Statistical Analysis Of Primary Tumors
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/13/97
EXPERIMENT: 91014 TEST: 03 TIME: 12:17:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: YARRINGTON, J. CAS: 93-83-4
Rats(FISCHER344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/13/97
EXPERIMENT: 91014 TEST: 03 TIME: 12:17:19
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: YARRINGTON, J. CAS: 93-83-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF OLEIC ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Testes Adenoma
Thyroid Gland: Follicular Cell Carcinoma or Adenoma
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Benign Tumors
===============================================================
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 6/50 (12%) 6/49 (12%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 33.9% 17.3% 16.2% | 5.7% 0.0% 3.5% |
|TERMINAL (d) | 2/8 (25%) 3/10 (30%) 4/14 (29%) | 1/15 (7%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 618 580 661 | 695 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.092N P=0.013N* | P=0.382N P=0.215N P=0.535N |
|POLY 3 | P=0.044N* P=0.085N P=0.063N | P=0.395N P=0.239N P=0.566N |
|POLY 1.5 | P=0.054N P=0.090N P=0.078N | P=0.386N P=0.242N P=0.547N |
|POLY 6 | P=0.034N* P=0.085N P=0.050N | P=0.398N P=0.232N P=0.578N |
|LOGISTIC REGRESSION| P=0.020N* P=0.081N P=0.025N* | P=0.398N P=0.220N P=0.558N |
|COCH-ARM / FISHERS | P=0.072N P=0.096N P=0.104N | P=0.360N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 6/50 (12%) 7/49 (14%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 33.9% 17.3% 18.7% | 5.7% 0.0% 3.5% |
|TERMINAL (d) | 2/8 (25%) 3/10 (30%) 4/14 (29%) | 1/15 (7%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 618 580 647 | 695 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022N* P=0.092N P=0.027N* | P=0.382N P=0.215N P=0.535N |
|POLY 3 | P=0.080N P=0.085N P=0.106N | P=0.395N P=0.239N P=0.566N |
|POLY 1.5 | P=0.096N P=0.090N P=0.128N | P=0.386N P=0.242N P=0.547N |
|POLY 6 | P=0.062N P=0.085N P=0.084N | P=0.398N P=0.232N P=0.578N |
|LOGISTIC REGRESSION| P=0.041N* P=0.081N P=0.051N | P=0.398N P=0.220N P=0.558N |
|COCH-ARM / FISHERS | P=0.122N P=0.096N P=0.166N | P=0.360N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 10/49 (20%) 3/47 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 2.7% | 27.6% 9.4% 13.6% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 4/15 (27%) 1/17 (6%) 1/14 (7%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) | 524 685 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.456 P=0.545 P=0.612 | P=0.066N P=0.032N* P=0.131N |
|POLY 3 | P=0.371 P=0.502 P=0.522 | P=0.066N P=0.050N P=0.138N |
|POLY 1.5 | P=0.354 P=0.500 P=0.513 | P=0.056N P=0.049N* P=0.111N |
|POLY 6 | P=0.397 P=0.503 P=0.537 | P=0.073N P=0.048N* P=0.162N |
|LOGISTIC REGRESSION| (e) P=0.545 P=0.612 | P=0.068N P=0.045N* P=0.121N |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.039N* P=0.042N* P=0.068N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 10/49 (20%) 4/47 (9%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 5.3% | 27.6% 12.5% 17.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 4/15 (27%) 2/17 (12%) 2/14 (14%) |
|FIRST INCIDENCE | --- 728 (T) 526 | 524 685 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 P=0.545 P=0.314 | P=0.129N P=0.062N P=0.206N |
|POLY 3 | P=0.169 P=0.502 P=0.266 | P=0.143N P=0.102N P=0.232N |
|POLY 1.5 | P=0.157 P=0.500 P=0.253 | P=0.121N P=0.099N P=0.191N |
|POLY 6 | P=0.190 P=0.503 P=0.286 | P=0.160N P=0.100N P=0.269N |
|LOGISTIC REGRESSION| P=0.159 P=0.545 P=0.226 | P=0.142N P=0.088N P=0.208N |
|COCH-ARM / FISHERS | P=0.142 P=0.500 P=0.247 | P=0.083N P=0.086N P=0.122N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.0% 0.0% 8.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 614 --- 647 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255 P=0.520N P=0.418 | (e) (e) (e) |
|POLY 3 | P=0.192 P=0.501N P=0.344 | (e) (e) (e) |
|POLY 1.5 | P=0.184 P=0.501N P=0.328 | (e) (e) (e) |
|POLY 6 | P=0.206 P=0.502N P=0.373 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.209 P=0.500N P=0.352 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.176 P=0.500N P=0.309 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 6.0% 3.0% 2.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 707 674 728 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227N P=0.460N P=0.306N | (e) (e) (e) |
|POLY 3 | P=0.353N P=0.496N P=0.462N | (e) (e) (e) |
|POLY 1.5 | P=0.365N P=0.499N P=0.478N | (e) (e) (e) |
|POLY 6 | P=0.335N P=0.491N P=0.436N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.264N P=0.483N P=0.322N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.378N P=0.500N P=0.500N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 4/50 (8%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.9% 3.0% 10.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 614 674 647 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565N P=0.287N P=0.591N | (e) (e) (e) |
|POLY 3 | P=0.453 P=0.303N P=0.560 | (e) (e) (e) |
|POLY 1.5 | P=0.435 P=0.305N P=0.534 | (e) (e) (e) |
|POLY 6 | P=0.484 P=0.300N P=0.600 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.526 P=0.296N P=0.631 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.412 P=0.309N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.0% 0.0% | 2.9% 2.9% 3.5% |
|TERMINAL (d) | 0/8 (0%) 2/10 (20%) 0/14 (0%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | --- 728 (T) --- | 610 728 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.284 (e) | P=0.606 P=0.744N P=0.721 |
|POLY 3 | P=0.631N P=0.237 (e) | P=0.603 P=0.757 P=0.716 |
|POLY 1.5 | P=0.647N P=0.237 (e) | P=0.612 P=0.755 P=0.730 |
|POLY 6 | P=0.604N P=0.237 (e) | P=0.600 P=0.762 P=0.708 |
|LOGISTIC REGRESSION| (e) P=0.284 (e) | P=0.591 P=0.761 P=0.727 |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | P=0.640 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 3.0% 0.0% 0.0% | 2.9% 0.0% 10.4% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 1/15 (7%) 0/18 (0%) 2/14 (14%) |
|FIRST INCIDENCE | 728 (T) --- --- | 728 (T) --- 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.197N P=0.455N P=0.388N | P=0.147 P=0.464N P=0.268 |
|POLY 3 | P=0.272N P=0.498N P=0.478N | P=0.166 P=0.502N P=0.241 |
|POLY 1.5 | P=0.271N P=0.500N P=0.487N | P=0.167 P=0.504N P=0.259 |
|POLY 6 | P=0.272N P=0.497N P=0.463N | P=0.167 P=0.496N P=0.232 |
|LOGISTIC REGRESSION| P=0.197N (e) (e) | P=0.134 (e) P=0.246 |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.176 P=0.500N P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 3.0% 0.0% 0.0% | 2.9% 2.9% 10.4% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 1/15 (7%) 1/18 (6%) 2/14 (14%) |
|FIRST INCIDENCE | 728 (T) --- --- | 728 (T) 728 (T) 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.197N P=0.455N P=0.388N | P=0.168 P=0.722N P=0.268 |
|POLY 3 | P=0.272N P=0.498N P=0.478N | P=0.175 P=0.759 P=0.241 |
|POLY 1.5 | P=0.271N P=0.500N P=0.487N | P=0.181 P=0.756 P=0.259 |
|POLY 6 | P=0.272N P=0.497N P=0.463N | P=0.173 P=0.758N P=0.232 |
|LOGISTIC REGRESSION| P=0.197N (e) (e) | P=0.155 P=0.722N P=0.246 |
|COCH-ARM / FISHERS | P=0.269N P=0.500N P=0.500N | P=0.202 P=0.753N P=0.309 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) | 9/50 (18%) 10/50 (20%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 8.9% 0.0% 2.7% | 24.7% 27.8% 20.6% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 0/14 (0%) | 4/15 (27%) 4/18 (22%) 4/14 (29%) |
|FIRST INCIDENCE | 618 --- 723 | 497 579 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.099N P=0.153N | P=0.363N P=0.588 P=0.388N |
|POLY 3 | P=0.165N P=0.117N P=0.268N | P=0.444N P=0.487 P=0.461N |
|POLY 1.5 | P=0.170N P=0.118N P=0.284N | P=0.379N P=0.476 P=0.401N |
|POLY 6 | P=0.156N P=0.115N P=0.245N | P=0.490N P=0.525 P=0.511N |
|LOGISTIC REGRESSION| P=0.118N P=0.113N P=0.205N | P=0.402N P=0.494 P=0.448N |
|COCH-ARM / FISHERS | P=0.176N P=0.121N P=0.309N | P=0.251N P=0.500 P=0.288N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) | 9/50 (18%) 11/50 (22%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 8.9% 0.0% 2.7% | 24.7% 30.6% 20.6% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 0/14 (0%) | 4/15 (27%) 5/18 (28%) 4/14 (29%) |
|FIRST INCIDENCE | 618 --- 723 | 497 579 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.099N P=0.153N | P=0.367N P=0.501 P=0.388N |
|POLY 3 | P=0.165N P=0.117N P=0.268N | P=0.462N P=0.381 P=0.461N |
|POLY 1.5 | P=0.170N P=0.118N P=0.284N | P=0.392N P=0.374 P=0.401N |
|POLY 6 | P=0.156N P=0.115N P=0.245N | P=0.513N P=0.416 P=0.511N |
|LOGISTIC REGRESSION| P=0.118N P=0.113N P=0.205N | P=0.412N P=0.394 P=0.448N |
|COCH-ARM / FISHERS | P=0.176N P=0.121N P=0.309N | P=0.254N P=0.402 P=0.288N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) | 10/50 (20%) 11/50 (22%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 11.9% 0.0% 2.7% | 27.5% 30.6% 27.3% |
|TERMINAL (d) | 3/8 (38%) 0/10 (0%) 0/14 (0%) | 5/15 (33%) 5/18 (28%) 5/14 (36%) |
|FIRST INCIDENCE | 618 --- 723 | 497 579 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.042N* P=0.062N | P=0.483N P=0.584N P=0.516N |
|POLY 3 | P=0.072N P=0.058N P=0.146N | P=0.546 P=0.485 P=0.607N |
|POLY 1.5 | P=0.075N P=0.059N P=0.160N | P=0.505N P=0.475 P=0.538N |
|POLY 6 | P=0.065N P=0.056N P=0.127N | P=0.508 P=0.527 P=0.569 |
|LOGISTIC REGRESSION| P=0.042N* P=0.053N P=0.089N | P=0.549N P=0.498 P=0.602N |
|COCH-ARM / FISHERS | P=0.082N P=0.059N P=0.181N | P=0.352N P=0.500 P=0.398N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 38/50 (76%) 40/49 (82%) | 29/50 (58%) 20/50 (40%) 19/50 (38%) |
|POLY-3 ADJUSTED (b)| 83.6% 82.8% 86.7% | 70.7% 55.7% 56.6% |
|TERMINAL (d) | 6/8 (75%) 8/10 (80%) 12/14 (86%) | 10/15 (67%) 11/18 (61%) 7/14 (50%) |
|FIRST INCIDENCE | 440 224 482 | 462 622 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136N P=0.481N P=0.134N | P=0.136N P=0.038N* P=0.205N |
|POLY 3 | P=0.385 P=0.579N P=0.447 | P=0.093N P=0.109N P=0.134N |
|POLY 1.5 | P=0.357 P=0.578N P=0.410 | P=0.065N P=0.084N P=0.091N |
|POLY 6 | P=0.408 P=0.589N P=0.482 | P=0.117N P=0.146N P=0.167N |
|LOGISTIC REGRESSION| P=0.343 P=0.593 P=0.413 | P=0.118N P=0.040N* P=0.140N |
|COCH-ARM / FISHERS | P=0.291 P=0.592N P=0.331 | P=0.028N* P=0.055N P=0.036N* |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.9% 3.0% 0.0% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 603 659 --- | --- 702 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.098N P=0.471N P=0.174N | P=0.731 P=0.542 (e) |
|POLY 3 | P=0.129N P=0.499N P=0.215N | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.135N P=0.500N P=0.224N | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.120N P=0.497N P=0.201N | P=0.694 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.124N P=0.496N P=0.211N | P=0.709 P=0.508 (e) |
|COCH-ARM / FISHERS | P=0.142N P=0.500N P=0.247N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.9% 8.8% 5.3% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 603 659 674 | --- 702 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419N P=0.537 P=0.563N | P=0.731 P=0.542 (e) |
|POLY 3 | P=0.544N P=0.504 P=0.656N | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.565N P=0.501 P=0.672N | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.507N P=0.510 P=0.628N | P=0.694 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.517N P=0.508 P=0.649N | P=0.709 P=0.508 (e) |
|COCH-ARM / FISHERS | P=0.594 P=0.500 P=0.691N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.9% 5.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 674 674 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 P=0.257 P=0.330 | (e) (e) (e) |
|POLY 3 | P=0.215 P=0.239 P=0.264 | (e) (e) (e) |
|POLY 1.5 | P=0.197 P=0.238 P=0.252 | (e) (e) (e) |
|POLY 6 | P=0.247 P=0.241 P=0.285 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.229 P=0.245 P=0.269 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.176 P=0.247 P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 535 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.134 (e) P=0.313 | (e) (e) (e) |
|POLY 3 | P=0.107 (e) P=0.266 | (e) (e) (e) |
|POLY 1.5 | P=0.101 (e) P=0.253 | (e) (e) (e) |
|POLY 6 | P=0.117 (e) P=0.288 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.089 (e) P=0.218 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 (e) P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 30/50 (60%) 37/50 (74%) | |
|POLY-3 ADJUSTED (b)| 62.8% 72.6% 83.0% | |
|TERMINAL (d) | 8/8 (100%) 9/10 (90%) 13/14 (93%) | |
|FIRST INCIDENCE | 440 440 526 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403 P=0.317 P=0.447 | |
|POLY 3 | P=0.011 * P=0.212 P=0.015 * | |
|POLY 1.5 | P=0.007 ** P=0.177 P=0.009 ** | |
|POLY 6 | P=0.029 * P=0.289 P=0.041 * | |
|LOGISTIC REGRESSION| P=0.015 * P=0.151 P=0.021 * | |
|COCH-ARM / FISHERS | P=0.005 ** P=0.158 P=0.007 ** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 7/50 (14%) | 4/50 (8%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 5.9% 14.1% 18.6% | 11.4% 11.4% 6.7% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 3/14 (21%) | 2/15 (13%) 2/18 (11%) 1/14 (7%) |
|FIRST INCIDENCE | 638 554 638 | 679 544 355 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171 P=0.197 P=0.241 | P=0.330N P=0.587N P=0.394N |
|POLY 3 | P=0.081 P=0.232 P=0.103 | P=0.361N P=0.645N P=0.415N |
|POLY 1.5 | P=0.072 P=0.223 P=0.092 | P=0.336N P=0.637 P=0.392N |
|POLY 6 | P=0.098 P=0.248 P=0.121 | P=0.372N P=0.624N P=0.427N |
|LOGISTIC REGRESSION| P=0.091 P=0.217 P=0.151 | P=0.339N P=0.641N P=0.406N |
|COCH-ARM / FISHERS | P=0.061 P=0.218 P=0.080 | P=0.274N P=0.643N P=0.339N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 6.0% 3.0% 2.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 694 728 (T) 638 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260N P=0.448N P=0.379N | (e) (e) (e) |
|POLY 3 | P=0.351N P=0.498N P=0.459N | (e) (e) (e) |
|POLY 1.5 | P=0.364N P=0.500N P=0.477N | (e) (e) (e) |
|POLY 6 | P=0.330N P=0.498N P=0.431N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.292N P=0.460N P=0.427N | (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 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 8/50 (16%) | 4/50 (8%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.9% 17.0% 21.1% | 11.4% 11.4% 6.7% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 3/14 (21%) | 2/15 (13%) 2/18 (11%) 1/14 (7%) |
|FIRST INCIDENCE | 638 554 638 | 679 544 355 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.229 P=0.248 P=0.299 | P=0.330N P=0.587N P=0.394N |
|POLY 3 | P=0.108 P=0.261 P=0.133 | P=0.361N P=0.645N P=0.415N |
|POLY 1.5 | P=0.094 P=0.250 P=0.118 | P=0.336N P=0.637 P=0.392N |
|POLY 6 | P=0.136 P=0.281 P=0.162 | P=0.372N P=0.624N P=0.427N |
|LOGISTIC REGRESSION| P=0.125 P=0.245 P=0.187 | P=0.339N P=0.641N P=0.406N |
|COCH-ARM / FISHERS | P=0.078 P=0.243 P=0.100 | P=0.274N P=0.643N P=0.339N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 11.6% 2.7% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 580 728 (T) | --- 693 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521 P=0.071 P=0.612 | P=0.708 P=0.509 (e) |
|POLY 3 | P=0.464 P=0.063 P=0.522 | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.432 P=0.061 P=0.513 | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.518 P=0.066 P=0.537 | P=0.694 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.439 P=0.063 P=0.612 | P=0.708 P=0.504 (e) |
|COCH-ARM / FISHERS | P=0.390 P=0.059 P=0.500 | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.9% 2.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 607 728 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472 P=0.264 P=0.612 | (e) (e) (e) |
|POLY 3 | P=0.413 P=0.240 P=0.522 | (e) (e) (e) |
|POLY 1.5 | P=0.390 P=0.238 P=0.513 | (e) (e) (e) |
|POLY 6 | P=0.450 P=0.243 P=0.537 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.423 P=0.240 P=0.612 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.247 P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 6/50 (12%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 17.2% 5.4% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 2/10 (20%) 2/14 (14%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 580 728 (T) | --- 693 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.412 P=0.023 * P=0.366 | P=0.708 P=0.509 (e) |
|POLY 3 | P=0.324 P=0.016 * P=0.262 | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.290 P=0.016 * P=0.251 | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.383 P=0.017 * P=0.279 | P=0.694 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.318 P=0.018 * P=0.366 | P=0.708 P=0.504 (e) |
|COCH-ARM / FISHERS | P=0.252 P=0.013 * P=0.247 | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| | 2.9% 5.8% 6.8% |
|TERMINAL (d) | | 0/15 (0%) 2/18 (11%) 1/14 (7%) |
|FIRST INCIDENCE | | 614 728 (T) 419 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.339 P=0.542 P=0.434 |
|POLY 3 | | P=0.337 P=0.492 P=0.441 |
|POLY 1.5 | | P=0.351 P=0.490 P=0.457 |
|POLY 6 | | P=0.330 P=0.500 P=0.432 |
|LOGISTIC REGRESSION| | P=0.348 P=0.505 P=0.512 |
|COCH-ARM / FISHERS | | P=0.390 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 13/50 (26%) 13/50 (26%) | 5/50 (10%) 9/50 (18%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 37.7% 35.5% 32.6% | 14.2% 25.0% 25.6% |
|TERMINAL (d) | 5/8 (63%) 5/10 (50%) 3/14 (21%) | 2/15 (13%) 3/18 (17%) 2/14 (14%) |
|FIRST INCIDENCE | 293 483 580 | 635 547 169 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152N P=0.406N P=0.193N | P=0.172 P=0.264 P=0.218 |
|POLY 3 | P=0.359N P=0.519N P=0.407N | P=0.153 P=0.194 P=0.191 |
|POLY 1.5 | P=0.405N P=0.516N P=0.451N | P=0.174 P=0.184 P=0.213 |
|POLY 6 | P=0.282N P=0.526N P=0.333N | P=0.153 P=0.225 P=0.188 |
|LOGISTIC REGRESSION| P=0.367N P=0.495N P=0.430N | P=0.152 P=0.189 P=0.198 |
|COCH-ARM / FISHERS | P=0.455N P=0.500N P=0.500N | P=0.240 P=0.194 P=0.277 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 2.9% 8.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 623 603 628 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.541 P=0.483N P=0.679 | (e) (e) (e) |
|POLY 3 | P=0.439 P=0.496N P=0.550 | (e) (e) (e) |
|POLY 1.5 | P=0.422 P=0.499N P=0.529 | (e) (e) (e) |
|POLY 6 | P=0.467 P=0.493N P=0.584 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.462 P=0.498N P=0.596 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.399 P=0.500N P=0.500 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 47/50 (94%) 49/50 (98%) | 38/50 (76%) 28/50 (56%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 98.1% 97.4% 98.6% | 86.5% 74.5% 72.3% |
|TERMINAL (d) | 8/8 (100%) 10/10 (100%) 14/14 (100%) | 13/15 (87%) 15/18 (83%) 10/14 (71%) |
|FIRST INCIDENCE | 440 224 482 | 462 544 355 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.472N P=0.094N | P=0.130N P=0.030N* P=0.192N |
|POLY 3 | P=0.600 P=0.738N P=0.794 | P=0.045N* P=0.101N P=0.067N |
|POLY 1.5 | P=0.432 P=0.688N P=0.586 | P=0.024N* P=0.058N P=0.034N* |
|POLY 6 | P=0.776N P=0.882N P=0.955N | P=0.086N P=0.195N P=0.127N |
|LOGISTIC REGRESSION| P=0.384 P=0.641 P=0.571 | P=0.069N P=0.019N* P=0.072N |
|COCH-ARM / FISHERS | P=0.238 P=0.661N P=0.309 | P=0.009N** P=0.028N* P=0.011N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 18/50 (36%) 22/50 (44%) | 12/50 (24%) 15/50 (30%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 53.1% 47.7% 52.0% | 31.7% 40.7% 38.3% |
|TERMINAL (d) | 6/8 (75%) 7/10 (70%) 5/14 (36%) | 4/15 (27%) 6/18 (33%) 5/14 (36%) |
|FIRST INCIDENCE | 293 483 526 | 429 541 169 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195N P=0.271N P=0.230N | P=0.390 P=0.437 P=0.436 |
|POLY 3 | P=0.514N P=0.396N P=0.551N | P=0.309 P=0.280 P=0.374 |
|POLY 1.5 | P=0.519 P=0.380N P=0.566 | P=0.383 P=0.282 P=0.447 |
|POLY 6 | P=0.396N P=0.417N P=0.439N | P=0.267 P=0.306 P=0.326 |
|LOGISTIC REGRESSION| P=0.534N P=0.335N P=0.546 | P=0.364 P=0.306 P=0.442 |
|COCH-ARM / FISHERS | P=0.459 P=0.341N P=0.500 | P=0.545 P=0.326 P=0.592N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 48/50 (96%) 50/50 (100%) | 40/50 (80%) 34/50 (68%) 32/50 (64%) |
|POLY-3 ADJUSTED (b)| 99.5% 98.8% 100.0% | 88.5% 86.8% 85.4% |
|TERMINAL (d) | 8/8 (100%) 10/10 (100%) 14/14 (100%) | 13/15 (87%) 17/18 (94%) 13/14 (93%) |
|FIRST INCIDENCE | 293 224 482 | 429 541 169 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.430N P=0.078N | P=0.362N P=0.111N P=0.428N |
|POLY 3 | P=0.694 P=0.894N P=0.997 | P=0.386N P=0.548N P=0.462N |
|POLY 1.5 | P=0.488 P=0.712N P=0.822 | P=0.177N P=0.332N P=0.225N |
|POLY 6 | P=0.987 P=1.000N P=1.000 | P=0.525 P=0.581 P=0.620 |
|LOGISTIC REGRESSION| P=0.508 P=0.561N P=0.706 | P=0.328N P=0.143N P=0.302N |
|COCH-ARM / FISHERS | P=0.360 P=0.500N P=0.500 | P=0.050N P=0.127N P=0.059N |
|=================================================================================================================================|
(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).