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TDMS Study 88007-05 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 10/18/99       
EXPERIMENT: 88007 TEST: 05                                                                                     TIME: 14:01:03       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007       
PATHOLOGIST: YARRINGTON, JOHN                                                                                  CAS: 7632-00-0       
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                      FINAL #1 CORE STUDY RATS                                                      
                                                                                                                                    

               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       SODIUM NITRITE                                    DATE: 10/18/99     
EXPERIMENT: 88007 TEST: 05                                                                                     TIME: 14:01:03     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                      
CONT: NO1-ES-55384                              ROUTE: DOSED WATER                                             NTP C#: C88007     
PATHOLOGIST: YARRINGTON, JOHN                                                                                  CAS: 7632-00-0     



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

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

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