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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: 09/23/97       
EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 09:38:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-15314                              ROUTE: SKIN APPLICATION                                        NTP C#: C91014       
PATHOLOGIST: SELLS, D.                                                                                         CAS: 93-83-4         
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                                                            14 WEEK SSAC                                                            
                                                                                                                                    

               REASONS FOR REMOVAL:    25017 Scheduled Sacrifice                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE 001    0 MG/KG                                                                       
                                       INCLUDE 002    0 MG/KG                                                                       
                                       INCLUDE 003    15 MG/KG                                                                      
                                       INCLUDE 004    15 MG/KG                                                                      
                                       INCLUDE 005    30 MG/KG                                                                      
                                       INCLUDE 006    30 MG/KG                                                                      
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                            OLEIC ACID DIETHANOLAMINE CONDENSATE                         DATE: 09/23/97       
EXPERIMENT: 91014 TEST: 04                                                                                     TIME: 09:38:11       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
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 THE STUDY OF OLEIC ACID DIETHANOLAMINE CONDENSATE

              ====================================================================================================

                                                           MALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Skin                          Hyperkeratosis
                                                           Hyperplasia
                                                           Inflammation Chronic
                                                           Parakeratosis

              ====================================================================================================

                                                           FEMALE MICE
                                                          -------------
                                 ORGAN                               MORPHOLOGY
                                -------                             ------------

                             Skin                          Hyperkeratosis
                                                           Hyperplasia
                                                           Inflammation Chronic

              ====================================================================================================
         DATE: 09/23/97                     EXPERIMENT: 91014 TEST: 04                                                 PAGE   1
                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE

                                                 TERMINAL SACRIFICE AT . 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                                                                                                        |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        4/5 (80%)       4/5 (80%)      |
|ADJUSTED (b)           |      0.0%          100.0%          100.0%          |      0.0%           80.0%           80.0%          |
|INTERIM SACRIFICE 1 (c)|     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        4/5 (80%)       4/5 (80%)      |
|TERMINAL (d)           |     0/0             0/0             0/0            |     0/0             0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---              94 (I)          94 (I)       |      ---              94 (I)          94 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.016 *       P=0.033 *       P=0.033 *      |
|INCIDENTAL TUMOR       |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.016 *       P=0.033 *       P=0.033 *      |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.016 *       P=0.033 *       P=0.033 *      |
|COCHRAN-ARMITAGE       |     P=0.001 **                                     |     P=0.013 *                                      |
|FISHER EXACT           |                     P=0.004 **      P=0.004 **     |                     P=0.024 *       P=0.024 *      |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Epidermis Skin, Site of Application                                                                                        |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        5/5 (100%)      4/5 (80%)      |
|ADJUSTED (b)           |      0.0%          100.0%          100.0%          |      0.0%          100.0%           80.0%          |
|INTERIM SACRIFICE 1 (c)|     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        5/5 (100%)      4/5 (80%)      |
|TERMINAL (d)           |     0/0             0/0             0/0            |     0/0             0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---              94 (I)          94 (I)       |      ---              94 (I)          94 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.015 *       P=0.008 **      P=0.033 *      |
|INCIDENTAL TUMOR       |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.015 *       P=0.008 **      P=0.033 *      |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.015 *       P=0.008 **      P=0.033 *      |
|COCHRAN-ARMITAGE       |     P=0.001 **                                     |     P=0.012 *                                      |
|FISHER EXACT           |                     P=0.004 **      P=0.004 **     |                     P=0.004 **      P=0.024 *      |
|=================================================================================================================================|
         DATE: 09/23/97                     EXPERIMENT: 91014 TEST: 04                                                 PAGE   2
                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE

                                                 TERMINAL SACRIFICE AT . 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                                                                                        |
|     Parakeratosis                                                                                                               |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/5 (0%)        1/5 (20%)       4/5 (80%)      |     0/5 (0%)        0/5 (0%)        0/5 (0%)       |
|ADJUSTED (b)           |      0.0%           20.0%           80.0%          |      0.0%            0.0%            0.0%          |
|INTERIM SACRIFICE 1 (c)|     0/5 (0%)        1/5 (20%)       4/5 (80%)      |     0/5 (0%)        0/5 (0%)        0/5 (0%)       |
|TERMINAL (d)           |     0/0             0/0             0/0            |     0/0             0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---              94 (I)          94 (I)       |      ---             ---             ---           |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.012 *       P=0.500         P=0.033 *      |       (e)             (e)             (e)          |
|INCIDENTAL TUMOR       |     P=0.012 *       P=0.500         P=0.033 *      |       (e)             (e)             (e)          |
|LOGISTIC REGRESSION    |     P=0.012 *       P=0.500         P=0.033 *      |       (e)             (e)             (e)          |
|COCHRAN-ARMITAGE       |     P=0.009 **                                     |       (e)                                          |
|FISHER EXACT           |                     P=0.500         P=0.024 *      |                       (e)             (e)          |
|=================================================================================================================================|
|                                                                                                                                 |
|Skin: Sebaceous Gland Skin, Site of Application                                                                                  |
|     Hyperplasia                                                                                                                 |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        5/5 (100%)      5/5 (100%)     |
|ADJUSTED (b)           |      0.0%          100.0%          100.0%          |      0.0%          100.0%          100.0%          |
|INTERIM SACRIFICE 1 (c)|     0/5 (0%)        5/5 (100%)      5/5 (100%)     |     0/5 (0%)        5/5 (100%)      5/5 (100%)     |
|TERMINAL (d)           |     0/0             0/0             0/0            |     0/0             0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---              94 (I)          94 (I)       |      ---              94 (I)          94 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.002 **      P=0.008 **      P=0.008 **     |
|INCIDENTAL TUMOR       |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.002 **      P=0.008 **      P=0.008 **     |
|LOGISTIC REGRESSION    |     P=0.002 **      P=0.008 **      P=0.008 **     |     P=0.002 **      P=0.008 **      P=0.008 **     |
|COCHRAN-ARMITAGE       |     P=0.001 **                                     |     P=0.001 **                                     |
|FISHER EXACT           |                     P=0.004 **      P=0.004 **     |                     P=0.004 **      P=0.004 **     |
|=================================================================================================================================|
         DATE: 09/23/97                     EXPERIMENT: 91014 TEST: 04                                                 PAGE   3
                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE

                                                 TERMINAL SACRIFICE AT . 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                                                                                                              |
|                                                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES           |                                                    |                                                    |
|-----------            |                                                    |                                                    |
|OVERALL (a)            |     0/5 (0%)        4/5 (80%)       4/5 (80%)      |     0/5 (0%)        2/5 (40%)       3/5 (60%)      |
|ADJUSTED (b)           |      0.0%           80.0%           80.0%          |      0.0%           40.0%           60.0%          |
|INTERIM SACRIFICE 1 (c)|     0/5 (0%)        4/5 (80%)       4/5 (80%)      |     0/5 (0%)        2/5 (40%)       3/5 (60%)      |
|TERMINAL (d)           |     0/0             0/0             0/0            |     0/0             0/0             0/0            |
|FIRST INCIDENCE (DAYS) |      ---              94 (I)          94 (I)       |      ---              94 (I)          94 (I)       |
|-----------------------|                                                    |                                                    |
|STATISTICAL TESTS (f)  |                                                    |                                                    |
|-----------------------|                                                    |                                                    |
|LIFE TABLE             |     P=0.016 *       P=0.033 *       P=0.033 *      |     P=0.053         P=0.227         P=0.095        |
|INCIDENTAL TUMOR       |     P=0.016 *       P=0.033 *       P=0.033 *      |     P=0.053         P=0.227         P=0.095        |
|LOGISTIC REGRESSION    |     P=0.016 *       P=0.033 *       P=0.033 *      |     P=0.053         P=0.227         P=0.095        |
|COCHRAN-ARMITAGE       |     P=0.013 *                                      |     P=0.047 *                                      |
|FISHER EXACT           |                     P=0.024 *       P=0.024 *      |                     P=0.222         P=0.083        |
|=================================================================================================================================|

 (a)  Number of tumor-bearing animals / number of animals examined at site.
 (b)  Kaplan-Meier estimated lifetime tumor incidence after adjustment for 
      intercurrent mortality.
 (c)  Observed incidence at interim kill.
          Male interim sacrifices(days):   94
          Female interim sacrifices(days): 94
 (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.  The incidental tumor 
      test regards these lesions as non-fatal.  Logistic regression is an alternative
      method for analyzing the incidence of non-fatal tumors.  The Cochran-Armitage
      and Fisher's 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).