TDMS Study 88127-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus PENTAERYTHRITOL TRIACRYLATE (PETA) DATE: 07/12/02 EXPERIMENT: 88127 TEST: 06 TIME: 08:41:41 TEST TYPE: SUBCHRON 26-WEEK PAGE: 1 CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88127B PATHOLOGIST: TOFT, JOHN CAS: 3524-68-3 ------------------------------------------------------------------------------------------------------------------------------------ Final#2 REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11 LAB: Battelle Columbus PENTAERYTHRITOL TRIACRYLATE (PETA) DATE: 07/12/02 EXPERIMENT: 88127 TEST: 06 TIME: 08:41:41 TEST TYPE: SUBCHRON 26-WEEK CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88127B PATHOLOGIST: TOFT, JOHN CAS: 3524-68-3 PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 185 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 132 145 155 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.75 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 129 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 185 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 3 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 0 CENSORED DEATHS 0 TERMINAL 15 | | | | UNCENSORED DEATHS | | NONE | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 163 166 184 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 5 CENSORED DEATHS 0 TERMINAL 10 | | | | UNCENSORED DEATHS | | 138 160 167 170 182 | | CENSORED DEATHS | | NONE | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 185 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 185 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 86.7 80.0 80.0 | | | | | | | |0.75 | 100.0 100.0 100.0 100.0 100.0 100.0 93.3 93.3 93.3 93.3 | |MG/KG | | | | | |1.5 | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | |MG/KG | | | | | |3 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 | | | | | | | |6 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 86.7 80.0 | | | | | | | |12 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 86.7 66.7 | | | | | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA MALE MICE FIRST TERMINAL SACRIFICE AT 185 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | MG/KG MG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 93.3% 100.0% 100.0% 80.0% 66.7% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.031 P=0.616N P=0.224N P=0.224N P=1.000N P=0.762 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 144.0 129.0 . . 171.0 163.4 | |NATURAL DEATHS (C) | ( 6.7) ( . ) ( . ) ( . ) ( 6.6) ( 7.3) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 176.8 181.3 185.0 185.0 182.2 177.8 | |(STANDARD ERROR) | ( 4.5) ( 3.7) ( 0.0) ( 0.0) ( 1.9) ( 3.5) | | | | =============================================================================================================================== (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) PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 186 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 0 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 63 70 177 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 0.75 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 1 CENSORED DEATHS 0 TERMINAL 14 | | | | UNCENSORED DEATHS | | 67 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 1.5 MG/KG | | ---------------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 5 109 149 | | CENSORED DEATHS | | NONE | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 186 DAYS INDIVIDUAL SURVIVAL TIMES (DAYS) ================================================================================== | DOSE = 3 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 3 CENSORED DEATHS 0 TERMINAL 12 | | | | UNCENSORED DEATHS | | 167 177 180 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 6 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 2 CENSORED DEATHS 0 TERMINAL 13 | | | | UNCENSORED DEATHS | | 85 182 | | CENSORED DEATHS | | NONE | | | |--------------------------------------------------------------------------------| | DOSE = 12 MG/KG | | --------------------- | | | | TOTAL 15 UNCENSORED DEATHS 6 CENSORED DEATHS 0 TERMINAL 9 | | | | UNCENSORED DEATHS | | 27 98 113 126 134 162 | | CENSORED DEATHS | | NONE | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 186 DAYS ================================================================================== | KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) | | | |--------------------------------------------------------------------------------| | DOSE TIME (DAYS) | | 19 38 57 76 95 114 133 152 171 186 (A) | | | |--------------------------------------------------------------------------------| | | | |0 MG/KG | 100.0 100.0 100.0 86.7 86.7 86.7 86.7 86.7 86.7 80.0 | | | | | | | |0.75 | 100.0 100.0 100.0 93.3 93.3 93.3 93.3 93.3 93.3 93.3 | |MG/KG | | | | | |1.5 | 93.3 93.3 93.3 93.3 93.3 86.7 86.7 86.7 80.0 80.0 | |MG/KG | | | | | |3 MG/KG | 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 93.3 80.0 | | | | | | | |6 MG/KG | 100.0 100.0 100.0 100.0 93.3 93.3 93.3 93.3 93.3 86.7 | | | | | | | |12 MG/KG | 100.0 93.3 93.3 93.3 93.3 86.7 73.3 66.7 60.0 60.0 | | | | | | | ================================================================================== PENTAERYTHRITOL TRIACRYLATE (PETA) STATISTICAL ANALYSIS OF SURVIVAL DATA FEMALE MICE FIRST TERMINAL SACRIFICE AT 186 DAYS =============================================================================================================================== | SURVIVAL SUMMARY STATISTICS | | | | | |-----------------------------------------------------------------------------------------------------------------------------| | DOSE | | | | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG | | MG/KG MG/KG | |-----------------------------------------------------------------------------------------------------------------------------| |SURVIVAL AT END OF STUDY| 80.0% 93.3% 80.0% 80.0% 86.7% 60.0% | |(KAPLAN-MEIER) | | | | | |SIGNIFICANCE (B) | P=0.087 P=0.592N P=1.000 P=1.000N P=0.922N P=0.416 | |(LIFE TABLE) | | | | | |MEAN DAY OF | 103.3 67.0 87.7 174.7 133.5 110.0 | |NATURAL DEATHS (C) | (36.9) ( . ) (42.9) ( 3.9) (48.5) (18.8) | |(STANDARD ERROR) | | | | | |MEAN LIFE SPAN (D) | 169.5 178.1 166.3 183.7 179.0 155.6 | |(STANDARD ERROR) | (10.8) ( 7.9) (12.8) ( 1.4) ( 6.7) (12.2) | | | | =============================================================================================================================== (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) PENTAERYTHRITOL TRIACRYLATE (PETA) KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0.75 MG/KG = 2 1.5 MG/KG = 3 3 MG/KG = 4 6 MG/KG = 5 12 MG/KG = 6 ------------------------------------------------------ SPECIES=MICE SEX=MALE ------------------------------------------------------- Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.00 + 1 1 6 5 3 | P | E | R 93.33 + 1 6 1 6 2 C | E | N | T 86.67 + 1 1 5 5 | S | U | R 80.00 + 1 6 6 1 V | I | V | A 73.33 + 6 6 L | | | 66.67 + 6 6 | ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+-- 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 WEEK NOTE: 11 obs hidden. PENTAERYTHRITOL TRIACRYLATE (PETA) KAPLAN-MEIER SURVIVAL CURVES 0 MG/KG = 1 0.75 MG/KG = 2 1.5 MG/KG = 3 3 MG/KG = 4 6 MG/KG = 5 12 MG/KG = 6 ----------------------------------------------------- SPECIES=MICE SEX=FEMALE ------------------------------------------------------ Plot of SURVIVAL*WEEK. Symbol is value of DOSE. | | 100.00 + 1 3 6 1 2 5 4 | | | P 93.33 + 3 6 1 1 5 6 3 4 4 2 E | R | C | E 86.67 + 1 6 3 6 3 1 5 N | T | | S 80.00 + 6 6 3 1 1 U | R | V | I 73.33 + 6 6 V | A | L | 66.67 + 6 6 | | | 60.00 + 6 6 | ---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+---+-- 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 WEEK NOTE: 11 obs hidden.