TDMS Study 55323-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 07/28/97
EXPERIMENT: 55323 TEST: 03 TIME: 14:26:32
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B
PATHOLOGIST: J. YARRINGTON CAS: 120-40-1
Rats(FISCHER344)
-----------------------------
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: 07/28/97
EXPERIMENT: 55323 TEST: 03 TIME: 14:26:32
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B
PATHOLOGIST: J. YARRINGTON CAS: 120-40-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF LAURIC ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Accessory Adrenal Cortical Nodule
Hyperplasia
Intestine Large, Colon Parasite Metazoan
Lung Mineralization
Mesentery: Fat Inflammation Chronic
Mineralization
Nose Inflammation
Pancreas: Acinus Atrophy
Preputial Gland Inflammation Chronic
Skin: Epidermis, Skin, Site of ApplicatHyperplasia
Skin: Sebaceous Gland, Skin, Site of ApHyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Inflammation Chronic
Parakeratosis
Ulcer
Stomach, Forestomach Ulcer
Thymus Atrophy
Thyroid Gland: Follicle Cyst
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral Gland Inflammation Chronic
Heart: Myocardium Inflammation Chronic
Liver Inflammation Chronic
Lung Inflammation Chronic
Lymph Node, Mesenteric Pigmentation Lipofuscin
Skin: Epidermis, Skin, Site of ApplicatHyperplasia
Skin: Sebaceous Gland, Skin, Site of ApHyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Inflammation Chronic
Parakeratosis
Ulcer
Spleen Thrombosis
Stomach, Glandular Erosion
===============================================================
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 6/50 (12%) | 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.6% 18.3% 15.4% | 5.1% 5.0% 8.2% |
|TERMINAL (d) | 1/12 (8%) 4/18 (22%) 3/16 (19%) | 2/28 (7%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) 614 527 | 729 (T) 458 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.098 P=0.064 P=0.106 | P=0.323 P=0.678 P=0.402 |
|POLY 3 | P=0.063 P=0.029 * P=0.058 | P=0.384 P=0.690N P=0.469 |
|POLY 1.5 | P=0.058 P=0.029 * P=0.055 | P=0.390 P=0.689N P=0.477 |
|POLY 6 | P=0.077 P=0.030 * P=0.067 | P=0.378 P=0.694 P=0.461 |
|LOGISTIC REGRESSION| P=0.065 P=0.030 * P=0.061 | P=0.384 P=0.695N P=0.454 |
|COCH-ARM / FISHERS | P=0.061 P=0.030 * P=0.056 | P=0.406 P=0.691N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 5.1% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 2/28 (7%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.118N P=0.254N P=0.292N |
|POLY 3 | (e) (e) (e) | P=0.101N P=0.238N P=0.254N |
|POLY 1.5 | (e) (e) (e) | P=0.099N P=0.236N P=0.249N |
|POLY 6 | (e) (e) (e) | P=0.103N P=0.243N P=0.260N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.118N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 5.0% 5.1% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 1/28 (4%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- --- | 499 605 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.455N P=0.678 P=0.561N |
|POLY 3 | (e) (e) (e) | P=0.433N P=0.690 P=0.533N |
|POLY 1.5 | (e) (e) (e) | P=0.419N P=0.694 P=0.522N |
|POLY 6 | (e) (e) (e) | P=0.447N P=0.682 P=0.544N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.397N P=0.693 P=0.506N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.390N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 7.8% | 2.5% 5.1% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 1/16 (6%) | 1/28 (4%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- 703 | 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 (e) P=0.182 | P=0.546 P=0.474 P=0.708 |
|POLY 3 | P=0.035 * (e) P=0.119 | P=0.596 P=0.498 P=0.744 |
|POLY 1.5 | P=0.035 * (e) P=0.117 | P=0.603 P=0.501 P=0.749 |
|POLY 6 | P=0.037 * (e) P=0.126 | P=0.588 P=0.489 P=0.739 |
|LOGISTIC REGRESSION| P=0.046 * (e) P=0.145 | P=0.546 P=0.474 P=0.708 |
|COCH-ARM / FISHERS | P=0.037 * (e) P=0.121 | P=0.622 P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 21/50 (42%) 22/50 (44%) | 5/50 (10%) 4/50 (8%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 45.1% 50.0% 53.3% | 12.4% 10.2% 19.2% |
|TERMINAL (d) | 3/12 (25%) 9/18 (50%) 9/16 (56%) | 3/28 (11%) 3/26 (12%) 6/22 (27%) |
|FIRST INCIDENCE | 500 485 513 | 374 645 703 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.559 P=0.562N | P=0.198 P=0.539N P=0.245 |
|POLY 3 | P=0.254 P=0.406 P=0.291 | P=0.262 P=0.515N P=0.307 |
|POLY 1.5 | P=0.259 P=0.412 P=0.295 | P=0.278 P=0.505N P=0.330 |
|POLY 6 | P=0.260 P=0.395 P=0.302 | P=0.246 P=0.532N P=0.286 |
|LOGISTIC REGRESSION| P=0.295 P=0.406 P=0.337 | P=0.262 P=0.500N P=0.325 |
|COCH-ARM / FISHERS | P=0.306 P=0.419 P=0.342 | P=0.314 P=0.500N P=0.380 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 10.5% 5.4% 2.6% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 2/12 (17%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 626 658 717 | --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.258N P=0.121N | P=0.237 (e) P=0.452 |
|POLY 3 | P=0.116N P=0.347N P=0.177N | P=0.273 (e) P=0.485 |
|POLY 1.5 | P=0.121N P=0.344N P=0.182N | P=0.272 (e) P=0.489 |
|POLY 6 | P=0.109N P=0.346N P=0.166N | P=0.274 (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.103N P=0.340N P=0.155N | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.118N P=0.339N P=0.181N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 5.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 717 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137 (e) P=0.344 | (e) (e) (e) |
|POLY 3 | P=0.095 (e) P=0.238 | (e) (e) (e) |
|POLY 1.5 | P=0.094 (e) P=0.235 | (e) (e) (e) |
|POLY 6 | P=0.098 (e) P=0.247 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.111 (e) P=0.272 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.619 P=0.221 (e) |
|POLY 3 | (e) (e) (e) | P=0.642 P=0.235 (e) |
|POLY 1.5 | (e) (e) (e) | P=0.650 P=0.238 (e) |
|POLY 6 | (e) (e) (e) | P=0.634 P=0.229 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.221 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 489 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.663 P=0.258 (e) |
|POLY 3 | (e) (e) (e) | P=0.642 P=0.242 (e) |
|POLY 1.5 | (e) (e) (e) | P=0.650 P=0.242 (e) |
|POLY 6 | (e) (e) (e) | P=0.634 P=0.240 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.609N P=0.202 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 4/49 (8%) 0/48 (0%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| | 10.4% 0.0% 2.9% |
|TERMINAL (d) | | 3/27 (11%) 0/25 (0%) 0/21 (0%) |
|FIRST INCIDENCE | | 707 --- 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.113N P=0.071N P=0.247N |
|POLY 3 | | P=0.089N P=0.061N P=0.208N |
|POLY 1.5 | | P=0.087N P=0.061N P=0.201N |
|POLY 6 | | P=0.090N P=0.064N P=0.213N |
|LOGISTIC REGRESSION| | P=0.098N P=0.067N P=0.217N |
|COCH-ARM / FISHERS | | P=0.085N P=0.061N P=0.187N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 30/49 (61%) 34/48 (71%) 36/48 (75%) |
|POLY-3 ADJUSTED (b)| | 67.9% 76.0% 81.9% |
|TERMINAL (d) | | 15/27 (56%) 22/25 (88%) 18/21 (86%) |
|FIRST INCIDENCE | | 416 238 36 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.035 * P=0.218 P=0.053 |
|POLY 3 | | P=0.072 P=0.264 P=0.092 |
|POLY 1.5 | | P=0.087 P=0.273 P=0.107 |
|POLY 6 | | P=0.048 * P=0.209 P=0.067 |
|LOGISTIC REGRESSION| | P=0.078 P=0.223 P=0.093 |
|COCH-ARM / FISHERS | | P=0.087 P=0.217 P=0.108 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye: Lens |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 1/1 (100%) 1/2 (50%) | 1/1 (100%) 0/1 (0%) 3/6 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 52.7% | 100.0% 0.0% 58.3% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 1/2 (50%) |
|FIRST INCIDENCE | --- 626 670 | 707 --- 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.329 P=0.514N P=0.457 |
|POLY 3 | (e) (e) (e) | P=0.542N P=1.000 P=0.631N |
|POLY 1.5 | (e) (e) (e) | P=0.509N P=1.000 P=0.608N |
|POLY 6 | (e) (e) (e) | P=0.571N P=1.000 P=0.646N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.411N (e) P=0.621N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.500N P=0.500N P=0.571N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 5.2% | 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/21 (0%) |
|FIRST INCIDENCE | 618 --- 717 | --- 728 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545N P=0.237N P=0.601N | P=0.701 P=0.493 (e) |
|POLY 3 | P=0.622 P=0.243N P=0.694 | P=0.713 P=0.499 (e) |
|POLY 1.5 | P=0.620 P=0.241N P=0.689 | P=0.718 P=0.501 (e) |
|POLY 6 | P=0.619N P=0.245N P=0.686N | P=0.708 P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.610N P=0.240N P=0.684N | P=0.708 P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | P=0.728 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 39/50 (78%) 41/50 (82%) | 27/50 (54%) 31/50 (62%) 35/49 (71%) |
|POLY-3 ADJUSTED (b)| 76.9% 86.6% 85.6% | 62.9% 72.2% 82.4% |
|TERMINAL (d) | 9/12 (75%) 18/18 (100%) 14/16 (88%) | 18/28 (64%) 20/26 (77%) 19/21 (91%) |
|FIRST INCIDENCE | 500 526 266 | 471 458 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523N P=0.461N P=0.549N | P=0.007 ** P=0.200 P=0.010 * |
|POLY 3 | P=0.140 P=0.149 P=0.192 | P=0.020 * P=0.234 P=0.028 * |
|POLY 1.5 | P=0.121 P=0.216 P=0.161 | P=0.027 * P=0.264 P=0.034 * |
|POLY 6 | P=0.183 P=0.084 P=0.247 | P=0.013 * P=0.179 P=0.020 * |
|LOGISTIC REGRESSION| P=0.116 P=0.280 P=0.167 | P=0.015 * P=0.261 P=0.023 * |
|COCH-ARM / FISHERS | P=0.141 P=0.322 P=0.171 | P=0.046 * P=0.272 P=0.056 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 0/50 (0%) 0/46 (0%) | 2/45 (4%) 4/46 (9%) 3/43 (7%) |
|POLY-3 ADJUSTED (b)| 10.7% 0.0% 0.0% | 5.5% 10.6% 8.8% |
|TERMINAL (d) | 2/12 (17%) 0/18 (0%) 0/16 (0%) | 2/28 (7%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 609 --- --- | 729 (T) 605 507 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010N* P=0.043N* P=0.047N* | P=0.334 P=0.312 P=0.410 |
|POLY 3 | P=0.014N* P=0.060N P=0.068N | P=0.387 P=0.358 P=0.473 |
|POLY 1.5 | P=0.015N* P=0.059N P=0.071N | P=0.387 P=0.360 P=0.473 |
|POLY 6 | P=0.014N* P=0.060N P=0.063N | P=0.386 P=0.350 P=0.473 |
|LOGISTIC REGRESSION| P=0.015N* P=0.061N P=0.067N | P=0.384 P=0.349 P=0.468 |
|COCH-ARM / FISHERS | P=0.016N* P=0.056N P=0.067N | P=0.394 P=0.349 P=0.478 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/49 (4%) 5/47 (11%) | 2/42 (5%) 2/45 (4%) 1/43 (2%) |
|POLY-3 ADJUSTED (b)| 5.6% 5.5% 13.6% | 5.6% 5.5% 3.1% |
|TERMINAL (d) | 2/12 (17%) 2/18 (11%) 2/16 (13%) | 1/28 (4%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 583 | 640 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 P=0.543N P=0.297 | P=0.472N P=0.658 P=0.576N |
|POLY 3 | P=0.146 P=0.692N P=0.221 | P=0.431N P=0.690N P=0.531N |
|POLY 1.5 | P=0.139 P=0.691N P=0.208 | P=0.414N P=0.679N P=0.518N |
|POLY 6 | P=0.164 P=0.690N P=0.249 | P=0.451N P=0.683 P=0.546N |
|LOGISTIC REGRESSION| P=0.155 P=0.543N P=0.217 | P=0.426N P=0.693N P=0.525N |
|COCH-ARM / FISHERS | P=0.139 P=0.684N P=0.209 | P=0.381N P=0.665N P=0.491N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 6/50 (12%) | 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 18.1% 10.6% 15.7% | 5.1% 0.0% 5.5% |
|TERMINAL (d) | 3/12 (25%) 2/18 (11%) 4/16 (25%) | 2/28 (7%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 641 613 703 | 729 (T) --- 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.182N P=0.323N | P=0.557 P=0.254N P=0.619 |
|POLY 3 | P=0.443N P=0.271N P=0.508N | P=0.616 P=0.238N P=0.669 |
|POLY 1.5 | P=0.449N P=0.268N P=0.515N | P=0.618 P=0.236N P=0.676 |
|POLY 6 | P=0.428N P=0.269N P=0.491N | P=0.614 P=0.243N P=0.662 |
|LOGISTIC REGRESSION| P=0.377N P=0.265N P=0.417N | P=0.587 (e) P=0.656 |
|COCH-ARM / FISHERS | P=0.437N P=0.262N P=0.500N | P=0.622 P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% | 0.0% 0.0% 5.4% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 565 --- --- | --- --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N P=0.519N P=0.514N | P=0.083 (e) P=0.213 |
|POLY 3 | P=0.271N P=0.507N P=0.501N | P=0.094 (e) P=0.224 |
|POLY 1.5 | P=0.273N P=0.504N P=0.504N | P=0.094 (e) P=0.228 |
|POLY 6 | P=0.270N P=0.508N P=0.496N | P=0.093 (e) P=0.221 |
|LOGISTIC REGRESSION| P=0.216N P=0.446N P=0.452N | P=0.105 (e) P=0.250 |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.095 (e) P=0.247 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) | 24/50 (48%) 23/50 (46%) 27/50 (54%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 7.6% | 53.0% 49.4% 58.5% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 15/28 (54%) 7/26 (27%) 9/22 (41%) |
|FIRST INCIDENCE | 624 625 513 | 322 238 36 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230 P=0.750 P=0.352 | P=0.174 P=0.552N P=0.176 |
|POLY 3 | P=0.208 P=0.757 P=0.314 | P=0.333 P=0.445N P=0.374 |
|POLY 1.5 | P=0.202 P=0.758 P=0.305 | P=0.321 P=0.464N P=0.360 |
|POLY 6 | P=0.221 P=0.759 P=0.332 | P=0.363 P=0.409N P=0.409 |
|LOGISTIC REGRESSION| P=0.224 P=0.753N P=0.333 | P=0.393 P=0.509N P=0.417 |
|COCH-ARM / FISHERS | P=0.202 P=0.753N P=0.309 | P=0.309 P=0.500N P=0.345 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 40/50 (80%) 40/50 (80%) | 40/50 (80%) 41/50 (82%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 91.4% 89.3% 90.3% | 91.3% 91.4% 93.3% |
|TERMINAL (d) | 12/12 (100%) 18/18 (100%) 16/16 (100%) | 28/28 (100%) 26/26 (100%) 22/22 (100%) |
|FIRST INCIDENCE | 509 485 522 | 475 489 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N P=0.181N P=0.142N | P=0.101 P=0.324 P=0.115 |
|POLY 3 | P=0.497N P=0.510N P=0.590N | P=0.430 P=0.676 P=0.528 |
|POLY 1.5 | P=0.477N P=0.453N P=0.550N | P=0.456 P=0.621 P=0.533 |
|POLY 6 | P=0.484N P=0.643N P=0.623N | P=0.419 P=0.701 P=0.553 |
|LOGISTIC REGRESSION| P=0.395N P=0.549N P=0.455N | P=0.248 P=0.612 P=0.313 |
|COCH-ARM / FISHERS | P=0.350N P=0.398N P=0.398N | P=0.550 P=0.500 P=0.598N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.3% 5.4% 0.0% | 5.0% 5.1% 5.5% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 0/16 (0%) | 1/28 (4%) 1/26 (4%) 2/22 (9%) |
|FIRST INCIDENCE | 710 729 (T) --- | 564 717 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122N P=0.583N P=0.189N | P=0.527 P=0.684 P=0.623 |
|POLY 3 | P=0.174N P=0.688 P=0.235N | P=0.570 P=0.688 P=0.662 |
|POLY 1.5 | P=0.179N P=0.689 P=0.239N | P=0.579 P=0.693 P=0.672 |
|POLY 6 | P=0.164N P=0.689 P=0.226N | P=0.558 P=0.677 P=0.650 |
|LOGISTIC REGRESSION| P=0.129N P=0.658N P=0.199N | P=0.568 P=0.694 P=0.672 |
|COCH-ARM / FISHERS | P=0.176N P=0.691N P=0.247N | P=0.601 P=0.691N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.2% 2.7% 2.6% | 5.1% 10.1% 5.5% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 2/28 (7%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 589 526 589 | 729 (T) 645 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379N P=0.511N P=0.496N | P=0.492 P=0.308 P=0.607 |
|POLY 3 | P=0.379N P=0.508N P=0.500N | P=0.547 P=0.338 P=0.667 |
|POLY 1.5 | P=0.383N P=0.505N P=0.505N | P=0.559 P=0.341 P=0.675 |
|POLY 6 | P=0.371N P=0.510N P=0.489N | P=0.535 P=0.331 P=0.658 |
|LOGISTIC REGRESSION| P=0.311N P=0.443N P=0.467N | P=0.538 P=0.322 P=0.607 |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | P=0.588 P=0.339 P=0.691N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.5% 7.6% 5.5% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 1/28 (4%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) 534 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.320 P=0.293 P=0.415 |
|POLY 3 | (e) (e) (e) | P=0.366 P=0.307 P=0.473 |
|POLY 1.5 | (e) (e) (e) | P=0.376 P=0.309 P=0.481 |
|POLY 6 | (e) (e) (e) | P=0.355 P=0.301 P=0.465 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.367 P=0.304 P=0.415 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.399 P=0.309 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% | 0.0% 7.7% 5.5% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 3/26 (12%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) --- --- | --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N P=0.419N P=0.443N | P=0.140 P=0.107 P=0.186 |
|POLY 3 | P=0.270N P=0.504N P=0.499N | P=0.176 P=0.116 P=0.220 |
|POLY 1.5 | P=0.272N P=0.503N P=0.502N | P=0.183 P=0.119 P=0.225 |
|POLY 6 | P=0.271N P=0.503N P=0.491N | P=0.168 P=0.112 P=0.214 |
|LOGISTIC REGRESSION| P=0.225N (e) (e) | (e) P=0.107 P=0.186 |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.202 P=0.121 P=0.247 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 6/50 (12%) | 12/50 (24%) 17/50 (34%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 13.0% 20.5% 15.7% | 28.0% 39.5% 30.5% |
|TERMINAL (d) | 1/12 (8%) 4/18 (22%) 4/16 (25%) | 5/28 (18%) 11/26 (42%) 7/22 (32%) |
|FIRST INCIDENCE | 641 500 719 | 374 238 347 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.378 P=0.577N | P=0.357 P=0.178 P=0.422 |
|POLY 3 | P=0.431 P=0.279 P=0.494 | P=0.429 P=0.182 P=0.497 |
|POLY 1.5 | P=0.425 P=0.277 P=0.487 | P=0.472 P=0.195 P=0.533 |
|POLY 6 | P=0.449 P=0.289 P=0.510 | P=0.374 P=0.157 P=0.452 |
|LOGISTIC REGRESSION| P=0.460 P=0.267 P=0.586 | P=0.525N P=0.183 P=0.580N |
|COCH-ARM / FISHERS | P=0.440 P=0.277 P=0.500 | P=0.545 P=0.189 P=0.592N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 3/50 (6%) | 13/50 (26%) 15/50 (30%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 15.2% 10.7% 7.8% | 30.8% 35.3% 10.9% |
|TERMINAL (d) | 2/12 (17%) 3/18 (17%) 2/16 (13%) | 8/28 (29%) 9/26 (35%) 2/22 (9%) |
|FIRST INCIDENCE | 509 646 589 | 475 403 655 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121N P=0.247N P=0.172N | P=0.060N P=0.366 P=0.049N* |
|POLY 3 | P=0.192N P=0.400N P=0.249N | P=0.041N* P=0.416 P=0.028N* |
|POLY 1.5 | P=0.196N P=0.388N P=0.253N | P=0.030N* P=0.425 P=0.022N* |
|POLY 6 | P=0.180N P=0.411N P=0.235N | P=0.055N P=0.392 P=0.035N* |
|LOGISTIC REGRESSION| P=0.185N P=0.379N P=0.245N | P=0.022N* P=0.412 P=0.020N* |
|COCH-ARM / FISHERS | P=0.187N P=0.370N P=0.243N | P=0.019N* P=0.412 P=0.016N* |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.3% 0.0% 5.1% | 0.0% 10.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 680 --- 555 | --- 582 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N P=0.204N P=0.652N | P=0.578 P=0.062 (e) |
|POLY 3 | P=0.619N P=0.242N P=0.686N | P=0.578 P=0.061 (e) |
|POLY 1.5 | P=0.622 P=0.240N P=0.694 | P=0.592 P=0.062 (e) |
|POLY 6 | P=0.612N P=0.242N P=0.668N | P=0.564 P=0.060 (e) |
|LOGISTIC REGRESSION| P=0.621N P=0.235N P=0.694N | P=0.616 P=0.063 (e) |
|COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | P=0.622 P=0.059 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 14/50 (28%) 15/50 (30%) | 3/50 (6%) 6/50 (12%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 26.9% 34.6% 36.9% | 7.6% 15.2% 5.5% |
|TERMINAL (d) | 2/12 (17%) 6/18 (33%) 7/16 (44%) | 1/28 (4%) 4/26 (15%) 2/22 (9%) |
|FIRST INCIDENCE | 535 485 522 | 669 623 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353 P=0.440 P=0.396 | P=0.531N P=0.219 P=0.586N |
|POLY 3 | P=0.195 P=0.301 P=0.229 | P=0.491N P=0.236 P=0.540N |
|POLY 1.5 | P=0.193 P=0.309 P=0.225 | P=0.469N P=0.243 P=0.527N |
|POLY 6 | P=0.211 P=0.298 P=0.247 | P=0.516N P=0.223 P=0.555N |
|LOGISTIC REGRESSION| P=0.208 P=0.322 P=0.240 | P=0.479N P=0.229 P=0.546N |
|COCH-ARM / FISHERS | P=0.214 P=0.322 P=0.247 | P=0.424N P=0.243 P=0.500N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 6/50 (12%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.0% 15.6% 15.1% | 0.0% 2.5% 0.0% |
|TERMINAL (d) | 3/12 (25%) 1/18 (6%) 2/16 (13%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 565 626 513 | --- 605 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.445N P=0.390N | P=0.711 P=0.484 (e) |
|POLY 3 | P=0.421N P=0.505N P=0.481N | P=0.717 P=0.501 (e) |
|POLY 1.5 | P=0.440N P=0.506N P=0.500N | P=0.721 P=0.502 (e) |
|POLY 6 | P=0.385N P=0.491N P=0.443N | P=0.713 P=0.498 (e) |
|LOGISTIC REGRESSION| P=0.443N P=0.514N P=0.503N | P=0.721N P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.440N P=0.500N P=0.500N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 2.5% 7.8% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 634 361 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.055 P=0.472 P=0.111 |
|POLY 3 | (e) (e) (e) | P=0.057 P=0.500 P=0.113 |
|POLY 1.5 | (e) (e) (e) | P=0.058 P=0.502 P=0.114 |
|POLY 6 | (e) (e) (e) | P=0.057 P=0.497 P=0.112 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.086 P=0.498 P=0.159 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.060 P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% | 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 106 | --- --- 36 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270 (e) P=0.500 | P=0.092 (e) P=0.233 |
|POLY 3 | P=0.276 (e) P=0.507 | P=0.094 (e) P=0.230 |
|POLY 1.5 | P=0.272 (e) P=0.502 | P=0.094 (e) P=0.233 |
|POLY 6 | P=0.283 (e) P=0.516 | P=0.093 (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.205 (e) P=0.407 |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.095 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) | 2/50 (4%) 2/50 (4%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 2.6% 8.1% 10.2% | 5.1% 5.0% 21.8% |
|TERMINAL (d) | 1/12 (8%) 2/18 (11%) 0/16 (0%) | 2/28 (7%) 0/26 (0%) 7/22 (32%) |
|FIRST INCIDENCE | 729 (T) 719 589 | 729 (T) 605 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.456 P=0.223 | P=0.009 ** P=0.659 P=0.017 * |
|POLY 3 | P=0.142 P=0.297 P=0.188 | P=0.015 * P=0.691N P=0.032 * |
|POLY 1.5 | P=0.133 P=0.300 P=0.179 | P=0.017 * P=0.689N P=0.036 * |
|POLY 6 | P=0.162 P=0.297 P=0.208 | P=0.014 * P=0.694N P=0.029 * |
|LOGISTIC REGRESSION| P=0.139 P=0.371 P=0.178 | P=0.014 * P=0.695N P=0.028 * |
|COCH-ARM / FISHERS | P=0.133 P=0.309 P=0.181 | P=0.021 * P=0.691N P=0.046 * |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 22/50 (44%) 34/50 (68%) | 23/50 (46%) 18/50 (36%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 51.4% 52.2% 75.6% | 54.0% 42.8% 47.9% |
|TERMINAL (d) | 8/12 (67%) 11/18 (61%) 12/16 (75%) | 17/28 (61%) 10/26 (39%) 10/22 (46%) |
|FIRST INCIDENCE | 563 485 513 | 322 518 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 P=0.414N P=0.123 | P=0.511N P=0.300N P=0.573N |
|POLY 3 | P=0.007 ** P=0.560 P=0.010 * | P=0.314N P=0.202N P=0.367N |
|POLY 1.5 | P=0.005 ** P=0.531 P=0.006 ** | P=0.292N P=0.201N P=0.339N |
|POLY 6 | P=0.018 * P=0.597N P=0.029 * | P=0.336N P=0.207N P=0.396N |
|LOGISTIC REGRESSION| P=0.005 ** P=0.466 P=0.005 ** | P=0.295N P=0.202N P=0.336N |
|COCH-ARM / FISHERS | P=0.006 ** P=0.500 P=0.008 ** | P=0.237N P=0.208N P=0.272N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.4% 0.0% | 5.1% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 0/16 (0%) | 2/28 (7%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- | 729 (T) 717 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.618N P=0.330 (e) | P=0.222N P=0.674 P=0.292N |
|POLY 3 | P=0.667N P=0.232 (e) | P=0.200N P=0.693 P=0.254N |
|POLY 1.5 | P=0.666 P=0.234 (e) | P=0.193N P=0.693N P=0.249N |
|POLY 6 | P=0.654N P=0.231 (e) | P=0.208N P=0.685 P=0.260N |
|LOGISTIC REGRESSION| (e) P=0.330 (e) | P=0.202N P=0.683 (e) |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | P=0.176N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 2.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 618 --- 696 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341N P=0.248N P=0.471N | (e) (e) (e) |
|POLY 3 | P=0.361N P=0.244N P=0.501N | (e) (e) (e) |
|POLY 1.5 | P=0.364N P=0.241N P=0.505N | (e) (e) (e) |
|POLY 6 | P=0.357N P=0.245N P=0.490N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.360N P=0.239N P=0.500N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.247N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 2.6% | 0.0% 2.6% 2.7% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 1/16 (6%) | 0/28 (0%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 674 729 (T) 729 (T) | --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551N P=0.584 P=0.716N | P=0.281 P=0.485 P=0.452 |
|POLY 3 | P=0.621N P=0.491 P=0.761N | P=0.318 P=0.499 P=0.485 |
|POLY 1.5 | P=0.617 P=0.494 P=0.758 | P=0.323 P=0.501 P=0.489 |
|POLY 6 | P=0.610N P=0.490 P=0.754N | P=0.314 P=0.494 P=0.480 |
|LOGISTIC REGRESSION| P=0.578N P=0.507 P=0.748N | (e) P=0.485 P=0.452 |
|COCH-ARM / FISHERS | P=0.622 P=0.500 P=0.753N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Pigmentation Lipofuscin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.1% 11.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 2/26 (8%) 4/22 (18%) |
|FIRST INCIDENCE | --- --- --- | --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.019 * P=0.221 P=0.035 * |
|POLY 3 | (e) (e) (e) | P=0.030 * P=0.235 P=0.050 |
|POLY 1.5 | (e) (e) (e) | P=0.032 * P=0.238 P=0.053 |
|POLY 6 | (e) (e) (e) | P=0.028 * P=0.229 P=0.047 * |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.221 P=0.035 * |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.037 * P=0.247 P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 34/50 (68%) 31/49 (63%) | 35/50 (70%) 40/50 (80%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 61.6% 76.4% 72.0% | 79.8% 86.8% 77.7% |
|TERMINAL (d) | 4/12 (33%) 16/18 (89%) 11/16 (69%) | 23/28 (82%) 22/26 (85%) 16/22 (73%) |
|FIRST INCIDENCE | 509 526 513 | 322 458 507 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.390 P=0.508N | P=0.327 P=0.160 P=0.365 |
|POLY 3 | P=0.148 P=0.084 P=0.197 | P=0.475N P=0.253 P=0.513N |
|POLY 1.5 | P=0.171 P=0.109 P=0.216 | P=0.439N P=0.213 P=0.476N |
|POLY 6 | P=0.130 P=0.059 P=0.184 | P=0.457N P=0.309 P=0.501N |
|LOGISTIC REGRESSION| P=0.229 P=0.144 P=0.274 | P=0.454N P=0.184 P=0.507N |
|COCH-ARM / FISHERS | P=0.258 P=0.151 P=0.298 | P=0.290N P=0.178 P=0.335N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 9/49 (18%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 15.3% 17.8% 23.1% | 2.5% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 2/18 (11%) 2/16 (13%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 509 527 558 | 691 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332 P=0.567 P=0.406 | P=0.283N P=0.507N P=0.520N |
|POLY 3 | P=0.229 P=0.501 P=0.277 | P=0.284N P=0.502N P=0.516N |
|POLY 1.5 | P=0.219 P=0.498 P=0.265 | P=0.280N P=0.500N P=0.511N |
|POLY 6 | P=0.255 P=0.515 P=0.307 | P=0.289N P=0.508N P=0.522N |
|LOGISTIC REGRESSION| P=0.225 P=0.509 P=0.268 | P=0.278N P=0.501N P=0.514N |
|COCH-ARM / FISHERS | P=0.227 P=0.500 P=0.274 | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 5/49 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 20.9% 24.1% 13.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/12 (42%) 7/18 (39%) 3/16 (19%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 646 684 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095N P=0.430N P=0.133N | (e) (e) (e) |
|POLY 3 | P=0.249N P=0.475 P=0.287N | (e) (e) (e) |
|POLY 1.5 | P=0.262N P=0.484 P=0.298N | (e) (e) (e) |
|POLY 6 | P=0.221N P=0.470 P=0.263N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.141N P=0.543 P=0.186N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.253N P=0.500 P=0.290N | (e) (e) (e) |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 8/50 (16%) 5/49 (10%) | 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 13.1% 20.6% 13.1% | 5.0% 7.6% 5.5% |
|TERMINAL (d) | 3/12 (25%) 3/18 (17%) 2/16 (13%) | 1/28 (4%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | 654 527 557 | 617 623 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443N P=0.416 P=0.512N | P=0.515 P=0.463 P=0.630 |
|POLY 3 | P=0.558N P=0.282 P=0.631N | P=0.557 P=0.497 P=0.664 |
|POLY 1.5 | P=0.546 P=0.277 P=0.617 | P=0.568 P=0.502 P=0.673 |
|POLY 6 | P=0.516N P=0.298 P=0.600N | P=0.545 P=0.486 P=0.655 |
|LOGISTIC REGRESSION| P=0.546 P=0.262 P=0.628 | P=0.563 P=0.499 P=0.670 |
|COCH-ARM / FISHERS | P=0.547 P=0.277 P=0.617 | P=0.594 P=0.500 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/12 (100%) 6/8 (75%) 2/6 (33%) | 4/5 (80%) 1/2 (50%) 3/4 (75%) |
|POLY-3 ADJUSTED (b)| 100.0% 75.0% 36.5% | 97.9% 50.0% 84.7% |
|TERMINAL (d) | 2/2 (100%) 2/4 (50%) 1/3 (33%) | 0/0 (0%) 1/2 (50%) 1/1 (100%) |
|FIRST INCIDENCE | 509 526 689 | 669 729 (T) 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.051N P=0.002N** | P=0.335N P=0.076N P=0.411N |
|POLY 3 | P<0.001N** P=0.134N P<0.001N** | P=0.498N P=0.360N P=0.803N |
|POLY 1.5 | P<0.001N** P=0.134N P<0.001N** | P=0.496N P=0.419N P=0.717N |
|POLY 6 | P=0.002N** P=0.134N P<0.001N** | P=0.554N P=0.336N P=0.984N |
|LOGISTIC REGRESSION| P=0.005N** (e) P=0.008N** | P=0.404N P=0.292N (e) |
|COCH-ARM / FISHERS | P=0.002N** P=0.147N P=0.005N** | P=0.568N P=0.524N P=0.722N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/12 (50%) 4/8 (50%) 1/6 (17%) | 0/5 (0%) 0/2 (0%) 2/4 (50%) |
|POLY-3 ADJUSTED (b)| 62.1% 50.3% 18.8% | 0.0% 0.0% 51.8% |
|TERMINAL (d) | 2/2 (100%) 1/4 (25%) 1/3 (33%) | 0/0 (0%) 0/2 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 645 526 729 (T) | --- --- 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018N* P=0.239N P=0.017N* | P=0.084 (e) P=0.209 |
|POLY 3 | P=0.096N P=0.493N P=0.119N | P=0.094 (e) P=0.218 |
|POLY 1.5 | P=0.125N P=0.578N P=0.152N | P=0.079 (e) P=0.187 |
|POLY 6 | P=0.066N P=0.356N P=0.078N | P=0.113 (e) P=0.261 |
|LOGISTIC REGRESSION| P=0.134N P=0.651N P=0.047N* | P=0.062 (e) P=0.166 |
|COCH-ARM / FISHERS | P=0.165N P=0.675N P=0.199N | P=0.072 (e) P=0.167 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 3/50 (6%) | 4/50 (8%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 27.5% 13.3% 7.9% | 9.8% 2.5% 5.4% |
|TERMINAL (d) | 4/12 (33%) 3/18 (17%) 2/16 (13%) | 0/28 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 509 625 719 | 374 634 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005N** P=0.050N P=0.010N* | P=0.292N P=0.205N P=0.407N |
|POLY 3 | P=0.012N* P=0.099N P=0.021N* | P=0.268N P=0.189N P=0.387N |
|POLY 1.5 | P=0.012N* P=0.093N P=0.022N* | P=0.258N P=0.182N P=0.371N |
|POLY 6 | P=0.010N* P=0.105N P=0.019N* | P=0.279N P=0.199N P=0.403N |
|LOGISTIC REGRESSION| P=0.010N* P=0.090N P=0.020N* | P=0.227N P=0.187N P=0.326N |
|COCH-ARM / FISHERS | P=0.012N* P=0.086N P=0.020N* | P=0.238N P=0.181N P=0.339N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| | 7.5% 2.6% 2.7% |
|TERMINAL (d) | | 2/28 (7%) 1/26 (4%) 1/22 (5%) |
|FIRST INCIDENCE | | 564 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.255N P=0.321N P=0.377N |
|POLY 3 | | P=0.224N P=0.312N P=0.338N |
|POLY 1.5 | | P=0.217N P=0.306N P=0.327N |
|POLY 6 | | P=0.233N P=0.323N P=0.349N |
|LOGISTIC REGRESSION| | P=0.221N P=0.306N P=0.328N |
|COCH-ARM / FISHERS | | P=0.202N P=0.309N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 5/50 (10%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| | 12.5% 19.5% 13.1% |
|TERMINAL (d) | | 2/28 (7%) 5/26 (19%) 2/22 (9%) |
|FIRST INCIDENCE | | 654 403 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.442 P=0.243 P=0.527 |
|POLY 3 | | P=0.521 P=0.288 P=0.599 |
|POLY 1.5 | | P=0.533 P=0.290 P=0.608 |
|POLY 6 | | P=0.505 P=0.273 P=0.588 |
|LOGISTIC REGRESSION| | P=0.560N P=0.277 P=0.626 |
|COCH-ARM / FISHERS | | P=0.561 P=0.277 P=0.630N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 11/50 (22%) | 3/50 (6%) 5/50 (10%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 12.9% 13.0% 28.6% | 7.6% 12.4% 2.8% |
|TERMINAL (d) | 2/12 (17%) 2/18 (11%) 7/16 (44%) | 2/28 (7%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | 500 557 684 | 682 518 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117 P=0.531N P=0.200 | P=0.345N P=0.330 P=0.384N |
|POLY 3 | P=0.048 * P=0.627 P=0.073 | P=0.309N P=0.364 P=0.335N |
|POLY 1.5 | P=0.048 * P=0.625 P=0.074 | P=0.297N P=0.365 P=0.328N |
|POLY 6 | P=0.050 P=0.633N P=0.079 | P=0.325N P=0.356 P=0.345N |
|LOGISTIC REGRESSION| P=0.063 P=0.624 P=0.106 | P=0.291N P=0.356 P=0.345N |
|COCH-ARM / FISHERS | P=0.056 P=0.630N P=0.086 | P=0.272N P=0.357 P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/47 (34%) 17/45 (38%) 13/47 (28%) | 1/47 (2%) 0/40 (0%) 2/45 (4%) |
|POLY-3 ADJUSTED (b)| 40.7% 47.7% 34.3% | 2.7% 0.0% 6.0% |
|TERMINAL (d) | 3/12 (25%) 9/16 (56%) 4/16 (25%) | 0/26 (0%) 0/21 (0%) 2/21 (10%) |
|FIRST INCIDENCE | 565 485 642 | 669 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.154N P=0.526N P=0.185N | P=0.314 P=0.518N P=0.436 |
|POLY 3 | P=0.327N P=0.347 P=0.363N | P=0.346 P=0.538N P=0.461 |
|POLY 1.5 | P=0.327N P=0.389 P=0.362N | P=0.347 P=0.535N P=0.467 |
|POLY 6 | P=0.319N P=0.284 P=0.358N | P=0.344 P=0.543N P=0.457 |
|LOGISTIC REGRESSION| P=0.247N P=0.380 P=0.296N | P=0.334 P=0.533N P=0.462 |
|COCH-ARM / FISHERS | P=0.292N P=0.438 P=0.328N | P=0.351 P=0.540N P=0.484 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 8/50 (16%) 5/50 (10%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% | 19.4% 12.2% 8.2% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 4/28 (14%) 1/26 (4%) 3/22 (14%) |
|FIRST INCIDENCE | --- 618 --- | 499 522 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.722 P=0.494 (e) | P=0.122N P=0.307N P=0.175N |
|POLY 3 | P=0.729N P=0.498 (e) | P=0.101N P=0.273N P=0.138N |
|POLY 1.5 | P=0.728 P=0.498 (e) | P=0.090N P=0.270N P=0.123N |
|POLY 6 | P=0.722N P=0.501 (e) | P=0.115N P=0.283N P=0.157N |
|LOGISTIC REGRESSION| P=0.722N P=0.513 (e) | P=0.078N P=0.280N P=0.117N |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.077N P=0.277N P=0.106N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 4/50 (8%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.6% | 10.0% 0.0% 5.5% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 1/16 (6%) | 2/28 (7%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 625 729 (T) | 527 --- 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.357 P=0.494 P=0.557 | P=0.277N P=0.070N P=0.419N |
|POLY 3 | P=0.334 P=0.498 P=0.501 | P=0.240N P=0.063N P=0.382N |
|POLY 1.5 | P=0.330 P=0.498 P=0.498 | P=0.234N P=0.061N P=0.367N |
|POLY 6 | P=0.348 P=0.501 P=0.509 | P=0.247N P=0.067N P=0.398N |
|LOGISTIC REGRESSION| P=0.333 P=0.510 P=0.557 | P=0.241N P=0.063N P=0.367N |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.228N P=0.059N P=0.349N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.5% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 682 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.416N P=0.472 P=0.526N |
|POLY 3 | (e) (e) (e) | P=0.395N P=0.496 P=0.516N |
|POLY 1.5 | (e) (e) (e) | P=0.383N P=0.501 P=0.511N |
|POLY 6 | (e) (e) (e) | P=0.409N P=0.486 P=0.522N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.388N P=0.487 P=0.512N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.366N P=0.500 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.5% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 1/28 (4%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.424N P=0.474 P=0.548N |
|POLY 3 | (e) (e) (e) | P=0.393N P=0.498 P=0.515N |
|POLY 1.5 | (e) (e) (e) | P=0.382N P=0.501 P=0.511N |
|POLY 6 | (e) (e) (e) | P=0.404N P=0.489 P=0.520N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.424N P=0.474 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.366N P=0.500 P=0.505N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 46/50 (92%) 43/50 (86%) | |
|POLY-3 ADJUSTED (b)| 98.4% 94.4% 90.2% | |
|TERMINAL (d) | 12/12 (100%) 18/18 (100%) 15/16 (94%) | |
|FIRST INCIDENCE | 500 430 106 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073N P=0.179N P=0.074N | |
|POLY 3 | P=0.034N* P=0.268N P=0.058N | |
|POLY 1.5 | P=0.026N* P=0.220N P=0.042N* | |
|POLY 6 | P=0.057N P=0.390N P=0.109N | |
|LOGISTIC REGRESSION| P=0.023N* P=0.183N P=0.034N* | |
|COCH-ARM / FISHERS | P=0.021N* P=0.181N P=0.030N* | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 3/49 (6%) | |
|POLY-3 ADJUSTED (b)| 17.8% 13.2% 7.9% | |
|TERMINAL (d) | 1/12 (8%) 3/18 (17%) 0/16 (0%) | |
|FIRST INCIDENCE | 583 578 684 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.086N P=0.299N P=0.118N | |
|POLY 3 | P=0.129N P=0.403N P=0.168N | |
|POLY 1.5 | P=0.134N P=0.394N P=0.174N | |
|POLY 6 | P=0.119N P=0.413N P=0.157N | |
|LOGISTIC REGRESSION| P=0.124N P=0.389N P=0.164N | |
|COCH-ARM / FISHERS | P=0.128N P=0.380N P=0.167N | |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) | |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 5.3% | |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 0/16 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 583 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454 P=0.670N P=0.585 | |
|POLY 3 | P=0.378 P=0.757 P=0.499 | |
|POLY 1.5 | P=0.371 P=0.758 P=0.491 | |
|POLY 6 | P=0.395 P=0.759 P=0.517 | |
|LOGISTIC REGRESSION| P=0.382 P=0.670N P=0.494 | |
|COCH-ARM / FISHERS | P=0.372 P=0.753N P=0.492 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 29/50 (58%) 44/50 (88%) | 5/50 (10%) 33/50 (66%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 0.0% 67.0% 90.9% | 12.4% 69.2% 91.7% |
|TERMINAL (d) | 0/12 (0%) 13/18 (72%) 14/16 (88%) | 3/28 (11%) 15/26 (58%) 20/22 (91%) |
|FIRST INCIDENCE | --- 500 106 | 471 238 323 |
|-------------------| | |
|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: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 27/50 (54%) 44/50 (88%) | 3/50 (6%) 41/50 (82%) 45/50 (90%) |
|POLY-3 ADJUSTED (b)| 0.0% 65.2% 91.0% | 7.5% 84.0% 95.1% |
|TERMINAL (d) | 0/12 (0%) 14/18 (78%) 14/16 (88%) | 2/28 (7%) 22/26 (85%) 21/22 (96%) |
|FIRST INCIDENCE | --- 500 106 | 471 238 323 |
|-------------------| | |
|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 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 23/50 (46%) 25/50 (50%) | 0/50 (0%) 20/50 (40%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 0.0% 55.3% 57.7% | 0.0% 44.8% 64.3% |
|TERMINAL (d) | 0/12 (0%) 8/18 (44%) 10/16 (63%) | 0/28 (0%) 4/26 (15%) 10/22 (46%) |
|FIRST INCIDENCE | --- 430 106 | --- 518 323 |
|-------------------| | |
|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: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 10/50 (20%) 28/50 (56%) | 3/50 (6%) 35/50 (70%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 0.0% 25.6% 63.1% | 7.5% 74.8% 76.1% |
|TERMINAL (d) | 0/12 (0%) 3/18 (17%) 9/16 (56%) | 2/28 (7%) 18/26 (69%) 15/22 (68%) |
|FIRST INCIDENCE | --- 526 106 | 471 403 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.003 ** 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 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Parakeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 21/50 (42%) 33/50 (66%) | 2/50 (4%) 12/50 (24%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 49.3% 71.8% | 5.0% 28.2% 54.7% |
|TERMINAL (d) | 0/12 (0%) 7/18 (39%) 10/16 (63%) | 1/28 (4%) 4/26 (15%) 4/22 (18%) |
|FIRST INCIDENCE | --- 430 106 | 471 518 323 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.007 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.005 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 25/50 (50%) | 3/50 (6%) 2/50 (4%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.4% 56.2% | 7.5% 5.1% 25.2% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 7/16 (44%) | 2/28 (7%) 1/26 (4%) 4/22 (18%) |
|FIRST INCIDENCE | --- 544 106 | 471 696 427 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.060 P<0.001 ** | P=0.009 ** P=0.515N P=0.023 * |
|POLY 3 | P<0.001 ** P=0.061 P<0.001 ** | P=0.012 * P=0.510N P=0.030 * |
|POLY 1.5 | P<0.001 ** P=0.060 P<0.001 ** | P=0.012 * P=0.503N P=0.030 * |
|POLY 6 | P<0.001 ** P=0.064 P<0.001 ** | P=0.012 * P=0.523N P=0.031 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.066 P<0.001 ** | P=0.015 * P=0.499N P=0.039 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P<0.001 ** | P=0.015 * P=0.500N P=0.036 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 20.7% 13.1% 13.0% | 2.5% 2.5% 2.7% |
|TERMINAL (d) | 5/12 (42%) 1/18 (6%) 4/16 (25%) | 1/28 (4%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 506 625 603 | 729 (T) 575 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130N P=0.176N P=0.136N | P=0.595 P=0.760 P=0.708 |
|POLY 3 | P=0.216N P=0.278N P=0.272N | P=0.624 P=0.760N P=0.744 |
|POLY 1.5 | P=0.227N P=0.281N P=0.284N | P=0.628 P=0.758N P=0.749 |
|POLY 6 | P=0.195N P=0.261N P=0.245N | P=0.620 P=0.759 P=0.739 |
|LOGISTIC REGRESSION| P=0.200N P=0.285N P=0.235N | P=0.627 P=0.762 P=0.708 |
|COCH-ARM / FISHERS | P=0.221N P=0.277N P=0.277N | P=0.640 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 7.6% 7.9% 7.8% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 500 578 696 | --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.533N P=0.646 P=0.603N | P=0.237 (e) P=0.452 |
|POLY 3 | P=0.572 P=0.650 P=0.652 | P=0.273 (e) P=0.485 |
|POLY 1.5 | P=0.570 P=0.653 P=0.650 | P=0.272 (e) P=0.489 |
|POLY 6 | P=0.580 P=0.650 P=0.661 | P=0.274 (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.576N P=0.621N P=0.660N | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.583 P=0.661N P=0.661N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 7.5% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 1/28 (4%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 527 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.046N* P=0.128N P=0.150N |
|POLY 3 | (e) (e) (e) | P=0.039N* P=0.123N P=0.136N |
|POLY 1.5 | (e) (e) (e) | P=0.038N* P=0.120N P=0.130N |
|POLY 6 | (e) (e) (e) | P=0.041N* P=0.129N P=0.143N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.037N* P=0.121N P=0.122N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.037N* P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 5.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118 (e) P=0.278 | (e) (e) (e) |
|POLY 3 | P=0.095 (e) P=0.239 | (e) (e) (e) |
|POLY 1.5 | P=0.094 (e) P=0.235 | (e) (e) (e) |
|POLY 6 | P=0.099 (e) P=0.249 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.104 (e) P=0.253 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 2.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 670 729 (T) 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.580 P=0.728N | (e) (e) (e) |
|POLY 3 | P=0.620N P=0.491 P=0.761N | (e) (e) (e) |
|POLY 1.5 | P=0.617 P=0.494 P=0.758 | (e) (e) (e) |
|POLY 6 | P=0.608N P=0.490 P=0.753N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.590N P=0.505 P=0.758N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.622 P=0.500 P=0.753N | (e) (e) (e) |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 589 729 (T) --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310N P=0.591 P=0.500N | (e) (e) (e) |
|POLY 3 | P=0.363N P=0.489 P=0.501N | (e) (e) (e) |
|POLY 1.5 | P=0.368N P=0.493 P=0.503N | (e) (e) (e) |
|POLY 6 | P=0.351N P=0.486 P=0.495N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.356N P=0.494 P=0.469N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.500 P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 6/50 (12%) 7/50 (14%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 24.1% 15.4% 17.8% | 0.0% 5.0% 5.4% |
|TERMINAL (d) | 0/12 (0%) 2/18 (11%) 2/16 (13%) | 0/28 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 506 485 522 | --- 575 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207N P=0.221N P=0.246N | P=0.159 P=0.245 P=0.208 |
|POLY 3 | P=0.271N P=0.239N P=0.334N | P=0.161 P=0.241 P=0.222 |
|POLY 1.5 | P=0.267N P=0.225N P=0.328N | P=0.165 P=0.241 P=0.226 |
|POLY 6 | P=0.272N P=0.258N P=0.336N | P=0.158 P=0.239 P=0.219 |
|LOGISTIC REGRESSION| P=0.229N P=0.173N P=0.286N | P=0.184 P=0.225 P=0.230 |
|COCH-ARM / FISHERS | P=0.244N P=0.207N P=0.298N | P=0.176 P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 3/50 (6%) | 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 26.4% 12.6% 7.8% | 5.0% 5.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 506 527 689 | 669 534 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014N* P=0.116N P=0.021N* | P=0.420N P=0.687 P=0.538N |
|POLY 3 | P=0.014N* P=0.097N P=0.026N* | P=0.423N P=0.690N P=0.526N |
|POLY 1.5 | P=0.013N* P=0.092N P=0.025N* | P=0.414N P=0.689N P=0.518N |
|POLY 6 | P=0.015N* P=0.102N P=0.028N* | P=0.433N P=0.694 P=0.533N |
|LOGISTIC REGRESSION| P=0.009N** P=0.057N P=0.020N* | P=0.374N P=0.690 P=0.509N |
|COCH-ARM / FISHERS | P=0.012N* P=0.086N P=0.020N* | P=0.390N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 0.0% | 7.3% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 680 --- --- | 322 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255N P=0.517N P=0.470N | P=0.041N* P=0.120N P=0.136N |
|POLY 3 | P=0.270N P=0.505N P=0.500N | P=0.041N* P=0.127N P=0.141N |
|POLY 1.5 | P=0.272N P=0.503N P=0.503N | P=0.039N* P=0.122N P=0.135N |
|POLY 6 | P=0.270N P=0.506N P=0.493N | P=0.043N* P=0.134N P=0.148N |
|LOGISTIC REGRESSION| P=0.268N P=0.503N P=0.498N | P=0.026N* P=0.136N P=0.089N |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.038N* P=0.121N P=0.125N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 0.0% 7.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 618 --- 717 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234 P=0.506N P=0.412 | (e) (e) (e) |
|POLY 3 | P=0.174 P=0.506N P=0.304 | (e) (e) (e) |
|POLY 1.5 | P=0.173 P=0.504N P=0.300 | (e) (e) (e) |
|POLY 6 | P=0.178 P=0.507N P=0.315 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.187 P=0.487N P=0.321 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.176 P=0.500N P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 16/50 (32%) 17/50 (34%) | |
|POLY-3 ADJUSTED (b)| 36.7% 40.6% 43.5% | |
|TERMINAL (d) | 3/12 (25%) 10/18 (56%) 9/16 (56%) | |
|FIRST INCIDENCE | 563 485 555 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.459N P=0.476N | |
|POLY 3 | P=0.299 P=0.445 P=0.342 | |
|POLY 1.5 | P=0.320 P=0.471 P=0.360 | |
|POLY 6 | P=0.272 P=0.403 P=0.318 | |
|LOGISTIC REGRESSION| P=0.409 P=0.472 P=0.461 | |
|COCH-ARM / FISHERS | P=0.374 P=0.500 P=0.415 | |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 5/50 (10%) | |
|POLY-3 ADJUSTED (b)| 5.2% 10.7% 13.0% | |
|TERMINAL (d) | 0/12 (0%) 3/18 (17%) 2/16 (13%) | |
|FIRST INCIDENCE | 634 663 695 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249 P=0.410 P=0.309 | |
|POLY 3 | P=0.165 P=0.322 P=0.212 | |
|POLY 1.5 | P=0.162 P=0.328 P=0.209 | |
|POLY 6 | P=0.175 P=0.318 P=0.223 | |
|LOGISTIC REGRESSION| P=0.196 P=0.329 P=0.238 | |
|COCH-ARM / FISHERS | P=0.169 P=0.339 P=0.218 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 7/50 (14%) | |
|POLY-3 ADJUSTED (b)| 10.5% 16.0% 17.9% | |
|TERMINAL (d) | 2/12 (17%) 4/18 (22%) 3/16 (19%) | |
|FIRST INCIDENCE | 654 626 603 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.522 P=0.395 | |
|POLY 3 | P=0.222 P=0.356 P=0.269 | |
|POLY 1.5 | P=0.211 P=0.361 P=0.257 | |
|POLY 6 | P=0.250 P=0.358 P=0.298 | |
|LOGISTIC REGRESSION| P=0.247 P=0.367 P=0.288 | |
|COCH-ARM / FISHERS | P=0.215 P=0.370 P=0.262 | |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 7.8% 5.2% 10.4% | |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 3/16 (19%) | |
|FIRST INCIDENCE | 563 544 642 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.522N P=0.587 | |
|POLY 3 | P=0.414 P=0.505N P=0.497 | |
|POLY 1.5 | P=0.410 P=0.504N P=0.491 | |
|POLY 6 | P=0.427 P=0.503N P=0.514 | |
|LOGISTIC REGRESSION| P=0.414 P=0.472N P=0.510 | |
|COCH-ARM / FISHERS | P=0.417 P=0.500N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/44 (16%) 0/50 (0%) 0/47 (0%) | 2/44 (5%) 1/49 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 20.0% 0.0% 0.0% | 5.6% 2.6% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/18 (0%) 0/15 (0%) | 0/24 (0%) 0/25 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 626 --- --- | 499 582 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.012N* P=0.007N** | P=0.153N P=0.497N P=0.259N |
|POLY 3 | P<0.001N** P=0.005N** P=0.006N** | P=0.144N P=0.470N P=0.238N |
|POLY 1.5 | P<0.001N** P=0.005N** P=0.006N** | P=0.138N P=0.465N P=0.232N |
|POLY 6 | P<0.001N** P=0.005N** P=0.006N** | P=0.150N P=0.480N P=0.245N |
|LOGISTIC REGRESSION| P<0.001N** P=0.006N** P=0.007N** | P=0.108N P=0.474N P=0.197N |
|COCH-ARM / FISHERS | P<0.001N** P=0.004N** P=0.005N** | P=0.126N P=0.459N P=0.226N |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) | 2/50 (4%) 5/50 (10%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.8% 0.0% 7.9% | 5.1% 12.5% 8.2% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 3/16 (19%) | 2/28 (7%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 646 --- 729 (T) | 729 (T) 623 724 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.134N P=0.572N | P=0.325 P=0.189 P=0.399 |
|POLY 3 | P=0.600 P=0.124N P=0.660 | P=0.374 P=0.220 P=0.465 |
|POLY 1.5 | P=0.599 P=0.122N P=0.655 | P=0.388 P=0.221 P=0.475 |
|POLY 6 | P=0.600N P=0.125N P=0.660N | P=0.360 P=0.217 P=0.454 |
|LOGISTIC REGRESSION| P=0.572N P=0.123N P=0.632N | P=0.372 P=0.211 P=0.431 |
|COCH-ARM / FISHERS | P=0.601 P=0.121N P=0.661N | P=0.421 P=0.218 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.4% 0.0% 5.2% | 0.0% 2.6% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 634 --- 695 | --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.047N* P=0.256N | P=0.699 P=0.485 (e) |
|POLY 3 | P=0.219N P=0.063N P=0.337N | P=0.717 P=0.499 (e) |
|POLY 1.5 | P=0.223N P=0.062N P=0.344N | P=0.721 P=0.501 (e) |
|POLY 6 | P=0.214N P=0.063N P=0.322N | P=0.713 P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.204N P=0.064N P=0.310N | (e) P=0.485 (e) |
|COCH-ARM / FISHERS | P=0.222N P=0.059N P=0.339N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
Date: 07/28/97 EXPERIMENT: 55323 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/49 (0%) 3/49 (6%) 0/47 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 7.7% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/27 (0%) 3/26 (12%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.586 P=0.113 (e) |
|POLY 3 | (e) (e) (e) | P=0.606 P=0.119 (e) |
|POLY 1.5 | (e) (e) (e) | P=0.612 P=0.120 (e) |
|POLY 6 | (e) (e) (e) | P=0.599 P=0.116 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.113 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.629 P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 4/50 (8%) 4/50 (8%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| | 9.9% 10.0% 20.3% |
|TERMINAL (d) | | 2/28 (7%) 1/26 (4%) 3/22 (14%) |
|FIRST INCIDENCE | | 479 594 36 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.093 P=0.613 P=0.127 |
|POLY 3 | | P=0.117 P=0.641 P=0.162 |
|POLY 1.5 | | P=0.121 P=0.643N P=0.168 |
|POLY 6 | | P=0.114 P=0.631 P=0.158 |
|LOGISTIC REGRESSION| | P=0.150 P=0.643N P=0.210 |
|COCH-ARM / FISHERS | | P=0.128 P=0.643N P=0.178 |
|=================================================================================================================================|
(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).