TDMS Study 88007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99
EXPERIMENT: 88007 TEST: 05 TIME: 14:01:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: YARRINGTON, JOHN CAS: 7632-00-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 CORE STUDY RATS
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: 10/18/99
EXPERIMENT: 88007 TEST: 05 TIME: 14:01:03
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55384 ROUTE: DOSED WATER NTP C#: C88007
PATHOLOGIST: YARRINGTON, JOHN CAS: 7632-00-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF SODIUM NITRITE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Heart Inflammation Chronic
Kidney Cyst
Liver Basophilic Focus
Degeneration Cystic
Eosinophilic Focus
Hepatodiaphragmatic Nodule
Inflammation Chronic
Mixed Cell Focus
Vacuolization Cytoplasmic
Liver: Bile Duct Hyperplasia
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Pancreas: Acinus Atrophy
Pituitary Gland: Pars Distalis Hyperplasia
Preputial Gland Inflammation Chronic
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Hyperkeratosis
Stomach, Forestomach: Epithelium Hyperplasia
Testes Mineralization
Urinary Bladder Inflammation Chronic
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Angiectasis
Clitoral Gland Cyst
Kidney Cyst
Nephropathy
Liver Angiectasis
Hepatodiaphragmatic Nodule
Mixed Cell Focus
Necrosis
Lung: Alveolar Epithelium Hyperplasia
Mammary Gland Hyperplasia
Nose Inflammation Chronic
Pituitary Gland Hemorrhage
Pituitary Gland: Pars Distalis Hyperplasia
Skin Ulcer
Stomach, Forestomach: Epithelium Hyperplasia
Thyroid Gland Ultimobranchial Cyst
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 21/50 (42%) 15/50 (30%) 22/50 (44%) |40/50 (80%) 39/50 (78%) 45/50 (90%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 38.7% 45.7% 32.1% 48.4% |82.7% 83.5% 91.8% 91.6% |
|TERMINAL (d) | 15/29 (52%) 18/38 (47%) 13/36 (36%) 22/36 (61%) |28/33 (85%) 29/31 (94%) 35/36 (97%) 30/33 (91%) |
|FIRST INCIDENCE | 252 480 400 729 (T) |511 536 337 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378 P=0.561 P=0.234N P=0.403 |P=0.198 P=0.523 P=0.428 P=0.266 |
|POLY 3 | P=0.284 P=0.329 P=0.333N P=0.241 |P=0.069 P=0.573 P=0.133 P=0.146 |
|POLY 1.5 | P=0.249 P=0.267 P=0.403N P=0.199 |P=0.059 P=0.597N P=0.134 P=0.134 |
|POLY 6 | P=0.323 P=0.427 P=0.250N P=0.303 |P=0.091 P=0.515 P=0.125 P=0.174 |
|LOGISTIC REGRESSION| P=0.343 P=0.340 P=0.367N P=0.361 |P=0.045 * P=0.513N P=0.131 P=0.125 |
|COCH-ARM / FISHERS | P=0.200 P=0.204 P=0.500N P=0.151 |P=0.053 P=0.500N P=0.131 P=0.131 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 15/50 (30%) 15/50 (30%) 10/50 (20%) |15/50 (30%) 11/50 (22%) 11/50 (22%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 29.2% 33.1% 32.3% 21.7% |33.7% 24.3% 24.2% 22.4% |
|TERMINAL (d) | 10/29 (35%) 13/38 (34%) 13/36 (36%) 8/36 (22%) |13/33 (39%) 7/31 (23%) 10/36 (28%) 9/33 (27%) |
|FIRST INCIDENCE | 589 680 593 636 |662 541 596 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.154N P=0.547N P=0.580 P=0.210N |P=0.150N P=0.292N P=0.173N P=0.166N |
|POLY 3 | P=0.185N P=0.435 P=0.467 P=0.289N |P=0.173N P=0.225N P=0.223N P=0.169N |
|POLY 1.5 | P=0.221N P=0.390 P=0.409 P=0.331N |P=0.177N P=0.237N P=0.236N P=0.176N |
|POLY 6 | P=0.151N P=0.496 P=0.541 P=0.243N |P=0.165N P=0.208N P=0.205N P=0.157N |
|LOGISTIC REGRESSION| P=0.165N P=0.534 P=0.537 P=0.255N |P=0.157N P=0.239N P=0.202N P=0.143N |
|COCH-ARM / FISHERS | P=0.293N P=0.326 P=0.326 P=0.405N |P=0.176N P=0.247N P=0.247N P=0.178N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 7/50 (14%) 2/50 (4%) 9/50 (18%) |8/50 (16%) 7/50 (14%) 7/50 (14%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 17.2% 15.6% 4.4% 19.5% |18.1% 15.8% 15.4% 8.9% |
|TERMINAL (d) | 6/29 (21%) 7/38 (18%) 2/36 (6%) 8/36 (22%) |7/33 (21%) 7/31 (23%) 6/36 (17%) 3/33 (9%) |
|FIRST INCIDENCE | 636 729 (T) 729 (T) 523 |714 730 (T) 624 658 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480 P=0.400N P=0.040N* P=0.572 |P=0.125N P=0.552N P=0.430N P=0.175N |
|POLY 3 | P=0.433 P=0.535N P=0.053N P=0.500 |P=0.135N P=0.500N P=0.479N P=0.170N |
|POLY 1.5 | P=0.411 P=0.566N P=0.062N P=0.459 |P=0.140N P=0.502N P=0.491N P=0.175N |
|POLY 6 | P=0.454 P=0.495N P=0.043N* P=0.546 |P=0.124N P=0.496N P=0.459N P=0.160N |
|LOGISTIC REGRESSION| P=0.473 P=0.446N P=0.039N* P=0.517 |P=0.123N P=0.520N P=0.460N P=0.159N |
|COCH-ARM / FISHERS | P=0.372 P=0.613N P=0.080N P=0.393 |P=0.143N P=0.500N P=0.500N P=0.178N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% 0.0% |4.4% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |513 665 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547N P=0.554 (e) (e) |P=0.100N P=0.494N P=0.237N P=0.239N |
|POLY 3 | P=0.544N P=0.521 (e) (e) |P=0.100N P=0.504N P=0.237N P=0.240N |
|POLY 1.5 | P=0.553N P=0.513 (e) (e) |P=0.101N P=0.504N P=0.238N P=0.240N |
|POLY 6 | P=0.532N P=0.533 (e) (e) |P=0.100N P=0.505N P=0.236N P=0.239N |
|LOGISTIC REGRESSION| (e) P=0.554 (e) (e) |P=0.086N P=0.445N P=0.183N P=0.167N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.101N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 8/50 (16%) 3/50 (6%) |4/50 (8%) 5/50 (10%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 6.6% 17.1% 6.6% |8.7% 11.1% 2.2% 6.7% |
|TERMINAL (d) | 1/29 (3%) 1/38 (3%) 4/36 (11%) 2/36 (6%) |1/33 (3%) 2/31 (7%) 1/36 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 589 480 582 710 |511 616 730 (T) 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.555N P=0.581N P=0.193 P=0.571N |P=0.287N P=0.492 P=0.176N P=0.501N |
|POLY 3 | P=0.543 P=0.613N P=0.142 P=0.616N |P=0.308N P=0.486 P=0.186N P=0.518N |
|POLY 1.5 | P=0.523 P=0.632N P=0.124 P=0.633N |P=0.305N P=0.489 P=0.184N P=0.513N |
|POLY 6 | P=0.562 P=0.589N P=0.168 P=0.597N |P=0.309N P=0.487 P=0.185N P=0.519N |
|LOGISTIC REGRESSION| P=0.448 P=0.589 P=0.094 P=0.663 |P=0.287N P=0.540 P=0.141N P=0.459N |
|COCH-ARM / FISHERS | P=0.483 P=0.661N P=0.100 P=0.661N |P=0.297N P=0.500 P=0.181N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 18/50 (36%) 16/50 (32%) 13/50 (26%) |6/50 (12%) 7/50 (14%) 5/45 (11%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 26.5% 39.8% 34.4% 28.3% |13.6% 15.7% 12.5% 11.4% |
|TERMINAL (d) | 7/29 (24%) 16/38 (42%) 12/36 (33%) 11/36 (31%) |5/33 (15%) 6/31 (19%) 5/31 (16%) 2/32 (6%) |
|FIRST INCIDENCE | 605 680 620 636 |714 665 730 (T) 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368N P=0.310 P=0.415 P=0.540N |P=0.368N P=0.460 P=0.535N P=0.495N |
|POLY 3 | P=0.432N P=0.136 P=0.281 P=0.517 |P=0.384N P=0.504 P=0.571N P=0.506N |
|POLY 1.5 | P=0.477N P=0.117 P=0.240 P=0.478 |P=0.391N P=0.500 P=0.574N P=0.513N |
|POLY 6 | P=0.391N P=0.163 P=0.336 P=0.557 |P=0.369N P=0.511 P=0.564N P=0.491N |
|LOGISTIC REGRESSION| P=0.388N P=0.192 P=0.317 P=0.570 |P=0.370N P=0.504 P=0.543N P=0.499N |
|COCH-ARM / FISHERS | P=0.521 P=0.093 P=0.184 P=0.408 |P=0.392N P=0.500 P=0.575N P=0.514N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 609 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.392N P=0.256 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.400N P=0.241 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.403N P=0.238 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.394N P=0.244 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.394N P=0.253 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 6.5% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 489 --- 620 --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.461N P=0.500N P=0.373 P=0.488N |P=0.699 (e) P=0.517 (e) |
|POLY 3 | P=0.474N P=0.482N P=0.350 P=0.480N |P=0.696 (e) P=0.504 (e) |
|POLY 1.5 | P=0.483N P=0.489N P=0.332 P=0.487N |P=0.694 (e) P=0.501 (e) |
|POLY 6 | P=0.466N P=0.472N P=0.375 P=0.471N |P=0.701 (e) P=0.507 (e) |
|LOGISTIC REGRESSION| P=0.596N P=0.659N P=0.223 P=0.744N |(e) (e) P=0.517 (e) |
|COCH-ARM / FISHERS | P=0.500N P=0.500N P=0.309 P=0.500N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |9/46 (20%) 1/48 (2%) 12/49 (24%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| |21.6% 2.4% 26.9% 6.6% |
|TERMINAL (d) | |9/32 (28%) 1/30 (3%) 11/35 (31%) 1/33 (3%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 554 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.169N P=0.011N* P=0.390 P=0.056N |
|POLY 3 | |P=0.143N P=0.007N** P=0.373 P=0.042N* |
|POLY 1.5 | |P=0.151N P=0.007N** P=0.369 P=0.044N* |
|POLY 6 | |P=0.132N P=0.007N** P=0.384 P=0.038N* |
|LOGISTIC REGRESSION| |P=0.167N P=0.011N* P=0.368 P=0.048N* |
|COCH-ARM / FISHERS | |P=0.171N P=0.006N** P=0.371 P=0.047N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |8/46 (17%) 4/48 (8%) 7/49 (14%) 7/49 (14%) |
|POLY-3 ADJUSTED (b)| |19.2% 9.4% 15.9% 15.6% |
|TERMINAL (d) | |8/32 (25%) 4/30 (13%) 6/35 (17%) 4/33 (12%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 727 658 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.536N P=0.202N P=0.424N P=0.469N |
|POLY 3 | |P=0.522N P=0.165N P=0.453N P=0.437N |
|POLY 1.5 | |P=0.530N P=0.163N P=0.454N P=0.444N |
|POLY 6 | |P=0.507N P=0.166N P=0.448N P=0.423N |
|LOGISTIC REGRESSION| |P=0.517N P=0.202N P=0.421N P=0.439N |
|COCH-ARM / FISHERS | |P=0.539N P=0.157N P=0.446N P=0.446N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/46 (0%) 1/48 (2%) 2/49 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 2.4% 4.5% 2.3% |
|TERMINAL (d) | |0/32 (0%) 1/30 (3%) 2/35 (6%) 1/33 (3%) |
|FIRST INCIDENCE | |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.384 P=0.487 P=0.258 P=0.506 |
|POLY 3 | |P=0.385 P=0.504 P=0.249 P=0.513 |
|POLY 1.5 | |P=0.384 P=0.505 P=0.249 P=0.512 |
|POLY 6 | |P=0.388 P=0.503 P=0.250 P=0.514 |
|LOGISTIC REGRESSION| |(e) P=0.487 P=0.258 P=0.506 |
|COCH-ARM / FISHERS | |P=0.382 P=0.511 P=0.263 P=0.516 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/1 (0%) 0/1 (0%) 2/2 (100%) |0/0 (0%) 0/1 (0%) 1/1 (100%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 100.0% |0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- 730 (T) 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N (e) (e) (e) |P=0.051 (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.124 (e) (e) (e) |P=0.188 (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 15/50 (30%) 16/50 (32%) 12/50 (24%) |3/50 (6%) 4/49 (8%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 18.6% 32.6% 34.5% 25.7% |6.7% 9.2% 6.7% 6.7% |
|TERMINAL (d) | 4/29 (14%) 13/38 (34%) 13/36 (36%) 9/36 (25%) |2/33 (6%) 3/31 (10%) 2/36 (6%) 3/33 (9%) |
|FIRST INCIDENCE | 252 481 593 589 |567 685 727 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.208 P=0.143 P=0.388 |P=0.504N P=0.478 P=0.627N P=0.662 |
|POLY 3 | P=0.398 P=0.100 P=0.070 P=0.291 |P=0.517N P=0.485 P=0.660N P=0.660 |
|POLY 1.5 | P=0.357 P=0.088 P=0.060 P=0.263 |P=0.518N P=0.485 P=0.662N P=0.659 |
|POLY 6 | P=0.451 P=0.120 P=0.088 P=0.329 |P=0.511N P=0.486 P=0.654N P=0.661N |
|LOGISTIC REGRESSION| P=0.310 P=0.060 P=0.043 * P=0.141 |P=0.507N P=0.488 P=0.661N P=0.663N |
|COCH-ARM / FISHERS | P=0.301 P=0.077 P=0.050 P=0.227 |P=0.516N P=0.489 P=0.661N P=0.661N |
|=================================================================================================================================|
| | | |
| | 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) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 609 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.392N P=0.256 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.399N P=0.236 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.402N P=0.234 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.393N P=0.239 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.393N P=0.249 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.404N P=0.242 (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 12.1% 8.9% 6.5% 4.4% |9.1% 2.3% 4.4% 15.4% |
|TERMINAL (d) | 4/29 (14%) 4/38 (11%) 3/36 (8%) 2/36 (6%) |4/33 (12%) 1/31 (3%) 1/36 (3%) 5/33 (15%) |
|FIRST INCIDENCE | 400 729 (T) 729 (T) 729 (T) |730 (T) 730 (T) 541 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106N P=0.351N P=0.256N P=0.148N |P=0.085 P=0.197N P=0.303N P=0.262 |
|POLY 3 | P=0.129N P=0.445N P=0.299N P=0.177N |P=0.082 P=0.178N P=0.323N P=0.276 |
|POLY 1.5 | P=0.137N P=0.468N P=0.322N P=0.192N |P=0.080 P=0.179N P=0.330N P=0.268 |
|POLY 6 | P=0.120N P=0.414N P=0.269N P=0.160N |P=0.086 P=0.175N P=0.311N P=0.291 |
|LOGISTIC REGRESSION| P=0.126N P=0.470N P=0.342N P=0.214N |P=0.080 P=0.197N P=0.336N P=0.262 |
|COCH-ARM / FISHERS | P=0.151N P=0.500N P=0.357N P=0.218N |P=0.080 P=0.181N P=0.339N P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 8.8% |0.0% 0.0% 4.4% 9.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 4/36 (11%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 3/33 (9%) |
|FIRST INCIDENCE | --- --- 680 729 (T) |--- --- 626 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * (e) P=0.300 P=0.093 |P=0.010 * (e) P=0.252 P=0.067 |
|POLY 3 | P=0.010 * (e) P=0.268 P=0.077 |P=0.008 ** (e) P=0.243 P=0.061 |
|POLY 1.5 | P=0.009 ** (e) P=0.255 P=0.070 |P=0.008 ** (e) P=0.240 P=0.060 |
|POLY 6 | P=0.011 * (e) P=0.285 P=0.085 |P=0.009 ** (e) P=0.248 P=0.063 |
|LOGISTIC REGRESSION| P=0.011 * (e) P=0.259 P=0.093 |P=0.009 ** (e) P=0.238 P=0.066 |
|COCH-ARM / FISHERS | P=0.009 ** (e) P=0.247 P=0.059 |P=0.009 ** (e) P=0.247 P=0.059 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 5/50 (10%) 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 11.3% 8.8% 11.2% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 4/31 (13%) 2/36 (6%) 5/33 (15%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 680 658 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.161 P=0.094 P=0.208 P=0.101 |
|POLY 3 | (e) (e) (e) (e) |P=0.150 P=0.102 P=0.186 P=0.102 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.148 P=0.101 P=0.182 P=0.101 |
|POLY 6 | (e) (e) (e) (e) |P=0.156 P=0.104 P=0.193 P=0.105 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.158 P=0.103 P=0.186 P=0.101 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.148 P=0.102 P=0.181 P=0.102 |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 2.1% 0.0% |2.2% 2.2% 4.4% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 489 --- 400 --- |513 609 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.397N P=0.500N P=0.753N P=0.488N |P=0.360N P=0.755N P=0.523 P=0.508N |
|POLY 3 | P=0.401N P=0.482N P=0.731N P=0.480N |P=0.369N P=0.760 P=0.501 P=0.502N |
|POLY 1.5 | P=0.402N P=0.489N P=0.743N P=0.487N |P=0.370N P=0.759 P=0.500 P=0.502N |
|POLY 6 | P=0.402N P=0.472N P=0.716N P=0.471N |P=0.366N P=0.760N P=0.506 P=0.500N |
|LOGISTIC REGRESSION| P=0.706 P=0.659N P=0.530 P=0.744N |P=0.351N P=0.695N P=0.510 P=0.337N |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.366N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 42/50 (84%) 45/50 (90%) 47/50 (94%) 47/50 (94%) |14/50 (28%) 16/50 (32%) 20/50 (40%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 92.6% 94.6% 95.3% 95.4% |31.4% 34.5% 43.4% 50.8% |
|TERMINAL (d) | 29/29 (100%) 38/38 (100%) 36/36 (100%) 36/36 (100%)|12/33 (36%) 11/31 (36%) 17/36 (47%) 19/33 (58%) |
|FIRST INCIDENCE | 252 480 400 520 |648 480 596 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.069N P=0.256N P=0.267N |P=0.037 * P=0.363 P=0.218 P=0.050 |
|POLY 3 | P=0.350 P=0.508 P=0.433 P=0.430 |P=0.024 * P=0.465 P=0.163 P=0.045 * |
|POLY 1.5 | P=0.179 P=0.378 P=0.235 P=0.233 |P=0.024 * P=0.440 P=0.152 P=0.044 * |
|POLY 6 | P=0.623N P=0.763 P=0.775 P=0.773 |P=0.026 * P=0.497 P=0.185 P=0.050 |
|LOGISTIC REGRESSION| P=0.270 P=0.617 P=0.304 P=0.390 |P=0.028 * P=0.412 P=0.167 P=0.053 |
|COCH-ARM / FISHERS | P=0.066 P=0.277 P=0.100 P=0.100 |P=0.028 * P=0.414 P=0.146 P=0.048 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.2% 0.0% 0.0% |4.5% 6.7% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 2/31 (7%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 666 641 --- --- |714 616 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207N P=0.704N P=0.443N P=0.457N |P=0.098N P=0.485 P=0.470N P=0.234N |
|POLY 3 | P=0.229N P=0.736N P=0.476N P=0.477N |P=0.102N P=0.504 P=0.494N P=0.236N |
|POLY 1.5 | P=0.231N P=0.746N P=0.485N P=0.486N |P=0.104N P=0.501 P=0.498N P=0.237N |
|POLY 6 | P=0.227N P=0.723N P=0.464N P=0.468N |P=0.099N P=0.509 P=0.488N P=0.233N |
|LOGISTIC REGRESSION| P=0.265N P=0.744 P=0.517N P=0.519N |P=0.102N P=0.500 P=0.480N P=0.230N |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.104N P=0.500 P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 6.5% 2.2% |0.0% 2.3% 6.6% 11.2% |
|TERMINAL (d) | 0/29 (0%) 2/38 (5%) 3/36 (8%) 1/36 (3%) |0/33 (0%) 1/31 (3%) 2/36 (6%) 4/33 (12%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |--- 730 (T) 596 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496 P=0.299 P=0.161 P=0.543 |P=0.010 * P=0.488 P=0.135 P=0.036 * |
|POLY 3 | P=0.512 P=0.262 P=0.143 P=0.524 |P=0.009 ** P=0.500 P=0.124 P=0.031 * |
|POLY 1.5 | P=0.487 P=0.252 P=0.133 P=0.515 |P=0.009 ** P=0.500 P=0.121 P=0.031 * |
|POLY 6 | P=0.540 P=0.275 P=0.157 P=0.534 |P=0.009 ** P=0.501 P=0.128 P=0.033 * |
|LOGISTIC REGRESSION| (e) P=0.299 P=0.161 P=0.543 |P=0.009 ** P=0.488 P=0.120 P=0.035 * |
|COCH-ARM / FISHERS | P=0.444 P=0.247 P=0.121 P=0.500 |P=0.009 ** P=0.500 P=0.121 P=0.028 * |
|=================================================================================================================================|
| | | |
| | 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) | 31/50 (62%) 34/50 (68%) 37/50 (74%) 42/50 (84%) |45/50 (90%) 42/50 (84%) 48/50 (96%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 74.6% 72.4% 78.3% 87.1% |93.2% 87.6% 96.6% 92.5% |
|TERMINAL (d) | 27/29 (93%) 30/38 (79%) 33/36 (92%) 35/36 (97%) |33/33 (100%) 31/31 (100%) 36/36 (100%) 32/33 (97%) |
|FIRST INCIDENCE | 523 415 505 520 |511 332 337 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073 P=0.146N P=0.477N P=0.263 |P=0.532 P=0.502N P=0.555N P=0.554N |
|POLY 3 | P=0.037 * P=0.502N P=0.432 P=0.079 |P=0.450 P=0.248N P=0.369 P=0.608N |
|POLY 1.5 | P=0.019 * P=0.545 P=0.282 P=0.035 * |P=0.405 P=0.255N P=0.292 P=0.624N |
|POLY 6 | P=0.079 P=0.305N P=0.575N P=0.213 |P=0.558 P=0.266N P=0.508 P=0.567N |
|LOGISTIC REGRESSION| P=0.043 * P=0.454N P=0.554N P=0.108 |P=0.351 P=0.294N P=0.199 P=0.589 |
|COCH-ARM / FISHERS | P=0.007 ** P=0.338 P=0.142 P=0.012 * |P=0.375 P=0.277N P=0.218 P=0.630N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 19/50 (38%) 25/50 (50%) 26/50 (52%) 23/50 (46%) |9/50 (18%) 6/50 (12%) 8/50 (16%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 47.1% 55.6% 56.7% 50.6% |20.4% 13.6% 17.6% 15.7% |
|TERMINAL (d) | 19/29 (66%) 25/38 (66%) 26/36 (72%) 23/36 (64%) |9/33 (27%) 6/31 (19%) 7/36 (19%) 7/33 (21%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 730 (T) 626 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503N P=0.593 P=0.378 P=0.549N |P=0.390N P=0.327N P=0.424N P=0.388N |
|POLY 3 | P=0.508 P=0.278 P=0.243 P=0.457 |P=0.412N P=0.284N P=0.476N P=0.386N |
|POLY 1.5 | P=0.430 P=0.221 P=0.180 P=0.380 |P=0.419N P=0.288N P=0.489N P=0.392N |
|POLY 6 | P=0.496N P=0.372 P=0.349 P=0.556 |P=0.398N P=0.278N P=0.453N P=0.371N |
|LOGISTIC REGRESSION| P=0.503N P=0.593 P=0.378 P=0.549N |P=0.375N P=0.327N P=0.450N P=0.388N |
|COCH-ARM / FISHERS | P=0.307 P=0.157 P=0.114 P=0.272 |P=0.420N P=0.288N P=0.500N P=0.393N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 15/50 (30%) 12/50 (24%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.2% 33.1% 26.1% 8.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/29 (10%) 14/38 (37%) 11/36 (31%) 4/36 (11%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 558 641 716 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105N P=0.052 P=0.133 P=0.374N |(e) (e) (e) (e) |
|POLY 3 | P=0.109N P=0.018 * P=0.084 P=0.436N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.134N P=0.014 * P=0.070 P=0.459N |(e) (e) (e) (e) |
|POLY 6 | P=0.087N P=0.023 * P=0.103 P=0.411N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.102N P=0.027 * P=0.112 P=0.427N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.192N P=0.011 * P=0.054 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 4/50 (8%) 10/50 (20%) 11/50 (22%) 6/50 (12%) |9/50 (18%) 10/50 (20%) 8/50 (16%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 9.9% 22.2% 23.7% 13.2% |20.4% 22.5% 17.8% 22.1% |
|TERMINAL (d) | 4/29 (14%) 9/38 (24%) 10/36 (28%) 5/36 (14%) |9/33 (27%) 9/31 (29%) 8/36 (22%) 8/33 (24%) |
|FIRST INCIDENCE | 729 (T) 680 551 705 |730 (T) 662 730 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.518N P=0.177 P=0.100 P=0.513 |P=0.519 P=0.443 P=0.419N P=0.505 |
|POLY 3 | P=0.524N P=0.107 P=0.078 P=0.448 |P=0.511 P=0.507 P=0.483N P=0.523 |
|POLY 1.5 | P=0.541 P=0.092 P=0.063 P=0.418 |P=0.497 P=0.501 P=0.493N P=0.508 |
|POLY 6 | P=0.475N P=0.131 P=0.102 P=0.484 |P=0.538 P=0.518 P=0.466N P=0.550 |
|LOGISTIC REGRESSION| P=0.512N P=0.155 P=0.096 P=0.520 |P=0.525 P=0.498 P=0.419N P=0.524 |
|COCH-ARM / FISHERS | P=0.461 P=0.074 P=0.045 * P=0.370 |P=0.488 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% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 4.8% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 252 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.229N P=0.227N P=0.224N |(e) (e) (e) (e) |
|POLY 3 | P=0.120N P=0.221N P=0.217N P=0.218N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.117N P=0.228N P=0.225N P=0.226N |(e) (e) (e) (e) |
|POLY 6 | P=0.125N P=0.211N P=0.206N P=0.210N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.314N P=0.455N P=0.487N P=0.632N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 6/50 (12%) 4/50 (8%) 8/50 (16%) |4/50 (8%) 11/50 (22%) 7/50 (14%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 25.2% 13.0% 8.7% 17.6% |9.0% 24.0% 15.6% 17.3% |
|TERMINAL (d) | 5/29 (17%) 3/38 (8%) 4/36 (11%) 8/36 (22%) |2/33 (6%) 5/31 (16%) 6/36 (17%) 5/33 (15%) |
|FIRST INCIDENCE | 252 481 729 (T) 729 (T) |694 480 727 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.083N P=0.026N* P=0.183N |P=0.346 P=0.050 P=0.314 P=0.187 |
|POLY 3 | P=0.294N P=0.112N P=0.033N* P=0.269N |P=0.355 P=0.050 P=0.269 P=0.198 |
|POLY 1.5 | P=0.298N P=0.126N P=0.038N* P=0.285N |P=0.338 P=0.047 * P=0.264 P=0.188 |
|POLY 6 | P=0.292N P=0.093N P=0.027N* P=0.249N |P=0.380 P=0.055 P=0.277 P=0.212 |
|LOGISTIC REGRESSION| P=0.397N P=0.254N P=0.089N P=0.410N |P=0.320 P=0.046 * P=0.297 P=0.183 |
|COCH-ARM / FISHERS | P=0.305N P=0.143N P=0.045N* P=0.306N |P=0.320 P=0.045 * P=0.262 P=0.178 |
|=================================================================================================================================|
| | | |
| | 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) | 12/50 (24%) 19/50 (38%) 25/50 (50%) 24/50 (48%) |23/50 (46%) 23/50 (46%) 28/50 (56%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| 29.5% 42.0% 53.0% 52.7% |52.1% 51.1% 59.2% 60.9% |
|TERMINAL (d) | 11/29 (38%) 18/38 (47%) 22/36 (61%) 23/36 (64%) |23/33 (70%) 20/31 (65%) 23/36 (64%) 21/33 (64%) |
|FIRST INCIDENCE | 631 641 505 705 |730 (T) 651 337 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.331 P=0.035 * P=0.048 * |P=0.164 P=0.474 P=0.338 P=0.209 |
|POLY 3 | P=0.021 * P=0.160 P=0.019 * P=0.021 * |P=0.172 P=0.551N P=0.313 P=0.256 |
|POLY 1.5 | P=0.016 * P=0.131 P=0.011 * P=0.016 * |P=0.148 P=0.571N P=0.265 P=0.225 |
|POLY 6 | P=0.028 * P=0.207 P=0.034 * P=0.029 * |P=0.228 P=0.511N P=0.388 P=0.330 |
|LOGISTIC REGRESSION| P=0.034 * P=0.264 P=0.028 * P=0.055 |P=0.144 P=0.579N P=0.238 P=0.246 |
|COCH-ARM / FISHERS | P=0.010 * P=0.097 P=0.006 ** P=0.011 * |P=0.136 P=0.579N P=0.212 P=0.212 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 7/50 (14%) 7/50 (14%) 4/50 (8%) 2/50 (4%) |11/50 (22%) 3/50 (6%) 7/50 (14%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 17.4% 15.6% 8.7% 4.4% |24.9% 6.7% 15.5% 20.2% |
|TERMINAL (d) | 7/29 (24%) 7/38 (18%) 4/36 (11%) 2/36 (6%) |11/33 (33%) 2/31 (7%) 6/36 (17%) 9/33 (27%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 651 668 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019N* P=0.395N P=0.147N P=0.037N* |P=0.555N P=0.026N* P=0.157N P=0.395N |
|POLY 3 | P=0.026N* P=0.528N P=0.191N P=0.053N |P=0.531 P=0.018N* P=0.198N P=0.393N |
|POLY 1.5 | P=0.030N* P=0.563N P=0.218N P=0.062N |P=0.527 P=0.019N* P=0.209N P=0.401N |
|POLY 6 | P=0.022N* P=0.483N P=0.160N P=0.043N* |P=0.540 P=0.016N* P=0.180N P=0.376N |
|LOGISTIC REGRESSION| P=0.019N* P=0.395N P=0.147N P=0.037N* |P=0.541N P=0.019N* P=0.168N P=0.395N |
|COCH-ARM / FISHERS | P=0.040N* P=0.613N P=0.262N P=0.080N |P=0.527 P=0.020N* P=0.218N P=0.402N |
|=================================================================================================================================|
| | | |
| | 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) | 5/50 (10%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |5/50 (10%) 2/50 (4%) 0/50 (0%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 11.8% 4.3% 2.2% 8.6% |11.1% 4.5% 0.0% 8.6% |
|TERMINAL (d) | 2/29 (7%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 252 481 728 589 |601 696 --- 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.187N P=0.082N P=0.412N |P=0.460N P=0.230N P=0.033N* P=0.486N |
|POLY 3 | P=0.489N P=0.184N P=0.085N P=0.444N |P=0.471N P=0.220N P=0.030N* P=0.482N |
|POLY 1.5 | P=0.493N P=0.198N P=0.092N P=0.467N |P=0.474N P=0.220N P=0.031N* P=0.490N |
|POLY 6 | P=0.486N P=0.166N P=0.075N P=0.413N |P=0.467N P=0.221N P=0.030N* P=0.473N |
|LOGISTIC REGRESSION| P=0.372 P=0.420N P=0.214N P=0.489 |P=0.453N P=0.215N P=0.033N* P=0.442N |
|COCH-ARM / FISHERS | P=0.500N P=0.218N P=0.102N P=0.500N |P=0.479N P=0.218N P=0.028N* P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 1/50 (2%) |1/50 (2%) 5/50 (10%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 18.8% 10.7% 8.6% 2.2% |2.3% 11.0% 8.8% 8.9% |
|TERMINAL (d) | 2/29 (7%) 2/38 (5%) 2/36 (6%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 558 415 582 729 (T) |714 616 687 629 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008N** P=0.187N P=0.113N P=0.011N* |P=0.287 P=0.120 P=0.213 P=0.197 |
|POLY 3 | P=0.010N* P=0.217N P=0.133N P=0.011N* |P=0.264 P=0.108 P=0.186 P=0.183 |
|POLY 1.5 | P=0.010N* P=0.237N P=0.149N P=0.013N* |P=0.258 P=0.104 P=0.182 P=0.180 |
|POLY 6 | P=0.009N** P=0.198N P=0.118N P=0.010N* |P=0.276 P=0.114 P=0.193 P=0.190 |
|LOGISTIC REGRESSION| P=0.028N* P=0.392N P=0.239N P=0.023N* |P=0.257 P=0.108 P=0.184 P=0.179 |
|COCH-ARM / FISHERS | P=0.012N* P=0.277N P=0.178N P=0.015N* |P=0.256 P=0.102 P=0.181 P=0.181 |
|=================================================================================================================================|
| | | |
| | 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) | 41/50 (82%) 38/50 (76%) 43/50 (86%) 38/50 (76%) |8/50 (16%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 91.1% 81.6% 89.7% 79.8% |17.9% 9.0% 8.8% 9.0% |
|TERMINAL (d) | 28/29 (97%) 33/38 (87%) 35/36 (97%) 30/36 (83%) |7/33 (21%) 4/31 (13%) 1/36 (3%) 4/33 (12%) |
|FIRST INCIDENCE | 523 582 505 589 |596 730 (T) 658 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.008N** P=0.108N P=0.025N* |P=0.155N P=0.202N P=0.149N P=0.174N |
|POLY 3 | P=0.126N P=0.130N P=0.556N P=0.088N |P=0.166N P=0.179N P=0.167N P=0.177N |
|POLY 1.5 | P=0.190N P=0.184N P=0.609 P=0.147N |P=0.169N P=0.180N P=0.174N P=0.179N |
|POLY 6 | P=0.085N P=0.092N P=0.436N P=0.054N |P=0.161N P=0.178N P=0.157N P=0.171N |
|LOGISTIC REGRESSION| P=0.064N P=0.043N* P=0.340N P=0.036N* |P=0.158N P=0.172N P=0.170N P=0.164N |
|COCH-ARM / FISHERS | P=0.360N P=0.312N P=0.393 P=0.312N |P=0.169N P=0.178N P=0.178N P=0.178N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 4.3% |0.0% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 622 |--- 536 541 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084 (e) P=0.543 P=0.287 |P=0.622N P=0.500 P=0.244 (e) |
|POLY 3 | P=0.081 (e) P=0.525 P=0.269 |P=0.614N P=0.503 P=0.247 (e) |
|POLY 1.5 | P=0.077 (e) P=0.515 P=0.256 |P=0.616N P=0.501 P=0.242 (e) |
|POLY 6 | P=0.086 (e) P=0.538 P=0.284 |P=0.608N P=0.505 P=0.254 (e) |
|LOGISTIC REGRESSION| P=0.053 (e) P=0.543 P=0.162 |P=0.553N P=0.614 P=0.299 (e) |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |P=0.616N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | 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) | 16/50 (32%) 7/50 (14%) 11/50 (22%) 11/50 (22%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 37.5% 15.6% 24.0% 23.6% |4.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 12/29 (41%) 7/38 (18%) 10/36 (28%) 8/36 (22%) |1/29 (3%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 252 729 (T) 724 605 |605 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174N P=0.005N** P=0.065N P=0.073N |P=0.101N P=0.200N P=0.204N P=0.202N |
|POLY 3 | P=0.231N P=0.016N* P=0.122N P=0.113N |P=0.123N P=0.216N P=0.212N P=0.214N |
|POLY 1.5 | P=0.254N P=0.020N* P=0.147N P=0.140N |P=0.119N P=0.224N P=0.222N P=0.222N |
|POLY 6 | P=0.206N P=0.011N* P=0.095N P=0.085N |P=0.128N P=0.206N P=0.200N P=0.204N |
|LOGISTIC REGRESSION| P=0.240N P=0.021N* P=0.133N P=0.176N |P=0.124N P=0.245N P=0.249N P=0.249N |
|COCH-ARM / FISHERS | P=0.293N P=0.028N* P=0.184N P=0.184N |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 11/50 (22%) 11/50 (22%) 20/50 (40%) 14/50 (28%) |10/50 (20%) 10/50 (20%) 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 26.6% 24.3% 43.5% 30.1% |22.6% 22.6% 17.5% 6.7% |
|TERMINAL (d) | 8/29 (28%) 10/38 (26%) 18/36 (50%) 11/36 (31%) |10/33 (30%) 10/31 (32%) 5/36 (14%) 3/33 (9%) |
|FIRST INCIDENCE | 558 641 708 605 |730 (T) 730 (T) 541 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345 P=0.337N P=0.149 P=0.549 |P=0.017N* P=0.540 P=0.326N P=0.033N* |
|POLY 3 | P=0.304 P=0.501N P=0.073 P=0.450 |P=0.019N* P=0.599N P=0.363N P=0.032N* |
|POLY 1.5 | P=0.261 P=0.538N P=0.058 P=0.400 |P=0.020N* P=0.597 P=0.381N P=0.034N* |
|POLY 6 | P=0.356 P=0.451N P=0.097 P=0.512 |P=0.016N* P=0.594N P=0.335N P=0.029N* |
|LOGISTIC REGRESSION| P=0.326 P=0.449N P=0.136 P=0.449 |P=0.017N* P=0.540 P=0.370N P=0.033N* |
|COCH-ARM / FISHERS | P=0.197 P=0.595N P=0.041 * P=0.322 |P=0.022N* P=0.598N P=0.398N P=0.036N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/49 (2%) 1/49 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 2.2% 4.4% |2.3% 2.3% 0.0% 4.5% |
|TERMINAL (d) | 1/29 (3%) 0/38 (0%) 0/36 (0%) 2/36 (6%) |1/32 (3%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- 708 729 (T) |730 (T) 665 --- 629 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282 P=0.446N P=0.703N P=0.576 |P=0.377 P=0.758N P=0.477N P=0.507 |
|POLY 3 | P=0.268 P=0.471N P=0.722N P=0.554 |P=0.377 P=0.759N P=0.492N P=0.513 |
|POLY 1.5 | P=0.264 P=0.479N P=0.734N P=0.540 |P=0.375 P=0.760N P=0.494N P=0.509 |
|POLY 6 | P=0.271 P=0.461N P=0.708N P=0.570 |P=0.382 P=0.756N P=0.488N P=0.521 |
|LOGISTIC REGRESSION| P=0.287 (e) P=0.712N P=0.576 |P=0.373 P=0.762 (e) P=0.507 |
|COCH-ARM / FISHERS | P=0.255 P=0.490N P=0.742N P=0.515 |P=0.373 P=0.753N P=0.495N P=0.508 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 2/47 (4%) 0/47 (0%) 1/47 (2%) |14/50 (28%) 10/50 (20%) 12/50 (24%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.7% 0.0% 2.3% |31.1% 22.3% 26.4% 21.8% |
|TERMINAL (d) | 0/28 (0%) 2/37 (5%) 0/34 (0%) 1/35 (3%) |10/33 (30%) 7/31 (23%) 9/36 (25%) 7/33 (21%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |648 648 624 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.301 (e) P=0.545 |P=0.248N P=0.287N P=0.332N P=0.248N |
|POLY 3 | P=0.584 P=0.264 (e) P=0.527 |P=0.242N P=0.239N P=0.394N P=0.220N |
|POLY 1.5 | P=0.568 P=0.255 (e) P=0.519 |P=0.255N P=0.242N P=0.404N P=0.232N |
|POLY 6 | P=0.605 P=0.277 (e) P=0.537 |P=0.223N P=0.234N P=0.378N P=0.202N |
|LOGISTIC REGRESSION| (e) P=0.301 (e) P=0.545 |P=0.258N P=0.233N P=0.374N P=0.240N |
|COCH-ARM / FISHERS | P=0.548 P=0.258 (e) P=0.511 |P=0.266N P=0.241N P=0.410N P=0.241N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/45 (9%) 6/47 (13%) 4/47 (9%) 3/47 (6%) |10/50 (20%) 5/50 (10%) 3/50 (6%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 10.5% 13.8% 9.2% 6.9% |22.0% 11.2% 6.7% 19.9% |
|TERMINAL (d) | 3/28 (11%) 5/37 (14%) 3/34 (9%) 3/35 (9%) |5/33 (15%) 3/31 (10%) 3/36 (8%) 5/33 (15%) |
|FIRST INCIDENCE | 680 480 400 729 (T) |513 616 730 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244N P=0.534 P=0.533N P=0.375N |P=0.508N P=0.156N P=0.032N* P=0.481N |
|POLY 3 | P=0.257N P=0.452 P=0.568N P=0.429N |P=0.544N P=0.136N P=0.036N* P=0.509N |
|POLY 1.5 | P=0.274N P=0.426 P=0.590N P=0.450N |P=0.545N P=0.135N P=0.036N* P=0.510N |
|POLY 6 | P=0.238N P=0.490 P=0.537N P=0.404N |P=0.539N P=0.137N P=0.035N* P=0.503N |
|LOGISTIC REGRESSION| P=0.312N P=0.416 P=0.641N P=0.378N |P=0.540N P=0.131N P=0.037N* P=0.500N |
|COCH-ARM / FISHERS | P=0.298N P=0.398 P=0.618N P=0.475N |P=0.542N P=0.131N P=0.036N* P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/11 (64%) 5/7 (71%) 5/5 (100%) 6/8 (75%) |6/7 (86%) 5/5 (100%) 7/7 (100%) 4/4 (100%) |
|POLY-3 ADJUSTED (b)| 74.1% 74.9% 100.0% 76.5% |85.7% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 5/6 (83%) 4/5 (80%) 4/4 (100%) 4/4 (100%) |5/6 (83%) 3/3 (100%) 6/6 (100%) 4/4 (100%) |
|FIRST INCIDENCE | 636 693 716 605 |729 480 596 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411 P=0.402N P=0.581N P=0.624 |P=0.448N P=0.357 P=0.518 P=0.720N |
|POLY 3 | P=0.533 P=0.714 P=0.275 P=0.677 |P=0.355 P=0.566 P=0.500 P=0.609 |
|POLY 1.5 | P=0.447 P=0.651 P=0.217 P=0.597 |P=0.355 P=0.566 P=0.500 P=0.609 |
|POLY 6 | P=0.636 P=0.709N P=0.388 P=0.703N |P=0.355 P=0.566 P=0.500 P=0.609 |
|LOGISTIC REGRESSION| P=0.572 P=0.563N P=0.573 P=0.707 |(e) (e) (e) P=0.720N |
|COCH-ARM / FISHERS | P=0.335 P=0.572 P=0.181 P=0.494 |P=0.349 P=0.583 P=0.500 P=0.636 |
|=================================================================================================================================|
| | | |
| | 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%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 6.7% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 252 729 (T) --- --- |--- --- --- 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N P=0.731N P=0.500N P=0.500N |P=0.014 * (e) (e) P=0.134 |
|POLY 3 | P=0.230N P=0.742N P=0.479N P=0.481N |P=0.011 * (e) (e) P=0.121 |
|POLY 1.5 | P=0.232N P=0.750N P=0.488N P=0.489N |P=0.011 * (e) (e) P=0.119 |
|POLY 6 | P=0.227N P=0.729N P=0.467N P=0.471N |P=0.012 * (e) (e) P=0.124 |
|LOGISTIC REGRESSION| P=0.465N P=0.608 (e) (e) |P=0.012 * (e) (e) P=0.121 |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.012 * (e) (e) P=0.121 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | |4/50 (8%) 4/49 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| |9.0% 9.1% 6.7% 11.2% |
|TERMINAL (d) | |2/33 (6%) 3/31 (10%) 3/36 (8%) 5/33 (15%) |
|FIRST INCIDENCE | |669 536 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.446 P=0.615 P=0.460N P=0.501 |
|POLY 3 | |P=0.433 P=0.640 P=0.493N P=0.501 |
|POLY 1.5 | |P=0.432 P=0.635 P=0.498N P=0.498 |
|POLY 6 | |P=0.438 P=0.641N P=0.485N P=0.508 |
|LOGISTIC REGRESSION| |P=0.442 P=0.633 P=0.475N P=0.522 |
|COCH-ARM / FISHERS | |P=0.434 P=0.631 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% |
| | | |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/49 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |2.3% 0.0% 4.4% 4.5% |
|TERMINAL (d) | |1/33 (3%) 0/31 (0%) 2/36 (6%) 0/33 (0%) |
|FIRST INCIDENCE | |730 (T) --- 730 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.262 P=0.512N P=0.530 P=0.519 |
|POLY 3 | |P=0.251 P=0.503N P=0.506 P=0.504 |
|POLY 1.5 | |P=0.249 P=0.504N P=0.503 P=0.501 |
|POLY 6 | |P=0.257 P=0.501N P=0.513 P=0.512 |
|LOGISTIC REGRESSION| |P=0.252 (e) P=0.530 P=0.502 |
|COCH-ARM / FISHERS | |P=0.248 P=0.505N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 27/50 (54%) 22/50 (44%) 28/49 (57%) |6/50 (12%) 6/50 (12%) 8/49 (16%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 38.1% 57.5% 46.3% 60.3% |13.5% 13.4% 17.6% 17.9% |
|TERMINAL (d) | 13/29 (45%) 22/38 (58%) 15/36 (42%) 23/36 (64%) |4/33 (12%) 3/31 (10%) 5/36 (14%) 6/33 (18%) |
|FIRST INCIDENCE | 400 415 551 523 |669 648 541 704 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131 P=0.170 P=0.417 P=0.090 |P=0.317 P=0.593 P=0.441 P=0.396 |
|POLY 3 | P=0.063 P=0.048 * P=0.284 P=0.026 * |P=0.292 P=0.614N P=0.406 P=0.389 |
|POLY 1.5 | P=0.044 * P=0.034 * P=0.222 P=0.017 * |P=0.289 P=0.619N P=0.389 P=0.385 |
|POLY 6 | P=0.092 P=0.075 P=0.381 P=0.042 * |P=0.301 P=0.605N P=0.431 P=0.399 |
|LOGISTIC REGRESSION| P=0.047 * P=0.041 * P=0.242 P=0.027 * |P=0.291 P=0.619N P=0.370 P=0.412 |
|COCH-ARM / FISHERS | P=0.025 * P=0.021 * P=0.151 P=0.010 * |P=0.289 P=0.620N P=0.371 P=0.387 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 6/50 (12%) 8/49 (16%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.9% 6.7% 13.1% 17.8% |2.3% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 4/29 (14%) 3/38 (8%) 6/36 (17%) 7/36 (19%) |1/33 (3%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 636 |730 (T) --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110 P=0.353N P=0.511 P=0.297 |P=0.398N P=0.512N P=0.742N P=0.500N |
|POLY 3 | P=0.092 P=0.441N P=0.452 P=0.232 |P=0.405N P=0.500N P=0.760 P=0.499N |
|POLY 1.5 | P=0.083 P=0.465N P=0.419 P=0.206 |P=0.406N P=0.500N P=0.758 P=0.500N |
|POLY 6 | P=0.102 P=0.411N P=0.495 P=0.266 |P=0.403N P=0.499N P=0.757N P=0.496N |
|LOGISTIC REGRESSION| P=0.113 P=0.353N P=0.511 P=0.277 |P=0.398N (e) P=0.742N (e) |
|COCH-ARM / FISHERS | P=0.069 P=0.500N P=0.370 P=0.168 |P=0.406N P=0.500N P=0.747 P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.6% 2.2% 0.0% |2.3% 4.5% 2.2% 4.5% |
|TERMINAL (d) | 0/29 (0%) 2/37 (5%) 1/36 (3%) 0/36 (0%) |1/33 (3%) 1/31 (3%) 0/36 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |730 (T) 616 687 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421N P=0.293 P=0.543 (e) |P=0.459 P=0.491 P=0.742N P=0.500 |
|POLY 3 | P=0.410N P=0.257 P=0.525 (e) |P=0.447 P=0.504 P=0.756N P=0.502 |
|POLY 1.5 | P=0.428N P=0.247 P=0.515 (e) |P=0.445 P=0.501 P=0.759N P=0.500 |
|POLY 6 | P=0.389N P=0.270 P=0.538 (e) |P=0.453 P=0.508 P=0.751N P=0.508 |
|LOGISTIC REGRESSION| (e) P=0.293 P=0.543 (e) |P=0.445 P=0.500 P=0.760N P=0.500 |
|COCH-ARM / FISHERS | P=0.459N P=0.242 P=0.500 (e) |P=0.444 P=0.500 P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% 0.0% |6.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/37 (0%) 0/36 (0%) 0/36 (0%) |3/33 (9%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 669 --- --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542N P=0.554 (e) (e) |P=0.044N* P=0.132N P=0.106N P=0.120N |
|POLY 3 | P=0.542N P=0.518 (e) (e) |P=0.045N* P=0.118N P=0.115N P=0.117N |
|POLY 1.5 | P=0.551N P=0.509 (e) (e) |P=0.045N* P=0.119N P=0.117N P=0.119N |
|POLY 6 | P=0.530N P=0.530 (e) (e) |P=0.045N* P=0.117N P=0.112N P=0.114N |
|LOGISTIC REGRESSION| P=0.586N P=0.487 (e) (e) |P=0.044N* (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.566N P=0.495 (e) (e) |P=0.047N* P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 0/50 (0%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.2% 2.2% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/37 (3%) 1/36 (3%) 1/36 (3%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |601 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421 P=0.549 P=0.543 P=0.543 |P=0.112N P=0.242N P=0.228N P=0.235N |
|POLY 3 | P=0.430 P=0.517 P=0.525 P=0.524 |P=0.112N P=0.239N P=0.235N P=0.238N |
|POLY 1.5 | P=0.414 P=0.509 P=0.515 P=0.515 |P=0.113N P=0.239N P=0.237N P=0.238N |
|POLY 6 | P=0.448 P=0.528 P=0.538 P=0.534 |P=0.112N P=0.239N P=0.232N P=0.236N |
|LOGISTIC REGRESSION| (e) P=0.549 P=0.543 P=0.543 |P=0.113N P=0.229N P=0.233N P=0.229N |
|COCH-ARM / FISHERS | P=0.386 P=0.495 P=0.500 P=0.500 |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% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |4/50 (8%) 10/50 (20%) 5/50 (10%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.3% 2.2% 2.2% |9.1% 22.3% 11.1% 20.0% |
|TERMINAL (d) | 2/29 (7%) 1/37 (3%) 1/36 (3%) 1/36 (3%) |4/33 (12%) 9/31 (29%) 5/36 (14%) 6/33 (18%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) 541 730 (T) 658 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.358N P=0.415N P=0.424N P=0.424N |P=0.221 P=0.055 P=0.555 P=0.126 |
|POLY 3 | P=0.392N P=0.470N P=0.456N P=0.458N |P=0.212 P=0.075 P=0.511 P=0.121 |
|POLY 1.5 | P=0.397N P=0.485N P=0.473N P=0.474N |P=0.205 P=0.073 P=0.505 P=0.117 |
|POLY 6 | P=0.388N P=0.451N P=0.433N P=0.440N |P=0.227 P=0.077 P=0.523 P=0.130 |
|LOGISTIC REGRESSION| P=0.358N P=0.415N P=0.424N P=0.424N |P=0.217 P=0.075 P=0.555 P=0.125 |
|COCH-ARM / FISHERS | P=0.407N P=0.508N P=0.500N P=0.500N |P=0.204 P=0.074 P=0.500 P=0.117 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 9/50 (18%) 9/49 (18%) 18/50 (36%) 10/50 (20%) |10/50 (20%) 10/50 (20%) 19/50 (38%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 22.0% 20.5% 38.1% 21.9% |22.3% 22.5% 41.3% 25.6% |
|TERMINAL (d) | 8/29 (28%) 9/37 (24%) 13/36 (36%) 9/36 (25%) |8/33 (24%) 8/31 (26%) 17/36 (47%) 9/33 (27%) |
|FIRST INCIDENCE | 558 729 (T) 400 655 |567 696 541 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509 P=0.385N P=0.122 P=0.502N |P=0.293 P=0.551 P=0.063 P=0.407 |
|POLY 3 | P=0.474 P=0.537N P=0.078 P=0.596N |P=0.321 P=0.592 P=0.040 * P=0.449 |
|POLY 1.5 | P=0.429 P=0.571N P=0.057 P=0.568 |P=0.297 P=0.592 P=0.038 * P=0.431 |
|POLY 6 | P=0.524 P=0.493N P=0.113 P=0.549N |P=0.349 P=0.594 P=0.044 * P=0.470 |
|LOGISTIC REGRESSION| P=0.476 P=0.448N P=0.065 P=0.534N |P=0.265 P=0.593N P=0.043 * P=0.411 |
|COCH-ARM / FISHERS | P=0.353 P=0.584 P=0.035 * P=0.500 |P=0.264 P=0.598N P=0.038 * P=0.405 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 7.4% 2.2% 2.2% 6.5% | |
|TERMINAL (d) | 3/29 (10%) 1/38 (3%) 1/36 (3%) 1/36 (3%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 655 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565 P=0.214N P=0.231N P=0.555N | |
|POLY 3 | P=0.522 P=0.267N P=0.261N P=0.602N | |
|POLY 1.5 | P=0.515 P=0.282N P=0.278N P=0.626N | |
|POLY 6 | P=0.529 P=0.249N P=0.240N P=0.574N | |
|LOGISTIC REGRESSION| P=0.557 P=0.214N P=0.231N P=0.587N | |
|COCH-ARM / FISHERS | P=0.500 P=0.309N P=0.309N P=0.661N | |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 8/50 (16%) 10/50 (20%) 6/50 (12%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 19.2% 22.2% 12.9% 2.2% | |
|TERMINAL (d) | 6/29 (21%) 9/38 (24%) 5/36 (14%) 1/36 (3%) | |
|FIRST INCIDENCE | 489 691 582 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003N** P=0.585N P=0.255N P=0.009N** | |
|POLY 3 | P=0.004N** P=0.471 P=0.305N P=0.010N* | |
|POLY 1.5 | P=0.005N** P=0.441 P=0.337N P=0.012N* | |
|POLY 6 | P=0.003N** P=0.513 P=0.265N P=0.008N** | |
|LOGISTIC REGRESSION| P=0.005N** P=0.489 P=0.364N P=0.016N* | |
|COCH-ARM / FISHERS | P=0.008N** P=0.398 P=0.387N P=0.015N* | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 34/50 (68%) 36/50 (72%) 33/49 (67%) | |
|POLY-3 ADJUSTED (b)| 76.4% 74.1% 75.3% 70.8% | |
|TERMINAL (d) | 22/29 (76%) 30/38 (79%) 27/36 (75%) 27/36 (75%) | |
|FIRST INCIDENCE | 558 641 551 551 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146N P=0.077N P=0.221N P=0.104N | |
|POLY 3 | P=0.314N P=0.494N P=0.549N P=0.350N | |
|POLY 1.5 | P=0.381N P=0.519N P=0.565 P=0.413N | |
|POLY 6 | P=0.275N P=0.480N P=0.475N P=0.314N | |
|LOGISTIC REGRESSION| P=0.197N P=0.255N P=0.454N P=0.216N | |
|COCH-ARM / FISHERS | P=0.533N P=0.585N P=0.414 P=0.558N | |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 0/49 (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% 4.5% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.238 |
|POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.239 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.237 |
|POLY 6 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.242 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (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% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 5.0% 6.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 3/38 (8%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.623 P=0.192N P=0.192N |(e) (e) (e) (e) |
|POLY 3 | P=0.060N P=0.549 P=0.210N P=0.211N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.064N P=0.529 P=0.220N P=0.221N |(e) (e) (e) (e) |
|POLY 6 | P=0.056N P=0.574 P=0.197N P=0.201N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.054N P=0.623 (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: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.0% 4.5% 6.5% 8.8% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/38 (5%) 3/36 (8%) 4/36 (11%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266 P=0.594N P=0.599 P=0.440 |P=0.301N P=0.512N P=0.483N P=0.500N |
|POLY 3 | P=0.253 P=0.655N P=0.558 P=0.394 |P=0.306N P=0.500N P=0.496N P=0.499N |
|POLY 1.5 | P=0.240 P=0.670N P=0.535 P=0.372 |P=0.305N P=0.500N P=0.499N P=0.500N |
|POLY 6 | P=0.266 P=0.633N P=0.587 P=0.419 |P=0.307N P=0.499N P=0.493N P=0.496N |
|LOGISTIC REGRESSION| P=0.266 P=0.594N P=0.599 P=0.440 |P=0.301N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.216 P=0.691N P=0.500 P=0.339 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | 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) | 5/50 (10%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 12.0% 0.0% 4.4% 2.2% |2.2% 2.3% 2.2% 8.8% |
|TERMINAL (d) | 1/29 (3%) 0/38 (0%) 2/36 (6%) 0/36 (0%) |0/33 (0%) 1/31 (3%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 589 --- 729 (T) 523 |511 730 (T) 730 (T) 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090N P=0.024N* P=0.157N P=0.079N |P=0.073 P=0.749 P=0.753N P=0.189 |
|POLY 3 | P=0.106N P=0.024N* P=0.179N P=0.079N |P=0.070 P=0.758 P=0.760N P=0.184 |
|POLY 1.5 | P=0.106N P=0.027N* P=0.193N P=0.087N |P=0.068 P=0.758 P=0.760 P=0.180 |
|POLY 6 | P=0.106N P=0.022N* P=0.163N P=0.072N |P=0.073 P=0.758 P=0.757N P=0.191 |
|LOGISTIC REGRESSION| P=0.149N P=0.039N* P=0.228N P=0.161N |P=0.071 P=0.736N P=0.744N P=0.214 |
|COCH-ARM / FISHERS | P=0.111N P=0.028N* P=0.218N P=0.102N |P=0.067 P=0.753N P=0.753N P=0.181 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 2.2% 2.2% |2.2% 6.7% 2.2% 2.2% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 558 --- 582 622 |644 616 730 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565 P=0.491N P=0.740N P=0.731N |P=0.437N P=0.313 P=0.753N P=0.755N |
|POLY 3 | P=0.558 P=0.481N P=0.732N P=0.735N |P=0.441N P=0.309 P=0.758N P=0.759N |
|POLY 1.5 | P=0.552 P=0.489N P=0.744N P=0.744N |P=0.444N P=0.306 P=0.760N P=0.760N |
|POLY 6 | P=0.564 P=0.472N P=0.717N P=0.723N |P=0.435N P=0.313 P=0.756N P=0.756N |
|LOGISTIC REGRESSION| P=0.374 P=0.596N P=0.660 P=0.662 |P=0.437N P=0.318 P=0.762 P=0.742N |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.444N P=0.309 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.2% 2.2% |0.0% 2.3% 4.4% 4.5% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 605 --- 694 729 (T) |--- 680 668 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.481N P=0.707N P=0.720N |P=0.177 P=0.511 P=0.255 P=0.258 |
|POLY 3 | P=0.556 P=0.481N P=0.733N P=0.736N |P=0.164 P=0.501 P=0.242 P=0.240 |
|POLY 1.5 | P=0.550 P=0.488N P=0.744N P=0.745N |P=0.161 P=0.500 P=0.239 P=0.238 |
|POLY 6 | P=0.560 P=0.471N P=0.719N P=0.725N |P=0.170 P=0.503 P=0.248 P=0.244 |
|LOGISTIC REGRESSION| P=0.518 P=0.558N P=0.734 P=0.751 |P=0.160 P=0.502 P=0.238 P=0.237 |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.160 P=0.500 P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 0.0% 0.0% |2.3% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 1/31 (3%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 589 --- --- --- |714 730 (T) 668 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.211N P=0.208N P=0.206N |P=0.301N P=0.750 P=0.746N P=0.489N |
|POLY 3 | P=0.121N P=0.218N P=0.214N P=0.216N |P=0.311N P=0.761N P=0.756N P=0.499N |
|POLY 1.5 | P=0.118N P=0.225N P=0.223N P=0.223N |P=0.312N P=0.760 P=0.758N P=0.500N |
|POLY 6 | P=0.126N P=0.209N P=0.204N P=0.208N |P=0.307N P=0.760N P=0.751N P=0.496N |
|LOGISTIC REGRESSION| P=0.155N P=0.289N P=0.302N P=0.313N |P=0.311N P=0.762N P=0.762 P=0.497N |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |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% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 8.7% 8.8% |2.2% 4.5% 4.3% 4.4% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 2/36 (6%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 646 680 698 |511 648 337 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044 * P=0.547 P=0.108 P=0.100 |P=0.423 P=0.501 P=0.498 P=0.492 |
|POLY 3 | P=0.038 * P=0.523 P=0.079 P=0.078 |P=0.429 P=0.499 P=0.511 P=0.503 |
|POLY 1.5 | P=0.034 * P=0.514 P=0.071 P=0.071 |P=0.425 P=0.498 P=0.506 P=0.500 |
|POLY 6 | P=0.043 * P=0.535 P=0.091 P=0.087 |P=0.436 P=0.502 P=0.518 P=0.508 |
|LOGISTIC REGRESSION| P=0.033 * P=0.473 P=0.078 P=0.087 |P=0.496 P=0.555 P=0.630 P=0.627 |
|COCH-ARM / FISHERS | P=0.029 * P=0.500 P=0.059 P=0.059 |P=0.423 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 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) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.5% 2.2% 4.3% 2.2% |8.7% 4.5% 4.4% 2.2% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 489 729 (T) 582 729 (T) |511 676 696 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.140N P=0.261N P=0.138N |P=0.136N P=0.328N P=0.327N P=0.188N |
|POLY 3 | P=0.156N P=0.159N P=0.293N P=0.156N |P=0.138N P=0.352N P=0.347N P=0.185N |
|POLY 1.5 | P=0.159N P=0.166N P=0.310N P=0.164N |P=0.138N P=0.347N P=0.345N P=0.183N |
|POLY 6 | P=0.155N P=0.151N P=0.273N P=0.149N |P=0.138N P=0.357N P=0.348N P=0.185N |
|LOGISTIC REGRESSION| P=0.245N P=0.242N P=0.495N P=0.276N |P=0.109N P=0.272N P=0.304N P=0.071N |
|COCH-ARM / FISHERS | P=0.165N P=0.181N P=0.339N P=0.181N |P=0.137N P=0.339N P=0.339N P=0.181N |
|=================================================================================================================================|
| | | |
| | 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) | 12/50 (24%) 9/50 (18%) 10/50 (20%) 44/50 (88%) |8/50 (16%) 6/50 (12%) 8/50 (16%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 27.1% 19.5% 21.4% 89.6% |17.2% 13.2% 17.1% 82.2% |
|TERMINAL (d) | 3/29 (10%) 6/38 (16%) 7/36 (19%) 34/36 (94%) |2/33 (6%) 1/31 (3%) 3/36 (8%) 28/33 (85%) |
|FIRST INCIDENCE | 252 480 582 520 |511 616 337 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.183N P=0.250N P<0.001 ** |P<0.001 ** P=0.387N P=0.561N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.271N P=0.349N P<0.001 ** |P<0.001 ** P=0.401N P=0.600N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.287N P=0.371N P<0.001 ** |P<0.001 ** P=0.398N P=0.602N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.255N P=0.326N P<0.001 ** |P<0.001 ** P=0.402N P=0.596N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.440N P=0.546N P<0.001 ** |P<0.001 ** P=0.361N P=0.597 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.312N P=0.405N P<0.001 ** |P<0.001 ** P=0.387N P=0.607N P<0.001 ** |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 6.4% 2.2% |0.0% 4.5% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 589 --- 582 729 (T) |--- 648 337 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511 P=0.486N P=0.362 P=0.724N |P=0.457N P=0.245 P=0.500 (e) |
|POLY 3 | P=0.504 P=0.481N P=0.355 P=0.736N |P=0.456N P=0.240 P=0.508 (e) |
|POLY 1.5 | P=0.492 P=0.488N P=0.335 P=0.745N |P=0.460N P=0.238 P=0.504 (e) |
|POLY 6 | P=0.515 P=0.471N P=0.382 P=0.726N |P=0.450N P=0.243 P=0.512 (e) |
|LOGISTIC REGRESSION| P=0.389 P=0.570N P=0.213 P=0.742 |P=0.399N P=0.242 (e) (e) |
|COCH-ARM / FISHERS | P=0.469 P=0.500N P=0.309 P=0.753N |P=0.461N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 6.8% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 2/31 (7%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 676 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.190N P=0.297 P=0.742N P=0.500N |
|POLY 3 | (e) (e) (e) (e) |P=0.197N P=0.307 P=0.757N P=0.499N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.199N P=0.305 P=0.759N P=0.500N |
|POLY 6 | (e) (e) (e) (e) |P=0.192N P=0.311 P=0.753N P=0.496N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.193N P=0.307 P=0.742N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.200N P=0.309 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 2.2% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 624 729 (T) 708 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.425N P=0.418N P=0.199N |(e) (e) (e) (e) |
|POLY 3 | P=0.145N P=0.468N P=0.461N P=0.215N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.148N P=0.480N P=0.476N P=0.223N |(e) (e) (e) (e) |
|POLY 6 | P=0.143N P=0.453N P=0.442N P=0.207N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.163N P=0.519N P=0.540N P=0.283N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.500N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/50 (24%) 11/50 (22%) 11/50 (22%) | |
|POLY-3 ADJUSTED (b)| 18.9% 25.8% 23.5% 23.9% | |
|TERMINAL (d) | 4/29 (14%) 8/38 (21%) 7/36 (19%) 9/36 (25%) | |
|FIRST INCIDENCE | 529 480 582 589 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481 P=0.411 P=0.476 P=0.478 | |
|POLY 3 | P=0.412 P=0.300 P=0.391 P=0.376 | |
|POLY 1.5 | P=0.389 P=0.270 P=0.357 P=0.351 | |
|POLY 6 | P=0.434 P=0.340 P=0.436 P=0.404 | |
|LOGISTIC REGRESSION| P=0.338 P=0.197 P=0.290 P=0.316 | |
|COCH-ARM / FISHERS | P=0.341 P=0.227 P=0.306 P=0.306 | |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 7/50 (14%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 16.7% 2.2% 4.4% 4.4% | |
|TERMINAL (d) | 3/29 (10%) 0/38 (0%) 2/36 (6%) 1/36 (3%) | |
|FIRST INCIDENCE | 529 680 729 (T) 698 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055N P=0.019N* P=0.048N* P=0.049N* | |
|POLY 3 | P=0.074N P=0.023N* P=0.059N P=0.060N | |
|POLY 1.5 | P=0.074N P=0.025N* P=0.066N P=0.066N | |
|POLY 6 | P=0.074N P=0.020N* P=0.052N P=0.054N | |
|LOGISTIC REGRESSION| P=0.088N P=0.038N* P=0.087N P=0.091N | |
|COCH-ARM / FISHERS | P=0.079N P=0.030N* P=0.080N P=0.080N | |
|=================================================================================================================================|
| | | |
| | 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) | 9/50 (18%) 6/50 (12%) 9/50 (18%) 7/50 (14%) | |
|POLY-3 ADJUSTED (b)| 20.4% 12.6% 18.8% 14.6% | |
|TERMINAL (d) | 2/29 (7%) 2/38 (5%) 4/36 (11%) 2/36 (6%) | |
|FIRST INCIDENCE | 400 415 400 520 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351N P=0.222N P=0.463N P=0.291N | |
|POLY 3 | P=0.383N P=0.233N P=0.526N P=0.323N | |
|POLY 1.5 | P=0.401N P=0.253N P=0.554N P=0.348N | |
|POLY 6 | P=0.363N P=0.212N P=0.492N P=0.294N | |
|LOGISTIC REGRESSION| P=0.282 P=0.563N P=0.323 P=0.452 | |
|COCH-ARM / FISHERS | P=0.434N P=0.288N P=0.602N P=0.393N | |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 2/49 (4%) 0/48 (0%) |1/49 (2%) 0/47 (0%) 1/49 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.3% 4.5% 0.0% |2.3% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 2/35 (6%) 0/34 (0%) |1/33 (3%) 0/31 (0%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | --- 691 729 (T) --- |730 (T) --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584N P=0.557 P=0.280 (e) |P=0.405N P=0.512N P=0.749N P=0.506N |
|POLY 3 | P=0.585N P=0.519 P=0.262 (e) |P=0.408N P=0.508N P=0.760N P=0.505N |
|POLY 1.5 | P=0.600N P=0.509 P=0.250 (e) |P=0.408N P=0.509N P=0.760 P=0.506N |
|POLY 6 | P=0.569N P=0.531 P=0.277 (e) |P=0.407N P=0.507N P=0.757N P=0.503N |
|LOGISTIC REGRESSION| P=0.597N P=0.504 P=0.280 (e) |P=0.405N (e) P=0.749N (e) |
|COCH-ARM / FISHERS | P=0.625N P=0.495 P=0.242 (e) |P=0.407N P=0.510N P=0.753N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 1/48 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 0.0% 2.3% 9.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 0/31 (0%) 1/36 (3%) 4/33 (12%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.035 * P=0.512N P=0.742N P=0.178 |
|POLY 3 | (e) (e) (e) (e) |P=0.035 * P=0.504N P=0.758 P=0.180 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.035 * P=0.505N P=0.754 P=0.179 |
|POLY 6 | (e) (e) (e) (e) |P=0.036 * P=0.503N P=0.758N P=0.185 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.035 * (e) P=0.742N P=0.178 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.035 * P=0.505N P=0.742 P=0.181 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 17/50 (34%) 16/50 (32%) 13/50 (26%) |24/50 (48%) 27/49 (55%) 34/48 (71%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 26.5% 37.8% 34.1% 28.6% |51.6% 59.6% 72.9% 56.3% |
|TERMINAL (d) | 8/29 (28%) 17/38 (45%) 12/36 (33%) 13/36 (36%) |15/33 (46%) 22/31 (71%) 25/36 (69%) 18/33 (55%) |
|FIRST INCIDENCE | 589 729 (T) 582 729 (T) |513 536 337 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.406N P=0.370 P=0.400 P=0.548N |P=0.437 P=0.286 P=0.121 P=0.451 |
|POLY 3 | P=0.475N P=0.184 P=0.294 P=0.510 |P=0.348 P=0.284 P=0.024 * P=0.402 |
|POLY 1.5 | P=0.516N P=0.163 P=0.246 P=0.474 |P=0.346 P=0.290 P=0.020 * P=0.403 |
|POLY 6 | P=0.437N P=0.212 P=0.359 P=0.547 |P=0.366 P=0.272 P=0.031 * P=0.410 |
|LOGISTIC REGRESSION| P=0.413N P=0.274 P=0.289 P=0.588N |P=0.365 P=0.300 P=0.019 * P=0.422 |
|COCH-ARM / FISHERS | P=0.489 P=0.133 P=0.184 P=0.408 |P=0.364 P=0.307 P=0.018 * P=0.421 |
|=================================================================================================================================|
| | | |
| | 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) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 1/48 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.7% 2.2% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/29 (0%) 3/38 (8%) 1/36 (3%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.324N P=0.172 P=0.543 (e) |P=0.699 (e) P=0.517 (e) |
|POLY 3 | P=0.309N P=0.139 P=0.525 (e) |P=0.695 (e) P=0.497 (e) |
|POLY 1.5 | P=0.330N P=0.131 P=0.515 (e) |P=0.693 (e) P=0.494 (e) |
|POLY 6 | P=0.286N P=0.151 P=0.538 (e) |P=0.699 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| (e) P=0.172 P=0.543 (e) |(e) (e) P=0.517 (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.121 P=0.500 (e) |P=0.694 (e) P=0.490 (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 6/50 (12%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 13.1% 2.2% |6.8% 4.5% 4.4% 11.2% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 6/36 (17%) 1/36 (3%) |3/33 (9%) 2/31 (7%) 2/36 (6%) 3/33 (9%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |730 (T) 730 (T) 730 (T) 658 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365 P=0.554 P=0.031 * P=0.543 |P=0.223 P=0.529N P=0.460N P=0.365 |
|POLY 3 | P=0.382 P=0.525 P=0.024 * P=0.527 |P=0.216 P=0.499N P=0.492N P=0.364 |
|POLY 1.5 | P=0.358 P=0.516 P=0.021 * P=0.518 |P=0.213 P=0.501N P=0.497N P=0.359 |
|POLY 6 | P=0.408 P=0.535 P=0.029 * P=0.536 |P=0.223 P=0.497N P=0.483N P=0.377 |
|LOGISTIC REGRESSION| (e) P=0.554 P=0.031 * P=0.543 |P=0.222 P=0.529N P=0.460N P=0.367 |
|COCH-ARM / FISHERS | P=0.319 P=0.505 P=0.014 * P=0.505 |P=0.210 P=0.500N P=0.500N P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | |0/33 (0%) 2/31 (7%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.398N P=0.224 (e) (e) |
|POLY 3 | |P=0.402N P=0.237 (e) (e) |
|POLY 1.5 | |P=0.404N P=0.237 (e) (e) |
|POLY 6 | |P=0.398N P=0.238 (e) (e) |
|LOGISTIC REGRESSION| |(e) P=0.224 (e) (e) |
|COCH-ARM / FISHERS | |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 2.3% 4.4% 2.2% |
|TERMINAL (d) | |0/33 (0%) 1/31 (3%) 1/36 (3%) 1/33 (3%) |
|FIRST INCIDENCE | |--- 730 (T) 626 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.376 P=0.488 P=0.252 P=0.500 |
|POLY 3 | |P=0.370 P=0.500 P=0.243 P=0.501 |
|POLY 1.5 | |P=0.367 P=0.500 P=0.240 P=0.500 |
|POLY 6 | |P=0.377 P=0.501 P=0.248 P=0.504 |
|LOGISTIC REGRESSION| |P=0.367 P=0.488 P=0.238 P=0.500 |
|COCH-ARM / FISHERS | |P=0.366 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | 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) | |3/50 (6%) 4/50 (8%) 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| |6.8% 8.9% 8.9% 11.2% |
|TERMINAL (d) | |2/33 (6%) 2/31 (7%) 4/36 (11%) 5/33 (15%) |
|FIRST INCIDENCE | |729 541 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.313 P=0.472 P=0.545 P=0.354 |
|POLY 3 | |P=0.301 P=0.509 P=0.510 P=0.360 |
|POLY 1.5 | |P=0.298 P=0.504 P=0.504 P=0.356 |
|POLY 6 | |P=0.307 P=0.517 P=0.520 P=0.368 |
|LOGISTIC REGRESSION| |P=0.308 P=0.499 P=0.548 P=0.351 |
|COCH-ARM / FISHERS | |P=0.299 P=0.500 P=0.500 P=0.357 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 4.4% 2.2% |
|TERMINAL (d) | |0/33 (0%) 0/31 (0%) 1/36 (3%) 0/33 (0%) |
|FIRST INCIDENCE | |--- --- 727 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.255 (e) P=0.259 P=0.520 |
|POLY 3 | |P=0.249 (e) P=0.241 P=0.502 |
|POLY 1.5 | |P=0.246 (e) P=0.239 P=0.500 |
|POLY 6 | |P=0.256 (e) P=0.245 P=0.506 |
|LOGISTIC REGRESSION| |P=0.248 (e) P=0.254 P=0.502 |
|COCH-ARM / FISHERS | |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
(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).