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TDMS Study 05162-09 Pathology Tables

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

EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 09:19:29
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2
                

Rats(FISCHER344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.

                                                 ----------------
                                                 Adrenal Gland
                                                 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: 09                                                                                     TIME: 09:19:29     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D     
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2      



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

Male Rats
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex                         Hyperplasia
Blood Vessel                           Mineralization
Eye: Lens                              Cataract
Kidney                                 Nephropathy
Liver                                  Basophilic Focus
Lung                                   Inflammation Granulomatous
                                       Mineralization
Lung: Alveolar Epithelium              Hyperplasia
Mammary Gland                          Hyperplasia Cystic
Nose                                   Inflammation
Oral Mucosa                            Inflammation
Parathyroid Gland                      Hyperplasia
Seminal Vesicle                        Atrophy
Skin: Epidermis, Skin, Site of ApplicatAcanthosis
                                       Degeneration
                                       Exudate
                                       Hyperkeratosis
Skin: Skin, Site of Application        Ulcer
Spleen                                 Fibrosis
Testes: Germinal Epithelium            Atrophy
Thyroid Gland: C-Cell                  Hyperplasia
===============================================================
Female Rats
------------
Organ                                  Morphology
-----                                  ----------
Adrenal Medulla                        Hyperplasia
Heart: Myocardium                      Mineralization
Intestine Large, Rectum                Parasite Metazoan
Kidney                                 Nephropathy
Liver                                  Basophilic Focus
                                       Cyst
                                       Degeneration Cystic
                                       Hepatodiaphragmatic Nodule
                                       Mixed Cell Focus
Lung                                   Inflammation Granulomatous
                                       Mineralization
Pituitary Gland: Pars Distalis         Hyperplasia
                                       Inflammation Granulomatous
Skin: Epidermis, Skin, Site of ApplicatAcanthosis
                                       Exudate
                                       Hyperkeratosis
Stomach, Forestomach                   Inflammation Chronic
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                                       DIETHANOLAMINE                                    DATE: 06/20/97     
EXPERIMENT: 05162 TEST: 09                                                                                     TIME: 09:19:29     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-05293                              ROUTE: SKIN APPLICATION                                        NTP C#: 55174D     
PATHOLOGIST: RYAN, M.                                                                                          CAS: 111-42-2      

Stomach, Glandular                     Mineralization
Thyroid Gland: C-Cell                  Hyperplasia
===============================================================
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 1
                     Statistical Analysis of Non-neoplastic Lesions in        Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     16/50 (32%)  15/50 (30%)  15/50 (30%)  12/50 (24%) |13/50 (26%)  13/50 (26%)  11/50 (22%)  11/50 (22%)  |
|POLY-3 ADJUSTED (b)|     38.6%        38.4%        34.9%        29.2%       |31.3%        29.5%        25.8%        26.9%        |
|TERMINAL (d)       |     6/14 (43%)   4/10 (40%)   6/21 (29%)   7/22 (32%)  |7/25 (28%)   8/29 (28%)   9/29 (31%)   8/24 (33%)   |
|FIRST INCIDENCE    |     560          542          499          277         |638          689          677          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.034N*    P=0.347      P=0.179N     P=0.102N    |P=0.392N     P=0.375N     P=0.264N     P=0.438N     |
|POLY 3             |     P=0.185N     P=0.587N     P=0.449N     P=0.249N    |P=0.357N     P=0.523N     P=0.377N     P=0.421N     |
|POLY 1.5           |     P=0.193N     P=0.526N     P=0.456N     P=0.241N    |P=0.344N     P=0.554N     P=0.395N     P=0.416N     |
|POLY 6             |     P=0.169N     P=0.498      P=0.436N     P=0.256N    |P=0.376N     P=0.481N     P=0.353N     P=0.432N     |
|LOGISTIC REGRESSION|     P=0.190N     P=0.571N     P=0.414N     P=0.247N    |P=0.361N     P=0.448N     P=0.305N     P=0.414N     |
|COCH-ARM / FISHERS |     P=0.215N     P=0.500N     P=0.500N     P=0.252N    |P=0.327N     P=0.590N     P=0.408N     P=0.408N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |1/50 (2%)    2/50 (4%)    0/50 (0%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.8%         0.0%        |2.5%         4.6%         0.0%         7.4%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    0/22 (0%)   |1/25 (4%)    1/29 (3%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          ---          702          ---         |730 (T)      666          ---          572          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.676N     (e)          P=0.334      (e)         |P=0.223      P=0.564      P=0.470N     P=0.302      |
|POLY 3             |     P=0.604      (e)          P=0.255      (e)         |P=0.241      P=0.530      P=0.490N     P=0.308      |
|POLY 1.5           |     P=0.598      (e)          P=0.249      (e)         |P=0.240      P=0.516      P=0.495N     P=0.306      |
|POLY 6             |     P=0.626      (e)          P=0.266      (e)         |P=0.244      P=0.550      P=0.481N     P=0.315      |
|LOGISTIC REGRESSION|     P=0.645      (e)          P=0.285      (e)         |P=0.239      P=0.542      (e)          P=0.304      |
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |P=0.242      P=0.500      P=0.500N     P=0.309      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 2
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Degeneration Cystic                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |0/49 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    2/10 (20%)   0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          729 (T)      ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.289N     P=0.164      (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.406N     P=0.223      (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.402N     P=0.233      (e)          (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.415N     P=0.206      (e)          (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     (e)          P=0.164      (e)          (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.405N     P=0.247      (e)          (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     11/50 (22%)  9/50 (18%)   15/50 (30%)  8/50 (16%)  |3/49 (6%)    10/50 (20%)  4/49 (8%)    10/50 (20%)  |
|POLY-3 ADJUSTED (b)|     26.8%        23.5%        35.0%        19.8%       |7.6%         22.3%        9.5%         24.9%        |
|TERMINAL (d)       |     4/14 (29%)   2/10 (20%)   8/21 (38%)   4/22 (18%)  |1/25 (4%)    5/29 (17%)   2/29 (7%)    7/24 (29%)   |
|FIRST INCIDENCE    |     302          562          499          431         |648          589          561          656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.097N     P=0.556      P=0.578N     P=0.162N    |P=0.067      P=0.077      P=0.566      P=0.037 *    |
|POLY 3             |     P=0.335N     P=0.469N     P=0.278      P=0.314N    |P=0.079      P=0.055      P=0.533      P=0.033 *    |
|POLY 1.5           |     P=0.346N     P=0.427N     P=0.270      P=0.310N    |P=0.082      P=0.047 *    P=0.515      P=0.035 *    |
|POLY 6             |     P=0.295N     P=0.539N     P=0.298      P=0.303N    |P=0.078      P=0.070      P=0.559      P=0.032 *    |
|LOGISTIC REGRESSION|     P=0.333N     P=0.405N     P=0.287      P=0.305N    |P=0.075      P=0.049 *    P=0.514      P=0.036 *    |
|COCH-ARM / FISHERS |     P=0.353N     P=0.402N     P=0.247      P=0.306N    |P=0.091      P=0.039 *    P=0.500      P=0.039 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 3
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel                                                                                                                     |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/4 (100%)   3/3 (100%)   0/0 (0%)     0/1 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     2/2 (100%)   |
|POLY-3 ADJUSTED (b)|     100.0%       100.0%       0.0%         0.0%        |0.0%         0.0%         0.0%         100.0%       |
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |     610          678          ---          ---         |---          ---          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.021N*    (e)          (e)          P=0.114N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=1.000N     (e)          (e)          P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=1.000N     (e)          (e)          P=1.000N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=1.000N     (e)          (e)          P=1.000N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.114N     (e)          (e)          P=0.317N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.037N*    (e)          (e)          P=0.200N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Fibrous Osteodystrophy                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    4/50 (8%)    4/50 (8%)    0/50 (0%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     7.6%         10.9%        9.5%         0.0%        |2.5%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     610          666          635          ---         |730 (T)      ---          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.057N     P=0.357      P=0.622      P=0.122N    |P=0.235      P=0.470N     P=0.470N     P=0.515      |
|POLY 3             |     P=0.092N     P=0.461      P=0.538      P=0.121N    |P=0.237      P=0.484N     P=0.490N     P=0.500      |
|POLY 1.5           |     P=0.093N     P=0.488      P=0.526      P=0.119N    |P=0.241      P=0.491N     P=0.495N     P=0.498      |
|POLY 6             |     P=0.087N     P=0.415      P=0.557      P=0.120N    |P=0.233      P=0.473N     P=0.481N     P=0.505      |
|LOGISTIC REGRESSION|     P=0.089N     P=0.478      P=0.503      P=0.121N    |P=0.236      (e)          (e)          P=0.498      |
|COCH-ARM / FISHERS |     P=0.095N     P=0.500      P=0.500      P=0.121N    |P=0.246      P=0.500N     P=0.500N     P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 4
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     10/50 (20%)  4/50 (8%)    7/50 (14%)   9/50 (18%)  |2/50 (4%)    6/50 (12%)   4/50 (8%)    5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     24.7%        10.8%        16.5%        22.7%       |5.0%         13.6%        9.2%         12.5%        |
|TERMINAL (d)       |     4/14 (29%)   2/10 (20%)   3/21 (14%)   4/22 (18%)  |1/25 (4%)    3/29 (10%)   2/29 (7%)    4/24 (17%)   |
|FIRST INCIDENCE    |     561          554          635          632         |666          638          561          656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.335N     P=0.181N     P=0.139N     P=0.297N    |P=0.256      P=0.211      P=0.393      P=0.213      |
|POLY 3             |     P=0.498      P=0.094N     P=0.258N     P=0.521N    |P=0.276      P=0.163      P=0.369      P=0.210      |
|POLY 1.5           |     P=0.483      P=0.079N     P=0.268N     P=0.509N    |P=0.280      P=0.148      P=0.353      P=0.212      |
|POLY 6             |     P=0.539      P=0.130N     P=0.241N     P=0.520N    |P=0.275      P=0.185      P=0.395      P=0.211      |
|LOGISTIC REGRESSION|     P=0.508      P=0.082N     P=0.259N     P=0.492N    |P=0.275      P=0.156      P=0.333      P=0.214      |
|COCH-ARM / FISHERS |     P=0.473      P=0.074N     P=0.298N     P=0.500N    |P=0.288      P=0.134      P=0.339      P=0.218      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Brain: Medulla                                                                                                                   |
|     Necrosis Focal                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    2/50 (4%)    0/50 (0%)   |0/50 (0%)    0/49 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         4.8%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          702          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.676N     (e)          P=0.334      (e)         |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.604      (e)          P=0.255      (e)         |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.598      (e)          P=0.249      (e)         |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.626      (e)          P=0.266      (e)         |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.645      (e)          P=0.285      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.595      (e)          P=0.247      (e)         |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 5
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |4/50 (8%)    4/50 (8%)    1/49 (2%)    2/47 (4%)    |
|POLY-3 ADJUSTED (b)|                                                        |9.8%         9.2%         2.4%         5.3%         |
|TERMINAL (d)       |                                                        |2/25 (8%)    2/29 (7%)    1/29 (3%)    0/22 (0%)    |
|FIRST INCIDENCE    |                                                        |600          703          730 (T)      656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.212N     P=0.535N     P=0.147N     P=0.360N     |
|POLY 3             |                                                        |P=0.213N     P=0.604N     P=0.172N     P=0.371N     |
|POLY 1.5           |                                                        |P=0.211N     P=0.622N     P=0.180N     P=0.370N     |
|POLY 6             |                                                        |P=0.213N     P=0.578N     P=0.161N     P=0.371N     |
|LOGISTIC REGRESSION|                                                        |P=0.213N     P=0.593N     P=0.169N     P=0.368N     |
|COCH-ARM / FISHERS |                                                        |P=0.207N     P=0.643N     P=0.187N     P=0.369N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Clitoral Gland                                                                                                                   |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |3/50 (6%)    4/50 (8%)    1/49 (2%)    1/47 (2%)    |
|POLY-3 ADJUSTED (b)|                                                        |7.5%         9.2%         2.4%         2.7%         |
|TERMINAL (d)       |                                                        |2/25 (8%)    2/29 (7%)    0/29 (0%)    1/22 (5%)    |
|FIRST INCIDENCE    |                                                        |701          704          665          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.155N     P=0.594      P=0.253N     P=0.337N     |
|POLY 3             |                                                        |P=0.153N     P=0.544      P=0.293N     P=0.330N     |
|POLY 1.5           |                                                        |P=0.153N     P=0.523      P=0.303N     P=0.330N     |
|POLY 6             |                                                        |P=0.151N     P=0.573      P=0.275N     P=0.329N     |
|LOGISTIC REGRESSION|                                                        |P=0.153N     P=0.602      P=0.282N     P=0.325N     |
|COCH-ARM / FISHERS |                                                        |P=0.152N     P=0.500      P=0.316N     P=0.332N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 6
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Eye                                                                                                                              |
|     Cataract                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     1/2 (50%)    2/2 (100%)   0/2 (0%)    |1/2 (50%)    0/0 (0%)     0/1 (0%)     1/2 (50%)    |
|POLY-3 ADJUSTED (b)|     0.0%         56.3%        100.0%       0.0%        |50.1%        0.0%         0.0%         50.0%        |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |1/1 (100%)   0/0 (0%)     0/0 (0%)     1/2 (50%)    |
|FIRST INCIDENCE    |     ---          723          689          ---         |730 (T)      ---          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.430N     P=1.000      P=1.000      P=0.638N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=1.000N     P=1.000      P=0.644N     P=0.760N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=1.000N     P=1.000      P=0.630N     P=0.760N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=1.000N     P=1.000      P=0.670N     P=0.760N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.430N     (e)          (e)          P=0.638N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.695      P=1.000      P=0.667N     P=0.833N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Eye: Lens                                                                                                                        |
|     Cataract                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/0 (0%)     0/2 (0%)     0/2 (0%)     2/2 (100%)  |0/2 (0%)     0/0 (0%)     0/1 (0%)     0/2 (0%)     |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         100.0%      |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)    |0/1 (0%)     0/0 (0%)     0/0 (0%)     0/2 (0%)     |
|FIRST INCIDENCE    |     ---          ---          ---          277         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|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: 09                                            Page 7
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Atrium                                                                                                                    |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    1/50 (2%)    2/50 (4%)   |1/50 (2%)    1/50 (2%)    4/50 (8%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.1%         2.7%         2.4%         5.0%        |2.5%         2.3%         9.2%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     645          638          715          379         |597          589          490          699          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.606N     P=0.599N     P=0.429N     P=0.686N    |P=0.510      P=0.750N     P=0.213      P=0.757N     |
|POLY 3             |     P=0.575      P=0.522N     P=0.477N     P=0.688N    |P=0.496      P=0.743N     P=0.200      P=0.757      |
|POLY 1.5           |     P=0.566      P=0.506N     P=0.484N     P=0.689N    |P=0.508      P=0.751N     P=0.189      P=0.758      |
|POLY 6             |     P=0.594      P=0.551N     P=0.466N     P=0.682N    |P=0.483      P=0.731N     P=0.219      P=0.758      |
|LOGISTIC REGRESSION|     P=0.543      P=0.500N     P=0.487N     P=0.683     |P=0.555      P=0.746      P=0.175      P=0.760N     |
|COCH-ARM / FISHERS |     P=0.556      P=0.500N     P=0.500N     P=0.691N    |P=0.526      P=0.753N     P=0.181      P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     41/50 (82%)  41/50 (82%)  44/50 (88%)  45/50 (90%) |36/50 (72%)  33/50 (66%)  35/50 (70%)  36/50 (72%)  |
|POLY-3 ADJUSTED (b)|     87.8%        87.4%        92.0%        93.3%       |79.5%        73.1%        76.5%        78.7%        |
|TERMINAL (d)       |     14/14 (100%) 9/10 (90%)   21/21 (100%) 22/22 (100%)|23/25 (92%)  24/29 (83%)  23/29 (79%)  20/24 (83%)  |
|FIRST INCIDENCE    |     302          463          499          277         |460          541          490          430          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.101N     P=0.120      P=0.137N     P=0.278N    |P=0.314      P=0.079N     P=0.202N     P=0.502      |
|POLY 3             |     P=0.152      P=0.611N     P=0.353      P=0.265     |P=0.499      P=0.303N     P=0.457N     P=0.570N     |
|POLY 1.5           |     P=0.153      P=0.560N     P=0.357      P=0.263     |P=0.474      P=0.327N     P=0.500N     P=0.587N     |
|POLY 6             |     P=0.152      P=0.605      P=0.353      P=0.257     |P=0.555      P=0.251N     P=0.351N     P=0.520N     |
|LOGISTIC REGRESSION|     P=0.129      P=0.580N     P=0.440      P=0.205     |P=0.369      P=0.145N     P=0.419N     P=0.558      |
|COCH-ARM / FISHERS |     P=0.117      P=0.602N     P=0.288      P=0.194     |P=0.459      P=0.333N     P=0.500N     P=0.588N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 8
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Myocardium                                                                                                                |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     2.6%         2.7%         2.4%         0.0%        |0.0%         0.0%         0.0%         7.3%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     687          695          635          ---         |---          ---          ---          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.269N     P=0.678      P=0.729N     P=0.479N    |P=0.011 *    (e)          (e)          P=0.134      |
|POLY 3             |     P=0.305N     P=0.748      P=0.743N     P=0.499N    |P=0.010 *    (e)          (e)          P=0.121      |
|POLY 1.5           |     P=0.309N     P=0.757      P=0.748N     P=0.499N    |P=0.011 *    (e)          (e)          P=0.120      |
|POLY 6             |     P=0.297N     P=0.730      P=0.732N     P=0.496N    |P=0.010 *    (e)          (e)          P=0.124      |
|LOGISTIC REGRESSION|     P=0.307N     P=0.735      P=0.763      P=0.498N    |P=0.015 *    (e)          (e)          P=0.129      |
|COCH-ARM / FISHERS |     P=0.311N     P=0.753N     P=0.753N     P=0.500N    |P=0.012 *    (e)          (e)          P=0.121      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Colon                                                                                                           |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    3/50 (6%)    3/50 (6%)   |3/50 (6%)    3/50 (6%)    1/50 (2%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     5.2%         0.0%         7.2%         7.6%        |7.4%         6.9%         2.4%         2.6%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    1/21 (5%)    2/22 (9%)   |2/25 (8%)    3/29 (10%)   1/29 (3%)    1/24 (4%)    |
|FIRST INCIDENCE    |     710          ---          689          533         |600          730 (T)      730 (T)      730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.411      P=0.308N     P=0.674N     P=0.651     |P=0.174N     P=0.601N     P=0.263N     P=0.321N     |
|POLY 3             |     P=0.253      P=0.250N     P=0.537      P=0.510     |P=0.176N     P=0.631N     P=0.290N     P=0.321N     |
|POLY 1.5           |     P=0.241      P=0.241N     P=0.525      P=0.507     |P=0.174N     P=0.645N     P=0.299N     P=0.318N     |
|POLY 6             |     P=0.282      P=0.269N     P=0.559      P=0.523     |P=0.177N     P=0.610N     P=0.277N     P=0.322N     |
|LOGISTIC REGRESSION|     P=0.255      P=0.300N     P=0.598      P=0.505     |P=0.174N     P=0.609N     P=0.287N     P=0.316N     |
|COCH-ARM / FISHERS |     P=0.232      P=0.247N     P=0.500      P=0.500     |P=0.169N     P=0.661N     P=0.309N     P=0.316N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 9
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Large, Rectum                                                                                                          |
|     Parasite Metazoan                                                                                                           |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    2/50 (4%)    4/50 (8%)    3/49 (6%)   |4/50 (8%)    0/50 (0%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     10.3%        5.5%         9.6%         7.8%        |9.8%         0.0%         2.4%         0.0%         |
|TERMINAL (d)       |     3/14 (21%)   2/10 (20%)   4/21 (19%)   2/22 (9%)   |3/25 (12%)   0/29 (0%)    1/29 (3%)    0/24 (0%)    |
|FIRST INCIDENCE    |     666          729 (T)      729 (T)      653         |522          ---          730 (T)      ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.249N     P=0.504N     P=0.436N     P=0.350N    |P=0.039N*    P=0.050N     P=0.146N     P=0.069N     |
|POLY 3             |     P=0.504N     P=0.366N     P=0.604N     P=0.504N    |P=0.040N*    P=0.052N     P=0.167N     P=0.062N     |
|POLY 1.5           |     P=0.518N     P=0.345N     P=0.616N     P=0.506N    |P=0.039N*    P=0.056N     P=0.174N     P=0.062N     |
|POLY 6             |     P=0.468N     P=0.407N     P=0.584N     P=0.490N    |P=0.042N*    P=0.047N*    P=0.155N     P=0.062N     |
|LOGISTIC REGRESSION|     P=0.362N     P=0.474N     P=0.465N     P=0.469N    |P=0.039N*    P=0.062N     P=0.171N     P=0.063N     |
|COCH-ARM / FISHERS |     P=0.531N     P=0.339N     P=0.643N     P=0.511N    |P=0.039N*    P=0.059N     P=0.181N     P=0.059N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Intestine Small, Duodenum                                                                                                        |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    2/49 (4%)    |
|POLY-3 ADJUSTED (b)|     7.5%         0.0%         0.0%         2.6%        |2.5%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     101          ---          ---          643         |648          ---          ---          656          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.229N     P=0.170N     P=0.096N     P=0.310N    |P=0.229      P=0.474N     P=0.479N     P=0.496      |
|POLY 3             |     P=0.227N     P=0.135N     P=0.110N     P=0.311N    |P=0.233      P=0.485N     P=0.491N     P=0.495      |
|POLY 1.5           |     P=0.236N     P=0.126N     P=0.114N     P=0.311N    |P=0.237      P=0.492N     P=0.496N     P=0.493      |
|POLY 6             |     P=0.211N     P=0.154N     P=0.105N     P=0.305N    |P=0.229      P=0.476N     P=0.484N     P=0.498      |
|LOGISTIC REGRESSION|     P=0.302N     P=0.180N     P=0.220N     P=0.345N    |P=0.241      P=0.513N     P=0.503N     P=0.493      |
|COCH-ARM / FISHERS |     P=0.247N     P=0.121N     P=0.121N     P=0.309N    |P=0.241      P=0.500N     P=0.500N     P=0.492      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 10
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    4/50 (8%)    5/50 (10%)   4/50 (8%)   |0/50 (0%)    0/50 (0%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     5.1%         10.7%        11.9%        10.1%       |0.0%         0.0%         2.4%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   1/21 (5%)    3/22 (14%)  |0/25 (0%)    0/29 (0%)    1/29 (3%)    1/24 (4%)    |
|FIRST INCIDENCE    |     595          554          681          277         |---          ---          730 (T)      730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.474      P=0.243      P=0.343      P=0.429     |P=0.215      (e)          P=0.530      P=0.492      |
|POLY 3             |     P=0.327      P=0.314      P=0.244      P=0.343     |P=0.225      (e)          P=0.510      P=0.498      |
|POLY 1.5           |     P=0.322      P=0.332      P=0.236      P=0.344     |P=0.230      (e)          P=0.505      P=0.498      |
|POLY 6             |     P=0.343      P=0.283      P=0.261      P=0.347     |P=0.220      (e)          P=0.519      P=0.499      |
|LOGISTIC REGRESSION|     P=0.308      P=0.337      P=0.238      P=0.328     |(e)          (e)          P=0.530      P=0.492      |
|COCH-ARM / FISHERS |     P=0.309      P=0.339      P=0.218      P=0.339     |P=0.236      (e)          P=0.500      P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    3/50 (6%)    2/50 (4%)    2/50 (4%)   |1/50 (2%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.8%         8.2%         4.7%         5.2%        |2.5%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     3/14 (21%)   2/10 (20%)   0/21 (0%)    2/22 (9%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     729 (T)      695          599          729 (T)     |730 (T)      ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.189N     P=0.502      P=0.382N     P=0.294N    |P=0.308N     P=0.470N     P=0.470N     P=0.508N     |
|POLY 3             |     P=0.354N     P=0.638      P=0.456N     P=0.496N    |P=0.309N     P=0.484N     P=0.490N     P=0.502N     |
|POLY 1.5           |     P=0.362N     P=0.656      P=0.471N     P=0.497N    |P=0.308N     P=0.491N     P=0.495N     P=0.502N     |
|POLY 6             |     P=0.335N     P=0.603      P=0.429N     P=0.486N    |P=0.312N     P=0.473N     P=0.481N     P=0.501N     |
|LOGISTIC REGRESSION|     P=0.317N     P=0.528      P=0.475N     P=0.294N    |P=0.308N     (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.371N     P=0.661N     P=0.500N     P=0.500N    |P=0.305N     P=0.500N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 11
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Infarct                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.1%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     610          ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.117N     P=0.298N     P=0.231N     P=0.259N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.105N     P=0.254N     P=0.223N     P=0.238N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.110N     P=0.242N     P=0.227N     P=0.237N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.098N     P=0.276N     P=0.217N     P=0.236N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.118N     P=0.238N     P=0.249N     P=0.239N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.115N     P=0.247N     P=0.247N     P=0.247N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     48/50 (96%)  48/50 (96%)  50/50 (100%) 48/50 (96%) |40/50 (80%)  47/50 (94%)  48/50 (96%)  48/50 (96%)  |
|POLY-3 ADJUSTED (b)|     98.4%        96.5%        100.0%       96.3%       |84.6%        96.5%        99.5%        96.5%        |
|TERMINAL (d)       |     14/14 (100%) 10/10 (100%) 21/21 (100%) 21/22 (96%) |22/25 (88%)  29/29 (100%) 29/29 (100%) 24/24 (100%) |
|FIRST INCIDENCE    |     302          463          471          277         |460          492          434          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.038N*    P=0.106      P=0.097N     P=0.142N    |P=0.067      P=0.546      P=0.419      P=0.115      |
|POLY 3             |     P=0.441N     P=0.517N     P=0.607      P=0.490N    |P=0.015 *    P=0.035 *    P=0.004 **   P=0.033 *    |
|POLY 1.5           |     P=0.469N     P=0.524N     P=0.526      P=0.510N    |P=0.010 *    P=0.029 *    P=0.004 **   P=0.022 *    |
|POLY 6             |     P=0.406N     P=0.534N     P=0.740      P=0.475N    |P=0.030 *    P=0.051      P=0.007 **   P=0.055      |
|LOGISTIC REGRESSION|     P=0.581      P=0.616N     P=0.489      P=0.664N    |P=0.005 **   P=0.054      P=0.012 *    P=0.015 *    |
|COCH-ARM / FISHERS |     P=0.556      P=0.691N     P=0.247      P=0.691N    |P=0.009 **   P=0.036 *    P=0.014 *    P=0.014 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 12
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     15/50 (30%)  5/50 (10%)   1/50 (2%)    2/50 (4%)   |40/50 (80%)  31/50 (62%)  20/50 (40%)  7/50 (14%)   |
|POLY-3 ADJUSTED (b)|     37.6%        13.5%        2.4%         5.1%        |87.2%        67.7%        46.5%        17.5%        |
|TERMINAL (d)       |     11/14 (79%)  2/10 (20%)   1/21 (5%)    1/22 (5%)   |25/25 (100%) 21/29 (72%)  17/29 (59%)  6/24 (25%)   |
|FIRST INCIDENCE    |     507          640          729 (T)      530         |460          544          606          642          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001N**   P=0.049N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.008N**   P<0.001N**   P<0.001N**   |
|POLY 3             |     P<0.001N**   P=0.012N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.015N*    P<0.001N**   P<0.001N**   |
|POLY 1.5           |     P<0.001N**   P=0.010N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.023N*    P<0.001N**   P<0.001N**   |
|POLY 6             |     P<0.001N**   P=0.017N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.008N**   P<0.001N**   P<0.001N**   |
|LOGISTIC REGRESSION|     P<0.001N**   P=0.029N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.009N**   P<0.001N**   P<0.001N**   |
|COCH-ARM / FISHERS |     P<0.001N**   P=0.011N*    P<0.001N**   P<0.001N**  |P<0.001N**   P=0.038N*    P<0.001N**   P<0.001N**   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    3/50 (6%)    2/50 (4%)   |0/50 (0%)    3/50 (6%)    2/50 (4%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.6%         0.0%         7.2%         5.2%        |0.0%         6.9%         4.7%         2.5%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    3/21 (14%)   2/22 (9%)   |0/25 (0%)    1/29 (3%)    2/29 (7%)    1/24 (4%)    |
|FIRST INCIDENCE    |     729 (T)      ---          729 (T)      729 (T)     |---          702          730 (T)      730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.448      P=0.567N     P=0.457      P=0.658     |P=0.533      P=0.163      P=0.271      P=0.492      |
|POLY 3             |     P=0.255      P=0.512N     P=0.333      P=0.503     |P=0.549      P=0.134      P=0.248      P=0.498      |
|POLY 1.5           |     P=0.247      P=0.503N     P=0.324      P=0.502     |P=0.550      P=0.127      P=0.242      P=0.498      |
|POLY 6             |     P=0.278      P=0.528N     P=0.349      P=0.510     |P=0.552      P=0.145      P=0.259      P=0.499      |
|LOGISTIC REGRESSION|     P=0.448      (e)          P=0.457      P=0.658     |P=0.542      P=0.151      P=0.271      P=0.492      |
|COCH-ARM / FISHERS |     P=0.242      P=0.500N     P=0.309      P=0.500     |P=0.555      P=0.121      P=0.247      P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 13
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |---          ---          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.041 *    (e)          (e)          P=0.257      |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.237      |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.044 *    (e)          (e)          P=0.236      |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.043 *    (e)          (e)          P=0.241      |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.047 *    (e)          (e)          P=0.237      |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Cystic                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    2/50 (4%)    5/50 (10%)   2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     5.2%         5.5%         11.9%        5.2%        |0.0%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     2/14 (14%)   2/10 (20%)   1/21 (5%)    2/22 (9%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      681          729 (T)     |---          ---          ---          584          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.383N     P=0.572      P=0.397      P=0.524N    |P=0.040 *    (e)          (e)          P=0.230      |
|POLY 3             |     P=0.540      P=0.674      P=0.252      P=0.692N    |P=0.044 *    (e)          (e)          P=0.237      |
|POLY 1.5           |     P=0.530      P=0.689      P=0.240      P=0.692N    |P=0.044 *    (e)          (e)          P=0.237      |
|POLY 6             |     P=0.573      P=0.645      P=0.275      P=0.685N    |P=0.043 *    (e)          (e)          P=0.240      |
|LOGISTIC REGRESSION|     P=0.492N     P=0.572      P=0.300      P=0.524N    |P=0.049 *    (e)          (e)          P=0.239      |
|COCH-ARM / FISHERS |     P=0.521      P=0.691N     P=0.218      P=0.691N    |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 14
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Degeneration Fatty                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   5/50 (10%)   9/50 (18%)   7/50 (14%)  |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     15.1%        13.1%        20.6%        17.5%       |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     2/14 (14%)   0/10 (0%)    1/21 (5%)    4/22 (18%)  |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     507          572          533          541         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.537N     P=0.618N     P=0.482      P=0.537N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.369      P=0.526N     P=0.357      P=0.504     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.358      P=0.504N     P=0.332      P=0.503     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.405      P=0.565N     P=0.402      P=0.519     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.350      P=0.501N     P=0.280      P=0.504     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.350      P=0.500N     P=0.288      P=0.500     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    2/50 (4%)    2/50 (4%)    2/50 (4%)   |1/50 (2%)    5/50 (10%)   2/50 (4%)    3/50 (6%)    |
|POLY-3 ADJUSTED (b)|     10.4%        5.5%         4.8%         5.1%        |2.5%         11.3%        4.7%         7.5%         |
|TERMINAL (d)       |     4/14 (29%)   2/10 (20%)   2/21 (10%)   1/22 (5%)   |1/25 (4%)    4/29 (14%)   2/29 (7%)    2/24 (8%)    |
|FIRST INCIDENCE    |     729 (T)      729 (T)      729 (T)      642         |730 (T)      544          730 (T)      706          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.109N     P=0.500N     P=0.160N     P=0.184N    |P=0.403      P=0.136      P=0.552      P=0.298      |
|POLY 3             |     P=0.271N     P=0.363N     P=0.300N     P=0.328N    |P=0.432      P=0.123      P=0.518      P=0.302      |
|POLY 1.5           |     P=0.282N     P=0.344N     P=0.313N     P=0.332N    |P=0.432      P=0.113      P=0.508      P=0.302      |
|POLY 6             |     P=0.247N     P=0.401N     P=0.280N     P=0.313N    |P=0.437      P=0.139      P=0.534      P=0.304      |
|LOGISTIC REGRESSION|     P=0.166N     P=0.500N     P=0.160N     P=0.282N    |P=0.416      P=0.118      P=0.552      P=0.306      |
|COCH-ARM / FISHERS |     P=0.292N     P=0.339N     P=0.339N     P=0.339N    |P=0.437      P=0.102      P=0.500      P=0.309      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 15
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         0.0%        |4.9%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |1/25 (4%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          ---          ---          ---         |506          ---          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     (e)          (e)          (e)          (e)         |P=0.477N     P=0.221N     P=0.226N     P=0.515N     |
|POLY 3             |     (e)          (e)          (e)          (e)         |P=0.468N     P=0.223N     P=0.229N     P=0.509N     |
|POLY 1.5           |     (e)          (e)          (e)          (e)         |P=0.465N     P=0.230N     P=0.234N     P=0.506N     |
|POLY 6             |     (e)          (e)          (e)          (e)         |P=0.472N     P=0.213N     P=0.221N     P=0.510N     |
|LOGISTIC REGRESSION|     (e)          (e)          (e)          (e)         |P=0.453N     P=0.256N     P=0.236N     P=0.497N     |
|COCH-ARM / FISHERS |     (e)          (e)          (e)          (e)         |P=0.460N     P=0.247N     P=0.247N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Hepatodiaphragmatic Nodule                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     6/50 (12%)   1/50 (2%)    8/50 (16%)   4/50 (8%)   |2/50 (4%)    6/50 (12%)   6/50 (12%)   8/50 (16%)   |
|POLY-3 ADJUSTED (b)|     15.4%        2.7%         18.3%        10.1%       |4.9%         13.7%        13.9%        19.8%        |
|TERMINAL (d)       |     3/14 (21%)   0/10 (0%)    2/21 (10%)   2/22 (9%)   |1/25 (4%)    4/29 (14%)   4/29 (14%)   6/24 (25%)   |
|FIRST INCIDENCE    |     687          542          504          541         |632          699          434          621          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.369N     P=0.123N     P=0.572      P=0.211N    |P=0.039 *    P=0.201      P=0.181      P=0.043 *    |
|POLY 3             |     P=0.510N     P=0.062N     P=0.480      P=0.357N    |P=0.048 *    P=0.158      P=0.154      P=0.042 *    |
|POLY 1.5           |     P=0.532N     P=0.057N     P=0.446      P=0.361N    |P=0.050      P=0.146      P=0.143      P=0.043 *    |
|POLY 6             |     P=0.459N     P=0.075N     P=0.536      P=0.341N    |P=0.048 *    P=0.175      P=0.170      P=0.043 *    |
|LOGISTIC REGRESSION|     P=0.542N     P=0.074N     P=0.408      P=0.356N    |P=0.046 *    P=0.176      P=0.133      P=0.045 *    |
|COCH-ARM / FISHERS |     P=0.549N     P=0.056N     P=0.387      P=0.370N    |P=0.054      P=0.134      P=0.134      P=0.046 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 16
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    3/50 (6%)    6/50 (12%)   1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.6%         0.0%         0.0%         2.6%        |0.0%         6.9%         14.1%        2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |0/25 (0%)    2/29 (7%)    5/29 (17%)   1/24 (4%)    |
|FIRST INCIDENCE    |     689          ---          ---          729 (T)     |---          704          656          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.682N     P=0.569N     P=0.431N     P=0.692N    |P=0.425      P=0.154      P=0.028 *    P=0.492      |
|POLY 3             |     P=0.606      P=0.513N     P=0.485N     P=0.760N    |P=0.433      P=0.134      P=0.018 *    P=0.498      |
|POLY 1.5           |     P=0.599      P=0.504N     P=0.490N     P=0.760N    |P=0.441      P=0.127      P=0.016 *    P=0.498      |
|POLY 6             |     P=0.620      P=0.529N     P=0.477N     P=0.757N    |P=0.427      P=0.145      P=0.021 *    P=0.499      |
|LOGISTIC REGRESSION|     P=0.629      P=0.525N     P=0.486N     P=0.749N    |P=0.435      P=0.153      P=0.024 *    P=0.492      |
|COCH-ARM / FISHERS |     P=0.595      P=0.500N     P=0.500N     P=0.753N    |P=0.456      P=0.121      P=0.013 *    P=0.500      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.1%         0.0%         0.0%         2.6%        |0.0%         2.3%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    1/29 (3%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     673          ---          ---          722         |---          730 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.387N     P=0.335N     P=0.203N     P=0.442N    |P=0.582N     P=0.530      (e)          (e)          |
|POLY 3             |     P=0.444N     P=0.252N     P=0.222N     P=0.500N    |P=0.556N     P=0.516      (e)          (e)          |
|POLY 1.5           |     P=0.453N     P=0.241N     P=0.226N     P=0.499N    |P=0.562N     P=0.509      (e)          (e)          |
|POLY 6             |     P=0.428N     P=0.273N     P=0.214N     P=0.496N    |P=0.547N     P=0.527      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.444N     P=0.250N     P=0.228N     P=0.494N    |(e)          P=0.530      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.461N     P=0.247N     P=0.247N     P=0.500N    |P=0.568N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 17
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    1/50 (2%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     7.7%         2.7%         4.7%         2.5%        |0.0%         2.3%         4.6%         0.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     561          639          471          379         |---          589          490          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.247N     P=0.387N     P=0.424N     P=0.260N    |P=0.629N     P=0.509      P=0.254      (e)          |
|POLY 3             |     P=0.261N     P=0.329N     P=0.462N     P=0.300N    |P=0.625N     P=0.518      P=0.253      (e)          |
|POLY 1.5           |     P=0.270N     P=0.312N     P=0.474N     P=0.301N    |P=0.622N     P=0.510      P=0.245      (e)          |
|POLY 6             |     P=0.243N     P=0.359N     P=0.442N     P=0.294N    |P=0.627N     P=0.530      P=0.266      (e)          |
|LOGISTIC REGRESSION|     P=0.308N     P=0.306N     P=0.556N     P=0.320N    |P=0.585N     P=0.485      P=0.242      (e)          |
|COCH-ARM / FISHERS |     P=0.279N     P=0.309N     P=0.500N     P=0.309N    |P=0.616N     P=0.500      P=0.247      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver: Centrilobular                                                                                                             |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    0/50 (0%)   |2/50 (4%)    0/50 (0%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.7%         2.4%         0.0%        |4.9%         0.0%         0.0%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          638          715          ---         |597          ---          ---          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.540N     P=0.466      P=0.589      (e)         |P=0.474N     P=0.207N     P=0.218N     P=0.506N     |
|POLY 3             |     P=0.591N     P=0.490      P=0.516      (e)         |P=0.468N     P=0.223N     P=0.229N     P=0.509N     |
|POLY 1.5           |     P=0.592N     P=0.498      P=0.511      (e)         |P=0.465N     P=0.230N     P=0.234N     P=0.506N     |
|POLY 6             |     P=0.586N     P=0.476      P=0.525      (e)         |P=0.471N     P=0.215N     P=0.222N     P=0.512N     |
|LOGISTIC REGRESSION|     P=0.591N     P=0.499      P=0.545      (e)         |P=0.457N     P=0.255N     P=0.239N     P=0.499N     |
|COCH-ARM / FISHERS |     P=0.595N     P=0.500      P=0.500      (e)         |P=0.460N     P=0.247N     P=0.247N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 18
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Congestion                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    3/50 (6%)    0/50 (0%)    0/50 (0%)   |5/50 (10%)   2/50 (4%)    5/50 (10%)   5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     2.6%         8.1%         0.0%         0.0%        |11.9%        4.5%         11.4%        11.8%        |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     479          661          ---          ---         |489          541          351          395          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.140N     P=0.239      P=0.492N     P=0.504N    |P=0.398      P=0.170N     P=0.557N     P=0.621      |
|POLY 3             |     P=0.152N     P=0.282      P=0.488N     P=0.502N    |P=0.403      P=0.194N     P=0.604N     P=0.628N     |
|POLY 1.5           |     P=0.150N     P=0.298      P=0.492N     P=0.501N    |P=0.408      P=0.204N     P=0.617N     P=0.629N     |
|POLY 6             |     P=0.152N     P=0.257      P=0.481N     P=0.500N    |P=0.396      P=0.180N     P=0.584N     P=0.625N     |
|LOGISTIC REGRESSION|     P=0.161N     P=0.299      P=0.644N     P=0.552N    |P=0.491      P=0.262N     P=0.623      P=0.580N     |
|COCH-ARM / FISHERS |     P=0.153N     P=0.309      P=0.500N     P=0.500N    |P=0.416      P=0.218N     P=0.630N     P=0.630N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/50 (10%)   0/50 (0%)    2/50 (4%)    2/50 (4%)   |3/50 (6%)    3/50 (6%)    5/50 (10%)   9/50 (18%)   |
|POLY-3 ADJUSTED (b)|     12.8%        0.0%         4.8%         5.2%        |7.4%         6.9%         11.8%        21.6%        |
|TERMINAL (d)       |     2/14 (14%)   0/10 (0%)    0/21 (0%)    2/22 (9%)   |1/25 (4%)    3/29 (10%)   4/29 (14%)   4/24 (17%)   |
|FIRST INCIDENCE    |     582          ---          664          729 (T)     |648          730 (T)      677          515          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.143N     P=0.064N     P=0.124N     P=0.108N    |P=0.014 *    P=0.590N     P=0.444      P=0.067      |
|POLY 3             |     P=0.238N     P=0.036N*    P=0.187N     P=0.217N    |P=0.017 *    P=0.632N     P=0.378      P=0.061      |
|POLY 1.5           |     P=0.252N     P=0.032N*    P=0.196N     P=0.216N    |P=0.017 *    P=0.646N     P=0.366      P=0.060      |
|POLY 6             |     P=0.213N     P=0.045N*    P=0.171N     P=0.212N    |P=0.017 *    P=0.614N     P=0.398      P=0.065      |
|LOGISTIC REGRESSION|     P=0.231N     P=0.043N*    P=0.189N     P=0.201N    |P=0.016 *    P=0.621N     P=0.393      P=0.061      |
|COCH-ARM / FISHERS |     P=0.263N     P=0.028N*    P=0.218N     P=0.218N    |P=0.019 *    P=0.661N     P=0.357      P=0.061      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 19
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    0/50 (0%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     7.7%         2.7%         0.0%         0.0%        |0.0%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     680          678          ---          ---         |---          ---          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.029N*    P=0.451N     P=0.079N     P=0.091N    |P=0.041 *    (e)          (e)          P=0.259      |
|POLY 3             |     P=0.039N*    P=0.327N     P=0.106N     P=0.118N    |P=0.044 *    (e)          (e)          P=0.236      |
|POLY 1.5           |     P=0.041N*    P=0.311N     P=0.110N     P=0.118N    |P=0.044 *    (e)          (e)          P=0.236      |
|POLY 6             |     P=0.036N*    P=0.357N     P=0.100N     P=0.115N    |P=0.043 *    (e)          (e)          P=0.239      |
|LOGISTIC REGRESSION|     P=0.038N*    P=0.358N     P=0.101N     P=0.114N    |P=0.045 *    (e)          (e)          P=0.236      |
|COCH-ARM / FISHERS |     P=0.044N*    P=0.309N     P=0.121N     P=0.121N    |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    5/50 (10%)   2/50 (4%)    2/50 (4%)   |2/50 (4%)    3/50 (6%)    2/50 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     0.0%         13.1%        4.8%         5.2%        |4.9%         6.9%         4.7%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    2/22 (9%)   |1/25 (4%)    3/29 (10%)   2/29 (7%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          541          709          729 (T)     |652          730 (T)      730 (T)      629          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.563N     P=0.023 *    P=0.337      P=0.341     |P=0.556N     P=0.571      P=0.641N     P=0.683      |
|POLY 3             |     P=0.485      P=0.028 *    P=0.255      P=0.238     |P=0.531N     P=0.533      P=0.679N     P=0.692      |
|POLY 1.5           |     P=0.484      P=0.031 *    P=0.249      P=0.238     |P=0.529N     P=0.518      P=0.687N     P=0.692      |
|POLY 6             |     P=0.499      P=0.024 *    P=0.265      P=0.242     |P=0.531N     P=0.554      P=0.665N     P=0.695      |
|LOGISTIC REGRESSION|     P=0.481      P=0.030 *    P=0.297      P=0.341     |P=0.541N     P=0.568      P=0.662N     P=0.693      |
|COCH-ARM / FISHERS |     P=0.477      P=0.028 *    P=0.247      P=0.247     |P=0.523N     P=0.500      P=0.691N     P=0.691N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 20
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Interstitium                                                                                                               |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    2/50 (4%)   |0/50 (0%)    2/50 (4%)    2/50 (4%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         8.2%         2.4%         5.1%        |0.0%         4.6%         4.7%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    1/22 (5%)   |0/25 (0%)    1/29 (3%)    1/29 (3%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          666          729 (T)      465         |---          666          727          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.461      P=0.076      P=0.581      P=0.289     |P=0.517N     P=0.285      P=0.272      (e)          |
|POLY 3             |     P=0.350      P=0.109      P=0.516      P=0.243     |P=0.505N     P=0.257      P=0.248      (e)          |
|POLY 1.5           |     P=0.346      P=0.116      P=0.511      P=0.241     |P=0.504N     P=0.247      P=0.242      (e)          |
|POLY 6             |     P=0.361      P=0.097      P=0.524      P=0.249     |P=0.502N     P=0.270      P=0.259      (e)          |
|LOGISTIC REGRESSION|     P=0.340      P=0.091      P=0.581      P=0.227     |P=0.512N     P=0.251      P=0.273      (e)          |
|COCH-ARM / FISHERS |     P=0.337      P=0.121      P=0.500      P=0.247     |P=0.500N     P=0.247      P=0.247      (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Ectasia                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/49 (0%)    |
|POLY-3 ADJUSTED (b)|     5.2%         0.0%         2.4%         2.6%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     674          ---          729 (T)      653         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.410N     P=0.309N     P=0.392N     P=0.470N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.482N     P=0.251N     P=0.475N     P=0.497N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.493N     P=0.241N     P=0.483N     P=0.498N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.461N     P=0.271N     P=0.462N     P=0.490N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.480N     P=0.272N     P=0.449N     P=0.497N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.500N     P=0.247N     P=0.500N     P=0.500N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 21
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mammary Gland                                                                                                                    |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     5/46 (11%)   5/48 (10%)   5/45 (11%)   1/42 (2%)   |0/50 (0%)    0/50 (0%)    0/49 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     13.4%        13.8%        13.2%        3.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/9 (0%)     2/19 (11%)   0/20 (0%)   |0/25 (0%)    0/29 (0%)    0/28 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     507          576          664          688         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.041N*    P=0.464      P=0.463N     P=0.074N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.095N     P=0.613      P=0.625N     P=0.124N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.099N     P=0.625N     P=0.631      P=0.123N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.087N     P=0.566      P=0.608N     P=0.122N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.095N     P=0.613N     P=0.626N     P=0.124N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.102N     P=0.602N     P=0.616      P=0.124N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Artery                                                                                                                |
|     Thrombosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/7 (29%)    0/4 (0%)     0/8 (0%)     0/3 (0%)    |0/4 (0%)     0/7 (0%)     0/6 (0%)     0/5 (0%)     |
|POLY-3 ADJUSTED (b)|     42.2%        0.0%         0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/0 (0%)     0/2 (0%)    |0/2 (0%)     0/1 (0%)     0/1 (0%)     0/1 (0%)     |
|FIRST INCIDENCE    |     663          ---          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.095N     P=0.333N     P=0.198N     P=0.216N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.151N     P=0.346N     P=0.191N     P=0.347N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.147N     P=0.345N     P=0.184N     P=0.382N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.143N     P=0.374N     P=0.226N     P=0.306N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.103N     P=0.356N     P=0.247N     P=0.289N    |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.139N     P=0.382N     P=0.200N     P=0.467N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 22
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/7 (57%)    3/4 (75%)    4/8 (50%)    3/3 (100%)  |4/4 (100%)   6/7 (86%)    4/6 (67%)    3/5 (60%)    |
|POLY-3 ADJUSTED (b)|     63.6%        75.0%        67.1%        100.0%      |100.0%       87.0%        83.0%        68.9%        |
|TERMINAL (d)       |     0/0 (0%)     0/1 (0%)     0/0 (0%)     2/2 (100%)  |2/2 (100%)   1/1 (100%)   1/1 (100%)   0/1 (0%)     |
|FIRST INCIDENCE    |     394          562          568          632         |506          655          490          584          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.251N     P=0.577N     P=0.543N     P=0.171N    |P=0.421N     P=0.320      P=0.537      P=0.600N     |
|POLY 3             |     P=0.245      P=0.616      P=0.688      P=0.335     |P=0.194N     P=0.651N     P=0.652N     P=0.384N     |
|POLY 1.5           |     P=0.258      P=0.570      P=0.694N     P=0.303     |P=0.159N     P=0.630N     P=0.467N     P=0.325N     |
|POLY 6             |     P=0.254      P=0.693      P=0.642      P=0.405     |P=0.244N     P=0.695N     P=0.935N     P=0.457N     |
|LOGISTIC REGRESSION|     P=0.289      P=0.547      P=0.596N     P=0.191     |P=0.176N     P=0.629N     P=0.477N     P=0.286N     |
|COCH-ARM / FISHERS |     P=0.289      P=0.530      P=0.595N     P=0.292     |P=0.124N     P=0.636N     P=0.333N     P=0.278N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Nose                                                                                                                             |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    5/50 (10%)   4/50 (8%)    9/49 (18%)  |1/49 (2%)    1/50 (2%)    1/50 (2%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     5.1%         13.4%        9.5%         21.9%       |2.5%         2.3%         2.4%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    2/10 (20%)   2/21 (10%)   3/22 (14%)  |0/24 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     663          572          635          277         |650          722          677          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.067      P=0.123      P=0.463      P=0.054     |P=0.321N     P=0.723N     P=0.721N     P=0.506N     |
|POLY 3             |     P=0.023 *    P=0.195      P=0.372      P=0.029 *   |P=0.315N     P=0.739N     P=0.744N     P=0.498N     |
|POLY 1.5           |     P=0.020 *    P=0.211      P=0.361      P=0.027 *   |P=0.313N     P=0.747N     P=0.751N     P=0.498N     |
|POLY 6             |     P=0.028 *    P=0.167      P=0.391      P=0.035 *   |P=0.316N     P=0.727N     P=0.734N     P=0.498N     |
|LOGISTIC REGRESSION|     P=0.017 *    P=0.193      P=0.376      P=0.023 *   |P=0.309N     P=0.754N     P=0.761N     P=0.494N     |
|COCH-ARM / FISHERS |     P=0.017 *    P=0.218      P=0.339      P=0.023 *   |P=0.308N     P=0.747N     P=0.747N     P=0.495N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 23
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa                                                                                                                      |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/7 (57%)    1/2 (50%)    0/2 (0%)     0/0 (0%)    |0/2 (0%)     0/2 (0%)     0/0 (0%)     0/1 (0%)     |
|POLY-3 ADJUSTED (b)|     58.9%        56.0%        0.0%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/1 (0%)     0/0 (0%)     0/1 (0%)     0/0 (0%)    |0/1 (0%)     0/2 (0%)     0/0 (0%)     0/1 (0%)     |
|FIRST INCIDENCE    |     653          666          ---          ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.014N*    P=0.319N     P=0.043N*    P=0.056N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=1.000      P=0.756N     P=0.273N     P=1.000     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=1.000      P=0.734N     P=0.268N     P=1.000     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=1.000      P=0.782      P=0.281N     P=1.000     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.337N     P=0.427N     P=0.477N     (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.287N     P=0.722N     P=0.278N     P=1.000     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Oral Mucosa: Gingival                                                                                                            |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/7 (29%)    0/2 (0%)     2/2 (100%)   0/0 (0%)    |2/2 (100%)   1/2 (50%)    0/0 (0%)     0/1 (0%)     |
|POLY-3 ADJUSTED (b)|     32.6%        0.0%         100.0%       0.0%        |100.0%       50.0%        0.0%         0.0%         |
|TERMINAL (d)       |     1/1 (100%)   0/0 (0%)     1/1 (100%)   0/0 (0%)    |1/1 (100%)   1/2 (50%)    0/0 (0%)     0/1 (0%)     |
|FIRST INCIDENCE    |     702          ---          694          ---         |729          730 (T)      ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.331N     P=0.576N     P=0.668N     P=0.453N    |P=0.115N     P=0.300N     (e)          P=0.249N     |
|POLY 3             |     P=1.000      P=0.571N     P=0.159      P=1.000     |P=1.000N     P=0.500N     (e)          P=1.000N     |
|POLY 1.5           |     P=1.000      P=0.555N     P=0.148      P=1.000     |P=1.000N     P=0.500N     (e)          P=1.000N     |
|POLY 6             |     P=1.000      P=0.606N     P=0.186      P=1.000     |P=1.000N     P=0.500N     (e)          P=1.000N     |
|LOGISTIC REGRESSION|     P=0.305      (e)          P=0.290      (e)         |(e)          P=0.300N     (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.256      P=0.583N     P=0.167      P=1.000     |P=0.160N     P=0.500N     (e)          P=0.333N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 24
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |4/50 (8%)    4/50 (8%)    5/50 (10%)   8/50 (16%)   |
|POLY-3 ADJUSTED (b)|                                                        |9.7%         9.2%         11.7%        19.6%        |
|TERMINAL (d)       |                                                        |2/25 (8%)    3/29 (10%)   3/29 (10%)   5/24 (21%)   |
|FIRST INCIDENCE    |                                                        |460          703          656          490          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |P=0.080      P=0.551N     P=0.584      P=0.175      |
|POLY 3             |                                                        |P=0.088      P=0.611N     P=0.523      P=0.168      |
|POLY 1.5           |                                                        |P=0.092      P=0.627N     P=0.509      P=0.171      |
|POLY 6             |                                                        |P=0.085      P=0.588N     P=0.549      P=0.169      |
|LOGISTIC REGRESSION|                                                        |P=0.090      P=0.633N     P=0.507      P=0.175      |
|COCH-ARM / FISHERS |                                                        |P=0.099      P=0.643N     P=0.500      P=0.178      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pancreas: Acinus                                                                                                                 |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     23/50 (46%)  18/50 (36%)  26/50 (52%)  24/50 (48%) |13/50 (26%)  21/50 (42%)  11/50 (22%)  14/50 (28%)  |
|POLY-3 ADJUSTED (b)|     53.7%        45.9%        60.0%        56.1%       |31.7%        46.2%        25.1%        33.2%        |
|TERMINAL (d)       |     9/14 (64%)   5/10 (50%)   15/21 (71%)  13/22 (59%) |9/25 (36%)   14/29 (48%)  8/29 (28%)   8/24 (33%)   |
|FIRST INCIDENCE    |     394          560          556          379         |638          541          365          465          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.159N     P=0.538      P=0.251N     P=0.254N    |P=0.445N     P=0.192      P=0.272N     P=0.476      |
|POLY 3             |     P=0.325      P=0.305N     P=0.350      P=0.496     |P=0.342N     P=0.118      P=0.332N     P=0.537      |
|POLY 1.5           |     P=0.308      P=0.238N     P=0.363      P=0.505     |P=0.354N     P=0.092      P=0.367N     P=0.517      |
|POLY 6             |     P=0.376      P=0.441N     P=0.344      P=0.504     |P=0.322N     P=0.165      P=0.285N     P=0.570      |
|LOGISTIC REGRESSION|     P=0.331      P=0.263N     P=0.474      P=0.508     |P=0.397N     P=0.127      P=0.355N     P=0.489      |
|COCH-ARM / FISHERS |     P=0.290      P=0.208N     P=0.345      P=0.500     |P=0.368N     P=0.069      P=0.408N     P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 25
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Parathyroid Gland                                                                                                                |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/46 (4%)    9/49 (18%)   1/48 (2%)    1/47 (2%)   |0/43 (0%)    0/42 (0%)    1/42 (2%)    1/49 (2%)    |
|POLY-3 ADJUSTED (b)|     5.6%         24.4%        2.5%         2.7%        |0.0%         0.0%         2.8%         2.6%         |
|TERMINAL (d)       |     0/13 (0%)    1/10 (10%)   0/20 (0%)    0/20 (0%)   |0/19 (0%)    0/25 (0%)    1/25 (4%)    0/23 (0%)    |
|FIRST INCIDENCE    |     610          584          710          640         |---          ---          730 (T)      668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.058N     P=0.012 *    P=0.442N     P=0.515N    |P=0.241      (e)          P=0.555      P=0.519      |
|POLY 3             |     P=0.080N     P=0.024 *    P=0.460N     P=0.492N    |P=0.260      (e)          P=0.515      P=0.530      |
|POLY 1.5           |     P=0.081N     P=0.030 *    P=0.467N     P=0.491N    |P=0.262      (e)          P=0.505      P=0.528      |
|POLY 6             |     P=0.078N     P=0.017 *    P=0.450N     P=0.490N    |P=0.258      (e)          P=0.530      P=0.536      |
|LOGISTIC REGRESSION|     P=0.086N     P=0.028 *    P=0.506N     P=0.500N    |P=0.259      (e)          P=0.555      P=0.527      |
|COCH-ARM / FISHERS |     P=0.092N     P=0.032 *    P=0.484N     P=0.492N    |P=0.265      (e)          P=0.494      P=0.533      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Degeneration Cystic                                                                                                         |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    2/50 (4%)    2/49 (4%)   |5/49 (10%)   3/50 (6%)    2/50 (4%)    4/50 (8%)    |
|POLY-3 ADJUSTED (b)|     5.1%         0.0%         4.8%         5.2%        |12.3%        6.8%         4.7%         10.0%        |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    1/21 (5%)   |2/25 (8%)    1/29 (3%)    1/29 (3%)    2/24 (8%)    |
|FIRST INCIDENCE    |     582          ---          715          379         |579          589          648          703          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.543      P=0.266N     P=0.613N     P=0.666N    |P=0.500N     P=0.294N     P=0.185N     P=0.520N     |
|POLY 3             |     P=0.457      P=0.255N     P=0.674N     P=0.688     |P=0.480N     P=0.313N     P=0.197N     P=0.513N     |
|POLY 1.5           |     P=0.446      P=0.243N     P=0.679N     P=0.689     |P=0.469N     P=0.328N     P=0.204N     P=0.503N     |
|POLY 6             |     P=0.482      P=0.278N     P=0.665N     P=0.691     |P=0.491N     P=0.294N     P=0.187N     P=0.525N     |
|LOGISTIC REGRESSION|     P=0.426      P=0.250N     P=0.692      P=0.670     |P=0.459N     P=0.368N     P=0.212N     P=0.493N     |
|COCH-ARM / FISHERS |     P=0.437      P=0.247N     P=0.691N     P=0.684     |P=0.453N     P=0.346N     P=0.210N     P=0.487N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 26
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    8/50 (16%)   7/50 (14%)   8/49 (16%)  |3/49 (6%)    11/50 (22%)  12/50 (24%)  5/50 (10%)   |
|POLY-3 ADJUSTED (b)|     10.2%        20.8%        16.8%        20.6%       |7.5%         25.1%        27.7%        12.4%        |
|TERMINAL (d)       |     1/14 (7%)    1/10 (10%)   5/21 (24%)   6/21 (29%)  |2/25 (8%)    9/29 (31%)   9/29 (31%)   4/24 (17%)   |
|FIRST INCIDENCE    |     645          554          689          277         |622          666          490          589          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.466      P=0.090      P=0.478      P=0.319     |P=0.452      P=0.043 *    P=0.026 *    P=0.331      |
|POLY 3             |     P=0.207      P=0.162      P=0.297      P=0.168     |P=0.502      P=0.029 *    P=0.015 *    P=0.361      |
|POLY 1.5           |     P=0.207      P=0.176      P=0.287      P=0.172     |P=0.510      P=0.025 *    P=0.013 *    P=0.362      |
|POLY 6             |     P=0.218      P=0.137      P=0.315      P=0.169     |P=0.497      P=0.035 *    P=0.019 *    P=0.361      |
|LOGISTIC REGRESSION|     P=0.209      P=0.169      P=0.356      P=0.169     |P=0.490      P=0.043 *    P=0.017 *    P=0.361      |
|COCH-ARM / FISHERS |     P=0.198      P=0.178      P=0.262      P=0.168     |P=0.527      P=0.022 *    P=0.013 *    P=0.369      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/49 (2%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         8.2%         2.5%         5.2%        |                                                    |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   1/20 (5%)    2/22 (9%)   |                                                    |
|FIRST INCIDENCE    |     ---          670          729 (T)      729 (T)     |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.515      P=0.073      P=0.571      P=0.341     |                                                    |
|POLY 3             |     P=0.341      P=0.108      P=0.511      P=0.238     |                                                    |
|POLY 1.5           |     P=0.341      P=0.116      P=0.506      P=0.238     |                                                    |
|POLY 6             |     P=0.349      P=0.096      P=0.519      P=0.242     |                                                    |
|LOGISTIC REGRESSION|     P=0.419      P=0.085      P=0.571      P=0.341     |                                                    |
|COCH-ARM / FISHERS |     P=0.337      P=0.121      P=0.495      P=0.247     |                                                    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 27
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Granulomatous                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    0/50 (0%)    5/49 (10%)   3/50 (6%)   |                                                    |
|POLY-3 ADJUSTED (b)|     5.2%         0.0%         12.1%        7.5%        |                                                    |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/20 (0%)    0/22 (0%)   |                                                    |
|FIRST INCIDENCE    |     680          ---          542          533         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.337      P=0.326N     P=0.369      P=0.552     |                                                    |
|POLY 3             |     P=0.248      P=0.251N     P=0.243      P=0.512     |                                                    |
|POLY 1.5           |     P=0.232      P=0.241N     P=0.231      P=0.508     |                                                    |
|POLY 6             |     P=0.287      P=0.272N     P=0.263      P=0.527     |                                                    |
|LOGISTIC REGRESSION|     P=0.223      P=0.265N     P=0.225      P=0.500     |                                                    |
|COCH-ARM / FISHERS |     P=0.221      P=0.247N     P=0.210      P=0.500     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Prostate                                                                                                                         |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    6/50 (12%)   3/50 (6%)    4/50 (8%)   |                                                    |
|POLY-3 ADJUSTED (b)|     5.2%         16.0%        7.1%         9.8%        |                                                    |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |                                                    |
|FIRST INCIDENCE    |     680          639          556          277         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.545      P=0.068      P=0.607      P=0.386     |                                                    |
|POLY 3             |     P=0.490      P=0.118      P=0.542      P=0.361     |                                                    |
|POLY 1.5           |     P=0.476      P=0.129      P=0.528      P=0.355     |                                                    |
|POLY 6             |     P=0.516      P=0.099      P=0.565      P=0.375     |                                                    |
|LOGISTIC REGRESSION|     P=0.428      P=0.108      P=0.496      P=0.303     |                                                    |
|COCH-ARM / FISHERS |     P=0.446      P=0.134      P=0.500      P=0.339     |                                                    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 28
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         5.1%        |                                                    |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |                                                    |
|FIRST INCIDENCE    |     ---          ---          ---          709         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.085      (e)          (e)          P=0.336     |                                                    |
|POLY 3             |     P=0.047 *    (e)          (e)          P=0.239     |                                                    |
|POLY 1.5           |     P=0.046 *    (e)          (e)          P=0.239     |                                                    |
|POLY 6             |     P=0.050      (e)          (e)          P=0.244     |                                                    |
|LOGISTIC REGRESSION|     P=0.059      (e)          (e)          P=0.262     |                                                    |
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Acanthosis                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    4/50 (8%)    10/50 (20%) |1/50 (2%)    1/50 (2%)    4/50 (8%)    6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         9.5%         25.1%       |2.5%         2.3%         9.5%         14.4%        |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   2/21 (10%)   7/22 (32%)  |0/25 (0%)    1/29 (3%)    4/29 (14%)   1/24 (4%)    |
|FIRST INCIDENCE    |     ---          695          659          577         |650          730 (T)      730 (T)      430          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P<0.001 **   P=0.171      P=0.099      P=0.005 **  |P=0.010 *    P=0.726N     P=0.225      P=0.066      |
|POLY 3             |     P<0.001 **   P=0.224      P=0.072      P<0.001 **  |P=0.012 *    P=0.744N     P=0.191      P=0.059      |
|POLY 1.5           |     P<0.001 **   P=0.234      P=0.068      P<0.001 **  |P=0.012 *    P=0.752N     P=0.184      P=0.057      |
|POLY 6             |     P<0.001 **   P=0.208      P=0.079      P<0.001 **  |P=0.012 *    P=0.734N     P=0.203      P=0.063      |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.179      P=0.073      P<0.001 **  |P=0.013 *    P=0.756N     P=0.212      P=0.062      |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.247      P=0.059      P<0.001 **  |P=0.013 *    P=0.753N     P=0.181      P=0.056      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 29
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Degeneration                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         5.1%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          577         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.045 *    (e)          (e)          P=0.219     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.048 *    (e)          (e)          P=0.243     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.047 *    (e)          (e)          P=0.241     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.052      (e)          (e)          P=0.251     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.046 *    (e)          (e)          P=0.231     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Exudate                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    2/50 (4%)    7/50 (14%)  |1/50 (2%)    7/50 (14%)   7/50 (14%)   7/50 (14%)   |
|POLY-3 ADJUSTED (b)|     0.0%         8.2%         4.8%         17.9%       |2.5%         16.1%        16.6%        17.6%        |
|TERMINAL (d)       |     0/14 (0%)    2/10 (20%)   2/21 (10%)   4/22 (18%)  |0/25 (0%)    6/29 (21%)   7/29 (24%)   5/24 (21%)   |
|FIRST INCIDENCE    |     ---          662          729 (T)      653         |638          702          730 (T)      700          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.026 *    P=0.069      P=0.330      P=0.030 *   |P=0.049 *    P=0.056      P=0.049 *    P=0.032 *    |
|POLY 3             |     P=0.004 **   P=0.108      P=0.255      P=0.007 **  |P=0.061      P=0.038 *    P=0.034 *    P=0.027 *    |
|POLY 1.5           |     P=0.004 **   P=0.116      P=0.249      P=0.008 **  |P=0.065      P=0.034 *    P=0.032 *    P=0.028 *    |
|POLY 6             |     P=0.005 **   P=0.095      P=0.264      P=0.008 **  |P=0.058      P=0.043 *    P=0.037 *    P=0.026 *    |
|LOGISTIC REGRESSION|     P=0.009 **   P=0.080      P=0.330      P=0.011 *   |P=0.052      P=0.050      P=0.046 *    P=0.031 *    |
|COCH-ARM / FISHERS |     P=0.004 **   P=0.121      P=0.247      P=0.006 **  |P=0.073      P=0.030 *    P=0.030 *    P=0.030 *    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 30
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    5/50 (10%)   11/50 (22%) |3/50 (6%)    13/50 (26%)  23/50 (46%)  23/50 (46%)  |
|POLY-3 ADJUSTED (b)|     0.0%         8.1%         12.0%        27.2%       |7.4%         29.0%        51.4%        53.2%        |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   3/21 (14%)   5/22 (23%)  |2/25 (8%)    7/29 (24%)   13/29 (45%)  13/24 (54%)  |
|FIRST INCIDENCE    |     ---          640          702          379         |650          589          579          515          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.002 **   P=0.075      P=0.082      P=0.005 **  |P<0.001 **   P=0.024 *    P<0.001 **   P<0.001 **   |
|POLY 3             |     P<0.001 **   P=0.110      P=0.037 *    P<0.001 **  |P<0.001 **   P=0.010 *    P<0.001 **   P<0.001 **   |
|POLY 1.5           |     P<0.001 **   P=0.116      P=0.035 *    P<0.001 **  |P<0.001 **   P=0.007 **   P<0.001 **   P<0.001 **   |
|POLY 6             |     P<0.001 **   P=0.098      P=0.042 *    P<0.001 **  |P<0.001 **   P=0.014 *    P<0.001 **   P<0.001 **   |
|LOGISTIC REGRESSION|     P<0.001 **   P=0.107      P=0.056      P<0.001 **  |P<0.001 **   P=0.010 *    P<0.001 **   P<0.001 **   |
|COCH-ARM / FISHERS |     P<0.001 **   P=0.121      P=0.028 *    P<0.001 **  |P<0.001 **   P=0.006 **   P<0.001 **   P<0.001 **   |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)   |2/50 (4%)    1/50 (2%)    1/50 (2%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         0.0%         0.0%         5.1%        |4.9%         2.3%         2.4%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          ---          ---          701         |650          655          677          430          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.082      (e)          (e)          P=0.319     |P=0.418N     P=0.428N     P=0.440N     P=0.502N     |
|POLY 3             |     P=0.047 *    (e)          (e)          P=0.239     |P=0.418N     P=0.475N     P=0.485N     P=0.501N     |
|POLY 1.5           |     P=0.046 *    (e)          (e)          P=0.239     |P=0.415N     P=0.486N     P=0.493N     P=0.501N     |
|POLY 6             |     P=0.050      (e)          (e)          P=0.244     |P=0.422N     P=0.459N     P=0.473N     P=0.501N     |
|LOGISTIC REGRESSION|     P=0.059      (e)          (e)          P=0.261     |P=0.380N     P=0.520N     P=0.504N     P=0.458N     |
|COCH-ARM / FISHERS |     P=0.046 *    (e)          (e)          P=0.247     |P=0.409N     P=0.500N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 31
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Congestion                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    1/50 (2%)    3/50 (6%)    0/50 (0%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     2.6%         2.7%         7.2%         0.0%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    3/21 (14%)   0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     729 (T)      625          729 (T)      ---         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.261N     P=0.707      P=0.457      P=0.410N    |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.398N     P=0.751      P=0.333      P=0.498N    |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.404N     P=0.758      P=0.324      P=0.499N    |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.378N     P=0.735      P=0.349      P=0.494N    |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.358N     P=0.751      P=0.457      (e)         |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.409N     P=0.753N     P=0.309      P=0.500N    |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Fibrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   10/50 (20%)  9/50 (18%)   2/50 (4%)   |1/50 (2%)    0/50 (0%)    3/50 (6%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     17.2%        26.4%        21.1%        5.1%        |2.5%         0.0%         7.1%         5.0%         |
|TERMINAL (d)       |     2/14 (14%)   3/10 (30%)   3/21 (14%)   1/22 (5%)   |0/25 (0%)    0/29 (0%)    2/29 (7%)    2/24 (8%)    |
|FIRST INCIDENCE    |     101          538          568          642         |648          ---          648          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.014N*    P=0.149      P=0.584N     P=0.058N    |P=0.213      P=0.474N     P=0.353      P=0.484      |
|POLY 3             |     P=0.048N*    P=0.237      P=0.434      P=0.085N    |P=0.221      P=0.485N     P=0.323      P=0.494      |
|POLY 1.5           |     P=0.050N     P=0.270      P=0.417      P=0.084N    |P=0.229      P=0.492N     P=0.313      P=0.496      |
|POLY 6             |     P=0.041N*    P=0.186      P=0.465      P=0.082N    |P=0.211      P=0.476N     P=0.339      P=0.494      |
|LOGISTIC REGRESSION|     P=0.047N*    P=0.298      P=0.359      P=0.085N    |P=0.229      P=0.513N     P=0.314      P=0.498      |
|COCH-ARM / FISHERS |     P=0.049N*    P=0.298      P=0.393      P=0.080N    |P=0.242      P=0.500N     P=0.309      P=0.500      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 32
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    3/50 (6%)    1/50 (2%)   |1/50 (2%)    3/50 (6%)    4/50 (8%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         7.1%         2.6%        |2.5%         6.8%         9.3%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |0/25 (0%)    2/29 (7%)    1/29 (3%)    1/24 (4%)    |
|FIRST INCIDENCE    |     ---          695          556          729 (T)     |666          589          561          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.563      P=0.183      P=0.152      P=0.590     |P=0.547N     P=0.362      P=0.237      P=0.758N     |
|POLY 3             |     P=0.453      P=0.224      P=0.137      P=0.502     |P=0.541N     P=0.336      P=0.198      P=0.758      |
|POLY 1.5           |     P=0.449      P=0.234      P=0.131      P=0.501     |P=0.535N     P=0.322      P=0.188      P=0.758      |
|POLY 6             |     P=0.471      P=0.208      P=0.149      P=0.506     |P=0.546N     P=0.356      P=0.216      P=0.758      |
|LOGISTIC REGRESSION|     P=0.452      P=0.182      P=0.101      P=0.590     |P=0.525N     P=0.303      P=0.176      P=0.761      |
|COCH-ARM / FISHERS |     P=0.444      P=0.247      P=0.121      P=0.500     |P=0.523N     P=0.309      P=0.181      P=0.753N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Pigmentation Hemosiderin                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    3/50 (6%)    1/50 (2%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         8.1%         2.4%         2.5%        |0.0%         0.0%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          639          568          379         |---          ---          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.618      P=0.080      P=0.505      P=0.504     |(e)          (e)          (e)          (e)          |
|POLY 3             |     P=0.606      P=0.110      P=0.518      P=0.506     |(e)          (e)          (e)          (e)          |
|POLY 1.5           |     P=0.603      P=0.117      P=0.512      P=0.504     |(e)          (e)          (e)          (e)          |
|POLY 6             |     P=0.617      P=0.099      P=0.528      P=0.512     |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.562      P=0.113      P=0.435      P=0.388     |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.591      P=0.121      P=0.500      P=0.500     |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 33
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen: Lymphoid Follicle                                                                                                        |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     1/50 (2%)    2/50 (4%)    0/50 (0%)    0/50 (0%)   |2/50 (4%)    1/50 (2%)    0/50 (0%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     2.6%         5.4%         0.0%         0.0%        |4.9%         2.3%         0.0%         2.5%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     729 (T)      625          ---          ---         |506          666          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.142N     P=0.411      P=0.419N     P=0.410N    |P=0.367N     P=0.439N     P=0.223N     P=0.487N     |
|POLY 3             |     P=0.184N     P=0.484      P=0.484N     P=0.498N    |P=0.372N     P=0.478N     P=0.230N     P=0.509N     |
|POLY 1.5           |     P=0.185N     P=0.497      P=0.489N     P=0.499N    |P=0.370N     P=0.488N     P=0.235N     P=0.506N     |
|POLY 6             |     P=0.183N     P=0.462      P=0.476N     P=0.494N    |P=0.374N     P=0.463N     P=0.223N     P=0.510N     |
|LOGISTIC REGRESSION|     P=0.181N     P=0.468      (e)          (e)         |P=0.348N     P=0.535N     P=0.222N     P=0.479N     |
|COCH-ARM / FISHERS |     P=0.188N     P=0.500      P=0.500N     P=0.500N    |P=0.366N     P=0.500N     P=0.247N     P=0.500N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     3/50 (6%)    1/50 (2%)    2/50 (4%)    2/50 (4%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     7.6%         2.7%         4.8%         5.1%        |0.0%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     582          572          681          653         |---          ---          ---          584          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.451N     P=0.373N     P=0.434N     P=0.508N    |P=0.040 *    (e)          (e)          P=0.235      |
|POLY 3             |     P=0.485N     P=0.331N     P=0.474N     P=0.506N    |P=0.044 *    (e)          (e)          P=0.237      |
|POLY 1.5           |     P=0.494N     P=0.313N     P=0.481N     P=0.502N    |P=0.044 *    (e)          (e)          P=0.237      |
|POLY 6             |     P=0.465N     P=0.364N     P=0.461N     P=0.504N    |P=0.043 *    (e)          (e)          P=0.241      |
|LOGISTIC REGRESSION|     P=0.502N     P=0.316N     P=0.515N     P=0.500N    |P=0.049 *    (e)          (e)          P=0.240      |
|COCH-ARM / FISHERS |     P=0.500N     P=0.309N     P=0.500N     P=0.500N    |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 34
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   8/50 (16%)   9/50 (18%)   10/50 (20%) |2/50 (4%)    3/50 (6%)    5/50 (10%)   6/50 (12%)   |
|POLY-3 ADJUSTED (b)|     17.7%        20.7%        20.7%        23.9%       |4.9%         6.8%         11.4%        14.7%        |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    1/22 (5%)   |0/25 (0%)    0/29 (0%)    1/29 (3%)    3/24 (13%)   |
|FIRST INCIDENCE    |     663          610          527          379         |638          597          490          572          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.429      P=0.281      P=0.596      P=0.398     |P=0.069      P=0.582      P=0.272      P=0.133      |
|POLY 3             |     P=0.296      P=0.477      P=0.470      P=0.337     |P=0.074      P=0.540      P=0.249      P=0.133      |
|POLY 1.5           |     P=0.273      P=0.500      P=0.445      P=0.323     |P=0.076      P=0.521      P=0.232      P=0.132      |
|POLY 6             |     P=0.343      P=0.437      P=0.508      P=0.366     |P=0.073      P=0.566      P=0.275      P=0.138      |
|LOGISTIC REGRESSION|     P=0.240      P=0.483      P=0.418      P=0.297     |P=0.085      P=0.493      P=0.209      P=0.133      |
|COCH-ARM / FISHERS |     P=0.242      P=0.500      P=0.393      P=0.298     |P=0.079      P=0.500      P=0.218      P=0.134      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach: Epithelium                                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    1/50 (2%)    1/50 (2%)    1/50 (2%)   |1/50 (2%)    0/50 (0%)    2/50 (4%)    1/50 (2%)    |
|POLY-3 ADJUSTED (b)|     0.0%         2.7%         2.4%         2.5%        |2.5%         0.0%         4.7%         2.5%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          666          702          277         |506          ---          634          700          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.412      P=0.425      P=0.584      P=0.504     |P=0.489      P=0.496N     P=0.525      P=0.757N     |
|POLY 3             |     P=0.400      P=0.490      P=0.516      P=0.506     |P=0.476      P=0.487N     P=0.516      P=0.756      |
|POLY 1.5           |     P=0.395      P=0.497      P=0.511      P=0.505     |P=0.486      P=0.493N     P=0.507      P=0.757      |
|POLY 6             |     P=0.413      P=0.475      P=0.525      P=0.512     |P=0.466      P=0.478N     P=0.532      P=0.757      |
|LOGISTIC REGRESSION|     P=0.344      P=0.495      P=0.524      P=0.296     |P=0.518      P=0.477N     P=0.502      P=0.748N     |
|COCH-ARM / FISHERS |     P=0.384      P=0.500      P=0.500      P=0.500     |P=0.500      P=0.500N     P=0.500      P=0.753N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 35
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     4/50 (8%)    3/50 (6%)    2/50 (4%)    1/50 (2%)   |0/50 (0%)    0/50 (0%)    0/50 (0%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     10.2%        8.2%         4.8%         2.6%        |0.0%         0.0%         0.0%         5.0%         |
|TERMINAL (d)       |     1/14 (7%)    0/10 (0%)    0/21 (0%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     610          678          681          643         |---          ---          ---          668          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.069N     P=0.628      P=0.233N     P=0.162N    |P=0.041 *    (e)          (e)          P=0.259      |
|POLY 3             |     P=0.106N     P=0.537N     P=0.307N     P=0.178N    |P=0.044 *    (e)          (e)          P=0.236      |
|POLY 1.5           |     P=0.110N     P=0.511N     P=0.316N     P=0.178N    |P=0.044 *    (e)          (e)          P=0.236      |
|POLY 6             |     P=0.097N     P=0.583N     P=0.293N     P=0.173N    |P=0.043 *    (e)          (e)          P=0.239      |
|LOGISTIC REGRESSION|     P=0.105N     P=0.550N     P=0.310N     P=0.178N    |P=0.045 *    (e)          (e)          P=0.236      |
|COCH-ARM / FISHERS |     P=0.114N     P=0.500N     P=0.339N     P=0.181N    |P=0.046 *    (e)          (e)          P=0.247      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     7/50 (14%)   4/50 (8%)    5/50 (10%)   4/50 (8%)   |3/50 (6%)    2/50 (4%)    2/50 (4%)    2/50 (4%)    |
|POLY-3 ADJUSTED (b)|     16.9%        10.8%        11.7%        9.9%        |7.3%         4.6%         4.6%         5.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    0/22 (0%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    2/24 (8%)    |
|FIRST INCIDENCE    |     101          638          471          379         |597          638          434          730 (T)      |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.181N     P=0.397N     P=0.256N     P=0.257N    |P=0.458N     P=0.435N     P=0.461N     P=0.516N     |
|POLY 3             |     P=0.246N     P=0.326N     P=0.356N     P=0.274N    |P=0.449N     P=0.467N     P=0.475N     P=0.512N     |
|POLY 1.5           |     P=0.257N     P=0.293N     P=0.366N     P=0.272N    |P=0.442N     P=0.483N     P=0.487N     P=0.508N     |
|POLY 6             |     P=0.221N     P=0.386N     P=0.338N     P=0.267N    |P=0.457N     P=0.447N     P=0.456N     P=0.516N     |
|LOGISTIC REGRESSION|     P=0.287N     P=0.296N     P=0.542N     P=0.281N    |P=0.422N     P=0.511N     P=0.504N     P=0.503N     |
|COCH-ARM / FISHERS |     P=0.262N     P=0.262N     P=0.380N     P=0.262N    |P=0.431N     P=0.500N     P=0.500N     P=0.500N     |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 36
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Germinal Epithelium                                                                                                      |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     16/50 (32%)  10/50 (20%)  11/50 (22%)  9/50 (18%)  |                                                    |
|POLY-3 ADJUSTED (b)|     37.7%        25.6%        25.7%        22.1%       |                                                    |
|TERMINAL (d)       |     0/14 (0%)    1/10 (10%)   2/21 (10%)   2/22 (9%)   |                                                    |
|FIRST INCIDENCE    |     560          509          635          541         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.036N*    P=0.369N     P=0.067N     P=0.063N    |                                                    |
|POLY 3             |     P=0.088N     P=0.171N     P=0.167N     P=0.092N    |                                                    |
|POLY 1.5           |     P=0.091N     P=0.137N     P=0.165N     P=0.084N    |                                                    |
|POLY 6             |     P=0.080N     P=0.250N     P=0.170N     P=0.099N    |                                                    |
|LOGISTIC REGRESSION|     P=0.090N     P=0.128N     P=0.158N     P=0.081N    |                                                    |
|COCH-ARM / FISHERS |     P=0.096N     P=0.127N     P=0.184N     P=0.083N    |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes: Interstitial Cell                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     2/50 (4%)    1/50 (2%)    0/50 (0%)    2/50 (4%)   |                                                    |
|POLY-3 ADJUSTED (b)|     5.1%         2.7%         0.0%         5.1%        |                                                    |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    0/21 (0%)    1/22 (5%)   |                                                    |
|FIRST INCIDENCE    |     653          688          ---          641         |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.571N     P=0.615N     P=0.209N     P=0.664N    |                                                    |
|POLY 3             |     P=0.605      P=0.523N     P=0.222N     P=0.693N    |                                                    |
|POLY 1.5           |     P=0.597      P=0.507N     P=0.227N     P=0.692N    |                                                    |
|POLY 6             |     P=0.620      P=0.553N     P=0.215N     P=0.688N    |                                                    |
|LOGISTIC REGRESSION|     P=0.601      P=0.520N     P=0.232N     P=0.693N    |                                                    |
|COCH-ARM / FISHERS |     P=0.591      P=0.500N     P=0.247N     P=0.691N    |                                                    |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 37
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: C-Cell                                                                                                            |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     33/50 (66%)  37/50 (74%)  42/50 (84%)  33/49 (67%) |31/50 (62%)  33/50 (66%)  39/50 (78%)  29/50 (58%)  |
|POLY-3 ADJUSTED (b)|     76.6%        81.5%        86.4%        75.7%       |67.8%        70.4%        84.9%        67.2%        |
|TERMINAL (d)       |     12/14 (86%)  9/10 (90%)   17/21 (81%)  20/22 (91%) |18/25 (72%)  20/29 (69%)  26/29 (90%)  18/24 (75%)  |
|FIRST INCIDENCE    |     560          463          471          277         |438          492          561          565          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.033N*    P=0.045 *    P=0.455N     P=0.125N    |P=0.520      P=0.384N     P=0.342      P=0.493N     |
|POLY 3             |     P=0.474N     P=0.371      P=0.154      P=0.564N    |P=0.493      P=0.480      P=0.035 *    P=0.568N     |
|POLY 1.5           |     P=0.494N     P=0.355      P=0.091      P=0.568N    |P=0.512N     P=0.445      P=0.038 *    P=0.510N     |
|POLY 6             |     P=0.447N     P=0.359      P=0.280      P=0.572N    |P=0.413      P=0.539      P=0.042 *    P=0.578      |
|LOGISTIC REGRESSION|     P=0.527      P=0.189      P=0.064      P=0.518     |P=0.454N     P=0.488      P=0.075      P=0.442N     |
|COCH-ARM / FISHERS |     P=0.505      P=0.257      P=0.032 *    P=0.528     |P=0.381N     P=0.418      P=0.063      P=0.419N     |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |     0/50 (0%)    2/50 (4%)    1/50 (2%)    2/49 (4%)   |0/50 (0%)    1/50 (2%)    0/50 (0%)    0/50 (0%)    |
|POLY-3 ADJUSTED (b)|     0.0%         5.5%         2.4%         5.3%        |0.0%         2.3%         0.0%         0.0%         |
|TERMINAL (d)       |     0/14 (0%)    0/10 (0%)    1/21 (5%)    1/22 (5%)   |0/25 (0%)    0/29 (0%)    0/29 (0%)    0/24 (0%)    |
|FIRST INCIDENCE    |     ---          662          729 (T)      722         |---          597          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |     P=0.379      P=0.179      P=0.581      P=0.346     |P=0.582N     P=0.509      (e)          (e)          |
|POLY 3             |     P=0.243      P=0.225      P=0.516      P=0.233     |P=0.555N     P=0.518      (e)          (e)          |
|POLY 1.5           |     P=0.242      P=0.234      P=0.511      P=0.233     |P=0.562N     P=0.510      (e)          (e)          |
|POLY 6             |     P=0.250      P=0.210      P=0.524      P=0.236     |P=0.545N     P=0.530      (e)          (e)          |
|LOGISTIC REGRESSION|     P=0.280      P=0.215      P=0.581      P=0.299     |P=0.551N     P=0.484      (e)          (e)          |
|COCH-ARM / FISHERS |     P=0.239      P=0.247      P=0.500      P=0.242     |P=0.568N     P=0.500      (e)          (e)          |
|=================================================================================================================================|
       Date:  06/20/97                           EXPERIMENT: 05162 TEST: 09                                            Page 38
                     Statistical Analysis of Non-neoplastic Lesions in       Rats(FISCHER344)  -              DIETHANOLAMINE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |     0 MG/KG      16 MG/KG     32 MG/KG     64 MG/KG    |0 MG/KG      8 MG/KG      16 MG/KG     32 MG/KG     |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Vagina                                                                                                                           |
|     Infiltration Cellular Polymorphonuclear                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |0/0 (0%)     2/2 (100%)   0/1 (0%)     0/1 (0%)     |
|POLY-3 ADJUSTED (b)|                                                        |0.0%         100.0%       0.0%         0.0%         |
|TERMINAL (d)       |                                                        |0/0 (0%)     0/0 (0%)     0/0 (0%)     0/0 (0%)     |
|FIRST INCIDENCE    |                                                        |---          556          ---          ---          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |(e)          (e)          (e)          (e)          |
|POLY 3             |                                                        |(e)          (e)          (e)          (e)          |
|POLY 1.5           |                                                        |(e)          (e)          (e)          (e)          |
|POLY 6             |                                                        |(e)          (e)          (e)          (e)          |
|LOGISTIC REGRESSION|                                                        |(e)          (e)          (e)          (e)          |
|COCH-ARM / FISHERS |                                                        |(e)          (e)          (e)          (e)          |
|=================================================================================================================================|

(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).