TDMS Study 05162-10 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIETHANOLAMINE DATE: 06/20/97
EXPERIMENT: 05162 TEST: 10 TIME: 09:32:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: PERSING, R. CAS: 111-42-2
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 DIETHANOLAMINE DATE: 06/20/97
EXPERIMENT: 05162 TEST: 10 TIME: 09:32:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: N01-ES-05293 ROUTE: SKIN APPLICATION NTP C#: 55174D
PATHOLOGIST: PERSING, R. CAS: 111-42-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIETHANOLAMINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Heart: Atrium Thrombosis
Kidney Nephropathy
Kidney: Cortex Cyst
Kidney: Glomerulus Dilatation Focal
Kidney: Renal Tubule Mineralization
Liver Necrosis
Syncytial Alteration
Liver: Centrilobular Cytoplasmic Alteration
Lymph Node, Mesenteric Necrosis
Salivary Glands: Duct Cytoplasmic Alteration
Skin: Skin, Site of Application Acanthosis
Exudate
Hyperkeratosis
Spleen Hematopoietic Cell Proliferation
Thymus Atrophy
Thyroid Gland: Follicular Cell Hyperplasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hemorrhage
Bone Marrow Myelofibrosis
Heart: Atrium Thrombosis
Kidney Nephropathy
Kidney: Renal Tubule Mineralization
Liver Eosinophilic Focus
Syncytial Alteration
Lymph Node, Mandibular Necrosis
Lymph Node, Mesenteric Necrosis
Ovary Atrophy
Ovary: Follicle Cyst
Skin: Skin, Site of Application Exudate
Hyperkeratosis
Spleen Hematopoietic Cell Proliferation
Stomach, Forestomach Hyperplasia Focal
Stomach, Glandular Necrosis Focal
Thymus Atrophy
Necrosis
Thyroid Gland: Follicular Cell Hyperplasia
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 9.2% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 633 607 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.003 ** (e) P=0.469 P=0.026 * |
|POLY 3 | (e) (e) (e) (e) |P=0.005 ** (e) P=0.484 P=0.049 * |
|POLY 1.5 | (e) (e) (e) (e) |P=0.005 ** (e) P=0.491 P=0.054 |
|POLY 6 | (e) (e) (e) (e) |P=0.004 ** (e) P=0.475 P=0.041 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.006 ** (e) P=0.607 P=0.075 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.006 ** (e) P=0.500 P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 6.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 1/34 (3%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 674 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * (e) P=0.468 P=0.089 |(e) (e) (e) (e) |
|POLY 3 | P=0.017 * (e) P=0.497 P=0.113 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.018 * (e) P=0.499 P=0.115 |(e) (e) (e) (e) |
|POLY 6 | P=0.016 * (e) P=0.493 P=0.110 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.017 * (e) P=0.468 P=0.114 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.020 * (e) P=0.500 P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 8/50 (16%) 4/50 (8%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 13.1% 16.6% 8.7% 15.6% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 6/40 (15%) 7/43 (16%) 3/34 (9%) 6/30 (20%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 729 (T) 692 445 230 |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313 P=0.446 P=0.463N P=0.302 |P=0.131 (e) (e) P=0.371 |
|POLY 3 | P=0.520 P=0.428 P=0.368N P=0.487 |P=0.192 (e) (e) P=0.478 |
|POLY 1.5 | P=0.531 P=0.413 P=0.366N P=0.494 |P=0.196 (e) (e) P=0.488 |
|POLY 6 | P=0.501 P=0.445 P=0.378N P=0.474 |P=0.183 (e) (e) P=0.461 |
|LOGISTIC REGRESSION| P=0.557N P=0.450 P=0.370N P=0.505 |(e) (e) (e) P=0.371 |
|COCH-ARM / FISHERS | P=0.543 P=0.387 P=0.370N P=0.500 |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Capsule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 5/50 (10%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 12.5% 11.0% 6.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 6/43 (14%) 3/34 (9%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 685 660 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395 P=0.158 P=0.170 P=0.394 |(e) (e) (e) (e) |
|POLY 3 | P=0.537 P=0.150 P=0.213 P=0.485 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.547 P=0.144 P=0.216 P=0.489 |(e) (e) (e) (e) |
|POLY 6 | P=0.523 P=0.156 P=0.206 P=0.479 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.520 P=0.158 P=0.202 P=0.480 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.570 P=0.134 P=0.218 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |14/50 (28%) 19/50 (38%) 11/50 (22%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |28.7% 44.6% 24.6% 18.1% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |13/44 (30%) 16/33 (49%) 10/33 (30%) 5/23 (22%) |
|FIRST INCIDENCE | --- --- --- --- |508 421 540 593 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.362N P=0.036 * P=0.565 P=0.580N |
|POLY 3 | (e) (e) (e) (e) |P=0.052N P=0.084 P=0.419N P=0.171N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.040N* P=0.119 P=0.377N P=0.143N |
|POLY 6 | (e) (e) (e) (e) |P=0.081N P=0.058 P=0.477N P=0.223N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.042N* P=0.112 P=0.381N P=0.114N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.032N* P=0.198 P=0.322N P=0.114N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Eye |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/1 (0%) 2/2 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 13.5% |0.0% 0.0% 2.3% 9.2% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 1/30 (3%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- 674 |--- --- 730 674 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.013 * |P=0.002 ** (e) P=0.449 P=0.026 * |
|POLY 3 | P<0.001 ** (e) (e) P=0.014 * |P=0.005 ** (e) P=0.482 P=0.048 * |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.014 * |P=0.005 ** (e) P=0.490 P=0.054 |
|POLY 6 | P<0.001 ** (e) (e) P=0.013 * |P=0.004 ** (e) P=0.472 P=0.041 * |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.016 * |P=0.005 ** (e) P=0.454 P=0.057 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.013 * |P=0.006 ** (e) P=0.500 P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 485 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129N P=0.227N P=0.255N P=0.274N |(e) (e) (e) (e) |
|POLY 3 | P=0.116N P=0.230N P=0.244N P=0.249N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.115N P=0.233N P=0.241N P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.117N P=0.227N P=0.250N P=0.255N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.071N P=0.351N P=0.262N P=0.184N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 4.9% 2.3% 4.7% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 2/33 (6%) 1/33 (3%) 1/23 (4%) |
|FIRST INCIDENCE | --- --- --- --- |--- 731 (T) 731 (T) 607 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.130 P=0.178 P=0.443 P=0.160 |
|POLY 3 | (e) (e) (e) (e) |P=0.207 P=0.203 P=0.482 P=0.211 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.222 P=0.215 P=0.490 P=0.221 |
|POLY 6 | (e) (e) (e) (e) |P=0.183 P=0.191 P=0.472 P=0.196 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.227 P=0.178 P=0.443 P=0.298 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.239 P=0.247 P=0.500 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 593 --- 558 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209N P=0.230N P=0.519N P=0.274N |(e) (e) (e) (e) |
|POLY 3 | P=0.198N P=0.228N P=0.504N P=0.248N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.195N P=0.232N P=0.501N P=0.244N |(e) (e) (e) (e) |
|POLY 6 | P=0.203N P=0.226N P=0.512N P=0.254N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.130N P=0.284N P=0.533N P=0.219N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Focal Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 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% 0.0% 0.0% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |2/44 (5%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.170N P=0.304N P=0.304N P=0.390N |
|POLY 3 | (e) (e) (e) (e) |P=0.102N P=0.276N P=0.258N P=0.263N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.106N P=0.261N P=0.249N P=0.251N |
|POLY 6 | (e) (e) (e) (e) |P=0.099N P=0.291N P=0.270N P=0.284N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.170N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 47/50 (94%) 45/50 (90%) 48/50 (96%) |25/50 (50%) 24/50 (48%) 16/50 (32%) 17/50 (34%) |
|POLY-3 ADJUSTED (b)| 95.0% 95.6% 93.9% 96.9% |51.7% 53.9% 34.1% 37.1% |
|TERMINAL (d) | 40/40 (100%) 43/43 (100%) 34/34 (100%) 30/30 (100%)|23/44 (52%) 18/33 (55%) 8/33 (24%) 6/23 (26%) |
|FIRST INCIDENCE | 473 576 556 230 |692 421 540 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.460N P=0.089 P=0.004 ** |P=0.536N P=0.190 P=0.298N P=0.352 |
|POLY 3 | P=0.422 P=0.655 P=0.606N P=0.523 |P=0.040N* P=0.498 P=0.061N P=0.107N |
|POLY 1.5 | P=0.327 P=0.514 P=0.611N P=0.368 |P=0.036N* P=0.558 P=0.056N P=0.091N |
|POLY 6 | P=0.547 P=0.674N P=0.637N P=0.745 |P=0.053N P=0.439 P=0.068N P=0.141N |
|LOGISTIC REGRESSION| P=0.074 P=0.641N P=0.620N P=0.118 |P=0.037N* P=0.507 P=0.055N P=0.109N |
|COCH-ARM / FISHERS | P=0.220 P=0.357 P=0.630N P=0.218 |P=0.036N* P=0.500N P=0.052N P=0.078N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.4% 4.4% 0.0% |2.1% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/40 (0%) 5/43 (12%) 2/34 (6%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |729 --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393N P=0.040 * P=0.203 (e) |P=0.527N P=0.562N P=0.696 P=0.634N |
|POLY 3 | P=0.292N P=0.035 * P=0.234 (e) |P=0.404N P=0.533N P=0.740 P=0.522N |
|POLY 1.5 | P=0.286N P=0.034 * P=0.236 (e) |P=0.402N P=0.520N P=0.749 P=0.512N |
|POLY 6 | P=0.301N P=0.037 * P=0.229 (e) |P=0.413N P=0.545N P=0.728 P=0.539N |
|LOGISTIC REGRESSION| (e) P=0.040 * P=0.203 (e) |P=0.490N P=0.556N P=0.711 P=0.588N |
|COCH-ARM / FISHERS | P=0.279N P=0.028 * P=0.247 (e) |P=0.405N P=0.500N P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |2.1% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 2/23 (9%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |576 --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619N P=0.514 (e) (e) |P=0.172 P=0.540N P=0.517N P=0.353 |
|POLY 3 | P=0.565N P=0.510 (e) (e) |P=0.246 P=0.535N P=0.520N P=0.457 |
|POLY 1.5 | P=0.565N P=0.506 (e) (e) |P=0.248 P=0.522N P=0.511N P=0.477 |
|POLY 6 | P=0.566N P=0.514 (e) (e) |P=0.238 P=0.548N P=0.531N P=0.427 |
|LOGISTIC REGRESSION| (e) P=0.514 (e) (e) |P=0.249 P=0.283N P=0.322N P=0.588 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Dilatation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 39/50 (78%) 39/50 (78%) 32/50 (64%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 48.0% 80.7% 82.8% 70.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 21/40 (53%) 38/43 (88%) 31/34 (91%) 24/30 (80%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 674 641 556 598 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.043 * P<0.001 ** P<0.001 ** P=0.020 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.052 P<0.001 ** P<0.001 ** P=0.023 * |(e) (e) (e) (e) |
|POLY 6 | P=0.036 * P<0.001 ** P<0.001 ** P=0.019 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * P<0.001 ** P<0.001 ** P=0.013 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.095 P<0.001 ** P<0.001 ** P=0.035 * |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 4.2% 0.0% 6.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/43 (5%) 0/34 (0%) 2/30 (7%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 540 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.163 P=0.525 P=0.532N P=0.233 |(e) (e) (e) (e) |
|POLY 3 | P=0.232 P=0.517 P=0.503N P=0.296 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.236 P=0.511 P=0.501N P=0.299 |(e) (e) (e) (e) |
|POLY 6 | P=0.227 P=0.524 P=0.507N P=0.292 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.245 P=0.525 (e) P=0.313 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242 P=0.500 P=0.500N P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 45/50 (90%) 38/50 (76%) 41/50 (82%) |0/50 (0%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 82.1% 92.7% 79.1% 87.3% |0.0% 9.7% 6.7% 0.0% |
|TERMINAL (d) | 36/40 (90%) 43/43 (100%) 27/34 (79%) 25/30 (83%) |0/44 (0%) 3/33 (9%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 611 641 556 540 |--- 691 540 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.143 P=0.179 P=0.012 * |P=0.523N P=0.035 * P=0.097 (e) |
|POLY 3 | P=0.492 P=0.086 P=0.456N P=0.331 |P=0.448N P=0.043 * P=0.106 (e) |
|POLY 1.5 | P=0.452 P=0.069 P=0.511N P=0.293 |P=0.412N P=0.049 * P=0.112 (e) |
|POLY 6 | P=0.549N P=0.110 P=0.396N P=0.417 |P=0.505N P=0.038 * P=0.100 (e) |
|LOGISTIC REGRESSION| P=0.252 P=0.167 P=0.573 P=0.179 |P=0.369N P=0.038 * P=0.185 (e) |
|COCH-ARM / FISHERS | P=0.476 P=0.054 P=0.592N P=0.312 |P=0.373N P=0.059 P=0.121 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.4% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 670 667 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326 P=0.518 P=0.220 P=0.495 |(e) (e) (e) (e) |
|POLY 3 | P=0.345 P=0.511 P=0.235 P=0.493 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.352 P=0.507 P=0.237 P=0.495 |(e) (e) (e) (e) |
|POLY 6 | P=0.336 P=0.515 P=0.231 P=0.490 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.384 P=0.459 P=0.238 P=0.504 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.500 P=0.247 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 2.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 473 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115N P=0.482N P=0.240N P=0.249N |(e) (e) (e) (e) |
|POLY 3 | P=0.105N P=0.491N P=0.246N P=0.252N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.103N P=0.494N P=0.242N P=0.247N |(e) (e) (e) (e) |
|POLY 6 | P=0.107N P=0.488N P=0.254N P=0.258N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.053N P=0.704N P=0.297N P=0.136N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 10.9% 14.6% 4.4% 4.6% |0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 5/40 (13%) 7/43 (16%) 2/34 (6%) 2/30 (7%) |0/44 (0%) 1/33 (3%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 689 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169N P=0.430 P=0.285N P=0.345N |P=0.488N P=0.183 (e) (e) |
|POLY 3 | P=0.088N P=0.415 P=0.222N P=0.232N |P=0.450N P=0.204 (e) (e) |
|POLY 1.5 | P=0.085N P=0.402 P=0.218N P=0.227N |P=0.431N P=0.216 (e) (e) |
|POLY 6 | P=0.094N P=0.428 P=0.231N P=0.239N |P=0.474N P=0.193 (e) (e) |
|LOGISTIC REGRESSION| P=0.169N P=0.430 P=0.285N P=0.345N |P=0.420N P=0.205 (e) (e) |
|COCH-ARM / FISHERS | P=0.079N P=0.380 P=0.218N P=0.218N |P=0.405N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |3/50 (6%) 4/50 (8%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.6% 8.3% 4.4% 11.2% |6.2% 9.1% 0.0% 0.0% |
|TERMINAL (d) | 3/40 (8%) 3/43 (7%) 2/34 (6%) 4/30 (13%) |3/44 (7%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 641 729 (T) 386 |731 (T) 418 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181 P=0.540 P=0.574N P=0.228 |P=0.048N* P=0.413 P=0.176N P=0.256N |
|POLY 3 | P=0.302 P=0.531 P=0.507N P=0.346 |P=0.035N* P=0.449 P=0.136N P=0.140N |
|POLY 1.5 | P=0.309 P=0.519 P=0.502N P=0.350 |P=0.032N* P=0.468 P=0.128N P=0.130N |
|POLY 6 | P=0.289 P=0.544 P=0.517N P=0.338 |P=0.042N* P=0.428 P=0.146N P=0.158N |
|LOGISTIC REGRESSION| P=0.325 P=0.519 P=0.574N P=0.364 |P=0.019N* P=0.310N (e) (e) |
|COCH-ARM / FISHERS | P=0.320 P=0.500 P=0.500N P=0.357 |P=0.030N* P=0.500 P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 0.0% 0.0% 0.0% |2.1% 2.4% 2.2% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 473 --- --- --- |659 491 474 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119N P=0.235N P=0.242N P=0.247N |P=0.325N P=0.716 P=0.738 P=0.552N |
|POLY 3 | P=0.115N P=0.232N P=0.246N P=0.252N |P=0.333N P=0.725 P=0.743 P=0.523N |
|POLY 1.5 | P=0.114N P=0.234N P=0.242N P=0.247N |P=0.322N P=0.739 P=0.751 P=0.513N |
|POLY 6 | P=0.116N P=0.230N P=0.254N P=0.259N |P=0.352N P=0.711 P=0.731 P=0.541N |
|LOGISTIC REGRESSION| P=0.038N* P=0.474N P=0.303N P=0.130N |P=0.361N P=0.547N P=0.556N P=0.425N |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Syncytial Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 28/50 (56%) 38/50 (76%) 23/50 (46%) |0/50 (0%) 2/50 (4%) 17/50 (34%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 0.0% 57.8% 78.2% 47.9% |0.0% 4.9% 35.6% 39.1% |
|TERMINAL (d) | 0/40 (0%) 26/43 (61%) 27/34 (79%) 13/30 (43%) |0/44 (0%) 2/33 (6%) 9/33 (27%) 6/23 (26%) |
|FIRST INCIDENCE | --- 641 445 230 |--- 731 (T) 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.178 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.203 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=0.215 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.191 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.178 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=0.247 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 17/50 (34%) 17/50 (34%) 12/50 (24%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 35.4% 37.3% 27.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 17/43 (40%) 15/34 (44%) 12/30 (40%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 599 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.019 * P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.023 * P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P=0.014 * P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.012 * P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.038 * P<0.001 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 2.3% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 2/33 (6%) 1/23 (4%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.131 (e) P=0.178 P=0.371 |
|POLY 3 | (e) (e) (e) (e) |P=0.222 (e) P=0.218 P=0.478 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.235 (e) P=0.226 P=0.488 |
|POLY 6 | (e) (e) (e) (e) |P=0.197 (e) P=0.207 P=0.461 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.178 P=0.371 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.4% 4.2% 4.4% 2.2% |2.1% 0.0% 4.5% 2.3% |
|TERMINAL (d) | 2/40 (5%) 2/43 (5%) 1/34 (3%) 0/30 (0%) |1/44 (2%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 641 540 |731 (T) --- 556 724 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467N P=0.669N P=0.647 P=0.566N |P=0.380 P=0.557N P=0.429 P=0.617 |
|POLY 3 | P=0.389N P=0.676N P=0.691 P=0.509N |P=0.479 P=0.532N P=0.473 P=0.735 |
|POLY 1.5 | P=0.384N P=0.682N P=0.693 P=0.506N |P=0.493 P=0.520N P=0.485 P=0.747 |
|POLY 6 | P=0.397N P=0.669N P=0.685 P=0.513N |P=0.450 P=0.545N P=0.457 P=0.715 |
|LOGISTIC REGRESSION| P=0.354N P=0.669N P=0.693 P=0.479N |P=0.506 (e) P=0.593 P=0.683 |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.500 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 2.3% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- 717 |--- --- 633 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 (e) (e) P=0.473 |P=0.543 (e) P=0.199 (e) |
|POLY 3 | P=0.191 (e) (e) P=0.493 |P=0.557 (e) P=0.220 (e) |
|POLY 1.5 | P=0.194 (e) (e) P=0.495 |P=0.578 (e) P=0.227 (e) |
|POLY 6 | P=0.188 (e) (e) P=0.489 |P=0.516 (e) P=0.211 (e) |
|LOGISTIC REGRESSION| P=0.189 (e) (e) P=0.490 |P=0.603 (e) P=0.288 (e) |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 3/46 (7%) 2/44 (5%) 2/36 (6%) |1/46 (2%) 0/48 (0%) 0/46 (0%) 3/43 (7%) |
|POLY-3 ADJUSTED (b)| 0.0% 6.8% 5.1% 6.5% |2.2% 0.0% 0.0% 7.9% |
|TERMINAL (d) | 0/40 (0%) 1/40 (3%) 0/28 (0%) 1/23 (4%) |0/43 (0%) 0/33 (0%) 0/32 (0%) 1/23 (4%) |
|FIRST INCIDENCE | --- 692 599 674 |659 --- --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 P=0.137 P=0.228 P=0.176 |P=0.048 * P=0.557N P=0.541N P=0.171 |
|POLY 3 | P=0.194 P=0.123 P=0.217 P=0.166 |P=0.073 P=0.526N P=0.519N P=0.245 |
|POLY 1.5 | P=0.208 P=0.122 P=0.222 P=0.172 |P=0.073 P=0.513N P=0.511N P=0.261 |
|POLY 6 | P=0.177 P=0.124 P=0.208 P=0.159 |P=0.070 P=0.539N P=0.529N P=0.222 |
|LOGISTIC REGRESSION| P=0.243 P=0.120 P=0.236 P=0.175 |P=0.072 P=0.420N P=0.384N P=0.311 |
|COCH-ARM / FISHERS | P=0.233 P=0.121 P=0.236 P=0.190 |P=0.073 P=0.489N P=0.500N P=0.283 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/45 (4%) 0/43 (0%) 1/41 (2%) 0/41 (0%) |0/48 (0%) 0/48 (0%) 1/44 (2%) 0/40 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 2.7% 0.0% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 1/36 (3%) 0/37 (0%) 0/29 (0%) 0/25 (0%) |0/42 (0%) 0/32 (0%) 0/31 (0%) 0/22 (0%) |
|FIRST INCIDENCE | 716 --- 667 --- |--- --- 712 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226N P=0.229N P=0.549N P=0.298N |P=0.650 (e) P=0.455 (e) |
|POLY 3 | P=0.215N P=0.236N P=0.532N P=0.268N |P=0.645 (e) P=0.468 (e) |
|POLY 1.5 | P=0.211N P=0.240N P=0.531N P=0.265N |P=0.659 (e) P=0.474 (e) |
|POLY 6 | P=0.220N P=0.232N P=0.537N P=0.272N |P=0.619 (e) P=0.460 (e) |
|LOGISTIC REGRESSION| P=0.205N P=0.232N P=0.533N P=0.273N |P=0.664 (e) P=0.478 (e) |
|COCH-ARM / FISHERS | P=0.204N P=0.259N P=0.535N P=0.271N |P=0.672 (e) P=0.478 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 4/43 (9%) 1/41 (2%) 6/41 (15%) |2/48 (4%) 3/48 (6%) 2/44 (5%) 7/40 (18%) |
|POLY-3 ADJUSTED (b)| 0.0% 9.7% 2.7% 16.5% |4.3% 7.5% 5.0% 19.9% |
|TERMINAL (d) | 0/36 (0%) 2/37 (5%) 0/29 (0%) 2/25 (8%) |0/42 (0%) 2/32 (6%) 0/31 (0%) 1/22 (5%) |
|FIRST INCIDENCE | --- 692 715 606 |659 655 633 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.075 P=0.474 P=0.011 * |P=0.011 * P=0.377 P=0.622 P=0.020 * |
|POLY 3 | P=0.012 * P=0.061 P=0.481 P=0.009 ** |P=0.013 * P=0.429 P=0.637 P=0.029 * |
|POLY 1.5 | P=0.012 * P=0.058 P=0.482 P=0.009 ** |P=0.015 * P=0.455 P=0.648 P=0.034 * |
|POLY 6 | P=0.012 * P=0.064 P=0.478 P=0.009 ** |P=0.011 * P=0.403 P=0.623 P=0.022 * |
|LOGISTIC REGRESSION| P=0.013 * P=0.062 P=0.479 P=0.012 * |P=0.017 * P=0.505 P=0.604N P=0.039 * |
|COCH-ARM / FISHERS | P=0.015 * P=0.053 P=0.477 P=0.010 * |P=0.017 * P=0.500 P=0.658 P=0.044 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/49 (2%) 0/47 (0%) 2/47 (4%) 0/40 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.1% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/44 (2%) 0/32 (0%) 2/32 (6%) 0/21 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.635N P=0.564N P=0.389 P=0.647N |
|POLY 3 | (e) (e) (e) (e) |P=0.531N P=0.538N P=0.452 P=0.566N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.519N P=0.527N P=0.466 P=0.554N |
|POLY 6 | (e) (e) (e) (e) |P=0.553N P=0.550N P=0.434 P=0.582N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.635N (e) P=0.389 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.511N P=0.510N P=0.484 P=0.551N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |3/4 (75%) 4/5 (80%) 0/1 (0%) 1/2 (50%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 0.0% 0.0% |86.0% 80.0% 0.0% 63.7% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 1/2 (50%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) 526 --- 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.597N P=0.289 P=1.000N P=0.459 |
|POLY 3 | (e) (e) (e) (e) |P=0.324N P=0.743N P=0.298N P=0.740N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.331N P=0.777N P=0.357N P=0.661N |
|POLY 6 | (e) (e) (e) (e) |P=0.311N P=0.681N P=0.187N P=0.924N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.310N P=0.734 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.326N P=0.722 P=0.400N P=0.600N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |42/49 (86%) 35/50 (70%) 44/49 (90%) 49/49 (100%) |
|POLY-3 ADJUSTED (b)| |88.2% 82.0% 91.5% 100.0% |
|TERMINAL (d) | |39/43 (91%) 29/33 (88%) 29/32 (91%) 22/22 (100%) |
|FIRST INCIDENCE | |659 534 539 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P<0.001 ** P=0.300 P=0.006 ** P<0.001 ** |
|POLY 3 | |P=0.004 ** P=0.279N P=0.421 P=0.013 * |
|POLY 1.5 | |P=0.002 ** P=0.147N P=0.399 P=0.010 * |
|POLY 6 | |P=0.010 * P=0.455N P=0.457 P=0.022 * |
|LOGISTIC REGRESSION| |P<0.001 ** P=0.590 P=0.184 P<0.001 ** |
|COCH-ARM / FISHERS | |P<0.001 ** P=0.050N P=0.380 P=0.006 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |10/49 (20%) 18/50 (36%) 12/49 (24%) 10/49 (20%) |
|POLY-3 ADJUSTED (b)| |21.1% 42.1% 27.7% 23.5% |
|TERMINAL (d) | |9/43 (21%) 14/33 (42%) 11/32 (34%) 8/22 (36%) |
|FIRST INCIDENCE | |674 491 684 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.180 P=0.011 * P=0.156 P=0.101 |
|POLY 3 | |P=0.438N P=0.025 * P=0.312 P=0.493 |
|POLY 1.5 | |P=0.374N P=0.036 * P=0.351 P=0.543 |
|POLY 6 | |P=0.534 P=0.018 * P=0.261 P=0.412 |
|LOGISTIC REGRESSION| |P=0.430N P=0.029 * P=0.228 P=0.383 |
|COCH-ARM / FISHERS | |P=0.316N P=0.066 P=0.405 P=0.599N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.3% 4.1% 0.0% 2.3% |0.0% 4.9% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 1/43 (2%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 2/33 (6%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 485 641 --- 717 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.351N P=0.668N P=0.255N P=0.551N |P=0.526N P=0.178 (e) (e) |
|POLY 3 | P=0.308N P=0.679N P=0.244N P=0.518N |P=0.454N P=0.203 (e) (e) |
|POLY 1.5 | P=0.304N P=0.684N P=0.241N P=0.512N |P=0.435N P=0.215 (e) (e) |
|POLY 6 | P=0.315N P=0.672N P=0.250N P=0.526N |P=0.478N P=0.191 (e) (e) |
|LOGISTIC REGRESSION| P=0.244N P=0.580 P=0.262N P=0.460N |(e) P=0.178 (e) (e) |
|COCH-ARM / FISHERS | P=0.296N P=0.691N P=0.247N P=0.500N |P=0.409N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 2.2% 6.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/43 (0%) 0/34 (0%) 1/30 (3%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) --- 724 606 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.064 P=0.486N P=0.727 P=0.248 |(e) (e) (e) (e) |
|POLY 3 | P=0.089 P=0.490N P=0.757 P=0.296 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.091 P=0.494N P=0.759 P=0.298 |(e) (e) (e) (e) |
|POLY 6 | P=0.085 P=0.486N P=0.753 P=0.292 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.097 (e) P=0.743 P=0.305 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097 P=0.500N P=0.753N P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/47 (2%) 1/46 (2%) 3/43 (7%) |1/50 (2%) 1/50 (2%) 2/47 (4%) 0/44 (0%) |
|POLY-3 ADJUSTED (b)| 4.5% 2.2% 2.4% 8.0% |2.1% 2.4% 4.9% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/40 (3%) 1/31 (3%) 3/27 (11%) |1/44 (2%) 1/33 (3%) 2/31 (7%) 0/20 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.186 P=0.491N P=0.580N P=0.335 |P=0.578N P=0.696 P=0.379 P=0.657N |
|POLY 3 | P=0.263 P=0.495N P=0.523N P=0.424 |P=0.433N P=0.723 P=0.446 P=0.548N |
|POLY 1.5 | P=0.270 P=0.500N P=0.518N P=0.432 |P=0.418N P=0.737 P=0.460 P=0.537N |
|POLY 6 | P=0.255 P=0.490N P=0.532N P=0.416 |P=0.461N P=0.707 P=0.427 P=0.563N |
|LOGISTIC REGRESSION| P=0.186 P=0.491N P=0.580N P=0.335 |P=0.578N P=0.696 P=0.379 (e) |
|COCH-ARM / FISHERS | P=0.284 P=0.508N P=0.516N P=0.447 |P=0.404N P=0.753N P=0.477 P=0.532N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/47 (0%) 0/46 (0%) 0/43 (0%) |4/50 (8%) 4/50 (8%) 3/47 (6%) 1/44 (2%) |
|POLY-3 ADJUSTED (b)| 4.5% 0.0% 0.0% 0.0% |8.3% 9.6% 7.2% 2.6% |
|TERMINAL (d) | 2/39 (5%) 0/40 (0%) 0/31 (0%) 0/27 (0%) |4/44 (9%) 3/33 (9%) 2/31 (7%) 0/20 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) 526 633 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150N P=0.233N P=0.290N P=0.322N |P=0.309N P=0.490 P=0.636 P=0.433N |
|POLY 3 | P=0.124N P=0.234N P=0.252N P=0.275N |P=0.177N P=0.559 P=0.580N P=0.258N |
|POLY 1.5 | P=0.123N P=0.237N P=0.249N P=0.271N |P=0.162N P=0.591 P=0.560N P=0.240N |
|POLY 6 | P=0.125N P=0.231N P=0.258N P=0.280N |P=0.205N P=0.528 P=0.605N P=0.288N |
|LOGISTIC REGRESSION| P=0.150N (e) (e) (e) |P=0.159N P=0.602 P=0.583N P=0.314N |
|COCH-ARM / FISHERS | P=0.124N P=0.253N P=0.258N P=0.275N |P=0.148N P=0.643N P=0.535N P=0.223N |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 12/50 (24%) 20/50 (40%) 12/49 (24%) | |
|POLY-3 ADJUSTED (b)| 34.7% 24.9% 42.2% 27.4% | |
|TERMINAL (d) | 15/40 (38%) 10/43 (23%) 13/34 (38%) 5/29 (17%) | |
|FIRST INCIDENCE | 611 670 558 606 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.362 P=0.188N P=0.147 P=0.551N | |
|POLY 3 | P=0.427N P=0.205N P=0.296 P=0.299N | |
|POLY 1.5 | P=0.408N P=0.222N P=0.286 P=0.293N | |
|POLY 6 | P=0.447N P=0.189N P=0.305 P=0.306N | |
|LOGISTIC REGRESSION| P=0.415N P=0.190N P=0.260 P=0.319N | |
|COCH-ARM / FISHERS | P=0.364N P=0.252N P=0.266 P=0.272N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 1/50 (2%) 3/49 (6%) | |
|POLY-3 ADJUSTED (b)| 6.5% 10.4% 2.2% 6.9% | |
|TERMINAL (d) | 2/40 (5%) 4/43 (9%) 1/34 (3%) 1/29 (3%) | |
|FIRST INCIDENCE | 649 692 729 (T) 674 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565N P=0.401 P=0.355N P=0.567 | |
|POLY 3 | P=0.453N P=0.383 P=0.313N P=0.634 | |
|POLY 1.5 | P=0.445N P=0.373 P=0.308N P=0.640 | |
|POLY 6 | P=0.466N P=0.392 P=0.323N P=0.625 | |
|LOGISTIC REGRESSION| P=0.458N P=0.369 P=0.308N P=0.644 | |
|COCH-ARM / FISHERS | P=0.431N P=0.357 P=0.309N P=0.651 | |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Salivary Glands: Duct |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 8/50 (16%) 23/50 (46%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 4.2% 17.2% 50.6% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 3/34 (9%) 11/30 (37%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 649 729 (T) 556 634 |692 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.524 P=0.016 * P<0.001 ** |P=0.336N P=0.560N P=0.543N P=0.555N |
|POLY 3 | P<0.001 ** P=0.515 P=0.016 * P<0.001 ** |P=0.286N P=0.533N P=0.518N P=0.523N |
|POLY 1.5 | P<0.001 ** P=0.510 P=0.016 * P<0.001 ** |P=0.293N P=0.521N P=0.510N P=0.512N |
|POLY 6 | P<0.001 ** P=0.520 P=0.016 * P<0.001 ** |P=0.277N P=0.546N P=0.529N P=0.540N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.489 P=0.016 * P<0.001 ** |P=0.304N P=0.496N P=0.475N P=0.471N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.015 * P<0.001 ** |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Acanthosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.4% 9.0% |0.0% 4.9% 2.3% 4.5% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 2/34 (6%) 2/30 (7%) |0/44 (0%) 1/33 (3%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 660 |--- 696 731 (T) 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) P=0.203 P=0.045 * |P=0.177 P=0.180 P=0.443 P=0.225 |
|POLY 3 | P=0.007 ** (e) P=0.234 P=0.056 |P=0.215 P=0.203 P=0.482 P=0.217 |
|POLY 1.5 | P=0.007 ** (e) P=0.236 P=0.058 |P=0.230 P=0.216 P=0.490 P=0.227 |
|POLY 6 | P=0.006 ** (e) P=0.229 P=0.055 |P=0.193 P=0.192 P=0.472 P=0.203 |
|LOGISTIC REGRESSION| P=0.007 ** (e) P=0.203 P=0.059 |P=0.251 P=0.201 P=0.443 P=0.351 |
|COCH-ARM / FISHERS | P=0.009 ** (e) P=0.247 P=0.059 |P=0.245 P=0.247 P=0.500 P=0.247 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Exudate |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 6.8% |0.0% 2.4% 2.3% 6.9% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 1/33 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- 660 |--- 691 731 (T) 611 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * (e) (e) P=0.112 |P=0.027 * P=0.445 P=0.443 P=0.063 |
|POLY 3 | P=0.010 * (e) (e) P=0.114 |P=0.046 * P=0.468 P=0.482 P=0.102 |
|POLY 1.5 | P=0.010 * (e) (e) P=0.115 |P=0.050 P=0.480 P=0.490 P=0.110 |
|POLY 6 | P=0.010 * (e) (e) P=0.112 |P=0.040 * P=0.457 P=0.472 P=0.091 |
|LOGISTIC REGRESSION| P=0.013 * (e) (e) P=0.121 |P=0.053 P=0.506 P=0.443 P=0.151 |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.054 P=0.500 P=0.500 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 13/50 (26%) 10/50 (20%) 17/50 (34%) |1/50 (2%) 3/50 (6%) 8/50 (16%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 0.0% 26.6% 21.7% 37.2% |2.1% 7.2% 17.7% 36.4% |
|TERMINAL (d) | 0/40 (0%) 10/43 (23%) 6/34 (18%) 8/30 (27%) |1/44 (2%) 0/33 (0%) 4/33 (12%) 11/23 (48%) |
|FIRST INCIDENCE | --- 576 631 598 |731 (T) 526 474 607 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.227 P=0.008 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.257 P=0.012 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.274 P=0.014 * P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.242 P=0.010 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.388 P=0.026 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.309 P=0.015 * P<0.001 ** |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 22/50 (44%) 29/50 (58%) 32/50 (64%) |24/50 (48%) 31/50 (62%) 41/50 (82%) 43/50 (86%) |
|POLY-3 ADJUSTED (b)| 27.1% 44.9% 58.9% 67.1% |49.1% 65.4% 85.0% 88.1% |
|TERMINAL (d) | 8/40 (20%) 17/43 (40%) 16/34 (47%) 17/30 (57%) |22/44 (50%) 20/33 (61%) 29/33 (88%) 20/23 (87%) |
|FIRST INCIDENCE | 473 576 445 386 |508 418 474 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.099 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.076 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.090 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.063 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.198 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.046 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |0.0% 4.9% 0.0% 2.3% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 2/33 (6%) 0/33 (0%) 1/23 (4%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.619N P=0.514 (e) (e) |P=0.386 P=0.178 (e) P=0.371 |
|POLY 3 | P=0.565N P=0.510 (e) (e) |P=0.489 P=0.203 (e) P=0.478 |
|POLY 1.5 | P=0.565N P=0.506 (e) (e) |P=0.511 P=0.215 (e) P=0.488 |
|POLY 6 | P=0.566N P=0.514 (e) (e) |P=0.455 P=0.191 (e) P=0.461 |
|LOGISTIC REGRESSION| (e) P=0.514 (e) (e) |(e) P=0.178 (e) P=0.371 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 4/50 (8%) 2/50 (4%) |1/50 (2%) 6/50 (12%) 5/50 (10%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 8.5% 8.7% 4.5% |2.1% 14.4% 11.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 4/43 (9%) 2/34 (6%) 1/30 (3%) |0/44 (0%) 5/33 (15%) 3/33 (9%) 0/23 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 583 605 |674 458 474 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394 P=0.202 P=0.154 P=0.434 |P=0.384N P=0.029 * P=0.072 P=0.553N |
|POLY 3 | P=0.498 P=0.188 P=0.180 P=0.490 |P=0.289N P=0.036 * P=0.087 P=0.527N |
|POLY 1.5 | P=0.506 P=0.182 P=0.180 P=0.493 |P=0.252N P=0.043 * P=0.094 P=0.516N |
|POLY 6 | P=0.487 P=0.194 P=0.176 P=0.486 |P=0.354N P=0.029 * P=0.079 P=0.544N |
|LOGISTIC REGRESSION| P=0.534 P=0.202 P=0.178 P=0.504 |P=0.198N P=0.060 P=0.206 P=0.447N |
|COCH-ARM / FISHERS | P=0.524 P=0.175 P=0.181 P=0.500 |P=0.217N P=0.056 P=0.102 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.006 ** (e) (e) P=0.064 |
|POLY 3 | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.098 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.106 |
|POLY 6 | (e) (e) (e) (e) |P=0.009 ** (e) (e) P=0.087 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.105 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.011 * (e) (e) P=0.117 |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 6.6% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/43 (0%) 0/34 (0%) 0/30 (0%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- --- 599 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.510 (e) P=0.112 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.506 (e) P=0.118 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.518 (e) P=0.119 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.491 (e) P=0.116 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.574 (e) P=0.117 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.541 (e) P=0.121 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/43 (2%) 0/34 (0%) 1/30 (3%) |0/44 (0%) 0/33 (0%) 0/33 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 634 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.103 P=0.514 (e) P=0.206 |(e) (e) (e) (e) |
|POLY 3 | P=0.136 P=0.506 (e) P=0.230 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.137 P=0.502 (e) P=0.232 |(e) (e) (e) (e) |
|POLY 6 | P=0.133 P=0.510 (e) P=0.227 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.142 P=0.514 (e) P=0.242 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.141 P=0.495 (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/37 (22%) 8/42 (19%) 18/39 (46%) 17/36 (47%) |3/48 (6%) 6/42 (14%) 8/41 (20%) 21/36 (58%) |
|POLY-3 ADJUSTED (b)| 23.3% 19.6% 48.4% 49.7% |6.4% 16.5% 21.4% 61.1% |
|TERMINAL (d) | 4/29 (14%) 5/37 (14%) 11/27 (41%) 7/21 (33%) |1/42 (2%) 0/27 (0%) 2/27 (7%) 7/16 (44%) |
|FIRST INCIDENCE | 596 641 556 605 |659 418 614 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.463N P=0.021 * P=0.015 * |P<0.001 ** P=0.160 P=0.050 P<0.001 ** |
|POLY 3 | P=0.002 ** P=0.456N P=0.022 * P=0.019 * |P<0.001 ** P=0.136 P=0.043 * P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.471N P=0.022 * P=0.018 * |P<0.001 ** P=0.151 P=0.048 * P<0.001 ** |
|POLY 6 | P=0.002 ** P=0.446N P=0.022 * P=0.020 * |P<0.001 ** P=0.123 P=0.038 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.003 ** P=0.552N P=0.021 * P=0.020 * |P<0.001 ** P=0.630 P=0.096 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.003 ** P=0.497N P=0.022 * P=0.019 * |P<0.001 ** P=0.180 P=0.058 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/37 (5%) 1/42 (2%) 3/39 (8%) 2/36 (6%) |0/48 (0%) 6/42 (14%) 3/41 (7%) 4/36 (11%) |
|POLY-3 ADJUSTED (b)| 5.9% 2.4% 8.5% 6.0% |0.0% 16.3% 8.1% 12.7% |
|TERMINAL (d) | 0/29 (0%) 0/37 (0%) 0/27 (0%) 0/21 (0%) |0/42 (0%) 0/27 (0%) 0/27 (0%) 0/16 (0%) |
|FIRST INCIDENCE | 473 499 599 540 |--- 421 539 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.488N P=0.491 P=0.677 |P=0.178 P=0.014 * P=0.110 P=0.035 * |
|POLY 3 | P=0.457 P=0.437N P=0.517 P=0.684 |P=0.078 P=0.006 ** P=0.083 P=0.023 * |
|POLY 1.5 | P=0.461 P=0.444N P=0.521 P=0.683 |P=0.091 P=0.007 ** P=0.087 P=0.026 * |
|POLY 6 | P=0.448 P=0.431N P=0.509 P=0.681 |P=0.060 P=0.006 ** P=0.079 P=0.019 * |
|LOGISTIC REGRESSION| P=0.544 P=0.695 P=0.450 P=0.695N |P=0.069 P=0.202 P=0.225 P=0.081 |
|COCH-ARM / FISHERS | P=0.471 P=0.452N P=0.525 P=0.682 |P=0.111 P=0.008 ** P=0.094 P=0.031 * |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 22/49 (45%) 30/50 (60%) 42/50 (84%) |18/50 (36%) 28/50 (56%) 32/50 (64%) 39/49 (80%) |
|POLY-3 ADJUSTED (b)| 39.0% 46.8% 65.6% 91.0% |37.4% 68.0% 70.8% 81.9% |
|TERMINAL (d) | 17/40 (43%) 22/42 (52%) 25/34 (74%) 29/30 (97%) |17/44 (39%) 26/33 (79%) 27/33 (82%) 20/23 (87%) |
|FIRST INCIDENCE | 593 729 (T) 654 605 |729 691 600 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.331 P=0.002 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.291 P=0.007 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.274 P=0.009 ** P<0.001 ** |P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.307 P=0.005 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.346 P=0.005 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.243 P=0.014 * P<0.001 ** |P<0.001 ** P=0.035 * P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Developmental Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/3 (33%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 33.3% 100.0% 0.0% 0.0% |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/3 (33%) 2/2 (100%) 0/0 (0%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.631 P=0.309 P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=1.000N P=0.281 P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 1.5 | P=1.000N P=0.281 P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 6 | P=1.000N P=0.281 P=1.000N P=1.000N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.631 P=0.309 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.645 P=0.300 P=1.000 P=1.000 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/20/97 EXPERIMENT: 05162 TEST: 10 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Tooth: Peridontal Tissue |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/3 (67%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 66.7% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/3 (67%) 0/2 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.631N P=0.309N P=1.000 P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=1.000N P=0.281N P=1.000 P=1.000N |(e) (e) (e) (e) |
|POLY 1.5 | P=1.000N P=0.281N P=1.000 P=1.000N |(e) (e) (e) (e) |
|POLY 6 | P=1.000N P=0.281N P=1.000 P=1.000N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.631N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.645N P=0.300N P=1.000 P=1.000 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 40 MG/KG 80 MG/KG 160 |0 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |45/50 (90%) 44/50 (88%) 31/50 (62%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| |91.4% 92.3% 65.4% 54.9% |
|TERMINAL (d) | |42/44 (96%) 32/33 (97%) 23/33 (70%) 13/23 (57%) |
|FIRST INCIDENCE | |508 418 474 594 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.181N P=0.010 * P=0.249N P=0.525N |
|POLY 3 | |P<0.001N** P=0.591 P<0.001N** P<0.001N** |
|POLY 1.5 | |P<0.001N** P=0.632N P<0.001N** P<0.001N** |
|POLY 6 | |P<0.001N** P=0.511 P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| |P<0.001N** P=0.471 P=0.003N** P<0.001N** |
|COCH-ARM / FISHERS | |P<0.001N** P=0.500N P<0.001N** P<0.001N** |
|=================================================================================================================================|
(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).