TDMS Study 89029-11 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: 11 TIME: 16:17:12 TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-65397 ROUTE: MAGNETIC FIELDS NTP C#: 89029D PATHOLOGIST: GRUMBEIN, SONDRA CAS: EMF+DMBA SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF MAGNETIC FIELDS + DMBA INITIATION PROMOTIO =============================================================== Female Rats ------------ Organ Morphology ----- ---------- Kidney Mineralization Liver Basophilic Focus Lung: Alveolar Epithelium Hyperplasia =============================================================== Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 1 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Kidney | | Mineralization | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/100 (1%) 1/98 (1%) 5/100 (5%) | |POLY-3 ADJUSTED (b)| 1.1% 1.1% 5.2% | |TERMINAL (d) | 0/88 (0%) 0/85 (0%) 4/91 (4%) | |FIRST INCIDENCE | 173 134 176 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.045 * P=0.749 P=0.115 | |POLY 3 | P=0.040 * P=0.754 P=0.108 | |POLY 1.5 | P=0.040 * P=0.755 P=0.107 | |POLY 6 | P=0.041 * P=0.752 P=0.109 | |LOGISTIC REGRESSION| P=0.038 * P=0.759N P=0.108 | |COCH-ARM / FISHERS | P=0.039 * P=0.746 P=0.106 | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 24/100 (24%) 15/98 (15%) 27/100 (27%) | |POLY-3 ADJUSTED (b)| 25.1% 16.3% 27.9% | |TERMINAL (d) | 22/88 (25%) 13/85 (15%) 24/91 (26%) | |FIRST INCIDENCE | 113 164 89 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.203 P=0.098N P=0.423 | |POLY 3 | P=0.180 P=0.096N P=0.396 | |POLY 1.5 | P=0.170 P=0.092N P=0.387 | |POLY 6 | P=0.190 P=0.100N P=0.407 | |LOGISTIC REGRESSION| P=0.161 P=0.092N P=0.373 | |COCH-ARM / FISHERS | P=0.158 P=0.087N P=0.373 | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 2 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/98 (6%) 3/99 (3%) 4/100 (4%) | |POLY-3 ADJUSTED (b)| 6.4% 3.3% 4.2% | |TERMINAL (d) | 6/88 (7%) 3/85 (4%) 4/91 (4%) | |FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.418N P=0.264N P=0.352N | |POLY 3 | P=0.429N P=0.253N P=0.360N | |POLY 1.5 | P=0.432N P=0.249N P=0.360N | |POLY 6 | P=0.424N P=0.259N P=0.359N | |LOGISTIC REGRESSION| P=0.418N P=0.264N P=0.352N | |COCH-ARM / FISHERS | P=0.437N P=0.244N P=0.361N | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/98 (4%) 3/99 (3%) 13/100 (13%) | |POLY-3 ADJUSTED (b)| 4.3% 3.3% 13.6% | |TERMINAL (d) | 4/88 (5%) 3/85 (4%) 13/91 (14%) | |FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.004 ** P=0.519N P=0.025 * | |POLY 3 | P=0.003 ** P=0.506N P=0.023 * | |POLY 1.5 | P=0.003 ** P=0.501N P=0.022 * | |POLY 6 | P=0.003 ** P=0.513N P=0.023 * | |LOGISTIC REGRESSION| P=0.004 ** P=0.519N P=0.025 * | |COCH-ARM / FISHERS | P=0.003 ** P=0.494N P=0.022 * | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 3 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 8/98 (8%) 11/99 (11%) 14/100 (14%) | |POLY-3 ADJUSTED (b)| 8.6% 11.9% 14.7% | |TERMINAL (d) | 8/88 (9%) 11/85 (13%) 14/91 (15%) | |FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.164 P=0.286 P=0.147 | |POLY 3 | P=0.149 P=0.305 P=0.140 | |POLY 1.5 | P=0.146 P=0.313 P=0.140 | |POLY 6 | P=0.151 P=0.295 P=0.140 | |LOGISTIC REGRESSION| P=0.164 P=0.286 P=0.147 | |COCH-ARM / FISHERS | P=0.144 P=0.324 P=0.140 | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/98 (1%) 2/99 (2%) 0/100 (0%) | |POLY-3 ADJUSTED (b)| 1.1% 2.2% 0.0% | |TERMINAL (d) | 1/88 (1%) 2/85 (2%) 0/91 (0%) | |FIRST INCIDENCE | 183 (T) 183 (T) --- | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.285N P=0.488 P=0.493N | |POLY 3 | P=0.290N P=0.496 P=0.496N | |POLY 1.5 | P=0.291N P=0.499 P=0.496N | |POLY 6 | P=0.289N P=0.492 P=0.496N | |LOGISTIC REGRESSION| P=0.285N P=0.488 (e) | |COCH-ARM / FISHERS | P=0.291N P=0.504 P=0.495N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 4 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Fatty Change | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/98 (0%) 0/99 (0%) 2/100 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% | |TERMINAL (d) | 0/88 (0%) 0/85 (0%) 1/91 (1%) | |FIRST INCIDENCE | --- --- 173 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.102 (e) P=0.245 | |POLY 3 | P=0.097 (e) P=0.244 | |POLY 1.5 | P=0.097 (e) P=0.243 | |POLY 6 | P=0.098 (e) P=0.244 | |LOGISTIC REGRESSION| P=0.097 (e) P=0.243 | |COCH-ARM / FISHERS | P=0.097 (e) P=0.254 | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 7/98 (7%) 5/99 (5%) 5/100 (5%) | |POLY-3 ADJUSTED (b)| 7.5% 5.4% 5.2% | |TERMINAL (d) | 6/88 (7%) 4/85 (5%) 4/91 (4%) | |FIRST INCIDENCE | 176 131 138 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.379N P=0.408N P=0.364N | |POLY 3 | P=0.386N P=0.387N P=0.365N | |POLY 1.5 | P=0.391N P=0.382N P=0.367N | |POLY 6 | P=0.382N P=0.395N P=0.364N | |LOGISTIC REGRESSION| P=0.397N P=0.376N P=0.369N | |COCH-ARM / FISHERS | P=0.396N P=0.377N P=0.370N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 5 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/98 (0%) 0/99 (0%) 2/100 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.1% | |TERMINAL (d) | 0/88 (0%) 0/85 (0%) 1/91 (1%) | |FIRST INCIDENCE | --- --- 77 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.099 (e) P=0.243 | |POLY 3 | P=0.098 (e) P=0.246 | |POLY 1.5 | P=0.098 (e) P=0.245 | |POLY 6 | P=0.099 (e) P=0.246 | |LOGISTIC REGRESSION| P=0.113 (e) P=0.270 | |COCH-ARM / FISHERS | P=0.097 (e) P=0.254 | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Liver: Centrilobular | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 4/98 (4%) 6/99 (6%) 4/100 (4%) | |POLY-3 ADJUSTED (b)| 4.2% 6.3% 4.1% | |TERMINAL (d) | 1/88 (1%) 1/85 (1%) 0/91 (0%) | |FIRST INCIDENCE | 135 115 106 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.484N P=0.361 P=0.632N | |POLY 3 | P=0.482N P=0.378 P=0.625N | |POLY 1.5 | P=0.485N P=0.379 P=0.627N | |POLY 6 | P=0.480N P=0.373 P=0.625N | |LOGISTIC REGRESSION| P=0.485N P=0.421 P=0.617N | |COCH-ARM / FISHERS | P=0.488N P=0.380 P=0.628N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 6 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Lung | | Thrombosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 1/98 (1%) 3/100 (3%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 1.1% 3.2% 1.0% | |TERMINAL (d) | 0/88 (0%) 1/85 (1%) 1/91 (1%) | |FIRST INCIDENCE | 135 131 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.487N P=0.298 P=0.755N | |POLY 3 | P=0.497N P=0.304 P=0.758N | |POLY 1.5 | P=0.496N P=0.308 P=0.757N | |POLY 6 | P=0.497N P=0.300 P=0.758N | |LOGISTIC REGRESSION| P=0.474N P=0.364 P=0.740N | |COCH-ARM / FISHERS | P=0.494N P=0.318 P=0.746N | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Lung: Alveolar Epithelium | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 21/98 (21%) 10/100 (10%) 14/100 (14%) | |POLY-3 ADJUSTED (b)| 22.4% 10.8% 14.7% | |TERMINAL (d) | 21/88 (24%) 10/85 (12%) 14/91 (15%) | |FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.226N P=0.031N* P=0.108N | |POLY 3 | P=0.244N P=0.026N* P=0.119N | |POLY 1.5 | P=0.251N P=0.024N* P=0.119N | |POLY 6 | P=0.236N P=0.029N* P=0.118N | |LOGISTIC REGRESSION| P=0.226N P=0.031N* P=0.108N | |COCH-ARM / FISHERS | P=0.260N P=0.021N* P=0.118N | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 7 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Lung: Alveolus | | Infiltration Cellular Histiocyte | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 21/98 (21%) 18/100 (18%) 14/100 (14%) | |POLY-3 ADJUSTED (b)| 21.9% 19.3% 14.6% | |TERMINAL (d) | 17/88 (19%) 17/85 (20%) 13/91 (14%) | |FIRST INCIDENCE | 89 91 135 | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.106N P=0.404N P=0.118N | |POLY 3 | P=0.123N P=0.396N P=0.131N | |POLY 1.5 | P=0.124N P=0.372N P=0.128N | |POLY 6 | P=0.119N P=0.422N P=0.133N | |LOGISTIC REGRESSION| P=0.121N P=0.303N P=0.112N | |COCH-ARM / FISHERS | P=0.121N P=0.334N P=0.118N | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Mammary Gland | | Galactocele | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 0/100 (0%) 2/100 (2%) 1/100 (1%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 1.0% | |TERMINAL (d) | 0/88 (0%) 1/85 (1%) 1/91 (1%) | |FIRST INCIDENCE | --- 166 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.616 P=0.231 P=0.507 | |POLY 3 | P=0.608 P=0.235 P=0.502 | |POLY 1.5 | P=0.607 P=0.236 P=0.501 | |POLY 6 | P=0.610 P=0.233 P=0.503 | |LOGISTIC REGRESSION| P=0.605 P=0.241 P=0.507 | |COCH-ARM / FISHERS | P=0.606 P=0.249 P=0.500 | |=================================================================================================================================| Date: 01/07/98 EXPERIMENT: 89029 TEST: 11 Page 8 Statistical Analysis of Non-neoplastic Lesions in Rats(SPRAGUE-DAWLEY) - MAGNETIC FIELDS + DMBA INITIATION PROMOTIO Terminal Sacrifice at 26 weeks |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Skin | | Cyst Epithelial Inclusion | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/19 (32%) 0/8 (0%) 3/13 (23%) | |POLY-3 ADJUSTED (b)| 31.6% 0.0% 23.1% | |TERMINAL (d) | 6/19 (32%) 0/8 (0%) 3/13 (23%) | |FIRST INCIDENCE | 183 (T) --- 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.538N P=0.102N P=0.451N | |POLY 3 | P=0.539N P=0.092N P=0.452N | |POLY 1.5 | P=0.539N P=0.092N P=0.452N | |POLY 6 | P=0.539N P=0.092N P=0.452N | |LOGISTIC REGRESSION| P=0.538N (e) P=0.451N | |COCH-ARM / FISHERS | P=0.539N P=0.092N P=0.455N | |=================================================================================================================================| | | | | | Females | |Dose | 10 DMBA 50 HZ/1G 50 HZ/5G | | | CONTROL 10 DMBA 10 DMBA | |=================================================================================================================================| | | |Skin | | Hyperplasia Basal Cell | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | |----------- | | |OVERALL (a) | 6/19 (32%) 1/8 (13%) 1/13 (8%) | |POLY-3 ADJUSTED (b)| 31.6% 12.5% 7.7% | |TERMINAL (d) | 6/19 (32%) 1/8 (13%) 1/13 (8%) | |FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) | |-------------------| | |STATISTICAL TESTS | | |-------------------| | |LIFE TABLE | P=0.125N P=0.294N P=0.125N | |POLY 3 | P=0.121N P=0.294N P=0.119N | |POLY 1.5 | P=0.121N P=0.294N P=0.119N | |POLY 6 | P=0.121N P=0.294N P=0.119N | |LOGISTIC REGRESSION| P=0.125N P=0.294N P=0.125N | |COCH-ARM / FISHERS | P=0.122N P=0.301N P=0.120N | |=================================================================================================================================| (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).