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TDMS Study 05162-10 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/20/97

EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 09:32:35
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 NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/20/97     
EXPERIMENT: 05162 TEST: 10                                                                                     TIME: 09:32:35     
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                         Hyperplasia Focal
Heart: Atrium                          Thrombosis
Kidney                                 Nephropathy
Kidney: Cortex                         Cyst
Kidney: Glomerulus                     Dilatation Focal
Kidney: Renal Tubule                   Mineralization
Liver                                  Necrosis
                                       Syncytial Alteration
Liver: Centrilobular                   Cytoplasmic Alteration
Lymph Node, Mesenteric                 Necrosis
Salivary Glands: Duct                  Cytoplasmic Alteration
Skin: Skin, Site of Application        Acanthosis
                                       Exudate
                                       Hyperkeratosis
Spleen                                 Hematopoietic Cell Proliferation
Thymus                                 Atrophy
Thyroid Gland: Follicular Cell         Hyperplasia
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Adrenal Cortex                         Hemorrhage
Bone Marrow                            Myelofibrosis
Heart: Atrium                          Thrombosis
Kidney                                 Nephropathy
Kidney: Renal Tubule                   Mineralization
Liver                                  Eosinophilic Focus
                                       Syncytial Alteration
Lymph Node, Mandibular                 Necrosis
Lymph Node, Mesenteric                 Necrosis
Ovary                                  Atrophy
Ovary: Follicle                        Cyst
Skin: Skin, Site of Application        Exudate
                                       Hyperkeratosis
Spleen                                 Hematopoietic Cell Proliferation
Stomach, Forestomach                   Hyperplasia Focal
Stomach, Glandular                     Necrosis Focal
Thymus                                 Atrophy
                                       Necrosis
Thyroid Gland: Follicular Cell         Hyperplasia
Uterus: Endometrium                    Hyperplasia Cystic
===============================================================
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 1
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                   |
|     Hemorrhage                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         2.3%         9.2%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          633          607          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.003 **   (e)          P=0.469      P=0.026 *    |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.005 **   (e)          P=0.484      P=0.049 *    |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.005 **   (e)          P=0.491      P=0.054      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.004 **   (e)          P=0.475      P=0.041 *    |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.006 **   (e)          P=0.607      P=0.075      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.006 **   (e)          P=0.500      P=0.059      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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                                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         2.2%         6.8%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    1/34 (3%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          729 (T)      674         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010 *    (e)          P=0.468      P=0.089     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.017 *    (e)          P=0.497      P=0.113     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.018 *    (e)          P=0.499      P=0.115     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.016 *    (e)          P=0.493      P=0.110     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.017 *    (e)          P=0.468      P=0.114     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.020 *    (e)          P=0.500      P=0.121     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                   |
|     Hypertrophy Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   8/50 (16%)   4/50 (8%)    7/50 (14%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     13.1%        16.6%        8.7%         15.6%       |0.0%         0.0%         0.0%         2.3%         |
|TERMINAL (d)       |     6/40 (15%)   7/43 (16%)   3/34 (9%)    6/30 (20%)  |0/44 (0%)    0/33 (0%)    0/33 (0%)    1/23 (4%)    |
|FIRST INCIDENCE    |     729 (T)      692          445          230         |---          ---          ---          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.313      P=0.446      P=0.463N     P=0.302     |P=0.131      (e)          (e)          P=0.371      |
|POLY 3             |     P=0.520      P=0.428      P=0.368N     P=0.487     |P=0.192      (e)          (e)          P=0.478      |
|POLY 1.5           |     P=0.531      P=0.413      P=0.366N     P=0.494     |P=0.196      (e)          (e)          P=0.488      |
|POLY 6             |     P=0.501      P=0.445      P=0.378N     P=0.474     |P=0.183      (e)          (e)          P=0.461      |
|LOGISTIC REGRESSION|     P=0.557N     P=0.450      P=0.370N     P=0.505     |(e)          (e)          (e)          P=0.371      |
|COCH-ARM / FISHERS |     P=0.543      P=0.387      P=0.370N     P=0.500     |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 Cortex: Capsule                                                                                                          |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    6/50 (12%)   5/50 (10%)   3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.4%         12.5%        11.0%        6.8%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/40 (5%)    6/43 (14%)   3/34 (9%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      685          660         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.395      P=0.158      P=0.170      P=0.394     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.537      P=0.150      P=0.213      P=0.485     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.547      P=0.144      P=0.216      P=0.489     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.523      P=0.156      P=0.206      P=0.479     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.520      P=0.158      P=0.202      P=0.480     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.570      P=0.134      P=0.218      P=0.500     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Myelofibrosis                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |14/50 (28%)  19/50 (38%)  11/50 (22%)  8/50 (16%)   |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |28.7%        44.6%        24.6%        18.1%        |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |13/44 (30%)  16/33 (49%)  10/33 (30%)  5/23 (22%)   |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |508          421          540          593          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.362N     P=0.036 *    P=0.565      P=0.580N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.052N     P=0.084      P=0.419N     P=0.171N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.040N*    P=0.119      P=0.377N     P=0.143N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.081N     P=0.058      P=0.477N     P=0.223N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.042N*    P=0.112      P=0.381N     P=0.114N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.032N*    P=0.198      P=0.322N     P=0.114N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Eye                                                                                                                              |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/1 (0%)     2/2 (100%)   |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         100.0%       |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/1 (0%)     1/1 (100%)   |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          606          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 4
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Atrium                                                                                                                    |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    6/50 (12%)  |0/50 (0%)    0/50 (0%)    1/50 (2%)    4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         13.5%       |0.0%         0.0%         2.3%         9.2%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    1/30 (3%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          674         |---          ---          730          674          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   (e)          (e)          P=0.013 *   |P=0.002 **   (e)          P=0.449      P=0.026 *    |
|POLY 3             |     P<0.001 **   (e)          (e)          P=0.014 *   |P=0.005 **   (e)          P=0.482      P=0.048 *    |
|POLY 1.5           |     P<0.001 **   (e)          (e)          P=0.014 *   |P=0.005 **   (e)          P=0.490      P=0.054      |
|POLY 6             |     P<0.001 **   (e)          (e)          P=0.013 *   |P=0.004 **   (e)          P=0.472      P=0.041 *    |
|LOGISTIC REGRESSION|     P<0.001 **   (e)          (e)          P=0.016 *   |P=0.005 **   (e)          P=0.454      P=0.057      |
|COCH-ARM / FISHERS |     P<0.001 **   (e)          (e)          P=0.013 *   |P=0.006 **   (e)          P=0.500      P=0.059      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     485          ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.129N     P=0.227N     P=0.255N     P=0.274N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.116N     P=0.230N     P=0.244N     P=0.249N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.115N     P=0.233N     P=0.241N     P=0.245N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.117N     P=0.227N     P=0.250N     P=0.255N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.071N     P=0.351N     P=0.262N     P=0.184N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    2/49 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         4.9%         2.3%         4.7%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    2/33 (6%)    1/33 (3%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          731 (T)      731 (T)      607          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.130      P=0.178      P=0.443      P=0.160      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.207      P=0.203      P=0.482      P=0.211      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.222      P=0.215      P=0.490      P=0.221      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.183      P=0.191      P=0.472      P=0.196      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.227      P=0.178      P=0.443      P=0.298      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.239      P=0.247      P=0.500      P=0.242      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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                                                                                                                           |
|     Infiltration Cellular Lymphocyte                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         2.2%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     593          ---          558          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.209N     P=0.230N     P=0.519N     P=0.274N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.198N     P=0.228N     P=0.504N     P=0.248N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.195N     P=0.232N     P=0.501N     P=0.244N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.203N     P=0.226N     P=0.512N     P=0.254N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.130N     P=0.284N     P=0.533N     P=0.219N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.188N     P=0.247N     P=0.500N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                           |
|     Metaplasia Focal Osseous                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.2%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |2/44 (5%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.170N     P=0.304N     P=0.304N     P=0.390N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.102N     P=0.276N     P=0.258N     P=0.263N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.106N     P=0.261N     P=0.249N     P=0.251N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.099N     P=0.291N     P=0.270N     P=0.284N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.170N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     45/50 (90%)  47/50 (94%)  45/50 (90%)  48/50 (96%) |25/50 (50%)  24/50 (48%)  16/50 (32%)  17/50 (34%)  |
|POLY-3 ADJUSTED (b)|     95.0%        95.6%        93.9%        96.9%       |51.7%        53.9%        34.1%        37.1%        |
|TERMINAL (d)       |     40/40 (100%) 43/43 (100%) 34/34 (100%) 30/30 (100%)|23/44 (52%)  18/33 (55%)  8/33 (24%)   6/23 (26%)   |
|FIRST INCIDENCE    |     473          576          556          230         |692          421          540          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.460N     P=0.089      P=0.004 **  |P=0.536N     P=0.190      P=0.298N     P=0.352      |
|POLY 3             |     P=0.422      P=0.655      P=0.606N     P=0.523     |P=0.040N*    P=0.498      P=0.061N     P=0.107N     |
|POLY 1.5           |     P=0.327      P=0.514      P=0.611N     P=0.368     |P=0.036N*    P=0.558      P=0.056N     P=0.091N     |
|POLY 6             |     P=0.547      P=0.674N     P=0.637N     P=0.745     |P=0.053N     P=0.439      P=0.068N     P=0.141N     |
|LOGISTIC REGRESSION|     P=0.074      P=0.641N     P=0.620N     P=0.118     |P=0.037N*    P=0.507      P=0.055N     P=0.109N     |
|COCH-ARM / FISHERS |     P=0.220      P=0.357      P=0.630N     P=0.218     |P=0.036N*    P=0.500N     P=0.052N     P=0.078N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions 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: Cortex                                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    5/50 (10%)   2/50 (4%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         10.4%        4.4%         0.0%        |2.1%         0.0%         2.3%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    5/43 (12%)   2/34 (6%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          729 (T)      729 (T)      ---         |729          ---          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.393N     P=0.040 *    P=0.203      (e)         |P=0.527N     P=0.562N     P=0.696      P=0.634N     |
|POLY 3             |     P=0.292N     P=0.035 *    P=0.234      (e)         |P=0.404N     P=0.533N     P=0.740      P=0.522N     |
|POLY 1.5           |     P=0.286N     P=0.034 *    P=0.236      (e)         |P=0.402N     P=0.520N     P=0.749      P=0.512N     |
|POLY 6             |     P=0.301N     P=0.037 *    P=0.229      (e)         |P=0.413N     P=0.545N     P=0.728      P=0.539N     |
|LOGISTIC REGRESSION|     (e)          P=0.040 *    P=0.203      (e)         |P=0.490N     P=0.556N     P=0.711      P=0.588N     |
|COCH-ARM / FISHERS |     P=0.279N     P=0.028 *    P=0.247      (e)         |P=0.405N     P=0.500N     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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Cortex                                                                                                                   |
|     Infarct                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |2.1%         0.0%         0.0%         4.6%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    2/23 (9%)    |
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |576          ---          ---          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.619N     P=0.514      (e)          (e)         |P=0.172      P=0.540N     P=0.517N     P=0.353      |
|POLY 3             |     P=0.565N     P=0.510      (e)          (e)         |P=0.246      P=0.535N     P=0.520N     P=0.457      |
|POLY 1.5           |     P=0.565N     P=0.506      (e)          (e)         |P=0.248      P=0.522N     P=0.511N     P=0.477      |
|POLY 6             |     P=0.566N     P=0.514      (e)          (e)         |P=0.238      P=0.548N     P=0.531N     P=0.427      |
|LOGISTIC REGRESSION|     (e)          P=0.514      (e)          (e)         |P=0.249      P=0.283N     P=0.322N     P=0.588      |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.246      P=0.500N     P=0.500N     P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions 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: Glomerulus                                                                                                               |
|     Dilatation Focal                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     22/50 (44%)  39/50 (78%)  39/50 (78%)  32/50 (64%) |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     48.0%        80.7%        82.8%        70.4%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     21/40 (53%)  38/43 (88%)  31/34 (91%)  24/30 (80%) |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     674          641          556          598         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.043 *    P<0.001 **   P<0.001 **   P=0.020 *   |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.052      P<0.001 **   P<0.001 **   P=0.023 *   |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.036 *    P<0.001 **   P<0.001 **   P=0.019 *   |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.022 *    P<0.001 **   P<0.001 **   P=0.013 *   |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.095      P<0.001 **   P<0.001 **   P=0.035 *   |(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                                                                                                             |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         4.2%         0.0%         6.7%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    2/43 (5%)    0/34 (0%)    2/30 (7%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          540         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.163      P=0.525      P=0.532N     P=0.233     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.232      P=0.517      P=0.503N     P=0.296     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.236      P=0.511      P=0.501N     P=0.299     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.227      P=0.524      P=0.507N     P=0.292     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.245      P=0.525      (e)          P=0.313     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.242      P=0.500      P=0.500N     P=0.309     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 9
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     38/50 (76%)  45/50 (90%)  38/50 (76%)  41/50 (82%) |0/50 (0%)    4/50 (8%)    3/50 (6%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     82.1%        92.7%        79.1%        87.3%       |0.0%         9.7%         6.7%         0.0%         |
|TERMINAL (d)       |     36/40 (90%)  43/43 (100%) 27/34 (79%)  25/30 (83%) |0/44 (0%)    3/33 (9%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     611          641          556          540         |---          691          540          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.004 **   P=0.143      P=0.179      P=0.012 *   |P=0.523N     P=0.035 *    P=0.097      (e)          |
|POLY 3             |     P=0.492      P=0.086      P=0.456N     P=0.331     |P=0.448N     P=0.043 *    P=0.106      (e)          |
|POLY 1.5           |     P=0.452      P=0.069      P=0.511N     P=0.293     |P=0.412N     P=0.049 *    P=0.112      (e)          |
|POLY 6             |     P=0.549N     P=0.110      P=0.396N     P=0.417     |P=0.505N     P=0.038 *    P=0.100      (e)          |
|LOGISTIC REGRESSION|     P=0.252      P=0.167      P=0.573      P=0.179     |P=0.369N     P=0.038 *    P=0.185      (e)          |
|COCH-ARM / FISHERS |     P=0.476      P=0.054      P=0.592N     P=0.312     |P=0.373N     P=0.059      P=0.121      (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                                                                                                             |
|     Pigmentation Hemosiderin                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         4.4%         2.3%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          670          667          684         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.326      P=0.518      P=0.220      P=0.495     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.345      P=0.511      P=0.235      P=0.493     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.352      P=0.507      P=0.237      P=0.495     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.336      P=0.515      P=0.231      P=0.490     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.384      P=0.459      P=0.238      P=0.504     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.366      P=0.500      P=0.247      P=0.500     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 10
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         2.1%         0.0%         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    |     473          729 (T)      ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.115N     P=0.482N     P=0.240N     P=0.249N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.105N     P=0.491N     P=0.246N     P=0.252N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.103N     P=0.494N     P=0.242N     P=0.247N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.107N     P=0.488N     P=0.254N     P=0.258N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.053N     P=0.704N     P=0.297N     P=0.136N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.101N     P=0.500N     P=0.247N     P=0.247N    |(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                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   7/50 (14%)   2/50 (4%)    2/50 (4%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     10.9%        14.6%        4.4%         4.6%        |0.0%         4.9%         0.0%         0.0%         |
|TERMINAL (d)       |     5/40 (13%)   7/43 (16%)   2/34 (6%)    2/30 (7%)   |0/44 (0%)    1/33 (3%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |---          689          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.169N     P=0.430      P=0.285N     P=0.345N    |P=0.488N     P=0.183      (e)          (e)          |
|POLY 3             |     P=0.088N     P=0.415      P=0.222N     P=0.232N    |P=0.450N     P=0.204      (e)          (e)          |
|POLY 1.5           |     P=0.085N     P=0.402      P=0.218N     P=0.227N    |P=0.431N     P=0.216      (e)          (e)          |
|POLY 6             |     P=0.094N     P=0.428      P=0.231N     P=0.239N    |P=0.474N     P=0.193      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.169N     P=0.430      P=0.285N     P=0.345N    |P=0.420N     P=0.205      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.079N     P=0.380      P=0.218N     P=0.218N    |P=0.405N     P=0.247      (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 11
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    4/50 (8%)    2/50 (4%)    5/50 (10%)  |3/50 (6%)    4/50 (8%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     6.6%         8.3%         4.4%         11.2%       |6.2%         9.1%         0.0%         0.0%         |
|TERMINAL (d)       |     3/40 (8%)    3/43 (7%)    2/34 (6%)    4/30 (13%)  |3/44 (7%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      641          729 (T)      386         |731 (T)      418          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.181      P=0.540      P=0.574N     P=0.228     |P=0.048N*    P=0.413      P=0.176N     P=0.256N     |
|POLY 3             |     P=0.302      P=0.531      P=0.507N     P=0.346     |P=0.035N*    P=0.449      P=0.136N     P=0.140N     |
|POLY 1.5           |     P=0.309      P=0.519      P=0.502N     P=0.350     |P=0.032N*    P=0.468      P=0.128N     P=0.130N     |
|POLY 6             |     P=0.289      P=0.544      P=0.517N     P=0.338     |P=0.042N*    P=0.428      P=0.146N     P=0.158N     |
|LOGISTIC REGRESSION|     P=0.325      P=0.519      P=0.574N     P=0.364     |P=0.019N*    P=0.310N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.320      P=0.500      P=0.500N     P=0.357     |P=0.030N*    P=0.500      P=0.121N     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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         0.0%         0.0%         0.0%        |2.1%         2.4%         2.2%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     473          ---          ---          ---         |659          491          474          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.119N     P=0.235N     P=0.242N     P=0.247N    |P=0.325N     P=0.716      P=0.738      P=0.552N     |
|POLY 3             |     P=0.115N     P=0.232N     P=0.246N     P=0.252N    |P=0.333N     P=0.725      P=0.743      P=0.523N     |
|POLY 1.5           |     P=0.114N     P=0.234N     P=0.242N     P=0.247N    |P=0.322N     P=0.739      P=0.751      P=0.513N     |
|POLY 6             |     P=0.116N     P=0.230N     P=0.254N     P=0.259N    |P=0.352N     P=0.711      P=0.731      P=0.541N     |
|LOGISTIC REGRESSION|     P=0.038N*    P=0.474N     P=0.303N     P=0.130N    |P=0.361N     P=0.547N     P=0.556N     P=0.425N     |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |P=0.311N     P=0.753N     P=0.753N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 12
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                            |
|     Syncytial Alteration                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    28/50 (56%)  38/50 (76%)  23/50 (46%) |0/50 (0%)    2/50 (4%)    17/50 (34%)  18/50 (36%)  |
|POLY-3 ADJUSTED (b)|     0.0%         57.8%        78.2%        47.9%       |0.0%         4.9%         35.6%        39.1%        |
|TERMINAL (d)       |     0/40 (0%)    26/43 (61%)  27/34 (79%)  13/30 (43%) |0/44 (0%)    2/33 (6%)    9/33 (27%)   6/23 (26%)   |
|FIRST INCIDENCE    |     ---          641          445          230         |---          731 (T)      474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.178      P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.203      P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.215      P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.191      P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.178      P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.247      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: Centrilobular                                                                                                             |
|     Cytoplasmic Alteration                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    17/50 (34%)  17/50 (34%)  12/50 (24%) |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         35.4%        37.3%        27.3%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    17/43 (40%)  15/34 (44%)  12/30 (40%) |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      599          729 (T)     |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.019 *    P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.023 *    P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.014 *    P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.012 *    P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.038 *    P<0.001 **   P<0.001 **   P<0.001 **  |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 13
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         4.5%         2.3%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    2/33 (6%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          731 (T)      731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.131      (e)          P=0.178      P=0.371      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.222      (e)          P=0.218      P=0.478      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.235      (e)          P=0.226      P=0.488      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.197      (e)          P=0.207      P=0.461      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |(e)          (e)          P=0.178      P=0.371      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.246      (e)          P=0.247      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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    2/50 (4%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     4.4%         4.2%         4.4%         2.2%        |2.1%         0.0%         4.5%         2.3%         |
|TERMINAL (d)       |     2/40 (5%)    2/43 (5%)    1/34 (3%)    0/30 (0%)   |1/44 (2%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      641          540         |731 (T)      ---          556          724          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.467N     P=0.669N     P=0.647      P=0.566N    |P=0.380      P=0.557N     P=0.429      P=0.617      |
|POLY 3             |     P=0.389N     P=0.676N     P=0.691      P=0.509N    |P=0.479      P=0.532N     P=0.473      P=0.735      |
|POLY 1.5           |     P=0.384N     P=0.682N     P=0.693      P=0.506N    |P=0.493      P=0.520N     P=0.485      P=0.747      |
|POLY 6             |     P=0.397N     P=0.669N     P=0.685      P=0.513N    |P=0.450      P=0.545N     P=0.457      P=0.715      |
|LOGISTIC REGRESSION|     P=0.354N     P=0.669N     P=0.693      P=0.479N    |P=0.506      (e)          P=0.593      P=0.683      |
|COCH-ARM / FISHERS |     P=0.373N     P=0.691N     P=0.691N     P=0.500N    |P=0.500      P=0.500N     P=0.500      P=0.753N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 14
                     Statistical Analysis of Non-neoplastic Lesions 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: Alveolus                                                                                                                   |
|     Infiltration Cellular Histiocyte                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         2.3%        |0.0%         0.0%         4.5%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          717         |---          ---          633          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.176      (e)          (e)          P=0.473     |P=0.543      (e)          P=0.199      (e)          |
|POLY 3             |     P=0.191      (e)          (e)          P=0.493     |P=0.557      (e)          P=0.220      (e)          |
|POLY 1.5           |     P=0.194      (e)          (e)          P=0.495     |P=0.578      (e)          P=0.227      (e)          |
|POLY 6             |     P=0.188      (e)          (e)          P=0.489     |P=0.516      (e)          P=0.211      (e)          |
|LOGISTIC REGRESSION|     P=0.189      (e)          (e)          P=0.490     |P=0.603      (e)          P=0.288      (e)          |
|COCH-ARM / FISHERS |     P=0.198      (e)          (e)          P=0.500     |P=0.595      (e)          P=0.247      (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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mandibular                                                                                                           |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/46 (0%)    3/46 (7%)    2/44 (5%)    2/36 (6%)   |1/46 (2%)    0/48 (0%)    0/46 (0%)    3/43 (7%)    |
|POLY-3 ADJUSTED (b)|     0.0%         6.8%         5.1%         6.5%        |2.2%         0.0%         0.0%         7.9%         |
|TERMINAL (d)       |     0/40 (0%)    1/40 (3%)    0/28 (0%)    1/23 (4%)   |0/43 (0%)    0/33 (0%)    0/32 (0%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          692          599          674         |659          ---          ---          694          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.233      P=0.137      P=0.228      P=0.176     |P=0.048 *    P=0.557N     P=0.541N     P=0.171      |
|POLY 3             |     P=0.194      P=0.123      P=0.217      P=0.166     |P=0.073      P=0.526N     P=0.519N     P=0.245      |
|POLY 1.5           |     P=0.208      P=0.122      P=0.222      P=0.172     |P=0.073      P=0.513N     P=0.511N     P=0.261      |
|POLY 6             |     P=0.177      P=0.124      P=0.208      P=0.159     |P=0.070      P=0.539N     P=0.529N     P=0.222      |
|LOGISTIC REGRESSION|     P=0.243      P=0.120      P=0.236      P=0.175     |P=0.072      P=0.420N     P=0.384N     P=0.311      |
|COCH-ARM / FISHERS |     P=0.233      P=0.121      P=0.236      P=0.190     |P=0.073      P=0.489N     P=0.500N     P=0.283      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 15
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Congestion                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/45 (4%)    0/43 (0%)    1/41 (2%)    0/41 (0%)   |0/48 (0%)    0/48 (0%)    1/44 (2%)    0/40 (0%)    |
|POLY-3 ADJUSTED (b)|     4.9%         0.0%         2.7%         0.0%        |0.0%         0.0%         2.5%         0.0%         |
|TERMINAL (d)       |     1/36 (3%)    0/37 (0%)    0/29 (0%)    0/25 (0%)   |0/42 (0%)    0/32 (0%)    0/31 (0%)    0/22 (0%)    |
|FIRST INCIDENCE    |     716          ---          667          ---         |---          ---          712          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.226N     P=0.229N     P=0.549N     P=0.298N    |P=0.650      (e)          P=0.455      (e)          |
|POLY 3             |     P=0.215N     P=0.236N     P=0.532N     P=0.268N    |P=0.645      (e)          P=0.468      (e)          |
|POLY 1.5           |     P=0.211N     P=0.240N     P=0.531N     P=0.265N    |P=0.659      (e)          P=0.474      (e)          |
|POLY 6             |     P=0.220N     P=0.232N     P=0.537N     P=0.272N    |P=0.619      (e)          P=0.460      (e)          |
|LOGISTIC REGRESSION|     P=0.205N     P=0.232N     P=0.533N     P=0.273N    |P=0.664      (e)          P=0.478      (e)          |
|COCH-ARM / FISHERS |     P=0.204N     P=0.259N     P=0.535N     P=0.271N    |P=0.672      (e)          P=0.478      (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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/45 (0%)    4/43 (9%)    1/41 (2%)    6/41 (15%)  |2/48 (4%)    3/48 (6%)    2/44 (5%)    7/40 (18%)   |
|POLY-3 ADJUSTED (b)|     0.0%         9.7%         2.7%         16.5%       |4.3%         7.5%         5.0%         19.9%        |
|TERMINAL (d)       |     0/36 (0%)    2/37 (5%)    0/29 (0%)    2/25 (8%)   |0/42 (0%)    2/32 (6%)    0/31 (0%)    1/22 (5%)    |
|FIRST INCIDENCE    |     ---          692          715          606         |659          655          633          696          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.009 **   P=0.075      P=0.474      P=0.011 *   |P=0.011 *    P=0.377      P=0.622      P=0.020 *    |
|POLY 3             |     P=0.012 *    P=0.061      P=0.481      P=0.009 **  |P=0.013 *    P=0.429      P=0.637      P=0.029 *    |
|POLY 1.5           |     P=0.012 *    P=0.058      P=0.482      P=0.009 **  |P=0.015 *    P=0.455      P=0.648      P=0.034 *    |
|POLY 6             |     P=0.012 *    P=0.064      P=0.478      P=0.009 **  |P=0.011 *    P=0.403      P=0.623      P=0.022 *    |
|LOGISTIC REGRESSION|     P=0.013 *    P=0.062      P=0.479      P=0.012 *   |P=0.017 *    P=0.505      P=0.604N     P=0.039 *    |
|COCH-ARM / FISHERS |     P=0.015 *    P=0.053      P=0.477      P=0.010 *   |P=0.017 *    P=0.500      P=0.658      P=0.044 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 16
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |1/49 (2%)    0/47 (0%)    2/47 (4%)    0/40 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |2.1%         0.0%         4.8%         0.0%         |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |1/44 (2%)    0/32 (0%)    2/32 (6%)    0/21 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |731 (T)      ---          731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.635N     P=0.564N     P=0.389      P=0.647N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.531N     P=0.538N     P=0.452      P=0.566N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.519N     P=0.527N     P=0.466      P=0.554N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.553N     P=0.550N     P=0.434      P=0.582N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.635N     (e)          P=0.389      (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.511N     P=0.510N     P=0.484      P=0.551N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)    |3/4 (75%)    4/5 (80%)    0/1 (0%)     1/2 (50%)    |
|POLY-3 ADJUSTED (b)|     100.0%       0.0%         0.0%         0.0%        |86.0%        80.0%        0.0%         63.7%        |
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)    |3/3 (100%)   1/2 (50%)    0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |731 (T)      526          ---          611          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.597N     P=0.289      P=1.000N     P=0.459      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.324N     P=0.743N     P=0.298N     P=0.740N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.331N     P=0.777N     P=0.357N     P=0.661N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.311N     P=0.681N     P=0.187N     P=0.924N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.310N     P=0.734      (e)          (e)          |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.326N     P=0.722      P=0.400N     P=0.600N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 17
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                                            |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |42/49 (86%)  35/50 (70%)  44/49 (90%)  49/49 (100%) |
|POLY-3 ADJUSTED (b)|                                                        |88.2%        82.0%        91.5%        100.0%       |
|TERMINAL (d)       |                                                        |39/43 (91%)  29/33 (88%)  29/32 (91%)  22/22 (100%) |
|FIRST INCIDENCE    |                                                        |659          534          539          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P<0.001 **   P=0.300      P=0.006 **   P<0.001 **   |
|POLY 3             |                                                        |P=0.004 **   P=0.279N     P=0.421      P=0.013 *    |
|POLY 1.5           |                                                        |P=0.002 **   P=0.147N     P=0.399      P=0.010 *    |
|POLY 6             |                                                        |P=0.010 *    P=0.455N     P=0.457      P=0.022 *    |
|LOGISTIC REGRESSION|                                                        |P<0.001 **   P=0.590      P=0.184      P<0.001 **   |
|COCH-ARM / FISHERS |                                                        |P<0.001 **   P=0.050N     P=0.380      P=0.006 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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: Follicle                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |10/49 (20%)  18/50 (36%)  12/49 (24%)  10/49 (20%)  |
|POLY-3 ADJUSTED (b)|                                                        |21.1%        42.1%        27.7%        23.5%        |
|TERMINAL (d)       |                                                        |9/43 (21%)   14/33 (42%)  11/32 (34%)  8/22 (36%)   |
|FIRST INCIDENCE    |                                                        |674          491          684          594          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.180      P=0.011 *    P=0.156      P=0.101      |
|POLY 3             |                                                        |P=0.438N     P=0.025 *    P=0.312      P=0.493      |
|POLY 1.5           |                                                        |P=0.374N     P=0.036 *    P=0.351      P=0.543      |
|POLY 6             |                                                        |P=0.534      P=0.018 *    P=0.261      P=0.412      |
|LOGISTIC REGRESSION|                                                        |P=0.430N     P=0.029 *    P=0.228      P=0.383      |
|COCH-ARM / FISHERS |                                                        |P=0.316N     P=0.066      P=0.405      P=0.599N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 18
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     4.3%         4.1%         0.0%         2.3%        |0.0%         4.9%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    1/43 (2%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    2/33 (6%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     485          641          ---          717         |---          731 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.351N     P=0.668N     P=0.255N     P=0.551N    |P=0.526N     P=0.178      (e)          (e)          |
|POLY 3             |     P=0.308N     P=0.679N     P=0.244N     P=0.518N    |P=0.454N     P=0.203      (e)          (e)          |
|POLY 1.5           |     P=0.304N     P=0.684N     P=0.241N     P=0.512N    |P=0.435N     P=0.215      (e)          (e)          |
|POLY 6             |     P=0.315N     P=0.672N     P=0.250N     P=0.526N    |P=0.478N     P=0.191      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.244N     P=0.580      P=0.262N     P=0.460N    |(e)          P=0.178      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.296N     P=0.691N     P=0.247N     P=0.500N    |P=0.409N     P=0.247      (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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Cytoplasmic Alteration                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    1/50 (2%)    3/50 (6%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         0.0%         2.2%         6.7%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/40 (3%)    0/43 (0%)    0/34 (0%)    1/30 (3%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      ---          724          606         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.064      P=0.486N     P=0.727      P=0.248     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.089      P=0.490N     P=0.757      P=0.296     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.091      P=0.494N     P=0.759      P=0.298     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.085      P=0.486N     P=0.753      P=0.292     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.097      (e)          P=0.743      P=0.305     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.097      P=0.500N     P=0.753N     P=0.309     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 19
                     Statistical Analysis of Non-neoplastic Lesions 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                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/48 (4%)    1/47 (2%)    1/46 (2%)    3/43 (7%)   |1/50 (2%)    1/50 (2%)    2/47 (4%)    0/44 (0%)    |
|POLY-3 ADJUSTED (b)|     4.5%         2.2%         2.4%         8.0%        |2.1%         2.4%         4.9%         0.0%         |
|TERMINAL (d)       |     2/39 (5%)    1/40 (3%)    1/31 (3%)    3/27 (11%)  |1/44 (2%)    1/33 (3%)    2/31 (7%)    0/20 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      729 (T)     |731 (T)      731 (T)      731 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.186      P=0.491N     P=0.580N     P=0.335     |P=0.578N     P=0.696      P=0.379      P=0.657N     |
|POLY 3             |     P=0.263      P=0.495N     P=0.523N     P=0.424     |P=0.433N     P=0.723      P=0.446      P=0.548N     |
|POLY 1.5           |     P=0.270      P=0.500N     P=0.518N     P=0.432     |P=0.418N     P=0.737      P=0.460      P=0.537N     |
|POLY 6             |     P=0.255      P=0.490N     P=0.532N     P=0.416     |P=0.461N     P=0.707      P=0.427      P=0.563N     |
|LOGISTIC REGRESSION|     P=0.186      P=0.491N     P=0.580N     P=0.335     |P=0.578N     P=0.696      P=0.379      (e)          |
|COCH-ARM / FISHERS |     P=0.284      P=0.508N     P=0.516N     P=0.447     |P=0.404N     P=0.753N     P=0.477      P=0.532N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/48 (4%)    0/47 (0%)    0/46 (0%)    0/43 (0%)   |4/50 (8%)    4/50 (8%)    3/47 (6%)    1/44 (2%)    |
|POLY-3 ADJUSTED (b)|     4.5%         0.0%         0.0%         0.0%        |8.3%         9.6%         7.2%         2.6%         |
|TERMINAL (d)       |     2/39 (5%)    0/40 (0%)    0/31 (0%)    0/27 (0%)   |4/44 (9%)    3/33 (9%)    2/31 (7%)    0/20 (0%)    |
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |731 (T)      526          633          701          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.150N     P=0.233N     P=0.290N     P=0.322N    |P=0.309N     P=0.490      P=0.636      P=0.433N     |
|POLY 3             |     P=0.124N     P=0.234N     P=0.252N     P=0.275N    |P=0.177N     P=0.559      P=0.580N     P=0.258N     |
|POLY 1.5           |     P=0.123N     P=0.237N     P=0.249N     P=0.271N    |P=0.162N     P=0.591      P=0.560N     P=0.240N     |
|POLY 6             |     P=0.125N     P=0.231N     P=0.258N     P=0.280N    |P=0.205N     P=0.528      P=0.605N     P=0.288N     |
|LOGISTIC REGRESSION|     P=0.150N     (e)          (e)          (e)         |P=0.159N     P=0.602      P=0.583N     P=0.314N     |
|COCH-ARM / FISHERS |     P=0.124N     P=0.253N     P=0.258N     P=0.275N    |P=0.148N     P=0.643N     P=0.535N     P=0.223N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 20
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     16/50 (32%)  12/50 (24%)  20/50 (40%)  12/49 (24%) |                                                    |
|POLY-3 ADJUSTED (b)|     34.7%        24.9%        42.2%        27.4%       |                                                    |
|TERMINAL (d)       |     15/40 (38%)  10/43 (23%)  13/34 (38%)  5/29 (17%)  |                                                    |
|FIRST INCIDENCE    |     611          670          558          606         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.362      P=0.188N     P=0.147      P=0.551N    |                                                    |
|POLY 3             |     P=0.427N     P=0.205N     P=0.296      P=0.299N    |                                                    |
|POLY 1.5           |     P=0.408N     P=0.222N     P=0.286      P=0.293N    |                                                    |
|POLY 6             |     P=0.447N     P=0.189N     P=0.305      P=0.306N    |                                                    |
|LOGISTIC REGRESSION|     P=0.415N     P=0.190N     P=0.260      P=0.319N    |                                                    |
|COCH-ARM / FISHERS |     P=0.364N     P=0.252N     P=0.266      P=0.272N    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    5/50 (10%)   1/50 (2%)    3/49 (6%)   |                                                    |
|POLY-3 ADJUSTED (b)|     6.5%         10.4%        2.2%         6.9%        |                                                    |
|TERMINAL (d)       |     2/40 (5%)    4/43 (9%)    1/34 (3%)    1/29 (3%)   |                                                    |
|FIRST INCIDENCE    |     649          692          729 (T)      674         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.565N     P=0.401      P=0.355N     P=0.567     |                                                    |
|POLY 3             |     P=0.453N     P=0.383      P=0.313N     P=0.634     |                                                    |
|POLY 1.5           |     P=0.445N     P=0.373      P=0.308N     P=0.640     |                                                    |
|POLY 6             |     P=0.466N     P=0.392      P=0.323N     P=0.625     |                                                    |
|LOGISTIC REGRESSION|     P=0.458N     P=0.369      P=0.308N     P=0.644     |                                                    |
|COCH-ARM / FISHERS |     P=0.431N     P=0.357      P=0.309N     P=0.651     |                                                    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 21
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Salivary Glands: Duct                                                                                                            |
|     Cytoplasmic Alteration                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    8/50 (16%)   23/50 (46%) |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         4.2%         17.2%        50.6%       |2.1%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    2/43 (5%)    3/34 (9%)    11/30 (37%) |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     649          729 (T)      556          634         |692          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.524      P=0.016 *    P<0.001 **  |P=0.336N     P=0.560N     P=0.543N     P=0.555N     |
|POLY 3             |     P<0.001 **   P=0.515      P=0.016 *    P<0.001 **  |P=0.286N     P=0.533N     P=0.518N     P=0.523N     |
|POLY 1.5           |     P<0.001 **   P=0.510      P=0.016 *    P<0.001 **  |P=0.293N     P=0.521N     P=0.510N     P=0.512N     |
|POLY 6             |     P<0.001 **   P=0.520      P=0.016 *    P<0.001 **  |P=0.277N     P=0.546N     P=0.529N     P=0.540N     |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.489      P=0.016 *    P<0.001 **  |P=0.304N     P=0.496N     P=0.475N     P=0.471N     |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.500      P=0.015 *    P<0.001 **  |P=0.306N     P=0.500N     P=0.500N     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: Skin, Site of Application                                                                                                  |
|     Acanthosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    4/50 (8%)   |0/50 (0%)    2/50 (4%)    1/50 (2%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.4%         9.0%        |0.0%         4.9%         2.3%         4.5%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    2/34 (6%)    2/30 (7%)   |0/44 (0%)    1/33 (3%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          729 (T)      660         |---          696          731 (T)      585          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.004 **   (e)          P=0.203      P=0.045 *   |P=0.177      P=0.180      P=0.443      P=0.225      |
|POLY 3             |     P=0.007 **   (e)          P=0.234      P=0.056     |P=0.215      P=0.203      P=0.482      P=0.217      |
|POLY 1.5           |     P=0.007 **   (e)          P=0.236      P=0.058     |P=0.230      P=0.216      P=0.490      P=0.227      |
|POLY 6             |     P=0.006 **   (e)          P=0.229      P=0.055     |P=0.193      P=0.192      P=0.472      P=0.203      |
|LOGISTIC REGRESSION|     P=0.007 **   (e)          P=0.203      P=0.059     |P=0.251      P=0.201      P=0.443      P=0.351      |
|COCH-ARM / FISHERS |     P=0.009 **   (e)          P=0.247      P=0.059     |P=0.245      P=0.247      P=0.500      P=0.247      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 22
                     Statistical Analysis of Non-neoplastic Lesions 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: Skin, Site of Application                                                                                                  |
|     Exudate                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    3/50 (6%)   |0/50 (0%)    1/50 (2%)    1/50 (2%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         6.8%        |0.0%         2.4%         2.3%         6.9%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    1/33 (3%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          660         |---          691          731 (T)      611          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.010 *    (e)          (e)          P=0.112     |P=0.027 *    P=0.445      P=0.443      P=0.063      |
|POLY 3             |     P=0.010 *    (e)          (e)          P=0.114     |P=0.046 *    P=0.468      P=0.482      P=0.102      |
|POLY 1.5           |     P=0.010 *    (e)          (e)          P=0.115     |P=0.050      P=0.480      P=0.490      P=0.110      |
|POLY 6             |     P=0.010 *    (e)          (e)          P=0.112     |P=0.040 *    P=0.457      P=0.472      P=0.091      |
|LOGISTIC REGRESSION|     P=0.013 *    (e)          (e)          P=0.121     |P=0.053      P=0.506      P=0.443      P=0.151      |
|COCH-ARM / FISHERS |     P=0.012 *    (e)          (e)          P=0.121     |P=0.054      P=0.500      P=0.500      P=0.121      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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: Skin, Site of Application                                                                                                  |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    13/50 (26%)  10/50 (20%)  17/50 (34%) |1/50 (2%)    3/50 (6%)    8/50 (16%)   16/50 (32%)  |
|POLY-3 ADJUSTED (b)|     0.0%         26.6%        21.7%        37.2%       |2.1%         7.2%         17.7%        36.4%        |
|TERMINAL (d)       |     0/40 (0%)    10/43 (23%)  6/34 (18%)   8/30 (27%)  |1/44 (2%)    0/33 (0%)    4/33 (12%)   11/23 (48%)  |
|FIRST INCIDENCE    |     ---          576          631          598         |731 (T)      526          474          607          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.227      P=0.008 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.257      P=0.012 *    P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.274      P=0.014 *    P<0.001 **   |
|POLY 6             |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.242      P=0.010 *    P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.388      P=0.026 *    P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **  |P<0.001 **   P=0.309      P=0.015 *    P<0.001 **   |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 23
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     13/50 (26%)  22/50 (44%)  29/50 (58%)  32/50 (64%) |24/50 (48%)  31/50 (62%)  41/50 (82%)  43/50 (86%)  |
|POLY-3 ADJUSTED (b)|     27.1%        44.9%        58.9%        67.1%       |49.1%        65.4%        85.0%        88.1%        |
|TERMINAL (d)       |     8/40 (20%)   17/43 (40%)  16/34 (47%)  17/30 (57%) |22/44 (50%)  20/33 (61%)  29/33 (88%)  20/23 (87%)  |
|FIRST INCIDENCE    |     473          576          445          386         |508          418          474          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.099      P=0.002 **   P<0.001 **  |P<0.001 **   P=0.011 *    P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.052      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.076      P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.049 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.090      P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.056      P<0.001 **   P<0.001 **  |P<0.001 **   P=0.063      P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.031 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.198      P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.046 *    P<0.001 **   P<0.001 **  |P<0.001 **   P=0.114      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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    2/50 (4%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         0.0%        |0.0%         4.9%         0.0%         2.3%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    2/33 (6%)    0/33 (0%)    1/23 (4%)    |
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |---          731 (T)      ---          731 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.619N     P=0.514      (e)          (e)         |P=0.386      P=0.178      (e)          P=0.371      |
|POLY 3             |     P=0.565N     P=0.510      (e)          (e)         |P=0.489      P=0.203      (e)          P=0.478      |
|POLY 1.5           |     P=0.565N     P=0.506      (e)          (e)         |P=0.511      P=0.215      (e)          P=0.488      |
|POLY 6             |     P=0.566N     P=0.514      (e)          (e)         |P=0.455      P=0.191      (e)          P=0.461      |
|LOGISTIC REGRESSION|     (e)          P=0.514      (e)          (e)         |(e)          P=0.178      (e)          P=0.371      |
|COCH-ARM / FISHERS |     P=0.567N     P=0.500      (e)          (e)         |P=0.539      P=0.247      (e)          P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 24
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    4/49 (8%)    4/50 (8%)    2/50 (4%)   |1/50 (2%)    6/50 (12%)   5/50 (10%)   0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     2.2%         8.5%         8.7%         4.5%        |2.1%         14.4%        11.0%        0.0%         |
|TERMINAL (d)       |     1/40 (3%)    4/43 (9%)    2/34 (6%)    1/30 (3%)   |0/44 (0%)    5/33 (15%)   3/33 (9%)    0/23 (0%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      583          605         |674          458          474          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.394      P=0.202      P=0.154      P=0.434     |P=0.384N     P=0.029 *    P=0.072      P=0.553N     |
|POLY 3             |     P=0.498      P=0.188      P=0.180      P=0.490     |P=0.289N     P=0.036 *    P=0.087      P=0.527N     |
|POLY 1.5           |     P=0.506      P=0.182      P=0.180      P=0.493     |P=0.252N     P=0.043 *    P=0.094      P=0.516N     |
|POLY 6             |     P=0.487      P=0.194      P=0.176      P=0.486     |P=0.354N     P=0.029 *    P=0.079      P=0.544N     |
|LOGISTIC REGRESSION|     P=0.534      P=0.202      P=0.178      P=0.504     |P=0.198N     P=0.060      P=0.206      P=0.447N     |
|COCH-ARM / FISHERS |     P=0.524      P=0.175      P=0.181      P=0.500     |P=0.217N     P=0.056      P=0.102      P=0.505N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Necrosis Focal                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    3/49 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         7.1%         |
|TERMINAL (d)       |     0/40 (0%)    0/43 (0%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          694          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.006 **   (e)          (e)          P=0.064      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.010 *    (e)          (e)          P=0.098      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.010 *    (e)          (e)          P=0.106      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.009 **   (e)          (e)          P=0.087      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.010 *    (e)          (e)          P=0.105      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.011 *    (e)          (e)          P=0.117      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 25
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Pigmentation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/49 (0%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (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%)    0/34 (0%)    0/30 (0%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          ---          599          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.510      (e)          P=0.112      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.506      (e)          P=0.118      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.518      (e)          P=0.119      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.491      (e)          P=0.116      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.574      (e)          P=0.117      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.541      (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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular: Epithelium                                                                                                   |
|     Hyperplasia Focal                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/49 (2%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.1%         0.0%         4.5%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/40 (0%)    1/43 (2%)    0/34 (0%)    1/30 (3%)   |0/44 (0%)    0/33 (0%)    0/33 (0%)    0/23 (0%)    |
|FIRST INCIDENCE    |     ---          729 (T)      ---          634         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.103      P=0.514      (e)          P=0.206     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.136      P=0.506      (e)          P=0.230     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.137      P=0.502      (e)          P=0.232     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.133      P=0.510      (e)          P=0.227     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.142      P=0.514      (e)          P=0.242     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.141      P=0.495      (e)          P=0.247     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 26
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     8/37 (22%)   8/42 (19%)   18/39 (46%)  17/36 (47%) |3/48 (6%)    6/42 (14%)   8/41 (20%)   21/36 (58%)  |
|POLY-3 ADJUSTED (b)|     23.3%        19.6%        48.4%        49.7%       |6.4%         16.5%        21.4%        61.1%        |
|TERMINAL (d)       |     4/29 (14%)   5/37 (14%)   11/27 (41%)  7/21 (33%)  |1/42 (2%)    0/27 (0%)    2/27 (7%)    7/16 (44%)   |
|FIRST INCIDENCE    |     596          641          556          605         |659          418          614          585          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.463N     P=0.021 *    P=0.015 *   |P<0.001 **   P=0.160      P=0.050      P<0.001 **   |
|POLY 3             |     P=0.002 **   P=0.456N     P=0.022 *    P=0.019 *   |P<0.001 **   P=0.136      P=0.043 *    P<0.001 **   |
|POLY 1.5           |     P=0.002 **   P=0.471N     P=0.022 *    P=0.018 *   |P<0.001 **   P=0.151      P=0.048 *    P<0.001 **   |
|POLY 6             |     P=0.002 **   P=0.446N     P=0.022 *    P=0.020 *   |P<0.001 **   P=0.123      P=0.038 *    P<0.001 **   |
|LOGISTIC REGRESSION|     P=0.003 **   P=0.552N     P=0.021 *    P=0.020 *   |P<0.001 **   P=0.630      P=0.096      P<0.001 **   |
|COCH-ARM / FISHERS |     P=0.003 **   P=0.497N     P=0.022 *    P=0.019 *   |P<0.001 **   P=0.180      P=0.058      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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/37 (5%)    1/42 (2%)    3/39 (8%)    2/36 (6%)   |0/48 (0%)    6/42 (14%)   3/41 (7%)    4/36 (11%)   |
|POLY-3 ADJUSTED (b)|     5.9%         2.4%         8.5%         6.0%        |0.0%         16.3%        8.1%         12.7%        |
|TERMINAL (d)       |     0/29 (0%)    0/37 (0%)    0/27 (0%)    0/21 (0%)   |0/42 (0%)    0/27 (0%)    0/27 (0%)    0/16 (0%)    |
|FIRST INCIDENCE    |     473          499          599          540         |---          421          539          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.475      P=0.488N     P=0.491      P=0.677     |P=0.178      P=0.014 *    P=0.110      P=0.035 *    |
|POLY 3             |     P=0.457      P=0.437N     P=0.517      P=0.684     |P=0.078      P=0.006 **   P=0.083      P=0.023 *    |
|POLY 1.5           |     P=0.461      P=0.444N     P=0.521      P=0.683     |P=0.091      P=0.007 **   P=0.087      P=0.026 *    |
|POLY 6             |     P=0.448      P=0.431N     P=0.509      P=0.681     |P=0.060      P=0.006 **   P=0.079      P=0.019 *    |
|LOGISTIC REGRESSION|     P=0.544      P=0.695      P=0.450      P=0.695N    |P=0.069      P=0.202      P=0.225      P=0.081      |
|COCH-ARM / FISHERS |     P=0.471      P=0.452N     P=0.525      P=0.682     |P=0.111      P=0.008 **   P=0.094      P=0.031 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 27
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     18/50 (36%)  22/49 (45%)  30/50 (60%)  42/50 (84%) |18/50 (36%)  28/50 (56%)  32/50 (64%)  39/49 (80%)  |
|POLY-3 ADJUSTED (b)|     39.0%        46.8%        65.6%        91.0%       |37.4%        68.0%        70.8%        81.9%        |
|TERMINAL (d)       |     17/40 (43%)  22/42 (52%)  25/34 (74%)  29/30 (97%) |17/44 (39%)  26/33 (79%)  27/33 (82%)  20/23 (87%)  |
|FIRST INCIDENCE    |     593          729 (T)      654          605         |729          691          600          522          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.331      P=0.002 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.291      P=0.007 **   P<0.001 **  |P<0.001 **   P=0.002 **   P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.274      P=0.009 **   P<0.001 **  |P<0.001 **   P=0.007 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.307      P=0.005 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.346      P=0.005 **   P<0.001 **  |P<0.001 **   P<0.001 **   P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.243      P=0.014 *    P<0.001 **  |P<0.001 **   P=0.035 *    P=0.004 **   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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Tooth                                                                                                                            |
|     Developmental Malformation                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/3 (33%)    2/2 (100%)   0/0 (0%)     0/0 (0%)    |1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|POLY-3 ADJUSTED (b)|     33.3%        100.0%       0.0%         0.0%        |100.0%       0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/3 (33%)    2/2 (100%)   0/0 (0%)     0/0 (0%)    |1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     729 (T)      729 (T)      ---          ---         |731 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.631      P=0.309      P=1.000N     P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=1.000N     P=0.281      P=1.000N     P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=1.000N     P=0.281      P=1.000N     P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=1.000N     P=0.281      P=1.000N     P=1.000N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.631      P=0.309      (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.645      P=0.300      P=1.000      P=1.000     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 10                                            Page 28
                     Statistical Analysis of Non-neoplastic Lesions 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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Tooth: Peridontal Tissue                                                                                                         |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/3 (67%)    0/2 (0%)     0/0 (0%)     0/0 (0%)    |0/1 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|POLY-3 ADJUSTED (b)|     66.7%        0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/3 (67%)    0/2 (0%)     0/0 (0%)     0/0 (0%)    |0/1 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     729 (T)      ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.631N     P=0.309N     P=1.000      P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=1.000N     P=0.281N     P=1.000      P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=1.000N     P=0.281N     P=1.000      P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=1.000N     P=0.281N     P=1.000      P=1.000N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.631N     (e)          (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.645N     P=0.300N     P=1.000      P=1.000     |(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        |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |45/50 (90%)  44/50 (88%)  31/50 (62%)  25/50 (50%)  |
|POLY-3 ADJUSTED (b)|                                                        |91.4%        92.3%        65.4%        54.9%        |
|TERMINAL (d)       |                                                        |42/44 (96%)  32/33 (97%)  23/33 (70%)  13/23 (57%)  |
|FIRST INCIDENCE    |                                                        |508          418          474          594          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.181N     P=0.010 *    P=0.249N     P=0.525N     |
|POLY 3             |                                                        |P<0.001N**   P=0.591      P<0.001N**   P<0.001N**   |
|POLY 1.5           |                                                        |P<0.001N**   P=0.632N     P<0.001N**   P<0.001N**   |
|POLY 6             |                                                        |P<0.001N**   P=0.511      P<0.001N**   P<0.001N**   |
|LOGISTIC REGRESSION|                                                        |P<0.001N**   P=0.471      P=0.003N**   P<0.001N**   |
|COCH-ARM / FISHERS |                                                        |P<0.001N**   P=0.500N     P<0.001N**   P<0.001N**   |
|=================================================================================================================================|

(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).