TDMS Study 55312-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 01/28/99
EXPERIMENT: 55312 TEST: 03 TIME: 08:14:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 01/28/99
EXPERIMENT: 55312 TEST: 03 TIME: 08:14:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Adrenal Medulla Hyperplasia
Blood Vessel: Pulmonary Artery Mineralization
Bone Marrow Hyperplasia
Heart: Atrium Thrombosis
Kidney Pigmentation Hemosiderin
Liver Basophilic Focus
Vacuolization Cytoplasmic
Liver: Hepatocyte Degeneration Cystic
Lung Inflammation Chronic
Mammary Gland Hyperplasia Cystic
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Cyst
Prostate Cyst Multilocular
Skin: Epidermis, Skin, Site of Application
Hyperkeratosis
Hyperplasia
Parakeratosis
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Spleen Fibrosis
Stomach, Forestomach Inflammation Chronic
Stomach, Forestomach: Epithelium Ulcer
Stomach, Glandular: Epithelium Ulcer
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Hypertrophy
Heart: Atrium Thrombosis
Kidney Mineralization
Liver Basophilic Focus
Inflammation Chronic
Liver: Bile Duct Hyperplasia
Lung Inflammation Chronic
Lung: Alveolus Infiltration Cellular Histiocyte
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Skin: Epidermis, Skin, Site of Application
Hyperkeratosis
Hyperplasia
Parakeratosis
Ulcer
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 01/28/99
EXPERIMENT: 55312 TEST: 03 TIME: 08:14:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
Stomach, Forestomach Inflammation Chronic
Stomach, Forestomach: Epithelium Hyperplasia
Ulcer
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.7% 2.9% | 0.0% 2.7% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 620 621 | --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437 P=0.317 P=0.553 | P=0.696 P=0.469 (e) |
|POLY 3 | P=0.427 P=0.270 P=0.527 | P=0.698 P=0.475 (e) |
|POLY 1.5 | P=0.400 P=0.257 P=0.516 | P=0.708 P=0.482 (e) |
|POLY 6 | P=0.467 P=0.289 P=0.543 | P=0.691 P=0.471 (e) |
|LOGISTIC REGRESSION| P=0.389 P=0.277 P=0.505 | (e) P=0.469 (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.247 P=0.500 | 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 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) | 8/50 (16%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 9.9% 11.6% 8.7% | 18.3% 15.7% 22.2% |
|TERMINAL (d) | 1/8 (13%) 3/12 (25%) 1/11 (9%) | 6/28 (21%) 4/24 (17%) 4/22 (18%) |
|FIRST INCIDENCE | 705 725 695 | 493 612 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448N P=0.587N P=0.551N | P=0.365 P=0.516N P=0.410 |
|POLY 3 | P=0.513N P=0.572 P=0.604N | P=0.409 P=0.497N P=0.438 |
|POLY 1.5 | P=0.539N P=0.545 P=0.627N | P=0.455 P=0.464N P=0.491 |
|POLY 6 | P=0.478N P=0.609 P=0.571N | P=0.379 P=0.518N P=0.406 |
|LOGISTIC REGRESSION| P=0.435N P=0.604N P=0.531N | P=0.399 P=0.467N P=0.453 |
|COCH-ARM / FISHERS | P=0.579 P=0.500 P=0.661N | P=0.556 P=0.387N P=0.607N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Fatty |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 40/50 (80%) 38/50 (76%) | 22/50 (44%) 14/50 (28%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 78.4% 83.8% 80.7% | 48.1% 35.8% 43.1% |
|TERMINAL (d) | 3/8 (38%) 7/12 (58%) 7/11 (64%) | 11/28 (39%) 8/24 (33%) 9/22 (41%) |
|FIRST INCIDENCE | 334 380 329 | 585 533 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.344N P=0.293N | P=0.392N P=0.218N P=0.455N |
|POLY 3 | P=0.444 P=0.338 P=0.494 | P=0.319N P=0.174N P=0.405N |
|POLY 1.5 | P=0.424 P=0.300 P=0.472 | P=0.239N P=0.132N P=0.306N |
|POLY 6 | P=0.490 P=0.427 P=0.543 | P=0.395N P=0.220N P=0.490N |
|LOGISTIC REGRESSION| P=0.300 P=0.190 P=0.341 | P=0.302N P=0.139N P=0.355N |
|COCH-ARM / FISHERS | P=0.363 P=0.241 P=0.410 | P=0.124N P=0.072N P=0.151N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 21/50 (42%) 24/50 (48%) | 22/50 (44%) 14/50 (28%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 38.6% 54.2% 58.6% | 48.3% 36.5% 30.4% |
|TERMINAL (d) | 2/8 (25%) 8/12 (67%) 6/11 (55%) | 12/28 (43%) 8/24 (33%) 8/22 (36%) |
|FIRST INCIDENCE | 458 534 485 | 585 677 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.144 P=0.351 P=0.169 | P=0.087N P=0.215N P=0.110N |
|POLY 3 | P=0.051 P=0.123 P=0.056 | P=0.053N P=0.189N P=0.075N |
|POLY 1.5 | P=0.030 * P=0.099 P=0.033 * | P=0.031N* P=0.139N P=0.045N* |
|POLY 6 | P=0.113 P=0.173 P=0.117 | P=0.085N P=0.244N P=0.115N |
|LOGISTIC REGRESSION| P=0.034 * P=0.152 P=0.038 * | P=0.049N* P=0.154N P=0.061N |
|COCH-ARM / FISHERS | P=0.016 * P=0.069 P=0.019 * | P=0.012N* P=0.072N P=0.016N* |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 5/50 (10%) | 10/50 (20%) 3/50 (6%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 6.6% 16.8% 14.0% | 22.8% 8.0% 19.1% |
|TERMINAL (d) | 2/8 (25%) 1/12 (8%) 1/11 (9%) | 6/28 (21%) 3/24 (13%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) 561 474 | 585 728 (T) 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318 P=0.283 P=0.364 | P=0.399N P=0.072N P=0.500N |
|POLY 3 | P=0.276 P=0.186 P=0.284 | P=0.322N P=0.062N P=0.446N |
|POLY 1.5 | P=0.237 P=0.164 P=0.255 | P=0.291N P=0.052N P=0.400N |
|POLY 6 | P=0.340 P=0.226 P=0.332 | P=0.343N P=0.072N P=0.475N |
|LOGISTIC REGRESSION| P=0.249 P=0.213 P=0.278 | P=0.351N P=0.060N P=0.430N |
|COCH-ARM / FISHERS | P=0.187 P=0.134 P=0.218 | P=0.231N P=0.036N* P=0.298N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 19/50 (38%) 16/50 (32%) | 1/50 (2%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 57.6% 52.0% 44.4% | 2.3% 5.2% 8.4% |
|TERMINAL (d) | 4/8 (50%) 9/12 (75%) 6/11 (55%) | 1/28 (4%) 1/24 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 540 575 593 | 728 (T) 562 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.122N P=0.081N | P=0.163 P=0.448 P=0.236 |
|POLY 3 | P=0.141N P=0.397N P=0.170N | P=0.178 P=0.461 P=0.246 |
|POLY 1.5 | P=0.168N P=0.420N P=0.198N | P=0.191 P=0.472 P=0.263 |
|POLY 6 | P=0.122N P=0.410N P=0.155N | P=0.171 P=0.457 P=0.237 |
|LOGISTIC REGRESSION| P=0.036N* P=0.175N P=0.058N | P=0.177 P=0.485 P=0.231 |
|COCH-ARM / FISHERS | P=0.234N P=0.500N P=0.266N | P=0.222 P=0.500 P=0.309 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 18.3% 11.3% 11.4% | 0.0% 2.6% 2.8% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 563 575 656 | --- 562 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.244N P=0.239N | P=0.283 P=0.472 P=0.457 |
|POLY 3 | P=0.264N P=0.318N P=0.320N | P=0.300 P=0.478 P=0.464 |
|POLY 1.5 | P=0.277N P=0.332N P=0.336N | P=0.309 P=0.484 P=0.475 |
|POLY 6 | P=0.253N P=0.308N P=0.307N | P=0.294 P=0.475 P=0.458 |
|LOGISTIC REGRESSION| P=0.252N P=0.322N P=0.328N | P=0.335 P=0.583 P=0.455 |
|COCH-ARM / FISHERS | P=0.303N P=0.370N P=0.370N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Pulmonary Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 12.6% 0.0% 5.8% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 593 --- 674 | --- --- 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.051N P=0.250N | P=0.243 (e) P=0.457 |
|POLY 3 | P=0.209N P=0.048N* P=0.296N | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.213N P=0.052N P=0.310N | P=0.273 (e) P=0.475 |
|POLY 6 | P=0.205N P=0.045N* P=0.283N | P=0.275 (e) P=0.458 |
|LOGISTIC REGRESSION| P=0.203N P=0.061N P=0.304N | P=0.240 (e) P=0.455 |
|COCH-ARM / FISHERS | P=0.222N P=0.059N P=0.339N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 6/50 (12%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 30.4% 33.3% 17.1% | 0.0% 5.2% 5.6% |
|TERMINAL (d) | 1/8 (13%) 4/12 (33%) 2/11 (18%) | 0/28 (0%) 1/24 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 593 575 656 | --- 562 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081N P=0.463N P=0.100N | P=0.131 P=0.208 P=0.191 |
|POLY 3 | P=0.122N P=0.500 P=0.150N | P=0.138 P=0.213 P=0.199 |
|POLY 1.5 | P=0.141N P=0.470 P=0.168N | P=0.149 P=0.219 P=0.210 |
|POLY 6 | P=0.108N P=0.524 P=0.137N | P=0.131 P=0.210 P=0.192 |
|LOGISTIC REGRESSION| P=0.078N P=0.597N P=0.114N | P=0.147 P=0.244 P=0.187 |
|COCH-ARM / FISHERS | P=0.185N P=0.405 P=0.207N | P=0.176 P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.7% 5.3% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 1/28 (4%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 708 708 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.235N P=0.641 P=0.295N |
|POLY 3 | (e) (e) (e) | P=0.238N P=0.649 P=0.280N |
|POLY 1.5 | (e) (e) (e) | P=0.218N P=0.662 P=0.266N |
|POLY 6 | (e) (e) (e) | P=0.253N P=0.641 P=0.289N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.228N P=0.641 P=0.288N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.176N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 22/50 (44%) 16/50 (32%) | 12/50 (24%) 14/50 (28%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 60.4% 55.8% 40.4% | 27.0% 34.7% 27.4% |
|TERMINAL (d) | 4/8 (50%) 4/12 (33%) 2/11 (18%) | 4/28 (14%) 8/24 (33%) 5/22 (23%) |
|FIRST INCIDENCE | 495 529 389 | 493 280 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050N P=0.202N P=0.063N | P=0.477 P=0.272 P=0.542 |
|POLY 3 | P=0.039N* P=0.424N P=0.052N | P=0.499 P=0.295 P=0.583 |
|POLY 1.5 | P=0.063N P=0.476N P=0.080N | P=0.528N P=0.328 P=0.548N |
|POLY 6 | P=0.023N* P=0.363N P=0.032N* | P=0.441 P=0.271 P=0.534 |
|LOGISTIC REGRESSION| P=0.064N P=0.354N P=0.092N | P=0.493N P=0.370 P=0.573N |
|COCH-ARM / FISHERS | P=0.131N P=0.580N P=0.151N | P=0.363N P=0.410 P=0.405N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 4/49 (8%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| | 9.5% 2.7% 8.4% |
|TERMINAL (d) | | 3/28 (11%) 1/24 (4%) 3/22 (14%) |
|FIRST INCIDENCE | | 636 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.524N P=0.228N P=0.628N |
|POLY 3 | | P=0.474N P=0.214N P=0.591N |
|POLY 1.5 | | P=0.451N P=0.201N P=0.559N |
|POLY 6 | | P=0.491N P=0.223N P=0.614N |
|LOGISTIC REGRESSION| | P=0.510N P=0.216N P=0.612N |
|COCH-ARM / FISHERS | | P=0.402N P=0.175N P=0.489N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 6/49 (12%) 6/50 (12%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| | 14.4% 15.4% 21.1% |
|TERMINAL (d) | | 6/28 (21%) 3/24 (13%) 2/22 (9%) |
|FIRST INCIDENCE | | 728 (T) 225 308 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.207 P=0.524 P=0.247 |
|POLY 3 | | P=0.265 P=0.571 P=0.311 |
|POLY 1.5 | | P=0.286 P=0.589 P=0.335 |
|POLY 6 | | P=0.258 P=0.564 P=0.304 |
|LOGISTIC REGRESSION| | P=0.316 P=0.589 P=0.352 |
|COCH-ARM / FISHERS | | P=0.344 P=0.606N P=0.403 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/49 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| | 4.8% 2.6% 5.6% |
|TERMINAL (d) | | 2/28 (7%) 0/24 (0%) 2/22 (9%) |
|FIRST INCIDENCE | | 728 (T) 677 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.520 P=0.546N P=0.607 |
|POLY 3 | | P=0.573 P=0.534N P=0.635 |
|POLY 1.5 | | P=0.587 P=0.523N P=0.656 |
|POLY 6 | | P=0.564 P=0.541N P=0.621 |
|LOGISTIC REGRESSION| | P=0.534 P=0.544N P=0.607 |
|COCH-ARM / FISHERS | | P=0.603N P=0.492N P=0.684N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Coagulating Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 2/3 (67%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 67.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 589 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.710N P=0.625 (e) | (e) (e) (e) |
|POLY 3 | (e) (e) (e) | (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) | (e) (e) (e) |
|POLY 6 | (e) (e) (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=1.000N P=1.000 (e) | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 2/3 (67%) 8/8 (100%) | 5/6 (83%) 1/2 (50%) 4/5 (80%) |
|POLY-3 ADJUSTED (b)| 100.0% 68.1% 100.0% | 86.0% 58.3% 80.9% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 3/3 (100%) | 1/1 (100%) 1/1 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 668 670 552 | 618 728 (T) 387 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 P=0.681N (e) | P=0.306N P=0.092N P=0.451N |
|POLY 3 | P=0.548 P=0.598N (e) | P=0.563N P=0.610N P=0.716N |
|POLY 1.5 | P=0.535 P=0.587N (e) | P=0.567N P=0.554N P=0.718N |
|POLY 6 | P=0.575 P=0.619N (e) | P=0.553N P=0.727N P=0.715N |
|LOGISTIC REGRESSION| P=0.554 P=0.605N (e) | P=0.532N P=0.482N P=0.699N |
|COCH-ARM / FISHERS | P=0.521 P=0.600N (e) | P=0.577N P=0.464N P=0.727N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 2/3 (67%) 8/8 (100%) | 3/6 (50%) 1/2 (50%) 3/5 (60%) |
|POLY-3 ADJUSTED (b)| 100.0% 68.1% 100.0% | 51.8% 58.3% 73.2% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 3/3 (100%) | 1/1 (100%) 1/1 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 668 670 552 | 618 728 (T) 545 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 P=0.681N (e) | P=0.419N P=0.274N P=0.570N |
|POLY 3 | P=0.548 P=0.598N (e) | P=0.385 P=0.734 P=0.493 |
|POLY 1.5 | P=0.535 P=0.587N (e) | P=0.419 P=0.747 P=0.525 |
|POLY 6 | P=0.575 P=0.619N (e) | P=0.363 P=0.710 P=0.483 |
|LOGISTIC REGRESSION| P=0.554 P=0.605N (e) | P=0.429 P=0.791 P=0.579 |
|COCH-ARM / FISHERS | P=0.521 P=0.600N (e) | P=0.491 P=0.786N P=0.608 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/50 (72%) 43/50 (86%) 42/50 (84%) | 22/50 (44%) 16/50 (32%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 82.2% 91.0% 90.6% | 48.8% 38.7% 36.9% |
|TERMINAL (d) | 6/8 (75%) 10/12 (83%) 11/11 (100%) | 14/28 (50%) 9/24 (38%) 8/22 (36%) |
|FIRST INCIDENCE | 110 380 421 | 522 280 377 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399N P=0.419N P=0.420N | P=0.251N P=0.352N P=0.292N |
|POLY 3 | P=0.118 P=0.144 P=0.160 | P=0.150N P=0.230N P=0.189N |
|POLY 1.5 | P=0.091 P=0.104 P=0.127 | P=0.113N P=0.206N P=0.142N |
|POLY 6 | P=0.174 P=0.217 P=0.230 | P=0.181N P=0.242N P=0.229N |
|LOGISTIC REGRESSION| P=0.131 P=0.100 P=0.169 | P=0.107N P=0.195N P=0.164N |
|COCH-ARM / FISHERS | P=0.082 P=0.070 P=0.114 | P=0.058N P=0.151N P=0.072N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 15.6% 8.6% 11.4% | 2.3% 0.0% 2.8% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 593 708 656 | 728 (T) --- 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.224N P=0.359N | P=0.617 P=0.531N P=0.709 |
|POLY 3 | P=0.382N P=0.306N P=0.440N | P=0.660 P=0.525N P=0.719 |
|POLY 1.5 | P=0.398N P=0.322N P=0.461N | P=0.663 P=0.518N P=0.732 |
|POLY 6 | P=0.364N P=0.293N P=0.415N | P=0.658 P=0.529N P=0.711 |
|LOGISTIC REGRESSION| P=0.344N P=0.275N P=0.433N | P=0.618 (e) P=0.711 |
|COCH-ARM / FISHERS | P=0.427N P=0.357N P=0.500N | P=0.669 P=0.500N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 19.0% 2.9% 2.9% | 0.0% 2.7% 8.3% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 593 728 687 | --- 708 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.025N* P=0.035N* | P=0.042 * P=0.473 P=0.086 |
|POLY 3 | P=0.016N* P=0.038N* P=0.039N* | P=0.048 * P=0.476 P=0.091 |
|POLY 1.5 | P=0.018N* P=0.044N* P=0.045N* | P=0.051 P=0.482 P=0.098 |
|POLY 6 | P=0.014N* P=0.033N* P=0.033N* | P=0.046 * P=0.472 P=0.087 |
|LOGISTIC REGRESSION| P=0.012N* P=0.031N* P=0.035N* | P=0.044 * P=0.472 P=0.090 |
|COCH-ARM / FISHERS | P=0.023N* P=0.056N P=0.056N | P=0.060 P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 702 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.167N P=0.222N | (e) (e) (e) |
|POLY 3 | P=0.094N P=0.208N P=0.210N | (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.219N P=0.220N | (e) (e) (e) |
|POLY 6 | P=0.094N P=0.194N P=0.197N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.065N P=0.168N P=0.177N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% | 4.7% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 2/28 (7%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 687 | 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329 (e) P=0.596 | P=0.122N P=0.272N P=0.292N |
|POLY 3 | P=0.292 (e) P=0.526 | P=0.112N P=0.266N P=0.279N |
|POLY 1.5 | P=0.283 (e) P=0.516 | P=0.106N P=0.257N P=0.266N |
|POLY 6 | P=0.305 (e) P=0.541 | P=0.116N P=0.271N P=0.288N |
|LOGISTIC REGRESSION| P=0.291 (e) P=0.543 | P=0.122N (e) (e) |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 1/50 (2%) | 2/50 (4%) 5/50 (10%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.5% 14.1% 2.9% | 4.7% 13.3% 2.8% |
|TERMINAL (d) | 1/8 (13%) 2/12 (17%) 0/11 (0%) | 1/28 (4%) 4/24 (17%) 0/22 (0%) |
|FIRST INCIDENCE | 556 621 593 | 717 722 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287N P=0.363 P=0.430N | P=0.527N P=0.159 P=0.582N |
|POLY 3 | P=0.337N P=0.272 P=0.458N | P=0.542N P=0.167 P=0.562N |
|POLY 1.5 | P=0.365N P=0.250 P=0.474N | P=0.502N P=0.181 P=0.544N |
|POLY 6 | P=0.299N P=0.307 P=0.435N | P=0.568N P=0.158 P=0.575N |
|LOGISTIC REGRESSION| P=0.351N P=0.290 P=0.486N | P=0.524N P=0.154 P=0.581N |
|COCH-ARM / FISHERS | P=0.412N P=0.218 P=0.500N | P=0.412N P=0.218 P=0.500N |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 0/50 (0%) | 6/50 (12%) 4/50 (8%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 6.6% 14.1% 0.0% | 14.0% 10.3% 16.1% |
|TERMINAL (d) | 2/8 (25%) 2/12 (17%) 0/11 (0%) | 5/28 (18%) 1/24 (4%) 3/22 (14%) |
|FIRST INCIDENCE | 729 (T) 534 --- | 698 562 314 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146N P=0.387 P=0.166N | P=0.416 P=0.463N P=0.466 |
|POLY 3 | P=0.174N P=0.281 P=0.209N | P=0.482 P=0.434N P=0.521 |
|POLY 1.5 | P=0.197N P=0.255 P=0.220N | P=0.506 P=0.418N P=0.549 |
|POLY 6 | P=0.144N P=0.324 P=0.194N | P=0.472 P=0.436N P=0.508 |
|LOGISTIC REGRESSION| P=0.163N P=0.318 (e) | P=0.505 P=0.442N P=0.554 |
|COCH-ARM / FISHERS | P=0.238N P=0.218 P=0.247N | P=0.564 P=0.370N P=0.620N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 2.9% | 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 725 640 | 493 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385 P=0.612 P=0.552 | P=0.120N P=0.267N P=0.287N |
|POLY 3 | P=0.380 P=0.527 P=0.527 | P=0.115N P=0.271N P=0.285N |
|POLY 1.5 | P=0.360 P=0.517 P=0.516 | P=0.108N P=0.260N P=0.269N |
|POLY 6 | P=0.408 P=0.541 P=0.542 | P=0.121N P=0.279N P=0.297N |
|LOGISTIC REGRESSION| P=0.368 P=0.587 P=0.516 | P=0.061N P=0.158N P=0.150N |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) 7/50 (14%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 24.7% 25.5% 20.0% | 4.6% 0.0% 2.8% |
|TERMINAL (d) | 0/8 (0%) 5/12 (42%) 4/11 (36%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 521 617 626 | 613 --- 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245N P=0.428N P=0.304N | P=0.424N P=0.286N P=0.576N |
|POLY 3 | P=0.372N P=0.584 P=0.431N | P=0.400N P=0.268N P=0.562N |
|POLY 1.5 | P=0.396N P=0.557 P=0.453N | P=0.387N P=0.259N P=0.544N |
|POLY 6 | P=0.349N P=0.611 P=0.410N | P=0.408N P=0.275N P=0.574N |
|LOGISTIC REGRESSION| P=0.274N P=0.536N P=0.352N | P=0.365N P=0.242N P=0.503N |
|COCH-ARM / FISHERS | P=0.446N P=0.500 P=0.500N | P=0.360N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 3/50 (6%) | 50/50 (100%) 45/50 (90%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 9.5% 8.5% 8.6% | 100.0% 90.3% 94.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 28/28 (100%) 20/24 (83%) 19/22 (86%) |
|FIRST INCIDENCE | 593 575 656 | 342 225 271 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480N P=0.560N P=0.548N | P=0.178 P=0.441 P=0.188 |
|POLY 3 | P=0.540N P=0.611N P=0.617N | P=0.128N P=0.032N* P=0.119N |
|POLY 1.5 | P=0.555N P=0.629N P=0.633N | P=0.129N P=0.031N* P=0.119N |
|POLY 6 | P=0.523N P=0.589N P=0.597N | P=0.125N P=0.034N* P=0.119N |
|LOGISTIC REGRESSION| P=0.541N P=0.637N P=0.627N | P=0.079N P=0.021N* (e) |
|COCH-ARM / FISHERS | P=0.583 P=0.661N P=0.661N | P=0.133N P=0.028N* P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 49/50 (98%) | 47/50 (94%) 46/50 (92%) 46/50 (92%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 98.3% | 98.1% 98.7% 98.3% |
|TERMINAL (d) | 8/8 (100%) 12/12 (100%) 11/11 (100%) | 28/28 (100%) 24/24 (100%) 22/22 (100%) |
|FIRST INCIDENCE | 334 380 329 | 522 280 271 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.138N P=0.135N P=0.152N | P=0.086 P=0.211 P=0.103 |
|POLY 3 | P=0.316N P=1.000 P=0.582N | P=0.693 P=0.826 P=0.864 |
|POLY 1.5 | P=0.321N P=1.000 P=0.566N | P=0.626N P=0.751 P=0.752N |
|POLY 6 | P=0.367N P=1.000 P=0.668N | P=0.882 P=0.993 P=0.993 |
|LOGISTIC REGRESSION| P=0.451N (e) P=0.612N | P=0.117 P=0.179 P=0.181 |
|COCH-ARM / FISHERS | P=0.669 P=0.500 P=0.753N | P=0.424N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 44/50 (88%) 50/50 (100%) | 48/50 (96%) 46/50 (92%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 93.6% 92.7% 100.0% | 98.4% 95.7% 98.7% |
|TERMINAL (d) | 8/8 (100%) 11/12 (92%) 11/11 (100%) | 28/28 (100%) 23/24 (96%) 22/22 (100%) |
|FIRST INCIDENCE | 334 444 329 | 493 280 294 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.416N P=0.148N P=0.419N | P=0.091 P=0.264 P=0.102 |
|POLY 3 | P=0.053 P=0.612N P=0.055 | P=0.613 P=0.421N P=0.853 |
|POLY 1.5 | P=0.028 * P=0.635N P=0.025 * | P=0.594N P=0.435N P=0.769N |
|POLY 6 | P=0.129 P=0.580N P=0.164 | P=0.592 P=0.361N P=0.939 |
|LOGISTIC REGRESSION| P=0.025 * P=0.539N P=0.020 * | P=0.339 P=0.687 P=0.358 |
|COCH-ARM / FISHERS | P=0.010 * P=0.500 P=0.006 ** | P=0.417N P=0.339N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.8% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 695 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.608N P=0.329 (e) | (e) (e) (e) |
|POLY 3 | P=0.625N P=0.268 (e) | (e) (e) (e) |
|POLY 1.5 | P=0.643N P=0.256 (e) | (e) (e) (e) |
|POLY 6 | P=0.600N P=0.286 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.619N P=0.310 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | (e) (e) (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 13/50 (26%) 3/50 (6%) | 31/50 (62%) 17/50 (34%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 9.9% 36.6% 8.6% | 68.5% 43.0% 11.2% |
|TERMINAL (d) | 2/8 (25%) 8/12 (67%) 2/11 (18%) | 23/28 (82%) 13/24 (54%) 4/22 (18%) |
|FIRST INCIDENCE | 713 558 607 | 552 514 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365N P=0.036 * P=0.539N | P<0.001N** P=0.027N* P<0.001N** |
|POLY 3 | P=0.399N P=0.009 ** P=0.600N | P<0.001N** P=0.011N* P<0.001N** |
|POLY 1.5 | P=0.466N P=0.008 ** P=0.625N | P<0.001N** P=0.008N** P<0.001N** |
|POLY 6 | P=0.305N P=0.012 * P=0.563N | P<0.001N** P=0.014N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.355N P=0.019 * P=0.537N | P<0.001N** P=0.017N* P<0.001N** |
|COCH-ARM / FISHERS | P=0.560 P=0.006 ** P=0.661N | P<0.001N** P=0.004N** P<0.001N** |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 2/50 (4%) | 5/50 (10%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.6% 16.9% 5.8% | 11.6% 10.6% 2.8% |
|TERMINAL (d) | 1/8 (13%) 3/12 (25%) 2/11 (18%) | 4/28 (14%) 4/24 (17%) 1/22 (5%) |
|FIRST INCIDENCE | 458 474 729 (T) | 632 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.431 P=0.374N | P=0.136N P=0.598N P=0.165N |
|POLY 3 | P=0.359N P=0.302 P=0.457N | P=0.133N P=0.583N P=0.150N |
|POLY 1.5 | P=0.382N P=0.280 P=0.473N | P=0.114N P=0.558N P=0.134N |
|POLY 6 | P=0.331N P=0.333 P=0.438N | P=0.148N P=0.601N P=0.163N |
|LOGISTIC REGRESSION| P=0.337N P=0.311 P=0.438N | P=0.133N P=0.595N P=0.157N |
|COCH-ARM / FISHERS | P=0.424N P=0.243 P=0.500N | P=0.080N P=0.500N P=0.102N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 8/50 (16%) | 10/50 (20%) 11/50 (22%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 26.1% 24.1% 21.4% | 22.7% 28.4% 36.5% |
|TERMINAL (d) | 1/8 (13%) 2/12 (17%) 2/11 (18%) | 7/28 (25%) 9/24 (38%) 5/22 (23%) |
|FIRST INCIDENCE | 467 511 421 | 522 514 537 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.413N P=0.376N | P=0.080 P=0.341 P=0.105 |
|POLY 3 | P=0.369N P=0.532N P=0.421N | P=0.103 P=0.368 P=0.126 |
|POLY 1.5 | P=0.396N P=0.554N P=0.448N | P=0.126 P=0.406 P=0.152 |
|POLY 6 | P=0.337N P=0.497N P=0.387N | P=0.097 P=0.341 P=0.121 |
|LOGISTIC REGRESSION| P=0.482N P=0.588 P=0.557N | P=0.110 P=0.395 P=0.152 |
|COCH-ARM / FISHERS | P=0.447N P=0.602N P=0.500N | P=0.204 P=0.500 P=0.241 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 25/50 (50%) 24/50 (48%) | 29/50 (58%) 26/50 (52%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 49.9% 56.4% 54.2% | 61.9% 60.0% 33.4% |
|TERMINAL (d) | 2/8 (25%) 6/12 (50%) 4/11 (36%) | 17/28 (61%) 13/24 (54%) 6/22 (27%) |
|FIRST INCIDENCE | 334 380 329 | 522 271 271 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530N P=0.509 P=0.550 | P=0.038N* P=0.486 P=0.033N* |
|POLY 3 | P=0.397 P=0.346 P=0.427 | P=0.007N** P=0.513N P=0.006N** |
|POLY 1.5 | P=0.338 P=0.295 P=0.368 | P=0.003N** P=0.458N P=0.003N** |
|POLY 6 | P=0.476 P=0.418 P=0.507 | P=0.014N* P=0.561N P=0.011N* |
|LOGISTIC REGRESSION| P=0.117 P=0.104 P=0.146 | P=0.002N** P=0.405N P=0.002N** |
|COCH-ARM / FISHERS | P=0.241 P=0.211 P=0.273 | P<0.001N** P=0.344N P<0.001N** |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.3% 5.2% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | 728 (T) 578 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.433N P=0.442 P=0.548N |
|POLY 3 | (e) (e) (e) | P=0.448N P=0.461 P=0.536N |
|POLY 1.5 | (e) (e) (e) | P=0.421N P=0.471 P=0.525N |
|POLY 6 | (e) (e) (e) | P=0.466N P=0.457 P=0.543N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.389N P=0.481 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.360N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 36/50 (72%) 33/50 (66%) | 23/50 (46%) 20/50 (40%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| 66.9% 78.6% 72.1% | 51.8% 50.4% 58.5% |
|TERMINAL (d) | 3/8 (38%) 10/12 (83%) 5/11 (46%) | 17/28 (61%) 13/24 (54%) 14/22 (64%) |
|FIRST INCIDENCE | 442 380 421 | 613 533 537 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503N P=0.471 P=0.541N | P=0.237 P=0.558 P=0.260 |
|POLY 3 | P=0.363 P=0.142 P=0.378 | P=0.324 P=0.536N P=0.347 |
|POLY 1.5 | P=0.252 P=0.101 P=0.275 | P=0.415 P=0.480N P=0.443 |
|POLY 6 | P=0.530 P=0.201 P=0.529 | P=0.273 P=0.567N P=0.292 |
|LOGISTIC REGRESSION| P=0.140 P=0.066 P=0.173 | P=0.259 P=0.580N P=0.278 |
|COCH-ARM / FISHERS | P=0.126 P=0.048 * P=0.154 | P=0.460N P=0.343N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 48/50 (96%) 50/50 (100%) | 26/50 (52%) 21/50 (42%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 98.4% 96.2% 100.0% | 56.8% 49.9% 39.8% |
|TERMINAL (d) | 8/8 (100%) 12/12 (100%) 11/11 (100%) | 15/28 (54%) 10/24 (42%) 8/22 (36%) |
|FIRST INCIDENCE | 334 380 329 | 522 382 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227N P=0.143N P=0.239N | P=0.209N P=0.484N P=0.221N |
|POLY 3 | P=0.395 P=0.479N P=0.646 | P=0.068N P=0.327N P=0.081N |
|POLY 1.5 | P=0.271 P=0.590N P=0.371 | P=0.051N P=0.298N P=0.062N |
|POLY 6 | P=0.540 P=0.377N P=0.986 | P=0.083N P=0.333N P=0.098N |
|LOGISTIC REGRESSION| P=0.141 P=0.666 P=0.247 | P=0.049N* P=0.308N P=0.057N |
|COCH-ARM / FISHERS | P=0.082 P=0.500 P=0.121 | P=0.027N* P=0.212N P=0.034N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 25.3% 22.4% 8.6% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 4/8 (50%) 3/12 (25%) 1/11 (9%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 603 617 627 | --- --- 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.340N P=0.036N* | P=0.251 (e) P=0.470 |
|POLY 3 | P=0.050N P=0.506N P=0.062N | P=0.274 (e) P=0.465 |
|POLY 1.5 | P=0.063N P=0.543N P=0.075N | P=0.273 (e) P=0.476 |
|POLY 6 | P=0.038N* P=0.456N P=0.048N* | P=0.275 (e) P=0.460 |
|LOGISTIC REGRESSION| P=0.036N* P=0.419N P=0.049N* | P=0.258 (e) P=0.489 |
|COCH-ARM / FISHERS | P=0.088N P=0.607N P=0.100N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.2% 8.5% 2.9% | 2.3% 5.3% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 521 589 582 | 618 712 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551N P=0.411 P=0.743N | P=0.426N P=0.443 P=0.542N |
|POLY 3 | P=0.557N P=0.352 P=0.735N | P=0.452N P=0.454 P=0.538N |
|POLY 1.5 | P=0.577N P=0.334 P=0.745N | P=0.423N P=0.468 P=0.526N |
|POLY 6 | P=0.530N P=0.379 P=0.721N | P=0.473N P=0.445 P=0.546N |
|LOGISTIC REGRESSION| P=0.606N P=0.324 P=0.730 | P=0.397N P=0.473 P=0.468N |
|COCH-ARM / FISHERS | P=0.610 P=0.309 P=0.753N | P=0.360N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 6.5% 2.9% 0.0% | 4.7% 2.7% 5.6% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 543 589 --- | 697 708 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.427N P=0.205N | P=0.520 P=0.553N P=0.602 |
|POLY 3 | P=0.130N P=0.455N P=0.213N | P=0.564 P=0.544N P=0.628 |
|POLY 1.5 | P=0.134N P=0.472N P=0.222N | P=0.579 P=0.532N P=0.648 |
|POLY 6 | P=0.125N P=0.432N P=0.201N | P=0.555 P=0.553N P=0.614 |
|LOGISTIC REGRESSION| P=0.140N P=0.494N P=0.223N | P=0.538 P=0.547N P=0.626 |
|COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.247N | P=0.610 P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Hepatocyte, Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 2.9% 0.0% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 650 686 --- | 708 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.094N P=0.372N P=0.196N | P=0.304N P=0.527N P=0.549N |
|POLY 3 | P=0.129N P=0.456N P=0.211N | P=0.303N P=0.525N P=0.536N |
|POLY 1.5 | P=0.134N P=0.472N P=0.221N | P=0.292N P=0.518N P=0.525N |
|POLY 6 | P=0.124N P=0.434N P=0.200N | P=0.310N P=0.530N P=0.544N |
|LOGISTIC REGRESSION| P=0.109N P=0.428N P=0.196N | P=0.299N P=0.528N P=0.542N |
|COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.247N | 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 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 8/50 (16%) 2/50 (4%) | 7/50 (14%) 16/50 (32%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 6.5% 21.9% 5.8% | 16.4% 40.6% 24.8% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 7/28 (25%) 11/24 (46%) 7/22 (32%) |
|FIRST INCIDENCE | 591 561 674 | 728 (T) 578 537 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439N P=0.131 P=0.577N | P=0.152 P=0.008 ** P=0.203 |
|POLY 3 | P=0.471N P=0.073 P=0.652N | P=0.172 P=0.012 * P=0.259 |
|POLY 1.5 | P=0.511N P=0.061 P=0.668N | P=0.220 P=0.014 * P=0.296 |
|POLY 6 | P=0.416N P=0.097 P=0.628N | P=0.148 P=0.011 * P=0.238 |
|LOGISTIC REGRESSION| P=0.496N P=0.072 P=0.636N | P=0.175 P=0.009 ** P=0.214 |
|COCH-ARM / FISHERS | P=0.573 P=0.046 * P=0.691N | P=0.357 P=0.028 * P=0.393 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.5% 0.0% 0.0% | 7.0% 2.7% 2.8% |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 0/11 (0%) | 2/28 (7%) 1/24 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 631 --- --- | 655 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.070N P=0.187N P=0.184N | P=0.268N P=0.361N P=0.389N |
|POLY 3 | P=0.093N P=0.209N P=0.211N | P=0.253N P=0.353N P=0.375N |
|POLY 1.5 | P=0.094N P=0.219N P=0.221N | P=0.237N P=0.339N P=0.353N |
|POLY 6 | P=0.094N P=0.196N P=0.199N | P=0.266N P=0.364N P=0.391N |
|LOGISTIC REGRESSION| P=0.074N P=0.191N P=0.194N | P=0.264N P=0.356N P=0.383N |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | 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 |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 618 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.213N P=0.190N | (e) (e) (e) |
|POLY 3 | P=0.093N P=0.212N P=0.214N | (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.220N P=0.222N | (e) (e) (e) |
|POLY 6 | P=0.093N P=0.202N P=0.204N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.091N P=0.227N P=0.227N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.5% 11.4% 2.9% | 4.6% 2.6% 8.4% |
|TERMINAL (d) | 0/8 (0%) 2/12 (17%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 3/22 (14%) |
|FIRST INCIDENCE | 618 611 626 | 632 585 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288N P=0.486 P=0.406N | P=0.311 P=0.560N P=0.396 |
|POLY 3 | P=0.346N P=0.396 P=0.460N | P=0.350 P=0.544N P=0.412 |
|POLY 1.5 | P=0.368N P=0.374 P=0.475N | P=0.366 P=0.531N P=0.440 |
|POLY 6 | P=0.319N P=0.426 P=0.441N | P=0.338 P=0.552N P=0.391 |
|LOGISTIC REGRESSION| P=0.347N P=0.418 P=0.481N | P=0.352 P=0.458N P=0.418 |
|COCH-ARM / FISHERS | P=0.406N P=0.339 P=0.500N | P=0.399 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 |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 13/50 (26%) 12/50 (24%) | 22/50 (44%) 24/50 (48%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| 21.9% 33.7% 32.3% | 50.5% 57.9% 69.7% |
|TERMINAL (d) | 2/8 (25%) 4/12 (33%) 4/11 (36%) | 19/28 (68%) 15/24 (63%) 18/22 (82%) |
|FIRST INCIDENCE | 543 495 565 | 619 271 374 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310 P=0.280 P=0.334 | P=0.013 * P=0.189 P=0.012 * |
|POLY 3 | P=0.230 P=0.197 P=0.238 | P=0.040 * P=0.312 P=0.048 * |
|POLY 1.5 | P=0.189 P=0.155 P=0.201 | P=0.058 P=0.334 P=0.069 |
|POLY 6 | P=0.296 P=0.273 P=0.302 | P=0.034 * P=0.321 P=0.040 * |
|LOGISTIC REGRESSION| P=0.189 P=0.149 P=0.232 | P=0.027 * P=0.226 P=0.025 * |
|COCH-ARM / FISHERS | P=0.136 P=0.105 P=0.154 | P=0.136 P=0.421 P=0.159 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 11.3% 5.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 593 575 656 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.478 P=0.590N | (e) (e) (e) |
|POLY 3 | P=0.530N P=0.394 P=0.655N | (e) (e) (e) |
|POLY 1.5 | P=0.551N P=0.373 P=0.670N | (e) (e) (e) |
|POLY 6 | P=0.502N P=0.422 P=0.636N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.539N P=0.393 P=0.679N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.588 P=0.339 P=0.691N | (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, Mediastinal |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 26/50 (52%) 33/50 (66%) | 38/50 (76%) 35/50 (70%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 70.1% 60.3% 74.5% | 79.3% 73.8% 78.1% |
|TERMINAL (d) | 5/8 (63%) 7/12 (58%) 8/11 (73%) | 23/28 (82%) 16/24 (67%) 15/22 (68%) |
|FIRST INCIDENCE | 334 380 389 | 342 271 294 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.414N P=0.113N P=0.413N | P=0.306 P=0.414 P=0.326 |
|POLY 3 | P=0.342 P=0.219N P=0.406 | P=0.482N P=0.342N P=0.548N |
|POLY 1.5 | P=0.309 P=0.249N P=0.360 | P=0.407N P=0.353N P=0.461N |
|POLY 6 | P=0.375 P=0.204N P=0.455 | P=0.497N P=0.314N P=0.569N |
|LOGISTIC REGRESSION| P=0.249 P=0.342N P=0.313 | P=0.283N P=0.294N P=0.442N |
|COCH-ARM / FISHERS | P=0.239 P=0.344N P=0.268 | P=0.219N P=0.326N P=0.252N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.4% 5.7% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 723 670 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278N P=0.656 P=0.460N | (e) (e) (e) |
|POLY 3 | P=0.313N P=0.558 P=0.470N | (e) (e) (e) |
|POLY 1.5 | P=0.329N P=0.539 P=0.480N | (e) (e) (e) |
|POLY 6 | P=0.293N P=0.586 P=0.457N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.284N P=0.615 P=0.444N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.355N P=0.508 P=0.495N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 6/49 (12%) 4/50 (8%) | 0/49 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.0% 17.4% 11.5% | 0.0% 8.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 2/12 (17%) 2/11 (18%) | 0/28 (0%) 2/24 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 656 575 586 | --- 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.293 P=0.478 | P=0.570 P=0.097 (e) |
|POLY 3 | P=0.415 P=0.191 P=0.427 | P=0.557 P=0.100 (e) |
|POLY 1.5 | P=0.372 P=0.170 P=0.398 | P=0.586 P=0.106 (e) |
|POLY 6 | P=0.474 P=0.225 P=0.467 | P=0.537 P=0.096 (e) |
|LOGISTIC REGRESSION| P=0.442 P=0.233 P=0.483 | P=0.575 P=0.094 (e) |
|COCH-ARM / FISHERS | P=0.311 P=0.141 P=0.359 | P=0.634N P=0.125 (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 36/48 (75%) 44/49 (90%) 43/50 (86%) | 44/49 (90%) 40/50 (80%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 85.1% 94.7% 92.4% | 92.8% 87.7% 91.3% |
|TERMINAL (d) | 7/8 (88%) 12/12 (100%) 9/11 (82%) | 26/28 (93%) 20/24 (83%) 20/22 (91%) |
|FIRST INCIDENCE | 334 444 329 | 493 280 314 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433N P=0.465N P=0.460N | P=0.221 P=0.406 P=0.238 |
|POLY 3 | P=0.133 P=0.084 P=0.190 | P=0.455N P=0.304N P=0.552N |
|POLY 1.5 | P=0.112 P=0.066 P=0.160 | P=0.311N P=0.247N P=0.377N |
|POLY 6 | P=0.222 P=0.148 P=0.294 | P=0.561N P=0.338N P=0.673N |
|LOGISTIC REGRESSION| P=0.195 P=0.107 P=0.232 | P=0.471N P=0.366N P=0.606N |
|COCH-ARM / FISHERS | P=0.094 P=0.049 * P=0.131 | P=0.122N P=0.140N P=0.140N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 3/7 (43%) 5/6 (83%) | 3/4 (75%) 4/5 (80%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 88.7% 46.8% 88.1% | 75.0% 91.1% 50.0% |
|TERMINAL (d) | 2/2 (100%) 1/3 (33%) 1/1 (100%) | 0/1 (0%) 3/3 (100%) 0/1 (0%) |
|FIRST INCIDENCE | 392 499 389 | 613 280 545 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.071N P=0.413N | P=0.294N P=0.651N P=0.405N |
|POLY 3 | P=0.540N P=0.109N P=0.800N | P=0.514N P=0.617 P=0.602N |
|POLY 1.5 | P=0.512N P=0.099N P=0.750N | P=0.502N P=0.664 P=0.602N |
|POLY 6 | P=0.585N P=0.124N P=0.822 | P=0.528N P=0.552 P=0.602N |
|LOGISTIC REGRESSION| P=0.500N P=0.170N P=0.716N | P=0.459N P=0.742 (e) |
|COCH-ARM / FISHERS | P=0.483N P=0.100N P=0.692N | P=0.483N P=0.722 P=0.600N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 10/50 (20%) | 1/50 (2%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 27.6% 18.6% 26.4% | 2.3% 10.3% 8.0% |
|TERMINAL (d) | 4/8 (50%) 0/12 (0%) 2/11 (18%) | 1/28 (4%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 458 511 389 | 728 (T) 225 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476N P=0.223N P=0.506N | P=0.203 P=0.153 P=0.256 |
|POLY 3 | P=0.546N P=0.267N P=0.560N | P=0.198 P=0.151 P=0.260 |
|POLY 1.5 | P=0.526 P=0.315N P=0.594 | P=0.213 P=0.159 P=0.273 |
|POLY 6 | P=0.492N P=0.201N P=0.478N | P=0.191 P=0.148 P=0.255 |
|LOGISTIC REGRESSION| P=0.449 P=0.357N P=0.539 | P=0.394 P=0.231 P=0.510 |
|COCH-ARM / FISHERS | P=0.447 P=0.393N P=0.500 | P=0.252 P=0.181 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 4/50 (8%) | 4/50 (8%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.5% 11.1% 11.4% | 9.3% 7.7% 8.4% |
|TERMINAL (d) | 0/8 (0%) 1/12 (8%) 0/11 (0%) | 3/28 (11%) 1/24 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 561 495 632 | 655 280 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396 P=0.465 P=0.477 | P=0.525N P=0.570N P=0.614N |
|POLY 3 | P=0.341 P=0.409 P=0.397 | P=0.518N P=0.550N P=0.597N |
|POLY 1.5 | P=0.314 P=0.381 P=0.373 | P=0.489N P=0.536N P=0.568N |
|POLY 6 | P=0.382 P=0.451 P=0.436 | P=0.536N P=0.558N P=0.615N |
|LOGISTIC REGRESSION| P=0.308 P=0.356 P=0.402 | P=0.423N P=0.428N P=0.613N |
|COCH-ARM / FISHERS | P=0.274 P=0.339 P=0.339 | P=0.421N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 9/50 (18%) | 1/50 (2%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 27.3% 18.6% 23.9% | 2.3% 10.3% 8.0% |
|TERMINAL (d) | 3/8 (38%) 0/12 (0%) 2/11 (18%) | 1/28 (4%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 458 511 389 | 728 (T) 225 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.388N P=0.236N P=0.427N | P=0.203 P=0.153 P=0.256 |
|POLY 3 | P=0.453N P=0.276N P=0.480N | P=0.198 P=0.151 P=0.260 |
|POLY 1.5 | P=0.489N P=0.320N P=0.526N | P=0.213 P=0.159 P=0.273 |
|POLY 6 | P=0.411N P=0.218N P=0.419N | P=0.191 P=0.148 P=0.255 |
|LOGISTIC REGRESSION| P=0.543 P=0.376N P=0.583N | P=0.394 P=0.231 P=0.510 |
|COCH-ARM / FISHERS | P=0.553 P=0.393N P=0.602N | P=0.252 P=0.181 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.5% 5.6% 8.5% | 0.0% 2.6% 5.4% |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 1/11 (9%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 458 511 389 | --- 225 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512N P=0.418N P=0.574N | P=0.134 P=0.500 P=0.219 |
|POLY 3 | P=0.548N P=0.442N P=0.608N | P=0.126 P=0.480 P=0.208 |
|POLY 1.5 | P=0.562N P=0.464N P=0.628N | P=0.131 P=0.486 P=0.216 |
|POLY 6 | P=0.532N P=0.412N P=0.581N | P=0.123 P=0.477 P=0.203 |
|LOGISTIC REGRESSION| P=0.531 P=0.552N P=0.635 | P=0.374 (e) P=0.630 |
|COCH-ARM / FISHERS | P=0.588 P=0.500N P=0.661N | P=0.142 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Nose: Vein, Turbinate, Septum |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 0.0% 5.8% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 650 --- 690 | 697 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559N P=0.167N P=0.614N | P=0.309N P=0.539N P=0.554N |
|POLY 3 | P=0.615N P=0.209N P=0.652N | P=0.303N P=0.525N P=0.536N |
|POLY 1.5 | P=0.616N P=0.219N P=0.668N | P=0.292N P=0.518N P=0.525N |
|POLY 6 | P=0.613N P=0.197N P=0.630N | P=0.310N P=0.530N P=0.544N |
|LOGISTIC REGRESSION| P=0.561N P=0.193N P=0.619N | P=0.294N P=0.523N P=0.536N |
|COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | 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 |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 7/50 (14%) 8/50 (16%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| | 16.2% 21.2% 21.3% |
|TERMINAL (d) | | 3/28 (11%) 7/24 (29%) 3/22 (14%) |
|FIRST INCIDENCE | | 636 722 387 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.269 P=0.374 P=0.327 |
|POLY 3 | | P=0.324 P=0.384 P=0.382 |
|POLY 1.5 | | P=0.358 P=0.420 P=0.415 |
|POLY 6 | | P=0.307 P=0.355 P=0.368 |
|LOGISTIC REGRESSION| | P=0.308 P=0.373 P=0.423 |
|COCH-ARM / FISHERS | | P=0.445 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 22/50 (44%) 25/50 (50%) | 19/50 (38%) 13/50 (26%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 33.2% 53.9% 61.2% | 42.1% 32.6% 28.0% |
|TERMINAL (d) | 3/8 (38%) 6/12 (50%) 8/11 (73%) | 13/28 (46%) 7/24 (29%) 5/22 (23%) |
|FIRST INCIDENCE | 392 444 421 | 552 533 308 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.152 P=0.054 | P=0.195N P=0.315N P=0.225N |
|POLY 3 | P=0.010 * P=0.050 P=0.009 ** | P=0.099N P=0.245N P=0.128N |
|POLY 1.5 | P=0.006 ** P=0.031 * P=0.005 ** | P=0.079N P=0.212N P=0.103N |
|POLY 6 | P=0.021 * P=0.099 P=0.019 * | P=0.115N P=0.267N P=0.147N |
|LOGISTIC REGRESSION| P=0.005 ** P=0.030 * P=0.007 ** | P=0.070N P=0.210N P=0.071N |
|COCH-ARM / FISHERS | P=0.003 ** P=0.016 * P=0.003 ** | P=0.049N* P=0.142N P=0.063N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/48 (29%) 15/46 (33%) 8/45 (18%) | 0/42 (0%) 1/46 (2%) 3/45 (7%) |
|POLY-3 ADJUSTED (b)| 41.7% 44.7% 24.6% | 0.0% 2.9% 9.2% |
|TERMINAL (d) | 1/8 (13%) 5/11 (46%) 2/9 (22%) | 0/22 (0%) 0/21 (0%) 0/20 (0%) |
|FIRST INCIDENCE | 563 575 626 | --- 562 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046N* P=0.340N P=0.058N | P=0.045 * P=0.472 P=0.091 |
|POLY 3 | P=0.084N P=0.496 P=0.102N | P=0.054 P=0.497 P=0.105 |
|POLY 1.5 | P=0.097N P=0.492 P=0.113N | P=0.057 P=0.502 P=0.111 |
|POLY 6 | P=0.080N P=0.477 P=0.099N | P=0.054 P=0.496 P=0.105 |
|LOGISTIC REGRESSION| P=0.054N P=0.573N P=0.082N | P=0.067 P=0.590 P=0.128 |
|COCH-ARM / FISHERS | P=0.135N P=0.445 P=0.147N | P=0.065 P=0.523 P=0.134 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 7/50 (14%) 3/49 (6%) | 23/50 (46%) 27/49 (55%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 43.7% 19.6% 8.6% | 51.2% 64.4% 44.6% |
|TERMINAL (d) | 3/8 (38%) 2/12 (17%) 1/11 (9%) | 16/28 (57%) 18/24 (75%) 14/22 (64%) |
|FIRST INCIDENCE | 458 617 565 | 342 225 308 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.011N* P<0.001N** | P=0.462N P=0.108 P=0.454N |
|POLY 3 | P<0.001N** P=0.020N* P<0.001N** | P=0.370N P=0.143 P=0.347N |
|POLY 1.5 | P<0.001N** P=0.020N* P<0.001N** | P=0.276N P=0.166 P=0.273N |
|POLY 6 | P<0.001N** P=0.020N* P<0.001N** | P=0.464N P=0.134 P=0.422N |
|LOGISTIC REGRESSION| P<0.001N** P=0.021N* P<0.001N** | P=0.258N P=0.158 P=0.308N |
|COCH-ARM / FISHERS | P<0.001N** P=0.028N* P<0.001N** | P=0.134N P=0.241 P=0.154N |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 10/50 (20%) 12/49 (24%) | 20/50 (40%) 19/49 (39%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 37.5% 27.0% 33.1% | 44.5% 45.1% 48.2% |
|TERMINAL (d) | 3/8 (38%) 4/12 (33%) 5/11 (46%) | 12/28 (43%) 11/24 (46%) 12/22 (55%) |
|FIRST INCIDENCE | 470 499 474 | 493 225 314 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232N P=0.139N P=0.256N | P=0.303 P=0.441 P=0.332 |
|POLY 3 | P=0.406N P=0.236N P=0.445N | P=0.414 P=0.563 P=0.451 |
|POLY 1.5 | P=0.425N P=0.260N P=0.467N | P=0.482 P=0.583 P=0.521 |
|POLY 6 | P=0.389N P=0.211N P=0.427N | P=0.361 P=0.549 P=0.395 |
|LOGISTIC REGRESSION| P=0.361N P=0.250N P=0.396N | P=0.521N P=0.532N P=0.522 |
|COCH-ARM / FISHERS | P=0.475N P=0.318N P=0.523N | P=0.459N P=0.532N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 Intermedia |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) | 1/50 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 3.2% 0.0% 2.9% | 2.3% 5.2% 5.4% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 467 --- 474 | 669 225 466 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.646N P=0.478N P=0.735N | P=0.337 P=0.469 P=0.436 |
|POLY 3 | P=0.671N P=0.478N P=0.735N | P=0.341 P=0.460 P=0.448 |
|POLY 1.5 | P=0.671N P=0.486N P=0.746N | P=0.355 P=0.470 P=0.463 |
|POLY 6 | P=0.673N P=0.467N P=0.720N | P=0.333 P=0.454 P=0.440 |
|LOGISTIC REGRESSION| P=0.515 P=0.621N P=0.653 | P=0.579 P=0.668 P=0.666 |
|COCH-ARM / FISHERS | P=0.665 P=0.500N P=0.747 | P=0.391 P=0.492 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 9.6% 2.9% 8.8% | |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 3/11 (27%) | |
|FIRST INCIDENCE | 467 713 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497N P=0.225N P=0.538N | |
|POLY 3 | P=0.574N P=0.268N P=0.623N | |
|POLY 1.5 | P=0.580N P=0.281N P=0.637N | |
|POLY 6 | P=0.568N P=0.251N P=0.607N | |
|LOGISTIC REGRESSION| P=0.525N P=0.283N P=0.592N | |
|COCH-ARM / FISHERS | P=0.594 P=0.309N P=0.661N | |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 46/50 (92%) 46/50 (92%) | |
|POLY-3 ADJUSTED (b)| 96.9% 94.9% 96.0% | |
|TERMINAL (d) | 7/8 (88%) 10/12 (83%) 11/11 (100%) | |
|FIRST INCIDENCE | 334 444 329 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121N P=0.105N P=0.130N | |
|POLY 3 | P=0.515N P=0.513N P=0.645N | |
|POLY 1.5 | P=0.408N P=0.469N P=0.510N | |
|POLY 6 | P=0.593 P=0.532N P=0.749 | |
|LOGISTIC REGRESSION| P=0.291N P=0.349N P=0.362N | |
|COCH-ARM / FISHERS | P=0.424N 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 |
|=================================================================================================================================|
| |
|Prostate |
| Cyst Multilocular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/50 (16%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 28.0% 21.8% 11.3% | |
|TERMINAL (d) | 2/8 (25%) 1/12 (8%) 2/11 (18%) | |
|FIRST INCIDENCE | 556 558 552 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043N* P=0.266N P=0.055N | |
|POLY 3 | P=0.057N P=0.374N P=0.071N | |
|POLY 1.5 | P=0.070N P=0.421N P=0.086N | |
|POLY 6 | P=0.046N* P=0.315N P=0.056N | |
|LOGISTIC REGRESSION| P=0.058N P=0.368N P=0.068N | |
|COCH-ARM / FISHERS | P=0.097N P=0.500N P=0.117N | |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 47/50 (94%) 46/50 (92%) | |
|POLY-3 ADJUSTED (b)| 92.7% 97.0% 94.3% | |
|TERMINAL (d) | 6/8 (75%) 11/12 (92%) 10/11 (91%) | |
|FIRST INCIDENCE | 110 444 329 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.161N P=0.172N | |
|POLY 3 | P=0.435 P=0.294 P=0.531 | |
|POLY 1.5 | P=0.498 P=0.355 P=0.580 | |
|POLY 6 | P=0.365 P=0.271 P=0.473 | |
|LOGISTIC REGRESSION| P=0.552 P=0.468 P=0.553 | |
|COCH-ARM / FISHERS | P=0.576 P=0.500 P=0.643N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.3% 0.0% 0.0% | 0.0% 5.2% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 603 --- --- | --- 578 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.247N P=0.473N P=0.467N | P=0.619 P=0.210 (e) |
|POLY 3 | P=0.276N P=0.476N P=0.478N | P=0.605 P=0.214 (e) |
|POLY 1.5 | P=0.273N P=0.485N P=0.486N | P=0.625 P=0.220 (e) |
|POLY 6 | P=0.280N P=0.465N P=0.467N | P=0.591 P=0.213 (e) |
|LOGISTIC REGRESSION| P=0.275N P=0.507N P=0.505N | P=0.646N P=0.267 (e) |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.6% 0.0% | 0.0% 2.6% 5.5% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 529 --- | --- 677 466 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639N P=0.277 (e) | P=0.112 P=0.482 P=0.197 |
|POLY 3 | P=0.625N P=0.274 (e) | P=0.123 P=0.476 P=0.203 |
|POLY 1.5 | P=0.643N P=0.259 (e) | P=0.129 P=0.483 P=0.213 |
|POLY 6 | P=0.600N P=0.297 (e) | P=0.120 P=0.473 P=0.197 |
|LOGISTIC REGRESSION| P=0.634 P=0.198 (e) | P=0.149 P=0.488 P=0.280 |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | P=0.142 P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | 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 |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 36/50 (72%) 48/50 (96%) | 3/50 (6%) 45/50 (90%) 47/50 (94%) |
|POLY-3 ADJUSTED (b)| 0.0% 83.7% 98.3% | 6.9% 92.9% 94.0% |
|TERMINAL (d) | 0/8 (0%) 12/12 (100%) 11/11 (100%) | 1/28 (4%) 21/24 (88%) 19/22 (86%) |
|FIRST INCIDENCE | --- 495 329 | 585 225 271 |
|-------------------| | |
|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: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 46/50 (92%) 50/50 (100%) | 3/50 (6%) 46/50 (92%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 94.4% 100.0% | 6.9% 95.6% 100.0% |
|TERMINAL (d) | 0/8 (0%) 12/12 (100%) 11/11 (100%) | 1/28 (4%) 23/24 (96%) 22/22 (100%) |
|FIRST INCIDENCE | --- 380 329 | 585 225 271 |
|-------------------| | |
|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: Epidermis, Skin, Site of Application |
| Parakeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 9/50 (18%) 28/50 (56%) | 1/50 (2%) 11/50 (22%) 23/50 (46%) |
|POLY-3 ADJUSTED (b)| 0.0% 25.0% 64.6% | 2.3% 28.2% 55.2% |
|TERMINAL (d) | 0/8 (0%) 3/12 (25%) 5/11 (46%) | 0/28 (0%) 6/24 (25%) 8/22 (36%) |
|FIRST INCIDENCE | --- 558 329 | 585 578 271 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.014 * P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.005 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.005 ** P<0.001 ** | P<0.001 ** P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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 |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 2.9% | 4.6% 0.0% 23.4% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 1/28 (4%) 0/24 (0%) 3/22 (14%) |
|FIRST INCIDENCE | --- 677 729 (T) | 585 --- 308 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399 P=0.567 P=0.564 | P=0.004 ** P=0.285N P=0.014 * |
|POLY 3 | P=0.376 P=0.528 P=0.525 | P=0.003 ** P=0.269N P=0.014 * |
|POLY 1.5 | P=0.359 P=0.517 P=0.515 | P=0.004 ** P=0.259N P=0.016 * |
|POLY 6 | P=0.401 P=0.544 P=0.539 | P=0.003 ** P=0.275N P=0.012 * |
|LOGISTIC REGRESSION| P=0.378 P=0.539 P=0.564 | P=0.007 ** P=0.230N P=0.037 * |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.006 ** P=0.247N P=0.026 * |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 45/50 (90%) 50/50 (100%) | 2/50 (4%) 46/50 (92%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 0.0% 94.2% 100.0% | 4.6% 95.9% 98.0% |
|TERMINAL (d) | 0/8 (0%) 12/12 (100%) 11/11 (100%) | 1/28 (4%) 23/24 (96%) 21/22 (96%) |
|FIRST INCIDENCE | --- 380 329 | 585 225 271 |
|-------------------| | |
|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: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 3/50 (6%) 0/50 (0%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 5.8% | 6.9% 0.0% 16.3% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 1/28 (4%) 0/24 (0%) 2/22 (9%) |
|FIRST INCIDENCE | --- 677 632 | 585 --- 545 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.191 P=0.567 P=0.304 | P=0.097 P=0.158N P=0.155 |
|POLY 3 | P=0.170 P=0.528 P=0.267 | P=0.118 P=0.146N P=0.165 |
|POLY 1.5 | P=0.159 P=0.517 P=0.255 | P=0.126 P=0.137N P=0.186 |
|POLY 6 | P=0.187 P=0.544 P=0.286 | P=0.113 P=0.153N P=0.154 |
|LOGISTIC REGRESSION| P=0.165 P=0.539 P=0.279 | P=0.123 P=0.113N P=0.207 |
|COCH-ARM / FISHERS | P=0.142 P=0.500 P=0.247 | P=0.146 P=0.121N P=0.243 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.6% 14.1% 2.9% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 2/8 (25%) 2/12 (17%) 0/11 (0%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 495 611 632 | 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024N* P=0.321N P=0.034N* | P=0.304N P=0.531N P=0.548N |
|POLY 3 | P=0.033N* P=0.433N P=0.041N* | P=0.302N P=0.525N P=0.536N |
|POLY 1.5 | P=0.038N* P=0.455N P=0.046N* | P=0.292N P=0.518N P=0.525N |
|POLY 6 | P=0.028N* P=0.403N P=0.035N* | P=0.309N P=0.529N P=0.543N |
|LOGISTIC REGRESSION| P=0.035N* P=0.424N P=0.052N | P=0.304N (e) (e) |
|COCH-ARM / FISHERS | P=0.049N* P=0.500N P=0.056N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) | 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 3.3% 8.7% 8.5% | 6.9% 10.5% 2.8% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 2/24 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 603 720 565 | 493 562 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.465 P=0.411 | P=0.348N P=0.425 P=0.382N |
|POLY 3 | P=0.300 P=0.348 P=0.355 | P=0.357N P=0.428 P=0.375N |
|POLY 1.5 | P=0.275 P=0.333 P=0.335 | P=0.323N P=0.449 P=0.353N |
|POLY 6 | P=0.338 P=0.369 P=0.386 | P=0.382N P=0.414 P=0.391N |
|LOGISTIC REGRESSION| P=0.285 P=0.397 P=0.316 | P=0.237N P=0.510 P=0.207N |
|COCH-ARM / FISHERS | P=0.238 P=0.309 P=0.309 | P=0.252N P=0.500 P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen: Red Pulp |
| Depletion Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION 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)| 6.5% 0.0% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 521 --- 695 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317N P=0.186N P=0.445N | (e) (e) (e) |
|POLY 3 | P=0.356N P=0.212N P=0.463N | (e) (e) (e) |
|POLY 1.5 | P=0.357N P=0.221N P=0.477N | (e) (e) (e) |
|POLY 6 | P=0.355N P=0.200N P=0.445N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.341N P=0.234N P=0.472N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.247N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 8/50 (16%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 17.8% 13.7% 21.5% | 2.3% 2.6% 5.6% |
|TERMINAL (d) | 0/8 (0%) 1/12 (8%) 2/11 (18%) | 0/28 (0%) 0/24 (0%) 2/22 (9%) |
|FIRST INCIDENCE | 334 474 329 | 655 280 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 P=0.396N P=0.517 | P=0.328 P=0.740 P=0.424 |
|POLY 3 | P=0.388 P=0.444N P=0.465 | P=0.339 P=0.737 P=0.435 |
|POLY 1.5 | P=0.367 P=0.462N P=0.438 | P=0.351 P=0.744 P=0.455 |
|POLY 6 | P=0.412 P=0.420N P=0.498 | P=0.330 P=0.731 P=0.421 |
|LOGISTIC REGRESSION| P=0.240 P=0.607N P=0.288 | P=0.438 P=0.577N P=0.431 |
|COCH-ARM / FISHERS | P=0.326 P=0.500N P=0.387 | P=0.378 P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 8/50 (16%) 14/50 (28%) | 1/50 (2%) 3/50 (6%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 43.0% 21.7% 37.8% | 2.3% 7.7% 27.1% |
|TERMINAL (d) | 3/8 (38%) 2/12 (17%) 3/11 (27%) | 1/28 (4%) 1/24 (4%) 4/22 (18%) |
|FIRST INCIDENCE | 334 561 565 | 728 (T) 280 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244N P=0.028N* P=0.257N | P<0.001 ** P=0.268 P=0.002 ** |
|POLY 3 | P=0.391N P=0.039N* P=0.416N | P<0.001 ** P=0.275 P<0.001 ** |
|POLY 1.5 | P=0.415N P=0.050N P=0.448N | P<0.001 ** P=0.283 P=0.002 ** |
|POLY 6 | P=0.355N P=0.026N* P=0.363N | P<0.001 ** P=0.271 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.353N P=0.053N P=0.368N | P<0.001 ** P=0.437 P=0.002 ** |
|COCH-ARM / FISHERS | P=0.454N P=0.077N P=0.500N | P=0.002 ** P=0.309 P=0.004 ** |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.6% 5.8% 5.7% | 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 593 708 656 | --- 533 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.244N P=0.231N | P=0.704 P=0.478 (e) |
|POLY 3 | P=0.225N P=0.294N P=0.294N | P=0.698 P=0.478 (e) |
|POLY 1.5 | P=0.234N P=0.307N P=0.309N | P=0.708 P=0.484 (e) |
|POLY 6 | P=0.214N P=0.282N P=0.278N | P=0.691 P=0.476 (e) |
|LOGISTIC REGRESSION| P=0.216N P=0.292N P=0.315N | P=0.680N P=0.612 (e) |
|COCH-ARM / FISHERS | P=0.252N P=0.339N P=0.339N | 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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Perforation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.9% 5.7% 11.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 1/11 (9%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 589 561 565 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476N P=0.217N P=0.524N | (e) (e) (e) |
|POLY 3 | P=0.536N P=0.276N P=0.573N | (e) (e) (e) |
|POLY 1.5 | P=0.552N P=0.298N P=0.601N | (e) (e) (e) |
|POLY 6 | P=0.515N P=0.248N P=0.535N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.503N P=0.259N P=0.545N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.579 P=0.339N P=0.643N | (e) (e) (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 16/50 (32%) 18/50 (36%) | 2/50 (4%) 5/50 (10%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 51.1% 40.7% 45.5% | 4.7% 12.7% 35.1% |
|TERMINAL (d) | 3/8 (38%) 4/12 (33%) 3/11 (27%) | 2/28 (7%) 1/24 (4%) 6/22 (27%) |
|FIRST INCIDENCE | 334 558 329 | 728 (T) 280 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N P=0.168N P=0.299N | P<0.001 ** P=0.175 P<0.001 ** |
|POLY 3 | P=0.374N P=0.239N P=0.394N | P<0.001 ** P=0.183 P<0.001 ** |
|POLY 1.5 | P=0.434N P=0.305N P=0.465N | P<0.001 ** P=0.191 P<0.001 ** |
|POLY 6 | P=0.306N P=0.164N P=0.309N | P<0.001 ** P=0.179 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.455N P=0.297N P=0.478N | P<0.001 ** P=0.252 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.542 P=0.417N P=0.582N | P<0.001 ** P=0.218 P=0.002 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 7/50 (14%) 13/50 (26%) | 1/50 (2%) 3/50 (6%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 37.8% 19.2% 35.1% | 2.3% 7.5% 29.8% |
|TERMINAL (d) | 3/8 (38%) 2/12 (17%) 2/11 (18%) | 1/28 (4%) 0/24 (0%) 5/22 (23%) |
|FIRST INCIDENCE | 334 561 565 | 728 (T) 280 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.325N P=0.039N* P=0.335N | P<0.001 ** P=0.272 P<0.001 ** |
|POLY 3 | P=0.486N P=0.062N P=0.504N | P<0.001 ** P=0.280 P<0.001 ** |
|POLY 1.5 | P=0.511N P=0.076N P=0.539N | P<0.001 ** P=0.286 P<0.001 ** |
|POLY 6 | P=0.443N P=0.045N* P=0.441N | P<0.001 ** P=0.279 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.459N P=0.079N P=0.480N | P<0.001 ** P=0.527 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.548 P=0.105N P=0.590N | P<0.001 ** P=0.309 P=0.002 ** |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.3% 0.0% 5.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 677 --- 565 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428 P=0.433N P=0.591 | (e) (e) (e) |
|POLY 3 | P=0.386 P=0.474N P=0.548 | (e) (e) (e) |
|POLY 1.5 | P=0.376 P=0.484N P=0.529 | (e) (e) (e) |
|POLY 6 | P=0.399 P=0.462N P=0.575 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.381 P=0.461N P=0.534 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.500N P=0.500 | (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, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/50 (8%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 21.5% 17.0% 11.4% | 0.0% 2.6% 2.8% |
|TERMINAL (d) | 0/8 (0%) 2/12 (17%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 593 575 656 | --- 562 715 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.301N P=0.139N | P=0.283 P=0.472 P=0.457 |
|POLY 3 | P=0.169N P=0.436N P=0.210N | P=0.300 P=0.478 P=0.464 |
|POLY 1.5 | P=0.184N P=0.454N P=0.227N | P=0.309 P=0.484 P=0.475 |
|POLY 6 | P=0.156N P=0.428N P=0.196N | P=0.294 P=0.475 P=0.458 |
|LOGISTIC REGRESSION| P=0.142N P=0.382N P=0.202N | P=0.335 P=0.583 P=0.455 |
|COCH-ARM / FISHERS | P=0.215N P=0.500N P=0.262N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.8% | 0.0% 2.7% 2.8% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 687 | --- 708 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119 (e) P=0.312 | P=0.284 P=0.473 P=0.455 |
|POLY 3 | P=0.105 (e) P=0.266 | P=0.300 P=0.476 P=0.465 |
|POLY 1.5 | P=0.101 (e) P=0.255 | P=0.310 P=0.482 P=0.476 |
|POLY 6 | P=0.111 (e) P=0.284 | P=0.295 P=0.472 P=0.459 |
|LOGISTIC REGRESSION| P=0.111 (e) P=0.291 | P=0.298 P=0.472 P=0.483 |
|COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 8.5% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 565 | 493 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 (e) P=0.181 | P=0.299N P=0.526N P=0.540N |
|POLY 3 | P=0.041 * (e) P=0.145 | P=0.306N P=0.528N P=0.539N |
|POLY 1.5 | P=0.039 * (e) P=0.134 | P=0.294N P=0.520N P=0.527N |
|POLY 6 | P=0.045 * (e) P=0.164 | P=0.314N P=0.534N P=0.547N |
|LOGISTIC REGRESSION| P=0.040 * (e) P=0.138 | P=0.166N P=0.346N P=0.325N |
|COCH-ARM / FISHERS | P=0.037 * (e) P=0.121 | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Arteriole |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 11/50 (22%) 13/50 (26%) | |
|POLY-3 ADJUSTED (b)| 27.9% 29.9% 35.5% | |
|TERMINAL (d) | 3/8 (38%) 3/12 (25%) 5/11 (46%) | |
|FIRST INCIDENCE | 603 561 607 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439 P=0.516N P=0.510 | |
|POLY 3 | P=0.285 P=0.534 P=0.333 | |
|POLY 1.5 | P=0.251 P=0.484 P=0.292 | |
|POLY 6 | P=0.336 P=0.600 P=0.396 | |
|LOGISTIC REGRESSION| P=0.326 P=0.568 P=0.390 | |
|COCH-ARM / FISHERS | P=0.199 P=0.402 P=0.235 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Arteriole |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) 13/50 (26%) | |
|POLY-3 ADJUSTED (b)| 27.9% 27.2% 35.5% | |
|TERMINAL (d) | 3/8 (38%) 3/12 (25%) 5/11 (46%) | |
|FIRST INCIDENCE | 603 561 607 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433 P=0.444N P=0.510 | |
|POLY 3 | P=0.276 P=0.584N P=0.333 | |
|POLY 1.5 | P=0.244 P=0.584 P=0.292 | |
|POLY 6 | P=0.322 P=0.528N P=0.396 | |
|LOGISTIC REGRESSION| P=0.316 P=0.553N P=0.390 | |
|COCH-ARM / FISHERS | P=0.196 P=0.500 P=0.235 | |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 15/50 (30%) 17/50 (34%) | |
|POLY-3 ADJUSTED (b)| 34.1% 39.9% 44.7% | |
|TERMINAL (d) | 5/8 (63%) 4/12 (33%) 4/11 (36%) | |
|FIRST INCIDENCE | 540 474 389 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345 P=0.572N P=0.396 | |
|POLY 3 | P=0.212 P=0.398 P=0.244 | |
|POLY 1.5 | P=0.167 P=0.336 P=0.192 | |
|POLY 6 | P=0.295 P=0.496 P=0.340 | |
|LOGISTIC REGRESSION| P=0.207 P=0.422 P=0.250 | |
|COCH-ARM / FISHERS | P=0.112 P=0.247 P=0.133 | |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 12/50 (24%) 13/50 (26%) | |
|POLY-3 ADJUSTED (b)| 34.9% 31.4% 33.7% | |
|TERMINAL (d) | 2/8 (25%) 2/12 (17%) 2/11 (18%) | |
|FIRST INCIDENCE | 470 495 474 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.337N P=0.435N | |
|POLY 3 | P=0.517N P=0.474N P=0.556N | |
|POLY 1.5 | P=0.538 P=0.515N P=0.589 | |
|POLY 6 | P=0.460N P=0.422N P=0.493N | |
|LOGISTIC REGRESSION| P=0.492 P=0.534N P=0.543 | |
|COCH-ARM / FISHERS | P=0.454 P=0.592N P=0.500 | |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 11/50 (22%) 11/50 (22%) | 17/50 (34%) 7/50 (14%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 19.0% 28.7% 30.2% | 39.5% 17.8% 19.5% |
|TERMINAL (d) | 2/8 (25%) 3/12 (25%) 3/11 (27%) | 15/28 (54%) 4/24 (17%) 5/22 (23%) |
|FIRST INCIDENCE | 593 474 485 | 619 476 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300 P=0.319 P=0.357 | P=0.037N* P=0.042N* P=0.062N |
|POLY 3 | P=0.195 P=0.252 P=0.211 | P=0.019N* P=0.024N* P=0.043N* |
|POLY 1.5 | P=0.166 P=0.204 P=0.182 | P=0.015N* P=0.023N* P=0.032N* |
|POLY 6 | P=0.238 P=0.330 P=0.257 | P=0.021N* P=0.023N* P=0.049N* |
|LOGISTIC REGRESSION| P=0.172 P=0.181 P=0.234 | P=0.030N* P=0.036N* P=0.055N |
|COCH-ARM / FISHERS | P=0.124 P=0.143 P=0.143 | P=0.009N** P=0.017N* P=0.017N* |
|=================================================================================================================================|
| | | |
| | 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 442 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076N P=0.189N P=0.203N | (e) (e) (e) |
|POLY 3 | P=0.093N P=0.212N P=0.214N | (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.221N P=0.223N | (e) (e) (e) |
|POLY 6 | P=0.093N P=0.199N P=0.202N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.105N P=0.253N P=0.250N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 01/28/99 EXPERIMENT: 55312 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 2.9% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 563 656 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.438N P=0.221N | (e) (e) (e) |
|POLY 3 | P=0.131N P=0.462N P=0.216N | (e) (e) (e) |
|POLY 1.5 | P=0.135N P=0.475N P=0.223N | (e) (e) (e) |
|POLY 6 | P=0.127N P=0.445N P=0.207N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.150N P=0.515N P=0.257N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 3.3% 0.0% 2.9% | 0.0% 2.7% 5.5% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 0/28 (0%) 1/24 (4%) 1/22 (5%) |
|FIRST INCIDENCE | 618 --- 729 (T) | --- 728 (T) 588 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.616N P=0.477N P=0.700N | P=0.109 P=0.469 P=0.188 |
|POLY 3 | P=0.668N P=0.476N P=0.736N | P=0.122 P=0.475 P=0.202 |
|POLY 1.5 | P=0.667N P=0.484N P=0.745N | P=0.128 P=0.482 P=0.212 |
|POLY 6 | P=0.670N P=0.464N P=0.725N | P=0.119 P=0.471 P=0.196 |
|LOGISTIC REGRESSION| P=0.637N P=0.497N P=0.725N | P=0.121 P=0.469 P=0.225 |
|COCH-ARM / FISHERS | P=0.669 P=0.500N P=0.753N | P=0.142 P=0.500 P=0.247 |
|=================================================================================================================================|
(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).