TDMS Study 05109-14 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 06/06/02
EXPERIMENT: 05109 TEST: 14 TIME: 08:42:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85427 ROUTE: SKIN APPLICATION NTP C#: 61621E
PATHOLOGIST: MISSING CAS: 102-71-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1/MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 06/06/02
EXPERIMENT: 05109 TEST: 14 TIME: 08:42:26
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85427 ROUTE: SKIN APPLICATION NTP C#: 61621E
PATHOLOGIST: MISSING CAS: 102-71-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRIETHANOLAMINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Hypertrophy Focal
Adrenal Medulla Hyperplasia Focal
Heart Inflammation Chronic
Heart: Artery Inflammation Chronic
Islets, Pancreatic Hyperplasia
Liver Clear Cell Focus
Eosinophilic Focus
Preputial Gland Inflammation
Skin: Site of Application - Epidermis Hyperplasia
Inflammation
Ulcer
Skin: Subcutaneous Tissue, Site of Application - Dermis
Inflammation Chronic
Spleen Atrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Kidney Metaplasia Osseous
Liver Eosinophilic Focus
Infiltration Cellular Lymphoid
Inflammation Chronic
Mixed Cell Focus
Necrosis Focal
Vacuolization Cytoplasmic Focal
Pituitary Gland: Pars Distalis Hyperplasia
Skin: Site of Application - Epidermis Hyperplasia
Inflammation
Ulcer
Skin: Subcutaneous Tissue, Site of Application - Dermis
Inflammation Chronic
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/47.57 4/47.22 3/43.85 1/46.39 |1/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 16.8% 8.5% 6.8% 2.2% |2.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 6/37 (16%) 3/43 (7%) 1/34 (3%) 0/40 (0%) |1/35 (3%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 664 637 614 628 |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028N* P=0.134N P=0.142N P=0.018N* |P=0.337N P=0.755 P=0.468N P=0.518N |
|POLY 3 | P=0.023N* P=0.181N P=0.126N P=0.017N* |P=0.325N P=0.758 P=0.498N P=0.500N |
|POLY 1.5 | P=0.023N* P=0.182N P=0.116N P=0.017N* |P=0.325N P=0.757 P=0.501N P=0.501N |
|POLY 6 | P=0.024N* P=0.176N P=0.136N P=0.018N* |P=0.326N P=0.759 P=0.491N P=0.498N |
|LOGISTIC REGRESSION| P=0.023N* P=0.180N P=0.113N P=0.017N* |P=0.337N P=0.755 (e) (e) |
|COCH-ARM / FISHERS | P=0.024N* P=0.178N P=0.100N P=0.015N* |P=0.325N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 21/50 (42%) 10/50 (20%) 10/50 (20%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 16/47.21 21/47.29 10/43.43 10/46.04 |0/44.21 2/43.59 1/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 33.9% 44.4% 23.0% 21.7% |0.0% 4.6% 2.2% 2.3% |
|TERMINAL (d) | 15/37 (41%) 20/43 (47%) 9/34 (27%) 10/40 (25%) |0/35 (0%) 2/34 (6%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 725 615 705 726 (T) |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026N* P=0.387 P=0.182N P=0.080N |P=0.603 P=0.232 P=0.532 P=0.482 |
|POLY 3 | P=0.033N* P=0.200 P=0.180N P=0.139N |P=0.627 P=0.234 P=0.502 P=0.500 |
|POLY 1.5 | P=0.032N* P=0.197 P=0.159N P=0.135N |P=0.625 P=0.234 P=0.499 P=0.499 |
|POLY 6 | P=0.035N* P=0.216 P=0.201N P=0.141N |P=0.630 P=0.235 P=0.509 P=0.502 |
|LOGISTIC REGRESSION| P=0.040N* P=0.218 P=0.223N P=0.080N |(e) P=0.232 P=0.532 P=0.482 |
|COCH-ARM / FISHERS | P=0.033N* P=0.204 P=0.127N P=0.127N |P=0.627 P=0.247 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 45/50 (90%) 40/50 (80%) 40/50 (80%) |49/50 (98%) 49/50 (98%) 50/50 (100%) 50/50 (100%) |
|POLY-3 RATE (b) | 39/48.72 45/49.33 40/48.45 40/48.55 |49/50.00 49/49.83 50/50.00 50/50.00 |
|POLY-3 PERCENT (g) | 80.1% 91.2% 82.6% 82.4% |98.0% 98.3% 100.0% 100.0% |
|TERMINAL (d) | 30/37 (81%) 39/43 (91%) 27/34 (79%) 34/40 (85%) |34/35 (97%) 34/34 (100%) 41/41 (100%) 32/32 (100%) |
|FIRST INCIDENCE | 580 334 443 399 |329 221 62 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.522 P=0.257 P=0.482N |P=0.235 P=0.507 P=0.208N P=0.308 |
|POLY 3 | P=0.425N P=0.091 P=0.477 P=0.485 |P=0.341 P=0.739 P=0.500 P=0.500 |
|POLY 1.5 | P=0.406N P=0.086 P=0.478 P=0.493 |P=0.333 P=0.750 P=0.500 P=0.500 |
|POLY 6 | P=0.463N P=0.107 P=0.497 P=0.470 |P=0.357 P=0.717 P=0.500 P=0.500 |
|LOGISTIC REGRESSION| P=0.412N P=0.070 P=0.405 P=0.439 |P=0.324 P=0.760N (e) (e) |
|COCH-ARM / FISHERS | P=0.394N P=0.086 P=0.500 P=0.500 |P=0.325 P=0.753N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex: Zona Glomerulosa |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 2/47.09 3/43.35 1/46.04 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 6.9% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 3/34 (9%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 676 726 (T) 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.635 P=0.256 P=0.106 P=0.516 |(e) (e) (e) (e) |
|POLY 3 | P=0.619 P=0.237 P=0.104 P=0.495 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.624 P=0.236 P=0.110 P=0.497 |(e) (e) (e) (e) |
|POLY 6 | P=0.613 P=0.240 P=0.099 P=0.494 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.623 P=0.240 P=0.106 P=0.516 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.633 P=0.247 P=0.121 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 2/46.04 |0/43.28 1/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.3% |0.0% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 2/40 (5%) |0/35 (0%) 1/34 (3%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * (e) (e) P=0.256 |P=0.559N P=0.494 P=0.532 (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.232 |P=0.533N P=0.501 P=0.506 (e) |
|POLY 1.5 | P=0.040 * (e) (e) P=0.234 |P=0.535N P=0.501 P=0.503 (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.230 |P=0.532N P=0.502 P=0.513 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.256 |(e) P=0.494 P=0.532 (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |P=0.534N P=0.505 P=0.505 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION 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 RATE (b) | 0/47.21 0/46.90 0/43.35 1/46.34 |0/44.21 0/43.59 2/45.61 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 644 |--- --- 338 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 (e) (e) P=0.491 |P=0.686N (e) P=0.257 (e) |
|POLY 3 | P=0.216 (e) (e) P=0.496 |P=0.673N (e) P=0.244 (e) |
|POLY 1.5 | P=0.217 (e) (e) P=0.497 |P=0.676N (e) P=0.239 (e) |
|POLY 6 | P=0.214 (e) (e) P=0.496 |P=0.671N (e) P=0.252 (e) |
|LOGISTIC REGRESSION| P=0.216 (e) (e) P=0.554 |P=0.651N (e) P=0.298 (e) |
|COCH-ARM / FISHERS | P=0.218 (e) (e) P=0.500 |P=0.675N (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 0/46.04 |1/44.45 2/44.69 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |2.3% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- --- |666 221 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585N P=0.530 (e) (e) |P=0.224N P=0.503 P=0.475N P=0.485N |
|POLY 3 | P=0.590N P=0.499 (e) (e) |P=0.229N P=0.502 P=0.499N P=0.501N |
|POLY 1.5 | P=0.590N P=0.498 (e) (e) |P=0.229N P=0.500 P=0.502N P=0.502N |
|POLY 6 | P=0.588N P=0.501 (e) (e) |P=0.229N P=0.504 P=0.493N P=0.500N |
|LOGISTIC REGRESSION| (e) P=0.530 (e) (e) |P=0.193N P=0.628 P=0.495N P=0.495N |
|COCH-ARM / FISHERS | P=0.590N P=0.500 (e) (e) |P=0.228N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |7/50 (14%) 6/50 (12%) 13/50 (26%) 10/50 (20%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 1/43.35 0/46.04 |7/44.61 6/44.04 13/45.23 10/44.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |15.7% 13.6% 28.7% 22.4% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/34 (3%) 0/40 (0%) |6/35 (17%) 4/34 (12%) 12/41 (29%) 8/32 (25%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |617 665 573 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.776N (e) P=0.483 (e) |P=0.170 P=0.509N P=0.181 P=0.242 |
|POLY 3 | P=0.786N (e) P=0.483 (e) |P=0.233 P=0.510N P=0.107 P=0.295 |
|POLY 1.5 | P=0.784N (e) P=0.489 (e) |P=0.230 P=0.512N P=0.100 P=0.291 |
|POLY 6 | P=0.787N (e) P=0.477 (e) |P=0.234 P=0.503N P=0.122 P=0.299 |
|LOGISTIC REGRESSION| (e) (e) P=0.483 (e) |P=0.237 P=0.509N P=0.112 P=0.303 |
|COCH-ARM / FISHERS | P=0.782N (e) P=0.500 (e) |P=0.233 P=0.500N P=0.105 P=0.298 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Brain: Hypothalamus |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 0/46.04 |0/44.21 0/43.59 3/43.71 1/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 6.9% 2.3% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 3/40 (8%) 1/32 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.391 (e) P=0.146 P=0.482 |
|POLY 3 | (e) (e) (e) (e) |P=0.428 (e) P=0.116 P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.424 (e) P=0.114 P=0.499 |
|POLY 6 | (e) (e) (e) (e) |P=0.433 (e) P=0.122 P=0.502 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.146 P=0.482 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.424 (e) P=0.117 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | |2/44.45 0/43.25 0/44.49 1/43.82 |
|POLY-3 PERCENT (g) | |4.5% 0.0% 0.0% 2.3% |
|TERMINAL (d) | |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | |666 --- --- 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.677N P=0.237N P=0.209N P=0.502N |
|POLY 3 | |P=0.675N P=0.243N P=0.237N P=0.505N |
|POLY 1.5 | |P=0.674N P=0.244N P=0.241N P=0.508N |
|POLY 6 | |P=0.677N P=0.242N P=0.230N P=0.501N |
|LOGISTIC REGRESSION| |P=0.675N P=0.243N P=0.242N P=0.507N |
|COCH-ARM / FISHERS | |P=0.675N P=0.253N P=0.253N P=0.508N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/43.35 2/46.20 | |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.3% 4.3% | |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 1/34 (3%) 1/40 (3%) | |
|FIRST INCIDENCE | 726 (T) --- 726 (T) 684 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 P=0.470N P=0.743 P=0.510 | |
|POLY 3 | P=0.232 P=0.501N P=0.741 P=0.493 | |
|POLY 1.5 | P=0.234 P=0.502N P=0.748 P=0.495 | |
|POLY 6 | P=0.229 P=0.499N P=0.734 P=0.491 | |
|LOGISTIC REGRESSION| P=0.231 (e) P=0.743 P=0.494 | |
|COCH-ARM / FISHERS | P=0.235 P=0.500N P=0.753N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 6/49 (12%) 7/50 (14%) |4/49 (8%) 3/50 (6%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/47.21 5/47.85 6/43.07 7/46.51 |4/44.06 3/43.59 4/44.71 5/44.82 |
|POLY-3 PERCENT (g) | 6.4% 10.5% 13.9% 15.1% |9.1% 6.9% 9.0% 11.2% |
|TERMINAL (d) | 3/37 (8%) 3/43 (7%) 5/34 (15%) 5/40 (13%) |3/35 (9%) 3/34 (9%) 4/41 (10%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) 554 705 644 |619 729 (T) 729 (T) 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182 P=0.418 P=0.200 P=0.184 |P=0.308 P=0.515N P=0.567N P=0.462 |
|POLY 3 | P=0.160 P=0.364 P=0.199 P=0.151 |P=0.371 P=0.506N P=0.635N P=0.511 |
|POLY 1.5 | P=0.165 P=0.359 P=0.211 P=0.154 |P=0.367 P=0.503N P=0.640N P=0.508 |
|POLY 6 | P=0.157 P=0.376 P=0.188 P=0.152 |P=0.375 P=0.509N P=0.624N P=0.514 |
|LOGISTIC REGRESSION| P=0.167 P=0.377 P=0.177 P=0.150 |P=0.364 P=0.500N P=0.628N P=0.509 |
|COCH-ARM / FISHERS | P=0.170 P=0.357 P=0.233 P=0.159 |P=0.364 P=0.489N P=0.631N P=0.513 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Infiltration Cellular Mononuclear Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.44 1/47.29 0/43.35 0/46.04 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 6.3% 2.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/37 (5%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 664 615 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.285N P=0.142N P=0.118N |(e) (e) (e) (e) |
|POLY 3 | P=0.103N P=0.307N P=0.136N P=0.124N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.102N P=0.308N P=0.129N P=0.122N |(e) (e) (e) (e) |
|POLY 6 | P=0.104N P=0.302N P=0.143N P=0.126N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.100N P=0.278N P=0.127N P=0.120N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.309N P=0.121N P=0.121N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 2/46.04 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 2/40 (5%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.046 * (e) (e) P=0.256 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.040 * (e) (e) P=0.234 |(e) (e) (e) (e) |
|POLY 6 | P=0.039 * (e) (e) P=0.230 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.256 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.042 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 3/46.04 |3/44.21 1/43.84 2/45.61 1/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 6.5% |6.8% 2.3% 4.4% 2.3% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 3/40 (8%) |3/35 (9%) 0/34 (0%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) |729 (T) 665 338 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * P=0.530 (e) P=0.135 |P=0.369N P=0.303N P=0.443N P=0.337N |
|POLY 3 | P=0.039 * P=0.499 (e) P=0.114 |P=0.346N P=0.308N P=0.486N P=0.304N |
|POLY 1.5 | P=0.039 * P=0.498 (e) P=0.116 |P=0.346N P=0.310N P=0.496N P=0.307N |
|POLY 6 | P=0.038 * P=0.501 (e) P=0.113 |P=0.346N P=0.304N P=0.470N P=0.301N |
|LOGISTIC REGRESSION| (e) P=0.530 (e) P=0.135 |P=0.344N P=0.309N P=0.477N P=0.337N |
|COCH-ARM / FISHERS | P=0.041 * P=0.500 (e) P=0.121 |P=0.347N P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.44 1/47.09 0/43.35 0/46.04 |2/44.26 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 0.0% |4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 664 676 --- --- |717 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.326N P=0.758 P=0.528N P=0.513N |P=0.267N P=0.249N P=0.209N P=0.253N |
|POLY 3 | P=0.315N P=0.759 P=0.518N P=0.506N |P=0.259N P=0.240N P=0.235N P=0.237N |
|POLY 1.5 | P=0.315N P=0.758 P=0.511N P=0.504N |P=0.258N P=0.241N P=0.239N P=0.238N |
|POLY 6 | P=0.316N P=0.760N P=0.525N P=0.508N |P=0.260N P=0.239N P=0.228N P=0.235N |
|LOGISTIC REGRESSION| P=0.307N P=0.742N P=0.456N P=0.466N |P=0.259N P=0.239N P=0.222N P=0.234N |
|COCH-ARM / FISHERS | P=0.315N P=0.753N P=0.500N P=0.500N |P=0.262N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/47.80 0/43.35 0/46.04 |4/44.66 0/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |9.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | --- 334 --- --- |640 --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590N P=0.500 (e) (e) |P=0.105N P=0.072N P=0.152N P=0.072N |
|POLY 3 | P=0.587N P=0.503 (e) (e) |P=0.095N P=0.063N P=0.178N P=0.061N |
|POLY 1.5 | P=0.588N P=0.501 (e) (e) |P=0.096N P=0.063N P=0.182N P=0.062N |
|POLY 6 | P=0.586N P=0.505 (e) (e) |P=0.095N P=0.063N P=0.171N P=0.061N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.101N P=0.064N P=0.179N P=0.063N |
|COCH-ARM / FISHERS | P=0.590N P=0.500 (e) (e) |P=0.101N P=0.059N P=0.181N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/43.35 2/46.20 |1/44.61 2/44.69 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.3% 4.3% |2.2% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/34 (3%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 725 --- 726 (T) 684 |617 221 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239 P=0.481N P=0.736 P=0.504 |P=0.228N P=0.489 P=0.513N P=0.509N |
|POLY 3 | P=0.232 P=0.501N P=0.741 P=0.493 |P=0.229N P=0.501 P=0.500N P=0.501N |
|POLY 1.5 | P=0.234 P=0.502N P=0.748 P=0.495 |P=0.229N P=0.500 P=0.502N P=0.502N |
|POLY 6 | P=0.229 P=0.499N P=0.734 P=0.491 |P=0.230N P=0.502 P=0.494N P=0.501N |
|LOGISTIC REGRESSION| P=0.231 P=0.489N P=0.731 P=0.494 |P=0.187N P=0.645 P=0.475N P=0.477N |
|COCH-ARM / FISHERS | P=0.235 P=0.500N P=0.753N P=0.500 |P=0.228N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 43/50 (86%) 43/50 (86%) 32/50 (64%) |25/50 (50%) 18/50 (36%) 20/50 (40%) 18/50 (36%) |
|POLY-3 RATE (b) | 45/48.99 43/49.33 43/49.39 32/49.53 |25/47.37 18/45.44 20/45.76 18/44.62 |
|POLY-3 PERCENT (g) | 91.9% 87.2% 87.1% 64.6% |52.8% 39.6% 43.7% 40.3% |
|TERMINAL (d) | 35/37 (95%) 37/43 (86%) 29/34 (85%) 24/40 (60%) |17/35 (49%) 12/34 (35%) 18/41 (44%) 16/32 (50%) |
|FIRST INCIDENCE | 511 334 439 399 |469 594 338 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.087N P=0.424 P=0.007N** |P=0.316N P=0.161N P=0.102N P=0.193N |
|POLY 3 | P<0.001N** P=0.329N P=0.323N P<0.001N** |P=0.256N P=0.141N P=0.251N P=0.159N |
|POLY 1.5 | P<0.001N** P=0.357N P=0.349N P<0.001N** |P=0.236N P=0.136N P=0.244N P=0.143N |
|POLY 6 | P<0.001N** P=0.279N P=0.282N P<0.001N** |P=0.289N P=0.143N P=0.250N P=0.183N |
|LOGISTIC REGRESSION| P<0.001N** P=0.419N P=0.418N P=0.002N** |P=0.204N P=0.118N P=0.216N P=0.113N |
|COCH-ARM / FISHERS | P<0.001N** P=0.380N P=0.380N P=0.002N** |P=0.209N P=0.113N P=0.211N P=0.113N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/47.21 3/46.90 2/43.54 4/46.04 |1/44.21 5/43.97 3/44.71 3/44.34 |
|POLY-3 PERCENT (g) | 4.2% 6.4% 4.6% 8.7% |2.3% 11.4% 6.7% 6.8% |
|TERMINAL (d) | 2/37 (5%) 3/43 (7%) 1/34 (3%) 4/40 (10%) |1/35 (3%) 3/34 (9%) 3/41 (7%) 2/32 (6%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 676 726 (T) |729 (T) 674 729 (T) 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300 P=0.569 P=0.658 P=0.373 |P=0.511 P=0.105 P=0.363 P=0.281 |
|POLY 3 | P=0.282 P=0.497 P=0.664 P=0.326 |P=0.548 P=0.100 P=0.309 P=0.306 |
|POLY 1.5 | P=0.286 P=0.496 P=0.675 P=0.330 |P=0.544 P=0.099 P=0.303 P=0.304 |
|POLY 6 | P=0.277 P=0.502 P=0.655 P=0.323 |P=0.551 P=0.102 P=0.321 P=0.309 |
|LOGISTIC REGRESSION| P=0.275 P=0.569 P=0.661 P=0.373 |P=0.552 P=0.100 P=0.363 P=0.308 |
|COCH-ARM / FISHERS | P=0.290 P=0.500 P=0.691N P=0.339 |P=0.546 P=0.102 P=0.309 P=0.309 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.21 0/46.90 0/43.35 0/46.04 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 725 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.258N P=0.217N P=0.269N P=0.233N |(e) (e) (e) (e) |
|POLY 3 | P=0.249N P=0.239N P=0.257N P=0.243N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.249N P=0.239N P=0.249N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.251N P=0.236N P=0.264N P=0.244N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.260N P=0.224N P=0.268N P=0.240N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.253N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/47.21 4/46.90 2/43.35 2/46.42 |0/44.21 0/43.59 1/44.71 3/44.29 |
|POLY-3 PERCENT (g) | 2.1% 8.5% 4.6% 4.3% |0.0% 0.0% 2.2% 6.8% |
|TERMINAL (d) | 1/37 (3%) 4/43 (9%) 2/34 (6%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 1/41 (2%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 618 |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.227 P=0.470 P=0.513 |P=0.015 * (e) P=0.532 P=0.105 |
|POLY 3 | P=0.570N P=0.177 P=0.470 P=0.494 |P=0.022 * (e) P=0.502 P=0.119 |
|POLY 1.5 | P=0.569N P=0.177 P=0.481 P=0.496 |P=0.022 * (e) P=0.499 P=0.118 |
|POLY 6 | P=0.571N P=0.180 P=0.460 P=0.494 |P=0.022 * (e) P=0.509 P=0.120 |
|LOGISTIC REGRESSION| P=0.575N P=0.227 P=0.470 P=0.520 |(e) (e) P=0.532 P=0.105 |
|COCH-ARM / FISHERS | P=0.566N P=0.181 P=0.500 P=0.500 |P=0.022 * (e) P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 42/50 (84%) 37/50 (74%) 40/50 (80%) |24/50 (48%) 18/50 (36%) 23/50 (46%) 20/50 (40%) |
|POLY-3 RATE (b) | 39/48.50 42/47.78 37/46.82 40/47.96 |24/47.98 18/46.50 23/47.01 20/45.91 |
|POLY-3 PERCENT (g) | 80.4% 87.9% 79.0% 83.4% |50.0% 38.7% 48.9% 43.6% |
|TERMINAL (d) | 33/37 (89%) 40/43 (93%) 29/34 (85%) 35/40 (88%) |17/35 (49%) 11/34 (32%) 19/41 (46%) 13/32 (41%) |
|FIRST INCIDENCE | 580 554 439 554 |329 444 338 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.486N P=0.348N P=0.463 P=0.461N |P=0.513N P=0.207N P=0.308N P=0.379N |
|POLY 3 | P=0.559 P=0.224 P=0.536N P=0.451 |P=0.454N P=0.183N P=0.539N P=0.337N |
|POLY 1.5 | P=0.562 P=0.244 P=0.486N P=0.465 |P=0.441N P=0.182N P=0.543N P=0.326N |
|POLY 6 | P=0.559 P=0.218 P=0.586N P=0.446 |P=0.463N P=0.176N P=0.518N P=0.338N |
|LOGISTIC REGRESSION| P=0.509 P=0.239 P=0.568 P=0.391 |P=0.399N P=0.142N P=0.494N P=0.273N |
|COCH-ARM / FISHERS | P=0.554N P=0.306 P=0.408N P=0.500 |P=0.399N P=0.156N P=0.500N P=0.273N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Amyloid Deposition |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 0/46.04 |0/44.21 2/45.53 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 221 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.396N P=0.238 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.387N P=0.244 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.389N P=0.242 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.386N P=0.246 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.201N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.392N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Glomerulus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.21 2/46.90 0/43.35 2/46.04 |0/44.21 0/43.59 0/44.71 1/44.36 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 4.3% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/37 (0%) 2/43 (5%) 0/34 (0%) 2/40 (5%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) |--- --- --- 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292 P=0.272 (e) P=0.256 |P=0.220 (e) (e) P=0.500 |
|POLY 3 | P=0.278 P=0.236 (e) P=0.232 |P=0.223 (e) (e) P=0.501 |
|POLY 1.5 | P=0.280 P=0.236 (e) P=0.234 |P=0.222 (e) (e) P=0.499 |
|POLY 6 | P=0.277 P=0.238 (e) P=0.230 |P=0.224 (e) (e) P=0.503 |
|LOGISTIC REGRESSION| (e) P=0.272 (e) P=0.256 |P=0.221 (e) (e) P=0.501 |
|COCH-ARM / FISHERS | P=0.283 P=0.247 (e) P=0.247 |P=0.221 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/47.33 2/46.90 0/43.35 4/46.04 |0/44.21 0/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 8.5% 4.3% 0.0% 8.7% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 3/37 (8%) 2/43 (5%) 0/34 (0%) 4/40 (10%) |0/35 (0%) 0/34 (0%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | 694 726 (T) --- 726 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403 P=0.279N P=0.078N P=0.609N |P=0.799N (e) P=0.532 (e) |
|POLY 3 | P=0.390 P=0.342N P=0.072N P=0.628 |P=0.778N (e) P=0.502 (e) |
|POLY 1.5 | P=0.393 P=0.342N P=0.068N P=0.633 |P=0.779N (e) P=0.499 (e) |
|POLY 6 | P=0.386 P=0.338N P=0.077N P=0.623 |P=0.777N (e) P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.378 P=0.333N P=0.078N P=0.627 |(e) (e) P=0.532 (e) |
|COCH-ARM / FISHERS | P=0.395 P=0.339N P=0.059N P=0.643N |P=0.779N (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 1/44.04 2/46.39 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.3% 4.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) 487 628 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202 P=0.530 P=0.488 P=0.243 |(e) (e) (e) (e) |
|POLY 3 | P=0.194 P=0.499 P=0.486 P=0.233 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.196 P=0.498 P=0.491 P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.193 P=0.501 P=0.481 P=0.233 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.199 P=0.530 P=0.922 P=0.258 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.197 P=0.500 P=0.500 P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/47.21 6/46.90 3/43.45 2/47.40 |4/44.84 0/43.59 3/44.71 3/44.29 |
|POLY-3 PERCENT (g) | 4.2% 12.8% 6.9% 4.2% |8.9% 0.0% 6.7% 6.8% |
|TERMINAL (d) | 2/37 (5%) 6/43 (14%) 2/34 (6%) 0/40 (0%) |2/35 (6%) 0/34 (0%) 3/41 (7%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 699 399 |619 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.186 P=0.460 P=0.680N |P=0.447 P=0.067N P=0.432N P=0.530N |
|POLY 3 | P=0.294N P=0.131 P=0.462 P=0.692N |P=0.488 P=0.064N P=0.502N P=0.507N |
|POLY 1.5 | P=0.296N P=0.131 P=0.476 P=0.693N |P=0.486 P=0.063N P=0.507N P=0.507N |
|POLY 6 | P=0.292N P=0.134 P=0.450 P=0.691N |P=0.488 P=0.064N P=0.490N P=0.508N |
|LOGISTIC REGRESSION| P=0.292N P=0.186 P=0.442 P=0.548N |P=0.486 P=0.062N P=0.500N P=0.501N |
|COCH-ARM / FISHERS | P=0.300N P=0.134 P=0.500 P=0.691N |P=0.483 P=0.059N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 23/50 (46%) 14/50 (28%) 11/50 (22%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 5/50 (10%) |
|POLY-3 RATE (b) | 19/47.57 23/46.90 14/43.35 11/46.34 |4/44.21 3/43.59 3/44.71 5/45.20 |
|POLY-3 PERCENT (g) | 39.9% 49.0% 32.3% 23.7% |9.1% 6.9% 6.7% 11.1% |
|TERMINAL (d) | 18/37 (49%) 23/43 (54%) 14/34 (41%) 10/40 (25%) |4/35 (11%) 3/34 (9%) 3/41 (7%) 3/32 (9%) |
|FIRST INCIDENCE | 624 726 (T) 726 (T) 644 |729 (T) 729 (T) 729 (T) 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009N** P=0.505 P=0.277N P=0.036N* |P=0.290 P=0.516N P=0.414N P=0.460 |
|POLY 3 | P=0.014N* P=0.246 P=0.294N P=0.069N |P=0.357 P=0.508N P=0.494N P=0.514 |
|POLY 1.5 | P=0.014N* P=0.251 P=0.255N P=0.067N |P=0.349 P=0.509N P=0.503N P=0.504 |
|POLY 6 | P=0.014N* P=0.250 P=0.338N P=0.071N |P=0.365 P=0.505N P=0.476N P=0.526 |
|LOGISTIC REGRESSION| P=0.018N* P=0.301 P=0.345N P=0.074N |P=0.343 P=0.516N P=0.414N P=0.498 |
|COCH-ARM / FISHERS | P=0.015N* P=0.272 P=0.198N P=0.063N |P=0.340 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 20/50 (40%) 31/50 (62%) 30/50 (60%) |16/50 (32%) 22/50 (44%) 28/50 (56%) 32/50 (64%) |
|POLY-3 RATE (b) | 9/47.21 20/47.45 31/45.55 30/46.94 |16/44.60 22/44.24 28/46.06 32/46.17 |
|POLY-3 PERCENT (g) | 19.1% 42.2% 68.1% 63.9% |35.9% 49.7% 60.8% 69.3% |
|TERMINAL (d) | 9/37 (24%) 19/43 (44%) 25/34 (74%) 27/40 (68%) |15/35 (43%) 19/34 (56%) 24/41 (59%) 21/32 (66%) |
|FIRST INCIDENCE | 726 (T) 554 439 618 |619 665 573 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.123 P=0.055 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.130 P=0.012 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.131 P=0.010 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.135 P=0.020 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.133 P=0.013 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P=0.002 ** P=0.151 P=0.013 * P<0.001 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 1/50 (2%) 2/50 (4%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/47.21 4/46.90 1/43.35 2/46.42 |4/45.41 3/43.84 3/45.63 4/45.22 |
|POLY-3 PERCENT (g) | 6.4% 8.5% 2.3% 4.3% |8.8% 6.8% 6.6% 8.9% |
|TERMINAL (d) | 3/37 (8%) 4/43 (9%) 1/34 (3%) 1/40 (3%) |2/35 (6%) 2/34 (6%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 618 |329 665 444 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.339N P=0.582 P=0.335N P=0.476N |P=0.493 P=0.499N P=0.454N P=0.618 |
|POLY 3 | P=0.347N P=0.496 P=0.337N P=0.508N |P=0.521 P=0.519N P=0.497N P=0.641 |
|POLY 1.5 | P=0.347N P=0.496 P=0.325N P=0.505N |P=0.516 P=0.517N P=0.506N P=0.636 |
|POLY 6 | P=0.347N P=0.502 P=0.348N P=0.508N |P=0.528 P=0.518N P=0.480N P=0.638N |
|LOGISTIC REGRESSION| P=0.356N P=0.582 P=0.335N P=0.498N |P=0.522 P=0.470N P=0.438N P=0.612N |
|COCH-ARM / FISHERS | P=0.345N P=0.500 P=0.309N P=0.500N |P=0.514 P=0.500N P=0.500N P=0.643N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/43.35 0/46.04 |0/44.21 2/43.84 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.3% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/34 (3%) 0/40 (0%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 725 --- 726 (T) --- |--- 665 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463N P=0.481N P=0.736 P=0.495N |P=0.399N P=0.250 (e) (e) |
|POLY 3 | P=0.467N P=0.501N P=0.741 P=0.505N |P=0.394N P=0.235 (e) (e) |
|POLY 1.5 | P=0.465N P=0.502N P=0.748 P=0.503N |P=0.394N P=0.234 (e) (e) |
|POLY 6 | P=0.470N P=0.499N P=0.734 P=0.506N |P=0.392N P=0.237 (e) (e) |
|LOGISTIC REGRESSION| P=0.470N P=0.489N P=0.731 P=0.503N |P=0.392N P=0.235 (e) (e) |
|COCH-ARM / FISHERS | P=0.464N P=0.500N P=0.753N P=0.500N |P=0.392N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |26/50 (52%) 30/50 (60%) 36/50 (72%) 20/50 (40%) |
|POLY-3 RATE (b) | 3/47.21 2/46.90 2/43.35 3/46.42 |26/45.27 30/45.03 36/45.97 20/44.90 |
|POLY-3 PERCENT (g) | 6.4% 4.3% 4.6% 6.5% |57.4% 66.6% 78.3% 44.6% |
|TERMINAL (d) | 3/37 (8%) 2/43 (5%) 2/34 (6%) 2/40 (5%) |23/35 (66%) 25/34 (74%) 33/41 (81%) 16/32 (50%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 618 |619 594 338 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526 P=0.431N P=0.539N P=0.635N |P=0.074N P=0.223 P=0.166 P=0.252N |
|POLY 3 | P=0.512 P=0.503N P=0.539N P=0.654 |P=0.021N* P=0.241 P=0.022 * P=0.150N |
|POLY 1.5 | P=0.514 P=0.504N P=0.524N P=0.656 |P=0.025N* P=0.238 P=0.021 * P=0.159N |
|POLY 6 | P=0.509 P=0.498N P=0.552N P=0.654 |P=0.019N* P=0.255 P=0.028 * P=0.141N |
|LOGISTIC REGRESSION| P=0.505 P=0.431N P=0.539N P=0.660 |P=0.022N* P=0.244 P=0.027 * P=0.129N |
|COCH-ARM / FISHERS | P=0.517 P=0.500N P=0.500N P=0.661N |P=0.033N* P=0.273 P=0.032 * P=0.158N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 14/50 (28%) 10/50 (20%) 11/50 (22%) |14/50 (28%) 27/50 (54%) 22/50 (44%) 15/50 (30%) |
|POLY-3 RATE (b) | 9/47.35 14/46.90 10/43.35 11/46.04 |14/45.33 27/44.25 22/45.61 15/44.72 |
|POLY-3 PERCENT (g) | 19.0% 29.9% 23.1% 23.9% |30.9% 61.0% 48.2% 33.5% |
|TERMINAL (d) | 8/37 (22%) 14/43 (33%) 10/34 (29%) 11/40 (28%) |12/35 (34%) 24/34 (71%) 21/41 (51%) 14/32 (44%) |
|FIRST INCIDENCE | 688 726 (T) 726 (T) 726 (T) |469 665 338 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N P=0.286 P=0.415 P=0.470 |P=0.249N P=0.004 ** P=0.171 P=0.392 |
|POLY 3 | P=0.537 P=0.161 P=0.415 P=0.374 |P=0.155N P=0.003 ** P=0.066 P=0.482 |
|POLY 1.5 | P=0.547 P=0.163 P=0.447 P=0.384 |P=0.161N P=0.003 ** P=0.063 P=0.481 |
|POLY 6 | P=0.523 P=0.165 P=0.383 P=0.364 |P=0.151N P=0.002 ** P=0.076 P=0.486 |
|LOGISTIC REGRESSION| P=0.524 P=0.195 P=0.366 P=0.375 |P=0.148N P=0.005 ** P=0.070 P=0.504 |
|COCH-ARM / FISHERS | P=0.557N P=0.171 P=0.500 P=0.402 |P=0.163N P=0.007 ** P=0.072 P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 11/50 (22%) 15/50 (30%) 8/50 (16%) |5/50 (10%) 8/50 (16%) 14/50 (28%) 11/50 (22%) |
|POLY-3 RATE (b) | 13/47.21 11/46.90 15/43.85 8/46.34 |5/44.60 8/43.59 14/44.71 11/44.64 |
|POLY-3 PERCENT (g) | 27.5% 23.5% 34.2% 17.3% |11.2% 18.4% 31.3% 24.6% |
|TERMINAL (d) | 13/37 (35%) 11/43 (26%) 13/34 (38%) 7/40 (18%) |4/35 (11%) 8/34 (24%) 14/41 (34%) 8/32 (25%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 614 644 |619 729 (T) 729 (T) 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133N P=0.248N P=0.304 P=0.117N |P=0.088 P=0.256 P=0.044 * P=0.072 |
|POLY 3 | P=0.152N P=0.414N P=0.322 P=0.172N |P=0.139 P=0.259 P=0.017 * P=0.082 |
|POLY 1.5 | P=0.150N P=0.416N P=0.354 P=0.170N |P=0.135 P=0.262 P=0.017 * P=0.081 |
|POLY 6 | P=0.155N P=0.402N P=0.296 P=0.172N |P=0.144 P=0.258 P=0.020 * P=0.084 |
|LOGISTIC REGRESSION| P=0.169N P=0.248N P=0.259 P=0.180N |P=0.140 P=0.269 P=0.026 * P=0.087 |
|COCH-ARM / FISHERS | P=0.147N P=0.408N P=0.412 P=0.163N |P=0.139 P=0.277 P=0.020 * P=0.086 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 7/50 (14%) 6/50 (12%) |0/50 (0%) 5/50 (10%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/47.72 3/47.22 7/44.85 6/47.34 |0/44.21 5/44.33 1/44.86 3/45.04 |
|POLY-3 PERCENT (g) | 8.4% 6.4% 15.6% 12.7% |0.0% 11.3% 2.2% 6.7% |
|TERMINAL (d) | 2/37 (5%) 2/43 (5%) 1/34 (3%) 3/40 (8%) |0/35 (0%) 2/34 (6%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 628 637 517 399 |--- 610 692 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261 P=0.458N P=0.211 P=0.386 |P=0.391 P=0.036 * P=0.525 P=0.124 |
|POLY 3 | P=0.254 P=0.506N P=0.227 P=0.365 |P=0.404 P=0.031 * P=0.503 P=0.122 |
|POLY 1.5 | P=0.256 P=0.506N P=0.239 P=0.367 |P=0.397 P=0.030 * P=0.499 P=0.119 |
|POLY 6 | P=0.249 P=0.502N P=0.218 P=0.363 |P=0.414 P=0.032 * P=0.510 P=0.125 |
|LOGISTIC REGRESSION| P=0.269 P=0.482N P=0.344 P=0.457 |P=0.397 P=0.033 * P=0.500 P=0.125 |
|COCH-ARM / FISHERS | P=0.256 P=0.500N P=0.262 P=0.370 |P=0.397 P=0.028 * P=0.500 P=0.121 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |8/50 (16%) 1/50 (2%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/47.35 1/46.90 3/43.35 5/46.70 |8/45.47 1/43.59 6/44.71 6/44.57 |
|POLY-3 PERCENT (g) | 4.2% 2.1% 6.9% 10.7% |17.6% 2.3% 13.4% 13.5% |
|TERMINAL (d) | 1/37 (3%) 1/43 (2%) 3/34 (9%) 3/40 (8%) |5/35 (14%) 1/34 (3%) 6/41 (15%) 5/32 (16%) |
|FIRST INCIDENCE | 688 726 (T) 726 (T) 628 |469 729 (T) 729 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.080 P=0.463N P=0.458 P=0.231 |P=0.398 P=0.021N* P=0.293N P=0.431N |
|POLY 3 | P=0.073 P=0.503N P=0.460 P=0.211 |P=0.460 P=0.018N* P=0.399N P=0.402N |
|POLY 1.5 | P=0.074 P=0.503N P=0.475 P=0.212 |P=0.457 P=0.018N* P=0.403N P=0.401N |
|POLY 6 | P=0.072 P=0.501N P=0.445 P=0.211 |P=0.463 P=0.019N* P=0.385N P=0.402N |
|LOGISTIC REGRESSION| P=0.074 P=0.502N P=0.446 P=0.230 |P=0.455 P=0.018N* P=0.389N P=0.388N |
|COCH-ARM / FISHERS | P=0.075 P=0.500N P=0.500 P=0.218 |P=0.453 P=0.015N* P=0.387N P=0.387N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 0/43.35 0/46.04 |2/44.91 0/43.59 3/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |4.5% 0.0% 6.7% 2.3% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 3/41 (7%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) --- --- --- |595 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.485N P=0.470N P=0.517N P=0.484N |P=0.585N P=0.239N P=0.546 P=0.504N |
|POLY 3 | P=0.485N P=0.501N P=0.517N P=0.505N |P=0.561N P=0.244N P=0.498 P=0.505N |
|POLY 1.5 | P=0.485N P=0.502N P=0.511N P=0.503N |P=0.562N P=0.243N P=0.494 P=0.505N |
|POLY 6 | P=0.485N P=0.499N P=0.523N P=0.506N |P=0.560N P=0.245N P=0.508 P=0.506N |
|LOGISTIC REGRESSION| P=0.485N (e) (e) (e) |P=0.563N P=0.212N P=0.500 P=0.490N |
|COCH-ARM / FISHERS | P=0.488N P=0.500N P=0.500N P=0.500N |P=0.563N P=0.247N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.25 0/46.90 0/43.35 0/46.04 |1/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 0.0% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 714 --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.258N P=0.218N P=0.270N P=0.234N |P=0.515N P=0.506N P=0.468N P=0.518N |
|POLY 3 | P=0.249N P=0.239N P=0.257N P=0.243N |P=0.499N P=0.503N P=0.498N P=0.500N |
|POLY 1.5 | P=0.249N P=0.239N P=0.250N P=0.241N |P=0.498N P=0.503N P=0.501N P=0.501N |
|POLY 6 | P=0.251N P=0.237N P=0.264N P=0.245N |P=0.501N P=0.502N P=0.491N P=0.498N |
|LOGISTIC REGRESSION| P=0.260N P=0.236N P=0.265N P=0.244N |P=0.515N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.253N P=0.247N P=0.247N P=0.247N |P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 0/46.04 |0/44.21 2/44.69 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 221 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.389N P=0.237 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.390N P=0.239 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.392N P=0.238 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.389N P=0.242 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.334N P=0.353 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.392N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/47.21 2/47.09 1/43.35 2/46.39 |0/44.21 0/43.59 1/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 4.2% 4.3% 2.3% 4.3% |0.0% 0.0% 2.2% 2.3% |
|TERMINAL (d) | 2/37 (5%) 1/43 (2%) 1/34 (3%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 676 726 (T) 628 |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.618 P=0.652N P=0.530N P=0.676N |P=0.299 (e) P=0.532 P=0.482 |
|POLY 3 | P=0.612 P=0.693 P=0.530N P=0.687 |P=0.328 (e) P=0.502 P=0.500 |
|POLY 1.5 | P=0.614 P=0.691 P=0.519N P=0.689 |P=0.326 (e) P=0.499 P=0.499 |
|POLY 6 | P=0.610 P=0.690N P=0.540N P=0.687 |P=0.331 (e) P=0.509 P=0.502 |
|LOGISTIC REGRESSION| P=0.615 P=0.693 P=0.530N P=0.691N |(e) (e) P=0.532 P=0.482 |
|COCH-ARM / FISHERS | P=0.618 P=0.691N P=0.500N P=0.691N |P=0.325 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/48 (0%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.25 0/46.57 0/42.35 0/44.04 |1/43.21 0/43.59 2/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/33 (0%) 0/38 (0%) |1/34 (3%) 0/34 (0%) 2/41 (5%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.460N P=0.500N P=0.565 P=0.512N |
|POLY 3 | (e) (e) (e) (e) |P=0.434N P=0.498N P=0.512 P=0.495N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.436N P=0.499N P=0.506 P=0.497N |
|POLY 6 | (e) (e) (e) (e) |P=0.432N P=0.497N P=0.524 P=0.493N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.460N (e) P=0.565 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.438N P=0.495N P=0.508 P=0.495N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) |1/6 (17%) 1/7 (14%) 0/4 (0%) 2/6 (33%) |
|POLY-3 RATE (b) | 0/0.35 0/0.00 0/0.86 0/0.47 |1/5.68 1/5.97 0/3.28 2/5.47 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |17.6% 16.8% 0.0% 36.6% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/5 (20%) 0/2 (0%) 0/2 (0%) 2/5 (40%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 665 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.426 P=0.681 P=0.682N P=0.500 |
|POLY 3 | (e) (e) (e) (e) |P=0.314 P=0.754N P=0.606N P=0.486 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.312 P=0.740N P=0.594N P=0.491 |
|POLY 6 | (e) (e) (e) (e) |P=0.323 P=0.758 P=0.623N P=0.483 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.338 P=0.773N (e) P=0.500 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.303 P=0.731N P=0.600N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/3 (100%) 3/3 (100%) 4/5 (80%) 5/7 (71%) |10/11 (91%) 6/6 (100%) 3/4 (75%) 9/9 (100%) |
|POLY-3 RATE (b) | 3/3.00 3/3.00 4/5.00 5/6.47 |10/11.00 6/6.00 3/3.49 9/9.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 80.0% 77.2% |90.9% 100.0% 86.1% 100.0% |
|TERMINAL (d) | 3/3 (100%) 3/3 (100%) 4/5 (80%) 4/5 (80%) |8/9 (89%) 4/4 (100%) 3/3 (100%) 8/8 (100%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 399 |329 610 729 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.591 (e) P=0.602N P=0.705 |P=0.583N P=0.554 P=0.378N P=0.681N |
|POLY 3 | P=0.331N (e) P=0.599N P=0.526N |P=0.465 P=0.619 P=0.769N P=0.540 |
|POLY 1.5 | P=0.289N (e) P=0.599N P=0.483N |P=0.460 P=0.619 P=0.664N P=0.540 |
|POLY 6 | P=0.392N (e) P=0.599N P=0.585N |P=0.473 P=0.619 P=0.833 P=0.540 |
|LOGISTIC REGRESSION| P=0.283N (e) P=0.602N P=0.487N |P=0.508 (e) P=0.513N (e) |
|COCH-ARM / FISHERS | P=0.228N (e) P=0.625N P=0.467N |P=0.453 P=0.647 P=0.476N P=0.550 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION 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 RATE (b) | 2/47.25 0/46.90 1/43.55 0/46.04 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 716 --- 673 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280N P=0.216N P=0.542N P=0.231N |(e) (e) (e) (e) |
|POLY 3 | P=0.275N P=0.239N P=0.528N P=0.243N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.274N P=0.239N P=0.518N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.278N P=0.237N P=0.538N P=0.245N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.275N P=0.235N P=0.518N P=0.244N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.274N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/31 (100%) 26/26 (100%) 35/35 (100%) 30/30 (100%)|26/26 (100%) 26/26 (100%) 31/31 (100%) 31/31 (100%) |
|POLY-3 RATE (b) | 31/31.00 26/26.00 35/35.00 30/30.00 |26/26.00 26/26.00 31/31.00 31/31.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 25/25 (100%) 26/26 (100%) 28/28 (100%) 27/27 (100%)|23/23 (100%) 22/22 (100%) 30/30 (100%) 25/25 (100%) |
|FIRST INCIDENCE | 580 726 (T) 439 566 |532 594 674 567 |
|-------------------| | |
|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: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |2/44.49 0/43.59 2/44.71 0/44.29 |
|POLY-3 PERCENT (g) | |4.5% 0.0% 4.5% 0.0% |
|TERMINAL (d) | |1/35 (3%) 0/34 (0%) 2/41 (5%) 0/32 (0%) |
|FIRST INCIDENCE | |653 --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.293N P=0.235N P=0.644N P=0.244N |
|POLY 3 | |P=0.276N P=0.242N P=0.692N P=0.238N |
|POLY 1.5 | |P=0.278N P=0.241N P=0.691 P=0.239N |
|POLY 6 | |P=0.276N P=0.241N P=0.683N P=0.237N |
|LOGISTIC REGRESSION| |P=0.279N P=0.238N P=0.693N P=0.238N |
|COCH-ARM / FISHERS | |P=0.280N P=0.247N P=0.691N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |27/50 (54%) 22/50 (44%) 21/50 (42%) 25/50 (50%) |
|POLY-3 RATE (b) | |27/45.63 22/45.88 21/47.21 25/45.75 |
|POLY-3 PERCENT (g) | |59.2% 48.0% 44.5% 54.7% |
|TERMINAL (d) | |23/35 (66%) 17/34 (50%) 17/41 (42%) 17/32 (53%) |
|FIRST INCIDENCE | |532 239 62 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.383 P=0.240N P=0.055N P=0.542N |
|POLY 3 | |P=0.509 P=0.188N P=0.109N P=0.409N |
|POLY 1.5 | |P=0.499 P=0.201N P=0.130N P=0.428N |
|POLY 6 | |P=0.526 P=0.174N P=0.083N P=0.380N |
|LOGISTIC REGRESSION| |P=0.515 P=0.229N P=0.162N P=0.408N |
|COCH-ARM / FISHERS | |P=0.514 P=0.212N P=0.158N P=0.421N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/44.21 1/44.25 3/45.98 1/44.29 |
|POLY-3 PERCENT (g) | |0.0% 2.3% 6.5% 2.3% |
|TERMINAL (d) | |0/35 (0%) 0/34 (0%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | |--- 510 444 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.533 P=0.496 P=0.129 P=0.482 |
|POLY 3 | |P=0.548 P=0.500 P=0.126 P=0.500 |
|POLY 1.5 | |P=0.545 P=0.499 P=0.121 P=0.499 |
|POLY 6 | |P=0.551 P=0.503 P=0.134 P=0.502 |
|LOGISTIC REGRESSION| |P=0.566 P=0.591 P=0.145 P=0.482 |
|COCH-ARM / FISHERS | |P=0.546 P=0.500 P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 0/46.04 |1/44.21 3/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |2.3% 6.9% 2.2% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 3/34 (9%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585N P=0.530 (e) (e) |P=0.189N P=0.294 P=0.726N P=0.518N |
|POLY 3 | P=0.590N P=0.499 (e) (e) |P=0.176N P=0.300 P=0.758N P=0.500N |
|POLY 1.5 | P=0.590N P=0.498 (e) (e) |P=0.178N P=0.300 P=0.759 P=0.501N |
|POLY 6 | P=0.588N P=0.501 (e) (e) |P=0.175N P=0.302 P=0.751N P=0.498N |
|LOGISTIC REGRESSION| (e) P=0.530 (e) (e) |P=0.189N P=0.294 P=0.726N (e) |
|COCH-ARM / FISHERS | P=0.590N P=0.500 (e) (e) |P=0.177N P=0.309 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 1/46.04 |1/44.21 2/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |2.3% 4.6% 2.2% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 1/40 (3%) |1/35 (3%) 2/34 (6%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224 (e) (e) P=0.516 |P=0.253N P=0.490 P=0.726N P=0.518N |
|POLY 3 | P=0.215 (e) (e) P=0.495 |P=0.239N P=0.495 P=0.758N P=0.500N |
|POLY 1.5 | P=0.216 (e) (e) P=0.497 |P=0.240N P=0.494 P=0.759 P=0.501N |
|POLY 6 | P=0.213 (e) (e) P=0.494 |P=0.238N P=0.497 P=0.751N P=0.498N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.516 |P=0.253N P=0.490 P=0.726N (e) |
|COCH-ARM / FISHERS | P=0.218 (e) (e) P=0.500 |P=0.238N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 0/49 (0%) 1/50 (2%) |11/50 (22%) 3/50 (6%) 9/50 (18%) 12/50 (24%) |
|POLY-3 RATE (b) | 1/47.21 2/46.22 0/42.35 1/46.04 |11/44.87 3/43.59 9/44.92 12/44.57 |
|POLY-3 PERCENT (g) | 2.1% 4.3% 0.0% 2.2% |24.5% 6.9% 20.0% 26.9% |
|TERMINAL (d) | 1/37 (3%) 2/43 (5%) 0/33 (0%) 1/40 (3%) |9/35 (26%) 3/34 (9%) 8/41 (20%) 11/32 (34%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |617 729 (T) 674 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.557N P=0.552 P=0.523N P=0.744N |P=0.080 P=0.024N* P=0.273N P=0.417 |
|POLY 3 | P=0.564N P=0.493 P=0.522N P=0.755 |P=0.126 P=0.021N* P=0.399N P=0.493 |
|POLY 1.5 | P=0.563N P=0.491 P=0.515N P=0.757 |P=0.125 P=0.022N* P=0.411N P=0.489 |
|POLY 6 | P=0.564N P=0.498 P=0.528N P=0.754 |P=0.126 P=0.021N* P=0.374N P=0.495 |
|LOGISTIC REGRESSION| P=0.557N P=0.552 (e) P=0.744N |P=0.128 P=0.022N* P=0.375N P=0.511 |
|COCH-ARM / FISHERS | P=0.562N P=0.492 P=0.505N P=0.753N |P=0.126 P=0.020N* P=0.402N P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 0/46.22 0/42.35 3/46.39 |0/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 6.5% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/33 (0%) 2/40 (5%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- --- 628 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059 P=0.470N P=0.523N P=0.324 |P=0.619N P=0.494 (e) (e) |
|POLY 3 | P=0.054 P=0.504N P=0.522N P=0.299 |P=0.603N P=0.497 (e) (e) |
|POLY 1.5 | P=0.054 P=0.505N P=0.515N P=0.301 |P=0.603N P=0.497 (e) (e) |
|POLY 6 | P=0.053 P=0.501N P=0.528N P=0.299 |P=0.604N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.055 (e) (e) P=0.309 |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.055 P=0.505N P=0.505N P=0.309 |P=0.601N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 14/50 (28%) 11/50 (22%) 15/50 (30%) | |
|POLY-3 RATE (b) | 10/47.33 14/47.29 11/44.90 15/46.95 | |
|POLY-3 PERCENT (g) | 21.1% 29.6% 24.5% 32.0% | |
|TERMINAL (d) | 9/37 (24%) 13/43 (30%) 8/34 (24%) 13/40 (33%) | |
|FIRST INCIDENCE | 694 615 443 554 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.377 P=0.416 P=0.232 | |
|POLY 3 | P=0.213 P=0.239 P=0.446 P=0.169 | |
|POLY 1.5 | P=0.217 P=0.236 P=0.466 P=0.171 | |
|POLY 6 | P=0.211 P=0.250 P=0.425 P=0.168 | |
|LOGISTIC REGRESSION| P=0.213 P=0.241 P=0.487 P=0.160 | |
|COCH-ARM / FISHERS | P=0.221 P=0.241 P=0.500 P=0.178 | |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 3/46.04 | |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 6.5% | |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 3/40 (8%) | |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * P=0.530 (e) P=0.135 | |
|POLY 3 | P=0.039 * P=0.499 (e) P=0.114 | |
|POLY 1.5 | P=0.039 * P=0.498 (e) P=0.116 | |
|POLY 6 | P=0.038 * P=0.501 (e) P=0.113 | |
|LOGISTIC REGRESSION| (e) P=0.530 (e) P=0.135 | |
|COCH-ARM / FISHERS | P=0.041 * P=0.500 (e) P=0.121 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/47.21 0/46.90 0/43.35 2/46.04 | |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 4.3% | |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/34 (0%) 2/40 (5%) | |
|FIRST INCIDENCE | 726 (T) --- --- 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195 P=0.470N P=0.517N P=0.527 | |
|POLY 3 | P=0.185 P=0.501N P=0.517N P=0.491 | |
|POLY 1.5 | P=0.186 P=0.502N P=0.511N P=0.494 | |
|POLY 6 | P=0.182 P=0.499N P=0.523N P=0.489 | |
|LOGISTIC REGRESSION| P=0.195 (e) (e) P=0.527 | |
|COCH-ARM / FISHERS | P=0.187 P=0.500N P=0.500N P=0.500 | |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/47.21 2/46.90 2/43.35 0/46.04 | |
|POLY-3 PERCENT (g) | 2.1% 4.3% 4.6% 0.0% | |
|TERMINAL (d) | 1/37 (3%) 2/43 (5%) 2/34 (6%) 0/40 (0%) | |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.552 P=0.470 P=0.484N | |
|POLY 3 | P=0.252N P=0.498 P=0.470 P=0.505N | |
|POLY 1.5 | P=0.249N P=0.497 P=0.481 P=0.503N | |
|POLY 6 | P=0.254N P=0.501 P=0.460 P=0.506N | |
|LOGISTIC REGRESSION| P=0.241N P=0.552 P=0.470 (e) | |
|COCH-ARM / FISHERS | P=0.244N P=0.500 P=0.500 P=0.500N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.21 0/46.90 0/43.35 0/46.04 |3/45.45 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 0.0% 0.0% |6.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/37 (5%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 725 --- --- --- |469 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145N P=0.101N P=0.142N P=0.113N |P=0.147N P=0.118N P=0.115N P=0.118N |
|POLY 3 | P=0.137N P=0.120N P=0.135N P=0.123N |P=0.140N P=0.126N P=0.122N P=0.123N |
|POLY 1.5 | P=0.137N P=0.120N P=0.129N P=0.122N |P=0.141N P=0.125N P=0.123N P=0.123N |
|POLY 6 | P=0.138N P=0.118N P=0.141N P=0.124N |P=0.139N P=0.128N P=0.118N P=0.124N |
|LOGISTIC REGRESSION| P=0.148N P=0.106N P=0.145N P=0.119N |P=0.137N P=0.085N P=0.086N P=0.090N |
|COCH-ARM / FISHERS | P=0.142N P=0.121N P=0.121N P=0.121N |P=0.149N P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 44/50 (88%) 45/50 (90%) 49/50 (98%) |14/50 (28%) 50/50 (100%) 46/50 (92%) 50/50 (100%) |
|POLY-3 RATE (b) | 5/47.37 44/48.38 45/47.73 49/49.62 |14/44.21 50/50.00 46/48.33 50/50.00 |
|POLY-3 PERCENT (g) | 10.6% 91.0% 94.3% 98.8% |31.7% 100.0% 95.2% 100.0% |
|TERMINAL (d) | 4/37 (11%) 40/43 (93%) 34/34 (100%) 40/40 (100%)|14/35 (40%) 34/34 (100%) 39/41 (95%) 32/32 (100%) |
|FIRST INCIDENCE | 684 502 439 399 |729 (T) 221 62 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 33/50 (66%) 42/50 (84%) |1/50 (2%) 2/50 (4%) 20/50 (40%) 32/50 (64%) |
|POLY-3 RATE (b) | 1/47.21 11/47.16 33/44.68 42/49.10 |1/44.21 2/43.59 20/46.20 32/47.07 |
|POLY-3 PERCENT (g) | 2.1% 23.3% 73.9% 85.5% |2.3% 4.6% 43.3% 68.0% |
|TERMINAL (d) | 1/37 (3%) 9/43 (21%) 28/34 (82%) 35/40 (88%) |1/35 (3%) 2/34 (6%) 17/41 (42%) 22/32 (69%) |
|FIRST INCIDENCE | 726 (T) 676 517 399 |729 (T) 729 (T) 573 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.495 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.497 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.490 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 20/50 (40%) 47/50 (94%) |1/50 (2%) 1/50 (2%) 6/50 (12%) 17/50 (34%) |
|POLY-3 RATE (b) | 0/47.21 3/46.90 20/43.45 47/49.06 |1/44.21 1/43.59 6/45.19 17/45.04 |
|POLY-3 PERCENT (g) | 0.0% 6.4% 46.0% 95.8% |2.3% 2.3% 13.3% 37.7% |
|TERMINAL (d) | 0/37 (0%) 3/43 (7%) 19/34 (56%) 39/40 (98%) |1/35 (3%) 1/34 (3%) 5/41 (12%) 14/32 (44%) |
|FIRST INCIDENCE | --- 726 (T) 699 399 |729 (T) 729 (T) 586 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.755 P=0.082 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.118 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.758 P=0.059 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.117 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.757 P=0.056 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.119 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.759 P=0.066 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.755 P=0.059 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.753N P=0.056 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue, Site of Application - Dermis |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 15/50 (30%) 40/50 (80%) 49/50 (98%) |4/50 (8%) 27/50 (54%) 31/50 (62%) 44/50 (88%) |
|POLY-3 RATE (b) | 1/47.37 15/47.55 40/46.51 49/49.62 |4/44.26 27/45.28 31/46.56 44/47.32 |
|POLY-3 PERCENT (g) | 2.1% 31.6% 86.0% 98.8% |9.0% 59.6% 66.6% 93.0% |
|TERMINAL (d) | 0/37 (0%) 12/43 (28%) 32/34 (94%) 40/40 (100%)|3/35 (9%) 22/34 (65%) 26/41 (63%) 31/32 (97%) |
|FIRST INCIDENCE | 684 615 443 399 |717 510 573 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.93 1/47.09 0/43.35 1/46.34 |1/44.21 2/44.69 1/45.48 1/44.46 |
|POLY-3 PERCENT (g) | 8.5% 2.1% 0.0% 2.2% |2.3% 4.5% 2.2% 2.3% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 628 676 --- 644 |729 (T) 221 447 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249N P=0.177N P=0.087N P=0.192N |P=0.543N P=0.494 P=0.748N P=0.759N |
|POLY 3 | P=0.228N P=0.178N P=0.071N P=0.183N |P=0.546N P=0.504 P=0.754N P=0.759N |
|POLY 1.5 | P=0.228N P=0.177N P=0.066N P=0.179N |P=0.548N P=0.501 P=0.759N P=0.760 |
|POLY 6 | P=0.230N P=0.177N P=0.077N P=0.187N |P=0.545N P=0.507 P=0.746N P=0.757N |
|LOGISTIC REGRESSION| P=0.223N P=0.153N P=0.049N* P=0.141N |P=0.485N P=0.607 P=0.765 P=0.762 |
|COCH-ARM / FISHERS | P=0.232N P=0.175N P=0.056N P=0.175N |P=0.545N P=0.500 P=0.747 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 20/50 (40%) 17/50 (34%) 19/50 (38%) |32/50 (64%) 24/50 (48%) 30/49 (61%) 33/50 (66%) |
|POLY-3 RATE (b) | 14/46.99 20/49.07 17/48.73 19/48.63 |32/48.20 24/45.57 30/46.64 33/49.12 |
|POLY-3 PERCENT (g) | 29.8% 40.8% 34.9% 39.1% |66.4% 52.7% 64.3% 67.2% |
|TERMINAL (d) | 11/37 (30%) 16/43 (37%) 5/34 (15%) 13/40 (33%) |22/35 (63%) 18/34 (53%) 26/41 (63%) 19/32 (59%) |
|FIRST INCIDENCE | 580 334 439 399 |329 444 444 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.278 P=0.255 P=0.264 |P=0.131 P=0.130N P=0.193N P=0.384 |
|POLY 3 | P=0.342 P=0.181 P=0.377 P=0.230 |P=0.279 P=0.122N P=0.501N P=0.553 |
|POLY 1.5 | P=0.339 P=0.172 P=0.367 P=0.225 |P=0.249 P=0.110N P=0.498N P=0.532 |
|POLY 6 | P=0.345 P=0.197 P=0.395 P=0.239 |P=0.313 P=0.136N P=0.489N P=0.577 |
|LOGISTIC REGRESSION| P=0.380 P=0.175 P=0.562N P=0.252 |P=0.190 P=0.085N P=0.462N P=0.503 |
|COCH-ARM / FISHERS | P=0.334 P=0.162 P=0.358 P=0.217 |P=0.191 P=0.079N P=0.469N P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 1/43.42 1/46.04 |0/44.21 1/43.84 2/45.37 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 2.2% |0.0% 2.3% 4.4% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 708 726 (T) |--- 665 573 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315 (e) P=0.468 P=0.516 |P=0.495N P=0.525 P=0.251 (e) |
|POLY 3 | P=0.307 (e) P=0.483 P=0.495 |P=0.499N P=0.498 P=0.243 (e) |
|POLY 1.5 | P=0.311 (e) P=0.489 P=0.497 |P=0.501N P=0.497 P=0.238 (e) |
|POLY 6 | P=0.303 (e) P=0.478 P=0.494 |P=0.496N P=0.500 P=0.252 (e) |
|LOGISTIC REGRESSION| P=0.311 (e) P=0.487 P=0.516 |P=0.495N P=0.506 P=0.253 (e) |
|COCH-ARM / FISHERS | P=0.315 (e) P=0.500 P=0.500 |P=0.500N P=0.500 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/47.21 0/46.90 3/44.18 2/46.88 |0/44.21 1/43.80 0/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 6.8% 4.3% |0.0% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 3/37 (8%) 0/43 (0%) 1/34 (3%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) --- 487 399 |--- 674 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.096N P=0.622 P=0.472N |P=0.460 P=0.516 (e) P=0.482 |
|POLY 3 | P=0.582 P=0.120N P=0.631 P=0.503N |P=0.464 P=0.498 (e) P=0.500 |
|POLY 1.5 | P=0.585 P=0.120N P=0.642 P=0.502N |P=0.463 P=0.497 (e) P=0.499 |
|POLY 6 | P=0.577 P=0.118N P=0.622 P=0.504N |P=0.466 P=0.500 (e) P=0.502 |
|LOGISTIC REGRESSION| P=0.605 (e) P=0.620N P=0.419N |P=0.464 P=0.504 (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.583 P=0.121N P=0.661N P=0.500N |P=0.464 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 2/43.50 0/46.04 |0/44.21 1/43.72 0/44.71 1/44.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.6% 0.0% |0.0% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 705 --- |--- 698 --- 685 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.693N (e) P=0.209 (e) |P=0.481 P=0.495 (e) P=0.520 |
|POLY 3 | P=0.695N (e) P=0.219 (e) |P=0.465 P=0.498 (e) P=0.501 |
|POLY 1.5 | P=0.691N (e) P=0.226 (e) |P=0.463 P=0.497 (e) P=0.499 |
|POLY 6 | P=0.699N (e) P=0.214 (e) |P=0.468 P=0.499 (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.687N (e) P=0.222 (e) |P=0.464 P=0.498 (e) P=0.501 |
|COCH-ARM / FISHERS | P=0.685N (e) P=0.247 (e) |P=0.464 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) | |
|POLY-3 RATE (b) | 4/47.21 2/47.29 1/43.35 2/46.04 | |
|POLY-3 PERCENT (g) | 8.5% 4.2% 2.3% 4.3% | |
|TERMINAL (d) | 4/37 (11%) 1/43 (2%) 1/34 (3%) 2/40 (5%) | |
|FIRST INCIDENCE | 726 (T) 615 726 (T) 726 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382N P=0.284N P=0.205N P=0.301N | |
|POLY 3 | P=0.394N P=0.337N P=0.206N P=0.349N | |
|POLY 1.5 | P=0.391N P=0.339N P=0.196N P=0.345N | |
|POLY 6 | P=0.399N P=0.329N P=0.216N P=0.352N | |
|LOGISTIC REGRESSION| P=0.397N P=0.337N P=0.205N P=0.301N | |
|COCH-ARM / FISHERS | P=0.388N P=0.339N P=0.181N P=0.339N | |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/47.21 2/47.29 1/43.60 0/46.04 | |
|POLY-3 PERCENT (g) | 0.0% 4.2% 2.3% 0.0% | |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 0/40 (0%) | |
|FIRST INCIDENCE | --- 615 659 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.388N P=0.254 P=0.477 (e) | |
|POLY 3 | P=0.386N P=0.238 P=0.484 (e) | |
|POLY 1.5 | P=0.385N P=0.237 P=0.490 (e) | |
|POLY 6 | P=0.387N P=0.241 P=0.479 (e) | |
|LOGISTIC REGRESSION| P=0.371N P=0.258 P=0.552 (e) | |
|COCH-ARM / FISHERS | P=0.381N P=0.247 P=0.500 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/48 (79%) 37/47 (79%) 37/48 (77%) 38/48 (79%) |13/49 (27%) 17/49 (35%) 19/49 (39%) 16/49 (33%) |
|POLY-3 RATE (b) | 38/48.00 37/46.33 37/44.83 38/46.95 |13/46.80 17/47.65 19/46.49 16/47.01 |
|POLY-3 PERCENT (g) | 79.2% 79.9% 82.5% 80.9% |27.8% 35.7% 40.9% 34.0% |
|TERMINAL (d) | 26/36 (72%) 32/41 (78%) 26/32 (81%) 31/38 (82%) |3/34 (9%) 6/34 (18%) 15/40 (38%) 5/31 (16%) |
|FIRST INCIDENCE | 511 334 439 399 |329 221 62 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504 P=0.244N P=0.339 P=0.484N |P=0.407 P=0.292 P=0.256 P=0.337 |
|POLY 3 | P=0.488 P=0.568 P=0.440 P=0.517 |P=0.451 P=0.274 P=0.132 P=0.333 |
|POLY 1.5 | P=0.517 P=0.587 P=0.540 P=0.553 |P=0.450 P=0.268 P=0.133 P=0.331 |
|POLY 6 | P=0.439 P=0.550 P=0.344 P=0.465 |P=0.453 P=0.276 P=0.133 P=0.336 |
|LOGISTIC REGRESSION| P=0.527 P=0.574N P=0.565 P=0.581N |P=0.442 P=0.250 P=0.148 P=0.320 |
|COCH-ARM / FISHERS | P=0.545 P=0.578N P=0.500N P=0.599N |P=0.454 P=0.256 P=0.141 P=0.329 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/42.55 0/46.04 |0/44.21 0/43.59 0/44.71 2/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.032 * (e) (e) P=0.219 |
|POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.237 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.236 |
|POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.239 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.219 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.21 1/46.90 0/42.55 1/46.39 |1/44.21 1/43.59 2/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 2.2% |2.3% 2.3% 4.5% 2.3% |
|TERMINAL (d) | 1/37 (3%) 1/43 (2%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 1/34 (3%) 2/41 (5%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 628 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.673 P=0.728N P=0.517N P=0.757N |P=0.655 P=0.755 P=0.555 P=0.742 |
|POLY 3 | P=0.671 P=0.759 P=0.521N P=0.757 |P=0.633N P=0.758 P=0.504 P=0.760N |
|POLY 1.5 | P=0.672 P=0.759 P=0.515N P=0.758 |P=0.635N P=0.757 P=0.498 P=0.759 |
|POLY 6 | P=0.671 P=0.760N P=0.526N P=0.756 |P=0.631N P=0.759 P=0.515 P=0.759N |
|LOGISTIC REGRESSION| P=0.677 P=0.728N (e) P=0.742N |P=0.655 P=0.755 P=0.555 P=0.742 |
|COCH-ARM / FISHERS | P=0.675 P=0.753N P=0.505N P=0.753N |P=0.636N P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/19 (100%) 18/18 (100%) 14/14 (100%) 13/13 (100%)|0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | 19/19.00 18/18.00 14/14.00 13/13.00 |0/0.00 0/0.00 0/1.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 14/14 (100%) 18/18 (100%) 11/11 (100%) 11/11 (100%)|0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 624 726 (T) 603 644 |--- --- --- --- |
|-------------------| | |
|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) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | |1/44.21 2/43.59 2/45.19 2/44.31 |
|POLY-3 PERCENT (g) | |2.3% 4.6% 4.4% 4.5% |
|TERMINAL (d) | |1/35 (3%) 2/34 (6%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 586 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.469 P=0.490 P=0.529 P=0.476 |
|POLY 3 | |P=0.503 P=0.495 P=0.508 P=0.501 |
|POLY 1.5 | |P=0.500 P=0.494 P=0.500 P=0.498 |
|POLY 6 | |P=0.505 P=0.497 P=0.521 P=0.504 |
|LOGISTIC REGRESSION| |P=0.502 P=0.490 P=0.502 P=0.497 |
|COCH-ARM / FISHERS | |P=0.500 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |49/50 (98%) 48/50 (96%) 47/50 (94%) 47/50 (94%) |
|POLY-3 RATE (b) | |49/49.68 48/48.57 47/48.23 47/48.60 |
|POLY-3 PERCENT (g) | |98.6% 98.8% 97.5% 96.7% |
|TERMINAL (d) | |35/35 (100%) 34/34 (100%) 40/41 (98%) 32/32 (100%) |
|FIRST INCIDENCE | |329 221 338 410 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.418 P=0.568N P=0.065N P=0.506 |
|POLY 3 | |P=0.353N P=0.871 P=0.633N P=0.517N |
|POLY 1.5 | |P=0.396N P=0.747N P=0.582N P=0.498N |
|POLY 6 | |P=0.322N P=0.933 P=0.636N P=0.533N |
|LOGISTIC REGRESSION| |P=0.316N P=0.625N P=0.460N P=0.393N |
|COCH-ARM / FISHERS | |P=0.300N P=0.500N P=0.309N P=0.309N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(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.
(g) Poly-3 adjusted lifetime tumor incidence.
(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).