TDMS Study 93027-14 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PEROXISOME PROJECT (DIBUTYL PHTHALATE) DATE: 10/25/04 EXPERIMENT: 93027 TEST: 14 TIME: 13:08:28 TEST TYPE: SUBCHRON 90-DAY PAGE: 1 CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: 93027A PATHOLOGIST: MELLICK, PAUL CAS: 84-74-2 ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus PEROXISOME PROJECT (DIBUTYL PHTHALATE) DATE: 10/25/04 EXPERIMENT: 93027 TEST: 14 TIME: 13:08:28 TEST TYPE: SUBCHRON 90-DAY CONT: NO1-ES-15320 ROUTE: DOSED FEED NTP C#: 93027A PATHOLOGIST: MELLICK, PAUL CAS: 84-74-2 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF PEROXISOME PROJECT (DIBUTYL PHTHAL =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Liver Cytoplasmic Alteration =============================================================== Date: 10/25/04 EXPERIMENT: 93027 TEST: 14 Page 1 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PEROXISOME PROJECT (DIBUTYL PHTHAL Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 1000 2500 5000 10,000 20,000 | | | PPM PPM PPM PPM PPM | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |POLY-3 RATE (b) | 2/10.00 1/10.00 0/10.00 2/10.00 1/10.00 1/10.00 | |POLY-3 PERCENT (g) | 20.0% 10.0% 0.0% 20.0% 10.0% 10.0% | |TERMINAL (d) | 2/10 (20%) 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 1/10 (10%) | |FIRST INCIDENCE | 92 (T) 92 (T) --- 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.525N P=0.500N P=0.234N P=0.707 P=0.500N P=0.500N | |POLY 3 | P=0.524N P=0.500N P=0.227N P=0.702 P=0.500N P=0.500N | |POLY 1.5 | P=0.524N P=0.500N P=0.227N P=0.702 P=0.500N P=0.500N | |POLY 6 | P=0.524N P=0.500N P=0.227N P=0.702 P=0.500N P=0.500N | |LOGISTIC REGRESSION| P=0.525N P=0.500N (e) P=0.707 P=0.500N P=0.500N | |COCH-ARM / FISHERS | P=0.525N P=0.500N P=0.237N P=0.709N P=0.500N P=0.500N | |ORDER RESTRICTED | P=0.456N (e) (e) (e) (e) (e) | |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 1000 2500 5000 10,000 20,000 | | | PPM PPM PPM PPM PPM | |=================================================================================================================================| | | |Liver | | Cytoplasmic Alteration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 10/10.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 100.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 10/10 (100%) | |FIRST INCIDENCE | --- --- --- --- 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.234 P<0.001 ** | |POLY 3 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |POLY 6 | P<0.001 ** (e) (e) (e) P=0.227 P<0.001 ** | |LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.234 P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.237 P<0.001 ** | |ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 93027 TEST: 14 Page 2 Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PEROXISOME PROJECT (DIBUTYL PHTHAL Terminal Sacrifice at 14 weeks |=================================================================================================================================| | | | | | Males | |Dose | 0 PPM 1000 2500 5000 10,000 20,000 | | | PPM PPM PPM PPM PPM | |=================================================================================================================================| | | |Liver | | Infiltration Cellular Mixed Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | |----------- | | |OVERALL (a) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 3/10 (30%) 4/10 (40%) | |POLY-3 RATE (b) | 2/10.00 1/10.00 2/10.00 1/10.00 3/10.00 4/10.00 | |POLY-3 PERCENT (g) | 20.0% 10.0% 20.0% 10.0% 30.0% 40.0% | |TERMINAL (d) | 2/10 (20%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 3/10 (30%) 4/10 (40%) | |FIRST INCIDENCE | 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) 92 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.071 P=0.500N P=0.707 P=0.500N P=0.500 P=0.317 | |POLY 3 | P=0.073 P=0.500N P=0.702 P=0.500N P=0.500 P=0.318 | |POLY 1.5 | P=0.073 P=0.500N P=0.702 P=0.500N P=0.500 P=0.318 | |POLY 6 | P=0.073 P=0.500N P=0.702 P=0.500N P=0.500 P=0.318 | |LOGISTIC REGRESSION| P=0.071 P=0.500N P=0.707 P=0.500N P=0.500 P=0.317 | |COCH-ARM / FISHERS | P=0.069 P=0.500N P=0.709N P=0.500N P=0.500 P=0.314 | |ORDER RESTRICTED | P=0.154 (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).