TDMS Study 88007-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99
EXPERIMENT: 88007 TEST: 05 TIME: 13:52:44
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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99
EXPERIMENT: 88007 TEST: 05 TIME: 13:52:44
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
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Spleen
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM NITRITE DATE: 10/18/99
EXPERIMENT: 88007 TEST: 05 TIME: 13:52:44
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
----- ----------
Islets, Pancreatic Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Malignant Tumors
===============================================================
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 1
Statistical Analysis of Primary Tumors 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 Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 10/50 (20%) 6/50 (12%) 10/50 (20%) |4/50 (8%) 2/50 (4%) 0/45 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 14.7% 21.7% 13.1% 21.7% |9.0% 4.5% 0.0% 4.6% |
|TERMINAL (d) | 5/29 (17%) 7/38 (18%) 4/36 (11%) 8/36 (22%) |3/33 (9%) 2/31 (7%) 0/31 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 620 481 724 605 |669 730 (T) --- 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374 P=0.389 P=0.464N P=0.360 |P=0.233N P=0.360N P=0.070N P=0.338N |
|POLY 3 | P=0.336 P=0.287 P=0.535N P=0.287 |P=0.243N P=0.339N P=0.074N P=0.346N |
|POLY 1.5 | P=0.307 P=0.253 P=0.569N P=0.255 |P=0.244N P=0.339N P=0.075N P=0.348N |
|POLY 6 | P=0.368 P=0.334 P=0.493N P=0.328 |P=0.241N P=0.338N P=0.072N P=0.341N |
|LOGISTIC REGRESSION| P=0.331 P=0.261 P=0.464N P=0.314 |P=0.236N P=0.333N P=0.075N P=0.338N |
|COCH-ARM / FISHERS | P=0.257 P=0.207 P=0.620N P=0.207 |P=0.245N P=0.339N P=0.072N P=0.349N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 6/50 (12%) 11/50 (22%) |4/50 (8%) 2/50 (4%) 0/45 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 17.2% 21.7% 13.1% 23.9% |9.0% 4.5% 0.0% 4.6% |
|TERMINAL (d) | 6/29 (21%) 7/38 (18%) 4/36 (11%) 9/36 (25%) |3/33 (9%) 2/31 (7%) 0/31 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 620 481 724 605 |669 730 (T) --- 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360 P=0.509 P=0.340N P=0.387 |P=0.233N P=0.360N P=0.070N P=0.338N |
|POLY 3 | P=0.314 P=0.397 P=0.408N P=0.307 |P=0.243N P=0.339N P=0.074N P=0.346N |
|POLY 1.5 | P=0.288 P=0.356 P=0.444N P=0.271 |P=0.244N P=0.339N P=0.075N P=0.348N |
|POLY 6 | P=0.343 P=0.451 P=0.365N P=0.351 |P=0.241N P=0.338N P=0.072N P=0.341N |
|LOGISTIC REGRESSION| P=0.321 P=0.372 P=0.330N P=0.346 |P=0.236N P=0.333N P=0.075N P=0.338N |
|COCH-ARM / FISHERS | P=0.242 P=0.298 P=0.500N P=0.218 |P=0.245N P=0.339N P=0.072N P=0.349N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 2
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |8/46 (17%) 10/48 (21%) 6/49 (12%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.7% 2.2% 4.4% |19.2% 23.5% 13.6% 6.7% |
|TERMINAL (d) | 0/29 (0%) 3/38 (8%) 0/36 (0%) 1/36 (3%) |8/32 (25%) 9/30 (30%) 6/35 (17%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) 697 698 |730 (T) 680 730 (T) 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.398 P=0.172 P=0.562 P=0.297 |P=0.030N* P=0.338 P=0.314N P=0.090N |
|POLY 3 | P=0.397 P=0.139 P=0.526 P=0.265 |P=0.029N* P=0.417 P=0.343N P=0.077N |
|POLY 1.5 | P=0.374 P=0.131 P=0.516 P=0.255 |P=0.031N* P=0.421 P=0.344N P=0.079N |
|POLY 6 | P=0.424 P=0.151 P=0.539 P=0.279 |P=0.027N* P=0.414 P=0.338N P=0.073N |
|LOGISTIC REGRESSION| P=0.383 P=0.172 P=0.514 P=0.272 |P=0.027N* P=0.385 P=0.314N P=0.076N |
|COCH-ARM / FISHERS | P=0.337 P=0.121 P=0.500 P=0.247 |P=0.033N* P=0.436 P=0.338N P=0.081N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 7/50 (14%) 5/50 (10%) |2/46 (4%) 1/48 (2%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 12.0% 2.2% 15.3% 10.6% |4.7% 2.4% 0.0% 2.2% |
|TERMINAL (d) | 3/29 (10%) 1/38 (3%) 5/36 (14%) 2/36 (6%) |1/32 (3%) 1/30 (3%) 0/35 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 400 729 (T) 724 523 |567 730 (T) --- 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415 P=0.069N P=0.516 P=0.534N |P=0.356N P=0.515N P=0.230N P=0.491N |
|POLY 3 | P=0.397 P=0.085N P=0.446 P=0.555N |P=0.348N P=0.498N P=0.228N P=0.479N |
|POLY 1.5 | P=0.374 P=0.092N P=0.418 P=0.585N |P=0.349N P=0.494N P=0.226N P=0.480N |
|POLY 6 | P=0.422 P=0.076N P=0.483 P=0.518N |P=0.347N P=0.502N P=0.228N P=0.478N |
|LOGISTIC REGRESSION| P=0.275 P=0.134N P=0.376 P=0.436 |P=0.349N P=0.465N P=0.190N P=0.439N |
|COCH-ARM / FISHERS | P=0.338 P=0.102N P=0.380 P=0.630N |P=0.350N P=0.484N P=0.232N P=0.476N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 3
Statistical Analysis of Primary Tumors 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/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 8/50 (16%) 7/50 (14%) |10/46 (22%) 11/48 (23%) 6/49 (12%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 12.0% 8.9% 17.4% 14.9% |23.7% 25.8% 13.6% 8.9% |
|TERMINAL (d) | 3/29 (10%) 4/38 (11%) 5/36 (14%) 3/36 (8%) |9/32 (28%) 10/30 (33%) 6/35 (17%) 1/33 (3%) |
|FIRST INCIDENCE | 400 729 (T) 697 523 |567 680 730 (T) 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.321 P=0.369N P=0.418 P=0.499 |P=0.021N* P=0.439 P=0.152N P=0.069N |
|POLY 3 | P=0.301 P=0.455N P=0.340 P=0.465 |P=0.019N* P=0.511 P=0.177N P=0.054N |
|POLY 1.5 | P=0.273 P=0.473N P=0.313 P=0.431 |P=0.020N* P=0.521 P=0.175N P=0.055N |
|POLY 6 | P=0.335 P=0.428N P=0.379 P=0.509 |P=0.017N* P=0.502 P=0.176N P=0.050N |
|LOGISTIC REGRESSION| P=0.205 P=0.528N P=0.275 P=0.227 |P=0.019N* P=0.512 P=0.167N P=0.058N |
|COCH-ARM / FISHERS | P=0.231 P=0.500N P=0.277 P=0.380 |P=0.022N* P=0.544 P=0.168N P=0.057N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.9% 0.0% 0.0% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/29 (14%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 638 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.034N* P=0.039N* P=0.121N |(e) (e) (e) (e) |
|POLY 3 | P=0.135N P=0.047N* P=0.045N* P=0.147N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.130N P=0.052N P=0.051N P=0.161N |(e) (e) (e) (e) |
|POLY 6 | P=0.143N P=0.042N* P=0.039N* P=0.132N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.109N (e) (e) P=0.140N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.128N P=0.059N P=0.059N P=0.187N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 4
Statistical Analysis of Primary Tumors 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% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/38 (0%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 636 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 P=0.446N P=0.457N P=0.576 |(e) (e) (e) (e) |
|POLY 3 | P=0.245 P=0.478N P=0.475N P=0.537 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.244 P=0.487N P=0.485N P=0.520 |(e) (e) (e) (e) |
|POLY 6 | P=0.246 P=0.467N P=0.462N P=0.558 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.245 (e) (e) P=0.520 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.241 P=0.500N P=0.500N P=0.492 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 0/50 (0%) 3/49 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.4% 0.0% 0.0% 6.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/29 (17%) 0/38 (0%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 636 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.015N* P=0.017N* P=0.246N |(e) (e) (e) (e) |
|POLY 3 | P=0.426N P=0.022N* P=0.021N* P=0.295N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.419N P=0.025N* P=0.025N* P=0.323N |(e) (e) (e) (e) |
|POLY 6 | P=0.439N P=0.019N* P=0.017N* P=0.262N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.380N (e) (e) P=0.299N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.412N P=0.028N* P=0.028N* P=0.369N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 5
Statistical Analysis of Primary Tumors 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/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.0% 6.7% 4.4% 4.4% |6.8% 4.5% 6.7% 4.5% |
|TERMINAL (d) | 2/29 (7%) 3/38 (8%) 1/36 (3%) 1/36 (3%) |2/33 (6%) 1/31 (3%) 3/36 (8%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 716 622 |693 680 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.623 P=0.610N P=0.616N |P=0.437N P=0.515N P=0.624N P=0.495N |
|POLY 3 | P=0.474N P=0.549 P=0.647N P=0.647N |P=0.455N P=0.499N P=0.656N P=0.498N |
|POLY 1.5 | P=0.492N P=0.529 P=0.666N P=0.665N |P=0.457N P=0.501N P=0.660N P=0.501N |
|POLY 6 | P=0.454N P=0.574 P=0.621N P=0.625N |P=0.449N P=0.496N P=0.649N P=0.493N |
|LOGISTIC REGRESSION| P=0.467N P=0.623 P=0.597N P=0.661N |P=0.440N P=0.498N P=0.639N P=0.485N |
|COCH-ARM / FISHERS | P=0.523N P=0.500 P=0.691N P=0.691N |P=0.456N P=0.500N P=0.661N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.0% 6.7% 6.5% 4.4% |6.8% 4.5% 8.9% 4.5% |
|TERMINAL (d) | 2/29 (7%) 3/38 (8%) 2/36 (6%) 1/36 (3%) |2/33 (6%) 1/31 (3%) 4/36 (11%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 716 622 |693 680 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476N P=0.623 P=0.602 P=0.616N |P=0.459N P=0.515N P=0.545 P=0.495N |
|POLY 3 | P=0.487N P=0.549 P=0.559 P=0.647N |P=0.477N P=0.499N P=0.508 P=0.498N |
|POLY 1.5 | P=0.508N P=0.529 P=0.535 P=0.665N |P=0.480N P=0.501N P=0.503 P=0.501N |
|POLY 6 | P=0.465N P=0.574 P=0.588 P=0.625N |P=0.471N P=0.496N P=0.517 P=0.493N |
|LOGISTIC REGRESSION| P=0.481N P=0.623 P=0.623 P=0.661N |P=0.461N P=0.498N P=0.532 P=0.485N |
|COCH-ARM / FISHERS | P=0.544N P=0.500 P=0.500 P=0.691N |P=0.479N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 6
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 0.0% 6.7% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 0/36 (0%) 0/36 (0%) |2/33 (6%) 1/31 (3%) 0/36 (0%) 3/33 (9%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.346 P=0.522N P=0.219N P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.339 P=0.499N P=0.233N P=0.503 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.338 P=0.501N P=0.236N P=0.500 |
|POLY 6 | (e) (e) (e) (e) |P=0.342 P=0.497N P=0.229N P=0.510 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.346 P=0.522N (e) P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.337 P=0.500N P=0.247N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |2.3% 2.3% 4.4% 4.4% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |1/33 (3%) 1/31 (3%) 2/36 (6%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |730 (T) 730 (T) 730 (T) 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.715 (e) P=0.543 (e) |P=0.350 P=0.748 P=0.530 P=0.512 |
|POLY 3 | P=0.726 (e) P=0.525 (e) |P=0.351 P=0.760N P=0.506 P=0.511 |
|POLY 1.5 | P=0.715 (e) P=0.515 (e) |P=0.345 P=0.760 P=0.503 P=0.505 |
|POLY 6 | P=0.738 (e) P=0.538 (e) |P=0.361 P=0.759N P=0.513 P=0.519 |
|LOGISTIC REGRESSION| (e) (e) P=0.543 (e) |P=0.346 P=0.748 P=0.530 P=0.594 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.337 P=0.753N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 7
Statistical Analysis of Primary Tumors 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |4.5% 4.5% 4.4% 11.0% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |2/33 (6%) 2/31 (7%) 2/36 (6%) 3/33 (9%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |730 (T) 730 (T) 730 (T) 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.715 (e) P=0.543 (e) |P=0.122 P=0.673 P=0.664N P=0.226 |
|POLY 3 | P=0.726 (e) P=0.525 (e) |P=0.121 P=0.694N P=0.687N P=0.228 |
|POLY 1.5 | P=0.715 (e) P=0.515 (e) |P=0.118 P=0.693 P=0.691N P=0.223 |
|POLY 6 | P=0.738 (e) P=0.538 (e) |P=0.126 P=0.692N P=0.681N P=0.237 |
|LOGISTIC REGRESSION| (e) (e) P=0.543 (e) |P=0.114 P=0.673 P=0.664N P=0.224 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.114 P=0.691N P=0.691N P=0.218 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 0/50 (0%) |21/50 (42%) 27/50 (54%) 31/50 (62%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 7.3% 11.1% 6.5% 0.0% |45.7% 58.5% 66.7% 54.4% |
|TERMINAL (d) | 1/29 (3%) 5/38 (13%) 2/36 (6%) 0/36 (0%) |15/33 (46%) 17/31 (55%) 26/36 (72%) 16/33 (49%) |
|FIRST INCIDENCE | 589 729 (T) 708 --- |547 541 541 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044N* P=0.487 P=0.566N P=0.096N |P=0.363 P=0.148 P=0.092 P=0.315 |
|POLY 3 | P=0.047N* P=0.405 P=0.611N P=0.102N |P=0.268 P=0.149 P=0.029 * P=0.263 |
|POLY 1.5 | P=0.052N P=0.386 P=0.631N P=0.108N |P=0.265 P=0.149 P=0.030 * P=0.260 |
|POLY 6 | P=0.042N* P=0.428 P=0.586N P=0.096N |P=0.289 P=0.154 P=0.030 * P=0.280 |
|LOGISTIC REGRESSION| P=0.052N P=0.395 P=0.667N P=0.145N |P=0.292 P=0.155 P=0.039 * P=0.279 |
|COCH-ARM / FISHERS | P=0.064N P=0.357 P=0.661N P=0.121N |P=0.283 P=0.158 P=0.036 * P=0.274 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 8
Statistical Analysis of Primary Tumors 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 |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) 0/50 (0%) |23/50 (46%) 27/50 (54%) 31/50 (62%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| 7.3% 11.1% 6.5% 0.0% |50.1% 58.5% 66.7% 61.0% |
|TERMINAL (d) | 1/29 (3%) 5/38 (13%) 2/36 (6%) 0/36 (0%) |17/33 (52%) 17/31 (55%) 26/36 (72%) 19/33 (58%) |
|FIRST INCIDENCE | 589 729 (T) 708 --- |547 541 541 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.044N* P=0.487 P=0.566N P=0.096N |P=0.266 P=0.241 P=0.173 P=0.255 |
|POLY 3 | P=0.047N* P=0.405 P=0.611N P=0.102N |P=0.169 P=0.270 P=0.073 P=0.196 |
|POLY 1.5 | P=0.052N P=0.386 P=0.631N P=0.108N |P=0.169 P=0.266 P=0.073 P=0.195 |
|POLY 6 | P=0.042N* P=0.428 P=0.586N P=0.096N |P=0.181 P=0.280 P=0.076 P=0.211 |
|LOGISTIC REGRESSION| P=0.052N P=0.395 P=0.667N P=0.145N |P=0.192 P=0.272 P=0.089 P=0.217 |
|COCH-ARM / FISHERS | P=0.064N P=0.357 P=0.661N P=0.121N |P=0.187 P=0.274 P=0.080 P=0.212 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |23/50 (46%) 27/50 (54%) 33/50 (66%) 30/50 (60%) |
|POLY-3 ADJUSTED (b)| 7.3% 11.1% 8.7% 0.0% |50.1% 58.5% 71.0% 63.8% |
|TERMINAL (d) | 1/29 (3%) 5/38 (13%) 3/36 (8%) 0/36 (0%) |17/33 (52%) 17/31 (55%) 28/36 (78%) 19/33 (58%) |
|FIRST INCIDENCE | 589 729 (T) 708 --- |547 541 541 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.487 P=0.607 P=0.096N |P=0.150 P=0.241 P=0.093 P=0.164 |
|POLY 3 | P=0.058N P=0.405 P=0.559 P=0.102N |P=0.092 P=0.270 P=0.027 * P=0.124 |
|POLY 1.5 | P=0.064N P=0.386 P=0.536 P=0.108N |P=0.086 P=0.266 P=0.028 * P=0.117 |
|POLY 6 | P=0.052N P=0.428 P=0.587 P=0.096N |P=0.108 P=0.280 P=0.027 * P=0.143 |
|LOGISTIC REGRESSION| P=0.063N P=0.395 P=0.518 P=0.145N |P=0.083 P=0.272 P=0.038 * P=0.112 |
|COCH-ARM / FISHERS | P=0.079N P=0.357 P=0.500 P=0.121N |P=0.085 P=0.274 P=0.035 * P=0.115 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 9
Statistical Analysis of Primary Tumors 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% |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |2.3% 4.5% 2.2% 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 | --- --- 593 --- |662 609 658 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.710 (e) P=0.528 (e) |P=0.243N P=0.519 P=0.755N P=0.495N |
|POLY 3 | P=0.726 (e) P=0.527 (e) |P=0.247N P=0.504 P=0.757N P=0.500N |
|POLY 1.5 | P=0.714 (e) P=0.516 (e) |P=0.249N P=0.501 P=0.759N P=0.501N |
|POLY 6 | P=0.738 (e) P=0.541 (e) |P=0.244N P=0.508 P=0.753N P=0.498N |
|LOGISTIC REGRESSION| P=0.625 (e) P=0.417 (e) |P=0.236N P=0.527 P=0.759N P=0.492N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.247N P=0.500 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% |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |2.3% 4.5% 2.2% 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 | --- --- 593 --- |662 609 658 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.710 (e) P=0.528 (e) |P=0.243N P=0.519 P=0.755N P=0.495N |
|POLY 3 | P=0.726 (e) P=0.527 (e) |P=0.247N P=0.504 P=0.757N P=0.500N |
|POLY 1.5 | P=0.714 (e) P=0.516 (e) |P=0.249N P=0.501 P=0.759N P=0.501N |
|POLY 6 | P=0.738 (e) P=0.541 (e) |P=0.244N P=0.508 P=0.753N P=0.498N |
|LOGISTIC REGRESSION| P=0.625 (e) P=0.417 (e) |P=0.236N P=0.527 P=0.759N P=0.492N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.247N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 10
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% 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 | --- 669 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.301 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.367N P=0.263 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.383N P=0.252 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.348N P=0.278 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.400N P=0.252 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 1/36 (3%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 669 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.420N P=0.301 P=0.543 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.417N P=0.263 P=0.525 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.435N P=0.252 P=0.515 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.395N P=0.278 P=0.538 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.442N P=0.252 P=0.543 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.466N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 11
Statistical Analysis of Primary Tumors 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 or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 13/49 (27%) 15/50 (30%) 10/50 (20%) |24/50 (48%) 25/50 (50%) 17/50 (34%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 31.5% 28.8% 31.5% 21.8% |51.9% 53.9% 36.7% 45.6% |
|TERMINAL (d) | 10/29 (35%) 10/37 (27%) 12/36 (33%) 9/36 (25%) |16/33 (49%) 16/31 (52%) 12/36 (33%) 14/33 (42%) |
|FIRST INCIDENCE | 589 481 505 622 |513 536 541 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.330N P=0.516N P=0.144N |P=0.200N P=0.437 P=0.086N P=0.343N |
|POLY 3 | P=0.191N P=0.488N P=0.587 P=0.218N |P=0.207N P=0.507 P=0.099N P=0.342N |
|POLY 1.5 | P=0.218N P=0.537N P=0.518 P=0.252N |P=0.214N P=0.498 P=0.105N P=0.351N |
|POLY 6 | P=0.168N P=0.426N P=0.515N P=0.184N |P=0.191N P=0.522 P=0.091N P=0.321N |
|LOGISTIC REGRESSION| P=0.212N P=0.499N P=0.511 P=0.178N |P=0.207N P=0.498 P=0.103N P=0.338N |
|COCH-ARM / FISHERS | P=0.275N P=0.567 P=0.412 P=0.318N |P=0.213N P=0.500 P=0.111N P=0.344N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% 0.0% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/29 (0%) 2/38 (5%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |730 (T) --- --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N P=0.299 (e) (e) |P=0.604 P=0.512N P=0.483N P=0.753N |
|POLY 3 | P=0.364N P=0.262 (e) (e) |P=0.597 P=0.500N P=0.496N P=0.757N |
|POLY 1.5 | P=0.379N P=0.252 (e) (e) |P=0.596 P=0.500N P=0.499N P=0.760N |
|POLY 6 | P=0.346N P=0.275 (e) (e) |P=0.600 P=0.499N P=0.493N P=0.753N |
|LOGISTIC REGRESSION| (e) P=0.299 (e) (e) |P=0.597 (e) (e) P=0.760N |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 12
Statistical Analysis of Primary Tumors 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 |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 4.5% 0.0% 0.0% |4.5% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/29 (0%) 2/38 (5%) 0/36 (0%) 0/36 (0%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 724 729 (T) --- --- |513 --- --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162N P=0.589 P=0.453N P=0.464N |P=0.506 P=0.249N P=0.230N P=0.687N |
|POLY 3 | P=0.169N P=0.537 P=0.475N P=0.476N |P=0.504 P=0.240N P=0.236N P=0.692N |
|POLY 1.5 | P=0.176N P=0.522 P=0.485N P=0.485N |P=0.502 P=0.240N P=0.238N P=0.693 |
|POLY 6 | P=0.162N P=0.557 P=0.462N P=0.466N |P=0.508 P=0.240N P=0.233N P=0.685N |
|LOGISTIC REGRESSION| P=0.155N P=0.585 P=0.449N P=0.456N |P=0.522 P=0.199N P=0.208N P=0.659N |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.500 P=0.247N P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 4/50 (8%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.3% 13.1% 8.7% 8.8% |6.7% 0.0% 0.0% 6.6% |
|TERMINAL (d) | 1/29 (3%) 4/38 (11%) 4/36 (11%) 4/36 (11%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 486 480 729 (T) 729 (T) |513 --- --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502N P=0.355 P=0.602 P=0.600 |P=0.457 P=0.128N P=0.118N P=0.647N |
|POLY 3 | P=0.525N P=0.299 P=0.560 P=0.555 |P=0.449 P=0.122N P=0.119N P=0.661N |
|POLY 1.5 | P=0.546N P=0.276 P=0.536 P=0.535 |P=0.446 P=0.121N P=0.120N P=0.660 |
|POLY 6 | P=0.503N P=0.331 P=0.590 P=0.579 |P=0.453 P=0.122N P=0.117N P=0.654N |
|LOGISTIC REGRESSION| P=0.568N P=0.215 P=0.528 P=0.530 |P=0.458 P=0.099N P=0.105N P=0.639N |
|COCH-ARM / FISHERS | P=0.551 P=0.243 P=0.500 P=0.500 |P=0.444 P=0.121N P=0.121N P=0.661N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 13
Statistical Analysis of Primary Tumors 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 |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 6/50 (12%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 13.0% 6.6% |2.3% 0.0% 4.4% 2.2% |
|TERMINAL (d) | 0/29 (0%) 1/38 (3%) 3/36 (8%) 2/36 (6%) |0/33 (0%) 0/31 (0%) 2/36 (6%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 694 697 |729 --- 730 (T) 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112 P=0.554 P=0.040 * P=0.170 |P=0.512 P=0.518N P=0.527 P=0.754N |
|POLY 3 | P=0.103 P=0.521 P=0.024 * P=0.142 |P=0.503 P=0.500N P=0.506 P=0.759N |
|POLY 1.5 | P=0.091 P=0.513 P=0.020 * P=0.133 |P=0.500 P=0.500N P=0.503 P=0.760N |
|POLY 6 | P=0.116 P=0.533 P=0.030 * P=0.154 |P=0.509 P=0.499N P=0.513 P=0.755N |
|LOGISTIC REGRESSION| P=0.099 P=0.554 P=0.028 * P=0.154 |P=0.514 P=0.505N P=0.531 P=0.756N |
|COCH-ARM / FISHERS | P=0.077 P=0.500 P=0.013 * P=0.121 |P=0.500 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 7/50 (14%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.2% 14.9% 10.8% |2.3% 0.0% 4.4% 4.5% |
|TERMINAL (d) | 1/29 (3%) 1/38 (3%) 3/36 (8%) 3/36 (8%) |0/33 (0%) 0/31 (0%) 2/36 (6%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 400 520 |729 --- 730 (T) 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061 P=0.701N P=0.070 P=0.161 |P=0.257 P=0.518N P=0.527 P=0.506 |
|POLY 3 | P=0.054 P=0.736N P=0.050 P=0.136 |P=0.248 P=0.500N P=0.506 P=0.503 |
|POLY 1.5 | P=0.047 * P=0.746N P=0.041 * P=0.122 |P=0.247 P=0.500N P=0.503 P=0.500 |
|POLY 6 | P=0.063 P=0.723N P=0.063 P=0.154 |P=0.253 P=0.499N P=0.513 P=0.509 |
|LOGISTIC REGRESSION| P=0.030 * P=0.701N P=0.026 * P=0.105 |P=0.258 P=0.505N P=0.531 P=0.513 |
|COCH-ARM / FISHERS | P=0.038 * P=0.753N P=0.030 * P=0.102 |P=0.245 P=0.500N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 14
Statistical Analysis of Primary Tumors 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 |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 4.3% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/29 (3%) 0/38 (0%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- --- 520 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270 P=0.446N P=0.457N P=0.560 |P=0.201 (e) (e) P=0.500 |
|POLY 3 | P=0.251 P=0.478N P=0.475N P=0.546 |P=0.200 (e) (e) P=0.501 |
|POLY 1.5 | P=0.250 P=0.487N P=0.485N P=0.529 |P=0.199 (e) (e) P=0.500 |
|POLY 6 | P=0.251 P=0.467N P=0.462N P=0.566 |P=0.202 (e) (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.205 (e) (e) P=0.453 |(e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 2.1% 4.3% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/29 (3%) 0/38 (0%) 0/36 (0%) 1/36 (3%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- 400 520 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271 P=0.446N P=0.734N P=0.560 |P=0.201 (e) (e) P=0.500 |
|POLY 3 | P=0.266 P=0.478N P=0.727N P=0.546 |P=0.200 (e) (e) P=0.501 |
|POLY 1.5 | P=0.260 P=0.487N P=0.740N P=0.529 |P=0.199 (e) (e) P=0.500 |
|POLY 6 | P=0.271 P=0.467N P=0.710N P=0.566 |P=0.202 (e) (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.116 (e) P=0.655 P=0.453 |(e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.247 P=0.500N P=0.753N P=0.500 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 15
Statistical Analysis of Primary Tumors 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 |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 6.6% 8.7% 8.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 2/38 (5%) 4/36 (11%) 4/36 (11%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 486 680 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.328 P=0.593 P=0.425 P=0.426 |(e) (e) (e) (e) |
|POLY 3 | P=0.310 P=0.543 P=0.389 P=0.385 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.294 P=0.526 P=0.368 P=0.367 |(e) (e) (e) (e) |
|POLY 6 | P=0.326 P=0.567 P=0.417 P=0.407 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.298 P=0.481 P=0.344 P=0.346 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.264 P=0.500 P=0.339 P=0.339 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |0.0% 0.0% 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 | 724 --- --- --- |--- --- 554 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.453N P=0.453N P=0.464N |P=0.598 (e) P=0.252 (e) |
|POLY 3 | P=0.324N P=0.479N P=0.475N P=0.476N |P=0.597 (e) P=0.244 (e) |
|POLY 1.5 | P=0.317N P=0.487N P=0.485N P=0.485N |P=0.595 (e) P=0.240 (e) |
|POLY 6 | P=0.335N P=0.468N P=0.462N P=0.466N |P=0.604 (e) P=0.250 (e) |
|LOGISTIC REGRESSION| P=0.281N P=0.456N P=0.449N P=0.456N |P=0.607 (e) P=0.247 (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 16
Statistical Analysis of Primary Tumors 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 |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous |
| Tumor (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 2.2% 0.0% 0.0% |4.4% 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%) 0/33 (0%) |
|FIRST INCIDENCE | 724 480 --- --- |513 --- --- 658 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.732N P=0.453N P=0.464N |P=0.507 P=0.239N P=0.237N P=0.684N |
|POLY 3 | P=0.229N P=0.733N P=0.475N P=0.476N |P=0.503 P=0.241N P=0.237N P=0.692 |
|POLY 1.5 | P=0.231N P=0.744N P=0.485N P=0.485N |P=0.501 P=0.240N P=0.238N P=0.691 |
|POLY 6 | P=0.227N P=0.718N P=0.462N P=0.466N |P=0.506 P=0.242N P=0.236N P=0.693N |
|LOGISTIC REGRESSION| P=0.315N P=0.705 P=0.449N P=0.456N |P=0.517 P=0.172N P=0.183N P=0.666N |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.500 P=0.247N P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 8.7% 8.7% 8.8% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/29 (3%) 2/38 (5%) 4/36 (11%) 4/36 (11%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 486 480 729 (T) 729 (T) |669 --- --- 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389 P=0.422 P=0.425 P=0.426 |P=0.606 P=0.495N P=0.495N P=0.748N |
|POLY 3 | P=0.372 P=0.389 P=0.389 P=0.385 |P=0.596 P=0.501N P=0.497N P=0.760N |
|POLY 1.5 | P=0.354 P=0.368 P=0.368 P=0.367 |P=0.595 P=0.501N P=0.499N P=0.760 |
|POLY 6 | P=0.392 P=0.418 P=0.417 P=0.407 |P=0.598 P=0.501N P=0.495N P=0.758N |
|LOGISTIC REGRESSION| P=0.314 P=0.262 P=0.344 P=0.346 |P=0.595 P=0.494N P=0.498N P=0.762N |
|COCH-ARM / FISHERS | P=0.320 P=0.339 P=0.339 P=0.339 |P=0.595 P=0.500N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 17
Statistical Analysis of Primary Tumors 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 |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 46/50 (92%) 47/50 (94%) 46/50 (92%) | |
|POLY-3 ADJUSTED (b)| 98.9% 96.3% 96.7% 95.1% | |
|TERMINAL (d) | 29/29 (100%) 37/38 (97%) 35/36 (97%) 36/36 (100%)| |
|FIRST INCIDENCE | 486 552 505 520 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.018N* P=0.056N P=0.038N* | |
|POLY 3 | P=0.200N P=0.416N P=0.478N P=0.248N | |
|POLY 1.5 | P=0.254N P=0.414N P=0.534N P=0.301N | |
|POLY 6 | P=0.272N P=0.470N P=0.469N P=0.330N | |
|LOGISTIC REGRESSION| P=0.043N* P=0.133N P=0.213N P=0.050N | |
|COCH-ARM / FISHERS | P=0.463N P=0.500N P=0.661N P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) 7/50 (14%) 5/50 (10%) |7/50 (14%) 4/49 (8%) 10/48 (21%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 29.3% 17.8% 15.2% 10.9% |15.8% 9.1% 22.7% 15.7% |
|TERMINAL (d) | 10/29 (35%) 8/38 (21%) 5/36 (14%) 4/36 (11%) |7/33 (21%) 2/31 (7%) 7/36 (19%) 6/33 (18%) |
|FIRST INCIDENCE | 620 729 (T) 708 636 |730 (T) 616 658 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020N* P=0.075N P=0.061N P=0.018N* |P=0.418 P=0.287N P=0.364 P=0.610N |
|POLY 3 | P=0.028N* P=0.157N P=0.092N P=0.028N* |P=0.399 P=0.263N P=0.293 P=0.605N |
|POLY 1.5 | P=0.033N* P=0.183N P=0.113N P=0.036N* |P=0.394 P=0.270N P=0.278 P=0.612N |
|POLY 6 | P=0.024N* P=0.129N P=0.070N P=0.021N* |P=0.413 P=0.252N P=0.321 P=0.591N |
|LOGISTIC REGRESSION| P=0.019N* P=0.102N P=0.059N P=0.023N* |P=0.411 P=0.270N P=0.312 P=0.583N |
|COCH-ARM / FISHERS | P=0.045N* P=0.227N P=0.154N P=0.054N |P=0.394 P=0.274N P=0.266 P=0.613N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 18
Statistical Analysis of Primary Tumors 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 |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 0/49 (0%) 0/48 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 4.3% 2.2% |4.5% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/29 (7%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |2/33 (6%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- 582 705 |730 (T) --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482N P=0.181N P=0.624N P=0.420N |P=0.453N P=0.252N P=0.219N P=0.500N |
|POLY 3 | P=0.518N P=0.214N P=0.643N P=0.458N |P=0.459N P=0.241N P=0.240N P=0.498N |
|POLY 1.5 | P=0.522N P=0.223N P=0.664N P=0.474N |P=0.459N P=0.242N P=0.244N P=0.500N |
|POLY 6 | P=0.517N P=0.202N P=0.616N P=0.439N |P=0.458N P=0.240N P=0.234N P=0.492N |
|LOGISTIC REGRESSION| P=0.525N (e) P=0.683N P=0.428N |P=0.453N (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.531N P=0.247N P=0.691N P=0.500N |P=0.461N P=0.253N P=0.258N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 8/50 (16%) 9/50 (18%) 6/50 (12%) |9/50 (18%) 4/49 (8%) 10/48 (21%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 34.1% 17.8% 19.4% 13.1% |20.4% 9.1% 22.7% 15.7% |
|TERMINAL (d) | 12/29 (41%) 8/38 (21%) 6/36 (17%) 4/36 (11%) |9/33 (27%) 2/31 (7%) 7/36 (19%) 6/33 (18%) |
|FIRST INCIDENCE | 620 729 (T) 582 636 |730 (T) 616 658 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019N* P=0.025N* P=0.064N P=0.011N* |P=0.498N P=0.135N P=0.578 P=0.384N |
|POLY 3 | P=0.027N* P=0.066N P=0.091N P=0.017N* |P=0.518N P=0.115N P=0.498 P=0.382N |
|POLY 1.5 | P=0.032N* P=0.082N P=0.119N P=0.023N* |P=0.524N P=0.120N P=0.478 P=0.391N |
|POLY 6 | P=0.022N* P=0.049N* P=0.064N P=0.011N* |P=0.505N P=0.107N P=0.533 P=0.365N |
|LOGISTIC REGRESSION| P=0.020N* P=0.036N* P=0.072N P=0.013N* |P=0.504N P=0.121N P=0.527 P=0.354N |
|COCH-ARM / FISHERS | P=0.045N* P=0.114N P=0.171N P=0.039N* |P=0.525N P=0.125N P=0.460 P=0.393N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 19
Statistical Analysis of Primary Tumors 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: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/49 (0%) 1/48 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 2.2% 2.2% |4.5% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 0/29 (0%) 0/38 (0%) 1/36 (3%) 0/36 (0%) |1/33 (3%) 0/31 (0%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 680 --- 729 (T) 622 |547 --- 723 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447N P=0.186N P=0.401N P=0.417N |P=0.494N P=0.251N P=0.480N P=0.505N |
|POLY 3 | P=0.499N P=0.216N P=0.459N P=0.459N |P=0.497N P=0.244N P=0.509N P=0.502N |
|POLY 1.5 | P=0.498N P=0.224N P=0.475N P=0.474N |P=0.498N P=0.244N P=0.513N P=0.503N |
|POLY 6 | P=0.501N P=0.206N P=0.439N P=0.442N |P=0.494N P=0.245N P=0.502N P=0.499N |
|LOGISTIC REGRESSION| P=0.522N P=0.234N P=0.475N P=0.542N |P=0.498N P=0.216N P=0.513N P=0.491N |
|COCH-ARM / FISHERS | P=0.500N P=0.247N P=0.500N P=0.500N |P=0.499N P=0.253N P=0.515N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | |1/33 (3%) 1/31 (3%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | |548 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.099N P=0.517N P=0.230N P=0.242N |
|POLY 3 | |P=0.100N P=0.504N P=0.236N P=0.238N |
|POLY 1.5 | |P=0.100N P=0.503N P=0.237N P=0.239N |
|POLY 6 | |P=0.099N P=0.504N P=0.233N P=0.236N |
|LOGISTIC REGRESSION| |P=0.099N P=0.491N P=0.220N P=0.212N |
|COCH-ARM / FISHERS | |P=0.101N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 20
Statistical Analysis of Primary Tumors 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 |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 3/50 (6%) 8/50 (16%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| |15.8% 6.5% 17.6% 15.7% |
|TERMINAL (d) | |7/33 (21%) 0/31 (0%) 6/36 (17%) 6/33 (18%) |
|FIRST INCIDENCE | |730 (T) 332 626 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.397 P=0.180N P=0.569 P=0.610N |
|POLY 3 | |P=0.364 P=0.138N P=0.525 P=0.605N |
|POLY 1.5 | |P=0.364 P=0.147N P=0.511 P=0.612N |
|POLY 6 | |P=0.371 P=0.130N P=0.549 P=0.591N |
|LOGISTIC REGRESSION| |P=0.373 P=0.137N P=0.535 P=0.583N |
|COCH-ARM / FISHERS | |P=0.372 P=0.159N P=0.500 P=0.613N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 3/50 (6%) 9/50 (18%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| |15.8% 6.5% 19.8% 15.7% |
|TERMINAL (d) | |7/33 (21%) 0/31 (0%) 7/36 (19%) 6/33 (18%) |
|FIRST INCIDENCE | |730 (T) 332 626 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.386 P=0.180N P=0.463 P=0.610N |
|POLY 3 | |P=0.352 P=0.138N P=0.417 P=0.605N |
|POLY 1.5 | |P=0.352 P=0.147N P=0.404 P=0.612N |
|POLY 6 | |P=0.360 P=0.130N P=0.441 P=0.591N |
|LOGISTIC REGRESSION| |P=0.361 P=0.137N P=0.428 P=0.583N |
|COCH-ARM / FISHERS | |P=0.361 P=0.159N P=0.393 P=0.613N |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 21
Statistical Analysis of Primary Tumors 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% |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 4.4% |0.0% 0.0% 2.2% 2.2% |
|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 | 610 --- --- 655 |--- --- 596 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 P=0.476N P=0.471N P=0.569 |P=0.235 (e) P=0.504 P=0.492 |
|POLY 3 | P=0.250 P=0.481N P=0.477N P=0.540 |P=0.243 (e) P=0.506 P=0.505 |
|POLY 1.5 | P=0.249 P=0.488N P=0.486N P=0.525 |P=0.239 (e) P=0.503 P=0.502 |
|POLY 6 | P=0.250 P=0.471N P=0.465N P=0.557 |P=0.248 (e) P=0.511 P=0.509 |
|LOGISTIC REGRESSION| P=0.211 P=0.554N P=0.568N P=0.464 |P=0.273 (e) P=0.542 P=0.744 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 12/50 (24%) 7/50 (14%) 3/50 (6%) |15/50 (30%) 10/50 (20%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 37.9% 25.7% 15.0% 6.6% |32.1% 21.9% 2.2% 2.2% |
|TERMINAL (d) | 7/29 (24%) 7/38 (18%) 1/36 (3%) 1/36 (3%) |8/33 (24%) 4/31 (13%) 0/36 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 486 552 620 698 |513 616 638 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.085N P=0.008N** P<0.001N** |P<0.001N** P=0.215N P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.151N P=0.010N* P<0.001N** |P<0.001N** P=0.191N P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.163N P=0.012N* P<0.001N** |P<0.001N** P=0.188N P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.137N P=0.008N** P<0.001N** |P<0.001N** P=0.192N P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.241N P=0.030N* P<0.001N** |P<0.001N** P=0.174N P<0.001N** P<0.001N** |
|COCH-ARM / FISHERS | P<0.001N** P=0.189N P=0.017N* P<0.001N** |P<0.001N** P=0.178N P<0.001N** P<0.001N** |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 22
Statistical Analysis of Primary Tumors 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% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 6.6% 8.6% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/38 (5%) 2/36 (6%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 558 641 593 705 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193N P=0.552N P=0.605 P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.211N P=0.615N P=0.569 P=0.267N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.224N P=0.634N P=0.541 P=0.281N |(e) (e) (e) (e) |
|POLY 6 | P=0.198N P=0.589N P=0.604 P=0.252N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.253N P=0.656N P=0.491 P=0.307N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.661N P=0.500 P=0.309N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.3% 6.6% 8.6% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/38 (5%) 2/36 (6%) 0/36 (0%) |0/33 (0%) 0/31 (0%) 0/36 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 558 641 593 705 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193N P=0.552N P=0.605 P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.211N P=0.615N P=0.569 P=0.267N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.224N P=0.634N P=0.541 P=0.281N |(e) (e) (e) (e) |
|POLY 6 | P=0.198N P=0.589N P=0.604 P=0.252N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.253N P=0.656N P=0.491 P=0.307N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.661N P=0.500 P=0.309N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 23
Statistical Analysis of Primary Tumors 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% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) 49/50 (98%) 49/50 (98%) |42/50 (84%) 42/50 (84%) 46/50 (92%) 42/50 (84%) |
|POLY-3 ADJUSTED (b)| 98.9% 99.0% 99.7% 99.1% |87.5% 84.6% 95.2% 89.4% |
|TERMINAL (d) | 29/29 (100%) 38/38 (100%) 36/36 (100%) 36/36 (100%)|29/33 (88%) 25/31 (81%) 35/36 (97%) 29/33 (88%) |
|FIRST INCIDENCE | 486 481 505 520 |511 332 541 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181N P=0.041N* P=0.106N P=0.114N |P=0.469N P=0.462 P=0.516 P=0.540N |
|POLY 3 | P=0.775 P=0.973 P=0.951 P=0.946 |P=0.303 P=0.452N P=0.140 P=0.517 |
|POLY 1.5 | P=0.457 P=0.784 P=0.608 P=0.685 |P=0.354 P=0.519N P=0.142 P=0.533 |
|POLY 6 | P=0.995N P=1.000 P=1.000 P=1.000N |P=0.300 P=0.374N P=0.156 P=0.549 |
|LOGISTIC REGRESSION| P=0.359N P=0.794 P=0.995 P=0.536N |P=0.472 P=0.604 P=0.165 P=0.593 |
|COCH-ARM / FISHERS | P=0.199 P=0.500 P=0.309 P=0.309 |P=0.500 P=0.607N P=0.178 P=0.607N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 22/50 (44%) 21/50 (42%) 20/50 (40%) |23/50 (46%) 16/50 (32%) 12/50 (24%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 63.1% 45.3% 43.1% 40.6% |47.8% 34.0% 25.1% 25.5% |
|TERMINAL (d) | 14/29 (48%) 13/38 (34%) 10/36 (28%) 8/36 (22%) |13/33 (39%) 7/31 (23%) 5/36 (14%) 5/33 (15%) |
|FIRST INCIDENCE | 400 480 400 520 |513 480 337 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028N* P=0.027N* P=0.022N* P=0.018N* |P=0.023N* P=0.166N P=0.023N* P=0.032N* |
|POLY 3 | P=0.029N* P=0.058N P=0.036N* P=0.020N* |P=0.013N* P=0.121N P=0.016N* P=0.018N* |
|POLY 1.5 | P=0.033N* P=0.064N P=0.041N* P=0.023N* |P=0.013N* P=0.118N P=0.016N* P=0.017N* |
|POLY 6 | P=0.026N* P=0.051N P=0.031N* P=0.016N* |P=0.014N* P=0.122N P=0.016N* P=0.018N* |
|LOGISTIC REGRESSION| P=0.112N P=0.142N P=0.116N P=0.106N |P=0.012N* P=0.104N P=0.018N* P=0.015N* |
|COCH-ARM / FISHERS | P=0.044N* P=0.080N P=0.055N P=0.036N* |P=0.014N* P=0.109N P=0.018N* P=0.018N* |
|=================================================================================================================================|
Date: 10/18/99 EXPERIMENT: 88007 TEST: 05 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - SODIUM NITRITE
Terminal Sacrifice at 105 weeks
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| | | |
| | Males | Females |
|Dose | 0.0% 0.075% 0.15% 0.30% |0.0% 0.075% 0.15% 0.30% |
| | | |
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| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 50/50 (100%) 50/50 (100%)|45/50 (90%) 45/50 (90%) 49/50 (98%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 99.9% 99.6% 100.0% 100.0% |90.8% 90.0% 98.0% 92.6% |
|TERMINAL (d) | 29/29 (100%) 38/38 (100%) 36/36 (100%) 36/36 (100%)|29/33 (88%) 26/31 (84%) 35/36 (97%) 30/33 (91%) |
|FIRST INCIDENCE | 400 480 400 520 |511 332 337 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150N P=0.033N* P=0.085N P=0.091N |P=0.468N P=0.465 P=0.516 P=0.539N |
|POLY 3 | P=0.998 P=1.000N P=1.000 P=1.000 |P=0.333 P=0.581N P=0.124 P=0.519 |
|POLY 1.5 | P=0.676 P=0.947N P=1.000 P=1.000 |P=0.389 P=0.603N P=0.113 P=0.559 |
|POLY 6 | P=1.000 P=1.000N P=1.000 P=1.000 |P=0.297 P=0.552N P=0.142 P=0.494 |
|LOGISTIC REGRESSION| P=0.900 P=0.415N (e) (e) |P=0.500 P=0.627 P=0.100 P=0.617 |
|COCH-ARM / FISHERS | P=0.236 P=0.753N P=0.500 P=0.500 |P=0.500 P=0.630N P=0.102 P=0.630N |
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(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).