TDMS Study 88007-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus SODIUM NITRITE DATE: 05/13/99
EXPERIMENT: 88007 TEST: 06 TIME: 09:44:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: TOFT, JOHN CAS: 7632-00-0
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus SODIUM NITRITE DATE: 05/13/99
EXPERIMENT: 88007 TEST: 06 TIME: 09:44:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: TOFT, JOHN CAS: 7632-00-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM NITRITE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Capsule Hyperplasia
Liver Necrosis
Lung Necrosis
Lung: Alveolar Epithelium Hyperplasia
Oral Mucosa: Gingival Inflammation Chronic
Preputial Gland: Duct Cyst
Prostate Infiltration Cellular Mononuclear Cell
Spleen Hematopoietic Cell Proliferation
Stomach, Glandular: Epithelium Hyperplasia
Testes Mineralization
Urinary Bladder Infiltration Cellular Mononuclear Cell
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Marrow Atrophy
Liver Angiectasis
Mixed Cell Focus
Liver: Centrilobular Necrosis
Lymph Node, Mandibular Hyperplasia Lymphoid
Mesentery: Fat Necrosis
Salivary Glands Atrophy
Infiltration Cellular Mononuclear Cell
Skin: Subcutaneous Tissue Infiltration Cellular Mononuclear Cell
Stomach, Glandular: Glands Ectasia
Thymus Cyst
===============================================================
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 6/50 (12%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 12.5% 8.8% |2.2% 4.4% 2.2% 2.2% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 4/42 (10%) 4/39 (10%) |1/40 (3%) 1/34 (3%) 1/37 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) --- 643 727 (T) |728 (T) 659 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 P=0.208N P=0.160 P=0.336 |P=0.505N P=0.465 P=0.744 P=0.756N |
|POLY 3 | P=0.098 P=0.233N P=0.141 P=0.324 |P=0.525N P=0.501 P=0.760N P=0.757N |
|POLY 1.5 | P=0.103 P=0.235N P=0.138 P=0.329 |P=0.528N P=0.502 P=0.759 P=0.759N |
|POLY 6 | P=0.092 P=0.229N P=0.146 P=0.319 |P=0.520N P=0.497 P=0.759N P=0.754N |
|LOGISTIC REGRESSION| P=0.100 (e) P=0.137 P=0.336 |P=0.525N P=0.500 P=0.744 P=0.756N |
|COCH-ARM / FISHERS | P=0.114 P=0.247N P=0.134 P=0.339 |P=0.531N P=0.500 P=0.747 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 2.1% 0.0% |0.0% 0.0% 2.2% 4.3% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) --- |--- --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412N P=0.471N P=0.745N P=0.500N |P=0.082 (e) P=0.484 P=0.244 |
|POLY 3 | P=0.413N P=0.496N P=0.757N P=0.506N |P=0.072 (e) P=0.500 P=0.241 |
|POLY 1.5 | P=0.410N P=0.498N P=0.758N P=0.504N |P=0.071 (e) P=0.498 P=0.239 |
|POLY 6 | P=0.416N P=0.492N P=0.755N P=0.508N |P=0.075 (e) P=0.502 P=0.244 |
|LOGISTIC REGRESSION| P=0.412N (e) P=0.745N (e) |(e) (e) P=0.484 P=0.244 |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.070 (e) P=0.495 P=0.247 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/49 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |1/40 (3%) 1/34 (3%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 659 --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.490 P=0.465 P=0.516N P=0.506 |
|POLY 3 | (e) (e) (e) (e) |P=0.478 P=0.501 P=0.500N P=0.510 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.473 P=0.502 P=0.502N P=0.505 |
|POLY 6 | (e) (e) (e) (e) |P=0.485 P=0.497 P=0.498N P=0.517 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.472 P=0.500 (e) P=0.501 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.469 P=0.500 P=0.505N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 42/50 (84%) 40/50 (80%) 40/50 (80%) |49/50 (98%) 50/50 (100%) 49/49 (100%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 92.7% 85.9% 82.1% 83.1% |99.1% 100.0% 100.0% 99.4% |
|TERMINAL (d) | 37/39 (95%) 39/45 (87%) 36/42 (86%) 32/39 (82%) |40/40 (100%) 34/34 (100%) 37/37 (100%) 41/41 (100%) |
|FIRST INCIDENCE | 501 601 577 549 |456 484 477 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.231N P=0.026N* P=0.041N* P=0.178N |P=0.238N P=0.120 P=0.356 P=0.478N |
|POLY 3 | P=0.112N P=0.217N P=0.091N P=0.118N |P=0.884 P=0.910 P=0.912 P=0.952 |
|POLY 1.5 | P=0.096N P=0.204N P=0.082N P=0.098N |P=0.766N P=0.702 P=0.705 P=0.852 |
|POLY 6 | P=0.129N P=0.222N P=0.110N P=0.137N |P=0.998 P=1.000 P=1.000 P=1.000 |
|LOGISTIC REGRESSION| P=0.118N P=0.159N P=0.056N P=0.097N |P=0.616 P=0.609 P=0.557 P=0.700 |
|COCH-ARM / FISHERS | P=0.076N P=0.178N P=0.074N P=0.074N |P=0.594N P=0.500 P=0.505 P=0.753N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Fasciculata |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 24/50 (48%) 14/50 (28%) 21/50 (42%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 38.2% 50.3% 29.4% 46.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 17/39 (44%) 24/45 (53%) 14/42 (33%) 20/39 (51%) |1/40 (3%) 1/34 (3%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 652 727 (T) 727 (T) 665 |728 (T) 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417 P=0.330 P=0.179N P=0.331 |P=0.231N P=0.725 P=0.516N P=0.495N |
|POLY 3 | P=0.437 P=0.164 P=0.245N P=0.291 |P=0.236N P=0.760 P=0.500N P=0.497N |
|POLY 1.5 | P=0.458 P=0.159 P=0.250N P=0.310 |P=0.237N P=0.760N P=0.502N P=0.499N |
|POLY 6 | P=0.414 P=0.175 P=0.240N P=0.273 |P=0.234N P=0.757 P=0.498N P=0.494N |
|LOGISTIC REGRESSION| P=0.385 P=0.226 P=0.216N P=0.270 |P=0.231N P=0.725 (e) (e) |
|COCH-ARM / FISHERS | P=0.490 P=0.156 P=0.260N P=0.341 |P=0.236N P=0.753N P=0.505N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |1/40 (3%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |586 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.115N P=0.250N P=0.244N P=0.237N |
|POLY 3 | (e) (e) (e) (e) |P=0.112N P=0.240N P=0.235N P=0.236N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.113N P=0.238N P=0.236N P=0.237N |
|POLY 6 | (e) (e) (e) (e) |P=0.110N P=0.245N P=0.234N P=0.234N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.111N P=0.257N P=0.256N P=0.231N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/41 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.054 (e) (e) P=0.252 |
|POLY 3 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.242 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.240 |
|POLY 6 | (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.247 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.237 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/41 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.606 (e) P=0.221 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.604 (e) P=0.242 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.598 (e) P=0.240 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.614 (e) P=0.244 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.221 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow: Myeloid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 4.3% |4.4% 6.5% 2.1% 6.4% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/41 (0%) 0/39 (0%) |2/40 (5%) 0/34 (0%) 1/37 (3%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- 707 502 |728 (T) 652 728 (T) 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 (e) P=0.514 P=0.237 |P=0.508 P=0.479 P=0.527N P=0.509 |
|POLY 3 | P=0.068 (e) P=0.499 P=0.235 |P=0.489 P=0.507 P=0.492N P=0.513 |
|POLY 1.5 | P=0.069 (e) P=0.498 P=0.236 |P=0.483 P=0.505 P=0.495N P=0.506 |
|POLY 6 | P=0.068 (e) P=0.501 P=0.235 |P=0.498 P=0.506 P=0.489N P=0.522 |
|LOGISTIC REGRESSION| P=0.113 (e) P=0.494 P=0.330 |P=0.478 P=0.488 P=0.527N P=0.498 |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.495 P=0.247 |P=0.477 P=0.500 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Brain: Neuron |
| 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 ADJUSTED (b)| 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 652 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120N P=0.235N P=0.240N P=0.253N |(e) (e) (e) (e) |
|POLY 3 | P=0.113N P=0.235N P=0.236N P=0.246N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.113N P=0.236N P=0.236N P=0.243N |(e) (e) (e) (e) |
|POLY 6 | P=0.113N P=0.233N P=0.236N P=0.250N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.105N P=0.240N P=0.275N P=0.210N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 4/49 (8%) 13/50 (26%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| |15.3% 8.8% 27.5% 6.6% |
|TERMINAL (d) | |6/40 (15%) 3/34 (9%) 8/37 (22%) 3/41 (7%) |
|FIRST INCIDENCE | |716 652 617 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.240N P=0.352N P=0.092 P=0.151N |
|POLY 3 | |P=0.270N P=0.268N P=0.117 P=0.162N |
|POLY 1.5 | |P=0.284N P=0.269N P=0.112 P=0.169N |
|POLY 6 | |P=0.247N P=0.273N P=0.124 P=0.154N |
|LOGISTIC REGRESSION| |P=0.261N P=0.285N P=0.118 P=0.145N |
|COCH-ARM / FISHERS | |P=0.299N P=0.274N P=0.105 P=0.176N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/49 (4%) 2/50 (4%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.5% 4.3% 0.0% |
|TERMINAL (d) | |0/40 (0%) 2/34 (6%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | |--- 728 (T) 716 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.480N P=0.203 P=0.231 (e) |
|POLY 3 | |P=0.497N P=0.233 P=0.242 (e) |
|POLY 1.5 | |P=0.503N P=0.234 P=0.240 (e) |
|POLY 6 | |P=0.487N P=0.230 P=0.244 (e) |
|LOGISTIC REGRESSION| |P=0.483N P=0.203 P=0.244 (e) |
|COCH-ARM / FISHERS | |P=0.510N P=0.242 P=0.247 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 22/50 (44%) 25/50 (50%) 25/50 (50%) | |
|POLY-3 ADJUSTED (b)| 42.4% 46.1% 51.8% 53.0% | |
|TERMINAL (d) | 18/39 (46%) 22/45 (49%) 23/42 (55%) 22/39 (56%) | |
|FIRST INCIDENCE | 652 727 (T) 596 472 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115 P=0.510N P=0.310 P=0.206 | |
|POLY 3 | P=0.159 P=0.437 P=0.234 P=0.201 | |
|POLY 1.5 | P=0.164 P=0.428 P=0.225 P=0.206 | |
|POLY 6 | P=0.151 P=0.454 P=0.244 P=0.196 | |
|LOGISTIC REGRESSION| P=0.120 P=0.517 P=0.237 P=0.178 | |
|COCH-ARM / FISHERS | P=0.169 P=0.420 P=0.211 P=0.211 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Gallbladder |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |0/48 (0%) 3/50 (6%) 1/50 (2%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 6.6% 2.1% 8.8% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/41 (0%) 0/38 (0%) |0/38 (0%) 3/34 (9%) 1/37 (3%) 4/41 (10%) |
|FIRST INCIDENCE | --- --- --- --- |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.095 P=0.102 P=0.495 P=0.073 |
|POLY 3 | (e) (e) (e) (e) |P=0.075 P=0.126 P=0.513 P=0.065 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.073 P=0.127 P=0.511 P=0.064 |
|POLY 6 | (e) (e) (e) (e) |P=0.078 P=0.123 P=0.515 P=0.068 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.102 P=0.495 P=0.073 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.072 P=0.129 P=0.510 P=0.061 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 2.1% 0.0% |2.2% 4.3% 0.0% 2.1% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 647 --- 641 --- |586 651 --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.112N P=0.298N P=0.131N |P=0.479N P=0.518 P=0.492N P=0.752N |
|POLY 3 | P=0.088N P=0.117N P=0.300N P=0.126N |P=0.498N P=0.500 P=0.498N P=0.758N |
|POLY 1.5 | P=0.086N P=0.118N P=0.302N P=0.123N |P=0.499N P=0.501 P=0.499N P=0.760N |
|POLY 6 | P=0.089N P=0.115N P=0.298N P=0.129N |P=0.496N P=0.495 P=0.497N P=0.756N |
|LOGISTIC REGRESSION| P=0.076N P=0.124N P=0.349N P=0.113N |P=0.472N P=0.434 P=0.544N P=0.754N |
|COCH-ARM / FISHERS | P=0.086N P=0.121N P=0.309N P=0.121N |P=0.500N P=0.500 P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 0.0% |0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 0/39 (0%) 1/45 (2%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 444 --- --- |--- --- --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N P=0.255 (e) (e) |P=0.196 (e) (e) P=0.500 |
|POLY 3 | P=0.403N P=0.246 (e) (e) |P=0.203 (e) (e) P=0.505 |
|POLY 1.5 | P=0.404N P=0.242 (e) (e) |P=0.201 (e) (e) P=0.503 |
|POLY 6 | P=0.401N P=0.250 (e) (e) |P=0.207 (e) (e) P=0.510 |
|LOGISTIC REGRESSION| P=0.323N P=0.226 (e) (e) |P=0.262 (e) (e) P=0.552 |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Heart: Valve |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |580 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.115N P=0.228N P=0.233N P=0.240N |
|POLY 3 | (e) (e) (e) (e) |P=0.112N P=0.242N P=0.237N P=0.238N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.113N P=0.239N P=0.237N P=0.238N |
|POLY 6 | (e) (e) (e) (e) |P=0.109N P=0.248N P=0.237N P=0.237N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.088N P=0.295N P=0.271N P=0.197N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/48 (0%) 2/49 (4%) |0/50 (0%) 0/48 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 2/45 (4%) 0/41 (0%) 1/38 (3%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) --- 549 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232 P=0.270 (e) P=0.237 |(e) (e) (e) (e) |
|POLY 3 | P=0.242 P=0.246 (e) P=0.233 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.243 P=0.244 (e) P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.241 P=0.250 (e) P=0.232 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.277 P=0.270 (e) P=0.283 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.245 P=0.253 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 0.0% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 2/45 (4%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- 727 (T) --- --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412N P=0.270 (e) (e) |P=0.213 (e) (e) P=0.505 |
|POLY 3 | P=0.405N P=0.242 (e) (e) |P=0.201 (e) (e) P=0.503 |
|POLY 1.5 | P=0.405N P=0.240 (e) (e) |P=0.200 (e) (e) P=0.501 |
|POLY 6 | P=0.404N P=0.246 (e) (e) |P=0.204 (e) (e) P=0.506 |
|LOGISTIC REGRESSION| (e) P=0.270 (e) (e) |(e) (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 47/50 (94%) 49/50 (98%) 44/50 (88%) |45/50 (90%) 44/50 (88%) 40/50 (80%) 42/50 (84%) |
|POLY-3 ADJUSTED (b)| 92.4% 96.3% 98.0% 90.4% |92.0% 90.4% 83.2% 86.6% |
|TERMINAL (d) | 37/39 (95%) 44/45 (98%) 41/42 (98%) 36/39 (92%) |37/40 (93%) 32/34 (94%) 34/37 (92%) 36/41 (88%) |
|FIRST INCIDENCE | 501 612 577 502 |456 605 524 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.160N P=0.585N P=0.446N |P=0.099N P=0.242 P=0.376N P=0.252N |
|POLY 3 | P=0.348N P=0.334 P=0.196 P=0.505N |P=0.197N P=0.535N P=0.144N P=0.289N |
|POLY 1.5 | P=0.306N P=0.394 P=0.188 P=0.450N |P=0.197N P=0.519N P=0.135N P=0.283N |
|POLY 6 | P=0.398N P=0.285 P=0.213 P=0.564N |P=0.197N P=0.565N P=0.167N P=0.298N |
|LOGISTIC REGRESSION| P=0.354N P=0.527 P=0.175 P=0.419N |P=0.184N P=0.438N P=0.088N P=0.267N |
|COCH-ARM / FISHERS | P=0.256N P=0.500 P=0.181 P=0.370N |P=0.198N P=0.500N P=0.131N P=0.277N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 10/50 (20%) 9/50 (18%) 13/50 (26%) |2/50 (4%) 4/50 (8%) 3/50 (6%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 23.3% 20.9% 18.9% 28.4% |4.4% 8.6% 6.4% 12.9% |
|TERMINAL (d) | 9/39 (23%) 10/45 (22%) 8/42 (19%) 12/39 (31%) |2/40 (5%) 1/34 (3%) 3/37 (8%) 6/41 (15%) |
|FIRST INCIDENCE | 661 727 (T) 707 629 |728 (T) 652 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286 P=0.365N P=0.338N P=0.401 |P=0.141 P=0.309 P=0.464 P=0.141 |
|POLY 3 | P=0.300 P=0.486N P=0.390N P=0.375 |P=0.114 P=0.344 P=0.510 P=0.138 |
|POLY 1.5 | P=0.313 P=0.493N P=0.394N P=0.388 |P=0.112 P=0.343 P=0.506 P=0.136 |
|POLY 6 | P=0.286 P=0.475N P=0.387N P=0.362 |P=0.119 P=0.343 P=0.514 P=0.143 |
|LOGISTIC REGRESSION| P=0.273 P=0.451N P=0.375N P=0.362 |P=0.115 P=0.331 P=0.464 P=0.141 |
|COCH-ARM / FISHERS | P=0.331 P=0.500N P=0.402N P=0.408 |P=0.110 P=0.339 P=0.500 P=0.134 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 41/50 (82%) 41/50 (82%) 45/50 (90%) |35/50 (70%) 37/50 (74%) 34/50 (68%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 85.7% 84.5% 84.8% 92.2% |74.7% 77.7% 72.3% 84.6% |
|TERMINAL (d) | 36/39 (92%) 40/45 (89%) 39/42 (93%) 38/39 (97%) |33/40 (83%) 28/34 (82%) 31/37 (84%) 38/41 (93%) |
|FIRST INCIDENCE | 643 444 596 472 |547 605 691 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 P=0.109N P=0.305N P=0.208 |P=0.376 P=0.095 P=0.452 P=0.191 |
|POLY 3 | P=0.159 P=0.551N P=0.572N P=0.224 |P=0.156 P=0.458 P=0.490N P=0.160 |
|POLY 1.5 | P=0.157 P=0.570N P=0.580N P=0.213 |P=0.161 P=0.440 P=0.494N P=0.162 |
|POLY 6 | P=0.156 P=0.537N P=0.583N P=0.231 |P=0.159 P=0.475 P=0.484N P=0.167 |
|LOGISTIC REGRESSION| P=0.060 P=0.516N P=0.525N P=0.103 |P=0.251 P=0.439 P=0.363N P=0.212 |
|COCH-ARM / FISHERS | P=0.148 P=0.602N P=0.602N P=0.194 |P=0.180 P=0.412 P=0.500N P=0.178 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 2.1% 0.0% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 637 --- 549 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377N P=0.467N P=0.222N P=0.500N |(e) (e) (e) (e) |
|POLY 3 | P=0.369N P=0.490N P=0.234N P=0.506N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.368N P=0.495N P=0.235N P=0.504N |(e) (e) (e) (e) |
|POLY 6 | P=0.371N P=0.483N P=0.232N P=0.508N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.315N P=0.506N (e) P=0.458N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 6.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 2/45 (4%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 612 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076N P=0.552 P=0.222N P=0.238N |(e) (e) (e) (e) |
|POLY 3 | P=0.073N P=0.513 P=0.234N P=0.244N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.073N P=0.507 P=0.235N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.074N P=0.523 P=0.232N P=0.246N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.071N P=0.495 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.073N P=0.500 P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 50/50 (100%) 48/50 (96%) 46/50 (92%) |5/50 (10%) 8/50 (16%) 6/50 (12%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 96.6% 100.0% 96.6% 93.8% |10.7% 17.5% 12.8% 8.5% |
|TERMINAL (d) | 38/39 (97%) 45/45 (100%) 42/42 (100%) 37/39 (95%) |3/40 (8%) 7/34 (21%) 6/37 (16%) 2/41 (5%) |
|FIRST INCIDENCE | 501 444 577 502 |586 709 728 (T) 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483N P=0.220N P=0.306N P=0.450N |P=0.277N P=0.204 P=0.461 P=0.482N |
|POLY 3 | P=0.165N P=0.282 P=0.720 P=0.425N |P=0.307N P=0.263 P=0.502 P=0.498N |
|POLY 1.5 | P=0.143N P=0.259 P=0.708N P=0.391N |P=0.312N P=0.271 P=0.502 P=0.500N |
|POLY 6 | P=0.185N P=0.330 P=0.735 P=0.454N |P=0.297N P=0.245 P=0.500 P=0.492N |
|LOGISTIC REGRESSION| P=0.155N P=0.242 P=0.660N P=0.402N |P=0.303N P=0.277 P=0.499 P=0.503N |
|COCH-ARM / FISHERS | P=0.111N P=0.247 P=0.691N P=0.339N |P=0.313N P=0.277 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 49/50 (98%) 45/50 (90%) 42/50 (84%) |20/50 (40%) 17/50 (34%) 13/50 (26%) 20/50 (40%) |
|POLY-3 ADJUSTED (b)| 91.7% 98.6% 93.4% 89.1% |43.2% 36.6% 27.7% 42.4% |
|TERMINAL (d) | 38/39 (97%) 45/45 (100%) 42/42 (100%) 38/39 (97%) |19/40 (48%) 13/34 (38%) 12/37 (32%) 17/41 (42%) |
|FIRST INCIDENCE | 643 444 643 502 |580 652 687 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332N P=0.495N P=0.369N P=0.411N |P=0.448N P=0.552N P=0.144N P=0.536N |
|POLY 3 | P=0.173N P=0.099 P=0.537 P=0.461N |P=0.535N P=0.327N P=0.085N P=0.552N |
|POLY 1.5 | P=0.149N P=0.075 P=0.528 P=0.422N |P=0.530 P=0.329N P=0.091N P=0.569N |
|POLY 6 | P=0.236N P=0.147 P=0.515 P=0.536N |P=0.502N P=0.335N P=0.080N P=0.519N |
|LOGISTIC REGRESSION| P=0.339N P=0.050 P=0.628 P=0.636 |P=0.497N P=0.357N P=0.076N P=0.538N |
|COCH-ARM / FISHERS | P=0.132N P=0.056 P=0.500 P=0.387N |P=0.520 P=0.339N P=0.101N P=0.581N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/45 (2%) 1/42 (2%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 444 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468N P=0.255 P=0.515 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.468N P=0.246 P=0.503 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.465N P=0.242 P=0.502 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.470N P=0.250 P=0.505 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.388N P=0.226 P=0.515 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.461N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 6/50 (12%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 10.7% 18.7% 12.6% 8.8% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 4/39 (10%) 8/45 (18%) 6/42 (14%) 4/39 (10%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 705 637 727 (T) 727 (T) |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304N P=0.275 P=0.550 P=0.503N |P=0.213 (e) (e) P=0.505 |
|POLY 3 | P=0.303N P=0.207 P=0.510 P=0.520N |P=0.201 (e) (e) P=0.503 |
|POLY 1.5 | P=0.293N P=0.201 P=0.507 P=0.512N |P=0.200 (e) (e) P=0.501 |
|POLY 6 | P=0.313N P=0.219 P=0.514 P=0.528N |P=0.204 (e) (e) P=0.506 |
|LOGISTIC REGRESSION| P=0.311N P=0.207 P=0.527 P=0.524N |(e) (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.278N P=0.194 P=0.500 P=0.500N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.055 (e) (e) P=0.244 |
|POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.241 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.239 |
|POLY 6 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.244 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.244 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 0/50 (0%) 1/50 (2%) |3/50 (6%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.4% 6.3% 0.0% 2.2% |6.6% 8.8% 6.4% 2.2% |
|TERMINAL (d) | 2/39 (5%) 3/45 (7%) 0/42 (0%) 1/39 (3%) |3/40 (8%) 4/34 (12%) 3/37 (8%) 1/41 (2%) |
|FIRST INCIDENCE | 713 727 (T) --- 727 (T) |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140N P=0.596N P=0.112N P=0.309N |P=0.168N P=0.411 P=0.627 P=0.296N |
|POLY 3 | P=0.137N P=0.653N P=0.116N P=0.317N |P=0.180N P=0.499 P=0.652N P=0.300N |
|POLY 1.5 | P=0.136N P=0.657N P=0.117N P=0.312N |P=0.184N P=0.501 P=0.656N P=0.303N |
|POLY 6 | P=0.138N P=0.646N P=0.115N P=0.321N |P=0.173N P=0.490 P=0.648N P=0.294N |
|LOGISTIC REGRESSION| P=0.143N P=0.632N P=0.115N P=0.319N |P=0.168N P=0.411 P=0.627 P=0.296N |
|COCH-ARM / FISHERS | P=0.134N P=0.661N P=0.121N P=0.309N |P=0.186N P=0.500 P=0.661N P=0.309N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 10/50 (20%) 7/50 (14%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.6% 12.6% 21.0% 15.4% |4.4% 6.6% 6.4% 4.3% |
|TERMINAL (d) | 4/39 (10%) 6/45 (13%) 10/42 (24%) 7/39 (18%) |2/40 (5%) 3/34 (9%) 3/37 (8%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178 P=0.462 P=0.095 P=0.259 |P=0.509N P=0.426 P=0.464 P=0.686N |
|POLY 3 | P=0.184 P=0.383 P=0.077 P=0.244 |P=0.534N P=0.499 P=0.510 P=0.688N |
|POLY 1.5 | P=0.194 P=0.377 P=0.076 P=0.251 |P=0.539N P=0.501 P=0.506 P=0.691N |
|POLY 6 | P=0.172 P=0.394 P=0.078 P=0.237 |P=0.524N P=0.491 P=0.514 P=0.683N |
|LOGISTIC REGRESSION| P=0.178 P=0.462 P=0.095 P=0.259 |P=0.509N P=0.426 P=0.464 P=0.686N |
|COCH-ARM / FISHERS | P=0.211 P=0.370 P=0.074 P=0.262 |P=0.544N P=0.500 P=0.500 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 14/50 (28%) 14/50 (28%) 7/50 (14%) |7/50 (14%) 3/50 (6%) 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 25.7% 29.3% 29.4% 15.4% |15.3% 6.6% 8.6% 10.8% |
|TERMINAL (d) | 12/39 (31%) 14/45 (31%) 14/42 (33%) 7/39 (18%) |7/40 (18%) 3/34 (9%) 4/37 (11%) 5/41 (12%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.580 P=0.497 P=0.147N |P=0.374N P=0.229N P=0.305N P=0.361N |
|POLY 3 | P=0.120N P=0.433 P=0.429 P=0.169N |P=0.408N P=0.158N P=0.248N P=0.368N |
|POLY 1.5 | P=0.113N P=0.422 P=0.422 P=0.163N |P=0.415N P=0.157N P=0.254N P=0.374N |
|POLY 6 | P=0.128N P=0.453 P=0.436 P=0.174N |P=0.394N P=0.164N P=0.243N P=0.357N |
|LOGISTIC REGRESSION| P=0.113N P=0.580 P=0.497 P=0.147N |P=0.374N P=0.229N P=0.305N P=0.361N |
|COCH-ARM / FISHERS | P=0.102N P=0.410 P=0.410 P=0.154N |P=0.419N P=0.159N P=0.262N P=0.380N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 5/50 (10%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 2.2% |4.4% 10.8% 6.4% 8.6% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 1/39 (3%) |1/40 (3%) 2/34 (6%) 1/37 (3%) 4/41 (10%) |
|FIRST INCIDENCE | --- --- 707 727 (T) |716 651 706 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 (e) P=0.514 P=0.500 |P=0.434 P=0.191 P=0.488 P=0.348 |
|POLY 3 | P=0.226 (e) P=0.504 P=0.494 |P=0.399 P=0.222 P=0.511 P=0.344 |
|POLY 1.5 | P=0.230 (e) P=0.502 P=0.496 |P=0.394 P=0.221 P=0.506 P=0.340 |
|POLY 6 | P=0.221 (e) P=0.505 P=0.492 |P=0.409 P=0.220 P=0.516 P=0.351 |
|LOGISTIC REGRESSION| P=0.227 (e) P=0.497 P=0.500 |P=0.393 P=0.214 P=0.512 P=0.356 |
|COCH-ARM / FISHERS | P=0.236 (e) P=0.500 P=0.500 |P=0.389 P=0.218 P=0.500 P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 617 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121N P=0.237N P=0.240N P=0.257N |(e) (e) (e) (e) |
|POLY 3 | P=0.113N P=0.235N P=0.236N P=0.247N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.113N P=0.236N P=0.236N P=0.243N |(e) (e) (e) (e) |
|POLY 6 | P=0.113N P=0.233N P=0.236N P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.101N P=0.235N P=0.296N P=0.195N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |30/50 (60%) 32/50 (64%) 29/50 (58%) 35/50 (70%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 6.2% 2.2% |65.6% 67.2% 61.1% 73.9% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 2/42 (5%) 1/39 (3%) |30/40 (75%) 24/34 (71%) 25/37 (68%) 34/41 (83%) |
|FIRST INCIDENCE | 727 (T) --- 577 727 (T) |728 (T) 605 617 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572N P=0.208N P=0.531 P=0.500N |P=0.360 P=0.127 P=0.493 P=0.200 |
|POLY 3 | P=0.572N P=0.233N P=0.512 P=0.510N |P=0.231 P=0.521 P=0.407N P=0.248 |
|POLY 1.5 | P=0.565N P=0.235N P=0.507 P=0.506N |P=0.216 P=0.478 P=0.449N P=0.225 |
|POLY 6 | P=0.580N P=0.229N P=0.518 P=0.514N |P=0.258 P=0.569 P=0.353N P=0.286 |
|LOGISTIC REGRESSION| P=0.546N (e) P=0.476 P=0.500N |P=0.267 P=0.381 P=0.392N P=0.264 |
|COCH-ARM / FISHERS | P=0.556N P=0.247N P=0.500 P=0.500N |P=0.200 P=0.418 P=0.500N P=0.201 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 25/50 (50%) 31/50 (62%) 19/50 (38%) |36/50 (72%) 35/50 (70%) 30/50 (60%) 35/50 (70%) |
|POLY-3 ADJUSTED (b)| 52.4% 52.3% 64.9% 41.8% |77.8% 74.6% 63.6% 73.1% |
|TERMINAL (d) | 21/39 (54%) 25/45 (56%) 30/42 (71%) 19/39 (49%) |34/40 (85%) 29/34 (85%) 28/37 (76%) 33/41 (81%) |
|FIRST INCIDENCE | 647 727 (T) 667 727 (T) |580 605 617 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187N P=0.320N P=0.265 P=0.158N |P=0.210N P=0.212 P=0.257N P=0.418N |
|POLY 3 | P=0.211N P=0.579N P=0.148 P=0.205N |P=0.313N P=0.450N P=0.090N P=0.384N |
|POLY 1.5 | P=0.180N P=0.580N P=0.154 P=0.183N |P=0.361N P=0.467N P=0.111N P=0.436N |
|POLY 6 | P=0.257N P=0.576N P=0.137 P=0.237N |P=0.247N P=0.455N P=0.069N P=0.319N |
|LOGISTIC REGRESSION| P=0.215N P=0.503N P=0.180 P=0.199N |P=0.288N P=0.546N P=0.061N P=0.428N |
|COCH-ARM / FISHERS | P=0.146N P=0.579N P=0.157 P=0.157N |P=0.419N P=0.500N P=0.146N P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 0.0% 4.4% |2.2% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 1/39 (3%) |1/40 (3%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 617 601 --- 698 |728 (T) 673 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345 P=0.760 P=0.500N P=0.484 |P=0.296N P=0.737 P=0.744 P=0.495N |
|POLY 3 | P=0.358 P=0.756N P=0.498N P=0.488 |P=0.309N P=0.760N P=0.756N P=0.497N |
|POLY 1.5 | P=0.362 P=0.758N P=0.499N P=0.492 |P=0.311N P=0.759N P=0.758N P=0.499N |
|POLY 6 | P=0.354 P=0.752N P=0.498N P=0.483 |P=0.304N P=0.758 P=0.754N P=0.494N |
|LOGISTIC REGRESSION| P=0.425 P=0.770N P=0.628N P=0.526 |P=0.310N P=0.762 P=0.744 (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.753N P=0.500N P=0.500 |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 7/50 (14%) 9/50 (18%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.8% 4.2% 14.7% 19.6% |6.6% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 6/39 (15%) 2/45 (4%) 7/42 (17%) 8/39 (21%) |3/40 (8%) 1/34 (3%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 556 |728 (T) 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 P=0.093N P=0.558 P=0.286 |P=0.043N* P=0.365N P=0.135N P=0.117N |
|POLY 3 | P=0.082 P=0.127N P=0.513 P=0.274 |P=0.042N* P=0.306N P=0.115N P=0.116N |
|POLY 1.5 | P=0.086 P=0.130N P=0.508 P=0.279 |P=0.043N* P=0.305N P=0.117N P=0.118N |
|POLY 6 | P=0.078 P=0.121N P=0.518 P=0.270 |P=0.041N* P=0.312N P=0.113N P=0.113N |
|LOGISTIC REGRESSION| P=0.075 P=0.093N P=0.558 P=0.264 |P=0.043N* P=0.365N (e) (e) |
|COCH-ARM / FISHERS | P=0.093 P=0.134N P=0.500 P=0.288 |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 4/50 (8%) 6/50 (12%) 2/50 (4%) |5/50 (10%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 24.9% 8.2% 12.2% 4.3% |10.9% 8.6% 6.3% 4.3% |
|TERMINAL (d) | 6/39 (15%) 2/45 (4%) 2/42 (5%) 0/39 (0%) |4/40 (10%) 1/34 (3%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 617 601 577 549 |716 650 610 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010N* P=0.025N* P=0.098N P=0.009N** |P=0.141N P=0.560N P=0.374N P=0.214N |
|POLY 3 | P=0.007N** P=0.025N* P=0.088N P=0.005N** |P=0.144N P=0.491N P=0.338N P=0.206N |
|POLY 1.5 | P=0.006N** P=0.026N* P=0.091N P=0.004N** |P=0.149N P=0.493N P=0.346N P=0.211N |
|POLY 6 | P=0.007N** P=0.024N* P=0.086N P=0.005N** |P=0.137N P=0.494N P=0.329N P=0.198N |
|LOGISTIC REGRESSION| P=0.002N** P=0.030N* P=0.122N P=0.003N** |P=0.152N P=0.500N P=0.356N P=0.217N |
|COCH-ARM / FISHERS | P=0.006N** P=0.027N* P=0.096N P=0.004N** |P=0.151N P=0.500N P=0.357N P=0.218N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |12/50 (24%) 17/50 (34%) 16/50 (32%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 4.2% 2.2% |26.2% 36.7% 33.9% 38.0% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 2/42 (5%) 1/39 (3%) |11/40 (28%) 14/34 (41%) 15/37 (41%) 15/41 (37%) |
|FIRST INCIDENCE | 617 --- 727 (T) 727 (T) |716 643 617 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548N P=0.226N P=0.673N P=0.510N |P=0.232 P=0.088 P=0.183 P=0.162 |
|POLY 3 | P=0.544N P=0.235N P=0.691N P=0.513N |P=0.186 P=0.192 P=0.279 P=0.158 |
|POLY 1.5 | P=0.538N P=0.236N P=0.691N P=0.508N |P=0.171 P=0.193 P=0.268 P=0.147 |
|POLY 6 | P=0.550N P=0.232N P=0.690N P=0.519N |P=0.215 P=0.183 P=0.291 P=0.178 |
|LOGISTIC REGRESSION| P=0.526N P=0.240N P=0.682 P=0.485N |P=0.190 P=0.141 P=0.282 P=0.152 |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.158 P=0.189 P=0.252 P=0.138 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |10/50 (20%) 17/50 (34%) 12/50 (24%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 6.3% 2.2% |21.3% 36.2% 25.0% 26.8% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 3/42 (7%) 1/39 (3%) |8/40 (20%) 11/34 (32%) 8/37 (22%) 8/41 (20%) |
|FIRST INCIDENCE | 617 --- 727 (T) 727 (T) |456 651 524 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390N P=0.110N P=0.634N P=0.318N |P=0.538 P=0.054 P=0.363 P=0.349 |
|POLY 3 | P=0.390N P=0.117N P=0.659N P=0.320N |P=0.501 P=0.084 P=0.428 P=0.348 |
|POLY 1.5 | P=0.382N P=0.118N P=0.659N P=0.314N |P=0.480 P=0.086 P=0.417 P=0.334 |
|POLY 6 | P=0.398N P=0.115N P=0.659N P=0.326N |P=0.534 P=0.081 P=0.441 P=0.369 |
|LOGISTIC REGRESSION| P=0.374N P=0.124N P=0.657 P=0.296N |P=0.446 P=0.087 P=0.374 P=0.302 |
|COCH-ARM / FISHERS | P=0.373N P=0.121N P=0.661N P=0.309N |P=0.457 P=0.088 P=0.405 P=0.318 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 2.1% 4.4% |2.2% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 0/42 (0%) 2/39 (5%) |1/40 (3%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 643 727 (T) |728 (T) 673 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.333 P=0.730N P=0.752N P=0.500 |P=0.591N P=0.737 P=0.516N P=0.756N |
|POLY 3 | P=0.341 P=0.756N P=0.755N P=0.490 |P=0.613N P=0.760N P=0.496N P=0.757N |
|POLY 1.5 | P=0.345 P=0.758N P=0.757N P=0.494 |P=0.614N P=0.759N P=0.497N P=0.759N |
|POLY 6 | P=0.336 P=0.752N P=0.753N P=0.486 |P=0.611N P=0.758 P=0.494N P=0.754N |
|LOGISTIC REGRESSION| P=0.348 P=0.730N P=0.742 P=0.500 |P=0.614N P=0.762 (e) P=0.756N |
|COCH-ARM / FISHERS | P=0.351 P=0.753N P=0.753N P=0.500 |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.055 (e) (e) P=0.248 |
|POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.242 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.239 |
|POLY 6 | (e) (e) (e) (e) |P=0.048 * (e) (e) P=0.246 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 4.4% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |1/40 (3%) 2/34 (6%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.479N P=0.443 P=0.516N P=0.756N |
|POLY 3 | (e) (e) (e) (e) |P=0.496N P=0.499 P=0.496N P=0.757N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.498N P=0.501 P=0.497N P=0.759N |
|POLY 6 | (e) (e) (e) (e) |P=0.493N P=0.493 P=0.494N P=0.754N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.479N P=0.443 (e) P=0.756N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.500 P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 2.1% 2.1% 0.0% |4.4% 6.6% 4.3% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/45 (2%) 1/42 (2%) 0/39 (0%) |2/40 (5%) 3/34 (9%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |728 (T) 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.450N P=0.474N P=0.238N |P=0.125N P=0.426 P=0.667 P=0.233N |
|POLY 3 | P=0.159N P=0.493N P=0.494N P=0.244N |P=0.130N P=0.499 P=0.686N P=0.234N |
|POLY 1.5 | P=0.157N P=0.496N P=0.496N P=0.241N |P=0.133N P=0.501 P=0.689N P=0.236N |
|POLY 6 | P=0.161N P=0.487N P=0.492N P=0.246N |P=0.126N P=0.491 P=0.683N P=0.230N |
|LOGISTIC REGRESSION| P=0.155N P=0.450N P=0.474N (e) |P=0.125N P=0.426 P=0.667 (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |P=0.134N P=0.500 P=0.691N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.5% 0.0% 6.3% 0.0% |0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 3/42 (7%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 652 --- 727 (T) --- |--- 605 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.055N P=0.470N P=0.070N |P=0.586N P=0.517 P=0.484 (e) |
|POLY 3 | P=0.091N P=0.059N P=0.495N P=0.065N |P=0.590N P=0.502 P=0.504 (e) |
|POLY 1.5 | P=0.088N P=0.060N P=0.497N P=0.063N |P=0.592N P=0.501 P=0.503 (e) |
|POLY 6 | P=0.095N P=0.057N P=0.495N P=0.068N |P=0.586N P=0.499 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.087N P=0.064N P=0.497N P=0.062N |P=0.585N P=0.441 P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.086N P=0.059N P=0.500N P=0.059N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- 502 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * (e) (e) P=0.233 |(e) (e) (e) (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.236 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.236 |(e) (e) (e) (e) |
|POLY 6 | P=0.044 * (e) (e) P=0.236 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.086 (e) (e) P=0.340 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 6/50 (12%) 9/50 (18%) |0/50 (0%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.4% 4.2% 12.6% 19.2% |0.0% 2.2% 8.5% 6.5% |
|TERMINAL (d) | 3/39 (8%) 2/45 (4%) 6/42 (14%) 6/39 (15%) |0/40 (0%) 1/34 (3%) 3/37 (8%) 3/41 (7%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 472 |--- 728 (T) 687 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.435N P=0.279 P=0.066 |P=0.090 P=0.468 P=0.060 P=0.126 |
|POLY 3 | P=0.012 * P=0.491N P=0.251 P=0.060 |P=0.074 P=0.500 P=0.064 P=0.122 |
|POLY 1.5 | P=0.012 * P=0.495N P=0.248 P=0.060 |P=0.072 P=0.500 P=0.062 P=0.120 |
|POLY 6 | P=0.011 * P=0.483N P=0.254 P=0.060 |P=0.079 P=0.496 P=0.065 P=0.124 |
|LOGISTIC REGRESSION| P=0.014 * P=0.435N P=0.279 P=0.072 |P=0.082 P=0.468 P=0.066 P=0.126 |
|COCH-ARM / FISHERS | P=0.013 * P=0.500N P=0.243 P=0.061 |P=0.072 P=0.500 P=0.059 P=0.121 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 6.3% 2.1% 4.2% 6.6% |0.0% 6.6% 4.3% 4.3% |
|TERMINAL (d) | 2/39 (5%) 1/45 (2%) 2/42 (5%) 3/39 (8%) |0/40 (0%) 3/34 (9%) 2/37 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 526 727 (T) 727 (T) 727 (T) |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459 P=0.270N P=0.471N P=0.660 |P=0.354 P=0.094 P=0.221 P=0.244 |
|POLY 3 | P=0.458 P=0.303N P=0.498N P=0.642 |P=0.334 P=0.118 P=0.242 P=0.241 |
|POLY 1.5 | P=0.466 P=0.305N P=0.499N P=0.650 |P=0.329 P=0.119 P=0.240 P=0.239 |
|POLY 6 | P=0.449 P=0.299N P=0.498N P=0.635 |P=0.342 P=0.115 P=0.244 P=0.244 |
|LOGISTIC REGRESSION| P=0.484 P=0.312N P=0.545N P=0.650N |(e) P=0.094 P=0.221 P=0.244 |
|COCH-ARM / FISHERS | P=0.477 P=0.309N P=0.500N P=0.661N |P=0.324 P=0.121 P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 1/50 (2%) 1/47 (2%) 0/48 (0%) |1/47 (2%) 0/46 (0%) 5/48 (10%) 5/48 (10%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.1% 2.2% 0.0% |2.3% 0.0% 11.1% 11.2% |
|TERMINAL (d) | 2/39 (5%) 1/45 (2%) 1/41 (2%) 0/39 (0%) |1/40 (3%) 0/32 (0%) 5/37 (14%) 5/40 (13%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |728 (T) --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.156N P=0.450N P=0.483N P=0.238N |P=0.027 * P=0.545N P=0.086 P=0.103 |
|POLY 3 | P=0.158N P=0.479N P=0.497N P=0.241N |P=0.022 * P=0.506N P=0.108 P=0.107 |
|POLY 1.5 | P=0.156N P=0.480N P=0.498N P=0.238N |P=0.022 * P=0.505N P=0.108 P=0.106 |
|POLY 6 | P=0.160N P=0.477N P=0.496N P=0.244N |P=0.024 * P=0.511N P=0.108 P=0.109 |
|LOGISTIC REGRESSION| P=0.156N P=0.450N P=0.483N (e) |P=0.027 * (e) P=0.086 P=0.103 |
|COCH-ARM / FISHERS | P=0.152N P=0.477N P=0.500N P=0.242N |P=0.023 * P=0.505N P=0.107 P=0.107 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 6.4% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 3/37 (8%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.270 (e) P=0.108 P=0.505 |
|POLY 3 | (e) (e) (e) (e) |P=0.253 (e) P=0.123 P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.249 (e) P=0.121 P=0.501 |
|POLY 6 | (e) (e) (e) (e) |P=0.263 (e) P=0.124 P=0.506 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.108 P=0.505 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 (e) P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/48 (0%) 0/49 (0%) |1/50 (2%) 1/49 (2%) 2/47 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |2.2% 2.2% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/45 (2%) 0/41 (0%) 0/38 (0%) |1/40 (3%) 1/34 (3%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) --- --- |728 (T) 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579N P=0.529 (e) (e) |P=0.350N P=0.725 P=0.473 P=0.495N |
|POLY 3 | P=0.564N P=0.506 (e) (e) |P=0.364N P=0.757 P=0.487 P=0.499N |
|POLY 1.5 | P=0.566N P=0.503 (e) (e) |P=0.369N P=0.757 P=0.483 P=0.501N |
|POLY 6 | P=0.561N P=0.510 (e) (e) |P=0.355N P=0.754 P=0.491 P=0.495N |
|LOGISTIC REGRESSION| (e) P=0.529 (e) (e) |P=0.350N P=0.725 P=0.473 (e) |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.373N P=0.747 P=0.477 P=0.505N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 1/48 (2%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/47 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.2% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 2/45 (4%) 1/41 (2%) 0/38 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.270 P=0.510 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.470N P=0.243 P=0.500 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.467N P=0.241 P=0.498 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.472N P=0.248 P=0.502 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.270 P=0.510 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.462N P=0.247 P=0.495 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 1/49 (2%) 2/47 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/41 (0%) 0/38 (0%) |0/40 (0%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 683 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.592N P=0.480 P=0.221 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.610N P=0.497 P=0.229 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.616N P=0.497 P=0.227 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.601N P=0.495 P=0.231 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.616N P=0.488 P=0.221 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.621N P=0.495 P=0.232 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/48 (2%) 2/49 (4%) |0/50 (0%) 0/49 (0%) 0/47 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 4.5% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 1/41 (2%) 2/38 (5%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 (e) P=0.510 P=0.233 |P=0.213 (e) (e) P=0.505 |
|POLY 3 | P=0.065 (e) P=0.500 P=0.230 |P=0.202 (e) (e) P=0.501 |
|POLY 1.5 | P=0.067 (e) P=0.498 P=0.233 |P=0.200 (e) (e) P=0.499 |
|POLY 6 | P=0.063 (e) P=0.502 P=0.227 |P=0.205 (e) (e) P=0.505 |
|LOGISTIC REGRESSION| (e) (e) P=0.510 P=0.233 |(e) (e) (e) P=0.505 |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.495 P=0.247 |P=0.198 (e) (e) P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |1/49 (2%) 3/50 (6%) 0/49 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.2% 6.5% 0.0% 2.2% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |1/40 (3%) 1/34 (3%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 643 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.388N P=0.293 P=0.516N P=0.756N |
|POLY 3 | (e) (e) (e) (e) |P=0.401N P=0.314 P=0.497N P=0.754N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.403N P=0.315 P=0.498N P=0.755N |
|POLY 6 | (e) (e) (e) (e) |P=0.399N P=0.310 P=0.496N P=0.752N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.405N P=0.307 (e) P=0.756N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.316 P=0.500N P=0.747N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 0/6 (0%) 0/7 (0%) 0/5 (0%) |0/14 (0%) 0/19 (0%) 0/17 (0%) 1/13 (8%) |
|POLY-3 ADJUSTED (b)| 30.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 7.8% |
|TERMINAL (d) | 2/6 (33%) 0/4 (0%) 0/6 (0%) 0/2 (0%) |0/10 (0%) 0/11 (0%) 0/9 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |--- --- --- 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.165N P=0.323N P=0.229N P=0.500N |P=0.213 (e) (e) P=0.505 |
|POLY 3 | P=0.094N P=0.292N P=0.214N P=0.351N |P=0.176 (e) (e) P=0.505 |
|POLY 1.5 | P=0.104N P=0.279N P=0.216N P=0.328N |P=0.171 (e) (e) P=0.496 |
|POLY 6 | P=0.080N P=0.303N P=0.212N P=0.393N |P=0.184 (e) (e) P=0.517 |
|LOGISTIC REGRESSION| P=0.165N (e) (e) (e) |P=0.172 (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.126N P=0.269N P=0.231N P=0.318N |P=0.165 (e) (e) P=0.481 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/7 (29%) 0/6 (0%) 2/7 (29%) 0/5 (0%) |1/14 (7%) 0/19 (0%) 0/17 (0%) 0/13 (0%) |
|POLY-3 ADJUSTED (b)| 30.3% 0.0% 29.9% 0.0% |8.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/6 (33%) 0/4 (0%) 2/6 (33%) 0/2 (0%) |1/10 (10%) 0/11 (0%) 0/9 (0%) 0/11 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) --- |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441N P=0.323N P=0.721 P=0.500N |P=0.302N P=0.481N P=0.521N P=0.481N |
|POLY 3 | P=0.317N P=0.292N P=0.707N P=0.351N |P=0.330N P=0.436N P=0.467N P=0.496N |
|POLY 1.5 | P=0.304N P=0.279N P=0.707N P=0.328N |P=0.324N P=0.437N P=0.465N P=0.504N |
|POLY 6 | P=0.343N P=0.303N P=0.707N P=0.393N |P=0.334N P=0.438N P=0.467N P=0.485N |
|LOGISTIC REGRESSION| P=0.441N (e) P=0.721 (e) |P=0.302N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.295N P=0.269N P=0.720N P=0.318N |P=0.313N P=0.424N P=0.452N P=0.519N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/7 (57%) 4/6 (67%) 3/7 (43%) 2/5 (40%) |10/14 (71%) 7/19 (37%) 10/17 (59%) 11/13 (85%) |
|POLY-3 ADJUSTED (b)| 60.5% 76.5% 44.8% 51.0% |74.7% 40.7% 63.1% 86.0% |
|TERMINAL (d) | 4/6 (67%) 3/4 (75%) 3/6 (50%) 2/2 (100%) |8/10 (80%) 6/11 (55%) 7/9 (78%) 10/11 (91%) |
|FIRST INCIDENCE | 727 (T) 644 727 (T) 727 (T) |547 706 477 708 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.598 P=0.417 P=0.500N P=0.500 |P=0.337 P=0.170N P=0.540 P=0.647 |
|POLY 3 | P=0.379N P=0.516 P=0.491N P=0.628N |P=0.113 P=0.052N P=0.390N P=0.406 |
|POLY 1.5 | P=0.346N P=0.534 P=0.495N P=0.564N |P=0.104 P=0.049N* P=0.381N P=0.385 |
|POLY 6 | P=0.436N P=0.518 P=0.488N P=0.736N |P=0.135 P=0.060N P=0.394N P=0.441 |
|LOGISTIC REGRESSION| P=0.581N P=0.422 P=0.500N P=0.500 |P=0.154 P=0.041N* P=0.379N P=0.499 |
|COCH-ARM / FISHERS | P=0.305N P=0.587 P=0.500N P=0.500N |P=0.107 P=0.053N P=0.364N P=0.362 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.1% 6.4% 2.2% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 3/41 (7%) 1/39 (3%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 647 727 (T) 727 (T) 727 (T) |--- --- 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493N P=0.469N P=0.516 P=0.508N |P=0.700 (e) P=0.495 (e) |
|POLY 3 | P=0.494N P=0.495N P=0.495 P=0.513N |P=0.700 (e) P=0.504 (e) |
|POLY 1.5 | P=0.486N P=0.498N P=0.494 P=0.508N |P=0.696 (e) P=0.503 (e) |
|POLY 6 | P=0.503N P=0.491N P=0.496 P=0.518N |P=0.707 (e) P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.487N P=0.505N P=0.491 P=0.497N |P=0.701 (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.475N P=0.500N P=0.490 P=0.500N |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.1% 4.3% 2.2% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 2/41 (5%) 1/39 (3%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |--- --- 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.730N P=0.517 P=0.762 |P=0.700 (e) P=0.495 (e) |
|POLY 3 | P=0.572 P=0.756N P=0.498 P=0.754 |P=0.700 (e) P=0.504 (e) |
|POLY 1.5 | P=0.579 P=0.758N P=0.496 P=0.756 |P=0.696 (e) P=0.503 (e) |
|POLY 6 | P=0.564 P=0.752N P=0.501 P=0.752 |P=0.707 (e) P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.578 P=0.730N P=0.517 P=0.762 |P=0.701 (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.590 P=0.753N P=0.492 P=0.753N |P=0.695 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/26 (100%) 27/27 (100%) 17/17 (100%) 19/19 (100%)|1/1 (100%) 0/0 (0%) 2/2 (100%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 100.0% 100.0% |100.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 25/25 (100%) 27/27 (100%) 15/15 (100%) 17/17 (100%)|1/1 (100%) 0/0 (0%) 1/1 (100%) 3/3 (100%) |
|FIRST INCIDENCE | 647 727 (T) 643 594 |728 (T) --- 723 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/26 (81%) 22/27 (81%) 14/17 (82%) 11/19 (58%) |1/1 (100%) 0/0 (0%) 2/2 (100%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 80.8% 81.5% 83.9% 59.8% |100.0% 0.0% 100.0% 66.7% |
|TERMINAL (d) | 20/25 (80%) 22/27 (82%) 13/15 (87%) 11/17 (65%) |1/1 (100%) 0/0 (0%) 1/1 (100%) 2/3 (67%) |
|FIRST INCIDENCE | 647 727 (T) 707 727 (T) |728 (T) --- 723 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.549N P=0.469 P=0.154N |P=0.502N (e) (e) P=0.718N |
|POLY 3 | P=0.070N P=0.610 P=0.559 P=0.114N |(e) (e) (e) P=0.691N |
|POLY 1.5 | P=0.059N P=0.610 P=0.580 P=0.101N |(e) (e) (e) P=0.691N |
|POLY 6 | P=0.090N P=0.610 P=0.525 P=0.135N |(e) (e) (e) P=0.691N |
|LOGISTIC REGRESSION| P=0.080N P=0.549N P=0.573 P=0.116N |P=0.502N (e) (e) P=0.718N |
|COCH-ARM / FISHERS | P=0.048N* P=0.611 P=0.612 P=0.091N |P=0.403N (e) (e) P=0.750N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/47 (13%) 9/49 (18%) 9/50 (18%) 7/49 (14%) |
|POLY-3 ADJUSTED (b)| |13.9% 20.0% 19.0% 15.1% |
|TERMINAL (d) | |4/37 (11%) 7/33 (21%) 6/37 (16%) 5/40 (13%) |
|FIRST INCIDENCE | |663 667 524 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.499N P=0.224 P=0.298 P=0.550 |
|POLY 3 | |P=0.530N P=0.321 P=0.361 P=0.555 |
|POLY 1.5 | |P=0.546N P=0.322 P=0.350 P=0.544 |
|POLY 6 | |P=0.504N P=0.310 P=0.371 P=0.572 |
|LOGISTIC REGRESSION| |P=0.549 P=0.311 P=0.339 P=0.535 |
|COCH-ARM / FISHERS | |P=0.545 P=0.319 P=0.334 P=0.533 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/47 (4%) 1/49 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |4.6% 2.2% 2.1% 2.2% |
|TERMINAL (d) | |0/37 (0%) 1/33 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | |547 728 (T) 716 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.391N P=0.535N P=0.502N P=0.494N |
|POLY 3 | |P=0.393N P=0.490N P=0.473N P=0.482N |
|POLY 1.5 | |P=0.396N P=0.487N P=0.475N P=0.484N |
|POLY 6 | |P=0.387N P=0.498N P=0.472N P=0.477N |
|LOGISTIC REGRESSION| |P=0.394N P=0.518N P=0.516N P=0.478N |
|COCH-ARM / FISHERS | |P=0.397N P=0.484N P=0.477N P=0.484N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/47 (6%) 0/49 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |6.9% 0.0% 0.0% 2.2% |
|TERMINAL (d) | |1/37 (3%) 0/33 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | |547 --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.237N P=0.142N P=0.125N P=0.298N |
|POLY 3 | |P=0.233N P=0.113N P=0.105N P=0.288N |
|POLY 1.5 | |P=0.235N P=0.112N P=0.107N P=0.290N |
|POLY 6 | |P=0.229N P=0.117N P=0.105N P=0.285N |
|LOGISTIC REGRESSION| |P=0.238N P=0.125N P=0.124N P=0.292N |
|COCH-ARM / FISHERS | |P=0.238N P=0.113N P=0.110N P=0.293N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/47 (4%) 0/49 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |4.6% 0.0% 2.1% 2.2% |
|TERMINAL (d) | |0/37 (0%) 0/33 (0%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | |547 --- 716 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.486N P=0.260N P=0.502N P=0.496N |
|POLY 3 | |P=0.485N P=0.230N P=0.473N P=0.483N |
|POLY 1.5 | |P=0.488N P=0.229N P=0.475N P=0.485N |
|POLY 6 | |P=0.479N P=0.235N P=0.472N P=0.480N |
|LOGISTIC REGRESSION| |P=0.486N P=0.267N P=0.516N P=0.485N |
|COCH-ARM / FISHERS | |P=0.489N P=0.237N P=0.477N P=0.484N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |14/50 (28%) 10/50 (20%) 7/50 (14%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 4.4% 4.2% 6.3% 4.4% |30.6% 21.9% 15.0% 28.0% |
|TERMINAL (d) | 2/39 (5%) 2/45 (4%) 3/42 (7%) 2/39 (5%) |14/40 (35%) 10/34 (29%) 7/37 (19%) 13/41 (32%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551 P=0.642N P=0.534 P=0.695 |P=0.419N P=0.397N P=0.094N P=0.469N |
|POLY 3 | P=0.555 P=0.679N P=0.517 P=0.690 |P=0.481N P=0.238N P=0.059N P=0.480N |
|POLY 1.5 | P=0.563 P=0.682N P=0.514 P=0.693N |P=0.492N P=0.237N P=0.063N P=0.491N |
|POLY 6 | P=0.547 P=0.673N P=0.520 P=0.687 |P=0.458N P=0.251N P=0.055N P=0.461N |
|LOGISTIC REGRESSION| P=0.551 P=0.642N P=0.534 P=0.695 |P=0.419N P=0.397N P=0.094N P=0.469N |
|COCH-ARM / FISHERS | P=0.576 P=0.684N P=0.510 P=0.684N |P=0.500N P=0.241N P=0.070N P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/47 (0%) 0/47 (0%) |1/48 (2%) 3/47 (6%) 0/43 (0%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 6.9% 0.0% 6.6% |
|TERMINAL (d) | 0/38 (0%) 0/44 (0%) 0/40 (0%) 0/37 (0%) |1/38 (3%) 3/32 (9%) 0/33 (0%) 3/40 (8%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.365 P=0.245 P=0.528N P=0.324 |
|POLY 3 | (e) (e) (e) (e) |P=0.337 P=0.302 P=0.515N P=0.316 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.331 P=0.302 P=0.518N P=0.311 |
|POLY 6 | (e) (e) (e) (e) |P=0.345 P=0.297 P=0.513N P=0.324 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.365 P=0.245 (e) P=0.324 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.325 P=0.301 P=0.527N P=0.308 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 2/47 (4%) 4/47 (9%) |0/48 (0%) 0/47 (0%) 2/43 (5%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 6.6% 4.3% 4.5% 9.2% |0.0% 0.0% 4.9% 4.4% |
|TERMINAL (d) | 3/38 (8%) 2/44 (5%) 2/40 (5%) 3/37 (8%) |0/38 (0%) 0/32 (0%) 2/33 (6%) 2/40 (5%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 556 |--- --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322 P=0.433N P=0.477N P=0.486 |P=0.107 (e) P=0.208 P=0.250 |
|POLY 3 | P=0.328 P=0.490N P=0.509N P=0.471 |P=0.093 (e) P=0.220 P=0.244 |
|POLY 1.5 | P=0.331 P=0.495N P=0.513N P=0.473 |P=0.090 (e) P=0.217 P=0.241 |
|POLY 6 | P=0.325 P=0.482N P=0.504N P=0.471 |P=0.098 (e) P=0.223 P=0.249 |
|LOGISTIC REGRESSION| P=0.329 P=0.433N P=0.477N P=0.479 |(e) (e) P=0.208 P=0.250 |
|COCH-ARM / FISHERS | P=0.334 P=0.500N P=0.520N P=0.476 |P=0.088 (e) P=0.221 P=0.247 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/47 (0%) 0/47 (0%) |2/48 (4%) 3/47 (6%) 4/43 (9%) 6/48 (13%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |4.6% 6.9% 9.8% 13.3% |
|TERMINAL (d) | 0/38 (0%) 1/44 (2%) 0/40 (0%) 0/37 (0%) |2/38 (5%) 3/32 (9%) 3/33 (9%) 6/40 (15%) |
|FIRST INCIDENCE | --- 727 (T) --- --- |728 (T) 728 (T) 687 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579N P=0.529 (e) (e) |P=0.112 P=0.421 P=0.290 P=0.150 |
|POLY 3 | P=0.571N P=0.504 (e) (e) |P=0.089 P=0.496 P=0.304 P=0.143 |
|POLY 1.5 | P=0.573N P=0.502 (e) (e) |P=0.085 P=0.496 P=0.298 P=0.138 |
|POLY 6 | P=0.569N P=0.508 (e) (e) |P=0.096 P=0.490 P=0.311 P=0.150 |
|LOGISTIC REGRESSION| (e) P=0.529 (e) (e) |P=0.107 P=0.421 P=0.307 P=0.150 |
|COCH-ARM / FISHERS | P=0.574N P=0.500 (e) (e) |P=0.081 P=0.490 P=0.287 P=0.134 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 28/50 (56%) 29/49 (59%) 25/50 (50%) | |
|POLY-3 ADJUSTED (b)| 57.7% 58.6% 61.9% 54.4% | |
|TERMINAL (d) | 27/39 (69%) 28/45 (62%) 28/41 (68%) 24/39 (62%) | |
|FIRST INCIDENCE | 727 (T) 727 (T) 664 556 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.330N P=0.537 P=0.410N | |
|POLY 3 | P=0.411N P=0.548 P=0.417 P=0.454N | |
|POLY 1.5 | P=0.392N P=0.524 P=0.400 P=0.442N | |
|POLY 6 | P=0.431N P=0.582N P=0.439 P=0.462N | |
|LOGISTIC REGRESSION| P=0.504N P=0.330N P=0.447 P=0.514N | |
|COCH-ARM / FISHERS | P=0.364N P=0.500 P=0.376 P=0.421N | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 1/41 (2%) 0/39 (0%) | |
|FIRST INCIDENCE | --- --- 707 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.586 (e) P=0.253 (e) | |
|POLY 3 | P=0.573 (e) P=0.237 (e) | |
|POLY 1.5 | P=0.582 (e) P=0.235 (e) | |
|POLY 6 | P=0.563 (e) P=0.238 (e) | |
|LOGISTIC REGRESSION| P=0.588 (e) P=0.236 (e) | |
|COCH-ARM / FISHERS | P=0.594 (e) P=0.242 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) 4/49 (8%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 14.9% 16.6% 8.6% 8.8% | |
|TERMINAL (d) | 6/39 (15%) 7/45 (16%) 4/41 (10%) 4/39 (10%) | |
|FIRST INCIDENCE | 705 612 727 (T) 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.606 P=0.234N P=0.264N | |
|POLY 3 | P=0.154N P=0.523 P=0.265N P=0.279N | |
|POLY 1.5 | P=0.149N P=0.512 P=0.268N P=0.273N | |
|POLY 6 | P=0.160N P=0.540 P=0.262N P=0.286N | |
|LOGISTIC REGRESSION| P=0.159N P=0.518 P=0.251N P=0.280N | |
|COCH-ARM / FISHERS | P=0.140N P=0.500 P=0.274N P=0.262N | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 32/50 (64%) 33/49 (67%) 39/50 (78%) | |
|POLY-3 ADJUSTED (b)| 69.2% 67.0% 69.3% 81.4% | |
|TERMINAL (d) | 28/39 (72%) 32/45 (71%) 30/41 (73%) 32/39 (82%) | |
|FIRST INCIDENCE | 647 727 (T) 577 549 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * P=0.175N P=0.458N P=0.151 | |
|POLY 3 | P=0.075 P=0.494N P=0.586 P=0.118 | |
|POLY 1.5 | P=0.076 P=0.498N P=0.565 P=0.120 | |
|POLY 6 | P=0.079 P=0.488N P=0.579N P=0.126 | |
|LOGISTIC REGRESSION| P=0.035 * P=0.372N P=0.586 P=0.075 | |
|COCH-ARM / FISHERS | P=0.083 P=0.500N P=0.528 P=0.133 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 22/50 (44%) 29/49 (59%) 28/50 (56%) | |
|POLY-3 ADJUSTED (b)| 32.0% 45.7% 61.0% 60.3% | |
|TERMINAL (d) | 14/39 (36%) 21/45 (47%) 26/41 (63%) 26/39 (67%) | |
|FIRST INCIDENCE | 687 601 596 549 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.233 P=0.008 ** P=0.006 ** | |
|POLY 3 | P=0.003 ** P=0.121 P=0.003 ** P=0.004 ** | |
|POLY 1.5 | P=0.003 ** P=0.114 P=0.003 ** P=0.005 ** | |
|POLY 6 | P=0.002 ** P=0.135 P=0.004 ** P=0.003 ** | |
|LOGISTIC REGRESSION| P=0.002 ** P=0.135 P=0.004 ** P=0.004 ** | |
|COCH-ARM / FISHERS | P=0.005 ** P=0.107 P=0.003 ** P=0.007 ** | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/49 (6%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 2.1% 4.2% 6.4% 0.0% | |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 2/41 (5%) 0/39 (0%) | |
|FIRST INCIDENCE | 727 (T) 637 643 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.533 P=0.320 P=0.500N | |
|POLY 3 | P=0.355N P=0.510 P=0.306 P=0.506N | |
|POLY 1.5 | P=0.349N P=0.505 P=0.303 P=0.504N | |
|POLY 6 | P=0.362N P=0.517 P=0.310 P=0.508N | |
|LOGISTIC REGRESSION| P=0.324N P=0.494 P=0.292 (e) | |
|COCH-ARM / FISHERS | P=0.338N P=0.500 P=0.301 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Prostate: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 1/45 (2%) 0/41 (0%) 0/39 (0%) | |
|FIRST INCIDENCE | --- 444 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N P=0.255 (e) (e) | |
|POLY 3 | P=0.404N P=0.246 (e) (e) | |
|POLY 1.5 | P=0.405N P=0.242 (e) (e) | |
|POLY 6 | P=0.402N P=0.250 (e) (e) | |
|LOGISTIC REGRESSION| P=0.323N P=0.226 (e) (e) | |
|COCH-ARM / FISHERS | P=0.406N P=0.247 (e) (e) | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/49 (0%) 0/48 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.2% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) --- --- --- |--- --- --- 520 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.471N P=0.485N P=0.500N |P=0.049 * (e) (e) P=0.250 |
|POLY 3 | P=0.304N P=0.496N P=0.497N P=0.506N |P=0.049 * (e) (e) P=0.249 |
|POLY 1.5 | P=0.304N P=0.498N P=0.498N P=0.504N |P=0.048 * (e) (e) P=0.246 |
|POLY 6 | P=0.304N P=0.492N P=0.495N P=0.508N |P=0.050 (e) (e) P=0.254 |
|LOGISTIC REGRESSION| P=0.307N (e) (e) (e) |P=0.072 (e) (e) P=0.267 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.048 * (e) (e) P=0.253 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 28/50 (56%) 33/50 (66%) 32/50 (64%) |34/49 (69%) 36/49 (73%) 40/48 (83%) 35/50 (70%) |
|POLY-3 ADJUSTED (b)| 56.1% 57.7% 67.6% 67.3% |73.4% 76.8% 86.0% 74.4% |
|TERMINAL (d) | 21/39 (54%) 27/45 (60%) 30/42 (71%) 27/39 (69%) |32/40 (80%) 27/34 (79%) 34/37 (92%) 32/41 (78%) |
|FIRST INCIDENCE | 617 444 577 502 |456 643 477 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096 P=0.387N P=0.284 P=0.217 |P=0.400N P=0.111 P=0.038 * P=0.580 |
|POLY 3 | P=0.112 P=0.520 P=0.168 P=0.176 |P=0.484 P=0.442 P=0.093 P=0.552 |
|POLY 1.5 | P=0.124 P=0.514 P=0.164 P=0.189 |P=0.480 P=0.427 P=0.086 P=0.543 |
|POLY 6 | P=0.099 P=0.520 P=0.166 P=0.160 |P=0.526 P=0.464 P=0.110 P=0.589 |
|LOGISTIC REGRESSION| P=0.111 P=0.524 P=0.170 P=0.173 |P=0.530N P=0.442 P=0.100 P=0.564N |
|COCH-ARM / FISHERS | P=0.142 P=0.500 P=0.154 P=0.208 |P=0.510 P=0.412 P=0.084 P=0.560 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 6.4% 6.3% 2.1% 0.0% | |
|TERMINAL (d) | 3/39 (8%) 3/45 (7%) 1/42 (2%) 0/39 (0%) | |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052N P=0.595N P=0.279N P=0.121N | |
|POLY 3 | P=0.054N P=0.653N P=0.299N P=0.124N | |
|POLY 1.5 | P=0.053N P=0.657N P=0.302N P=0.122N | |
|POLY 6 | P=0.055N P=0.645N P=0.297N P=0.126N | |
|LOGISTIC REGRESSION| P=0.052N P=0.595N P=0.279N (e) | |
|COCH-ARM / FISHERS | P=0.052N P=0.661N P=0.309N P=0.121N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% | |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 0/42 (0%) 0/39 (0%) | |
|FIRST INCIDENCE | 727 (T) --- --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.208N P=0.222N P=0.238N | |
|POLY 3 | P=0.114N P=0.233N P=0.234N P=0.244N | |
|POLY 1.5 | P=0.113N P=0.235N P=0.235N P=0.241N | |
|POLY 6 | P=0.114N P=0.229N P=0.232N P=0.246N | |
|LOGISTIC REGRESSION| P=0.114N (e) (e) (e) | |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.5% 2.1% 2.1% 4.4% |2.2% 6.5% 4.3% 0.0% |
|TERMINAL (d) | 3/39 (8%) 1/45 (2%) 0/42 (0%) 2/39 (5%) |0/40 (0%) 2/34 (6%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 647 727 (T) 707 727 (T) |580 659 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329N P=0.150N P=0.168N P=0.343N |P=0.231N P=0.285 P=0.484 P=0.504N |
|POLY 3 | P=0.321N P=0.175N P=0.175N P=0.354N |P=0.239N P=0.303 P=0.504 P=0.499N |
|POLY 1.5 | P=0.318N P=0.177N P=0.177N P=0.348N |P=0.241N P=0.305 P=0.502 P=0.500N |
|POLY 6 | P=0.326N P=0.171N P=0.174N P=0.361N |P=0.236N P=0.296 P=0.505 P=0.497N |
|LOGISTIC REGRESSION| P=0.321N P=0.179N P=0.182N P=0.350N |P=0.243N P=0.283 P=0.481 P=0.457N |
|COCH-ARM / FISHERS | P=0.313N P=0.181N P=0.181N P=0.339N |P=0.242N P=0.309 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 2.1% 2.1% 4.4% |2.2% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/45 (2%) 0/42 (0%) 2/39 (5%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 647 727 (T) 707 727 (T) |580 659 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493N P=0.271N P=0.291N P=0.506N |P=0.304N P=0.753N P=0.754 P=0.504N |
|POLY 3 | P=0.483N P=0.300N P=0.301N P=0.516N |P=0.311N P=0.759 P=0.758N P=0.499N |
|POLY 1.5 | P=0.479N P=0.303N P=0.303N P=0.510N |P=0.312N P=0.760 P=0.759N P=0.500N |
|POLY 6 | P=0.488N P=0.296N P=0.300N P=0.523N |P=0.308N P=0.755 P=0.758N P=0.497N |
|LOGISTIC REGRESSION| P=0.481N P=0.307N P=0.315N P=0.510N |P=0.297N P=0.719 P=0.743 P=0.457N |
|COCH-ARM / FISHERS | P=0.474N P=0.309N P=0.309N P=0.500N |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 2.1% 2.1% 0.0% |0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/45 (2%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 0/41 (0%) |
|FIRST INCIDENCE | 647 727 (T) 707 --- |--- 659 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.159N P=0.469N P=0.486N P=0.247N |P=0.576N P=0.505 P=0.484 (e) |
|POLY 3 | P=0.159N P=0.495N P=0.496N P=0.245N |P=0.590N P=0.501 P=0.504 (e) |
|POLY 1.5 | P=0.157N P=0.498N P=0.497N P=0.242N |P=0.592N P=0.501 P=0.503 (e) |
|POLY 6 | P=0.162N P=0.491N P=0.494N P=0.249N |P=0.586N P=0.498 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.148N P=0.505N P=0.524N P=0.224N |P=0.595N P=0.480 P=0.484 (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |2/40 (5%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.114N P=0.275N P=0.256N P=0.233N |
|POLY 3 | (e) (e) (e) (e) |P=0.113N P=0.238N P=0.232N P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.113N P=0.237N P=0.234N P=0.236N |
|POLY 6 | (e) (e) (e) (e) |P=0.112N P=0.241N P=0.230N P=0.230N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.114N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |0/40 (0%) 0/34 (0%) 0/37 (0%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- 664 --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.692 (e) P=0.509 (e) |P=0.055 (e) (e) P=0.244 |
|POLY 3 | P=0.677 (e) P=0.504 (e) |P=0.046 * (e) (e) P=0.241 |
|POLY 1.5 | P=0.684 (e) P=0.503 (e) |P=0.046 * (e) (e) P=0.239 |
|POLY 6 | P=0.670 (e) P=0.507 (e) |P=0.047 * (e) (e) P=0.244 |
|LOGISTIC REGRESSION| P=0.712 (e) P=0.451 (e) |(e) (e) (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spinal Cord |
| Demyelination |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 11/50 (22%) 14/50 (28%) 20/50 (40%) |37/49 (76%) 39/50 (78%) 35/50 (70%) 39/50 (78%) |
|POLY-3 ADJUSTED (b)| 44.9% 22.8% 28.8% 41.4% |77.7% 81.6% 72.0% 82.3% |
|TERMINAL (d) | 16/39 (41%) 10/45 (22%) 10/42 (24%) 12/39 (31%) |31/40 (78%) 30/34 (88%) 30/37 (81%) 35/41 (85%) |
|FIRST INCIDENCE | 501 601 596 502 |456 651 477 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.009N** P=0.063N P=0.449N |P=0.411N P=0.120 P=0.564 P=0.497 |
|POLY 3 | P=0.459 P=0.017N* P=0.073N P=0.445N |P=0.416 P=0.414 P=0.336N P=0.381 |
|POLY 1.5 | P=0.462 P=0.016N* P=0.073N P=0.438N |P=0.438 P=0.443 P=0.338N P=0.411 |
|POLY 6 | P=0.460 P=0.017N* P=0.074N P=0.444N |P=0.408 P=0.368 P=0.345N P=0.363 |
|LOGISTIC REGRESSION| P=0.539 P=0.018N* P=0.085N P=0.354N |P=0.495 P=0.479 P=0.337N P=0.475 |
|COCH-ARM / FISHERS | P=0.470 P=0.016N* P=0.072N P=0.420N |P=0.492 P=0.478 P=0.349N P=0.478 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |4/49 (8%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 2.1% 0.0% |8.8% 6.6% 8.6% 2.2% |
|TERMINAL (d) | 1/39 (3%) 0/45 (0%) 1/42 (2%) 0/39 (0%) |4/40 (10%) 3/34 (9%) 4/37 (11%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) --- |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412N P=0.471N P=0.745N P=0.500N |P=0.140N P=0.589N P=0.601 P=0.172N |
|POLY 3 | P=0.413N P=0.496N P=0.757N P=0.506N |P=0.148N P=0.496N P=0.626N P=0.171N |
|POLY 1.5 | P=0.410N P=0.498N P=0.758N P=0.504N |P=0.151N P=0.491N P=0.628N P=0.173N |
|POLY 6 | P=0.416N P=0.492N P=0.755N P=0.508N |P=0.142N P=0.508N P=0.624N P=0.168N |
|LOGISTIC REGRESSION| P=0.412N (e) P=0.745N (e) |P=0.140N P=0.589N P=0.601 P=0.172N |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.152N P=0.489N P=0.631N P=0.175N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.3% 0.0% 2.1% 2.2% |2.2% 4.3% 4.2% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 0/39 (0%) |1/40 (3%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 501 --- 667 629 |728 (T) 652 524 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.116N P=0.302N P=0.325N |P=0.282N P=0.487 P=0.497 P=0.495N |
|POLY 3 | P=0.301N P=0.119N P=0.304N P=0.320N |P=0.290N P=0.503 P=0.513 P=0.497N |
|POLY 1.5 | P=0.299N P=0.119N P=0.305N P=0.315N |P=0.294N P=0.503 P=0.508 P=0.499N |
|POLY 6 | P=0.304N P=0.117N P=0.304N P=0.325N |P=0.284N P=0.501 P=0.519 P=0.494N |
|LOGISTIC REGRESSION| P=0.223N P=0.111N P=0.424N P=0.211N |P=0.275N P=0.487 P=0.460 (e) |
|COCH-ARM / FISHERS | P=0.296N P=0.121N P=0.309N P=0.309N |P=0.296N P=0.500 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 12.4% 2.1% 4.2% 6.5% |4.4% 6.5% 6.3% 12.9% |
|TERMINAL (d) | 2/39 (5%) 0/45 (0%) 1/42 (2%) 1/39 (3%) |2/40 (5%) 1/34 (3%) 1/37 (3%) 6/41 (15%) |
|FIRST INCIDENCE | 501 644 667 549 |728 (T) 652 524 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.055N P=0.131N P=0.263N |P=0.104 P=0.460 P=0.483 P=0.141 |
|POLY 3 | P=0.282N P=0.057N P=0.137N P=0.263N |P=0.084 P=0.504 P=0.517 P=0.138 |
|POLY 1.5 | P=0.278N P=0.057N P=0.136N P=0.256N |P=0.082 P=0.504 P=0.510 P=0.136 |
|POLY 6 | P=0.287N P=0.056N P=0.138N P=0.270N |P=0.088 P=0.501 P=0.525 P=0.143 |
|LOGISTIC REGRESSION| P=0.172N P=0.054N P=0.188N P=0.136N |P=0.079 P=0.499 P=0.476 P=0.141 |
|COCH-ARM / FISHERS | P=0.273N P=0.056N P=0.134N P=0.243N |P=0.080 P=0.500 P=0.500 P=0.134 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 4.2% 2.2% |4.3% 6.5% 6.2% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 1/42 (2%) 0/39 (0%) |1/40 (3%) 0/34 (0%) 0/37 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 501 --- 667 629 |565 652 477 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548N P=0.237N P=0.683N P=0.518N |P=0.326N P=0.482 P=0.499 P=0.497N |
|POLY 3 | P=0.542N P=0.237N P=0.692N P=0.514N |P=0.340N P=0.501 P=0.519 P=0.498N |
|POLY 1.5 | P=0.537N P=0.237N P=0.693N P=0.509N |P=0.343N P=0.502 P=0.512 P=0.500N |
|POLY 6 | P=0.548N P=0.235N P=0.691N P=0.518N |P=0.334N P=0.496 P=0.526 P=0.495N |
|LOGISTIC REGRESSION| P=0.440N P=0.207N P=0.583 P=0.373N |P=0.296N P=0.454 P=0.398 P=0.499N |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.343N P=0.500 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 22.0% |0.0% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 2/42 (5%) 10/39 (26%) |0/40 (0%) 0/34 (0%) 1/37 (3%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- 727 (T) 727 (T) |--- --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.255 P<0.001 ** |P=0.254 (e) P=0.484 P=0.505 |
|POLY 3 | P<0.001 ** (e) P=0.241 P<0.001 ** |P=0.241 (e) P=0.504 P=0.503 |
|POLY 1.5 | P<0.001 ** (e) P=0.240 P<0.001 ** |P=0.238 (e) P=0.503 P=0.501 |
|POLY 6 | P<0.001 ** (e) P=0.242 P<0.001 ** |P=0.247 (e) P=0.506 P=0.506 |
|LOGISTIC REGRESSION| (e) (e) P=0.255 P<0.001 ** |(e) (e) P=0.484 P=0.505 |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.247 P<0.001 ** |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 48
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 18/50 (36%) 16/50 (32%) 14/50 (28%) |19/50 (38%) 16/50 (32%) 10/50 (20%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 25.4% 37.1% 33.6% 30.8% |41.5% 34.9% 21.4% 44.9% |
|TERMINAL (d) | 10/39 (26%) 17/45 (38%) 16/42 (38%) 14/39 (36%) |18/40 (45%) 15/34 (44%) 10/37 (27%) 20/41 (49%) |
|FIRST INCIDENCE | 617 444 727 (T) 727 (T) |716 673 728 (T) 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440 P=0.255 P=0.325 P=0.402 |P=0.464 P=0.570N P=0.057N P=0.459 |
|POLY 3 | P=0.429 P=0.154 P=0.256 P=0.362 |P=0.384 P=0.330N P=0.029N* P=0.451 |
|POLY 1.5 | P=0.458 P=0.147 P=0.256 P=0.382 |P=0.369 P=0.330N P=0.032N* P=0.433 |
|POLY 6 | P=0.396 P=0.164 P=0.253 P=0.341 |P=0.415 P=0.347N P=0.026N* P=0.481 |
|LOGISTIC REGRESSION| P=0.432 P=0.141 P=0.276 P=0.358 |P=0.477 P=0.493N P=0.035N* P=0.495 |
|COCH-ARM / FISHERS | P=0.500 P=0.138 P=0.252 P=0.410 |P=0.361 P=0.338N P=0.038N* P=0.419 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.4% | |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 0/42 (0%) 2/39 (5%) | |
|FIRST INCIDENCE | --- --- --- 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041 * (e) (e) P=0.238 | |
|POLY 3 | P=0.044 * (e) (e) P=0.231 | |
|POLY 1.5 | P=0.044 * (e) (e) P=0.233 | |
|POLY 6 | P=0.043 * (e) (e) P=0.228 | |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.238 | |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 49
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 0.0% | |
|TERMINAL (d) | 0/39 (0%) 0/45 (0%) 2/42 (5%) 0/39 (0%) | |
|FIRST INCIDENCE | --- --- 727 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588 (e) P=0.255 (e) | |
|POLY 3 | P=0.574 (e) P=0.241 (e) | |
|POLY 1.5 | P=0.582 (e) P=0.240 (e) | |
|POLY 6 | P=0.564 (e) P=0.242 (e) | |
|LOGISTIC REGRESSION| (e) (e) P=0.255 (e) | |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/37 (24%) 14/39 (36%) 16/38 (42%) 9/42 (21%) |10/46 (22%) 12/47 (26%) 17/44 (39%) 16/46 (35%) |
|POLY-3 ADJUSTED (b)| 25.8% 36.7% 43.6% 24.0% |23.2% 27.7% 40.4% 36.2% |
|TERMINAL (d) | 8/30 (27%) 13/36 (36%) 15/33 (46%) 9/32 (28%) |8/37 (22%) 10/33 (30%) 14/32 (44%) 14/38 (37%) |
|FIRST INCIDENCE | 652 444 667 727 (T) |580 667 617 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.303 P=0.116 P=0.551N |P=0.121 P=0.312 P=0.047 * P=0.145 |
|POLY 3 | P=0.404N P=0.228 P=0.089 P=0.537N |P=0.091 P=0.409 P=0.067 P=0.136 |
|POLY 1.5 | P=0.367N P=0.216 P=0.087 P=0.515N |P=0.085 P=0.420 P=0.066 P=0.131 |
|POLY 6 | P=0.453N P=0.243 P=0.091 P=0.565N |P=0.102 P=0.385 P=0.068 P=0.143 |
|LOGISTIC REGRESSION| P=0.389N P=0.200 P=0.096 P=0.565N |P=0.078 P=0.424 P=0.070 P=0.122 |
|COCH-ARM / FISHERS | P=0.318N P=0.198 P=0.082 P=0.484N |P=0.077 P=0.426 P=0.064 P=0.123 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 50
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/37 (0%) 0/39 (0%) 0/38 (0%) 0/42 (0%) |1/46 (2%) 5/47 (11%) 3/44 (7%) 2/46 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.4% 11.5% 7.2% 4.7% |
|TERMINAL (d) | 0/30 (0%) 0/36 (0%) 0/33 (0%) 0/32 (0%) |1/37 (3%) 4/33 (12%) 3/32 (9%) 2/38 (5%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 659 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.535N P=0.085 P=0.254 P=0.509 |
|POLY 3 | (e) (e) (e) (e) |P=0.560N P=0.107 P=0.299 P=0.504 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.565N P=0.107 P=0.295 P=0.502 |
|POLY 6 | (e) (e) (e) (e) |P=0.550N P=0.103 P=0.301 P=0.509 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.544N P=0.104 P=0.254 P=0.509 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.569N P=0.107 P=0.292 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 1/49 (2%) 0/48 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |4.4% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 1/45 (2%) 0/42 (0%) 0/39 (0%) |2/40 (5%) 1/33 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 727 (T) --- --- |728 (T) 728 (T) --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.529 (e) (e) |P=0.359N P=0.567N P=0.256N P=0.500N |
|POLY 3 | P=0.565N P=0.504 (e) (e) |P=0.364N P=0.503N P=0.238N P=0.492N |
|POLY 1.5 | P=0.566N P=0.502 (e) (e) |P=0.366N P=0.500N P=0.239N P=0.496N |
|POLY 6 | P=0.563N P=0.508 (e) (e) |P=0.360N P=0.510N P=0.236N P=0.486N |
|LOGISTIC REGRESSION| (e) P=0.529 (e) (e) |P=0.366N P=0.567N (e) P=0.497N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.367N P=0.500N P=0.253N P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 51
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 2/49 (4%) 0/48 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 8.6% 2.1% 2.1% 4.4% |0.0% 4.5% 0.0% 2.2% |
|TERMINAL (d) | 4/39 (10%) 0/45 (0%) 1/42 (2%) 2/39 (5%) |0/40 (0%) 1/33 (3%) 0/37 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 727 (T) 644 727 (T) 727 (T) |--- 706 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.149N P=0.158N P=0.336N |P=0.553 P=0.205 (e) P=0.500 |
|POLY 3 | P=0.322N P=0.171N P=0.174N P=0.351N |P=0.543 P=0.236 (e) P=0.502 |
|POLY 1.5 | P=0.318N P=0.175N P=0.176N P=0.346N |P=0.540 P=0.237 (e) P=0.501 |
|POLY 6 | P=0.328N P=0.164N P=0.171N P=0.356N |P=0.545 P=0.231 (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.324N P=0.179N P=0.158N P=0.336N |P=0.548 P=0.230 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.313N P=0.181N P=0.181N P=0.339N |P=0.538 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/5 (100%) 4/5 (80%) 3/4 (75%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 80.0% 75.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/3 (100%) 4/5 (80%) 3/4 (75%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 652 727 (T) 727 (T) 556 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360N P=0.142N P=0.138N (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.567N P=0.500N P=0.455N (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.567N P=0.500N P=0.455N (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.567N P=0.500N P=0.455N (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.142N P=0.138N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.574N P=0.500N P=0.444N (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 52
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 16/50 (32%) 10/49 (20%) |25/50 (50%) 29/50 (58%) 24/50 (48%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 12.7% 14.7% 33.2% 22.3% |53.5% 60.4% 51.1% 52.5% |
|TERMINAL (d) | 4/39 (10%) 7/45 (16%) 14/42 (33%) 9/38 (24%) |23/40 (58%) 21/34 (62%) 22/37 (60%) 23/41 (56%) |
|FIRST INCIDENCE | 652 727 (T) 596 629 |547 484 677 520 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 P=0.595 P=0.026 * P=0.191 |P=0.285N P=0.106 P=0.525 P=0.537N |
|POLY 3 | P=0.084 P=0.510 P=0.015 * P=0.173 |P=0.385N P=0.318 P=0.488N P=0.542N |
|POLY 1.5 | P=0.092 P=0.505 P=0.014 * P=0.181 |P=0.403N P=0.303 P=0.493N P=0.561N |
|POLY 6 | P=0.075 P=0.518 P=0.015 * P=0.165 |P=0.354N P=0.324 P=0.484N P=0.512N |
|LOGISTIC REGRESSION| P=0.088 P=0.521 P=0.016 * P=0.173 |P=0.381N P=0.277 P=0.432N P=0.555N |
|COCH-ARM / FISHERS | P=0.108 P=0.500 P=0.014 * P=0.194 |P=0.415N P=0.274 P=0.500N P=0.579N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |32/50 (64%) 31/50 (62%) 33/50 (66%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| |67.2% 64.6% 68.7% 79.0% |
|TERMINAL (d) | |28/40 (70%) 24/34 (71%) 24/37 (65%) 35/41 (85%) |
|FIRST INCIDENCE | |456 484 617 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.286 P=0.344 P=0.366 P=0.244 |
|POLY 3 | |P=0.084 P=0.475N P=0.527 P=0.137 |
|POLY 1.5 | |P=0.096 P=0.481N P=0.512 P=0.153 |
|POLY 6 | |P=0.081 P=0.487N P=0.555 P=0.129 |
|LOGISTIC REGRESSION| |P=0.142 P=0.491N P=0.551 P=0.220 |
|COCH-ARM / FISHERS | |P=0.127 P=0.500N P=0.500 P=0.194 |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 53
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |2/40 (5%) 0/34 (0%) 0/37 (0%) 0/41 (0%) |
|FIRST INCIDENCE | |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.114N P=0.275N P=0.256N P=0.233N |
|POLY 3 | |P=0.113N P=0.238N P=0.232N P=0.234N |
|POLY 1.5 | |P=0.113N P=0.237N P=0.234N P=0.236N |
|POLY 6 | |P=0.112N P=0.241N P=0.230N P=0.230N |
|LOGISTIC REGRESSION| |P=0.114N (e) (e) (e) |
|COCH-ARM / FISHERS | |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |2.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |1/40 (3%) 0/34 (0%) 2/37 (5%) 0/41 (0%) |
|FIRST INCIDENCE | |728 (T) --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.444N P=0.532N P=0.473 P=0.495N |
|POLY 3 | |P=0.455N P=0.500N P=0.508 P=0.497N |
|POLY 1.5 | |P=0.459N P=0.500N P=0.505 P=0.499N |
|POLY 6 | |P=0.447N P=0.504N P=0.511 P=0.494N |
|LOGISTIC REGRESSION| |P=0.444N (e) P=0.473 (e) |
|COCH-ARM / FISHERS | |P=0.461N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 05/13/99 EXPERIMENT: 88007 TEST: 06 Page 54
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - SODIUM NITRITE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |13/50 (26%) 10/50 (20%) 16/50 (32%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| |27.9% 21.6% 34.1% 38.0% |
|TERMINAL (d) | |10/40 (25%) 7/34 (21%) 15/37 (41%) 16/41 (39%) |
|FIRST INCIDENCE | |586 652 677 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.130 P=0.450N P=0.264 P=0.225 |
|POLY 3 | |P=0.087 P=0.324N P=0.335 P=0.205 |
|POLY 1.5 | |P=0.083 P=0.318N P=0.334 P=0.199 |
|POLY 6 | |P=0.096 P=0.341N P=0.333 P=0.214 |
|LOGISTIC REGRESSION| |P=0.088 P=0.317N P=0.358 P=0.199 |
|COCH-ARM / FISHERS | |P=0.080 P=0.318N P=0.330 P=0.194 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).