TDMS Study 55323-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/01/97 EXPERIMENT: 55323 TEST: 04 TIME: 15:08:30 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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10 LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/01/97 EXPERIMENT: 55323 TEST: 04 TIME: 15:08:30 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 ----- ---------- Adrenal Cortex Hyperplasia Focal Islets, Pancreatic Hyperplasia Liver Clear Cell Focus Skin: Epidermis, Skin, Site of ApplicatHyperplasia Skin: Sebaceous Gland, Skin, Site of ApHyperplasia Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Parakeratosis Thyroid Gland: Follicle Hyperplasia Focal =============================================================== Female Mice ------------ Organ Morphology ----- ---------- Islets, Pancreatic Hyperplasia Kidney Nephropathy Liver Eosinophilic Focus Skin: Epidermis, Skin, Site of ApplicatHyperplasia Skin: Sebaceous Gland, Skin, Site of ApHyperplasia Skin: Skin, Site of Application Hyperkeratosis Inflammation Chronic Parakeratosis Ulcer Spleen Hyperplasia Lymphoid Stomach, Forestomach Ulcer Uterus: Endometrium Hyperplasia Cystic =============================================================== Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 1 Statistical Analysis of Non-neoplastic Lesions 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 | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 29/50 (58%) 17/50 (34%) 24/50 (48%) | 1/50 (2%) 4/49 (8%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 62.9% 38.0% 52.4% | 2.2% 8.7% 0.0% | |TERMINAL (d) | 26/40 (65%) 16/37 (43%) 23/41 (56%) | 1/37 (3%) 4/40 (10%) 0/29 (0%) | |FIRST INCIDENCE | 562 719 643 | 736 (T) 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.149N P=0.027N* P=0.173N | P=0.472N P=0.203 P=0.549N | |POLY 3 | P=0.174N P=0.012N* P=0.207N | P=0.461N P=0.186 P=0.520N | |POLY 1.5 | P=0.172N P=0.012N* P=0.203N | P=0.436N P=0.181 P=0.513N | |POLY 6 | P=0.178N P=0.014N* P=0.213N | P=0.491N P=0.192 P=0.529N | |LOGISTIC REGRESSION| P=0.150N P=0.010N* P=0.178N | P=0.472N P=0.203 (e) | |COCH-ARM / FISHERS | P=0.184N P=0.013N* P=0.212N | P=0.391N P=0.175 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 | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) | 2/50 (4%) 2/49 (4%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 4.5% 4.3% 4.9% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 2/41 (5%) | 2/37 (5%) 1/40 (3%) 1/29 (3%) | |FIRST INCIDENCE | --- --- 735 (T) | 736 (T) 651 646 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102 (e) P=0.244 | P=0.522 P=0.662N P=0.614 | |POLY 3 | P=0.094 (e) P=0.238 | P=0.570 P=0.683N P=0.660 | |POLY 1.5 | P=0.094 (e) P=0.237 | P=0.579 P=0.690N P=0.671 | |POLY 6 | P=0.095 (e) P=0.241 | P=0.561 P=0.674N P=0.647 | |LOGISTIC REGRESSION| (e) (e) P=0.244 | P=0.582 P=0.694 P=0.658 | |COCH-ARM / FISHERS | P=0.093 (e) P=0.242 | P=0.600 P=0.684 P=0.691N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 2 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Bone | | Fibrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 3/49 (6%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.2% 6.5% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 1/37 (3%) 3/40 (8%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | 736 (T) 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.449N P=0.333 P=0.549N | |POLY 3 | (e) (e) (e) | P=0.439N P=0.314 P=0.520N | |POLY 1.5 | (e) (e) (e) | P=0.418N P=0.308 P=0.513N | |POLY 6 | (e) (e) (e) | P=0.466N P=0.321 P=0.529N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.449N P=0.333 (e) | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.379N P=0.301 P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Heart: Myocardium | | Degeneration | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 5/50 (10%) 3/50 (6%) 8/50 (16%) | 5/50 (10%) 10/49 (20%) 5/50 (10%) | |POLY-3 ADJUSTED (b)| 11.1% 6.6% 17.3% | 11.0% 21.7% 12.2% | |TERMINAL (d) | 4/40 (10%) 0/37 (0%) 7/41 (17%) | 3/37 (8%) 9/40 (23%) 4/29 (14%) | |FIRST INCIDENCE | 670 638 444 | 602 668 625 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.231 P=0.377N P=0.296 | P=0.392 P=0.171 P=0.491 | |POLY 3 | P=0.218 P=0.353N P=0.292 | P=0.461 P=0.136 P=0.563 | |POLY 1.5 | P=0.216 P=0.357N P=0.288 | P=0.494 P=0.131 P=0.586 | |POLY 6 | P=0.220 P=0.348N P=0.295 | P=0.424 P=0.144 P=0.536 | |LOGISTIC REGRESSION| P=0.209 P=0.357N P=0.279 | P=0.471 P=0.139 P=0.574 | |COCH-ARM / FISHERS | P=0.209 P=0.357N P=0.277 | P=0.558 P=0.122 P=0.630N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 3 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Intestine Small, Duodenum | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | 638 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.110N P=0.222N P=0.287N | |POLY 3 | (e) (e) (e) | P=0.105N P=0.234N P=0.262N | |POLY 1.5 | (e) (e) (e) | P=0.101N P=0.237N P=0.254N | |POLY 6 | (e) (e) (e) | P=0.108N P=0.230N P=0.274N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.089N P=0.259N P=0.235N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.096N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Islets, Pancreatic | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 27/50 (54%) 28/50 (56%) 12/50 (24%) | 2/50 (4%) 9/49 (18%) 6/50 (12%) | |POLY-3 ADJUSTED (b)| 59.2% 60.2% 25.3% | 4.5% 19.6% 14.4% | |TERMINAL (d) | 25/40 (63%) 23/37 (62%) 9/41 (22%) | 2/37 (5%) 9/40 (23%) 3/29 (10%) | |FIRST INCIDENCE | 562 415 444 | 736 (T) 736 (T) 539 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.002N** P=0.357 P=0.002N** | P=0.064 P=0.036 * P=0.084 | |POLY 3 | P<0.001N** P=0.543 P<0.001N** | P=0.098 P=0.027 * P=0.109 | |POLY 1.5 | P<0.001N** P=0.520 P<0.001N** | P=0.108 P=0.026 * P=0.116 | |POLY 6 | P<0.001N** P=0.565 P<0.001N** | P=0.089 P=0.029 * P=0.101 | |LOGISTIC REGRESSION| P<0.001N** P=0.491 P=0.002N** | P=0.096 P=0.036 * P=0.122 | |COCH-ARM / FISHERS | P=0.002N** P=0.500 P=0.002N** | P=0.135 P=0.023 * P=0.134 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 4 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Kidney | | Nephropathy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 28/50 (56%) 31/50 (62%) 33/50 (66%) | 19/50 (38%) 30/49 (61%) 16/50 (32%) | |POLY-3 ADJUSTED (b)| 60.7% 69.4% 72.6% | 42.4% 63.5% 39.0% | |TERMINAL (d) | 26/40 (65%) 31/37 (84%) 32/41 (78%) | 19/37 (51%) 27/40 (68%) 14/29 (48%) | |FIRST INCIDENCE | 353 735 (T) 730 | 736 (T) 481 650 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.183 P=0.153 P=0.230 | P=0.388 P=0.041 * P=0.486 | |POLY 3 | P=0.124 P=0.250 P=0.153 | P=0.479N P=0.029 * P=0.462N | |POLY 1.5 | P=0.144 P=0.276 P=0.173 | P=0.421N P=0.023 * P=0.420N | |POLY 6 | P=0.108 P=0.220 P=0.138 | P=0.541N P=0.040 * P=0.509N | |LOGISTIC REGRESSION| P=0.177 P=0.328 P=0.208 | P=0.523 P=0.030 * P=0.570 | |COCH-ARM / FISHERS | P=0.178 P=0.342 P=0.206 | P=0.307N P=0.017 * P=0.338N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Kidney: Renal Tubule | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 4.4% 4.5% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 1/37 (3%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | 636 719 --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.176N P=0.676 P=0.237N | (e) (e) (e) | |POLY 3 | P=0.175N P=0.690 P=0.236N | (e) (e) (e) | |POLY 1.5 | P=0.175N P=0.690 P=0.236N | (e) (e) (e) | |POLY 6 | P=0.175N P=0.689 P=0.236N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.175N P=0.694 P=0.241N | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.176N P=0.691N P=0.247N | (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 5 Statistical Analysis of Non-neoplastic Lesions 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 | | Basophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 4.5% 2.2% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 1/40 (3%) 2/37 (5%) 1/41 (2%) | 0/37 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | 735 (T) 735 (T) 735 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.612N P=0.473 P=0.756N | (e) (e) (e) | |POLY 3 | P=0.617N P=0.499 P=0.758N | (e) (e) (e) | |POLY 1.5 | P=0.618N P=0.498 P=0.758N | (e) (e) (e) | |POLY 6 | P=0.615N P=0.499 P=0.757N | (e) (e) (e) | |LOGISTIC REGRESSION| P=0.612N P=0.473 P=0.756N | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.622 P=0.500 P=0.753N | (e) (e) (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Clear Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 14/50 (28%) 7/50 (14%) 6/50 (12%) | 2/50 (4%) 2/49 (4%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 31.2% 15.7% 13.2% | 4.4% 4.4% 2.5% | |TERMINAL (d) | 14/40 (35%) 7/37 (19%) 6/41 (15%) | 1/37 (3%) 2/40 (5%) 1/29 (3%) | |FIRST INCIDENCE | 735 (T) 735 (T) 735 (T) | 602 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.021N* P=0.094N P=0.032N* | P=0.463N P=0.670N P=0.569N | |POLY 3 | P=0.021N* P=0.066N P=0.033N* | P=0.441N P=0.689N P=0.539N | |POLY 1.5 | P=0.022N* P=0.068N P=0.034N* | P=0.424N P=0.693N P=0.525N | |POLY 6 | P=0.020N* P=0.065N P=0.031N* | P=0.462N P=0.684N P=0.556N | |LOGISTIC REGRESSION| P=0.021N* P=0.094N P=0.032N* | P=0.411N P=0.678 P=0.507N | |COCH-ARM / FISHERS | P=0.025N* P=0.070N P=0.039N* | P=0.391N P=0.684 P=0.500N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 6 Statistical Analysis of Non-neoplastic Lesions 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 | | Degeneration Fatty Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 4.4% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 2/40 (5%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | --- 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.624 P=0.256 (e) | |POLY 3 | (e) (e) (e) | P=0.632 P=0.242 (e) | |POLY 1.5 | (e) (e) (e) | P=0.645 P=0.239 (e) | |POLY 6 | (e) (e) (e) | P=0.617 P=0.247 (e) | |LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.256 (e) | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.668 P=0.242 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Eosinophilic Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 15/50 (30%) 9/50 (18%) 15/50 (30%) | 15/50 (30%) 20/49 (41%) 23/50 (46%) | |POLY-3 ADJUSTED (b)| 33.5% 19.6% 33.0% | 32.3% 42.7% 53.5% | |TERMINAL (d) | 15/40 (38%) 5/37 (14%) 15/41 (37%) | 12/37 (32%) 17/40 (43%) 16/29 (55%) | |FIRST INCIDENCE | 735 (T) 528 735 (T) | 542 638 523 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.515N P=0.166N P=0.557N | P=0.010 * P=0.290 P=0.015 * | |POLY 3 | P=0.533N P=0.104N P=0.571N | P=0.027 * P=0.205 P=0.031 * | |POLY 1.5 | P=0.536N P=0.112N P=0.574N | P=0.035 * P=0.194 P=0.042 * | |POLY 6 | P=0.529N P=0.094N P=0.565N | P=0.022 * P=0.221 P=0.024 * | |LOGISTIC REGRESSION| P=0.527N P=0.121N P=0.557N | P=0.032 * P=0.196 P=0.041 * | |COCH-ARM / FISHERS | P=0.545 P=0.121N P=0.586N | P=0.062 P=0.180 P=0.074 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 7 Statistical Analysis of Non-neoplastic Lesions 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 | | Hepatodiaphragmatic Nodule | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 0.0% 0.0% 2.4% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 2/41 (5%) | 0/37 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- 735 (T) | --- --- 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102 (e) P=0.244 | P=0.267 (e) P=0.496 | |POLY 3 | P=0.096 (e) P=0.240 | P=0.276 (e) P=0.483 | |POLY 1.5 | P=0.095 (e) P=0.240 | P=0.274 (e) P=0.489 | |POLY 6 | P=0.096 (e) P=0.241 | P=0.279 (e) P=0.476 | |LOGISTIC REGRESSION| (e) (e) P=0.244 | P=0.432 (e) P=0.682 | |COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.270 (e) P=0.500 | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver | | Mixed Cell Focus | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 2/50 (4%) 5/50 (10%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| 4.5% 11.2% 4.4% | 0.0% 0.0% 4.9% | |TERMINAL (d) | 2/40 (5%) 5/37 (14%) 2/41 (5%) | 0/37 (0%) 0/40 (0%) 2/29 (7%) | |FIRST INCIDENCE | 735 (T) 735 (T) 735 (T) | --- --- 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.570N P=0.185 P=0.686N | P=0.068 (e) P=0.186 | |POLY 3 | P=0.575N P=0.214 P=0.689N | P=0.096 (e) P=0.215 | |POLY 1.5 | P=0.577N P=0.214 P=0.690N | P=0.095 (e) P=0.222 | |POLY 6 | P=0.572N P=0.214 P=0.687N | P=0.097 (e) P=0.206 | |LOGISTIC REGRESSION| P=0.570N P=0.185 P=0.686N | (e) (e) P=0.186 | |COCH-ARM / FISHERS | P=0.583 P=0.218 P=0.691N | P=0.096 (e) P=0.247 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 8 Statistical Analysis of Non-neoplastic Lesions 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 | | Necrosis Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 6.4% | 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 1/41 (2%) | 0/37 (0%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | 562 --- 519 | --- 574 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.178 P=0.504N P=0.305 | P=0.640 P=0.253 (e) | |POLY 3 | P=0.179 P=0.503N P=0.315 | P=0.632 P=0.245 (e) | |POLY 1.5 | P=0.178 P=0.503N P=0.312 | P=0.645 P=0.240 (e) | |POLY 6 | P=0.181 P=0.505N P=0.319 | P=0.617 P=0.251 (e) | |LOGISTIC REGRESSION| P=0.141 P=0.464N P=0.228 | P=0.628N P=0.181 (e) | |COCH-ARM / FISHERS | P=0.176 P=0.500N P=0.309 | P=0.668 P=0.242 (e) | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Liver: Bile Duct | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% | 0.0% 0.0% 2.5% | |TERMINAL (d) | 0/40 (0%) 2/37 (5%) 0/41 (0%) | 0/37 (0%) 0/40 (0%) 1/29 (3%) | |FIRST INCIDENCE | --- 735 (T) --- | --- --- 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.661N P=0.221 (e) | P=0.232 (e) P=0.451 | |POLY 3 | P=0.665N P=0.236 (e) | P=0.277 (e) P=0.480 | |POLY 1.5 | P=0.666N P=0.236 (e) | P=0.274 (e) P=0.487 | |POLY 6 | P=0.663N P=0.236 (e) | P=0.282 (e) P=0.471 | |LOGISTIC REGRESSION| (e) P=0.221 (e) | (e) (e) P=0.451 | |COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | P=0.270 (e) P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 9 Statistical Analysis of Non-neoplastic Lesions 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 Epithelium | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) | 2/50 (4%) 1/49 (2%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 2.2% 6.7% 4.4% | 4.5% 2.2% 2.5% | |TERMINAL (d) | 1/40 (3%) 2/37 (5%) 2/41 (5%) | 2/37 (5%) 1/40 (3%) 1/29 (3%) | |FIRST INCIDENCE | 735 (T) 706 735 (T) | 736 (T) 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.412 P=0.288 P=0.509 | P=0.449N P=0.473N P=0.585N | |POLY 3 | P=0.407 P=0.305 P=0.505 | P=0.412N P=0.492N P=0.536N | |POLY 1.5 | P=0.405 P=0.304 P=0.504 | P=0.401N P=0.498N P=0.524N | |POLY 6 | P=0.410 P=0.305 P=0.506 | P=0.425N P=0.485N P=0.550N | |LOGISTIC REGRESSION| P=0.409 P=0.302 P=0.509 | P=0.449N P=0.473N P=0.585N | |COCH-ARM / FISHERS | P=0.399 P=0.309 P=0.500 | P=0.379N P=0.508N P=0.500N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Lymph Node, Mesenteric | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/49 (0%) 2/49 (4%) 2/50 (4%) | 1/49 (2%) 0/48 (0%) 0/47 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.6% 4.4% | 2.3% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/36 (6%) 2/41 (5%) | 0/36 (0%) 0/39 (0%) 0/27 (0%) | |FIRST INCIDENCE | --- 735 (T) 735 (T) | 671 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.186 P=0.215 P=0.244 | P=0.291N P=0.495N P=0.538N | |POLY 3 | P=0.183 P=0.234 P=0.243 | P=0.294N P=0.496N P=0.530N | |POLY 1.5 | P=0.183 P=0.235 P=0.243 | P=0.288N P=0.499N P=0.523N | |POLY 6 | P=0.183 P=0.233 P=0.243 | P=0.302N P=0.493N P=0.539N | |LOGISTIC REGRESSION| (e) P=0.215 P=0.244 | P=0.256N P=0.535N P=0.498N | |COCH-ARM / FISHERS | P=0.181 P=0.247 P=0.253 | P=0.275N P=0.505N P=0.510N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 10 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Mesentery: Fat | | Necrosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/0 (0%) 0/1 (0%) 2/2 (100%) | 7/7 (100%) 10/10 (100%) 3/4 (75%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% | 100.0% 100.0% 75.0% | |TERMINAL (d) | 0/0 (0%) 0/0 (0%) 2/2 (100%) | 7/7 (100%) 9/9 (100%) 2/3 (67%) | |FIRST INCIDENCE | --- --- 735 (T) | 736 (T) 651 539 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.622N (e) P=0.689N | |POLY 3 | (e) (e) (e) | P=0.166N (e) P=0.384N | |POLY 1.5 | (e) (e) (e) | P=0.166N (e) P=0.384N | |POLY 6 | (e) (e) (e) | P=0.166N (e) P=0.384N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.622N (e) (e) | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.177N (e) P=0.364N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Nose | | Inflammation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 2/37 (5%) 0/41 (0%) | 0/36 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- 735 (T) --- | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.661N P=0.221 (e) | (e) (e) (e) | |POLY 3 | P=0.665N P=0.236 (e) | (e) (e) (e) | |POLY 1.5 | P=0.666N P=0.236 (e) | (e) (e) (e) | |POLY 6 | P=0.663N P=0.236 (e) | (e) (e) (e) | |LOGISTIC REGRESSION| (e) P=0.221 (e) | (e) (e) (e) | |COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | (e) (e) (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 11 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Nose | | Polyp, Inflammatory | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 0.0% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 2/41 (5%) | 0/36 (0%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- 735 (T) | --- --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102 (e) P=0.244 | (e) (e) (e) | |POLY 3 | P=0.096 (e) P=0.240 | (e) (e) (e) | |POLY 1.5 | P=0.095 (e) P=0.240 | (e) (e) (e) | |POLY 6 | P=0.096 (e) P=0.241 | (e) (e) (e) | |LOGISTIC REGRESSION| (e) (e) P=0.244 | (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 | |=================================================================================================================================| | | |Ovary | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 6/50 (12%) 9/49 (18%) 8/50 (16%) | |POLY-3 ADJUSTED (b)| | 13.4% 19.3% 19.2% | |TERMINAL (d) | | 6/37 (16%) 7/40 (18%) 6/29 (21%) | |FIRST INCIDENCE | | 736 (T) 638 414 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.188 P=0.348 P=0.231 | |POLY 3 | | P=0.282 P=0.314 P=0.330 | |POLY 1.5 | | P=0.300 P=0.297 P=0.348 | |POLY 6 | | P=0.263 P=0.337 P=0.308 | |LOGISTIC REGRESSION| | P=0.289 P=0.309 P=0.331 | |COCH-ARM / FISHERS | | P=0.339 P=0.274 P=0.387 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 12 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Pancreas: Acinus | | Atrophy | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/49 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.2% 4.4% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 2/40 (5%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | 629 736 (T) --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.417N P=0.526 P=0.540N | |POLY 3 | (e) (e) (e) | P=0.415N P=0.505 P=0.522N | |POLY 1.5 | (e) (e) (e) | P=0.396N P=0.500 P=0.514N | |POLY 6 | (e) (e) (e) | P=0.440N P=0.510 P=0.531N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.364N P=0.479 P=0.458N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.361N P=0.492 P=0.500N | |=================================================================================================================================| | | | | | | 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 | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/48 (0%) 1/49 (2%) 1/50 (2%) | 11/47 (23%) 6/49 (12%) 11/50 (22%) | |POLY-3 ADJUSTED (b)| 0.0% 2.3% 2.2% | 25.8% 13.1% 26.7% | |TERMINAL (d) | 0/38 (0%) 1/36 (3%) 1/41 (2%) | 8/34 (24%) 6/40 (15%) 9/29 (31%) | |FIRST INCIDENCE | --- 735 (T) 735 (T) | 602 736 (T) 625 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.351 P=0.489 P=0.515 | P=0.409 P=0.086N P=0.430 | |POLY 3 | P=0.347 P=0.504 P=0.512 | P=0.545 P=0.104N P=0.564 | |POLY 1.5 | P=0.346 P=0.503 P=0.511 | P=0.542N P=0.111N P=0.596 | |POLY 6 | P=0.350 P=0.504 P=0.513 | P=0.523 P=0.098N P=0.525 | |LOGISTIC REGRESSION| (e) P=0.489 P=0.515 | P=0.506 P=0.095N P=0.547 | |COCH-ARM / FISHERS | P=0.340 P=0.505 P=0.510 | P=0.492N P=0.122N P=0.530N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 13 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Preputial Gland | | Cyst | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 23/50 (46%) 19/50 (38%) 18/50 (36%) | | |POLY-3 ADJUSTED (b)| 50.9% 41.8% 39.6% | | |TERMINAL (d) | 22/40 (55%) 15/37 (41%) 17/41 (42%) | | |FIRST INCIDENCE | 646 626 730 | | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.154N P=0.374N P=0.171N | | |POLY 3 | P=0.162N P=0.252N P=0.188N | | |POLY 1.5 | P=0.165N P=0.265N P=0.192N | | |POLY 6 | P=0.158N P=0.236N P=0.184N | | |LOGISTIC REGRESSION| P=0.146N P=0.265N P=0.159N | | |COCH-ARM / FISHERS | P=0.179N P=0.272N P=0.208N | | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Skin: Epidermis, Skin, Site of Application | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 4/50 (8%) 45/50 (90%) 50/50 (100%) | 0/50 (0%) 42/49 (86%) 50/50 (100%) | |POLY-3 ADJUSTED (b)| 8.9% 90.9% 100.0% | 0.0% 86.2% 100.0% | |TERMINAL (d) | 4/40 (10%) 33/37 (89%) 41/41 (100%) | 0/37 (0%) 34/40 (85%) 29/29 (100%) | |FIRST INCIDENCE | 735 (T) 164 444 | --- 481 84 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 14 Statistical Analysis of Non-neoplastic Lesions 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: Sebaceous Gland, Skin, Site of Application | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 45/50 (90%) 48/50 (96%) | 0/50 (0%) 43/49 (88%) 45/50 (90%) | |POLY-3 ADJUSTED (b)| 2.2% 90.9% 98.1% | 0.0% 87.8% 90.9% | |TERMINAL (d) | 1/40 (3%) 33/37 (89%) 41/41 (100%) | 0/37 (0%) 34/40 (85%) 26/29 (90%) | |FIRST INCIDENCE | 735 (T) 164 444 | --- 481 84 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** 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 | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 45/50 (90%) 49/50 (98%) | 4/50 (8%) 41/49 (84%) 48/50 (96%) | |POLY-3 ADJUSTED (b)| 6.7% 90.9% 98.0% | 8.8% 84.2% 96.0% | |TERMINAL (d) | 3/40 (8%) 33/37 (89%) 40/41 (98%) | 0/37 (0%) 33/40 (83%) 27/29 (93%) | |FIRST INCIDENCE | 735 (T) 164 444 | 646 481 84 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 15 Statistical Analysis of Non-neoplastic Lesions 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: Skin, Site of Application | | Inflammation Chronic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 13/50 (26%) 28/50 (56%) | 0/50 (0%) 24/49 (49%) 40/50 (80%) | |POLY-3 ADJUSTED (b)| 2.2% 27.2% 57.1% | 0.0% 49.6% 81.7% | |TERMINAL (d) | 0/40 (0%) 7/37 (19%) 21/41 (51%) | 0/37 (0%) 17/40 (43%) 21/29 (72%) | |FIRST INCIDENCE | 344 164 444 | --- 481 84 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** | |COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** 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 | |=================================================================================================================================| | | |Skin: Skin, Site of Application | | Parakeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 1/50 (2%) 5/50 (10%) | 0/50 (0%) 3/49 (6%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 0.0% 2.2% 11.0% | 0.0% 6.5% 21.3% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 5/41 (12%) | 0/37 (0%) 3/40 (8%) 5/29 (17%) | |FIRST INCIDENCE | --- 719 735 (T) | --- 736 (T) 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.013 * P=0.490 P=0.035 * | P<0.001 ** P=0.135 P<0.001 ** | |POLY 3 | P=0.010 * P=0.499 P=0.032 * | P<0.001 ** P=0.123 P<0.001 ** | |POLY 1.5 | P=0.010 * P=0.499 P=0.031 * | P<0.001 ** P=0.120 P<0.001 ** | |POLY 6 | P=0.010 * P=0.500 P=0.032 * | P<0.001 ** P=0.127 P<0.001 ** | |LOGISTIC REGRESSION| P=0.012 * P=0.499 P=0.035 * | P<0.001 ** P=0.135 P=0.003 ** | |COCH-ARM / FISHERS | P=0.011 * P=0.500 P=0.028 * | P<0.001 ** P=0.117 P<0.001 ** | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 16 Statistical Analysis of Non-neoplastic Lesions 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: Skin, Site of Application | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/49 (0%) 3/50 (6%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% | 0.0% 0.0% 7.2% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 2/41 (5%) | 0/37 (0%) 0/40 (0%) 1/29 (3%) | |FIRST INCIDENCE | --- --- 735 (T) | --- --- 476 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.102 (e) P=0.244 | P=0.029 * (e) P=0.100 | |POLY 3 | P=0.096 (e) P=0.240 | P=0.035 * (e) P=0.106 | |POLY 1.5 | P=0.095 (e) P=0.240 | P=0.035 * (e) P=0.110 | |POLY 6 | P=0.096 (e) P=0.241 | P=0.035 * (e) P=0.101 | |LOGISTIC REGRESSION| (e) (e) P=0.244 | P=0.060 (e) P=0.158 | |COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.038 * (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 | | Hematopoietic Cell Proliferation | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 6/50 (12%) 7/50 (14%) 2/50 (4%) | 7/50 (14%) 6/49 (12%) 9/50 (18%) | |POLY-3 ADJUSTED (b)| 12.8% 15.0% 4.3% | 15.1% 12.9% 20.9% | |TERMINAL (d) | 2/40 (5%) 2/37 (5%) 0/41 (0%) | 3/37 (8%) 3/40 (8%) 2/29 (7%) | |FIRST INCIDENCE | 353 415 444 | 562 638 539 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.129N P=0.488 P=0.142N | P=0.224 P=0.448N P=0.273 | |POLY 3 | P=0.123N P=0.496 P=0.135N | P=0.292 P=0.493N P=0.333 | |POLY 1.5 | P=0.121N P=0.495 P=0.134N | P=0.304 P=0.502N P=0.350 | |POLY 6 | P=0.124N P=0.497 P=0.136N | P=0.281 P=0.484N P=0.317 | |LOGISTIC REGRESSION| P=0.137N P=0.530 P=0.157N | P=0.419 P=0.579N P=0.462 | |COCH-ARM / FISHERS | P=0.122N P=0.500 P=0.134N | P=0.336 P=0.516N P=0.393 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 17 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Spleen | | Hyperplasia Lymphoid | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 3/50 (6%) 2/50 (4%) 0/50 (0%) | 6/50 (12%) 3/49 (6%) 1/50 (2%) | |POLY-3 ADJUSTED (b)| 6.7% 4.5% 0.0% | 13.3% 6.5% 2.5% | |TERMINAL (d) | 3/40 (8%) 2/37 (5%) 0/41 (0%) | 5/37 (14%) 3/40 (8%) 1/29 (3%) | |FIRST INCIDENCE | 735 (T) 735 (T) --- | 646 736 (T) 736 (T) | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.081N P=0.536N P=0.117N | P=0.058N P=0.206N P=0.103N | |POLY 3 | P=0.080N P=0.502N P=0.116N | P=0.048N* P=0.234N P=0.075N | |POLY 1.5 | P=0.080N P=0.503N P=0.117N | P=0.043N* P=0.241N P=0.068N | |POLY 6 | P=0.079N P=0.502N P=0.115N | P=0.053N P=0.226N P=0.085N | |LOGISTIC REGRESSION| P=0.081N P=0.536N (e) | P=0.049N* P=0.223N P=0.083N | |COCH-ARM / FISHERS | P=0.082N P=0.500N P=0.121N | P=0.036N* P=0.254N P=0.056N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Stomach, Forestomach | | Ulcer | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% | 6.5% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | 616 --- 492 | 562 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P=0.665 P=0.500N P=0.758 | P=0.045N* P=0.119N P=0.152N | |POLY 3 | P=0.667N P=0.503N P=0.756N | P=0.041N* P=0.119N P=0.143N | |POLY 1.5 | P=0.667N P=0.502N P=0.757N | P=0.039N* P=0.120N P=0.134N | |POLY 6 | P=0.667N P=0.504N P=0.755N | P=0.044N* P=0.117N P=0.155N | |LOGISTIC REGRESSION| P=0.646 P=0.483N P=0.699 | P=0.017N* P=0.177N P=0.073N | |COCH-ARM / FISHERS | P=0.669 P=0.500N P=0.753N | P=0.038N* P=0.125N P=0.121N | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 18 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Stomach, Forestomach: Epithelium | | Hyperkeratosis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/49 (0%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | 643 --- --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.109N P=0.224N P=0.284N | |POLY 3 | (e) (e) (e) | P=0.105N P=0.234N P=0.262N | |POLY 1.5 | (e) (e) (e) | P=0.101N P=0.237N P=0.253N | |POLY 6 | (e) (e) (e) | P=0.108N P=0.230N P=0.274N | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.090N P=0.257N P=0.237N | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.096N P=0.253N P=0.247N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Thyroid Gland: C-Cell | | Hyperplasia | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/49 (4%) 0/50 (0%) | |POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 4.3% 0.0% | |TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/41 (0%) | 0/37 (0%) 1/40 (3%) 0/29 (0%) | |FIRST INCIDENCE | --- --- --- | --- 666 --- | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | (e) (e) (e) | P=0.628 P=0.256 (e) | |POLY 3 | (e) (e) (e) | P=0.632 P=0.244 (e) | |POLY 1.5 | (e) (e) (e) | P=0.645 P=0.239 (e) | |POLY 6 | (e) (e) (e) | P=0.617 P=0.249 (e) | |LOGISTIC REGRESSION| (e) (e) (e) | P=0.666 P=0.223 (e) | |COCH-ARM / FISHERS | (e) (e) (e) | P=0.668 P=0.242 (e) | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 19 Statistical Analysis of Non-neoplastic Lesions 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: Follicle | | Hyperplasia Focal | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | 18/50 (36%) 24/50 (48%) 36/50 (72%) | 38/50 (76%) 34/49 (69%) 36/50 (72%) | |POLY-3 ADJUSTED (b)| 39.9% 53.6% 77.7% | 80.5% 73.6% 83.9% | |TERMINAL (d) | 17/40 (43%) 22/37 (60%) 33/41 (81%) | 30/37 (81%) 32/40 (80%) 27/29 (93%) | |FIRST INCIDENCE | 670 717 560 | 562 666 583 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | P<0.001 ** P=0.083 P<0.001 ** | P=0.128 P=0.112N P=0.145 | |POLY 3 | P<0.001 ** P=0.134 P<0.001 ** | P=0.415 P=0.285N P=0.433 | |POLY 1.5 | P<0.001 ** P=0.139 P<0.001 ** | P=0.526 P=0.285N P=0.563 | |POLY 6 | P<0.001 ** P=0.128 P<0.001 ** | P=0.287 P=0.308N P=0.279 | |LOGISTIC REGRESSION| P<0.001 ** P=0.128 P<0.001 ** | P=0.297 P=0.137N P=0.347 | |COCH-ARM / FISHERS | P<0.001 ** P=0.156 P<0.001 ** | P=0.368N P=0.304N P=0.410N | |=================================================================================================================================| | | | | | | Males | Females | |Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 | | | MG/KG MG/KG | MG/KG MG/KG | |=================================================================================================================================| | | |Uterus | | Angiectasis | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 1/50 (2%) 1/49 (2%) 2/50 (4%) | |POLY-3 ADJUSTED (b)| | 2.2% 2.2% 4.9% | |TERMINAL (d) | | 1/37 (3%) 0/40 (0%) 0/29 (0%) | |FIRST INCIDENCE | | 736 (T) 656 615 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.325 P=0.741N P=0.442 | |POLY 3 | | P=0.363 P=0.754N P=0.470 | |POLY 1.5 | | P=0.368 P=0.758N P=0.479 | |POLY 6 | | P=0.359 P=0.748N P=0.459 | |LOGISTIC REGRESSION| | P=0.414 P=0.748 P=0.512 | |COCH-ARM / FISHERS | | P=0.379 P=0.747 P=0.500 | |=================================================================================================================================| Date: 08/01/97 EXPERIMENT: 55323 TEST: 04 Page 20 Statistical Analysis of Non-neoplastic Lesions 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 | |=================================================================================================================================| | | |Uterus: Endometrium | | Hyperplasia Cystic | | | | | |---------------------------------------------------------------------------------------------------------------------------------| |TUMOR RATES | | | |----------- | | | |OVERALL (a) | | 38/50 (76%) 46/49 (94%) 39/50 (78%) | |POLY-3 ADJUSTED (b)| | 82.1% 96.0% 87.0% | |TERMINAL (d) | | 34/37 (92%) 39/40 (98%) 28/29 (97%) | |FIRST INCIDENCE | | 602 574 457 | |-------------------| | | |STATISTICAL TESTS | | | |-------------------| | | |LIFE TABLE | | P=0.013 * P=0.163 P=0.025 * | |POLY 3 | | P=0.251 P=0.019 * P=0.349 | |POLY 1.5 | | P=0.297 P=0.014 * P=0.385 | |POLY 6 | | P=0.206 P=0.035 * P=0.309 | |LOGISTIC REGRESSION| | P=0.081 P=0.029 * P=0.137 | |COCH-ARM / FISHERS | | P=0.448 P=0.013 * 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).