Statistical Analysis Of Non-Neoplastic Lesions
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/13/97
EXPERIMENT: 91014 TEST: 03 TIME: 12:31:54
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 NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 08/13/97
EXPERIMENT: 91014 TEST: 03 TIME: 12:31:54
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 Cortex Vacuolization Cytoplasmic
Blood Vessel Mineralization
Kidney Cyst
Lung Inflammation Chronic
Parathyroid Gland Hyperplasia
Preputial Gland Cyst
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Hyperplasia
Inflammation Chronic
Parakeratosis
Ulcer
Stomach, Forestomach Hyperkeratosis
Inflammation Chronic
Stomach, Forestomach: Epithelium Hyperplasia
Stomach, Glandular Mineralization
Testes Degeneration
Testes: Interstitial Cell Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Bone Osteosclerosis
Kidney Pigmentation Hemosiderin
Liver Basophilic Focus
Pituitary Gland: Pars Distalis Angiectasis
Hyperplasia
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Hyperkeratosis
Hyperplasia
Inflammation Chronic
Parakeratosis
Ulcer
Spleen Fibrosis
===============================================================
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 0.0% | 0.0% 0.0% 6.6% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 707 --- | --- --- 302 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.644N P=0.536 (e) | P=0.078 (e) P=0.198 |
|POLY 3 | P=0.711N P=0.502 (e) | P=0.093 (e) P=0.206 |
|POLY 1.5 | P=0.719N P=0.501 (e) | P=0.093 (e) P=0.214 |
|POLY 6 | P=0.697N P=0.505 (e) | P=0.094 (e) P=0.205 |
|LOGISTIC REGRESSION| P=0.680N P=0.513 (e) | P=0.154 (e) P=0.374 |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.095 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) | 25/50 (50%) 19/50 (38%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 3.0% 6.0% 5.4% | 65.6% 52.8% 70.1% |
|TERMINAL (d) | 0/8 (0%) 2/10 (20%) 2/14 (14%) | 13/15 (87%) 13/18 (72%) 10/14 (71%) |
|FIRST INCIDENCE | 678 728 (T) 728 (T) | 529 541 356 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.578 P=0.545 P=0.659 | P=0.234 P=0.056N P=0.238 |
|POLY 3 | P=0.438 P=0.501 P=0.537 | P=0.385 P=0.166N P=0.424 |
|POLY 1.5 | P=0.418 P=0.500 P=0.521 | P=0.369 P=0.172N P=0.397 |
|POLY 6 | P=0.471 P=0.501 P=0.561 | P=0.478 P=0.156N P=0.544 |
|LOGISTIC REGRESSION| P=0.564 P=0.528 P=0.636 | P=0.141 P=0.106N P=0.164 |
|COCH-ARM / FISHERS | P=0.390 P=0.500 P=0.500 | P=0.460 P=0.157N P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.7% | 2.9% 2.9% 6.9% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 676 | 635 728 (T) 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337 (e) P=0.581 | P=0.329 P=0.748N P=0.436 |
|POLY 3 | P=0.290 (e) P=0.523 | P=0.344 P=0.757 P=0.436 |
|POLY 1.5 | P=0.281 (e) P=0.513 | P=0.352 P=0.755 P=0.454 |
|POLY 6 | P=0.306 (e) P=0.540 | P=0.341 P=0.762N P=0.428 |
|LOGISTIC REGRESSION| P=0.293 (e) P=0.532 | P=0.318 P=0.763N P=0.440 |
|COCH-ARM / FISHERS | P=0.269 (e) P=0.500 | P=0.378 P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.5% 0.0% 2.7% | 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 | 440 --- 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053N P=0.073N P=0.110N | (e) (e) (e) |
|POLY 3 | P=0.073N P=0.062N P=0.154N | (e) (e) (e) |
|POLY 1.5 | P=0.076N P=0.062N P=0.165N | (e) (e) (e) |
|POLY 6 | P=0.068N P=0.064N P=0.140N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.081N P=0.063N P=0.183N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.082N P=0.059N P=0.181N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions 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 Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 23/50 (46%) 13/50 (26%) | 7/50 (14%) 7/50 (14%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 29.7% 55.2% 32.6% | 19.5% 19.5% 13.7% |
|TERMINAL (d) | 1/8 (13%) 3/10 (30%) 5/14 (36%) | 2/15 (13%) 2/18 (11%) 3/14 (21%) |
|FIRST INCIDENCE | 440 224 497 | 579 547 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387N P=0.028 * P=0.457N | P=0.323N P=0.558N P=0.369N |
|POLY 3 | P=0.489 P=0.014 * P=0.487 | P=0.356N P=0.617 P=0.389N |
|POLY 1.5 | P=0.440 P=0.011 * P=0.454 | P=0.313N P=0.603 P=0.346N |
|POLY 6 | P=0.549N P=0.026 * P=0.537 | P=0.387N P=0.594N P=0.424N |
|LOGISTIC REGRESSION| P=0.363 P=0.010 * P=0.438 | P=0.324N P=0.606 P=0.386N |
|COCH-ARM / FISHERS | P=0.373 P=0.010 * P=0.408 | P=0.221N P=0.613N P=0.262N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 5/49 (10%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 8.7% 13.2% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 674 567 580 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317 P=0.530 P=0.409 | (e) (e) (e) |
|POLY 3 | P=0.199 P=0.512 P=0.265 | (e) (e) (e) |
|POLY 1.5 | P=0.177 P=0.505 P=0.239 | (e) (e) (e) |
|POLY 6 | P=0.240 P=0.523 P=0.310 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.205 P=0.506 P=0.285 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.151 P=0.500 P=0.210 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 5/50 (10%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 33.1% 14.6% 18.3% | 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 | 473 630 576 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.062N P=0.038N* | (e) (e) (e) |
|POLY 3 | P=0.078N P=0.054N P=0.109N | (e) (e) (e) |
|POLY 1.5 | P=0.090N P=0.054N P=0.126N | (e) (e) (e) |
|POLY 6 | P=0.063N P=0.059N P=0.090N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.060N P=0.049N* P=0.094N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.110N P=0.054N P=0.154N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 11/49 (22%) 6/50 (12%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 25.7% 30.1% 15.9% | 0.0% 0.0% 3.5% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 2/14 (14%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 549 580 676 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090N P=0.445 P=0.081N | P=0.253 (e) P=0.486 |
|POLY 3 | P=0.183N P=0.439 P=0.225N | P=0.282 (e) P=0.463 |
|POLY 1.5 | P=0.211N P=0.408 P=0.250N | P=0.277 (e) P=0.474 |
|POLY 6 | P=0.148N P=0.493 P=0.192N | P=0.287 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.168N P=0.397 P=0.155N | (e) (e) P=0.486 |
|COCH-ARM / FISHERS | P=0.255N P=0.382 P=0.288N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteosclerosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) | 5/50 (10%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 14.1% 0.0% 3.4% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 3/15 (20%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- | 529 --- 563 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.048N* P=0.025N* P=0.147N |
|POLY 3 | (e) (e) (e) | P=0.043N* P=0.032N* P=0.148N |
|POLY 1.5 | (e) (e) (e) | P=0.041N* P=0.032N* P=0.133N |
|POLY 6 | (e) (e) (e) | P=0.042N* P=0.029N* P=0.154N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.048N* P=0.032N* P=0.141N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.037N* P=0.028N* P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.9% 0.0% 0.0% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 618 --- --- | --- 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089N P=0.261N P=0.210N | P=0.691 P=0.500 (e) |
|POLY 3 | P=0.092N P=0.240N P=0.216N | P=0.698 P=0.500 (e) |
|POLY 1.5 | P=0.094N P=0.241N P=0.225N | P=0.707 P=0.497 (e) |
|POLY 6 | P=0.090N P=0.241N P=0.204N | P=0.694 P=0.508 (e) |
|LOGISTIC REGRESSION| P=0.094N P=0.241N P=0.235N | P=0.725 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.096N P=0.253N P=0.247N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions 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 Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/49 (4%) 2/47 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| | 5.8% 6.1% 3.5% |
|TERMINAL (d) | | 0/15 (0%) 0/17 (0%) 1/14 (7%) |
|FIRST INCIDENCE | | 610 541 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.459N P=0.671N P=0.563N |
|POLY 3 | | P=0.475N P=0.676 P=0.563N |
|POLY 1.5 | | P=0.447N P=0.671 P=0.541N |
|POLY 6 | | P=0.494N P=0.690 P=0.579N |
|LOGISTIC REGRESSION| | P=0.432N P=0.676 P=0.561N |
|COCH-ARM / FISHERS | | P=0.384N P=0.676 P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 46/49 (94%) 44/47 (94%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| | 97.8% 97.4% 94.5% |
|TERMINAL (d) | | 15/15 (100%) 17/17 (100%) 14/14 (100%) |
|FIRST INCIDENCE | | 429 244 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.325 P=0.348N P=0.335 |
|POLY 3 | | P=0.240N P=0.735N P=0.353N |
|POLY 1.5 | | P=0.163N P=0.726N P=0.248N |
|POLY 6 | | P=0.392N P=0.712N P=0.556N |
|LOGISTIC REGRESSION| | P=0.306N P=0.519 P=0.411N |
|COCH-ARM / FISHERS | | P=0.114N P=0.641N P=0.167N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 0/0 (0%) 1/1 (100%) | 0/3 (0%) 1/3 (33%) 3/6 (50%) |
|POLY-3 ADJUSTED (b)| 58.0% 0.0% 100.0% | 0.0% 46.0% 64.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) | 0/1 (0%) 1/1 (100%) 3/4 (75%) |
|FIRST INCIDENCE | 440 --- 728 (T) | --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254N P=0.529N P=0.467N | P=0.302 P=0.500 P=0.419 |
|POLY 3 | P=1.000 P=1.000 P=0.694 | P=0.092 P=0.464 P=0.155 |
|POLY 1.5 | P=1.000 P=1.000 P=0.651 | P=0.109 P=0.479 P=0.177 |
|POLY 6 | P=1.000 P=1.000 P=0.789 | P=0.085 P=0.451 P=0.153 |
|LOGISTIC REGRESSION| P=0.221 (e) P=0.547 | (e) P=0.500 P=0.419 |
|COCH-ARM / FISHERS | P=0.414 P=1.000 P=0.667 | P=0.134 P=0.500 P=0.238 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/0 (0%) 1/1 (100%) | 2/3 (67%) 3/3 (100%) 4/6 (67%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 100.0% | 74.6% 100.0% 85.3% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 1/1 (100%) | 1/1 (100%) 1/1 (100%) 4/4 (100%) |
|FIRST INCIDENCE | --- --- 728 (T) | 698 508 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000N (e) P=1.000N | P=0.410N P=0.527 P=0.527N |
|POLY 3 | P=1.000N (e) P=0.535 | P=0.627 P=0.651 P=0.763 |
|POLY 1.5 | P=1.000N (e) P=0.238 | P=0.658 P=0.570 P=0.744 |
|POLY 6 | P=1.000N (e) P=0.742 | P=0.648 P=0.829 P=0.864 |
|LOGISTIC REGRESSION| (e) (e) P=1.000N | P=0.597 P=0.448 P=0.527N |
|COCH-ARM / FISHERS | P=0.140 (e) P=0.333 | P=0.580N P=0.500 P=0.762 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 38/49 (78%) 33/50 (66%) | 18/50 (36%) 20/50 (40%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 77.5% 85.4% 75.0% | 45.9% 54.3% 44.8% |
|TERMINAL (d) | 8/8 (100%) 10/10 (100%) 14/14 (100%) | 4/15 (27%) 14/18 (78%) 7/14 (50%) |
|FIRST INCIDENCE | 440 331 482 | 462 524 394 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056N P=0.424 P=0.059N | P=0.406N P=0.562 P=0.454N |
|POLY 3 | P=0.427N P=0.218 P=0.488N | P=0.544 P=0.300 P=0.561N |
|POLY 1.5 | P=0.424N P=0.202 P=0.479N | P=0.440N P=0.333 P=0.448N |
|POLY 6 | P=0.448N P=0.247 P=0.518N | P=0.429 P=0.268 P=0.536 |
|LOGISTIC REGRESSION| P=0.338N P=0.203 P=0.370N | P=0.470N P=0.391 P=0.478N |
|COCH-ARM / FISHERS | P=0.456N P=0.200 P=0.500N | P=0.231N P=0.418 P=0.260N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/49 (8%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 19.9% 11.8% 18.3% | 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 | 571 630 576 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.288N P=0.346N | (e) (e) (e) |
|POLY 3 | P=0.512N P=0.274N P=0.553N | (e) (e) (e) |
|POLY 1.5 | P=0.532N P=0.274N P=0.576N | (e) (e) (e) |
|POLY 6 | P=0.482N P=0.281N P=0.521N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.466N P=0.261N P=0.525N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.561 P=0.274N P=0.613N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.0% 11.6% 2.7% | 2.9% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 694 567 580 | 718 702 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.509N P=0.188 P=0.714N | P=0.338N P=0.711N P=0.513N |
|POLY 3 | P=0.534N P=0.184 P=0.734N | P=0.399N P=0.760 P=0.537N |
|POLY 1.5 | P=0.563N P=0.178 P=0.746N | P=0.379N P=0.757 P=0.526N |
|POLY 6 | P=0.487N P=0.196 P=0.715N | P=0.410N P=0.757N P=0.543N |
|LOGISTIC REGRESSION| P=0.595N P=0.177 P=0.765N | P=0.366N P=0.750N P=0.531N |
|COCH-ARM / FISHERS | P=0.600 P=0.175 P=0.753N | P=0.331N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/48 (6%) 2/49 (4%) | 0/47 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.2% 5.4% | 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 | --- 630 677 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310 P=0.122 P=0.344 | (e) (e) (e) |
|POLY 3 | P=0.260 P=0.118 P=0.268 | (e) (e) (e) |
|POLY 1.5 | P=0.233 P=0.116 P=0.254 | (e) (e) (e) |
|POLY 6 | P=0.307 P=0.123 P=0.291 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.252 P=0.119 P=0.292 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.202 P=0.117 P=0.247 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/48 (2%) 2/49 (4%) | 2/47 (4%) 3/50 (6%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 8.8% 3.1% 5.4% | 5.8% 8.4% 14.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 2/14 (14%) | 0/15 (0%) 1/18 (6%) 3/14 (21%) |
|FIRST INCIDENCE | 495 483 728 (T) | 462 371 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.305N P=0.376N | P=0.222 P=0.518 P=0.298 |
|POLY 3 | P=0.377N P=0.316N P=0.464N | P=0.200 P=0.515 P=0.251 |
|POLY 1.5 | P=0.387N P=0.315N P=0.479N | P=0.221 P=0.514 P=0.281 |
|POLY 6 | P=0.362N P=0.319N P=0.443N | P=0.187 P=0.525 P=0.228 |
|LOGISTIC REGRESSION| P=0.446N P=0.290N P=0.530N | P=0.243 P=0.594 P=0.259 |
|COCH-ARM / FISHERS | P=0.400N P=0.316N P=0.500N | P=0.270 P=0.530 P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) 2/48 (4%) | 1/38 (3%) 1/47 (2%) 2/46 (4%) |
|POLY-3 ADJUSTED (b)| 6.1% 0.0% 5.5% | 3.5% 3.0% 7.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 1/14 (7%) | 1/15 (7%) 1/18 (6%) 1/14 (7%) |
|FIRST INCIDENCE | 603 --- 661 | 728 (T) 728 (T) 574 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.212N P=0.545N | P=0.330 P=0.722N P=0.442 |
|POLY 3 | P=0.611N P=0.234N P=0.660N | P=0.396 P=0.732N P=0.496 |
|POLY 1.5 | P=0.616N P=0.234N P=0.674N | P=0.408 P=0.727N P=0.518 |
|POLY 6 | P=0.599N P=0.235N P=0.637N | P=0.388 P=0.734N P=0.480 |
|LOGISTIC REGRESSION| P=0.568N P=0.233N P=0.640N | P=0.356 P=0.722N P=0.491 |
|COCH-ARM / FISHERS | P=0.622 P=0.242N P=0.692N | P=0.435 P=0.697N P=0.572 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 653 677 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278 P=0.248 P=0.344 | (e) (e) (e) |
|POLY 3 | P=0.214 P=0.240 P=0.264 | (e) (e) (e) |
|POLY 1.5 | P=0.197 P=0.238 P=0.252 | (e) (e) (e) |
|POLY 6 | P=0.244 P=0.243 P=0.284 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.225 P=0.241 P=0.286 | (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 |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Duodenum |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 5.4% | 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 | --- --- 696 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162 (e) P=0.366 | (e) (e) (e) |
|POLY 3 | P=0.105 (e) P=0.263 | (e) (e) (e) |
|POLY 1.5 | P=0.100 (e) P=0.251 | (e) (e) (e) |
|POLY 6 | P=0.113 (e) P=0.282 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.137 (e) P=0.317 | (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 12
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 12/50 (24%) 4/50 (8%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.6% 33.9% 10.5% | 2.8% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 3/10 (30%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 580 638 | 447 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202N P=0.085 P=0.308N | P=0.292N P=0.513N P=0.533N |
|POLY 3 | P=0.327N P=0.048 * P=0.435N | P=0.306N P=0.507N P=0.541N |
|POLY 1.5 | P=0.375N P=0.050 P=0.462N | P=0.295N P=0.507N P=0.529N |
|POLY 6 | P=0.258N P=0.046 * P=0.394N | P=0.313N P=0.502N P=0.549N |
|LOGISTIC REGRESSION| P=0.308N P=0.050 P=0.422N | P=0.175N P=0.411N P=0.371N |
|COCH-ARM / FISHERS | P=0.443N P=0.054 P=0.500N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 5/50 (10%) 7/50 (14%) | 35/50 (70%) 37/50 (74%) 37/50 (74%) |
|POLY-3 ADJUSTED (b)| 27.7% 14.1% 18.3% | 79.6% 77.9% 79.8% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 1/14 (7%) | 11/15 (73%) 11/18 (61%) 9/14 (64%) |
|FIRST INCIDENCE | 473 440 576 | 423 270 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.098N P=0.150N P=0.103N | P=0.162 P=0.552N P=0.173 |
|POLY 3 | P=0.197N P=0.125N P=0.241N | P=0.543 P=0.524N P=0.601 |
|POLY 1.5 | P=0.214N P=0.128N P=0.263N | P=0.459 P=0.570 P=0.510 |
|POLY 6 | P=0.174N P=0.125N P=0.213N | P=0.487N P=0.408N P=0.535N |
|LOGISTIC REGRESSION| P=0.200N P=0.131N P=0.225N | P=0.422 P=0.409 P=0.426 |
|COCH-ARM / FISHERS | P=0.240N P=0.131N P=0.298N | P=0.368 P=0.412 P=0.412 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 42/50 (84%) 40/50 (80%) | 9/50 (18%) 8/50 (16%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 89.0% 93.1% 87.5% | 24.8% 23.3% 17.3% |
|TERMINAL (d) | 8/8 (100%) 10/10 (100%) 13/14 (93%) | 6/15 (40%) 7/18 (39%) 4/14 (29%) |
|FIRST INCIDENCE | 440 483 497 | 462 722 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055N P=0.544 P=0.059N | P=0.187N P=0.361N P=0.256N |
|POLY 3 | P=0.464N P=0.348 P=0.549N | P=0.299N P=0.553N P=0.332N |
|POLY 1.5 | P=0.491N P=0.344 P=0.558N | P=0.251N P=0.542N P=0.283N |
|POLY 6 | P=0.424N P=0.418 P=0.546N | P=0.333N P=0.552N P=0.369N |
|LOGISTIC REGRESSION| P=0.291N P=0.405 P=0.362N | P=0.265N P=0.475N P=0.321N |
|COCH-ARM / FISHERS | P=0.551 P=0.398 P=0.598N | P=0.161N P=0.500N P=0.194N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 8/50 (16%) | 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.2% 14.1% 20.7% | 11.2% 8.6% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 1/14 (7%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 440 483 580 | 579 623 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.608N P=0.495 | P=0.074N P=0.467N P=0.100N |
|POLY 3 | P=0.268 P=0.630N P=0.334 | P=0.083N P=0.514N P=0.091N |
|POLY 1.5 | P=0.247 P=0.631N P=0.308 | P=0.070N P=0.516N P=0.080N |
|POLY 6 | P=0.308 P=0.630N P=0.381 | P=0.093N P=0.503N P=0.100N |
|LOGISTIC REGRESSION| P=0.226 P=0.630N P=0.300 | P=0.065N P=0.506N P=0.082N |
|COCH-ARM / FISHERS | P=0.221 P=0.630N P=0.277 | P=0.049N* P=0.500N P=0.059N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% 2.9% 0.0% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 603 603 --- | --- 685 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133N P=0.511N P=0.220N | P=0.711 P=0.517 (e) |
|POLY 3 | P=0.130N P=0.501N P=0.217N | P=0.698 P=0.499 (e) |
|POLY 1.5 | P=0.135N P=0.501N P=0.225N | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.122N P=0.502N P=0.205N | P=0.694 P=0.506 (e) |
|LOGISTIC REGRESSION| P=0.148N P=0.500N P=0.249N | P=0.709 P=0.502 (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 |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 2.7% | 2.9% 5.8% 6.9% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 2/18 (11%) 1/14 (7%) |
|FIRST INCIDENCE | --- 637 631 | 679 728 (T) 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370 P=0.469 P=0.532 | P=0.346 P=0.547 P=0.447 |
|POLY 3 | P=0.374 P=0.504 P=0.524 | P=0.332 P=0.494 P=0.435 |
|POLY 1.5 | P=0.356 P=0.501 P=0.514 | P=0.348 P=0.491 P=0.454 |
|POLY 6 | P=0.405 P=0.508 P=0.541 | P=0.325 P=0.503 P=0.425 |
|LOGISTIC REGRESSION| P=0.332 P=0.500 P=0.496 | P=0.320 P=0.525 P=0.428 |
|COCH-ARM / FISHERS | P=0.331 P=0.500 P=0.500 | P=0.390 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 6.0% 2.7% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/8 (13%) 2/10 (20%) 1/14 (7%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 659 728 (T) 728 (T) | --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.637N P=0.330N | P=0.729 P=0.536 (e) |
|POLY 3 | P=0.354N P=0.696N P=0.464N | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.370N P=0.695 P=0.479N | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.329N P=0.699 P=0.440N | P=0.694 P=0.504 (e) |
|LOGISTIC REGRESSION| P=0.245N P=0.675N P=0.385N | (e) P=0.536 (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.691N P=0.500N | 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 11/50 (22%) 7/50 (14%) | 18/50 (36%) 15/50 (30%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 20.7% 31.4% 18.7% | 51.0% 43.0% 35.9% |
|TERMINAL (d) | 5/8 (63%) 6/10 (60%) 5/14 (36%) | 15/15 (100%) 14/18 (78%) 7/14 (50%) |
|FIRST INCIDENCE | 654 580 676 | 635 541 560 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162N P=0.289 P=0.212N | P=0.059N P=0.042N* P=0.112N |
|POLY 3 | P=0.443N P=0.226 P=0.531N | P=0.123N P=0.324N P=0.147N |
|POLY 1.5 | P=0.491N P=0.219 P=0.567N | P=0.119N P=0.349N P=0.140N |
|POLY 6 | P=0.363N P=0.238 P=0.472N | P=0.093N P=0.262N P=0.115N |
|LOGISTIC REGRESSION| P=0.284N P=0.206 P=0.312N | P=0.177N P=0.167N P=0.233N |
|COCH-ARM / FISHERS | P=0.553 P=0.218 P=0.613N | P=0.077N P=0.335N P=0.093N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.9% 2.7% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 0/14 (0%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | --- 549 713 | --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489 P=0.275 P=0.650 | P=0.729 P=0.536 (e) |
|POLY 3 | P=0.414 P=0.241 P=0.522 | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.391 P=0.239 P=0.513 | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.452 P=0.245 P=0.538 | P=0.694 P=0.504 (e) |
|LOGISTIC REGRESSION| P=0.392 P=0.238 P=0.581 | (e) P=0.536 (e) |
|COCH-ARM / FISHERS | P=0.360 P=0.247 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.8% 0.0% 0.0% | 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 | 440 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093N P=0.252N P=0.224N | (e) (e) (e) |
|POLY 3 | P=0.092N P=0.241N P=0.219N | (e) (e) (e) |
|POLY 1.5 | P=0.093N P=0.240N P=0.226N | (e) (e) (e) |
|POLY 6 | P=0.089N P=0.243N P=0.207N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.110N P=0.226N P=0.322N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) | 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 0.0% | 0.0% 8.7% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 0/14 (0%) | 0/15 (0%) 2/18 (11%) 0/14 (0%) |
|FIRST INCIDENCE | --- 728 (T) --- | --- 722 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.651N P=0.545 (e) | P=0.633 P=0.159 (e) |
|POLY 3 | P=0.711N P=0.502 (e) | P=0.549 P=0.115 (e) |
|POLY 1.5 | P=0.719N P=0.500 (e) | P=0.577 P=0.114 (e) |
|POLY 6 | P=0.697N P=0.503 (e) | P=0.534 P=0.119 (e) |
|LOGISTIC REGRESSION| (e) P=0.545 (e) | P=0.629 P=0.147 (e) |
|COCH-ARM / FISHERS | P=0.731 P=0.500 (e) | P=0.640 P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 5/50 (10%) | 7/50 (14%) 14/50 (28%) 11/50 (22%) |
|POLY-3 ADJUSTED (b)| 11.4% 19.3% 13.1% | 18.8% 37.2% 32.9% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 2/14 (14%) | 1/15 (7%) 6/18 (33%) 3/14 (21%) |
|FIRST INCIDENCE | 506 331 580 | 524 270 331 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.524N P=0.290 P=0.619N | P=0.122 P=0.128 P=0.134 |
|POLY 3 | P=0.502 P=0.272 P=0.551 | P=0.103 P=0.059 P=0.134 |
|POLY 1.5 | P=0.475 P=0.267 P=0.530 | P=0.123 P=0.060 P=0.153 |
|POLY 6 | P=0.545 P=0.277 P=0.583 | P=0.100 P=0.062 P=0.130 |
|LOGISTIC REGRESSION| P=0.402 P=0.263 P=0.495 | P=0.178 P=0.068 P=0.223 |
|COCH-ARM / FISHERS | P=0.436 P=0.262 P=0.500 | P=0.196 P=0.070 P=0.218 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) | 13/50 (26%) 7/50 (14%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 5.9% 11.1% 5.4% | 34.7% 19.2% 26.5% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 2/14 (14%) | 6/15 (40%) 2/18 (11%) 1/14 (7%) |
|FIRST INCIDENCE | 638 224 728 (T) | 462 371 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490N P=0.330 P=0.564N | P=0.313N P=0.085N P=0.384N |
|POLY 3 | P=0.539N P=0.366 P=0.662N | P=0.233N P=0.102N P=0.306N |
|POLY 1.5 | P=0.559N P=0.354 P=0.675N | P=0.226N P=0.109N P=0.293N |
|POLY 6 | P=0.510N P=0.380 P=0.643N | P=0.219N P=0.087N P=0.290N |
|LOGISTIC REGRESSION| P=0.507 P=0.353 P=0.624N | P=0.186N P=0.111N P=0.233N |
|COCH-ARM / FISHERS | P=0.588 P=0.339 P=0.691N | P=0.188N P=0.105N P=0.235N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 5/50 (10%) | 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.9% 8.8% 13.5% | 2.9% 5.8% 0.0% |
|TERMINAL (d) | 1/8 (13%) 1/10 (10%) 5/14 (36%) | 1/15 (7%) 2/18 (11%) 0/14 (0%) |
|FIRST INCIDENCE | 638 621 728 (T) | 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552 P=0.617N P=0.656N | P=0.371N P=0.565 P=0.514N |
|POLY 3 | P=0.328 P=0.661N P=0.410 | P=0.452N P=0.496 P=0.537N |
|POLY 1.5 | P=0.309 P=0.662N P=0.388 | P=0.425N P=0.492 P=0.526N |
|POLY 6 | P=0.359 P=0.660N P=0.444 | P=0.466N P=0.508 P=0.543N |
|LOGISTIC REGRESSION| P=0.465 P=0.655N P=0.596 | P=0.371N P=0.565 (e) |
|COCH-ARM / FISHERS | P=0.283 P=0.661N P=0.357 | P=0.360N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.9% 0.0% 5.3% | 2.9% 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 | 618 --- 628 | 635 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.538N P=0.232N P=0.602N | P=0.312N P=0.513N P=0.568N |
|POLY 3 | P=0.607N P=0.237N P=0.653N | P=0.304N P=0.504N P=0.539N |
|POLY 1.5 | P=0.614N P=0.237N P=0.671N | P=0.294N P=0.505N P=0.527N |
|POLY 6 | P=0.593N P=0.237N P=0.624N | P=0.310N P=0.500N P=0.546N |
|LOGISTIC REGRESSION| P=0.607N P=0.235N P=0.684N | P=0.279N P=0.502N P=0.522N |
|COCH-ARM / FISHERS | P=0.622 P=0.247N P=0.691N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 15/50 (30%) | 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 28.3% 31.9% 36.8% | 8.4% 8.7% 6.8% |
|TERMINAL (d) | 2/8 (25%) 1/10 (10%) 4/14 (29%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 542 549 497 | 462 623 560 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433 P=0.420 P=0.513 | P=0.497N P=0.624N P=0.597N |
|POLY 3 | P=0.247 P=0.468 P=0.289 | P=0.516N P=0.649 P=0.590N |
|POLY 1.5 | P=0.200 P=0.433 P=0.236 | P=0.486N P=0.647 P=0.563N |
|POLY 6 | P=0.330 P=0.529 P=0.380 | P=0.531N P=0.659 P=0.604N |
|LOGISTIC REGRESSION| P=0.195 P=0.409 P=0.252 | P=0.460N P=0.658 P=0.517N |
|COCH-ARM / FISHERS | P=0.148 P=0.405 P=0.178 | P=0.412N P=0.661N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.7% 11.8% 5.3% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/8 (0%) 2/10 (20%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 580 621 580 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.537 P=0.436N | (e) (e) (e) |
|POLY 3 | P=0.365N P=0.491 P=0.458N | (e) (e) (e) |
|POLY 1.5 | P=0.387N P=0.495 P=0.475N | (e) (e) (e) |
|POLY 6 | P=0.332N P=0.483 P=0.432N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.384N P=0.505 P=0.541N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.417N P=0.500 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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.6% 6.6% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- | --- 244 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.143 P=0.236 P=0.207 |
|POLY 3 | (e) (e) (e) | P=0.147 P=0.242 P=0.207 |
|POLY 1.5 | (e) (e) (e) | P=0.154 P=0.237 P=0.215 |
|POLY 6 | (e) (e) (e) | P=0.146 P=0.252 P=0.205 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.383 P=0.330 P=0.479 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.176 P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 647 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.138 (e) P=0.315 | (e) (e) (e) |
|POLY 3 | P=0.105 (e) P=0.264 | (e) (e) (e) |
|POLY 1.5 | P=0.100 (e) P=0.252 | (e) (e) (e) |
|POLY 6 | P=0.114 (e) P=0.284 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.120 (e) P=0.283 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 (e) 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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) 4/50 (8%) | 5/50 (10%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 14.4% 0.0% 10.6% | 14.2% 8.6% 13.8% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | 2/15 (13%) 2/18 (11%) 3/14 (21%) |
|FIRST INCIDENCE | 469 --- 611 | 653 567 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267N P=0.037N* P=0.306N | P=0.496N P=0.294N P=0.571N |
|POLY 3 | P=0.393N P=0.031N* P=0.448N | P=0.527N P=0.359N P=0.624N |
|POLY 1.5 | P=0.404N P=0.031N* P=0.470N | P=0.499N P=0.366N P=0.586N |
|POLY 6 | P=0.373N P=0.032N* P=0.416N | P=0.542N P=0.342N P=0.636 |
|LOGISTIC REGRESSION| P=0.377N P=0.033N* P=0.457N | P=0.545N P=0.345N P=0.627N |
|COCH-ARM / FISHERS | P=0.417N P=0.028N* P=0.500N | P=0.427N P=0.357N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 14.6% 8.8% 7.9% | 0.0% 0.0% 3.5% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 608 630 535 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.160N P=0.353N P=0.204N | P=0.253 (e) P=0.486 |
|POLY 3 | P=0.236N P=0.355N P=0.297N | P=0.282 (e) P=0.463 |
|POLY 1.5 | P=0.256N P=0.356N P=0.322N | P=0.277 (e) P=0.474 |
|POLY 6 | P=0.207N P=0.355N P=0.263N | P=0.287 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.233N P=0.347N P=0.309N | (e) (e) P=0.486 |
|COCH-ARM / FISHERS | P=0.283N P=0.357N P=0.357N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 5/48 (10%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.1% 15.1% 13.1% | 2.9% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 2/14 (14%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 647 623 580 | 694 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.340 P=0.208 P=0.363 | P=0.357N P=0.740N P=0.542N |
|POLY 3 | P=0.250 P=0.213 P=0.276 | P=0.400N P=0.758 P=0.538N |
|POLY 1.5 | P=0.222 P=0.209 P=0.254 | P=0.379N P=0.756 P=0.527N |
|POLY 6 | P=0.298 P=0.222 P=0.314 | P=0.412N P=0.760N P=0.544N |
|LOGISTIC REGRESSION| P=0.241 P=0.212 P=0.271 | P=0.365N P=0.749N P=0.541N |
|COCH-ARM / FISHERS | P=0.187 P=0.209 P=0.226 | P=0.331N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions 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 |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 16/49 (33%) 12/49 (24%) | 9/49 (18%) 11/49 (22%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 26.3% 43.0% 30.7% | 25.4% 31.9% 22.5% |
|TERMINAL (d) | 2/8 (25%) 4/10 (40%) 3/14 (21%) | 3/14 (21%) 5/18 (28%) 0/14 (0%) |
|FIRST INCIDENCE | 608 549 554 | 529 635 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.450N P=0.131 P=0.520N | P=0.473N P=0.534 P=0.541N |
|POLY 3 | P=0.440 P=0.099 P=0.437 | P=0.483N P=0.364 P=0.505N |
|POLY 1.5 | P=0.367 P=0.088 P=0.381 | P=0.445N P=0.365 P=0.472N |
|POLY 6 | P=0.555 P=0.123 P=0.525 | P=0.485N P=0.385 P=0.509N |
|LOGISTIC REGRESSION| P=0.393 P=0.080 P=0.454 | P=0.484N P=0.418 P=0.496N |
|COCH-ARM / FISHERS | P=0.280 P=0.082 P=0.312 | P=0.331N P=0.401 P=0.376N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 8/49 (16%) 10/49 (20%) | 1/49 (2%) 2/49 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 17.2% 22.5% 25.9% | 2.9% 5.9% 3.5% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 4/14 (29%) | 0/14 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 530 549 549 | 462 667 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364 P=0.398 P=0.435 | P=0.593 P=0.532 P=0.742 |
|POLY 3 | P=0.224 P=0.396 P=0.266 | P=0.563 P=0.493 P=0.720 |
|POLY 1.5 | P=0.200 P=0.389 P=0.240 | P=0.581 P=0.490 P=0.734 |
|POLY 6 | P=0.267 P=0.412 P=0.310 | P=0.555 P=0.507 P=0.713 |
|LOGISTIC REGRESSION| P=0.183 P=0.387 P=0.230 | P=0.594 P=0.501 P=0.762N |
|COCH-ARM / FISHERS | P=0.169 P=0.387 P=0.207 | P=0.615N P=0.500 P=0.747N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions 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 |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/49 (0%) 0/49 (0%) | 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.2% 0.0% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 0/14 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 700 --- --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056N P=0.215N P=0.139N | (e) (e) (e) |
|POLY 3 | P=0.091N P=0.235N P=0.210N | (e) (e) (e) |
|POLY 1.5 | P=0.093N P=0.236N P=0.221N | (e) (e) (e) |
|POLY 6 | P=0.088N P=0.233N P=0.193N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.058N P=0.215N P=0.144N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/5 (80%) 5/7 (71%) 2/3 (67%) | 3/3 (100%) 3/3 (100%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 80.0% 81.3% 75.7% | 100.0% 100.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 1/1 (100%) 0/0 (0%) | 1/1 (100%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 440 653 631 | 560 528 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187N P=0.558 P=0.209N | (e) (e) (e) |
|POLY 3 | P=0.649N P=0.764 P=0.761N | (e) (e) (e) |
|POLY 1.5 | P=0.567N P=0.716N P=0.708N | (e) (e) (e) |
|POLY 6 | P=0.647 P=0.690 P=0.792 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.456N P=0.613N P=0.676N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.489N P=0.636N P=0.643N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 2/7 (29%) 0/3 (0%) | 0/3 (0%) 0/3 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 34.1% 0.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/0 (0%) | 0/1 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 668 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545N P=0.293 (e) | (e) (e) (e) |
|POLY 3 | P=0.621 P=0.336 (e) | (e) (e) (e) |
|POLY 1.5 | P=0.620 P=0.324 (e) | (e) (e) (e) |
|POLY 6 | P=0.603 P=0.347 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.605 P=0.319 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.597 P=0.318 (e) | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 3/50 (6%) | 2/49 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.6% 0.0% 7.9% | 5.9% 5.7% 3.4% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 1/15 (7%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 517 --- 636 | 635 567 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.075N P=0.415N | P=0.462N P=0.674N P=0.572N |
|POLY 3 | P=0.384N P=0.062N P=0.447N | P=0.462N P=0.689N P=0.556N |
|POLY 1.5 | P=0.394N P=0.061N P=0.470N | P=0.440N P=0.693N P=0.538N |
|POLY 6 | P=0.363N P=0.064N P=0.413N | P=0.472N P=0.677N P=0.565N |
|LOGISTIC REGRESSION| P=0.407N P=0.063N P=0.512N | P=0.435N P=0.691N P=0.555N |
|COCH-ARM / FISHERS | P=0.406N P=0.059N P=0.500N | P=0.383N P=0.684N P=0.492N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) | 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 3.0% 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 | --- 653 580 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 P=0.482 P=0.293 | (e) (e) (e) |
|POLY 3 | P=0.169 P=0.503 P=0.266 | (e) (e) (e) |
|POLY 1.5 | P=0.157 P=0.501 P=0.253 | (e) (e) (e) |
|POLY 6 | P=0.191 P=0.507 P=0.287 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.147 P=0.501 P=0.236 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.142 P=0.500 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 |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| | 0.0% 8.4% 0.0% |
|TERMINAL (d) | | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | | --- 270 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.602 P=0.134 (e) |
|POLY 3 | | P=0.548 P=0.121 (e) |
|POLY 1.5 | | P=0.576 P=0.118 (e) |
|POLY 6 | | P=0.534 P=0.130 (e) |
|LOGISTIC REGRESSION| | P=0.583N P=0.139 (e) |
|COCH-ARM / FISHERS | | P=0.640 P=0.121 (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 3/50 (6%) 8/50 (16%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| | 8.4% 22.3% 10.4% |
|TERMINAL (d) | | 1/15 (7%) 5/18 (28%) 3/14 (21%) |
|FIRST INCIDENCE | | 571 244 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.481 P=0.132 P=0.581 |
|POLY 3 | | P=0.392 P=0.092 P=0.561 |
|POLY 1.5 | | P=0.447 P=0.092 P=0.594 |
|POLY 6 | | P=0.353 P=0.098 P=0.535 |
|LOGISTIC REGRESSION| | P=0.470 P=0.096 P=0.571 |
|COCH-ARM / FISHERS | | P=0.568 P=0.100 P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) 3/50 (6%) | 3/50 (6%) 5/50 (10%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 8.8% 17.1% 7.9% | 8.4% 14.3% 3.4% |
|TERMINAL (d) | 0/8 (0%) 2/10 (20%) 1/14 (7%) | 0/15 (0%) 3/18 (17%) 0/14 (0%) |
|FIRST INCIDENCE | 571 528 611 | 462 579 394 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N P=0.287 P=0.535N | P=0.329N P=0.409 P=0.365N |
|POLY 3 | P=0.499N P=0.250 P=0.614N | P=0.379N P=0.342 P=0.373N |
|POLY 1.5 | P=0.531N P=0.246 P=0.635N | P=0.343N P=0.340 P=0.353N |
|POLY 6 | P=0.448N P=0.255 P=0.581N | P=0.401N P=0.357 P=0.386N |
|LOGISTIC REGRESSION| P=0.532N P=0.244 P=0.633N | P=0.298N P=0.349 P=0.257N |
|COCH-ARM / FISHERS | P=0.573 P=0.243 P=0.661N | P=0.264N P=0.357 P=0.309N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/45 (38%) 18/47 (38%) 12/50 (24%) | 0/42 (0%) 0/43 (0%) 1/42 (2%) |
|POLY-3 ADJUSTED (b)| 49.9% 49.3% 31.3% | 0.0% 0.0% 4.0% |
|TERMINAL (d) | 3/8 (38%) 1/9 (11%) 5/14 (36%) | 0/11 (0%) 0/15 (0%) 1/13 (8%) |
|FIRST INCIDENCE | 549 497 526 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032N* P=0.516 P=0.025N* | P=0.283 (e) P=0.533 |
|POLY 3 | P=0.056N P=0.580N P=0.074N | P=0.279 (e) P=0.470 |
|POLY 1.5 | P=0.064N P=0.589 P=0.083N | P=0.275 (e) P=0.477 |
|POLY 6 | P=0.055N P=0.554N P=0.072N | P=0.281 (e) P=0.469 |
|LOGISTIC REGRESSION| P=0.040N* P=0.550 P=0.038N* | (e) (e) P=0.533 |
|COCH-ARM / FISHERS | P=0.090N P=0.565 P=0.109N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) | 3/50 (6%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 8.4% 5.8% 13.5% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 1/15 (7%) 1/18 (6%) 2/14 (14%) |
|FIRST INCIDENCE | --- --- --- | 579 667 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.334 P=0.478N P=0.402 |
|POLY 3 | (e) (e) (e) | P=0.354 P=0.513N P=0.399 |
|POLY 1.5 | (e) (e) (e) | P=0.370 P=0.514N P=0.428 |
|POLY 6 | (e) (e) (e) | P=0.347 P=0.505N P=0.384 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.333 P=0.504N P=0.410 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.417 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/49 (4%) | 8/50 (16%) 6/50 (12%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 3.0% 5.9% 5.4% | 21.1% 16.8% 16.8% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 2/15 (13%) 3/18 (17%) 2/14 (14%) |
|FIRST INCIDENCE | 634 653 576 | 429 397 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500 P=0.498 P=0.590 | P=0.327N P=0.360N P=0.398N |
|POLY 3 | P=0.436 P=0.502 P=0.534 | P=0.376N P=0.432N P=0.445N |
|POLY 1.5 | P=0.413 P=0.501 P=0.516 | P=0.326N P=0.423N P=0.388N |
|POLY 6 | P=0.473 P=0.504 P=0.561 | P=0.410N P=0.431N P=0.488N |
|LOGISTIC REGRESSION| P=0.425 P=0.505 P=0.506 | P=0.270N P=0.384N P=0.320N |
|COCH-ARM / FISHERS | P=0.383 P=0.500 P=0.492 | P=0.226N P=0.387N P=0.277N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.9% 0.0% 0.0% | 0.0% 2.9% 3.4% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 598 --- --- | --- 524 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.077N P=0.240N P=0.190N | P=0.277 P=0.505 P=0.440 |
|POLY 3 | P=0.093N P=0.237N P=0.219N | P=0.304 P=0.501 P=0.466 |
|POLY 1.5 | P=0.095N P=0.238N P=0.229N | P=0.311 P=0.498 P=0.475 |
|POLY 6 | P=0.090N P=0.238N P=0.206N | P=0.303 P=0.510 P=0.463 |
|LOGISTIC REGRESSION| P=0.090N P=0.236N P=0.229N | P=0.350 P=0.535 P=0.486 |
|COCH-ARM / FISHERS | P=0.097N P=0.247N P=0.253N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/49 (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%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 567 674 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.456 P=0.270 P=0.577 | (e) (e) (e) |
|POLY 3 | P=0.411 P=0.241 P=0.520 | (e) (e) (e) |
|POLY 1.5 | P=0.386 P=0.239 P=0.509 | (e) (e) (e) |
|POLY 6 | P=0.452 P=0.245 P=0.537 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.378 P=0.238 P=0.526 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.355 P=0.247 P=0.495 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.0% 5.9% 2.7% | 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 | 712 630 703 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465N P=0.530 P=0.617N | (e) (e) (e) |
|POLY 3 | P=0.590N P=0.507 P=0.740N | (e) (e) (e) |
|POLY 1.5 | P=0.606N P=0.503 P=0.751N | (e) (e) (e) |
|POLY 6 | P=0.561N P=0.514 P=0.722N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.553N P=0.507 P=0.690N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.616 P=0.500 P=0.747 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) | 8/50 (16%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 5.9% 0.0% 0.0% | 21.3% 5.7% 13.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 2/15 (13%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 469 --- --- | 423 545 394 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069N P=0.215N P=0.174N | P=0.188N P=0.053N P=0.291N |
|POLY 3 | P=0.093N P=0.239N P=0.220N | P=0.157N P=0.052N P=0.278N |
|POLY 1.5 | P=0.095N P=0.239N P=0.230N | P=0.143N P=0.052N P=0.245N |
|POLY 6 | P=0.090N P=0.239N P=0.206N | P=0.164N P=0.050N P=0.302N |
|LOGISTIC REGRESSION| P=0.103N P=0.237N P=0.271N | P=0.101N P=0.046N* P=0.162N |
|COCH-ARM / FISHERS | P=0.097N P=0.247N P=0.253N | P=0.114N P=0.046N* P=0.178N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/49 (2%) | 4/50 (8%) 4/50 (8%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| 6.0% 2.9% 2.7% | 11.2% 11.2% 28.2% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 2/15 (13%) 2/18 (11%) 5/14 (36%) |
|FIRST INCIDENCE | 654 497 526 | 545 429 355 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305N P=0.481N P=0.399N | P=0.046 * P=0.605N P=0.073 |
|POLY 3 | P=0.357N P=0.493N P=0.464N | P=0.049 * P=0.646 P=0.067 |
|POLY 1.5 | P=0.369N P=0.497N P=0.483N | P=0.056 P=0.637 P=0.079 |
|POLY 6 | P=0.337N P=0.489N P=0.436N | P=0.046 * P=0.631N P=0.061 |
|LOGISTIC REGRESSION| P=0.414N P=0.500N P=0.508N | P=0.069 P=0.640 P=0.097 |
|COCH-ARM / FISHERS | P=0.384N P=0.500N P=0.508N | P=0.078 P=0.643N P=0.117 |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 23.4% 5.9% 2.7% | |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | 653 611 713 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002N** P=0.049N* P=0.003N** | |
|POLY 3 | P=0.003N** P=0.038N* P=0.009N** | |
|POLY 1.5 | P=0.004N** P=0.042N* P=0.011N* | |
|POLY 6 | P=0.002N** P=0.034N* P=0.006N** | |
|LOGISTIC REGRESSION| P=0.002N** P=0.039N* P=0.004N** | |
|COCH-ARM / FISHERS | P=0.006N** P=0.046N* P=0.015N* | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 35/50 (70%) 38/50 (76%) | |
|POLY-3 ADJUSTED (b)| 69.2% 79.1% 81.8% | |
|TERMINAL (d) | 4/8 (50%) 8/10 (80%) 13/14 (93%) | |
|FIRST INCIDENCE | 293 224 482 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331N P=0.458 P=0.382N | |
|POLY 3 | P=0.074 P=0.180 P=0.104 | |
|POLY 1.5 | P=0.087 P=0.247 P=0.113 | |
|POLY 6 | P=0.073 P=0.107 P=0.112 | |
|LOGISTIC REGRESSION| P=0.091 P=0.328 P=0.085 | |
|COCH-ARM / FISHERS | P=0.115 P=0.335 P=0.138 | |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 3.0% 8.7% 0.0% | |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | 728 (T) 567 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.310 P=0.388N | |
|POLY 3 | P=0.327N P=0.318 P=0.478N | |
|POLY 1.5 | P=0.349N P=0.311 P=0.487N | |
|POLY 6 | P=0.294N P=0.332 P=0.463N | |
|LOGISTIC REGRESSION| P=0.362N P=0.306 (e) | |
|COCH-ARM / FISHERS | P=0.378N P=0.309 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 10/50 (20%) 7/50 (14%) | |
|POLY-3 ADJUSTED (b)| 27.6% 26.8% 17.8% | |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | |
|FIRST INCIDENCE | 293 497 482 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.575N P=0.131N | |
|POLY 3 | P=0.187N P=0.576N P=0.227N | |
|POLY 1.5 | P=0.218N P=0.595N P=0.258N | |
|POLY 6 | P=0.144N P=0.538N P=0.183N | |
|LOGISTIC REGRESSION| P=0.281N P=0.599 P=0.325N | |
|COCH-ARM / FISHERS | P=0.258N P=0.598N P=0.298N | |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 3.0% 0.0% 5.3% | |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | 706 --- 580 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.456 P=0.467N P=0.613 | |
|POLY 3 | P=0.388 P=0.499N P=0.545 | |
|POLY 1.5 | P=0.376 P=0.500N P=0.525 | |
|POLY 6 | P=0.411 P=0.498N P=0.576 | |
|LOGISTIC REGRESSION| P=0.376 P=0.488N P=0.517 | |
|COCH-ARM / FISHERS | P=0.360 P=0.500N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 5.9% 0.0% | |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | |
|FIRST INCIDENCE | --- 630 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.594N P=0.246 (e) | |
|POLY 3 | P=0.631N P=0.240 (e) | |
|POLY 1.5 | P=0.647N P=0.238 (e) | |
|POLY 6 | P=0.603N P=0.244 (e) | |
|LOGISTIC REGRESSION| P=0.640N P=0.240 (e) | |
|COCH-ARM / FISHERS | P=0.669 P=0.247 (e) | |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions 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: Sebaceous Gland, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 45/50 (90%) 45/50 (90%) | 2/50 (4%) 48/50 (96%) 49/50 (98%) |
|POLY-3 ADJUSTED (b)| 3.0% 94.9% 93.2% | 5.7% 96.8% 100.0% |
|TERMINAL (d) | 0/8 (0%) 10/10 (100%) 13/14 (93%) | 1/15 (7%) 18/18 (100%) 14/14 (100%) |
|FIRST INCIDENCE | 659 331 482 | 524 244 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 44/50 (88%) 40/50 (80%) | 1/50 (2%) 38/50 (76%) 31/50 (62%) |
|POLY-3 ADJUSTED (b)| 0.0% 91.0% 84.3% | 2.9% 82.9% 77.7% |
|TERMINAL (d) | 0/8 (0%) 8/10 (80%) 10/14 (71%) | 1/15 (7%) 14/18 (78%) 10/14 (71%) |
|FIRST INCIDENCE | --- 224 482 | 728 (T) 244 302 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions 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: Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 49/50 (98%) 47/50 (94%) | 3/50 (6%) 50/50 (100%) 50/50 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 98.6% 94.9% | 8.5% 100.0% 100.0% |
|TERMINAL (d) | 0/8 (0%) 10/10 (100%) 12/14 (86%) | 1/15 (7%) 18/18 (100%) 14/14 (100%) |
|FIRST INCIDENCE | --- 224 482 | 524 244 169 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 48/50 (96%) 41/50 (82%) | 2/50 (4%) 44/50 (88%) 48/50 (96%) |
|POLY-3 ADJUSTED (b)| 0.0% 97.6% 85.4% | 5.7% 89.8% 99.8% |
|TERMINAL (d) | 0/8 (0%) 10/10 (100%) 10/14 (71%) | 1/15 (7%) 17/18 (94%) 14/14 (100%) |
|FIRST INCIDENCE | --- 224 482 | 692 244 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions 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: Skin, Site of Application |
| Parakeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 10/50 (20%) 11/50 (22%) | 2/50 (4%) 27/50 (54%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 0.0% 25.9% 27.7% | 5.6% 62.2% 91.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 3/14 (21%) | 0/15 (0%) 11/18 (61%) 13/14 (93%) |
|FIRST INCIDENCE | --- 224 482 | 524 270 169 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.002 ** P=0.007 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.003 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.002 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.006 ** P=0.002 ** P=0.002 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 7/50 (14%) 6/50 (12%) | 3/50 (6%) 20/50 (40%) 36/50 (72%) |
|POLY-3 ADJUSTED (b)| 0.0% 18.9% 15.6% | 8.5% 48.6% 84.7% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 1/15 (7%) 10/18 (56%) 13/14 (93%) |
|FIRST INCIDENCE | --- 440 535 | 524 270 302 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071 P=0.012 * P=0.061 | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.043 * P=0.010 * P=0.023 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P=0.033 * P=0.009 ** P=0.019 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.066 P=0.013 * P=0.031 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.018 * P=0.009 ** P=0.023 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.025 * P=0.006 ** P=0.013 * | P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/50 (12%) 5/50 (10%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 17.2% 17.1% 13.3% | 8.6% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | 2/15 (13%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 608 621 611 | 698 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230N P=0.610 P=0.274N | P=0.036N* P=0.093N P=0.137N |
|POLY 3 | P=0.378N P=0.622N P=0.443N | P=0.043N* P=0.119N P=0.154N |
|POLY 1.5 | P=0.402N P=0.622N P=0.465N | P=0.041N* P=0.122N P=0.143N |
|POLY 6 | P=0.345N P=0.623N P=0.412N | P=0.043N* P=0.113N P=0.160N |
|LOGISTIC REGRESSION| P=0.346N P=0.616N P=0.403N | P=0.039N* P=0.099N P=0.144N |
|COCH-ARM / FISHERS | P=0.437N P=0.620N P=0.500N | P=0.037N* P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.8% 16.5% 7.9% | 2.9% 0.0% 3.5% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 440 497 526 | 698 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.145 P=0.625 | P=0.655 P=0.469N P=0.740 |
|POLY 3 | P=0.508 P=0.146 P=0.550 | P=0.669 P=0.503N P=0.718 |
|POLY 1.5 | P=0.471 P=0.139 P=0.528 | P=0.666 P=0.505N P=0.731 |
|POLY 6 | P=0.568 P=0.161 P=0.584 | P=0.673 P=0.497N P=0.710 |
|LOGISTIC REGRESSION| P=0.346 P=0.135 P=0.417 | P=0.637 P=0.494N P=0.725 |
|COCH-ARM / FISHERS | P=0.424 P=0.134 P=0.500 | P=0.669 P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/50 (12%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.7% 16.7% 7.9% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 580 591 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.499 P=0.203N | (e) (e) (e) |
|POLY 3 | P=0.235N P=0.538 P=0.295N | (e) (e) (e) |
|POLY 1.5 | P=0.263N P=0.517 P=0.321N | (e) (e) (e) |
|POLY 6 | P=0.196N P=0.574 P=0.259N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.278N P=0.503 P=0.287N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.303N P=0.500 P=0.357N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 26/50 (52%) 11/50 (22%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 38.4% 59.4% 27.8% | 2.9% 2.9% 3.5% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 3/14 (21%) | 0/15 (0%) 1/18 (6%) 1/14 (7%) |
|FIRST INCIDENCE | 549 440 497 | 695 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.042 * P=0.093N | P=0.618 P=0.735N P=0.735 |
|POLY 3 | P=0.154N P=0.040 * P=0.221N | P=0.604 P=0.758 P=0.718 |
|POLY 1.5 | P=0.201N P=0.021 * P=0.259N | P=0.613 P=0.756 P=0.731 |
|POLY 6 | P=0.115N P=0.099 P=0.182N | P=0.602 P=0.760N P=0.710 |
|LOGISTIC REGRESSION| P=0.286N P=0.012 * P=0.226N | P=0.602 P=0.749N P=0.723 |
|COCH-ARM / FISHERS | P=0.299N P=0.012 * P=0.322N | P=0.640 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia Basal Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 2.9% 5.3% | 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 | 694 591 618 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.497N P=0.563N | (e) (e) (e) |
|POLY 3 | P=0.581N P=0.495N P=0.654N | (e) (e) (e) |
|POLY 1.5 | P=0.594N P=0.498N P=0.671N | (e) (e) (e) |
|POLY 6 | P=0.561N P=0.491N P=0.626N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.564N P=0.496N P=0.625N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.610 P=0.500N P=0.691N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.9% 8.6% 2.7% | 0.0% 2.9% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | 654 483 636 | --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.651 P=0.212N | P=0.729 P=0.536 (e) |
|POLY 3 | P=0.200N P=0.649N P=0.267N | P=0.698 P=0.498 (e) |
|POLY 1.5 | P=0.217N P=0.656N P=0.283N | P=0.707 P=0.496 (e) |
|POLY 6 | P=0.177N P=0.640N P=0.244N | P=0.694 P=0.504 (e) |
|LOGISTIC REGRESSION| P=0.240N P=0.663N P=0.260N | (e) P=0.536 (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.661N P=0.309N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 23/50 (46%) 11/50 (22%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 33.2% 54.8% 27.4% | 2.9% 2.9% 3.5% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 3/14 (21%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 549 497 497 | 695 635 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203N P=0.047 * P=0.212N | P=0.591 P=0.758 P=0.735 |
|POLY 3 | P=0.279N P=0.037 * P=0.380N | P=0.605 P=0.761 P=0.718 |
|POLY 1.5 | P=0.346N P=0.024 * P=0.428N | P=0.613 P=0.757 P=0.731 |
|POLY 6 | P=0.210N P=0.077 P=0.323N | P=0.603 P=0.755N P=0.710 |
|LOGISTIC REGRESSION| P=0.438N P=0.018 * P=0.434N | P=0.590 P=0.761 P=0.723 |
|COCH-ARM / FISHERS | P=0.457N P=0.018 * P=0.500N | P=0.640 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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)| 5.9% 3.0% 8.0% | 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 | 638 630 677 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.566 P=0.531N P=0.660N | (e) (e) (e) |
|POLY 3 | P=0.438 P=0.498N P=0.549 | (e) (e) (e) |
|POLY 1.5 | P=0.421 P=0.500N P=0.528 | (e) (e) (e) |
|POLY 6 | P=0.466 P=0.497N P=0.583 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.469 P=0.497N P=0.594 | (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 42
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- 576 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132 (e) P=0.313 | (e) (e) (e) |
|POLY 3 | P=0.106 (e) P=0.265 | (e) (e) (e) |
|POLY 1.5 | P=0.101 (e) P=0.253 | (e) (e) (e) |
|POLY 6 | P=0.116 (e) P=0.286 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.102 (e) P=0.248 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 (e) 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 |
| Perforation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.8% 26.9% 2.7% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 580 535 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.138N P=0.081 P=0.109N | (e) (e) (e) |
|POLY 3 | P=0.124N P=0.092 P=0.145N | (e) (e) (e) |
|POLY 1.5 | P=0.152N P=0.080 P=0.159N | (e) (e) (e) |
|POLY 6 | P=0.090N P=0.118 P=0.126N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.201N P=0.075 P=0.160N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.202N P=0.074 P=0.181N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 14/50 (28%) 7/50 (14%) | 1/50 (2%) 5/50 (10%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 27.7% 35.4% 17.9% | 2.9% 14.0% 6.9% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 549 483 497 | 718 547 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.144N P=0.263 P=0.141N | P=0.341 P=0.134 P=0.460 |
|POLY 3 | P=0.179N P=0.315 P=0.224N | P=0.306 P=0.104 P=0.438 |
|POLY 1.5 | P=0.211N P=0.277 P=0.251N | P=0.334 P=0.099 P=0.455 |
|POLY 6 | P=0.147N P=0.376 P=0.194N | P=0.297 P=0.119 P=0.432 |
|LOGISTIC REGRESSION| P=0.296N P=0.241 P=0.278N | P=0.335 P=0.100 P=0.428 |
|COCH-ARM / FISHERS | P=0.268N P=0.241 P=0.298N | P=0.412 P=0.102 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 25/50 (50%) 13/50 (26%) | 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 38.4% 58.1% 32.4% | 2.9% 2.9% 3.5% |
|TERMINAL (d) | 2/8 (25%) 0/10 (0%) 4/14 (29%) | 0/15 (0%) 1/18 (6%) 1/14 (7%) |
|FIRST INCIDENCE | 549 440 497 | 695 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182N P=0.056 P=0.173N | P=0.618 P=0.735N P=0.735 |
|POLY 3 | P=0.281N P=0.053 P=0.374N | P=0.604 P=0.758 P=0.718 |
|POLY 1.5 | P=0.345N P=0.031 * P=0.424N | P=0.613 P=0.756 P=0.731 |
|POLY 6 | P=0.219N P=0.118 P=0.318N | P=0.602 P=0.760N P=0.710 |
|LOGISTIC REGRESSION| P=0.427N P=0.020 * P=0.388N | P=0.602 P=0.749N P=0.723 |
|COCH-ARM / FISHERS | P=0.458N P=0.020 * P=0.500N | P=0.640 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 6/49 (12%) 8/50 (16%) | 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 36.4% 17.4% 21.0% | 0.0% 0.0% 3.5% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 2/14 (14%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 608 580 576 | --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.073N P=0.033N* | P=0.253 (e) P=0.486 |
|POLY 3 | P=0.080N P=0.055N P=0.104N | P=0.282 (e) P=0.463 |
|POLY 1.5 | P=0.095N P=0.061N P=0.126N | P=0.277 (e) P=0.474 |
|POLY 6 | P=0.062N P=0.053N P=0.082N | P=0.287 (e) P=0.457 |
|LOGISTIC REGRESSION| P=0.051N P=0.053N P=0.065N | (e) (e) P=0.486 |
|COCH-ARM / FISHERS | P=0.121N P=0.068N P=0.163N | P=0.269 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.0% 3.0% 0.0% | 2.8% 0.0% 0.0% |
|TERMINAL (d) | 1/8 (13%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 614 653 --- | 579 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.108N P=0.496N P=0.168N | P=0.320N P=0.517N P=0.581N |
|POLY 3 | P=0.130N P=0.502N P=0.215N | P=0.305N P=0.505N P=0.540N |
|POLY 1.5 | P=0.135N P=0.505N P=0.224N | P=0.294N P=0.506N P=0.528N |
|POLY 6 | P=0.121N P=0.498N P=0.201N | P=0.311N P=0.501N P=0.548N |
|LOGISTIC REGRESSION| P=0.124N P=0.499N P=0.206N | P=0.255N P=0.489N P=0.488N |
|COCH-ARM / FISHERS | P=0.143N P=0.508N P=0.247N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions 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 |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 14/50 (28%) 11/50 (22%) | |
|POLY-3 ADJUSTED (b)| 43.4% 37.2% 28.2% | |
|TERMINAL (d) | 4/8 (50%) 2/10 (20%) 4/14 (29%) | |
|FIRST INCIDENCE | 549 497 580 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039N* P=0.402N P=0.037N* | |
|POLY 3 | P=0.096N P=0.373N P=0.118N | |
|POLY 1.5 | P=0.118N P=0.394N P=0.142N | |
|POLY 6 | P=0.072N P=0.349N P=0.092N | |
|LOGISTIC REGRESSION| P=0.089N P=0.403N P=0.090N | |
|COCH-ARM / FISHERS | P=0.156N P=0.414N P=0.184N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 6/50 (12%) 5/50 (10%) | |
|POLY-3 ADJUSTED (b)| 11.6% 17.1% 13.1% | |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | |
|FIRST INCIDENCE | 549 549 580 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N P=0.387 P=0.574N | |
|POLY 3 | P=0.512 P=0.377 P=0.564 | |
|POLY 1.5 | P=0.479 P=0.372 P=0.537 | |
|POLY 6 | P=0.565 P=0.385 P=0.606 | |
|LOGISTIC REGRESSION| P=0.476 P=0.371 P=0.536 | |
|COCH-ARM / FISHERS | P=0.434 P=0.370 P=0.500 | |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions 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: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 23/50 (46%) 20/50 (40%) | |
|POLY-3 ADJUSTED (b)| 63.1% 54.7% 44.5% | |
|TERMINAL (d) | 2/8 (25%) 4/10 (40%) 2/14 (14%) | |
|FIRST INCIDENCE | 293 331 482 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036N* P=0.275N P=0.046N* | |
|POLY 3 | P=0.040N* P=0.271N P=0.052N | |
|POLY 1.5 | P=0.049N* P=0.246N P=0.062N | |
|POLY 6 | P=0.031N* P=0.321N P=0.043N* | |
|LOGISTIC REGRESSION| P=0.129N P=0.211N P=0.179N | |
|COCH-ARM / FISHERS | P=0.067N P=0.212N P=0.080N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/45 (2%) 0/42 (0%) 2/44 (5%) | 0/47 (0%) 0/46 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.3% 0.0% 6.0% | 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/6 (0%) 0/7 (0%) 1/14 (7%) | 0/14 (0%) 0/16 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 603 --- 618 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463 P=0.500N P=0.617 | (e) (e) (e) |
|POLY 3 | P=0.385 P=0.517N P=0.537 | (e) (e) (e) |
|POLY 1.5 | P=0.371 P=0.516N P=0.517 | (e) (e) (e) |
|POLY 6 | P=0.410 P=0.517N P=0.571 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.376 P=0.512N P=0.512 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.355 P=0.517N P=0.491 | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions 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 |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 3.0% 2.9% 0.0% | 5.6% 2.8% 0.0% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 613 224 --- | 497 244 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.325N P=0.746 P=0.483N | P=0.160N P=0.488N P=0.276N |
|POLY 3 | P=0.313N P=0.757N P=0.480N | P=0.187N P=0.503N P=0.286N |
|POLY 1.5 | P=0.321N P=0.757N P=0.488N | P=0.173N P=0.505N P=0.270N |
|POLY 6 | P=0.301N P=0.757N P=0.468N | P=0.196N P=0.494N P=0.296N |
|LOGISTIC REGRESSION| P=0.457N P=0.722N P=0.519N | P=0.068N P=0.393N P=0.232N |
|COCH-ARM / FISHERS | P=0.331N P=0.753N P=0.500N | P=0.142N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) | 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 8.8% 2.7% | 2.9% 2.9% 0.0% |
|TERMINAL (d) | 0/8 (0%) 1/10 (10%) 1/14 (7%) | 0/15 (0%) 1/18 (6%) 0/14 (0%) |
|FIRST INCIDENCE | --- 611 728 (T) | 635 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497 P=0.131 P=0.612 | P=0.371N P=0.748N P=0.568N |
|POLY 3 | P=0.442 P=0.121 P=0.522 | P=0.402N P=0.757 P=0.539N |
|POLY 1.5 | P=0.414 P=0.120 P=0.513 | P=0.380N P=0.755 P=0.527N |
|POLY 6 | P=0.487 P=0.125 P=0.537 | P=0.416N P=0.762N P=0.546N |
|LOGISTIC REGRESSION| P=0.439 P=0.122 P=0.612 | P=0.369N P=0.763N P=0.522N |
|COCH-ARM / FISHERS | P=0.378 P=0.121 P=0.500 | P=0.331N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 48
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Trachea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 5.9% 0.0% 0.0% | 0.0% 2.9% 3.4% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 0/14 (0%) | 0/15 (0%) 0/18 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 542 --- --- | --- 662 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089N P=0.249N P=0.216N | P=0.276 P=0.515 P=0.440 |
|POLY 3 | P=0.092N P=0.240N P=0.218N | P=0.303 P=0.499 P=0.466 |
|POLY 1.5 | P=0.093N P=0.239N P=0.226N | P=0.310 P=0.496 P=0.475 |
|POLY 6 | P=0.089N P=0.243N P=0.206N | P=0.303 P=0.507 P=0.463 |
|LOGISTIC REGRESSION| P=0.103N P=0.236N P=0.274N | P=0.306 P=0.498 P=0.486 |
|COCH-ARM / FISHERS | P=0.095N P=0.247N P=0.247N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 1/50 (2%) | 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 8.6% 2.9% 2.7% | 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 | 473 440 631 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187N P=0.302N P=0.276N | (e) (e) (e) |
|POLY 3 | P=0.184N P=0.308N P=0.277N | (e) (e) (e) |
|POLY 1.5 | P=0.190N P=0.304N P=0.286N | (e) (e) (e) |
|POLY 6 | P=0.174N P=0.316N P=0.262N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.268N P=0.251N P=0.436N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.196N P=0.301N P=0.301N | (e) (e) (e) |
|=================================================================================================================================|
Date: 08/13/97 EXPERIMENT: 91014 TEST: 03 Page 49
Statistical Analysis of Non-neoplastic Lesions 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 |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/49 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 5.9% 5.8% 2.7% | 0.0% 2.9% 6.8% |
|TERMINAL (d) | 0/8 (0%) 0/10 (0%) 1/14 (7%) | 0/15 (0%) 0/18 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 473 440 728 (T) | --- 541 170 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.330N P=0.670 P=0.413N | P=0.122 P=0.505 P=0.230 |
|POLY 3 | P=0.358N P=0.689N P=0.468N | P=0.123 P=0.497 P=0.200 |
|POLY 1.5 | P=0.369N P=0.688N P=0.478N | P=0.127 P=0.493 P=0.209 |
|POLY 6 | P=0.341N P=0.690N P=0.452N | P=0.123 P=0.507 P=0.197 |
|LOGISTIC REGRESSION| P=0.431N P=0.673N P=0.519N | P=0.211 P=0.523 P=0.356 |
|COCH-ARM / FISHERS | P=0.383N P=0.684N P=0.492N | P=0.139 P=0.495 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 50 MG/KG 100MG/KG | 0 MG/KG 50 MG/KG 100MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| | 0.0% 11.4% 6.6% |
|TERMINAL (d) | | 0/15 (0%) 2/18 (11%) 0/14 (0%) |
|FIRST INCIDENCE | | --- 524 305 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.191 P=0.086 P=0.216 |
|POLY 3 | | P=0.168 P=0.059 P=0.208 |
|POLY 1.5 | | P=0.181 P=0.058 P=0.216 |
|POLY 6 | | P=0.166 P=0.064 P=0.207 |
|LOGISTIC REGRESSION| | P=0.254 P=0.061 P=0.485 |
|COCH-ARM / FISHERS | | P=0.222 P=0.059 P=0.247 |
|=================================================================================================================================|
(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).