Statistical Analysis Of Non-Neoplastic Lesions
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/30/97
EXPERIMENT: 91014 TEST: 04 TIME: 08:21:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/30/97
EXPERIMENT: 91014 TEST: 04 TIME: 08:21:25
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF OLEIC ACID DIETHANOLAMINE CONDENSATE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Kidney Mineralization
Nephropathy
Liver Infarct
Mixed Cell Focus
Necrosis
Skin: Dermis, Skin, Site of Application
Inflammation Chronic
Skin: Epidermis, Skin, Site of Application
Hyperplasia
Inflammation
Parakeratosis
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Exudate
Hyperkeratosis
Ulcer
Thymus Atrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Mineralization
Kidney: Renal Tubule Dilatation
Ovary Atrophy
Ovary: Periovarian Tissue Cyst
Skin: Dermis, Skin, Site of Application
Inflammation Chronic
Skin: Epidermis, Skin, Site of Application
Hyperplasia
Parakeratosis
Skin: Sebaceous Gland, Skin, Site of Application
Hyperplasia
Skin: Skin, Site of Application Exudate
Hyperkeratosis
Uterus: Endometrium Hyperplasia
Hyperplasia Cystic
===============================================================
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 5/50 (10%) | 1/50 (2%) 0/50 (0%) 1/51 (2%) |
|POLY-3 ADJUSTED (b)| 4.3% 2.2% 11.6% | 2.3% 0.0% 2.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|TERMINAL (d) | 1/41 (2%) 1/35 (3%) 4/34 (12%) | 1/34 (3%) 0/30 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 561 729 (T) 606 | 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 P=0.534N P=0.165 | P=0.659N P=0.525N P=0.755N |
|POLY 3 | P=0.123 P=0.510N P=0.188 | P=0.666N P=0.503N P=0.760N |
|POLY 1.5 | P=0.128 P=0.504N P=0.203 | P=0.666N P=0.501N P=0.759N |
|POLY 6 | P=0.116 P=0.520N P=0.172 | P=0.666N P=0.507N P=0.759N |
|LOGISTIC REGRESSION| P=0.136 P=0.473N P=0.230 | P=0.659N (e) P=0.755N |
|COCH-ARM / FISHERS | P=0.138 P=0.492N P=0.226 | P=0.664N P=0.500N P=0.748N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/49 (45%) 12/50 (24%) 10/50 (20%) | 1/50 (2%) 1/50 (2%) 0/51 (0%) |
|POLY-3 ADJUSTED (b)| 48.2% 26.7% 23.5% | 2.3% 2.3% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|TERMINAL (d) | 22/41 (54%) 11/35 (31%) 10/34 (29%) | 1/34 (3%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 697 729 (T) | 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022N* P=0.076N P=0.031N* | P=0.329N P=0.734 P=0.494N |
|POLY 3 | P=0.007N** P=0.026N* P=0.012N* | P=0.334N P=0.757 P=0.499N |
|POLY 1.5 | P=0.005N** P=0.025N* P=0.009N** | P=0.333N P=0.760 P=0.499N |
|POLY 6 | P=0.009N** P=0.029N* P=0.017N* | P=0.332N P=0.753 P=0.498N |
|LOGISTIC REGRESSION| P=0.020N* P=0.052N P=0.031N* | P=0.329N P=0.734 (e) |
|COCH-ARM / FISHERS | P=0.005N** P=0.024N* P=0.007N** | P=0.328N P=0.753N P=0.495N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 7/50 (14%) 7/50 (14%) | 0/50 (0%) 0/50 (0%) 0/51 (0%) |
|POLY-3 ADJUSTED (b)| 24.0% 15.6% 16.3% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|TERMINAL (d) | 10/41 (24%) 5/35 (14%) 5/34 (15%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 691 697 676 | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.306N P=0.330N P=0.365N | (e) (e) (e) |
|POLY 3 | P=0.207N P=0.226N P=0.262N | (e) (e) (e) |
|POLY 1.5 | P=0.188N P=0.219N P=0.237N | (e) (e) (e) |
|POLY 6 | P=0.233N P=0.240N P=0.295N | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.254N P=0.253N P=0.312N | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.162N P=0.204N P=0.204N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 4.7% | 2.3% 0.0% 4.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/41 (2%) 0/35 (0%) 2/34 (6%) | 1/34 (3%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) | 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.532N P=0.435 | P=0.371 P=0.525N P=0.510 |
|POLY 3 | P=0.360 P=0.503N P=0.476 | P=0.361 P=0.503N P=0.501 |
|POLY 1.5 | P=0.363 P=0.501N P=0.489 | P=0.362 P=0.501N P=0.501 |
|POLY 6 | P=0.358 P=0.508N P=0.460 | P=0.362 P=0.507N P=0.503 |
|LOGISTIC REGRESSION| P=0.312 (e) P=0.435 | P=0.371 (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.366 P=0.495N P=0.508 | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.5% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- | 621 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.098N P=0.246N P=0.240N |
|POLY 3 | (e) (e) (e) | P=0.095N P=0.243N P=0.239N |
|POLY 1.5 | (e) (e) (e) | P=0.095N P=0.240N P=0.238N |
|POLY 6 | (e) (e) (e) | P=0.096N P=0.251N P=0.240N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.097N P=0.239N P=0.242N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrous Osteodystrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 2.3% 0.0% 4.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- --- | 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.371 P=0.525N P=0.510 |
|POLY 3 | (e) (e) (e) | P=0.361 P=0.503N P=0.501 |
|POLY 1.5 | (e) (e) (e) | P=0.362 P=0.501N P=0.501 |
|POLY 6 | (e) (e) (e) | P=0.362 P=0.507N P=0.503 |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.371 (e) P=0.510 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.360 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 4/50 (8%) 6/50 (12%) | 3/50 (6%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 8.7% 8.8% 13.3% | 6.8% 2.3% 4.5% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/41 (7%) 2/35 (6%) 1/34 (3%) | 0/34 (0%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 699 621 468 | 621 730 (T) 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.575 P=0.305 | P=0.394N P=0.344N P=0.491N |
|POLY 3 | P=0.297 P=0.638 P=0.361 | P=0.399N P=0.316N P=0.500N |
|POLY 1.5 | P=0.304 P=0.643 P=0.369 | P=0.399N P=0.309N P=0.499N |
|POLY 6 | P=0.288 P=0.628 P=0.349 | P=0.398N P=0.327N P=0.498N |
|LOGISTIC REGRESSION| P=0.369 P=0.644 P=0.493 | P=0.400N P=0.305N P=0.504N |
|COCH-ARM / FISHERS | P=0.314 P=0.631N P=0.383 | P=0.399N P=0.309N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 0/50 (0%) | 11/50 (22%) 9/50 (18%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.7% 0.0% | 24.9% 20.8% 18.2% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 3/35 (9%) 0/34 (0%) | 9/34 (27%) 7/30 (23%) 7/35 (20%) |
|FIRST INCIDENCE | --- 729 (T) --- | 562 639 605 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587 P=0.095 (e) | P=0.247N P=0.507N P=0.288N |
|POLY 3 | P=0.604 P=0.116 (e) | P=0.260N P=0.419N P=0.305N |
|POLY 1.5 | P=0.622 P=0.118 (e) | P=0.259N P=0.408N P=0.303N |
|POLY 6 | P=0.582 P=0.112 (e) | P=0.258N P=0.441N P=0.304N |
|LOGISTIC REGRESSION| (e) P=0.095 (e) | P=0.255N P=0.425N P=0.300N |
|COCH-ARM / FISHERS | P=0.634N P=0.125 (e) | P=0.261N P=0.402N P=0.306N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 8.9% 0.0% 2.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- | 435 --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.086N P=0.076N P=0.184N |
|POLY 3 | (e) (e) (e) | P=0.081N P=0.066N P=0.183N |
|POLY 1.5 | (e) (e) (e) | P=0.080N P=0.063N P=0.181N |
|POLY 6 | (e) (e) (e) | P=0.081N P=0.070N P=0.183N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.088N P=0.064N P=0.191N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.082N P=0.059N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart: Pericardium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 4.5% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- | 562 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.101N P=0.245N P=0.247N |
|POLY 3 | (e) (e) (e) | P=0.096N P=0.245N P=0.241N |
|POLY 1.5 | (e) (e) (e) | P=0.095N P=0.240N P=0.239N |
|POLY 6 | (e) (e) (e) | P=0.096N P=0.252N P=0.242N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.102N P=0.244N P=0.252N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.095N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/49 (61%) 28/50 (56%) 26/50 (52%) | 7/49 (14%) 8/50 (16%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 63.4% 59.0% 56.0% | 15.8% 18.3% 13.7% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 26/41 (63%) 19/35 (54%) 17/34 (50%) | 4/34 (12%) 6/30 (20%) 4/35 (11%) |
|FIRST INCIDENCE | 452 425 356 | 562 501 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483 P=0.444 P=0.525 | P=0.431N P=0.435 P=0.491N |
|POLY 3 | P=0.267N P=0.409N P=0.302N | P=0.454N P=0.488 P=0.508N |
|POLY 1.5 | P=0.239N P=0.404N P=0.272N | P=0.440N P=0.505 P=0.496N |
|POLY 6 | P=0.303N P=0.417N P=0.341N | P=0.466N P=0.460 P=0.519N |
|LOGISTIC REGRESSION| P=0.226N P=0.397N P=0.248N | P=0.426N P=0.517 P=0.484N |
|COCH-ARM / FISHERS | P=0.205N P=0.373N P=0.235N | P=0.427N P=0.517 P=0.484N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) | 3/50 (6%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 0.0% | 6.6% 6.9% 6.7% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | --- 567 --- | 435 659 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.729 P=0.509 (e) | P=0.577N P=0.642 P=0.657 |
|POLY 3 | P=0.718 P=0.499 (e) | P=0.577 P=0.639 P=0.656 |
|POLY 1.5 | P=0.724 P=0.500 (e) | P=0.579 P=0.649 P=0.658 |
|POLY 6 | P=0.710 P=0.496 (e) | P=0.579 P=0.624 P=0.659 |
|LOGISTIC REGRESSION| P=0.704N P=0.578 (e) | P=0.551 P=0.650 P=0.629 |
|COCH-ARM / FISHERS | P=0.728N P=0.505 (e) | P=0.583 P=0.661N P=0.661N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/50 (2%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 2.2% 7.0% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/41 (7%) 1/35 (3%) 3/34 (9%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510 P=0.363N P=0.574 | (e) (e) (e) |
|POLY 3 | P=0.580 P=0.312N P=0.630 | (e) (e) (e) |
|POLY 1.5 | P=0.589 P=0.307N P=0.647 | (e) (e) (e) |
|POLY 6 | P=0.568 P=0.320N P=0.608 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.510 P=0.363N P=0.574 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.585N P=0.301N P=0.651N | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/49 (76%) 39/50 (78%) 28/50 (56%) | 9/50 (18%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 80.9% 84.4% 62.5% | 20.1% 4.7% 4.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 36/41 (88%) 32/35 (91%) 22/34 (65%) | 4/34 (12%) 2/30 (7%) 2/35 (6%) |
|FIRST INCIDENCE | 695 567 468 | 562 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.046 * P=0.311N | P=0.012N* P=0.045N* P=0.031N* |
|POLY 3 | P=0.021N* P=0.428 P=0.035N* | P=0.010N* P=0.030N* P=0.028N* |
|POLY 1.5 | P=0.020N* P=0.434 P=0.032N* | P=0.009N** P=0.027N* P=0.026N* |
|POLY 6 | P=0.024N* P=0.409 P=0.040N* | P=0.010N* P=0.035N* P=0.029N* |
|LOGISTIC REGRESSION| P=0.086N P=0.220 P=0.108N | P=0.010N* P=0.028N* P=0.027N* |
|COCH-ARM / FISHERS | P=0.022N* P=0.478 P=0.033N* | P=0.010N* P=0.026N* P=0.026N* |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/49 (90%) 38/50 (76%) 38/50 (76%) | 11/50 (22%) 6/50 (12%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 93.9% 81.5% 84.1% | 25.0% 13.8% 36.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 40/41 (98%) 32/35 (91%) 29/34 (85%) | 10/34 (29%) 4/30 (13%) 14/35 (40%) |
|FIRST INCIDENCE | 452 547 577 | 562 624 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.596N P=0.471 | P=0.156 P=0.200N P=0.198 |
|POLY 3 | P=0.086N P=0.049N* P=0.096N | P=0.134 P=0.144N P=0.185 |
|POLY 1.5 | P=0.070N P=0.055N P=0.076N | P=0.136 P=0.142N P=0.186 |
|POLY 6 | P=0.103N P=0.048N* P=0.124N | P=0.136 P=0.150N P=0.190 |
|LOGISTIC REGRESSION| P=0.179N P=0.065N P=0.188N | P=0.139 P=0.151N P=0.183 |
|COCH-ARM / FISHERS | P=0.055N P=0.059N P=0.059N | P=0.139 P=0.143N P=0.184 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) | 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 6.7% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- --- | 562 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.040N* P=0.128N P=0.128N |
|POLY 3 | (e) (e) (e) | P=0.036N* P=0.126N P=0.123N |
|POLY 1.5 | (e) (e) (e) | P=0.036N* P=0.122N P=0.120N |
|POLY 6 | (e) (e) (e) | P=0.037N* P=0.133N P=0.125N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.039N* P=0.123N P=0.128N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.037N* P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 3/50 (6%) 3/50 (6%) | 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 8.8% 6.7% 6.9% | 0.0% 2.3% 2.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 4/41 (10%) 3/35 (9%) 1/34 (3%) | 0/34 (0%) 0/30 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 537 | --- 704 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.512N P=0.586N P=0.587N | P=0.342 P=0.483 P=0.506 |
|POLY 3 | P=0.448N P=0.510N P=0.528N | P=0.333 P=0.497 P=0.501 |
|POLY 1.5 | P=0.433N P=0.503N P=0.512N | P=0.334 P=0.499 P=0.501 |
|POLY 6 | P=0.468N P=0.522N P=0.547N | P=0.335 P=0.494 P=0.502 |
|LOGISTIC REGRESSION| P=0.437N P=0.586N P=0.496N | P=0.334 P=0.498 P=0.506 |
|COCH-ARM / FISHERS | P=0.410N P=0.489N P=0.489N | P=0.331 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 7/50 (14%) 8/50 (16%) | 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 8.8% 15.6% 18.8% | 6.9% 4.7% 6.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 4/41 (10%) 7/35 (20%) 8/34 (24%) | 2/34 (6%) 2/30 (7%) 3/35 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) | 682 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 P=0.176 P=0.098 | P=0.574N P=0.553N P=0.651N |
|POLY 3 | P=0.116 P=0.251 P=0.144 | P=0.587 P=0.509N P=0.662 |
|POLY 1.5 | P=0.131 P=0.258 P=0.161 | P=0.587N P=0.503N P=0.661N |
|POLY 6 | P=0.098 P=0.237 P=0.124 | P=0.588 P=0.521N P=0.663 |
|LOGISTIC REGRESSION| P=0.075 P=0.176 P=0.098 | P=0.579N P=0.526N P=0.658N |
|COCH-ARM / FISHERS | P=0.155 P=0.274 P=0.188 | P=0.588 P=0.500N P=0.661N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 9/50 (18%) 9/50 (18%) | 15/50 (30%) 13/50 (26%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 26.2% 19.8% 21.1% | 33.5% 29.2% 31.8% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 11/41 (27%) 7/35 (20%) 8/34 (24%) | 11/34 (32%) 8/30 (27%) 12/35 (34%) |
|FIRST INCIDENCE | 699 547 691 | 562 501 673 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.436N P=0.450N P=0.496N | P=0.430N P=0.529N P=0.471N |
|POLY 3 | P=0.319N P=0.315N P=0.374N | P=0.476N P=0.416N P=0.523N |
|POLY 1.5 | P=0.290N P=0.309N P=0.340N | P=0.465N P=0.410N P=0.510N |
|POLY 6 | P=0.357N P=0.330N P=0.419N | P=0.484N P=0.432N P=0.531N |
|LOGISTIC REGRESSION| P=0.362N P=0.331N P=0.467N | P=0.451N P=0.418N P=0.495N |
|COCH-ARM / FISHERS | P=0.249N P=0.294N P=0.294N | P=0.456N P=0.412N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.5% 0.0% 0.0% | 0.0% 2.3% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/41 (2%) 0/35 (0%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 456 --- --- | --- 682 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.139N P=0.148N | P=0.727 P=0.484 (e) |
|POLY 3 | P=0.039N* P=0.126N P=0.135N | P=0.729N P=0.498 (e) |
|POLY 1.5 | P=0.037N* P=0.122N P=0.127N | P=0.729N P=0.500 (e) |
|POLY 6 | P=0.042N* P=0.131N P=0.146N | P=0.729N P=0.494 (e) |
|LOGISTIC REGRESSION| P=0.024N* P=0.082N P=0.073N | P=0.730 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.036N* P=0.117N P=0.117N | P=0.731 P=0.500 (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 15/50 (30%) 10/50 (20%) | 8/50 (16%) 8/50 (16%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 8.8% 33.5% 23.5% | 18.2% 18.3% 16.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 4/41 (10%) 15/35 (43%) 10/34 (29%) | 6/34 (18%) 5/30 (17%) 7/35 (20%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) | 621 584 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P<0.001 ** P=0.031 * | P=0.423N P=0.522 P=0.476N |
|POLY 3 | P=0.046 * P=0.003 ** P=0.053 | P=0.450N P=0.604 P=0.506N |
|POLY 1.5 | P=0.060 P=0.004 ** P=0.063 | P=0.446N P=0.607N P=0.501N |
|POLY 6 | P=0.032 * P=0.002 ** P=0.043 * | P=0.452N P=0.593 P=0.508N |
|LOGISTIC REGRESSION| P=0.027 * P<0.001 ** P=0.031 * | P=0.439N P=0.594 P=0.490N |
|COCH-ARM / FISHERS | P=0.089 P=0.005 ** P=0.080 | P=0.445N P=0.607N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 1/50 (2%) 9/50 (18%) | 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 14.8% 2.2% 19.6% | 4.6% 2.3% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/41 (7%) 0/35 (0%) 1/34 (3%) | 0/34 (0%) 1/30 (3%) 0/35 (0%) |
|FIRST INCIDENCE | 452 720 468 | 654 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.263 P=0.050N P=0.321 | P=0.146N P=0.541N P=0.237N |
|POLY 3 | P=0.309 P=0.036N* P=0.370 | P=0.143N P=0.508N P=0.238N |
|POLY 1.5 | P=0.316 P=0.033N* P=0.383 | P=0.142N P=0.503N P=0.237N |
|POLY 6 | P=0.302 P=0.041N* P=0.356 | P=0.143N P=0.518N P=0.238N |
|LOGISTIC REGRESSION| P=0.453 P=0.020N* P=0.611N | P=0.142N P=0.503N P=0.237N |
|COCH-ARM / FISHERS | P=0.331 P=0.028N* P=0.410 | P=0.142N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.6% 0.0% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 0/34 (0%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- 621 --- | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.596 P=0.106 (e) | (e) (e) (e) |
|POLY 3 | P=0.604 P=0.117 (e) | (e) (e) (e) |
|POLY 1.5 | P=0.622 P=0.119 (e) | (e) (e) (e) |
|POLY 6 | P=0.581 P=0.114 (e) | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.636N P=0.125 (e) | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.634N P=0.125 (e) | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 3/50 (6%) 8/50 (16%) | 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 11.0% 6.7% 18.7% | 4.5% 0.0% 2.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 5/41 (12%) 1/35 (3%) 7/34 (21%) | 1/34 (3%) 0/30 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) 712 691 | 471 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131 P=0.441N P=0.167 | P=0.358N P=0.253N P=0.493N |
|POLY 3 | P=0.186 P=0.365N P=0.234 | P=0.363N P=0.244N P=0.505N |
|POLY 1.5 | P=0.199 P=0.359N P=0.256 | P=0.362N P=0.241N P=0.502N |
|POLY 6 | P=0.171 P=0.376N P=0.208 | P=0.364N P=0.250N P=0.505N |
|LOGISTIC REGRESSION| P=0.136 P=0.396N P=0.176 | P=0.369N P=0.245N P=0.511N |
|COCH-ARM / FISHERS | P=0.219 P=0.346N P=0.290 | P=0.360N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/46 (0%) 0/47 (0%) | 1/49 (2%) 2/49 (4%) 3/47 (6%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% | 2.4% 4.8% 7.1% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/41 (2%) 0/32 (0%) 0/34 (0%) | 1/34 (3%) 2/29 (7%) 3/34 (9%) |
|FIRST INCIDENCE | 729 (T) --- --- | 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301N P=0.549N P=0.537N | P=0.226 P=0.444 P=0.304 |
|POLY 3 | P=0.287N P=0.519N P=0.518N | P=0.220 P=0.494 P=0.301 |
|POLY 1.5 | P=0.281N P=0.515N P=0.513N | P=0.217 P=0.498 P=0.299 |
|POLY 6 | P=0.294N P=0.524N P=0.526N | P=0.223 P=0.486 P=0.305 |
|LOGISTIC REGRESSION| P=0.301N (e) (e) | P=0.226 P=0.444 P=0.304 |
|COCH-ARM / FISHERS | P=0.273N P=0.511N P=0.505N | P=0.209 P=0.500 P=0.293 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/48 (0%) 2/48 (4%) | 0/49 (0%) 0/47 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 0.0% 4.9% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/40 (3%) 0/34 (0%) 2/32 (6%) | 0/34 (0%) 0/28 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.303 P=0.532N P=0.422 | (e) (e) (e) |
|POLY 3 | P=0.360 P=0.503N P=0.469 | (e) (e) (e) |
|POLY 1.5 | P=0.362 P=0.499N P=0.484 | (e) (e) (e) |
|POLY 6 | P=0.357 P=0.508N P=0.451 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.303 (e) P=0.422 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.495N P=0.508 | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 0/48 (0%) 0/48 (0%) | 1/49 (2%) 0/47 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% | 2.3% 0.0% 4.7% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/40 (5%) 0/34 (0%) 0/32 (0%) | 1/34 (3%) 0/28 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 729 (T) --- --- | 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121N P=0.275N P=0.289N | P=0.364 P=0.539N P=0.500 |
|POLY 3 | P=0.102N P=0.240N P=0.258N | P=0.360 P=0.515N P=0.495 |
|POLY 1.5 | P=0.098N P=0.236N P=0.247N | P=0.361 P=0.512N P=0.498 |
|POLY 6 | P=0.107N P=0.246N P=0.270N | P=0.360 P=0.520N P=0.495 |
|LOGISTIC REGRESSION| P=0.121N (e) (e) | P=0.364 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.093N P=0.242N P=0.242N | P=0.361 P=0.510N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/4 (0%) 0/4 (0%) 0/3 (0%) | 2/12 (17%) 2/7 (29%) 1/9 (11%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 17.8% 30.5% 13.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/2 (0%) 0/3 (0%) 0/3 (0%) | 1/8 (13%) 2/5 (40%) 1/6 (17%) |
|FIRST INCIDENCE | --- --- --- | 578 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.482N P=0.569 P=0.568N |
|POLY 3 | (e) (e) (e) | P=0.580N P=0.488 P=0.647N |
|POLY 1.5 | (e) (e) (e) | P=0.555N P=0.489 P=0.632N |
|POLY 6 | (e) (e) (e) | P=0.604N P=0.482 P=0.662N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.523N P=0.454 P=0.599N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.508N P=0.475 P=0.612N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/4 (50%) 3/4 (75%) 2/3 (67%) | 9/12 (75%) 5/7 (71%) 5/9 (56%) |
|POLY-3 ADJUSTED (b)| 63.3% 75.7% 66.7% | 78.6% 71.4% 64.8% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/2 (100%) 3/3 (100%) 2/3 (67%) | 7/8 (88%) 3/5 (60%) 4/6 (67%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) | 562 659 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=1.000N P=0.581N | P=0.208N P=0.421N P=0.271N |
|POLY 3 | P=0.645 P=0.665 P=0.750 | P=0.352N P=0.582N P=0.444N |
|POLY 1.5 | P=0.571 P=0.597 P=0.695 | P=0.320N P=0.607N P=0.402N |
|POLY 6 | P=0.639N P=0.743 P=0.759N | P=0.373N P=0.546N P=0.475N |
|LOGISTIC REGRESSION| P=0.315N P=1.000N P=0.581N | P=0.316N P=0.628N P=0.418N |
|COCH-ARM / FISHERS | P=0.457 P=0.500 P=0.629 | P=0.245N P=0.634N P=0.319N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 5/51 (10%) 0/50 (0%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| | 11.3% 0.0% 11.2% |
|INT SACRIFICE 1 (c)| | 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | | 3/34 (9%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | | 562 --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.568N P=0.045N* P=0.617N |
|POLY 3 | | P=0.579 P=0.033N* P=0.626N |
|POLY 1.5 | | P=0.577 P=0.032N* P=0.627N |
|POLY 6 | | P=0.581N P=0.036N* P=0.620N |
|LOGISTIC REGRESSION| | P=0.570 P=0.034N* P=0.620 |
|COCH-ARM / FISHERS | | P=0.569 P=0.030N* P=0.617 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 8/51 (16%) 11/50 (22%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| | 17.8% 25.3% 30.9% |
|INT SACRIFICE 1 (c)| | 1/1 (100%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | | 6/34 (18%) 9/30 (30%) 11/35 (31%) |
|FIRST INCIDENCE | | 94 (I) 585 369 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.069 P=0.153 P=0.082 |
|POLY 3 | | P=0.092 P=0.276 P=0.113 |
|POLY 1.5 | | P=0.091 P=0.285 P=0.111 |
|POLY 6 | | P=0.095 P=0.260 P=0.117 |
|LOGISTIC REGRESSION| | P=0.084 P=0.289 P=0.095 |
|COCH-ARM / FISHERS | | P=0.084 P=0.289 P=0.104 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/51 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| | 0.0% 0.0% 6.8% |
|INT SACRIFICE 1 (c)| | 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | | 0/34 (0%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | | --- --- 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.040 * (e) P=0.124 |
|POLY 3 | | P=0.036 * (e) P=0.121 |
|POLY 1.5 | | P=0.036 * (e) P=0.121 |
|POLY 6 | | P=0.036 * (e) P=0.123 |
|LOGISTIC REGRESSION| | P=0.035 * (e) P=0.114 |
|COCH-ARM / FISHERS | | P=0.036 * (e) P=0.118 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/47 (0%) 0/50 (0%) | 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 9.2% 0.0% 2.3% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/33 (0%) 0/34 (0%) | 4/34 (12%) 0/30 (0%) 1/35 (3%) |
|FIRST INCIDENCE | --- --- --- | 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.081N P=0.079N P=0.170N |
|POLY 3 | (e) (e) (e) | P=0.079N P=0.062N P=0.177N |
|POLY 1.5 | (e) (e) (e) | P=0.079N P=0.061N P=0.177N |
|POLY 6 | (e) (e) (e) | P=0.079N P=0.064N P=0.175N |
|LOGISTIC REGRESSION| (e) (e) (e) | P=0.081N (e) P=0.170N |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.082N P=0.059N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/47 (0%) 1/50 (2%) | 9/50 (18%) 6/50 (12%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.3% | 20.2% 13.8% 16.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/41 (2%) 0/33 (0%) 1/34 (3%) | 6/34 (18%) 4/30 (13%) 6/35 (17%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) | 562 585 692 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624 P=0.543N P=0.720 | P=0.326N P=0.355N P=0.379N |
|POLY 3 | P=0.668 P=0.513N P=0.745 | P=0.348N P=0.302N P=0.408N |
|POLY 1.5 | P=0.669 P=0.510N P=0.753 | P=0.341N P=0.293N P=0.399N |
|POLY 6 | P=0.667 P=0.518N P=0.734 | P=0.355N P=0.320N P=0.415N |
|LOGISTIC REGRESSION| P=0.624 (e) P=0.720 | P=0.333N P=0.289N P=0.389N |
|COCH-ARM / FISHERS | P=0.663N P=0.510N P=0.747N | P=0.336N P=0.288N P=0.393N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/48 (35%) 12/50 (24%) 10/50 (20%) | |
|POLY-3 ADJUSTED (b)| 38.0% 26.3% 23.4% | |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | |
|TERMINAL (d) | 16/40 (40%) 10/35 (29%) 9/34 (27%) | |
|FIRST INCIDENCE | 691 547 660 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157N P=0.312N P=0.190N | |
|POLY 3 | P=0.079N P=0.167N P=0.103N | |
|POLY 1.5 | P=0.067N P=0.164N P=0.087N | |
|POLY 6 | P=0.098N P=0.178N P=0.128N | |
|LOGISTIC REGRESSION| P=0.105N P=0.189N P=0.157N | |
|COCH-ARM / FISHERS | P=0.054N P=0.155N P=0.069N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 11.1% 2.2% 4.7% | |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | |
|TERMINAL (d) | 3/40 (8%) 1/35 (3%) 2/34 (6%) | |
|FIRST INCIDENCE | 667 729 (T) 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186N P=0.137N P=0.294N | |
|POLY 3 | P=0.139N P=0.102N P=0.239N | |
|POLY 1.5 | P=0.131N P=0.099N P=0.222N | |
|POLY 6 | P=0.150N P=0.109N P=0.262N | |
|LOGISTIC REGRESSION| P=0.147N P=0.099N P=0.237N | |
|COCH-ARM / FISHERS | P=0.122N P=0.093N P=0.201N | |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 4.5% 0.0% | |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 0/34 (0%) | |
|FIRST INCIDENCE | --- 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.626 P=0.204 (e) | |
|POLY 3 | P=0.643 P=0.233 (e) | |
|POLY 1.5 | P=0.656 P=0.236 (e) | |
|POLY 6 | P=0.626 P=0.228 (e) | |
|LOGISTIC REGRESSION| (e) P=0.204 (e) | |
|COCH-ARM / FISHERS | P=0.665N P=0.253 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 0/55 (0%) 2/55 (4%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.7% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 2/34 (6%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 (e) P=0.198 | (e) (e) (e) |
|POLY 3 | P=0.095 (e) P=0.222 | (e) (e) (e) |
|POLY 1.5 | P=0.095 (e) P=0.230 | (e) (e) (e) |
|POLY 6 | P=0.095 (e) P=0.213 | (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.198 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097 (e) P=0.252 | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Dermis, Skin, Site of Application |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 39/55 (71%) 55/55 (100%) | 0/55 (0%) 44/55 (80%) 53/55 (96%) |
|POLY-3 ADJUSTED (b)| 0.0% 74.0% 100.0% | 0.0% 84.2% 99.8% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 4/5 (80%) 4/5 (80%) |
|TERMINAL (d) | 0/41 (0%) 24/35 (69%) 34/34 (100%) | 0/34 (0%) 23/30 (77%) 35/35 (100%) |
|FIRST INCIDENCE | --- 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-------------------| | |
|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 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/54 (2%) 45/55 (82%) 52/55 (95%) | 0/55 (0%) 48/55 (87%) 54/55 (98%) |
|POLY-3 ADJUSTED (b)| 2.2% 83.4% 94.5% | 0.0% 91.1% 100.0% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 4/5 (80%) |
|TERMINAL (d) | 1/41 (2%) 29/35 (83%) 31/34 (91%) | 0/34 (0%) 28/30 (93%) 35/35 (100%) |
|FIRST INCIDENCE | 729 (T) 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-------------------| | |
|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: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 0/55 (0%) 4/55 (7%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 9.2% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 1/5 (20%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 3/34 (9%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 94 (I) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * (e) P=0.048 * | (e) (e) (e) |
|POLY 3 | P=0.013 * (e) P=0.055 | (e) (e) (e) |
|POLY 1.5 | P=0.014 * (e) P=0.059 | (e) (e) (e) |
|POLY 6 | P=0.013 * (e) P=0.050 | (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.016 * (e) P=0.069 | (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.015 * (e) P=0.061 | (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis, Skin, Site of Application |
| Parakeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 3/55 (5%) 12/55 (22%) | 0/55 (0%) 0/55 (0%) 4/55 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.5% 24.9% | 0.0% 0.0% 8.9% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 1/5 (20%) 4/5 (80%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 5/34 (15%) | 0/34 (0%) 0/30 (0%) 2/35 (6%) |
|FIRST INCIDENCE | --- 94 (I) 94 (I) | --- --- 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.105 P<0.001 ** | P=0.017 * (e) P=0.069 |
|POLY 3 | P<0.001 ** P=0.120 P<0.001 ** | P=0.014 * (e) P=0.065 |
|POLY 1.5 | P<0.001 ** P=0.122 P<0.001 ** | P=0.014 * (e) P=0.063 |
|POLY 6 | P<0.001 ** P=0.116 P<0.001 ** | P=0.015 * (e) P=0.067 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.128 P<0.001 ** | P=0.015 * (e) P=0.063 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.125 P<0.001 ** | P=0.015 * (e) P=0.059 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland, Skin, Site of Application |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/54 (2%) 26/55 (47%) 39/55 (71%) | 0/55 (0%) 44/55 (80%) 51/55 (93%) |
|POLY-3 ADJUSTED (b)| 2.2% 49.9% 75.3% | 0.0% 85.5% 96.2% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 5/5 (100%) |
|TERMINAL (d) | 1/41 (2%) 17/35 (49%) 25/34 (74%) | 0/34 (0%) 27/30 (90%) 35/35 (100%) |
|FIRST INCIDENCE | 729 (T) 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-------------------| | |
|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 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Exudate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/54 (2%) 3/55 (5%) 9/55 (16%) | 0/55 (0%) 0/55 (0%) 6/55 (11%) |
|POLY-3 ADJUSTED (b)| 2.2% 6.7% 20.6% | 0.0% 0.0% 13.5% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 0/5 (0%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/41 (0%) 2/35 (6%) 7/34 (21%) | 0/34 (0%) 0/30 (0%) 5/35 (14%) |
|FIRST INCIDENCE | 667 660 488 | --- --- 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.267 P=0.006 ** | P=0.003 ** (e) P=0.020 * |
|POLY 3 | P=0.003 ** P=0.299 P=0.006 ** | P=0.002 ** (e) P=0.016 * |
|POLY 1.5 | P=0.003 ** P=0.304 P=0.007 ** | P=0.002 ** (e) P=0.016 * |
|POLY 6 | P=0.002 ** P=0.291 P=0.005 ** | P=0.002 ** (e) P=0.017 * |
|LOGISTIC REGRESSION| P=0.003 ** P=0.304 P=0.009 ** | P=0.003 ** (e) P=0.018 * |
|COCH-ARM / FISHERS | P=0.004 ** P=0.316 P=0.009 ** | P=0.003 ** (e) P=0.014 * |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/54 (2%) 42/55 (76%) 41/55 (75%) | 0/55 (0%) 38/55 (69%) 45/55 (82%) |
|POLY-3 ADJUSTED (b)| 2.2% 78.3% 76.4% | 0.0% 77.1% 87.3% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 4/5 (80%) 4/5 (80%) | 0/5 (0%) 2/5 (40%) 3/5 (60%) |
|TERMINAL (d) | 0/41 (0%) 24/35 (69%) 22/34 (65%) | 0/34 (0%) 22/30 (73%) 29/35 (83%) |
|FIRST INCIDENCE | 667 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-------------------| | |
|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 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/54 (0%) 0/55 (0%) 8/55 (15%) | 0/55 (0%) 0/55 (0%) 0/55 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 17.8% | 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/5 (0%) 0/5 (0%) 1/5 (20%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 4/34 (12%) | 0/34 (0%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | --- --- 94 (I) | --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.004 ** | (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) P=0.003 ** | (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) P=0.004 ** | (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) P=0.003 ** | (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.006 ** | (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.003 ** | (e) (e) (e) |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/49 (20%) 12/50 (24%) 16/50 (32%) | 22/50 (44%) 27/50 (54%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 21.8% 25.5% 34.7% | 46.6% 58.5% 32.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 8/41 (20%) 4/35 (11%) 7/34 (21%) | 14/34 (41%) 17/30 (57%) 8/35 (23%) |
|FIRST INCIDENCE | 691 547 488 | 435 501 386 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 P=0.313 P=0.072 | P=0.115N P=0.148 P=0.126N |
|POLY 3 | P=0.103 P=0.432 P=0.126 | P=0.105N P=0.168 P=0.119N |
|POLY 1.5 | P=0.106 P=0.425 P=0.130 | P=0.097N P=0.186 P=0.112N |
|POLY 6 | P=0.101 P=0.436 P=0.124 | P=0.107N P=0.148 P=0.122N |
|LOGISTIC REGRESSION| P=0.133 P=0.432 P=0.156 | P=0.095N P=0.212 P=0.109N |
|COCH-ARM / FISHERS | P=0.113 P=0.426 P=0.140 | P=0.094N P=0.212 P=0.107N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 2/50 (4%) | 4/50 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.2% 4.7% | 9.2% 7.0% 11.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 1/35 (3%) 1/34 (3%) | 4/34 (12%) 3/30 (10%) 4/35 (11%) |
|FIRST INCIDENCE | --- 729 (T) 638 | 730 (T) 730 (T) 637 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.121 P=0.468 P=0.209 | P=0.445 P=0.569N P=0.518 |
|POLY 3 | P=0.136 P=0.497 P=0.224 | P=0.433 P=0.508N P=0.507 |
|POLY 1.5 | P=0.139 P=0.499 P=0.231 | P=0.431 P=0.502N P=0.505 |
|POLY 6 | P=0.131 P=0.492 P=0.215 | P=0.439 P=0.520N P=0.513 |
|LOGISTIC REGRESSION| P=0.139 P=0.468 P=0.247 | P=0.436 P=0.569N P=0.506 |
|COCH-ARM / FISHERS | P=0.145 P=0.505 P=0.253 | P=0.427 P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/50 (4%) 1/50 (2%) | 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.4% 2.3% | 0.0% 6.9% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/41 (0%) 0/35 (0%) 1/34 (3%) | 0/34 (0%) 2/30 (7%) 0/35 (0%) |
|FIRST INCIDENCE | --- 686 729 (T) | --- 624 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.224 P=0.463 | P=0.629N P=0.111 (e) |
|POLY 3 | P=0.337 P=0.234 P=0.486 | P=0.640N P=0.117 (e) |
|POLY 1.5 | P=0.349 P=0.237 P=0.494 | P=0.639N P=0.119 (e) |
|POLY 6 | P=0.322 P=0.231 P=0.477 | P=0.638N P=0.114 (e) |
|LOGISTIC REGRESSION| P=0.348 P=0.242 P=0.463 | P=0.639N P=0.120 (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.253 P=0.505 | P=0.640 P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/50 (0%) 1/50 (2%) | 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 0.0% 2.3% | 2.3% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/41 (7%) 0/35 (0%) 1/34 (3%) | 1/34 (3%) 0/30 (0%) 0/35 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) | 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.150N P=0.374N | P=0.271N P=0.525N P=0.494N |
|POLY 3 | P=0.183N P=0.122N P=0.330N | P=0.270N P=0.503N P=0.499N |
|POLY 1.5 | P=0.178N P=0.120N P=0.317N | P=0.270N P=0.501N P=0.499N |
|POLY 6 | P=0.190N P=0.126N P=0.347N | P=0.270N P=0.507N P=0.498N |
|LOGISTIC REGRESSION| P=0.222N (e) P=0.374N | P=0.271N (e) (e) |
|COCH-ARM / FISHERS | P=0.171N P=0.117N P=0.301N | P=0.269N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 4.7% | 0.0% 0.0% 4.6% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/41 (2%) 0/35 (0%) 2/34 (6%) | 0/34 (0%) 0/30 (0%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) | --- --- 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.532N P=0.435 | P=0.107 (e) P=0.249 |
|POLY 3 | P=0.360 P=0.503N P=0.476 | P=0.095 (e) P=0.238 |
|POLY 1.5 | P=0.363 P=0.501N P=0.489 | P=0.095 (e) P=0.238 |
|POLY 6 | P=0.358 P=0.508N P=0.460 | P=0.095 (e) P=0.239 |
|LOGISTIC REGRESSION| P=0.312 (e) P=0.435 | P=0.101 (e) P=0.241 |
|COCH-ARM / FISHERS | P=0.366 P=0.495N P=0.508 | P=0.095 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 2.2% 6.6% 0.0% | |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | |
|TERMINAL (d) | 1/41 (2%) 0/35 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 729 (T) 621 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432N P=0.277 P=0.537N | |
|POLY 3 | P=0.423N P=0.303 P=0.514N | |
|POLY 1.5 | P=0.402N P=0.306 P=0.506N | |
|POLY 6 | P=0.450N P=0.298 P=0.523N | |
|LOGISTIC REGRESSION| P=0.374N P=0.314 (e) | |
|COCH-ARM / FISHERS | P=0.372N P=0.316 P=0.495N | |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/45 (11%) 0/36 (0%) 5/39 (13%) | 6/41 (15%) 4/45 (9%) 5/47 (11%) |
|POLY-3 ADJUSTED (b)| 11.5% 0.0% 13.7% | 15.3% 9.8% 11.7% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/38 (3%) 0/28 (0%) 0/29 (0%) | 0/31 (0%) 0/28 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 456 --- 416 | 150 240 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519 P=0.050N P=0.556 | P=0.433N P=0.380N P=0.498N |
|POLY 3 | P=0.486 P=0.063N P=0.515 | P=0.375N P=0.342N P=0.439N |
|POLY 1.5 | P=0.491 P=0.059N P=0.523 | P=0.365N P=0.328N P=0.428N |
|POLY 6 | P=0.480 P=0.067N P=0.506 | P=0.384N P=0.367N P=0.450N |
|LOGISTIC REGRESSION| P=0.496N P=0.033N* P=0.462N | P=0.356N P=0.333N P=0.429N |
|COCH-ARM / FISHERS | P=0.500 P=0.048N* P=0.536 | P=0.346N P=0.311N P=0.403N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 0/36 (0%) 0/39 (0%) | 0/41 (0%) 2/45 (4%) 2/47 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% | 0.0% 5.2% 4.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/38 (0%) 0/28 (0%) 0/29 (0%) | 0/31 (0%) 2/28 (7%) 2/33 (6%) |
|FIRST INCIDENCE | --- --- --- | --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) | P=0.194 P=0.216 P=0.252 |
|POLY 3 | (e) (e) (e) | P=0.207 P=0.255 P=0.269 |
|POLY 1.5 | (e) (e) (e) | P=0.208 P=0.258 P=0.270 |
|POLY 6 | (e) (e) (e) | P=0.205 P=0.249 P=0.268 |
|LOGISTIC REGRESSION| (e) (e) (e) | (e) P=0.216 P=0.252 |
|COCH-ARM / FISHERS | (e) (e) (e) | P=0.205 P=0.271 P=0.282 |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 7/50 (14%) 9/50 (18%) | 14/50 (28%) 15/50 (30%) 15/50 (30%) |
|POLY-3 ADJUSTED (b)| 17.5% 15.6% 21.1% | 32.2% 34.2% 34.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 8/41 (20%) 7/35 (20%) 9/34 (27%) | 13/34 (38%) 11/30 (37%) 14/35 (40%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) | 719 616 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286 P=0.593 P=0.331 | P=0.494 P=0.357 P=0.540 |
|POLY 3 | P=0.394 P=0.515N P=0.438 | P=0.459 P=0.512 P=0.504 |
|POLY 1.5 | P=0.422 P=0.504N P=0.471 | P=0.461 P=0.510 P=0.505 |
|POLY 6 | P=0.359 P=0.534N P=0.396 | P=0.464 P=0.510 P=0.510 |
|LOGISTIC REGRESSION| P=0.286 P=0.593 P=0.331 | P=0.475 P=0.436 P=0.543 |
|COCH-ARM / FISHERS | P=0.463 P=0.483N P=0.518 | P=0.456 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 0/50 (0%) 0/50 (0%) 9/50 (18%) |
|POLY-3 ADJUSTED (b)| | 0.0% 0.0% 20.6% |
|INT SACRIFICE 1 (c)| | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | | 0/34 (0%) 0/30 (0%) 8/35 (23%) |
|FIRST INCIDENCE | | --- --- 723 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P<0.001 ** (e) P=0.003 ** |
|POLY 3 | | P<0.001 ** (e) P=0.002 ** |
|POLY 1.5 | | P<0.001 ** (e) P=0.002 ** |
|POLY 6 | | P<0.001 ** (e) P=0.002 ** |
|LOGISTIC REGRESSION| | P<0.001 ** (e) P=0.003 ** |
|COCH-ARM / FISHERS | | P<0.001 ** (e) P<0.001 ** |
|=================================================================================================================================|
Date: 09/30/97 EXPERIMENT: 91014 TEST: 04 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - OLEIC ACID DIETHANOLAMINE CONDENSATE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 35/50 (70%) 20/50 (40%) 28/50 (56%) |
|POLY-3 ADJUSTED (b)| | 76.5% 44.5% 61.6% |
|INT SACRIFICE 1 (c)| | 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | | 28/34 (82%) 13/30 (43%) 22/35 (63%) |
|FIRST INCIDENCE | | 562 584 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.094N P=0.018N* P=0.097N |
|POLY 3 | | P=0.075N P<0.001N** P=0.086N |
|POLY 1.5 | | P=0.077N P<0.001N** P=0.089N |
|POLY 6 | | P=0.068N P<0.001N** P=0.078N |
|LOGISTIC REGRESSION| | P=0.084N P=0.002N** P=0.091N |
|COCH-ARM / FISHERS | | P=0.096N P=0.002N** P=0.107N |
|=================================================================================================================================|
(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).