TDMS Study 55323-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 02/24/98
EXPERIMENT: 55323 TEST: 03 TIME: 12:29:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B
PATHOLOGIST: J. YARRINGTON CAS: 120-40-1
Rats(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 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 PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus LAURIC ACID DIETHANOLAMINE CONDENSATE DATE: 02/24/98
EXPERIMENT: 55323 TEST: 03 TIME: 12:29:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: 55323B
PATHOLOGIST: J. YARRINGTON CAS: 120-40-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF LAURIC ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Skin Keratoacanthoma
All Organs Mesothelioma: Malignant
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Benign Tumors
===============================================================
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.3% 18.2% | 0.0% 2.6% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 5/16 (31%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 641 626 645 | --- 710 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.067 P=0.677N P=0.141 | P=0.718 P=0.507 (e) |
|POLY 3 | P=0.038 * P=0.686 P=0.074 | P=0.717 P=0.499 (e) |
|POLY 1.5 | P=0.038 * P=0.688 P=0.074 | P=0.721 P=0.501 (e) |
|POLY 6 | P=0.039 * P=0.685 P=0.078 | P=0.713 P=0.495 (e) |
|LOGISTIC REGRESSION| P=0.048 * P=0.693 P=0.093 | P=0.718 P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.042 * P=0.691N P=0.080 | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 5.3% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 726 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.063N P=0.164N P=0.175N | (e) (e) (e) |
|POLY 3 | P=0.094N P=0.241N P=0.235N | (e) (e) (e) |
|POLY 1.5 | P=0.095N P=0.240N P=0.239N | (e) (e) (e) |
|POLY 6 | P=0.092N P=0.239N P=0.225N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.064N P=0.178N P=0.170N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 7/50 (14%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.4% 5.3% 18.2% | 0.0% 2.6% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 5/16 (31%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 641 626 645 | --- 710 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 P=0.274N P=0.403 | P=0.718 P=0.507 (e) |
|POLY 3 | P=0.180 P=0.348N P=0.255 | P=0.717 P=0.499 (e) |
|POLY 1.5 | P=0.179 P=0.344N P=0.250 | P=0.721 P=0.501 (e) |
|POLY 6 | P=0.187 P=0.348N P=0.269 | P=0.713 P=0.495 (e) |
|LOGISTIC REGRESSION| P=0.214 P=0.344N P=0.306 | P=0.718 P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.187 P=0.339N P=0.262 | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 2/50 (4%) | 7/49 (14%) 6/48 (13%) 7/48 (15%) |
|POLY-3 ADJUSTED (b)| 10.3% 0.0% 5.3% | 18.1% 15.7% 20.1% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 2/16 (13%) | 6/27 (22%) 4/25 (16%) 5/21 (24%) |
|FIRST INCIDENCE | 589 --- 729 (T) | 617 627 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.058N P=0.271N | P=0.391 P=0.557N P=0.435 |
|POLY 3 | P=0.223N P=0.065N P=0.345N | P=0.483 P=0.512N P=0.530 |
|POLY 1.5 | P=0.225N P=0.063N P=0.348N | P=0.501 P=0.508N P=0.551 |
|POLY 6 | P=0.219N P=0.067N P=0.338N | P=0.465 P=0.526N P=0.510 |
|LOGISTIC REGRESSION| P=0.220N P=0.062N P=0.334N | P=0.458 P=0.530N P=0.510 |
|COCH-ARM / FISHERS | P=0.222N P=0.059N P=0.339N | P=0.542 P=0.516N P=0.597 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 3/49 (6%) 3/48 (6%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.3% 2.6% | 7.8% 7.9% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 3/27 (11%) 2/25 (8%) 0/21 (0%) |
|FIRST INCIDENCE | 500 500 703 | 729 (T) 696 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.672N P=0.466N | P=0.142N P=0.636 P=0.167N |
|POLY 3 | P=0.396N P=0.687 P=0.504N | P=0.125N P=0.658 P=0.136N |
|POLY 1.5 | P=0.400N P=0.689 P=0.507N | P=0.119N P=0.659 P=0.132N |
|POLY 6 | P=0.384N P=0.687 P=0.495N | P=0.130N P=0.651 P=0.140N |
|LOGISTIC REGRESSION| P=0.367N P=0.660N P=0.486N | P=0.124N P=0.643 (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.691N P=0.500N | P=0.105N P=0.651 P=0.125N |
|=================================================================================================================================|
| | | |
| | 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) | 6/50 (12%) 2/50 (4%) 3/50 (6%) | 10/49 (20%) 9/48 (19%) 7/48 (15%) |
|POLY-3 ADJUSTED (b)| 15.1% 5.3% 7.9% | 25.8% 23.5% 20.1% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 2/16 (13%) | 9/27 (33%) 6/25 (24%) 5/21 (24%) |
|FIRST INCIDENCE | 500 500 703 | 617 627 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.124N P=0.188N | P=0.431N P=0.567N P=0.492N |
|POLY 3 | P=0.177N P=0.146N P=0.259N | P=0.334N P=0.512N P=0.381N |
|POLY 1.5 | P=0.177N P=0.141N P=0.258N | P=0.314N P=0.508N P=0.360N |
|POLY 6 | P=0.174N P=0.153N P=0.255N | P=0.354N P=0.526N P=0.401N |
|LOGISTIC REGRESSION| P=0.169N P=0.119N P=0.245N | P=0.350N P=0.546N P=0.404N |
|COCH-ARM / FISHERS | P=0.169N P=0.134N P=0.243N | P=0.270N P=0.520N P=0.314N |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) | 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 2.7% 12.9% | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 2/16 (13%) | 0/28 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 583 729 (T) 603 | --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181 P=0.412N P=0.295 | P=0.619 P=0.221 (e) |
|POLY 3 | P=0.132 P=0.511N P=0.218 | P=0.644 P=0.235 (e) |
|POLY 1.5 | P=0.129 P=0.507N P=0.211 | P=0.651 P=0.238 (e) |
|POLY 6 | P=0.140 P=0.514N P=0.235 | P=0.637 P=0.229 (e) |
|LOGISTIC REGRESSION| P=0.140 P=0.506N P=0.220 | (e) P=0.221 (e) |
|COCH-ARM / FISHERS | P=0.133 P=0.500N P=0.218 | P=0.665 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 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 10.2% 2.7% 5.2% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 565 729 (T) 683 | --- --- 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.162N P=0.294N | P=0.259 (e) P=0.486 |
|POLY 3 | P=0.244N P=0.194N P=0.348N | P=0.269 (e) P=0.485 |
|POLY 1.5 | P=0.246N P=0.188N P=0.350N | P=0.269 (e) P=0.488 |
|POLY 6 | P=0.239N P=0.202N P=0.340N | P=0.270 (e) P=0.481 |
|LOGISTIC REGRESSION| P=0.240N P=0.173N P=0.334N | P=0.256 (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.238N P=0.181N P=0.339N | P=0.266 (e) P=0.495 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 7/50 (14%) | 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 15.1% 5.4% 18.0% | 0.0% 5.1% 2.7% |
|TERMINAL (d) | 1/12 (8%) 2/18 (11%) 3/16 (19%) | 0/28 (0%) 2/26 (8%) 0/22 (0%) |
|FIRST INCIDENCE | 565 729 (T) 603 | --- 729 (T) 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.535 P=0.099N P=0.604 | P=0.313 P=0.221 P=0.486 |
|POLY 3 | P=0.421 P=0.153N P=0.483 | P=0.336 P=0.235 P=0.485 |
|POLY 1.5 | P=0.421 P=0.145N P=0.480 | P=0.342 P=0.238 P=0.488 |
|POLY 6 | P=0.430 P=0.164N P=0.498 | P=0.330 P=0.229 P=0.481 |
|LOGISTIC REGRESSION| P=0.436 P=0.135N P=0.496 | P=0.328 P=0.221 P=0.482 |
|COCH-ARM / FISHERS | P=0.434 P=0.134N P=0.500 | P=0.355 P=0.247 P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.5% 5.0% 5.5% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 1/28 (4%) 0/26 (0%) 2/22 (9%) |
|FIRST INCIDENCE | --- --- --- | 729 (T) 534 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.331 P=0.490 P=0.415 |
|POLY 3 | (e) (e) (e) | P=0.366 P=0.506 P=0.473 |
|POLY 1.5 | (e) (e) (e) | P=0.373 P=0.506 P=0.481 |
|POLY 6 | (e) (e) (e) | P=0.358 P=0.503 P=0.465 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.376 P=0.496 P=0.415 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.390 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 2.7% 0.0% | 0.0% 5.1% 8.1% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | --- 729 (T) --- | --- 729 (T) 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.703N P=0.581 (e) | P=0.060 P=0.221 P=0.099 |
|POLY 3 | P=0.729N P=0.496 (e) | P=0.072 P=0.235 P=0.107 |
|POLY 1.5 | P=0.728 P=0.497 (e) | P=0.075 P=0.238 P=0.110 |
|POLY 6 | P=0.722N P=0.497 (e) | P=0.070 P=0.229 P=0.104 |
|LOGISTIC REGRESSION| (e) P=0.581 (e) | P=0.069 P=0.221 P=0.110 |
|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 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 1/50 (2%) 4/50 (8%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 0.0% | 2.5% 10.0% 13.5% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 1/28 (4%) 2/26 (8%) 3/22 (14%) |
|FIRST INCIDENCE | --- 729 (T) --- | 729 (T) 534 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.703N P=0.581 (e) | P=0.052 P=0.169 P=0.067 |
|POLY 3 | P=0.729N P=0.496 (e) | P=0.066 P=0.183 P=0.085 |
|POLY 1.5 | P=0.728 P=0.497 (e) | P=0.069 P=0.183 P=0.090 |
|POLY 6 | P=0.722N P=0.497 (e) | P=0.063 P=0.179 P=0.082 |
|LOGISTIC REGRESSION| (e) P=0.581 (e) | P=0.067 P=0.180 P=0.082 |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.080 P=0.181 P=0.102 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 11/50 (22%) 12/50 (24%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.3% 5.3% | 27.0% 28.9% 23.6% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 2/16 (13%) | 8/28 (29%) 6/26 (23%) 5/22 (23%) |
|FIRST INCIDENCE | 565 614 729 (T) | 499 458 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541N P=0.629N P=0.623N | P=0.534N P=0.455 P=0.584N |
|POLY 3 | P=0.598 P=0.687 P=0.693 | P=0.422N P=0.525 P=0.464N |
|POLY 1.5 | P=0.594 P=0.689 P=0.688 | P=0.406N P=0.523 P=0.447N |
|POLY 6 | P=0.593N P=0.689 P=0.688N | P=0.436N P=0.514 P=0.476N |
|LOGISTIC REGRESSION| P=0.594N P=0.693 P=0.686N | P=0.402N P=0.502 P=0.459N |
|COCH-ARM / FISHERS | P=0.601 P=0.691N P=0.691N | P=0.357N P=0.500 P=0.402N |
|=================================================================================================================================|
| | | |
| | 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) | 2/50 (4%) 2/50 (4%) 2/50 (4%) | 11/50 (22%) 14/50 (28%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 5.2% 5.3% 5.3% | 27.0% 32.9% 28.8% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 2/16 (13%) | 8/28 (29%) 6/26 (23%) 7/22 (32%) |
|FIRST INCIDENCE | 565 614 729 (T) | 499 458 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541N P=0.629N P=0.623N | P=0.363 P=0.295 P=0.396 |
|POLY 3 | P=0.598 P=0.687 P=0.693 | P=0.472 P=0.365 P=0.529 |
|POLY 1.5 | P=0.594 P=0.689 P=0.688 | P=0.491 P=0.354 P=0.546 |
|POLY 6 | P=0.593N P=0.689 P=0.688N | P=0.457 P=0.368 P=0.515 |
|LOGISTIC REGRESSION| P=0.594N P=0.693 P=0.686N | P=0.498 P=0.324 P=0.528 |
|COCH-ARM / FISHERS | P=0.601 P=0.691N P=0.691N | P=0.547 P=0.322 P=0.595N |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) | 11/50 (22%) 16/50 (32%) 13/50 (26%) |
|POLY-3 ADJUSTED (b)| 5.2% 8.0% 5.3% | 27.0% 37.6% 33.8% |
|TERMINAL (d) | 1/12 (8%) 2/18 (11%) 2/16 (13%) | 8/28 (29%) 8/26 (31%) 8/22 (36%) |
|FIRST INCIDENCE | 565 614 729 (T) | 499 458 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521N P=0.601 P=0.623N | P=0.203 P=0.167 P=0.225 |
|POLY 3 | P=0.591 P=0.489 P=0.693 | P=0.293 P=0.211 P=0.340 |
|POLY 1.5 | P=0.586 P=0.493 P=0.688 | P=0.310 P=0.205 P=0.356 |
|POLY 6 | P=0.585N P=0.490 P=0.688N | P=0.284 P=0.210 P=0.331 |
|LOGISTIC REGRESSION| P=0.579N P=0.493 P=0.686N | P=0.311 P=0.184 P=0.335 |
|COCH-ARM / FISHERS | P=0.594 P=0.500 P=0.691N | P=0.367 P=0.184 P=0.408 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 2.6% | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 563 729 (T) 727 | --- 728 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.730N P=0.733N | P=0.618 P=0.228 (e) |
|POLY 3 | P=0.637 P=0.754 P=0.760 | P=0.642 P=0.235 (e) |
|POLY 1.5 | P=0.635 P=0.756 P=0.757 | P=0.650 P=0.238 (e) |
|POLY 6 | P=0.634N P=0.753 P=0.757N | P=0.634 P=0.229 (e) |
|LOGISTIC REGRESSION| P=0.639N P=0.761N P=0.761N | P=0.637 P=0.230 (e) |
|COCH-ARM / FISHERS | P=0.640 P=0.753N P=0.753N | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 2.6% | 0.0% 5.1% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 1/26 (4%) 0/22 (0%) |
|FIRST INCIDENCE | 563 729 (T) 727 | --- 728 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.730N P=0.733N | P=0.618 P=0.228 (e) |
|POLY 3 | P=0.637 P=0.754 P=0.760 | P=0.642 P=0.235 (e) |
|POLY 1.5 | P=0.635 P=0.756 P=0.757 | P=0.650 P=0.238 (e) |
|POLY 6 | P=0.634N P=0.753 P=0.757N | P=0.634 P=0.229 (e) |
|LOGISTIC REGRESSION| P=0.639N P=0.761N P=0.761N | P=0.637 P=0.230 (e) |
|COCH-ARM / FISHERS | P=0.640 P=0.753N P=0.753N | 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 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 45/50 (90%) 46/50 (92%) | 23/50 (46%) 30/50 (60%) 30/49 (61%) |
|POLY-3 ADJUSTED (b)| 98.6% 93.6% 96.6% | 55.8% 69.8% 73.2% |
|TERMINAL (d) | 12/12 (100%) 17/18 (94%) 15/16 (94%) | 16/28 (57%) 19/26 (73%) 17/22 (77%) |
|FIRST INCIDENCE | 509 485 513 | 564 489 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.188N P=0.168N | P=0.018 * P=0.082 P=0.024 * |
|POLY 3 | P=0.373N P=0.174N P=0.505N | P=0.050 P=0.122 P=0.066 |
|POLY 1.5 | P=0.405N P=0.186N P=0.522N | P=0.056 P=0.122 P=0.071 |
|POLY 6 | P=0.313N P=0.199N P=0.455N | P=0.053 P=0.113 P=0.071 |
|LOGISTIC REGRESSION| P=0.478N P=0.286N P=0.612N | P=0.030 * P=0.089 P=0.041 * |
|COCH-ARM / FISHERS | P=0.283N P=0.218N P=0.339N | P=0.077 P=0.115 P=0.094 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.3% 0.0% 2.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 668 --- 729 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305N P=0.211N P=0.425N | (e) (e) (e) |
|POLY 3 | P=0.360N P=0.242N P=0.500N | (e) (e) (e) |
|POLY 1.5 | P=0.363N P=0.241N P=0.505N | (e) (e) (e) |
|POLY 6 | P=0.357N P=0.242N P=0.488N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.333N P=0.238N P=0.463N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360N P=0.247N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.3% 0.0% 5.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 668 --- 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559N P=0.211N P=0.618N | (e) (e) (e) |
|POLY 3 | P=0.622N P=0.242N P=0.694N | (e) (e) (e) |
|POLY 1.5 | P=0.621 P=0.241N P=0.690 | (e) (e) (e) |
|POLY 6 | P=0.618N P=0.242N P=0.682N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.591N P=0.238N P=0.662N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 17.9% 5.3% 10.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 1/18 (6%) 1/16 (6%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 609 646 558 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.144N P=0.060N P=0.201N | (e) (e) (e) |
|POLY 3 | P=0.182N P=0.085N P=0.257N | (e) (e) (e) |
|POLY 1.5 | P=0.188N P=0.083N P=0.267N | (e) (e) (e) |
|POLY 6 | P=0.169N P=0.086N P=0.237N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.184N P=0.084N P=0.259N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.187N P=0.080N P=0.262N | (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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 1/50 (2%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.8% 12.9% 2.6% | 5.0% 2.5% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 646 597 603 | 479 696 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.246N P=0.376 P=0.267N | P=0.157N P=0.499N P=0.261N |
|POLY 3 | P=0.257N P=0.362 P=0.301N | P=0.163N P=0.510N P=0.260N |
|POLY 1.5 | P=0.268N P=0.357 P=0.308N | P=0.156N P=0.503N P=0.252N |
|POLY 6 | P=0.235N P=0.379 P=0.286N | P=0.171N P=0.521N P=0.268N |
|LOGISTIC REGRESSION| P=0.263N P=0.355 P=0.306N | P=0.133N P=0.508N P=0.213N |
|COCH-ARM / FISHERS | P=0.264N P=0.357 P=0.309N | P=0.142N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 3/50 (6%) | 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 10.3% 15.5% 7.7% | 5.0% 2.5% 2.7% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 563 597 603 | 479 696 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383N P=0.404 P=0.452N | P=0.407N P=0.499N P=0.533N |
|POLY 3 | P=0.424N P=0.368 P=0.497N | P=0.406N P=0.510N P=0.528N |
|POLY 1.5 | P=0.438N P=0.366 P=0.506N | P=0.397N P=0.503N P=0.520N |
|POLY 6 | P=0.396N P=0.381 P=0.475N | P=0.415N P=0.521N P=0.538N |
|LOGISTIC REGRESSION| P=0.429N P=0.370 P=0.501N | P=0.339N P=0.508N P=0.443N |
|COCH-ARM / FISHERS | P=0.429N P=0.370 P=0.500N | P=0.378N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 2.7% 5.2% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 563 614 654 | --- --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390 P=0.748 P=0.519 | P=0.256 (e) P=0.482 |
|POLY 3 | P=0.380 P=0.756 P=0.502 | P=0.272 (e) P=0.489 |
|POLY 1.5 | P=0.376 P=0.757 P=0.496 | P=0.272 (e) P=0.492 |
|POLY 6 | P=0.394 P=0.758 P=0.516 | P=0.272 (e) P=0.485 |
|LOGISTIC REGRESSION| P=0.392 P=0.732N P=0.510 | P=0.326 (e) P=0.563 |
|COCH-ARM / FISHERS | P=0.378 P=0.753N P=0.500 | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.6% 5.3% 5.2% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 563 614 654 | --- --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.429 P=0.530 P=0.519 | P=0.256 (e) P=0.482 |
|POLY 3 | P=0.392 P=0.492 P=0.502 | P=0.272 (e) P=0.489 |
|POLY 1.5 | P=0.387 P=0.495 P=0.496 | P=0.272 (e) P=0.492 |
|POLY 6 | P=0.411 P=0.494 P=0.516 | P=0.272 (e) P=0.485 |
|LOGISTIC REGRESSION| P=0.393 P=0.512 P=0.510 | P=0.326 (e) P=0.563 |
|COCH-ARM / FISHERS | P=0.390 P=0.500 P=0.500 | 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) | 5/50 (10%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.9% 0.0% 5.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 609 --- 558 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105N P=0.027N* P=0.190N | (e) (e) (e) |
|POLY 3 | P=0.113N P=0.033N* P=0.212N | (e) (e) (e) |
|POLY 1.5 | P=0.116N P=0.032N* P=0.220N | (e) (e) (e) |
|POLY 6 | P=0.107N P=0.034N* P=0.197N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.119N P=0.034N* P=0.218N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.118N P=0.028N* P=0.218N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.3% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | --- 646 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639N P=0.280 (e) | (e) (e) (e) |
|POLY 3 | P=0.667N P=0.234 (e) | (e) (e) (e) |
|POLY 1.5 | P=0.666 P=0.235 (e) | (e) (e) (e) |
|POLY 6 | P=0.654N P=0.235 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.662N P=0.234 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.9% 5.3% 5.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 609 646 558 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N P=0.174N P=0.190N | (e) (e) (e) |
|POLY 3 | P=0.143N P=0.228N P=0.212N | (e) (e) (e) |
|POLY 1.5 | P=0.148N P=0.224N P=0.220N | (e) (e) (e) |
|POLY 6 | P=0.133N P=0.231N P=0.197N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.148N P=0.223N P=0.218N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.146N P=0.218N P=0.218N | (e) (e) (e) |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 12.9% 5.3% 5.1% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/18 (6%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 609 646 558 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N P=0.174N P=0.190N | (e) (e) (e) |
|POLY 3 | P=0.143N P=0.228N P=0.212N | (e) (e) (e) |
|POLY 1.5 | P=0.148N P=0.224N P=0.220N | (e) (e) (e) |
|POLY 6 | P=0.133N P=0.231N P=0.197N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.148N P=0.223N P=0.218N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.146N P=0.218N P=0.218N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 22/50 (44%) 17/50 (34%) | |
|POLY-3 ADJUSTED (b)| 50.5% 56.0% 42.8% | |
|TERMINAL (d) | 10/12 (83%) 14/18 (78%) 9/16 (56%) | |
|FIRST INCIDENCE | 609 597 555 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089N P=0.338N P=0.109N | |
|POLY 3 | P=0.271N P=0.389 P=0.315N | |
|POLY 1.5 | P=0.308N P=0.398 P=0.346N | |
|POLY 6 | P=0.204N P=0.397 P=0.255N | |
|LOGISTIC REGRESSION| P=0.191N P=0.349 P=0.226N | |
|COCH-ARM / FISHERS | P=0.304N P=0.420 P=0.339N | |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 5.3% 8.1% 5.2% | 2.5% 10.0% 8.2% |
|TERMINAL (d) | 0/12 (0%) 3/18 (17%) 1/16 (6%) | 0/28 (0%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 708 729 (T) 645 | 707 534 655 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504N P=0.624 P=0.629N | P=0.195 P=0.182 P=0.242 |
|POLY 3 | P=0.589N P=0.489 P=0.691N | P=0.220 P=0.180 P=0.279 |
|POLY 1.5 | P=0.590 P=0.493 P=0.691 | P=0.230 P=0.182 P=0.286 |
|POLY 6 | P=0.569N P=0.488 P=0.677N | P=0.212 P=0.175 P=0.272 |
|LOGISTIC REGRESSION| P=0.542N P=0.544 P=0.674N | P=0.225 P=0.179 P=0.272 |
|COCH-ARM / FISHERS | P=0.594 P=0.500 P=0.691N | P=0.252 P=0.181 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) | 2/50 (4%) 4/50 (8%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 7.9% 8.1% 5.2% | 5.1% 10.0% 8.2% |
|TERMINAL (d) | 1/12 (8%) 3/18 (17%) 1/16 (6%) | 1/28 (4%) 2/26 (8%) 2/22 (9%) |
|FIRST INCIDENCE | 708 729 (T) 645 | 707 534 655 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.520N P=0.413N | P=0.334 P=0.331 P=0.408 |
|POLY 3 | P=0.406N P=0.654 P=0.495N | P=0.379 P=0.340 P=0.467 |
|POLY 1.5 | P=0.416N P=0.656 P=0.504N | P=0.390 P=0.343 P=0.476 |
|POLY 6 | P=0.385N P=0.654 P=0.475N | P=0.368 P=0.333 P=0.458 |
|LOGISTIC REGRESSION| P=0.350N P=0.618N P=0.460N | P=0.380 P=0.334 P=0.454 |
|COCH-ARM / FISHERS | P=0.412N P=0.661N P=0.500N | P=0.417 P=0.339 P=0.500 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 2.6% | 2.5% 5.1% 2.7% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 0/16 (0%) | 1/28 (4%) 2/26 (8%) 1/22 (5%) |
|FIRST INCIDENCE | --- 729 (T) 632 | 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362 P=0.581 P=0.506 | P=0.546 P=0.474 P=0.708 |
|POLY 3 | P=0.337 P=0.496 P=0.503 | P=0.596 P=0.498 P=0.744 |
|POLY 1.5 | P=0.331 P=0.497 P=0.499 | P=0.603 P=0.501 P=0.749 |
|POLY 6 | P=0.354 P=0.497 P=0.513 | P=0.588 P=0.489 P=0.739 |
|LOGISTIC REGRESSION| P=0.335 P=0.581 P=0.507 | P=0.546 P=0.474 P=0.708 |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.622 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | 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) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.7% 5.2% | 2.5% 7.7% 2.7% |
|TERMINAL (d) | 0/12 (0%) 1/18 (6%) 1/16 (6%) | 1/28 (4%) 3/26 (12%) 1/22 (5%) |
|FIRST INCIDENCE | --- 729 (T) 632 | 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168 P=0.581 P=0.275 | P=0.524 P=0.277 P=0.708 |
|POLY 3 | P=0.145 P=0.496 P=0.240 | P=0.575 P=0.302 P=0.744 |
|POLY 1.5 | P=0.141 P=0.497 P=0.235 | P=0.586 P=0.306 P=0.749 |
|POLY 6 | P=0.154 P=0.497 P=0.250 | P=0.565 P=0.292 P=0.739 |
|LOGISTIC REGRESSION| P=0.151 P=0.581 P=0.239 | P=0.524 P=0.277 P=0.708 |
|COCH-ARM / FISHERS | P=0.142 P=0.500 P=0.247 | P=0.610 P=0.309 P=0.753N |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 5/50 (10%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| | 5.1% 12.4% 13.6% |
|TERMINAL (d) | | 2/28 (7%) 2/26 (8%) 3/22 (14%) |
|FIRST INCIDENCE | | 729 (T) 582 634 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.121 P=0.201 P=0.142 |
|POLY 3 | | P=0.150 P=0.224 P=0.187 |
|POLY 1.5 | | P=0.158 P=0.224 P=0.195 |
|POLY 6 | | P=0.143 P=0.223 P=0.180 |
|LOGISTIC REGRESSION| | P=0.151 P=0.217 P=0.172 |
|COCH-ARM / FISHERS | | P=0.178 P=0.218 P=0.218 |
|=================================================================================================================================|
| | | |
| | 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) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.1% | 0.0% 0.0% 2.7% |
|TERMINAL (d) | 0/12 (0%) 0/18 (0%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- --- 527 | --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.097 (e) P=0.235 | P=0.237 (e) P=0.452 |
|POLY 3 | P=0.097 (e) P=0.245 | P=0.273 (e) P=0.485 |
|POLY 1.5 | P=0.095 (e) P=0.238 | P=0.272 (e) P=0.489 |
|POLY 6 | P=0.103 (e) P=0.258 | P=0.274 (e) P=0.480 |
|LOGISTIC REGRESSION| P=0.124 (e) P=0.294 | (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 12/50 (24%) 8/50 (16%) | 10/50 (20%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 15.2% 29.6% 20.0% | 23.3% 14.8% 13.5% |
|TERMINAL (d) | 1/12 (8%) 3/18 (17%) 2/16 (13%) | 2/28 (7%) 2/26 (8%) 3/22 (14%) |
|FIRST INCIDENCE | 506 527 603 | 219 582 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426 P=0.139 P=0.469 | P=0.166N P=0.238N P=0.219N |
|POLY 3 | P=0.356 P=0.096 P=0.396 | P=0.150N P=0.237N P=0.202N |
|POLY 1.5 | P=0.335 P=0.093 P=0.380 | P=0.131N P=0.222N P=0.176N |
|POLY 6 | P=0.407 P=0.109 P=0.434 | P=0.174N P=0.262N P=0.233N |
|LOGISTIC REGRESSION| P=0.347 P=0.099 P=0.385 | P=0.094N P=0.214N P=0.126N |
|COCH-ARM / FISHERS | P=0.346 P=0.096 P=0.387 | P=0.097N P=0.207N P=0.131N |
|=================================================================================================================================|
| | | |
| | 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) | 6/50 (12%) 3/50 (6%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 15.2% 8.0% 5.2% | 2.5% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 2/18 (11%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 509 526 632 | 669 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.064N P=0.166N P=0.103N | P=0.288N P=0.518N P=0.525N |
|POLY 3 | P=0.091N P=0.260N P=0.136N | P=0.284N P=0.503N P=0.517N |
|POLY 1.5 | P=0.094N P=0.253N P=0.140N | P=0.280N P=0.500N P=0.511N |
|POLY 6 | P=0.083N P=0.265N P=0.126N | P=0.289N P=0.509N P=0.522N |
|LOGISTIC REGRESSION| P=0.090N P=0.242N P=0.134N | P=0.273N P=0.500N P=0.508N |
|COCH-ARM / FISHERS | P=0.090N P=0.243N P=0.134N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 15.2% 8.0% 2.6% | 2.5% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 2/18 (11%) 0/16 (0%) | 0/28 (0%) 0/26 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 509 526 632 | 669 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024N* P=0.166N P=0.045N* | P=0.288N P=0.518N P=0.525N |
|POLY 3 | P=0.035N* P=0.260N P=0.057N | P=0.284N P=0.503N P=0.517N |
|POLY 1.5 | P=0.037N* P=0.253N P=0.059N | P=0.280N P=0.500N P=0.511N |
|POLY 6 | P=0.032N* P=0.265N P=0.052N | P=0.289N P=0.509N P=0.522N |
|LOGISTIC REGRESSION| P=0.035N* P=0.242N P=0.057N | P=0.273N P=0.500N P=0.508N |
|COCH-ARM / FISHERS | P=0.036N* P=0.243N P=0.056N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 48/50 (96%) 46/50 (92%) 48/50 (96%) | 33/50 (66%) 39/50 (78%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 98.6% 95.7% 99.9% | 75.5% 86.5% 87.9% |
|TERMINAL (d) | 12/12 (100%) 18/18 (100%) 16/16 (100%) | 22/28 (79%) 23/26 (89%) 20/22 (91%) |
|FIRST INCIDENCE | 509 485 513 | 416 458 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233N P=0.214N P=0.232N | P=0.045 * P=0.120 P=0.054 |
|POLY 3 | P=0.466 P=0.357N P=0.802 | P=0.062 P=0.125 P=0.094 |
|POLY 1.5 | P=0.404 P=0.337N P=0.567 | P=0.087 P=0.131 P=0.121 |
|POLY 6 | P=0.697 P=0.494N P=1.000 | P=0.057 P=0.113 P=0.093 |
|LOGISTIC REGRESSION| P=0.263 P=0.474N (e) | P=0.071 P=0.128 P=0.099 |
|COCH-ARM / FISHERS | P=0.588 P=0.339N P=0.691N | P=0.216 P=0.133 P=0.257 |
|=================================================================================================================================|
Date: 02/24/98 EXPERIMENT: 55323 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - LAURIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100 | 0 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) 19/50 (38%) | 18/50 (36%) 13/50 (26%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 52.3% 48.7% 45.0% | 40.9% 31.2% 31.3% |
|TERMINAL (d) | 5/12 (42%) 6/18 (33%) 7/16 (44%) | 8/28 (29%) 6/26 (23%) 5/22 (23%) |
|FIRST INCIDENCE | 500 430 527 | 219 575 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166N P=0.312N P=0.173N | P=0.253N P=0.255N P=0.303N |
|POLY 3 | P=0.279N P=0.447N P=0.316N | P=0.198N P=0.235N P=0.246N |
|POLY 1.5 | P=0.282N P=0.440N P=0.318N | P=0.170N P=0.218N P=0.210N |
|POLY 6 | P=0.254N P=0.440N P=0.292N | P=0.229N P=0.262N P=0.283N |
|LOGISTIC REGRESSION| P=0.237N P=0.400N P=0.275N | P=0.122N P=0.195N P=0.148N |
|COCH-ARM / FISHERS | P=0.239N P=0.420N P=0.272N | P=0.112N P=0.194N P=0.138N |
|=================================================================================================================================|
| | | |
| | 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) | 50/50 (100%) 49/50 (98%) 48/50 (96%) | 40/50 (80%) 41/50 (82%) 38/50 (76%) |
|POLY-3 ADJUSTED (b)| 100.0% 98.7% 99.9% | 85.5% 89.1% 88.7% |
|TERMINAL (d) | 12/12 (100%) 18/18 (100%) 16/16 (100%) | 23/28 (82%) 23/26 (89%) 20/22 (91%) |
|FIRST INCIDENCE | 500 430 513 | 219 458 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171N P=0.264N P=0.168N | P=0.246 P=0.375 P=0.272 |
|POLY 3 | P=0.803N P=0.719N P=1.000N | P=0.368 P=0.411 P=0.441 |
|POLY 1.5 | P=0.623N P=0.601N P=0.999N | P=0.461 P=0.438 P=0.528 |
|POLY 6 | P=0.937N P=0.934N P=1.000N | P=0.321 P=0.381 P=0.399 |
|LOGISTIC REGRESSION| P=0.576N P=0.510N (e) | P=0.523N P=0.535 P=0.564N |
|COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.247N | P=0.356N P=0.500 P=0.405N |
|=================================================================================================================================|
(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).