TDMS Study 55312-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 02/24/99
EXPERIMENT: 55312 TEST: 03 TIME: 13:45:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHONIC RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 02/24/99
EXPERIMENT: 55312 TEST: 03 TIME: 13:45:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
Rats(FISCHER 344)
-----------------------------
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 THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Liver
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus COCONUT OIL ACID DIETHANOLAMINE CONDENSATE DATE: 02/24/99
EXPERIMENT: 55312 TEST: 03 TIME: 13:45:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55312B
PATHOLOGIST: TOFT, J. CAS: 68603-42-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Carcinoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 0.0% | 0.0% 5.3% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 2/24 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- 611 --- | --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.711N P=0.541 (e) | P=0.616 P=0.204 (e) |
|POLY 3 | P=0.709N P=0.529 (e) | P=0.605 P=0.210 (e) |
|POLY 1.5 | P=0.717N P=0.518 (e) | P=0.625 P=0.218 (e) |
|POLY 6 | P=0.698N P=0.546 (e) | P=0.592 P=0.205 (e) |
|LOGISTIC REGRESSION| P=0.729 P=0.498 (e) | (e) P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 6/50 (12%) | 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.7% 14.0% 17.1% | 0.0% 10.6% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 4/11 (36%) | 0/28 (0%) 3/24 (13%) 0/22 (0%) |
|FIRST INCIDENCE | 603 586 607 | --- 677 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389N P=0.341N P=0.427N | P=0.542 P=0.048 * (e) |
|POLY 3 | P=0.511N P=0.422N P=0.561N | P=0.516 P=0.046 * (e) |
|POLY 1.5 | P=0.527N P=0.449N P=0.580N | P=0.550 P=0.050 (e) |
|POLY 6 | P=0.498N P=0.392N P=0.545N | P=0.494 P=0.044 * (e) |
|LOGISTIC REGRESSION| P=0.467N P=0.422N P=0.513N | P=0.550 P=0.045 * (e) |
|COCH-ARM / FISHERS | P=0.563 P=0.500N P=0.620N | P=0.622 P=0.059 (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 6/50 (12%) | 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 18.7% 16.8% 17.1% | 0.0% 10.6% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 4/11 (36%) | 0/28 (0%) 3/24 (13%) 0/22 (0%) |
|FIRST INCIDENCE | 603 586 607 | --- 677 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.433N P=0.427N | P=0.542 P=0.048 * (e) |
|POLY 3 | P=0.503N P=0.545N P=0.561N | P=0.516 P=0.046 * (e) |
|POLY 1.5 | P=0.521N P=0.571N P=0.580N | P=0.550 P=0.050 (e) |
|POLY 6 | P=0.488N P=0.517N P=0.545N | P=0.494 P=0.044 * (e) |
|LOGISTIC REGRESSION| P=0.454N P=0.528N P=0.513N | P=0.550 P=0.045 * (e) |
|COCH-ARM / FISHERS | P=0.561 P=0.620N P=0.620N | P=0.622 P=0.059 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) | 8/49 (16%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 3.3% 5.7% 2.9% | 19.1% 13.1% 11.1% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 6/28 (21%) 4/24 (17%) 1/22 (5%) |
|FIRST INCIDENCE | 729 (T) 611 640 | 680 578 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.542N P=0.618 P=0.694N | P=0.256N P=0.385N P=0.318N |
|POLY 3 | P=0.578N P=0.551 P=0.731N | P=0.200N P=0.338N P=0.259N |
|POLY 1.5 | P=0.595N P=0.531 P=0.743N | P=0.176N P=0.317N P=0.229N |
|POLY 6 | P=0.555N P=0.580 P=0.713N | P=0.216N P=0.350N P=0.278N |
|LOGISTIC REGRESSION| P=0.569N P=0.584 P=0.718N | P=0.222N P=0.360N P=0.287N |
|COCH-ARM / FISHERS | P=0.622 P=0.500 P=0.753N | P=0.127N P=0.264N P=0.168N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 2/49 (4%) 8/50 (16%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 5.7% | 4.8% 21.0% 11.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 1/28 (4%) 7/24 (29%) 2/22 (9%) |
|FIRST INCIDENCE | --- 620 552 | 669 578 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 P=0.539 P=0.300 | P=0.185 P=0.026 * P=0.243 |
|POLY 3 | P=0.173 P=0.529 P=0.270 | P=0.197 P=0.029 * P=0.272 |
|POLY 1.5 | P=0.160 P=0.518 P=0.257 | P=0.229 P=0.034 * P=0.293 |
|POLY 6 | P=0.192 P=0.545 P=0.291 | P=0.179 P=0.026 * P=0.260 |
|LOGISTIC REGRESSION| P=0.139 P=0.504 P=0.237 | P=0.218 P=0.029 * P=0.291 |
|COCH-ARM / FISHERS | P=0.142 P=0.500 P=0.247 | P=0.314 P=0.049 * P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) | 9/49 (18%) 13/50 (26%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 3.3% 8.5% 8.5% | 21.3% 33.6% 21.8% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 6/28 (21%) 11/24 (46%) 3/22 (14%) |
|FIRST INCIDENCE | 729 (T) 611 552 | 669 578 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.334 P=0.419 P=0.411 | P=0.411 P=0.124 P=0.501 |
|POLY 3 | P=0.307 P=0.362 P=0.362 | P=0.487 P=0.158 P=0.587 |
|POLY 1.5 | P=0.278 P=0.339 P=0.338 | P=0.541 P=0.182 P=0.587N |
|POLY 6 | P=0.352 P=0.398 P=0.399 | P=0.457 P=0.143 P=0.566 |
|LOGISTIC REGRESSION| P=0.269 P=0.369 P=0.341 | P=0.467 P=0.138 P=0.554 |
|COCH-ARM / FISHERS | P=0.238 P=0.309 P=0.309 | P=0.430N P=0.251 P=0.482N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 9.7% 11.3% 8.8% | 2.3% 0.0% 5.6% |
|TERMINAL (d) | 0/8 (0%) 2/12 (17%) 3/11 (27%) | 1/28 (4%) 0/24 (0%) 2/22 (9%) |
|FIRST INCIDENCE | 607 523 729 (T) | 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460N P=0.639N P=0.543N | P=0.297 P=0.531N P=0.415 |
|POLY 3 | P=0.530N P=0.571 P=0.619N | P=0.346 P=0.525N P=0.437 |
|POLY 1.5 | P=0.546N P=0.545 P=0.634N | P=0.351 P=0.518N P=0.456 |
|POLY 6 | P=0.514N P=0.603 P=0.604N | P=0.343 P=0.529N P=0.425 |
|LOGISTIC REGRESSION| P=0.481N P=0.583 P=0.559N | P=0.297 (e) P=0.415 |
|COCH-ARM / FISHERS | P=0.579 P=0.500 P=0.661N | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.3% 14.4% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 2/12 (17%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 642 695 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.299N P=0.216 P=0.445N | (e) (e) (e) |
|POLY 3 | P=0.322N P=0.129 P=0.477N | (e) (e) (e) |
|POLY 1.5 | P=0.350N P=0.119 P=0.486N | (e) (e) (e) |
|POLY 6 | P=0.287N P=0.144 P=0.466N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.297N P=0.175 P=0.483N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.399N P=0.102 P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 0.0% | 0.0% 5.3% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- 656 --- | --- 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.685N P=0.569 (e) | P=0.613 P=0.208 (e) |
|POLY 3 | P=0.709N P=0.528 (e) | P=0.605 P=0.210 (e) |
|POLY 1.5 | P=0.717N P=0.517 (e) | P=0.625 P=0.218 (e) |
|POLY 6 | P=0.698N P=0.544 (e) | P=0.592 P=0.206 (e) |
|LOGISTIC REGRESSION| P=0.719N P=0.526 (e) | P=0.618 P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.3% 17.1% 0.0% | 0.0% 5.3% 0.0% |
|TERMINAL (d) | 0/8 (0%) 2/12 (17%) 0/11 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 642 656 --- | --- 719 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.147 P=0.445N | P=0.613 P=0.208 (e) |
|POLY 3 | P=0.319N P=0.076 P=0.477N | P=0.605 P=0.210 (e) |
|POLY 1.5 | P=0.351N P=0.068 P=0.486N | P=0.625 P=0.218 (e) |
|POLY 6 | P=0.279N P=0.088 P=0.466N | P=0.592 P=0.206 (e) |
|LOGISTIC REGRESSION| P=0.304N P=0.104 P=0.483N | P=0.618 P=0.204 (e) |
|COCH-ARM / FISHERS | P=0.406N P=0.056 P=0.500N | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.9% 2.9% | 4.7% 5.3% 5.6% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 2/28 (7%) 2/24 (8%) 2/22 (9%) |
|FIRST INCIDENCE | --- 713 729 (T) | 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365 P=0.575 P=0.564 | P=0.503 P=0.640 P=0.607 |
|POLY 3 | P=0.376 P=0.527 P=0.525 | P=0.535 P=0.649 P=0.627 |
|POLY 1.5 | P=0.359 P=0.517 P=0.515 | P=0.555 P=0.662 P=0.648 |
|POLY 6 | P=0.401 P=0.542 P=0.539 | P=0.522 P=0.641 P=0.614 |
|LOGISTIC REGRESSION| P=0.379 P=0.569 P=0.564 | P=0.503 P=0.640 P=0.607 |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.601 P=0.691N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 3.3% 2.9% 2.9% | 7.0% 5.3% 5.6% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 3/28 (11%) 2/24 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 563 713 729 (T) | 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.599N P=0.703N P=0.712N | P=0.513N P=0.571N P=0.611N |
|POLY 3 | P=0.619N P=0.735N P=0.738N | P=0.490N P=0.557N P=0.582N |
|POLY 1.5 | P=0.626N P=0.744N P=0.746N | P=0.464N P=0.541N P=0.557N |
|POLY 6 | P=0.612N P=0.722N P=0.727N | P=0.507N P=0.567N P=0.598N |
|LOGISTIC REGRESSION| P=0.602N P=0.748N P=0.743N | P=0.513N P=0.571N P=0.611N |
|COCH-ARM / FISHERS | P=0.640 P=0.753N P=0.753N | P=0.406N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 18/50 (36%) 16/50 (32%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.6% 2.9% 2.9% | 41.4% 41.0% 8.4% |
|TERMINAL (d) | 2/8 (25%) 0/12 (0%) 0/11 (0%) | 13/28 (46%) 9/24 (38%) 2/22 (9%) |
|FIRST INCIDENCE | 729 (T) 670 621 | 618 578 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.362N P=0.395N | P=0.005N** P=0.529 P=0.002N** |
|POLY 3 | P=0.352N P=0.451N P=0.452N | P<0.001N** P=0.577N P<0.001N** |
|POLY 1.5 | P=0.362N P=0.470N P=0.471N | P<0.001N** P=0.533N P<0.001N** |
|POLY 6 | P=0.340N P=0.422N P=0.424N | P=0.002N** P=0.591 P<0.001N** |
|LOGISTIC REGRESSION| P=0.313N P=0.387N P=0.419N | P=0.002N** P=0.546 P<0.001N** |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | P<0.001N** P=0.417N P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 18/50 (36%) 16/50 (32%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 9.8% 2.9% 2.9% | 41.4% 41.0% 8.4% |
|TERMINAL (d) | 2/8 (25%) 0/12 (0%) 0/11 (0%) | 13/28 (46%) 9/24 (38%) 2/22 (9%) |
|FIRST INCIDENCE | 563 670 621 | 618 578 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.134N P=0.197N P=0.221N | P=0.005N** P=0.529 P=0.002N** |
|POLY 3 | P=0.182N P=0.260N P=0.261N | P<0.001N** P=0.577N P<0.001N** |
|POLY 1.5 | P=0.189N P=0.276N P=0.278N | P<0.001N** P=0.533N P<0.001N** |
|POLY 6 | P=0.173N P=0.237N P=0.238N | P=0.002N** P=0.591 P<0.001N** |
|LOGISTIC REGRESSION| P=0.165N P=0.240N P=0.256N | P=0.002N** P=0.546 P<0.001N** |
|COCH-ARM / FISHERS | P=0.202N P=0.309N P=0.309N | P<0.001N** P=0.417N P<0.001N** |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) | 20/50 (40%) 16/50 (32%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 9.8% 5.7% 5.8% | 46.0% 41.0% 14.0% |
|TERMINAL (d) | 2/8 (25%) 0/12 (0%) 1/11 (9%) | 15/28 (54%) 9/24 (38%) 4/22 (18%) |
|FIRST INCIDENCE | 563 670 621 | 618 578 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300N P=0.349N P=0.379N | P=0.007N** P=0.483N P=0.004N** |
|POLY 3 | P=0.367N P=0.442N P=0.445N | P=0.002N** P=0.407N P=0.002N** |
|POLY 1.5 | P=0.382N P=0.464N P=0.466N | P<0.001N** P=0.368N P<0.001N** |
|POLY 6 | P=0.348N P=0.411N P=0.415N | P=0.003N** P=0.420N P=0.002N** |
|LOGISTIC REGRESSION| P=0.328N P=0.405N P=0.419N | P=0.003N** P=0.470N P=0.003N** |
|COCH-ARM / FISHERS | P=0.406N P=0.500N P=0.500N | P<0.001N** P=0.266N P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 39/50 (78%) 36/49 (73%) | 27/50 (54%) 26/49 (53%) 24/50 (48%) |
|POLY-3 ADJUSTED (b)| 80.8% 83.5% 77.6% | 58.3% 62.2% 60.0% |
|TERMINAL (d) | 5/8 (63%) 8/12 (67%) 6/11 (55%) | 15/28 (54%) 12/24 (50%) 11/22 (50%) |
|FIRST INCIDENCE | 334 444 329 | 522 382 479 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.243N P=0.187N | P=0.340 P=0.363 P=0.379 |
|POLY 3 | P=0.392N P=0.472 P=0.451N | P=0.471 P=0.437 P=0.524 |
|POLY 1.5 | P=0.422N P=0.460 P=0.475N | P=0.532N P=0.480 P=0.564N |
|POLY 6 | P=0.370N P=0.500 P=0.433N | P=0.431 P=0.427 P=0.485 |
|LOGISTIC REGRESSION| P=0.510 P=0.395 P=0.528 | P=0.537 P=0.480 P=0.573 |
|COCH-ARM / FISHERS | P=0.523N P=0.408 P=0.567N | P=0.308N P=0.543N P=0.345N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Prostate |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 6.6% 0.0% 0.0% | |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | |
|FIRST INCIDENCE | 680 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.161N P=0.188N | |
|POLY 3 | P=0.093N P=0.209N P=0.211N | |
|POLY 1.5 | P=0.094N P=0.219N P=0.221N | |
|POLY 6 | P=0.094N P=0.196N P=0.198N | |
|LOGISTIC REGRESSION| P=0.070N P=0.182N P=0.186N | |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 392 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.192N P=0.203N | (e) (e) (e) |
|POLY 3 | P=0.093N P=0.212N P=0.214N | (e) (e) (e) |
|POLY 1.5 | P=0.094N P=0.222N P=0.223N | (e) (e) (e) |
|POLY 6 | P=0.093N P=0.200N P=0.202N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.115N P=0.271N P=0.265N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 2.9% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 392 695 627 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.406N P=0.433N | (e) (e) (e) |
|POLY 3 | P=0.357N P=0.461N P=0.462N | (e) (e) (e) |
|POLY 1.5 | P=0.365N P=0.476N P=0.477N | (e) (e) (e) |
|POLY 6 | P=0.345N P=0.439N P=0.439N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.385N P=0.509N P=0.529N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 18.6% 25.2% 2.9% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 2/8 (25%) 4/12 (33%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 392 600 627 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031N* P=0.530 P=0.038N* | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.043N* P=0.358 P=0.041N* | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.052N P=0.331 P=0.046N* | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.032N* P=0.406 P=0.034N* | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.045N* P=0.391 P=0.056N | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.072N P=0.288 P=0.056N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.7% 8.6% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 603 626 485 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166N P=0.526N P=0.236N | (e) (e) (e) |
|POLY 3 | P=0.197N P=0.608N P=0.261N | (e) (e) (e) |
|POLY 1.5 | P=0.212N P=0.627N P=0.277N | (e) (e) (e) |
|POLY 6 | P=0.179N P=0.583N P=0.242N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.209N P=0.581N P=0.305N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.661N P=0.309N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.7% 14.3% 8.4% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/8 (13%) 2/12 (17%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 603 626 485 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441N P=0.546 P=0.549N | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.490N P=0.422 P=0.597N | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.523N P=0.398 P=0.623N | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.446N P=0.453 P=0.563N | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.518N P=0.481 P=0.664 | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.576 P=0.357 P=0.661N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.8% 5.7% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 0/8 (0%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 725 562 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 P=0.350 P=0.300 | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.224 P=0.267 P=0.270 | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.204 P=0.256 P=0.257 | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.256 P=0.284 P=0.291 | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.204 P=0.338 P=0.236 | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.176 P=0.247 P=0.247 | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 9.6% 17.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 3/12 (25%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 467 600 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.088N P=0.413 P=0.103N | (e) (e) (e) |
|POLY 3 | P=0.105N P=0.297 P=0.101N | (e) (e) (e) |
|POLY 1.5 | P=0.118N P=0.277 P=0.107N | (e) (e) (e) |
|POLY 6 | P=0.090N P=0.326 P=0.094N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.104N P=0.323 P=0.121N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.146N P=0.243 P=0.121N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 3.3% 5.7% 0.0% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 729 (T) 620 --- | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.279N P=0.617 P=0.436N | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.320N P=0.551 P=0.475N | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.335N P=0.531 P=0.485N | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.299N P=0.580 P=0.461N | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.300N P=0.588 (e) | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.360N P=0.500 P=0.500N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 12.7% 22.4% 0.0% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/8 (13%) 4/12 (33%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 467 600 --- | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.363 P=0.046N* | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.059N P=0.234 P=0.047N* | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.071N P=0.212 P=0.052N | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.047N* P=0.270 P=0.042N* | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.058N P=0.270 P=0.053N | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.099N P=0.178 P=0.059N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 12.7% 22.4% 0.0% | 0.0% 0.0% 2.8% |
|TERMINAL (d) | 1/8 (13%) 4/12 (33%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 467 600 --- | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.363 P=0.046N* | P=0.239 (e) P=0.452 |
|POLY 3 | P=0.059N P=0.234 P=0.047N* | P=0.275 (e) P=0.464 |
|POLY 1.5 | P=0.071N P=0.212 P=0.052N | P=0.274 (e) P=0.475 |
|POLY 6 | P=0.047N* P=0.270 P=0.042N* | P=0.276 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.058N P=0.270 P=0.053N | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.099N P=0.178 P=0.059N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.8% 2.9% 2.9% | 0.0% 2.7% 2.8% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 1/22 (5%) |
|FIRST INCIDENCE | 617 729 (T) 552 | --- 719 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.149N P=0.201N P=0.247N | P=0.281 P=0.471 P=0.452 |
|POLY 3 | P=0.181N P=0.261N P=0.259N | P=0.299 P=0.475 P=0.464 |
|POLY 1.5 | P=0.189N P=0.277N P=0.277N | P=0.309 P=0.482 P=0.475 |
|POLY 6 | P=0.171N P=0.242N P=0.237N | P=0.293 P=0.471 P=0.457 |
|LOGISTIC REGRESSION| P=0.162N P=0.215N P=0.266N | P=0.283 P=0.470 P=0.452 |
|COCH-ARM / FISHERS | P=0.202N P=0.309N P=0.309N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 20/50 (40%) 19/50 (38%) | |
|POLY-3 ADJUSTED (b)| 63.6% 51.8% 50.8% | |
|TERMINAL (d) | 5/8 (63%) 8/12 (67%) 9/11 (82%) | |
|FIRST INCIDENCE | 467 499 552 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067N P=0.081N P=0.080N | |
|POLY 3 | P=0.147N P=0.192N P=0.169N | |
|POLY 1.5 | P=0.173N P=0.237N P=0.198N | |
|POLY 6 | P=0.133N P=0.158N P=0.154N | |
|LOGISTIC REGRESSION| P=0.077N P=0.139N P=0.084N | |
|COCH-ARM / FISHERS | P=0.239N P=0.343N P=0.272N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) | 4/50 (8%) 3/50 (6%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 9.7% 11.3% 11.5% | 9.4% 8.0% 16.7% |
|TERMINAL (d) | 2/8 (25%) 1/12 (8%) 2/11 (18%) | 4/28 (14%) 3/24 (13%) 5/22 (23%) |
|FIRST INCIDENCE | 526 621 579 | 728 (T) 728 (T) 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N P=0.645N P=0.649 | P=0.177 P=0.586N P=0.227 |
|POLY 3 | P=0.498 P=0.578 P=0.569 | P=0.224 P=0.568N P=0.266 |
|POLY 1.5 | P=0.469 P=0.547 P=0.542 | P=0.245 P=0.549N P=0.295 |
|POLY 6 | P=0.538 P=0.625 P=0.609 | P=0.211 P=0.580N P=0.249 |
|LOGISTIC REGRESSION| P=0.508 P=0.584 P=0.594 | P=0.182 P=0.586N P=0.233 |
|COCH-ARM / FISHERS | P=0.424 P=0.500 P=0.500 | P=0.297 P=0.500N P=0.370 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.9% | 2.3% 5.3% 5.6% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 1/11 (9%) | 1/28 (4%) 2/24 (8%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) | 728 (T) 728 (T) 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302 (e) P=0.564 | P=0.313 P=0.446 P=0.424 |
|POLY 3 | P=0.291 (e) P=0.525 | P=0.331 P=0.456 P=0.439 |
|POLY 1.5 | P=0.283 (e) P=0.515 | P=0.349 P=0.469 P=0.457 |
|POLY 6 | P=0.303 (e) P=0.539 | P=0.321 P=0.449 P=0.428 |
|LOGISTIC REGRESSION| (e) (e) P=0.564 | P=0.310 P=0.446 P=0.422 |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.390 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 5/50 (10%) | 5/50 (10%) 5/50 (10%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 9.7% 11.3% 14.3% | 11.7% 13.3% 22.1% |
|TERMINAL (d) | 2/8 (25%) 1/12 (8%) 3/11 (27%) | 5/28 (18%) 5/24 (21%) 5/22 (23%) |
|FIRST INCIDENCE | 526 621 579 | 728 (T) 728 (T) 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442 P=0.645N P=0.517 | P=0.109 P=0.532 P=0.145 |
|POLY 3 | P=0.353 P=0.578 P=0.424 | P=0.142 P=0.550 P=0.174 |
|POLY 1.5 | P=0.329 P=0.547 P=0.397 | P=0.164 P=0.573 P=0.202 |
|POLY 6 | P=0.387 P=0.625 P=0.465 | P=0.130 P=0.536 P=0.160 |
|LOGISTIC REGRESSION| P=0.373 P=0.584 P=0.464 | P=0.109 P=0.532 P=0.143 |
|COCH-ARM / FISHERS | P=0.290 P=0.500 P=0.357 | P=0.221 P=0.630N P=0.277 |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.7% 2.9% | 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 3/12 (25%) 1/11 (9%) | 1/28 (4%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) | 613 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469 P=0.192 P=0.564 | P=0.127N P=0.286N P=0.296N |
|POLY 3 | P=0.452 P=0.142 P=0.525 | P=0.114N P=0.268N P=0.282N |
|POLY 1.5 | P=0.422 P=0.133 P=0.515 | P=0.107N P=0.259N P=0.267N |
|POLY 6 | P=0.494 P=0.155 P=0.539 | P=0.118N P=0.275N P=0.292N |
|LOGISTIC REGRESSION| (e) P=0.192 P=0.564 | P=0.102N P=0.242N P=0.250N |
|COCH-ARM / FISHERS | P=0.378 P=0.121 P=0.500 | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 0.0% 2.9% | 2.3% 2.7% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 1/28 (4%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 521 --- 701 | 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.217N P=0.451N | P=0.384N P=0.728 P=0.548N |
|POLY 3 | P=0.356N P=0.214N P=0.466N | P=0.396N P=0.732 P=0.536N |
|POLY 1.5 | P=0.357N P=0.222N P=0.478N | P=0.376N P=0.741 P=0.525N |
|POLY 6 | P=0.355N P=0.204N P=0.452N | P=0.409N P=0.727 P=0.543N |
|LOGISTIC REGRESSION| P=0.364N P=0.264N P=0.498N | P=0.384N P=0.728 (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.247N P=0.500N | P=0.331N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) | 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.4% 8.7% 5.8% | 7.0% 2.7% 0.0% |
|TERMINAL (d) | 0/8 (0%) 3/12 (25%) 1/11 (9%) | 2/28 (7%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 521 729 (T) 701 | 613 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495N P=0.629 P=0.624N | P=0.091N P=0.372N P=0.170N |
|POLY 3 | P=0.553N P=0.547 P=0.661N | P=0.083N P=0.355N P=0.156N |
|POLY 1.5 | P=0.567N P=0.531 P=0.673N | P=0.075N P=0.340N P=0.144N |
|POLY 6 | P=0.536N P=0.566 P=0.648N | P=0.090N P=0.365N P=0.165N |
|LOGISTIC REGRESSION| P=0.518N P=0.572 P=0.666N | P=0.081N P=0.349N P=0.146N |
|COCH-ARM / FISHERS | P=0.594 P=0.500 P=0.691N | P=0.060N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 6/50 (12%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| | 13.8% 15.9% 13.9% |
|TERMINAL (d) | | 4/28 (14%) 5/24 (21%) 3/22 (14%) |
|FIRST INCIDENCE | | 585 689 665 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.522 P=0.508 P=0.595 |
|POLY 3 | | P=0.553 P=0.521 P=0.622 |
|POLY 1.5 | | P=0.539N P=0.552 P=0.591N |
|POLY 6 | | P=0.523 P=0.499 P=0.596 |
|LOGISTIC REGRESSION| | P=0.538 P=0.521 P=0.624 |
|COCH-ARM / FISHERS | | P=0.437N P=0.620N P=0.500N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 6/50 (12%) 6/50 (12%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| | 13.8% 15.9% 16.4% |
|TERMINAL (d) | | 4/28 (14%) 5/24 (21%) 3/22 (14%) |
|FIRST INCIDENCE | | 585 689 466 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.395 P=0.508 P=0.462 |
|POLY 3 | | P=0.437 P=0.521 P=0.499 |
|POLY 1.5 | | P=0.475 P=0.552 P=0.536 |
|POLY 6 | | P=0.413 P=0.499 P=0.476 |
|LOGISTIC REGRESSION| | P=0.433 P=0.521 P=0.536 |
|COCH-ARM / FISHERS | | P=0.561 P=0.620N P=0.620N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.2% 5.6% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 540 529 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.547 P=0.480N | (e) (e) (e) |
|POLY 3 | P=0.326N P=0.551 P=0.479N | (e) (e) (e) |
|POLY 1.5 | P=0.339N P=0.531 P=0.487N | (e) (e) (e) |
|POLY 6 | P=0.311N P=0.578 P=0.469N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.415N P=0.433 P=0.543N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.500 P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 10/50 (20%) 12/50 (24%) | 10/50 (20%) 9/50 (18%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 45.0% 26.8% 32.3% | 22.8% 22.6% 11.2% |
|TERMINAL (d) | 3/8 (38%) 3/12 (25%) 3/11 (27%) | 5/28 (18%) 5/24 (21%) 3/22 (14%) |
|FIRST INCIDENCE | 470 529 474 | 618 280 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085N P=0.044N* P=0.100N | P=0.158N P=0.554 P=0.173N |
|POLY 3 | P=0.155N P=0.075N P=0.181N | P=0.141N P=0.595N P=0.144N |
|POLY 1.5 | P=0.171N P=0.089N P=0.202N | P=0.111N P=0.567N P=0.117N |
|POLY 6 | P=0.140N P=0.063N P=0.164N | P=0.170N P=0.592 P=0.168N |
|LOGISTIC REGRESSION| P=0.150N P=0.086N P=0.176N | P=0.096N P=0.528N P=0.140N |
|COCH-ARM / FISHERS | P=0.210N P=0.127N P=0.252N | P=0.063N P=0.500N P=0.074N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.2% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/12 (0%) 0/11 (0%) | 0/28 (0%) 1/24 (4%) 0/22 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 533 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.621 P=0.211 (e) |
|POLY 3 | (e) (e) (e) | P=0.605 P=0.213 (e) |
|POLY 1.5 | (e) (e) (e) | P=0.625 P=0.220 (e) |
|POLY 6 | (e) (e) (e) | P=0.591 P=0.210 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.659N P=0.254 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 2.9% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 607 729 (T) 508 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.386N P=0.430N | (e) (e) (e) |
|POLY 3 | P=0.352N P=0.458N P=0.454N | (e) (e) (e) |
|POLY 1.5 | P=0.362N P=0.473N P=0.472N | (e) (e) (e) |
|POLY 6 | P=0.341N P=0.438N P=0.431N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.353N P=0.418N P=0.497N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 2.9% 2.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/12 (8%) 0/11 (0%) | 0/28 (0%) 0/24 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 607 729 (T) 508 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.386N P=0.430N | (e) (e) (e) |
|POLY 3 | P=0.352N P=0.458N P=0.454N | (e) (e) (e) |
|POLY 1.5 | P=0.362N P=0.473N P=0.472N | (e) (e) (e) |
|POLY 6 | P=0.341N P=0.438N P=0.431N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.353N P=0.418N P=0.497N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 49/50 (98%) 46/50 (92%) | 43/50 (86%) 39/50 (78%) 34/50 (68%) |
|POLY-3 ADJUSTED (b)| 99.3% 99.7% 95.9% | 89.8% 91.3% 82.8% |
|TERMINAL (d) | 8/8 (100%) 12/12 (100%) 11/11 (100%) | 26/28 (93%) 23/24 (96%) 19/22 (86%) |
|FIRST INCIDENCE | 334 444 329 | 522 382 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.134N P=0.105N | P=0.523 P=0.404 P=0.557N |
|POLY 3 | P=0.117N P=0.991 P=0.291N | P=0.187N P=0.558 P=0.235N |
|POLY 1.5 | P=0.110N P=0.864 P=0.243N | P=0.085N P=0.546N P=0.118N |
|POLY 6 | P=0.166N P=1.000 P=0.420N | P=0.320N P=0.394 P=0.363N |
|LOGISTIC REGRESSION| P=0.073N P=0.596N P=0.151N | P=0.250N P=0.544 P=0.267N |
|COCH-ARM / FISHERS | P=0.238N P=0.500 P=0.339N | P=0.021N* P=0.218N P=0.028N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 20/50 (40%) 21/50 (42%) | 19/50 (38%) 20/50 (40%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 63.5% 51.6% 51.8% | 42.4% 48.9% 40.0% |
|TERMINAL (d) | 5/8 (63%) 6/12 (50%) 5/11 (46%) | 11/28 (39%) 13/24 (54%) 9/22 (41%) |
|FIRST INCIDENCE | 392 529 389 | 493 280 466 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089N P=0.052N P=0.103N | P=0.525 P=0.288 P=0.570N |
|POLY 3 | P=0.158N P=0.182N P=0.186N | P=0.497N P=0.347 P=0.505N |
|POLY 1.5 | P=0.182N P=0.180N P=0.210N | P=0.406N P=0.391 P=0.424N |
|POLY 6 | P=0.136N P=0.193N P=0.164N | P=0.539 P=0.316 P=0.563N |
|LOGISTIC REGRESSION| P=0.171N P=0.124N P=0.230N | P=0.416N P=0.381 P=0.480N |
|COCH-ARM / FISHERS | P=0.240N P=0.211N P=0.274N | P=0.233N P=0.500 P=0.263N |
|=================================================================================================================================|
Date: 02/24/99 EXPERIMENT: 55312 TEST: 03 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - COCONUT OIL ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 49/50 (98%) 48/50 (96%) | 48/50 (96%) 43/50 (86%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 100.0% 99.7% 96.9% | 97.8% 95.8% 86.9% |
|TERMINAL (d) | 8/8 (100%) 12/12 (100%) 11/11 (100%) | 27/28 (96%) 24/24 (100%) 19/22 (86%) |
|FIRST INCIDENCE | 334 444 329 | 493 280 373 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.111N P=0.129N | P=0.466N P=0.433 P=0.483N |
|POLY 3 | P=0.126N P=1.000N P=0.318N | P=0.015N* P=0.522N P=0.038N* |
|POLY 1.5 | P=0.132N P=0.962N P=0.292N | P=0.004N** P=0.256N P=0.010N* |
|POLY 6 | P=0.163N P=1.000N P=0.426N | P=0.044N* P=0.796 P=0.094N |
|LOGISTIC REGRESSION| P=0.189N P=0.228N P=0.357N | P=0.028N* P=0.438N P=0.047N* |
|COCH-ARM / FISHERS | P=0.378N P=0.753N P=0.500N | P<0.001N** P=0.080N 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).