TDMS Study 55312-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/26/97
EXPERIMENT: 55312 TEST: 04 TIME: 10:39:02
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: SINGER, A. CAS: 68603-42-9
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 09/26/97
EXPERIMENT: 55312 TEST: 04 TIME: 10:39:02
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: SINGER, A. CAS: 68603-42-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex: Capsule Hyperplasia
Bone Marrow Hyperplasia
Kidney Nephropathy
Pigmentation Hemosiderin
Liver Eosinophilic Focus
Skin: Epidermis, Skin, Site of Application
Hyperplasia
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Ulcer
Thyroid Gland: Follicular Cell Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Kidney Nephropathy
Liver Eosinophilic Focus
Necrosis
Skin: Control Inflammation
Skin: Epidermis, Skin, Site of Application
Hyperplasia
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Inflammation
Parakeratosis
Spleen Hematopoietic Cell Proliferation
Thyroid Gland: Follicular Cell Hyperplasia
Uterus Hyperplasia
===============================================================
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.5% 13.5% 6.7% | 0.0% 2.2% 2.5% |
|TERMINAL (d) | 3/41 (7%) 5/37 (14%) 3/36 (8%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) 711 727 (T) | --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.499 P=0.197 P=0.602 | P=0.268 P=0.506 P=0.441 |
|POLY 3 | P=0.553 P=0.222 P=0.649 | P=0.314 P=0.496 P=0.479 |
|POLY 1.5 | P=0.561 P=0.228 P=0.654 | P=0.320 P=0.498 P=0.486 |
|POLY 6 | P=0.544 P=0.216 P=0.643 | P=0.305 P=0.492 P=0.468 |
|LOGISTIC REGRESSION| P=0.532 P=0.204 P=0.602 | (e) P=0.506 P=0.441 |
|COCH-ARM / FISHERS | P=0.573 P=0.243 P=0.661N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 30/50 (60%) 26/50 (52%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 59.5% 66.0% 56.0% | 2.2% 0.0% 0.0% |
|TERMINAL (d) | 27/41 (66%) 27/37 (73%) 21/36 (58%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 490 507 555 | 701 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426 P=0.199 P=0.482 | P=0.304N P=0.521N P=0.551N |
|POLY 3 | P=0.405N P=0.329 P=0.446N | P=0.289N P=0.504N P=0.522N |
|POLY 1.5 | P=0.401N P=0.354 P=0.441N | P=0.282N P=0.502N P=0.514N |
|POLY 6 | P=0.396N P=0.313 P=0.438N | P=0.299N P=0.509N P=0.533N |
|LOGISTIC REGRESSION| P=0.451N P=0.304 P=0.486N | P=0.276N P=0.501N P=0.516N |
|COCH-ARM / FISHERS | P=0.381N P=0.420 P=0.421N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 15/50 (30%) 11/50 (22%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 17.3% 33.0% 24.3% | 0.0% 4.5% 0.0% |
|TERMINAL (d) | 8/41 (20%) 13/37 (35%) 10/36 (28%) | 0/35 (0%) 1/36 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) 507 692 | --- 649 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.045 * P=0.205 | P=0.621 P=0.232 (e) |
|POLY 3 | P=0.245 P=0.065 P=0.282 | P=0.632 P=0.234 (e) |
|POLY 1.5 | P=0.256 P=0.067 P=0.291 | P=0.645 P=0.236 (e) |
|POLY 6 | P=0.233 P=0.063 P=0.272 | P=0.611 P=0.231 (e) |
|LOGISTIC REGRESSION| P=0.243 P=0.061 P=0.249 | P=0.668 P=0.239 (e) |
|COCH-ARM / FISHERS | P=0.275 P=0.077 P=0.306 | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 4.3% 4.5% 0.0% | 4.4% 2.2% 4.9% |
|TERMINAL (d) | 2/41 (5%) 2/37 (5%) 0/36 (0%) | 1/35 (3%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) 727 (T) --- | 702 729 (T) 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207N P=0.658 P=0.267N | P=0.509 P=0.503N P=0.586 |
|POLY 3 | P=0.185N P=0.678 P=0.244N | P=0.586 P=0.507N P=0.656 |
|POLY 1.5 | P=0.182N P=0.683 P=0.241N | P=0.594 P=0.503N P=0.670 |
|POLY 6 | P=0.189N P=0.674 P=0.247N | P=0.575 P=0.515N P=0.637 |
|LOGISTIC REGRESSION| P=0.207N P=0.658 (e) | P=0.562 P=0.515N P=0.655 |
|COCH-ARM / FISHERS | P=0.176N P=0.691N P=0.247N | P=0.610 P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 19/50 (38%) | 7/50 (14%) 10/50 (20%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 20.9% 21.7% 40.4% | 15.0% 21.6% 43.9% |
|TERMINAL (d) | 5/41 (12%) 5/37 (14%) 12/36 (33%) | 1/35 (3%) 6/36 (17%) 10/26 (39%) |
|FIRST INCIDENCE | 584 454 401 | 506 473 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * P=0.519 P=0.031 * | P<0.001 ** P=0.304 P=0.002 ** |
|POLY 3 | P=0.021 * P=0.562 P=0.031 * | P<0.001 ** P=0.289 P=0.002 ** |
|POLY 1.5 | P=0.023 * P=0.573 P=0.034 * | P=0.002 ** P=0.295 P=0.002 ** |
|POLY 6 | P=0.019 * P=0.550 P=0.028 * | P<0.001 ** P=0.276 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.028 * P=0.563N P=0.043 * | P=0.004 ** P=0.302 P=0.005 ** |
|COCH-ARM / FISHERS | P=0.026 * P=0.598N P=0.038 * | P=0.004 ** P=0.298 P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 21/50 (42%) 21/50 (42%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 45.3% 47.0% 44.9% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 15/35 (43%) 20/36 (56%) 13/26 (50%) |
|FIRST INCIDENCE | --- --- --- | 589 680 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.277 P=0.561N P=0.322 |
|POLY 3 | (e) (e) (e) | P=0.536N P=0.518 P=0.572N |
|POLY 1.5 | (e) (e) (e) | P=0.479N P=0.551 P=0.518N |
|POLY 6 | (e) (e) (e) | P=0.478 P=0.459 P=0.528 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.434 P=0.498 P=0.538 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.380N P=0.580N P=0.419N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Neuron |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% | 0.0% 4.4% 7.2% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 692 --- | --- 611 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.725 P=0.490 (e) | P=0.066 P=0.229 P=0.100 |
|POLY 3 | P=0.725 P=0.492 (e) | P=0.071 P=0.236 P=0.105 |
|POLY 1.5 | P=0.727 P=0.494 (e) | P=0.075 P=0.237 P=0.109 |
|POLY 6 | P=0.723 P=0.490 (e) | P=0.067 P=0.235 P=0.099 |
|LOGISTIC REGRESSION| P=0.730N P=0.502 (e) | P=0.116 P=0.220 P=0.145 |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.082 P=0.247 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 4.2% 2.2% 4.4% | |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 2/36 (6%) | |
|FIRST INCIDENCE | 490 454 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579 P=0.519N P=0.656 | |
|POLY 3 | P=0.599 P=0.514N P=0.678 | |
|POLY 1.5 | P=0.603 P=0.510N P=0.684 | |
|POLY 6 | P=0.594 P=0.518N P=0.672 | |
|LOGISTIC REGRESSION| P=0.582N P=0.329N P=0.674N | |
|COCH-ARM / FISHERS | P=0.610 P=0.500N P=0.691N | |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 2/2 (100%) 1/1 (100%) | 1/1 (100%) 0/2 (0%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% | 100.0% 0.0% 100.0% |
|TERMINAL (d) | 0/1 (0%) 2/2 (100%) 0/0 (0%) | 0/0 (0%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- 727 (T) 630 | 429 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 P=0.362 P=0.480 | P=0.512N P=0.504N (e) |
|POLY 3 | P=1.000N P=1.000N P=1.000N | P=0.949 P=0.223N (e) |
|POLY 1.5 | P=1.000N P=1.000N P=1.000N | P=0.998 P=0.030N* (e) |
|POLY 6 | P=1.000N P=1.000N P=1.000N | P=0.850 P=0.406N (e) |
|LOGISTIC REGRESSION| (e) P=0.362 (e) | P=0.681 (e) (e) |
|COCH-ARM / FISHERS | P=0.207 P=0.333 P=0.500 | P=0.760 P=0.333N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.6% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 1/37 (3%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 356 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622 P=0.116 (e) | (e) (e) (e) |
|POLY 3 | P=0.627 P=0.116 (e) | (e) (e) (e) |
|POLY 1.5 | P=0.633 P=0.117 (e) | (e) (e) (e) |
|POLY 6 | P=0.621 P=0.115 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.612N P=0.180 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.640 P=0.121 (e) | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/40 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- | --- --- 661 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.072 (e) P=0.184 |
|POLY 3 | (e) (e) (e) | P=0.094 (e) P=0.217 |
|POLY 1.5 | (e) (e) (e) | P=0.094 (e) P=0.224 |
|POLY 6 | (e) (e) (e) | P=0.094 (e) P=0.207 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.102 (e) P=0.248 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/49 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.3% 0.0% 4.9% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 1/34 (3%) 0/36 (0%) 2/26 (8%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.289 P=0.489N P=0.406 |
|POLY 3 | (e) (e) (e) | P=0.361 P=0.499N P=0.471 |
|POLY 1.5 | (e) (e) (e) | P=0.362 P=0.497N P=0.484 |
|POLY 6 | (e) (e) (e) | P=0.359 P=0.503N P=0.452 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.289 (e) P=0.406 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.366 P=0.495N P=0.508 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 23/50 (46%) 21/50 (42%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 43.4% 49.3% 46.0% | 2.2% 0.0% 4.9% |
|TERMINAL (d) | 17/41 (42%) 17/37 (46%) 17/36 (47%) | 1/35 (3%) 0/36 (0%) 1/26 (4%) |
|FIRST INCIDENCE | 490 507 667 | 729 (T) --- 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.359 P=0.293 P=0.396 | P=0.292 P=0.494N P=0.408 |
|POLY 3 | P=0.435 P=0.356 P=0.482 | P=0.355 P=0.504N P=0.465 |
|POLY 1.5 | P=0.476 P=0.372 P=0.521 | P=0.357 P=0.502N P=0.478 |
|POLY 6 | P=0.393 P=0.347 P=0.441 | P=0.353 P=0.508N P=0.448 |
|LOGISTIC REGRESSION| P=0.515 P=0.410 P=0.549 | P=0.336 (e) P=0.467 |
|COCH-ARM / FISHERS | P=0.540 P=0.420 P=0.580N | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.2% 0.0% | 4.4% 0.0% 2.4% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 612 454 --- | 664 --- 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340N P=0.753 P=0.513N | P=0.430N P=0.253N P=0.589N |
|POLY 3 | P=0.345N P=0.753 P=0.507N | P=0.381N P=0.243N P=0.537N |
|POLY 1.5 | P=0.340N P=0.755 P=0.504N | P=0.374N P=0.240N P=0.523N |
|POLY 6 | P=0.352N P=0.750 P=0.511N | P=0.392N P=0.248N P=0.555N |
|LOGISTIC REGRESSION| P=0.272N P=0.643N P=0.466N | P=0.351N P=0.237N P=0.499N |
|COCH-ARM / FISHERS | P=0.331N P=0.753N P=0.500N | P=0.360N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 16/50 (32%) 11/50 (22%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 25.5% 35.6% 24.2% | 0.0% 0.0% 2.5% |
|TERMINAL (d) | 9/41 (22%) 14/37 (38%) 9/36 (25%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 612 645 662 | --- --- 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.499 P=0.175 P=0.565 | P=0.233 (e) P=0.450 |
|POLY 3 | P=0.500N P=0.205 P=0.537N | P=0.275 (e) P=0.479 |
|POLY 1.5 | P=0.482N P=0.219 P=0.522N | P=0.273 (e) P=0.487 |
|POLY 6 | P=0.522N P=0.191 P=0.554N | P=0.278 (e) P=0.468 |
|LOGISTIC REGRESSION| P=0.492N P=0.208 P=0.529N | P=0.238 (e) P=0.456 |
|COCH-ARM / FISHERS | P=0.455N P=0.252 P=0.500N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- | 679 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.129N P=0.268N P=0.311N |
|POLY 3 | (e) (e) (e) | P=0.105N P=0.243N P=0.264N |
|POLY 1.5 | (e) (e) (e) | P=0.101N P=0.240N P=0.254N |
|POLY 6 | (e) (e) (e) | P=0.111N P=0.249N P=0.279N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.089N P=0.236N P=0.232N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) 50/50 (100%) | 27/50 (54%) 24/50 (48%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 96.3% 99.9% 100.0% | 58.6% 52.3% 34.6% |
|TERMINAL (d) | 40/41 (98%) 37/37 (100%) 36/36 (100%) | 23/35 (66%) 21/36 (58%) 9/26 (35%) |
|FIRST INCIDENCE | 490 356 401 | 568 561 422 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050 P=0.113 P=0.059 | P=0.111N P=0.304N P=0.141N |
|POLY 3 | P=0.088 P=0.269 P=0.244 | P=0.014N* P=0.344N P=0.016N* |
|POLY 1.5 | P=0.060 P=0.243 P=0.176 | P=0.012N* P=0.339N P=0.014N* |
|POLY 6 | P=0.150 P=0.354 P=0.347 | P=0.017N* P=0.362N P=0.020N* |
|LOGISTIC REGRESSION| P=0.022 * P=0.095 P=0.074 | P=0.024N* P=0.399N P=0.027N* |
|COCH-ARM / FISHERS | P=0.060 P=0.309 P=0.121 | P=0.010N* P=0.345N P=0.013N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.7% | 2.2% 0.0% 4.8% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 2/36 (6%) | 1/35 (3%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 713 | 729 (T) --- 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * (e) P=0.104 | P=0.307 P=0.494N P=0.429 |
|POLY 3 | P=0.035 * (e) P=0.114 | P=0.356 P=0.504N P=0.467 |
|POLY 1.5 | P=0.035 * (e) P=0.116 | P=0.357 P=0.502N P=0.479 |
|POLY 6 | P=0.035 * (e) P=0.112 | P=0.353 P=0.508N P=0.451 |
|LOGISTIC REGRESSION| P=0.035 * (e) P=0.111 | P=0.374 (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.037 * (e) P=0.121 | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 2.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/37 (0%) 1/36 (3%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.397N P=0.261N P=0.545N | (e) (e) (e) |
|POLY 3 | P=0.367N P=0.247N P=0.510N | (e) (e) (e) |
|POLY 1.5 | P=0.364N P=0.244N P=0.506N | (e) (e) (e) |
|POLY 6 | P=0.369N P=0.249N P=0.515N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.397N (e) P=0.545N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.247N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR 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)| 2.2% 0.0% 4.4% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 1/36 (3%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) --- 722 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330 P=0.520N P=0.458 | (e) (e) (e) |
|POLY 3 | P=0.358 P=0.509N P=0.490 | (e) (e) (e) |
|POLY 1.5 | P=0.359 P=0.506N P=0.494 | (e) (e) (e) |
|POLY 6 | P=0.357 P=0.511N P=0.486 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.343 (e) P=0.477 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.500N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.6% 0.0% | 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 2/37 (5%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- 356 --- | 702 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615 P=0.110 (e) | P=0.123N P=0.255N P=0.304N |
|POLY 3 | P=0.627 P=0.115 (e) | P=0.104N P=0.242N P=0.263N |
|POLY 1.5 | P=0.633 P=0.116 (e) | P=0.101N P=0.240N P=0.253N |
|POLY 6 | P=0.621 P=0.113 (e) | P=0.110N P=0.247N P=0.277N |
|LOGISTIC REGRESSION| P=0.617N P=0.164 (e) | P=0.103N P=0.240N P=0.260N |
|COCH-ARM / FISHERS | P=0.640 P=0.121 (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 4/50 (8%) | 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 17.3% 18.0% 8.8% | 4.4% 4.4% 4.8% |
|TERMINAL (d) | 8/41 (20%) 8/37 (22%) 3/36 (8%) | 2/35 (6%) 1/36 (3%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 667 | 729 (T) 553 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216N P=0.520 P=0.242N | P=0.531 P=0.682N P=0.623 |
|POLY 3 | P=0.163N P=0.571 P=0.188N | P=0.571 P=0.692 P=0.662 |
|POLY 1.5 | P=0.159N P=0.582 P=0.184N | P=0.581 P=0.693 P=0.673 |
|POLY 6 | P=0.167N P=0.562 P=0.192N | P=0.558 P=0.688 P=0.647 |
|LOGISTIC REGRESSION| P=0.178N P=0.520 P=0.200N | P=0.556N P=0.693N P=0.686N |
|COCH-ARM / FISHERS | P=0.152N P=0.607N P=0.178N | P=0.601 P=0.691N P=0.691N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 29/50 (58%) 31/50 (62%) | 18/50 (36%) 25/50 (50%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 42.5% 63.1% 65.2% | 38.8% 54.4% 54.0% |
|TERMINAL (d) | 18/41 (44%) 24/37 (65%) 25/36 (69%) | 16/35 (46%) 21/36 (58%) 16/26 (62%) |
|FIRST INCIDENCE | 618 507 456 | 506 584 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.023 * P=0.007 ** | P=0.013 * P=0.128 P=0.020 * |
|POLY 3 | P=0.014 * P=0.034 * P=0.019 * | P=0.082 P=0.093 P=0.103 |
|POLY 1.5 | P=0.015 * P=0.038 * P=0.019 * | P=0.098 P=0.102 P=0.119 |
|POLY 6 | P=0.014 * P=0.032 * P=0.019 * | P=0.061 P=0.082 P=0.079 |
|LOGISTIC REGRESSION| P=0.012 * P=0.032 * P=0.018 * | P=0.082 P=0.094 P=0.120 |
|COCH-ARM / FISHERS | P=0.018 * P=0.055 P=0.022 * | P=0.134 P=0.113 P=0.156 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- | 701 644 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.182N P=0.523N P=0.300N |
|POLY 3 | (e) (e) (e) | P=0.166N P=0.505N P=0.262N |
|POLY 1.5 | (e) (e) (e) | P=0.157N P=0.502N P=0.253N |
|POLY 6 | (e) (e) (e) | P=0.179N P=0.511N P=0.277N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.140N P=0.498N P=0.264N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.142N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 6/50 (12%) | 1/50 (2%) 5/50 (10%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.7% 15.8% 13.3% | 2.2% 11.1% 0.0% |
|TERMINAL (d) | 5/41 (12%) 7/37 (19%) 6/36 (17%) | 1/35 (3%) 4/36 (11%) 0/26 (0%) |
|FIRST INCIDENCE | 490 727 (T) 727 (T) | 729 (T) 553 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.464 P=0.425 P=0.534 | P=0.495N P=0.112 P=0.559N |
|POLY 3 | P=0.526 P=0.456 P=0.590 | P=0.480N P=0.100 P=0.521N |
|POLY 1.5 | P=0.539 P=0.470 P=0.601 | P=0.450N P=0.101 P=0.514N |
|POLY 6 | P=0.511 P=0.442 P=0.577 | P=0.524N P=0.096 P=0.532N |
|LOGISTIC REGRESSION| P=0.536 P=0.476 P=0.611 | P=0.423N P=0.103 (e) |
|COCH-ARM / FISHERS | P=0.560 P=0.500 P=0.620N | P=0.399N P=0.102 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) | 2/50 (4%) 5/50 (10%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 2.1% 6.6% 4.4% | 4.3% 10.9% 18.6% |
|TERMINAL (d) | 0/41 (0%) 1/37 (3%) 1/36 (3%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 664 576 667 | 429 553 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375 P=0.286 P=0.477 | P=0.022 * P=0.218 P=0.035 * |
|POLY 3 | P=0.387 P=0.295 P=0.490 | P=0.023 * P=0.208 P=0.033 * |
|POLY 1.5 | P=0.392 P=0.298 P=0.494 | P=0.026 * P=0.212 P=0.036 * |
|POLY 6 | P=0.381 P=0.294 P=0.485 | P=0.021 * P=0.205 P=0.029 * |
|LOGISTIC REGRESSION| P=0.415 P=0.355 P=0.509 | P=0.082 P=0.160 P=0.097 |
|COCH-ARM / FISHERS | P=0.399 P=0.309 P=0.500 | P=0.033 * P=0.218 P=0.046 * |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% | 0.0% 4.4% 2.5% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 1/36 (3%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) | --- 553 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639 P=0.520N P=0.733 | P=0.305 P=0.247 P=0.441 |
|POLY 3 | P=0.667 P=0.509N P=0.754 | P=0.326 P=0.236 P=0.479 |
|POLY 1.5 | P=0.667 P=0.506N P=0.757 | P=0.339 P=0.237 P=0.486 |
|POLY 6 | P=0.666 P=0.511N P=0.751 | P=0.309 P=0.233 P=0.468 |
|LOGISTIC REGRESSION| P=0.639 (e) P=0.733 | P=0.379 P=0.226 P=0.441 |
|COCH-ARM / FISHERS | P=0.669 P=0.500N P=0.753N | P=0.360 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.6% 9.0% 2.2% | 2.2% 2.2% 4.9% |
|TERMINAL (d) | 3/41 (7%) 3/37 (8%) 1/36 (3%) | 0/35 (0%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 618 692 727 (T) | 664 729 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.184N P=0.593 P=0.217N | P=0.298 P=0.750 P=0.410 |
|POLY 3 | P=0.160N P=0.617 P=0.190N | P=0.357 P=0.755 P=0.463 |
|POLY 1.5 | P=0.154N P=0.625 P=0.186N | P=0.365 P=0.758 P=0.477 |
|POLY 6 | P=0.167N P=0.609 P=0.196N | P=0.347 P=0.750 P=0.445 |
|LOGISTIC REGRESSION| P=0.154N P=0.627 P=0.182N | P=0.366 P=0.762N P=0.500 |
|COCH-ARM / FISHERS | P=0.146N P=0.643N P=0.181N | P=0.378 P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/45 (2%) 0/44 (0%) | 0/49 (0%) 0/47 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% | 0.0% 0.0% 5.0% |
|TERMINAL (d) | 0/40 (0%) 1/34 (3%) 0/32 (0%) | 0/35 (0%) 0/35 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- 727 (T) --- | --- --- 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.698 P=0.468 (e) | P=0.068 (e) P=0.180 |
|POLY 3 | P=0.716 P=0.481 (e) | P=0.095 (e) P=0.212 |
|POLY 1.5 | P=0.718 P=0.484 (e) | P=0.095 (e) P=0.221 |
|POLY 6 | P=0.713 P=0.478 (e) | P=0.095 (e) P=0.201 |
|LOGISTIC REGRESSION| (e) P=0.468 (e) | P=0.074 (e) P=0.190 |
|COCH-ARM / FISHERS | P=0.721 P=0.489 (e) | P=0.097 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 1/48 (2%) 1/47 (2%) | 0/48 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.3% 2.3% | 0.0% 2.2% 5.0% |
|TERMINAL (d) | 1/38 (3%) 1/37 (3%) 0/35 (0%) | 0/33 (0%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 722 | --- 729 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615 P=0.756 P=0.740 | P=0.102 P=0.517 P=0.188 |
|POLY 3 | P=0.637N P=0.755N P=0.758N | P=0.133 P=0.505 P=0.218 |
|POLY 1.5 | P=0.635N P=0.754N P=0.757N | P=0.137 P=0.507 P=0.227 |
|POLY 6 | P=0.639N P=0.756N P=0.760N | P=0.127 P=0.502 P=0.207 |
|LOGISTIC REGRESSION| P=0.636 P=0.756 P=0.761 | P=0.102 P=0.517 P=0.186 |
|COCH-ARM / FISHERS | P=0.635N P=0.742N P=0.747N | P=0.144 P=0.510 P=0.253 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/48 (0%) 2/47 (4%) | 0/48 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/37 (0%) 1/35 (3%) | 0/33 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 722 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 (e) P=0.220 | (e) (e) (e) |
|POLY 3 | P=0.095 (e) P=0.239 | (e) (e) (e) |
|POLY 1.5 | P=0.095 (e) P=0.241 | (e) (e) (e) |
|POLY 6 | P=0.095 (e) P=0.238 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.093 (e) P=0.235 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.096 (e) P=0.253 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 2/48 (4%) 3/47 (6%) | 1/48 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.7% 4.6% 7.0% | 2.3% 0.0% 5.0% |
|TERMINAL (d) | 2/38 (5%) 1/37 (3%) 3/35 (9%) | 0/33 (0%) 0/36 (0%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) 696 727 (T) | 681 --- 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.374 P=0.682 P=0.462 | P=0.291 P=0.525N P=0.407 |
|POLY 3 | P=0.412 P=0.684N P=0.505 | P=0.360 P=0.496N P=0.469 |
|POLY 1.5 | P=0.413 P=0.683N P=0.507 | P=0.362 P=0.493N P=0.483 |
|POLY 6 | P=0.409 P=0.684N P=0.502 | P=0.358 P=0.500N P=0.449 |
|LOGISTIC REGRESSION| P=0.405 P=0.688N P=0.462 | P=0.335 P=0.492N P=0.467 |
|COCH-ARM / FISHERS | P=0.415 P=0.675N P=0.510 | P=0.365 P=0.490N P=0.508 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 0/48 (0%) 2/47 (4%) | 1/48 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 4.7% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/37 (0%) 1/35 (3%) | 1/33 (3%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) --- 713 | 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341 P=0.505N P=0.472 | P=0.293N P=0.483N P=0.548N |
|POLY 3 | P=0.365 P=0.495N P=0.504 | P=0.284N P=0.495N P=0.517N |
|POLY 1.5 | P=0.365 P=0.494N P=0.506 | P=0.278N P=0.493N P=0.509N |
|POLY 6 | P=0.365 P=0.496N P=0.502 | P=0.294N P=0.498N P=0.528N |
|LOGISTIC REGRESSION| P=0.359 (e) P=0.499 | P=0.293N (e) (e) |
|COCH-ARM / FISHERS | P=0.365 P=0.489N P=0.508 | P=0.266N P=0.490N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/3 (0%) 0/3 (0%) 0/4 (0%) | 2/12 (17%) 0/9 (0%) 0/8 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 17.2% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/2 (0%) 0/3 (0%) | 2/8 (25%) 0/5 (0%) 0/6 (0%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.135N P=0.341N P=0.298N |
|POLY 3 | (e) (e) (e) | P=0.149N P=0.349N P=0.344N |
|POLY 1.5 | (e) (e) (e) | P=0.144N P=0.327N P=0.337N |
|POLY 6 | (e) (e) (e) | P=0.156N P=0.377N P=0.353N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.135N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.137N P=0.314N P=0.347N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/3 (33%) 1/3 (33%) 2/4 (50%) | 9/12 (75%) 8/9 (89%) 7/8 (88%) |
|POLY-3 ADJUSTED (b)| 42.1% 34.8% 50.0% | 75.1% 96.7% 93.8% |
|TERMINAL (d) | 1/1 (100%) 1/2 (50%) 1/3 (33%) | 6/8 (75%) 5/5 (100%) 6/6 (100%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 595 | 687 616 661 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.648 P=0.638N P=0.758 | P=0.530 P=0.397 P=0.619 |
|POLY 3 | P=0.564 P=0.730N P=0.702 | P=0.154 P=0.243 P=0.330 |
|POLY 1.5 | P=0.521 P=0.745N P=0.660 | P=0.217 P=0.300 P=0.383 |
|POLY 6 | P=0.634 P=0.700N P=0.757N | P=0.099 P=0.202 P=0.269 |
|LOGISTIC REGRESSION| P=0.470 P=0.638N P=0.631 | P=0.148 P=0.186 P=0.274 |
|COCH-ARM / FISHERS | P=0.469 P=0.800N P=0.629 | P=0.313 P=0.414 P=0.465 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% | 0.0% 2.2% 5.0% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 1/36 (3%) | 0/35 (0%) 0/36 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) | --- 678 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639 P=0.520N P=0.733 | P=0.110 P=0.481 P=0.202 |
|POLY 3 | P=0.667 P=0.509N P=0.754 | P=0.128 P=0.497 P=0.212 |
|POLY 1.5 | P=0.667 P=0.506N P=0.757 | P=0.132 P=0.499 P=0.219 |
|POLY 6 | P=0.666 P=0.511N P=0.751 | P=0.124 P=0.494 P=0.203 |
|LOGISTIC REGRESSION| P=0.639 (e) P=0.733 | P=0.159 P=0.501 P=0.258 |
|COCH-ARM / FISHERS | P=0.669 P=0.500N P=0.753N | P=0.138 P=0.500 P=0.242 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 0.0% 4.5% 0.0% |
|TERMINAL (d) | | 0/35 (0%) 2/36 (6%) 0/26 (0%) |
|FIRST INCIDENCE | | --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.612 P=0.244 (e) |
|POLY 3 | | P=0.632 P=0.233 (e) |
|POLY 1.5 | | P=0.645 P=0.235 (e) |
|POLY 6 | | P=0.611 P=0.229 (e) |
|LOGISTIC REGRESSION| | (e) P=0.244 (e) |
|COCH-ARM / FISHERS | | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 15/50 (30%) 14/50 (28%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| | 32.1% 30.8% 35.6% |
|TERMINAL (d) | | 11/35 (31%) 11/36 (31%) 9/26 (35%) |
|FIRST INCIDENCE | | 479 561 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.239 P=0.491N P=0.265 |
|POLY 3 | | P=0.419 P=0.536N P=0.453 |
|POLY 1.5 | | P=0.461 P=0.518N P=0.499 |
|POLY 6 | | P=0.368 P=0.563N P=0.398 |
|LOGISTIC REGRESSION| | P=0.431 P=0.510N P=0.480 |
|COCH-ARM / FISHERS | | P=0.544 P=0.500N P=0.586N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| | 4.3% 0.0% 4.9% |
|TERMINAL (d) | | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | | 479 --- 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.551 P=0.253N P=0.610 |
|POLY 3 | | P=0.611 P=0.246N P=0.650 |
|POLY 1.5 | | P=0.615 P=0.242N P=0.666 |
|POLY 6 | | P=0.606 P=0.253N P=0.628 |
|LOGISTIC REGRESSION| | P=0.541N P=0.275N P=0.635N |
|COCH-ARM / FISHERS | | P=0.622 P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 5/50 (10%) | 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.3% 4.5% 10.9% | 2.2% 9.0% 2.4% |
|TERMINAL (d) | 1/41 (2%) 1/37 (3%) 3/36 (8%) | 0/35 (0%) 4/36 (11%) 0/26 (0%) |
|FIRST INCIDENCE | 673 617 555 | 617 729 (T) 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.665 P=0.188 | P=0.512 P=0.185 P=0.737 |
|POLY 3 | P=0.143 P=0.680 P=0.212 | P=0.543 P=0.170 P=0.737 |
|POLY 1.5 | P=0.145 P=0.684 P=0.214 | P=0.564 P=0.175 P=0.745 |
|POLY 6 | P=0.142 P=0.677 P=0.210 | P=0.513 P=0.163 P=0.724 |
|LOGISTIC REGRESSION| P=0.152 P=0.687N P=0.233 | P=0.591 P=0.176 P=0.722N |
|COCH-ARM / FISHERS | P=0.146 P=0.691N P=0.218 | P=0.601 P=0.181 P=0.753N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% | 6.5% 2.2% 2.5% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 1/36 (3%) | 2/35 (6%) 1/36 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- 727 (T) | 568 729 (T) 728 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 (e) P=0.474 | P=0.264N P=0.301N P=0.394N |
|POLY 3 | P=0.271 (e) P=0.494 | P=0.232N P=0.316N P=0.349N |
|POLY 1.5 | P=0.271 (e) P=0.496 | P=0.221N P=0.311N P=0.332N |
|POLY 6 | P=0.271 (e) P=0.492 | P=0.249N P=0.325N P=0.372N |
|LOGISTIC REGRESSION| (e) (e) P=0.474 | P=0.211N P=0.303N P=0.311N |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.202N P=0.309N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 2.2% | 4.4% 2.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 1/36 (3%) | 2/35 (6%) 1/36 (3%) 0/26 (0%) |
|FIRST INCIDENCE | --- 617 727 (T) | 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315 P=0.496 P=0.474 | P=0.183N P=0.490N P=0.306N |
|POLY 3 | P=0.327 P=0.493 P=0.494 | P=0.165N P=0.507N P=0.262N |
|POLY 1.5 | P=0.329 P=0.495 P=0.496 | P=0.157N P=0.503N P=0.253N |
|POLY 6 | P=0.325 P=0.492 P=0.492 | P=0.178N P=0.513N P=0.275N |
|LOGISTIC REGRESSION| P=0.337 P=0.552 P=0.474 | P=0.183N P=0.490N (e) |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.142N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/45 (4%) 3/47 (6%) 0/49 (0%) | 0/48 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.8% 7.1% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/37 (5%) 2/34 (6%) 0/35 (0%) | 0/34 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 727 (T) 454 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217N P=0.467 P=0.251N | (e) (e) (e) |
|POLY 3 | P=0.192N P=0.504 P=0.226N | (e) (e) (e) |
|POLY 1.5 | P=0.187N P=0.508 P=0.223N | (e) (e) (e) |
|POLY 6 | P=0.198N P=0.498 P=0.229N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.169N P=0.552 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.180N P=0.521 P=0.226N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/45 (9%) 2/47 (4%) 4/49 (8%) | 28/48 (58%) 31/50 (62%) 27/49 (55%) |
|POLY-3 ADJUSTED (b)| 9.5% 4.8% 9.1% | 63.6% 67.3% 63.2% |
|TERMINAL (d) | 3/37 (8%) 2/34 (6%) 3/35 (9%) | 26/34 (77%) 27/36 (75%) 18/26 (69%) |
|FIRST INCIDENCE | 673 727 (T) 713 | 679 473 422 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 P=0.376N P=0.610 | P=0.124 P=0.437 P=0.151 |
|POLY 3 | P=0.552N P=0.344N P=0.617N | P=0.535N P=0.442 P=0.575N |
|POLY 1.5 | P=0.545N P=0.335N P=0.608N | P=0.498N P=0.448 P=0.538N |
|POLY 6 | P=0.561N P=0.354N P=0.628N | P=0.511 P=0.414 P=0.564 |
|LOGISTIC REGRESSION| P=0.563N P=0.347N P=0.624N | P=0.355 P=0.309 P=0.403 |
|COCH-ARM / FISHERS | P=0.535N P=0.318N P=0.594N | P=0.412N P=0.435 P=0.454N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/49 (43%) 21/50 (42%) 14/50 (28%) | |
|POLY-3 ADJUSTED (b)| 46.1% 45.7% 30.8% | |
|TERMINAL (d) | 20/40 (50%) 16/37 (43%) 10/36 (28%) | |
|FIRST INCIDENCE | 673 507 662 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174N P=0.457 P=0.188N | |
|POLY 3 | P=0.082N P=0.570N P=0.096N | |
|POLY 1.5 | P=0.080N P=0.570N P=0.094N | |
|POLY 6 | P=0.084N P=0.560N P=0.098N | |
|LOGISTIC REGRESSION| P=0.092N P=0.544 P=0.112N | |
|COCH-ARM / FISHERS | P=0.077N P=0.547N P=0.091N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Control |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 0.0% 7.3% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- | --- --- 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.025 * (e) P=0.088 |
|POLY 3 | (e) (e) (e) | P=0.034 * (e) P=0.102 |
|POLY 1.5 | (e) (e) (e) | P=0.035 * (e) P=0.108 |
|POLY 6 | (e) (e) (e) | P=0.034 * (e) P=0.095 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.035 * (e) P=0.114 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.037 * (e) P=0.121 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 47/50 (94%) 50/50 (100%) | 9/50 (18%) 47/50 (94%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 10.8% 95.8% 100.0% | 19.7% 96.5% 100.0% |
|TERMINAL (d) | 5/41 (12%) 35/37 (95%) 36/36 (100%) | 7/35 (20%) 35/36 (97%) 26/26 (100%) |
|FIRST INCIDENCE | 727 (T) 356 401 | 679 561 98 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 44/50 (88%) 49/50 (98%) | 0/50 (0%) 42/50 (84%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 0.0% 92.8% 98.3% | 0.0% 87.9% 97.5% |
|TERMINAL (d) | 0/41 (0%) 34/37 (92%) 36/36 (100%) | 0/35 (0%) 33/36 (92%) 26/26 (100%) |
|FIRST INCIDENCE | --- 507 401 | --- 561 98 |
|-------------------| | |
|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: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 24/50 (48%) 23/50 (46%) | 5/50 (10%) 30/50 (60%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 0.0% 50.7% 48.9% | 11.0% 63.4% 86.8% |
|TERMINAL (d) | 0/41 (0%) 16/37 (43%) 14/36 (39%) | 4/35 (11%) 21/36 (58%) 23/26 (89%) |
|FIRST INCIDENCE | --- 454 555 | 701 553 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 3/50 (6%) 2/50 (4%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 4.3% 4.5% 4.4% | 6.6% 4.5% 25.7% |
|TERMINAL (d) | 2/41 (5%) 2/37 (5%) 1/36 (3%) | 2/35 (6%) 2/36 (6%) 6/26 (23%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 630 | 701 729 (T) 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.555 P=0.658 P=0.656 | P=0.002 ** P=0.499N P=0.008 ** |
|POLY 3 | P=0.593 P=0.678 P=0.686 | P=0.005 ** P=0.510N P=0.013 * |
|POLY 1.5 | P=0.595 P=0.683 P=0.689 | P=0.005 ** P=0.504N P=0.015 * |
|POLY 6 | P=0.590 P=0.674 P=0.684 | P=0.004 ** P=0.519N P=0.010 * |
|LOGISTIC REGRESSION| P=0.591 P=0.658 P=0.693 | P=0.007 ** P=0.524N P=0.022 * |
|COCH-ARM / FISHERS | P=0.601 P=0.691N P=0.691N | P=0.008 ** P=0.500N P=0.020 * |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Parakeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 5/50 (10%) | 3/50 (6%) 4/50 (8%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 2.2% 8.9% 10.9% | 6.6% 8.9% 36.9% |
|TERMINAL (d) | 1/41 (2%) 2/37 (5%) 2/36 (6%) | 1/35 (3%) 3/36 (8%) 7/26 (27%) |
|FIRST INCIDENCE | 727 (T) 645 555 | 679 644 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 P=0.160 P=0.089 | P<0.001 ** P=0.486 P<0.001 ** |
|POLY 3 | P=0.078 P=0.169 P=0.100 | P<0.001 ** P=0.490 P<0.001 ** |
|POLY 1.5 | P=0.079 P=0.171 P=0.101 | P<0.001 ** P=0.496 P<0.001 ** |
|POLY 6 | P=0.078 P=0.167 P=0.100 | P<0.001 ** P=0.479 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.082 P=0.173 P=0.112 | P<0.001 ** P=0.495 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.080 P=0.181 P=0.102 | P<0.001 ** P=0.500 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 7/50 (14%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 15.3% | 2.2% 0.0% 7.3% |
|TERMINAL (d) | 1/41 (2%) 0/37 (0%) 4/36 (11%) | 1/35 (3%) 0/36 (0%) 1/26 (4%) |
|FIRST INCIDENCE | 727 (T) --- 630 | 729 (T) --- 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.520N P=0.026 * | P=0.121 P=0.494N P=0.215 |
|POLY 3 | P=0.006 ** P=0.509N P=0.028 * | P=0.169 P=0.504N P=0.269 |
|POLY 1.5 | P=0.006 ** P=0.506N P=0.029 * | P=0.171 P=0.502N P=0.282 |
|POLY 6 | P=0.005 ** P=0.511N P=0.028 * | P=0.167 P=0.508N P=0.251 |
|LOGISTIC REGRESSION| P=0.007 ** (e) P=0.031 * | P=0.129 (e) P=0.226 |
|COCH-ARM / FISHERS | P=0.007 ** P=0.500N P=0.030 * | P=0.176 P=0.500N P=0.309 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 23/50 (46%) 30/50 (60%) | 33/50 (66%) 33/50 (66%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 50.7% 47.8% 61.5% | 67.0% 69.3% 76.1% |
|TERMINAL (d) | 18/41 (44%) 14/37 (38%) 19/36 (53%) | 20/35 (57%) 25/36 (69%) 19/26 (73%) |
|FIRST INCIDENCE | 420 356 401 | 429 553 98 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124 P=0.565 P=0.135 | P=0.044 * P=0.557N P=0.058 |
|POLY 3 | P=0.165 P=0.468N P=0.190 | P=0.187 P=0.490 P=0.216 |
|POLY 1.5 | P=0.173 P=0.457N P=0.198 | P=0.235 P=0.532 P=0.268 |
|POLY 6 | P=0.158 P=0.472N P=0.180 | P=0.126 P=0.429 P=0.149 |
|LOGISTIC REGRESSION| P=0.209 P=0.355N P=0.247 | P=0.329 P=0.580N P=0.401 |
|COCH-ARM / FISHERS | P=0.184 P=0.421N P=0.211 | P=0.296 P=0.583N P=0.333 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 5/50 (10%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.2% 11.2% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 1/35 (3%) 5/36 (14%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.512N P=0.108 P=0.559N |
|POLY 3 | (e) (e) (e) | P=0.480N P=0.097 P=0.521N |
|POLY 1.5 | (e) (e) (e) | P=0.450N P=0.100 P=0.514N |
|POLY 6 | (e) (e) (e) | P=0.524N P=0.092 P=0.532N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.512N P=0.108 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.399N P=0.102 P=0.500N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 2.3% 0.0% | 4.4% 4.5% 2.5% |
|TERMINAL (d) | 0/41 (0%) 1/37 (3%) 0/36 (0%) | 1/35 (3%) 1/36 (3%) 1/26 (4%) |
|FIRST INCIDENCE | 420 727 (T) --- | 713 616 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.744 P=0.504N | P=0.481N P=0.690 P=0.603N |
|POLY 3 | P=0.348N P=0.747 P=0.509N | P=0.439N P=0.690 P=0.538N |
|POLY 1.5 | P=0.342N P=0.751 P=0.506N | P=0.421N P=0.692 P=0.524N |
|POLY 6 | P=0.354N P=0.744 P=0.513N | P=0.464N P=0.685 P=0.557N |
|LOGISTIC REGRESSION| P=0.288N P=0.680N P=0.363N | P=0.419N P=0.695N P=0.583N |
|COCH-ARM / FISHERS | P=0.331N P=0.753N P=0.500N | P=0.390N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.1% 0.0% 0.0% | 2.2% 0.0% 4.9% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 0/35 (0%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | 490 --- --- | 719 --- 661 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274N P=0.508N P=0.504N | P=0.293 P=0.505N P=0.410 |
|POLY 3 | P=0.278N P=0.512N P=0.509N | P=0.355 P=0.504N P=0.465 |
|POLY 1.5 | P=0.275N P=0.508N P=0.505N | P=0.357 P=0.502N P=0.477 |
|POLY 6 | P=0.281N P=0.515N P=0.512N | P=0.353 P=0.508N P=0.448 |
|LOGISTIC REGRESSION| P=0.204N P=0.325N P=0.415N | P=0.340 P=0.508N P=0.473 |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 2/35 (6%) 0/36 (0%) 0/26 (0%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.118N P=0.232N P=0.306N |
|POLY 3 | (e) (e) (e) | P=0.104N P=0.241N P=0.262N |
|POLY 1.5 | (e) (e) (e) | P=0.100N P=0.239N P=0.253N |
|POLY 6 | (e) (e) (e) | P=0.109N P=0.245N P=0.275N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.118N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.4% 2.2% 2.5% |
|TERMINAL (d) | 0/41 (0%) 0/37 (0%) 0/36 (0%) | 1/35 (3%) 0/36 (0%) 1/26 (4%) |
|FIRST INCIDENCE | --- --- --- | 679 678 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.475N P=0.522N P=0.606N |
|POLY 3 | (e) (e) (e) | P=0.416N P=0.507N P=0.539N |
|POLY 1.5 | (e) (e) (e) | P=0.402N P=0.503N P=0.524N |
|POLY 6 | (e) (e) (e) | P=0.435N P=0.513N P=0.559N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.404N P=0.499N P=0.550N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.378N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 4.2% 4.4% 2.2% | |
|TERMINAL (d) | 1/41 (2%) 1/37 (3%) 1/36 (3%) | |
|FIRST INCIDENCE | 490 356 727 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421N P=0.668 P=0.532N | |
|POLY 3 | P=0.411N P=0.680 P=0.515N | |
|POLY 1.5 | P=0.403N P=0.685 P=0.509N | |
|POLY 6 | P=0.419N P=0.675 P=0.522N | |
|LOGISTIC REGRESSION| P=0.343N P=0.554N P=0.465N | |
|COCH-ARM / FISHERS | P=0.390N P=0.691N P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/43 (30%) 13/44 (30%) 14/41 (34%) | 7/47 (15%) 4/40 (10%) 8/41 (20%) |
|POLY-3 ADJUSTED (b)| 31.2% 31.2% 35.3% | 16.2% 10.7% 22.8% |
|TERMINAL (d) | 9/36 (25%) 7/33 (21%) 7/31 (23%) | 1/33 (3%) 1/30 (3%) 1/24 (4%) |
|FIRST INCIDENCE | 584 356 456 | 664 553 610 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349 P=0.505 P=0.382 | P=0.288 P=0.313N P=0.305 |
|POLY 3 | P=0.394 P=0.589N P=0.440 | P=0.301 P=0.350N P=0.328 |
|POLY 1.5 | P=0.395 P=0.584N P=0.440 | P=0.311 P=0.353N P=0.344 |
|POLY 6 | P=0.395 P=0.591N P=0.441 | P=0.289 P=0.352N P=0.311 |
|LOGISTIC REGRESSION| P=0.427 P=0.465N P=0.478 | P=0.387 P=0.362N P=0.377 |
|COCH-ARM / FISHERS | P=0.396 P=0.565N P=0.440 | P=0.338 P=0.362N P=0.385 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 0/44 (0%) 0/41 (0%) | 1/47 (2%) 2/40 (5%) 1/41 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.4% 5.6% 3.0% |
|TERMINAL (d) | 0/36 (0%) 0/33 (0%) 0/31 (0%) | 1/33 (3%) 2/30 (7%) 1/24 (4%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.522 P=0.467 P=0.689 |
|POLY 3 | (e) (e) (e) | P=0.542 P=0.442 P=0.707 |
|POLY 1.5 | (e) (e) (e) | P=0.553 P=0.443 P=0.715 |
|POLY 6 | (e) (e) (e) | P=0.528 P=0.439 P=0.698 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.522 P=0.467 P=0.689 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.576 P=0.439 P=0.718 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 20/50 (40%) 23/50 (46%) | 27/50 (54%) 36/50 (72%) 33/50 (66%) |
|POLY-3 ADJUSTED (b)| 23.6% 44.7% 50.3% | 58.1% 77.4% 77.6% |
|TERMINAL (d) | 10/41 (24%) 18/37 (49%) 20/36 (56%) | 24/35 (69%) 30/36 (83%) 24/26 (92%) |
|FIRST INCIDENCE | 673 652 555 | 506 567 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.019 * P=0.003 ** | P<0.001 ** P=0.057 P=0.002 ** |
|POLY 3 | P=0.004 ** P=0.026 * P=0.006 ** | P=0.019 * P=0.031 * P=0.032 * |
|POLY 1.5 | P=0.005 ** P=0.030 * P=0.007 ** | P=0.041 * P=0.038 * P=0.061 |
|POLY 6 | P=0.003 ** P=0.023 * P=0.005 ** | P=0.006 ** P=0.025 * P=0.013 * |
|LOGISTIC REGRESSION| P=0.004 ** P=0.023 * P=0.006 ** | P=0.010 * P=0.028 * P=0.014 * |
|COCH-ARM / FISHERS | P=0.008 ** P=0.041 * P=0.010 * | P=0.126 P=0.048 * P=0.154 |
|=================================================================================================================================|
Date: 09/26/97 EXPERIMENT: 55312 TEST: 04 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 103 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 100 200 | 0 MG/KG 100 200 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 37/50 (74%) 26/50 (52%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| | 77.1% 55.3% 47.9% |
|TERMINAL (d) | | 29/35 (83%) 19/36 (53%) 10/26 (39%) |
|FIRST INCIDENCE | | 429 561 366 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.085N P=0.032N* P=0.123N |
|POLY 3 | | P=0.002N** P=0.016N* P=0.002N** |
|POLY 1.5 | | P=0.002N** P=0.017N* P=0.002N** |
|POLY 6 | | P=0.002N** P=0.017N* P=0.002N** |
|LOGISTIC REGRESSION| | P=0.002N** P=0.020N* P=0.002N** |
|COCH-ARM / FISHERS | | P=0.002N** P=0.019N* P=0.002N** |
|=================================================================================================================================|
(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).