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TDMS Study 05197-12 Pathology Tables


NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 02/18/98
EXPERIMENT: 05197 TEST: 12                                                                                     TIME: 09:11:28
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D
PATHOLOGIST: MILLER, RODNEY                                                                                    CAS: 111-76-0002
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
                                                 ----------------
                                                 Adrenal Gland
                                                 Adrenal Medulla
                                                 Bone Marrow
                                                 Brain
                                                 Clitoral Gland
                                                 Clitoral/Preputial 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: Battelle Northwest                                     2-BUTOXYETHANOL                                    DATE: 02/18/98     
EXPERIMENT: 05197 TEST: 12                                                                                     TIME: 09:11:28     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: NO1-ES-15318                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: 62077D     
PATHOLOGIST: MILLER, RODNEY                                                                                    CAS: 111-76-0002   
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF                 2-BUTOXYETHANOL
===============================================================
Male Mice
------------
Organ                                 Morphology
-----                                 ----------
Liver                                  Hemangiosarcoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Testes                                 Adenoma
All Organs                             Hemangiosarcoma
                                       Hemangiosarcoma or Hemangioma
                                       Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Liver                                  Hepatocellular Adenoma
Lung                                   Alveolar/Bronchiolar Adenoma
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland                          Carcinoma
Skin                                   Sarcoma
Stomach, Forestomach                   Squamous Cell Carcinoma or Papilloma Squamous
                                       Squamous Cell Papilloma
All Organs                             Benign Tumors
                                       Malignant and Benign Tumors
===============================================================
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 1
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/49 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         4.2%         5.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    1/39 (3%)    1/27 (4%)    0/26 (0%)   |0/29 (0%)    0/31 (0%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     729 (T)      670          583          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.251N     P=0.681N     P=0.583      P=0.331N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.207N     P=0.675N     P=0.653      P=0.267N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.192N     P=0.681N     P=0.668      P=0.257N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.225N     P=0.669N     P=0.631      P=0.279N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.177N     P=0.681N     P=0.675      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.164N     P=0.691N     P=0.684      P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    0/49 (0%)    0/49 (0%)   |3/50 (6%)    1/50 (2%)    1/49 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |7.0%         2.4%         2.4%         2.3%         |
|TERMINAL (d)       |     0/38 (0%)    0/39 (0%)    0/27 (0%)    0/25 (0%)   |2/29 (7%)    0/31 (0%)    1/33 (3%)    1/36 (3%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |713          592          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.203N     P=0.299N     P=0.268N     P=0.248N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.238N     P=0.311N     P=0.321N     P=0.297N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.240N     P=0.312N     P=0.324N     P=0.301N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.236N     P=0.304N     P=0.310N     P=0.291N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.237N     P=0.310N     P=0.292N     P=0.280N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.243N     P=0.309N     P=0.316N     P=0.309N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 2
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma: Benign, Complex, Malignant, NOS                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    1/50 (2%)    0/49 (0%)    0/49 (0%)   |3/50 (6%)    1/50 (2%)    1/49 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |7.0%         2.4%         2.4%         2.3%         |
|TERMINAL (d)       |     0/38 (0%)    0/39 (0%)    0/27 (0%)    0/25 (0%)   |2/29 (7%)    0/31 (0%)    1/33 (3%)    1/36 (3%)    |
|FIRST INCIDENCE    |     ---          549          ---          ---         |713          592          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.588N     P=0.508      (e)          (e)         |P=0.203N     P=0.299N     P=0.268N     P=0.248N     |
|POLY 3             |     P=0.578N     P=0.517      (e)          (e)         |P=0.238N     P=0.311N     P=0.321N     P=0.297N     |
|POLY 1.5           |     P=0.573N     P=0.512      (e)          (e)         |P=0.240N     P=0.312N     P=0.324N     P=0.301N     |
|POLY 6             |     P=0.587N     P=0.520      (e)          (e)         |P=0.236N     P=0.304N     P=0.310N     P=0.291N     |
|LOGISTIC REGRESSION|     P=0.430N     P=0.263      (e)          (e)         |P=0.237N     P=0.310N     P=0.292N     P=0.280N     |
|COCH-ARM / FISHERS |     P=0.568N     P=0.505      (e)          (e)         |P=0.243N     P=0.309N     P=0.316N     P=0.309N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/49 (0%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         5.0%        |2.3%         0.0%         2.4%         2.3%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    1/26 (4%)   |0/29 (0%)    0/31 (0%)    1/33 (3%)    1/36 (3%)    |
|FIRST INCIDENCE    |     ---          670          ---          454         |689          ---          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.102      P=0.529      (e)          P=0.185     |P=0.576      P=0.505N     P=0.743N     P=0.737N     |
|POLY 3             |     P=0.121      P=0.511      (e)          P=0.213     |P=0.551      P=0.506N     P=0.755      P=0.756N     |
|POLY 1.5           |     P=0.127      P=0.507      (e)          P=0.221     |P=0.547      P=0.505N     P=0.753      P=0.758N     |
|POLY 6             |     P=0.114      P=0.514      (e)          P=0.204     |P=0.554      P=0.504N     P=0.760      P=0.753N     |
|LOGISTIC REGRESSION|     P=0.200      P=0.460      (e)          P=0.292     |P=0.550      P=0.502N     P=0.759      P=0.757N     |
|COCH-ARM / FISHERS |     P=0.140      P=0.500      (e)          P=0.247     |P=0.539      P=0.500N     P=0.753N     P=0.753N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 3
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |4/50 (8%)    3/50 (6%)    2/50 (4%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     6.7%         6.4%         5.0%         5.1%        |9.3%         7.2%         4.8%         6.8%         |
|TERMINAL (d)       |     3/39 (8%)    3/39 (8%)    2/27 (7%)    2/26 (8%)   |4/29 (14%)   3/31 (10%)   2/33 (6%)    2/36 (6%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |731 (T)      731 (T)      731 (T)      656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.587N     P=0.664      P=0.665N     P=0.681     |P=0.319N     P=0.463N     P=0.277N     P=0.392N     |
|POLY 3             |     P=0.440N     P=0.640N     P=0.555N     P=0.559N    |P=0.405N     P=0.514N     P=0.348N     P=0.484N     |
|POLY 1.5           |     P=0.416N     P=0.647N     P=0.531N     P=0.540N    |P=0.412N     P=0.514N     P=0.352N     P=0.492N     |
|POLY 6             |     P=0.470N     P=0.634N     P=0.586N     P=0.582N    |P=0.396N     P=0.508N     P=0.335N     P=0.471N     |
|LOGISTIC REGRESSION|     P=0.587N     P=0.664      P=0.665N     P=0.681     |P=0.387N     P=0.463N     P=0.277N     P=0.474N     |
|COCH-ARM / FISHERS |     P=0.371N     P=0.661N     P=0.500N     P=0.500N    |P=0.420N     P=0.500N     P=0.339N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.3%         2.4%         2.4%         4.5%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    0/26 (0%)   |1/29 (3%)    1/31 (3%)    1/33 (3%)    0/36 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      731 (T)      731 (T)      656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.406      P=0.747N     P=0.733N     P=0.549      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.366      P=0.755      P=0.755      P=0.512      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.360      P=0.755      P=0.753      P=0.506      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.376      P=0.758      P=0.761N     P=0.522      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.358      P=0.747N     P=0.733N     P=0.497      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.351      P=0.753N     P=0.753N     P=0.500      |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 4
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |5/50 (10%)   4/50 (8%)    3/50 (6%)    4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     6.7%         6.4%         5.0%         5.1%        |11.6%        9.5%         7.1%         9.0%         |
|TERMINAL (d)       |     3/39 (8%)    3/39 (8%)    2/27 (7%)    2/26 (8%)   |5/29 (17%)   4/31 (13%)   3/33 (9%)    2/36 (6%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |731 (T)      731 (T)      731 (T)      656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.587N     P=0.664      P=0.665N     P=0.681     |P=0.314N     P=0.457N     P=0.284N     P=0.383N     |
|POLY 3             |     P=0.440N     P=0.640N     P=0.555N     P=0.559N    |P=0.408N     P=0.516N     P=0.369N     P=0.478N     |
|POLY 1.5           |     P=0.416N     P=0.647N     P=0.531N     P=0.540N    |P=0.418N     P=0.516N     P=0.374N     P=0.488N     |
|POLY 6             |     P=0.470N     P=0.634N     P=0.586N     P=0.582N    |P=0.393N     P=0.509N     P=0.354N     P=0.460N     |
|LOGISTIC REGRESSION|     P=0.587N     P=0.664      P=0.665N     P=0.681     |P=0.397N     P=0.457N     P=0.284N     P=0.479N     |
|COCH-ARM / FISHERS |     P=0.371N     P=0.661N     P=0.500N     P=0.500N    |P=0.430N     P=0.500N     P=0.357N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/47 (0%)    0/46 (0%)   |2/50 (4%)    1/50 (2%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         0.0%         0.0%         0.0%        |4.6%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    0/39 (0%)    0/27 (0%)    0/25 (0%)   |2/29 (7%)    1/31 (3%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     669          ---          ---          ---         |731 (T)      731 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.150N     P=0.227N     P=0.307N     P=0.308N    |P=0.080N     P=0.477N     P=0.210N     P=0.192N     |
|POLY 3             |     P=0.124N     P=0.228N     P=0.270N     P=0.284N    |P=0.100N     P=0.509N     P=0.242N     P=0.232N     |
|POLY 1.5           |     P=0.123N     P=0.231N     P=0.261N     P=0.275N    |P=0.100N     P=0.509N     P=0.245N     P=0.234N     |
|POLY 6             |     P=0.127N     P=0.226N     P=0.285N     P=0.295N    |P=0.099N     P=0.505N     P=0.236N     P=0.228N     |
|LOGISTIC REGRESSION|     P=0.126N     P=0.241N     P=0.259N     P=0.272N    |P=0.080N     P=0.477N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.123N     P=0.247N     P=0.263N     P=0.269N    |P=0.101N     P=0.500N     P=0.253N     P=0.247N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 5
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/47 (0%)    1/46 (2%)   |2/50 (4%)    1/50 (2%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         0.0%         0.0%         2.7%        |4.6%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    0/39 (0%)    0/27 (0%)    1/25 (4%)   |2/29 (7%)    1/31 (3%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     669          ---          ---          729 (T)     |731 (T)      731 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.566N     P=0.227N     P=0.307N     P=0.620N    |P=0.080N     P=0.477N     P=0.210N     P=0.192N     |
|POLY 3             |     P=0.495N     P=0.228N     P=0.270N     P=0.570N    |P=0.100N     P=0.509N     P=0.242N     P=0.232N     |
|POLY 1.5           |     P=0.490N     P=0.231N     P=0.261N     P=0.557N    |P=0.100N     P=0.509N     P=0.245N     P=0.234N     |
|POLY 6             |     P=0.501N     P=0.226N     P=0.285N     P=0.585N    |P=0.099N     P=0.505N     P=0.236N     P=0.228N     |
|LOGISTIC REGRESSION|     P=0.521N     P=0.241N     P=0.259N     P=0.571N    |P=0.080N     P=0.477N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.484N     P=0.247N     P=0.263N     P=0.532N    |P=0.101N     P=0.500N     P=0.253N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/49 (4%)    4/49 (8%)   |0/50 (0%)    1/50 (2%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         5.0%         10.0%       |0.0%         2.4%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    1/27 (4%)    2/26 (8%)   |0/29 (0%)    1/31 (3%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     ---          670          704          454         |---          731 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.009 **   P=0.529      P=0.170      P=0.037 *   |P=0.535N     P=0.513      (e)          (e)          |
|POLY 3             |     P=0.014 *    P=0.511      P=0.211      P=0.046 *   |P=0.569N     P=0.495      (e)          (e)          |
|POLY 1.5           |     P=0.016 *    P=0.507      P=0.220      P=0.049 *   |P=0.570N     P=0.495      (e)          (e)          |
|POLY 6             |     P=0.012 *    P=0.514      P=0.198      P=0.043 *   |P=0.566N     P=0.497      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.022 *    P=0.460      P=0.191      P=0.067     |(e)          P=0.513      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.021 *    P=0.500      P=0.242      P=0.056     |P=0.567N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 6
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     22/50 (44%)  18/50 (36%)  18/49 (37%)  17/49 (35%) |16/50 (32%)  8/50 (16%)   7/49 (14%)   8/50 (16%)   |
|POLY-3 ADJUSTED (b)|     48.6%        37.2%        43.8%        40.3%       |35.8%        18.7%        16.7%        18.0%        |
|TERMINAL (d)       |     21/39 (54%)  13/39 (33%)  14/27 (52%)  10/26 (39%) |9/29 (31%)   5/31 (16%)   6/33 (18%)   7/36 (19%)   |
|FIRST INCIDENCE    |     642          549          582          368         |586          456          715          582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.280      P=0.262N     P=0.347      P=0.446     |P=0.026N*    P=0.053N     P=0.020N*    P=0.023N*    |
|POLY 3             |     P=0.345N     P=0.180N     P=0.407N     P=0.283N    |P=0.048N*    P=0.057N     P=0.035N*    P=0.045N*    |
|POLY 1.5           |     P=0.313N     P=0.212N     P=0.355N     P=0.275N    |P=0.050N     P=0.055N     P=0.035N*    P=0.047N*    |
|POLY 6             |     P=0.382N     P=0.152N     P=0.485N     P=0.292N    |P=0.046N*    P=0.057N     P=0.033N*    P=0.044N*    |
|LOGISTIC REGRESSION|     P=0.410N     P=0.196N     P=0.586N     P=0.342N    |P=0.048N*    P=0.056N     P=0.031N*    P=0.045N*    |
|COCH-ARM / FISHERS |     P=0.235N     P=0.270N     P=0.298N     P=0.229N    |P=0.056N     P=0.050N     P=0.031N*    P=0.050N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     10/50 (20%)  11/50 (22%)  16/49 (33%)  21/49 (43%) |10/50 (20%)  12/50 (24%)  13/49 (27%)  10/50 (20%)  |
|POLY-3 ADJUSTED (b)|     20.8%        22.9%        35.9%        45.9%       |22.3%        27.5%        29.8%        21.9%        |
|TERMINAL (d)       |     3/39 (8%)    7/39 (18%)   5/27 (19%)   7/26 (27%)  |5/29 (17%)   5/31 (16%)   10/33 (30%)  5/36 (14%)   |
|FIRST INCIDENCE    |     374          621          430          312         |376          592          537          582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.534      P=0.060      P=0.007 **  |P=0.364N     P=0.435      P=0.402      P=0.460N     |
|POLY 3             |     P=0.002 **   P=0.500      P=0.080      P=0.007 **  |P=0.483N     P=0.375      P=0.288      P=0.583N     |
|POLY 1.5           |     P=0.002 **   P=0.502      P=0.094      P=0.008 **  |P=0.498N     P=0.375      P=0.279      P=0.593N     |
|POLY 6             |     P=0.002 **   P=0.492      P=0.063      P=0.006 **  |P=0.458N     P=0.395      P=0.312      P=0.561N     |
|LOGISTIC REGRESSION|     P=0.031 *    P=0.301      P=0.280      P=0.045 *   |P=0.511N     P=0.404      P=0.298      P=0.588      |
|COCH-ARM / FISHERS |     P=0.004 **   P=0.500      P=0.115      P=0.012 *   |P=0.514N     P=0.405      P=0.298      P=0.598N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 7
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     30/50 (60%)  24/50 (48%)  31/49 (63%)  30/49 (61%) |22/50 (44%)  16/50 (32%)  18/49 (37%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|     61.9%        48.9%        67.5%        64.8%       |47.8%        36.1%        41.2%        39.1%        |
|TERMINAL (d)       |     22/39 (56%)  17/39 (44%)  16/27 (59%)  14/26 (54%) |13/29 (45%)  8/31 (26%)   14/33 (42%)  12/36 (33%)  |
|FIRST INCIDENCE    |     374          549          430          312         |376          456          537          582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.024 *    P=0.174N     P=0.082      P=0.110     |P=0.170N     P=0.158N     P=0.188N     P=0.134N     |
|POLY 3             |     P=0.225      P=0.137N     P=0.362      P=0.469     |P=0.307N     P=0.175N     P=0.336N     P=0.260N     |
|POLY 1.5           |     P=0.242      P=0.143N     P=0.401      P=0.478     |P=0.318N     P=0.175N     P=0.339N     P=0.269N     |
|POLY 6             |     P=0.203      P=0.135N     P=0.309      P=0.450     |P=0.291N     P=0.163N     P=0.317N     P=0.241N     |
|LOGISTIC REGRESSION|     P=0.422      P=0.198N     P=0.503      P=0.567N    |P=0.317N     P=0.158N     P=0.311N     P=0.267N     |
|COCH-ARM / FISHERS |     P=0.306      P=0.158N     P=0.449      P=0.532     |P=0.331N     P=0.151N     P=0.298N     P=0.270N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     30/50 (60%)  24/50 (48%)  31/49 (63%)  30/49 (61%) |22/50 (44%)  16/50 (32%)  18/49 (37%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|     61.9%        48.9%        67.5%        64.8%       |47.8%        36.1%        41.2%        39.1%        |
|TERMINAL (d)       |     22/39 (56%)  17/39 (44%)  16/27 (59%)  14/26 (54%) |13/29 (45%)  8/31 (26%)   14/33 (42%)  12/36 (33%)  |
|FIRST INCIDENCE    |     374          549          430          312         |376          456          537          582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.024 *    P=0.174N     P=0.082      P=0.110     |P=0.170N     P=0.158N     P=0.188N     P=0.134N     |
|POLY 3             |     P=0.225      P=0.137N     P=0.362      P=0.469     |P=0.307N     P=0.175N     P=0.336N     P=0.260N     |
|POLY 1.5           |     P=0.242      P=0.143N     P=0.401      P=0.478     |P=0.318N     P=0.175N     P=0.339N     P=0.269N     |
|POLY 6             |     P=0.203      P=0.135N     P=0.309      P=0.450     |P=0.291N     P=0.163N     P=0.317N     P=0.241N     |
|LOGISTIC REGRESSION|     P=0.422      P=0.198N     P=0.503      P=0.567N    |P=0.317N     P=0.158N     P=0.311N     P=0.267N     |
|COCH-ARM / FISHERS |     P=0.306      P=0.158N     P=0.449      P=0.532     |P=0.331N     P=0.151N     P=0.298N     P=0.270N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 8
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocholangiocarcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/49 (0%)    0/49 (0%)   |2/50 (4%)    0/50 (0%)    0/49 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.2%         0.0%         0.0%         0.0%        |4.6%         0.0%         0.0%         2.2%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    0/26 (0%)   |1/29 (3%)    0/31 (0%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     459          ---          ---          ---         |577          ---          ---          489          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.322N     P=0.496N     P=0.508N     P=0.526N    |P=0.442N     P=0.237N     P=0.235N     P=0.475N     |
|POLY 3             |     P=0.306N     P=0.494N     P=0.528N     P=0.532N    |P=0.456N     P=0.245N     P=0.245N     P=0.491N     |
|POLY 1.5           |     P=0.305N     P=0.496N     P=0.518N     P=0.523N    |P=0.458N     P=0.244N     P=0.247N     P=0.495N     |
|POLY 6             |     P=0.307N     P=0.492N     P=0.542N     P=0.542N    |P=0.456N     P=0.244N     P=0.241N     P=0.485N     |
|LOGISTIC REGRESSION|     P=0.106N     P=0.933N     P=0.531N     P=0.328N    |P=0.474N     P=0.223N     P=0.229N     P=0.524N     |
|COCH-ARM / FISHERS |     P=0.308N     P=0.500N     P=0.505N     P=0.505N    |P=0.462N     P=0.247N     P=0.253N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     9/50 (18%)   7/50 (14%)   10/49 (20%)  8/50 (16%)  |7/50 (14%)   2/50 (4%)    4/50 (8%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     19.9%        14.7%        24.2%        19.5%       |16.3%        4.8%         9.5%         2.3%         |
|TERMINAL (d)       |     8/39 (21%)   6/39 (15%)   5/27 (19%)   4/26 (15%)  |7/29 (24%)   2/31 (7%)    2/33 (6%)    1/36 (3%)    |
|FIRST INCIDENCE    |     642          649          537          402         |731 (T)      731 (T)      715          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.246      P=0.383N     P=0.236      P=0.417     |P=0.020N*    P=0.061N     P=0.194N     P=0.014N*    |
|POLY 3             |     P=0.445      P=0.353N     P=0.413      P=0.591N    |P=0.032N*    P=0.083N     P=0.272N     P=0.027N*    |
|POLY 1.5           |     P=0.485      P=0.366N     P=0.443      P=0.564N    |P=0.033N*    P=0.084N     P=0.279N     P=0.029N*    |
|POLY 6             |     P=0.400      P=0.343N     P=0.373      P=0.590     |P=0.030N*    P=0.079N     P=0.254N     P=0.025N*    |
|LOGISTIC REGRESSION|     P=0.500      P=0.347N     P=0.415      P=0.574N    |P=0.026N*    P=0.061N     P=0.221N     P=0.014N*    |
|COCH-ARM / FISHERS |     P=0.527N     P=0.393N     P=0.480      P=0.500N    |P=0.038N*    P=0.080N     P=0.262N     P=0.030N*    |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 9
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   2/50 (4%)    3/49 (6%)    3/50 (6%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     11.1%        4.2%         7.6%         7.6%        |0.0%         4.7%         2.4%         0.0%         |
|TERMINAL (d)       |     5/39 (13%)   1/39 (3%)    3/27 (11%)   3/26 (12%)  |0/29 (0%)    1/31 (3%)    1/33 (3%)    0/36 (0%)    |
|FIRST INCIDENCE    |     729 (T)      649          729 (T)      729 (T)     |---          676          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.554      P=0.212N     P=0.569N     P=0.591N    |P=0.423N     P=0.247      P=0.526      (e)          |
|POLY 3             |     P=0.446N     P=0.195N     P=0.427N     P=0.429N    |P=0.455N     P=0.232      P=0.495      (e)          |
|POLY 1.5           |     P=0.419N     P=0.202N     P=0.400N     P=0.406N    |P=0.459N     P=0.232      P=0.494      (e)          |
|POLY 6             |     P=0.477N     P=0.188N     P=0.466N     P=0.459N    |P=0.447N     P=0.236      P=0.500      (e)          |
|LOGISTIC REGRESSION|     P=0.532N     P=0.196N     P=0.569N     P=0.591N    |P=0.452N     P=0.233      P=0.526      (e)          |
|COCH-ARM / FISHERS |     P=0.369N     P=0.218N     P=0.369N     P=0.357N    |P=0.461N     P=0.247      P=0.500      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     14/50 (28%)  8/50 (16%)   12/49 (24%)  11/50 (22%) |7/50 (14%)   4/50 (8%)    5/50 (10%)   1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     30.9%        16.9%        29.0%        26.9%       |16.3%        9.5%         11.9%        2.3%         |
|TERMINAL (d)       |     13/39 (33%)  7/39 (18%)   7/27 (26%)   7/26 (27%)  |7/29 (24%)   3/31 (10%)   3/33 (9%)    1/36 (3%)    |
|FIRST INCIDENCE    |     642          649          537          402         |731 (T)      676          715          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.248      P=0.108N     P=0.397      P=0.463     |P=0.017N*    P=0.224N     P=0.293N     P=0.014N*    |
|POLY 3             |     P=0.524      P=0.087N     P=0.515N     P=0.430N    |P=0.027N*    P=0.271N     P=0.394N     P=0.027N*    |
|POLY 1.5           |     P=0.520N     P=0.095N     P=0.478N     P=0.397N    |P=0.029N*    P=0.273N     P=0.401N     P=0.029N*    |
|POLY 6             |     P=0.472      P=0.081N     P=0.566N     P=0.472N    |P=0.026N*    P=0.261N     P=0.373N     P=0.025N*    |
|LOGISTIC REGRESSION|     P=0.520      P=0.083N     P=0.567N     P=0.459N    |P=0.024N*    P=0.256N     P=0.330N     P=0.014N*    |
|COCH-ARM / FISHERS |     P=0.423N     P=0.114N     P=0.433N     P=0.322N    |P=0.033N*    P=0.262N     P=0.380N     P=0.030N*    |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 10
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         2.4%         0.0%         6.7%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    0/26 (0%)   |0/29 (0%)    0/31 (0%)    0/33 (0%)    1/36 (3%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          694          ---          621          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.054      P=0.500      (e)          P=0.145      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.045 *    P=0.495      (e)          P=0.125      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.044 *    P=0.495      (e)          P=0.122      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.046 *    P=0.498      (e)          P=0.129      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.045 *    P=0.497      (e)          P=0.120      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.044 *    P=0.500      (e)          P=0.121      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |2/50 (4%)    1/49 (2%)    3/49 (6%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |4.6%         2.4%         7.3%         0.0%         |
|TERMINAL (d)       |                                                        |1/29 (3%)    1/31 (3%)    3/32 (9%)    0/35 (0%)    |
|FIRST INCIDENCE    |                                                        |721          731 (T)      731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.197N     P=0.485N     P=0.546      P=0.207N     |
|POLY 3             |                                                        |P=0.236N     P=0.514N     P=0.477      P=0.237N     |
|POLY 1.5           |                                                        |P=0.240N     P=0.515N     P=0.475      P=0.239N     |
|POLY 6             |                                                        |P=0.232N     P=0.508N     P=0.488      P=0.233N     |
|LOGISTIC REGRESSION|                                                        |P=0.223N     P=0.499N     P=0.518      P=0.228N     |
|COCH-ARM / FISHERS |                                                        |P=0.247N     P=0.508N     P=0.490      P=0.253N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 11
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Teratoma Benign                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |0/50 (0%)    0/49 (0%)    2/49 (4%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |0.0%         0.0%         4.8%         0.0%         |
|TERMINAL (d)       |                                                        |0/29 (0%)    0/31 (0%)    1/32 (3%)    0/35 (0%)    |
|FIRST INCIDENCE    |                                                        |---          ---          196          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.612      (e)          P=0.248      (e)          |
|POLY 3             |                                                        |P=0.607      (e)          P=0.231      (e)          |
|POLY 1.5           |                                                        |P=0.602      (e)          P=0.229      (e)          |
|POLY 6             |                                                        |P=0.612      (e)          P=0.237      (e)          |
|LOGISTIC REGRESSION|                                                        |P=0.604      (e)          P=0.372      (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.592      (e)          P=0.242      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    0/46 (0%)    0/48 (0%)   |5/50 (10%)   8/49 (16%)   8/48 (17%)   4/49 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |11.5%        19.6%        18.9%        9.2%         |
|TERMINAL (d)       |     0/38 (0%)    0/39 (0%)    0/27 (0%)    0/25 (0%)   |3/29 (10%)   8/30 (27%)   7/33 (21%)   2/35 (6%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |565          731 (T)      570          660          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.236N     P=0.289      P=0.343      P=0.425N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.334N     P=0.233      P=0.255      P=0.502N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.345N     P=0.240      P=0.246      P=0.507N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.316N     P=0.232      P=0.271      P=0.491N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.332N     P=0.248      P=0.252      P=0.508N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.359N     P=0.264      P=0.250      P=0.513N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 12
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/49 (0%)    0/46 (0%)    0/48 (0%)   |6/50 (12%)   8/49 (16%)   8/48 (17%)   4/49 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |13.7%        19.6%        18.9%        9.2%         |
|TERMINAL (d)       |     0/38 (0%)    0/39 (0%)    0/27 (0%)    0/25 (0%)   |3/29 (10%)   8/30 (27%)   7/33 (21%)   2/35 (6%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |565          731 (T)      570          660          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.170N     P=0.399      P=0.461      P=0.306N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.251N     P=0.335      P=0.361      P=0.372N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.260N     P=0.343      P=0.351      P=0.377N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.236N     P=0.334      P=0.381      P=0.361N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.249N     P=0.354      P=0.359      P=0.376N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.274N     P=0.371      P=0.355      P=0.383N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Sarcoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |3/50 (6%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |6.8%         4.6%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    0/26 (0%)   |0/29 (0%)    0/31 (0%)    0/33 (0%)    0/36 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |521          369          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.039N*    P=0.505N     P=0.124N     P=0.119N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.039N*    P=0.510N     P=0.127N     P=0.118N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.039N*    P=0.509N     P=0.127N     P=0.119N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.038N*    P=0.507N     P=0.125N     P=0.117N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.032N*    P=0.373N     P=0.095N     P=0.126N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.039N*    P=0.500N     P=0.121N     P=0.121N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 13
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Carcinoma or Papilloma Squamous                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    2/50 (4%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     2.2%         2.1%         5.0%         5.0%        |0.0%         2.4%         4.8%         13.4%        |
|TERMINAL (d)       |     1/39 (3%)    1/39 (3%)    2/27 (7%)    1/26 (4%)   |0/29 (0%)    1/31 (3%)    2/33 (6%)    4/36 (11%)   |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      402         |---          731 (T)      731 (T)      582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.212      P=0.762      P=0.372      P=0.400     |P=0.005 **   P=0.513      P=0.267      P=0.030 *    |
|POLY 3             |     P=0.285      P=0.750N     P=0.458      P=0.462     |P=0.002 **   P=0.495      P=0.231      P=0.017 *    |
|POLY 1.5           |     P=0.302      P=0.753N     P=0.477      P=0.474     |P=0.002 **   P=0.495      P=0.230      P=0.016 *    |
|POLY 6             |     P=0.266      P=0.747N     P=0.434      P=0.447     |P=0.003 **   P=0.497      P=0.237      P=0.019 *    |
|LOGISTIC REGRESSION|     P=0.348      P=0.762      P=0.372      P=0.570     |P=0.003 **   P=0.513      P=0.267      P=0.018 *    |
|COCH-ARM / FISHERS |     P=0.337      P=0.753N     P=0.500      P=0.500     |P=0.002 **   P=0.500      P=0.247      P=0.013 *    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Squamous Cell Papilloma                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    1/50 (2%)    2/50 (4%)    5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     2.2%         2.1%         5.0%         5.0%        |0.0%         2.4%         4.8%         11.2%        |
|TERMINAL (d)       |     1/39 (3%)    1/39 (3%)    2/27 (7%)    1/26 (4%)   |0/29 (0%)    1/31 (3%)    2/33 (6%)    3/36 (8%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      402         |---          731 (T)      731 (T)      582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.212      P=0.762      P=0.372      P=0.400     |P=0.013 *    P=0.513      P=0.267      P=0.049 *    |
|POLY 3             |     P=0.285      P=0.750N     P=0.458      P=0.462     |P=0.008 **   P=0.495      P=0.231      P=0.034 *    |
|POLY 1.5           |     P=0.302      P=0.753N     P=0.477      P=0.474     |P=0.007 **   P=0.495      P=0.230      P=0.032 *    |
|POLY 6             |     P=0.266      P=0.747N     P=0.434      P=0.447     |P=0.008 **   P=0.497      P=0.237      P=0.036 *    |
|LOGISTIC REGRESSION|     P=0.348      P=0.762      P=0.372      P=0.570     |P=0.008 **   P=0.513      P=0.267      P=0.033 *    |
|COCH-ARM / FISHERS |     P=0.337      P=0.753N     P=0.500      P=0.500     |P=0.007 **   P=0.500      P=0.247      P=0.028 *    |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 14
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/49 (0%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         5.1%        |                                                    |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    0/27 (0%)    2/26 (8%)   |                                                    |
|FIRST INCIDENCE    |     ---          ---          ---          729 (T)     |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.024 *    (e)          (e)          P=0.154     |                                                    |
|POLY 3             |     P=0.039 *    (e)          (e)          P=0.209     |                                                    |
|POLY 1.5           |     P=0.041 *    (e)          (e)          P=0.218     |                                                    |
|POLY 6             |     P=0.037 *    (e)          (e)          P=0.199     |                                                    |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          P=0.154     |                                                    |
|COCH-ARM / FISHERS |     P=0.047 *    (e)          (e)          P=0.247     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/48 (2%)    1/49 (2%)    1/50 (2%)   |1/50 (2%)    2/50 (4%)    5/50 (10%)   1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     4.4%         2.2%         2.5%         2.5%        |2.3%         4.8%         11.9%        2.3%         |
|TERMINAL (d)       |     2/39 (5%)    1/38 (3%)    1/27 (4%)    0/26 (0%)   |1/29 (3%)    1/31 (3%)    5/33 (15%)   1/35 (3%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      604         |731 (T)      712          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.536N     P=0.509N     P=0.628N     P=0.601N    |P=0.538N     P=0.515      P=0.132      P=0.720N     |
|POLY 3             |     P=0.446N     P=0.497N     P=0.543N     P=0.541N    |P=0.581      P=0.492      P=0.095      P=0.761N     |
|POLY 1.5           |     P=0.432N     P=0.503N     P=0.527N     P=0.529N    |P=0.573      P=0.492      P=0.094      P=0.758      |
|POLY 6             |     P=0.462N     P=0.492N     P=0.567N     P=0.556N    |P=0.591      P=0.496      P=0.100      P=0.757N     |
|LOGISTIC REGRESSION|     P=0.451N     P=0.509N     P=0.628N     P=0.518N    |P=0.587N     P=0.500      P=0.132      P=0.720N     |
|COCH-ARM / FISHERS |     P=0.406N     P=0.515N     P=0.508N     P=0.500N    |P=0.560      P=0.500      P=0.102      P=0.747      |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 15
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/48 (2%)    1/49 (2%)    1/50 (2%)   |1/50 (2%)    3/50 (6%)    5/50 (10%)   1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     4.4%         2.2%         2.5%         2.5%        |2.3%         7.1%         11.9%        2.3%         |
|TERMINAL (d)       |     2/39 (5%)    1/38 (3%)    1/27 (4%)    0/26 (0%)   |1/29 (3%)    2/31 (7%)    5/33 (15%)   1/35 (3%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      604         |731 (T)      712          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.536N     P=0.509N     P=0.628N     P=0.601N    |P=0.462N     P=0.324      P=0.132      P=0.720N     |
|POLY 3             |     P=0.446N     P=0.497N     P=0.543N     P=0.541N    |P=0.537N     P=0.296      P=0.095      P=0.761N     |
|POLY 1.5           |     P=0.432N     P=0.503N     P=0.527N     P=0.529N    |P=0.544N     P=0.297      P=0.094      P=0.758      |
|POLY 6             |     P=0.462N     P=0.492N     P=0.567N     P=0.556N    |P=0.526N     P=0.301      P=0.100      P=0.757N     |
|LOGISTIC REGRESSION|     P=0.451N     P=0.509N     P=0.628N     P=0.518N    |P=0.513N     P=0.305      P=0.132      P=0.720N     |
|COCH-ARM / FISHERS |     P=0.406N     P=0.515N     P=0.508N     P=0.500N    |P=0.554N     P=0.309      P=0.102      P=0.747      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |0.0%         0.0%         4.8%         0.0%         |
|TERMINAL (d)       |                                                        |0/29 (0%)    0/31 (0%)    2/33 (6%)    0/36 (0%)    |
|FIRST INCIDENCE    |                                                        |---          ---          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.637      (e)          P=0.267      (e)          |
|POLY 3             |                                                        |P=0.614      (e)          P=0.231      (e)          |
|POLY 1.5           |                                                        |P=0.608      (e)          P=0.230      (e)          |
|POLY 6             |                                                        |P=0.621      (e)          P=0.237      (e)          |
|LOGISTIC REGRESSION|                                                        |(e)          (e)          P=0.267      (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.595      (e)          P=0.247      (e)          |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 16
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |1/50 (2%)    2/50 (4%)    4/50 (8%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|                                                        |2.3%         4.8%         9.5%         4.5%         |
|TERMINAL (d)       |                                                        |1/29 (3%)    2/31 (7%)    3/33 (9%)    2/36 (6%)    |
|FIRST INCIDENCE    |                                                        |731 (T)      731 (T)      723          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.480      P=0.523      P=0.223      P=0.576      |
|POLY 3             |                                                        |P=0.406      P=0.491      P=0.171      P=0.508      |
|POLY 1.5           |                                                        |P=0.399      P=0.491      P=0.169      P=0.504      |
|POLY 6             |                                                        |P=0.416      P=0.495      P=0.178      P=0.514      |
|LOGISTIC REGRESSION|                                                        |P=0.438      P=0.523      P=0.199      P=0.576      |
|COCH-ARM / FISHERS |                                                        |P=0.387      P=0.500      P=0.181      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Sarcoma Stromal or Polyp Stromal                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |1/50 (2%)    2/50 (4%)    4/50 (8%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|                                                        |2.3%         4.8%         9.5%         4.5%         |
|TERMINAL (d)       |                                                        |1/29 (3%)    2/31 (7%)    3/33 (9%)    2/36 (6%)    |
|FIRST INCIDENCE    |                                                        |731 (T)      731 (T)      723          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.480      P=0.523      P=0.223      P=0.576      |
|POLY 3             |                                                        |P=0.406      P=0.491      P=0.171      P=0.508      |
|POLY 1.5           |                                                        |P=0.399      P=0.491      P=0.169      P=0.504      |
|POLY 6             |                                                        |P=0.416      P=0.495      P=0.178      P=0.514      |
|LOGISTIC REGRESSION|                                                        |P=0.438      P=0.523      P=0.199      P=0.576      |
|COCH-ARM / FISHERS |                                                        |P=0.387      P=0.500      P=0.181      P=0.500      |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 17
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |3/50 (6%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         5.0%         0.0%        |6.9%         0.0%         4.7%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/39 (0%)    2/27 (7%)    0/26 (0%)   |1/29 (3%)    0/31 (0%)    1/33 (3%)    0/36 (0%)    |
|FIRST INCIDENCE    |     ---          ---          729 (T)      ---         |572          ---          591          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.502      (e)          P=0.162      (e)         |P=0.113N     P=0.126N     P=0.485N     P=0.110N     |
|POLY 3             |     P=0.525      (e)          P=0.211      (e)         |P=0.118N     P=0.126N     P=0.513N     P=0.117N     |
|POLY 1.5           |     P=0.545      (e)          P=0.222      (e)         |P=0.120N     P=0.125N     P=0.516N     P=0.118N     |
|POLY 6             |     P=0.504      (e)          P=0.197      (e)         |P=0.116N     P=0.125N     P=0.503N     P=0.115N     |
|LOGISTIC REGRESSION|     (e)          (e)          P=0.162      (e)         |P=0.125N     P=0.115N     P=0.489N     P=0.124N     |
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.125N     P=0.121N     P=0.500N     P=0.121N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    2/50 (4%)    5/50 (10%)  |2/50 (4%)    2/50 (4%)    3/50 (6%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.2%         2.1%         5.0%         12.4%       |4.6%         4.7%         7.1%         2.3%         |
|TERMINAL (d)       |     1/39 (3%)    0/39 (0%)    1/27 (4%)    3/26 (12%)  |1/29 (3%)    1/31 (3%)    3/33 (9%)    1/36 (3%)    |
|FIRST INCIDENCE    |     729 (T)      670          704          454         |689          670          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.009 **   P=0.745N     P=0.382      P=0.049 *   |P=0.339N     P=0.678N     P=0.549      P=0.450N     |
|POLY 3             |     P=0.019 *    P=0.749N     P=0.459      P=0.079     |P=0.392N     P=0.686      P=0.487      P=0.493N     |
|POLY 1.5           |     P=0.022 *    P=0.753N     P=0.477      P=0.085     |P=0.397N     P=0.685      P=0.484      P=0.496N     |
|POLY 6             |     P=0.016 *    P=0.745N     P=0.436      P=0.071     |P=0.386N     P=0.690      P=0.497      P=0.488N     |
|LOGISTIC REGRESSION|     P=0.025 *    P=0.760      P=0.416      P=0.099     |P=0.385N     P=0.688      P=0.509      P=0.486N     |
|COCH-ARM / FISHERS |     P=0.029 *    P=0.753N     P=0.500      P=0.102     |P=0.404N     P=0.691N     P=0.500      P=0.500N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 18
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    4/50 (8%)    5/50 (10%)  |5/50 (10%)   2/50 (4%)    5/50 (10%)   1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.2%         2.1%         10.0%        12.4%       |11.4%        4.7%         11.8%        2.3%         |
|TERMINAL (d)       |     1/39 (3%)    0/39 (0%)    3/27 (11%)   3/26 (12%)  |2/29 (7%)    1/31 (3%)    4/33 (12%)   1/36 (3%)    |
|FIRST INCIDENCE    |     729 (T)      670          704          454         |572          670          591          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.009 **   P=0.745N     P=0.092      P=0.049 *   |P=0.101N     P=0.216N     P=0.583N     P=0.084N     |
|POLY 3             |     P=0.020 *    P=0.749N     P=0.145      P=0.079     |P=0.124N     P=0.231N     P=0.611      P=0.100N     |
|POLY 1.5           |     P=0.023 *    P=0.753N     P=0.159      P=0.085     |P=0.126N     P=0.229N     P=0.607      P=0.101N     |
|POLY 6             |     P=0.017 *    P=0.745N     P=0.127      P=0.071     |P=0.122N     P=0.230N     P=0.623      P=0.098N     |
|LOGISTIC REGRESSION|     P=0.025 *    P=0.760      P=0.105      P=0.099     |P=0.129N     P=0.221N     P=0.618      P=0.103N     |
|COCH-ARM / FISHERS |     P=0.033 *    P=0.753N     P=0.181      P=0.102     |P=0.132N     P=0.218N     P=0.630N     P=0.102N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         0.0%         0.0%         5.0%        |2.3%         2.4%         4.7%         0.0%         |
|TERMINAL (d)       |     1/39 (3%)    0/39 (0%)    0/27 (0%)    0/26 (0%)   |1/29 (3%)    0/31 (0%)    1/33 (3%)    0/36 (0%)    |
|FIRST INCIDENCE    |     729 (T)      ---          ---          629         |731 (T)      606          666          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.178      P=0.500N     P=0.573N     P=0.402     |P=0.334N     P=0.756N     P=0.536      P=0.457N     |
|POLY 3             |     P=0.222      P=0.490N     P=0.524N     P=0.459     |P=0.357N     P=0.757      P=0.493      P=0.495N     |
|POLY 1.5           |     P=0.230      P=0.494N     P=0.513N     P=0.471     |P=0.361N     P=0.756      P=0.490      P=0.498N     |
|POLY 6             |     P=0.214      P=0.488N     P=0.538N     P=0.445     |P=0.352N     P=0.760N     P=0.504      P=0.492N     |
|LOGISTIC REGRESSION|     P=0.234      (e)          (e)          P=0.483     |P=0.366N     P=0.759N     P=0.494      (e)          |
|COCH-ARM / FISHERS |     P=0.246      P=0.500N     P=0.500N     P=0.500     |P=0.366N     P=0.753N     P=0.500      P=0.500N     |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 19
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    0/50 (0%)    0/50 (0%)   |7/50 (14%)   9/50 (18%)   10/50 (20%)  7/50 (14%)   |
|POLY-3 ADJUSTED (b)|     2.2%         6.3%         0.0%         0.0%        |16.1%        20.8%        23.0%        15.2%        |
|TERMINAL (d)       |     0/39 (0%)    1/39 (3%)    0/27 (0%)    0/26 (0%)   |5/29 (17%)   5/31 (16%)   5/33 (15%)   3/36 (8%)    |
|FIRST INCIDENCE    |     621          611          ---          ---         |572          544          397          437          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.208N     P=0.330      P=0.546N     P=0.524N    |P=0.387N     P=0.425      P=0.381      P=0.503N     |
|POLY 3             |     P=0.179N     P=0.324      P=0.526N     P=0.527N    |P=0.448N     P=0.384      P=0.292      P=0.568N     |
|POLY 1.5           |     P=0.168N     P=0.318      P=0.514N     P=0.518N    |P=0.474N     P=0.379      P=0.282      P=0.587N     |
|POLY 6             |     P=0.196N     P=0.329      P=0.541N     P=0.539N    |P=0.417N     P=0.402      P=0.317      P=0.543N     |
|LOGISTIC REGRESSION|     P=0.129N     P=0.219      P=0.458N     P=0.461N    |P=0.516N     P=0.376      P=0.283      P=0.598      |
|COCH-ARM / FISHERS |     P=0.153N     P=0.309      P=0.500N     P=0.500N    |P=0.513N     P=0.393      P=0.298      P=0.613N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     30/50 (60%)  28/50 (56%)  26/50 (52%)  28/50 (56%) |31/50 (62%)  23/50 (46%)  27/50 (54%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|     65.9%        57.2%        60.2%        63.4%       |67.4%        53.0%        61.3%        39.8%        |
|TERMINAL (d)       |     28/39 (72%)  21/39 (54%)  17/27 (63%)  17/26 (65%) |19/29 (66%)  18/31 (58%)  22/33 (67%)  14/36 (39%)  |
|FIRST INCIDENCE    |     642          549          537          368         |565          456          196          582          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.047 *    P=0.394N     P=0.205      P=0.091     |P=0.002N**   P=0.075N     P=0.149N     P=0.003N**   |
|POLY 3             |     P=0.534N     P=0.252N     P=0.361N     P=0.487N    |P=0.007N**   P=0.112N     P=0.345N     P=0.005N**   |
|POLY 1.5           |     P=0.496N     P=0.313N     P=0.321N     P=0.482N    |P=0.008N**   P=0.101N     P=0.334N     P=0.006N**   |
|POLY 6             |     P=0.507      P=0.195N     P=0.415N     P=0.492N    |P=0.006N**   P=0.123N     P=0.345N     P=0.005N**   |
|LOGISTIC REGRESSION|     P=0.410      P=0.286N     P=0.588      P=0.526     |P=0.008N**   P=0.095N     P=0.333N     P=0.005N**   |
|COCH-ARM / FISHERS |     P=0.386N     P=0.420N     P=0.273N     P=0.420N    |P=0.013N*    P=0.080N     P=0.272N     P=0.008N**   |
|=================================================================================================================================|
       Date:  02/18/98                           EXPERIMENT: 05197 TEST: 12                                            Page 20
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -                  2-BUTOXYETHANOL
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     19/50 (38%)  16/50 (32%)  19/50 (38%)  28/50 (56%) |27/50 (54%)  26/50 (52%)  28/50 (56%)  22/50 (44%)  |
|POLY-3 ADJUSTED (b)|     38.6%        32.4%        42.4%        59.4%       |56.9%        56.4%        60.2%        45.3%        |
|TERMINAL (d)       |     10/39 (26%)  8/39 (21%)   7/27 (26%)   12/26 (46%) |12/29 (41%)  12/31 (39%)  17/33 (52%)  11/36 (31%)  |
|FIRST INCIDENCE    |     374          549          430          312         |376          369          72           437          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P=0.320N     P=0.263      P=0.012 *   |P=0.105N     P=0.461N     P=0.495N     P=0.129N     |
|POLY 3             |     P=0.008 **   P=0.332N     P=0.435      P=0.031 *   |P=0.132N     P=0.563N     P=0.456      P=0.172N     |
|POLY 1.5           |     P=0.010 *    P=0.334N     P=0.496      P=0.036 *   |P=0.151N     P=0.559N     P=0.454      P=0.189N     |
|POLY 6             |     P=0.005 **   P=0.331N     P=0.362      P=0.024 *   |P=0.113N     P=0.538N     P=0.479      P=0.149N     |
|LOGISTIC REGRESSION|     P=0.086      P=0.529N     P=0.357N     P=0.138     |P=0.196N     P=0.499N     P=0.516      P=0.234N     |
|COCH-ARM / FISHERS |     P=0.018 *    P=0.338N     P=0.582N     P=0.054     |P=0.188N     P=0.500N     P=0.500      P=0.212N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     CONTROL      62.5 PPM     125 PPM      250 PPM     |CONTROL      62.5 PPM     125 PPM      250 PPM      |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     42/50 (84%)  33/50 (66%)  36/50 (72%)  41/50 (82%) |43/50 (86%)  38/50 (76%)  38/50 (76%)  35/50 (70%)  |
|POLY-3 ADJUSTED (b)|     84.9%        66.4%        76.1%        85.3%       |87.7%        81.1%        80.0%        71.0%        |
|TERMINAL (d)       |     32/39 (82%)  24/39 (62%)  18/27 (67%)  21/26 (81%) |24/29 (83%)  23/31 (74%)  26/33 (79%)  22/36 (61%)  |
|FIRST INCIDENCE    |     374          549          430          312         |376          369          72           437          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.009 **   P=0.070N     P=0.253      P=0.045 *   |P=0.023N*    P=0.212N     P=0.125N     P=0.029N*    |
|POLY 3             |     P=0.278      P=0.025N*    P=0.192N     P=0.596     |P=0.023N*    P=0.268N     P=0.219N     P=0.033N*    |
|POLY 1.5           |     P=0.306      P=0.027N*    P=0.156N     P=0.608N    |P=0.029N*    P=0.236N     P=0.194N     P=0.037N*    |
|POLY 6             |     P=0.242      P=0.024N*    P=0.242N     P=0.563     |P=0.018N*    P=0.274N     P=0.241N     P=0.027N*    |
|LOGISTIC REGRESSION|     P=0.448      P=0.044N*    P=0.108N     P=0.529N    |P=0.047N*    P=0.187N     P=0.160N     P=0.049N*    |
|COCH-ARM / FISHERS |     P=0.411      P=0.032N*    P=0.114N     P=0.500N    |P=0.050N     P=0.154N     P=0.154N     P=0.045N*    |
|=================================================================================================================================|
(a)  Number of tumor-bearing animals /  number of animals examined at site.
(b)  Poly-3 adjusted lifetime tumor incidence.
(d)  Observed incidence at terminal kill.
(f)  Beneath the control incidence are the P-values associated with the trend 
test.  Beneath the dosed group incidence are the P-values corresponding to 
pairwise comparisons between the controls and that dosed group.  The life
table analysis regards tumors in animals dying prior to  terminal kill as
 being (directly or indirectly) the cause of death.
Logistic regression is an alternative
 method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e)  Value of Statistic cannot be computed.
(I)  Interim sacrifice
(T)  Terminal sacrifice
#   Tumor rates based on number of animals necropsied.
*   To the right of any statistical result, indicates significance at (P<=0.05).
**  To the right of any statistical result, indicates significance at (P<=0.01).