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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 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|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     |
|=================================================================================================================================|

(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).