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TDMS Study 96001-05 Pathology Tables

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                STODDARD SOLVENT (TYPE IIC)                             DATE: 01/08/03       
EXPERIMENT: 96001 TEST: 05                                                                                     TIME: 12:18:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1-ES-75410                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C96001       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 64742-88-7      
------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                    
                                                             FINAL/RATS                                                             
                                                                                                                                    
                                                                                                                                    
               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  
                                                                                                                                   
NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Battelle Northwest                                STODDARD SOLVENT (TYPE IIC)                             DATE: 01/08/03       
EXPERIMENT: 96001 TEST: 05                                                                                     TIME: 12:18:19       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                        
CONT: NO1-ES-75410                              ROUTE: RESPIRATORY EXPOSURE WHOLE BODY                         NTP C#: C96001       
PATHOLOGIST: RENNE, ROGER                                                                                      CAS: 64742-88-7      
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 21     CENSORED DEATHS 0    TERMINAL 29        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      476   576   611   611   621   626   656   670   670   670                 |                                                 
 |      674   674   684   691   696   705   712   712   716   717                 |                                                 
 |      726                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 138     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 31     CENSORED DEATHS 0    TERMINAL 19        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      403   421   472   537   565   579   582   590   605   621                 |                                                 
 |      621   621   625   636   640   642   642   642   642   642                 |                                                 
 |      652   656   656   658   667   670   670   670   671   682                 |                                                 
 |      726                                                                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 550     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 29     CENSORED DEATHS 0    TERMINAL 21        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      396   509   529   541   546   556   558   589   593   618                 |                                                 
 |      621   633   642   647   673   675   675   691   696   698                 |                                                 
 |      702   705   708   712   715   715   717   720   726                       |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 1100    MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 34     CENSORED DEATHS 0    TERMINAL 16        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      432   465   522   529   548   563   565   578   581   593                 |                                                 
 |      606   610   636   642   645   647   652   667   673   675                 |                                                 
 |      683   684   684   684   691   691   691   698   705   705                 |                                                 
 |      712   712   717   725                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                     MALE RATS                                                                                      
                       FIRST TERMINAL SACRIFICE AT 729 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   729 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  98.0  96.0  86.0  58.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |138        |   100.0 100.0 100.0 100.0  96.0  94.0  92.0  82.0  52.0  38.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |550        |   100.0 100.0 100.0 100.0  98.0  98.0  92.0  82.0  72.0  42.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1100       |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  80.0  66.0  32.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      138          550          1100     |                                                 
 |                                             MG/M3        MG/M3        MG/M3    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       58.0%        38.0%        42.0%        32.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.057      P=0.014      P=0.125      P=0.007  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       661.6        616.3        638.1        635.6    |                                                 
 |NATURAL DEATHS (C)      |       (12.9)       (13.0)       (15.2)       (12.8)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       700.7        659.1        676.3        665.5    |                                                 
 |(STANDARD ERROR)        |       ( 7.2)       (11.2)       (10.9)       (10.7)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                                DOSE = CONTROL                                  |                                                 
 |                             ---------------------                              |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 14     CENSORED DEATHS 0    TERMINAL 36        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      481   495   509   537   540   582   606   634   656   656                 |                                                 
 |      698   712   712   722                                                     |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 550     MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 20     CENSORED DEATHS 0    TERMINAL 30        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      481   481   506   537   575   593   606   646   652   656                 |                                                 
 |      656   670   675   691   703   703   719   726   726   729                 |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                          DOSE = 1100    MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 18     CENSORED DEATHS 0    TERMINAL 32        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      401   433   563   565   581   610   610   682   683   689                 |                                                 
 |      695   698   703   705   710   718   722   726                             |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
                                                                                                                                    
                          INDIVIDUAL SURVIVAL TIMES (DAYS)                                                                          
 ==================================================================================                                                 
 |                          DOSE = 2200    MG/M3                                  |                                                 
 |                       ----------------------------                             |                                                 
 |                                                                                |                                                 
 |  TOTAL 50     UNCENSORED DEATHS 25     CENSORED DEATHS 0    TERMINAL 25        |                                                 
 |                                                                                |                                                 
 |  UNCENSORED DEATHS                                                             |                                                 
 |      285   451   506   509   522   522   537   549   589   606                 |                                                 
 |      611   621   625   647   656   674   682   682   693   694                 |                                                 
 |      696   712   714   718   722                                               |                                                 
 |  CENSORED DEATHS                                                               |                                                 
 |      NONE                                                                      |                                                 
 |                                                                                |                                                 
 ==================================================================================                                                 
                                                                                                                                   
                            STODDARD SOLVENT (TYPE IIC)                                                                             
                       STATISTICAL ANALYSIS OF SURVIVAL DATA                                                                        
                                    FEMALE RATS                                                                                     
                       FIRST TERMINAL SACRIFICE AT 730 DAYS                                                                         
 ==================================================================================                                                 
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |    DOSE                               TIME (DAYS)                              |                                                 
 |                 90   180   270   365   425   485   545   605   665   730 (A)   |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |           |                                                                    |                                                 
 |CONTROL    |   100.0 100.0 100.0 100.0 100.0  98.0  90.0  88.0  80.0  72.0      |                                                 
 |           |                                                                    |                                                 
 |           |                                                                    |                                                 
 |550        |   100.0 100.0 100.0 100.0 100.0  96.0  92.0  88.0  78.0  60.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |1100       |   100.0 100.0 100.0 100.0  98.0  96.0  96.0  90.0  86.0  64.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 |2200       |   100.0 100.0 100.0  98.0  98.0  96.0  86.0  82.0  70.0  50.0      |                                                 
 |MG/M3      |                                                                    |                                                 
 |           |                                                                    |                                                 
 ==================================================================================                                                 
 ==================================================================================                                                 
 |                           SURVIVAL SUMMARY STATISTICS                          |                                                 
 |                                                                                |                                                 
 |                                                                                |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |                                                  DOSE                          |                                                 
 |                                                                                |                                                 
 |                                CONTROL      550          1100         2200     |                                                 
 |                                             MG/M3        MG/M3        MG/M3    |                                                 
 |--------------------------------------------------------------------------------|                                                 
 |SURVIVAL AT END OF STUDY|       72.0%        60.0%        64.0%        50.0%    |                                                 
 |(KAPLAN-MEIER)          |                                                       |                                                 
 |                        |                                                       |                                                 
 |SIGNIFICANCE (B)        |       P=0.037      P=0.331      P=0.576      P=0.040  |                                                 
 |(LIFE TABLE)            |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN DAY OF             |       610.0        636.6        638.6        608.9    |                                                 
 |NATURAL DEATHS (C)      |       (23.1)       (18.4)       (23.0)       (20.9)   |                                                 
 |(STANDARD ERROR)        |                                                       |                                                 
 |                        |                                                       |                                                 
 |MEAN LIFE SPAN (D)      |       696.4        692.6        697.1        669.5    |                                                 
 |(STANDARD ERROR)        |       ( 9.9)       ( 9.8)       (10.3)       (13.5)   |                                                 
 |                        |                                                       |                                                 
 ==================================================================================                                                 
                                                                                                                                    
       (A)  FIRST TERMINAL SACRIFICE                                                                                                
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.                                                                
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS                                                                    
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".                                                                      
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE                                                               
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)                                                           
                                                                                                                                   
                                                    STODDARD SOLVENT (TYPE IIC)                                                     
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        138     MG/M3    = 2                                                        
                                                        550     MG/M3    = 3                                                        
                                                        1100    MG/M3    = 4                                                        
                                                                                                                                    
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
      |                                                                                                                             
  104 +                                                                                                                             
      |                                                                                                                             
      | 1                                                              32   4      1                                                
      |                                                                32  24     41    3          1                                
   96 +                                                                    2      42    3  43      1     1                          
      |                                                                            2       4323                                     
      |                                                                                     42 4 2       11                         
      |                                                                                       3432 2      11                        
   88 +                                                                                            22      1   1                    
      |                                                                                         34 42 2        1  1                 
P     |                                                                                               2 2                           
E     |                                                                                            4  3 2 2                         
R  80 +                                                                                               4 4         11                
C     |                                                                                                 443 3                       
E     |                                                                                                  42233     11               
N     |                                                                                                    2233     11              
T  72 +                                                                                                     223    3 11             
      |                                                                                                               11            
S     |                                                                                                       44       11           
U     |                                                                                                        4  43 3              
R  64 +                                                                                                           44 33 11          
V     |                                                                                                                             
I     |                                                                                                      2 2   44 33 11         
V     |                                                                                                                   1 1       
A  56 +                                                                                                                33           
L     |                                                                                                                             
      |                                                                                                        2  2 44  33          
      |                                                                                                                             
   48 +                                                                                                                             
      |                                                                                                              44             
      |                                                                                                               44 33         
      |                                                                                                           2 2     3 3       
   40 +                                                                                                             2  44 2         
      |                                                                                                                   2 2       
      |                                                                                                                 44          
      |                                                                                                                  44         
   32 +                                                                                                                   4 4       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 13 obs hidden.                                                                                                                
                                                                                                                                   
                                                    STODDARD SOLVENT (TYPE IIC)                                                     
                                                    KAPLAN-MEIER SURVIVAL CURVES                                                    
                                                        CONTROL          = 1                                                        
                                                        550     MG/M3    = 2                                                        
                                                        1100    MG/M3    = 3                                                        
                                                        2200    MG/M3    = 4                                                        
                                                                                                                                    
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
                                                                                                                                    
                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.                                           
                                                                                                                                    
      |                                                                                                                             
  100 + 1                                            4                  3           1                                               
      |                                                                                                                             
      |                                              4                  3   3   4   1 1                                             
      |                                                                     3   4   2 1 1        3                                  
   95 +                                                                                                                             
      |                                                                                 1    1                                      
      |                                                                                 4  4 11  3 2                                
      |                                                                                                                             
   90 +                                                                                       1    21 2  3                          
      |                                                                                                                             
      |                                                                                    4 4      1 2 1                           
      |                                                                                      4 4        13  1 2     3               
P  85 +                                                                                                                             
E     |                                                                                        4      4     1 21                    
R     |                                                                                               4 4           33              
C     |                                                                                                                             
E  80 +                                                                                                 44     1     31             
N     |                                                                                                                             
T     |                                                                                                  44    2  2   1 1           
      |                                                                                                   44      22  33            
S  75 +                                                                                                                             
U     |                                                                                                    4  4    2 2  1 1         
R     |                                                                                                       44     2 23 1 1       
V     |                                                                                                                             
I  70 +                                                                                                        4   4    33          
V     |                                                                                                                             
A     |                                                                                                            44  2 23         
L     |                                                                                                                  22         
   65 +                                                                                                                             
      |                                                                                                             44    3 3       
      |                                                                                                              44   2 2       
      |                                                                                                                             
   60 +                                                                                                                     2       
      |                                                                                                                             
      |                                                                                                               4 4           
      |                                                                                                                             
   55 +                                                                                                                             
      |                                                                                                                 44          
      |                                                                                                                  44         
      |                                                                                                                             
   50 +                                                                                                                   4 4       
      |                                                                                                                             
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110 
                                                                                                                                    
                                                                   WEEK                                                             
                                                                                                                                    
NOTE: 17 obs hidden.