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TDMS Study 05172-01 Pathology Tables


                              INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)
                                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE


NTP Experiment-Test: 05172-01                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/18/94
Route: DOSED WATER                                                                                                Time: 06:28:49




       Facility:  Hazleton Laboratories America, Inc.

       Chemical CAS #:  20325400

       Lock Date:  None

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All
































a  Number of animals examined microscopically at site and number of animals with lesion

                                                             Page   1

NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Moribund                                          10           27           60           51                                     
    Dead                                               5            3            9            9                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                45           15            6                                                  
  Animals Examined Microscopically                    60           45           75           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (60)         (44)         (75)         (58)                                   
   Intestine Large, Colon                             (60)         (44)         (75)         (59)                                   
      Sarcoma Stromal, Metastatic, Uterus                                        1 (1%)                                             
      Descending Colon, Adenocarcinoma                              1 (2%)                                                          
      Descending Colon, Polyp Adenomatous                                        1 (1%)       2 (3%)                                
   Intestine Large, Rectum                            (60)         (43)         (74)         (59)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Polyp Adenomatous                                                                       1 (2%)                                
   Intestine Small, Duodenum                          (60)         (43)         (73)         (58)                                   
      Adenocarcinoma, Cystic, Mucinous                                                        1 (2%)                                
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (2%)                                
   Intestine Small, Jejunum                           (60)         (43)         (72)         (58)                                   
      Adenocarcinoma, Cystic, Mucinous                              1 (2%)       1 (1%)       1 (2%)                                
   Liver                                              (60)         (44)         (75)         (60)                                   
      Carcinoma, Multiple, Metastatic, Uterus                                    1 (1%)                                             
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (2%)                                
      Carcinoma, Metastatic, Uterus                                 1 (2%)                                                          
      Hepatocellular Carcinoma                                                                1 (2%)                                
      Neoplastic Nodule                                             1 (2%)                                                          
      Neoplastic Nodule, Multiple                                                             2 (3%)                                
   Mesentery                                          (6)          (1)          (8)          (7)                                    
      Carcinoma, Multiple, Metastatic, Urinary                                                                                      
          Bladder                                                                             1 (14%)                               
      Carcinoma, Multiple, Metastatic, Uterus                                    1 (13%)                                            
      Sarcoma Stromal, Metastatic, Uterus                                        1 (13%)      1 (14%)                               
   Pancreas                                           (60)         (43)         (75)         (59)                                   
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (2%)                                
   Pharynx                                            (1)          (1)          (6)          (2)                                    
      Palate, Squamous Cell Carcinoma                                            1 (17%)                                            
      Palate, Squamous Cell Papilloma                  1 (100%)                  3 (50%)      1 (50%)                               
   Salivary Glands                                    (59)         (44)         (75)         (59)                                   
                                                             Page   2                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
      Schwannoma Malignant                                                       1 (1%)                                             
      Bilateral, Carcinosarcoma                                     1 (2%)                                                          
   Stomach, Forestomach                               (60)         (44)         (74)         (58)                                   
   Stomach, Glandular                                 (60)         (44)         (75)         (59)                                   
   Tongue                                             (1)          (2)          (5)          (4)                                    
      Squamous Cell Carcinoma                                                    2 (40%)      2 (50%)                               
      Squamous Cell Papilloma                          1 (100%)     2 (100%)                  2 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (45)         (75)         (60)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (60)         (45)         (75)         (60)                                   
   Adrenal Gland, Medulla                             (60)         (45)         (74)         (59)                                   
      Pheochromocytoma Benign                          5 (8%)       1 (2%)       1 (1%)                                             
   Pituitary Gland                                    (60)         (45)         (75)         (60)                                   
      Adenoma                                          1 (2%)                                                                       
      Pars Distalis, Adenoma                          14 (23%)      9 (20%)      5 (7%)       8 (13%)                               
      Pars Distalis, Carcinoma                         2 (3%)                                                                       
   Thyroid Gland                                      (60)         (44)         (75)         (59)                                   
      C-Cell, Adenoma                                  4 (7%)       1 (2%)       2 (3%)       1 (2%)                                
      C-Cell, Carcinoma                                1 (2%)                    1 (1%)                                             
      Follicular Cell, Adenoma                                                   1 (1%)       1 (2%)                                
      Follicular Cell, Carcinoma                       2 (3%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)                                                 
      Carcinoma, Metastatic, Uterus                                              1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (58)         (44)         (74)         (55)                                   
      Adenoma                                          4 (7%)      13 (30%)     12 (16%)     13 (24%)                               
      Carcinoma                                        2 (3%)      12 (27%)     27 (36%)     26 (47%)                               
      Carcinoma, Metastatic, Clitoral Gland                                                   1 (2%)                                
      Bilateral, Adenoma                               1 (2%)       2 (5%)       1 (1%)       3 (5%)                                
      Bilateral, Carcinoma                                          5 (11%)     14 (19%)      4 (7%)                                
   Ovary                                              (60)         (45)         (75)         (58)                                   
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (2%)                                
   Uterus                                             (60)         (45)         (75)         (59)                                   
                                                             Page   3                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
GENITAL SYSTEM - cont                                                                                                               
      Adenoma                                                       3 (7%)                    2 (3%)                                
      Carcinoma                                                                  1 (1%)                                             
      Deciduoma Benign                                                                        1 (2%)                                
      Polyp Stromal                                    5 (8%)       5 (11%)      6 (8%)       5 (8%)                                
      Polyp Stromal, Multiple                          1 (2%)       3 (7%)       1 (1%)                                             
      Sarcoma Stromal                                  1 (2%)       1 (2%)       2 (3%)       1 (2%)                                
      Cervix, Adenoma, Papillary                                                 1 (1%)                                             
      Cervix, Carcinoma                                             1 (2%)                                                          
      Cervix, Sarcoma Stromal, Metastatic, Uterus                                             1 (2%)                                
   Vagina                                             (1)                       (1)                                                 
      Mucosa, Polyp                                                              1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (45)         (75)         (60)                                   
   Lymph Node                                         (60)         (45)         (75)         (60)                                   
      Renal, Carcinoma, Metastatic, Uterus                                       1 (1%)                                             
   Lymph Node, Mandibular                             (59)         (44)         (74)         (59)                                   
      Carcinoma, Metastatic, Zymbal's Gland                         1 (2%)                                                          
      Axillary, Renal, Carcinoma, Metastatic                                     1 (1%)                                             
   Lymph Node, Mesenteric                             (60)         (44)         (75)         (58)                                   
   Spleen                                             (60)         (44)         (75)         (60)                                   
   Thymus                                             (53)         (41)         (68)         (54)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (59)         (43)         (75)         (59)                                   
      Adenocarcinoma                                   1 (2%)       2 (5%)      13 (17%)     18 (31%)                               
      Adenocarcinoma, Multiple                                                   1 (1%)       2 (3%)                                
      Adenoma                                                       1 (2%)                    2 (3%)                                
      Fibroadenoma                                    12 (20%)      9 (21%)      8 (11%)      4 (7%)                                
      Fibroadenoma, Multiple                           2 (3%)       2 (5%)       1 (1%)                                             
      Mixed Tumor Malignant                                                                   1 (2%)                                
   Skin                                               (60)         (45)         (75)         (60)                                   
      Basal Cell Adenoma                                            3 (7%)       3 (4%)       2 (3%)                                
      Basal Cell Carcinoma                                          1 (2%)                                                          
      Squamous Cell Papilloma                                                    2 (3%)                                             
      Squamous Cell Papilloma, Multiple                                          1 (1%)                                             
      Subcutaneous Tissue, Carcinoma, Metastatic                                 1 (1%)                                             
      Subcutaneous Tissue, Fibroma                                  1 (2%)                                                          
      Subcutaneous Tissue, Squamous Cell Carcinoma,                                                                                 
           Metastatic, Pharynx                                                   1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   4                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (2)          (5)          (8)          (4)                                    
      Cranium, Carcinoma, Metastatic, Zymbal's                                                                                      
          Gland                                                     1 (20%)                                                         
   Skeletal Muscle                                                              (1)          (1)                                    
      Diaphragm, Carcinoma, Metastatic, Urinary                                                                                     
          Bladder                                                                             1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (45)         (75)         (60)                                   
      Cerebellum, Astrocytoma Malignant                                          1 (1%)                                             
      Cerebrum, Astrocytoma Malignant                               1 (2%)                                                          
      Cerebrum, Carcinoma, Metastatic, Pituitary                                                                                    
          Gland                                        1 (2%)                                                                       
      Meninges, Cerebrum, Nerve, Carcinoma,                                                                                         
          Metastatic, Zymbal's Gland                                             1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (45)         (75)         (60)                                   
      Adenocarcinoma, Multiple, Metastatic,                                                                                         
          Mammary Gland                                                          1 (1%)                                             
      Alveolar/Bronchiolar Adenoma                                  1 (2%)       1 (1%)       1 (2%)                                
      Carcinoma, Multiple, Metastatic, Uterus                                    1 (1%)                                             
      Carcinoma, Multiple, Metastatic, Zymbal's                                                                                     
          Gland                                                                  1 (1%)                                             
      Carcinoma, Metastatic, Clitoral Gland                                      1 (1%)                                             
      Carcinoma, Metastatic, Uncertain Primary Site                 1 (2%)                                                          
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (2%)                                
      Carcinoma, Metastatic, Metastatic                                          1 (1%)                                             
      Mixed Tumor Malignant, Multiple, Metastatic,                                                                                  
           Mammary Gland                                                                      1 (2%)                                
      Squamous Cell Carcinoma, Metastatic, Pharynx                               1 (1%)                                             
      Mediastinum, Sarcoma                                                       1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Zymbal's Gland                                     (60)         (45)         (75)         (60)                                   
      Adenoma                                                       3 (7%)       4 (5%)       3 (5%)                                
      Carcinoma                                        1 (2%)      10 (22%)     17 (23%)     10 (17%)                               
      Bilateral, Carcinoma                                                                    3 (5%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   5                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (45)         (75)         (60)                                   
      Lipoma                                           2 (3%)                                                                       
      Renal Tubule, Adenoma                                         1 (2%)                                                          
      Renal Tubule, Carcinoma, Metastatic, Urinary                                                                                  
          Bladder                                                                             1 (2%)                                
      Transitional Epithelium, Carcinoma                                                      1 (2%)                                
   Ureter                                             (2)                       (2)          (1)                                    
      Carcinoma, Metastatic, Urinary Bladder                                                  1 (100%)                              
   Urinary Bladder                                    (60)         (45)         (75)         (59)                                   
      Sarcoma Stromal, Metastatic, Uterus                                                     1 (2%)                                
      Transitional Epithelium, Carcinoma                                                      1 (2%)                                
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(45)        *(75)        *(60)                                   
      Leukemia Mononuclear                            21 (35%)     15 (33%)     12 (16%)      4 (7%)                                
      Lymphoma Malignant Lymphocytic                                             1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   6                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            48          42          73          57                                       
     Total Primary Neoplasms                           84         113         151         132                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 35          30          32          34                                       
     Total Benign Neoplasms                            53          61          55          54                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              27          32          68          56                                       
     Total Malignant Neoplasms                         31          52          96          78                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              1           3           7           4                                       
     Total Metastatic Neoplasm                          1           4          16          14                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                           1                                                               
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page   7                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Dead                                               9            9           25           14                                     
    Moribund                                           7           28           50           46                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                44            8                                                               
  Animals Examined Microscopically                    60           45           75           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (60)         (42)         (72)         (58)                                   
      Adenocarcinoma, Cystic, Mucinous                                                        1 (2%)                                
   Intestine Large, Colon                             (60)         (43)         (73)         (58)                                   
      Adenocarcinoma                                                             2 (3%)                                             
      Ascending Colon, Polyp Adenomatous                            1 (2%)                                                          
      Descending Colon, Adenocarcinoma                                           2 (3%)       2 (3%)                                
      Descending Colon, Polyp Adenomatous                                        3 (4%)       4 (7%)                                
      Descending Colon, Polyp Adenomatous, Multiple                              1 (1%)                                             
   Intestine Large, Rectum                            (59)         (42)         (73)         (58)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Polyp Adenomatous                                                                       1 (2%)                                
   Intestine Small, Duodenum                          (60)         (42)         (70)         (55)                                   
      Adenocarcinoma                                                             1 (1%)                                             
      Adenocarcinoma, Cystic, Mucinous                              2 (5%)       1 (1%)                                             
   Intestine Small, Ileum                             (59)         (42)         (69)         (57)                                   
      Adenocarcinoma                                                                          1 (2%)                                
   Intestine Small, Jejunum                           (59)         (41)         (69)         (56)                                   
      Adenocarcinoma                                                             1 (1%)       1 (2%)                                
      Adenocarcinoma, Cystic, Mucinous                              2 (5%)       4 (6%)       3 (5%)                                
   Liver                                              (60)         (45)         (74)         (60)                                   
      Hepatocellular Carcinoma                         1 (2%)       1 (2%)                    2 (3%)                                
      Neoplastic Nodule                                             3 (7%)       7 (9%)       4 (7%)                                
      Neoplastic Nodule, Multiple                                                             2 (3%)                                
   Mesentery                                          (22)         (9)          (28)         (11)                                   
      Sarcoma                                          1 (5%)                                                                       
      Schwannoma Malignant                                                       2 (7%)                                             
   Pancreas                                           (60)         (44)         (75)         (60)                                   
      Adenocarcinoma, Multiple, Metastatic,                                                                                         
          Intestine Small                                           1 (2%)                                                          
      Acinus, Adenoma                                               2 (5%)                    1 (2%)                                
   Pharynx                                            (1)          (4)          (7)          (7)                                    
                                                             Page   8                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
      Carcinoma, Metastatic, Zymbal's Gland                                                   1 (14%)                               
      Mucosa, Carcinoma, Metastatic, Skin                                                     1 (14%)                               
      Palate, Carcinoma, Metastatic, Zymbal's Gland                                           1 (14%)                               
      Palate, Squamous Cell Carcinoma                                                         1 (14%)                               
      Palate, Squamous Cell Papilloma                               4 (100%)     5 (71%)      3 (43%)                               
   Salivary Glands                                    (60)         (44)         (75)         (60)                                   
      Schwannoma Malignant                                          2 (5%)                                                          
   Stomach, Forestomach                               (59)         (44)         (73)         (57)                                   
      Leiomyosarcoma                                                             1 (1%)                                             
   Tongue                                             (2)          (4)          (6)          (10)                                   
      Squamous Cell Carcinoma                                       1 (25%)                   1 (10%)                               
      Squamous Cell Papilloma                          1 (50%)      3 (75%)      5 (83%)      7 (70%)                               
      Parenchyma, Carcinoma                            1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (44)         (75)         (60)                                   
      Fibrous Histiocytoma, Metastatic, Skin                                     1 (1%)                                             
      Schwannoma Benign                                                          1 (1%)                                             
      Schwannoma Malignant                                                       1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland                                      (60)         (44)         (74)         (60)                                   
   Adrenal Gland, Cortex                              (60)         (44)         (74)         (60)                                   
   Adrenal Gland, Medulla                             (60)         (44)         (74)         (60)                                   
      Pheochromocytoma Malignant                       2 (3%)       1 (2%)       3 (4%)                                             
      Pheochromocytoma Benign                         12 (20%)     10 (23%)     16 (22%)      5 (8%)                                
      Bilateral, Pheochromocytoma Benign               2 (3%)       7 (16%)      7 (9%)       4 (7%)                                
   Islets, Pancreatic                                 (60)         (44)         (75)         (60)                                   
      Adenoma                                          1 (2%)                                                                       
      Carcinoma                                                     1 (2%)                                                          
   Pituitary Gland                                    (58)         (43)         (74)         (59)                                   
      Schwannoma Malignant, Metastatic, Eye                                                   1 (2%)                                
      Pars Distalis, Adenoma                           2 (3%)       1 (2%)                    3 (5%)                                
   Thyroid Gland                                      (60)         (44)         (74)         (60)                                   
      C-Cell, Adenoma                                  6 (10%)      6 (14%)      5 (7%)       1 (2%)                                
      C-Cell, Carcinoma                                             1 (2%)       2 (3%)       1 (2%)                                
      Follicular Cell, Adenoma                                                                1 (2%)                                
      Follicular Cell, Carcinoma                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   9                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)                                                 
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (45)         (75)         (59)                                   
   Preputial Gland                                    (60)         (43)         (73)         (59)                                   
      Adenoma                                         13 (22%)      4 (9%)      17 (23%)     11 (19%)                               
      Carcinoma                                        2 (3%)       5 (12%)     12 (16%)     17 (29%)                               
      Bilateral, Adenoma                               1 (2%)       2 (5%)       2 (3%)       1 (2%)                                
      Bilateral, Carcinoma                                          1 (2%)       3 (4%)       2 (3%)                                
   Prostate                                           (60)         (44)         (75)         (60)                                   
      Adenoma                                                                    1 (1%)                                             
   Seminal Vesicle                                    (58)         (42)         (58)         (44)                                   
      Adenocarcinoma, Multiple, Metastatic,                                                                                         
          Intestine Small                                           1 (2%)                                                          
      Adenoma                                                                                 1 (2%)                                
   Testes                                             (60)         (45)         (75)         (59)                                   
      Bilateral, Interstitial Cell, Adenoma           49 (82%)     35 (78%)     51 (68%)     24 (41%)                               
      Interstitial Cell, Adenoma                       8 (13%)      4 (9%)      17 (23%)     18 (31%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (43)         (74)         (60)                                   
   Lymph Node                                         (60)         (43)         (75)         (58)                                   
      Axillary, Mediastinal, Basal Cell Carcinoma,                                                                                  
           Metastatic, Skin                                                                   1 (2%)                                
      Deep Cervical, Carcinoma, Metastatic,                                                                                         
          Thyroid Gland                                                                       1 (2%)                                
      Inguinal, Carcinoma, Metastatic                                                         1 (2%)                                
      Inguinal, Iliac, Carcinoma, Metastatic,                                                                                       
          Preputial Gland                                                                     1 (2%)                                
      Mediastinal, Fibrous Histiocytoma,                                                                                            
          Metastatic, Skin                                                       1 (1%)                                             
   Lymph Node, Mandibular                             (60)         (43)         (74)         (58)                                   
      Squamous Cell Carcinoma, Metastatic, Skin                     1 (2%)                                                          
   Lymph Node, Mesenteric                             (59)         (42)         (73)         (56)                                   
      Mediastinal, Pancreatic, Adenocarcinoma,                                                                                      
           Metastatic, Intestine Small                              1 (2%)                                                          
   Spleen                                             (60)         (42)         (74)         (59)                                   
      Basal Cell Carcinoma, Metastatic, Skin                                                  1 (2%)                                
      Hemangiosarcoma                                                                         1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page  10                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (56)         (42)         (68)         (56)                                   
      Fibroadenoma                                     1 (2%)                    2 (3%)                                             
   Skin                                               (60)         (45)         (75)         (60)                                   
      Basal Cell Adenoma                               1 (2%)      15 (33%)     12 (16%)     10 (17%)                               
      Basal Cell Adenoma, Multiple                                 16 (36%)     35 (47%)     25 (42%)                               
      Basal Cell Carcinoma                             1 (2%)       3 (7%)      14 (19%)     13 (22%)                               
      Basal Cell Carcinoma, Multiple                                1 (2%)       4 (5%)       4 (7%)                                
      Keratoacanthoma                                  1 (2%)       5 (11%)      7 (9%)       1 (2%)                                
      Squamous Cell Carcinoma                                       8 (18%)     15 (20%)     15 (25%)                               
      Squamous Cell Carcinoma, Multiple                             1 (2%)       9 (12%)      6 (10%)                               
      Squamous Cell Papilloma                                       3 (7%)       7 (9%)       3 (5%)                                
      Squamous Cell Papilloma, Multiple                             2 (4%)                    2 (3%)                                
      Sebaceous Gland, Adenoma                                      2 (4%)       2 (3%)       1 (2%)                                
      Sebaceous Gland, Carcinoma                                                 1 (1%)       1 (2%)                                
      Subcutaneous Tissue, Carcinoma, Metastatic                                              1 (2%)                                
      Subcutaneous Tissue, Fibroma                                  4 (9%)       4 (5%)       1 (2%)                                
      Subcutaneous Tissue, Fibroma, Multiple                                                  1 (2%)                                
      Subcutaneous Tissue, Fibrosarcoma                                                       1 (2%)                                
      Subcutaneous Tissue, Fibrous Histiocytoma                                  1 (1%)                                             
      Subcutaneous Tissue, Neurofibroma                             2 (4%)       2 (3%)       2 (3%)                                
      Subcutaneous Tissue, Sarcoma                     2 (3%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                                            (3)          (1)          (6)                                    
      Chordoma                                                      1 (33%)                                                         
      Cranium, Carcinoma, Metastatic, Zymbal's                                                                                      
          Gland                                                     1 (33%)                   5 (83%)                               
      Cranium, Squamous Cell Carcinoma, Metastatic                                            1 (17%)                               
      Cranium, Squamous Cell Carcinoma, Metastatic,                                                                                 
           Skin                                                     1 (33%)                                                         
   Skeletal Muscle                                                              (3)          (1)                                    
      Abdominal, Schwannoma Malignant, Metastatic,                                                                                  
           Mesentery                                                             2 (67%)                                            
      Cervical, Carcinoma, Metastatic, Zymbal's                                                                                     
          Gland                                                                               1 (100%)                              
      Thoracic, Fibrous Histiocytoma, Metastatic,                                                                                   
           Skin                                                                  1 (33%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page  11                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (44)         (75)         (60)                                   
      Astrocytoma Malignant                                                      1 (1%)                                             
      Cerebellum, Astrocytoma Malignant                             1 (2%)                                                          
      Cerebellum, Cerebrum, Astrocytoma Malignant                                1 (1%)                                             
      Cerebrum, Astrocytoma Malignant                               1 (2%)       1 (1%)       1 (2%)                                
      Meninges, Cerebrum, Perivascular, Squamous                                                                                    
          Cell Carcinoma, Metastatic, Skin                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (44)         (75)         (60)                                   
      Adenocarcinoma, Multiple, Metastatic,                                                                                         
          Intestine Small                                           1 (2%)                                                          
      Alveolar/Bronchiolar Adenoma                                               2 (3%)       1 (2%)                                
      Basal Cell Carcinoma, Multiple, Metastatic,                                                                                   
           Skin                                                     1 (2%)                    1 (2%)                                
      Carcinoma, Multiple, Metastatic, Preputial                                                                                    
          Gland                                                                               1 (2%)                                
      Carcinoma, Multiple, Metastatic, Zymbal's                                                                                     
          Gland                                                     1 (2%)                    2 (3%)                                
      Carcinoma, Metastatic, Preputial Gland                                     1 (1%)                                             
      Carcinoma, Metastatic, Zymbal's Gland                         1 (2%)       1 (1%)       1 (2%)                                
      Fibrosarcoma, Multiple, Metastatic, Skin                                                1 (2%)                                
      Fibrous Histiocytoma, Metastatic, Skin                                     1 (1%)                                             
      Squamous Cell Carcinoma, Multiple,                                                                                            
          Metastatic, Skin                                          1 (2%)                    1 (2%)                                
      Squamous Cell Carcinoma, Metastatic, Skin                                               2 (3%)                                
   Nose                                               (60)         (44)         (74)         (60)                                   
      Adenoma                                                                    1 (1%)                                             
      Squamous Cell Carcinoma, Metastatic, Skin                     1 (2%)                                                          
      Submucosa, Schwannoma Malignant, Metastatic,                                                                                  
           Eye                                                                                1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (4)          (3)          (3)          (2)                                    
      Choroid, Conjunctiva, Retrobulbar, Squamous                                                                                   
          Cell Carcinoma, Metastatic, Skin                          1 (33%)                                                         
      Optic Nerve, Schwannoma Malignant                                                       1 (50%)                               
   Zymbal's Gland                                     (59)         (45)         (75)         (60)                                   
      Adenoma                                                       3 (7%)      11 (15%)      9 (15%)                               
      Carcinoma                                                     7 (16%)     13 (17%)     20 (33%)                               
      Bilateral, Adenoma                                            1 (2%)                                                          
      Bilateral, Carcinoma                                                       1 (1%)       1 (2%)                                
                                                             Page  12                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (44)         (74)         (60)                                   
      Adenocarcinoma, Metastatic, Intestine Small                   1 (2%)                                                          
   Urinary Bladder                                    (60)         (44)         (75)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(45)        *(75)        *(60)                                   
      Leukemia Mononuclear                            19 (32%)     17 (38%)     17 (23%)      4 (7%)                                
      Lymphoma Malignant Histiocytic                                             1 (1%)                                             
      Mesothelioma Benign                                                                     2 (3%)                                
      Mesothelioma Malignant                           2 (3%)       1 (2%)       7 (9%)       4 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page  13                                                               
NTP Experiment-Test: 05172-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHOXYBENZIDINE DIHYDROCHLORIDE                          Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 06:28:49  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      80 PPM       170 PPM      330 PPM                                   
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            59          45          75          60                                       
     Total Primary Neoplasms                          129         194         344         254                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 57          43          70          53                                       
     Total Benign Neoplasms                            98         135         223         149                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms              27          36          66          59                                       
     Total Malignant Neoplasms                         31          59         121         105                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms              2           6          11          19                                       
     Total Metastatic Neoplasm                         17          16          36          39                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms                                                                                           
   Uncertain Primary Site                                                                                                           
                                                                                                                                    
   Total Animals with Neoplasms Uncertain-                                                                                          
   Benign or Malignant                                                                                                              
     Total Uncertain Neoplasms                                                                                                      
                                                                                                                                    
____________________________________________________________________________________________________________________________________
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Primary tumors: all tumors except metastatic tumors                                                                              
                                                             Page  14                                                               
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