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TDMS Study 99036-01 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                      TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN)                   DATE: 04/21/04       
EXPERIMENT: 99036 TEST: 01                                                                                     TIME: 08:35:19       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: N01-ES-65406                              ROUTE: DOSED FEED                                              NTP C#: C99036       
PATHOLOGIST: MISSING                                                                                           CAS: 77-09-08        
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                                                           FINAL #1 MICE                                                            
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                      TRANSGENIC MODEL EVALUATION II (PHENOLPHTHALEIN)                   DATE: 04/21/04       
EXPERIMENT: 99036 TEST: 01                                                                                     TIME: 08:35:19       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: N01-ES-65406                              ROUTE: DOSED FEED                                              NTP C#: C99036       
PATHOLOGIST: MISSING                                                                                           CAS: 77-09-08        
Mice(P16(INK4A)/(+/-) (C57BL/6))                                                                                                    
-----------------------------                                                                                                       
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 THE NUMBER OF ANIMALS NECROPSIED.                                                                                      
                                                 ---------------                                                                    
                                                 Adrenal Medulla                                                                    
                                                                                                                                   
       Date:  04/21/04                           EXPERIMENT: 99036 TEST: 01                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))        -     TRANSGENIC MODEL EVALUATION II (PHENOLP     
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        0/15 (0%)        1/15 (7%)        1/15 (7%)        0/15 (0%)        0/15 (0%)       | 
|POLY-3 RATE (b)    |        0/13.07          0/15.00          1/15.00          1/13.01          0/15.00          0/14.00         | 
|POLY-3 PERCENT (g) |        0.0%             0.0%             6.7%             7.7%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/13 (0%)        0/15 (0%)        1/15 (7%)        1/13 (8%)        0/15 (0%)        0/14 (0%)       | 
|FIRST INCIDENCE    |        ---              ---              183 (T)          183 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.512N         (e)              P=0.529          P=0.500          (e)              (e)             | 
|POLY 3             |        P=0.511N         (e)              P=0.527          P=0.499          (e)              (e)             | 
|POLY 1.5           |        P=0.512N         (e)              P=0.524          P=0.498          (e)              (e)             | 
|POLY 6             |        P=0.510N         (e)              P=0.528          P=0.500          (e)              (e)             | 
|LOGISTIC REGRESSION|        (e)              (e)              P=0.529          P=0.500          (e)              (e)             | 
|COCH-ARM / FISHERS |        P=0.512N         (e)              P=0.500          P=0.500          (e)              (e)             | 
|ORDER RESTRICTED   |        P=0.506N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Histiocytic Sarcoma                                                                                                         | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        2/15 (13%)       1/15 (7%)        1/15 (7%)        1/15 (7%)       | 
|POLY-3 RATE (b)    |        0/15.00          1/13.00          2/14.00          1/15.00          1/14.00          1/15.00         | 
|POLY-3 PERCENT (g) |        0.0%             7.7%             14.3%            6.7%             7.1%             6.7%            | 
|TERMINAL (d)       |        0/15 (0%)        1/13 (8%)        2/14 (14%)       1/15 (7%)        1/14 (7%)        1/15 (7%)       | 
|FIRST INCIDENCE    |        ---              184 (T)          184 (T)          184 (T)          184 (T)          184 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.664N         P=0.471          P=0.221          P=0.500          P=0.486          P=0.500         | 
|POLY 3             |        P=0.668          P=0.472          P=0.216          P=0.500          P=0.486          P=0.500         | 
|POLY 1.5           |        P=0.668          P=0.472          P=0.216          P=0.500          P=0.487          P=0.500         | 
|POLY 6             |        P=0.668          P=0.471          P=0.216          P=0.500          P=0.486          P=0.500         | 
|LOGISTIC REGRESSION|        (e)              P=0.471          P=0.221          P=0.500          P=0.486          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.658          P=0.500          P=0.241          P=0.500          P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.317          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/21/04                           EXPERIMENT: 99036 TEST: 01                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -     TRANSGENIC MODEL EVALUATION II (PHENOLP      
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/15 (7%)        0/15 (0%)        1/15 (7%)        1/15 (7%)        0/15 (0%)        0/15 (0%)       | 
|POLY-3 RATE (b)    |        1/14.00          0/15.00          1/15.00          1/13.01          0/15.00          0/14.00         | 
|POLY-3 PERCENT (g) |        7.1%             0.0%             6.7%             7.7%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/13 (0%)        0/15 (0%)        1/15 (7%)        1/13 (8%)        0/15 (0%)        0/14 (0%)       | 
|FIRST INCIDENCE    |        76               ---              183 (T)          183 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.366N         P=0.486N         P=0.737N         P=0.752          P=0.486N         P=0.500N        | 
|POLY 3             |        P=0.374N         P=0.486N         P=0.745N         P=0.745          P=0.486N         P=0.500N        | 
|POLY 1.5           |        P=0.373N         P=0.487N         P=0.745N         P=0.746          P=0.487N         P=0.499N        | 
|POLY 6             |        P=0.374N         P=0.486N         P=0.745N         P=0.744          P=0.486N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.360N         P=0.896N         P=0.626          P=0.763N         P=0.896N         P=0.572N        | 
|COCH-ARM / FISHERS |        P=0.364N         P=0.500N         P=0.759N         P=0.759N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.282N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant Tumors                                                                                                            | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        2/15 (13%)       1/15 (7%)        1/15 (7%)        1/15 (7%)       | 
|POLY-3 RATE (b)    |        0/15.00          1/13.00          2/14.00          1/15.00          1/14.00          1/15.00         | 
|POLY-3 PERCENT (g) |        0.0%             7.7%             14.3%            6.7%             7.1%             6.7%            | 
|TERMINAL (d)       |        0/15 (0%)        1/13 (8%)        2/14 (14%)       1/15 (7%)        1/14 (7%)        1/15 (7%)       | 
|FIRST INCIDENCE    |        ---              184 (T)          184 (T)          184 (T)          184 (T)          184 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.664N         P=0.471          P=0.221          P=0.500          P=0.486          P=0.500         | 
|POLY 3             |        P=0.668          P=0.472          P=0.216          P=0.500          P=0.486          P=0.500         | 
|POLY 1.5           |        P=0.668          P=0.472          P=0.216          P=0.500          P=0.487          P=0.500         | 
|POLY 6             |        P=0.668          P=0.471          P=0.216          P=0.500          P=0.486          P=0.500         | 
|LOGISTIC REGRESSION|        (e)              P=0.471          P=0.221          P=0.500          P=0.486          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.658          P=0.500          P=0.241          P=0.500          P=0.500          P=0.500         | 
|ORDER RESTRICTED   |        P=0.317          (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  04/21/04                           EXPERIMENT: 99036 TEST: 01                                            Page 3       
Statistical Analysis of Primary Tumors in Mice(P16(INK4A)/(+/-) (C57BL/6))       -     TRANSGENIC MODEL EVALUATION II (PHENOLP      
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Males                                                  | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        1/15 (7%)        0/15 (0%)        1/15 (7%)        1/15 (7%)        0/15 (0%)        0/15 (0%)       | 
|POLY-3 RATE (b)    |        1/14.00          0/15.00          1/15.00          1/13.01          0/15.00          0/14.00         | 
|POLY-3 PERCENT (g) |        7.1%             0.0%             6.7%             7.7%             0.0%             0.0%            | 
|TERMINAL (d)       |        0/13 (0%)        0/15 (0%)        1/15 (7%)        1/13 (8%)        0/15 (0%)        0/14 (0%)       | 
|FIRST INCIDENCE    |        76               ---              183 (T)          183 (T)          ---              ---             | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.366N         P=0.486N         P=0.737N         P=0.752          P=0.486N         P=0.500N        | 
|POLY 3             |        P=0.374N         P=0.486N         P=0.745N         P=0.745          P=0.486N         P=0.500N        | 
|POLY 1.5           |        P=0.373N         P=0.487N         P=0.745N         P=0.746          P=0.487N         P=0.499N        | 
|POLY 6             |        P=0.374N         P=0.486N         P=0.745N         P=0.744          P=0.486N         P=0.500N        | 
|LOGISTIC REGRESSION|        P=0.360N         P=0.896N         P=0.626          P=0.763N         P=0.896N         P=0.572N        | 
|COCH-ARM / FISHERS |        P=0.364N         P=0.500N         P=0.759N         P=0.759N         P=0.500N         P=0.500N        | 
|ORDER RESTRICTED   |        P=0.282N         (e)              (e)              (e)              (e)              (e)             | 
|=================================================================================================================================| 
|                   |                                                                                                             | 
|                   |                                                      Females                                                | 
|Dose               |        0 PPM            200 PPM          375 PPM          750 PPM          3000 PPM         12,000          | 
|                   |                                                                                             PPM             | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |        #                #                #                #                #                #               | 
|-----------        |                                                                                                             | 
|OVERALL (a)        |        0/15 (0%)        1/15 (7%)        2/15 (13%)       1/15 (7%)        2/15 (13%)       1/15 (7%)       | 
|POLY-3 RATE (b)    |        0/15.00          1/13.00          2/14.00          1/15.00          2/14.00          1/15.00         | 
|POLY-3 PERCENT (g) |        0.0%             7.7%             14.3%            6.7%             14.3%            6.7%            | 
|TERMINAL (d)       |        0/15 (0%)        1/13 (8%)        2/14 (14%)       1/15 (7%)        2/14 (14%)       1/15 (7%)       | 
|FIRST INCIDENCE    |        ---              184 (T)          184 (T)          184 (T)          184 (T)          184 (T)         | 
|-------------------|                                                                                                             | 
|STATISTICAL TESTS  |                                                                                                             | 
|-------------------|                                                                                                             | 
|LIFE TABLE         |        P=0.655          P=0.471          P=0.221          P=0.500          P=0.221          P=0.500         | 
|POLY 3             |        P=0.654          P=0.472          P=0.216          P=0.500          P=0.216          P=0.500         | 
|POLY 1.5           |        P=0.653          P=0.472          P=0.216          P=0.500          P=0.216          P=0.500         | 
|POLY 6             |        P=0.654          P=0.471          P=0.216          P=0.500          P=0.216          P=0.500         | 
|LOGISTIC REGRESSION|        P=0.656          P=0.471          P=0.221          P=0.500          P=0.221          P=0.500         | 
|COCH-ARM / FISHERS |        P=0.639          P=0.500          P=0.241          P=0.500          P=0.241          P=0.500         | 
|ORDER RESTRICTED   |        P=0.264          (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).