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TR 341 Mouse Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  NITROFURANTOIN                                    DATE: 09/07/94       
EXPERIMENT: 05051 TEST: 02                                                                                     TIME: 14:53:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NOIES28024            ROUTE: DOSED FEED                                                                  NTP C#: C55196       
PATHOLOGIST: H. GILES                                                                                          CAS: 67-20-9         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                  NITROFURANTOIN                                    DATE: 09/07/94      
EXPERIMENT: 05051 TEST: 02                                                                                     TIME: 14:53:27      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NOIES28024            ROUTE: DOSED FEED                                                                  NTP C#: C55196      
PATHOLOGIST: H. GILES                                                                                          CAS: 67-20-9        
 
 
 
 
 
                                                    MICE(B6C3F1)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Gallbladder
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                  NITROFURANTOIN                                    DATE: 09/07/94       
EXPERIMENT: 05051 TEST: 02                                                                                     TIME: 14:53:27       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOIES28024            ROUTE: DOSED FEED                                                                  NTP C#: C55196       
PATHOLOGIST: H. GILES                                                                                          CAS: 67-20-9         
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                         IN THE ANALYSIS OF THE STUDY OF NITROFURANTOIN
 
              ====================================================================================================
 
                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Skin: Subcutaneous Tissue     Schwannoma Malignant
                             All Organs                    Hemangiosarcoma
                                                           Hemangiosarcoma or Hemangioma
                                                           Malignant Tumors
 
              ====================================================================================================
 
                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Lung                          Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
                             Mammary Gland                 Carcinoma
                             Ovary                         Adenoma
                                                           Mixed Tumor Benign
                             Thyroid Gland: Follicular Cell
                                                           Adenoma
                                                           Carcinoma or Adenoma
                             All Organs                    Hemangiosarcoma
                                                           Malignant Lymphoma And Histiocytic Sarcoma
                                                           Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,
                                                            NOS, or Undifferentiated Cell Type
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   1
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     4/49 (8%)       0/48 (0%)       1/49 (2%)      |     1/48 (2%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     13.3%            0.0%            3.0%          |      4.8%            0.0%            0.0%          |
|TERMINAL (d)           |     3/28 (11%)      0/28 (0%)       1/33 (3%)      |     0/18 (0%)       0/37 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      688             ---             730 (T)       |      728             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.062N        P=0.065N        P=0.138N       |     P=0.183N        P=0.387N        P=0.372N       |
|INCIDENTAL TUMOR       |     P=0.063N        P=0.073N        P=0.137N       |     P=0.323N        P=0.581N        P=0.557N       |
|LOGISTIC REGRESSION    |     P=0.059N        P=0.061N        P=0.132N       |     P=0.193N        P=0.392N        P=0.391N       |
|COCHRAN-ARMITAGE       |     P=0.079N                                       |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.061N        P=0.181N       |                     P=0.495N        P=0.495N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/49 (4%)       0/48 (0%)       0/49 (0%)      |     1/48 (2%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |      6.9%            0.0%            0.0%          |      4.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/28 (0%)       0/33 (0%)      |     0/18 (0%)       0/37 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      714             ---             ---           |      714             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.079N        P=0.229N        P=0.199N       |     P=0.206N        P=0.422N        P=0.406N       |
|INCIDENTAL TUMOR       |     P=0.089N        P=0.271N        P=0.209N       |     P=0.323N        P=0.581N        P=0.557N       |
|LOGISTIC REGRESSION    |     P=0.081N        P=0.236N        P=0.201N       |     P=0.221N        P=0.430N        P=0.429N       |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |     P=0.269N                                       |
|FISHER EXACT           |                     P=0.253N        P=0.247N       |                     P=0.495N        P=0.495N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   2
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/49 (12%)      0/48 (0%)       1/49 (2%)      |     2/48 (4%)       0/49 (0%)       0/49 (0%)      |
|ADJUSTED (b)           |     19.7%            0.0%            3.0%          |      8.6%            0.0%            0.0%          |
|TERMINAL (d)           |     4/28 (14%)      0/28 (0%)       1/33 (3%)      |     0/18 (0%)       0/37 (0%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      688             ---             730 (T)       |      714             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.010N*       P=0.018N*       P=0.038N*      |     P=0.045N*       P=0.142N        P=0.128N       |
|INCIDENTAL TUMOR       |     P=0.011N*       P=0.023N*       P=0.038N*      |     P=0.135N        P=0.328N        P=0.300N       |
|LOGISTIC REGRESSION    |     P=0.010N**      P=0.016N*       P=0.035N*      |     P=0.051N        P=0.145N        P=0.145N       |
|COCHRAN-ARMITAGE       |     P=0.015N*                                      |     P=0.092N                                       |
|FISHER EXACT           |                     P=0.014N*       P=0.056N       |                     P=0.242N        P=0.242N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       2/50 (4%)      |     1/50 (2%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |      7.1%            9.9%            5.5%          |      3.4%            5.4%            2.7%          |
|TERMINAL (d)           |     2/28 (7%)       2/29 (7%)       1/34 (3%)      |     0/19 (0%)       2/37 (5%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         723             694           |      686             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.515N        P=0.522         P=0.624N       |     P=0.458N        P=0.697         P=0.642N       |
|INCIDENTAL TUMOR       |     P=0.526N        P=0.487         P=0.630N       |     P=0.524N        P=0.597         P=0.736N       |
|LOGISTIC REGRESSION    |     P=0.518N        P=0.521         P=0.626N       |     P=0.528N        P=0.611         P=0.714N       |
|COCHRAN-ARMITAGE       |     P=0.592                                        |     P=0.620                                        |
|FISHER EXACT           |                     P=0.500         P=0.691N       |                     P=0.500         P=0.753N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   3
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       3/50 (6%)       2/50 (4%)      |     2/50 (4%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      7.1%            9.9%            5.5%          |      8.5%            8.1%            2.7%          |
|TERMINAL (d)           |     2/28 (7%)       2/29 (7%)       1/34 (3%)      |     1/19 (5%)       3/37 (8%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         723             694           |      686             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.515N        P=0.522         P=0.624N       |     P=0.198N        P=0.596N        P=0.308N       |
|INCIDENTAL TUMOR       |     P=0.526N        P=0.487         P=0.630N       |     P=0.243N        P=0.676N        P=0.390N       |
|LOGISTIC REGRESSION    |     P=0.518N        P=0.521         P=0.626N       |     P=0.259N        P=0.673         P=0.384N       |
|COCHRAN-ARMITAGE       |     P=0.592                                        |     P=0.411N                                       |
|FISHER EXACT           |                     P=0.500         P=0.691N       |                     P=0.500         P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/50 (4%)       5/50 (10%)      4/50 (8%)      |     1/50 (2%)       1/50 (2%)       7/50 (14%)     |
|ADJUSTED (b)           |      7.1%           17.2%           11.4%          |      2.7%            2.7%           18.1%          |
|TERMINAL (d)           |     2/28 (7%)       5/29 (17%)      3/34 (9%)      |     0/19 (0%)       1/37 (3%)       6/37 (16%)     |
|FIRST INCIDENCE (DAYS) |      730 (T)         730 (T)         729           |      603             730 (T)         660           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.380         P=0.226         P=0.434        |     P=0.042 *       P=0.658N        P=0.147        |
|INCIDENTAL TUMOR       |     P=0.374         P=0.226         P=0.424        |     P=0.024 *       P=0.761         P=0.080        |
|LOGISTIC REGRESSION    |     P=0.400         P=0.226         P=0.448        |     P=0.016 *       P=0.758         P=0.054        |
|COCHRAN-ARMITAGE       |     P=0.278                                        |     P=0.012 *                                      |
|FISHER EXACT           |                     P=0.218         P=0.339        |                     P=0.753N        P=0.030 *      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   4
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      7/50 (14%)      7/50 (14%)     |     1/50 (2%)       1/50 (2%)       2/50 (4%)      |
|ADJUSTED (b)           |     26.6%           20.2%           17.3%          |      4.0%            2.2%            5.0%          |
|TERMINAL (d)           |     5/28 (18%)      4/29 (14%)      3/34 (9%)      |     0/19 (0%)       0/37 (0%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      611             496             602           |      714             670             678           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.220N        P=0.380N        P=0.263N       |     P=0.532         P=0.665N        P=0.672        |
|INCIDENTAL TUMOR       |     P=0.187N        P=0.214N        P=0.170N       |     P=0.336         P=0.652         P=0.490        |
|LOGISTIC REGRESSION    |     P=0.160N        P=0.254N        P=0.189N       |     P=0.406         P=0.750N        P=0.587        |
|COCHRAN-ARMITAGE       |     P=0.338N                                       |     P=0.386                                        |
|FISHER EXACT           |                     P=0.393N        P=0.393N       |                     P=0.753N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     12/50 (24%)     11/50 (22%)     |     2/50 (4%)       2/50 (4%)       8/50 (16%)     |
|ADJUSTED (b)           |     29.8%           36.2%           27.4%          |      6.6%            4.9%           20.0%          |
|TERMINAL (d)           |     6/28 (21%)      9/29 (31%)      6/34 (18%)     |     0/19 (0%)       1/37 (3%)       6/37 (16%)     |
|FIRST INCIDENCE (DAYS) |      611             496             602           |      603             670             660           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.449N        P=0.433         P=0.503N       |     P=0.093         P=0.531N        P=0.217        |
|INCIDENTAL TUMOR       |     P=0.435N        P=0.587         P=0.419N       |     P=0.032 *       P=0.597         P=0.083        |
|LOGISTIC REGRESSION    |     P=0.499N        P=0.445         P=0.551N       |     P=0.029 *       P=0.704N        P=0.079        |
|COCHRAN-ARMITAGE       |     P=0.450                                        |     P=0.023 *                                      |
|FISHER EXACT           |                     P=0.405         P=0.500        |                     P=0.691N        P=0.046 *      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   5
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)     12/50 (24%)     11/50 (22%)     |     2/50 (4%)       2/50 (4%)       8/50 (16%)     |
|ADJUSTED (b)           |     29.8%           36.2%           27.4%          |      6.6%            4.9%           20.0%          |
|TERMINAL (d)           |     6/28 (21%)      9/29 (31%)      6/34 (18%)     |     0/19 (0%)       1/37 (3%)       6/37 (16%)     |
|FIRST INCIDENCE (DAYS) |      611             496             602           |      603             670             660           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.449N        P=0.433         P=0.503N       |     P=0.093         P=0.531N        P=0.217        |
|INCIDENTAL TUMOR       |     P=0.435N        P=0.587         P=0.419N       |     P=0.032 *       P=0.597         P=0.083        |
|LOGISTIC REGRESSION    |     P=0.499N        P=0.445         P=0.551N       |     P=0.029 *       P=0.704N        P=0.079        |
|COCHRAN-ARMITAGE       |     P=0.450                                        |     P=0.023 *                                      |
|FISHER EXACT           |                     P=0.405         P=0.500        |                     P=0.691N        P=0.046 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      2/50 (4%)       4/50 (8%)      |     2/50 (4%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     15.0%            6.4%           11.8%          |      7.8%            5.4%            0.0%          |
|TERMINAL (d)           |     2/28 (7%)       1/29 (3%)       4/34 (12%)     |     1/19 (5%)       2/37 (5%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      611             699             730 (T)       |      603             730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.328N        P=0.214N        P=0.394N       |     P=0.079N        P=0.482N        P=0.143N       |
|INCIDENTAL TUMOR       |     P=0.304N        P=0.188N        P=0.346N       |     P=0.126N        P=0.590N        P=0.239N       |
|LOGISTIC REGRESSION    |     P=0.325N        P=0.200N        P=0.397N       |     P=0.153N        P=0.646N        P=0.245N       |
|COCHRAN-ARMITAGE       |     P=0.417N                                       |     P=0.184N                                       |
|FISHER EXACT           |                     P=0.218N        P=0.500N       |                     P=0.691N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   6
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      3.6%            6.9%            7.7%          |      2.4%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       2/29 (7%)       1/34 (3%)      |     0/19 (0%)       0/37 (0%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         730 (T)         602           |      561             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.296         P=0.512         P=0.384        |     P=0.243N        P=0.464N        P=0.460N       |
|INCIDENTAL TUMOR       |     P=0.312         P=0.512         P=0.435        |     P=0.407N        P=0.662N        P=0.662N       |
|LOGISTIC REGRESSION    |     P=0.280         P=0.512         P=0.352        |     P=0.405N        P=0.643N        P=0.665N       |
|COCHRAN-ARMITAGE       |     P=0.225                                        |     P=0.272N                                       |
|FISHER EXACT           |                     P=0.500         P=0.309        |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     6/50 (12%)      4/50 (8%)       7/50 (14%)     |     3/50 (6%)       2/50 (4%)       0/50 (0%)      |
|ADJUSTED (b)           |     18.3%           13.1%           18.9%          |     10.1%            5.4%            0.0%          |
|TERMINAL (d)           |     3/28 (11%)      3/29 (10%)      5/34 (15%)     |     1/19 (5%)       2/37 (5%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      611             699             602           |      561             730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.549N        P=0.356N        P=0.592N       |     P=0.030N*       P=0.292N        P=0.065N       |
|INCIDENTAL TUMOR       |     P=0.516N        P=0.338N        P=0.523N       |     P=0.075N        P=0.462N        P=0.161N       |
|LOGISTIC REGRESSION    |     P=0.560N        P=0.343N        P=0.618N       |     P=0.099N        P=0.526N        P=0.161N       |
|COCHRAN-ARMITAGE       |     P=0.448                                        |     P=0.085N                                       |
|FISHER EXACT           |                     P=0.370N        P=0.500        |                     P=0.500N        P=0.121N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   7
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |     5/50 (10%)      3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     19.6%            7.2%            2.7%          |
|TERMINAL (d)           |     0/28 (0%)       0/29 (0%)       0/34 (0%)      |     2/19 (11%)      1/37 (3%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      635             596             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.016N*       P=0.144N        P=0.026N*      |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.081N        P=0.426N        P=0.081N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.053N        P=0.301N        P=0.056N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.071N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.357N        P=0.102N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       5/50 (10%)     |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%           13.0%          |
|TERMINAL (d)           |                                                    |     0/19 (0%)       0/37 (0%)       4/37 (11%)     |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.019 *         (e)           P=0.127        |
|INCIDENTAL TUMOR       |                                                    |     P=0.013 *         (e)           P=0.083        |
|LOGISTIC REGRESSION    |                                                    |     P=0.018 *         (e)           P=0.112        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.007 **                                     |
|FISHER EXACT           |                                                    |                       (e)           P=0.028 *      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   8
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |                                                    |      8.4%            2.7%            2.4%          |
|TERMINAL (d)           |                                                    |     1/19 (5%)       1/37 (3%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      667             730 (T)         708           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.227N        P=0.305N        P=0.333N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.349N        P=0.403N        P=0.510N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.309N        P=0.411N        P=0.434N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.380N                                       |
|FISHER EXACT           |                                                    |                     P=0.500N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor Benign                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       3/50 (6%)       1/50 (2%)      |
|ADJUSTED (b)           |                                                    |      0.0%            8.1%            2.7%          |
|TERMINAL (d)           |                                                    |     0/19 (0%)       3/37 (8%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.564         P=0.260         P=0.633        |
|INCIDENTAL TUMOR       |                                                    |     P=0.564         P=0.260         P=0.633        |
|LOGISTIC REGRESSION    |                                                    |     P=0.564         P=0.258         P=0.633        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.367                                        |
|FISHER EXACT           |                                                    |                     P=0.121         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE   9
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Granulosa Cell Tumor, Benign, Malignant, NOS                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       3/50 (6%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            8.1%            5.1%          |
|TERMINAL (d)           |                                                    |     0/19 (0%)       3/37 (8%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             730 (T)         729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.375         P=0.260         P=0.404        |
|INCIDENTAL TUMOR       |                                                    |     P=0.301         P=0.260         P=0.264        |
|LOGISTIC REGRESSION    |                                                    |     P=0.362         P=0.258         P=0.374        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.197                                        |
|FISHER EXACT           |                                                    |                     P=0.121         P=0.247        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Mixed Tumor Benign                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       4/50 (8%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%           10.0%          |
|TERMINAL (d)           |                                                    |     0/19 (0%)       0/37 (0%)       3/37 (8%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             630           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.035 *         (e)           P=0.162        |
|INCIDENTAL TUMOR       |                                                    |     P=0.020 *         (e)           P=0.096        |
|LOGISTIC REGRESSION    |                                                    |     P=0.018 *         (e)           P=0.084        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.017 *                                      |
|FISHER EXACT           |                                                    |                       (e)           P=0.059        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  10
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/46 (0%)       0/48 (0%)       0/43 (0%)      |     3/48 (6%)       1/44 (2%)       2/49 (4%)      |
|ADJUSTED (b)           |      0.0%            0.0%            0.0%          |     16.7%            2.9%            4.7%          |
|TERMINAL (d)           |     0/26 (0%)       0/28 (0%)       0/28 (0%)      |     3/18 (17%)      1/35 (3%)       0/36 (0%)      |
|FIRST INCIDENCE (DAYS) |      ---             ---             ---           |      730 (T)         730 (T)         656           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |       (e)             (e)             (e)          |     P=0.178N        P=0.107N        P=0.229N       |
|INCIDENTAL TUMOR       |       (e)             (e)             (e)          |     P=0.281N        P=0.107N        P=0.367N       |
|LOGISTIC REGRESSION    |       (e)             (e)             (e)          |     P=0.256N        P=0.107N        P=0.330N       |
|COCHRAN-ARMITAGE       |       (e)                                          |     P=0.390N                                       |
|FISHER EXACT           |                       (e)             (e)          |                     P=0.342N        P=0.490N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       2/50 (4%)       3/50 (6%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      2.9%            6.9%            8.4%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     0/28 (0%)       2/29 (7%)       2/34 (6%)      |     0/19 (0%)       0/37 (0%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      688             730 (T)         695           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.285         P=0.505         P=0.366        |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.285         P=0.475         P=0.362        |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.287         P=0.513         P=0.367        |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.225                                        |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.309        |                       (e)             (e)          |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  11
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     9/50 (18%)      5/50 (10%)     12/50 (24%)     |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     25.8%           12.8%           27.0%          |      0.0%            2.3%            2.7%          |
|TERMINAL (d)           |     4/28 (14%)      0/29 (0%)       4/34 (12%)     |     0/19 (0%)       0/37 (0%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      408             335             575           |      ---             694             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.429         P=0.192N        P=0.495        |     P=0.440         P=0.593         P=0.633        |
|INCIDENTAL TUMOR       |     P=0.311         P=0.269N        P=0.444        |     P=0.351         P=0.403         P=0.633        |
|LOGISTIC REGRESSION    |     P=0.259         P=0.190N        P=0.336        |     P=0.380         P=0.524         P=0.633        |
|COCHRAN-ARMITAGE       |     P=0.269                                        |     P=0.334                                        |
|FISHER EXACT           |                     P=0.194N        P=0.312        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    10/50 (20%)      7/50 (14%)     14/50 (28%)     |     0/50 (0%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |     28.0%           18.8%           31.9%          |      0.0%            2.3%            2.7%          |
|TERMINAL (d)           |     4/28 (14%)      2/29 (7%)       6/34 (18%)     |     0/19 (0%)       0/37 (0%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      408             335             575           |      ---             694             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.372         P=0.289N        P=0.433        |     P=0.440         P=0.593         P=0.633        |
|INCIDENTAL TUMOR       |     P=0.261         P=0.399N        P=0.372        |     P=0.351         P=0.403         P=0.633        |
|LOGISTIC REGRESSION    |     P=0.225         P=0.285N        P=0.282        |     P=0.380         P=0.524         P=0.633        |
|COCHRAN-ARMITAGE       |     P=0.204                                        |     P=0.334                                        |
|FISHER EXACT           |                     P=0.298N        P=0.241        |                     P=0.500         P=0.500        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  12
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Schwannoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       0/50 (0%)       0/50 (0%)      |     0/50 (0%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      8.8%            0.0%            0.0%          |      0.0%            0.0%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/29 (0%)       0/34 (0%)      |     0/19 (0%)       0/37 (0%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      533             ---             ---           |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.029N*       P=0.119N        P=0.096N       |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.060N        P=0.181N        P=0.180N       |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.033N*       P=0.117N        P=0.114N       |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.036N*                                      |       (e)                                          |
|FISHER EXACT           |                     P=0.121N        P=0.121N       |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     1/50 (2%)       0/50 (0%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       1/50 (2%)      |
|ADJUSTED (b)           |      3.6%            0.0%            0.0%          |      7.4%            0.0%            2.7%          |
|TERMINAL (d)           |     1/28 (4%)       0/29 (0%)       0/34 (0%)      |     1/19 (5%)       0/37 (0%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      730 (T)         ---             ---           |      521             ---             730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.248N        P=0.493N        P=0.461N       |     P=0.236N        P=0.159N        P=0.335N       |
|INCIDENTAL TUMOR       |     P=0.248N        P=0.493N        P=0.461N       |     P=0.495N        P=0.316N        P=0.606N       |
|LOGISTIC REGRESSION    |     P=0.248N        P=0.493N        P=0.461N       |     P=0.426N        P=0.295N        P=0.558N       |
|COCHRAN-ARMITAGE       |     P=0.272N                                       |     P=0.355N                                       |
|FISHER EXACT           |                     P=0.500N        P=0.500N       |                     P=0.247N        P=0.500N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  13
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       0/47 (0%)       0/48 (0%)      |     3/48 (6%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.0%            0.0%            0.0%          |     12.3%            2.8%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/28 (0%)       0/33 (0%)      |     1/19 (5%)       1/36 (3%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      473             ---             ---           |      635             730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.080N        P=0.229N        P=0.200N       |     P=0.018N*       P=0.146N        P=0.047N*      |
|INCIDENTAL TUMOR       |     P=0.166N        P=0.336N        P=0.369N       |     P=0.058N        P=0.291N        P=0.138N       |
|LOGISTIC REGRESSION    |     P=0.102N        P=0.246N        P=0.274N       |     P=0.039N*       P=0.233N        P=0.087N       |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |     P=0.057N                                       |
|FISHER EXACT           |                     P=0.253N        P=0.247N       |                     P=0.301N        P=0.114N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     2/48 (4%)       0/47 (0%)       0/48 (0%)      |     4/48 (8%)       1/49 (2%)       0/50 (0%)      |
|ADJUSTED (b)           |      6.0%            0.0%            0.0%          |     17.2%            2.8%            0.0%          |
|TERMINAL (d)           |     1/28 (4%)       0/28 (0%)       0/33 (0%)      |     2/19 (11%)      1/36 (3%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      473             ---             ---           |      635             730 (T)         ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.080N        P=0.229N        P=0.200N       |     P=0.005N**      P=0.058N        P=0.016N*      |
|INCIDENTAL TUMOR       |     P=0.166N        P=0.336N        P=0.369N       |     P=0.017N*       P=0.132N        P=0.050N       |
|LOGISTIC REGRESSION    |     P=0.102N        P=0.246N        P=0.274N       |     P=0.012N*       P=0.109N        P=0.033N*      |
|COCHRAN-ARMITAGE       |     P=0.095N                                       |     P=0.023N*                                      |
|FISHER EXACT           |                     P=0.253N        P=0.247N       |                     P=0.175N        P=0.054N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  14
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       2/50 (4%)       1/50 (2%)      |
|ADJUSTED (b)           |                                                    |      9.6%            5.4%            2.7%          |
|TERMINAL (d)           |                                                    |     1/19 (5%)       2/37 (5%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      722             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.194N        P=0.454N        P=0.284N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.256N        P=0.558N        P=0.390N       |
|LOGISTIC REGRESSION    |                                                    |     P=0.223N        P=0.510N        P=0.328N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.397N                                       |
|FISHER EXACT           |                                                    |                     P=0.691N        P=0.500N       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     0/50 (0%)       0/50 (0%)       2/50 (4%)      |
|ADJUSTED (b)           |                                                    |      0.0%            0.0%            5.1%          |
|TERMINAL (d)           |                                                    |     0/19 (0%)       0/37 (0%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      ---             ---             729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.164           (e)           P=0.404        |
|INCIDENTAL TUMOR       |                                                    |     P=0.109           (e)           P=0.264        |
|LOGISTIC REGRESSION    |                                                    |     P=0.152           (e)           P=0.374        |
|COCHRAN-ARMITAGE       |                                                    |     P=0.103                                        |
|FISHER EXACT           |                                                    |                       (e)           P=0.247        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  15
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    |     2/50 (4%)       2/50 (4%)       3/50 (6%)      |
|ADJUSTED (b)           |                                                    |      9.6%            5.4%            7.8%          |
|TERMINAL (d)           |                                                    |     1/19 (5%)       2/37 (5%)       2/37 (5%)      |
|FIRST INCIDENCE (DAYS) |                                                    |      722             730 (T)         729           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |     P=0.525N        P=0.454N        P=0.574N       |
|INCIDENTAL TUMOR       |                                                    |     P=0.548         P=0.558N        P=0.612        |
|LOGISTIC REGRESSION    |                                                    |     P=0.571N        P=0.510N        P=0.639N       |
|COCHRAN-ARMITAGE       |                                                    |     P=0.412                                        |
|FISHER EXACT           |                                                    |                     P=0.691N        P=0.500        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/50 (0%)      |     2/50 (4%)       0/50 (0%)       0/50 (0%)      |
|ADJUSTED (b)           |      9.6%            2.3%            0.0%          |      9.8%            0.0%            0.0%          |
|TERMINAL (d)           |     2/28 (7%)       0/29 (0%)       0/34 (0%)      |     1/19 (5%)       0/37 (0%)       0/37 (0%)      |
|FIRST INCIDENCE (DAYS) |      611             530             ---           |      728             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.047N*       P=0.293N        P=0.092N       |     P=0.038N*       P=0.118N        P=0.112N       |
|INCIDENTAL TUMOR       |     P=0.059N        P=0.252N        P=0.057N       |     P=0.083N        P=0.212N        P=0.202N       |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.298N        P=0.099N       |     P=0.042N*       P=0.131N        P=0.123N       |
|COCHRAN-ARMITAGE       |     P=0.061N                                       |     P=0.095N                                       |
|FISHER EXACT           |                     P=0.309N        P=0.121N       |                     P=0.247N        P=0.247N       |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  16
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     3/50 (6%)       1/50 (2%)       0/50 (0%)      |     3/50 (6%)       1/50 (2%)       1/50 (2%)      |
|ADJUSTED (b)           |      9.6%            2.3%            0.0%          |     14.8%            2.7%            2.7%          |
|TERMINAL (d)           |     2/28 (7%)       0/29 (0%)       0/34 (0%)      |     2/19 (11%)      1/37 (3%)       1/37 (3%)      |
|FIRST INCIDENCE (DAYS) |      611             530             ---           |      728             730 (T)         730 (T)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.047N*       P=0.293N        P=0.092N       |     P=0.067N        P=0.116N        P=0.112N       |
|INCIDENTAL TUMOR       |     P=0.059N        P=0.252N        P=0.057N       |     P=0.102N        P=0.179N        P=0.172N       |
|LOGISTIC REGRESSION    |     P=0.057N        P=0.298N        P=0.099N       |     P=0.072N        P=0.134N        P=0.120N       |
|COCHRAN-ARMITAGE       |     P=0.061N                                       |     P=0.201N                                       |
|FISHER EXACT           |                     P=0.309N        P=0.121N       |                     P=0.309N        P=0.309N       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       6/50 (12%)     |    12/50 (24%)     19/50 (38%)     24/50 (48%)     |
|ADJUSTED (b)           |     16.4%            9.0%           15.3%          |     50.2%           43.4%           52.7%          |
|TERMINAL (d)           |     3/28 (11%)      1/29 (3%)       3/34 (9%)      |     8/19 (42%)     13/37 (35%)     16/37 (43%)     |
|FIRST INCIDENCE (DAYS) |      697             605             527           |      631             596             568           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.567         P=0.336N        P=0.614N       |     P=0.352         P=0.447N        P=0.449        |
|INCIDENTAL TUMOR       |     P=0.495         P=0.325N        P=0.513        |     P=0.039 *       P=0.304         P=0.075        |
|LOGISTIC REGRESSION    |     P=0.535         P=0.333N        P=0.601        |     P=0.038 *       P=0.295         P=0.076        |
|COCHRAN-ARMITAGE       |     P=0.444                                        |     P=0.008 **                                     |
|FISHER EXACT           |                     P=0.357N        P=0.500        |                     P=0.097         P=0.011 *      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  17
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     5/50 (10%)      3/50 (6%)       6/50 (12%)     |    12/50 (24%)     19/50 (38%)     24/50 (48%)     |
|ADJUSTED (b)           |     16.4%            9.0%           15.3%          |     50.2%           43.4%           52.7%          |
|TERMINAL (d)           |     3/28 (11%)      1/29 (3%)       3/34 (9%)      |     8/19 (42%)     13/37 (35%)     16/37 (43%)     |
|FIRST INCIDENCE (DAYS) |      697             605             527           |      631             596             568           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.567         P=0.336N        P=0.614N       |     P=0.352         P=0.447N        P=0.449        |
|INCIDENTAL TUMOR       |     P=0.495         P=0.325N        P=0.513        |     P=0.039 *       P=0.304         P=0.075        |
|LOGISTIC REGRESSION    |     P=0.535         P=0.333N        P=0.601        |     P=0.038 *       P=0.295         P=0.076        |
|COCHRAN-ARMITAGE       |     P=0.444                                        |     P=0.008 **                                     |
|FISHER EXACT           |                     P=0.357N        P=0.500        |                     P=0.097         P=0.011 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    12/50 (24%)     11/50 (22%)     14/50 (28%)     |    15/50 (30%)     15/50 (30%)     22/50 (44%)     |
|ADJUSTED (b)           |     36.2%           35.3%           37.7%          |     57.9%           39.1%           50.8%          |
|TERMINAL (d)           |     8/28 (29%)      9/29 (31%)     11/34 (32%)     |     9/19 (47%)     14/37 (38%)     16/37 (43%)     |
|FIRST INCIDENCE (DAYS) |      473             699             694           |      603             575             630           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.510N        P=0.460N        P=0.551N       |     P=0.327N        P=0.039N*       P=0.283N       |
|INCIDENTAL TUMOR       |     P=0.538         P=0.505N        P=0.578        |     P=0.397         P=0.154N        P=0.433        |
|LOGISTIC REGRESSION    |     P=0.517N        P=0.455N        P=0.575N       |     P=0.365         P=0.219N        P=0.461        |
|COCHRAN-ARMITAGE       |     P=0.370                                        |     P=0.090                                        |
|FISHER EXACT           |                     P=0.500N        P=0.410        |                     P=0.586N        P=0.107        |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  18
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |      UNTREATD        0.13%           0.25%         |      UNTREATD        0.13%           0.25%         |
|                       |      CONTROL                                       |      CONTROL                                       |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    28/50 (56%)     20/50 (40%)     24/50 (48%)     |    21/50 (42%)     27/50 (54%)     31/50 (62%)     |
|ADJUSTED (b)           |     68.2%           48.8%           49.9%          |     70.5%           57.3%           64.5%          |
|TERMINAL (d)           |    15/28 (54%)      9/29 (31%)     10/34 (29%)     |    11/19 (58%)     17/37 (46%)     20/37 (54%)     |
|FIRST INCIDENCE (DAYS) |      408             335             527           |      521             596             568           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.098N        P=0.103N        P=0.112N       |     P=0.298N        P=0.155N        P=0.271N       |
|INCIDENTAL TUMOR       |     P=0.098N        P=0.055N        P=0.057N       |     P=0.073         P=0.317         P=0.133        |
|LOGISTIC REGRESSION    |     P=0.102N        P=0.040N*       P=0.059N       |     P=0.120         P=0.434         P=0.192        |
|COCHRAN-ARMITAGE       |     P=0.233N                                       |     P=0.028 *                                      |
|FISHER EXACT           |                     P=0.080N        P=0.274N       |                     P=0.158         P=0.036 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |       #               #               #            |       #               #               #            |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |    31/50 (62%)     27/50 (54%)     33/50 (66%)     |    30/50 (60%)     35/50 (70%)     41/50 (82%)     |
|ADJUSTED (b)           |     73.8%           65.3%           68.7%          |     90.4%           72.8%           82.0%          |
|TERMINAL (d)           |    17/28 (61%)     15/29 (52%)     19/34 (56%)     |    16/19 (84%)     24/37 (65%)     28/37 (76%)     |
|FIRST INCIDENCE (DAYS) |      408             335             527           |      521             575             568           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.299N        P=0.263N        P=0.323N       |     P=0.121N        P=0.025N*       P=0.090N       |
|INCIDENTAL TUMOR       |     P=0.472N        P=0.254N        P=0.418N       |     P=0.106         P=0.577N        P=0.202        |
|LOGISTIC REGRESSION    |     P=0.435N        P=0.173N        P=0.406N       |     P=0.121         P=0.504N        P=0.243        |
|COCHRAN-ARMITAGE       |     P=0.391                                        |     P=0.011 *                                      |
|FISHER EXACT           |                     P=0.272N        P=0.418        |                     P=0.201         P=0.013 *      |
|=================================================================================================================================|
 
         DATE: 09/07/94                     EXPERIMENT: 05051 TEST: 02                                                 PAGE  19
                               STATISTICAL ANALYSIS OF PRIMARY TUMORS IN MICE(B6C3F1) -- NITROFURANTOIN
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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).

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