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Statistical Analysis Of Non-Neoplastic Lesions

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 09/30/97

EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 08:21:25
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014
PATHOLOGIST: SELLS, D.                                                                                         CAS: 93-83-4
            

Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.

                                                 ----------------
                                                 Adrenal Gland
                                                 Adrenal Medulla
                                                 Bone Marrow
                                                 Brain
                                                 Clitoral Gland
                                                 Clitoral/Preputial Gland
                                                 Epididymis
                                                 Heart
                                                 Islets, Pancreatic
                                                 Kidney
                                                 Liver
                                                 Lung
                                                 Nose
                                                 Ovary
                                                 Pancreas
                                                 Parathyroid Gland
                                                 Pituitary Gland
                                                 Preputial Gland
                                                 Prostate
                                                 Salivary Glands
                                                 Spleen
                                                 Testes
                                                 Thymus
                                                 Thyroid Gland
                                                 Urinary Bladder
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10   
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 09/30/97     
EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 08:21:25     
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:              
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014     
PATHOLOGIST: SELLS, D.                                                                                         CAS: 93-83-4       



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

Male Mice
------------
Organ                                 Morphology
-----                                 ----------
Adrenal Cortex                         Hypertrophy
Kidney                                 Mineralization
                                       Nephropathy
Liver                                  Infarct
                                       Mixed Cell Focus
                                       Necrosis
Skin: Dermis, Skin, Site of Application
                                       Inflammation Chronic
Skin: Epidermis, Skin, Site of Application
                                       Hyperplasia
                                       Inflammation
                                       Parakeratosis
Skin: Sebaceous Gland, Skin, Site of Application
                                       Hyperplasia
Skin: Skin, Site of Application        Exudate
                                       Hyperkeratosis
                                       Ulcer
Thymus                                 Atrophy
===============================================================
Female Mice
------------
Organ                                  Morphology
-----                                  ----------
Kidney                                 Mineralization
Kidney: Renal Tubule                   Dilatation
Ovary                                  Atrophy
Ovary: Periovarian Tissue              Cyst
Skin: Dermis, Skin, Site of Application
                                       Inflammation Chronic
Skin: Epidermis, Skin, Site of Application
                                       Hyperplasia
                                       Parakeratosis
Skin: Sebaceous Gland, Skin, Site of Application
                                       Hyperplasia
Skin: Skin, Site of Application        Exudate
                                       Hyperkeratosis
Uterus: Endometrium                    Hyperplasia
                                       Hyperplasia Cystic
===============================================================
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 1

Statistical Analysis of Non-neoplastic Lesions in        Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/49 (4%)        1/50 (2%)        5/50 (10%)    |  1/50 (2%)        0/50 (0%)        1/51 (2%)       |
|POLY-3 ADJUSTED (b)|        4.3%             2.2%             11.6%         |  2.3%             0.0%             2.3%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/1 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        1/35 (3%)        4/34 (12%)    |  1/34 (3%)        0/30 (0%)        1/35 (3%)       |
|FIRST INCIDENCE    |        561              729 (T)          606           |  730 (T)          ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.100          P=0.534N         P=0.165       |  P=0.659N         P=0.525N         P=0.755N        |
|POLY 3             |        P=0.123          P=0.510N         P=0.188       |  P=0.666N         P=0.503N         P=0.760N        |
|POLY 1.5           |        P=0.128          P=0.504N         P=0.203       |  P=0.666N         P=0.501N         P=0.759N        |
|POLY 6             |        P=0.116          P=0.520N         P=0.172       |  P=0.666N         P=0.507N         P=0.759N        |
|LOGISTIC REGRESSION|        P=0.136          P=0.473N         P=0.230       |  P=0.659N         (e)              P=0.755N        |
|COCH-ARM / FISHERS |        P=0.138          P=0.492N         P=0.226       |  P=0.664N         P=0.500N         P=0.748N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex                                                                                                                   |
|     Hypertrophy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        22/49 (45%)      12/50 (24%)      10/50 (20%)   |  1/50 (2%)        1/50 (2%)        0/51 (0%)       |
|POLY-3 ADJUSTED (b)|        48.2%            26.7%            23.5%         |  2.3%             2.3%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/1 (0%)        |
|TERMINAL (d)       |        22/41 (54%)      11/35 (31%)      10/34 (29%)   |  1/34 (3%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          697              729 (T)       |  730 (T)          730 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.022N*        P=0.076N         P=0.031N*     |  P=0.329N         P=0.734          P=0.494N        |
|POLY 3             |        P=0.007N**       P=0.026N*        P=0.012N*     |  P=0.334N         P=0.757          P=0.499N        |
|POLY 1.5           |        P=0.005N**       P=0.025N*        P=0.009N**    |  P=0.333N         P=0.760          P=0.499N        |
|POLY 6             |        P=0.009N**       P=0.029N*        P=0.017N*     |  P=0.332N         P=0.753          P=0.498N        |
|LOGISTIC REGRESSION|        P=0.020N*        P=0.052N         P=0.031N*     |  P=0.329N         P=0.734          (e)             |
|COCH-ARM / FISHERS |        P=0.005N**       P=0.024N*        P=0.007N**    |  P=0.328N         P=0.753N         P=0.495N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 2

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Cortex: Capsule                                                                                                          |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        11/49 (22%)      7/50 (14%)       7/50 (14%)    |  0/50 (0%)        0/50 (0%)        0/51 (0%)       |
|POLY-3 ADJUSTED (b)|        24.0%            15.6%            16.3%         |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/1 (0%)        |
|TERMINAL (d)       |        10/41 (24%)      5/35 (14%)       5/34 (15%)    |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        691              697              676           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.306N         P=0.330N         P=0.365N      |  (e)              (e)              (e)             |
|POLY 3             |        P=0.207N         P=0.226N         P=0.262N      |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.188N         P=0.219N         P=0.237N      |  (e)              (e)              (e)             |
|POLY 6             |        P=0.233N         P=0.240N         P=0.295N      |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.254N         P=0.253N         P=0.312N      |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.162N         P=0.204N         P=0.204N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Adrenal Medulla                                                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/49 (2%)        0/50 (0%)        2/50 (4%)     |  1/50 (2%)        0/50 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             4.7%          |  2.3%             0.0%             4.6%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        0/35 (0%)        2/34 (6%)     |  1/34 (3%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |        729 (T)          ---              729 (T)       |  730 (T)          ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.312          P=0.532N         P=0.435       |  P=0.371          P=0.525N         P=0.510         |
|POLY 3             |        P=0.360          P=0.503N         P=0.476       |  P=0.361          P=0.503N         P=0.501         |
|POLY 1.5           |        P=0.363          P=0.501N         P=0.489       |  P=0.362          P=0.501N         P=0.501         |
|POLY 6             |        P=0.358          P=0.508N         P=0.460       |  P=0.362          P=0.507N         P=0.503         |
|LOGISTIC REGRESSION|        P=0.312          (e)              P=0.435       |  P=0.371          (e)              P=0.510         |
|COCH-ARM / FISHERS |        P=0.366          P=0.495N         P=0.508       |  P=0.360          P=0.500N         P=0.500         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 3

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Blood Vessel: Aorta                                                                                                              |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  2/50 (4%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  4.5%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  621              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.098N         P=0.246N         P=0.240N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.095N         P=0.243N         P=0.239N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.095N         P=0.240N         P=0.238N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.096N         P=0.251N         P=0.240N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.097N         P=0.239N         P=0.242N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.095N         P=0.247N         P=0.247N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone                                                                                                                             |
|     Fibrous Osteodystrophy                                                                                                      |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  1/50 (2%)        0/50 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  2.3%             0.0%             4.6%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  730 (T)          ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.371          P=0.525N         P=0.510         |
|POLY 3             |        (e)              (e)              (e)           |  P=0.361          P=0.503N         P=0.501         |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.362          P=0.501N         P=0.501         |
|POLY 6             |        (e)              (e)              (e)           |  P=0.362          P=0.507N         P=0.503         |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.371          (e)              P=0.510         |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.360          P=0.500N         P=0.500         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 4

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/49 (8%)        4/50 (8%)        6/50 (12%)    |  3/50 (6%)        1/50 (2%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        8.7%             8.8%             13.3%         |  6.8%             2.3%             4.5%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        3/41 (7%)        2/35 (6%)        1/34 (3%)     |  0/34 (0%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        699              621              468           |  621              730 (T)          659             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.242          P=0.575          P=0.305       |  P=0.394N         P=0.344N         P=0.491N        |
|POLY 3             |        P=0.297          P=0.638          P=0.361       |  P=0.399N         P=0.316N         P=0.500N        |
|POLY 1.5           |        P=0.304          P=0.643          P=0.369       |  P=0.399N         P=0.309N         P=0.499N        |
|POLY 6             |        P=0.288          P=0.628          P=0.349       |  P=0.398N         P=0.327N         P=0.498N        |
|LOGISTIC REGRESSION|        P=0.369          P=0.644          P=0.493       |  P=0.400N         P=0.305N         P=0.504N        |
|COCH-ARM / FISHERS |        P=0.314          P=0.631N         P=0.383       |  P=0.399N         P=0.309N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Bone Marrow                                                                                                                      |
|     Myelofibrosis                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        3/50 (6%)        0/50 (0%)     |  11/50 (22%)      9/50 (18%)       8/50 (16%)      |
|POLY-3 ADJUSTED (b)|        0.0%             6.7%             0.0%          |  24.9%            20.8%            18.2%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        3/35 (9%)        0/34 (0%)     |  9/34 (27%)       7/30 (23%)       7/35 (20%)      |
|FIRST INCIDENCE    |        ---              729 (T)          ---           |  562              639              605             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.587          P=0.095          (e)           |  P=0.247N         P=0.507N         P=0.288N        |
|POLY 3             |        P=0.604          P=0.116          (e)           |  P=0.260N         P=0.419N         P=0.305N        |
|POLY 1.5           |        P=0.622          P=0.118          (e)           |  P=0.259N         P=0.408N         P=0.303N        |
|POLY 6             |        P=0.582          P=0.112          (e)           |  P=0.258N         P=0.441N         P=0.304N        |
|LOGISTIC REGRESSION|        (e)              P=0.095          (e)           |  P=0.255N         P=0.425N         P=0.300N        |
|COCH-ARM / FISHERS |        P=0.634N         P=0.125          (e)           |  P=0.261N         P=0.402N         P=0.306N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 5

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart                                                                                                                            |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  4/50 (8%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  8.9%             0.0%             2.3%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  435              ---              604             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.086N         P=0.076N         P=0.184N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.081N         P=0.066N         P=0.183N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.080N         P=0.063N         P=0.181N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.081N         P=0.070N         P=0.183N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.088N         P=0.064N         P=0.191N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.082N         P=0.059N         P=0.181N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Heart: Pericardium                                                                                                               |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  2/50 (4%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  4.5%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  562              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.101N         P=0.245N         P=0.247N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.096N         P=0.245N         P=0.241N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.095N         P=0.240N         P=0.239N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.096N         P=0.252N         P=0.242N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.102N         P=0.244N         P=0.252N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.095N         P=0.247N         P=0.247N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 6

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Islets, Pancreatic                                                                                                               |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        30/49 (61%)      28/50 (56%)      26/50 (52%)   |  7/49 (14%)       8/50 (16%)       6/50 (12%)      |
|POLY-3 ADJUSTED (b)|        63.4%            59.0%            56.0%         |  15.8%            18.3%            13.7%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        26/41 (63%)      19/35 (54%)      17/34 (50%)   |  4/34 (12%)       6/30 (20%)       4/35 (11%)      |
|FIRST INCIDENCE    |        452              425              356           |  562              501              669             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.483          P=0.444          P=0.525       |  P=0.431N         P=0.435          P=0.491N        |
|POLY 3             |        P=0.267N         P=0.409N         P=0.302N      |  P=0.454N         P=0.488          P=0.508N        |
|POLY 1.5           |        P=0.239N         P=0.404N         P=0.272N      |  P=0.440N         P=0.505          P=0.496N        |
|POLY 6             |        P=0.303N         P=0.417N         P=0.341N      |  P=0.466N         P=0.460          P=0.519N        |
|LOGISTIC REGRESSION|        P=0.226N         P=0.397N         P=0.248N      |  P=0.426N         P=0.517          P=0.484N        |
|COCH-ARM / FISHERS |        P=0.205N         P=0.373N         P=0.235N      |  P=0.427N         P=0.517          P=0.484N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Accumulation, Hyaline Droplet                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        1/50 (2%)        0/50 (0%)     |  3/50 (6%)        3/50 (6%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             0.0%          |  6.6%             6.9%             6.7%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              567              ---           |  435              659              552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.729          P=0.509          (e)           |  P=0.577N         P=0.642          P=0.657         |
|POLY 3             |        P=0.718          P=0.499          (e)           |  P=0.577          P=0.639          P=0.656         |
|POLY 1.5           |        P=0.724          P=0.500          (e)           |  P=0.579          P=0.649          P=0.658         |
|POLY 6             |        P=0.710          P=0.496          (e)           |  P=0.579          P=0.624          P=0.659         |
|LOGISTIC REGRESSION|        P=0.704N         P=0.578          (e)           |  P=0.551          P=0.650          P=0.629         |
|COCH-ARM / FISHERS |        P=0.728N         P=0.505          (e)           |  P=0.583          P=0.661N         P=0.661N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 7

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/49 (6%)        1/50 (2%)        3/50 (6%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.6%             2.2%             7.0%          |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        3/41 (7%)        1/35 (3%)        3/34 (9%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.510          P=0.363N         P=0.574       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.580          P=0.312N         P=0.630       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.589          P=0.307N         P=0.647       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.568          P=0.320N         P=0.608       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.510          P=0.363N         P=0.574       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.585N         P=0.301N         P=0.651N      |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        37/49 (76%)      39/50 (78%)      28/50 (56%)   |  9/50 (18%)       2/50 (4%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        80.9%            84.4%            62.5%         |  20.1%            4.7%             4.6%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        36/41 (88%)      32/35 (91%)      22/34 (65%)   |  4/34 (12%)       2/30 (7%)        2/35 (6%)       |
|FIRST INCIDENCE    |        695              567              468           |  562              730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.315N         P=0.046 *        P=0.311N      |  P=0.012N*        P=0.045N*        P=0.031N*       |
|POLY 3             |        P=0.021N*        P=0.428          P=0.035N*     |  P=0.010N*        P=0.030N*        P=0.028N*       |
|POLY 1.5           |        P=0.020N*        P=0.434          P=0.032N*     |  P=0.009N**       P=0.027N*        P=0.026N*       |
|POLY 6             |        P=0.024N*        P=0.409          P=0.040N*     |  P=0.010N*        P=0.035N*        P=0.029N*       |
|LOGISTIC REGRESSION|        P=0.086N         P=0.220          P=0.108N      |  P=0.010N*        P=0.028N*        P=0.027N*       |
|COCH-ARM / FISHERS |        P=0.022N*        P=0.478          P=0.033N*     |  P=0.010N*        P=0.026N*        P=0.026N*       |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 8

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney                                                                                                                           |
|     Nephropathy                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        44/49 (90%)      38/50 (76%)      38/50 (76%)   |  11/50 (22%)      6/50 (12%)       16/50 (32%)     |
|POLY-3 ADJUSTED (b)|        93.9%            81.5%            84.1%         |  25.0%            13.8%            36.0%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        40/41 (98%)      32/35 (91%)      29/34 (85%)   |  10/34 (29%)      4/30 (13%)       14/35 (40%)     |
|FIRST INCIDENCE    |        452              547              577           |  562              624              527             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.432          P=0.596N         P=0.471       |  P=0.156          P=0.200N         P=0.198         |
|POLY 3             |        P=0.086N         P=0.049N*        P=0.096N      |  P=0.134          P=0.144N         P=0.185         |
|POLY 1.5           |        P=0.070N         P=0.055N         P=0.076N      |  P=0.136          P=0.142N         P=0.186         |
|POLY 6             |        P=0.103N         P=0.048N*        P=0.124N      |  P=0.136          P=0.150N         P=0.190         |
|LOGISTIC REGRESSION|        P=0.179N         P=0.065N         P=0.188N      |  P=0.139          P=0.151N         P=0.183         |
|COCH-ARM / FISHERS |        P=0.055N         P=0.059N         P=0.059N      |  P=0.139          P=0.143N         P=0.184         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Kidney: Renal Tubule                                                                                                             |
|     Dilatation                                                                                                                  |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/50 (0%)        0/50 (0%)     |  3/50 (6%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  6.7%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  562              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.040N*        P=0.128N         P=0.128N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.036N*        P=0.126N         P=0.123N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.036N*        P=0.122N         P=0.120N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.037N*        P=0.133N         P=0.125N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.039N*        P=0.123N         P=0.128N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.037N*        P=0.121N         P=0.121N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 9

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Basophilic Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/49 (8%)        3/50 (6%)        3/50 (6%)     |  0/50 (0%)        1/50 (2%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        8.8%             6.7%             6.9%          |  0.0%             2.3%             2.3%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        4/41 (10%)       3/35 (9%)        1/34 (3%)     |  0/34 (0%)        0/30 (0%)        1/35 (3%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          537           |  ---              704              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.512N         P=0.586N         P=0.587N      |  P=0.342          P=0.483          P=0.506         |
|POLY 3             |        P=0.448N         P=0.510N         P=0.528N      |  P=0.333          P=0.497          P=0.501         |
|POLY 1.5           |        P=0.433N         P=0.503N         P=0.512N      |  P=0.334          P=0.499          P=0.501         |
|POLY 6             |        P=0.468N         P=0.522N         P=0.547N      |  P=0.335          P=0.494          P=0.502         |
|LOGISTIC REGRESSION|        P=0.437N         P=0.586N         P=0.496N      |  P=0.334          P=0.498          P=0.506         |
|COCH-ARM / FISHERS |        P=0.410N         P=0.489N         P=0.489N      |  P=0.331          P=0.500          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Clear Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/49 (8%)        7/50 (14%)       8/50 (16%)    |  3/50 (6%)        2/50 (4%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|        8.8%             15.6%            18.8%         |  6.9%             4.7%             6.9%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        4/41 (10%)       7/35 (20%)       8/34 (24%)    |  2/34 (6%)        2/30 (7%)        3/35 (9%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)       |  682              730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.075          P=0.176          P=0.098       |  P=0.574N         P=0.553N         P=0.651N        |
|POLY 3             |        P=0.116          P=0.251          P=0.144       |  P=0.587          P=0.509N         P=0.662         |
|POLY 1.5           |        P=0.131          P=0.258          P=0.161       |  P=0.587N         P=0.503N         P=0.661N        |
|POLY 6             |        P=0.098          P=0.237          P=0.124       |  P=0.588          P=0.521N         P=0.663         |
|LOGISTIC REGRESSION|        P=0.075          P=0.176          P=0.098       |  P=0.579N         P=0.526N         P=0.658N        |
|COCH-ARM / FISHERS |        P=0.155          P=0.274          P=0.188       |  P=0.588          P=0.500N         P=0.661N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 10

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Eosinophilic Focus                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        12/49 (24%)      9/50 (18%)       9/50 (18%)    |  15/50 (30%)      13/50 (26%)      14/50 (28%)     |
|POLY-3 ADJUSTED (b)|        26.2%            19.8%            21.1%         |  33.5%            29.2%            31.8%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        11/41 (27%)      7/35 (20%)       8/34 (24%)    |  11/34 (32%)      8/30 (27%)       12/35 (34%)     |
|FIRST INCIDENCE    |        699              547              691           |  562              501              673             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.436N         P=0.450N         P=0.496N      |  P=0.430N         P=0.529N         P=0.471N        |
|POLY 3             |        P=0.319N         P=0.315N         P=0.374N      |  P=0.476N         P=0.416N         P=0.523N        |
|POLY 1.5           |        P=0.290N         P=0.309N         P=0.340N      |  P=0.465N         P=0.410N         P=0.510N        |
|POLY 6             |        P=0.357N         P=0.330N         P=0.419N      |  P=0.484N         P=0.432N         P=0.531N        |
|LOGISTIC REGRESSION|        P=0.362N         P=0.331N         P=0.467N      |  P=0.451N         P=0.418N         P=0.495N        |
|COCH-ARM / FISHERS |        P=0.249N         P=0.294N         P=0.294N      |  P=0.456N         P=0.412N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Infarct                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/49 (6%)        0/50 (0%)        0/50 (0%)     |  0/50 (0%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.5%             0.0%             0.0%          |  0.0%             2.3%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        0/35 (0%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        456              ---              ---           |  ---              682              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.047N*        P=0.139N         P=0.148N      |  P=0.727          P=0.484          (e)             |
|POLY 3             |        P=0.039N*        P=0.126N         P=0.135N      |  P=0.729N         P=0.498          (e)             |
|POLY 1.5           |        P=0.037N*        P=0.122N         P=0.127N      |  P=0.729N         P=0.500          (e)             |
|POLY 6             |        P=0.042N*        P=0.131N         P=0.146N      |  P=0.729N         P=0.494          (e)             |
|LOGISTIC REGRESSION|        P=0.024N*        P=0.082N         P=0.073N      |  P=0.730          P=0.500          (e)             |
|COCH-ARM / FISHERS |        P=0.036N*        P=0.117N         P=0.117N      |  P=0.731          P=0.500          (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 11

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Mixed Cell Focus                                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        4/49 (8%)        15/50 (30%)      10/50 (20%)   |  8/50 (16%)       8/50 (16%)       7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        8.8%             33.5%            23.5%         |  18.2%            18.3%            16.1%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        4/41 (10%)       15/35 (43%)      10/34 (29%)   |  6/34 (18%)       5/30 (17%)       7/35 (20%)      |
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)       |  621              584              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.027 *        P<0.001 **       P=0.031 *     |  P=0.423N         P=0.522          P=0.476N        |
|POLY 3             |        P=0.046 *        P=0.003 **       P=0.053       |  P=0.450N         P=0.604          P=0.506N        |
|POLY 1.5           |        P=0.060          P=0.004 **       P=0.063       |  P=0.446N         P=0.607N         P=0.501N        |
|POLY 6             |        P=0.032 *        P=0.002 **       P=0.043 *     |  P=0.452N         P=0.593          P=0.508N        |
|LOGISTIC REGRESSION|        P=0.027 *        P<0.001 **       P=0.031 *     |  P=0.439N         P=0.594          P=0.490N        |
|COCH-ARM / FISHERS |        P=0.089          P=0.005 **       P=0.080       |  P=0.445N         P=0.607N         P=0.500N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Liver                                                                                                                            |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        7/49 (14%)       1/50 (2%)        9/50 (18%)    |  2/50 (4%)        1/50 (2%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        14.8%            2.2%             19.6%         |  4.6%             2.3%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        3/41 (7%)        0/35 (0%)        1/34 (3%)     |  0/34 (0%)        1/30 (3%)        0/35 (0%)       |
|FIRST INCIDENCE    |        452              720              468           |  654              730 (T)          ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.263          P=0.050N         P=0.321       |  P=0.146N         P=0.541N         P=0.237N        |
|POLY 3             |        P=0.309          P=0.036N*        P=0.370       |  P=0.143N         P=0.508N         P=0.238N        |
|POLY 1.5           |        P=0.316          P=0.033N*        P=0.383       |  P=0.142N         P=0.503N         P=0.237N        |
|POLY 6             |        P=0.302          P=0.041N*        P=0.356       |  P=0.143N         P=0.518N         P=0.238N        |
|LOGISTIC REGRESSION|        P=0.453          P=0.020N*        P=0.611N      |  P=0.142N         P=0.503N         P=0.237N        |
|COCH-ARM / FISHERS |        P=0.331          P=0.028N*        P=0.410       |  P=0.142N         P=0.500N         P=0.247N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 12

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung                                                                                                                             |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        3/50 (6%)        0/50 (0%)     |  0/50 (0%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             6.6%             0.0%          |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        0/34 (0%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              621              ---           |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.596          P=0.106          (e)           |  (e)              (e)              (e)             |
|POLY 3             |        P=0.604          P=0.117          (e)           |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.622          P=0.119          (e)           |  (e)              (e)              (e)             |
|POLY 6             |        P=0.581          P=0.114          (e)           |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.636N         P=0.125          (e)           |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.634N         P=0.125          (e)           |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lung: Alveolar Epithelium                                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        5/49 (10%)       3/50 (6%)        8/50 (16%)    |  2/50 (4%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        11.0%            6.7%             18.7%         |  4.5%             0.0%             2.3%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        5/41 (12%)       1/35 (3%)        7/34 (21%)    |  1/34 (3%)        0/30 (0%)        1/35 (3%)       |
|FIRST INCIDENCE    |        729 (T)          712              691           |  471              ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.131          P=0.441N         P=0.167       |  P=0.358N         P=0.253N         P=0.493N        |
|POLY 3             |        P=0.186          P=0.365N         P=0.234       |  P=0.363N         P=0.244N         P=0.505N        |
|POLY 1.5           |        P=0.199          P=0.359N         P=0.256       |  P=0.362N         P=0.241N         P=0.502N        |
|POLY 6             |        P=0.171          P=0.376N         P=0.208       |  P=0.364N         P=0.250N         P=0.505N        |
|LOGISTIC REGRESSION|        P=0.136          P=0.396N         P=0.176       |  P=0.369N         P=0.245N         P=0.511N        |
|COCH-ARM / FISHERS |        P=0.219          P=0.346N         P=0.290       |  P=0.360N         P=0.247N         P=0.500N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 13

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mandibular                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/48 (2%)        0/46 (0%)        0/47 (0%)     |  1/49 (2%)        2/49 (4%)        3/47 (6%)       |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             0.0%          |  2.4%             4.8%             7.1%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        0/32 (0%)        0/34 (0%)     |  1/34 (3%)        2/29 (7%)        3/34 (9%)       |
|FIRST INCIDENCE    |        729 (T)          ---              ---           |  730 (T)          730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.301N         P=0.549N         P=0.537N      |  P=0.226          P=0.444          P=0.304         |
|POLY 3             |        P=0.287N         P=0.519N         P=0.518N      |  P=0.220          P=0.494          P=0.301         |
|POLY 1.5           |        P=0.281N         P=0.515N         P=0.513N      |  P=0.217          P=0.498          P=0.299         |
|POLY 6             |        P=0.294N         P=0.524N         P=0.526N      |  P=0.223          P=0.486          P=0.305         |
|LOGISTIC REGRESSION|        P=0.301N         (e)              (e)           |  P=0.226          P=0.444          P=0.304         |
|COCH-ARM / FISHERS |        P=0.273N         P=0.511N         P=0.505N      |  P=0.209          P=0.500          P=0.293         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/47 (2%)        0/48 (0%)        2/48 (4%)     |  0/49 (0%)        0/47 (0%)        0/49 (0%)       |
|POLY-3 ADJUSTED (b)|        2.3%             0.0%             4.9%          |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/40 (3%)        0/34 (0%)        2/32 (6%)     |  0/34 (0%)        0/28 (0%)        0/34 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              729 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.303          P=0.532N         P=0.422       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.360          P=0.503N         P=0.469       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.362          P=0.499N         P=0.484       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.357          P=0.508N         P=0.451       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.303          (e)              P=0.422       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.366          P=0.495N         P=0.508       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 14

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Lymph Node, Mesenteric                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/47 (4%)        0/48 (0%)        0/48 (0%)     |  1/49 (2%)        0/47 (0%)        2/49 (4%)       |
|POLY-3 ADJUSTED (b)|        4.5%             0.0%             0.0%          |  2.3%             0.0%             4.7%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        2/40 (5%)        0/34 (0%)        0/32 (0%)     |  1/34 (3%)        0/28 (0%)        2/34 (6%)       |
|FIRST INCIDENCE    |        729 (T)          ---              ---           |  730 (T)          ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.121N         P=0.275N         P=0.289N      |  P=0.364          P=0.539N         P=0.500         |
|POLY 3             |        P=0.102N         P=0.240N         P=0.258N      |  P=0.360          P=0.515N         P=0.495         |
|POLY 1.5           |        P=0.098N         P=0.236N         P=0.247N      |  P=0.361          P=0.512N         P=0.498         |
|POLY 6             |        P=0.107N         P=0.246N         P=0.270N      |  P=0.360          P=0.520N         P=0.495         |
|LOGISTIC REGRESSION|        P=0.121N         (e)              (e)           |  P=0.364          (e)              P=0.500         |
|COCH-ARM / FISHERS |        P=0.093N         P=0.242N         P=0.242N      |  P=0.361          P=0.510N         P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery                                                                                                                        |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/4 (0%)         0/4 (0%)         0/3 (0%)      |  2/12 (17%)       2/7 (29%)        1/9 (11%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  17.8%            30.5%            13.6%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/2 (0%)         0/3 (0%)         0/3 (0%)      |  1/8 (13%)        2/5 (40%)        1/6 (17%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  578              730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.482N         P=0.569          P=0.568N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.580N         P=0.488          P=0.647N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.555N         P=0.489          P=0.632N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.604N         P=0.482          P=0.662N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.523N         P=0.454          P=0.599N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.508N         P=0.475          P=0.612N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 15

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Mesentery: Fat                                                                                                                   |
|     Necrosis                                                                                                                    |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        2/4 (50%)        3/4 (75%)        2/3 (67%)     |  9/12 (75%)       5/7 (71%)        5/9 (56%)       |
|POLY-3 ADJUSTED (b)|        63.3%            75.7%            66.7%         |  78.6%            71.4%            64.8%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        2/2 (100%)       3/3 (100%)       2/3 (67%)     |  7/8 (88%)        3/5 (60%)        4/6 (67%)       |
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)       |  562              659              637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.315N         P=1.000N         P=0.581N      |  P=0.208N         P=0.421N         P=0.271N        |
|POLY 3             |        P=0.645          P=0.665          P=0.750       |  P=0.352N         P=0.582N         P=0.444N        |
|POLY 1.5           |        P=0.571          P=0.597          P=0.695       |  P=0.320N         P=0.607N         P=0.402N        |
|POLY 6             |        P=0.639N         P=0.743          P=0.759N      |  P=0.373N         P=0.546N         P=0.475N        |
|LOGISTIC REGRESSION|        P=0.315N         P=1.000N         P=0.581N      |  P=0.316N         P=0.628N         P=0.418N        |
|COCH-ARM / FISHERS |        P=0.457          P=0.500          P=0.629       |  P=0.245N         P=0.634N         P=0.319N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary                                                                                                                            |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  5/51 (10%)       0/50 (0%)        5/50 (10%)      |
|POLY-3 ADJUSTED (b)|                                                        |  11.3%            0.0%             11.2%           |
|INT SACRIFICE 1 (c)|                                                        |  0/1 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |                                                        |  3/34 (9%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |                                                        |  562              ---              604             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.568N         P=0.045N*        P=0.617N        |
|POLY 3             |                                                        |  P=0.579          P=0.033N*        P=0.626N        |
|POLY 1.5           |                                                        |  P=0.577          P=0.032N*        P=0.627N        |
|POLY 6             |                                                        |  P=0.581N         P=0.036N*        P=0.620N        |
|LOGISTIC REGRESSION|                                                        |  P=0.570          P=0.034N*        P=0.620         |
|COCH-ARM / FISHERS |                                                        |  P=0.569          P=0.030N*        P=0.617         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 16

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary: Follicle                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  8/51 (16%)       11/50 (22%)      14/50 (28%)     |
|POLY-3 ADJUSTED (b)|                                                        |  17.8%            25.3%            30.9%           |
|INT SACRIFICE 1 (c)|                                                        |  1/1 (100%)       0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |                                                        |  6/34 (18%)       9/30 (30%)       11/35 (31%)     |
|FIRST INCIDENCE    |                                                        |  94 (I)           585              369             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.069          P=0.153          P=0.082         |
|POLY 3             |                                                        |  P=0.092          P=0.276          P=0.113         |
|POLY 1.5           |                                                        |  P=0.091          P=0.285          P=0.111         |
|POLY 6             |                                                        |  P=0.095          P=0.260          P=0.117         |
|LOGISTIC REGRESSION|                                                        |  P=0.084          P=0.289          P=0.095         |
|COCH-ARM / FISHERS |                                                        |  P=0.084          P=0.289          P=0.104         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Ovary: Periovarian Tissue                                                                                                        |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  0/51 (0%)        0/50 (0%)        3/50 (6%)       |
|POLY-3 ADJUSTED (b)|                                                        |  0.0%             0.0%             6.8%            |
|INT SACRIFICE 1 (c)|                                                        |  0/1 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |                                                        |  0/34 (0%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |                                                        |  ---              ---              552             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.040 *        (e)              P=0.124         |
|POLY 3             |                                                        |  P=0.036 *        (e)              P=0.121         |
|POLY 1.5           |                                                        |  P=0.036 *        (e)              P=0.121         |
|POLY 6             |                                                        |  P=0.036 *        (e)              P=0.123         |
|LOGISTIC REGRESSION|                                                        |  P=0.035 *        (e)              P=0.114         |
|COCH-ARM / FISHERS |                                                        |  P=0.036 *        (e)              P=0.118         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 17

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland                                                                                                                  |
|     Angiectasis                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        0/47 (0%)        0/50 (0%)     |  4/50 (8%)        0/50 (0%)        1/50 (2%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  9.2%             0.0%             2.3%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/33 (0%)        0/34 (0%)     |  4/34 (12%)       0/30 (0%)        1/35 (3%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  730 (T)          ---              730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.081N         P=0.079N         P=0.170N        |
|POLY 3             |        (e)              (e)              (e)           |  P=0.079N         P=0.062N         P=0.177N        |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.079N         P=0.061N         P=0.177N        |
|POLY 6             |        (e)              (e)              (e)           |  P=0.079N         P=0.064N         P=0.175N        |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  P=0.081N         (e)              P=0.170N        |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.082N         P=0.059N         P=0.181N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Pituitary Gland: Pars Distalis                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/49 (2%)        0/47 (0%)        1/50 (2%)     |  9/50 (18%)       6/50 (12%)       7/50 (14%)      |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             2.3%          |  20.2%            13.8%            16.0%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        0/33 (0%)        1/34 (3%)     |  6/34 (18%)       4/30 (13%)       6/35 (17%)      |
|FIRST INCIDENCE    |        729 (T)          ---              729 (T)       |  562              585              692             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.624          P=0.543N         P=0.720       |  P=0.326N         P=0.355N         P=0.379N        |
|POLY 3             |        P=0.668          P=0.513N         P=0.745       |  P=0.348N         P=0.302N         P=0.408N        |
|POLY 1.5           |        P=0.669          P=0.510N         P=0.753       |  P=0.341N         P=0.293N         P=0.399N        |
|POLY 6             |        P=0.667          P=0.518N         P=0.734       |  P=0.355N         P=0.320N         P=0.415N        |
|LOGISTIC REGRESSION|        P=0.624          (e)              P=0.720       |  P=0.333N         P=0.289N         P=0.389N        |
|COCH-ARM / FISHERS |        P=0.663N         P=0.510N         P=0.747N      |  P=0.336N         P=0.288N         P=0.393N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 18

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        17/48 (35%)      12/50 (24%)      10/50 (20%)   |                                                    |
|POLY-3 ADJUSTED (b)|        38.0%            26.3%            23.4%         |                                                    |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |                                                    |
|TERMINAL (d)       |        16/40 (40%)      10/35 (29%)      9/34 (27%)    |                                                    |
|FIRST INCIDENCE    |        691              547              660           |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.157N         P=0.312N         P=0.190N      |                                                    |
|POLY 3             |        P=0.079N         P=0.167N         P=0.103N      |                                                    |
|POLY 1.5           |        P=0.067N         P=0.164N         P=0.087N      |                                                    |
|POLY 6             |        P=0.098N         P=0.178N         P=0.128N      |                                                    |
|LOGISTIC REGRESSION|        P=0.105N         P=0.189N         P=0.157N      |                                                    |
|COCH-ARM / FISHERS |        P=0.054N         P=0.155N         P=0.069N      |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Preputial Gland                                                                                                                  |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        5/48 (10%)       1/50 (2%)        2/50 (4%)     |                                                    |
|POLY-3 ADJUSTED (b)|        11.1%            2.2%             4.7%          |                                                    |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |                                                    |
|TERMINAL (d)       |        3/40 (8%)        1/35 (3%)        2/34 (6%)     |                                                    |
|FIRST INCIDENCE    |        667              729 (T)          729 (T)       |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.186N         P=0.137N         P=0.294N      |                                                    |
|POLY 3             |        P=0.139N         P=0.102N         P=0.239N      |                                                    |
|POLY 1.5           |        P=0.131N         P=0.099N         P=0.222N      |                                                    |
|POLY 6             |        P=0.150N         P=0.109N         P=0.262N      |                                                    |
|LOGISTIC REGRESSION|        P=0.147N         P=0.099N         P=0.237N      |                                                    |
|COCH-ARM / FISHERS |        P=0.122N         P=0.093N         P=0.201N      |                                                    |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 19

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Seminal Vesicle                                                                                                                  |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        0/50 (0%)     |                                                    |
|POLY-3 ADJUSTED (b)|        0.0%             4.5%             0.0%          |                                                    |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |                                                    |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        0/34 (0%)     |                                                    |
|FIRST INCIDENCE    |        ---              729 (T)          ---           |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.626          P=0.204          (e)           |                                                    |
|POLY 3             |        P=0.643          P=0.233          (e)           |                                                    |
|POLY 1.5           |        P=0.656          P=0.236          (e)           |                                                    |
|POLY 6             |        P=0.626          P=0.228          (e)           |                                                    |
|LOGISTIC REGRESSION|        (e)              P=0.204          (e)           |                                                    |
|COCH-ARM / FISHERS |        P=0.665N         P=0.253          (e)           |                                                    |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin                                                                                                                             |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/54 (0%)        0/55 (0%)        2/55 (4%)     |  0/55 (0%)        0/55 (0%)        0/55 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             4.7%          |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/5 (0%)         0/5 (0%)         0/5 (0%)      |  0/5 (0%)         0/5 (0%)         0/5 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        2/34 (6%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              729 (T)       |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.080          (e)              P=0.198       |  (e)              (e)              (e)             |
|POLY 3             |        P=0.095          (e)              P=0.222       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.095          (e)              P=0.230       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.095          (e)              P=0.213       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        (e)              (e)              P=0.198       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.097          (e)              P=0.252       |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 20

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Dermis, Skin, Site of Application                                                                                          |
|     Inflammation Chronic                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/54 (0%)        39/55 (71%)      55/55 (100%)  |  0/55 (0%)        44/55 (80%)      53/55 (96%)     |
|POLY-3 ADJUSTED (b)|        0.0%             74.0%            100.0%        |  0.0%             84.2%            99.8%           |
|INT SACRIFICE 1 (c)|        0/5 (0%)         5/5 (100%)       5/5 (100%)    |  0/5 (0%)         4/5 (80%)        4/5 (80%)       |
|TERMINAL (d)       |        0/41 (0%)        24/35 (69%)      34/34 (100%)  |  0/34 (0%)        23/30 (77%)      35/35 (100%)    |
|FIRST INCIDENCE    |        ---              94 (I)           94 (I)        |  ---              94 (I)           94 (I)          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/54 (2%)        45/55 (82%)      52/55 (95%)   |  0/55 (0%)        48/55 (87%)      54/55 (98%)     |
|POLY-3 ADJUSTED (b)|        2.2%             83.4%            94.5%         |  0.0%             91.1%            100.0%          |
|INT SACRIFICE 1 (c)|        0/5 (0%)         5/5 (100%)       5/5 (100%)    |  0/5 (0%)         5/5 (100%)       4/5 (80%)       |
|TERMINAL (d)       |        1/41 (2%)        29/35 (83%)      31/34 (91%)   |  0/34 (0%)        28/30 (93%)      35/35 (100%)    |
|FIRST INCIDENCE    |        729 (T)          94 (I)           94 (I)        |  ---              94 (I)           94 (I)          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 21

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Inflammation                                                                                                                |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/54 (0%)        0/55 (0%)        4/55 (7%)     |  0/55 (0%)        0/55 (0%)        0/55 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             9.2%          |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/5 (0%)         0/5 (0%)         1/5 (20%)     |  0/5 (0%)         0/5 (0%)         0/5 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        3/34 (9%)     |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              94 (I)        |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.012 *        (e)              P=0.048 *     |  (e)              (e)              (e)             |
|POLY 3             |        P=0.013 *        (e)              P=0.055       |  (e)              (e)              (e)             |
|POLY 1.5           |        P=0.014 *        (e)              P=0.059       |  (e)              (e)              (e)             |
|POLY 6             |        P=0.013 *        (e)              P=0.050       |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P=0.016 *        (e)              P=0.069       |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.015 *        (e)              P=0.061       |  (e)              (e)              (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis, Skin, Site of Application                                                                                       |
|     Parakeratosis                                                                                                               |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/54 (0%)        3/55 (5%)        12/55 (22%)   |  0/55 (0%)        0/55 (0%)        4/55 (7%)       |
|POLY-3 ADJUSTED (b)|        0.0%             6.5%             24.9%         |  0.0%             0.0%             8.9%            |
|INT SACRIFICE 1 (c)|        0/5 (0%)         1/5 (20%)        4/5 (80%)     |  0/5 (0%)         0/5 (0%)         0/5 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        5/34 (15%)    |  0/34 (0%)        0/30 (0%)        2/35 (6%)       |
|FIRST INCIDENCE    |        ---              94 (I)           94 (I)        |  ---              ---              478             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P=0.105          P<0.001 **    |  P=0.017 *        (e)              P=0.069         |
|POLY 3             |        P<0.001 **       P=0.120          P<0.001 **    |  P=0.014 *        (e)              P=0.065         |
|POLY 1.5           |        P<0.001 **       P=0.122          P<0.001 **    |  P=0.014 *        (e)              P=0.063         |
|POLY 6             |        P<0.001 **       P=0.116          P<0.001 **    |  P=0.015 *        (e)              P=0.067         |
|LOGISTIC REGRESSION|        P<0.001 **       P=0.128          P<0.001 **    |  P=0.015 *        (e)              P=0.063         |
|COCH-ARM / FISHERS |        P<0.001 **       P=0.125          P<0.001 **    |  P=0.015 *        (e)              P=0.059         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 22

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland, Skin, Site of Application                                                                                 |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/54 (2%)        26/55 (47%)      39/55 (71%)   |  0/55 (0%)        44/55 (80%)      51/55 (93%)     |
|POLY-3 ADJUSTED (b)|        2.2%             49.9%            75.3%         |  0.0%             85.5%            96.2%           |
|INT SACRIFICE 1 (c)|        0/5 (0%)         5/5 (100%)       5/5 (100%)    |  0/5 (0%)         5/5 (100%)       5/5 (100%)      |
|TERMINAL (d)       |        1/41 (2%)        17/35 (49%)      25/34 (74%)   |  0/34 (0%)        27/30 (90%)      35/35 (100%)    |
|FIRST INCIDENCE    |        729 (T)          94 (I)           94 (I)        |  ---              94 (I)           94 (I)          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Exudate                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/54 (2%)        3/55 (5%)        9/55 (16%)    |  0/55 (0%)        0/55 (0%)        6/55 (11%)      |
|POLY-3 ADJUSTED (b)|        2.2%             6.7%             20.6%         |  0.0%             0.0%             13.5%           |
|INT SACRIFICE 1 (c)|        0/5 (0%)         0/5 (0%)         0/5 (0%)      |  0/5 (0%)         0/5 (0%)         0/5 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        2/35 (6%)        7/34 (21%)    |  0/34 (0%)        0/30 (0%)        5/35 (14%)      |
|FIRST INCIDENCE    |        667              660              488           |  ---              ---              478             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.002 **       P=0.267          P=0.006 **    |  P=0.003 **       (e)              P=0.020 *       |
|POLY 3             |        P=0.003 **       P=0.299          P=0.006 **    |  P=0.002 **       (e)              P=0.016 *       |
|POLY 1.5           |        P=0.003 **       P=0.304          P=0.007 **    |  P=0.002 **       (e)              P=0.016 *       |
|POLY 6             |        P=0.002 **       P=0.291          P=0.005 **    |  P=0.002 **       (e)              P=0.017 *       |
|LOGISTIC REGRESSION|        P=0.003 **       P=0.304          P=0.009 **    |  P=0.003 **       (e)              P=0.018 *       |
|COCH-ARM / FISHERS |        P=0.004 **       P=0.316          P=0.009 **    |  P=0.003 **       (e)              P=0.014 *       |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 23

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Hyperkeratosis                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/54 (2%)        42/55 (76%)      41/55 (75%)   |  0/55 (0%)        38/55 (69%)      45/55 (82%)     |
|POLY-3 ADJUSTED (b)|        2.2%             78.3%            76.4%         |  0.0%             77.1%            87.3%           |
|INT SACRIFICE 1 (c)|        0/5 (0%)         4/5 (80%)        4/5 (80%)     |  0/5 (0%)         2/5 (40%)        3/5 (60%)       |
|TERMINAL (d)       |        0/41 (0%)        24/35 (69%)      22/34 (65%)   |  0/34 (0%)        22/30 (73%)      29/35 (83%)     |
|FIRST INCIDENCE    |        667              94 (I)           94 (I)        |  ---              94 (I)           94 (I)          |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 3             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 1.5           |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|POLY 6             |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|LOGISTIC REGRESSION|        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|COCH-ARM / FISHERS |        P<0.001 **       P<0.001 **       P<0.001 **    |  P<0.001 **       P<0.001 **       P<0.001 **      |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Skin, Site of Application                                                                                                  |
|     Ulcer                                                                                                                       |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/54 (0%)        0/55 (0%)        8/55 (15%)    |  0/55 (0%)        0/55 (0%)        0/55 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             17.8%         |  0.0%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/5 (0%)         0/5 (0%)         1/5 (20%)     |  0/5 (0%)         0/5 (0%)         0/5 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        4/34 (12%)    |  0/34 (0%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              ---              94 (I)        |  ---              ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P<0.001 **       (e)              P=0.004 **    |  (e)              (e)              (e)             |
|POLY 3             |        P<0.001 **       (e)              P=0.003 **    |  (e)              (e)              (e)             |
|POLY 1.5           |        P<0.001 **       (e)              P=0.004 **    |  (e)              (e)              (e)             |
|POLY 6             |        P<0.001 **       (e)              P=0.003 **    |  (e)              (e)              (e)             |
|LOGISTIC REGRESSION|        P<0.001 **       (e)              P=0.006 **    |  (e)              (e)              (e)             |
|COCH-ARM / FISHERS |        P<0.001 **       (e)              P=0.003 **    |  (e)              (e)              (e)             |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 24

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hematopoietic Cell Proliferation                                                                                            |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        10/49 (20%)      12/50 (24%)      16/50 (32%)   |  22/50 (44%)      27/50 (54%)      15/50 (30%)     |
|POLY-3 ADJUSTED (b)|        21.8%            25.5%            34.7%         |  46.6%            58.5%            32.6%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        8/41 (20%)       4/35 (11%)       7/34 (21%)    |  14/34 (41%)      17/30 (57%)      8/35 (23%)      |
|FIRST INCIDENCE    |        691              547              488           |  435              501              386             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.062          P=0.313          P=0.072       |  P=0.115N         P=0.148          P=0.126N        |
|POLY 3             |        P=0.103          P=0.432          P=0.126       |  P=0.105N         P=0.168          P=0.119N        |
|POLY 1.5           |        P=0.106          P=0.425          P=0.130       |  P=0.097N         P=0.186          P=0.112N        |
|POLY 6             |        P=0.101          P=0.436          P=0.124       |  P=0.107N         P=0.148          P=0.122N        |
|LOGISTIC REGRESSION|        P=0.133          P=0.432          P=0.156       |  P=0.095N         P=0.212          P=0.109N        |
|COCH-ARM / FISHERS |        P=0.113          P=0.426          P=0.140       |  P=0.094N         P=0.212          P=0.107N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Spleen                                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        1/50 (2%)        2/50 (4%)     |  4/50 (8%)        3/50 (6%)        5/50 (10%)      |
|POLY-3 ADJUSTED (b)|        0.0%             2.2%             4.7%          |  9.2%             7.0%             11.4%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        1/35 (3%)        1/34 (3%)     |  4/34 (12%)       3/30 (10%)       4/35 (11%)      |
|FIRST INCIDENCE    |        ---              729 (T)          638           |  730 (T)          730 (T)          637             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.121          P=0.468          P=0.209       |  P=0.445          P=0.569N         P=0.518         |
|POLY 3             |        P=0.136          P=0.497          P=0.224       |  P=0.433          P=0.508N         P=0.507         |
|POLY 1.5           |        P=0.139          P=0.499          P=0.231       |  P=0.431          P=0.502N         P=0.505         |
|POLY 6             |        P=0.131          P=0.492          P=0.215       |  P=0.439          P=0.520N         P=0.513         |
|LOGISTIC REGRESSION|        P=0.139          P=0.468          P=0.247       |  P=0.436          P=0.569N         P=0.506         |
|COCH-ARM / FISHERS |        P=0.145          P=0.505          P=0.253       |  P=0.427          P=0.500N         P=0.500         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 25

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Forestomach                                                                                                             |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/49 (0%)        2/50 (4%)        1/50 (2%)     |  0/50 (0%)        3/50 (6%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        0.0%             4.4%             2.3%          |  0.0%             6.9%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/41 (0%)        0/35 (0%)        1/34 (3%)     |  0/34 (0%)        2/30 (7%)        0/35 (0%)       |
|FIRST INCIDENCE    |        ---              686              729 (T)       |  ---              624              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.312          P=0.224          P=0.463       |  P=0.629N         P=0.111          (e)             |
|POLY 3             |        P=0.337          P=0.234          P=0.486       |  P=0.640N         P=0.117          (e)             |
|POLY 1.5           |        P=0.349          P=0.237          P=0.494       |  P=0.639N         P=0.119          (e)             |
|POLY 6             |        P=0.322          P=0.231          P=0.477       |  P=0.638N         P=0.114          (e)             |
|LOGISTIC REGRESSION|        P=0.348          P=0.242          P=0.463       |  P=0.639N         P=0.120          (e)             |
|COCH-ARM / FISHERS |        P=0.366          P=0.253          P=0.505       |  P=0.640          P=0.121          (e)             |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Cyst                                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        3/49 (6%)        0/50 (0%)        1/50 (2%)     |  1/50 (2%)        0/50 (0%)        0/50 (0%)       |
|POLY-3 ADJUSTED (b)|        6.6%             0.0%             2.3%          |  2.3%             0.0%             0.0%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        3/41 (7%)        0/35 (0%)        1/34 (3%)     |  1/34 (3%)        0/30 (0%)        0/35 (0%)       |
|FIRST INCIDENCE    |        729 (T)          ---              729 (T)       |  730 (T)          ---              ---             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.222N         P=0.150N         P=0.374N      |  P=0.271N         P=0.525N         P=0.494N        |
|POLY 3             |        P=0.183N         P=0.122N         P=0.330N      |  P=0.270N         P=0.503N         P=0.499N        |
|POLY 1.5           |        P=0.178N         P=0.120N         P=0.317N      |  P=0.270N         P=0.501N         P=0.499N        |
|POLY 6             |        P=0.190N         P=0.126N         P=0.347N      |  P=0.270N         P=0.507N         P=0.498N        |
|LOGISTIC REGRESSION|        P=0.222N         (e)              P=0.374N      |  P=0.271N         (e)              (e)             |
|COCH-ARM / FISHERS |        P=0.171N         P=0.117N         P=0.301N      |  P=0.269N         P=0.500N         P=0.500N        |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 26

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Stomach, Glandular                                                                                                               |
|     Mineralization                                                                                                              |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/49 (2%)        0/50 (0%)        2/50 (4%)     |  0/50 (0%)        0/50 (0%)        2/50 (4%)       |
|POLY-3 ADJUSTED (b)|        2.2%             0.0%             4.7%          |  0.0%             0.0%             4.6%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/41 (2%)        0/35 (0%)        2/34 (6%)     |  0/34 (0%)        0/30 (0%)        1/35 (3%)       |
|FIRST INCIDENCE    |        729 (T)          ---              729 (T)       |  ---              ---              721             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.312          P=0.532N         P=0.435       |  P=0.107          (e)              P=0.249         |
|POLY 3             |        P=0.360          P=0.503N         P=0.476       |  P=0.095          (e)              P=0.238         |
|POLY 1.5           |        P=0.363          P=0.501N         P=0.489       |  P=0.095          (e)              P=0.238         |
|POLY 6             |        P=0.358          P=0.508N         P=0.460       |  P=0.095          (e)              P=0.239         |
|LOGISTIC REGRESSION|        P=0.312          (e)              P=0.435       |  P=0.101          (e)              P=0.241         |
|COCH-ARM / FISHERS |        P=0.366          P=0.495N         P=0.508       |  P=0.095          (e)              P=0.247         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Testes                                                                                                                           |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        1/49 (2%)        3/50 (6%)        0/50 (0%)     |                                                    |
|POLY-3 ADJUSTED (b)|        2.2%             6.6%             0.0%          |                                                    |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |                                                    |
|TERMINAL (d)       |        1/41 (2%)        0/35 (0%)        0/34 (0%)     |                                                    |
|FIRST INCIDENCE    |        729 (T)          621              ---           |                                                    |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.432N         P=0.277          P=0.537N      |                                                    |
|POLY 3             |        P=0.423N         P=0.303          P=0.514N      |                                                    |
|POLY 1.5           |        P=0.402N         P=0.306          P=0.506N      |                                                    |
|POLY 6             |        P=0.450N         P=0.298          P=0.523N      |                                                    |
|LOGISTIC REGRESSION|        P=0.374N         P=0.314          (e)           |                                                    |
|COCH-ARM / FISHERS |        P=0.372N         P=0.316          P=0.495N      |                                                    |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 27

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Atrophy                                                                                                                     |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        5/45 (11%)       0/36 (0%)        5/39 (13%)    |  6/41 (15%)       4/45 (9%)        5/47 (11%)      |
|POLY-3 ADJUSTED (b)|        11.5%            0.0%             13.7%         |  15.3%            9.8%             11.7%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        1/38 (3%)        0/28 (0%)        0/29 (0%)     |  0/31 (0%)        0/28 (0%)        0/33 (0%)       |
|FIRST INCIDENCE    |        456              ---              416           |  150              240              478             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.519          P=0.050N         P=0.556       |  P=0.433N         P=0.380N         P=0.498N        |
|POLY 3             |        P=0.486          P=0.063N         P=0.515       |  P=0.375N         P=0.342N         P=0.439N        |
|POLY 1.5           |        P=0.491          P=0.059N         P=0.523       |  P=0.365N         P=0.328N         P=0.428N        |
|POLY 6             |        P=0.480          P=0.067N         P=0.506       |  P=0.384N         P=0.367N         P=0.450N        |
|LOGISTIC REGRESSION|        P=0.496N         P=0.033N*        P=0.462N      |  P=0.356N         P=0.333N         P=0.429N        |
|COCH-ARM / FISHERS |        P=0.500          P=0.048N*        P=0.536       |  P=0.346N         P=0.311N         P=0.403N        |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thymus                                                                                                                           |
|     Hyperplasia Lymphoid                                                                                                        |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        0/45 (0%)        0/36 (0%)        0/39 (0%)     |  0/41 (0%)        2/45 (4%)        2/47 (4%)       |
|POLY-3 ADJUSTED (b)|        0.0%             0.0%             0.0%          |  0.0%             5.2%             4.9%            |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        0/38 (0%)        0/28 (0%)        0/29 (0%)     |  0/31 (0%)        2/28 (7%)        2/33 (6%)       |
|FIRST INCIDENCE    |        ---              ---              ---           |  ---              730 (T)          730 (T)         |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        (e)              (e)              (e)           |  P=0.194          P=0.216          P=0.252         |
|POLY 3             |        (e)              (e)              (e)           |  P=0.207          P=0.255          P=0.269         |
|POLY 1.5           |        (e)              (e)              (e)           |  P=0.208          P=0.258          P=0.270         |
|POLY 6             |        (e)              (e)              (e)           |  P=0.205          P=0.249          P=0.268         |
|LOGISTIC REGRESSION|        (e)              (e)              (e)           |  (e)              P=0.216          P=0.252         |
|COCH-ARM / FISHERS |        (e)              (e)              (e)           |  P=0.205          P=0.271          P=0.282         |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 28

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Thyroid Gland: Follicular Cell                                                                                                   |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |        8/49 (16%)       7/50 (14%)       9/50 (18%)    |  14/50 (28%)      15/50 (30%)      15/50 (30%)     |
|POLY-3 ADJUSTED (b)|        17.5%            15.6%            21.1%         |  32.2%            34.2%            34.4%           |
|INT SACRIFICE 1 (c)|        0/0 (0%)         0/0 (0%)         0/0 (0%)      |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |        8/41 (20%)       7/35 (20%)       9/34 (27%)    |  13/34 (38%)      11/30 (37%)      14/35 (40%)     |
|FIRST INCIDENCE    |        729 (T)          729 (T)          729 (T)       |  719              616              721             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |        P=0.286          P=0.593          P=0.331       |  P=0.494          P=0.357          P=0.540         |
|POLY 3             |        P=0.394          P=0.515N         P=0.438       |  P=0.459          P=0.512          P=0.504         |
|POLY 1.5           |        P=0.422          P=0.504N         P=0.471       |  P=0.461          P=0.510          P=0.505         |
|POLY 6             |        P=0.359          P=0.534N         P=0.396       |  P=0.464          P=0.510          P=0.510         |
|LOGISTIC REGRESSION|        P=0.286          P=0.593          P=0.331       |  P=0.475          P=0.436          P=0.543         |
|COCH-ARM / FISHERS |        P=0.463          P=0.483N         P=0.518       |  P=0.456          P=0.500          P=0.500         |
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  0/50 (0%)        0/50 (0%)        9/50 (18%)      |
|POLY-3 ADJUSTED (b)|                                                        |  0.0%             0.0%             20.6%           |
|INT SACRIFICE 1 (c)|                                                        |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |                                                        |  0/34 (0%)        0/30 (0%)        8/35 (23%)      |
|FIRST INCIDENCE    |                                                        |  ---              ---              723             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P<0.001 **       (e)              P=0.003 **      |
|POLY 3             |                                                        |  P<0.001 **       (e)              P=0.002 **      |
|POLY 1.5           |                                                        |  P<0.001 **       (e)              P=0.002 **      |
|POLY 6             |                                                        |  P<0.001 **       (e)              P=0.002 **      |
|LOGISTIC REGRESSION|                                                        |  P<0.001 **       (e)              P=0.003 **      |
|COCH-ARM / FISHERS |                                                        |  P<0.001 **       (e)              P<0.001 **      |
|=================================================================================================================================|
       Date:  09/30/97                           EXPERIMENT: 91014 TEST: 04                                            Page 29

Statistical Analysis of Non-neoplastic Lesions in       Mice(B6C3F1)  -        OLEIC ACID DIETHANOLAMINE CONDENSATE
                                         Terminal Sacrifice at 104 weeks 
|=================================================================================================================================|
|                   |                                                        |                                                    |
|                   |                              Males                     |                       Females                      |
|Dose               |        0 MG/KG          15 MG/KG         30 MG/KG      |  0 MG/KG          15 MG/KG         30 MG/KG        |
|                   |                                                        |                                                    |
|=================================================================================================================================|
|                                                                                                                                 |
|Uterus: Endometrium                                                                                                              |
|     Hyperplasia Cystic                                                                                                          |
|                                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES        |                                                        |                                                    |
|-----------        |                                                        |                                                    |
|OVERALL (a)        |                                                        |  35/50 (70%)      20/50 (40%)      28/50 (56%)     |
|POLY-3 ADJUSTED (b)|                                                        |  76.5%            44.5%            61.6%           |
|INT SACRIFICE 1 (c)|                                                        |  0/0 (0%)         0/0 (0%)         0/0 (0%)        |
|TERMINAL (d)       |                                                        |  28/34 (82%)      13/30 (43%)      22/35 (63%)     |
|FIRST INCIDENCE    |                                                        |  562              584              604             |
|-------------------|                                                        |                                                    |
|STATISTICAL TESTS  |                                                        |                                                    |
|-------------------|                                                        |                                                    |
|LIFE TABLE         |                                                        |  P=0.094N         P=0.018N*        P=0.097N        |
|POLY 3             |                                                        |  P=0.075N         P<0.001N**       P=0.086N        |
|POLY 1.5           |                                                        |  P=0.077N         P<0.001N**       P=0.089N        |
|POLY 6             |                                                        |  P=0.068N         P<0.001N**       P=0.078N        |
|LOGISTIC REGRESSION|                                                        |  P=0.084N         P=0.002N**       P=0.091N        |
|COCH-ARM / FISHERS |                                                        |  P=0.096N         P=0.002N**       P=0.107N        |
|=================================================================================================================================|

(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).