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TDMS Study 88007-06 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 05/13/99       
EXPERIMENT: 88007 TEST: 06                                                                                     TIME: 09:44:54       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007       
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7632-00-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                        2 YEAR CHRONIC MICE                                                         
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 05/13/99     
EXPERIMENT: 88007 TEST: 06                                                                                     TIME: 09:44:54     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007     
PATHOLOGIST: TOFT, JOHN                                                                                        CAS: 7632-00-0     



SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF                  SODIUM NITRITE
===============================================================

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex: Capsule                Hyperplasia
Liver                                  Necrosis
Lung                                   Necrosis
Lung: Alveolar Epithelium              Hyperplasia
Oral Mucosa: Gingival                  Inflammation Chronic
Preputial Gland: Duct                  Cyst
Prostate                               Infiltration Cellular Mononuclear Cell
Spleen                                 Hematopoietic Cell Proliferation
Stomach, Glandular: Epithelium         Hyperplasia
Testes                                 Mineralization
Urinary Bladder                        Infiltration Cellular Mononuclear Cell
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Bone Marrow                            Atrophy
Liver                                  Angiectasis
                                       Mixed Cell Focus
Liver: Centrilobular                   Necrosis
Lymph Node, Mandibular                 Hyperplasia Lymphoid
Mesentery: Fat                         Necrosis
Salivary Glands                        Atrophy
                                       Infiltration Cellular Mononuclear Cell
Skin: Subcutaneous Tissue              Infiltration Cellular Mononuclear Cell
Stomach, Glandular: Glands             Ectasia
Thymus                                 Cyst
===============================================================
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 1
                     Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Accessory Adrenal Cortical Nodule                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    6/50 (12%)   4/50 (8%)   |1/50 (2%)    2/50 (4%)    1/49 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         12.5%        8.8%        |2.2%         4.4%         2.2%         2.2%         |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    4/42 (10%)   4/39 (10%)  |1/40 (3%)    1/34 (3%)    1/37 (3%)    1/41 (2%)    |
|FIRST INCIDENCE    |     727 (T)      ---          643          727 (T)     |728 (T)      659          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.099      P=0.208N     P=0.160      P=0.336     |P=0.505N     P=0.465      P=0.744      P=0.756N     |
|POLY 3             |     P=0.098      P=0.233N     P=0.141      P=0.324     |P=0.525N     P=0.501      P=0.760N     P=0.757N     |
|POLY 1.5           |     P=0.103      P=0.235N     P=0.138      P=0.329     |P=0.528N     P=0.502      P=0.759      P=0.759N     |
|POLY 6             |     P=0.092      P=0.229N     P=0.146      P=0.319     |P=0.520N     P=0.497      P=0.759N     P=0.754N     |
|LOGISTIC REGRESSION|     P=0.100      (e)          P=0.137      P=0.336     |P=0.525N     P=0.500      P=0.744      P=0.756N     |
|COCH-ARM / FISHERS |     P=0.114      P=0.247N     P=0.134      P=0.339     |P=0.531N     P=0.500      P=0.747      P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Degeneration Fatty                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/49 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     2.1%         0.0%         2.1%         0.0%        |0.0%         0.0%         2.2%         4.3%         |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    1/42 (2%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    1/37 (3%)    2/41 (5%)    |
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |---          ---          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.412N     P=0.471N     P=0.745N     P=0.500N    |P=0.082      (e)          P=0.484      P=0.244      |
|POLY 3             |     P=0.413N     P=0.496N     P=0.757N     P=0.506N    |P=0.072      (e)          P=0.500      P=0.241      |
|POLY 1.5           |     P=0.410N     P=0.498N     P=0.758N     P=0.504N    |P=0.071      (e)          P=0.498      P=0.239      |
|POLY 6             |     P=0.416N     P=0.492N     P=0.755N     P=0.508N    |P=0.075      (e)          P=0.502      P=0.244      |
|LOGISTIC REGRESSION|     P=0.412N     (e)          P=0.745N     (e)         |(e)          (e)          P=0.484      P=0.244      |
|COCH-ARM / FISHERS |     P=0.405N     P=0.500N     P=0.753N     P=0.500N    |P=0.070      (e)          P=0.495      P=0.247      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    0/49 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.2%         4.4%         0.0%         4.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |1/40 (3%)    1/34 (3%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      659          ---          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.490      P=0.465      P=0.516N     P=0.506      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.478      P=0.501      P=0.500N     P=0.510      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.473      P=0.502      P=0.502N     P=0.505      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.485      P=0.497      P=0.498N     P=0.517      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.472      P=0.500      (e)          P=0.501      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.469      P=0.500      P=0.505N     P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex: Capsule                                                                                                          |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     46/50 (92%)  42/50 (84%)  40/50 (80%)  40/50 (80%) |49/50 (98%)  50/50 (100%) 49/49 (100%) 49/50 (98%)  |
|POLY-3 ADJUSTED (b)|     92.7%        85.9%        82.1%        83.1%       |99.1%        100.0%       100.0%       99.4%        |
|TERMINAL (d)       |     37/39 (95%)  39/45 (87%)  36/42 (86%)  32/39 (82%) |40/40 (100%) 34/34 (100%) 37/37 (100%) 41/41 (100%) |
|FIRST INCIDENCE    |     501          601          577          549         |456          484          477          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.231N     P=0.026N*    P=0.041N*    P=0.178N    |P=0.238N     P=0.120      P=0.356      P=0.478N     |
|POLY 3             |     P=0.112N     P=0.217N     P=0.091N     P=0.118N    |P=0.884      P=0.910      P=0.912      P=0.952      |
|POLY 1.5           |     P=0.096N     P=0.204N     P=0.082N     P=0.098N    |P=0.766N     P=0.702      P=0.705      P=0.852      |
|POLY 6             |     P=0.129N     P=0.222N     P=0.110N     P=0.137N    |P=0.998      P=1.000      P=1.000      P=1.000      |
|LOGISTIC REGRESSION|     P=0.118N     P=0.159N     P=0.056N     P=0.097N    |P=0.616      P=0.609      P=0.557      P=0.700      |
|COCH-ARM / FISHERS |     P=0.076N     P=0.178N     P=0.074N     P=0.074N    |P=0.594N     P=0.500      P=0.505      P=0.753N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex: Zona Fasciculata                                                                                                 |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     18/50 (36%)  24/50 (48%)  14/50 (28%)  21/50 (42%) |1/50 (2%)    1/50 (2%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     38.2%        50.3%        29.4%        46.0%       |2.2%         2.2%         0.0%         0.0%         |
|TERMINAL (d)       |     17/39 (44%)  24/45 (53%)  14/42 (33%)  20/39 (51%) |1/40 (3%)    1/34 (3%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     652          727 (T)      727 (T)      665         |728 (T)      728 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.417      P=0.330      P=0.179N     P=0.331     |P=0.231N     P=0.725      P=0.516N     P=0.495N     |
|POLY 3             |     P=0.437      P=0.164      P=0.245N     P=0.291     |P=0.236N     P=0.760      P=0.500N     P=0.497N     |
|POLY 1.5           |     P=0.458      P=0.159      P=0.250N     P=0.310     |P=0.237N     P=0.760N     P=0.502N     P=0.499N     |
|POLY 6             |     P=0.414      P=0.175      P=0.240N     P=0.273     |P=0.234N     P=0.757      P=0.498N     P=0.494N     |
|LOGISTIC REGRESSION|     P=0.385      P=0.226      P=0.216N     P=0.270     |P=0.231N     P=0.725      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.490      P=0.156      P=0.260N     P=0.341     |P=0.236N     P=0.753N     P=0.505N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel: Aorta                                                                                                              |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.3%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |1/40 (3%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |586          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.250N     P=0.244N     P=0.237N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.112N     P=0.240N     P=0.235N     P=0.236N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.238N     P=0.236N     P=0.237N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.110N     P=0.245N     P=0.234N     P=0.234N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.111N     P=0.257N     P=0.256N     P=0.231N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 4
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/41 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          659          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.054      (e)          (e)          P=0.252      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.047 *    (e)          (e)          P=0.242      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.240      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.048 *    (e)          (e)          P=0.247      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.048 *    (e)          (e)          P=0.237      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Myelofibrosis                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.3%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/41 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.606      (e)          P=0.221      (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.604      (e)          P=0.242      (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.598      (e)          P=0.240      (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.614      (e)          P=0.244      (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.221      (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.595      (e)          P=0.247      (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow: Myeloid Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/49 (2%)    2/50 (4%)   |2/50 (4%)    3/50 (6%)    1/50 (2%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.1%         4.3%        |4.4%         6.5%         2.1%         6.4%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/41 (0%)    0/39 (0%)   |2/40 (5%)    0/34 (0%)    1/37 (3%)    2/41 (5%)    |
|FIRST INCIDENCE    |     ---          ---          707          502         |728 (T)      652          728 (T)      567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.067      (e)          P=0.514      P=0.237     |P=0.508      P=0.479      P=0.527N     P=0.509      |
|POLY 3             |     P=0.068      (e)          P=0.499      P=0.235     |P=0.489      P=0.507      P=0.492N     P=0.513      |
|POLY 1.5           |     P=0.069      (e)          P=0.498      P=0.236     |P=0.483      P=0.505      P=0.495N     P=0.506      |
|POLY 6             |     P=0.068      (e)          P=0.501      P=0.235     |P=0.498      P=0.506      P=0.489N     P=0.522      |
|LOGISTIC REGRESSION|     P=0.113      (e)          P=0.494      P=0.330     |P=0.478      P=0.488      P=0.527N     P=0.498      |
|COCH-ARM / FISHERS |     P=0.070      (e)          P=0.495      P=0.247     |P=0.477      P=0.500      P=0.500N     P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain: Neuron                                                                                                                    |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.2%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     652          ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.120N     P=0.235N     P=0.240N     P=0.253N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.113N     P=0.235N     P=0.236N     P=0.246N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.113N     P=0.236N     P=0.236N     P=0.243N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.113N     P=0.233N     P=0.236N     P=0.250N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.105N     P=0.240N     P=0.275N     P=0.210N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |7/50 (14%)   4/49 (8%)    13/50 (26%)  3/48 (6%)    |
|POLY-3 ADJUSTED (b)|                                                        |15.3%        8.8%         27.5%        6.6%         |
|TERMINAL (d)       |                                                        |6/40 (15%)   3/34 (9%)    8/37 (22%)   3/41 (7%)    |
|FIRST INCIDENCE    |                                                        |716          652          617          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.240N     P=0.352N     P=0.092      P=0.151N     |
|POLY 3             |                                                        |P=0.270N     P=0.268N     P=0.117      P=0.162N     |
|POLY 1.5           |                                                        |P=0.284N     P=0.269N     P=0.112      P=0.169N     |
|POLY 6             |                                                        |P=0.247N     P=0.273N     P=0.124      P=0.154N     |
|LOGISTIC REGRESSION|                                                        |P=0.261N     P=0.285N     P=0.118      P=0.145N     |
|COCH-ARM / FISHERS |                                                        |P=0.299N     P=0.274N     P=0.105      P=0.176N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |0/50 (0%)    2/49 (4%)    2/50 (4%)    0/48 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |0.0%         4.5%         4.3%         0.0%         |
|TERMINAL (d)       |                                                        |0/40 (0%)    2/34 (6%)    1/37 (3%)    0/41 (0%)    |
|FIRST INCIDENCE    |                                                        |---          728 (T)      716          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.480N     P=0.203      P=0.231      (e)          |
|POLY 3             |                                                        |P=0.497N     P=0.233      P=0.242      (e)          |
|POLY 1.5           |                                                        |P=0.503N     P=0.234      P=0.240      (e)          |
|POLY 6             |                                                        |P=0.487N     P=0.230      P=0.244      (e)          |
|LOGISTIC REGRESSION|                                                        |P=0.483N     P=0.203      P=0.244      (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.510N     P=0.242      P=0.247      (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Epididymis                                                                                                                       |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     20/50 (40%)  22/50 (44%)  25/50 (50%)  25/50 (50%) |                                                    |
|POLY-3 ADJUSTED (b)|     42.4%        46.1%        51.8%        53.0%       |                                                    |
|TERMINAL (d)       |     18/39 (46%)  22/45 (49%)  23/42 (55%)  22/39 (56%) |                                                    |
|FIRST INCIDENCE    |     652          727 (T)      596          472         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.115      P=0.510N     P=0.310      P=0.206     |                                                    |
|POLY 3             |     P=0.159      P=0.437      P=0.234      P=0.201     |                                                    |
|POLY 1.5           |     P=0.164      P=0.428      P=0.225      P=0.206     |                                                    |
|POLY 6             |     P=0.151      P=0.454      P=0.244      P=0.196     |                                                    |
|LOGISTIC REGRESSION|     P=0.120      P=0.517      P=0.237      P=0.178     |                                                    |
|COCH-ARM / FISHERS |     P=0.169      P=0.420      P=0.211      P=0.211     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Gallbladder                                                                                                                      |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    0/49 (0%)   |0/48 (0%)    3/50 (6%)    1/50 (2%)    4/49 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         6.6%         2.1%         8.8%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/41 (0%)    0/38 (0%)   |0/38 (0%)    3/34 (9%)    1/37 (3%)    4/41 (10%)   |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.095      P=0.102      P=0.495      P=0.073      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.075      P=0.126      P=0.513      P=0.065      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.073      P=0.127      P=0.511      P=0.064      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.078      P=0.123      P=0.515      P=0.068      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          P=0.102      P=0.495      P=0.073      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.072      P=0.129      P=0.510      P=0.061      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     6.4%         0.0%         2.1%         0.0%        |2.2%         4.3%         0.0%         2.1%         |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     647          ---          641          ---         |586          651          ---          687          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.092N     P=0.112N     P=0.298N     P=0.131N    |P=0.479N     P=0.518      P=0.492N     P=0.752N     |
|POLY 3             |     P=0.088N     P=0.117N     P=0.300N     P=0.126N    |P=0.498N     P=0.500      P=0.498N     P=0.758N     |
|POLY 1.5           |     P=0.086N     P=0.118N     P=0.302N     P=0.123N    |P=0.499N     P=0.501      P=0.499N     P=0.760N     |
|POLY 6             |     P=0.089N     P=0.115N     P=0.298N     P=0.129N    |P=0.496N     P=0.495      P=0.497N     P=0.756N     |
|LOGISTIC REGRESSION|     P=0.076N     P=0.124N     P=0.349N     P=0.113N    |P=0.472N     P=0.434      P=0.544N     P=0.754N     |
|COCH-ARM / FISHERS |     P=0.086N     P=0.121N     P=0.309N     P=0.121N    |P=0.500N     P=0.500      P=0.500N     P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Artery                                                                                                                    |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.1%         0.0%         0.0%        |0.0%         0.0%         0.0%         2.1%         |
|TERMINAL (d)       |     0/39 (0%)    1/45 (2%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          444          ---          ---         |---          ---          ---          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.409N     P=0.255      (e)          (e)         |P=0.196      (e)          (e)          P=0.500      |
|POLY 3             |     P=0.403N     P=0.246      (e)          (e)         |P=0.203      (e)          (e)          P=0.505      |
|POLY 1.5           |     P=0.404N     P=0.242      (e)          (e)         |P=0.201      (e)          (e)          P=0.503      |
|POLY 6             |     P=0.401N     P=0.250      (e)          (e)         |P=0.207      (e)          (e)          P=0.510      |
|LOGISTIC REGRESSION|     P=0.323N     P=0.226      (e)          (e)         |P=0.262      (e)          (e)          P=0.552      |
|COCH-ARM / FISHERS |     P=0.405N     P=0.247      (e)          (e)         |P=0.198      (e)          (e)          P=0.500      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 9
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Valve                                                                                                                     |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.3%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |580          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.228N     P=0.233N     P=0.240N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.112N     P=0.242N     P=0.237N     P=0.238N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.239N     P=0.237N     P=0.238N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.109N     P=0.248N     P=0.237N     P=0.237N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.088N     P=0.295N     P=0.271N     P=0.197N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Duodenum                                                                                                        |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    2/50 (4%)    0/48 (0%)    2/49 (4%)   |0/50 (0%)    0/48 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.2%         0.0%         4.4%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    2/45 (4%)    0/41 (0%)    1/38 (3%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          727 (T)      ---          549         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.232      P=0.270      (e)          P=0.237     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.242      P=0.246      (e)          P=0.233     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.243      P=0.244      (e)          P=0.235     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.241      P=0.250      (e)          P=0.232     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.277      P=0.270      (e)          P=0.283     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.245      P=0.253      (e)          P=0.247     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 10
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Jejunum: Peyer's Patch                                                                                          |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.2%         0.0%         0.0%        |0.0%         0.0%         0.0%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    2/45 (4%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          727 (T)      ---          ---         |---          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.412N     P=0.270      (e)          (e)         |P=0.213      (e)          (e)          P=0.505      |
|POLY 3             |     P=0.405N     P=0.242      (e)          (e)         |P=0.201      (e)          (e)          P=0.503      |
|POLY 1.5           |     P=0.405N     P=0.240      (e)          (e)         |P=0.200      (e)          (e)          P=0.501      |
|POLY 6             |     P=0.404N     P=0.246      (e)          (e)         |P=0.204      (e)          (e)          P=0.506      |
|LOGISTIC REGRESSION|     (e)          P=0.270      (e)          (e)         |(e)          (e)          (e)          P=0.505      |
|COCH-ARM / FISHERS |     P=0.405N     P=0.247      (e)          (e)         |P=0.198      (e)          (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     46/50 (92%)  47/50 (94%)  49/50 (98%)  44/50 (88%) |45/50 (90%)  44/50 (88%)  40/50 (80%)  42/50 (84%)  |
|POLY-3 ADJUSTED (b)|     92.4%        96.3%        98.0%        90.4%       |92.0%        90.4%        83.2%        86.6%        |
|TERMINAL (d)       |     37/39 (95%)  44/45 (98%)  41/42 (98%)  36/39 (92%) |37/40 (93%)  32/34 (94%)  34/37 (92%)  36/41 (88%)  |
|FIRST INCIDENCE    |     501          612          577          502         |456          605          524          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.544N     P=0.160N     P=0.585N     P=0.446N    |P=0.099N     P=0.242      P=0.376N     P=0.252N     |
|POLY 3             |     P=0.348N     P=0.334      P=0.196      P=0.505N    |P=0.197N     P=0.535N     P=0.144N     P=0.289N     |
|POLY 1.5           |     P=0.306N     P=0.394      P=0.188      P=0.450N    |P=0.197N     P=0.519N     P=0.135N     P=0.283N     |
|POLY 6             |     P=0.398N     P=0.285      P=0.213      P=0.564N    |P=0.197N     P=0.565N     P=0.167N     P=0.298N     |
|LOGISTIC REGRESSION|     P=0.354N     P=0.527      P=0.175      P=0.419N    |P=0.184N     P=0.438N     P=0.088N     P=0.267N     |
|COCH-ARM / FISHERS |     P=0.256N     P=0.500      P=0.181      P=0.370N    |P=0.198N     P=0.500N     P=0.131N     P=0.277N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 11
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Infarct                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     11/50 (22%)  10/50 (20%)  9/50 (18%)   13/50 (26%) |2/50 (4%)    4/50 (8%)    3/50 (6%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     23.3%        20.9%        18.9%        28.4%       |4.4%         8.6%         6.4%         12.9%        |
|TERMINAL (d)       |     9/39 (23%)   10/45 (22%)  8/42 (19%)   12/39 (31%) |2/40 (5%)    1/34 (3%)    3/37 (8%)    6/41 (15%)   |
|FIRST INCIDENCE    |     661          727 (T)      707          629         |728 (T)      652          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.286      P=0.365N     P=0.338N     P=0.401     |P=0.141      P=0.309      P=0.464      P=0.141      |
|POLY 3             |     P=0.300      P=0.486N     P=0.390N     P=0.375     |P=0.114      P=0.344      P=0.510      P=0.138      |
|POLY 1.5           |     P=0.313      P=0.493N     P=0.394N     P=0.388     |P=0.112      P=0.343      P=0.506      P=0.136      |
|POLY 6             |     P=0.286      P=0.475N     P=0.387N     P=0.362     |P=0.119      P=0.343      P=0.514      P=0.143      |
|LOGISTIC REGRESSION|     P=0.273      P=0.451N     P=0.375N     P=0.362     |P=0.115      P=0.331      P=0.464      P=0.141      |
|COCH-ARM / FISHERS |     P=0.331      P=0.500N     P=0.402N     P=0.408     |P=0.110      P=0.339      P=0.500      P=0.134      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     41/50 (82%)  41/50 (82%)  41/50 (82%)  45/50 (90%) |35/50 (70%)  37/50 (74%)  34/50 (68%)  40/50 (80%)  |
|POLY-3 ADJUSTED (b)|     85.7%        84.5%        84.8%        92.2%       |74.7%        77.7%        72.3%        84.6%        |
|TERMINAL (d)       |     36/39 (92%)  40/45 (89%)  39/42 (93%)  38/39 (97%) |33/40 (83%)  28/34 (82%)  31/37 (84%)  38/41 (93%)  |
|FIRST INCIDENCE    |     643          444          596          472         |547          605          691          484          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.056      P=0.109N     P=0.305N     P=0.208     |P=0.376      P=0.095      P=0.452      P=0.191      |
|POLY 3             |     P=0.159      P=0.551N     P=0.572N     P=0.224     |P=0.156      P=0.458      P=0.490N     P=0.160      |
|POLY 1.5           |     P=0.157      P=0.570N     P=0.580N     P=0.213     |P=0.161      P=0.440      P=0.494N     P=0.162      |
|POLY 6             |     P=0.156      P=0.537N     P=0.583N     P=0.231     |P=0.159      P=0.475      P=0.484N     P=0.167      |
|LOGISTIC REGRESSION|     P=0.060      P=0.516N     P=0.525N     P=0.103     |P=0.251      P=0.439      P=0.363N     P=0.212      |
|COCH-ARM / FISHERS |     P=0.148      P=0.602N     P=0.602N     P=0.194     |P=0.180      P=0.412      P=0.500N     P=0.178      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 12
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         2.1%         0.0%         2.2%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      637          ---          549         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.377N     P=0.467N     P=0.222N     P=0.500N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.369N     P=0.490N     P=0.234N     P=0.506N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.368N     P=0.495N     P=0.235N     P=0.504N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.371N     P=0.483N     P=0.232N     P=0.508N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.315N     P=0.506N     (e)          P=0.458N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.366N     P=0.500N     P=0.247N     P=0.500N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Metaplasia Osseous                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    3/50 (6%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         6.2%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    2/45 (4%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      612          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.076N     P=0.552      P=0.222N     P=0.238N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.073N     P=0.513      P=0.234N     P=0.244N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.073N     P=0.507      P=0.235N     P=0.241N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.074N     P=0.523      P=0.232N     P=0.246N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.071N     P=0.495      (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.073N     P=0.500      P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 13
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     48/50 (96%)  50/50 (100%) 48/50 (96%)  46/50 (92%) |5/50 (10%)   8/50 (16%)   6/50 (12%)   4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     96.6%        100.0%       96.6%        93.8%       |10.7%        17.5%        12.8%        8.5%         |
|TERMINAL (d)       |     38/39 (97%)  45/45 (100%) 42/42 (100%) 37/39 (95%) |3/40 (8%)    7/34 (21%)   6/37 (16%)   2/41 (5%)    |
|FIRST INCIDENCE    |     501          444          577          502         |586          709          728 (T)      673          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.483N     P=0.220N     P=0.306N     P=0.450N    |P=0.277N     P=0.204      P=0.461      P=0.482N     |
|POLY 3             |     P=0.165N     P=0.282      P=0.720      P=0.425N    |P=0.307N     P=0.263      P=0.502      P=0.498N     |
|POLY 1.5           |     P=0.143N     P=0.259      P=0.708N     P=0.391N    |P=0.312N     P=0.271      P=0.502      P=0.500N     |
|POLY 6             |     P=0.185N     P=0.330      P=0.735      P=0.454N    |P=0.297N     P=0.245      P=0.500      P=0.492N     |
|LOGISTIC REGRESSION|     P=0.155N     P=0.242      P=0.660N     P=0.402N    |P=0.303N     P=0.277      P=0.499      P=0.503N     |
|COCH-ARM / FISHERS |     P=0.111N     P=0.247      P=0.691N     P=0.339N    |P=0.313N     P=0.277      P=0.500      P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     44/50 (88%)  49/50 (98%)  45/50 (90%)  42/50 (84%) |20/50 (40%)  17/50 (34%)  13/50 (26%)  20/50 (40%)  |
|POLY-3 ADJUSTED (b)|     91.7%        98.6%        93.4%        89.1%       |43.2%        36.6%        27.7%        42.4%        |
|TERMINAL (d)       |     38/39 (97%)  45/45 (100%) 42/42 (100%) 38/39 (97%) |19/40 (48%)  13/34 (38%)  12/37 (32%)  17/41 (42%)  |
|FIRST INCIDENCE    |     643          444          643          502         |580          652          687          659          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.332N     P=0.495N     P=0.369N     P=0.411N    |P=0.448N     P=0.552N     P=0.144N     P=0.536N     |
|POLY 3             |     P=0.173N     P=0.099      P=0.537      P=0.461N    |P=0.535N     P=0.327N     P=0.085N     P=0.552N     |
|POLY 1.5           |     P=0.149N     P=0.075      P=0.528      P=0.422N    |P=0.530      P=0.329N     P=0.091N     P=0.569N     |
|POLY 6             |     P=0.236N     P=0.147      P=0.515      P=0.536N    |P=0.502N     P=0.335N     P=0.080N     P=0.519N     |
|LOGISTIC REGRESSION|     P=0.339N     P=0.050      P=0.628      P=0.636     |P=0.497N     P=0.357N     P=0.076N     P=0.538N     |
|COCH-ARM / FISHERS |     P=0.132N     P=0.056      P=0.500      P=0.387N    |P=0.520      P=0.339N     P=0.101N     P=0.581N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 14
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Artery                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.1%         2.1%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    1/45 (2%)    1/42 (2%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          444          727 (T)      ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.468N     P=0.255      P=0.515      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.468N     P=0.246      P=0.503      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.465N     P=0.242      P=0.502      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.470N     P=0.250      P=0.505      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.388N     P=0.226      P=0.515      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.461N     P=0.247      P=0.500      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Cortex                                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   9/50 (18%)   6/50 (12%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     10.7%        18.7%        12.6%        8.8%        |0.0%         0.0%         0.0%         2.2%         |
|TERMINAL (d)       |     4/39 (10%)   8/45 (18%)   6/42 (14%)   4/39 (10%)  |0/40 (0%)    0/34 (0%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     705          637          727 (T)      727 (T)     |---          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.304N     P=0.275      P=0.550      P=0.503N    |P=0.213      (e)          (e)          P=0.505      |
|POLY 3             |     P=0.303N     P=0.207      P=0.510      P=0.520N    |P=0.201      (e)          (e)          P=0.503      |
|POLY 1.5           |     P=0.293N     P=0.201      P=0.507      P=0.512N    |P=0.200      (e)          (e)          P=0.501      |
|POLY 6             |     P=0.313N     P=0.219      P=0.514      P=0.528N    |P=0.204      (e)          (e)          P=0.506      |
|LOGISTIC REGRESSION|     P=0.311N     P=0.207      P=0.527      P=0.524N    |(e)          (e)          (e)          P=0.505      |
|COCH-ARM / FISHERS |     P=0.278N     P=0.194      P=0.500      P=0.500N    |P=0.198      (e)          (e)          P=0.500      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 15
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    2/41 (5%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.055      (e)          (e)          P=0.244      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.241      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.239      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.047 *    (e)          (e)          P=0.244      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          P=0.244      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    0/50 (0%)    1/50 (2%)   |3/50 (6%)    4/50 (8%)    3/50 (6%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     6.4%         6.3%         0.0%         2.2%        |6.6%         8.8%         6.4%         2.2%         |
|TERMINAL (d)       |     2/39 (5%)    3/45 (7%)    0/42 (0%)    1/39 (3%)   |3/40 (8%)    4/34 (12%)   3/37 (8%)    1/41 (2%)    |
|FIRST INCIDENCE    |     713          727 (T)      ---          727 (T)     |728 (T)      728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.140N     P=0.596N     P=0.112N     P=0.309N    |P=0.168N     P=0.411      P=0.627      P=0.296N     |
|POLY 3             |     P=0.137N     P=0.653N     P=0.116N     P=0.317N    |P=0.180N     P=0.499      P=0.652N     P=0.300N     |
|POLY 1.5           |     P=0.136N     P=0.657N     P=0.117N     P=0.312N    |P=0.184N     P=0.501      P=0.656N     P=0.303N     |
|POLY 6             |     P=0.138N     P=0.646N     P=0.115N     P=0.321N    |P=0.173N     P=0.490      P=0.648N     P=0.294N     |
|LOGISTIC REGRESSION|     P=0.143N     P=0.632N     P=0.115N     P=0.319N    |P=0.168N     P=0.411      P=0.627      P=0.296N     |
|COCH-ARM / FISHERS |     P=0.134N     P=0.661N     P=0.121N     P=0.309N    |P=0.186N     P=0.500      P=0.661N     P=0.309N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 16
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    6/50 (12%)   10/50 (20%)  7/50 (14%)  |2/50 (4%)    3/50 (6%)    3/50 (6%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     8.6%         12.6%        21.0%        15.4%       |4.4%         6.6%         6.4%         4.3%         |
|TERMINAL (d)       |     4/39 (10%)   6/45 (13%)   10/42 (24%)  7/39 (18%)  |2/40 (5%)    3/34 (9%)    3/37 (8%)    2/41 (5%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |728 (T)      728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.178      P=0.462      P=0.095      P=0.259     |P=0.509N     P=0.426      P=0.464      P=0.686N     |
|POLY 3             |     P=0.184      P=0.383      P=0.077      P=0.244     |P=0.534N     P=0.499      P=0.510      P=0.688N     |
|POLY 1.5           |     P=0.194      P=0.377      P=0.076      P=0.251     |P=0.539N     P=0.501      P=0.506      P=0.691N     |
|POLY 6             |     P=0.172      P=0.394      P=0.078      P=0.237     |P=0.524N     P=0.491      P=0.514      P=0.683N     |
|LOGISTIC REGRESSION|     P=0.178      P=0.462      P=0.095      P=0.259     |P=0.509N     P=0.426      P=0.464      P=0.686N     |
|COCH-ARM / FISHERS |     P=0.211      P=0.370      P=0.074      P=0.262     |P=0.544N     P=0.500      P=0.500      P=0.691N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     12/50 (24%)  14/50 (28%)  14/50 (28%)  7/50 (14%)  |7/50 (14%)   3/50 (6%)    4/50 (8%)    5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     25.7%        29.3%        29.4%        15.4%       |15.3%        6.6%         8.6%         10.8%        |
|TERMINAL (d)       |     12/39 (31%)  14/45 (31%)  14/42 (33%)  7/39 (18%)  |7/40 (18%)   3/34 (9%)    4/37 (11%)   5/41 (12%)   |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |728 (T)      728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.113N     P=0.580      P=0.497      P=0.147N    |P=0.374N     P=0.229N     P=0.305N     P=0.361N     |
|POLY 3             |     P=0.120N     P=0.433      P=0.429      P=0.169N    |P=0.408N     P=0.158N     P=0.248N     P=0.368N     |
|POLY 1.5           |     P=0.113N     P=0.422      P=0.422      P=0.163N    |P=0.415N     P=0.157N     P=0.254N     P=0.374N     |
|POLY 6             |     P=0.128N     P=0.453      P=0.436      P=0.174N    |P=0.394N     P=0.164N     P=0.243N     P=0.357N     |
|LOGISTIC REGRESSION|     P=0.113N     P=0.580      P=0.497      P=0.147N    |P=0.374N     P=0.229N     P=0.305N     P=0.361N     |
|COCH-ARM / FISHERS |     P=0.102N     P=0.410      P=0.410      P=0.154N    |P=0.419N     P=0.159N     P=0.262N     P=0.380N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 17
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |2/50 (4%)    5/50 (10%)   3/50 (6%)    4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.1%         2.2%        |4.4%         10.8%        6.4%         8.6%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    1/39 (3%)   |1/40 (3%)    2/34 (6%)    1/37 (3%)    4/41 (10%)   |
|FIRST INCIDENCE    |     ---          ---          707          727 (T)     |716          651          706          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.223      (e)          P=0.514      P=0.500     |P=0.434      P=0.191      P=0.488      P=0.348      |
|POLY 3             |     P=0.226      (e)          P=0.504      P=0.494     |P=0.399      P=0.222      P=0.511      P=0.344      |
|POLY 1.5           |     P=0.230      (e)          P=0.502      P=0.496     |P=0.394      P=0.221      P=0.506      P=0.340      |
|POLY 6             |     P=0.221      (e)          P=0.505      P=0.492     |P=0.409      P=0.220      P=0.516      P=0.351      |
|LOGISTIC REGRESSION|     P=0.227      (e)          P=0.497      P=0.500     |P=0.393      P=0.214      P=0.512      P=0.356      |
|COCH-ARM / FISHERS |     P=0.236      (e)          P=0.500      P=0.500     |P=0.389      P=0.218      P=0.500      P=0.339      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Infarct                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.2%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     617          ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.121N     P=0.237N     P=0.240N     P=0.257N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.113N     P=0.235N     P=0.236N     P=0.247N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.113N     P=0.236N     P=0.236N     P=0.243N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.113N     P=0.233N     P=0.236N     P=0.251N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.101N     P=0.235N     P=0.296N     P=0.195N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 18
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |30/50 (60%)  32/50 (64%)  29/50 (58%)  35/50 (70%)  |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         6.2%         2.2%        |65.6%        67.2%        61.1%        73.9%        |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    2/42 (5%)    1/39 (3%)   |30/40 (75%)  24/34 (71%)  25/37 (68%)  34/41 (83%)  |
|FIRST INCIDENCE    |     727 (T)      ---          577          727 (T)     |728 (T)      605          617          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.572N     P=0.208N     P=0.531      P=0.500N    |P=0.360      P=0.127      P=0.493      P=0.200      |
|POLY 3             |     P=0.572N     P=0.233N     P=0.512      P=0.510N    |P=0.231      P=0.521      P=0.407N     P=0.248      |
|POLY 1.5           |     P=0.565N     P=0.235N     P=0.507      P=0.506N    |P=0.216      P=0.478      P=0.449N     P=0.225      |
|POLY 6             |     P=0.580N     P=0.229N     P=0.518      P=0.514N    |P=0.258      P=0.569      P=0.353N     P=0.286      |
|LOGISTIC REGRESSION|     P=0.546N     (e)          P=0.476      P=0.500N    |P=0.267      P=0.381      P=0.392N     P=0.264      |
|COCH-ARM / FISHERS |     P=0.556N     P=0.247N     P=0.500      P=0.500N    |P=0.200      P=0.418      P=0.500N     P=0.201      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     25/50 (50%)  25/50 (50%)  31/50 (62%)  19/50 (38%) |36/50 (72%)  35/50 (70%)  30/50 (60%)  35/50 (70%)  |
|POLY-3 ADJUSTED (b)|     52.4%        52.3%        64.9%        41.8%       |77.8%        74.6%        63.6%        73.1%        |
|TERMINAL (d)       |     21/39 (54%)  25/45 (56%)  30/42 (71%)  19/39 (49%) |34/40 (85%)  29/34 (85%)  28/37 (76%)  33/41 (81%)  |
|FIRST INCIDENCE    |     647          727 (T)      667          727 (T)     |580          605          617          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.187N     P=0.320N     P=0.265      P=0.158N    |P=0.210N     P=0.212      P=0.257N     P=0.418N     |
|POLY 3             |     P=0.211N     P=0.579N     P=0.148      P=0.205N    |P=0.313N     P=0.450N     P=0.090N     P=0.384N     |
|POLY 1.5           |     P=0.180N     P=0.580N     P=0.154      P=0.183N    |P=0.361N     P=0.467N     P=0.111N     P=0.436N     |
|POLY 6             |     P=0.257N     P=0.576N     P=0.137      P=0.237N    |P=0.247N     P=0.455N     P=0.069N     P=0.319N     |
|LOGISTIC REGRESSION|     P=0.215N     P=0.503N     P=0.180      P=0.199N    |P=0.288N     P=0.546N     P=0.061N     P=0.428N     |
|COCH-ARM / FISHERS |     P=0.146N     P=0.579N     P=0.157      P=0.157N    |P=0.419N     P=0.500N     P=0.146N     P=0.500N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 19
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.1%         2.1%         0.0%         4.4%        |2.2%         2.2%         2.1%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    1/39 (3%)   |1/40 (3%)    0/34 (0%)    1/37 (3%)    0/41 (0%)    |
|FIRST INCIDENCE    |     617          601          ---          698         |728 (T)      673          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.345      P=0.760      P=0.500N     P=0.484     |P=0.296N     P=0.737      P=0.744      P=0.495N     |
|POLY 3             |     P=0.358      P=0.756N     P=0.498N     P=0.488     |P=0.309N     P=0.760N     P=0.756N     P=0.497N     |
|POLY 1.5           |     P=0.362      P=0.758N     P=0.499N     P=0.492     |P=0.311N     P=0.759N     P=0.758N     P=0.499N     |
|POLY 6             |     P=0.354      P=0.752N     P=0.498N     P=0.483     |P=0.304N     P=0.758      P=0.754N     P=0.494N     |
|LOGISTIC REGRESSION|     P=0.425      P=0.770N     P=0.628N     P=0.526     |P=0.310N     P=0.762      P=0.744      (e)          |
|COCH-ARM / FISHERS |     P=0.366      P=0.753N     P=0.500N     P=0.500     |P=0.311N     P=0.753N     P=0.753N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   2/50 (4%)    7/50 (14%)   9/50 (18%)  |3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     12.8%        4.2%         14.7%        19.6%       |6.6%         2.2%         0.0%         0.0%         |
|TERMINAL (d)       |     6/39 (15%)   2/45 (4%)    7/42 (17%)   8/39 (21%)  |3/40 (8%)    1/34 (3%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      556         |728 (T)      728 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.075      P=0.093N     P=0.558      P=0.286     |P=0.043N*    P=0.365N     P=0.135N     P=0.117N     |
|POLY 3             |     P=0.082      P=0.127N     P=0.513      P=0.274     |P=0.042N*    P=0.306N     P=0.115N     P=0.116N     |
|POLY 1.5           |     P=0.086      P=0.130N     P=0.508      P=0.279     |P=0.043N*    P=0.305N     P=0.117N     P=0.118N     |
|POLY 6             |     P=0.078      P=0.121N     P=0.518      P=0.270     |P=0.041N*    P=0.312N     P=0.113N     P=0.113N     |
|LOGISTIC REGRESSION|     P=0.075      P=0.093N     P=0.558      P=0.264     |P=0.043N*    P=0.365N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.093      P=0.134N     P=0.500      P=0.288     |P=0.044N*    P=0.309N     P=0.121N     P=0.121N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 20
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     12/50 (24%)  4/50 (8%)    6/50 (12%)   2/50 (4%)   |5/50 (10%)   4/50 (8%)    3/50 (6%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     24.9%        8.2%         12.2%        4.3%        |10.9%        8.6%         6.3%         4.3%         |
|TERMINAL (d)       |     6/39 (15%)   2/45 (4%)    2/42 (5%)    0/39 (0%)   |4/40 (10%)   1/34 (3%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     617          601          577          549         |716          650          610          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010N*    P=0.025N*    P=0.098N     P=0.009N**  |P=0.141N     P=0.560N     P=0.374N     P=0.214N     |
|POLY 3             |     P=0.007N**   P=0.025N*    P=0.088N     P=0.005N**  |P=0.144N     P=0.491N     P=0.338N     P=0.206N     |
|POLY 1.5           |     P=0.006N**   P=0.026N*    P=0.091N     P=0.004N**  |P=0.149N     P=0.493N     P=0.346N     P=0.211N     |
|POLY 6             |     P=0.007N**   P=0.024N*    P=0.086N     P=0.005N**  |P=0.137N     P=0.494N     P=0.329N     P=0.198N     |
|LOGISTIC REGRESSION|     P=0.002N**   P=0.030N*    P=0.122N     P=0.003N**  |P=0.152N     P=0.500N     P=0.356N     P=0.217N     |
|COCH-ARM / FISHERS |     P=0.006N**   P=0.027N*    P=0.096N     P=0.004N**  |P=0.151N     P=0.500N     P=0.357N     P=0.218N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Pigmentation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    1/50 (2%)   |12/50 (24%)  17/50 (34%)  16/50 (32%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|     4.2%         0.0%         4.2%         2.2%        |26.2%        36.7%        33.9%        38.0%        |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    2/42 (5%)    1/39 (3%)   |11/40 (28%)  14/34 (41%)  15/37 (41%)  15/41 (37%)  |
|FIRST INCIDENCE    |     617          ---          727 (T)      727 (T)     |716          643          617          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.548N     P=0.226N     P=0.673N     P=0.510N    |P=0.232      P=0.088      P=0.183      P=0.162      |
|POLY 3             |     P=0.544N     P=0.235N     P=0.691N     P=0.513N    |P=0.186      P=0.192      P=0.279      P=0.158      |
|POLY 1.5           |     P=0.538N     P=0.236N     P=0.691N     P=0.508N    |P=0.171      P=0.193      P=0.268      P=0.147      |
|POLY 6             |     P=0.550N     P=0.232N     P=0.690N     P=0.519N    |P=0.215      P=0.183      P=0.291      P=0.178      |
|LOGISTIC REGRESSION|     P=0.526N     P=0.240N     P=0.682      P=0.485N    |P=0.190      P=0.141      P=0.282      P=0.152      |
|COCH-ARM / FISHERS |     P=0.531N     P=0.247N     P=0.691N     P=0.500N    |P=0.158      P=0.189      P=0.252      P=0.138      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 21
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Vacuolization Cytoplasmic                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    3/50 (6%)    1/50 (2%)   |10/50 (20%)  17/50 (34%)  12/50 (24%)  13/50 (26%)  |
|POLY-3 ADJUSTED (b)|     6.4%         0.0%         6.3%         2.2%        |21.3%        36.2%        25.0%        26.8%        |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    3/42 (7%)    1/39 (3%)   |8/40 (20%)   11/34 (32%)  8/37 (22%)   8/41 (20%)   |
|FIRST INCIDENCE    |     617          ---          727 (T)      727 (T)     |456          651          524          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.390N     P=0.110N     P=0.634N     P=0.318N    |P=0.538      P=0.054      P=0.363      P=0.349      |
|POLY 3             |     P=0.390N     P=0.117N     P=0.659N     P=0.320N    |P=0.501      P=0.084      P=0.428      P=0.348      |
|POLY 1.5           |     P=0.382N     P=0.118N     P=0.659N     P=0.314N    |P=0.480      P=0.086      P=0.417      P=0.334      |
|POLY 6             |     P=0.398N     P=0.115N     P=0.659N     P=0.326N    |P=0.534      P=0.081      P=0.441      P=0.369      |
|LOGISTIC REGRESSION|     P=0.374N     P=0.124N     P=0.657      P=0.296N    |P=0.446      P=0.087      P=0.374      P=0.302      |
|COCH-ARM / FISHERS |     P=0.373N     P=0.121N     P=0.661N     P=0.309N    |P=0.457      P=0.088      P=0.405      P=0.318      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Bile Duct                                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.1%         2.1%         2.1%         4.4%        |2.2%         2.2%         0.0%         2.2%         |
|TERMINAL (d)       |     1/39 (3%)    1/45 (2%)    0/42 (0%)    2/39 (5%)   |1/40 (3%)    0/34 (0%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      643          727 (T)     |728 (T)      673          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.333      P=0.730N     P=0.752N     P=0.500     |P=0.591N     P=0.737      P=0.516N     P=0.756N     |
|POLY 3             |     P=0.341      P=0.756N     P=0.755N     P=0.490     |P=0.613N     P=0.760N     P=0.496N     P=0.757N     |
|POLY 1.5           |     P=0.345      P=0.758N     P=0.757N     P=0.494     |P=0.614N     P=0.759N     P=0.497N     P=0.759N     |
|POLY 6             |     P=0.336      P=0.752N     P=0.753N     P=0.486     |P=0.611N     P=0.758      P=0.494N     P=0.754N     |
|LOGISTIC REGRESSION|     P=0.348      P=0.730N     P=0.742      P=0.500     |P=0.614N     P=0.762      (e)          P=0.756N     |
|COCH-ARM / FISHERS |     P=0.351      P=0.753N     P=0.753N     P=0.500     |P=0.616N     P=0.753N     P=0.500N     P=0.753N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 22
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          705          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.055      (e)          (e)          P=0.248      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.242      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.239      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.048 *    (e)          (e)          P=0.246      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.238      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.2%         4.4%         0.0%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |1/40 (3%)    2/34 (6%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      728 (T)      ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.479N     P=0.443      P=0.516N     P=0.756N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.496N     P=0.499      P=0.496N     P=0.757N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.498N     P=0.501      P=0.497N     P=0.759N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.493N     P=0.493      P=0.494N     P=0.754N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.479N     P=0.443      (e)          P=0.756N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.500N     P=0.500      P=0.500N     P=0.753N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 23
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |2/50 (4%)    3/50 (6%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         2.1%         2.1%         0.0%        |4.4%         6.6%         4.3%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    1/45 (2%)    1/42 (2%)    0/39 (0%)   |2/40 (5%)    3/34 (9%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---         |728 (T)      728 (T)      728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.155N     P=0.450N     P=0.474N     P=0.238N    |P=0.125N     P=0.426      P=0.667      P=0.233N     |
|POLY 3             |     P=0.159N     P=0.493N     P=0.494N     P=0.244N    |P=0.130N     P=0.499      P=0.686N     P=0.234N     |
|POLY 1.5           |     P=0.157N     P=0.496N     P=0.496N     P=0.241N    |P=0.133N     P=0.501      P=0.689N     P=0.236N     |
|POLY 6             |     P=0.161N     P=0.487N     P=0.492N     P=0.246N    |P=0.126N     P=0.491      P=0.683N     P=0.230N     |
|LOGISTIC REGRESSION|     P=0.155N     P=0.450N     P=0.474N     (e)         |P=0.125N     P=0.426      P=0.667      (e)          |
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.500N     P=0.247N    |P=0.134N     P=0.500      P=0.691N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     8.5%         0.0%         6.3%         0.0%        |0.0%         2.2%         2.1%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    3/42 (7%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    1/37 (3%)    0/41 (0%)    |
|FIRST INCIDENCE    |     652          ---          727 (T)      ---         |---          605          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.092N     P=0.055N     P=0.470N     P=0.070N    |P=0.586N     P=0.517      P=0.484      (e)          |
|POLY 3             |     P=0.091N     P=0.059N     P=0.495N     P=0.065N    |P=0.590N     P=0.502      P=0.504      (e)          |
|POLY 1.5           |     P=0.088N     P=0.060N     P=0.497N     P=0.063N    |P=0.592N     P=0.501      P=0.503      (e)          |
|POLY 6             |     P=0.095N     P=0.057N     P=0.495N     P=0.068N    |P=0.586N     P=0.499      P=0.506      (e)          |
|LOGISTIC REGRESSION|     P=0.087N     P=0.064N     P=0.497N     P=0.062N    |P=0.585N     P=0.441      P=0.484      (e)          |
|COCH-ARM / FISHERS |     P=0.086N     P=0.059N     P=0.500N     P=0.059N    |P=0.595N     P=0.500      P=0.500      (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 24
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         4.3%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          502         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.044 *    (e)          (e)          P=0.233     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.045 *    (e)          (e)          P=0.236     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.045 *    (e)          (e)          P=0.236     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.044 *    (e)          (e)          P=0.236     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.086      (e)          (e)          P=0.340     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    2/50 (4%)    6/50 (12%)   9/50 (18%)  |0/50 (0%)    1/50 (2%)    4/50 (8%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     6.4%         4.2%         12.6%        19.2%       |0.0%         2.2%         8.5%         6.5%         |
|TERMINAL (d)       |     3/39 (8%)    2/45 (4%)    6/42 (14%)   6/39 (15%)  |0/40 (0%)    1/34 (3%)    3/37 (8%)    3/41 (7%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      472         |---          728 (T)      687          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010 *    P=0.435N     P=0.279      P=0.066     |P=0.090      P=0.468      P=0.060      P=0.126      |
|POLY 3             |     P=0.012 *    P=0.491N     P=0.251      P=0.060     |P=0.074      P=0.500      P=0.064      P=0.122      |
|POLY 1.5           |     P=0.012 *    P=0.495N     P=0.248      P=0.060     |P=0.072      P=0.500      P=0.062      P=0.120      |
|POLY 6             |     P=0.011 *    P=0.483N     P=0.254      P=0.060     |P=0.079      P=0.496      P=0.065      P=0.124      |
|LOGISTIC REGRESSION|     P=0.014 *    P=0.435N     P=0.279      P=0.072     |P=0.082      P=0.468      P=0.066      P=0.126      |
|COCH-ARM / FISHERS |     P=0.013 *    P=0.500N     P=0.243      P=0.061     |P=0.072      P=0.500      P=0.059      P=0.121      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 25
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolus                                                                                                                   |
|     Infiltration Cellular Histiocyte                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    2/50 (4%)    3/50 (6%)   |0/50 (0%)    3/50 (6%)    2/50 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     6.3%         2.1%         4.2%         6.6%        |0.0%         6.6%         4.3%         4.3%         |
|TERMINAL (d)       |     2/39 (5%)    1/45 (2%)    2/42 (5%)    3/39 (8%)   |0/40 (0%)    3/34 (9%)    2/37 (5%)    2/41 (5%)    |
|FIRST INCIDENCE    |     526          727 (T)      727 (T)      727 (T)     |---          728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.459      P=0.270N     P=0.471N     P=0.660     |P=0.354      P=0.094      P=0.221      P=0.244      |
|POLY 3             |     P=0.458      P=0.303N     P=0.498N     P=0.642     |P=0.334      P=0.118      P=0.242      P=0.241      |
|POLY 1.5           |     P=0.466      P=0.305N     P=0.499N     P=0.650     |P=0.329      P=0.119      P=0.240      P=0.239      |
|POLY 6             |     P=0.449      P=0.299N     P=0.498N     P=0.635     |P=0.342      P=0.115      P=0.244      P=0.244      |
|LOGISTIC REGRESSION|     P=0.484      P=0.312N     P=0.545N     P=0.650N    |(e)          P=0.094      P=0.221      P=0.244      |
|COCH-ARM / FISHERS |     P=0.477      P=0.309N     P=0.500N     P=0.661N    |P=0.324      P=0.121      P=0.247      P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mandibular                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/47 (4%)    1/50 (2%)    1/47 (2%)    0/48 (0%)   |1/47 (2%)    0/46 (0%)    5/48 (10%)   5/48 (10%)   |
|POLY-3 ADJUSTED (b)|     4.4%         2.1%         2.2%         0.0%        |2.3%         0.0%         11.1%        11.2%        |
|TERMINAL (d)       |     2/39 (5%)    1/45 (2%)    1/41 (2%)    0/39 (0%)   |1/40 (3%)    0/32 (0%)    5/37 (14%)   5/40 (13%)   |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---         |728 (T)      ---          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.156N     P=0.450N     P=0.483N     P=0.238N    |P=0.027 *    P=0.545N     P=0.086      P=0.103      |
|POLY 3             |     P=0.158N     P=0.479N     P=0.497N     P=0.241N    |P=0.022 *    P=0.506N     P=0.108      P=0.107      |
|POLY 1.5           |     P=0.156N     P=0.480N     P=0.498N     P=0.238N    |P=0.022 *    P=0.505N     P=0.108      P=0.106      |
|POLY 6             |     P=0.160N     P=0.477N     P=0.496N     P=0.244N    |P=0.024 *    P=0.511N     P=0.108      P=0.109      |
|LOGISTIC REGRESSION|     P=0.156N     P=0.450N     P=0.483N     (e)         |P=0.027 *    (e)          P=0.086      P=0.103      |
|COCH-ARM / FISHERS |     P=0.152N     P=0.477N     P=0.500N     P=0.242N    |P=0.023 *    P=0.505N     P=0.107      P=0.107      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 26
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mediastinal                                                                                                          |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    3/50 (6%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         6.4%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    3/37 (8%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.270      (e)          P=0.108      P=0.505      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.253      (e)          P=0.123      P=0.503      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.249      (e)          P=0.121      P=0.501      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.263      (e)          P=0.124      P=0.506      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.108      P=0.505      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.247      (e)          P=0.121      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    1/49 (2%)    0/48 (0%)    0/49 (0%)   |1/50 (2%)    1/49 (2%)    2/47 (4%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |2.2%         2.2%         4.5%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    1/45 (2%)    0/41 (0%)    0/38 (0%)   |1/40 (3%)    1/34 (3%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          727 (T)      ---          ---         |728 (T)      728 (T)      728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.579N     P=0.529      (e)          (e)         |P=0.350N     P=0.725      P=0.473      P=0.495N     |
|POLY 3             |     P=0.564N     P=0.506      (e)          (e)         |P=0.364N     P=0.757      P=0.487      P=0.499N     |
|POLY 1.5           |     P=0.566N     P=0.503      (e)          (e)         |P=0.369N     P=0.757      P=0.483      P=0.501N     |
|POLY 6             |     P=0.561N     P=0.510      (e)          (e)         |P=0.355N     P=0.754      P=0.491      P=0.495N     |
|LOGISTIC REGRESSION|     (e)          P=0.529      (e)          (e)         |P=0.350N     P=0.725      P=0.473      (e)          |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.373N     P=0.747      P=0.477      P=0.505N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 27
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    2/49 (4%)    1/48 (2%)    0/49 (0%)   |0/50 (0%)    0/49 (0%)    0/47 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.2%         2.2%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    2/45 (4%)    1/41 (2%)    0/38 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          727 (T)      727 (T)      ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.478N     P=0.270      P=0.510      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.470N     P=0.243      P=0.500      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.467N     P=0.241      P=0.498      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.472N     P=0.248      P=0.502      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          P=0.270      P=0.510      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.462N     P=0.247      P=0.495      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    0/48 (0%)    0/49 (0%)   |0/50 (0%)    1/49 (2%)    2/47 (4%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         2.2%         4.5%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/41 (0%)    0/38 (0%)   |0/40 (0%)    0/34 (0%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          683          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.592N     P=0.480      P=0.221      (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.610N     P=0.497      P=0.229      (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.616N     P=0.497      P=0.227      (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.601N     P=0.495      P=0.231      (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.616N     P=0.488      P=0.221      (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.621N     P=0.495      P=0.232      (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 28
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    1/48 (2%)    2/49 (4%)   |0/50 (0%)    0/49 (0%)    0/47 (0%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.2%         4.5%        |0.0%         0.0%         0.0%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    1/41 (2%)    2/38 (5%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)     |---          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.060      (e)          P=0.510      P=0.233     |P=0.213      (e)          (e)          P=0.505      |
|POLY 3             |     P=0.065      (e)          P=0.500      P=0.230     |P=0.202      (e)          (e)          P=0.501      |
|POLY 1.5           |     P=0.067      (e)          P=0.498      P=0.233     |P=0.200      (e)          (e)          P=0.499      |
|POLY 6             |     P=0.063      (e)          P=0.502      P=0.227     |P=0.205      (e)          (e)          P=0.505      |
|LOGISTIC REGRESSION|     (e)          (e)          P=0.510      P=0.233     |(e)          (e)          (e)          P=0.505      |
|COCH-ARM / FISHERS |     P=0.070      (e)          P=0.495      P=0.247     |P=0.198      (e)          (e)          P=0.495      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/1 (0%)     0/0 (0%)    |1/49 (2%)    3/50 (6%)    0/49 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.2%         6.5%         0.0%         2.2%         |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/1 (0%)     0/0 (0%)    |1/40 (3%)    1/34 (3%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      643          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.388N     P=0.293      P=0.516N     P=0.756N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.401N     P=0.314      P=0.497N     P=0.754N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.403N     P=0.315      P=0.498N     P=0.755N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.399N     P=0.310      P=0.496N     P=0.752N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.405N     P=0.307      (e)          P=0.756N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.405N     P=0.316      P=0.500N     P=0.747N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 29
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery                                                                                                                        |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/7 (29%)    0/6 (0%)     0/7 (0%)     0/5 (0%)    |0/14 (0%)    0/19 (0%)    0/17 (0%)    1/13 (8%)    |
|POLY-3 ADJUSTED (b)|     30.3%        0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         7.8%         |
|TERMINAL (d)       |     2/6 (33%)    0/4 (0%)     0/6 (0%)     0/2 (0%)    |0/10 (0%)    0/11 (0%)    0/9 (0%)     0/11 (0%)    |
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |---          ---          ---          708          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.165N     P=0.323N     P=0.229N     P=0.500N    |P=0.213      (e)          (e)          P=0.505      |
|POLY 3             |     P=0.094N     P=0.292N     P=0.214N     P=0.351N    |P=0.176      (e)          (e)          P=0.505      |
|POLY 1.5           |     P=0.104N     P=0.279N     P=0.216N     P=0.328N    |P=0.171      (e)          (e)          P=0.496      |
|POLY 6             |     P=0.080N     P=0.303N     P=0.212N     P=0.393N    |P=0.184      (e)          (e)          P=0.517      |
|LOGISTIC REGRESSION|     P=0.165N     (e)          (e)          (e)         |P=0.172      (e)          (e)          P=0.482      |
|COCH-ARM / FISHERS |     P=0.126N     P=0.269N     P=0.231N     P=0.318N    |P=0.165      (e)          (e)          P=0.481      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery                                                                                                                        |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/7 (29%)    0/6 (0%)     2/7 (29%)    0/5 (0%)    |1/14 (7%)    0/19 (0%)    0/17 (0%)    0/13 (0%)    |
|POLY-3 ADJUSTED (b)|     30.3%        0.0%         29.9%        0.0%        |8.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/6 (33%)    0/4 (0%)     2/6 (33%)    0/2 (0%)    |1/10 (10%)   0/11 (0%)    0/9 (0%)     0/11 (0%)    |
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |728 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.441N     P=0.323N     P=0.721      P=0.500N    |P=0.302N     P=0.481N     P=0.521N     P=0.481N     |
|POLY 3             |     P=0.317N     P=0.292N     P=0.707N     P=0.351N    |P=0.330N     P=0.436N     P=0.467N     P=0.496N     |
|POLY 1.5           |     P=0.304N     P=0.279N     P=0.707N     P=0.328N    |P=0.324N     P=0.437N     P=0.465N     P=0.504N     |
|POLY 6             |     P=0.343N     P=0.303N     P=0.707N     P=0.393N    |P=0.334N     P=0.438N     P=0.467N     P=0.485N     |
|LOGISTIC REGRESSION|     P=0.441N     (e)          P=0.721      (e)         |P=0.302N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.295N     P=0.269N     P=0.720N     P=0.318N    |P=0.313N     P=0.424N     P=0.452N     P=0.519N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 30
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/7 (57%)    4/6 (67%)    3/7 (43%)    2/5 (40%)   |10/14 (71%)  7/19 (37%)   10/17 (59%)  11/13 (85%)  |
|POLY-3 ADJUSTED (b)|     60.5%        76.5%        44.8%        51.0%       |74.7%        40.7%        63.1%        86.0%        |
|TERMINAL (d)       |     4/6 (67%)    3/4 (75%)    3/6 (50%)    2/2 (100%)  |8/10 (80%)   6/11 (55%)   7/9 (78%)    10/11 (91%)  |
|FIRST INCIDENCE    |     727 (T)      644          727 (T)      727 (T)     |547          706          477          708          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.598      P=0.417      P=0.500N     P=0.500     |P=0.337      P=0.170N     P=0.540      P=0.647      |
|POLY 3             |     P=0.379N     P=0.516      P=0.491N     P=0.628N    |P=0.113      P=0.052N     P=0.390N     P=0.406      |
|POLY 1.5           |     P=0.346N     P=0.534      P=0.495N     P=0.564N    |P=0.104      P=0.049N*    P=0.381N     P=0.385      |
|POLY 6             |     P=0.436N     P=0.518      P=0.488N     P=0.736N    |P=0.135      P=0.060N     P=0.394N     P=0.441      |
|LOGISTIC REGRESSION|     P=0.581N     P=0.422      P=0.500N     P=0.500     |P=0.154      P=0.041N*    P=0.379N     P=0.499      |
|COCH-ARM / FISHERS |     P=0.305N     P=0.587      P=0.500N     P=0.500N    |P=0.107      P=0.053N     P=0.364N     P=0.362      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Foreign Body                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    3/49 (6%)    1/50 (2%)   |0/50 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.2%         2.1%         6.4%         2.2%        |0.0%         0.0%         2.1%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    1/45 (2%)    3/41 (7%)    1/39 (3%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     647          727 (T)      727 (T)      727 (T)     |---          ---          723          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.493N     P=0.469N     P=0.516      P=0.508N    |P=0.700      (e)          P=0.495      (e)          |
|POLY 3             |     P=0.494N     P=0.495N     P=0.495      P=0.513N    |P=0.700      (e)          P=0.504      (e)          |
|POLY 1.5           |     P=0.486N     P=0.498N     P=0.494      P=0.508N    |P=0.696      (e)          P=0.503      (e)          |
|POLY 6             |     P=0.503N     P=0.491N     P=0.496      P=0.518N    |P=0.707      (e)          P=0.506      (e)          |
|LOGISTIC REGRESSION|     P=0.487N     P=0.505N     P=0.491      P=0.497N    |P=0.701      (e)          P=0.506      (e)          |
|COCH-ARM / FISHERS |     P=0.475N     P=0.500N     P=0.490      P=0.500N    |P=0.695      (e)          P=0.500      (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 31
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/49 (4%)    1/50 (2%)   |0/50 (0%)    0/49 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.1%         2.1%         4.3%         2.2%        |0.0%         0.0%         2.1%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    1/45 (2%)    2/41 (5%)    1/39 (3%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |---          ---          723          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.578      P=0.730N     P=0.517      P=0.762     |P=0.700      (e)          P=0.495      (e)          |
|POLY 3             |     P=0.572      P=0.756N     P=0.498      P=0.754     |P=0.700      (e)          P=0.504      (e)          |
|POLY 1.5           |     P=0.579      P=0.758N     P=0.496      P=0.756     |P=0.696      (e)          P=0.503      (e)          |
|POLY 6             |     P=0.564      P=0.752N     P=0.501      P=0.752     |P=0.707      (e)          P=0.506      (e)          |
|LOGISTIC REGRESSION|     P=0.578      P=0.730N     P=0.517      P=0.762     |P=0.701      (e)          P=0.506      (e)          |
|COCH-ARM / FISHERS |     P=0.590      P=0.753N     P=0.492      P=0.753N    |P=0.695      (e)          P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa: Gingival                                                                                                            |
|     Foreign Body                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     26/26 (100%) 27/27 (100%) 17/17 (100%) 19/19 (100%)|1/1 (100%)   0/0 (0%)     2/2 (100%)   3/3 (100%)   |
|POLY-3 ADJUSTED (b)|     100.0%       100.0%       100.0%       100.0%      |100.0%       0.0%         100.0%       100.0%       |
|TERMINAL (d)       |     25/25 (100%) 27/27 (100%) 15/15 (100%) 17/17 (100%)|1/1 (100%)   0/0 (0%)     1/1 (100%)   3/3 (100%)   |
|FIRST INCIDENCE    |     647          727 (T)      643          594         |728 (T)      ---          723          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 32
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa: Gingival                                                                                                            |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     21/26 (81%)  22/27 (81%)  14/17 (82%)  11/19 (58%) |1/1 (100%)   0/0 (0%)     2/2 (100%)   2/3 (67%)    |
|POLY-3 ADJUSTED (b)|     80.8%        81.5%        83.9%        59.8%       |100.0%       0.0%         100.0%       66.7%        |
|TERMINAL (d)       |     20/25 (80%)  22/27 (82%)  13/15 (87%)  11/17 (65%) |1/1 (100%)   0/0 (0%)     1/1 (100%)   2/3 (67%)    |
|FIRST INCIDENCE    |     647          727 (T)      707          727 (T)     |728 (T)      ---          723          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.126N     P=0.549N     P=0.469      P=0.154N    |P=0.502N     (e)          (e)          P=0.718N     |
|POLY 3             |     P=0.070N     P=0.610      P=0.559      P=0.114N    |(e)          (e)          (e)          P=0.691N     |
|POLY 1.5           |     P=0.059N     P=0.610      P=0.580      P=0.101N    |(e)          (e)          (e)          P=0.691N     |
|POLY 6             |     P=0.090N     P=0.610      P=0.525      P=0.135N    |(e)          (e)          (e)          P=0.691N     |
|LOGISTIC REGRESSION|     P=0.080N     P=0.549N     P=0.573      P=0.116N    |P=0.502N     (e)          (e)          P=0.718N     |
|COCH-ARM / FISHERS |     P=0.048N*    P=0.611      P=0.612      P=0.091N    |P=0.403N     (e)          (e)          P=0.750N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |6/47 (13%)   9/49 (18%)   9/50 (18%)   7/49 (14%)   |
|POLY-3 ADJUSTED (b)|                                                        |13.9%        20.0%        19.0%        15.1%        |
|TERMINAL (d)       |                                                        |4/37 (11%)   7/33 (21%)   6/37 (16%)   5/40 (13%)   |
|FIRST INCIDENCE    |                                                        |663          667          524          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.499N     P=0.224      P=0.298      P=0.550      |
|POLY 3             |                                                        |P=0.530N     P=0.321      P=0.361      P=0.555      |
|POLY 1.5           |                                                        |P=0.546N     P=0.322      P=0.350      P=0.544      |
|POLY 6             |                                                        |P=0.504N     P=0.310      P=0.371      P=0.572      |
|LOGISTIC REGRESSION|                                                        |P=0.549      P=0.311      P=0.339      P=0.535      |
|COCH-ARM / FISHERS |                                                        |P=0.545      P=0.319      P=0.334      P=0.533      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 33
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |2/47 (4%)    1/49 (2%)    1/50 (2%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|                                                        |4.6%         2.2%         2.1%         2.2%         |
|TERMINAL (d)       |                                                        |0/37 (0%)    1/33 (3%)    0/37 (0%)    0/40 (0%)    |
|FIRST INCIDENCE    |                                                        |547          728 (T)      716          673          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.391N     P=0.535N     P=0.502N     P=0.494N     |
|POLY 3             |                                                        |P=0.393N     P=0.490N     P=0.473N     P=0.482N     |
|POLY 1.5           |                                                        |P=0.396N     P=0.487N     P=0.475N     P=0.484N     |
|POLY 6             |                                                        |P=0.387N     P=0.498N     P=0.472N     P=0.477N     |
|LOGISTIC REGRESSION|                                                        |P=0.394N     P=0.518N     P=0.516N     P=0.478N     |
|COCH-ARM / FISHERS |                                                        |P=0.397N     P=0.484N     P=0.477N     P=0.484N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |3/47 (6%)    0/49 (0%)    0/50 (0%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|                                                        |6.9%         0.0%         0.0%         2.2%         |
|TERMINAL (d)       |                                                        |1/37 (3%)    0/33 (0%)    0/37 (0%)    1/40 (3%)    |
|FIRST INCIDENCE    |                                                        |547          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.237N     P=0.142N     P=0.125N     P=0.298N     |
|POLY 3             |                                                        |P=0.233N     P=0.113N     P=0.105N     P=0.288N     |
|POLY 1.5           |                                                        |P=0.235N     P=0.112N     P=0.107N     P=0.290N     |
|POLY 6             |                                                        |P=0.229N     P=0.117N     P=0.105N     P=0.285N     |
|LOGISTIC REGRESSION|                                                        |P=0.238N     P=0.125N     P=0.124N     P=0.292N     |
|COCH-ARM / FISHERS |                                                        |P=0.238N     P=0.113N     P=0.110N     P=0.293N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 34
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |2/47 (4%)    0/49 (0%)    1/50 (2%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|                                                        |4.6%         0.0%         2.1%         2.2%         |
|TERMINAL (d)       |                                                        |0/37 (0%)    0/33 (0%)    0/37 (0%)    1/40 (3%)    |
|FIRST INCIDENCE    |                                                        |547          ---          716          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.486N     P=0.260N     P=0.502N     P=0.496N     |
|POLY 3             |                                                        |P=0.485N     P=0.230N     P=0.473N     P=0.483N     |
|POLY 1.5           |                                                        |P=0.488N     P=0.229N     P=0.475N     P=0.485N     |
|POLY 6             |                                                        |P=0.479N     P=0.235N     P=0.472N     P=0.480N     |
|LOGISTIC REGRESSION|                                                        |P=0.486N     P=0.267N     P=0.516N     P=0.485N     |
|COCH-ARM / FISHERS |                                                        |P=0.489N     P=0.237N     P=0.477N     P=0.484N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas                                                                                                                         |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/49 (4%)    2/50 (4%)    3/50 (6%)    2/50 (4%)   |14/50 (28%)  10/50 (20%)  7/50 (14%)   13/50 (26%)  |
|POLY-3 ADJUSTED (b)|     4.4%         4.2%         6.3%         4.4%        |30.6%        21.9%        15.0%        28.0%        |
|TERMINAL (d)       |     2/39 (5%)    2/45 (4%)    3/42 (7%)    2/39 (5%)   |14/40 (35%)  10/34 (29%)  7/37 (19%)   13/41 (32%)  |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      727 (T)     |728 (T)      728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.551      P=0.642N     P=0.534      P=0.695     |P=0.419N     P=0.397N     P=0.094N     P=0.469N     |
|POLY 3             |     P=0.555      P=0.679N     P=0.517      P=0.690     |P=0.481N     P=0.238N     P=0.059N     P=0.480N     |
|POLY 1.5           |     P=0.563      P=0.682N     P=0.514      P=0.693N    |P=0.492N     P=0.237N     P=0.063N     P=0.491N     |
|POLY 6             |     P=0.547      P=0.673N     P=0.520      P=0.687     |P=0.458N     P=0.251N     P=0.055N     P=0.461N     |
|LOGISTIC REGRESSION|     P=0.551      P=0.642N     P=0.534      P=0.695     |P=0.419N     P=0.397N     P=0.094N     P=0.469N     |
|COCH-ARM / FISHERS |     P=0.576      P=0.684N     P=0.510      P=0.684N    |P=0.500N     P=0.241N     P=0.070N     P=0.500N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 35
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    0/47 (0%)    0/47 (0%)   |1/48 (2%)    3/47 (6%)    0/43 (0%)    3/48 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.3%         6.9%         0.0%         6.6%         |
|TERMINAL (d)       |     0/38 (0%)    0/44 (0%)    0/40 (0%)    0/37 (0%)   |1/38 (3%)    3/32 (9%)    0/33 (0%)    3/40 (8%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      728 (T)      ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.365      P=0.245      P=0.528N     P=0.324      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.337      P=0.302      P=0.515N     P=0.316      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.331      P=0.302      P=0.518N     P=0.311      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.345      P=0.297      P=0.513N     P=0.324      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.365      P=0.245      (e)          P=0.324      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.325      P=0.301      P=0.527N     P=0.308      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/49 (6%)    2/49 (4%)    2/47 (4%)    4/47 (9%)   |0/48 (0%)    0/47 (0%)    2/43 (5%)    2/48 (4%)    |
|POLY-3 ADJUSTED (b)|     6.6%         4.3%         4.5%         9.2%        |0.0%         0.0%         4.9%         4.4%         |
|TERMINAL (d)       |     3/38 (8%)    2/44 (5%)    2/40 (5%)    3/37 (8%)   |0/38 (0%)    0/32 (0%)    2/33 (6%)    2/40 (5%)    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      556         |---          ---          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.322      P=0.433N     P=0.477N     P=0.486     |P=0.107      (e)          P=0.208      P=0.250      |
|POLY 3             |     P=0.328      P=0.490N     P=0.509N     P=0.471     |P=0.093      (e)          P=0.220      P=0.244      |
|POLY 1.5           |     P=0.331      P=0.495N     P=0.513N     P=0.473     |P=0.090      (e)          P=0.217      P=0.241      |
|POLY 6             |     P=0.325      P=0.482N     P=0.504N     P=0.471     |P=0.098      (e)          P=0.223      P=0.249      |
|LOGISTIC REGRESSION|     P=0.329      P=0.433N     P=0.477N     P=0.479     |(e)          (e)          P=0.208      P=0.250      |
|COCH-ARM / FISHERS |     P=0.334      P=0.500N     P=0.520N     P=0.476     |P=0.088      (e)          P=0.221      P=0.247      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 36
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    1/49 (2%)    0/47 (0%)    0/47 (0%)   |2/48 (4%)    3/47 (6%)    4/43 (9%)    6/48 (13%)   |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |4.6%         6.9%         9.8%         13.3%        |
|TERMINAL (d)       |     0/38 (0%)    1/44 (2%)    0/40 (0%)    0/37 (0%)   |2/38 (5%)    3/32 (9%)    3/33 (9%)    6/40 (15%)   |
|FIRST INCIDENCE    |     ---          727 (T)      ---          ---         |728 (T)      728 (T)      687          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.579N     P=0.529      (e)          (e)         |P=0.112      P=0.421      P=0.290      P=0.150      |
|POLY 3             |     P=0.571N     P=0.504      (e)          (e)         |P=0.089      P=0.496      P=0.304      P=0.143      |
|POLY 1.5           |     P=0.573N     P=0.502      (e)          (e)         |P=0.085      P=0.496      P=0.298      P=0.138      |
|POLY 6             |     P=0.569N     P=0.508      (e)          (e)         |P=0.096      P=0.490      P=0.311      P=0.150      |
|LOGISTIC REGRESSION|     (e)          P=0.529      (e)          (e)         |P=0.107      P=0.421      P=0.307      P=0.150      |
|COCH-ARM / FISHERS |     P=0.574N     P=0.500      (e)          (e)         |P=0.081      P=0.490      P=0.287      P=0.134      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     27/50 (54%)  28/50 (56%)  29/49 (59%)  25/50 (50%) |                                                    |
|POLY-3 ADJUSTED (b)|     57.7%        58.6%        61.9%        54.4%       |                                                    |
|TERMINAL (d)       |     27/39 (69%)  28/45 (62%)  28/41 (68%)  24/39 (62%) |                                                    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      664          556         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.452N     P=0.330N     P=0.537      P=0.410N    |                                                    |
|POLY 3             |     P=0.411N     P=0.548      P=0.417      P=0.454N    |                                                    |
|POLY 1.5           |     P=0.392N     P=0.524      P=0.400      P=0.442N    |                                                    |
|POLY 6             |     P=0.431N     P=0.582N     P=0.439      P=0.462N    |                                                    |
|LOGISTIC REGRESSION|     P=0.504N     P=0.330N     P=0.447      P=0.514N    |                                                    |
|COCH-ARM / FISHERS |     P=0.364N     P=0.500      P=0.376      P=0.421N    |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 37
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/49 (4%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.3%         0.0%        |                                                    |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    1/41 (2%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     ---          ---          707          ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.586      (e)          P=0.253      (e)         |                                                    |
|POLY 3             |     P=0.573      (e)          P=0.237      (e)         |                                                    |
|POLY 1.5           |     P=0.582      (e)          P=0.235      (e)         |                                                    |
|POLY 6             |     P=0.563      (e)          P=0.238      (e)         |                                                    |
|LOGISTIC REGRESSION|     P=0.588      (e)          P=0.236      (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.594      (e)          P=0.242      (e)         |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   8/50 (16%)   4/49 (8%)    4/50 (8%)   |                                                    |
|POLY-3 ADJUSTED (b)|     14.9%        16.6%        8.6%         8.8%        |                                                    |
|TERMINAL (d)       |     6/39 (15%)   7/45 (16%)   4/41 (10%)   4/39 (10%)  |                                                    |
|FIRST INCIDENCE    |     705          612          727 (T)      727 (T)     |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.155N     P=0.606      P=0.234N     P=0.264N    |                                                    |
|POLY 3             |     P=0.154N     P=0.523      P=0.265N     P=0.279N    |                                                    |
|POLY 1.5           |     P=0.149N     P=0.512      P=0.268N     P=0.273N    |                                                    |
|POLY 6             |     P=0.160N     P=0.540      P=0.262N     P=0.286N    |                                                    |
|LOGISTIC REGRESSION|     P=0.159N     P=0.518      P=0.251N     P=0.280N    |                                                    |
|COCH-ARM / FISHERS |     P=0.140N     P=0.500      P=0.274N     P=0.262N    |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 38
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland: Duct                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     33/50 (66%)  32/50 (64%)  33/49 (67%)  39/50 (78%) |                                                    |
|POLY-3 ADJUSTED (b)|     69.2%        67.0%        69.3%        81.4%       |                                                    |
|TERMINAL (d)       |     28/39 (72%)  32/45 (71%)  30/41 (73%)  32/39 (82%) |                                                    |
|FIRST INCIDENCE    |     647          727 (T)      577          549         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.046 *    P=0.175N     P=0.458N     P=0.151     |                                                    |
|POLY 3             |     P=0.075      P=0.494N     P=0.586      P=0.118     |                                                    |
|POLY 1.5           |     P=0.076      P=0.498N     P=0.565      P=0.120     |                                                    |
|POLY 6             |     P=0.079      P=0.488N     P=0.579N     P=0.126     |                                                    |
|LOGISTIC REGRESSION|     P=0.035 *    P=0.372N     P=0.586      P=0.075     |                                                    |
|COCH-ARM / FISHERS |     P=0.083      P=0.500N     P=0.528      P=0.133     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     15/50 (30%)  22/50 (44%)  29/49 (59%)  28/50 (56%) |                                                    |
|POLY-3 ADJUSTED (b)|     32.0%        45.7%        61.0%        60.3%       |                                                    |
|TERMINAL (d)       |     14/39 (36%)  21/45 (47%)  26/41 (63%)  26/39 (67%) |                                                    |
|FIRST INCIDENCE    |     687          601          596          549         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P=0.233      P=0.008 **   P=0.006 **  |                                                    |
|POLY 3             |     P=0.003 **   P=0.121      P=0.003 **   P=0.004 **  |                                                    |
|POLY 1.5           |     P=0.003 **   P=0.114      P=0.003 **   P=0.005 **  |                                                    |
|POLY 6             |     P=0.002 **   P=0.135      P=0.004 **   P=0.003 **  |                                                    |
|LOGISTIC REGRESSION|     P=0.002 **   P=0.135      P=0.004 **   P=0.004 **  |                                                    |
|COCH-ARM / FISHERS |     P=0.005 **   P=0.107      P=0.003 **   P=0.007 **  |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 39
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    3/49 (6%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     2.1%         4.2%         6.4%         0.0%        |                                                    |
|TERMINAL (d)       |     1/39 (3%)    1/45 (2%)    2/41 (5%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     727 (T)      637          643          ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.355N     P=0.533      P=0.320      P=0.500N    |                                                    |
|POLY 3             |     P=0.355N     P=0.510      P=0.306      P=0.506N    |                                                    |
|POLY 1.5           |     P=0.349N     P=0.505      P=0.303      P=0.504N    |                                                    |
|POLY 6             |     P=0.362N     P=0.517      P=0.310      P=0.508N    |                                                    |
|LOGISTIC REGRESSION|     P=0.324N     P=0.494      P=0.292      (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.338N     P=0.500      P=0.301      P=0.500N    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate: Artery                                                                                                                 |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/49 (0%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         4.1%         0.0%         0.0%        |                                                    |
|TERMINAL (d)       |     0/39 (0%)    1/45 (2%)    0/41 (0%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     ---          444          ---          ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.409N     P=0.255      (e)          (e)         |                                                    |
|POLY 3             |     P=0.404N     P=0.246      (e)          (e)         |                                                    |
|POLY 1.5           |     P=0.405N     P=0.242      (e)          (e)         |                                                    |
|POLY 6             |     P=0.402N     P=0.250      (e)          (e)         |                                                    |
|LOGISTIC REGRESSION|     P=0.323N     P=0.226      (e)          (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.406N     P=0.247      (e)          (e)         |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 40
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands                                                                                                                  |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/49 (0%)    0/49 (0%)    0/48 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     2.1%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         4.2%         |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |---          ---          ---          520          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.307N     P=0.471N     P=0.485N     P=0.500N    |P=0.049 *    (e)          (e)          P=0.250      |
|POLY 3             |     P=0.304N     P=0.496N     P=0.497N     P=0.506N    |P=0.049 *    (e)          (e)          P=0.249      |
|POLY 1.5           |     P=0.304N     P=0.498N     P=0.498N     P=0.504N    |P=0.048 *    (e)          (e)          P=0.246      |
|POLY 6             |     P=0.304N     P=0.492N     P=0.495N     P=0.508N    |P=0.050      (e)          (e)          P=0.254      |
|LOGISTIC REGRESSION|     P=0.307N     (e)          (e)          (e)         |P=0.072      (e)          (e)          P=0.267      |
|COCH-ARM / FISHERS |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.048 *    (e)          (e)          P=0.253      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands                                                                                                                  |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     27/50 (54%)  28/50 (56%)  33/50 (66%)  32/50 (64%) |34/49 (69%)  36/49 (73%)  40/48 (83%)  35/50 (70%)  |
|POLY-3 ADJUSTED (b)|     56.1%        57.7%        67.6%        67.3%       |73.4%        76.8%        86.0%        74.4%        |
|TERMINAL (d)       |     21/39 (54%)  27/45 (60%)  30/42 (71%)  27/39 (69%) |32/40 (80%)  27/34 (79%)  34/37 (92%)  32/41 (78%)  |
|FIRST INCIDENCE    |     617          444          577          502         |456          643          477          659          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.096      P=0.387N     P=0.284      P=0.217     |P=0.400N     P=0.111      P=0.038 *    P=0.580      |
|POLY 3             |     P=0.112      P=0.520      P=0.168      P=0.176     |P=0.484      P=0.442      P=0.093      P=0.552      |
|POLY 1.5           |     P=0.124      P=0.514      P=0.164      P=0.189     |P=0.480      P=0.427      P=0.086      P=0.543      |
|POLY 6             |     P=0.099      P=0.520      P=0.166      P=0.160     |P=0.526      P=0.464      P=0.110      P=0.589      |
|LOGISTIC REGRESSION|     P=0.111      P=0.524      P=0.170      P=0.173     |P=0.530N     P=0.442      P=0.100      P=0.564N     |
|COCH-ARM / FISHERS |     P=0.142      P=0.500      P=0.154      P=0.208     |P=0.510      P=0.412      P=0.084      P=0.560      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 41
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    1/50 (2%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     6.4%         6.3%         2.1%         0.0%        |                                                    |
|TERMINAL (d)       |     3/39 (8%)    3/45 (7%)    1/42 (2%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     727 (T)      727 (T)      727 (T)      ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.052N     P=0.595N     P=0.279N     P=0.121N    |                                                    |
|POLY 3             |     P=0.054N     P=0.653N     P=0.299N     P=0.124N    |                                                    |
|POLY 1.5           |     P=0.053N     P=0.657N     P=0.302N     P=0.122N    |                                                    |
|POLY 6             |     P=0.055N     P=0.645N     P=0.297N     P=0.126N    |                                                    |
|LOGISTIC REGRESSION|     P=0.052N     P=0.595N     P=0.279N     (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.052N     P=0.661N     P=0.309N     P=0.121N    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         0.0%         0.0%        |                                                    |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     727 (T)      ---          ---          ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.114N     P=0.208N     P=0.222N     P=0.238N    |                                                    |
|POLY 3             |     P=0.114N     P=0.233N     P=0.234N     P=0.244N    |                                                    |
|POLY 1.5           |     P=0.113N     P=0.235N     P=0.235N     P=0.241N    |                                                    |
|POLY 6             |     P=0.114N     P=0.229N     P=0.232N     P=0.246N    |                                                    |
|LOGISTIC REGRESSION|     P=0.114N     (e)          (e)          (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 42
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |1/50 (2%)    3/50 (6%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     8.5%         2.1%         2.1%         4.4%        |2.2%         6.5%         4.3%         0.0%         |
|TERMINAL (d)       |     3/39 (8%)    1/45 (2%)    0/42 (0%)    2/39 (5%)   |0/40 (0%)    2/34 (6%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |     647          727 (T)      707          727 (T)     |580          659          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.329N     P=0.150N     P=0.168N     P=0.343N    |P=0.231N     P=0.285      P=0.484      P=0.504N     |
|POLY 3             |     P=0.321N     P=0.175N     P=0.175N     P=0.354N    |P=0.239N     P=0.303      P=0.504      P=0.499N     |
|POLY 1.5           |     P=0.318N     P=0.177N     P=0.177N     P=0.348N    |P=0.241N     P=0.305      P=0.502      P=0.500N     |
|POLY 6             |     P=0.326N     P=0.171N     P=0.174N     P=0.361N    |P=0.236N     P=0.296      P=0.505      P=0.497N     |
|LOGISTIC REGRESSION|     P=0.321N     P=0.179N     P=0.182N     P=0.350N    |P=0.243N     P=0.283      P=0.481      P=0.457N     |
|COCH-ARM / FISHERS |     P=0.313N     P=0.181N     P=0.181N     P=0.339N    |P=0.242N     P=0.309      P=0.500      P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     6.4%         2.1%         2.1%         4.4%        |2.2%         2.2%         2.1%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    1/45 (2%)    0/42 (0%)    2/39 (5%)   |0/40 (0%)    0/34 (0%)    1/37 (3%)    0/41 (0%)    |
|FIRST INCIDENCE    |     647          727 (T)      707          727 (T)     |580          659          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.493N     P=0.271N     P=0.291N     P=0.506N    |P=0.304N     P=0.753N     P=0.754      P=0.504N     |
|POLY 3             |     P=0.483N     P=0.300N     P=0.301N     P=0.516N    |P=0.311N     P=0.759      P=0.758N     P=0.499N     |
|POLY 1.5           |     P=0.479N     P=0.303N     P=0.303N     P=0.510N    |P=0.312N     P=0.760      P=0.759N     P=0.500N     |
|POLY 6             |     P=0.488N     P=0.296N     P=0.300N     P=0.523N    |P=0.308N     P=0.755      P=0.758N     P=0.497N     |
|LOGISTIC REGRESSION|     P=0.481N     P=0.307N     P=0.315N     P=0.510N    |P=0.297N     P=0.719      P=0.743      P=0.457N     |
|COCH-ARM / FISHERS |     P=0.474N     P=0.309N     P=0.309N     P=0.500N    |P=0.311N     P=0.753N     P=0.753N     P=0.500N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 43
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.2%         2.1%         2.1%         0.0%        |0.0%         2.2%         2.1%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    1/45 (2%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    1/37 (3%)    0/41 (0%)    |
|FIRST INCIDENCE    |     647          727 (T)      707          ---         |---          659          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.159N     P=0.469N     P=0.486N     P=0.247N    |P=0.576N     P=0.505      P=0.484      (e)          |
|POLY 3             |     P=0.159N     P=0.495N     P=0.496N     P=0.245N    |P=0.590N     P=0.501      P=0.504      (e)          |
|POLY 1.5           |     P=0.157N     P=0.498N     P=0.497N     P=0.242N    |P=0.592N     P=0.501      P=0.503      (e)          |
|POLY 6             |     P=0.162N     P=0.491N     P=0.494N     P=0.249N    |P=0.586N     P=0.498      P=0.506      (e)          |
|LOGISTIC REGRESSION|     P=0.148N     P=0.505N     P=0.524N     P=0.224N    |P=0.595N     P=0.480      P=0.484      (e)          |
|COCH-ARM / FISHERS |     P=0.153N     P=0.500N     P=0.500N     P=0.247N    |P=0.595N     P=0.500      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.4%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |2/40 (5%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.114N     P=0.275N     P=0.256N     P=0.233N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.238N     P=0.232N     P=0.234N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.113N     P=0.237N     P=0.234N     P=0.236N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.112N     P=0.241N     P=0.230N     P=0.230N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.114N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 44
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.1%         0.0%        |0.0%         0.0%         0.0%         4.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |0/40 (0%)    0/34 (0%)    0/37 (0%)    2/41 (5%)    |
|FIRST INCIDENCE    |     ---          ---          664          ---         |---          ---          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.692      (e)          P=0.509      (e)         |P=0.055      (e)          (e)          P=0.244      |
|POLY 3             |     P=0.677      (e)          P=0.504      (e)         |P=0.046 *    (e)          (e)          P=0.241      |
|POLY 1.5           |     P=0.684      (e)          P=0.503      (e)         |P=0.046 *    (e)          (e)          P=0.239      |
|POLY 6             |     P=0.670      (e)          P=0.507      (e)         |P=0.047 *    (e)          (e)          P=0.244      |
|LOGISTIC REGRESSION|     P=0.712      (e)          P=0.451      (e)         |(e)          (e)          (e)          P=0.244      |
|COCH-ARM / FISHERS |     P=0.694      (e)          P=0.500      (e)         |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spinal Cord                                                                                                                      |
|     Demyelination                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     2/2 (100%)   |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         100.0%       |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 45
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     22/50 (44%)  11/50 (22%)  14/50 (28%)  20/50 (40%) |37/49 (76%)  39/50 (78%)  35/50 (70%)  39/50 (78%)  |
|POLY-3 ADJUSTED (b)|     44.9%        22.8%        28.8%        41.4%       |77.7%        81.6%        72.0%        82.3%        |
|TERMINAL (d)       |     16/39 (41%)  10/45 (22%)  10/42 (24%)  12/39 (31%) |31/40 (78%)  30/34 (88%)  30/37 (81%)  35/41 (85%)  |
|FIRST INCIDENCE    |     501          601          596          502         |456          651          477          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.411      P=0.009N**   P=0.063N     P=0.449N    |P=0.411N     P=0.120      P=0.564      P=0.497      |
|POLY 3             |     P=0.459      P=0.017N*    P=0.073N     P=0.445N    |P=0.416      P=0.414      P=0.336N     P=0.381      |
|POLY 1.5           |     P=0.462      P=0.016N*    P=0.073N     P=0.438N    |P=0.438      P=0.443      P=0.338N     P=0.411      |
|POLY 6             |     P=0.460      P=0.017N*    P=0.074N     P=0.444N    |P=0.408      P=0.368      P=0.345N     P=0.363      |
|LOGISTIC REGRESSION|     P=0.539      P=0.018N*    P=0.085N     P=0.354N    |P=0.495      P=0.479      P=0.337N     P=0.475      |
|COCH-ARM / FISHERS |     P=0.470      P=0.016N*    P=0.072N     P=0.420N    |P=0.492      P=0.478      P=0.349N     P=0.478      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |4/49 (8%)    3/50 (6%)    4/50 (8%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.1%         0.0%         2.1%         0.0%        |8.8%         6.6%         8.6%         2.2%         |
|TERMINAL (d)       |     1/39 (3%)    0/45 (0%)    1/42 (2%)    0/39 (0%)   |4/40 (10%)   3/34 (9%)    4/37 (11%)   1/41 (2%)    |
|FIRST INCIDENCE    |     727 (T)      ---          727 (T)      ---         |728 (T)      728 (T)      728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.412N     P=0.471N     P=0.745N     P=0.500N    |P=0.140N     P=0.589N     P=0.601      P=0.172N     |
|POLY 3             |     P=0.413N     P=0.496N     P=0.757N     P=0.506N    |P=0.148N     P=0.496N     P=0.626N     P=0.171N     |
|POLY 1.5           |     P=0.410N     P=0.498N     P=0.758N     P=0.504N    |P=0.151N     P=0.491N     P=0.628N     P=0.173N     |
|POLY 6             |     P=0.416N     P=0.492N     P=0.755N     P=0.508N    |P=0.142N     P=0.508N     P=0.624N     P=0.168N     |
|LOGISTIC REGRESSION|     P=0.412N     (e)          P=0.745N     (e)         |P=0.140N     P=0.589N     P=0.601      P=0.172N     |
|COCH-ARM / FISHERS |     P=0.405N     P=0.500N     P=0.753N     P=0.500N    |P=0.152N     P=0.489N     P=0.631N     P=0.175N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 46
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    2/50 (4%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     6.3%         0.0%         2.1%         2.2%        |2.2%         4.3%         4.2%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    0/39 (0%)   |1/40 (3%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |     501          ---          667          629         |728 (T)      652          524          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.313N     P=0.116N     P=0.302N     P=0.325N    |P=0.282N     P=0.487      P=0.497      P=0.495N     |
|POLY 3             |     P=0.301N     P=0.119N     P=0.304N     P=0.320N    |P=0.290N     P=0.503      P=0.513      P=0.497N     |
|POLY 1.5           |     P=0.299N     P=0.119N     P=0.305N     P=0.315N    |P=0.294N     P=0.503      P=0.508      P=0.499N     |
|POLY 6             |     P=0.304N     P=0.117N     P=0.304N     P=0.325N    |P=0.284N     P=0.501      P=0.519      P=0.494N     |
|LOGISTIC REGRESSION|     P=0.223N     P=0.111N     P=0.424N     P=0.211N    |P=0.275N     P=0.487      P=0.460      (e)          |
|COCH-ARM / FISHERS |     P=0.296N     P=0.121N     P=0.309N     P=0.309N    |P=0.296N     P=0.500      P=0.500      P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach: Epithelium                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   1/50 (2%)    2/50 (4%)    3/50 (6%)   |2/50 (4%)    3/50 (6%)    3/50 (6%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     12.4%        2.1%         4.2%         6.5%        |4.4%         6.5%         6.3%         12.9%        |
|TERMINAL (d)       |     2/39 (5%)    0/45 (0%)    1/42 (2%)    1/39 (3%)   |2/40 (5%)    1/34 (3%)    1/37 (3%)    6/41 (15%)   |
|FIRST INCIDENCE    |     501          644          667          549         |728 (T)      652          524          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.296N     P=0.055N     P=0.131N     P=0.263N    |P=0.104      P=0.460      P=0.483      P=0.141      |
|POLY 3             |     P=0.282N     P=0.057N     P=0.137N     P=0.263N    |P=0.084      P=0.504      P=0.517      P=0.138      |
|POLY 1.5           |     P=0.278N     P=0.057N     P=0.136N     P=0.256N    |P=0.082      P=0.504      P=0.510      P=0.136      |
|POLY 6             |     P=0.287N     P=0.056N     P=0.138N     P=0.270N    |P=0.088      P=0.501      P=0.525      P=0.143      |
|LOGISTIC REGRESSION|     P=0.172N     P=0.054N     P=0.188N     P=0.136N    |P=0.079      P=0.499      P=0.476      P=0.141      |
|COCH-ARM / FISHERS |     P=0.273N     P=0.056N     P=0.134N     P=0.243N    |P=0.080      P=0.500      P=0.500      P=0.134      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 47
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach: Epithelium                                                                                                 |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    1/50 (2%)   |2/50 (4%)    3/50 (6%)    3/50 (6%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     4.2%         0.0%         4.2%         2.2%        |4.3%         6.5%         6.2%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    1/42 (2%)    0/39 (0%)   |1/40 (3%)    0/34 (0%)    0/37 (0%)    1/41 (2%)    |
|FIRST INCIDENCE    |     501          ---          667          629         |565          652          477          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.548N     P=0.237N     P=0.683N     P=0.518N    |P=0.326N     P=0.482      P=0.499      P=0.497N     |
|POLY 3             |     P=0.542N     P=0.237N     P=0.692N     P=0.514N    |P=0.340N     P=0.501      P=0.519      P=0.498N     |
|POLY 1.5           |     P=0.537N     P=0.237N     P=0.693N     P=0.509N    |P=0.343N     P=0.502      P=0.512      P=0.500N     |
|POLY 6             |     P=0.548N     P=0.235N     P=0.691N     P=0.518N    |P=0.334N     P=0.496      P=0.526      P=0.495N     |
|LOGISTIC REGRESSION|     P=0.440N     P=0.207N     P=0.583      P=0.373N    |P=0.296N     P=0.454      P=0.398      P=0.499N     |
|COCH-ARM / FISHERS |     P=0.531N     P=0.247N     P=0.691N     P=0.500N    |P=0.343N     P=0.500      P=0.500      P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular: Epithelium                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    10/50 (20%) |0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.2%         22.0%       |0.0%         0.0%         2.1%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    2/42 (5%)    10/39 (26%) |0/40 (0%)    0/34 (0%)    1/37 (3%)    1/41 (2%)    |
|FIRST INCIDENCE    |     ---          ---          727 (T)      727 (T)     |---          ---          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   (e)          P=0.255      P<0.001 **  |P=0.254      (e)          P=0.484      P=0.505      |
|POLY 3             |     P<0.001 **   (e)          P=0.241      P<0.001 **  |P=0.241      (e)          P=0.504      P=0.503      |
|POLY 1.5           |     P<0.001 **   (e)          P=0.240      P<0.001 **  |P=0.238      (e)          P=0.503      P=0.501      |
|POLY 6             |     P<0.001 **   (e)          P=0.242      P<0.001 **  |P=0.247      (e)          P=0.506      P=0.506      |
|LOGISTIC REGRESSION|     (e)          (e)          P=0.255      P<0.001 **  |(e)          (e)          P=0.484      P=0.505      |
|COCH-ARM / FISHERS |     P<0.001 **   (e)          P=0.247      P<0.001 **  |P=0.236      (e)          P=0.500      P=0.500      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 48
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular: Glands                                                                                                       |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     12/50 (24%)  18/50 (36%)  16/50 (32%)  14/50 (28%) |19/50 (38%)  16/50 (32%)  10/50 (20%)  21/50 (42%)  |
|POLY-3 ADJUSTED (b)|     25.4%        37.1%        33.6%        30.8%       |41.5%        34.9%        21.4%        44.9%        |
|TERMINAL (d)       |     10/39 (26%)  17/45 (38%)  16/42 (38%)  14/39 (36%) |18/40 (45%)  15/34 (44%)  10/37 (27%)  20/41 (49%)  |
|FIRST INCIDENCE    |     617          444          727 (T)      727 (T)     |716          673          728 (T)      659          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.440      P=0.255      P=0.325      P=0.402     |P=0.464      P=0.570N     P=0.057N     P=0.459      |
|POLY 3             |     P=0.429      P=0.154      P=0.256      P=0.362     |P=0.384      P=0.330N     P=0.029N*    P=0.451      |
|POLY 1.5           |     P=0.458      P=0.147      P=0.256      P=0.382     |P=0.369      P=0.330N     P=0.032N*    P=0.433      |
|POLY 6             |     P=0.396      P=0.164      P=0.253      P=0.341     |P=0.415      P=0.347N     P=0.026N*    P=0.481      |
|LOGISTIC REGRESSION|     P=0.432      P=0.141      P=0.276      P=0.358     |P=0.477      P=0.493N     P=0.035N*    P=0.495      |
|COCH-ARM / FISHERS |     P=0.500      P=0.138      P=0.252      P=0.410     |P=0.361      P=0.338N     P=0.038N*    P=0.419      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         4.4%        |                                                    |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    0/42 (0%)    2/39 (5%)   |                                                    |
|FIRST INCIDENCE    |     ---          ---          ---          727 (T)     |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.041 *    (e)          (e)          P=0.238     |                                                    |
|POLY 3             |     P=0.044 *    (e)          (e)          P=0.231     |                                                    |
|POLY 1.5           |     P=0.044 *    (e)          (e)          P=0.233     |                                                    |
|POLY 6             |     P=0.043 *    (e)          (e)          P=0.228     |                                                    |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.238     |                                                    |
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |                                                    |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 49
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Interstitial Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.2%         0.0%        |                                                    |
|TERMINAL (d)       |     0/39 (0%)    0/45 (0%)    2/42 (5%)    0/39 (0%)   |                                                    |
|FIRST INCIDENCE    |     ---          ---          727 (T)      ---         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.588      (e)          P=0.255      (e)         |                                                    |
|POLY 3             |     P=0.574      (e)          P=0.241      (e)         |                                                    |
|POLY 1.5           |     P=0.582      (e)          P=0.240      (e)         |                                                    |
|POLY 6             |     P=0.564      (e)          P=0.242      (e)         |                                                    |
|LOGISTIC REGRESSION|     (e)          (e)          P=0.255      (e)         |                                                    |
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     9/37 (24%)   14/39 (36%)  16/38 (42%)  9/42 (21%)  |10/46 (22%)  12/47 (26%)  17/44 (39%)  16/46 (35%)  |
|POLY-3 ADJUSTED (b)|     25.8%        36.7%        43.6%        24.0%       |23.2%        27.7%        40.4%        36.2%        |
|TERMINAL (d)       |     8/30 (27%)   13/36 (36%)  15/33 (46%)  9/32 (28%)  |8/37 (22%)   10/33 (30%)  14/32 (44%)  14/38 (37%)  |
|FIRST INCIDENCE    |     652          444          667          727 (T)     |580          667          617          401          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.443N     P=0.303      P=0.116      P=0.551N    |P=0.121      P=0.312      P=0.047 *    P=0.145      |
|POLY 3             |     P=0.404N     P=0.228      P=0.089      P=0.537N    |P=0.091      P=0.409      P=0.067      P=0.136      |
|POLY 1.5           |     P=0.367N     P=0.216      P=0.087      P=0.515N    |P=0.085      P=0.420      P=0.066      P=0.131      |
|POLY 6             |     P=0.453N     P=0.243      P=0.091      P=0.565N    |P=0.102      P=0.385      P=0.068      P=0.143      |
|LOGISTIC REGRESSION|     P=0.389N     P=0.200      P=0.096      P=0.565N    |P=0.078      P=0.424      P=0.070      P=0.122      |
|COCH-ARM / FISHERS |     P=0.318N     P=0.198      P=0.082      P=0.484N    |P=0.077      P=0.426      P=0.064      P=0.123      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 50
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Ectopic Parathyroid Gland                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/37 (0%)    0/39 (0%)    0/38 (0%)    0/42 (0%)   |1/46 (2%)    5/47 (11%)   3/44 (7%)    2/46 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.4%         11.5%        7.2%         4.7%         |
|TERMINAL (d)       |     0/30 (0%)    0/36 (0%)    0/33 (0%)    0/32 (0%)   |1/37 (3%)    4/33 (12%)   3/32 (9%)    2/38 (5%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |728 (T)      659          728 (T)      728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.535N     P=0.085      P=0.254      P=0.509      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.560N     P=0.107      P=0.299      P=0.504      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.565N     P=0.107      P=0.295      P=0.502      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.550N     P=0.103      P=0.301      P=0.509      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.544N     P=0.104      P=0.254      P=0.509      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.569N     P=0.107      P=0.292      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland                                                                                                                    |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |2/49 (4%)    1/49 (2%)    0/48 (0%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |4.4%         2.2%         0.0%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    1/45 (2%)    0/42 (0%)    0/39 (0%)   |2/40 (5%)    1/33 (3%)    0/37 (0%)    0/40 (0%)    |
|FIRST INCIDENCE    |     ---          727 (T)      ---          ---         |728 (T)      728 (T)      ---          567          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.575N     P=0.529      (e)          (e)         |P=0.359N     P=0.567N     P=0.256N     P=0.500N     |
|POLY 3             |     P=0.565N     P=0.504      (e)          (e)         |P=0.364N     P=0.503N     P=0.238N     P=0.492N     |
|POLY 1.5           |     P=0.566N     P=0.502      (e)          (e)         |P=0.366N     P=0.500N     P=0.239N     P=0.496N     |
|POLY 6             |     P=0.563N     P=0.508      (e)          (e)         |P=0.360N     P=0.510N     P=0.236N     P=0.486N     |
|LOGISTIC REGRESSION|     (e)          P=0.529      (e)          (e)         |P=0.366N     P=0.567N     (e)          P=0.497N     |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.367N     P=0.500N     P=0.253N     P=0.500N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 51
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicle                                                                                                          |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |0/49 (0%)    2/49 (4%)    0/48 (0%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     8.6%         2.1%         2.1%         4.4%        |0.0%         4.5%         0.0%         2.2%         |
|TERMINAL (d)       |     4/39 (10%)   0/45 (0%)    1/42 (2%)    2/39 (5%)   |0/40 (0%)    1/33 (3%)    0/37 (0%)    1/40 (3%)    |
|FIRST INCIDENCE    |     727 (T)      644          727 (T)      727 (T)     |---          706          ---          728 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.327N     P=0.149N     P=0.158N     P=0.336N    |P=0.553      P=0.205      (e)          P=0.500      |
|POLY 3             |     P=0.322N     P=0.171N     P=0.174N     P=0.351N    |P=0.543      P=0.236      (e)          P=0.502      |
|POLY 1.5           |     P=0.318N     P=0.175N     P=0.176N     P=0.346N    |P=0.540      P=0.237      (e)          P=0.501      |
|POLY 6             |     P=0.328N     P=0.164N     P=0.171N     P=0.356N    |P=0.545      P=0.231      (e)          P=0.504      |
|LOGISTIC REGRESSION|     P=0.324N     P=0.179N     P=0.158N     P=0.336N    |P=0.548      P=0.230      (e)          P=0.500      |
|COCH-ARM / FISHERS |     P=0.313N     P=0.181N     P=0.181N     P=0.339N    |P=0.538      P=0.247      (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tooth                                                                                                                            |
|     Malformation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/5 (100%)   4/5 (80%)    3/4 (75%)    1/1 (100%)  |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|POLY-3 ADJUSTED (b)|     100.0%       80.0%        75.0%        100.0%      |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/3 (100%)   4/5 (80%)    3/4 (75%)    0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     652          727 (T)      727 (T)      556         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.360N     P=0.142N     P=0.138N     (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.567N     P=0.500N     P=0.455N     (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.567N     P=0.500N     P=0.455N     (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.567N     P=0.500N     P=0.455N     (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          P=0.142N     P=0.138N     (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.574N     P=0.500N     P=0.444N     (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 52
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Urinary Bladder                                                                                                                  |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   7/50 (14%)   16/50 (32%)  10/49 (20%) |25/50 (50%)  29/50 (58%)  24/50 (48%)  25/50 (50%)  |
|POLY-3 ADJUSTED (b)|     12.7%        14.7%        33.2%        22.3%       |53.5%        60.4%        51.1%        52.5%        |
|TERMINAL (d)       |     4/39 (10%)   7/45 (16%)   14/42 (33%)  9/38 (24%)  |23/40 (58%)  21/34 (62%)  22/37 (60%)  23/41 (56%)  |
|FIRST INCIDENCE    |     652          727 (T)      596          629         |547          484          677          520          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.085      P=0.595      P=0.026 *    P=0.191     |P=0.285N     P=0.106      P=0.525      P=0.537N     |
|POLY 3             |     P=0.084      P=0.510      P=0.015 *    P=0.173     |P=0.385N     P=0.318      P=0.488N     P=0.542N     |
|POLY 1.5           |     P=0.092      P=0.505      P=0.014 *    P=0.181     |P=0.403N     P=0.303      P=0.493N     P=0.561N     |
|POLY 6             |     P=0.075      P=0.518      P=0.015 *    P=0.165     |P=0.354N     P=0.324      P=0.484N     P=0.512N     |
|LOGISTIC REGRESSION|     P=0.088      P=0.521      P=0.016 *    P=0.173     |P=0.381N     P=0.277      P=0.432N     P=0.555N     |
|COCH-ARM / FISHERS |     P=0.108      P=0.500      P=0.014 *    P=0.194     |P=0.415N     P=0.274      P=0.500N     P=0.579N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hydrometra                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |32/50 (64%)  31/50 (62%)  33/50 (66%)  37/50 (74%)  |
|POLY-3 ADJUSTED (b)|                                                        |67.2%        64.6%        68.7%        79.0%        |
|TERMINAL (d)       |                                                        |28/40 (70%)  24/34 (71%)  24/37 (65%)  35/41 (85%)  |
|FIRST INCIDENCE    |                                                        |456          484          617          659          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.286      P=0.344      P=0.366      P=0.244      |
|POLY 3             |                                                        |P=0.084      P=0.475N     P=0.527      P=0.137      |
|POLY 1.5           |                                                        |P=0.096      P=0.481N     P=0.512      P=0.153      |
|POLY 6             |                                                        |P=0.081      P=0.487N     P=0.555      P=0.129      |
|LOGISTIC REGRESSION|                                                        |P=0.142      P=0.491N     P=0.551      P=0.220      |
|COCH-ARM / FISHERS |                                                        |P=0.127      P=0.500N     P=0.500      P=0.194      |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 53
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Infiltration Cellular Mononuclear Cell                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |4.4%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |                                                        |2/40 (5%)    0/34 (0%)    0/37 (0%)    0/41 (0%)    |
|FIRST INCIDENCE    |                                                        |728 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.114N     P=0.275N     P=0.256N     P=0.233N     |
|POLY 3             |                                                        |P=0.113N     P=0.238N     P=0.232N     P=0.234N     |
|POLY 1.5           |                                                        |P=0.113N     P=0.237N     P=0.234N     P=0.236N     |
|POLY 6             |                                                        |P=0.112N     P=0.241N     P=0.230N     P=0.230N     |
|LOGISTIC REGRESSION|                                                        |P=0.114N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |2.2%         0.0%         4.3%         0.0%         |
|TERMINAL (d)       |                                                        |1/40 (3%)    0/34 (0%)    2/37 (5%)    0/41 (0%)    |
|FIRST INCIDENCE    |                                                        |728 (T)      ---          728 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.444N     P=0.532N     P=0.473      P=0.495N     |
|POLY 3             |                                                        |P=0.455N     P=0.500N     P=0.508      P=0.497N     |
|POLY 1.5           |                                                        |P=0.459N     P=0.500N     P=0.505      P=0.499N     |
|POLY 6             |                                                        |P=0.447N     P=0.504N     P=0.511      P=0.494N     |
|LOGISTIC REGRESSION|                                                        |P=0.444N     (e)          P=0.473      (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.461N     P=0.500N     P=0.500      P=0.500N     |
|=================================================================================================================================|
       Date:  05/13/99                           EXPERIMENT: 88007 TEST: 06                                            Page 54
                     Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -                   SODIUM NITRITE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0.0%         0.075%       0.15%        0.30%       |0.0%         0.075%       0.15%        0.30%        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES       |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |13/50 (26%)  10/50 (20%)  16/50 (32%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|                                                        |27.9%        21.6%        34.1%        38.0%        |
|TERMINAL (d)       |                                                        |10/40 (25%)  7/34 (21%)   15/37 (41%)  16/41 (39%)  |
|FIRST INCIDENCE    |                                                        |586          652          677          484          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.130      P=0.450N     P=0.264      P=0.225      |
|POLY 3             |                                                        |P=0.087      P=0.324N     P=0.335      P=0.205      |
|POLY 1.5           |                                                        |P=0.083      P=0.318N     P=0.334      P=0.199      |
|POLY 6             |                                                        |P=0.096      P=0.341N     P=0.333      P=0.214      |
|LOGISTIC REGRESSION|                                                        |P=0.088      P=0.317N     P=0.358      P=0.199      |
|COCH-ARM / FISHERS |                                                        |P=0.080      P=0.318N     P=0.330      P=0.194      |
|=================================================================================================================================|

(a)  Number of tumor-bearing animals /  number of animals examined at site.
(b)  Poly-3 adjusted lifetime tumor incidence.
(d)  Observed incidence at terminal kill.
(f)  Beneath the control incidence are the P-values associated with the trend 
test.  Beneath the dosed group incidence are the P-values corresponding to 
pairwise comparisons between the controls and that dosed group.  The life
table analysis regards tumors in animals dying prior to  terminal kill as
 being (directly or indirectly) the cause of death.
Logistic regression is an alternative
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e)  Value of Statistic cannot be computed.
(I)  Interim sacrifice
(T)  Terminal sacrifice
#   Tumor rates based on number of animals necropsied.
*   To the right of any statistical result, indicates significance at (P<=0.05).
**  To the right of any statistical result, indicates significance at (P<=0.01).