National Toxicology Program

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TDMS Study 97013-04 Pathology Tables

NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 04                                                                                     TIME: 10:43:27       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013E       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
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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                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 04                                                                                     TIME: 10:43:27       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013E       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
Mice(P53 Heterozygous Transgenic)                                                                                                   
-----------------------------                                                                                                       
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.                                                                                      
                                                 ---------------                                                                    
                                                 Liver                                                                              
                                                 Thyroid Gland                                                                      
                                                                                                                                   
NTP                                        STATISTICAL ANALYSIS OF PRIMARY TUMORS                              REPORT: PEIRPT08     
LAB: Battelle Columbus                       WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                   DATE: 06/11/04       
EXPERIMENT: 97013 TEST: 04                                                                                     TIME: 10:43:27       
TEST TYPE:  SUBCHRON 26-WEEK                    CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-65406                              ROUTE: DOSED WATER                                             NTP C#: 97013E       
PATHOLOGIST: MISSING                                                                                           CAS: 75-27-4         
                                                                                                                                    
                                                                                                                                    
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS                                                                               
IN THE ANALYSIS OF     WATER DISINFECTION MODEL (BROMODICHLOR                                                                       
===============================================================                                                                     
Male Mice                                                                                                                           
------------                                                                                                                        
Organ                                 Morphology                                                                                    
-----                                 ----------                                                                                    
All Organs                             Malignant and Benign Tumors                                                                  
===============================================================                                                                     
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 04                                            Page 1       
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic)        -      WATER DISINFECTION MODEL (BROMODICHLOR    
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       175 MG/L     350 MG/L     700 MG/L    |0 MG/L       175 MG/L     350 MG/L     700 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|Uterus                                                                                                                           | 
|     Polyp Stromal                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |                                                        |1/15 (7%)    2/15 (13%)   0/15 (0%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |                                                        |1/15.00      2/15.00      0/14.01      1/15.00      | 
|POLY-3 PERCENT (g) |                                                        |6.7%         13.3%        0.0%         6.7%         | 
|TERMINAL (d)       |                                                        |1/15 (7%)    2/15 (13%)   0/14 (0%)    1/15 (7%)    | 
|FIRST INCIDENCE    |                                                        |185 (T)      185 (T)      ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |                                                        |P=0.502N     P=0.500      P=0.514N     P=0.764      | 
|POLY 3             |                                                        |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|POLY 1.5           |                                                        |P=0.505N     P=0.500      P=0.513N     P=0.760      | 
|POLY 6             |                                                        |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|LOGISTIC REGRESSION|                                                        |P=0.502N     P=0.500      (e)          P=0.764      | 
|COCH-ARM / FISHERS |                                                        |P=0.500N     P=0.500      P=0.500N     P=0.759N     | 
|ORDER RESTRICTED   |                                                        |P=0.381N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       175 MG/L     350 MG/L     700 MG/L    |0 MG/L       175 MG/L     350 MG/L     700 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Benign Tumors                                                                                                               | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   0/15 (0%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     1/15.00      0/15.00      0/15.00      0/15.00     |1/15.00      2/15.00      0/14.01      1/15.00      | 
|POLY-3 PERCENT (g) |     6.7%         0.0%         0.0%         0.0%        |6.7%         13.3%        0.0%         6.7%         | 
|TERMINAL (d)       |     1/15 (7%)    0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   0/14 (0%)    1/15 (7%)    | 
|FIRST INCIDENCE    |     184 (T)      ---          ---          ---         |185 (T)      185 (T)      ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.502N     P=0.500      P=0.514N     P=0.764      | 
|POLY 3             |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|POLY 1.5           |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.505N     P=0.500      P=0.513N     P=0.760      | 
|POLY 6             |     P=0.306N     P=0.500N     P=0.500N     P=0.500N    |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|LOGISTIC REGRESSION|     P=0.306N     (e)          (e)          (e)         |P=0.502N     P=0.500      (e)          P=0.764      | 
|COCH-ARM / FISHERS |     P=0.305N     P=0.500N     P=0.500N     P=0.500N    |P=0.500N     P=0.500      P=0.500N     P=0.759N     | 
|ORDER RESTRICTED   |     P=0.121N     (e)          (e)          (e)         |P=0.381N     (e)          (e)          (e)          | 
|=================================================================================================================================| 
                                                                                                                                   
       Date:  06/11/04                           EXPERIMENT: 97013 TEST: 04                                            Page 2       
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic)       -      WATER DISINFECTION MODEL (BROMODICHLOR     
                                         Terminal Sacrifice at 27 weeks                                                             
|=================================================================================================================================| 
|                   |                                                        |                                                    | 
|                   |                              Males                     |                       Females                      | 
|Dose               |     0 MG/L       175 MG/L     350 MG/L     700 MG/L    |0 MG/L       175 MG/L     350 MG/L     700 MG/L     | 
|                   |                                                        |                                                    | 
|=================================================================================================================================| 
|                                                                                                                                 | 
|All Organs                                                                                                                       | 
|     Malignant and Benign Tumors                                                                                                 | 
|                                                                                                                                 | 
|                                                                                                                                 | 
|---------------------------------------------------------------------------------------------------------------------------------| 
|TUMOR RATES        |     #            #            #            #           |#            #            #            #            | 
|-----------        |                                                        |                                                    | 
|OVERALL (a)        |     2/15 (13%)   0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   0/15 (0%)    1/15 (7%)    | 
|POLY-3 RATE (b)    |     2/15.00      0/15.00      0/15.00      0/15.00     |1/15.00      2/15.00      0/14.01      1/15.00      | 
|POLY-3 PERCENT (g) |     13.3%        0.0%         0.0%         0.0%        |6.7%         13.3%        0.0%         6.7%         | 
|TERMINAL (d)       |     2/15 (13%)   0/15 (0%)    0/15 (0%)    0/15 (0%)   |1/15 (7%)    2/15 (13%)   0/14 (0%)    1/15 (7%)    | 
|FIRST INCIDENCE    |     184 (T)      ---          ---          ---         |185 (T)      185 (T)      ---          185 (T)      | 
|-------------------|                                                        |                                                    | 
|STATISTICAL TESTS  |                                                        |                                                    | 
|-------------------|                                                        |                                                    | 
|LIFE TABLE         |     P=0.114N     P=0.236N     P=0.236N     P=0.236N    |P=0.502N     P=0.500      P=0.514N     P=0.764      | 
|POLY 3             |     P=0.107N     P=0.232N     P=0.232N     P=0.232N    |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|POLY 1.5           |     P=0.107N     P=0.232N     P=0.232N     P=0.232N    |P=0.505N     P=0.500      P=0.513N     P=0.760      | 
|POLY 6             |     P=0.107N     P=0.232N     P=0.232N     P=0.232N    |P=0.506N     P=0.500      P=0.514N     P=0.760      | 
|LOGISTIC REGRESSION|     P=0.114N     (e)          (e)          (e)         |P=0.502N     P=0.500      (e)          P=0.764      | 
|COCH-ARM / FISHERS |     P=0.112N     P=0.241N     P=0.241N     P=0.241N    |P=0.500N     P=0.500      P=0.500N     P=0.759N     | 
|ORDER RESTRICTED   |     P=0.025N*    (e)          (e)          (e)         |P=0.381N     (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).                                                    
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.