TDMS Study 55312-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08 LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/26/97 EXPERIMENT: 55312 TEST: 04 TIME: 09:27:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B PATHOLOGIST: SINGER, A. CAS: 68603-42-9 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 COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/26/97 EXPERIMENT: 55312 TEST: 04 TIME: 09:27:06 TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B PATHOLOGIST: SINGER, A. CAS: 68603-42-9 SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS IN THE ANALYSIS OF COCONUT OIL ACID DIETHANOLAMINE CONDENSATE =============================================================== Male Mice ------------ Organ Morphology ----- ---------- Harderian Gland Carcinoma Kidney: Renal Tubule Adenoma Carcinoma or Adenoma Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma All Organs Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Liver Hepatoblastoma Hepatocellular Adenoma Hepatocellular Carcinoma Hepatocellular Carcinoma or Hepatoblastoma Hepatocellular Carcinoma or Hepatocellular Adenoma Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma Pituitary Gland: Pars Distalis or Unspecified Site Carcinoma or Adenoma All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type Benign Tumors Malignant Tumors Malignant and Benign Tumors =============================================================== Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 1 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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 | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 1/35 (3%) 1/36 (3%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- | 687 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.186N P=0.505N P=0.305N | |POLY 3 | (e) (e) (e) | P=0.166N P=0.508N P=0.262N | |POLY 1.5 | (e) (e) (e) | P=0.157N P=0.504N P=0.253N | |POLY 6 | (e) (e) (e) | P=0.179N P=0.516N P=0.277N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.164N P=0.510N P=0.261N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.142N P=0.500N P=0.247N | |=================================================================================================================================| | | | | | | 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%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 4.9% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 1/35 (3%) 1/36 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- --- --- | 687 729 (T) 632 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.518 P=0.505N P=0.599 | |POLY 3 | (e) (e) (e) | P=0.587 P=0.508N P=0.657 | |POLY 1.5 | (e) (e) (e) | P=0.594 P=0.504N P=0.670 | |POLY 6 | (e) (e) (e) | P=0.575 P=0.516N P=0.638 | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.585 P=0.510N P=0.680 | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.610 P=0.500N P=0.691N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 2 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | 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) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 2/41 (5%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) --- --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.111N P=0.261N P=0.267N | (e) (e) (e) | |POLY 3 | P=0.097N P=0.247N P=0.244N | (e) (e) (e) | |POLY 1.5 | P=0.096N P=0.244N P=0.241N | (e) (e) (e) | |POLY 6 | P=0.098N P=0.249N P=0.247N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.111N (e) (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Harderian Gland | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 6.8% 8.8% | 2.2% 4.4% 2.5% | |TERMINAL (d) | 0/41 (0%) 3/37 (8%) 1/36 (3%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- 727 (T) 630 | 429 567 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.042 * P=0.104 P=0.058 | P=0.568 P=0.503 P=0.720 | |POLY 3 | P=0.045 * P=0.111 P=0.058 | P=0.580 P=0.491 P=0.732 | |POLY 1.5 | P=0.046 * P=0.114 P=0.059 | P=0.595 P=0.495 P=0.743 | |POLY 6 | P=0.045 * P=0.109 P=0.057 | P=0.560 P=0.486 P=0.718 | |LOGISTIC REGRESSION| P=0.047 * P=0.104 P=0.064 | P=0.513N P=0.427 P=0.692N | |COCH-ARM / FISHERS | P=0.049 * P=0.121 P=0.059 | P=0.622 P=0.500 P=0.753N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 3 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 2/50 (4%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 4.3% 6.8% 8.8% | 2.2% 4.4% 2.5% | |TERMINAL (d) | 2/41 (5%) 3/37 (8%) 1/36 (3%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) | |FIRST INCIDENCE | 727 (T) 727 (T) 630 | 429 567 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.227 P=0.453 P=0.301 | P=0.568 P=0.503 P=0.720 | |POLY 3 | P=0.258 P=0.480 P=0.329 | P=0.580 P=0.491 P=0.732 | |POLY 1.5 | P=0.260 P=0.486 P=0.332 | P=0.595 P=0.495 P=0.743 | |POLY 6 | P=0.256 P=0.475 P=0.327 | P=0.560 P=0.486 P=0.718 | |LOGISTIC REGRESSION| P=0.253 P=0.453 P=0.333 | P=0.513N P=0.427 P=0.692N | |COCH-ARM / FISHERS | P=0.264 P=0.500 P=0.339 | P=0.622 P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.3% 15.3% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 4/36 (11%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) 727 (T) 597 | --- --- 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.009 ** P=0.739 P=0.027 * | P=0.257 (e) P=0.481 | |POLY 3 | P=0.009 ** P=0.751 P=0.029 * | P=0.274 (e) P=0.481 | |POLY 1.5 | P=0.009 ** P=0.754 P=0.029 * | P=0.273 (e) P=0.487 | |POLY 6 | P=0.009 ** P=0.748 P=0.029 * | P=0.277 (e) P=0.471 | |LOGISTIC REGRESSION| P=0.010 * P=0.739 P=0.033 * | P=0.305 (e) P=0.545 | |COCH-ARM / FISHERS | P=0.010 * P=0.753N P=0.030 * | P=0.269 (e) P=0.500 | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 4 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 2/36 (6%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 727 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085 (e) P=0.210 | (e) (e) (e) | |POLY 3 | P=0.094 (e) P=0.231 | (e) (e) (e) | |POLY 1.5 | P=0.094 (e) P=0.233 | (e) (e) (e) | |POLY 6 | P=0.094 (e) P=0.228 | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.210 | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 9/50 (18%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 2.3% 19.6% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 6/36 (17%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) 727 (T) 597 | --- --- 621 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002 ** P=0.739 P=0.007 ** | P=0.257 (e) P=0.481 | |POLY 3 | P<0.001 ** P=0.751 P=0.007 ** | P=0.274 (e) P=0.481 | |POLY 1.5 | P<0.001 ** P=0.754 P=0.008 ** | P=0.273 (e) P=0.487 | |POLY 6 | P<0.001 ** P=0.748 P=0.007 ** | P=0.277 (e) P=0.471 | |LOGISTIC REGRESSION| P=0.002 ** P=0.739 P=0.009 ** | P=0.305 (e) P=0.545 | |COCH-ARM / FISHERS | P=0.002 ** P=0.753N P=0.008 ** | P=0.269 (e) P=0.500 | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 5 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | 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) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.2% 4.5% 2.2% | 2.2% 0.0% 0.0% | |TERMINAL (d) | 0/41 (0%) 2/37 (5%) 1/36 (3%) | 1/35 (3%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | 420 727 (T) 727 (T) | 729 (T) --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.423N P=0.666 P=0.520N | P=0.303N P=0.494N P=0.559N | |POLY 3 | P=0.418N P=0.667 P=0.521N | P=0.288N P=0.504N P=0.521N | |POLY 1.5 | P=0.408N P=0.675 P=0.513N | P=0.282N P=0.502N P=0.514N | |POLY 6 | P=0.429N P=0.659 P=0.529N | P=0.298N P=0.508N P=0.532N | |LOGISTIC REGRESSION| P=0.350N P=0.576N P=0.390N | P=0.303N (e) (e) | |COCH-ARM / FISHERS | P=0.390N P=0.691N P=0.500N | P=0.269N 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 | |=================================================================================================================================| | | |Liver | | Hepatoblastoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 1/50 (2%) 10/50 (20%) | 0/50 (0%) 1/50 (2%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 2.1% 2.2% 22.1% | 0.0% 2.2% 7.3% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 8/36 (22%) | 0/35 (0%) 0/36 (0%) 1/26 (4%) | |FIRST INCIDENCE | 664 507 692 | --- 629 567 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.747 P=0.004 ** | P=0.044 * P=0.491 P=0.090 | |POLY 3 | P<0.001 ** P=0.753 P=0.003 ** | P=0.054 P=0.498 P=0.103 | |POLY 1.5 | P<0.001 ** P=0.755 P=0.004 ** | P=0.056 P=0.499 P=0.108 | |POLY 6 | P<0.001 ** P=0.751 P=0.003 ** | P=0.051 P=0.495 P=0.095 | |LOGISTIC REGRESSION| P<0.001 ** P=0.690N P=0.004 ** | P=0.068 P=0.487 P=0.121 | |COCH-ARM / FISHERS | P<0.001 ** P=0.753N P=0.004 ** | P=0.060 P=0.500 P=0.121 | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 6 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 22/50 (44%) 35/50 (70%) 45/50 (90%) | 32/50 (64%) 44/50 (88%) 43/50 (86%) | |POLY-3 ADJUSTED (b)| 46.2% 75.4% 91.4% | 69.0% 90.3% 90.7% | |TERMINAL (d) | 18/41 (44%) 29/37 (78%) 34/36 (94%) | 26/35 (74%) 32/36 (89%) 25/26 (96%) | |FIRST INCIDENCE | 612 507 401 | 568 561 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P=0.024 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** | P=0.002 ** P=0.006 ** P=0.005 ** | |POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** | P=0.002 ** P=0.005 ** P=0.005 ** | |POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** | P=0.002 ** P=0.010 * P=0.006 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P=0.003 ** P=0.002 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.007 ** P<0.001 ** | P=0.005 ** P=0.005 ** P=0.010 * | |=================================================================================================================================| | | | | | | 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) | 12/50 (24%) 12/50 (24%) 20/50 (40%) | 3/50 (6%) 21/50 (42%) 32/50 (64%) | |POLY-3 ADJUSTED (b)| 25.4% 26.2% 43.0% | 6.6% 45.8% 70.4% | |TERMINAL (d) | 9/41 (22%) 7/37 (19%) 15/36 (42%) | 1/35 (3%) 17/36 (47%) 18/26 (69%) | |FIRST INCIDENCE | 584 576 456 | 681 584 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.033 * P=0.496 P=0.039 * | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.041 * P=0.561 P=0.055 | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.044 * P=0.568 P=0.059 | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=0.038 * P=0.558 P=0.050 | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.046 * P=0.578 P=0.061 | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.050 P=0.592N P=0.066 | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 7 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 13/50 (26%) 13/50 (26%) 25/50 (50%) | 3/50 (6%) 21/50 (42%) 33/50 (66%) | |POLY-3 ADJUSTED (b)| 27.4% 28.0% 53.7% | 6.6% 45.8% 71.8% | |TERMINAL (d) | 9/41 (22%) 7/37 (19%) 19/36 (53%) | 1/35 (3%) 17/36 (47%) 18/26 (69%) | |FIRST INCIDENCE | 584 507 456 | 681 584 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.006 ** P=0.491 P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P=0.005 ** P=0.567 P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P=0.005 ** P=0.571 P=0.008 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P=0.004 ** P=0.566 P=0.005 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P=0.007 ** P=0.580N P=0.010 * | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P=0.008 ** P=0.590N P=0.011 * | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | 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%) 39/50 (78%) 47/50 (94%) | 33/50 (66%) 46/50 (92%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 58.0% 82.4% 95.3% | 70.9% 94.4% 99.0% | |TERMINAL (d) | 22/41 (54%) 30/37 (81%) 34/36 (94%) | 26/35 (74%) 34/36 (94%) 26/26 (100%) | |FIRST INCIDENCE | 584 507 401 | 568 561 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.011 * P<0.001 ** | P<0.001 ** P=0.014 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.007 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.008 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** | P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.009 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.016 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 8 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 29/50 (58%) 39/50 (78%) 49/50 (98%) | 33/50 (66%) 46/50 (92%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 59.8% 82.4% 99.3% | 70.9% 94.4% 99.0% | |TERMINAL (d) | 22/41 (54%) 30/37 (81%) 36/36 (100%) | 26/35 (74%) 34/36 (94%) 26/26 (100%) | |FIRST INCIDENCE | 584 507 401 | 568 561 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.019 * P<0.001 ** | P<0.001 ** P=0.014 * P<0.001 ** | |POLY 3 | P<0.001 ** P=0.011 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P=0.013 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P=0.010 * P<0.001 ** | P<0.001 ** P=0.002 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P=0.016 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P=0.026 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| | | | | | | 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) | 11/50 (22%) 10/50 (20%) 7/50 (14%) | 2/50 (4%) 4/50 (8%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 23.7% 22.3% 15.3% | 4.4% 9.0% 0.0% | |TERMINAL (d) | 11/41 (27%) 8/37 (22%) 5/36 (14%) | 2/35 (6%) 3/36 (8%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) 645 630 | 729 (T) 691 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.272N P=0.595 P=0.307N | P=0.308N P=0.343 P=0.306N | |POLY 3 | P=0.193N P=0.535N P=0.226N | P=0.277N P=0.330 P=0.262N | |POLY 1.5 | P=0.191N P=0.526N P=0.224N | P=0.256N P=0.334 P=0.253N | |POLY 6 | P=0.194N P=0.539N P=0.227N | P=0.309N P=0.322 P=0.275N | |LOGISTIC REGRESSION| P=0.208N P=0.562N P=0.242N | P=0.289N P=0.313 (e) | |COCH-ARM / FISHERS | P=0.185N P=0.500N P=0.218N | P=0.222N P=0.339 P=0.247N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 9 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 4/50 (8%) 7/50 (14%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 8.6% 15.6% 6.6% | 0.0% 2.2% 2.4% | |TERMINAL (d) | 4/41 (10%) 5/37 (14%) 2/36 (6%) | 0/35 (0%) 1/36 (3%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) 653 667 | --- 729 (T) 506 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.501N P=0.214 P=0.562N | P=0.298 P=0.506 P=0.496 | |POLY 3 | P=0.451N P=0.243 P=0.513N | P=0.316 P=0.496 P=0.482 | |POLY 1.5 | P=0.444N P=0.248 P=0.508N | P=0.322 P=0.498 P=0.488 | |POLY 6 | P=0.458N P=0.242 P=0.518N | P=0.308 P=0.492 P=0.473 | |LOGISTIC REGRESSION| P=0.449N P=0.237 P=0.522N | P=0.397 P=0.506 P=0.636 | |COCH-ARM / FISHERS | P=0.432N P=0.262 P=0.500N | P=0.331 P=0.500 P=0.500 | |=================================================================================================================================| | | | | | | 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) | 15/50 (30%) 17/50 (34%) 9/50 (18%) | 2/50 (4%) 5/50 (10%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 32.3% 37.4% 19.6% | 4.4% 11.2% 2.4% | |TERMINAL (d) | 15/41 (37%) 13/37 (35%) 6/36 (17%) | 2/35 (6%) 4/36 (11%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) 645 630 | 729 (T) 691 506 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.195N P=0.295 P=0.201N | P=0.527N P=0.223 P=0.571N | |POLY 3 | P=0.110N P=0.385 P=0.122N | P=0.477N P=0.209 P=0.531N | |POLY 1.5 | P=0.110N P=0.389 P=0.122N | P=0.453N P=0.214 P=0.520N | |POLY 6 | P=0.107N P=0.392 P=0.120N | P=0.511N P=0.203 P=0.548N | |LOGISTIC REGRESSION| P=0.126N P=0.344 P=0.140N | P=0.433N P=0.194 P=0.465N | |COCH-ARM / FISHERS | P=0.109N P=0.415 P=0.121N | P=0.412N P=0.218 P=0.500N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 10 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | | 3/50 (6%) 0/50 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| | 6.6% 0.0% 2.5% | |TERMINAL (d) | | 2/35 (6%) 0/36 (0%) 1/26 (4%) | |FIRST INCIDENCE | | 664 --- 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.237N P=0.127N P=0.416N | |POLY 3 | | P=0.191N P=0.123N P=0.346N | |POLY 1.5 | | P=0.185N P=0.121N P=0.331N | |POLY 6 | | P=0.200N P=0.127N P=0.369N | |LOGISTIC REGRESSION| | P=0.203N P=0.122N P=0.356N | |COCH-ARM / FISHERS | | P=0.176N P=0.121N P=0.309N | |=================================================================================================================================| | | | | | | 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) | 0/45 (0%) 0/47 (0%) 1/49 (2%) | 5/48 (10%) 2/50 (4%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% | 11.3% 4.5% 2.5% | |TERMINAL (d) | 0/37 (0%) 0/34 (0%) 1/35 (3%) | 4/34 (12%) 2/36 (6%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 727 (T) | 568 729 (T) 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.264 (e) P=0.489 | P=0.092N P=0.199N P=0.166N | |POLY 3 | P=0.283 (e) P=0.510 | P=0.073N P=0.214N P=0.128N | |POLY 1.5 | P=0.283 (e) P=0.513 | P=0.066N P=0.207N P=0.115N | |POLY 6 | P=0.283 (e) P=0.507 | P=0.084N P=0.225N P=0.147N | |LOGISTIC REGRESSION| (e) (e) P=0.489 | P=0.071N P=0.204N P=0.116N | |COCH-ARM / FISHERS | P=0.281 (e) P=0.521 | P=0.056N P=0.201N P=0.097N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 11 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | 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 | | Carcinoma or Adenoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/45 (0%) 0/47 (0%) 1/49 (2%) | 6/48 (13%) 3/50 (6%) 1/49 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% | 13.4% 6.7% 2.5% | |TERMINAL (d) | 0/37 (0%) 0/34 (0%) 1/35 (3%) | 4/34 (12%) 2/36 (6%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 727 (T) | 506 616 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.264 (e) P=0.489 | P=0.058N P=0.229N P=0.101N | |POLY 3 | P=0.283 (e) P=0.510 | P=0.048N* P=0.242N P=0.078N | |POLY 1.5 | P=0.283 (e) P=0.513 | P=0.041N* P=0.233N P=0.067N | |POLY 6 | P=0.283 (e) P=0.507 | P=0.059N P=0.256N P=0.094N | |LOGISTIC REGRESSION| (e) (e) P=0.489 | P=0.027N* P=0.216N P=0.047N* | |COCH-ARM / FISHERS | P=0.281 (e) P=0.521 | P=0.033N* P=0.223N P=0.053N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Skin | | Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, | | or Fibrous Histiocytoma | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 2.4% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 2/35 (6%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- | 729 (T) 680 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.467N P=0.505N P=0.598N | |POLY 3 | (e) (e) (e) | P=0.413N P=0.505N P=0.536N | |POLY 1.5 | (e) (e) (e) | P=0.401N P=0.502N P=0.523N | |POLY 6 | (e) (e) (e) | P=0.430N P=0.510N P=0.554N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.415N P=0.508N P=0.570N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.378N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 12 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Skin | | Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 2.4% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 2/35 (6%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | --- --- --- | 729 (T) 680 701 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.467N P=0.505N P=0.598N | |POLY 3 | (e) (e) (e) | P=0.413N P=0.505N P=0.536N | |POLY 1.5 | (e) (e) (e) | P=0.401N P=0.502N P=0.523N | |POLY 6 | (e) (e) (e) | P=0.430N P=0.510N P=0.554N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.415N P=0.508N P=0.570N | |COCH-ARM / FISHERS | (e) (e) (e) | 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 | |=================================================================================================================================| | | |Spleen | | Hemangiosarcoma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 6.5% 0.0% 2.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 3/41 (7%) 0/37 (0%) 1/36 (3%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) | |FIRST INCIDENCE | 727 (T) --- 727 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.207N P=0.140N P=0.353N | (e) (e) (e) | |POLY 3 | P=0.180N P=0.127N P=0.316N | (e) (e) (e) | |POLY 1.5 | P=0.178N P=0.124N P=0.312N | (e) (e) (e) | |POLY 6 | P=0.181N P=0.129N P=0.320N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.207N (e) P=0.353N | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.176N P=0.121N P=0.309N | (e) (e) (e) | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 13 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Squamous Cell Papilloma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 2.2% 4.5% 2.5% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 1/36 (3%) | 1/35 (3%) 1/36 (3%) 1/26 (4%) | |FIRST INCIDENCE | --- --- 710 | 729 (T) 680 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.090 (e) P=0.220 | P=0.531 P=0.495 P=0.694 | |POLY 3 | P=0.094 (e) P=0.231 | P=0.586 P=0.495 P=0.736 | |POLY 1.5 | P=0.094 (e) P=0.234 | P=0.599 P=0.498 P=0.745 | |POLY 6 | P=0.094 (e) P=0.229 | P=0.568 P=0.490 P=0.723 | |LOGISTIC REGRESSION| P=0.092 (e) P=0.228 | P=0.570 P=0.492 P=0.694 | |COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.622 P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | 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) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 5/50 (10%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 0.0% | 4.4% 11.2% 7.4% | |TERMINAL (d) | 0/41 (0%) 1/37 (3%) 0/36 (0%) | 2/35 (6%) 4/36 (11%) 3/26 (12%) | |FIRST INCIDENCE | --- 727 (T) --- | 729 (T) 649 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.711 P=0.480 (e) | P=0.281 P=0.222 P=0.365 | |POLY 3 | P=0.725 P=0.491 (e) | P=0.357 P=0.211 P=0.451 | |POLY 1.5 | P=0.727 P=0.494 (e) | P=0.380 P=0.214 P=0.469 | |POLY 6 | P=0.723 P=0.489 (e) | P=0.326 P=0.205 P=0.427 | |LOGISTIC REGRESSION| (e) P=0.480 (e) | P=0.315 P=0.201 P=0.365 | |COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.421 P=0.218 P=0.500 | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 14 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 weeks |=================================================================================================================================| | | | | | | 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) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| | 2.2% 4.5% 4.9% | |TERMINAL (d) | | 0/35 (0%) 1/36 (3%) 2/26 (8%) | |FIRST INCIDENCE | | 664 678 729 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.290 P=0.478 P=0.399 | |POLY 3 | | P=0.355 P=0.493 P=0.461 | |POLY 1.5 | | P=0.368 P=0.497 P=0.475 | |POLY 6 | | P=0.337 P=0.486 P=0.440 | |LOGISTIC REGRESSION| | P=0.355 P=0.502 P=0.460 | |COCH-ARM / FISHERS | | P=0.390 P=0.500 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 | | Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 4.4% 4.5% 0.0% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 2/36 (6%) | 2/35 (6%) 2/36 (6%) 0/26 (0%) | |FIRST INCIDENCE | --- --- 727 (T) | 729 (T) 729 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.085 (e) P=0.210 | P=0.233N P=0.685N P=0.306N | |POLY 3 | P=0.094 (e) P=0.231 | P=0.211N P=0.687 P=0.262N | |POLY 1.5 | P=0.094 (e) P=0.233 | P=0.198N P=0.691 P=0.253N | |POLY 6 | P=0.094 (e) P=0.228 | P=0.231N P=0.681 P=0.275N | |LOGISTIC REGRESSION| (e) (e) P=0.210 | P=0.233N P=0.685N (e) | |COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.176N P=0.691N P=0.247N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 15 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 6/50 (12%) 2/50 (4%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 12.5% 4.5% 6.6% | 2.2% 0.0% 4.9% | |TERMINAL (d) | 4/41 (10%) 2/37 (5%) 2/36 (6%) | 1/35 (3%) 0/36 (0%) 1/26 (4%) | |FIRST INCIDENCE | 420 727 (T) 555 | 729 (T) --- 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.212N P=0.168N P=0.295N | P=0.303 P=0.494N P=0.424 | |POLY 3 | P=0.184N P=0.159N P=0.267N | P=0.356 P=0.504N P=0.466 | |POLY 1.5 | P=0.178N P=0.151N P=0.258N | P=0.357 P=0.502N P=0.478 | |POLY 6 | P=0.189N P=0.166N P=0.275N | P=0.353 P=0.508N P=0.450 | |LOGISTIC REGRESSION| P=0.148N P=0.098N P=0.187N | P=0.355 (e) P=0.490 | |COCH-ARM / FISHERS | P=0.169N P=0.134N P=0.243N | P=0.360 P=0.500N 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 | | Hemangiosarcoma or Hemangioma | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | # # # | # # # | |----------- | | | |OVERALL (a) | 6/50 (12%) 2/50 (4%) 5/50 (10%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 12.5% 4.5% 11.0% | 6.6% 4.5% 4.9% | |TERMINAL (d) | 4/41 (10%) 2/37 (5%) 4/36 (11%) | 3/35 (9%) 2/36 (6%) 1/26 (4%) | |FIRST INCIDENCE | 420 727 (T) 555 | 729 (T) 729 (T) 610 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.494N P=0.168N P=0.568N | P=0.515N P=0.487N P=0.613N | |POLY 3 | P=0.454N P=0.159N P=0.534N | P=0.449N P=0.509N P=0.544N | |POLY 1.5 | P=0.445N P=0.151N P=0.522N | P=0.434N P=0.504N P=0.528N | |POLY 6 | P=0.462N P=0.166N P=0.545N | P=0.470N P=0.517N P=0.565N | |LOGISTIC REGRESSION| P=0.408N P=0.098N P=0.448N | P=0.464N P=0.487N P=0.546N | |COCH-ARM / FISHERS | P=0.429N P=0.134N P=0.500N | P=0.406N P=0.500N P=0.500N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 16 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.1% 4.4% 0.0% | 2.2% 4.5% 2.4% | |TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 2/36 (6%) 0/26 (0%) | |FIRST INCIDENCE | 618 454 --- | 664 729 (T) 653 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.373N P=0.484 P=0.509N | P=0.538 P=0.493 P=0.705 | |POLY 3 | P=0.378N P=0.489 P=0.507N | P=0.586 P=0.491 P=0.737 | |POLY 1.5 | P=0.371N P=0.492 P=0.504N | P=0.599 P=0.496 P=0.745 | |POLY 6 | P=0.387N P=0.486 P=0.511N | P=0.568 P=0.483 P=0.724 | |LOGISTIC REGRESSION| P=0.317N P=0.626 P=0.469N | P=0.613 P=0.496 P=0.749N | |COCH-ARM / FISHERS | P=0.360N P=0.500 P=0.500N | P=0.622 P=0.500 P=0.753N | |=================================================================================================================================| | | | | | | 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) | 3/50 (6%) 5/50 (10%) 3/50 (6%) | 14/50 (28%) 7/50 (14%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| 6.4% 10.7% 6.6% | 30.1% 15.3% 19.1% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 2/36 (6%) | 8/35 (23%) 3/36 (8%) 4/26 (15%) | |FIRST INCIDENCE | 612 304 505 | 589 584 564 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.536 P=0.335 P=0.621 | P=0.217N P=0.090N P=0.307N | |POLY 3 | P=0.557 P=0.349 P=0.648 | P=0.116N P=0.072N P=0.172N | |POLY 1.5 | P=0.565 P=0.352 P=0.654 | P=0.102N P=0.070N P=0.148N | |POLY 6 | P=0.546 P=0.345 P=0.639 | P=0.138N P=0.077N P=0.209N | |LOGISTIC REGRESSION| P=0.517N P=0.520 P=0.624N | P=0.088N P=0.069N P=0.144N | |COCH-ARM / FISHERS | P=0.576 P=0.357 P=0.661N | P=0.082N P=0.070N P=0.114N | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 17 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 2/50 (4%) 3/50 (6%) 3/50 (6%) | 13/50 (26%) 5/50 (10%) 7/50 (14%) | |POLY-3 ADJUSTED (b)| 4.3% 6.6% 6.6% | 28.1% 10.9% 16.8% | |TERMINAL (d) | 1/41 (2%) 1/37 (3%) 2/36 (6%) | 8/35 (23%) 1/36 (3%) 4/26 (15%) | |FIRST INCIDENCE | 612 304 505 | 589 584 564 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.378 P=0.476 P=0.459 | P=0.177N P=0.046N* P=0.278N | |POLY 3 | P=0.402 P=0.489 P=0.490 | P=0.094N P=0.033N* P=0.158N | |POLY 1.5 | P=0.407 P=0.493 P=0.494 | P=0.084N P=0.032N* P=0.137N | |POLY 6 | P=0.396 P=0.485 P=0.484 | P=0.110N P=0.034N* P=0.192N | |LOGISTIC REGRESSION| P=0.453 P=0.636 P=0.536 | P=0.075N P=0.033N* P=0.142N | |COCH-ARM / FISHERS | P=0.412 P=0.500 P=0.500 | P=0.070N P=0.033N* P=0.105N | |=================================================================================================================================| | | | | | | 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) | 26/50 (52%) 39/50 (78%) 47/50 (94%) | 39/50 (78%) 45/50 (90%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 54.7% 83.6% 95.3% | 83.1% 92.4% 94.9% | |TERMINAL (d) | 22/41 (54%) 31/37 (84%) 35/36 (97%) | 30/35 (86%) 33/36 (92%) 26/26 (100%) | |FIRST INCIDENCE | 612 507 401 | 568 561 366 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.003 ** P<0.001 ** | P=0.002 ** P=0.185 P=0.003 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.029 * P=0.126 P=0.048 * | |POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** | P=0.029 * P=0.104 P=0.050 | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P=0.028 * P=0.162 P=0.046 * | |LOGISTIC REGRESSION| P<0.001 ** P=0.002 ** P<0.001 ** | P=0.007 ** P=0.059 P=0.013 * | |COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P<0.001 ** | P=0.056 P=0.086 P=0.086 | |=================================================================================================================================| Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 18 Statistical Analysis of Primary Tumors in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE Terminal Sacrifice at 103 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) | 22/50 (44%) 28/50 (56%) 35/50 (70%) | 23/50 (46%) 30/50 (60%) 41/50 (82%) | |POLY-3 ADJUSTED (b)| 44.3% 57.0% 71.7% | 47.4% 61.8% 84.6% | |TERMINAL (d) | 14/41 (34%) 16/37 (43%) 24/36 (67%) | 12/35 (34%) 20/36 (56%) 20/26 (77%) | |FIRST INCIDENCE | 420 304 456 | 429 473 98 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.008 ** P=0.130 P=0.008 ** | P<0.001 ** P=0.167 P<0.001 ** | |POLY 3 | P=0.003 ** P=0.143 P=0.004 ** | P<0.001 ** P=0.109 P<0.001 ** | |POLY 1.5 | P=0.004 ** P=0.146 P=0.005 ** | P<0.001 ** P=0.112 P<0.001 ** | |POLY 6 | P=0.003 ** P=0.146 P=0.004 ** | P<0.001 ** P=0.102 P<0.001 ** | |LOGISTIC REGRESSION| P=0.007 ** P=0.216 P=0.010 * | P<0.001 ** P=0.125 P<0.001 ** | |COCH-ARM / FISHERS | P=0.006 ** P=0.159 P=0.007 ** | P<0.001 ** P=0.115 P<0.001 ** | |=================================================================================================================================| | | | | | | 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) | 35/50 (70%) 45/50 (90%) 50/50 (100%) | 47/50 (94%) 48/50 (96%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 70.0% 91.6% 100.0% | 95.4% 97.1% 100.0% | |TERMINAL (d) | 26/41 (63%) 33/37 (89%) 36/36 (100%) | 33/35 (94%) 35/36 (97%) 26/26 (100%) | |FIRST INCIDENCE | 420 304 401 | 429 473 98 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.018 * P<0.001 ** | P=0.009 ** P=0.522 P=0.013 * | |POLY 3 | P<0.001 ** P=0.005 ** P<0.001 ** | P=0.109 P=0.533 P=0.180 | |POLY 1.5 | P<0.001 ** P=0.006 ** P<0.001 ** | P=0.094 P=0.526 P=0.149 | |POLY 6 | P<0.001 ** P=0.005 ** P<0.001 ** | P=0.129 P=0.524 P=0.216 | |LOGISTIC REGRESSION| P<0.001 ** P=0.014 * (e) | P=0.053 P=0.511 P=0.092 | |COCH-ARM / FISHERS | P<0.001 ** P=0.011 * P<0.001 ** | P=0.082 P=0.500 P=0.121 | |=================================================================================================================================| (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).