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TDMS Study 93027-11 Pathology Tables

NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                           PEROXISOME PROJECT (DIBUTYL PHTHALATE)                        DATE: 10/25/04       
EXPERIMENT: 93027 TEST: 11                                                                                     TIME: 13:08:03       
TEST TYPE:  SUBCHRON 90-DAY                                                                                    PAGE:       1        
CONT: NO1-ES-15320                              ROUTE: DOSED FEED                                              NTP C#: 93027A       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 84-74-2         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                    STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS                          REPORT: PEIRPT10     
LAB: Battelle Columbus                           PEROXISOME PROJECT (DIBUTYL PHTHALATE)                        DATE: 10/25/04       
EXPERIMENT: 93027 TEST: 11                                                                                     TIME: 13:08:03       
TEST TYPE:  SUBCHRON 90-DAY                                                                                                         
CONT: NO1-ES-15320                              ROUTE: DOSED FEED                                              NTP C#: 93027A       
PATHOLOGIST: MELLICK, PAUL                                                                                     CAS: 84-74-2         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF         PEROXISOME PROJECT (DIBUTYL PHTHAL                                                                       
===============================================================                                                                     
Male Rats                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
Liver                                  Cytoplasmic Alteration                                                                       
Testes                                 Atrophy                                                                                      
===============================================================                                                                     
                                                                                                                                   
       Date:  10/25/04                           EXPERIMENT: 93027 TEST: 11                                            Page 1       
Statistical Analysis of Non-neoplastic Lesions in        Rats(SPRAGUE-DAWLEY)  -          PEROXISOME PROJECT (DIBUTYL PHTHAL        
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000             2500             5000             10,000           20,000          | 
|                   |                         PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Kidney                                                                                                                           | 
|     Nephropathy                                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        9/10 (90%)       7/10 (70%)       9/10 (90%)       5/10 (50%)       6/10 (60%)       7/10 (70%)      | 
|POLY-3 RATE (b)    |        9/10.00          7/10.00          9/10.00          5/10.00          6/10.00          7/10.00         | 
|POLY-3 PERCENT (g) |        90.0%            70.0%            90.0%            50.0%            60.0%            70.0%           | 
|TERMINAL (d)       |        9/10 (90%)       7/10 (70%)       9/10 (90%)       5/10 (50%)       6/10 (60%)       7/10 (70%)      | 
|FIRST INCIDENCE    |        92 (T)           92 (T)           92 (T)           92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.249N         P=0.293N         P=0.766          P=0.077N         P=0.157N         P=0.293N        | 
|POLY 3             |        P=0.247N         P=0.292N         P=0.760          P=0.061N         P=0.148N         P=0.292N        | 
|POLY 1.5           |        P=0.247N         P=0.292N         P=0.760          P=0.061N         P=0.148N         P=0.292N        | 
|POLY 6             |        P=0.247N         P=0.292N         P=0.760          P=0.061N         P=0.148N         P=0.292N        | 
|LOGISTIC REGRESSION|        P=0.249N         P=0.293N         P=0.766          P=0.077N         P=0.157N         P=0.293N        | 
|COCH-ARM / FISHERS |        P=0.248N         P=0.291N         P=0.763N         P=0.070N         P=0.152N         P=0.291N        | 
|ORDER RESTRICTED   |        P=0.109N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000             2500             5000             10,000           20,000          | 
|                   |                         PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Cytoplasmic Alteration                                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|POLY-3 RATE (b)    |        0/10.00          0/10.00          0/10.00          0/10.00          10/10.00         10/10.00        | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             0.0%             0.0%             100.0%           100.0%          | 
|TERMINAL (d)       |        0/10 (0%)        0/10 (0%)        0/10 (0%)        0/10 (0%)        10/10 (100%)     10/10 (100%)    | 
|FIRST INCIDENCE    |        ---              ---              ---              ---              92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 3             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 1.5           |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|POLY 6             |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|LOGISTIC REGRESSION|        (e)              (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|COCH-ARM / FISHERS |        P<0.001 **       (e)              (e)              (e)              P<0.001 **       P<0.001 **      | 
|ORDER RESTRICTED   |        P<0.001 **       (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/25/04                           EXPERIMENT: 93027 TEST: 11                                            Page 2       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -          PEROXISOME PROJECT (DIBUTYL PHTHAL         
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000             2500             5000             10,000           20,000          | 
|                   |                         PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Liver                                                                                                                            | 
|     Infiltration Cellular Mononuclear Cell                                                                                      | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        5/10 (50%)       4/10 (40%)       7/10 (70%)       4/10 (40%)       4/10 (40%)       6/10 (60%)      | 
|POLY-3 RATE (b)    |        5/10.00          4/10.00          7/10.00          4/10.00          4/10.00          6/10.00         | 
|POLY-3 PERCENT (g) |        50.0%            40.0%            70.0%            40.0%            40.0%            60.0%           | 
|TERMINAL (d)       |        5/10 (50%)       4/10 (40%)       7/10 (70%)       4/10 (40%)       4/10 (40%)       6/10 (60%)      | 
|FIRST INCIDENCE    |        92 (T)           92 (T)           92 (T)           92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.441          P=0.500N         P=0.328          P=0.500N         P=0.500N         P=0.500         | 
|POLY 3             |        P=0.442          P=0.500N         P=0.329          P=0.500N         P=0.500N         P=0.500         | 
|POLY 1.5           |        P=0.442          P=0.500N         P=0.329          P=0.500N         P=0.500N         P=0.500         | 
|POLY 6             |        P=0.442          P=0.500N         P=0.329          P=0.500N         P=0.500N         P=0.500         | 
|LOGISTIC REGRESSION|        P=0.440          P=0.500N         P=0.328          P=0.500N         P=0.500N         P=0.500         | 
|COCH-ARM / FISHERS |        P=0.440          P=0.500N         P=0.325          P=0.500N         P=0.500N         P=0.500         | 
|ORDER RESTRICTED   |        P=0.468          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000             2500             5000             10,000           20,000          | 
|                   |                         PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Preputial Gland                                                                                                                  | 
|     Inflammation Chronic                                                                                                        | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        10/10 (100%)     7/10 (70%)       8/10 (80%)       9/10 (90%)       9/10 (90%)       10/10 (100%)    | 
|POLY-3 RATE (b)    |        10/10.00         7/10.00          8/10.00          9/10.00          9/10.00          10/10.00        | 
|POLY-3 PERCENT (g) |        100.0%           70.0%            80.0%            90.0%            90.0%            100.0%          | 
|TERMINAL (d)       |        10/10 (100%)     7/10 (70%)       8/10 (80%)       9/10 (90%)       9/10 (90%)       10/10 (100%)    | 
|FIRST INCIDENCE    |        92 (T)           92 (T)           92 (T)           92 (T)           92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.164          P=0.111N         P=0.234N         P=0.500N         P=0.500N         (e)             | 
|POLY 3             |        P=0.160          P=0.095N         P=0.227N         P=0.500N         P=0.500N         (e)             | 
|POLY 1.5           |        P=0.160          P=0.095N         P=0.227N         P=0.500N         P=0.500N         (e)             | 
|POLY 6             |        P=0.160          P=0.095N         P=0.227N         P=0.500N         P=0.500N         (e)             | 
|LOGISTIC REGRESSION|        P=0.164          P=0.111N         P=0.234N         P=0.500N         P=0.500N         (e)             | 
|COCH-ARM / FISHERS |        P=0.162          P=0.105N         P=0.237N         P=0.500N         P=0.500N         (e)             | 
|ORDER RESTRICTED   |        P=0.210          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  10/25/04                           EXPERIMENT: 93027 TEST: 11                                            Page 3       
Statistical Analysis of Non-neoplastic Lesions in       Rats(SPRAGUE-DAWLEY)  -          PEROXISOME PROJECT (DIBUTYL PHTHAL         
                                         Terminal Sacrifice at 14 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            1000             2500             5000             10,000           20,000          | 
|                   |                         PPM              PPM              PPM              PPM              PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Testes                                                                                                                           | 
|     Atrophy                                                                                                                     | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|LESION RATES       |                                                                                                             | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)        1/10 (10%)       3/10 (30%)      | 
|POLY-3 RATE (b)    |        0/10.00          1/10.00          1/10.00          0/10.00          1/10.00          3/10.00         | 
|POLY-3 PERCENT (g) |        0.0%             10.0%            10.0%            0.0%             10.0%            30.0%           | 
|TERMINAL (d)       |        0/10 (0%)        1/10 (10%)       1/10 (10%)       0/10 (0%)        1/10 (10%)       3/10 (30%)      | 
|FIRST INCIDENCE    |        ---              92 (T)           92 (T)           ---              92 (T)           92 (T)          | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.032 *        P=0.500          P=0.500          (e)              P=0.500          P=0.111         | 
|POLY 3             |        P=0.030 *        P=0.500          P=0.500          (e)              P=0.500          P=0.095         | 
|POLY 1.5           |        P=0.030 *        P=0.500          P=0.500          (e)              P=0.500          P=0.095         | 
|POLY 6             |        P=0.030 *        P=0.500          P=0.500          (e)              P=0.500          P=0.095         | 
|LOGISTIC REGRESSION|        (e)              P=0.500          P=0.500          (e)              P=0.500          P=0.111         | 
|COCH-ARM / FISHERS |        P=0.031 *        P=0.500          P=0.500          (e)              P=0.500          P=0.105         | 
|ORDER RESTRICTED   |        P=0.015 *        (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
(a)  Number of tumor-bearing animals /  number of animals examined at site.                                                         
(b)  Number of tumor-bearing animals / Poly-3 number                                                                                
(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.                                                                                         
(g)  Poly-3 adjusted lifetime tumor incidence.                                                                                      
(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).