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TDMS Study 05166-01 Pathology Tables


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


NTP Experiment-Test: 05166-01                                                                                     Report: PEIRPT05
Study Type: CHRONIC                                                                                               Date: 09/18/94
Route: DOSED WATER                                                                                                Time: 00:50:59




       Facility:  Hazleton Laboratories America, Inc.

       Chemical CAS #:  612-82-8

       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: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Moribund                                           1            5           37           45                                     
    Dead                                                            1            6            5                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                59           39           32           10                                     
  Animals Examined Microscopically                    60           45           75           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Colon                             (60)         (45)         (75)         (60)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Polyp Adenomatous                                             1 (2%)       4 (5%)       2 (3%)                                
   Intestine Large, Rectum                            (60)         (45)         (74)         (60)                                   
      Adenocarcinoma                                                             1 (1%)                                             
      Polyp Adenomatous                                                          2 (3%)       2 (3%)                                
   Intestine Small, Duodenum                          (60)         (45)         (74)         (59)                                   
      Adenocarcinoma                                                                          1 (2%)                                
   Intestine Small, Ileum                             (60)         (45)         (75)         (59)                                   
      Adenocarcinoma, Mucinous                                                                1 (2%)                                
      Polyp Adenomatous                                                          1 (1%)                                             
   Intestine Small, Jejunum                           (60)         (45)         (74)         (59)                                   
      Adenocarcinoma                                                             1 (1%)                                             
      Adenocarcinoma, Cystic, Mucinous                                           1 (1%)       3 (5%)                                
      Leiomyoma                                                     1 (2%)                                                          
      Polyp Adenomatous                                             1 (2%)                                                          
   Liver                                              (60)         (45)         (74)         (60)                                   
      Hepatocellular Carcinoma                                                   1 (1%)       1 (2%)                                
      Hepatocholangiocarcinoma                                                   1 (1%)                                             
      Neoplastic Nodule                                                          5 (7%)       3 (5%)                                
      Neoplastic Nodule, Multiple                                                2 (3%)                                             
   Pharynx                                                         (1)          (8)          (7)                                    
      Squamous Cell Carcinoma                                                    2 (25%)      3 (43%)                               
      Squamous Cell Carcinoma, Metastatic,                                                                                          
          Zymbal's Gland                                                         1 (13%)                                            
      Squamous Cell Papilloma                                       1 (100%)     5 (63%)      4 (57%)                               
   Tongue                                                          (2)          (3)          (10)                                   
      Squamous Cell Carcinoma                                       1 (50%)                   1 (10%)                               
      Squamous Cell Papilloma                                       2 (100%)     2 (67%)      7 (70%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   2                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (45)         (74)         (60)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (60)         (45)         (74)         (60)                                   
   Adrenal Gland, Medulla                             (60)         (45)         (74)         (60)                                   
   Pituitary Gland                                    (58)         (45)         (75)         (60)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                      1 (1%)                                             
      Pars Distalis, Adenoma                           3 (5%)       1 (2%)       4 (5%)                                             
   Thyroid Gland                                      (60)         (45)         (74)         (60)                                   
      C-Cell, Adenoma                                  1 (2%)       1 (2%)       2 (3%)       1 (2%)                                
      Follicular Cell, Adenoma                                                   1 (1%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (6)          (3)                                    
      Carcinoma, Metastatic, Zymbal's Gland                                      2 (33%)      2 (67%)                               
      Sarcoma                                                                                 1 (33%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (60)         (45)         (75)         (59)                                   
      Adenoma                                                       8 (18%)     26 (35%)     11 (19%)                               
      Carcinoma                                                     5 (11%)     10 (13%)     16 (27%)                               
      Sarcoma                                                                    1 (1%)                                             
      Bilateral, Adenoma                                            1 (2%)       6 (8%)       6 (10%)                               
      Bilateral, Carcinoma                                                       1 (1%)       2 (3%)                                
   Ovary                                              (60)         (44)         (75)         (60)                                   
      Choriocarcinoma, Metastatic, Uterus                                        1 (1%)                                             
      Granulosa Cell Tumor Malignant                                                          1 (2%)                                
      Granulosa-Theca Tumor Benign                                  1 (2%)                                                          
   Uterus                                             (60)         (44)         (75)         (60)                                   
      Choriocarcinoma                                                            1 (1%)                                             
      Polyp Stromal                                   11 (18%)      9 (20%)      2 (3%)       1 (2%)                                
      Sarcoma Stromal                                               1 (2%)       1 (1%)                                             
      Cervix, Polyp Stromal                                                      1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   3                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                         (60)         (45)         (75)         (60)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                      1 (1%)                                             
   Lymph Node, Mandibular                             (60)         (43)         (72)         (60)                                   
      Basal Cell Carcinoma, Metastatic, Skin                                     1 (1%)                                             
   Lymph Node, Mesenteric                             (60)         (45)         (73)         (60)                                   
   Spleen                                             (60)         (45)         (74)         (60)                                   
   Thymus                                             (54)         (32)         (67)         (45)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (56)         (42)         (73)         (54)                                   
      Adenocarcinoma                                                1 (2%)       3 (4%)       5 (9%)                                
      Adenocarcinoma, Multiple                                                                1 (2%)                                
      Fibroadenoma                                     2 (4%)       1 (2%)       3 (4%)                                             
      Fibroadenoma, Multiple                                                     1 (1%)                                             
   Skin                                               (60)         (45)         (75)         (59)                                   
      Basal Cell Adenoma                                            3 (7%)       5 (7%)       3 (5%)                                
      Basal Cell Adenoma, Multiple                                                            2 (3%)                                
      Basal Cell Carcinoma                                                       5 (7%)       4 (7%)                                
      Keratoacanthoma                                                                         1 (2%)                                
      Squamous Cell Carcinoma                                       2 (4%)       3 (4%)       7 (12%)                               
      Squamous Cell Carcinoma, Multiple                                          1 (1%)                                             
      Squamous Cell Papilloma                                       1 (2%)       5 (7%)       5 (8%)                                
      Squamous Cell Papilloma, Multiple                                          1 (1%)                                             
      Sebaceous Gland, Adenoma                                                                1 (2%)                                
      Sebaceous Gland, Carcinoma                                                 1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Skeletal Muscle                                                              (1)                                                 
      Sarcoma                                                                    1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (45)         (75)         (60)                                   
      Astrocytoma Malignant                                         1 (2%)       1 (1%)                                             
      Carcinoma, Metastatic, Zymbal's Gland                                      2 (3%)       3 (5%)                                
      Glioma Malignant                                                           1 (1%)       1 (2%)                                
      Meningioma Malignant                                          1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   4                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (45)         (74)         (60)                                   
      Alveolar/Bronchiolar Adenoma                     1 (2%)       1 (2%)       3 (4%)       3 (5%)                                
      Alveolar/Bronchiolar Carcinoma                                                          1 (2%)                                
      Basal Cell Carcinoma, Metastatic, Skin                                     1 (1%)                                             
      Carcinoma, Metastatic, Clitoral Gland                                      1 (1%)       2 (3%)                                
      Carcinoma, Metastatic, Uncertain Primary Site                                           1 (2%)                                
      Carcinoma, Metastatic, Zymbal's Gland                                      2 (3%)       1 (2%)                                
      Squamous Cell Carcinoma, Metastatic, Pharynx                                            1 (2%)                                
      Mediastinum, Sarcoma, Metastatic, Skeletal                                                                                    
          Muscle                                                                 1 (1%)                                             
   Nose                                               (60)         (44)         (75)         (60)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                      1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                                       (1)                                    
      Canal, Squamous Cell Papilloma                                                          1 (100%)                              
   Eye                                                             (1)          (4)          (4)                                    
      Conjunctiva, Squamous Cell Carcinoma                                                    1 (25%)                               
   Zymbal's Gland                                     (57)         (44)         (73)         (60)                                   
      Adenoma                                                       4 (9%)       9 (12%)     12 (20%)                               
      Carcinoma                                                     2 (5%)      20 (27%)     34 (57%)                               
      Bilateral, Adenoma                                                         2 (3%)                                             
      Bilateral, Carcinoma                                                       2 (3%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (45)         (74)         (60)                                   
      Renal Tubule, Adenoma                                                                   1 (2%)                                
   Urinary Bladder                                    (60)         (45)         (75)         (60)                                   
      Sarcoma Stromal, Metastatic, Uterus                                        1 (1%)                                             
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(45)        *(75)        *(60)                                   
      Leukemia Mononuclear                             1 (2%)       3 (7%)       6 (8%)       4 (7%)                                
      Lymphoma Malignant                                            1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page   5                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            18          33          71          58                                       
     Total Primary Neoplasms                           19          55         157         157                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 17          24          54          41                                       
     Total Benign Neoplasms                            18          37          92          67                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms               1          14          49          56                                       
     Total Malignant Neoplasms                          1          18          65          90                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                                     11           9                                       
     Total Metastatic Neoplasm                                                 16          10                                       
                                                                                                                                    
   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   6                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
  Animals Initially in Study                          70           45           75           70                                     
  Scheduled Sacrifice                                 10                                     10                                     
  Early Deaths                                                                                                                      
    Moribund                                                        2           19           45                                     
    Dead                                                            2            5           15                                     
    Accident                                                                     1                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                60           41           49                                                  
    Dead                                                                         1                                                  
  Animals Examined Microscopically                    60           45           75           60                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Cecum                             (60)         (45)         (75)         (58)                                   
      Polyp Adenomatous                                                          1 (1%)       1 (2%)                                
   Intestine Large, Colon                             (60)         (45)         (75)         (58)                                   
      Adenocarcinoma                                                                          5 (9%)                                
      Adenocarcinoma, Cystic, Mucinous                                                        1 (2%)                                
      Polyp Adenomatous                                                          5 (7%)       3 (5%)                                
      Polyp Adenomatous, Multiple                                                             2 (3%)                                
   Intestine Large, Rectum                            (60)         (44)         (75)         (60)                                   
      Adenocarcinoma                                                                          1 (2%)                                
      Polyp Adenomatous                                                                       3 (5%)                                
   Intestine Small, Duodenum                          (60)         (44)         (75)         (56)                                   
      Adenocarcinoma, Cystic, Mucinous                                           2 (3%)                                             
   Intestine Small, Ileum                             (60)         (44)         (75)         (54)                                   
      Adenocarcinoma, Multiple                                                                1 (2%)                                
      Polyp Adenomatous                                                          1 (1%)       1 (2%)                                
   Intestine Small, Jejunum                           (60)         (44)         (75)         (55)                                   
      Adenocarcinoma, Cystic, Multiple, Mucinous                                              1 (2%)                                
      Adenocarcinoma, Cystic, Mucinous                                           1 (1%)       6 (11%)                               
   Liver                                              (60)         (45)         (75)         (60)                                   
      Cholangiocarcinoma                                                                      1 (2%)                                
      Hepatoblastoma                                                                          1 (2%)                                
      Hepatocellular Carcinoma                                                  11 (15%)     10 (17%)                               
      Hepatocellular Carcinoma, Multiple                                         1 (1%)       2 (3%)                                
      Neoplastic Nodule                                                         15 (20%)     15 (25%)                               
      Neoplastic Nodule, Multiple                                               14 (19%)     11 (18%)                               
   Pancreas                                           (60)         (44)         (75)         (57)                                   
   Pharynx                                                                      (3)          (3)                                    
      Squamous Cell Carcinoma                                                    1 (33%)      1 (33%)                               
      Squamous Cell Papilloma                                                    2 (67%)      2 (67%)                               
                                                             Page   7                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - cont                                                                                                            
   Stomach, Glandular                                 (60)         (45)         (75)         (59)                                   
   Tongue                                                                       (1)          (3)                                    
      Squamous Cell Carcinoma                                                                 2 (67%)                               
      Squamous Cell Papilloma                                                    1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (60)         (45)         (75)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Gland, Cortex                              (60)         (44)         (75)         (59)                                   
   Adrenal Gland, Medulla                             (60)         (45)         (75)         (59)                                   
      Pheochromocytoma Benign                                       2 (4%)       1 (1%)       3 (5%)                                
   Pituitary Gland                                    (60)         (45)         (75)         (60)                                   
      Pars Distalis, Adenoma                           1 (2%)       2 (4%)       4 (5%)       1 (2%)                                
   Thyroid Gland                                      (60)         (44)         (75)         (60)                                   
      C-Cell, Adenoma                                  2 (3%)       1 (2%)       3 (4%)       1 (2%)                                
      Follicular Cell, Adenoma                         1 (2%)       1 (2%)       1 (1%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                                   (1)          (4)                                    
      Sarcoma                                                                                 1 (25%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (60)         (45)         (75)         (60)                                   
   Preputial Gland                                    (60)         (45)         (75)         (60)                                   
      Adenoma                                          2 (3%)       4 (9%)       4 (5%)       8 (13%)                               
      Carcinoma                                                                  2 (3%)       1 (2%)                                
   Testes                                             (60)         (45)         (75)         (60)                                   
      Bilateral, Interstitial Cell, Adenoma            7 (12%)      9 (20%)      6 (8%)       1 (2%)                                
      Interstitial Cell, Adenoma                      17 (28%)     17 (38%)     20 (27%)      1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (60)         (44)         (75)         (60)                                   
   Lymph Node                                         (60)         (45)         (75)         (60)                                   
      Mediastinal, Squamous Cell Carcinoma,                                                                                         
          Metastatic, Skin                                          1 (2%)                                                          
   Lymph Node, Mandibular                             (60)         (45)         (74)         (60)                                   
                                                             Page   8                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - cont                                                                                                         
      Squamous Cell Carcinoma, Metastatic, Skin                                               1 (2%)                                
   Lymph Node, Mesenteric                             (60)         (44)         (75)         (56)                                   
   Spleen                                             (60)         (45)         (75)         (55)                                   
      Fibroma                                                                                 1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (60)         (44)         (75)         (60)                                   
      Basal Cell Adenoma                                            7 (16%)     17 (23%)      8 (13%)                               
      Basal Cell Adenoma, Multiple                                  3 (7%)      35 (47%)     21 (35%)                               
      Basal Cell Carcinoma                                          1 (2%)       4 (5%)       2 (3%)                                
      Keratoacanthoma                                  1 (2%)       1 (2%)       7 (9%)       5 (8%)                                
      Keratoacanthoma, Multiple                                                  1 (1%)                                             
      Squamous Cell Carcinoma                                       1 (2%)       8 (11%)     10 (17%)                               
      Squamous Cell Carcinoma, Multiple                             1 (2%)       2 (3%)       3 (5%)                                
      Squamous Cell Papilloma                                                    8 (11%)     13 (22%)                               
      Squamous Cell Papilloma, Multiple                                                       2 (3%)                                
      Sebaceous Gland, Adenoma                                                   6 (8%)       4 (7%)                                
      Sebaceous Gland, Adenoma, Multiple                                         1 (1%)       1 (2%)                                
      Subcutaneous Tissue, Fibroma                                                            2 (3%)                                
      Subcutaneous Tissue, Fibrosarcoma                1 (2%)                                                                       
      Subcutaneous Tissue, Schwannoma Benign                                     1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (60)         (45)         (75)         (60)                                   
      Carcinoma, Metastatic, Zymbal's Gland                                      1 (1%)                                             
      Glioma Malignant                                                           1 (1%)                                             
      Glioma Malignant, Focal, Mild                                                           1 (2%)                                
      Meningioma Malignant                                                                    1 (2%)                                
      Cranial Nerve, Meninges, Carcinoma,                                                                                           
          Metastatic, Zymbal's Gland                                                          1 (2%)                                
      Meninges, Sarcoma                                                          1 (1%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                             Page   9                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (60)         (45)         (75)         (60)                                   
      Alveolar/Bronchiolar Adenoma                     1 (2%)                    6 (8%)       4 (7%)                                
      Alveolar/Bronchiolar Adenoma, Multiple                                     1 (1%)       2 (3%)                                
      Alveolar/Bronchiolar Carcinoma                                             1 (1%)                                             
      Carcinoma, Metastatic, Zymbal's Gland                         1 (2%)       3 (4%)       3 (5%)                                
      Squamous Cell Carcinoma, Metastatic, Skin                     1 (2%)                    3 (5%)                                
   Nose                                               (60)         (45)         (75)         (60)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                                       (2)                                    
      Squamous Cell Carcinoma                                                                 1 (50%)                               
      Canal, Squamous Cell Papilloma                                                          1 (50%)                               
   Zymbal's Gland                                     (59)         (45)         (75)         (59)                                   
      Adenoma                                          1 (2%)       1 (2%)      13 (17%)     13 (22%)                               
      Carcinoma                                                     2 (4%)      20 (27%)     22 (37%)                               
      Bilateral, Adenoma                                                                      3 (5%)                                
      Bilateral, Carcinoma                                                       1 (1%)       1 (2%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (60)         (45)         (75)         (59)                                   
      Lipoma                                                                     1 (1%)                                             
   Urinary Bladder                                    (60)         (45)         (75)         (59)                                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SYSTEMIC LESIONS                                                                                                                   
   Multiple Organs                                   *(60)        *(45)        *(75)        *(60)                                   
      Leukemia Mononuclear                                          1 (2%)       1 (1%)       1 (2%)                                
      Lymphoma Malignant Histiocytic                                             1 (1%)                                             
      Lymphoma Malignant Undifferentiated Cell                                   1 (1%)                                             
      Mesothelioma Malignant                                                     3 (4%)       4 (7%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
     *   Number of animals with any tissue examined microscopically                                                                 
                                                             Page  10                                                               
NTP Experiment-Test: 05166-01  INCIDENCE RATES OF NEOPLASMS BY ANATOMIC SITE (SYSTEMIC LESIONS ABRIDGED) (a)      Report: PEIRPT05
Study Type: CHRONIC                               3,3-DIMETHYLBENZIDINE DIHYDROCHLORIDE                           Date: 09/18/94  
Route: DOSED WATER                                                                                                Time: 00:50:59  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     CONTROL      0.003        0.007        0.015                                     
                                                                                                                                    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
TUMOR SUMMARY                                                                                                                       
                                                                                                                                    
   Total Animals with Primary Neoplasms (b)            28          38          73          58                                       
     Total Primary Neoplasms                           34          54         237         214                                       
                                                                                                                                    
   Total Animals with Benign Neoplasms                 28          34          66          47                                       
     Total Benign Neoplasms                            33          48         175         134                                       
                                                                                                                                    
   Total Animals with Malignant Neoplasms               1           6          48          50                                       
     Total Malignant Neoplasms                          1           6          62          80                                       
                                                                                                                                    
   Total Animals with Metastatic Neoplasms                          2           5          11                                       
     Total Metastatic Neoplasm                                      3           6          11                                       
                                                                                                                                    
   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  11                                                               
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