TDMS Study 55323-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/01/97 EXPERIMENT: 55323 TEST: 04 TIME: 09:03:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B PATHOLOGIST: M. RYAN CAS: 120-40-1 Mice(B6C3F1) ----------------------------- FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED. ---------------- Adrenal Gland Adrenal Medulla Bone Marrow Brain Clitoral Gland Clitoral/Preputial Gland Epididymis Heart Islets, Pancreatic Kidney Liver Lung Nose Ovary Pancreas Parathyroid Gland Pituitary Gland Preputial Gland Prostate Salivary Glands Spleen Testes Thymus Thyroid Gland Urinary Bladder NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/01/97 EXPERIMENT: 55323 TEST: 04 TIME: 09:03:03 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B PATHOLOGIST: M. RYAN CAS: 120-40-1 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF LAURIC ACID DIETHANOLAMINE CONDENSATE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- All Organs Hemangiosarcoma Hemangiosarcoma or Hemangioma Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Skin Fibrosarcoma Thyroid Gland: Follicular Cell Adenoma All Organs Malignant and Benign Tumors =============================================================== Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Cortex | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 7/50 (14%) 1/50 (2%) | 1/50 (2%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.5% 15.7% 2.2% | 2.2% 0.0% 0.0% | |TERMINAL (d) | 2/40 (5%) 7/37 (19%) 1/41 (2%) | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | 735 (T) 735 (T) 735 (T) | 736 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.408N P=0.062 P=0.491N | P=0.294N P=0.484N P=0.549N | |POLY 3 | P=0.409N P=0.077 P=0.495N | P=0.288N P=0.495N P=0.520N | |POLY 1.5 | P=0.411N P=0.077 P=0.496N | P=0.282N P=0.499N P=0.513N | |POLY 6 | P=0.404N P=0.077 P=0.494N | P=0.295N P=0.491N P=0.529N | |LOGISTIC REGRESSION| P=0.408N P=0.062 P=0.491N | P=0.294N (e) (e) | |COCH-ARM / FISHERS | P=0.421N P=0.080 P=0.500N | P=0.270N P=0.505N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) | 1/50 (2%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% | 2.2% 0.0% 4.9% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 2/29 (7%) | |FIRST INCIDENCE | --- 462 --- | 638 --- 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.727N P=0.500 (e) | P=0.302 P=0.482N P=0.423 | |POLY 3 | P=0.729N P=0.502 (e) | P=0.358 P=0.497N P=0.462 | |POLY 1.5 | P=0.730N P=0.501 (e) | P=0.358 P=0.500N P=0.475 | |POLY 6 | P=0.727N P=0.503 (e) | P=0.359 P=0.494N P=0.445 | |LOGISTIC REGRESSION| P=0.719 P=0.582 (e) | P=0.350 P=0.562N P=0.477 | |COCH-ARM / FISHERS | P=0.728 P=0.500 (e) | P=0.361 P=0.505N P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Adrenal Medulla | | Pheochromocytoma: Benign, Complex, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/49 (0%) | 1/50 (2%) 0/49 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% | 2.2% 0.0% 7.3% | |TERMINAL (d) | 0/40 (0%) 1/37 (3%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 2/29 (7%) | |FIRST INCIDENCE | --- 462 --- | 638 --- 539 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.661N P=0.231 (e) | P=0.136 P=0.482N P=0.242 | |POLY 3 | P=0.665N P=0.240 (e) | P=0.172 P=0.497N P=0.272 | |POLY 1.5 | P=0.668N P=0.238 (e) | P=0.172 P=0.500N P=0.283 | |POLY 6 | P=0.661N P=0.241 (e) | P=0.172 P=0.494N P=0.258 | |LOGISTIC REGRESSION| P=0.643 P=0.257 (e) | P=0.209 P=0.562N P=0.332 | |COCH-ARM / FISHERS | P=0.665 P=0.247 (e) | P=0.177 P=0.505N P=0.309 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.4% 6.6% | 2.2% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/37 (3%) 3/41 (7%) | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | 735 (T) 638 735 (T) | 736 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234 P=0.485 P=0.314 | P=0.294N P=0.484N P=0.549N | |POLY 3 | P=0.227 P=0.501 P=0.310 | P=0.287N P=0.495N P=0.520N | |POLY 1.5 | P=0.227 P=0.499 P=0.309 | P=0.282N P=0.498N P=0.513N | |POLY 6 | P=0.229 P=0.503 P=0.312 | P=0.294N P=0.491N P=0.529N | |LOGISTIC REGRESSION| P=0.226 P=0.499 P=0.314 | P=0.294N (e) (e) | |COCH-ARM / FISHERS | P=0.222 P=0.500 P=0.309 | P=0.269N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 4.4% 6.6% | 4.5% 2.2% 2.5% | |TERMINAL (d) | 1/40 (3%) 1/37 (3%) 3/41 (7%) | 2/37 (5%) 1/40 (3%) 1/29 (3%) | |FIRST INCIDENCE | 735 (T) 638 735 (T) | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.234 P=0.485 P=0.314 | P=0.449N P=0.473N P=0.585N | |POLY 3 | P=0.227 P=0.501 P=0.310 | P=0.412N P=0.492N P=0.536N | |POLY 1.5 | P=0.227 P=0.499 P=0.309 | P=0.401N P=0.497N P=0.524N | |POLY 6 | P=0.229 P=0.503 P=0.312 | P=0.424N P=0.485N P=0.550N | |LOGISTIC REGRESSION| P=0.226 P=0.499 P=0.314 | P=0.449N P=0.473N P=0.585N | |COCH-ARM / FISHERS | P=0.222 P=0.500 P=0.309 | P=0.378N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.5% 2.2% | 2.2% 2.2% 0.0% | |TERMINAL (d) | 0/40 (0%) 1/37 (3%) 1/41 (2%) | 1/37 (3%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- 719 735 (T) | 736 (T) 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.372 P=0.226 P=0.505 | P=0.376N P=0.744N P=0.549N | |POLY 3 | P=0.367 P=0.236 P=0.503 | P=0.369N P=0.755N P=0.520N | |POLY 1.5 | P=0.366 P=0.236 P=0.502 | P=0.357N P=0.759N P=0.513N | |POLY 6 | P=0.369 P=0.237 P=0.504 | P=0.384N P=0.751N P=0.529N | |LOGISTIC REGRESSION| P=0.367 P=0.236 P=0.505 | P=0.376N P=0.744N (e) | |COCH-ARM / FISHERS | P=0.360 P=0.247 P=0.500 | P=0.332N P=0.747 P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.5% 2.2% | 2.2% 2.2% 0.0% | |TERMINAL (d) | 0/40 (0%) 1/37 (3%) 1/41 (2%) | 1/37 (3%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | 584 719 735 (T) | 736 (T) 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.615N P=0.485 P=0.758 | P=0.376N P=0.744N P=0.549N | |POLY 3 | P=0.620N P=0.495 P=0.760N | P=0.369N P=0.755N P=0.520N | |POLY 1.5 | P=0.620N P=0.496 P=0.760N | P=0.357N P=0.759N P=0.513N | |POLY 6 | P=0.621N P=0.493 P=0.760N | P=0.384N P=0.751N P=0.529N | |LOGISTIC REGRESSION| P=0.620 P=0.504 P=0.751 | P=0.376N P=0.744N (e) | |COCH-ARM / FISHERS | P=0.622 P=0.500 P=0.753N | P=0.332N P=0.747 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 7/50 (14%) 2/50 (4%) 3/50 (6%) | 2/50 (4%) 1/49 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 15.2% 4.5% 6.4% | 4.4% 2.2% 0.0% | |TERMINAL (d) | 4/40 (10%) 1/37 (3%) 1/41 (2%) | 1/37 (3%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | 562 706 519 | 671 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.104N P=0.098N P=0.165N | P=0.172N P=0.479N P=0.289N | |POLY 3 | P=0.094N P=0.085N P=0.152N | P=0.166N P=0.494N P=0.262N | |POLY 1.5 | P=0.095N P=0.083N P=0.153N | P=0.158N P=0.499N P=0.253N | |POLY 6 | P=0.094N P=0.088N P=0.151N | P=0.176N P=0.488N P=0.273N | |LOGISTIC REGRESSION| P=0.103N P=0.081N P=0.175N | P=0.152N P=0.502N P=0.250N | |COCH-ARM / FISHERS | P=0.099N P=0.080N P=0.159N | P=0.143N P=0.508N P=0.247N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 19/50 (38%) 26/50 (52%) 25/50 (50%) | 23/50 (46%) 32/49 (65%) 29/50 (58%) | |POLY-3 ADJUSTED (b)| 42.1% 55.8% 54.3% | 49.5% 68.8% 65.8% | |TERMINAL (d) | 18/40 (45%) 20/37 (54%) 24/41 (59%) | 19/37 (51%) 30/40 (75%) 19/29 (66%) | |FIRST INCIDENCE | 670 528 554 | 542 651 517 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.165 P=0.073 P=0.173 | P=0.012 * P=0.113 P=0.027 * | |POLY 3 | P=0.145 P=0.133 P=0.166 | P=0.059 P=0.041 * P=0.081 | |POLY 1.5 | P=0.143 P=0.119 P=0.164 | P=0.075 P=0.040 * P=0.099 | |POLY 6 | P=0.149 P=0.153 P=0.171 | P=0.049 * P=0.042 * P=0.070 | |LOGISTIC REGRESSION| P=0.140 P=0.105 P=0.164 | P=0.045 * P=0.067 P=0.077 | |COCH-ARM / FISHERS | P=0.135 P=0.114 P=0.157 | P=0.134 P=0.041 * P=0.158 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 8/50 (16%) 12/50 (24%) | 10/50 (20%) 13/49 (27%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 23.3% 17.7% 24.6% | 21.6% 27.9% 38.2% | |TERMINAL (d) | 7/40 (18%) 6/37 (16%) 6/41 (15%) | 6/37 (16%) 10/40 (25%) 11/29 (38%) | |FIRST INCIDENCE | 353 626 444 | 542 638 615 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.470 P=0.356N P=0.513 | P=0.035 * P=0.399 P=0.048 * | |POLY 3 | P=0.484 P=0.342N P=0.537 | P=0.059 P=0.324 P=0.068 | |POLY 1.5 | P=0.471 P=0.332N P=0.523 | P=0.072 P=0.314 P=0.085 | |POLY 6 | P=0.500 P=0.352N P=0.555 | P=0.048 * P=0.335 P=0.054 | |LOGISTIC REGRESSION| P=0.425 P=0.299N P=0.463 | P=0.071 P=0.291 P=0.086 | |COCH-ARM / FISHERS | P=0.451 P=0.306N P=0.500 | P=0.105 P=0.298 P=0.127 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 11/50 (22%) 8/50 (16%) 12/50 (24%) | 10/50 (20%) 13/49 (27%) 17/50 (34%) | |POLY-3 ADJUSTED (b)| 23.3% 17.7% 24.6% | 21.6% 27.9% 40.6% | |TERMINAL (d) | 7/40 (18%) 6/37 (16%) 6/41 (15%) | 6/37 (16%) 10/40 (25%) 12/29 (41%) | |FIRST INCIDENCE | 353 626 444 | 542 638 615 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.470 P=0.356N P=0.513 | P=0.021 * P=0.399 P=0.030 * | |POLY 3 | P=0.484 P=0.342N P=0.537 | P=0.036 * P=0.324 P=0.042 * | |POLY 1.5 | P=0.471 P=0.332N P=0.523 | P=0.045 * P=0.314 P=0.054 | |POLY 6 | P=0.500 P=0.352N P=0.555 | P=0.029 * P=0.335 P=0.032 * | |LOGISTIC REGRESSION| P=0.425 P=0.299N P=0.463 | P=0.044 * P=0.291 P=0.055 | |COCH-ARM / FISHERS | P=0.451 P=0.306N P=0.500 | P=0.071 P=0.298 P=0.088 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma or Hepatocellular Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 29/50 (58%) 32/50 (64%) | 28/50 (56%) 40/49 (82%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 59.1% 62.1% 65.6% | 59.3% 84.7% 80.3% | |TERMINAL (d) | 23/40 (58%) 22/37 (60%) 26/41 (63%) | 22/37 (60%) 35/40 (88%) 24/29 (83%) | |FIRST INCIDENCE | 353 528 444 | 542 638 517 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.306 P=0.377 P=0.332 | P=0.002 ** P=0.049 * P=0.007 ** | |POLY 3 | P=0.288 P=0.467 P=0.326 | P=0.009 ** P=0.004 ** P=0.019 * | |POLY 1.5 | P=0.269 P=0.466 P=0.306 | P=0.014 * P=0.004 ** P=0.029 * | |POLY 6 | P=0.313 P=0.475 P=0.352 | P=0.006 ** P=0.004 ** P=0.014 * | |LOGISTIC REGRESSION| P=0.246 P=0.490 P=0.270 | P=0.009 ** P=0.010 * P=0.023 * | |COCH-ARM / FISHERS | P=0.238 P=0.500 P=0.270 | P=0.051 P=0.005 ** P=0.072 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Hepatocellular Carcinoma, Hepatocellular Adenoma, | | or Hepatoblastoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 29/50 (58%) 32/50 (64%) | 28/50 (56%) 40/49 (82%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 59.1% 62.1% 65.6% | 59.3% 84.7% 80.3% | |TERMINAL (d) | 23/40 (58%) 22/37 (60%) 26/41 (63%) | 22/37 (60%) 35/40 (88%) 24/29 (83%) | |FIRST INCIDENCE | 353 528 444 | 542 638 517 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.306 P=0.377 P=0.332 | P=0.002 ** P=0.049 * P=0.007 ** | |POLY 3 | P=0.288 P=0.467 P=0.326 | P=0.009 ** P=0.004 ** P=0.019 * | |POLY 1.5 | P=0.269 P=0.466 P=0.306 | P=0.014 * P=0.004 ** P=0.029 * | |POLY 6 | P=0.313 P=0.475 P=0.352 | P=0.006 ** P=0.004 ** P=0.014 * | |LOGISTIC REGRESSION| P=0.246 P=0.490 P=0.270 | P=0.009 ** P=0.010 * P=0.023 * | |COCH-ARM / FISHERS | P=0.238 P=0.500 P=0.270 | P=0.051 P=0.005 ** P=0.072 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 6/50 (12%) 10/50 (20%) | 1/50 (2%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 13.3% 13.4% 21.6% | 2.2% 4.4% 2.5% | |TERMINAL (d) | 5/40 (13%) 6/37 (16%) 7/41 (17%) | 1/37 (3%) 2/40 (5%) 1/29 (3%) | |FIRST INCIDENCE | 646 735 (T) 573 | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.180 P=0.570 P=0.228 | P=0.551 P=0.527 P=0.707 | |POLY 3 | P=0.172 P=0.613 P=0.221 | P=0.588 P=0.508 P=0.737 | |POLY 1.5 | P=0.169 P=0.614 P=0.216 | P=0.599 P=0.502 P=0.745 | |POLY 6 | P=0.178 P=0.609 P=0.228 | P=0.575 P=0.515 P=0.728 | |LOGISTIC REGRESSION| P=0.167 P=0.618 P=0.211 | P=0.551 P=0.527 P=0.707 | |COCH-ARM / FISHERS | P=0.161 P=0.620N P=0.207 | P=0.621 P=0.492 P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 8/50 (16%) 8/50 (16%) 6/50 (12%) | 7/50 (14%) 3/49 (6%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 17.7% 17.8% 13.2% | 15.6% 6.5% 7.4% | |TERMINAL (d) | 7/40 (18%) 6/37 (16%) 6/41 (15%) | 7/37 (19%) 3/40 (8%) 3/29 (10%) | |FIRST INCIDENCE | 616 668 735 (T) | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.322N P=0.551 P=0.372N | P=0.172N P=0.127N P=0.270N | |POLY 3 | P=0.332N P=0.603 P=0.383N | P=0.132N P=0.147N P=0.201N | |POLY 1.5 | P=0.332N P=0.602 P=0.383N | P=0.124N P=0.155N P=0.186N | |POLY 6 | P=0.332N P=0.603 P=0.383N | P=0.142N P=0.139N P=0.221N | |LOGISTIC REGRESSION| P=0.322N P=0.605 P=0.372N | P=0.172N P=0.127N P=0.270N | |COCH-ARM / FISHERS | P=0.336N P=0.607N P=0.387N | P=0.107N P=0.167N P=0.159N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Lung | | Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar | | Adenoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 14/50 (28%) 16/50 (32%) | 8/50 (16%) 5/49 (10%) 4/50 (8%) | |POLY-3 ADJUSTED (b)| 30.7% 31.1% 34.5% | 17.8% 10.9% 9.9% | |TERMINAL (d) | 12/40 (30%) 12/37 (32%) 13/41 (32%) | 8/37 (22%) 5/40 (13%) 4/29 (14%) | |FIRST INCIDENCE | 616 668 573 | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.403 P=0.505 P=0.442 | P=0.229N P=0.224N P=0.311N | |POLY 3 | P=0.389 P=0.573 P=0.433 | P=0.174N P=0.260N P=0.229N | |POLY 1.5 | P=0.385 P=0.576 P=0.428 | P=0.161N P=0.272N P=0.211N | |POLY 6 | P=0.396 P=0.567 P=0.440 | P=0.190N P=0.246N P=0.252N | |LOGISTIC REGRESSION| P=0.386 P=0.585 P=0.428 | P=0.229N P=0.224N P=0.311N | |COCH-ARM / FISHERS | P=0.371 P=0.588N P=0.414 | P=0.135N P=0.290N P=0.178N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Ovary | | Cystadenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 4/50 (8%) 1/49 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| | 8.9% 2.2% 4.9% | |TERMINAL (d) | | 4/37 (11%) 1/40 (3%) 2/29 (7%) | |FIRST INCIDENCE | | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.315N P=0.156N P=0.454N | |POLY 3 | | P=0.266N P=0.172N P=0.385N | |POLY 1.5 | | P=0.258N P=0.177N P=0.369N | |POLY 6 | | P=0.275N P=0.165N P=0.405N | |LOGISTIC REGRESSION| | P=0.315N P=0.156N P=0.454N | |COCH-ARM / FISHERS | | P=0.239N P=0.187N P=0.339N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor Benign | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| | 2.2% 4.4% 2.5% | |TERMINAL (d) | | 1/37 (3%) 2/40 (5%) 1/29 (3%) | |FIRST INCIDENCE | | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.551 P=0.527 P=0.707 | |POLY 3 | | P=0.588 P=0.508 P=0.737 | |POLY 1.5 | | P=0.599 P=0.502 P=0.745 | |POLY 6 | | P=0.575 P=0.515 P=0.728 | |LOGISTIC REGRESSION| | P=0.551 P=0.527 P=0.707 | |COCH-ARM / FISHERS | | P=0.621 P=0.492 P=0.753N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Ovary | | Granulosa Cell Tumor: Benign, Malignant, NOS | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 3/49 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| | 2.2% 6.5% 2.5% | |TERMINAL (d) | | 1/37 (3%) 3/40 (8%) 1/29 (3%) | |FIRST INCIDENCE | | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.528 P=0.333 P=0.707 | |POLY 3 | | P=0.564 P=0.314 P=0.737 | |POLY 1.5 | | P=0.579 P=0.308 P=0.745 | |POLY 6 | | P=0.546 P=0.321 P=0.728 | |LOGISTIC REGRESSION| | P=0.528 P=0.333 P=0.707 | |COCH-ARM / FISHERS | | P=0.609 P=0.301 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Pituitary Gland: Pars Distalis or Unspecified Site | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/49 (2%) 0/50 (0%) | 10/47 (21%) 9/49 (18%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% | 23.8% 19.5% 17.0% | |TERMINAL (d) | 0/38 (0%) 1/36 (3%) 0/41 (0%) | 9/34 (27%) 8/40 (20%) 5/29 (17%) | |FIRST INCIDENCE | --- 735 (T) --- | 719 651 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.716N P=0.489 (e) | P=0.366N P=0.354N P=0.428N | |POLY 3 | P=0.721N P=0.504 (e) | P=0.263N P=0.405N P=0.305N | |POLY 1.5 | P=0.722N P=0.503 (e) | P=0.247N P=0.428N P=0.288N | |POLY 6 | P=0.720N P=0.504 (e) | P=0.278N P=0.378N P=0.324N | |LOGISTIC REGRESSION| (e) P=0.489 (e) | P=0.292N P=0.372N P=0.347N | |COCH-ARM / FISHERS | P=0.725N P=0.505 (e) | P=0.210N P=0.459N P=0.250N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 0.0% 7.3% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 1/29 (3%) | |FIRST INCIDENCE | --- --- --- | --- --- 625 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.025 * (e) P=0.093 | |POLY 3 | (e) (e) (e) | P=0.035 * (e) P=0.104 | |POLY 1.5 | (e) (e) (e) | P=0.035 * (e) P=0.108 | |POLY 6 | (e) (e) (e) | P=0.035 * (e) P=0.099 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.040 * (e) P=0.125 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.037 * (e) P=0.121 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 2/50 (4%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.4% 0.0% 4.4% | 4.4% 0.0% 2.5% | |TERMINAL (d) | 1/40 (3%) 0/37 (0%) 2/41 (5%) | 0/37 (0%) 0/40 (0%) 1/29 (3%) | |FIRST INCIDENCE | 670 --- 735 (T) | 629 --- 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.612N P=0.248N P=0.684N | P=0.413N P=0.230N P=0.573N | |POLY 3 | P=0.621N P=0.239N P=0.691N | P=0.382N P=0.235N P=0.540N | |POLY 1.5 | P=0.621N P=0.239N P=0.691N | P=0.375N P=0.238N P=0.526N | |POLY 6 | P=0.621N P=0.240N P=0.691N | P=0.390N P=0.233N P=0.558N | |LOGISTIC REGRESSION| P=0.618N P=0.238N P=0.691N | P=0.337N P=0.288N P=0.490N | |COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | P=0.361N P=0.253N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Thyroid Gland: Follicular Cell | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) | 4/50 (8%) 3/49 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 9.0% 4.3% | 8.8% 6.5% 0.0% | |TERMINAL (d) | 1/40 (3%) 4/37 (11%) 1/41 (2%) | 3/37 (8%) 2/40 (5%) 0/29 (0%) | |FIRST INCIDENCE | 735 (T) 735 (T) 519 | 562 668 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.417 P=0.156 P=0.506 | P=0.071N P=0.466N P=0.094N | |POLY 3 | P=0.424 P=0.177 P=0.510 | P=0.066N P=0.491N P=0.076N | |POLY 1.5 | P=0.418 P=0.177 P=0.507 | P=0.060N P=0.499N P=0.070N | |POLY 6 | P=0.431 P=0.177 P=0.513 | P=0.075N P=0.481N P=0.084N | |LOGISTIC REGRESSION| P=0.408 P=0.156 P=0.481 | P=0.049N* P=0.530N P=0.063N | |COCH-ARM / FISHERS | P=0.406 P=0.181 P=0.500 | P=0.049N* P=0.511N P=0.059N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Polyp Stromal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | | 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| | 4.5% 2.2% 0.0% | |TERMINAL (d) | | 2/37 (5%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | | 736 (T) 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.172N P=0.473N P=0.293N | |POLY 3 | | P=0.164N P=0.492N P=0.261N | |POLY 1.5 | | P=0.156N P=0.497N P=0.253N | |POLY 6 | | P=0.173N P=0.485N P=0.271N | |LOGISTIC REGRESSION| | P=0.172N P=0.473N (e) | |COCH-ARM / FISHERS | | P=0.142N P=0.500N P=0.247N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 8/50 (16%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 17.4% 4.5% 10.7% | 6.6% 4.4% 4.9% | |TERMINAL (d) | 5/40 (13%) 1/37 (3%) 3/41 (7%) | 1/37 (3%) 2/40 (5%) 1/29 (3%) | |FIRST INCIDENCE | 562 706 519 | 629 736 (T) 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.205N P=0.061N P=0.277N | P=0.491N P=0.471N P=0.586N | |POLY 3 | P=0.195N P=0.049N* P=0.266N | P=0.450N P=0.495N P=0.546N | |POLY 1.5 | P=0.197N P=0.048N* P=0.268N | P=0.436N P=0.499N P=0.530N | |POLY 6 | P=0.195N P=0.052N P=0.265N | P=0.468N P=0.491N P=0.566N | |LOGISTIC REGRESSION| P=0.207N P=0.048N* P=0.291N | P=0.385N P=0.501N P=0.455N | |COCH-ARM / FISHERS | P=0.202N P=0.046N* P=0.277N | P=0.406N P=0.500N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 9/50 (18%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 19.6% 4.5% 10.7% | 6.6% 4.4% 4.9% | |TERMINAL (d) | 6/40 (15%) 1/37 (3%) 3/41 (7%) | 1/37 (3%) 2/40 (5%) 1/29 (3%) | |FIRST INCIDENCE | 562 706 519 | 629 736 (T) 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.132N P=0.038N* P=0.197N | P=0.491N P=0.471N P=0.586N | |POLY 3 | P=0.121N P=0.028N* P=0.184N | P=0.450N P=0.495N P=0.546N | |POLY 1.5 | P=0.123N P=0.027N* P=0.186N | P=0.436N P=0.499N P=0.530N | |POLY 6 | P=0.121N P=0.029N* P=0.183N | P=0.468N P=0.491N P=0.566N | |LOGISTIC REGRESSION| P=0.131N P=0.028N* P=0.204N | P=0.385N P=0.501N P=0.455N | |COCH-ARM / FISHERS | P=0.128N P=0.026N* P=0.194N | P=0.406N P=0.500N P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 0.0% 4.9% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | --- --- 596 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.078 (e) P=0.207 | |POLY 3 | (e) (e) (e) | P=0.094 (e) P=0.217 | |POLY 1.5 | (e) (e) (e) | P=0.094 (e) P=0.224 | |POLY 6 | (e) (e) (e) | P=0.095 (e) P=0.210 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.104 (e) P=0.251 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.095 (e) P=0.247 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma And Histiocytic Sarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) | 9/50 (18%) 5/50 (10%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 8.7% 6.5% 4.4% | 19.6% 10.8% 25.9% | |TERMINAL (d) | 2/40 (5%) 1/37 (3%) 2/41 (5%) | 5/37 (14%) 4/40 (10%) 6/29 (21%) | |FIRST INCIDENCE | 344 164 735 (T) | 562 668 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263N P=0.517N P=0.332N | P=0.208 P=0.168N P=0.244 | |POLY 3 | P=0.271N P=0.502N P=0.343N | P=0.297 P=0.188N P=0.328 | |POLY 1.5 | P=0.268N P=0.501N P=0.341N | P=0.310 P=0.193N P=0.351 | |POLY 6 | P=0.272N P=0.503N P=0.345N | P=0.282 P=0.182N P=0.302 | |LOGISTIC REGRESSION| P=0.294N P=0.450N P=0.364N | P=0.336 P=0.192N P=0.393 | |COCH-ARM / FISHERS | P=0.264N P=0.500N P=0.339N | P=0.344 P=0.194N P=0.402 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, | | NOS, or Undifferentiated Cell Type | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) | 9/50 (18%) 5/50 (10%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 8.7% 6.5% 4.4% | 19.6% 10.8% 21.4% | |TERMINAL (d) | 2/40 (5%) 1/37 (3%) 2/41 (5%) | 5/37 (14%) 4/40 (10%) 6/29 (21%) | |FIRST INCIDENCE | 344 164 735 (T) | 562 668 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.263N P=0.517N P=0.332N | P=0.392 P=0.168N P=0.421 | |POLY 3 | P=0.271N P=0.502N P=0.343N | P=0.500 P=0.188N P=0.523 | |POLY 1.5 | P=0.268N P=0.501N P=0.341N | P=0.518 P=0.193N P=0.550 | |POLY 6 | P=0.272N P=0.503N P=0.345N | P=0.480 P=0.182N P=0.489 | |LOGISTIC REGRESSION| P=0.294N P=0.450N P=0.364N | P=0.540 P=0.192N P=0.588 | |COCH-ARM / FISHERS | P=0.264N P=0.500N P=0.339N | P=0.555 P=0.194N P=0.602N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 27/50 (54%) 36/50 (72%) 35/50 (70%) | 34/50 (68%) 37/50 (74%) 35/50 (70%) | |POLY-3 ADJUSTED (b)| 59.5% 75.4% 73.6% | 72.5% 79.1% 78.0% | |TERMINAL (d) | 25/40 (63%) 28/37 (76%) 30/41 (73%) | 28/37 (76%) 34/40 (85%) 22/29 (76%) | |FIRST INCIDENCE | 646 462 519 | 542 651 517 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.098 P=0.026 * P=0.104 | P=0.057 P=0.557 P=0.091 | |POLY 3 | P=0.085 P=0.071 P=0.103 | P=0.299 P=0.300 P=0.352 | |POLY 1.5 | P=0.072 P=0.055 P=0.090 | P=0.332 P=0.297 P=0.383 | |POLY 6 | P=0.104 P=0.094 P=0.123 | P=0.289 P=0.316 P=0.342 | |LOGISTIC REGRESSION| P=0.059 P=0.040 * P=0.074 | P=0.184 P=0.420 P=0.256 | |COCH-ARM / FISHERS | P=0.058 P=0.048 * P=0.074 | P=0.456 P=0.330 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - LAURIC ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 105 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 29/50 (58%) 23/50 (46%) 22/50 (44%) | 30/50 (60%) 22/50 (44%) 31/50 (62%) | |POLY-3 ADJUSTED (b)| 58.0% 48.4% 44.0% | 62.3% 46.9% 67.5% | |TERMINAL (d) | 19/40 (48%) 15/37 (41%) 14/41 (34%) | 20/37 (54%) 18/40 (45%) 17/29 (59%) | |FIRST INCIDENCE | 344 164 444 | 542 638 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.128N P=0.272N P=0.151N | P=0.153 P=0.062N P=0.164 | |POLY 3 | P=0.095N P=0.227N P=0.115N | P=0.360 P=0.094N P=0.376 | |POLY 1.5 | P=0.096N P=0.200N P=0.115N | P=0.384 P=0.090N P=0.406 | |POLY 6 | P=0.095N P=0.257N P=0.116N | P=0.337 P=0.101N P=0.347 | |LOGISTIC REGRESSION| P=0.099N P=0.148N P=0.135N | P=0.391 P=0.076N P=0.439 | |COCH-ARM / FISHERS | P=0.097N P=0.158N P=0.115N | P=0.460 P=0.080N P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |All Organs | | Malignant and Benign Tumors | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 45/50 (90%) 44/50 (88%) 42/50 (84%) | 44/50 (88%) 43/50 (86%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 90.0% 89.5% 84.0% | 90.3% 90.6% 94.8% | |TERMINAL (d) | 35/40 (88%) 32/37 (87%) 33/41 (81%) | 33/37 (89%) 37/40 (93%) 27/29 (93%) | |FIRST INCIDENCE | 344 164 444 | 542 638 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.271N P=0.459 P=0.304N | P=0.035 * P=0.252N P=0.057 | |POLY 3 | P=0.222N P=0.596N P=0.277N | P=0.257 P=0.625 P=0.317 | |POLY 1.5 | P=0.223N P=0.567N P=0.277N | P=0.282 P=0.615N P=0.339 | |POLY 6 | P=0.222N P=0.613N P=0.277N | P=0.253 P=0.591 P=0.317 | |LOGISTIC REGRESSION| P=0.232N P=0.498N (e) | P=0.163 P=0.451N P=0.238 | |COCH-ARM / FISHERS | P=0.226N P=0.500N P=0.277N | P=0.439 P=0.500N 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).