TDMS Study 89029-12 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Northwest MAGNETIC FIELDS + DMBA INITIATION PROMOTION DATE: 01/07/98 EXPERIMENT: 89029 TEST: 12 TIME: 16:17:51 TEST TYPE: SUBCHRON 90-DAY CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-65397 ROUTE: MAGNETIC FIELDS NTP C#: 89029D PATHOLOGIST: GRUMBEIN, S. CAS: EMF+DMBA SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF MAGNETIC FIELDS + DMBA INITIATION PROMOTIO =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Liver Clear Cell Focus Hematopoietic Cell Proliferation Lung: Alveolar Epithelium Hyperplasia Lung: Alveolus Infiltration Cellular Histiocyte =============================================================== Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 2/100 (2%) 0/100 (0%) 0/100 (0%) 2/100 (2%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 2.0% 0.0% 0.0% 2.0% 1.0% | |TERMINAL (d) | 1/94 (1%) 0/100 (0%) 0/87 (0%) 2/95 (2%) 1/92 (1%) | |FIRST INCIDENCE | 72 --- --- 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.552 P=0.232N P=0.251N P=0.690N P=0.507N | |POLY 3 | P=0.556 P=0.234N P=0.245N P=0.691N P=0.505N | |POLY 1.5 | P=0.559 P=0.236N P=0.243N P=0.691N P=0.503N | |POLY 6 | P=0.552 P=0.232N P=0.250N P=0.690N P=0.508N | |LOGISTIC REGRESSION| P=0.548N P=0.386N P=0.187N P=0.662 P=0.486N | |COCH-ARM / FISHERS | P=0.563N P=0.249N P=0.249N P=0.689N P=0.500N | |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 15/100 (15%) 10/100 (10%) 16/100 (16%) 16/100 (16%) 10/100 (10%) | |POLY-3 ADJUSTED (b)| 15.3% 10.0% 16.8% 16.0% 10.4% | |TERMINAL (d) | 14/94 (15%) 10/100 (10%) 15/87 (17%) 13/95 (14%) 10/92 (11%) | |FIRST INCIDENCE | 72 90 (T) 84 64 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.418N P=0.156N P=0.410 P=0.512 P=0.213N | |POLY 3 | P=0.394N P=0.181N P=0.465 P=0.523 P=0.206N | |POLY 1.5 | P=0.385N P=0.187N P=0.480 P=0.514 P=0.202N | |POLY 6 | P=0.407N P=0.174N P=0.446 P=0.533 P=0.212N | |LOGISTIC REGRESSION| P=0.366N P=0.208N P=0.470 P=0.454 P=0.201N | |COCH-ARM / FISHERS | P=0.373N P=0.196N P=0.500 P=0.500 P=0.196N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/100 (1%) 0/100 (0%) 0/100 (0%) 3/100 (3%) 3/100 (3%) | |POLY-3 ADJUSTED (b)| 1.0% 0.0% 0.0% 3.1% 3.1% | |TERMINAL (d) | 1/94 (1%) 0/100 (0%) 0/87 (0%) 3/95 (3%) 3/92 (3%) | |FIRST INCIDENCE | 90 (T) --- --- 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.037 * P=0.488N P=0.515N P=0.311 P=0.300 | |POLY 3 | P=0.038 * P=0.495N P=0.505N P=0.311 P=0.304 | |POLY 1.5 | P=0.039 * P=0.497N P=0.503N P=0.309 P=0.305 | |POLY 6 | P=0.038 * P=0.492N P=0.508N P=0.312 P=0.302 | |LOGISTIC REGRESSION| P=0.037 * (e) (e) P=0.311 P=0.300 | |COCH-ARM / FISHERS | P=0.040 * P=0.500N P=0.500N P=0.311 P=0.311 | |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/100 (0%) 1/100 (1%) 2/100 (2%) 2/100 (2%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 0.0% 1.0% 2.1% 2.0% 1.0% | |TERMINAL (d) | 0/94 (0%) 1/100 (1%) 2/87 (2%) 1/95 (1%) 0/92 (0%) | |FIRST INCIDENCE | --- 90 (T) 90 (T) 84 77 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.227 P=0.512 P=0.222 P=0.243 P=0.504 | |POLY 3 | P=0.232 P=0.505 P=0.233 P=0.241 P=0.499 | |POLY 1.5 | P=0.233 P=0.503 P=0.235 P=0.240 P=0.499 | |POLY 6 | P=0.230 P=0.508 P=0.230 P=0.242 P=0.498 | |LOGISTIC REGRESSION| P=0.244 P=0.512 P=0.222 P=0.225 P=0.514 | |COCH-ARM / FISHERS | P=0.234 P=0.500 P=0.249 P=0.249 P=0.500 | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 19/100 (19%) 0/100 (0%) 12/100 (12%) 22/100 (22%) 12/100 (12%) | |POLY-3 ADJUSTED (b)| 19.4% 0.0% 12.6% 22.3% 12.4% | |TERMINAL (d) | 18/94 (19%) 0/100 (0%) 12/87 (14%) 21/95 (22%) 12/92 (13%) | |FIRST INCIDENCE | 72 --- 90 (T) 70 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.206 P<0.001N** P=0.172N P=0.377 P=0.135N | |POLY 3 | P=0.209 P<0.001N** P=0.139N P=0.377 P=0.128N | |POLY 1.5 | P=0.220 P<0.001N** P=0.131N P=0.372 P=0.125N | |POLY 6 | P=0.195 P<0.001N** P=0.151N P=0.382 P=0.133N | |LOGISTIC REGRESSION| P=0.230 P<0.001N** P=0.140N P=0.360 P=0.125N | |COCH-ARM / FISHERS | P=0.240 P<0.001N** P=0.120N P=0.363 P=0.120N | |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/100 (0%) 0/100 (0%) 1/100 (1%) 2/100 (2%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 1.1% 2.0% 1.0% | |TERMINAL (d) | 0/94 (0%) 0/100 (0%) 1/87 (1%) 2/95 (2%) 0/92 (0%) | |FIRST INCIDENCE | --- --- 90 (T) 90 (T) 59 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.104 (e) P=0.485 P=0.241 P=0.502 | |POLY 3 | P=0.106 (e) P=0.495 P=0.241 P=0.500 | |POLY 1.5 | P=0.107 (e) P=0.497 P=0.240 P=0.500 | |POLY 6 | P=0.105 (e) P=0.492 P=0.242 P=0.499 | |LOGISTIC REGRESSION| P=0.116 (e) P=0.485 P=0.241 P=0.469 | |COCH-ARM / FISHERS | P=0.107 (e) P=0.500 P=0.249 P=0.500 | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/100 (1%) 0/100 (0%) 3/100 (3%) 1/100 (1%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 1.0% 0.0% 3.1% 1.0% 1.0% | |TERMINAL (d) | 1/94 (1%) 0/100 (0%) 0/87 (0%) 1/95 (1%) 0/92 (0%) | |FIRST INCIDENCE | 90 (T) --- 81 90 (T) 79 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.433 P=0.488N P=0.293 P=0.759N P=0.758 | |POLY 3 | P=0.436 P=0.495N P=0.301 P=0.758N P=0.759 | |POLY 1.5 | P=0.439 P=0.497N P=0.303 P=0.759N P=0.760 | |POLY 6 | P=0.433 P=0.492N P=0.298 P=0.757N P=0.758 | |LOGISTIC REGRESSION| P=0.470 (e) P=0.352 P=0.759N P=0.754N | |COCH-ARM / FISHERS | P=0.442 P=0.500N P=0.311 P=0.751N P=0.751N | |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/100 (6%) 0/100 (0%) 0/100 (0%) 4/100 (4%) 5/100 (5%) | |POLY-3 ADJUSTED (b)| 6.2% 0.0% 0.0% 4.1% 5.2% | |TERMINAL (d) | 6/94 (6%) 0/100 (0%) 0/87 (0%) 4/95 (4%) 5/92 (5%) | |FIRST INCIDENCE | 90 (T) --- --- 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.370 P=0.016N* P=0.024N* P=0.366N P=0.515N | |POLY 3 | P=0.379 P=0.017N* P=0.020N* P=0.367N P=0.506N | |POLY 1.5 | P=0.384 P=0.017N* P=0.019N* P=0.370N P=0.503N | |POLY 6 | P=0.374 P=0.016N* P=0.020N* P=0.365N P=0.510N | |LOGISTIC REGRESSION| P=0.370 (e) (e) P=0.366N P=0.515N | |COCH-ARM / FISHERS | P=0.390 P=0.014N* P=0.014N* P=0.374N P=0.500N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/100 (7%) 1/100 (1%) 2/100 (2%) 6/100 (6%) 15/100 (15%) | |POLY-3 ADJUSTED (b)| 7.2% 1.0% 2.1% 6.1% 15.5% | |TERMINAL (d) | 7/94 (7%) 1/100 (1%) 2/87 (2%) 6/95 (6%) 15/92 (16%) | |FIRST INCIDENCE | 90 (T) 90 (T) 90 (T) 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.003 ** P=0.029N* P=0.106N P=0.492N P=0.051 | |POLY 3 | P=0.003 ** P=0.032N* P=0.092N P=0.493N P=0.053 | |POLY 1.5 | P=0.003 ** P=0.033N* P=0.089N P=0.496N P=0.055 | |POLY 6 | P=0.003 ** P=0.030N* P=0.096N P=0.490N P=0.052 | |LOGISTIC REGRESSION| P=0.003 ** P=0.029N* P=0.106N P=0.492N P=0.051 | |COCH-ARM / FISHERS | P=0.004 ** P=0.032N* P=0.085N P=0.500N P=0.056 | |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Mammary Gland | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/100 (4%) 0/100 (0%) 0/100 (0%) 7/100 (7%) 3/100 (3%) | |POLY-3 ADJUSTED (b)| 4.1% 0.0% 0.0% 7.1% 3.1% | |TERMINAL (d) | 4/94 (4%) 0/100 (0%) 0/87 (0%) 7/95 (7%) 3/92 (3%) | |FIRST INCIDENCE | 90 (T) --- --- 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.181 P=0.058N P=0.076N P=0.274 P=0.512N | |POLY 3 | P=0.182 P=0.060N P=0.067N P=0.273 P=0.505N | |POLY 1.5 | P=0.186 P=0.062N P=0.066N P=0.271 P=0.503N | |POLY 6 | P=0.177 P=0.059N P=0.069N P=0.275 P=0.508N | |LOGISTIC REGRESSION| P=0.181 (e) (e) P=0.274 P=0.512N | |COCH-ARM / FISHERS | P=0.194 P=0.061N P=0.061N P=0.269 P=0.500N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 12 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 12 weeks |=================================================================================================================================| | | | | | Females | |Dose | 20 DMBA UNTREATD 50 HZ/1G 60 HZ/1G 50 HZ/5G | | | CONTROL CONTROL 20 DMBA 20 DMBA 20 DMBA | |=================================================================================================================================| | | |Mammary Gland | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/100 (0%) 0/100 (0%) 0/100 (0%) 2/100 (2%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.0% 1.0% | |TERMINAL (d) | 0/94 (0%) 0/100 (0%) 0/87 (0%) 2/95 (2%) 1/92 (1%) | |FIRST INCIDENCE | --- --- --- 90 (T) 90 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.073 (e) (e) P=0.241 P=0.496 | |POLY 3 | P=0.074 (e) (e) P=0.241 P=0.498 | |POLY 1.5 | P=0.075 (e) (e) P=0.240 P=0.499 | |POLY 6 | P=0.073 (e) (e) P=0.242 P=0.497 | |LOGISTIC REGRESSION| (e) (e) (e) P=0.241 P=0.496 | |COCH-ARM / FISHERS | P=0.076 (e) (e) P=0.249 P=0.500 | |=================================================================================================================================| (a) Number of tumor-bearing animals / number of animals examined at site. (b) Poly-3 adjusted lifetime tumor incidence. (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. (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).