TDMS Study 89029-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: I. I. T. Research Inst MAGNETIC FIELDS (EMF) DATE: 10/25/04 EXPERIMENT: 89029 TEST: 01 TIME: 11:32:02 TEST TYPE: SUBCHRON 8-WEEK PAGE: 1 CONT: N01-ES-25351 ROUTE: MAGNETIC FIELDS NTP C#: C89029 PATHOLOGIST: BRENNECKE, L. CAS: ELECTROMAG ------------------------------------------------------------------------------------------------------------------------------------ REASONS FOR REMOVAL: ALL REMOVAL DATE RANGE: ALL TREATMENT GROUPS: INCLUDE ALL NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: I. I. T. Research Inst MAGNETIC FIELDS (EMF) DATE: 10/25/04 EXPERIMENT: 89029 TEST: 01 TIME: 11:32:02 TEST TYPE: SUBCHRON 8-WEEK CONT: N01-ES-25351 ROUTE: MAGNETIC FIELDS NTP C#: C89029 PATHOLOGIST: BRENNECKE, L. CAS: ELECTROMAG SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF MAGNETIC FIELDS (EMF) =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Lung Hemorrhage Pancreas: Acinus Atrophy =============================================================== Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF) Terminal Sacrifice at 9 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Harderian Gland | | Infiltration Cellular Lymphocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/20 (15%) |1/10 (10%) 1/10 (10%) 0/10 (0%) 1/20 (5%) | |POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 3/20.00 |1/10.00 1/10.00 0/9.57 1/20.00 | |POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 15.0% |10.0% 10.0% 0.0% 5.0% | |TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/20 (15%) |1/10 (10%) 1/10 (10%) 0/9 (0%) 1/20 (5%) | |FIRST INCIDENCE | 58 (T) --- --- 58 (T) |59 (T) 59 (T) --- 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.175 P=0.500N P=0.500N P=0.574 |P=0.533N P=0.766 P=0.521N P=0.600N | |POLY 3 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.532N P=0.760 P=0.509N P=0.599N | |POLY 1.5 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.535N P=0.760 P=0.505N P=0.599N | |POLY 6 | P=0.175 P=0.500N P=0.500N P=0.573 |P=0.527N P=0.760 P=0.514N P=0.599N | |LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.574 |P=0.533N P=0.766 (e) P=0.600N | |COCH-ARM / FISHERS | P=0.172 P=0.500N P=0.500N P=0.593 |P=0.541N P=0.763N P=0.500N P=0.563N | |ORDER RESTRICTED | P=0.218 (e) (e) (e) |P=0.389N (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Heart | | Cardiomyopathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 7/10 (70%) 4/10 (40%) 5/10 (50%) 13/20 (65%) |1/10 (10%) 0/10 (0%) 0/10 (0%) 2/20 (10%) | |POLY-3 RATE (b) | 7/10.00 4/10.00 5/10.00 13/20.00 |1/10.00 0/10.00 0/9.57 2/20.00 | |POLY-3 PERCENT (g) | 70.0% 40.0% 50.0% 65.0% |10.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 7/10 (70%) 4/10 (40%) 5/10 (50%) 13/20 (65%) |1/10 (10%) 0/10 (0%) 0/9 (0%) 2/20 (10%) | |FIRST INCIDENCE | 58 (T) 58 (T) 58 (T) 58 (T) |59 (T) --- --- 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.304 P=0.190N P=0.328N P=0.554N |P=0.369 P=0.500N P=0.521N P=0.737 | |POLY 3 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.366 P=0.500N P=0.509N P=0.734 | |POLY 1.5 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.364 P=0.500N P=0.505N P=0.734 | |POLY 6 | P=0.305 P=0.186N P=0.329N P=0.553N |P=0.367 P=0.500N P=0.514N P=0.734 | |LOGISTIC REGRESSION| P=0.304 P=0.190N P=0.328N P=0.554N |P=0.369 (e) (e) P=0.737 | |COCH-ARM / FISHERS | P=0.302 P=0.185N P=0.325N P=0.560N |P=0.360 P=0.500N P=0.500N P=0.719N | |ORDER RESTRICTED | P=0.356N (e) (e) (e) |P=0.386 (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF) Terminal Sacrifice at 9 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 2/20 (10%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/20.00 |0/10.00 0/10.00 0/9.57 2/20.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 10.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |0/10 (0%) 0/10 (0%) 0/9 (0%) 2/20 (10%) | |FIRST INCIDENCE | --- --- --- --- |--- --- --- 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.138 (e) (e) P=0.400 | |POLY 3 | (e) (e) (e) (e) |P=0.134 (e) (e) P=0.400 | |POLY 1.5 | (e) (e) (e) (e) |P=0.133 (e) (e) P=0.400 | |POLY 6 | (e) (e) (e) (e) |P=0.134 (e) (e) P=0.400 | |LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.400 | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.131 (e) (e) P=0.437 | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.151 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Lung | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/20 (15%) |3/10 (30%) 0/10 (0%) 1/10 (10%) 0/20 (0%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 3/20.00 |3/10.00 0/10.00 1/9.57 0/20.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 15.0% |30.0% 0.0% 10.5% 0.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 3/20 (15%) |3/10 (30%) 0/10 (0%) 1/9 (11%) 0/20 (0%) | |FIRST INCIDENCE | --- --- 58 (T) 58 (T) |59 (T) --- 59 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.123 (e) P=0.500 P=0.263 |P=0.095N P=0.111N P=0.333N P=0.028N* | |POLY 3 | P=0.123 (e) P=0.500 P=0.261 |P=0.080N P=0.095N P=0.308N P=0.017N* | |POLY 1.5 | P=0.123 (e) P=0.500 P=0.261 |P=0.081N P=0.095N P=0.301N P=0.017N* | |POLY 6 | P=0.123 (e) P=0.500 P=0.261 |P=0.078N P=0.095N P=0.318N P=0.017N* | |LOGISTIC REGRESSION| (e) (e) P=0.500 P=0.263 |P=0.095N (e) P=0.333N (e) | |COCH-ARM / FISHERS | P=0.121 (e) P=0.500 P=0.281 |P=0.095N P=0.105N P=0.291N P=0.030N* | |ORDER RESTRICTED | P=0.126 (e) (e) (e) |P=0.002N** (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF) Terminal Sacrifice at 9 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |0/10 (0%) 1/10 (10%) 2/10 (20%) 2/20 (10%) | |POLY-3 RATE (b) | |0/10.00 1/10.00 2/9.57 2/20.00 | |POLY-3 PERCENT (g) | |0.0% 10.0% 20.9% 10.0% | |TERMINAL (d) | |0/10 (0%) 1/10 (10%) 2/9 (22%) 2/20 (10%) | |FIRST INCIDENCE | |--- 59 (T) 59 (T) 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.589 P=0.500 P=0.210 P=0.400 | |POLY 3 | |P=0.577 P=0.500 P=0.216 P=0.400 | |POLY 1.5 | |P=0.578 P=0.500 P=0.220 P=0.400 | |POLY 6 | |P=0.576 P=0.500 P=0.210 P=0.400 | |LOGISTIC REGRESSION| |(e) P=0.500 P=0.210 P=0.400 | |COCH-ARM / FISHERS | |P=0.581 P=0.500 P=0.237 P=0.437 | |ORDER RESTRICTED | |P=0.204 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |2/10 (20%) 0/10 (0%) 0/10 (0%) 1/20 (5%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/20.00 |2/10.00 0/10.00 0/9.57 1/20.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |20.0% 0.0% 0.0% 5.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/20 (0%) |2/10 (20%) 0/10 (0%) 0/9 (0%) 1/20 (5%) | |FIRST INCIDENCE | --- --- --- --- |59 (T) --- --- 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) (e) |P=0.532N P=0.234N P=0.257N P=0.263N | |POLY 3 | (e) (e) (e) (e) |P=0.532N P=0.227N P=0.237N P=0.261N | |POLY 1.5 | (e) (e) (e) (e) |P=0.536N P=0.227N P=0.232N P=0.261N | |POLY 6 | (e) (e) (e) (e) |P=0.527N P=0.227N P=0.243N P=0.261N | |LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.532N (e) (e) P=0.263N | |COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.540N P=0.237N P=0.237N P=0.251N | |ORDER RESTRICTED | (e) (e) (e) (e) |P=0.044N* (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF) Terminal Sacrifice at 9 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) |1/10 (10%) 0/10 (0%) 2/10 (20%) 2/20 (10%) | |POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/20.00 |1/10.00 0/10.00 2/9.57 2/20.00 | |POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 5.0% |10.0% 0.0% 20.9% 10.0% | |TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/20 (5%) |1/10 (10%) 0/10 (0%) 2/9 (22%) 2/20 (10%) | |FIRST INCIDENCE | --- --- --- 58 (T) |59 (T) --- 59 (T) 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.365 (e) (e) P=0.638 |P=0.590 P=0.500N P=0.461 P=0.737 | |POLY 3 | P=0.367 (e) (e) P=0.637 |P=0.578 P=0.500N P=0.484 P=0.734 | |POLY 1.5 | P=0.367 (e) (e) P=0.637 |P=0.579 P=0.500N P=0.491 P=0.734 | |POLY 6 | P=0.367 (e) (e) P=0.637 |P=0.577 P=0.500N P=0.475 P=0.734 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.638 |P=0.590 (e) P=0.461 P=0.737 | |COCH-ARM / FISHERS | P=0.364 (e) (e) P=0.667 |P=0.582 P=0.500N P=0.500 P=0.719N | |ORDER RESTRICTED | P=0.296 (e) (e) (e) |P=0.380 (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Thymus | | Hemorrhage | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 5/20 (25%) |2/10 (20%) 2/10 (20%) 1/10 (10%) 2/20 (10%) | |POLY-3 RATE (b) | 1/10.00 1/10.00 2/10.00 5/20.00 |2/10.00 2/10.00 1/10.00 2/20.00 | |POLY-3 PERCENT (g) | 10.0% 10.0% 20.0% 25.0% |20.0% 20.0% 10.0% 10.0% | |TERMINAL (d) | 1/10 (10%) 1/10 (10%) 2/10 (20%) 5/20 (25%) |2/10 (20%) 2/10 (20%) 0/9 (0%) 2/20 (10%) | |FIRST INCIDENCE | 58 (T) 58 (T) 58 (T) 58 (T) |59 (T) 59 (T) 49 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.207 P=0.766 P=0.500 P=0.317 |P=0.333N P=0.707 P=0.525N P=0.426N | |POLY 3 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N | |POLY 1.5 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N | |POLY 6 | P=0.210 P=0.760 P=0.500 P=0.317 |P=0.341N P=0.702 P=0.500N P=0.427N | |LOGISTIC REGRESSION| P=0.207 P=0.766 P=0.500 P=0.317 |P=0.333N P=0.707 (e) P=0.426N | |COCH-ARM / FISHERS | P=0.204 P=0.763N P=0.500 P=0.326 |P=0.337N P=0.709N P=0.500N P=0.407N | |ORDER RESTRICTED | P=0.261 (e) (e) (e) |P=0.377N (e) (e) (e) | |=================================================================================================================================| Date: 10/25/04 EXPERIMENT: 89029 TEST: 01 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - MAGNETIC FIELDS (EMF) Terminal Sacrifice at 9 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | UNTREAT. .02 2 10 |UNTREAT. .02 2 10 | | | CONTROL GAUSS GAUSS GAUSS |CONTROL GAUSS GAUSS GAUSS | |=================================================================================================================================| | | |Uterus | | Hydrometra | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |LESION RATES | | | |----------- | | | |OVERALL (a) | |1/10 (10%) 1/10 (10%) 2/10 (20%) 7/20 (35%) | |POLY-3 RATE (b) | |1/10.00 1/10.00 2/10.00 7/20.00 | |POLY-3 PERCENT (g) | |10.0% 10.0% 20.0% 35.0% | |TERMINAL (d) | |1/10 (10%) 1/10 (10%) 1/9 (11%) 7/20 (35%) | |FIRST INCIDENCE | |59 (T) 59 (T) 49 59 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | |P=0.067 P=0.766 P=0.475 P=0.158 | |POLY 3 | |P=0.056 P=0.760 P=0.500 P=0.153 | |POLY 1.5 | |P=0.056 P=0.760 P=0.500 P=0.153 | |POLY 6 | |P=0.056 P=0.760 P=0.500 P=0.153 | |LOGISTIC REGRESSION| |P=0.067 P=0.766 (e) P=0.158 | |COCH-ARM / FISHERS | |P=0.056 P=0.763N P=0.500 P=0.154 | |ORDER RESTRICTED | |P=0.095 (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).