41.08 |1/45.55 1/41.52 0/39.90 1/43.48 | |POLY-3 PERCENT (g) | 10.7% 6.8% 15.3% 14.6% |2.2% 2.4% 0.0% 2.3% | |TERMINAL (d) | 5/39 (13%) 3/33 (9%) 7/36 (19%) 3/27 (11%) |1/38 (3%) 1/32 (3%) 0/30 (0%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 654 |731 (T) 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.138 P=0.450N P=0.322 P=0.278 |P=0.651 P=0.723 P=0.547N P=0.723 | |POLY 3 | P=0.234 P=0.389N P=0.365 P=0.410 |P=0.624N P=0.740 P=0.526N P=0.750 | |POLY 1.5 | P=0.262 P=0.376N P=0.371 P=0.446 |P=0.619N P=0.746 P=0.518N P=0.757 | |POLY 6 | P=0.203 P=0.405N P=0.356 P=0.367 |P=0.628N P=0.732 P=0.534N P=0.743 | |LOGISTIC REGRESSION| P=0.170 P=0.450N P=0.322 P=0.371 |P=0.651 P=0.723 (e) P=0.723 | |COCH-ARM / FISHERS | P=0.306 P=0.357N P=0.380 P=0.500 |P=0.616N P=0.753N P=0.505N P=0.753N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Kidney | | Hydronephrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 2/44.58 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 590 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.456N P=0.218 (e) (e) |(e) (e) (e) (e) | |POLY 3 | P=0.433N P=0.227 (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.422N P=0.231 (e) (e) |(e) (e) (e) (e) | |POLY 6 | P=0.447N P=0.222 (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.354N P=0.274 (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 10 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Kidney | | Infarct Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 2/45.85 0/40.35 |0/45.55 0/41.52 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 2/36 (6%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.531 (e) P=0.221 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.516 (e) P=0.233 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.550 (e) P=0.235 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.470 (e) P=0.230 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.221 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |(e) (e) (e) (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 | |=================================================================================================================================| | | |Kidney | | Metaplasia Osseous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 7/50 (14%) 1/50 (2%) |3/50 (6%) 3/50 (6%) 1/49 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 2/46.78 7/44.57 7/45.85 1/40.35 |3/45.55 3/41.78 1/39.90 2/43.65 | |POLY-3 PERCENT (g) | 4.3% 15.7% 15.3% 2.5% |6.6% 7.2% 2.5% 4.6% | |TERMINAL (d) | 2/39 (5%) 6/33 (18%) 7/36 (19%) 1/27 (4%) |3/38 (8%) 2/32 (6%) 1/30 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 590 729 (T) 729 (T) |731 (T) 660 731 (T) 687 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.436N P=0.050 P=0.062 P=0.628N |P=0.403N P=0.581 P=0.393N P=0.567N | |POLY 3 | P=0.376N P=0.068 P=0.074 P=0.551N |P=0.359N P=0.622 P=0.354N P=0.519N | |POLY 1.5 | P=0.324N P=0.072 P=0.076 P=0.530N |P=0.349N P=0.633 P=0.338N P=0.507N | |POLY 6 | P=0.446N P=0.062 P=0.071 P=0.578N |P=0.370N P=0.608 P=0.368N P=0.533N | |LOGISTIC REGRESSION| P=0.391N P=0.067 P=0.062 P=0.628N |P=0.367N P=0.611 P=0.393N P=0.537N | |COCH-ARM / FISHERS | P=0.260N P=0.080 P=0.080 P=0.500N |P=0.345N P=0.661N P=0.316N P=0.500N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 11 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 48/50 (96%) 50/50 (100%) 48/50 (96%) 48/50 (96%) |43/50 (86%) 33/50 (66%) 43/49 (88%) 39/50 (78%) | |POLY-3 RATE (b) | 48/48.98 50/50.00 48/49.59 48/48.57 |43/47.63 33/43.47 43/45.16 39/48.55 | |POLY-3 PERCENT (g) | 98.0% 100.0% 96.8% 98.8% |90.3% 75.9% 95.2% 80.3% | |TERMINAL (d) | 39/39 (100%) 33/33 (100%) 35/36 (97%) 27/27 (100%)|35/38 (92%) 27/32 (84%) 30/30 (100%) 25/32 (78%) | |FIRST INCIDENCE | 499 405 422 394 |505 522 270 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** P=0.055 P=0.312 P=0.004 ** |P=0.224 P=0.278N P=0.044 * P=0.430 | |POLY 3 | P=0.679 P=0.503 P=0.618N P=0.755 |P=0.234N P=0.047N* P=0.291 P=0.131N | |POLY 1.5 | P=0.595N P=0.343 P=0.655N P=0.698 |P=0.257N P=0.031N* P=0.408 P=0.125N | |POLY 6 | P=0.704 P=0.881 P=0.564N P=0.938 |P=0.202N P=0.090N P=0.213 P=0.142N | |LOGISTIC REGRESSION| P=0.470 P=0.098 P=0.641 P=0.215 |P=0.461N P=0.054N P=0.242 P=0.208N | |COCH-ARM / FISHERS | P=0.444N P=0.247 P=0.691N P=0.691N |P=0.486N P=0.017N* P=0.516 P=0.218N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Kidney: Papilla | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/46.78 0/44.10 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/39 (5%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.141N P=0.276N P=0.256N P=0.322N |(e) (e) (e) (e) | |POLY 3 | P=0.104N P=0.251N P=0.242N P=0.272N |(e) (e) (e) (e) | |POLY 1.5 | P=0.108N P=0.245N P=0.240N P=0.257N |(e) (e) (e) (e) | |POLY 6 | P=0.099N P=0.257N P=0.244N P=0.292N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.141N (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 12 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 7/50 (14%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 5/46.78 7/44.10 2/45.90 4/40.96 |0/45.55 0/41.52 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 10.7% 15.9% 4.4% 9.8% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/39 (13%) 7/33 (21%) 1/36 (3%) 2/27 (7%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 718 573 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.466N P=0.264 P=0.250N P=0.566 |(e) (e) (e) (e) | |POLY 3 | P=0.334N P=0.338 P=0.224N P=0.583N |(e) (e) (e) (e) | |POLY 1.5 | P=0.312N P=0.355 P=0.221N P=0.549N |(e) (e) (e) (e) | |POLY 6 | P=0.362N P=0.318 P=0.228N P=0.625N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.402N P=0.264 P=0.241N P=0.604N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.279N P=0.380 P=0.218N P=0.500N |(e) (e) (e) (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 | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/47.16 2/44.98 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.90 0/43.48 | |POLY-3 PERCENT (g) | 2.1% 4.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 620 558 --- --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.211N P=0.477 P=0.509N P=0.542N |(e) (e) (e) (e) | |POLY 3 | P=0.205N P=0.483 P=0.506N P=0.531N |(e) (e) (e) (e) | |POLY 1.5 | P=0.198N P=0.490 P=0.503N P=0.518N |(e) (e) (e) (e) | |POLY 6 | P=0.214N P=0.476 P=0.509N P=0.548N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.098N P=0.659 P=0.455N P=0.397N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 13 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Larynx | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 0/50 (0%) 3/49 (6%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 3/49 (6%) 1/50 (2%) | |POLY-3 RATE (b) | 2/46.31 0/44.10 3/45.59 0/40.35 |3/46.54 2/42.01 3/39.63 1/43.62 | |POLY-3 PERCENT (g) | 4.3% 0.0% 6.6% 0.0% |6.5% 4.8% 7.6% 2.3% | |TERMINAL (d) | 1/39 (3%) 0/33 (0%) 2/36 (6%) 0/27 (0%) |2/38 (5%) 0/32 (0%) 3/30 (10%) 0/32 (0%) | |FIRST INCIDENCE | 692 --- 639 --- |181 603 731 (T) 695 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.381N P=0.275N P=0.474 P=0.329N |P=0.308N P=0.554N P=0.571 P=0.344N | |POLY 3 | P=0.337N P=0.248N P=0.493 P=0.269N |P=0.281N P=0.546N P=0.586 P=0.329N | |POLY 1.5 | P=0.317N P=0.242N P=0.496 P=0.254N |P=0.271N P=0.535N P=0.608 P=0.318N | |POLY 6 | P=0.364N P=0.257N P=0.489 P=0.291N |P=0.292N P=0.559N P=0.570 P=0.340N | |LOGISTIC REGRESSION| P=0.310N P=0.241N P=0.505 P=0.268N |P=0.267N P=0.449N P=0.649N P=0.337N | |COCH-ARM / FISHERS | P=0.292N P=0.242N P=0.500 P=0.242N |P=0.264N P=0.500N P=0.651 P=0.309N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Larynx: Respiratory Epithelium, Epiglottis | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 45/50 (90%) 41/49 (84%) 41/50 (82%) |0/50 (0%) 39/50 (78%) 45/49 (92%) 44/50 (88%) | |POLY-3 RATE (b) | 2/46.16 45/49.91 41/47.00 41/47.66 |0/45.55 39/47.47 45/48.49 44/49.71 | |POLY-3 PERCENT (g) | 4.3% 90.2% 87.2% 86.0% |0.0% 82.2% 92.8% 88.5% | |TERMINAL (d) | 2/39 (5%) 30/33 (91%) 34/36 (94%) 22/27 (82%) |0/38 (0%) 25/32 (78%) 27/30 (90%) 27/32 (84%) | |FIRST INCIDENCE | 729 (T) 405 606 387 |--- 23 251 255 | |-------------------| | | |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 14 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Larynx: Squamous Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/49 (10%) 4/50 (8%) 11/49 (22%) 5/50 (10%) |15/50 (30%) 10/50 (20%) 17/49 (35%) 14/50 (28%) | |POLY-3 RATE (b) | 5/46.16 4/44.81 11/45.59 5/40.35 |15/47.49 10/43.56 17/43.97 14/46.13 | |POLY-3 PERCENT (g) | 10.8% 8.9% 24.1% 12.4% |31.6% 23.0% 38.7% 30.4% | |TERMINAL (d) | 5/39 (13%) 2/33 (6%) 10/36 (28%) 5/27 (19%) |11/38 (29%) 4/32 (13%) 8/30 (27%) 8/32 (25%) | |FIRST INCIDENCE | 729 (T) 514 639 729 (T) |181 23 251 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.210 P=0.585N P=0.061 P=0.388 |P=0.344 P=0.323N P=0.215 P=0.509 | |POLY 3 | P=0.298 P=0.519N P=0.079 P=0.544 |P=0.452 P=0.246N P=0.313 P=0.537N | |POLY 1.5 | P=0.354 P=0.506N P=0.081 P=0.586 |P=0.469 P=0.225N P=0.333 P=0.513N | |POLY 6 | P=0.231 P=0.535N P=0.075 P=0.487 |P=0.434 P=0.268N P=0.313 P=0.563N | |LOGISTIC REGRESSION| P=0.289 P=0.492N P=0.072 P=0.388 |P=0.445 P=0.158N P=0.432 P=0.495N | |COCH-ARM / FISHERS | P=0.439 P=0.487N P=0.085 P=0.617N |P=0.455 P=0.178N P=0.388 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 | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 RATE (b) | 2/46.85 0/44.10 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.96 1/43.48 | |POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.3% | |TERMINAL (d) | 1/39 (3%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 1/32 (3%) | |FIRST INCIDENCE | 710 --- --- --- |--- --- --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143N P=0.270N P=0.257N P=0.329N |P=0.187 (e) (e) P=0.466 | |POLY 3 | P=0.104N P=0.251N P=0.242N P=0.272N |P=0.197 (e) (e) P=0.491 | |POLY 1.5 | P=0.108N P=0.245N P=0.240N P=0.257N |P=0.200 (e) (e) P=0.497 | |POLY 6 | P=0.099N P=0.258N P=0.245N P=0.292N |P=0.194 (e) (e) P=0.484 | |LOGISTIC REGRESSION| P=0.130N P=0.256N P=0.243N P=0.295N |(e) (e) (e) P=0.466 | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.198 (e) (e) P=0.500 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 15 Statistical Analysis of Non-neoplastic Lesions 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 | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 4/46.78 3/44.10 0/45.85 0/40.35 |1/45.55 0/41.52 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 8.6% 6.8% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% | |TERMINAL (d) | 4/39 (10%) 3/33 (9%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) --- --- |731 (T) --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.028N* P=0.591N P=0.073N P=0.118N |P=0.328N P=0.534N P=0.547N P=0.534N | |POLY 3 | P=0.017N* P=0.532N P=0.063N P=0.082N |P=0.301N P=0.518N P=0.526N P=0.509N | |POLY 1.5 | P=0.017N* P=0.519N P=0.062N P=0.072N |P=0.303N P=0.513N P=0.517N P=0.503N | |POLY 6 | P=0.019N* P=0.548N P=0.064N P=0.095N |P=0.298N P=0.525N P=0.534N P=0.516N | |LOGISTIC REGRESSION| P=0.028N* P=0.591N (e) (e) |P=0.328N (e) (e) (e) | |COCH-ARM / FISHERS | P=0.016N* P=0.500N P=0.059N P=0.059N |P=0.306N P=0.500N P=0.500N 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 | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 20/50 (40%) 16/50 (32%) 19/50 (38%) 19/50 (38%) |16/50 (32%) 14/50 (28%) 4/50 (8%) 8/50 (16%) | |POLY-3 RATE (b) | 20/47.84 16/44.71 19/47.21 19/44.03 |16/46.59 14/42.91 4/41.83 8/43.92 | |POLY-3 PERCENT (g) | 41.8% 35.8% 40.2% 43.2% |34.3% 32.6% 9.6% 18.2% | |TERMINAL (d) | 18/39 (46%) 15/33 (46%) 15/36 (42%) 9/27 (33%) |13/38 (34%) 11/32 (34%) 1/30 (3%) 6/32 (19%) | |FIRST INCIDENCE | 499 534 534 494 |505 522 318 611 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.142 P=0.484N P=0.548 P=0.217 |P=0.039N* P=0.549 P=0.015N* P=0.117N | |POLY 3 | P=0.422 P=0.351N P=0.521N P=0.532 |P=0.016N* P=0.521N P=0.005N** P=0.065N | |POLY 1.5 | P=0.458 P=0.316N P=0.514N P=0.581 |P=0.014N* P=0.491N P=0.003N** P=0.054N | |POLY 6 | P=0.387 P=0.398N P=0.529N P=0.480 |P=0.020N* P=0.558N P=0.006N** P=0.078N | |LOGISTIC REGRESSION| P=0.421 P=0.341N P=0.510N P=0.539N |P=0.016N* P=0.491N P=0.003N** P=0.059N | |COCH-ARM / FISHERS | P=0.520 P=0.266N P=0.500N P=0.500N |P=0.015N* P=0.414N P=0.003N** P=0.050N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 16 Statistical Analysis of Non-neoplastic Lesions 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 6/50 (12%) 3/50 (6%) | |POLY-3 RATE (b) | 0/46.78 1/44.10 0/45.85 0/40.35 |4/46.14 0/41.52 6/42.73 3/44.16 | |POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |8.7% 0.0% 14.0% 6.8% | |TERMINAL (d) | 0/39 (0%) 1/33 (3%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 1/30 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- 729 (T) --- --- |662 --- 270 550 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.617N P=0.467 (e) (e) |P=0.444 P=0.095N P=0.282 P=0.557N | |POLY 3 | P=0.578N P=0.488 (e) (e) |P=0.486 P=0.075N P=0.322 P=0.524N | |POLY 1.5 | P=0.574N P=0.493 (e) (e) |P=0.496 P=0.070N P=0.341 P=0.508N | |POLY 6 | P=0.581N P=0.483 (e) (e) |P=0.475 P=0.082N P=0.308 P=0.543N | |LOGISTIC REGRESSION| (e) P=0.467 (e) (e) |P=0.460 P=0.066N P=0.430 P=0.500N | |COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.481 P=0.059N P=0.370 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 | |=================================================================================================================================| | | |Liver | | Inflammation Focal Granulomatous | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 6/50 (12%) 7/50 (14%) 3/50 (6%) |12/50 (24%) 26/50 (52%) 19/50 (38%) 21/50 (42%) | |POLY-3 RATE (b) | 2/47.46 6/44.16 7/45.85 3/40.83 |12/45.64 26/41.88 19/40.59 21/44.19 | |POLY-3 PERCENT (g) | 4.2% 13.6% 15.3% 7.4% |26.3% 62.1% 46.8% 47.5% | |TERMINAL (d) | 1/39 (3%) 5/33 (15%) 7/36 (19%) 2/27 (7%) |11/38 (29%) 24/32 (75%) 17/30 (57%) 17/32 (53%) | |FIRST INCIDENCE | 499 714 729 (T) 586 |709 635 584 612 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.340 P=0.098 P=0.066 P=0.383 |P=0.044 * P<0.001 ** P=0.015 * P=0.012 * | |POLY 3 | P=0.400 P=0.111 P=0.071 P=0.432 |P=0.099 P<0.001 ** P=0.036 * P=0.028 * | |POLY 1.5 | P=0.454 P=0.120 P=0.074 P=0.460 |P=0.128 P<0.001 ** P=0.053 P=0.036 * | |POLY 6 | P=0.335 P=0.101 P=0.067 P=0.398 |P=0.075 P<0.001 ** P=0.027 * P=0.021 * | |LOGISTIC REGRESSION| P=0.460 P=0.136 P=0.082 P=0.617 |P=0.077 P<0.001 ** P=0.022 * P=0.017 * | |COCH-ARM / FISHERS | P=0.533 P=0.134 P=0.080 P=0.500 |P=0.152 P=0.004 ** P=0.097 P=0.044 * | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 17 Statistical Analysis of Non-neoplastic Lesions 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 | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |2/50 (4%) 6/50 (12%) 9/50 (18%) 5/50 (10%) | |POLY-3 RATE (b) | 8/46.87 3/44.16 5/47.15 4/41.48 |2/45.74 6/43.38 9/43.00 5/45.02 | |POLY-3 PERCENT (g) | 17.1% 6.8% 10.6% 9.6% |4.4% 13.8% 20.9% 11.1% | |TERMINAL (d) | 6/39 (15%) 2/33 (6%) 2/36 (6%) 1/27 (4%) |1/38 (3%) 1/32 (3%) 4/30 (13%) 3/32 (9%) | |FIRST INCIDENCE | 710 714 534 573 |683 446 270 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.374N P=0.160N P=0.326N P=0.383N |P=0.214 P=0.103 P=0.016 * P=0.182 | |POLY 3 | P=0.249N P=0.118N P=0.272N P=0.241N |P=0.236 P=0.116 P=0.019 * P=0.210 | |POLY 1.5 | P=0.234N P=0.110N P=0.274N P=0.214N |P=0.254 P=0.120 P=0.021 * P=0.218 | |POLY 6 | P=0.267N P=0.128N P=0.270N P=0.278N |P=0.215 P=0.112 P=0.017 * P=0.198 | |LOGISTIC REGRESSION| P=0.199N P=0.138N P=0.263N P=0.211N |P=0.218 P=0.143 P=0.037 * P=0.199 | |COCH-ARM / FISHERS | P=0.213N P=0.100N P=0.277N P=0.178N |P=0.246 P=0.134 P=0.026 * P=0.218 | |=================================================================================================================================| | | | | | | 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 | | Pigmentation Hemosiderin | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 3/46.03 1/40.35 |1/45.73 0/41.52 2/39.96 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 6.5% 2.5% |2.2% 0.0% 5.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 1/36 (3%) 1/27 (4%) |0/38 (0%) 0/32 (0%) 2/30 (7%) 0/32 (0%) | |FIRST INCIDENCE | --- --- 695 729 (T) |686 --- 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.168 (e) P=0.115 P=0.427 |P=0.491N P=0.536N P=0.424 P=0.515N | |POLY 3 | P=0.186 (e) P=0.116 P=0.471 |P=0.461N P=0.519N P=0.453 P=0.510N | |POLY 1.5 | P=0.210 (e) P=0.117 P=0.483 |P=0.456N P=0.513N P=0.470 P=0.504N | |POLY 6 | P=0.157 (e) P=0.114 P=0.455 |P=0.468N P=0.527N P=0.439 P=0.517N | |LOGISTIC REGRESSION| P=0.192 (e) P=0.118 P=0.427 |P=0.473N P=0.504N P=0.451 P=0.500N | |COCH-ARM / FISHERS | P=0.247 (e) P=0.121 P=0.500 |P=0.461N P=0.500N P=0.500 P=0.500N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 18 Statistical Analysis of Non-neoplastic Lesions 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 | | Tension Lipidosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |2/50 (4%) 4/50 (8%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 2/46.78 4/44.10 2/46.66 3/40.48 |2/45.74 4/42.20 1/40.57 2/43.48 | |POLY-3 PERCENT (g) | 4.3% 9.1% 4.3% 7.4% |4.4% 9.5% 2.5% 4.6% | |TERMINAL (d) | 2/39 (5%) 4/33 (12%) 1/36 (3%) 2/27 (7%) |1/38 (3%) 2/32 (6%) 0/30 (0%) 2/32 (6%) | |FIRST INCIDENCE | 729 (T) 729 (T) 422 695 |681 522 534 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.372 P=0.262 P=0.672 P=0.335 |P=0.475N P=0.277 P=0.566N P=0.635 | |POLY 3 | P=0.450 P=0.310 P=0.693 P=0.435 |P=0.459N P=0.301 P=0.542N P=0.676 | |POLY 1.5 | P=0.479 P=0.321 P=0.694N P=0.462 |P=0.444N P=0.311 P=0.527N P=0.687 | |POLY 6 | P=0.415 P=0.297 P=0.690 P=0.401 |P=0.477N P=0.288 P=0.554N P=0.662 | |LOGISTIC REGRESSION| P=0.503 P=0.262 P=0.658N P=0.363 |P=0.431N P=0.326 P=0.485N P=0.674 | |COCH-ARM / FISHERS | P=0.521 P=0.339 P=0.691N P=0.500 |P=0.431N P=0.339 P=0.500N 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 | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |4/50 (8%) 3/50 (6%) 4/50 (8%) 4/50 (8%) | |POLY-3 RATE (b) | 2/46.85 3/44.10 3/45.85 1/40.35 |4/45.55 3/41.52 4/40.29 4/43.48 | |POLY-3 PERCENT (g) | 4.3% 6.8% 6.5% 2.5% |8.8% 7.2% 9.9% 9.2% | |TERMINAL (d) | 1/39 (3%) 3/33 (9%) 3/36 (8%) 1/27 (4%) |4/38 (11%) 3/32 (9%) 2/30 (7%) 4/32 (13%) | |FIRST INCIDENCE | 710 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 646 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.484N P=0.430 P=0.464 P=0.632N |P=0.434 P=0.594N P=0.516 P=0.547 | |POLY 3 | P=0.411N P=0.472 P=0.490 P=0.552N |P=0.502 P=0.550N P=0.574 P=0.618 | |POLY 1.5 | P=0.383N P=0.484 P=0.494 P=0.530N |P=0.518 P=0.536N P=0.599 P=0.634 | |POLY 6 | P=0.449N P=0.459 P=0.484 P=0.580N |P=0.485 P=0.569N P=0.556 P=0.599 | |LOGISTIC REGRESSION| P=0.482N P=0.448 P=0.477 P=0.608N |P=0.474 P=0.594N P=0.556 P=0.547 | |COCH-ARM / FISHERS | P=0.343N P=0.500 P=0.500 P=0.500N |P=0.518 P=0.500N P=0.643N P=0.643N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 19 Statistical Analysis of Non-neoplastic Lesions 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 | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 42/50 (84%) 45/50 (90%) 47/50 (94%) |4/50 (8%) 37/50 (74%) 39/50 (78%) 49/50 (98%) | |POLY-3 RATE (b) | 6/46.85 42/48.01 45/48.50 47/48.74 |4/45.93 37/47.09 39/45.22 49/50.00 | |POLY-3 PERCENT (g) | 12.8% 87.5% 92.8% 96.4% |8.7% 78.6% 86.2% 98.0% | |TERMINAL (d) | 5/39 (13%) 30/33 (91%) 34/36 (94%) 27/27 (100%)|2/38 (5%) 26/32 (81%) 27/30 (90%) 31/32 (97%) | |FIRST INCIDENCE | 710 405 534 387 |681 23 251 255 | |-------------------| | | |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 Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 41/50 (82%) 49/50 (98%) 50/50 (100%)|0/50 (0%) 31/50 (62%) 38/50 (76%) 50/50 (100%) | |POLY-3 RATE (b) | 3/46.78 41/48.96 49/49.96 50/50.00 |0/45.55 31/44.06 38/43.14 50/50.00 | |POLY-3 PERCENT (g) | 6.4% 83.7% 98.1% 100.0% |0.0% 70.4% 88.1% 100.0% | |TERMINAL (d) | 3/39 (8%) 29/33 (88%) 36/36 (100%) 27/27 (100%)|0/38 (0%) 23/32 (72%) 28/30 (93%) 32/32 (100%) | |FIRST INCIDENCE | 729 (T) 405 422 387 |--- 522 416 255 | |-------------------| | | |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 20 Statistical Analysis of Non-neoplastic Lesions 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: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 10/50 (20%) 36/50 (72%) 45/50 (90%) 49/50 (98%) |0/50 (0%) 34/50 (68%) 35/50 (70%) 45/50 (90%) | |POLY-3 RATE (b) | 10/47.09 36/47.41 45/48.78 49/49.42 |0/45.55 34/44.18 35/42.55 45/48.32 | |POLY-3 PERCENT (g) | 21.2% 75.9% 92.3% 99.2% |0.0% 77.0% 82.3% 93.1% | |TERMINAL (d) | 8/39 (21%) 26/33 (79%) 33/36 (92%) 27/27 (100%)|0/38 (0%) 25/32 (78%) 25/30 (83%) 29/32 (91%) | |FIRST INCIDENCE | 667 530 534 387 |--- 522 534 542 | |-------------------| | | |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: Bronchiole, Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 15/50 (30%) 37/50 (74%) 46/50 (92%) |0/50 (0%) 12/50 (24%) 34/50 (68%) 48/50 (96%) | |POLY-3 RATE (b) | 0/46.78 15/44.85 37/48.30 46/49.67 |0/45.55 12/41.52 34/45.57 48/49.98 | |POLY-3 PERCENT (g) | 0.0% 33.4% 76.6% 92.6% |0.0% 28.9% 74.6% 96.0% | |TERMINAL (d) | 0/39 (0%) 13/33 (39%) 30/36 (83%) 25/27 (93%) |0/38 (0%) 12/32 (38%) 24/30 (80%) 31/32 (97%) | |FIRST INCIDENCE | --- 530 422 387 |--- 731 (T) 270 255 | |-------------------| | | |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 21 Statistical Analysis of Non-neoplastic Lesions 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: Interstitium | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 6/50 (12%) 9/50 (18%) 12/50 (24%) |0/50 (0%) 1/50 (2%) 4/50 (8%) 8/50 (16%) | |POLY-3 RATE (b) | 1/46.78 6/45.61 9/47.57 12/42.68 |0/45.55 1/41.52 4/40.15 8/44.03 | |POLY-3 PERCENT (g) | 2.1% 13.2% 18.9% 28.1% |0.0% 2.4% 10.0% 18.2% | |TERMINAL (d) | 1/39 (3%) 2/33 (6%) 2/36 (6%) 5/27 (19%) |0/38 (0%) 1/32 (3%) 2/30 (7%) 4/32 (13%) | |FIRST INCIDENCE | 729 (T) 534 534 494 |--- 731 (T) 705 639 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.047 * P=0.011 * P<0.001 ** |P<0.001 ** P=0.466 P=0.043 * P=0.004 ** | |POLY 3 | P<0.001 ** P=0.052 P=0.009 ** P<0.001 ** |P<0.001 ** P=0.482 P=0.046 * P=0.003 ** | |POLY 1.5 | P<0.001 ** P=0.054 P=0.008 ** P<0.001 ** |P<0.001 ** P=0.487 P=0.051 P=0.003 ** | |POLY 6 | P<0.001 ** P=0.050 P=0.009 ** P<0.001 ** |P<0.001 ** P=0.475 P=0.042 * P=0.003 ** | |LOGISTIC REGRESSION| P=0.003 ** P=0.083 P=0.011 * P=0.002 ** |P<0.001 ** P=0.466 P=0.044 * P=0.004 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.056 P=0.008 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.059 P=0.003 ** | |=================================================================================================================================| | | | | | | 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: Perivascular | | Infiltration Cellular | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 0/45.85 0/40.35 |2/45.55 2/41.52 3/40.55 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 4.8% 7.4% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |2/38 (5%) 2/32 (6%) 1/30 (3%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 577 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.243N P=0.632 P=0.407 P=0.277N | |POLY 3 | (e) (e) (e) (e) |P=0.209N P=0.660 P=0.447 P=0.248N | |POLY 1.5 | (e) (e) (e) (e) |P=0.200N P=0.670 P=0.466 P=0.241N | |POLY 6 | (e) (e) (e) (e) |P=0.219N P=0.648 P=0.434 P=0.255N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.207N P=0.632 P=0.472 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.199N P=0.691N P=0.500 P=0.247N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 22 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Lymph Node | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/1 (0%) |3/3 (100%) 1/1 (100%) 0/5 (0%) 0/1 (0%) | |POLY-3 RATE (b) | 0/0.00 0/0.67 0/0.00 0/0.52 |3/3.00 1/1.00 0/4.89 0/0.71 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |100.0% 100.0% 0.0% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 1/1 (100%) 0/3 (0%) 0/0 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.063N (e) P=0.068N P=1.000N | |POLY 3 | (e) (e) (e) (e) |P<0.001N** (e) P<0.001N** P=1.000N | |POLY 1.5 | (e) (e) (e) (e) |P<0.001N** (e) P<0.001N** P<0.001N** | |POLY 6 | (e) (e) (e) (e) |P<0.001N** (e) P<0.001N** P=1.000N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.063N (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.016N* (e) P=0.018N* P=0.250N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Lymph Node, Bronchial | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/40 (18%) 7/38 (18%) 12/36 (33%) 13/40 (33%) |3/39 (8%) 13/40 (33%) 14/45 (31%) 20/41 (49%) | |POLY-3 RATE (b) | 7/38.85 7/34.54 12/34.77 13/35.33 |3/36.66 13/36.01 14/37.77 20/39.30 | |POLY-3 PERCENT (g) | 18.0% 20.3% 34.5% 36.8% |8.2% 36.1% 37.1% 50.9% | |TERMINAL (d) | 6/33 (18%) 2/23 (9%) 8/27 (30%) 4/21 (19%) |3/31 (10%) 9/25 (36%) 9/28 (32%) 9/25 (36%) | |FIRST INCIDENCE | 667 530 617 494 |731 (T) 522 577 542 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.010 * P=0.421 P=0.083 P=0.024 * |P<0.001 ** P=0.002 ** P=0.002 ** P<0.001 ** | |POLY 3 | P=0.026 * P=0.521 P=0.087 P=0.057 |P<0.001 ** P=0.003 ** P=0.002 ** P<0.001 ** | |POLY 1.5 | P=0.033 * P=0.541 P=0.089 P=0.071 |P<0.001 ** P=0.004 ** P=0.003 ** P<0.001 ** | |POLY 6 | P=0.019 * P=0.499 P=0.085 P=0.044 * |P<0.001 ** P=0.003 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.078 P=0.567N P=0.099 P=0.167 |P<0.001 ** P=0.006 ** P=0.003 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.047 * P=0.574 P=0.092 P=0.098 |P<0.001 ** P=0.006 ** P=0.007 ** P<0.001 ** | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 23 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Lymph Node, Mandibular | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/34 (3%) 0/43 (0%) 1/27 (4%) 1/35 (3%) |0/41 (0%) 2/40 (5%) 1/40 (3%) 3/46 (7%) | |POLY-3 RATE (b) | 1/31.74 0/38.91 1/24.86 1/28.33 |0/38.25 2/33.97 1/31.83 3/40.06 | |POLY-3 PERCENT (g) | 3.2% 0.0% 4.0% 3.5% |0.0% 5.9% 3.1% 7.5% | |TERMINAL (d) | 1/27 (4%) 0/30 (0%) 0/18 (0%) 1/18 (6%) |0/32 (0%) 2/26 (8%) 1/24 (4%) 2/30 (7%) | |FIRST INCIDENCE | 729 (T) --- 639 729 (T) |--- 731 (T) 731 (T) 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.440 P=0.479N P=0.716 P=0.669 |P=0.106 P=0.193 P=0.443 P=0.111 | |POLY 3 | P=0.475 P=0.459N P=0.705 P=0.735 |P=0.115 P=0.211 P=0.464 P=0.126 | |POLY 1.5 | P=0.493 P=0.457N P=0.707 P=0.749 |P=0.122 P=0.216 P=0.474 P=0.132 | |POLY 6 | P=0.450 P=0.461N P=0.703 P=0.715 |P=0.107 P=0.203 P=0.454 P=0.120 | |LOGISTIC REGRESSION| P=0.509 (e) P=0.724 P=0.669 |P=0.116 P=0.193 P=0.443 P=0.121 | |COCH-ARM / FISHERS | P=0.518 P=0.442N P=0.693 P=0.746N |P=0.131 P=0.241 P=0.494 P=0.143 | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Lymph Node, Mediastinal | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/38 (5%) 3/36 (8%) 4/43 (9%) 6/37 (16%) |6/43 (14%) 4/37 (11%) 5/42 (12%) 6/42 (14%) | |POLY-3 RATE (b) | 2/36.05 3/32.08 4/40.87 6/30.64 |6/41.29 4/33.07 5/35.75 6/38.04 | |POLY-3 PERCENT (g) | 5.6% 9.4% 9.8% 19.6% |14.5% 12.1% 14.0% 15.8% | |TERMINAL (d) | 1/30 (3%) 2/26 (8%) 1/33 (3%) 2/20 (10%) |4/35 (11%) 4/25 (16%) 3/28 (11%) 2/27 (7%) | |FIRST INCIDENCE | 667 639 639 535 |662 731 (T) 577 550 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.032 * P=0.442 P=0.344 P=0.058 |P=0.387 P=0.571N P=0.607 P=0.499 | |POLY 3 | P=0.053 P=0.447 P=0.396 P=0.083 |P=0.465 P=0.514N P=0.601N P=0.563 | |POLY 1.5 | P=0.062 P=0.457 P=0.396 P=0.097 |P=0.475 P=0.493N P=0.577N P=0.577 | |POLY 6 | P=0.045 * P=0.436 P=0.396 P=0.067 |P=0.454 P=0.543N P=0.616N P=0.545 | |LOGISTIC REGRESSION| P=0.085 P=0.483 P=0.392 P=0.135 |P=0.478 P=0.517N P=0.548N P=0.616 | |COCH-ARM / FISHERS | P=0.075 P=0.474 P=0.399 P=0.122 |P=0.500 P=0.469N P=0.517N P=0.605 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 24 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/46 (0%) 1/47 (2%) 2/48 (4%) 0/44 (0%) |0/46 (0%) 0/47 (0%) 0/48 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/43.55 1/42.75 2/44.46 0/36.08 |0/41.55 0/41.52 0/39.58 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 2.3% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/37 (0%) 0/33 (0%) 1/35 (3%) 0/26 (0%) |0/34 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 639 639 --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.641 P=0.486 P=0.234 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.603 P=0.496 P=0.242 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.635 P=0.499 P=0.244 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.562 P=0.493 P=0.239 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.576N P=0.572 P=0.263 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.629N P=0.505 P=0.258 (e) |(e) (e) (e) (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 | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/46 (7%) 7/47 (15%) 2/48 (4%) 2/44 (5%) |2/46 (4%) 1/47 (2%) 1/48 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 3/43.55 7/42.54 2/44.13 2/36.08 |2/41.55 1/41.86 1/39.58 1/43.48 | |POLY-3 PERCENT (g) | 6.9% 16.5% 4.5% 5.5% |4.8% 2.4% 2.5% 2.3% | |TERMINAL (d) | 3/37 (8%) 5/33 (15%) 2/35 (6%) 2/26 (8%) |2/34 (6%) 0/32 (0%) 1/30 (3%) 1/32 (3%) | |FIRST INCIDENCE | 729 (T) 714 729 (T) 729 (T) |731 (T) 635 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341N P=0.120 P=0.526N P=0.659N |P=0.431N P=0.530N P=0.544N P=0.521N | |POLY 3 | P=0.273N P=0.147 P=0.494N P=0.585N |P=0.395N P=0.497N P=0.517N P=0.484N | |POLY 1.5 | P=0.249N P=0.154 P=0.489N P=0.559N |P=0.390N P=0.490N P=0.504N P=0.475N | |POLY 6 | P=0.304N P=0.139 P=0.501N P=0.616N |P=0.400N P=0.506N P=0.527N P=0.494N | |LOGISTIC REGRESSION| P=0.342N P=0.130 P=0.526N P=0.659N |P=0.396N P=0.492N P=0.544N P=0.521N | |COCH-ARM / FISHERS | P=0.215N P=0.167 P=0.480N P=0.521N |P=0.383N P=0.492N P=0.484N P=0.468N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 25 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |3/50 (6%) 0/50 (0%) 4/50 (8%) 0/50 (0%) | |POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.00 0/1.00 |3/45.55 0/41.52 4/40.77 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.6% 0.0% 9.8% 0.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |3/38 (8%) 0/32 (0%) 3/30 (10%) 0/32 (0%) | |FIRST INCIDENCE | --- --- --- --- |731 (T) --- 416 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.240N P=0.153N P=0.386 P=0.153N | |POLY 3 | (e) (e) (e) (e) |P=0.194N P=0.136N P=0.440 P=0.127N | |POLY 1.5 | (e) (e) (e) (e) |P=0.189N P=0.131N P=0.462 P=0.122N | |POLY 6 | (e) (e) (e) (e) |P=0.200N P=0.143N P=0.422 P=0.133N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.200N (e) P=0.482 (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.199N P=0.121N P=0.500 P=0.121N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Mesentery: Fat | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/9 (33%) 0/7 (0%) 3/8 (38%) 0/1 (0%) |1/14 (7%) 1/9 (11%) 1/5 (20%) 0/4 (0%) | |POLY-3 RATE (b) | 3/9.00 0/6.23 3/7.59 0/1.00 |1/13.59 1/8.68 1/4.51 0/3.11 | |POLY-3 PERCENT (g) | 33.3% 0.0% 39.6% 0.0% |7.4% 11.5% 22.2% 0.0% | |TERMINAL (d) | 3/9 (33%) 0/5 (0%) 3/6 (50%) 0/1 (0%) |1/12 (8%) 1/7 (14%) 0/3 (0%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) --- |731 (T) 731 (T) 662 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.670 P=0.227N P=0.459 P=0.669N |P=0.687 P=0.640 P=0.599 P=1.000N | |POLY 3 | P=0.604N P=0.167N P=0.593 P=0.663N |P=0.622 P=0.658 P=0.499 P=0.769N | |POLY 1.5 | P=0.599N P=0.154N P=0.607 P=0.663N |P=0.651N P=0.659 P=0.506 P=0.759N | |POLY 6 | P=0.614N P=0.188N P=0.570 P=0.663N |P=0.556 P=0.657 P=0.490 P=0.783N | |LOGISTIC REGRESSION| P=0.670 (e) P=0.459 (e) |P=0.631N P=0.640 P=0.635 (e) | |COCH-ARM / FISHERS | P=0.595N P=0.150N P=0.627 P=0.700N |P=0.631N P=0.640 P=0.468 P=0.778N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 26 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 5/9 (56%) 3/7 (43%) 4/8 (50%) 1/1 (100%) |11/14 (79%) 9/9 (100%) 5/5 (100%) 3/4 (75%) | |POLY-3 RATE (b) | 5/9.00 3/6.23 4/7.59 1/1.00 |11/13.68 9/9.00 5/5.00 3/3.43 | |POLY-3 PERCENT (g) | 55.6% 48.2% 52.7% 100.0% |80.4% 100.0% 100.0% 87.6% | |TERMINAL (d) | 5/9 (56%) 3/5 (60%) 4/6 (67%) 1/1 (100%) |10/12 (83%) 7/7 (100%) 3/3 (100%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |709 660 584 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.341 P=0.651 P=0.541 P=0.581 |P=0.145 P=0.218 P=0.299 P=0.267 | |POLY 3 | P=0.482 P=0.589N P=0.641N P=0.579 |P=0.337 P=0.217 P=0.371 P=0.678 | |POLY 1.5 | P=0.494 P=0.548N P=0.619N P=0.579 |P=0.447 P=0.206 P=0.357 P=0.728 | |POLY 6 | P=0.460 P=0.648N P=0.676N P=0.579 |P=0.231 P=0.240 P=0.396 P=0.614 | |LOGISTIC REGRESSION| P=0.341 P=0.651 P=0.541 P=0.581 |P=0.188 P=0.173 P=0.235 P=0.342 | |COCH-ARM / FISHERS | P=0.506 P=0.500N P=0.601N P=0.600 |P=0.601 P=0.206 P=0.376 P=0.673N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 16/50 (32%) 11/50 (22%) 32/50 (64%) 23/50 (46%) |19/50 (38%) 14/50 (28%) 32/50 (64%) 30/50 (60%) | |POLY-3 RATE (b) | 16/47.91 11/46.00 32/47.92 23/42.47 |19/48.01 14/42.69 32/45.50 30/45.44 | |POLY-3 PERCENT (g) | 33.4% 23.9% 66.8% 54.2% |39.6% 32.8% 70.3% 66.0% | |TERMINAL (d) | 12/39 (31%) 7/33 (21%) 26/36 (72%) 16/27 (59%) |13/38 (34%) 11/32 (34%) 20/30 (67%) 24/32 (75%) | |FIRST INCIDENCE | 499 514 422 546 |181 522 251 478 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.325N P<0.001 ** P=0.007 ** |P<0.001 ** P=0.388N P=0.002 ** P=0.006 ** | |POLY 3 | P<0.001 ** P=0.215N P<0.001 ** P=0.034 * |P<0.001 ** P=0.326N P=0.002 ** P=0.007 ** | |POLY 1.5 | P=0.003 ** P=0.202N P<0.001 ** P=0.056 |P<0.001 ** P=0.288N P=0.003 ** P=0.012 * | |POLY 6 | P<0.001 ** P=0.235N P<0.001 ** P=0.018 * |P<0.001 ** P=0.375N P<0.001 ** P=0.004 ** | |LOGISTIC REGRESSION| P=0.006 ** P=0.154N P<0.001 ** P=0.036 * |P=0.002 ** P=0.223N P=0.008 ** P=0.021 * | |COCH-ARM / FISHERS | P=0.014 * P=0.184N P<0.001 ** P=0.109 |P=0.002 ** P=0.198N P=0.008 ** P=0.022 * | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 27 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Nose | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION 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 1/44.75 1/46.66 0/40.35 |0/45.55 0/41.52 2/41.53 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.1% 0.0% |0.0% 0.0% 4.8% 0.0% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 514 422 --- |--- --- 251 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.603N P=0.500 P=0.500 (e) |P=0.602 (e) P=0.232 (e) | |POLY 3 | P=0.632N P=0.491 P=0.499 (e) |P=0.588 (e) P=0.217 (e) | |POLY 1.5 | P=0.617N P=0.495 P=0.500 (e) |P=0.599 (e) P=0.225 (e) | |POLY 6 | P=0.650N P=0.487 P=0.498 (e) |P=0.576 (e) P=0.211 (e) | |LOGISTIC REGRESSION| P=0.257N P=0.715 (e) (e) |P=0.494 (e) P=0.226 (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 | |=================================================================================================================================| | | |Nose: Lateral Wall | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 2/45.85 1/40.35 |0/45.55 0/41.52 1/40.45 2/43.59 | |POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 2.5% |0.0% 0.0% 2.5% 4.6% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 2/36 (6%) 1/27 (4%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 584 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.177 (e) P=0.221 P=0.427 |P=0.066 (e) P=0.468 P=0.213 | |POLY 3 | P=0.196 (e) P=0.233 P=0.471 |P=0.069 (e) P=0.476 P=0.227 | |POLY 1.5 | P=0.216 (e) P=0.235 P=0.483 |P=0.071 (e) P=0.485 P=0.234 | |POLY 6 | P=0.172 (e) P=0.230 P=0.455 |P=0.066 (e) P=0.470 P=0.221 | |LOGISTIC REGRESSION| (e) (e) P=0.221 P=0.427 |P=0.070 (e) P=0.519 P=0.223 | |COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.070 (e) P=0.500 P=0.247 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 28 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Nose: Lateral Wall | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 4/50 (8%) 1/50 (2%) | |POLY-3 RATE (b) | 0/46.78 1/44.75 1/45.99 1/40.48 |1/45.55 1/42.15 4/42.44 1/43.48 | |POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 2.5% |2.2% 2.4% 9.4% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 1/30 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- 514 695 695 |731 (T) 522 251 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.321 P=0.500 P=0.495 P=0.421 |P=0.507 P=0.739 P=0.152 P=0.723 | |POLY 3 | P=0.331 P=0.491 P=0.497 P=0.471 |P=0.510 P=0.743 P=0.158 P=0.750 | |POLY 1.5 | P=0.353 P=0.495 P=0.498 P=0.483 |P=0.526 P=0.748 P=0.167 P=0.757 | |POLY 6 | P=0.304 P=0.487 P=0.495 P=0.456 |P=0.493 P=0.737 P=0.151 P=0.743 | |LOGISTIC REGRESSION| P=0.489 P=0.715 P=0.505 P=0.490 |P=0.466 P=0.750N P=0.215 P=0.723 | |COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.526 P=0.753N P=0.181 P=0.753N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 7/50 (14%) 9/50 (18%) 12/50 (24%) |2/50 (4%) 8/50 (16%) 5/50 (10%) 14/50 (28%) | |POLY-3 RATE (b) | 6/46.90 7/45.07 9/47.77 12/43.03 |2/46.48 8/41.88 5/39.96 14/45.73 | |POLY-3 PERCENT (g) | 12.8% 15.5% 18.8% 27.9% |4.3% 19.1% 12.5% 30.6% | |TERMINAL (d) | 5/39 (13%) 3/33 (9%) 4/36 (11%) 7/27 (26%) |0/38 (0%) 5/32 (16%) 5/30 (17%) 5/32 (16%) | |FIRST INCIDENCE | 698 514 422 387 |505 668 731 (T) 542 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.016 * P=0.396 P=0.258 P=0.025 * |P<0.001 ** P=0.031 * P=0.142 P<0.001 ** | |POLY 3 | P=0.037 * P=0.469 P=0.301 P=0.062 |P<0.001 ** P=0.030 * P=0.160 P<0.001 ** | |POLY 1.5 | P=0.044 * P=0.481 P=0.297 P=0.075 |P<0.001 ** P=0.034 * P=0.180 P<0.001 ** | |POLY 6 | P=0.029 * P=0.455 P=0.303 P=0.047 * |P<0.001 ** P=0.025 * P=0.144 P<0.001 ** | |LOGISTIC REGRESSION| P=0.100 P=0.491 P=0.316 P=0.123 |P<0.001 ** P=0.042 * P=0.198 P<0.001 ** | |COCH-ARM / FISHERS | P=0.056 P=0.500 P=0.288 P=0.096 |P<0.001 ** P=0.046 * P=0.218 P<0.001 ** | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 29 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Nose: Olfactory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 7/50 (14%) 23/50 (46%) 30/50 (60%) |11/50 (22%) 23/50 (46%) 34/50 (68%) 48/50 (96%) | |POLY-3 RATE (b) | 1/46.78 7/44.79 23/47.66 30/45.45 |11/46.79 23/43.40 34/45.52 48/49.05 | |POLY-3 PERCENT (g) | 2.1% 15.6% 48.3% 66.0% |23.5% 53.0% 74.7% 97.9% | |TERMINAL (d) | 1/39 (3%) 4/33 (12%) 16/36 (44%) 17/27 (63%) |8/38 (21%) 19/32 (59%) 22/30 (73%) 32/32 (100%) | |FIRST INCIDENCE | 729 (T) 558 422 394 |181 564 270 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P=0.026 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.027 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.024 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.030 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.010 * 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 | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Degeneration Hyaline | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 22/50 (44%) 38/50 (76%) 41/50 (82%) |35/50 (70%) 39/50 (78%) 46/50 (92%) 50/50 (100%) | |POLY-3 RATE (b) | 8/46.90 22/45.57 38/48.06 41/46.11 |35/47.67 39/44.36 46/47.42 50/50.00 | |POLY-3 PERCENT (g) | 17.1% 48.3% 79.1% 88.9% |73.4% 87.9% 97.0% 100.0% | |TERMINAL (d) | 7/39 (18%) 15/33 (46%) 28/36 (78%) 25/27 (93%) |27/38 (71%) 29/32 (91%) 29/30 (97%) 32/32 (100%) | |FIRST INCIDENCE | 698 558 534 541 |505 564 270 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.046 * P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.062 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=0.093 P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.037 * P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.081 P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.247 P=0.005 ** P<0.001 ** | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 30 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Metaplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 6/50 (12%) 6/50 (12%) 2/50 (4%) |0/50 (0%) 3/50 (6%) 7/50 (14%) 8/50 (16%) | |POLY-3 RATE (b) | 0/46.78 6/46.24 6/46.70 2/40.48 |0/45.55 3/42.25 7/40.90 8/44.29 | |POLY-3 PERCENT (g) | 0.0% 13.0% 12.9% 4.9% |0.0% 7.1% 17.1% 18.1% | |TERMINAL (d) | 0/39 (0%) 2/33 (6%) 4/36 (11%) 1/27 (4%) |0/38 (0%) 1/32 (3%) 5/30 (17%) 5/32 (16%) | |FIRST INCIDENCE | --- 514 422 695 |--- 522 318 565 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.335 P=0.016 * P=0.016 * P=0.161 |P=0.002 ** P=0.105 P=0.005 ** P=0.003 ** | |POLY 3 | P=0.330 P=0.015 * P=0.015 * P=0.207 |P=0.002 ** P=0.106 P=0.005 ** P=0.003 ** | |POLY 1.5 | P=0.383 P=0.015 * P=0.015 * P=0.219 |P=0.002 ** P=0.109 P=0.006 ** P=0.003 ** | |POLY 6 | P=0.267 P=0.014 * P=0.015 * P=0.192 |P=0.002 ** P=0.102 P=0.004 ** P=0.003 ** | |LOGISTIC REGRESSION| P=0.534N P=0.035 * P=0.020 * P=0.191 |P=0.003 ** P=0.124 P=0.009 ** P=0.005 ** | |COCH-ARM / FISHERS | P=0.463 P=0.013 * P=0.013 * P=0.247 |P=0.003 ** P=0.121 P=0.006 ** P=0.003 ** | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Nose: Respiratory Epithelium | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 7/50 (14%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 1/45.85 2/40.35 |0/45.55 0/41.52 1/40.57 7/44.19 | |POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 5.0% |0.0% 0.0% 2.5% 15.8% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 1/36 (3%) 2/27 (7%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 5/32 (16%) | |FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 534 565 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.040 * (e) P=0.484 P=0.162 |P<0.001 ** (e) P=0.478 P=0.006 ** | |POLY 3 | P=0.057 (e) P=0.496 P=0.206 |P<0.001 ** (e) P=0.477 P=0.007 ** | |POLY 1.5 | P=0.062 (e) P=0.498 P=0.219 |P<0.001 ** (e) P=0.485 P=0.007 ** | |POLY 6 | P=0.051 (e) P=0.494 P=0.190 |P<0.001 ** (e) P=0.471 P=0.006 ** | |LOGISTIC REGRESSION| (e) (e) P=0.484 P=0.162 |P<0.001 ** (e) P=0.519 P=0.009 ** | |COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |P<0.001 ** (e) P=0.500 P=0.006 ** | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 31 Statistical Analysis of Non-neoplastic Lesions 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 | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |16/48 (33%) 16/50 (32%) 15/49 (31%) 17/47 (36%) | |POLY-3 RATE (b) | |16/44.95 16/42.39 15/41.59 17/43.22 | |POLY-3 PERCENT (g) | |35.6% 37.7% 36.1% 39.3% | |TERMINAL (d) | |13/37 (35%) 11/32 (34%) 10/30 (33%) 8/29 (28%) | |FIRST INCIDENCE | |505 603 490 550 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.255 P=0.396 P=0.415 P=0.280 | |POLY 3 | |P=0.411 P=0.506 P=0.571 P=0.443 | |POLY 1.5 | |P=0.429 P=0.547 P=0.554N P=0.467 | |POLY 6 | |P=0.400 P=0.457 P=0.532 P=0.424 | |LOGISTIC REGRESSION| |P=0.389 P=0.527 P=0.564N P=0.461 | |COCH-ARM / FISHERS | |P=0.411 P=0.530N P=0.472N P=0.470 | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Pancreas | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 3/50 (6%) 5/50 (10%) 2/50 (4%) |3/50 (6%) 4/50 (8%) 2/49 (4%) 4/50 (8%) | |POLY-3 RATE (b) | 3/46.90 3/44.10 5/46.46 2/40.35 |3/45.92 4/41.52 2/39.90 4/43.59 | |POLY-3 PERCENT (g) | 6.4% 6.8% 10.8% 5.0% |6.5% 9.6% 5.0% 9.2% | |TERMINAL (d) | 2/39 (5%) 3/33 (9%) 4/36 (11%) 2/27 (7%) |2/38 (5%) 4/32 (13%) 2/30 (7%) 3/32 (9%) | |FIRST INCIDENCE | 698 729 (T) 534 729 (T) |626 731 (T) 731 (T) 705 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.551 P=0.584 P=0.321 P=0.668N |P=0.405 P=0.408 P=0.602N P=0.418 | |POLY 3 | P=0.527N P=0.634 P=0.351 P=0.568N |P=0.455 P=0.445 P=0.564N P=0.472 | |POLY 1.5 | P=0.492N P=0.645 P=0.354 P=0.540N |P=0.472 P=0.462 P=0.542N P=0.489 | |POLY 6 | P=0.560 P=0.619 P=0.346 P=0.604N |P=0.435 P=0.424 P=0.582N P=0.452 | |LOGISTIC REGRESSION| P=0.524N P=0.613 P=0.363 P=0.640N |P=0.448 P=0.447 P=0.552N P=0.481 | |COCH-ARM / FISHERS | P=0.442N P=0.661N P=0.357 P=0.500N |P=0.479 P=0.500 P=0.510N P=0.500 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 32 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Parathyroid Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/33 (0%) 0/43 (0%) 0/44 (0%) 0/35 (0%) |0/42 (0%) 2/41 (5%) 0/43 (0%) 1/39 (3%) | |POLY-3 RATE (b) | 0/31.22 0/39.13 0/40.52 0/28.58 |0/37.87 2/35.41 0/36.36 1/35.54 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 5.7% 0.0% 2.8% | |TERMINAL (d) | 0/26 (0%) 0/31 (0%) 0/34 (0%) 0/20 (0%) |0/32 (0%) 2/31 (7%) 0/29 (0%) 1/27 (4%) | |FIRST INCIDENCE | --- --- --- --- |--- 731 (T) --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.495 P=0.231 (e) P=0.466 | |POLY 3 | (e) (e) (e) (e) |P=0.521 P=0.222 (e) P=0.487 | |POLY 1.5 | (e) (e) (e) (e) |P=0.527 P=0.222 (e) P=0.490 | |POLY 6 | (e) (e) (e) (e) |P=0.515 P=0.221 (e) P=0.484 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.231 (e) P=0.466 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.523 P=0.241 (e) P=0.481 | |=================================================================================================================================| | | | | | | 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 | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 3/48 (6%) 3/49 (6%) 0/49 (0%) |2/49 (4%) 0/50 (0%) 1/50 (2%) 2/47 (4%) | |POLY-3 RATE (b) | 2/46.92 3/42.16 3/44.85 0/39.35 |2/45.54 0/41.52 1/39.96 2/41.06 | |POLY-3 PERCENT (g) | 4.3% 7.1% 6.7% 0.0% |4.4% 0.0% 2.5% 4.9% | |TERMINAL (d) | 1/39 (3%) 2/32 (6%) 3/35 (9%) 0/26 (0%) |2/38 (5%) 0/32 (0%) 1/30 (3%) 2/30 (7%) | |FIRST INCIDENCE | 692 715 729 (T) --- |731 (T) --- 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.265N P=0.424 P=0.457 P=0.334N |P=0.398 P=0.277N P=0.583N P=0.607 | |POLY 3 | P=0.222N P=0.451 P=0.479 P=0.278N |P=0.454 P=0.258N P=0.545N P=0.656 | |POLY 1.5 | P=0.198N P=0.464 P=0.484 P=0.263N |P=0.458 P=0.252N P=0.528N P=0.667 | |POLY 6 | P=0.255N P=0.436 P=0.472 P=0.300N |P=0.449 P=0.267N P=0.559N P=0.645 | |LOGISTIC REGRESSION| P=0.240N P=0.439 P=0.473 P=0.279N |P=0.398 (e) P=0.583N P=0.607 | |COCH-ARM / FISHERS | P=0.168N P=0.480 P=0.490 P=0.253N |P=0.453 P=0.242N P=0.492N P=0.676 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 33 Statistical Analysis of Non-neoplastic Lesions 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 | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/48 (6%) 0/49 (0%) 1/49 (2%) |22/49 (45%) 26/50 (52%) 15/50 (30%) 20/47 (43%) | |POLY-3 RATE (b) | 4/47.53 3/42.27 0/44.85 1/39.35 |22/45.54 26/42.14 15/40.21 20/42.03 | |POLY-3 PERCENT (g) | 8.4% 7.1% 0.0% 2.5% |48.3% 61.7% 37.3% 47.6% | |TERMINAL (d) | 2/39 (5%) 1/32 (3%) 0/35 (0%) 1/26 (4%) |22/38 (58%) 23/32 (72%) 12/30 (40%) 13/30 (43%) | |FIRST INCIDENCE | 499 695 --- 729 (T) |731 (T) 635 695 611 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123N P=0.573N P=0.077N P=0.297N |P=0.524N P=0.053 P=0.350N P=0.387 | |POLY 3 | P=0.083N P=0.564N P=0.068N P=0.242N |P=0.311N P=0.143 P=0.207N P=0.558N | |POLY 1.5 | P=0.079N P=0.547N P=0.066N P=0.217N |P=0.284N P=0.178 P=0.160N P=0.526N | |POLY 6 | P=0.088N P=0.582N P=0.071N P=0.275N |P=0.326N P=0.109 P=0.242N P=0.580N | |LOGISTIC REGRESSION| P=0.069N P=0.489N P=0.052N P=0.153N |P=0.408N P=0.060 P=0.296N P=0.486 | |COCH-ARM / FISHERS | P=0.073N P=0.523N P=0.061N P=0.187N |P=0.272N P=0.307 P=0.093N P=0.490N | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Pleura: Mesothelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 4/4 (100%) 2/2 (100%) 1/2 (50%) |0/0 (0%) 1/1 (100%) 0/0 (0%) 1/1 (100%) | |POLY-3 RATE (b) | 0/0.00 4/4.00 2/2.00 1/2.00 |0/0.00 1/1.00 0/0.00 1/1.00 | |POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 50.0% |0.0% 100.0% 0.0% 100.0% | |TERMINAL (d) | 0/0 (0%) 2/2 (100%) 1/1 (100%) 0/1 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) | |FIRST INCIDENCE | --- 639 639 586 |--- 718 --- 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.579N (e) (e) P=0.471 |(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 | P=0.191N (e) (e) P=1.000 |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 34 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Preputial Gland | | Ectasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/49 (31%) 19/50 (38%) 13/50 (26%) 20/49 (41%) | | |POLY-3 RATE (b) | 15/45.91 19/46.22 13/46.03 20/41.77 | | |POLY-3 PERCENT (g) | 32.7% 41.1% 28.2% 47.9% | | |TERMINAL (d) | 14/39 (36%) 11/33 (33%) 11/36 (31%) 12/26 (46%) | | |FIRST INCIDENCE | 701 514 695 535 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * P=0.139 P=0.507N P=0.017 * | | |POLY 3 | P=0.143 P=0.266 P=0.407N P=0.105 | | |POLY 1.5 | P=0.177 P=0.273 P=0.399N P=0.137 | | |POLY 6 | P=0.111 P=0.262 P=0.419N P=0.076 | | |LOGISTIC REGRESSION| P=0.116 P=0.239 P=0.452N P=0.064 | | |COCH-ARM / FISHERS | P=0.240 P=0.287 P=0.387N P=0.200 | | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Preputial Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/49 (4%) 5/50 (10%) 5/50 (10%) 3/49 (6%) | | |POLY-3 RATE (b) | 2/45.91 5/44.58 5/46.46 3/39.35 | | |POLY-3 PERCENT (g) | 4.4% 11.2% 10.8% 7.6% | | |TERMINAL (d) | 1/39 (3%) 3/33 (9%) 4/36 (11%) 3/26 (12%) | | |FIRST INCIDENCE | 701 590 534 729 (T) | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.332 P=0.169 P=0.195 P=0.321 | | |POLY 3 | P=0.403 P=0.204 P=0.221 P=0.430 | | |POLY 1.5 | P=0.449 P=0.212 P=0.223 P=0.459 | | |POLY 6 | P=0.344 P=0.194 P=0.217 P=0.393 | | |LOGISTIC REGRESSION| P=0.459 P=0.215 P=0.231 P=0.351 | | |COCH-ARM / FISHERS | P=0.515 P=0.226 P=0.226 P=0.500 | | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 35 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Prostate | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 2/49 (4%) 0/49 (0%) 0/49 (0%) | | |POLY-3 RATE (b) | 4/46.87 2/43.43 0/44.85 0/39.94 | | |POLY-3 PERCENT (g) | 8.5% 4.6% 0.0% 0.0% | | |TERMINAL (d) | 2/39 (5%) 1/33 (3%) 0/35 (0%) 0/27 (0%) | | |FIRST INCIDENCE | 710 728 --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.032N* P=0.410N P=0.080N P=0.126N | | |POLY 3 | P=0.019N* P=0.373N P=0.066N P=0.083N | | |POLY 1.5 | P=0.018N* P=0.363N P=0.065N P=0.074N | | |POLY 6 | P=0.020N* P=0.386N P=0.068N P=0.097N | | |LOGISTIC REGRESSION| P=0.028N* P=0.391N P=0.071N P=0.105N | | |COCH-ARM / FISHERS | P=0.019N* P=0.349N P=0.061N P=0.061N | | |=================================================================================================================================| | | | | | | 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 | |=================================================================================================================================| | | |Salivary Glands | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 0/46.78 4/44.87 2/45.85 0/40.35 |0/45.55 0/41.52 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 0.0% 8.9% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/39 (0%) 2/33 (6%) 2/36 (6%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | --- 614 729 (T) --- |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.429N P=0.053 P=0.221 (e) |(e) (e) (e) (e) | |POLY 3 | P=0.413N P=0.055 P=0.233 (e) |(e) (e) (e) (e) | |POLY 1.5 | P=0.381N P=0.057 P=0.235 (e) |(e) (e) (e) (e) | |POLY 6 | P=0.456N P=0.053 P=0.230 (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.332N P=0.074 P=0.221 (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.337N P=0.059 P=0.247 (e) |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 36 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Seminal Vesicle | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | | |POLY-3 RATE (b) | 0/46.78 2/44.23 0/45.85 0/40.35 | | |POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% | | |TERMINAL (d) | 0/39 (0%) 1/33 (3%) 0/36 (0%) 0/27 (0%) | | |FIRST INCIDENCE | --- 695 --- --- | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.471N P=0.208 (e) (e) | | |POLY 3 | P=0.434N P=0.225 (e) (e) | | |POLY 1.5 | P=0.423N P=0.230 (e) (e) | | |POLY 6 | P=0.448N P=0.219 (e) (e) | | |LOGISTIC REGRESSION| P=0.434N P=0.225 (e) (e) | | |COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (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 | |=================================================================================================================================| | | |Skin | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 1/46.78 0/44.10 1/45.85 1/40.93 |1/45.55 2/43.01 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 2.1% 0.0% 2.2% 2.4% |2.2% 4.7% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/33 (0%) 1/36 (3%) 0/27 (0%) |1/38 (3%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 729 (T) --- 729 (T) 545 |731 (T) 23 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.480 P=0.533N P=0.744 P=0.712 |P=0.205N P=0.472 P=0.547N P=0.534N | |POLY 3 | P=0.506 P=0.512N P=0.756 P=0.730 |P=0.202N P=0.480 P=0.526N P=0.509N | |POLY 1.5 | P=0.520 P=0.507N P=0.758 P=0.743 |P=0.195N P=0.487 P=0.517N P=0.503N | |POLY 6 | P=0.487 P=0.517N P=0.754 P=0.713 |P=0.209N P=0.471 P=0.534N P=0.516N | |LOGISTIC REGRESSION| P=0.588 (e) P=0.744 P=0.693N |P=0.222N P=0.604 (e) (e) | |COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.188N P=0.500 P=0.500N P=0.500N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 37 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Skin: Epidermis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 2/46.85 0/44.10 0/45.85 0/40.35 |0/45.55 1/42.01 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% | |TERMINAL (d) | 1/39 (3%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 710 --- --- --- |--- 584 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.143N P=0.270N P=0.257N P=0.329N |P=0.578N P=0.482 (e) (e) | |POLY 3 | P=0.104N P=0.251N P=0.242N P=0.272N |P=0.586N P=0.484 (e) (e) | |POLY 1.5 | P=0.108N P=0.245N P=0.240N P=0.257N |P=0.579N P=0.488 (e) (e) | |POLY 6 | P=0.099N P=0.258N P=0.245N P=0.292N |P=0.594N P=0.478 (e) (e) | |LOGISTIC REGRESSION| P=0.130N P=0.256N P=0.243N P=0.295N |P=0.584N P=0.524 (e) (e) | |COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.567N P=0.500 (e) (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 | |=================================================================================================================================| | | |Skin: Prepuce | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 RATE (b) | 7/46.92 1/44.11 1/46.66 2/40.93 |0/45.55 0/41.52 0/39.96 0/43.48 | |POLY-3 PERCENT (g) | 14.9% 2.3% 2.1% 4.9% |0.0% 0.0% 0.0% 0.0% | |TERMINAL (d) | 5/39 (13%) 0/33 (0%) 0/36 (0%) 1/27 (4%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 0/32 (0%) | |FIRST INCIDENCE | 698 728 422 545 |--- --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.116N P=0.058N P=0.045N* P=0.195N |(e) (e) (e) (e) | |POLY 3 | P=0.063N P=0.037N* P=0.031N* P=0.116N |(e) (e) (e) (e) | |POLY 1.5 | P=0.062N P=0.034N* P=0.030N* P=0.100N |(e) (e) (e) (e) | |POLY 6 | P=0.063N P=0.041N* P=0.031N* P=0.141N |(e) (e) (e) (e) | |LOGISTIC REGRESSION| P=0.048N* P=0.045N* P=0.027N* P=0.107N |(e) (e) (e) (e) | |COCH-ARM / FISHERS | P=0.064N P=0.030N* P=0.030N* P=0.080N |(e) (e) (e) (e) | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 38 Statistical Analysis of Non-neoplastic Lesions 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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 13/50 (26%) 18/50 (36%) 10/50 (20%) |21/50 (42%) 12/48 (25%) 18/49 (37%) 11/50 (22%) | |POLY-3 RATE (b) | 15/47.12 13/46.33 18/47.24 10/41.60 |21/47.23 12/43.03 18/41.92 11/45.24 | |POLY-3 PERCENT (g) | 31.8% 28.1% 38.1% 24.0% |44.5% 27.9% 42.9% 24.3% | |TERMINAL (d) | 12/39 (31%) 9/33 (27%) 11/36 (31%) 6/27 (22%) |14/38 (37%) 9/32 (28%) 12/30 (40%) 5/32 (16%) | |FIRST INCIDENCE | 692 405 606 541 |505 522 416 542 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.534N P=0.582 P=0.271 P=0.533N |P=0.139N P=0.146N P=0.485 P=0.092N | |POLY 3 | P=0.330N P=0.432N P=0.336 P=0.281N |P=0.056N P=0.076N P=0.527N P=0.032N* | |POLY 1.5 | P=0.272N P=0.422N P=0.335 P=0.235N |P=0.049N* P=0.064N P=0.463N P=0.026N* | |POLY 6 | P=0.404N P=0.447N P=0.340 P=0.347N |P=0.065N P=0.097N P=0.584N P=0.041N* | |LOGISTIC REGRESSION| P=0.247N P=0.401N P=0.314 P=0.333N |P=0.054N P=0.063N P=0.460N P=0.028N* | |COCH-ARM / FISHERS | P=0.197N P=0.412N P=0.335 P=0.178N |P=0.051N P=0.058N P=0.371N P=0.026N* | |=================================================================================================================================| | | | | | | 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 | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 9/50 (18%) 12/50 (24%) 15/50 (30%) 10/50 (20%) |17/50 (34%) 18/48 (38%) 15/49 (31%) 15/50 (30%) | |POLY-3 RATE (b) | 9/46.78 12/44.16 15/45.85 10/40.35 |17/45.64 18/42.20 15/41.35 15/44.25 | |POLY-3 PERCENT (g) | 19.2% 27.2% 32.7% 24.8% |37.3% 42.7% 36.3% 33.9% | |TERMINAL (d) | 9/39 (23%) 11/33 (33%) 15/36 (42%) 10/27 (37%) |16/38 (42%) 15/32 (47%) 12/30 (40%) 11/32 (34%) | |FIRST INCIDENCE | 729 (T) 715 729 (T) 729 (T) |709 635 416 565 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.144 P=0.173 P=0.071 P=0.172 |P=0.506N P=0.263 P=0.449 P=0.541 | |POLY 3 | P=0.300 P=0.258 P=0.105 P=0.358 |P=0.333N P=0.382 P=0.551N P=0.455N | |POLY 1.5 | P=0.371 P=0.280 P=0.111 P=0.417 |P=0.307N P=0.413 P=0.507N P=0.426N | |POLY 6 | P=0.217 P=0.234 P=0.097 P=0.286 |P=0.359N P=0.347 P=0.584N P=0.487N | |LOGISTIC REGRESSION| P=0.124 P=0.196 P=0.071 P=0.172 |P=0.374N P=0.283 P=0.580 P=0.536N | |COCH-ARM / FISHERS | P=0.477 P=0.312 P=0.121 P=0.500 |P=0.300N P=0.440 P=0.442N P=0.415N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 39 Statistical Analysis of Non-neoplastic Lesions 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 | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/46.78 0/44.10 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.96 2/43.50 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 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 | --- --- --- --- |--- --- --- 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.209 | |POLY 3 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.227 | |POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.233 | |POLY 6 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.220 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.214 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 | |=================================================================================================================================| | | | | | | 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 | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 RATE (b) | 0/46.78 2/44.63 1/45.85 0/40.35 |0/45.55 0/41.52 1/39.96 1/43.48 | |POLY-3 PERCENT (g) | 0.0% 4.5% 2.2% 0.0% |0.0% 0.0% 2.5% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 1/36 (3%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 1/30 (3%) 1/32 (3%) | |FIRST INCIDENCE | --- 590 729 (T) --- |--- --- 731 (T) 731 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.534N P=0.221 P=0.484 (e) |P=0.215 (e) P=0.453 P=0.466 | |POLY 3 | P=0.512N P=0.227 P=0.496 (e) |P=0.234 (e) P=0.474 P=0.491 | |POLY 1.5 | P=0.491N P=0.231 P=0.498 (e) |P=0.239 (e) P=0.483 P=0.497 | |POLY 6 | P=0.538N P=0.222 P=0.494 (e) |P=0.227 (e) P=0.466 P=0.484 | |LOGISTIC REGRESSION| P=0.431N P=0.281 P=0.484 (e) |(e) (e) P=0.453 P=0.466 | |COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |P=0.236 (e) P=0.500 P=0.500 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 40 Statistical Analysis of Non-neoplastic Lesions 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 | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 RATE (b) | 1/46.92 2/44.71 2/46.70 1/40.86 |1/45.74 1/42.29 2/40.84 1/43.77 | |POLY-3 PERCENT (g) | 2.1% 4.5% 4.3% 2.5% |2.2% 2.4% 4.9% 2.3% | |TERMINAL (d) | 0/39 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 1/30 (3%) 0/32 (0%) | |FIRST INCIDENCE | 692 626 422 573 |681 446 353 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.594 P=0.464 P=0.489 P=0.699 |P=0.570 P=0.733 P=0.442 P=0.734 | |POLY 3 | P=0.598 P=0.483 P=0.498 P=0.729 |P=0.579 P=0.743 P=0.461 P=0.751 | |POLY 1.5 | P=0.585N P=0.490 P=0.500 P=0.742 |P=0.590 P=0.748 P=0.476 P=0.757 | |POLY 6 | P=0.562 P=0.476 P=0.495 P=0.711 |P=0.568 P=0.736 P=0.448 P=0.744 | |LOGISTIC REGRESSION| P=0.359N P=0.564 P=0.577 P=0.686N |P=0.560 P=0.734N P=0.535 P=0.762 | |COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N |P=0.591 P=0.753N P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | 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: Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 10/50 (20%) 6/50 (12%) 4/50 (8%) |3/50 (6%) 1/50 (2%) 7/50 (14%) 1/50 (2%) | |POLY-3 RATE (b) | 3/47.03 10/47.37 6/47.13 4/41.19 |3/45.74 1/42.29 7/42.97 1/43.77 | |POLY-3 PERCENT (g) | 6.4% 21.1% 12.7% 9.7% |6.6% 2.4% 16.3% 2.3% | |TERMINAL (d) | 1/39 (3%) 2/33 (6%) 3/36 (8%) 1/27 (4%) |2/38 (5%) 0/32 (0%) 2/30 (7%) 0/32 (0%) | |FIRST INCIDENCE | 692 514 422 590 |681 446 318 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.517 P=0.033 * P=0.226 P=0.323 |P=0.460N P=0.361N P=0.109 P=0.361N | |POLY 3 | P=0.540N P=0.036 * P=0.243 P=0.428 |P=0.429N P=0.334N P=0.132 P=0.321N | |POLY 1.5 | P=0.494N P=0.035 * P=0.244 P=0.457 |P=0.415N P=0.326N P=0.142 P=0.311N | |POLY 6 | P=0.508 P=0.036 * P=0.240 P=0.392 |P=0.445N P=0.346N P=0.125 P=0.333N | |LOGISTIC REGRESSION| P=0.228N P=0.074 P=0.271 P=0.511 |P=0.450N P=0.290N P=0.195 P=0.307N | |COCH-ARM / FISHERS | P=0.426N P=0.036 * P=0.243 P=0.500 |P=0.420N P=0.309N P=0.159 P=0.309N | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 41 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Testes | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 7/50 (14%) 1/50 (2%) 5/50 (10%) | | |POLY-3 RATE (b) | 4/47.52 7/44.16 1/45.93 5/40.76 | | |POLY-3 PERCENT (g) | 8.4% 15.9% 2.2% 12.3% | | |TERMINAL (d) | 1/39 (3%) 6/33 (18%) 0/36 (0%) 3/27 (11%) | | |FIRST INCIDENCE | 620 715 709 654 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.426 P=0.190 P=0.206N P=0.307 | | |POLY 3 | P=0.542 P=0.220 P=0.189N P=0.405 | | |POLY 1.5 | P=0.557N P=0.237 P=0.185N P=0.444 | | |POLY 6 | P=0.502 P=0.200 P=0.196N P=0.356 | | |LOGISTIC REGRESSION| P=0.544 P=0.238 P=0.164N P=0.472 | | |COCH-ARM / FISHERS | P=0.517N P=0.262 P=0.181N 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 | |=================================================================================================================================| | | |Thyroid Gland | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/48 (0%) 2/50 (4%) | |POLY-3 RATE (b) | 0/44.78 0/44.10 0/45.85 0/40.35 |0/45.55 0/41.52 0/39.85 2/43.65 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% | |TERMINAL (d) | 0/37 (0%) 0/33 (0%) 0/36 (0%) 0/27 (0%) |0/38 (0%) 0/32 (0%) 0/30 (0%) 1/32 (3%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 687 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.216 | |POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.228 | |POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.234 | |POLY 6 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.221 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.231 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.247 | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 42 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Tooth | | Malformation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 2/2 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) | |POLY-3 RATE (b) | 2/2.00 1/1.00 2/2.00 0/0.00 |0/0.00 0/0.00 0/0.00 1/1.00 | |POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 0.0% |0.0% 0.0% 0.0% 100.0% | |TERMINAL (d) | 2/2 (100%) 1/1 (100%) 2/2 (100%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) | |FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- 726 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) | |POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 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 | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |5/50 (10%) 4/49 (8%) 1/49 (2%) 0/50 (0%) | |POLY-3 RATE (b) | |5/45.55 4/41.52 1/39.90 0/43.48 | |POLY-3 PERCENT (g) | |11.0% 9.6% 2.5% 0.0% | |TERMINAL (d) | |5/38 (13%) 4/32 (13%) 1/30 (3%) 0/32 (0%) | |FIRST INCIDENCE | |731 (T) 731 (T) 731 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.017N* P=0.608N P=0.163N P=0.049N* | |POLY 3 | |P=0.011N* P=0.558N P=0.135N P=0.034N* | |POLY 1.5 | |P=0.010N* P=0.541N P=0.123N P=0.032N* | |POLY 6 | |P=0.012N* P=0.579N P=0.145N P=0.037N* | |LOGISTIC REGRESSION| |P=0.017N* P=0.608N P=0.163N (e) | |COCH-ARM / FISHERS | |P=0.011N* P=0.513N P=0.107N P=0.028N* | |=================================================================================================================================| Date: 11/19/01 EXPERIMENT: 61427 TEST: 08 Page 43 Statistical Analysis of Non-neoplastic Lesions 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 | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |46/50 (92%) 43/49 (88%) 42/49 (86%) 41/50 (82%) | |POLY-3 RATE (b) | |46/47.95 43/46.05 42/43.60 41/47.06 | |POLY-3 PERCENT (g) | |95.9% 93.4% 96.3% 87.1% | |TERMINAL (d) | |37/38 (97%) 31/32 (97%) 30/30 (100%) 30/32 (94%) | |FIRST INCIDENCE | |505 446 490 255 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.454 P=0.245 P=0.157 P=0.453 | |POLY 3 | |P=0.050N P=0.462N P=0.694 P=0.098N | |POLY 1.5 | |P=0.028N* P=0.419N P=0.491N P=0.062N | |POLY 6 | |P=0.120N P=0.543N P=0.509 P=0.192N | |LOGISTIC REGRESSION| |P=0.054N P=0.489N P=0.623 P=0.099N | |COCH-ARM / FISHERS | |P=0.091N P=0.357N P=0.251N P=0.117N | |=================================================================================================================================| (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).