Skip to Main Navigation
Skip to Page Content
Share This:
https://ntp.niehs.nih.gov/go/1553

TDMS Study 05162-10 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/19/97

EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 12:11:41
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D
PATHOLOGIST: PERSING, R.                                                                                       CAS: 111-42-2
            

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 Columbus                                       DIETHANOLAMINE                                    DATE: 06/19/97     
EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 12:11:41     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D     
PATHOLOGIST: PERSING, R.                                                                                       CAS: 111-42-2      



SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF             DIETHANOLAMINE
===============================================================

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex                         Adenoma
Kidney: Renal Tubule                   Adenoma
                                       Carcinoma or Adenoma
Liver                                  Hepatoblastoma
                                       Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatoblastoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung                                   Alveolar/Bronchiolar Adenoma
                                       Alveolar/Bronchiolar Carcinoma
                                       Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs                             Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Liver                                  Hepatocellular Adenoma
                                       Hepatocellular Carcinoma
                                       Hepatocellular Carcinoma or Hepatoblastoma
                                       Hepatocellular Carcinoma or Hepatocellular Adenoma
                                       Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Pituitary Gland: Pars Distalis or UnspeAdenomaSite
Thyroid Gland: Follicular Cell         Adenoma
All Organs                             Hemangiosarcoma or Hemangioma
                                       Malignant Lymphoma And Histiocytic Sarcoma
                                       Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
                                       Benign Tumors
                                       Malignant Tumors
                                       Malignant and Benign Tumors
===============================================================
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 1
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)        -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   9/50 (18%)   1/50 (2%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     10.9%        18.7%        2.2%         4.6%        |0.0%         0.0%         0.0%         2.3%         |
|TERMINAL (d)       |     4/40 (10%)   9/43 (21%)   1/34 (3%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    1/23 (4%)    |
|FIRST INCIDENCE    |     678          729 (T)      729 (T)      729 (T)     |---          ---          ---          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.110N     P=0.237      P=0.141N     P=0.330N    |P=0.131      (e)          (e)          P=0.371      |
|POLY 3             |     P=0.051N     P=0.219      P=0.106N     P=0.234N    |P=0.192      (e)          (e)          P=0.478      |
|POLY 1.5           |     P=0.048N*    P=0.210      P=0.103N     P=0.228N    |P=0.196      (e)          (e)          P=0.488      |
|POLY 6             |     P=0.055N     P=0.228      P=0.111N     P=0.243N    |P=0.183      (e)          (e)          P=0.461      |
|LOGISTIC REGRESSION|     P=0.069N     P=0.237      P=0.112N     P=0.242N    |(e)          (e)          (e)          P=0.371      |
|COCH-ARM / FISHERS |     P=0.047N*    P=0.194      P=0.102N     P=0.218N    |P=0.198      (e)          (e)          P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Pheochromocytoma Benign                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/49 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.2%         0.0%         2.3%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |2/44 (5%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      ---          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.293N     P=0.304N     P=0.600N     P=0.390N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.183N     P=0.276N     P=0.531N     P=0.263N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.183N     P=0.261N     P=0.518N     P=0.251N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.188N     P=0.291N     P=0.549N     P=0.284N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.293N     (e)          P=0.600N     (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.188N     P=0.247N     P=0.500N     P=0.247N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 2
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         4.4%         0.0%        |2.1%         2.4%         2.3%         4.6%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    1/34 (3%)    0/30 (0%)   |1/44 (2%)    0/33 (0%)    1/33 (3%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          729 (T)      558          ---         |731 (T)      649          731 (T)      726          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.638      P=0.514      P=0.224      (e)         |P=0.205      P=0.701      P=0.696      P=0.285      |
|POLY 3             |     P=0.634N     P=0.510      P=0.237      (e)         |P=0.328      P=0.724      P=0.740      P=0.461      |
|POLY 1.5           |     P=0.628N     P=0.506      P=0.238      (e)         |P=0.341      P=0.738      P=0.749      P=0.479      |
|POLY 6             |     P=0.642N     P=0.514      P=0.233      (e)         |P=0.303      P=0.711      P=0.728      P=0.433      |
|LOGISTIC REGRESSION|     P=0.583N     P=0.514      P=0.221      (e)         |P=0.320      P=0.767N     P=0.696      P=0.341      |
|COCH-ARM / FISHERS |     P=0.616N     P=0.500      P=0.247      (e)         |P=0.351      P=0.753N     P=0.753N     P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Harderian Gland                                                                                                                  |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |1/50 (2%)    2/50 (4%)    1/50 (2%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         4.4%         2.3%        |2.1%         4.8%         2.3%         6.9%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    1/34 (3%)    1/30 (3%)   |1/44 (2%)    0/33 (0%)    1/33 (3%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          729 (T)      558          729 (T)     |731 (T)      424          731 (T)      606          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.293      P=0.514      P=0.224      P=0.443     |P=0.140      P=0.433      P=0.696      P=0.153      |
|POLY 3             |     P=0.343      P=0.510      P=0.237      P=0.492     |P=0.212      P=0.452      P=0.740      P=0.270      |
|POLY 1.5           |     P=0.351      P=0.506      P=0.238      P=0.495     |P=0.225      P=0.470      P=0.749      P=0.286      |
|POLY 6             |     P=0.333      P=0.514      P=0.233      P=0.489     |P=0.190      P=0.435      P=0.728      P=0.245      |
|LOGISTIC REGRESSION|     P=0.384      P=0.514      P=0.221      P=0.443     |P=0.240      P=0.760N     P=0.696      P=0.326      |
|COCH-ARM / FISHERS |     P=0.366      P=0.500      P=0.247      P=0.500     |P=0.237      P=0.500      P=0.753N     P=0.309      |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 3
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Jejunum                                                                                                         |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         6.6%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    2/34 (6%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          631          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.478      (e)          P=0.106      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.505      (e)          P=0.117      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.516      (e)          P=0.119      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.490      (e)          P=0.114      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.544      (e)          P=0.121      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.539      (e)          P=0.121      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small: Site Unspecified                                                                                                |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         6.6%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    2/34 (6%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          631          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.478      (e)          P=0.106      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.505      (e)          P=0.117      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.516      (e)          P=0.119      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.490      (e)          P=0.114      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.544      (e)          P=0.121      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.539      (e)          P=0.121      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 4
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    4/50 (8%)    6/50 (12%)   6/50 (12%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         8.3%         13.1%        13.3%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    3/43 (7%)    3/34 (9%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      692          654          540         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.028 *    P=0.207      P=0.047 *    P=0.042 *   |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.049 *    P=0.196      P=0.056      P=0.053     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.051      P=0.189      P=0.057      P=0.054     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.047 *    P=0.202      P=0.054      P=0.053     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.058      P=0.197      P=0.058      P=0.061     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.056      P=0.181      P=0.056      P=0.056     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         2.1%         0.0%         4.6%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/40 (5%)    1/43 (2%)    0/34 (0%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          729 (T)     |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.482      P=0.475N     P=0.275N     P=0.588     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.574      P=0.483N     P=0.240N     P=0.680     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.580      P=0.489N     P=0.238N     P=0.684     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.566      P=0.476N     P=0.245N     P=0.674     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.482      P=0.475N     (e)          P=0.588     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.591      P=0.500N     P=0.247N     P=0.691N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 5
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Carcinoma or Adenoma                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    5/50 (10%)   6/50 (12%)   8/50 (16%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     6.6%         10.4%        13.1%        17.8%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/40 (8%)    4/43 (9%)    3/34 (9%)    4/30 (13%)  |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      692          654          540         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.030 *    P=0.400      P=0.193      P=0.056     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.064      P=0.386      P=0.242      P=0.093     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.067      P=0.375      P=0.244      P=0.095     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.061      P=0.398      P=0.237      P=0.092     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.068      P=0.396      P=0.238      P=0.096     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.073      P=0.357      P=0.243      P=0.100     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         4.4%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          729 (T)      583          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.651N     P=0.514      P=0.237      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.634N     P=0.510      P=0.238      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.628N     P=0.506      P=0.238      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.642N     P=0.514      P=0.235      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.562N     P=0.514      P=0.206      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.616N     P=0.500      P=0.247      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 6
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatoblastoma                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    8/50 (16%)   5/50 (10%)  |0/50 (0%)    2/50 (4%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         4.2%         17.5%        11.3%       |0.0%         4.8%         2.3%         2.3%         |
|TERMINAL (d)       |     0/40 (0%)    2/43 (5%)    4/34 (12%)   2/30 (7%)   |0/44 (0%)    1/33 (3%)    1/33 (3%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          729 (T)      633          684         |---          421          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010 *    P=0.254      P=0.004 **   P=0.023 *   |P=0.370      P=0.206      P=0.443      P=0.371      |
|POLY 3             |     P=0.018 *    P=0.249      P=0.004 **   P=0.028 *   |P=0.446      P=0.207      P=0.482      P=0.478      |
|POLY 1.5           |     P=0.019 *    P=0.244      P=0.004 **   P=0.029 *   |P=0.471      P=0.218      P=0.490      P=0.488      |
|POLY 6             |     P=0.016 *    P=0.253      P=0.003 **   P=0.027 *   |P=0.407      P=0.196      P=0.472      P=0.461      |
|LOGISTIC REGRESSION|     P=0.021 *    P=0.254      P=0.005 **   P=0.030 *   |P=0.509      P=0.451      P=0.443      P=0.371      |
|COCH-ARM / FISHERS |     P=0.026 *    P=0.247      P=0.003 **   P=0.028 *   |P=0.500      P=0.247      P=0.500      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Adenoma                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     31/50 (62%)  42/50 (84%)  49/50 (98%)  45/50 (90%) |32/50 (64%)  50/50 (100%) 48/50 (96%)  48/50 (96%)  |
|POLY-3 ADJUSTED (b)|     65.0%        86.5%        98.0%        93.5%       |66.1%        100.0%       96.4%        96.4%        |
|TERMINAL (d)       |     28/40 (70%)  40/43 (93%)  33/34 (97%)  28/30 (93%) |30/44 (68%)  33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE    |     411          641          445          386         |674          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.037 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.009 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.009 **   P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.010 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.022 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.012 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 7
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     12/50 (24%)  17/50 (34%)  33/50 (66%)  34/50 (68%) |5/50 (10%)   19/50 (38%)  38/50 (76%)  42/50 (84%)  |
|POLY-3 ADJUSTED (b)|     25.1%        34.9%        66.9%        72.3%       |10.4%        43.4%        77.9%        84.9%        |
|TERMINAL (d)       |     6/40 (15%)   13/43 (30%)  20/34 (59%)  20/30 (67%) |4/44 (9%)    12/33 (36%)  26/33 (79%)  18/23 (78%)  |
|FIRST INCIDENCE    |     485          576          445          446         |729          423          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.275      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.206      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.201      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.208      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.147      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.189      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatoblastoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     12/50 (24%)  18/50 (36%)  34/50 (68%)  34/50 (68%) |5/50 (10%)   20/50 (40%)  39/50 (78%)  43/50 (86%)  |
|POLY-3 ADJUSTED (b)|     25.1%        36.9%        68.9%        72.3%       |10.4%        44.9%        79.9%        86.9%        |
|TERMINAL (d)       |     6/40 (15%)   14/43 (33%)  20/34 (59%)  20/30 (67%) |4/44 (9%)    12/33 (36%)  27/33 (82%)  19/23 (83%)  |
|FIRST INCIDENCE    |     485          576          445          446         |729          421          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.217      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.151      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.147      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.152      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.106      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.138      P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 8
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma or Hepatocellular Adenoma                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     39/50 (78%)  47/50 (94%)  50/50 (100%) 49/50 (98%) |33/50 (66%)  50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)|     79.0%        95.3%        100.0%       99.9%       |68.2%        100.0%       100.0%       100.0%       |
|TERMINAL (d)       |     31/40 (78%)  41/43 (95%)  34/34 (100%) 30/30 (100%)|31/44 (71%)  33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE    |     411          576          445          386         |674          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.208      P=0.003 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.015 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.025 *    P<0.001 **   P=0.002 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.020 *    P<0.001 **   P=0.002 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatocellular Carcinoma, Hepatocellular Adenoma,                                                                           |
|     or Hepatoblastoma                                                                                                           |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     39/50 (78%)  47/50 (94%)  50/50 (100%) 49/50 (98%) |33/50 (66%)  50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)|     79.0%        95.3%        100.0%       99.9%       |68.2%        100.0%       100.0%       100.0%       |
|TERMINAL (d)       |     31/40 (78%)  41/43 (95%)  34/34 (100%) 30/30 (100%)|31/44 (71%)  33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE    |     411          576          445          386         |674          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.208      P=0.003 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.015 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.025 *    P<0.001 **   P=0.002 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.020 *    P<0.001 **   P=0.002 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 9
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Adenoma                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     11/50 (22%)  15/50 (30%)  10/50 (20%)  4/50 (8%)   |4/50 (8%)    1/50 (2%)    2/50 (4%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     24.1%        30.9%        21.8%        9.1%        |8.3%         2.4%         4.5%         2.3%         |
|TERMINAL (d)       |     11/40 (28%)  12/43 (28%)  7/34 (21%)   4/30 (13%)  |4/44 (9%)    1/33 (3%)    2/33 (6%)    1/23 (4%)    |
|FIRST INCIDENCE    |     729 (T)      670          641          729 (T)     |731 (T)      731 (T)      731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.076N     P=0.325      P=0.548      P=0.130N    |P=0.349N     P=0.275N     P=0.476N     P=0.417N     |
|POLY 3             |     P=0.020N*    P=0.304      P=0.496N     P=0.051N    |P=0.169N     P=0.233N     P=0.379N     P=0.215N     |
|POLY 1.5           |     P=0.018N*    P=0.281      P=0.495N     P=0.049N*   |P=0.164N     P=0.212N     P=0.361N     P=0.198N     |
|POLY 6             |     P=0.024N*    P=0.333      P=0.504N     P=0.054N    |P=0.183N     P=0.256N     P=0.405N     P=0.244N     |
|LOGISTIC REGRESSION|     P=0.024N*    P=0.317      P=0.532N     P=0.130N    |P=0.349N     P=0.275N     P=0.476N     P=0.417N     |
|COCH-ARM / FISHERS |     P=0.016N*    P=0.247      P=0.500N     P=0.045N*   |P=0.165N     P=0.181N     P=0.339N     P=0.181N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   1/50 (2%)    3/50 (6%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     10.9%        2.1%         6.7%         0.0%        |4.1%         2.4%         4.5%         0.0%         |
|TERMINAL (d)       |     4/40 (10%)   1/43 (2%)    3/34 (9%)    0/30 (0%)   |1/44 (2%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     678          729 (T)      729 (T)      ---         |659          418          684          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.067N     P=0.089N     P=0.440N     P=0.059N    |P=0.279N     P=0.566N     P=0.605      P=0.342N     |
|POLY 3             |     P=0.042N*    P=0.091N     P=0.367N     P=0.034N*   |P=0.218N     P=0.552N     P=0.661      P=0.264N     |
|POLY 1.5           |     P=0.040N*    P=0.095N     P=0.361N     P=0.033N*   |P=0.208N     P=0.532N     P=0.675      P=0.252N     |
|POLY 6             |     P=0.045N*    P=0.088N     P=0.381N     P=0.036N*   |P=0.239N     P=0.572N     P=0.641      P=0.286N     |
|LOGISTIC REGRESSION|     P=0.045N*    P=0.090N     P=0.385N     P=0.037N*   |P=0.184N     P=0.232N     P=0.682N     P=0.204N     |
|COCH-ARM / FISHERS |     P=0.037N*    P=0.102N     P=0.357N     P=0.028N*   |P=0.200N     P=0.500N     P=0.691N     P=0.247N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 10
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar                                                                      |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     15/50 (30%)  16/50 (32%)  12/50 (24%)  4/50 (8%)   |6/50 (12%)   2/50 (4%)    4/50 (8%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     32.7%        33.0%        26.2%        9.1%        |12.4%        4.8%         9.0%         2.3%         |
|TERMINAL (d)       |     14/40 (35%)  13/43 (30%)  9/34 (27%)   4/30 (13%)  |5/44 (11%)   1/33 (3%)    3/33 (9%)    1/23 (4%)    |
|FIRST INCIDENCE    |     678          670          641          729 (T)     |659          418          684          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.020N*    P=0.570N     P=0.494N     P=0.025N*   |P=0.189N     P=0.232N     P=0.543N     P=0.208N     |
|POLY 3             |     P=0.003N**   P=0.574      P=0.324N     P=0.005N**  |P=0.075N     P=0.187N     P=0.428N     P=0.078N     |
|POLY 1.5           |     P=0.003N**   P=0.546      P=0.322N     P=0.005N**  |P=0.069N     P=0.165N     P=0.403N     P=0.067N     |
|POLY 6             |     P=0.004N**   P=0.568N     P=0.335N     P=0.006N**  |P=0.089N     P=0.213N     P=0.463N     P=0.097N     |
|LOGISTIC REGRESSION|     P=0.004N**   P=0.582N     P=0.359N     P=0.009N**  |P=0.068N     P=0.094N     P=0.433N     P=0.090N     |
|COCH-ARM / FISHERS |     P=0.002N**   P=0.500      P=0.326N     P=0.005N**  |P=0.066N     P=0.134N     P=0.370N     P=0.056N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Carcinoma                                                                                                                   |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.1%         0.0%         4.5%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |1/44 (2%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      ---          626          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.572N     P=0.557N     P=0.418      P=0.629N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.472N     P=0.532N     P=0.472      P=0.522N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.464N     P=0.520N     P=0.484      P=0.512N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.493N     P=0.545N     P=0.456      P=0.539N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.462N     (e)          P=0.533      (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.461N     P=0.500N     P=0.500      P=0.500N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 11
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cystadenoma                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |2/49 (4%)    0/50 (0%)    0/49 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |4.2%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |                                                        |2/43 (5%)    0/33 (0%)    0/32 (0%)    0/22 (0%)    |
|FIRST INCIDENCE    |                                                        |731 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.172N     P=0.298N     P=0.306N     P=0.395N     |
|POLY 3             |                                                        |P=0.102N     P=0.271N     P=0.258N     P=0.264N     |
|POLY 1.5           |                                                        |P=0.106N     P=0.256N     P=0.249N     P=0.251N     |
|POLY 6             |                                                        |P=0.099N     P=0.286N     P=0.271N     P=0.285N     |
|LOGISTIC REGRESSION|                                                        |P=0.172N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.115N     P=0.242N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |3/49 (6%)    0/50 (0%)    0/49 (0%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|                                                        |6.4%         0.0%         0.0%         2.4%         |
|TERMINAL (d)       |                                                        |3/43 (7%)    0/33 (0%)    0/32 (0%)    0/22 (0%)    |
|FIRST INCIDENCE    |                                                        |731 (T)      ---          ---          721          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.392N     P=0.172N     P=0.178N     P=0.550N     |
|POLY 3             |                                                        |P=0.228N     P=0.147N     P=0.136N     P=0.347N     |
|POLY 1.5           |                                                        |P=0.234N     P=0.134N     P=0.128N     P=0.328N     |
|POLY 6             |                                                        |P=0.226N     P=0.160N     P=0.147N     P=0.380N     |
|LOGISTIC REGRESSION|                                                        |P=0.331N     (e)          (e)          P=0.462N     |
|COCH-ARM / FISHERS |                                                        |P=0.249N     P=0.117N     P=0.121N     P=0.309N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 12
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis or Unspecified Site                                                                               |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/48 (0%)    0/47 (0%)    0/46 (0%)    0/43 (0%)   |7/50 (14%)   0/50 (0%)    3/47 (6%)    1/44 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |14.5%        0.0%         7.3%         2.6%         |
|TERMINAL (d)       |     0/39 (0%)    0/40 (0%)    0/31 (0%)    0/27 (0%)   |6/44 (14%)   0/33 (0%)    3/31 (10%)   1/20 (5%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |674          ---          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.165N     P=0.024N*    P=0.325N     P=0.188N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.052N     P=0.015N*    P=0.231N     P=0.065N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.051N     P=0.012N*    P=0.210N     P=0.056N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.057N     P=0.019N*    P=0.262N     P=0.083N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.096N     P=0.018N*    P=0.265N     P=0.086N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.057N     P=0.006N**   P=0.185N     P=0.044N*    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Intermedia                                                                                                 |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/48 (2%)    0/47 (0%)    0/46 (0%)    2/43 (5%)   |1/50 (2%)    0/50 (0%)    0/47 (0%)    0/44 (0%)    |
|POLY-3 ADJUSTED (b)|     2.3%         0.0%         0.0%         5.3%        |2.1%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/39 (0%)    0/40 (0%)    0/31 (0%)    2/27 (7%)   |0/44 (0%)    0/33 (0%)    0/31 (0%)    0/20 (0%)    |
|FIRST INCIDENCE    |     716          ---          ---          729 (T)     |659          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.176      P=0.486N     P=0.532N     P=0.397     |P=0.334N     P=0.557N     P=0.541N     P=0.552N     |
|POLY 3             |     P=0.210      P=0.497N     P=0.513N     P=0.442     |P=0.302N     P=0.534N     P=0.532N     P=0.549N     |
|POLY 1.5           |     P=0.214      P=0.500N     P=0.511N     P=0.448     |P=0.309N     P=0.521N     P=0.524N     P=0.538N     |
|POLY 6             |     P=0.206      P=0.495N     P=0.519N     P=0.435     |P=0.294N     P=0.546N     P=0.544N     P=0.565N     |
|LOGISTIC REGRESSION|     P=0.194      P=0.500N     P=0.515N     P=0.428     |P=0.311N     P=0.442N     P=0.437N     P=0.448N     |
|COCH-ARM / FISHERS |     P=0.221      P=0.505N     P=0.511N     P=0.458     |P=0.321N     P=0.500N     P=0.515N     P=0.532N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 13
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma,                                                                        |
|     or Fibrous Histiocytoma                                                                                                     |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    3/50 (6%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         2.1%         2.2%         2.3%        |2.1%         7.3%         4.5%         0.0%         |
|TERMINAL (d)       |     2/40 (5%)    1/43 (2%)    1/34 (3%)    0/30 (0%)   |1/44 (2%)    2/33 (6%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      660         |731 (T)      691          684          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.500N     P=0.475N     P=0.557N     P=0.569N    |P=0.386N     P=0.212      P=0.415      P=0.629N     |
|POLY 3             |     P=0.425N     P=0.483N     P=0.505N     P=0.511N    |P=0.287N     P=0.251      P=0.470      P=0.522N     |
|POLY 1.5           |     P=0.419N     P=0.489N     P=0.502N     P=0.508N    |P=0.265N     P=0.271      P=0.483      P=0.512N     |
|POLY 6             |     P=0.432N     P=0.476N     P=0.513N     P=0.516N    |P=0.324N     P=0.233      P=0.454      P=0.539N     |
|LOGISTIC REGRESSION|     P=0.427N     P=0.475N     P=0.557N     P=0.508N    |P=0.277N     P=0.232      P=0.476      (e)          |
|COCH-ARM / FISHERS |     P=0.409N     P=0.500N     P=0.500N     P=0.500N    |P=0.242N     P=0.309      P=0.500      P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    3/50 (6%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         0.0%         2.2%         0.0%        |0.0%         7.3%         2.3%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    1/34 (3%)    0/30 (0%)   |0/44 (0%)    2/33 (6%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      ---         |---          691          684          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.472N     P=0.486N     P=0.725      P=0.557N    |P=0.482N     P=0.078      P=0.467      (e)          |
|POLY 3             |     P=0.419N     P=0.490N     P=0.757      P=0.508N    |P=0.426N     P=0.093      P=0.483      (e)          |
|POLY 1.5           |     P=0.414N     P=0.494N     P=0.759      P=0.505N    |P=0.399N     P=0.102      P=0.490      (e)          |
|POLY 6             |     P=0.425N     P=0.486N     P=0.753      P=0.511N    |P=0.465N     P=0.085      P=0.473      (e)          |
|LOGISTIC REGRESSION|     P=0.472N     (e)          P=0.725      (e)         |P=0.385N     P=0.087      P=0.537      (e)          |
|COCH-ARM / FISHERS |     P=0.405N     P=0.500N     P=0.753N     P=0.500N    |P=0.366N     P=0.121      P=0.500      (e)          |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 14
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |1/50 (2%)    3/50 (6%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         0.0%         2.2%         0.0%        |2.1%         7.3%         2.3%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    1/34 (3%)    0/30 (0%)   |1/44 (2%)    2/33 (6%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      ---         |731 (T)      691          684          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.472N     P=0.486N     P=0.725      P=0.557N    |P=0.312N     P=0.212      P=0.709      P=0.629N     |
|POLY 3             |     P=0.419N     P=0.490N     P=0.757      P=0.508N    |P=0.237N     P=0.251      P=0.741      P=0.522N     |
|POLY 1.5           |     P=0.414N     P=0.494N     P=0.759      P=0.505N    |P=0.219N     P=0.271      P=0.750      P=0.512N     |
|POLY 6             |     P=0.425N     P=0.486N     P=0.753      P=0.511N    |P=0.265N     P=0.233      P=0.730      P=0.539N     |
|LOGISTIC REGRESSION|     P=0.472N     (e)          P=0.725      (e)         |P=0.223N     P=0.232      P=0.768N     (e)          |
|COCH-ARM / FISHERS |     P=0.405N     P=0.500N     P=0.753N     P=0.500N    |P=0.200N     P=0.309      P=0.753N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    4/50 (8%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         8.2%         0.0%         0.0%        |4.2%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    2/43 (5%)    0/34 (0%)    0/30 (0%)   |2/44 (5%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     678          499          ---          ---         |731 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.154N     P=0.209      P=0.510N     P=0.510N    |P=0.170N     P=0.304N     P=0.304N     P=0.390N     |
|POLY 3             |     P=0.127N     P=0.200      P=0.504N     P=0.509N    |P=0.102N     P=0.276N     P=0.258N     P=0.263N     |
|POLY 1.5           |     P=0.125N     P=0.192      P=0.501N     P=0.506N    |P=0.106N     P=0.261N     P=0.249N     P=0.251N     |
|POLY 6             |     P=0.131N     P=0.208      P=0.509N     P=0.513N    |P=0.099N     P=0.291N     P=0.270N     P=0.284N     |
|LOGISTIC REGRESSION|     P=0.092N     P=0.096      P=0.502N     P=0.493N    |P=0.170N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.125N     P=0.181      P=0.500N     P=0.500N    |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 15
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         4.4%         4.6%        |                                                    |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    2/34 (6%)    2/30 (7%)   |                                                    |
|FIRST INCIDENCE    |     596          ---          729 (T)      729 (T)     |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.343      P=0.227N     P=0.649      P=0.615     |                                                    |
|POLY 3             |     P=0.415      P=0.228N     P=0.685      P=0.676     |                                                    |
|POLY 1.5           |     P=0.425      P=0.232N     P=0.690      P=0.682     |                                                    |
|POLY 6             |     P=0.403      P=0.226N     P=0.675      P=0.668     |                                                    |
|LOGISTIC REGRESSION|     P=0.435      P=0.282N     P=0.695N     P=0.694     |                                                    |
|COCH-ARM / FISHERS |     P=0.444      P=0.247N     P=0.691N     P=0.691N    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Adenoma                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    5/49 (10%)   4/50 (8%)    2/50 (4%)   |4/50 (8%)    9/50 (18%)   7/50 (14%)   3/49 (6%)    |
|POLY-3 ADJUSTED (b)|     8.8%         10.6%        8.8%         4.6%        |8.3%         22.0%        15.7%        7.1%         |
|TERMINAL (d)       |     4/40 (10%)   5/42 (12%)   3/34 (9%)    2/30 (7%)   |4/44 (9%)    9/33 (27%)   6/33 (18%)   3/23 (13%)   |
|FIRST INCIDENCE    |     729 (T)      729 (T)      667          729 (T)     |731 (T)      731 (T)      600          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.370N     P=0.531      P=0.560      P=0.476N    |P=0.457      P=0.037 *    P=0.132      P=0.468      |
|POLY 3             |     P=0.243N     P=0.518      P=0.638      P=0.355N    |P=0.355N     P=0.063      P=0.217      P=0.571N     |
|POLY 1.5           |     P=0.234N     P=0.507      P=0.642      P=0.349N    |P=0.314N     P=0.080      P=0.236      P=0.543N     |
|POLY 6             |     P=0.255N     P=0.530      P=0.629      P=0.363N    |P=0.429N     P=0.049 *    P=0.194      P=0.614N     |
|LOGISTIC REGRESSION|     P=0.271N     P=0.531      P=0.619      P=0.476N    |P=0.434N     P=0.037 *    P=0.202      P=0.468      |
|COCH-ARM / FISHERS |     P=0.218N     P=0.487      P=0.643N     P=0.339N    |P=0.274N     P=0.117      P=0.262      P=0.511N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 16
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus                                                                                                                           |
|     Polyp Stromal                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |3/50 (6%)    2/50 (4%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|                                                        |6.2%         4.8%         4.5%         0.0%         |
|TERMINAL (d)       |                                                        |3/44 (7%)    1/33 (3%)    2/33 (6%)    0/23 (0%)    |
|FIRST INCIDENCE    |                                                        |731 (T)      418          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.179N     P=0.603N     P=0.630N     P=0.256N     |
|POLY 3             |                                                        |P=0.098N     P=0.565N     P=0.541N     P=0.140N     |
|POLY 1.5           |                                                        |P=0.092N     P=0.540N     P=0.523N     P=0.130N     |
|POLY 6             |                                                        |P=0.112N     P=0.590N     P=0.564N     P=0.158N     |
|LOGISTIC REGRESSION|                                                        |P=0.082N     P=0.404N     P=0.630N     (e)          |
|COCH-ARM / FISHERS |                                                        |P=0.086N     P=0.500N     P=0.500N     P=0.121N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangioma                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |3/50 (6%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |6.2%         0.0%         0.0%         4.6%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |3/44 (7%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      ---          ---          701          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.552      P=0.176N     P=0.176N     P=0.618      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.509N     P=0.151N     P=0.136N     P=0.549N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.515N     P=0.138N     P=0.128N     P=0.526N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.507N     P=0.165N     P=0.146N     P=0.585N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.599N     (e)          (e)          P=0.619N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.531N     P=0.121N     P=0.121N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 17
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma                                                                                                             |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    3/50 (6%)    1/50 (2%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         8.2%         6.5%         2.3%        |4.2%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    2/43 (5%)    0/34 (0%)    1/30 (3%)   |2/44 (5%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     674          499          583          729 (T)     |731 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.352N     P=0.376      P=0.487      P=0.544N    |P=0.170N     P=0.304N     P=0.304N     P=0.390N     |
|POLY 3             |     P=0.320N     P=0.366      P=0.500      P=0.516N    |P=0.102N     P=0.276N     P=0.258N     P=0.263N     |
|POLY 1.5           |     P=0.310N     P=0.356      P=0.502      P=0.511N    |P=0.106N     P=0.261N     P=0.249N     P=0.251N     |
|POLY 6             |     P=0.335N     P=0.376      P=0.495      P=0.526N    |P=0.099N     P=0.291N     P=0.270N     P=0.284N     |
|LOGISTIC REGRESSION|     P=0.211N     P=0.217      P=0.476      P=0.500N    |P=0.170N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.292N     P=0.339      P=0.500      P=0.500N    |P=0.115N     P=0.247N     P=0.247N     P=0.247N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Hemangiosarcoma or Hemangioma                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    3/50 (6%)    1/50 (2%)   |5/50 (10%)   0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     4.3%         8.2%         6.5%         2.3%        |10.4%        0.0%         0.0%         4.6%         |
|TERMINAL (d)       |     0/40 (0%)    2/43 (5%)    0/34 (0%)    1/30 (3%)   |5/44 (11%)   0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     674          499          583          729 (T)     |731 (T)      ---          ---          701          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.352N     P=0.376      P=0.487      P=0.544N    |P=0.364N     P=0.064N     P=0.064N     P=0.498N     |
|POLY 3             |     P=0.320N     P=0.366      P=0.500      P=0.516N    |P=0.176N     P=0.047N*    P=0.039N*    P=0.263N     |
|POLY 1.5           |     P=0.310N     P=0.356      P=0.502      P=0.511N    |P=0.181N     P=0.040N*    P=0.035N*    P=0.241N     |
|POLY 6             |     P=0.335N     P=0.376      P=0.495      P=0.526N    |P=0.175N     P=0.055N     P=0.045N*    P=0.300N     |
|LOGISTIC REGRESSION|     P=0.211N     P=0.217      P=0.476      P=0.500N    |P=0.270N     (e)          (e)          P=0.348N     |
|COCH-ARM / FISHERS |     P=0.292N     P=0.339      P=0.500      P=0.500N    |P=0.199N     P=0.028N*    P=0.028N*    P=0.218N     |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 18
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Histiocytic Sarcoma                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.1%         2.4%         0.0%         4.6%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    1/33 (3%)    0/33 (0%)    2/23 (9%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |692          731 (T)      ---          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.233      P=0.693      P=0.543N     P=0.323      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.349      P=0.722      P=0.518N     P=0.460      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.359      P=0.737      P=0.510N     P=0.479      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.331      P=0.706      P=0.529N     P=0.430      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.315      P=0.739      P=0.475N     P=0.440      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.366      P=0.753N     P=0.500N     P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma And Histiocytic Sarcoma                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |13/50 (26%)  6/50 (12%)   11/50 (22%)  4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         2.3%        |26.5%        14.4%        24.7%        9.2%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    1/30 (3%)   |9/44 (21%)   4/33 (12%)   9/33 (27%)   3/23 (13%)   |
|FIRST INCIDENCE    |     ---          729 (T)      ---          729 (T)     |576          599          614          606          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.334      P=0.514      (e)          P=0.443     |P=0.229N     P=0.201N     P=0.489      P=0.165N     |
|POLY 3             |     P=0.395      P=0.510      (e)          P=0.492     |P=0.043N*    P=0.124N     P=0.516N     P=0.028N*    |
|POLY 1.5           |     P=0.399      P=0.506      (e)          P=0.495     |P=0.035N*    P=0.097N     P=0.469N     P=0.021N*    |
|POLY 6             |     P=0.390      P=0.514      (e)          P=0.489     |P=0.063N     P=0.156N     P=0.580N     P=0.045N*    |
|LOGISTIC REGRESSION|     (e)          P=0.514      (e)          P=0.443     |P=0.044N*    P=0.080N     P=0.480N     P=0.016N*    |
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P=0.032N*    P=0.062N     P=0.408N     P=0.016N*    |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 19
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed,                                                                        |
|     NOS, or Undifferentiated Cell Type                                                                                          |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    1/50 (2%)   |12/50 (24%)  6/50 (12%)   11/50 (22%)  2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         2.3%        |24.5%        14.4%        24.7%        4.6%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    1/30 (3%)   |9/44 (21%)   4/33 (12%)   9/33 (27%)   1/23 (4%)    |
|FIRST INCIDENCE    |     ---          729 (T)      ---          729 (T)     |576          599          614          606          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.334      P=0.514      (e)          P=0.443     |P=0.106N     P=0.259N     P=0.407      P=0.057N     |
|POLY 3             |     P=0.395      P=0.510      (e)          P=0.492     |P=0.015N*    P=0.173N     P=0.586      P=0.007N**   |
|POLY 1.5           |     P=0.399      P=0.506      (e)          P=0.495     |P=0.012N*    P=0.140N     P=0.559N     P=0.005N**   |
|POLY 6             |     P=0.390      P=0.514      (e)          P=0.489     |P=0.024N*    P=0.210N     P=0.527      P=0.012N*    |
|LOGISTIC REGRESSION|     (e)          P=0.514      (e)          P=0.443     |P=0.015N*    P=0.123N     P=0.583N     P=0.004N**   |
|COCH-ARM / FISHERS |     P=0.405      P=0.500      (e)          P=0.500     |P=0.011N*    P=0.096N     P=0.500N     P=0.004N**   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Benign Tumors                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     38/50 (76%)  45/50 (90%)  49/50 (98%)  45/50 (90%) |40/50 (80%)  50/50 (100%) 49/50 (98%)  48/50 (96%)  |
|POLY-3 ADJUSTED (b)|     78.5%        92.2%        98.0%        93.5%       |82.2%        100.0%       98.3%        96.4%        |
|TERMINAL (d)       |     32/40 (80%)  41/43 (95%)  33/34 (97%)  28/30 (93%) |37/44 (84%)  33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE    |     411          641          445          386         |659          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.242      P=0.002 **   P=0.003 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P=0.012 *    P=0.044 *    P=0.002 **   P=0.028 *   |P=0.013 *    P<0.001 **   P=0.006 **   P=0.019 *    |
|POLY 1.5           |     P=0.013 *    P=0.046 *    P<0.001 **   P=0.029 *   |P=0.011 *    P<0.001 **   P=0.005 **   P=0.016 *    |
|POLY 6             |     P=0.016 *    P=0.046 *    P=0.003 **   P=0.033 *   |P=0.015 *    P=0.002 **   P=0.007 **   P=0.022 *    |
|LOGISTIC REGRESSION|     P=0.013 *    P=0.095      P<0.001 **   P=0.033 *   |P=0.011 *    P<0.001 **   P=0.002 **   P=0.005 **   |
|COCH-ARM / FISHERS |     P=0.033 *    P=0.054      P<0.001 **   P=0.054     |P=0.011 *    P<0.001 **   P=0.004 **   P=0.014 *    |
|=================================================================================================================================|
       Date:  06/19/97                           EXPERIMENT: 05162 TEST: 10                                            Page 20
                     Statistical Analysis of Primary Tumors in Mice(B6C3F1)       -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant Tumors                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     21/50 (42%)  22/50 (44%)  38/50 (76%)  35/50 (70%) |22/50 (44%)  26/50 (52%)  44/50 (88%)  44/50 (88%)  |
|POLY-3 ADJUSTED (b)|     43.8%        44.2%        76.0%        74.5%       |44.0%        56.3%        89.4%        88.9%        |
|TERMINAL (d)       |     14/40 (35%)  16/43 (37%)  22/34 (65%)  21/30 (70%) |16/44 (36%)  16/33 (49%)  30/33 (91%)  20/23 (87%)  |
|FIRST INCIDENCE    |     485          499          445          446         |508          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.532N     P<0.001 **   P<0.001 **  |P<0.001 **   P=0.061      P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.563      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.158      P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.542      P<0.001 **   P=0.002 **  |P<0.001 **   P=0.198      P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.578      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.122      P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.428      P<0.001 **   P=0.003 **  |P<0.001 **   P=0.447      P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.500      P<0.001 **   P=0.004 **  |P<0.001 **   P=0.274      P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      40 MG/KG     80 MG/KG     160         |0 MG/KG      40 MG/KG     80 MG/KG     160          |
|                   |                                            MG/KG       |                                       MG/KG        |
|=================================================================================================================================|
|                                                                                                                                 |
|All Organs                                                                                                                       |
|     Malignant and Benign Tumors                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     46/50 (92%)  49/50 (98%)  50/50 (100%) 49/50 (98%) |47/50 (94%)  50/50 (100%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)|     92.0%        98.0%        100.0%       99.9%       |94.0%        100.0%       100.0%       100.0%       |
|TERMINAL (d)       |     36/40 (90%)  42/43 (98%)  34/34 (100%) 30/30 (100%)|41/44 (93%)  33/33 (100%) 33/33 (100%) 23/23 (100%) |
|FIRST INCIDENCE    |     411          499          445          386         |508          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P=0.555N     P=0.048 *    P=0.015 *   |P<0.001 **   P=0.002 **   P=0.003 **   P<0.001 **   |
|POLY 3             |     P=0.019 *    P=0.180      P=0.061      P=0.065     |P=0.045 *    P=0.119      P=0.119      P=0.119      |
|POLY 1.5           |     P=0.025 *    P=0.180      P=0.061      P=0.076     |P=0.045 *    P=0.119      P=0.119      P=0.119      |
|POLY 6             |     P=0.018 *    P=0.180      P=0.061      P=0.063     |P=0.045 *    P=0.119      P=0.119      P=0.119      |
|LOGISTIC REGRESSION|     P=0.066      (e)          (e)          P=0.132     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.104      P=0.181      P=0.059      P=0.181     |P=0.047 *    P=0.121      P=0.121      P=0.121      |
|=================================================================================================================================|

(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).