National Toxicology Program

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TDMS Study 05019-03 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94       
EXPERIMENT: 05019 TEST: 03                                                                                     TIME: 14:50:15       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6       
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               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08    
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94      
EXPERIMENT: 05019 TEST: 03                                                                                     TIME: 14:50:15      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366       
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6      
 
 
 
 
 
                                                    RATS(FISCHER344)
                                              ----------------------------
             FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
             IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
 
 
                                                    ----------------
 
                                                    Adrenal Gland
                                                    Bone Marrow
                                                    Brain
                                                    Clitoral Gland
                                                    Epididymis
                                                    Heart
                                                    Islets, Pancreatic
                                                    Kidney
                                                    Liver
                                                    Lung
                                                    Nose
                                                    Ovary
                                                    Pancreas
                                                    Parathyroid Gland
                                                    Pituitary Gland
                                                    Preputial Gland
                                                    Prostate
                                                    Salivary Glands
                                                    Spleen
                                                    Testes
                                                    Thymus
                                                    Thyroid Gland
                                                    Urinary Bladder
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94       
EXPERIMENT: 05019 TEST: 03                                                                                     TIME: 14:50:15       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 3
 
              ====================================================================================================
 
                                                           MALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma Benign
                                                           Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Ear                           Schwannoma Benign
                             Islets, Pancreatic            Adenoma
                                                           Carcinoma or Adenoma
                             Mammary Gland                 Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Pituitary Gland: Pars Distalis or Unspecified Site
                                                           Carcinoma or Adenoma
                             Skin                          Squamous Cell Papilloma
                                                           Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Skin: Subcutaneous Tissue     Fibroma
                                                           Neurofibrosarcoma, Fibrosarcoma, or Sarcoma
                             Testes                        Adenoma
                             Zymbal's Gland                Carcinoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
 
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Southern Research Inst                                 CI PIGMENT RED 3                                   DATE: 09/03/94       
EXPERIMENT: 05019 TEST: 03                                                                                     TIME: 14:50:15       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NOIES9565102          ROUTE: DOSED FEED                                                                  NTP C#: 60366        
PATHOLOGIST: H. GILES                        S. EUSTIS                                                         CAS: 2425-85-6       
 
 
 
 
 
                                     SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
                                        IN THE ANALYSIS OF THE STUDY OF CI PIGMENT RED 3
 
              ====================================================================================================
 
                                                           FEMALE RATS
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------
 
                             Adrenal Medulla               Pheochromocytoma: Benign, Complex, Malignant, NOS
                             Brain                         Ependymoma Malignant
                             Clitoral/Preputial Gland      Adenoma
                                                           Carcinoma or Adenoma
                             Liver                         Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma or Hepatocellular Adenoma
                                                           Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
                             Mammary Gland                 Carcinoma
                                                           Fibroadenoma
                                                           Fibroma, Fibroadenoma or Adenoma
                                                           Fibroma, Fibroadenoma, Carcinoma, or Adenoma
                             Skin                          Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,
                                                            Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma
                             Thyroid Gland: C-Cell         Carcinoma
                             All Organs                    Leukemia: Lymphocytic, Monocytic, Mononuclear,
                                                            or Undifferentiated
                                                           Benign Tumors
                                                           Malignant Tumors
                                                           Malignant and Benign Tumors
 
              ====================================================================================================
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   1
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |  2/50 (4%)    1/16 (6%)    0/13 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         2.5%         3.6%         0.0%      |   6.3%        14.3%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    1/28 (4%)    0/20 (0%)  |  2/32 (6%)    1/7 (14%)    0/2 (0%)     0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      ---       |   729 (T)      729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.694N     P=0.571      P=0.500        (e)      |  P=0.091N     P=0.524      P=0.878N     P=0.191N   |
|INCIDENTAL TUMOR       |  P=0.694N     P=0.571      P=0.500        (e)      |  P=0.091N     P=0.524      P=0.878N     P=0.191N   |
|LOGISTIC REGRESSION    |  P=0.694N     P=0.571      P=0.500        (e)      |  P=0.091N     P=0.524      P=0.878N     P=0.191N   |
|COCHRAN-ARMITAGE       |  P=0.591N                                          |  P=0.117N                                          |
|FISHER EXACT           |               P=0.500      P=0.500        (e)      |               P=0.572      P=0.627N     P=0.247N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/50 (44%)  29/50 (58%)  35/50 (70%)  34/50 (68%) |  4/49 (8%)    3/16 (19%)   0/13 (0%)    4/50 (8%)  |
|ADJUSTED (b)           |  60.2%        65.7%        89.3%        79.9%      |  12.0%        42.9%         0.0%        10.0%      |
|TERMINAL (d)           | 14/28 (50%)  25/40 (63%)  24/28 (86%)  12/20 (60%) |  2/31 (6%)    3/7 (43%)    0/2 (0%)     4/40 (10%) |
|FIRST INCIDENCE (DAYS) |   653          605          529          486       |   723          729 (T)      ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.527N     P=0.019 *    P=0.005 ** |  P=0.305N     P=0.326      P=0.187N     P=0.508N   |
|INCIDENTAL TUMOR       |  P=0.004 **   P=0.136      P=0.005 **   P=0.013 *  |  P=0.377N     P=0.086      P=0.346N     P=0.614    |
|LOGISTIC REGRESSION    |  P=0.004 **   P=0.191      P=0.006 **   P=0.010 ** |  P=0.303N     P=0.080      P=0.648N     P=0.548N   |
|COCHRAN-ARMITAGE       |  P=0.010 **                                        |  P=0.440N                                          |
|FISHER EXACT           |               P=0.115      P=0.007 **   P=0.013 *  |               P=0.227      P=0.380N     P=0.631N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   2
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Malignant                                                                                                  |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   7/50 (14%)  10/50 (20%)   4/50 (8%)  |  0/49 (0%)    1/16 (6%)    0/13 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  19.4%        17.0%        25.8%        11.5%      |   0.0%        14.3%         0.0%         0.0%      |
|TERMINAL (d)           |  4/28 (14%)   6/40 (15%)   3/28 (11%)   1/20 (5%)  |  0/31 (0%)    1/7 (14%)    0/2 (0%)     0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   666          660          529          567       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.553N     P=0.499N     P=0.247      P=0.498N   |  P=0.464N     P=0.208        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.278N     P=0.503      P=0.201      P=0.370N   |  P=0.464N     P=0.208        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.318N     P=0.588      P=0.207      P=0.358N   |  P=0.464N     P=0.208        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.325N                                          |  P=0.517N                                          |
|FISHER EXACT           |               P=0.500      P=0.207      P=0.370N   |               P=0.246        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 24/50 (48%)  32/50 (64%)  37/50 (74%)  36/50 (72%) |  5/49 (10%)   4/16 (25%)   1/13 (8%)    4/50 (8%)  |
|ADJUSTED (b)           |  64.1%        71.0%        89.9%        82.8%      |  15.0%        57.1%        50.0%        10.0%      |
|TERMINAL (d)           | 15/28 (54%)  27/40 (68%)  24/28 (86%)  13/20 (65%) |  3/31 (10%)   4/7 (57%)    1/2 (50%)    4/40 (10%) |
|FIRST INCIDENCE (DAYS) |   653          605          529          486       |   723          729 (T)      729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001 **   P=0.555N     P=0.025 *    P=0.005 ** |  P=0.161N     P=0.170      P=0.590N     P=0.354N   |
|INCIDENTAL TUMOR       |  P=0.005 **   P=0.070      P=0.003 **   P=0.012 *  |  P=0.207N     P=0.034 *    P=0.698      P=0.516N   |
|LOGISTIC REGRESSION    |  P=0.005 **   P=0.133      P=0.005 **   P=0.010 ** |  P=0.162N     P=0.027 *    P=0.450      P=0.388N   |
|COCHRAN-ARMITAGE       |  P=0.010 *                                         |  P=0.287N                                          |
|FISHER EXACT           |               P=0.079      P=0.007 **   P=0.012 *  |               P=0.143      P=0.631N     P=0.487N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   3
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Ependymoma Malignant                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/11 (0%)    0/22 (0%)    0/50 (0%)  |  0/50 (0%)    0/10 (0%)    2/13 (15%)   0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.1%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/1 (0%)     0/0          0/20 (0%)  |  0/32 (0%)    0/1 (0%)     0/2 (0%)     0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          429          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.590        (e)        P=0.244        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.603        (e)        P=0.240        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.498        (e)        P=0.039 *      (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.627                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.040 *      (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain                                                                                                                            |
|     Oligodendroglioma, Glioma, or Astrocytoma                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/11 (0%)    2/22 (9%)    0/50 (0%)  |  1/50 (2%)    1/10 (10%)   1/13 (8%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         0.0%         0.0%      |   2.9%         2.3%        50.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/1 (0%)     0/0          0/20 (0%)  |  0/32 (0%)    0/1 (0%)     1/2 (50%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          540          ---       |   723          665          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.493N     P=0.995N     P=0.252      P=0.567N   |  P=0.265N     P=0.742N     P=0.567      P=0.463N   |
|INCIDENTAL TUMOR       |  P=0.424N     P=0.995N     P=0.295      P=0.567N   |  P=0.398N     P=0.326      P=0.419      P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.396N     P=0.995N     P=0.324      P=0.567N   |  P=0.272N     P=0.287      P=0.165      P=0.488N   |
|COCHRAN-ARMITAGE       |  P=0.403N                                          |  P=0.284N                                          |
|FISHER EXACT           |               P=0.820N     P=0.219      P=0.500N   |               P=0.308      P=0.373      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   4
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/49 (12%)   0/13 (0%)    1/25 (4%)    1/50 (2%)  |  9/47 (19%)   1/14 (7%)    0/14 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  18.0%         0.0%        33.3%         2.9%      |  29.1%         2.1%         0.0%         2.5%      |
|TERMINAL (d)           |  3/28 (11%)   0/3 (0%)     1/3 (33%)    0/20 (0%)  |  8/29 (28%)   0/6 (0%)     0/3 (0%)     1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   658          ---          729 (T)      679       |   532          518          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.087N     P=0.080N     P=0.338N     P=0.100N   |  P=0.001N**   P=0.235N     P=0.197N     P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.049N*    P=0.305N     P=0.390N     P=0.053N   |  P=0.001N**   P=0.170N     P=0.197N     P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.048N*    P=0.289N     P=0.345N     P=0.061N   |  P=0.003N**   P=0.269N     P=0.127N     P=0.007N** |
|COCHRAN-ARMITAGE       |  P=0.040N*                                         |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.227N     P=0.242N     P=0.053N   |               P=0.269N     P=0.079N     P=0.006N** |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral/Preputial Gland                                                                                                         |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  7/49 (14%)   0/13 (0%)    1/25 (4%)    1/50 (2%)  |  9/47 (19%)   1/14 (7%)    0/14 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |  21.2%         0.0%        33.3%         2.9%      |  29.1%         2.1%         0.0%         2.5%      |
|TERMINAL (d)           |  4/28 (14%)   0/3 (0%)     1/3 (33%)    0/20 (0%)  |  8/29 (28%)   0/6 (0%)     0/3 (0%)     1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   658          ---          729 (T)      679       |   532          518          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.054N     P=0.073N     P=0.310N     P=0.066N   |  P=0.001N**   P=0.235N     P=0.197N     P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.030N*    P=0.276N     P=0.358N     P=0.034N*  |  P=0.001N**   P=0.170N     P=0.197N     P=0.002N** |
|LOGISTIC REGRESSION    |  P=0.027N*    P=0.260N     P=0.285N     P=0.035N*  |  P=0.003N**   P=0.269N     P=0.127N     P=0.007N** |
|COCHRAN-ARMITAGE       |  P=0.020N*                                         |  P=0.004N**                                        |
|FISHER EXACT           |               P=0.175N     P=0.172N     P=0.028N*  |               P=0.269N     P=0.079N     P=0.006N** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   5
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Ear                                                                                                                              |
|     Schwannoma Benign                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         8.4%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    1/20 (5%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          708       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.023 *      (e)          (e)        P=0.196    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.056        (e)          (e)        P=0.232    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.034 *      (e)          (e)        P=0.212    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.046 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)          (e)        P=0.247    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   0/50 (0%)    3/49 (6%)    0/50 (0%)  |  0/49 (0%)    1/50 (2%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |  14.4%         0.0%         9.1%         0.0%      |   0.0%         2.4%         0.0%         0.0%      |
|TERMINAL (d)           |  3/28 (11%)   0/40 (0%)    2/28 (7%)    0/20 (0%)  |  0/32 (0%)    1/41 (2%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   534          ---          576          ---       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072N     P=0.020N*    P=0.369N     P=0.057N   |  P=0.537N     P=0.549        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.051N     P=0.022N*    P=0.311N     P=0.045N*  |  P=0.537N     P=0.549        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.039N*    P=0.034N*    P=0.358N     P=0.026N*  |  P=0.537N     P=0.549        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.047N*                                         |  P=0.560N                                          |
|FISHER EXACT           |               P=0.028N*    P=0.369N     P=0.028N*  |               P=0.505        (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   6
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   0/50 (0%)    3/49 (6%)    0/50 (0%)  |  0/49 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)  |
|ADJUSTED (b)           |  14.4%         0.0%         9.1%         0.0%      |   0.0%         4.9%         0.0%         0.0%      |
|TERMINAL (d)           |  3/28 (11%)   0/40 (0%)    2/28 (7%)    0/20 (0%)  |  0/32 (0%)    2/41 (5%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   534          ---          576          ---       |   ---          729 (T)      ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.072N     P=0.020N*    P=0.369N     P=0.057N   |  P=0.362N     P=0.294        (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.051N     P=0.022N*    P=0.311N     P=0.045N*  |  P=0.362N     P=0.294        (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.039N*    P=0.034N*    P=0.358N     P=0.026N*  |  P=0.362N     P=0.294        (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.047N*                                         |  P=0.395N                                          |
|FISHER EXACT           |               P=0.028N*    P=0.369N     P=0.028N*  |               P=0.253        (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    3/50 (6%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)   10/50 (20%) |
|ADJUSTED (b)           |   0.0%         2.5%        10.7%         2.2%      |   0.0%         0.0%         2.6%        23.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    3/28 (11%)   0/20 (0%)  |  0/32 (0%)    0/41 (0%)    1/39 (3%)    7/40 (18%) |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      612       |   ---          ---          729 (T)      553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.232      P=0.571      P=0.120      P=0.500    |  P<0.001 **     (e)        P=0.539      P=0.004 ** |
|INCIDENTAL TUMOR       |  P=0.266      P=0.571      P=0.120      P=0.581    |  P<0.001 **     (e)        P=0.539      P=0.002 ** |
|LOGISTIC REGRESSION    |  P=0.334      P=0.571      P=0.120      P=0.558    |  P<0.001 **     (e)        P=0.539      P=0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.350                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500      P=0.121      P=0.500    |                 (e)        P=0.500      P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   7
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    4/50 (8%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)   10/50 (20%) |
|ADJUSTED (b)           |   0.0%         2.5%        14.3%         2.2%      |   0.0%         0.0%         2.6%        23.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    4/28 (14%)   0/20 (0%)  |  0/32 (0%)    0/41 (0%)    1/39 (3%)    7/40 (18%) |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      612       |   ---          ---          729 (T)      553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.205      P=0.571      P=0.061      P=0.500    |  P<0.001 **     (e)        P=0.539      P=0.004 ** |
|INCIDENTAL TUMOR       |  P=0.234      P=0.571      P=0.061      P=0.581    |  P<0.001 **     (e)        P=0.539      P=0.002 ** |
|LOGISTIC REGRESSION    |  P=0.310      P=0.571      P=0.061      P=0.558    |  P<0.001 **     (e)        P=0.539      P=0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.336                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500      P=0.059      P=0.500    |                 (e)        P=0.500      P<0.001 ** |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    4/50 (8%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    1/50 (2%)   10/50 (20%) |
|ADJUSTED (b)           |   0.0%         2.5%        14.3%         2.2%      |   0.0%         0.0%         2.6%        23.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    4/28 (14%)   0/20 (0%)  |  0/32 (0%)    0/41 (0%)    1/39 (3%)    7/40 (18%) |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      729 (T)      612       |   ---          ---          729 (T)      553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.205      P=0.571      P=0.061      P=0.500    |  P<0.001 **     (e)        P=0.539      P=0.004 ** |
|INCIDENTAL TUMOR       |  P=0.234      P=0.571      P=0.061      P=0.581    |  P<0.001 **     (e)        P=0.539      P=0.002 ** |
|LOGISTIC REGRESSION    |  P=0.310      P=0.571      P=0.061      P=0.558    |  P<0.001 **     (e)        P=0.539      P=0.001 ** |
|COCHRAN-ARMITAGE       |  P=0.336                                           |  P<0.001 **                                        |
|FISHER EXACT           |               P=0.500      P=0.059      P=0.500    |                 (e)        P=0.500      P<0.001 ** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   8
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    2/50 (4%)    0/50 (0%)    2/50 (4%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   0.0%         4.4%         0.0%         9.3%      |   3.1%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    0/28 (0%)    1/20 (5%)  |  1/32 (3%)    0/41 (0%)    0/39 (0%)    2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   ---          420          ---          723       |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.170      P=0.279        (e)        P=0.179    |  P=0.273      P=0.451N     P=0.461N     P=0.578    |
|INCIDENTAL TUMOR       |  P=0.240      P=0.279        (e)        P=0.232    |  P=0.273      P=0.451N     P=0.461N     P=0.578    |
|LOGISTIC REGRESSION    |  P=0.284      P=0.275        (e)        P=0.195    |  P=0.273      P=0.451N     P=0.461N     P=0.578    |
|COCHRAN-ARMITAGE       |  P=0.252                                           |  P=0.243                                           |
|FISHER EXACT           |               P=0.247        (e)        P=0.247    |               P=0.500N     P=0.500N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         2.3%         0.0%      |   0.0%         0.0%         5.1%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    2/39 (5%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   690          ---          598          ---       |   ---          ---          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.427N     P=0.458N     P=0.755N     P=0.518N   |  P=0.623        (e)        P=0.283        (e)      |
|INCIDENTAL TUMOR       |  P=0.308N     P=0.761N     P=0.760N     P=0.443N   |  P=0.623        (e)        P=0.283        (e)      |
|LOGISTIC REGRESSION    |  P=0.383N     P=0.505N     P=0.746N     P=0.499N   |  P=0.623        (e)        P=0.283        (e)      |
|COCHRAN-ARMITAGE       |  P=0.409N                                          |  P=0.591                                           |
|FISHER EXACT           |               P=0.500N     P=0.753N     P=0.500N   |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE   9
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    1/50 (2%)    2/50 (4%)  |  1/50 (2%)    0/50 (0%)    2/50 (4%)    2/50 (4%)  |
|ADJUSTED (b)           |   2.9%         4.4%         2.3%         9.3%      |   3.1%         0.0%         5.1%         5.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    0/28 (0%)    1/20 (5%)  |  1/32 (3%)    0/41 (0%)    2/39 (5%)    2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   690          420          598          723       |   729 (T)      ---          729 (T)      729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.358      P=0.565      P=0.755N     P=0.423    |  P=0.281      P=0.451N     P=0.569      P=0.578    |
|INCIDENTAL TUMOR       |  P=0.515      P=0.402      P=0.760N     P=0.528    |  P=0.281      P=0.451N     P=0.569      P=0.578    |
|LOGISTIC REGRESSION    |  P=0.496      P=0.530      P=0.746N     P=0.470    |  P=0.281      P=0.451N     P=0.569      P=0.578    |
|COCHRAN-ARMITAGE       |  P=0.447                                           |  P=0.241                                           |
|FISHER EXACT           |               P=0.500      P=0.753N     P=0.500    |               P=0.500N     P=0.500      P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  4/50 (8%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         0.0%         0.0%      |  10.1%         2.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  2/32 (6%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   158          390          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.018N*    P=0.157N     P=0.054N     P=0.054N   |
|INCIDENTAL TUMOR       |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.038N*    P=0.210N     P=0.100N     P=0.098N   |
|LOGISTIC REGRESSION    |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.033N*    P=0.209N     P=0.094N     P=0.087N   |
|COCHRAN-ARMITAGE       |  P=0.309N                                          |  P=0.020N*                                         |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.181N     P=0.059N     P=0.059N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  10
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  4/50 (8%)    1/50 (2%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   3.6%         0.0%         0.0%         0.0%      |  10.1%         2.0%         0.0%         2.5%      |
|TERMINAL (d)           |  1/28 (4%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  2/32 (6%)    0/41 (0%)    0/39 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   158          390          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.095N     P=0.157N     P=0.054N     P=0.148N   |
|INCIDENTAL TUMOR       |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.176N     P=0.210N     P=0.100N     P=0.249N   |
|LOGISTIC REGRESSION    |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.163N     P=0.209N     P=0.094N     P=0.232N   |
|COCHRAN-ARMITAGE       |  P=0.309N                                          |  P=0.105N                                          |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |               P=0.181N     P=0.059N     P=0.181N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroadenoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    0/50 (0%)    1/50 (2%)    2/50 (4%)  | 23/50 (46%)  16/50 (32%)  20/50 (40%)  12/50 (24%) |
|ADJUSTED (b)           |  10.7%         0.0%         2.9%         7.1%      |  56.6%        35.4%        45.4%        27.8%      |
|TERMINAL (d)           |  3/28 (11%)   0/40 (0%)    0/28 (0%)    1/20 (5%)  | 15/32 (47%)  12/41 (29%)  15/39 (38%)   9/40 (23%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          708          605       |   604          518          611          553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546      P=0.066N     P=0.292N     P=0.623N   |  P=0.013N*    P=0.038N*    P=0.173N     P=0.006N** |
|INCIDENTAL TUMOR       |  P=0.596N     P=0.066N     P=0.319N     P=0.586N   |  P=0.045N*    P=0.197N     P=0.368N     P=0.029N*  |
|LOGISTIC REGRESSION    |  P=0.578N     P=0.066N     P=0.284N     P=0.520N   |  P=0.024N*    P=0.103N     P=0.310N     P=0.015N*  |
|COCHRAN-ARMITAGE       |  P=0.562N                                          |  P=0.028N*                                         |
|FISHER EXACT           |               P=0.121N     P=0.309N     P=0.500N   |               P=0.109N     P=0.343N     P=0.018N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  11
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma or Adenoma                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    0/50 (0%)    1/50 (2%)    2/50 (4%)  | 23/50 (46%)  16/50 (32%)  20/50 (40%)  13/50 (26%) |
|ADJUSTED (b)           |  10.7%         0.0%         2.9%         7.1%      |  56.6%        35.4%        45.4%        30.1%      |
|TERMINAL (d)           |  3/28 (11%)   0/40 (0%)    0/28 (0%)    1/20 (5%)  | 15/32 (47%)  12/41 (29%)  15/39 (38%)  10/40 (25%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          708          605       |   604          518          611          553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.546      P=0.066N     P=0.292N     P=0.623N   |  P=0.022N*    P=0.038N*    P=0.173N     P=0.010N** |
|INCIDENTAL TUMOR       |  P=0.596N     P=0.066N     P=0.319N     P=0.586N   |  P=0.070N     P=0.197N     P=0.368N     P=0.046N*  |
|LOGISTIC REGRESSION    |  P=0.578N     P=0.066N     P=0.284N     P=0.520N   |  P=0.041N*    P=0.103N     P=0.310N     P=0.025N*  |
|COCHRAN-ARMITAGE       |  P=0.562N                                          |  P=0.047N*                                         |
|FISHER EXACT           |               P=0.121N     P=0.309N     P=0.500N   |               P=0.109N     P=0.343N     P=0.030N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Fibroma, Fibroadenoma, Carcinoma, or Adenoma                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    0/50 (0%)    1/50 (2%)    2/50 (4%)  | 26/50 (52%)  17/50 (34%)  20/50 (40%)  13/50 (26%) |
|ADJUSTED (b)           |  14.3%         0.0%         2.9%         7.1%      |  60.9%        36.7%        45.4%        30.1%      |
|TERMINAL (d)           |  4/28 (14%)   0/40 (0%)    0/28 (0%)    1/20 (5%)  | 16/32 (50%)  12/41 (29%)  15/39 (38%)  10/40 (25%) |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          708          605       |   158          390          611          553       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.512N     P=0.027N*    P=0.171N     P=0.473N   |  P=0.006N**   P=0.020N*    P=0.073N     P=0.002N** |
|INCIDENTAL TUMOR       |  P=0.430N     P=0.027N*    P=0.189N     P=0.437N   |  P=0.029N*    P=0.125N     P=0.220N     P=0.016N*  |
|LOGISTIC REGRESSION    |  P=0.401N     P=0.027N*    P=0.160N     P=0.364N   |  P=0.013N*    P=0.056N     P=0.157N     P=0.007N** |
|COCHRAN-ARMITAGE       |  P=0.380N                                          |  P=0.012N*                                         |
|FISHER EXACT           |               P=0.059N     P=0.181N     P=0.339N   |               P=0.053N     P=0.158N     P=0.007N** |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  12
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         2.5%         0.0%         0.0%      |   0.0%         0.0%         4.5%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      ---          ---       |   ---          ---          491          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.634N     P=0.571        (e)          (e)      |  P=0.603        (e)        P=0.254        (e)      |
|INCIDENTAL TUMOR       |  P=0.634N     P=0.571        (e)          (e)      |  P=0.510        (e)        P=0.166        (e)      |
|LOGISTIC REGRESSION    |  P=0.634N     P=0.571        (e)          (e)      |  P=0.528        (e)        P=0.171        (e)      |
|COCHRAN-ARMITAGE       |  P=0.559N                                          |  P=0.591                                           |
|FISHER EXACT           |               P=0.500        (e)          (e)      |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)                                                                           |
|     Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    1/50 (2%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.6%         2.5%         0.0%         0.0%      |   0.0%         2.4%         4.5%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    1/40 (3%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    1/41 (2%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      729 (T)      ---          ---       |   ---          729 (T)      491          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.289N     P=0.680N     P=0.500N     P=0.567N   |  P=0.591N     P=0.549      P=0.254        (e)      |
|INCIDENTAL TUMOR       |  P=0.289N     P=0.680N     P=0.500N     P=0.567N   |  P=0.640      P=0.549      P=0.166        (e)      |
|LOGISTIC REGRESSION    |  P=0.289N     P=0.680N     P=0.500N     P=0.567N   |  P=0.652N     P=0.549      P=0.171        (e)      |
|COCHRAN-ARMITAGE       |  P=0.233N                                          |  P=0.614N                                          |
|FISHER EXACT           |               P=0.753N     P=0.500N     P=0.500N   |               P=0.500      P=0.247        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  13
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)   9/16 (56%)   8/25 (32%)  12/50 (24%) | 25/50 (50%)  13/22 (59%)  12/20 (60%)  22/50 (44%) |
|ADJUSTED (b)           |  47.9%        73.9%        71.7%        35.3%      |  60.3%        78.5%        89.9%        49.9%      |
|TERMINAL (d)           | 11/28 (39%)   5/7 (71%)    2/3 (67%)    3/20 (15%) | 16/32 (50%)  10/13 (77%)   8/9 (89%)   18/40 (45%) |
|FIRST INCIDENCE (DAYS) |   637          581          529          577       |   604          639          611          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.428N     P=0.471      P=0.474      P=0.419N   |  P=0.081N     P=0.470N     P=0.569      P=0.128N   |
|INCIDENTAL TUMOR       |  P=0.108N     P=0.094      P=0.426      P=0.183N   |  P=0.227N     P=0.108      P=0.219      P=0.420N   |
|LOGISTIC REGRESSION    |  P=0.093N     P=0.071      P=0.547      P=0.195N   |  P=0.177N     P=0.127      P=0.141      P=0.313N   |
|COCHRAN-ARMITAGE       |  P=0.088N                                          |  P=0.250N                                          |
|FISHER EXACT           |               P=0.099      P=0.538N     P=0.189N   |               P=0.325      P=0.312      P=0.344N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 17/50 (34%)  10/16 (63%)   8/25 (32%)  12/50 (24%) | 25/50 (50%)  13/22 (59%)  13/20 (65%)  22/50 (44%) |
|ADJUSTED (b)           |  47.9%        86.9%        71.7%        35.3%      |  60.3%        78.5%        90.1%        49.9%      |
|TERMINAL (d)           | 11/28 (39%)   6/7 (86%)    2/3 (67%)    3/20 (15%) | 16/32 (50%)  10/13 (77%)   8/9 (89%)   18/40 (45%) |
|FIRST INCIDENCE (DAYS) |   637          581          529          577       |   604          639          611          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.403N     P=0.317      P=0.474      P=0.419N   |  P=0.087N     P=0.470N     P=0.481      P=0.128N   |
|INCIDENTAL TUMOR       |  P=0.097N     P=0.037 *    P=0.426      P=0.183N   |  P=0.250N     P=0.108      P=0.124      P=0.420N   |
|LOGISTIC REGRESSION    |  P=0.080N     P=0.026 *    P=0.547      P=0.195N   |  P=0.183N     P=0.127      P=0.076      P=0.313N   |
|COCHRAN-ARMITAGE       |  P=0.075N                                          |  P=0.255N                                          |
|FISHER EXACT           |               P=0.043 *    P=0.538N     P=0.189N   |               P=0.325      P=0.192      P=0.344N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  14
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Basal Cell Adenoma                                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    1/50 (2%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.2%         5.0%         3.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    2/40 (5%)    1/28 (4%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   706          729 (T)      729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.322N     P=0.611      P=0.744N     P=0.520N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.274N     P=0.444      P=0.745      P=0.443N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.279N     P=0.554      P=0.757N     P=0.510N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.244N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.753N     P=0.500N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Keratoacanthoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/50 (0%)    2/50 (4%)    2/50 (4%)  |  2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.0%         0.0%         7.1%        10.0%      |   6.3%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/40 (0%)    2/28 (7%)    2/20 (10%) |  2/32 (6%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   663          ---          729 (T)      729 (T)   |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.293      P=0.193N     P=0.689N     P=0.596    |  P=0.100N     P=0.186N     P=0.196N     P=0.191N   |
|INCIDENTAL TUMOR       |  P=0.342      P=0.320N     P=0.681      P=0.630    |  P=0.100N     P=0.186N     P=0.196N     P=0.191N   |
|LOGISTIC REGRESSION    |  P=0.387      P=0.240N     P=0.690N     P=0.668    |  P=0.100N     P=0.186N     P=0.196N     P=0.191N   |
|COCHRAN-ARMITAGE       |  P=0.438                                           |  P=0.118N                                          |
|FISHER EXACT           |               P=0.247N     P=0.691N     P=0.691N   |               P=0.247N     P=0.247N     P=0.247N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  15
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    4/50 (8%)    2/50 (4%)    6/50 (12%) |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%        10.0%         5.9%        25.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    4/40 (10%)   1/28 (4%)    4/20 (20%) |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          729 (T)      641          679       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.004 **   P=0.117      P=0.235      P=0.008 ** |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.010 *    P=0.117      P=0.257      P=0.011 *  |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.014 *    P=0.117      P=0.239      P=0.013 *  |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.023 *                                         |    (e)                                             |
|FISHER EXACT           |               P=0.059      P=0.247      P=0.013 *  |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    3/50 (6%)    1/50 (2%)    0/50 (0%)  |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.7%         7.5%         3.6%         0.0%      |   3.1%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    3/40 (8%)    1/28 (4%)    0/20 (0%)  |  1/32 (3%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   706          729 (T)      729 (T)      ---       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.156N     P=0.650      P=0.483N     P=0.289N   |  P=0.287N     P=0.451N     P=0.461N     P=0.455N   |
|INCIDENTAL TUMOR       |  P=0.133N     P=0.524      P=0.517N     P=0.242N   |  P=0.287N     P=0.451N     P=0.461N     P=0.455N   |
|LOGISTIC REGRESSION    |  P=0.126N     P=0.592      P=0.484N     P=0.259N   |  P=0.287N     P=0.451N     P=0.461N     P=0.455N   |
|COCHRAN-ARMITAGE       |  P=0.101N                                          |  P=0.309N                                          |
|FISHER EXACT           |               P=0.500      P=0.500N     P=0.247N   |               P=0.500N     P=0.500N     P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  16
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma,                                                                |
|     Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    7/50 (14%)   5/50 (10%)   8/50 (16%) |  3/50 (6%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |  12.4%        17.5%        16.3%        34.3%      |   9.4%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  2/28 (7%)    7/40 (18%)   4/28 (14%)   6/20 (30%) |  3/32 (9%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   663          729 (T)      641          679       |   729 (T)      ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.042 *    P=0.468      P=0.510      P=0.085    |  P=0.038N*    P=0.081N     P=0.088N     P=0.085N   |
|INCIDENTAL TUMOR       |  P=0.089      P=0.300      P=0.491      P=0.119    |  P=0.038N*    P=0.081N     P=0.088N     P=0.085N   |
|LOGISTIC REGRESSION    |  P=0.120      P=0.347      P=0.505      P=0.136    |  P=0.038N*    P=0.081N     P=0.088N     P=0.085N   |
|COCHRAN-ARMITAGE       |  P=0.191                                           |  P=0.049N*                                         |
|FISHER EXACT           |               P=0.262      P=0.500      P=0.178    |               P=0.121N     P=0.121N     P=0.121N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibroma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    0/50 (0%)    2/50 (4%)    4/50 (8%)  |  0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |  12.0%         0.0%         5.2%        13.2%      |   0.0%         2.4%         2.6%         0.0%      |
|TERMINAL (d)           |  2/28 (7%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    1/41 (2%)    1/39 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   653          ---          687          581       |   ---          729 (T)      729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.260      P=0.040N*    P=0.318N     P=0.545    |  P=0.560N     P=0.549      P=0.539        (e)      |
|INCIDENTAL TUMOR       |  P=0.568      P=0.109N     P=0.380N     P=0.562N   |  P=0.560N     P=0.549      P=0.539        (e)      |
|LOGISTIC REGRESSION    |  P=0.376      P=0.062N     P=0.337N     P=0.640N   |  P=0.560N     P=0.549      P=0.539        (e)      |
|COCHRAN-ARMITAGE       |  P=0.363                                           |  P=0.591N                                          |
|FISHER EXACT           |               P=0.059N     P=0.339N     P=0.643N   |               P=0.500      P=0.500        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  17
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   5.9%         5.0%         0.0%         0.0%      |   2.4%         2.2%         2.6%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    2/40 (5%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    1/39 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   658          729 (T)      ---          ---       |   687          612          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.114N     P=0.593N     P=0.242N     P=0.285N   |  P=0.301N     P=0.758      P=0.741N     P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.095N     P=0.695      P=0.255N     P=0.242N   |  P=0.370N     P=0.593      P=0.712      P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.089N     P=0.678N     P=0.237N     P=0.238N   |  P=0.321N     P=0.751      P=0.759N     P=0.503N   |
|COCHRAN-ARMITAGE       |  P=0.085N                                          |  P=0.311N                                          |
|FISHER EXACT           |               P=0.691N     P=0.247N     P=0.247N   |               P=0.753N     P=0.753N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, Sarcoma,                                                                                   |
|     Neurofibroma, or Fibroma                                                                                                    |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  6/50 (12%)   2/50 (4%)    2/50 (4%)    4/50 (8%)  |  1/50 (2%)    2/50 (4%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |  17.0%         5.0%         5.2%        13.2%      |   2.4%         4.6%         5.1%         0.0%      |
|TERMINAL (d)           |  2/28 (7%)    2/40 (5%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    1/41 (2%)    2/39 (5%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   653          729 (T)      687          581       |   687          612          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.541N     P=0.075N     P=0.132N     P=0.482N   |  P=0.269N     P=0.526      P=0.543      P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.226N     P=0.284N     P=0.163N     P=0.261N   |  P=0.319N     P=0.354      P=0.468      P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.391N     P=0.128N     P=0.134N     P=0.364N   |  P=0.294N     P=0.492      P=0.509      P=0.503N   |
|COCHRAN-ARMITAGE       |  P=0.394N                                          |  P=0.294N                                          |
|FISHER EXACT           |               P=0.134N     P=0.134N     P=0.370N   |               P=0.500      P=0.500      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  18
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Subcutaneous Tissue                                                                                                        |
|     Neurofibrosarcoma, Fibrosarcoma, or Sarcoma                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    2/50 (4%)    0/50 (0%)    0/50 (0%)  |  1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)  |
|ADJUSTED (b)           |   9.1%         5.0%         0.0%         0.0%      |   2.4%         2.2%         2.6%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    2/40 (5%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    1/39 (3%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   658          729 (T)      ---          ---       |   687          612          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.057N     P=0.374N     P=0.126N     P=0.167N   |  P=0.301N     P=0.758      P=0.741N     P=0.495N   |
|INCIDENTAL TUMOR       |  P=0.038N*    P=0.622N     P=0.138N     P=0.106N   |  P=0.370N     P=0.593      P=0.712      P=0.718N   |
|LOGISTIC REGRESSION    |  P=0.042N*    P=0.469N     P=0.120N     P=0.126N   |  P=0.321N     P=0.751      P=0.759N     P=0.503N   |
|COCHRAN-ARMITAGE       |  P=0.039N*                                         |  P=0.311N                                          |
|FISHER EXACT           |               P=0.500N     P=0.121N     P=0.121N   |               P=0.753N     P=0.753N     P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    1/50 (2%)    0/49 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.1%         4.6%         3.6%         0.0%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    1/28 (4%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   587          610          729 (T)      ---       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.297N     P=0.541      P=0.751      P=0.508N   |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.241N     P=0.499      P=0.743N     P=0.443N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.229N     P=0.505      P=0.752N     P=0.425N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.248N                                          |    (e)                                             |
|FISHER EXACT           |               P=0.500      P=0.753N     P=0.505N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  19
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 47/50 (94%)  47/49 (96%)  45/48 (94%)  49/50 (98%) |                                                    |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |                                                    |
|TERMINAL (d)           | 28/28 (100%) 39/39 (100%) 26/26 (100%) 20/20 (100%)|                                                    |
|FIRST INCIDENCE (DAYS) |   534          420          540          486       |                                                    |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.002 **   P=0.016N*    P=0.518N     P=0.056    |                                                    |
|INCIDENTAL TUMOR       |  P=0.115      P=0.517N     P=0.599      P=0.190    |                                                    |
|LOGISTIC REGRESSION    |  P=0.176      P=0.519      P=0.582      P=0.239    |                                                    |
|COCHRAN-ARMITAGE       |  P=0.265                                           |                                                    |
|FISHER EXACT           |               P=0.510      P=0.641N     P=0.309    |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  4/50 (8%)    0/11 (0%)    0/23 (0%)    4/50 (8%)  |  6/50 (12%)   1/12 (8%)    1/13 (8%)    6/50 (12%) |
|ADJUSTED (b)           |  11.5%         0.0%         0.0%        13.4%      |  16.1%        33.3%         2.4%        15.0%      |
|TERMINAL (d)           |  2/28 (7%)    0/1 (0%)     0/1 (0%)     1/20 (5%)  |  3/32 (9%)    1/3 (33%)    0/2 (0%)     6/40 (15%) |
|FIRST INCIDENCE (DAYS) |   610          ---          ---          612       |   687          729 (T)      682          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.366      P=0.214N     P=0.226N     P=0.551    |  P=0.452N     P=0.350N     P=0.257N     P=0.486N   |
|INCIDENTAL TUMOR       |  P=0.531      P=0.368N     P=0.223N     P=0.598N   |  P=0.544      P=0.637      P=0.496N     P=0.563    |
|LOGISTIC REGRESSION    |  P=0.525      P=0.372N     P=0.188N     P=0.631N   |  P=0.511N     P=0.684      P=0.658N     P=0.597N   |
|COCHRAN-ARMITAGE       |  P=0.526                                           |  P=0.540                                           |
|FISHER EXACT           |               P=0.441N     P=0.212N     P=0.643N   |               P=0.591N     P=0.554N     P=0.620N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  20
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    1/11 (9%)    0/23 (0%)    1/50 (2%)  |  1/50 (2%)    2/12 (17%)   1/13 (8%)    0/50 (0%)  |
|ADJUSTED (b)           |   6.1%       100.0%         0.0%         3.6%      |   3.1%        34.9%        50.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    1/1 (100%)   0/1 (0%)     0/20 (0%)  |  1/32 (3%)    1/3 (33%)    1/2 (50%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   666          729 (T)      ---          708       |   729 (T)      694          729 (T)      ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.415N     P=0.567      P=0.460N     P=0.550N   |  P=0.176N     P=0.104      P=0.122      P=0.455N   |
|INCIDENTAL TUMOR       |  P=0.329N     P=0.323      P=0.501N     P=0.472N   |  P=0.218N     P=0.012 *    P=0.122      P=0.455N   |
|LOGISTIC REGRESSION    |  P=0.328N     P=0.362      P=0.464N     P=0.511N   |  P=0.202N     P=0.010 *    P=0.122      P=0.455N   |
|COCHRAN-ARMITAGE       |  P=0.311N                                          |  P=0.226N                                          |
|FISHER EXACT           |               P=0.455      P=0.466N     P=0.500N   |               P=0.093      P=0.373      P=0.500N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  5/50 (10%)   1/11 (9%)    0/23 (0%)    5/50 (10%) |  7/50 (14%)   3/12 (25%)   2/13 (15%)   6/50 (12%) |
|ADJUSTED (b)           |  14.9%       100.0%         0.0%        16.5%      |  19.0%        67.5%        51.2%        15.0%      |
|TERMINAL (d)           |  3/28 (11%)   1/1 (100%)   0/1 (0%)     1/20 (5%)  |  4/32 (13%)   2/3 (67%)    1/2 (50%)    6/40 (15%) |
|FIRST INCIDENCE (DAYS) |   610          729 (T)      ---          612       |   687          694          682          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.387      P=0.666N     P=0.218N     P=0.520    |  P=0.238N     P=0.532      P=0.564N     P=0.360N   |
|INCIDENTAL TUMOR       |  P=0.559      P=0.661      P=0.215N     P=0.592N   |  P=0.361N     P=0.054      P=0.551      P=0.548N   |
|LOGISTIC REGRESSION    |  P=0.569      P=0.670      P=0.154N     P=0.630N   |  P=0.297N     P=0.071      P=0.430      P=0.471N   |
|COCHRAN-ARMITAGE       |  P=0.564N                                          |  P=0.372N                                          |
|FISHER EXACT           |               P=0.706N     P=0.141N     P=0.630N   |               P=0.295      P=0.599      P=0.500N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  21
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/11 (0%)    1/23 (4%)    1/50 (2%)  |  1/50 (2%)    0/12 (0%)    0/13 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   3.0%         0.0%       100.0%         4.2%      |   3.1%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/1 (0%)     1/1 (100%)   0/20 (0%)  |  1/32 (3%)    0/3 (0%)     0/2 (0%)     2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   700          ---          729 (T)      718       |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.480      P=0.462N     P=0.542      P=0.721    |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|INCIDENTAL TUMOR       |  P=0.615      P=0.761N     P=0.499      P=0.698N   |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|LOGISTIC REGRESSION    |  P=0.577      P=0.882N     P=0.460      P=0.750    |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|COCHRAN-ARMITAGE       |  P=0.598                                           |  P=0.338                                           |
|FISHER EXACT           |               P=0.820N     P=0.534      P=0.753N   |               P=0.806N     P=0.794N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/11 (0%)    1/23 (4%)    2/50 (4%)  |  0/50 (0%)    0/12 (0%)    0/13 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         2.6%         5.2%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/1 (0%)     0/1 (0%)     0/20 (0%)  |  0/32 (0%)    0/3 (0%)     0/2 (0%)     0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          687          626       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.236      P=0.995N     P=0.551      P=0.454    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.375      P=0.995N     P=0.499      P=0.541    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.349      P=0.995N     P=0.494      P=0.515    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.349                                           |    (e)                                             |
|FISHER EXACT           |               P=0.820N     P=0.534      P=0.500    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  22
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  2/50 (4%)    0/11 (0%)    2/23 (9%)    3/50 (6%)  |  1/50 (2%)    0/12 (0%)    0/13 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |   6.5%         0.0%       100.0%         9.1%      |   3.1%         0.0%         0.0%         5.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/1 (0%)     1/1 (100%)   0/20 (0%)  |  1/32 (3%)    0/3 (0%)     0/2 (0%)     2/40 (5%)  |
|FIRST INCIDENCE (DAYS) |   700          ---          687          626       |   729 (T)      ---          ---          729 (T)   |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.207      P=0.438N     P=0.309      P=0.433    |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|INCIDENTAL TUMOR       |  P=0.394      P=0.716N     P=0.248      P=0.584    |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|LOGISTIC REGRESSION    |  P=0.357      P=0.810N     P=0.239      P=0.502    |  P=0.440      P=0.931N     P=0.970N     P=0.578    |
|COCHRAN-ARMITAGE       |  P=0.362                                           |  P=0.338                                           |
|FISHER EXACT           |               P=0.669N     P=0.374      P=0.500    |               P=0.806N     P=0.794N     P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.5%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          ---          ---       |   ---          ---          491          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |    (e)          (e)          (e)          (e)      |  P=0.603        (e)        P=0.254        (e)      |
|INCIDENTAL TUMOR       |    (e)          (e)          (e)          (e)      |  P=0.510        (e)        P=0.166        (e)      |
|LOGISTIC REGRESSION    |    (e)          (e)          (e)          (e)      |  P=0.528        (e)        P=0.171        (e)      |
|COCHRAN-ARMITAGE       |    (e)                                             |  P=0.591                                           |
|FISHER EXACT           |                 (e)          (e)          (e)      |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  23
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Tongue                                                                                                                           |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)  |
|ADJUSTED (b)           |   3.6%         0.0%         0.0%         0.0%      |   0.0%         0.0%         4.5%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   729 (T)      ---          ---          ---       |   ---          ---          491          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.603        (e)        P=0.254        (e)      |
|INCIDENTAL TUMOR       |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.510        (e)        P=0.166        (e)      |
|LOGISTIC REGRESSION    |  P=0.353N     P=0.429N     P=0.500N     P=0.567N   |  P=0.528        (e)        P=0.171        (e)      |
|COCHRAN-ARMITAGE       |  P=0.309N                                          |  P=0.591                                           |
|FISHER EXACT           |               P=0.500N     P=0.500N     P=0.500N   |                 (e)        P=0.247        (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 10/50 (20%)   7/50 (14%)   6/50 (12%)  10/50 (20%) |
|ADJUSTED (b)           |                                                    |  25.6%        16.5%        14.7%        23.4%      |
|TERMINAL (d)           |                                                    |  6/32 (19%)   6/41 (15%)   5/39 (13%)   8/40 (20%) |
|FIRST INCIDENCE (DAYS) |                                                    |   409          587          611          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.511N     P=0.189N     P=0.141N     P=0.449N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.529N     P=0.197N     P=0.149N     P=0.454N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.473      P=0.304N     P=0.221N     P=0.575    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.485                                           |
|FISHER EXACT           |                                                    |               P=0.298N     P=0.207N     P=0.598N   |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  24
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |                                                    |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |                                                    | 11/50 (22%)   7/50 (14%)   6/50 (12%)  11/50 (22%) |
|ADJUSTED (b)           |                                                    |  27.7%        16.5%        14.7%        25.0%      |
|TERMINAL (d)           |                                                    |  6/32 (19%)   6/41 (15%)   5/39 (13%)   8/40 (20%) |
|FIRST INCIDENCE (DAYS) |                                                    |   409          587          611          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |                                                    |  P=0.532N     P=0.131N     P=0.095N     P=0.445N   |
|INCIDENTAL TUMOR       |                                                    |  P=0.526      P=0.179N     P=0.117N     P=0.484N   |
|LOGISTIC REGRESSION    |                                                    |  P=0.440      P=0.222N     P=0.154N     P=0.563    |
|COCHRAN-ARMITAGE       |                                                    |  P=0.459                                           |
|FISHER EXACT           |                                                    |               P=0.218N     P=0.143N     P=0.595N   |
|=================================================================================================================================|
|                                                                                                                                 |
|Zymbal's Gland                                                                                                                   |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  0/50 (0%)    0/50 (0%)    2/50 (4%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   0.0%         0.0%         4.2%         9.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   ---          ---          575          624       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.021 *      (e)        P=0.237      P=0.103    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.089        (e)        P=0.265      P=0.185    |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.035 *      (e)        P=0.308      P=0.126    |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.027 *                                         |    (e)                                             |
|FISHER EXACT           |                 (e)        P=0.247      P=0.121    |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  25
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.1%         4.6%         7.1%         0.0%      |   0.0%         0.0%         0.0%         2.2%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    2/28 (7%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   587          610          729 (T)      ---       |   ---          ---          ---          611       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.373N     P=0.541      P=0.490      P=0.508N   |  P=0.196        (e)          (e)        P=0.496    |
|INCIDENTAL TUMOR       |  P=0.300N     P=0.499      P=0.518      P=0.419N   |  P=0.198        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.275N     P=0.505      P=0.504      P=0.416N   |  P=0.164        (e)          (e)        P=0.460    |
|COCHRAN-ARMITAGE       |  P=0.294N                                          |  P=0.197                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    2/50 (4%)    2/50 (4%)    0/50 (0%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)  |
|ADJUSTED (b)           |   2.1%         4.6%         7.1%         0.0%      |   0.0%         0.0%         0.0%         2.2%      |
|TERMINAL (d)           |  0/28 (0%)    1/40 (3%)    2/28 (7%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   587          610          729 (T)      ---       |   ---          ---          ---          611       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.373N     P=0.541      P=0.490      P=0.508N   |  P=0.196        (e)          (e)        P=0.496    |
|INCIDENTAL TUMOR       |  P=0.300N     P=0.499      P=0.518      P=0.419N   |  P=0.198        (e)          (e)        P=0.500    |
|LOGISTIC REGRESSION    |  P=0.275N     P=0.505      P=0.504      P=0.416N   |  P=0.164        (e)          (e)        P=0.460    |
|COCHRAN-ARMITAGE       |  P=0.294N                                          |  P=0.197                                           |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500N   |                 (e)          (e)        P=0.500    |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  26
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Leukemia: Lymphocytic, Monocytic, Mononuclear,                                                                              |
|     or Undifferentiated                                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 22/50 (44%)   6/50 (12%)   2/50 (4%)    1/50 (2%)  | 10/50 (20%)   1/50 (2%)    0/50 (0%)    2/50 (4%)  |
|ADJUSTED (b)           |  55.1%        12.9%         5.8%         2.6%      |  25.6%         2.4%         0.0%         4.7%      |
|TERMINAL (d)           | 11/28 (39%)   2/40 (5%)    1/28 (4%)    0/20 (0%)  |  4/32 (13%)   1/41 (2%)    0/39 (0%)    1/40 (3%)  |
|FIRST INCIDENCE (DAYS) |   610          420          610          658       |   686          729 (T)      ---          682       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |  P=0.006N**   P=0.003N**   P=0.001N**   P=0.010N*  |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.003N**   P<0.001N**   P<0.001N** |  P=0.023N*    P=0.044N*    P=0.004N**   P=0.073N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P<0.001N**   P<0.001N**   P<0.001N** |  P=0.007N**   P=0.005N**   P=0.001N**   P=0.014N*  |
|COCHRAN-ARMITAGE       |  P<0.001N**                                        |  P=0.007N**                                        |
|FISHER EXACT           |               P<0.001N**   P<0.001N**   P<0.001N** |               P=0.004N**   P<0.001N**   P=0.014N*  |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Mesothelioma Benign, Malignant, NOS                                                                                         |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  3/50 (6%)    1/50 (2%)    2/50 (4%)    3/50 (6%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   8.0%         2.5%         5.9%        11.5%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  1/28 (4%)    1/40 (3%)    1/28 (4%)    1/20 (5%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   553          729 (T)      682          690       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.356      P=0.239N     P=0.478N     P=0.590    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.548      P=0.359N     P=0.512N     P=0.617N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.482      P=0.316N     P=0.489N     P=0.646N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.473                                           |    (e)                                             |
|FISHER EXACT           |               P=0.309N     P=0.500N     P=0.661N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  27
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma                                                                                                                |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         4.7%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   690          ---          598          658       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.465      P=0.458N     P=0.527      P=0.742    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.578N     P=0.761N     P=0.485      P=0.698N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.528      P=0.505N     P=0.520      P=0.752N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.495                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.753N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Osteosarcoma or Osteoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |  1/50 (2%)    0/50 (0%)    2/50 (4%)    1/50 (2%)  |  0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)  |
|ADJUSTED (b)           |   2.9%         0.0%         4.7%         2.6%      |   0.0%         0.0%         0.0%         0.0%      |
|TERMINAL (d)           |  0/28 (0%)    0/40 (0%)    0/28 (0%)    0/20 (0%)  |  0/32 (0%)    0/41 (0%)    0/39 (0%)    0/40 (0%)  |
|FIRST INCIDENCE (DAYS) |   690          ---          598          658       |   ---          ---          ---          ---       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.465      P=0.458N     P=0.527      P=0.742    |    (e)          (e)          (e)          (e)      |
|INCIDENTAL TUMOR       |  P=0.578N     P=0.761N     P=0.485      P=0.698N   |    (e)          (e)          (e)          (e)      |
|LOGISTIC REGRESSION    |  P=0.528      P=0.505N     P=0.520      P=0.752N   |    (e)          (e)          (e)          (e)      |
|COCHRAN-ARMITAGE       |  P=0.495                                           |    (e)                                             |
|FISHER EXACT           |               P=0.500N     P=0.500      P=0.753N   |                 (e)          (e)          (e)      |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  28
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  50/50 (100%) 50/50 (100%) 49/50 (98%) | 44/50 (88%)  31/50 (62%)  32/50 (64%)  38/50 (76%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  91.6%        67.4%        71.1%        82.6%      |
|TERMINAL (d)           | 28/28 (100%) 40/40 (100%) 28/28 (100%) 20/20 (100%)| 28/32 (88%)  26/41 (63%)  26/39 (67%)  32/40 (80%) |
|FIRST INCIDENCE (DAYS) |   534          420          529          486       |   409          518          611          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.008 **   P=0.021N*    P=0.543      P=0.101    |  P=0.088N     P<0.001N**   P=0.002N**   P=0.014N*  |
|INCIDENTAL TUMOR       |  P=0.647      P=0.761      P=0.529      P=0.681    |  P=0.294N     P=0.006N**   P=0.004N**   P=0.079N   |
|LOGISTIC REGRESSION    |  P=0.621N     P=0.507      P=0.498      P=0.717    |  P=0.235N     P=0.002N**   P=0.003N**   P=0.071N   |
|COCHRAN-ARMITAGE       |  P=0.591N                                          |  P=0.277N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.753N   |               P=0.002N**   P=0.005N**   P=0.096N   |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 32/50 (64%)  22/50 (44%)  22/50 (44%)  16/50 (32%) | 17/50 (34%)  10/50 (20%)  14/50 (28%)   7/50 (14%) |
|ADJUSTED (b)           |  70.6%        45.5%        49.5%        42.7%      |  39.4%        22.0%        29.7%        15.8%      |
|TERMINAL (d)           | 15/28 (54%)  14/40 (35%)   8/28 (29%)   3/20 (15%) |  7/32 (22%)   6/41 (15%)   7/39 (18%)   4/40 (10%) |
|FIRST INCIDENCE (DAYS) |   553          420          529          567       |   158          390          429          519       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.081N     P=0.009N**   P=0.078N     P=0.046N*  |  P=0.024N*    P=0.054N     P=0.244N     P=0.012N*  |
|INCIDENTAL TUMOR       |  P<0.001N**   P=0.159N     P=0.030N*    P<0.001N** |  P=0.093N     P=0.415N     P=0.588N     P=0.077N   |
|LOGISTIC REGRESSION    |  P<0.001N**   P=0.065N     P=0.033N*    P<0.001N** |  P=0.034N*    P=0.093N     P=0.380N     P=0.020N*  |
|COCHRAN-ARMITAGE       |  P=0.002N**                                        |  P=0.030N*                                         |
|FISHER EXACT           |               P=0.035N*    P=0.035N*    P=0.001N** |               P=0.088N     P=0.333N     P=0.017N*  |
|=================================================================================================================================|
 
         DATE: 09/03/94                     EXPERIMENT: 05019 TEST: 03                                                 PAGE  29
                            STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- CI PIGMENT RED 3
 
                                                 TERMINAL SACRIFICE AT 105 WEEKS
 
|=================================================================================================================================|
|                       |                                                    |                                                    |
|                       |                       MALES                        |                      FEMALES                       |
|                       |                                                    |                                                    |
|DOSE                   |   UNTREATD     0.6%         1.25%        2.5%      |   UNTREATD     0.6%         1.25%        2.5%      |
|                       |   CONTROL                                          |   CONTROL                                          |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES            |    #            #            #            #        |    #            #            #            #        |
|-----------            |                                                    |                                                    |
|OVERALL (a)            | 49/50 (98%)  50/50 (100%) 50/50 (100%) 50/50 (100%)| 46/50 (92%)  35/50 (70%)  38/50 (76%)  41/50 (82%) |
|ADJUSTED (b)           | 100.0%       100.0%       100.0%       100.0%      |  92.0%        72.9%        76.0%        85.4%      |
|TERMINAL (d)           | 28/28 (100%) 40/40 (100%) 28/28 (100%) 20/20 (100%)| 28/32 (88%)  28/41 (68%)  27/39 (69%)  33/40 (83%) |
|FIRST INCIDENCE (DAYS) |   534          420          529          486       |   158          390          429          477       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |  P=0.005 **   P=0.021N*    P=0.543      P=0.080    |  P=0.125N     P=0.002N**   P=0.023N*    P=0.027N*  |
|INCIDENTAL TUMOR       |  P=0.252      P=0.761      P=0.529      P=0.443    |  P=0.473N     P=0.028N*    P=0.062N     P=0.222N   |
|LOGISTIC REGRESSION    |  P=0.302      P=0.507      P=0.498      P=0.493    |  P=0.333N     P=0.006N**   P=0.062N     P=0.115N   |
|COCHRAN-ARMITAGE       |  P=0.309                                           |  P=0.325N                                          |
|FISHER EXACT           |               P=0.500      P=0.500      P=0.500    |               P=0.005N**   P=0.027N*    P=0.117N   |
|=================================================================================================================================|
 
 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (d)  Observed incidence at terminal kill.
 (f)  Beneath the control incidence are the P-values associated with the trend 
      test.  Beneath the dosed group incidence are the P-values corresponding to 
      pairwise comparisons between the controls and that dosed group.  The life
      table analysis regards tumors in animals dying  prior to terminal kill as
      being (directly or indirectly) the cause of death.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's exact tests compare directly the overall incidence rates.  
      For all tests, a negative trend is indicated by "N".
 (e)  Value of Statistic cannot be computed. 
 (I)  Interim sacrifice
 (T)  Terminal sacrifice
  #   Tumor rates based on number of animals necropsied.
 
  *   To the right of any statistical result, indicates significance at (P<=0.05).
  **  To the right of any statistical result, indicates significance at (P<=0.01).
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.