Statistical Analysis of Primary Tumors
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/30/97
EXPERIMENT: 91014 TEST: 04 TIME: 08:20:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/30/97
EXPERIMENT: 91014 TEST: 04 TIME: 08:20:48
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF OLEIC ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
All Organs Hemangioma
Malignant Lymphoma And Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
Malignant and Benign Tumors
===============================================================
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.274N P=0.280N | (e) (e) (e) |
|POLY 3 | P=0.100N P=0.241N P=0.253N | (e) (e) (e) |
|POLY 1.5 | P=0.097N P=0.238N P=0.245N | (e) (e) (e) |
|POLY 6 | P=0.104N P=0.246N P=0.264N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118N (e) (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.093N P=0.242N P=0.242N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 2/34 (6%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- | 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.098N P=0.266N P=0.232N |
|POLY 3 | (e) (e) (e) | P=0.094N P=0.240N P=0.236N |
|POLY 1.5 | (e) (e) (e) | P=0.094N P=0.238N P=0.236N |
|POLY 6 | (e) (e) (e) | P=0.094N P=0.245N P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.098N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 2/34 (6%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) | 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 (e) P=0.198 | P=0.271N P=0.525N P=0.494N |
|POLY 3 | P=0.095 (e) P=0.222 | P=0.270N P=0.503N P=0.499N |
|POLY 1.5 | P=0.095 (e) P=0.230 | P=0.270N P=0.501N P=0.499N |
|POLY 6 | P=0.095 (e) P=0.213 | P=0.270N P=0.507N P=0.498N |
|LOGISTIC REGRESSION| (e) (e) P=0.198 | P=0.271N (e) (e) |
|COCH-ARM / FISHERS | P=0.097 (e) P=0.253 | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) | 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.2% 9.3% | 6.8% 2.3% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/35 (3%) 2/34 (6%) | 2/34 (6%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 638 | 621 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186 P=0.555N P=0.264 | P=0.062N P=0.338N P=0.120N |
|POLY 3 | P=0.227 P=0.506N P=0.311 | P=0.060N P=0.314N P=0.119N |
|POLY 1.5 | P=0.233 P=0.502N P=0.325 | P=0.060N P=0.309N P=0.119N |
|POLY 6 | P=0.219 P=0.514N P=0.295 | P=0.060N P=0.324N P=0.119N |
|LOGISTIC REGRESSION| P=0.217 P=0.555N P=0.313 | P=0.060N P=0.308N P=0.120N |
|COCH-ARM / FISHERS | P=0.238 P=0.500N P=0.339 | P=0.060N P=0.309N P=0.121N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 4/50 (8%) | 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.2% 9.3% | 6.8% 4.7% 0.0% |
|TERMINAL (d) | 2/41 (5%) 1/35 (3%) 2/34 (6%) | 2/34 (6%) 2/30 (7%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 638 | 621 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186 P=0.555N P=0.264 | P=0.083N P=0.543N P=0.120N |
|POLY 3 | P=0.227 P=0.506N P=0.311 | P=0.082N P=0.511N P=0.119N |
|POLY 1.5 | P=0.233 P=0.502N P=0.325 | P=0.081N P=0.504N P=0.119N |
|POLY 6 | P=0.219 P=0.514N P=0.295 | P=0.082N P=0.524N P=0.119N |
|LOGISTIC REGRESSION| P=0.217 P=0.555N P=0.313 | P=0.082N P=0.508N P=0.120N |
|COCH-ARM / FISHERS | P=0.238 P=0.500N P=0.339 | P=0.082N P=0.500N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.274N P=0.280N | (e) (e) (e) |
|POLY 3 | P=0.101N P=0.241N P=0.253N | (e) (e) (e) |
|POLY 1.5 | P=0.097N P=0.238N P=0.245N | (e) (e) (e) |
|POLY 6 | P=0.105N P=0.246N P=0.264N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118N (e) (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N P=0.274N P=0.280N | (e) (e) (e) |
|POLY 3 | P=0.101N P=0.241N P=0.253N | (e) (e) (e) |
|POLY 1.5 | P=0.097N P=0.238N P=0.245N | (e) (e) (e) |
|POLY 6 | P=0.105N P=0.246N P=0.264N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.118N (e) (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 2/50 (4%) | 1/49 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 4.7% | 2.3% 0.0% 2.3% |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 2/34 (6%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) | 730 (T) --- 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.204 P=0.198 | P=0.655N P=0.525N P=0.751N |
|POLY 3 | P=0.160 P=0.233 P=0.222 | P=0.664N P=0.500N P=0.756N |
|POLY 1.5 | P=0.168 P=0.236 P=0.230 | P=0.664N P=0.497N P=0.755N |
|POLY 6 | P=0.151 P=0.228 P=0.213 | P=0.663N P=0.505N P=0.755N |
|LOGISTIC REGRESSION| (e) P=0.204 P=0.198 | P=0.664N (e) P=0.758N |
|COCH-ARM / FISHERS | P=0.180 P=0.253 P=0.253 | P=0.665N P=0.495N P=0.747N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 2/50 (4%) | 1/49 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 4.7% | 2.3% 2.3% 2.3% |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 2/34 (6%) | 1/34 (3%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) | 730 (T) 730 (T) 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.204 P=0.198 | P=0.626N P=0.734 P=0.751N |
|POLY 3 | P=0.160 P=0.233 P=0.222 | P=0.633N P=0.761N P=0.756N |
|POLY 1.5 | P=0.168 P=0.236 P=0.230 | P=0.632N P=0.757N P=0.755N |
|POLY 6 | P=0.151 P=0.228 P=0.213 | P=0.632N P=0.756 P=0.755N |
|LOGISTIC REGRESSION| (e) P=0.204 P=0.198 | P=0.633N P=0.734 P=0.758N |
|COCH-ARM / FISHERS | P=0.180 P=0.253 P=0.253 | P=0.634N P=0.747N P=0.747N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 8.9% 4.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/41 (2%) 4/35 (11%) 1/34 (3%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 468 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341 P=0.135 P=0.459 | (e) (e) (e) |
|POLY 3 | P=0.377 P=0.173 P=0.482 | (e) (e) (e) |
|POLY 1.5 | P=0.392 P=0.177 P=0.492 | (e) (e) (e) |
|POLY 6 | P=0.356 P=0.166 P=0.468 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.416 P=0.135 P=0.572 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.415 P=0.187 P=0.508 | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/49 (45%) 22/50 (44%) 22/50 (44%) | 26/50 (52%) 30/50 (60%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| 46.7% 48.6% 49.2% | 57.7% 65.5% 63.1% |
|TERMINAL (d) | 20/41 (49%) 19/35 (54%) 17/34 (50%) | 20/34 (59%) 21/30 (70%) 24/35 (69%) |
|FIRST INCIDENCE | 456 660 356 | 578 501 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251 P=0.330 P=0.301 | P=0.443 P=0.143 P=0.476 |
|POLY 3 | P=0.448 P=0.511 P=0.490 | P=0.332 P=0.286 P=0.376 |
|POLY 1.5 | P=0.501 P=0.545 P=0.541 | P=0.359 P=0.287 P=0.401 |
|POLY 6 | P=0.386 P=0.467 P=0.429 | P=0.309 P=0.272 P=0.356 |
|LOGISTIC REGRESSION| P=0.469 P=0.563 P=0.566 | P=0.376 P=0.247 P=0.423 |
|COCH-ARM / FISHERS | P=0.505N P=0.545N P=0.545N | P=0.381 P=0.273 P=0.421 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 9/50 (18%) 13/50 (26%) | 5/50 (10%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 19.0% 19.6% 29.2% | 11.3% 22.5% 15.9% |
|TERMINAL (d) | 4/41 (10%) 4/35 (11%) 7/34 (21%) | 3/34 (9%) 4/30 (13%) 4/35 (11%) |
|FIRST INCIDENCE | 452 547 537 | 562 585 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122 P=0.514 P=0.148 | P=0.362 P=0.112 P=0.400 |
|POLY 3 | P=0.155 P=0.575 P=0.185 | P=0.331 P=0.130 P=0.376 |
|POLY 1.5 | P=0.174 P=0.590 P=0.209 | P=0.335 P=0.131 P=0.379 |
|POLY 6 | P=0.136 P=0.553 P=0.161 | P=0.332 P=0.127 P=0.378 |
|LOGISTIC REGRESSION| P=0.237 P=0.546N P=0.305 | P=0.338 P=0.131 P=0.381 |
|COCH-ARM / FISHERS | P=0.208 P=0.584N P=0.251 | P=0.336 P=0.131 P=0.380 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 9/50 (18%) 13/50 (26%) | 6/50 (12%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 19.0% 19.6% 29.2% | 13.4% 22.5% 15.9% |
|TERMINAL (d) | 4/41 (10%) 4/35 (11%) 7/34 (21%) | 3/34 (9%) 4/30 (13%) 4/35 (11%) |
|FIRST INCIDENCE | 452 547 537 | 562 585 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122 P=0.514 P=0.148 | P=0.465 P=0.180 P=0.516 |
|POLY 3 | P=0.155 P=0.575 P=0.185 | P=0.430 P=0.200 P=0.489 |
|POLY 1.5 | P=0.174 P=0.590 P=0.209 | P=0.438 P=0.205 P=0.495 |
|POLY 6 | P=0.136 P=0.553 P=0.161 | P=0.426 P=0.193 P=0.486 |
|LOGISTIC REGRESSION| P=0.237 P=0.546N P=0.305 | P=0.446 P=0.207 P=0.502 |
|COCH-ARM / FISHERS | P=0.208 P=0.584N P=0.251 | P=0.445 P=0.207 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/49 (59%) 27/50 (54%) 30/50 (60%) | 28/50 (56%) 35/50 (70%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 59.3% 58.4% 65.2% | 61.4% 74.3% 65.2% |
|TERMINAL (d) | 22/41 (54%) 21/35 (60%) 21/34 (62%) | 21/34 (62%) 22/30 (73%) 24/35 (69%) |
|FIRST INCIDENCE | 452 547 356 | 562 501 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174 P=0.455 P=0.206 | P=0.518 P=0.063 P=0.553 |
|POLY 3 | P=0.321 P=0.545N P=0.352 | P=0.385 P=0.126 P=0.438 |
|POLY 1.5 | P=0.391 P=0.488N P=0.426 | P=0.423 P=0.118 P=0.471 |
|POLY 6 | P=0.253 P=0.556 P=0.282 | P=0.353 P=0.135 P=0.410 |
|LOGISTIC REGRESSION| P=0.458 P=0.388N P=0.561 | P=0.459 P=0.097 P=0.504 |
|COCH-ARM / FISHERS | P=0.506 P=0.376N P=0.548 | P=0.459 P=0.107 P=0.500 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/49 (59%) 27/50 (54%) 30/50 (60%) | 28/50 (56%) 35/50 (70%) 29/50 (58%) |
|POLY-3 ADJUSTED (b)| 59.3% 58.4% 65.2% | 61.4% 74.3% 65.2% |
|TERMINAL (d) | 22/41 (54%) 21/35 (60%) 21/34 (62%) | 21/34 (62%) 22/30 (73%) 24/35 (69%) |
|FIRST INCIDENCE | 452 547 356 | 562 501 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174 P=0.455 P=0.206 | P=0.518 P=0.063 P=0.553 |
|POLY 3 | P=0.321 P=0.545N P=0.352 | P=0.385 P=0.126 P=0.438 |
|POLY 1.5 | P=0.391 P=0.488N P=0.426 | P=0.423 P=0.118 P=0.471 |
|POLY 6 | P=0.253 P=0.556 P=0.282 | P=0.353 P=0.135 P=0.410 |
|LOGISTIC REGRESSION| P=0.458 P=0.388N P=0.561 | P=0.459 P=0.097 P=0.504 |
|COCH-ARM / FISHERS | P=0.506 P=0.376N P=0.548 | P=0.459 P=0.107 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 686 572 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.227 P=0.496 | (e) (e) (e) |
|POLY 3 | P=0.341 P=0.235 P=0.489 | (e) (e) (e) |
|POLY 1.5 | P=0.351 P=0.237 P=0.495 | (e) (e) (e) |
|POLY 6 | P=0.328 P=0.231 P=0.481 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.395 P=0.244 P=0.592 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.253 P=0.505 | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 8/50 (16%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 15.1% 17.7% 11.5% | 2.3% 2.3% 9.2% |
|TERMINAL (d) | 6/41 (15%) 6/35 (17%) 4/34 (12%) | 0/34 (0%) 1/30 (3%) 4/35 (11%) |
|FIRST INCIDENCE | 452 621 416 | 615 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.456N P=0.390 P=0.493N | P=0.110 P=0.749 P=0.187 |
|POLY 3 | P=0.386N P=0.479 P=0.426N | P=0.099 P=0.755 P=0.176 |
|POLY 1.5 | P=0.356N P=0.491 P=0.401N | P=0.100 P=0.758 P=0.178 |
|POLY 6 | P=0.425N P=0.462 P=0.459N | P=0.098 P=0.749 P=0.175 |
|LOGISTIC REGRESSION| P=0.316N P=0.511 P=0.328N | P=0.102 P=0.762 P=0.180 |
|COCH-ARM / FISHERS | P=0.315N P=0.517 P=0.365N | P=0.101 P=0.753N P=0.181 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 10/50 (20%) 9/50 (18%) | 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 15.4% 21.8% 21.1% | 6.8% 4.6% 6.9% |
|TERMINAL (d) | 7/41 (17%) 7/35 (20%) 8/34 (24%) | 2/34 (6%) 1/30 (3%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) 547 691 | 578 585 723 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.204 P=0.244 | P=0.575N P=0.526N P=0.649N |
|POLY 3 | P=0.289 P=0.300 P=0.337 | P=0.585 P=0.507N P=0.659 |
|POLY 1.5 | P=0.318 P=0.303 P=0.366 | P=0.587 P=0.502N P=0.661 |
|POLY 6 | P=0.255 P=0.292 P=0.303 | P=0.585 P=0.517N P=0.659 |
|LOGISTIC REGRESSION| P=0.274 P=0.292 P=0.255 | P=0.587N P=0.500N P=0.662N |
|COCH-ARM / FISHERS | P=0.363 P=0.314 P=0.410 | P=0.588 P=0.500N P=0.661N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 18/50 (36%) 13/50 (26%) | 4/50 (8%) 3/50 (6%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 25.9% 38.9% 29.9% | 9.0% 6.9% 16.0% |
|TERMINAL (d) | 11/41 (27%) 13/35 (37%) 11/34 (32%) | 2/34 (6%) 2/30 (7%) 6/35 (17%) |
|FIRST INCIDENCE | 452 547 416 | 578 585 723 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260 P=0.070 P=0.308 | P=0.212 P=0.530N P=0.278 |
|POLY 3 | P=0.365 P=0.130 P=0.427 | P=0.187 P=0.514N P=0.250 |
|POLY 1.5 | P=0.412 P=0.135 P=0.466 | P=0.192 P=0.505N P=0.257 |
|POLY 6 | P=0.310 P=0.123 P=0.378 | P=0.183 P=0.529N P=0.245 |
|LOGISTIC REGRESSION| P=0.423 P=0.141 P=0.471 | P=0.196 P=0.500N P=0.263 |
|COCH-ARM / FISHERS | P=0.481 P=0.152 P=0.523 | P=0.195 P=0.500N P=0.262 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 6.7% 4.7% 0.0% |
|TERMINAL (d) | | 1/34 (3%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | | 150 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.086N P=0.532N P=0.124N |
|POLY 3 | | P=0.087N P=0.522N P=0.124N |
|POLY 1.5 | | P=0.085N P=0.513N P=0.123N |
|POLY 6 | | P=0.087N P=0.535N P=0.125N |
|LOGISTIC REGRESSION| | P=0.093N P=0.525N P=0.142N |
|COCH-ARM / FISHERS | | P=0.082N P=0.500N P=0.121N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Teratoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 0.0% 4.6% 0.0% |
|TERMINAL (d) | | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | | --- 662 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.663N P=0.225 (e) |
|POLY 3 | | P=0.668N P=0.236 (e) |
|POLY 1.5 | | P=0.668N P=0.237 (e) |
|POLY 6 | | P=0.667N P=0.233 (e) |
|LOGISTIC REGRESSION| | P=0.667 P=0.237 (e) |
|COCH-ARM / FISHERS | | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/50 (0%) | 9/50 (18%) 6/50 (12%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 20.6% 13.8% 6.9% |
|TERMINAL (d) | 0/41 (0%) 0/33 (0%) 0/34 (0%) | 8/34 (24%) 4/30 (13%) 3/35 (9%) |
|FIRST INCIDENCE | --- --- --- | 660 616 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.044N* P=0.363N P=0.055N |
|POLY 3 | (e) (e) (e) | P=0.043N* P=0.288N P=0.058N |
|POLY 1.5 | (e) (e) (e) | P=0.043N* P=0.285N P=0.058N |
|POLY 6 | (e) (e) (e) | P=0.042N* P=0.296N P=0.058N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.044N* P=0.302N P=0.056N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.045N* P=0.288N P=0.061N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/50 (0%) | 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 6.9% 2.3% |
|TERMINAL (d) | 0/41 (0%) 0/33 (0%) 0/34 (0%) | 0/34 (0%) 2/30 (7%) 1/35 (3%) |
|FIRST INCIDENCE | --- --- --- | --- 604 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.389 P=0.111 P=0.506 |
|POLY 3 | (e) (e) (e) | P=0.379 P=0.117 P=0.501 |
|POLY 1.5 | (e) (e) (e) | P=0.380 P=0.119 P=0.501 |
|POLY 6 | (e) (e) (e) | P=0.382 P=0.114 P=0.502 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.379 P=0.120 P=0.506 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.378 P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.3% | 4.6% 6.9% 4.6% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- 549 | 675 585 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266 (e) P=0.496 | P=0.584N P=0.476 P=0.688N |
|POLY 3 | P=0.272 (e) P=0.489 | P=0.593 P=0.500 P=0.693 |
|POLY 1.5 | P=0.271 (e) P=0.495 | P=0.592N P=0.502 P=0.693N |
|POLY 6 | P=0.274 (e) P=0.481 | P=0.593 P=0.495 P=0.694 |
|LOGISTIC REGRESSION| P=0.239 (e) P=0.469 | P=0.593N P=0.500 P=0.693N |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.594 P=0.500 P=0.691N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 5/50 (10%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 11.1% 4.6% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/41 (7%) 4/35 (11%) 1/34 (3%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 697 468 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510N P=0.281 P=0.566N | (e) (e) (e) |
|POLY 3 | P=0.460N P=0.348 P=0.524N | (e) (e) (e) |
|POLY 1.5 | P=0.439N P=0.355 P=0.510N | (e) (e) (e) |
|POLY 6 | P=0.488N P=0.337 P=0.542N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.423N P=0.319 P=0.462N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.410N P=0.369 P=0.490N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) | 4/50 (8%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.6% 0.0% | 9.2% 4.7% 9.2% |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 0/34 (0%) | 4/34 (12%) 2/30 (7%) 4/35 (11%) |
|FIRST INCIDENCE | --- 628 --- | 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.595 P=0.104 (e) | P=0.563N P=0.395N P=0.629N |
|POLY 3 | P=0.608 P=0.117 (e) | P=0.578N P=0.344N P=0.642N |
|POLY 1.5 | P=0.625 P=0.119 (e) | P=0.578N P=0.339N P=0.641N |
|POLY 6 | P=0.585 P=0.114 (e) | P=0.577N P=0.354N P=0.640N |
|LOGISTIC REGRESSION| P=0.637 P=0.120 (e) | P=0.563N P=0.395N P=0.629N |
|COCH-ARM / FISHERS | P=0.640 P=0.121 (e) | P=0.579 P=0.339N P=0.643N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 0.0% | 6.9% 4.7% 9.2% |
|TERMINAL (d) | 0/41 (0%) 1/35 (3%) 0/34 (0%) | 3/34 (9%) 2/30 (7%) 4/35 (11%) |
|FIRST INCIDENCE | --- 628 --- | 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.637 P=0.220 (e) | P=0.432 P=0.558N P=0.516 |
|POLY 3 | P=0.645 P=0.235 (e) | P=0.418 P=0.507N P=0.502 |
|POLY 1.5 | P=0.658 P=0.237 (e) | P=0.419 P=0.502N P=0.502 |
|POLY 6 | P=0.629 P=0.231 (e) | P=0.420 P=0.517N P=0.504 |
|LOGISTIC REGRESSION| P=0.667N P=0.237 (e) | P=0.432 P=0.558N P=0.516 |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | P=0.417 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 2.3% | 4.6% 0.0% 0.0% |
|TERMINAL (d) | 2/41 (5%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- 606 | 615 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.274N P=0.551N | P=0.098N P=0.251N P=0.239N |
|POLY 3 | P=0.371N P=0.241N P=0.521N | P=0.095N P=0.243N P=0.238N |
|POLY 1.5 | P=0.365N P=0.238N P=0.509N | P=0.095N P=0.239N P=0.237N |
|POLY 6 | P=0.379N P=0.246N P=0.534N | P=0.095N P=0.249N P=0.239N |
|LOGISTIC REGRESSION| P=0.349N (e) P=0.486N | P=0.096N P=0.238N P=0.239N |
|COCH-ARM / FISHERS | P=0.355N P=0.242N P=0.492N | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 0.0% 2.3% | 4.6% 0.0% 0.0% |
|TERMINAL (d) | 3/41 (7%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- 606 | 615 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.150N P=0.364N | P=0.098N P=0.251N P=0.239N |
|POLY 3 | P=0.182N P=0.122N P=0.327N | P=0.095N P=0.243N P=0.238N |
|POLY 1.5 | P=0.177N P=0.120N P=0.315N | P=0.095N P=0.239N P=0.237N |
|POLY 6 | P=0.188N P=0.126N P=0.341N | P=0.095N P=0.249N P=0.239N |
|LOGISTIC REGRESSION| P=0.174N (e) P=0.303N | P=0.096N P=0.238N P=0.239N |
|COCH-ARM / FISHERS | P=0.171N P=0.117N P=0.301N | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 0.0% 4.7% 0.0% |
|TERMINAL (d) | | 0/34 (0%) 2/30 (7%) 0/35 (0%) |
|FIRST INCIDENCE | | --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.659N P=0.211 (e) |
|POLY 3 | | P=0.668N P=0.233 (e) |
|POLY 1.5 | | P=0.668N P=0.236 (e) |
|POLY 6 | | P=0.667N P=0.228 (e) |
|LOGISTIC REGRESSION| | (e) P=0.211 (e) |
|COCH-ARM / FISHERS | | P=0.669 P=0.247 (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 2.3% 4.6% 0.0% |
|TERMINAL (d) | | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | | 621 641 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.360N P=0.493 P=0.500N |
|POLY 3 | | P=0.363N P=0.495 P=0.501N |
|POLY 1.5 | | P=0.361N P=0.499 P=0.500N |
|POLY 6 | | P=0.364N P=0.488 P=0.501N |
|LOGISTIC REGRESSION| | P=0.366N P=0.498 P=0.513N |
|COCH-ARM / FISHERS | | P=0.360N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 4.6% 4.6% 0.0% |
|TERMINAL (d) | | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | | 621 641 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.178N P=0.675 P=0.237N |
|POLY 3 | | P=0.178N P=0.689 P=0.238N |
|POLY 1.5 | | P=0.176N P=0.692 P=0.237N |
|POLY 6 | | P=0.178N P=0.682 P=0.238N |
|LOGISTIC REGRESSION| | P=0.177N P=0.695 P=0.238N |
|COCH-ARM / FISHERS | | P=0.176N P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 4/50 (8%) | 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 9.3% | 2.3% 7.0% 4.6% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 2/34 (6%) | 1/34 (3%) 2/30 (7%) 2/35 (6%) |
|FIRST INCIDENCE | --- 709 638 | 730 (T) 659 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * P=0.485 P=0.048 * | P=0.413 P=0.272 P=0.510 |
|POLY 3 | P=0.022 * P=0.497 P=0.053 | P=0.401 P=0.302 P=0.501 |
|POLY 1.5 | P=0.023 * P=0.499 P=0.057 | P=0.402 P=0.305 P=0.501 |
|POLY 6 | P=0.021 * P=0.493 P=0.049 * | P=0.403 P=0.295 P=0.503 |
|LOGISTIC REGRESSION| P=0.024 * P=0.499 P=0.059 | P=0.404 P=0.294 P=0.510 |
|COCH-ARM / FISHERS | P=0.026 * P=0.500 P=0.059 | P=0.399 P=0.309 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.8% 15.6% 9.2% | 2.3% 0.0% 0.0% |
|TERMINAL (d) | 4/41 (10%) 6/35 (17%) 3/34 (9%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 697 468 | 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.450 P=0.184 P=0.552 | P=0.271N P=0.525N P=0.494N |
|POLY 3 | P=0.527 P=0.252 P=0.615 | P=0.270N P=0.503N P=0.499N |
|POLY 1.5 | P=0.550 P=0.259 P=0.631 | P=0.270N P=0.501N P=0.499N |
|POLY 6 | P=0.497 P=0.241 P=0.592 | P=0.270N P=0.507N P=0.498N |
|LOGISTIC REGRESSION| P=0.532 P=0.216 P=0.636 | P=0.271N (e) (e) |
|COCH-ARM / FISHERS | P=0.566 P=0.262 P=0.643N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 8/50 (16%) | 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.8% 17.8% 18.3% | 4.6% 7.0% 4.6% |
|TERMINAL (d) | 4/41 (10%) 6/35 (17%) 5/34 (15%) | 2/34 (6%) 2/30 (7%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) 697 468 | 730 (T) 659 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091 P=0.120 P=0.116 | P=0.579N P=0.452 P=0.685N |
|POLY 3 | P=0.130 P=0.170 P=0.156 | P=0.592N P=0.496 P=0.693N |
|POLY 1.5 | P=0.142 P=0.176 P=0.168 | P=0.591N P=0.499 P=0.692N |
|POLY 6 | P=0.115 P=0.161 P=0.141 | P=0.590N P=0.488 P=0.692N |
|LOGISTIC REGRESSION| P=0.129 P=0.146 P=0.168 | P=0.588N P=0.483 P=0.685N |
|COCH-ARM / FISHERS | P=0.152 P=0.178 P=0.178 | P=0.594 P=0.500 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% | 6.7% 4.7% 2.3% |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 2/30 (7%) 0/35 (0%) |
|FIRST INCIDENCE | --- 567 --- | 435 730 (T) 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.729 P=0.509 (e) | P=0.226N P=0.534N P=0.312N |
|POLY 3 | P=0.718 P=0.499 (e) | P=0.229N P=0.523N P=0.312N |
|POLY 1.5 | P=0.724 P=0.500 (e) | P=0.227N P=0.512N P=0.309N |
|POLY 6 | P=0.710 P=0.496 (e) | P=0.228N P=0.538N P=0.311N |
|LOGISTIC REGRESSION| P=0.715 P=0.480 (e) | P=0.241N P=0.512N P=0.348N |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.222N P=0.500N P=0.309N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 2/50 (4%) | 6/50 (12%) 11/50 (22%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 2.2% 14.8% 4.6% | 13.2% 25.3% 26.6% |
|TERMINAL (d) | 0/41 (0%) 1/35 (3%) 1/34 (3%) | 2/34 (6%) 8/30 (27%) 7/35 (20%) |
|FIRST INCIDENCE | 695 176 356 | 435 646 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368 P=0.033 * P=0.457 | P=0.106 P=0.113 P=0.120 |
|POLY 3 | P=0.380 P=0.034 * P=0.482 | P=0.073 P=0.115 P=0.088 |
|POLY 1.5 | P=0.404 P=0.034 * P=0.493 | P=0.076 P=0.127 P=0.091 |
|POLY 6 | P=0.347 P=0.034 * P=0.467 | P=0.074 P=0.100 P=0.089 |
|LOGISTIC REGRESSION| P=0.407 P=0.024 * P=0.482 | P=0.082 P=0.143 P=0.092 |
|COCH-ARM / FISHERS | P=0.421 P=0.030 * P=0.500 | P=0.082 P=0.143 P=0.096 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 2/50 (4%) | 3/50 (6%) 9/50 (18%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 2.2% 12.8% 4.6% | 6.8% 20.7% 24.7% |
|TERMINAL (d) | 0/41 (0%) 1/35 (3%) 1/34 (3%) | 1/34 (3%) 6/30 (20%) 7/35 (20%) |
|FIRST INCIDENCE | 695 176 356 | 603 646 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362 P=0.056 P=0.457 | P=0.028 * P=0.048 * P=0.030 * |
|POLY 3 | P=0.380 P=0.060 P=0.482 | P=0.017 * P=0.054 P=0.020 * |
|POLY 1.5 | P=0.402 P=0.060 P=0.493 | P=0.018 * P=0.058 P=0.020 * |
|POLY 6 | P=0.350 P=0.058 P=0.467 | P=0.018 * P=0.049 * P=0.020 * |
|LOGISTIC REGRESSION| P=0.399 P=0.047 * P=0.482 | P=0.019 * P=0.059 P=0.022 * |
|COCH-ARM / FISHERS | P=0.417 P=0.056 P=0.500 | P=0.019 * P=0.061 P=0.020 * |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 30/50 (60%) 32/50 (64%) | 37/50 (74%) 40/50 (80%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 58.6% 64.4% 69.3% | 79.7% 85.2% 69.7% |
|TERMINAL (d) | 25/41 (61%) 23/35 (66%) 24/34 (71%) | 29/34 (85%) 26/30 (87%) 26/35 (74%) |
|FIRST INCIDENCE | 452 547 356 | 150 501 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.175 P=0.068 | P=0.114N P=0.144 P=0.116N |
|POLY 3 | P=0.160 P=0.354 P=0.188 | P=0.146N P=0.325 P=0.182N |
|POLY 1.5 | P=0.202 P=0.383 P=0.233 | P=0.131N P=0.305 P=0.166N |
|POLY 6 | P=0.122 P=0.328 P=0.146 | P=0.157N P=0.359 P=0.195N |
|LOGISTIC REGRESSION| P=0.202 P=0.414 P=0.248 | P=0.093N P=0.307 P=0.125N |
|COCH-ARM / FISHERS | P=0.237 P=0.420 P=0.270 | P=0.110N P=0.318 P=0.142N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 29/50 (58%) 25/50 (50%) | 22/50 (44%) 24/50 (48%) 21/50 (42%) |
|POLY-3 ADJUSTED (b)| 49.7% 58.9% 52.8% | 46.1% 53.2% 45.8% |
|TERMINAL (d) | 17/41 (42%) 15/35 (43%) 15/34 (44%) | 12/34 (35%) 14/30 (47%) 12/35 (34%) |
|FIRST INCIDENCE | 452 176 356 | 435 585 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.231 P=0.136 P=0.263 | P=0.437N P=0.304 P=0.474N |
|POLY 3 | P=0.417 P=0.240 P=0.461 | P=0.538N P=0.315 P=0.571N |
|POLY 1.5 | P=0.452 P=0.240 P=0.493 | P=0.506N P=0.360 P=0.542N |
|POLY 6 | P=0.374 P=0.241 P=0.420 | P=0.532 P=0.268 P=0.582 |
|LOGISTIC REGRESSION| P=0.491 P=0.212 P=0.516 | P=0.456N P=0.420 P=0.501N |
|COCH-ARM / FISHERS | P=0.460 P=0.212 P=0.500 | P=0.460N P=0.421 P=0.500N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # | # # # |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 43/50 (86%) 44/50 (88%) | 46/50 (92%) 45/50 (90%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 85.7% 87.4% 89.2% | 92.1% 93.2% 78.5% |
|TERMINAL (d) | 34/41 (83%) 29/35 (83%) 29/34 (85%) | 31/34 (91%) 27/30 (90%) 27/35 (77%) |
|FIRST INCIDENCE | 452 176 356 | 150 501 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.073 P=0.175 P=0.085 | P=0.042N* P=0.370 P=0.044N* |
|POLY 3 | P=0.353 P=0.520 P=0.411 | P=0.028N* P=0.565 P=0.047N* |
|POLY 1.5 | P=0.378 P=0.544 P=0.436 | P=0.012N* P=0.618 P=0.024N* |
|POLY 6 | P=0.332 P=0.504 P=0.389 | P=0.057N P=0.540 P=0.082N |
|LOGISTIC REGRESSION| P=0.323 P=0.505 P=0.374 | P=0.003N** P=0.493N P=0.008N** |
|COCH-ARM / FISHERS | P=0.333 P=0.500 P=0.387 | P=0.004N** P=0.500N P=0.009N** |
|=================================================================================================================================|
(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).