TDMS Study 93020-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 07/19/04
EXPERIMENT: 93020 TEST: 08 TIME: 09:18:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: FARNELL, DANIEL CAS: 693-13-0
------------------------------------------------------------------------------------------------------------------------------------
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: Southern Research Inst DIISOPROPYLCARBODIIMIDE DATE: 07/19/04
EXPERIMENT: 93020 TEST: 08 TIME: 09:18:54
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05451 ROUTE: SKIN APPLICATION NTP C#: 93020D
PATHOLOGIST: FARNELL, DANIEL CAS: 693-13-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIISOPROPYLCARBODIIMIDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Kidney Cyst
Inflammation
Metaplasia Focal Osseous
Nephropathy
Liver: Hepatocyte Clear Cell Focus
Eosinophilic Focus
Pancreas: Acinus Atrophy Focal
Preputial Gland Cyst
Skin: Site of Application - Dermis Inflammation Focal
Skin: Site of Application - Epidermis Hyperplasia
Skin: Subcutaneous Tissue Edema
Stomach, Glandular Erosion
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Marrow Hyperplasia
Heart Thrombosis
Kidney Metaplasia Focal Osseous
Liver Eosinophilic Focus
Infiltration Cellular Mixed Cell
Liver: Hepatocyte Mixed Cell Focus
Lymph Node, Mandibular Hyperplasia Lymphoid
Lymph Node: Iliac Ectasia
Hemorrhage
Ovary Hemorrhage
Spleen Hematopoietic Cell Proliferation
Thymus Hyperplasia Lymphoid
Thyroid Gland: Follicular Cell Hyperplasia Focal
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 2/49 (4%) |2/50 (4%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/46.83 2/46.60 2/44.84 2/42.72 |2/42.68 1/44.63 1/43.22 3/45.70 |
|POLY-3 PERCENT (g) | 6.4% 4.3% 4.5% 4.7% |4.7% 2.2% 2.3% 6.6% |
|TERMINAL (d) | 3/39 (8%) 1/40 (3%) 2/38 (5%) 2/36 (6%) |2/33 (6%) 0/33 (0%) 1/38 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 545 729 (T) 729 (T) |729 (T) 12 729 (T) 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.472N P=0.491N P=0.512N P=0.537N |P=0.386 P=0.500N P=0.451N P=0.575 |
|POLY 3 | P=0.469N P=0.502N P=0.520N P=0.542N |P=0.340 P=0.484N P=0.496N P=0.531 |
|POLY 1.5 | P=0.464N P=0.505N P=0.519N P=0.536N |P=0.332 P=0.485N P=0.502N P=0.521 |
|POLY 6 | P=0.474N P=0.498N P=0.520N P=0.546N |P=0.351 P=0.488N P=0.489N P=0.543 |
|LOGISTIC REGRESSION| P=0.461N P=0.489N P=0.512N P=0.537N |P=0.296 P=0.536N P=0.451N P=0.508 |
|COCH-ARM / FISHERS | P=0.440N P=0.500N P=0.500N P=0.510N |P=0.324 P=0.500N P=0.508N P=0.500 |
|ORDER RESTRICTED | P=0.533N (e) (e) (e) |P=0.318 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 7/50 (14%) 4/49 (8%) |1/50 (2%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 9/46.83 5/46.01 7/44.84 4/42.72 |1/42.68 2/43.63 1/43.38 0/45.13 |
|POLY-3 PERCENT (g) | 19.2% 10.9% 15.6% 9.4% |2.3% 4.6% 2.3% 0.0% |
|TERMINAL (d) | 9/39 (23%) 5/40 (13%) 7/38 (18%) 4/36 (11%) |1/33 (3%) 2/33 (6%) 0/38 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.176N P=0.413N P=0.146N |P=0.208N P=0.500 P=0.736N P=0.462N |
|POLY 3 | P=0.169N P=0.202N P=0.429N P=0.153N |P=0.235N P=0.508 P=0.757N P=0.489N |
|POLY 1.5 | P=0.164N P=0.204N P=0.428N P=0.149N |P=0.240N P=0.507 P=0.760 P=0.492N |
|POLY 6 | P=0.174N P=0.200N P=0.430N P=0.157N |P=0.229N P=0.503 P=0.752N P=0.485N |
|LOGISTIC REGRESSION| P=0.167N P=0.176N P=0.413N P=0.146N |P=0.230N P=0.500 P=0.761N (e) |
|COCH-ARM / FISHERS | P=0.139N P=0.194N P=0.393N P=0.125N |P=0.248N P=0.500 P=0.747 P=0.500N |
|ORDER RESTRICTED | P=0.139N (e) (e) (e) |P=0.218N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Hyperostosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.92 2/46.01 1/44.84 0/43.48 |3/43.07 1/43.63 1/44.38 2/45.13 |
|POLY-3 PERCENT (g) | 4.3% 4.4% 2.2% 0.0% |7.0% 2.3% 2.3% 4.4% |
|TERMINAL (d) | 1/39 (3%) 2/40 (5%) 1/38 (3%) 0/36 (0%) |2/33 (6%) 1/33 (3%) 0/39 (0%) 2/40 (5%) |
|FIRST INCIDENCE | 706 729 (T) 729 (T) --- |619 729 (T) 690 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141N P=0.689N P=0.512N P=0.260N |P=0.407N P=0.304N P=0.272N P=0.428N |
|POLY 3 | P=0.138N P=0.687 P=0.516N P=0.255N |P=0.464N P=0.300N P=0.294N P=0.479N |
|POLY 1.5 | P=0.136N P=0.686 P=0.515N P=0.251N |P=0.469N P=0.299N P=0.300N P=0.485N |
|POLY 6 | P=0.141N P=0.687 P=0.517N P=0.258N |P=0.456N P=0.307N P=0.289N P=0.473N |
|LOGISTIC REGRESSION| P=0.140N P=0.690 P=0.515N P=0.254N |P=0.457N P=0.299N P=0.302N P=0.481N |
|COCH-ARM / FISHERS | P=0.125N P=0.691N P=0.500N P=0.247N |P=0.474N P=0.309N P=0.309N P=0.500N |
|ORDER RESTRICTED | P=0.166N (e) (e) (e) |P=0.273N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 13/50 (26%) 12/50 (24%) 7/50 (14%) |14/49 (29%) 5/50 (10%) 10/50 (20%) 2/49 (4%) |
|POLY-3 RATE (b) | 9/46.49 13/46.24 12/45.27 7/44.68 |14/44.39 5/44.15 10/45.05 2/44.17 |
|POLY-3 PERCENT (g) | 19.4% 28.1% 26.5% 15.7% |31.5% 11.3% 22.2% 4.5% |
|TERMINAL (d) | 7/39 (18%) 12/40 (30%) 10/38 (26%) 3/36 (8%) |8/33 (24%) 3/33 (9%) 8/39 (21%) 2/40 (5%) |
|FIRST INCIDENCE | 682 670 653 558 |488 625 560 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337N P=0.253 P=0.288 P=0.470N |P=0.002N** P=0.027N* P=0.161N P<0.001N** |
|POLY 3 | P=0.290N P=0.228 P=0.286 P=0.426N |P=0.003N** P=0.018N* P=0.224N P<0.001N** |
|POLY 1.5 | P=0.284N P=0.230 P=0.290 P=0.420N |P=0.003N** P=0.016N* P=0.226N P<0.001N** |
|POLY 6 | P=0.293N P=0.225 P=0.283 P=0.429N |P=0.002N** P=0.021N* P=0.225N P<0.001N** |
|LOGISTIC REGRESSION| P=0.294N P=0.225 P=0.279 P=0.407N |P=0.003N** P=0.018N* P=0.219N P<0.001N** |
|COCH-ARM / FISHERS | P=0.234N P=0.251 P=0.331 P=0.376N |P=0.004N** P=0.017N* P=0.224N P<0.001N** |
|ORDER RESTRICTED | P=0.241N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.84 0/43.48 |2/43.44 2/44.39 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 4.5% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |521 540 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.267N P=0.680N P=0.226N P=0.456N |
|POLY 3 | (e) (e) (e) (e) |P=0.291N P=0.686N P=0.233N P=0.487N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.293N P=0.686N P=0.236N P=0.490N |
|POLY 6 | (e) (e) (e) (e) |P=0.288N P=0.691N P=0.231N P=0.483N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.307N P=0.680 P=0.236N P=0.516N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.296N P=0.691N P=0.247N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.84 0/43.48 |1/42.68 2/44.91 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 12 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.177N P=0.500 P=0.467N P=0.462N |
|POLY 3 | (e) (e) (e) (e) |P=0.179N P=0.518 P=0.493N P=0.489N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.182N P=0.516 P=0.497N P=0.492N |
|POLY 6 | (e) (e) (e) (e) |P=0.177N P=0.516 P=0.489N P=0.485N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.201N P=0.459 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.188N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.167N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 0/46 (0%) 0/47 (0%) 0/44 (0%) |1/47 (2%) 0/48 (0%) 2/49 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/44.17 0/42.61 0/42.82 0/40.40 |1/41.09 0/41.91 2/44.11 0/44.17 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |2.4% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/32 (0%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 725 --- --- --- |603 --- 614 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.319N P=0.500N P=0.510N P=0.521N |P=0.437N P=0.500N P=0.522 P=0.496N |
|POLY 3 | P=0.305N P=0.507N P=0.506N P=0.518N |P=0.440N P=0.496N P=0.525 P=0.486N |
|POLY 1.5 | P=0.306N P=0.506N P=0.505N P=0.516N |P=0.444N P=0.494N P=0.519 P=0.487N |
|POLY 6 | P=0.304N P=0.508N P=0.508N P=0.520N |P=0.434N P=0.502N P=0.530 P=0.485N |
|LOGISTIC REGRESSION| P=0.317N P=0.508N P=0.508N P=0.521N |P=0.458N P=0.503N P=0.514 P=0.510N |
|COCH-ARM / FISHERS | P=0.309N P=0.500N P=0.495N P=0.511N |P=0.451N P=0.495N P=0.516 P=0.490N |
|ORDER RESTRICTED | P=0.137N (e) (e) (e) |P=0.312N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 3/46 (7%) 1/47 (2%) 3/44 (7%) |0/47 (0%) 1/48 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/44.16 3/42.61 1/42.97 3/40.40 |0/40.66 1/41.91 0/43.71 0/44.17 |
|POLY-3 PERCENT (g) | 4.5% 7.0% 2.3% 7.4% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 3/40 (8%) 0/38 (0%) 3/36 (8%) |0/33 (0%) 1/32 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 690 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.512 P=0.512N P=0.463 |P=0.533N P=0.494 (e) (e) |
|POLY 3 | P=0.439 P=0.484 P=0.509N P=0.460 |P=0.557N P=0.506 (e) (e) |
|POLY 1.5 | P=0.443 P=0.486 P=0.508N P=0.464 |P=0.558N P=0.507 (e) (e) |
|POLY 6 | P=0.434 P=0.482 P=0.511N P=0.454 |P=0.558N P=0.502 (e) (e) |
|LOGISTIC REGRESSION| P=0.433 P=0.512 P=0.506N P=0.463 |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.457 P=0.500 P=0.492N P=0.479 |P=0.561N P=0.505 (e) (e) |
|ORDER RESTRICTED | P=0.441 (e) (e) (e) |P=0.372N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Gallbladder |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/45 (2%) 1/42 (2%) 2/43 (5%) 0/41 (0%) |0/42 (0%) 1/47 (2%) 0/42 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/43.81 1/40.34 2/41.14 0/38.54 |0/36.97 1/41.56 0/39.63 0/42.83 |
|POLY-3 PERCENT (g) | 2.3% 2.5% 4.9% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/39 (3%) 1/37 (3%) 0/36 (0%) |0/31 (0%) 1/33 (3%) 0/37 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 496 --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.762 P=0.481 P=0.516N |P=0.528N P=0.512 (e) (e) |
|POLY 3 | P=0.400N P=0.742 P=0.478 P=0.526N |P=0.550N P=0.523 (e) (e) |
|POLY 1.5 | P=0.398N P=0.741 P=0.478 P=0.525N |P=0.552N P=0.523 (e) (e) |
|POLY 6 | P=0.402N P=0.743 P=0.478 P=0.527N |P=0.550N P=0.521 (e) (e) |
|LOGISTIC REGRESSION| P=0.365N P=0.762 P=0.550 (e) |(e) P=0.512 (e) (e) |
|COCH-ARM / FISHERS | P=0.388N P=0.735 P=0.483 P=0.523N |P=0.556N P=0.528 (e) (e) |
|ORDER RESTRICTED | P=0.280N (e) (e) (e) |P=0.378N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.83 0/46.01 0/44.84 1/43.48 |0/42.68 2/43.06 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 2.3% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |--- 690 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.495N P=0.505N P=0.744 |P=0.372N P=0.237 (e) (e) |
|POLY 3 | P=0.585 P=0.504N P=0.509N P=0.744 |P=0.388N P=0.239 (e) (e) |
|POLY 1.5 | P=0.587 P=0.504N P=0.508N P=0.747 |P=0.393N P=0.238 (e) (e) |
|POLY 6 | P=0.582 P=0.503N P=0.509N P=0.741 |P=0.385N P=0.237 (e) (e) |
|LOGISTIC REGRESSION| P=0.577 (e) (e) P=0.744 |P=0.395N P=0.238 (e) (e) |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.404N P=0.242 (e) (e) |
|ORDER RESTRICTED | P=0.380 (e) (e) (e) |P=0.238N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/46.83 0/46.01 3/45.53 1/43.48 |1/42.68 1/42.91 1/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 6.4% 0.0% 6.6% 2.3% |2.3% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 3/39 (8%) 0/40 (0%) 2/38 (5%) 1/36 (3%) |1/33 (3%) 1/33 (3%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- 493 729 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.406N P=0.117N P=0.649 P=0.334N |P=0.266N P=0.762 P=0.724N P=0.462N |
|POLY 3 | P=0.396N P=0.122N P=0.649 P=0.332N |P=0.300N P=0.760N P=0.753N P=0.489N |
|POLY 1.5 | P=0.391N P=0.122N P=0.647 P=0.328N |P=0.304N P=0.760N P=0.757N P=0.492N |
|POLY 6 | P=0.401N P=0.121N P=0.652 P=0.337N |P=0.295N P=0.760 P=0.749N P=0.485N |
|LOGISTIC REGRESSION| P=0.376N (e) P=0.657N P=0.334N |P=0.266N P=0.762 P=0.724N (e) |
|COCH-ARM / FISHERS | P=0.373N P=0.121N P=0.661N P=0.309N |P=0.310N P=0.747 P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.248N (e) (e) (e) |P=0.317N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 1/45.02 1/44.19 |0/42.68 3/43.91 1/43.71 1/45.56 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 2.3% |0.0% 6.8% 2.3% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 2/33 (6%) 0/38 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 681 484 |--- 653 584 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.219 (e) P=0.491 P=0.488 |P=0.613N P=0.123 P=0.504 P=0.514 |
|POLY 3 | P=0.222 (e) P=0.492 P=0.488 |P=0.623N P=0.124 P=0.505 P=0.513 |
|POLY 1.5 | P=0.224 (e) P=0.492 P=0.490 |P=0.613 P=0.123 P=0.500 P=0.509 |
|POLY 6 | P=0.220 (e) P=0.493 P=0.487 |P=0.614N P=0.122 P=0.510 P=0.518 |
|LOGISTIC REGRESSION| P=0.277 (e) P=0.508 P=0.652 |P=0.583 P=0.123 P=0.499 P=0.480 |
|COCH-ARM / FISHERS | P=0.236 (e) P=0.500 P=0.500 |P=0.590 P=0.121 P=0.495 P=0.500 |
|ORDER RESTRICTED | P=0.240 (e) (e) (e) |P=0.227 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 1/46.01 0/44.84 0/43.48 |4/44.10 0/43.63 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |9.1% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/40 (3%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 0/33 (0%) 1/38 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |44 --- 67 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.582N P=0.505 (e) (e) |P=0.054N P=0.068N P=0.312N P=0.055N |
|POLY 3 | P=0.575N P=0.496 (e) (e) |P=0.057N P=0.061N P=0.336N P=0.057N |
|POLY 1.5 | P=0.574N P=0.496 (e) (e) |P=0.059N P=0.061N P=0.342N P=0.059N |
|POLY 6 | P=0.575N P=0.497 (e) (e) |P=0.054N P=0.064N P=0.330N P=0.056N |
|LOGISTIC REGRESSION| (e) P=0.505 (e) (e) |P=0.066N P=0.067N P=0.311N P=0.078N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.062N P=0.059N P=0.349N P=0.059N |
|ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/49 (4%) 1/50 (2%) |0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.28 2/46.01 2/44.29 1/43.48 |0/42.68 2/42.80 1/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 4.3% 4.4% 4.5% 2.3% |0.0% 4.7% 2.3% 0.0% |
|TERMINAL (d) | 2/39 (5%) 2/40 (5%) 2/38 (5%) 1/36 (3%) |0/33 (0%) 2/33 (6%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.686N P=0.686 P=0.528N |P=0.406N P=0.238 P=0.533 (e) |
|POLY 3 | P=0.398N P=0.692 P=0.678 P=0.522N |P=0.438N P=0.238 P=0.507 (e) |
|POLY 1.5 | P=0.392N P=0.692 P=0.678 P=0.516N |P=0.445N P=0.237 P=0.503 (e) |
|POLY 6 | P=0.405N P=0.691 P=0.678 P=0.528N |P=0.432N P=0.235 P=0.511 (e) |
|LOGISTIC REGRESSION| P=0.407N P=0.686N P=0.686 P=0.528N |(e) P=0.238 P=0.533 (e) |
|COCH-ARM / FISHERS | P=0.367N P=0.684N P=0.691N P=0.492N |P=0.459N P=0.242 P=0.500 (e) |
|ORDER RESTRICTED | P=0.483N (e) (e) (e) |P=0.315N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 10/48 (21%) 5/50 (10%) 3/48 (6%) |1/49 (2%) 0/49 (0%) 4/50 (8%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/45.74 10/44.38 5/44.90 3/41.93 |1/41.96 0/42.91 4/44.51 0/44.17 |
|POLY-3 PERCENT (g) | 6.6% 22.5% 11.1% 7.2% |2.4% 0.0% 9.0% 0.0% |
|TERMINAL (d) | 3/39 (8%) 10/40 (25%) 4/38 (11%) 3/36 (8%) |1/33 (3%) 0/33 (0%) 3/39 (8%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 715 729 (T) |729 (T) --- 653 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.336N P=0.039 * P=0.341 P=0.626 |P=0.469N P=0.500N P=0.227 P=0.462N |
|POLY 3 | P=0.341N P=0.029 * P=0.346 P=0.622 |P=0.507N P=0.496N P=0.197 P=0.490N |
|POLY 1.5 | P=0.327N P=0.030 * P=0.351 P=0.630 |P=0.515N P=0.496N P=0.191 P=0.493N |
|POLY 6 | P=0.355N P=0.029 * P=0.341 P=0.614 |P=0.495N P=0.498N P=0.203 P=0.487N |
|LOGISTIC REGRESSION| P=0.347N P=0.039 * P=0.329 P=0.626 |P=0.512N (e) P=0.195 (e) |
|COCH-ARM / FISHERS | P=0.275N P=0.035 * P=0.381 P=0.661N |P=0.530N P=0.500N P=0.187 P=0.500N |
|ORDER RESTRICTED | P=0.230N (e) (e) (e) |P=0.219N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/45.74 1/44.38 0/44.84 0/41.93 |0/41.96 0/42.91 1/44.22 1/44.56 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 0.0% 0.0% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 2/39 (5%) 1/40 (3%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 729 (T) 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109N P=0.491N P=0.244N P=0.256N |P=0.257 (e) P=0.533 P=0.505 |
|POLY 3 | P=0.102N P=0.511N P=0.242N P=0.257N |P=0.252 (e) P=0.510 P=0.512 |
|POLY 1.5 | P=0.101N P=0.509N P=0.240N P=0.253N |P=0.246 (e) P=0.507 P=0.508 |
|POLY 6 | P=0.103N P=0.511N P=0.244N P=0.261N |P=0.260 (e) P=0.514 P=0.516 |
|LOGISTIC REGRESSION| P=0.109N P=0.491N (e) (e) |P=0.234 (e) P=0.533 P=0.484 |
|COCH-ARM / FISHERS | P=0.099N P=0.500N P=0.237N P=0.247N |P=0.235 (e) P=0.505 P=0.500 |
|ORDER RESTRICTED | P=0.087N (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) |2/49 (4%) 2/49 (4%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/45.74 0/44.38 0/44.84 0/41.93 |2/42.08 2/42.91 1/44.22 1/44.17 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.8% 4.7% 2.3% 2.3% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 2/33 (6%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |698 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.273N P=0.688 P=0.452N P=0.441N |
|POLY 3 | (e) (e) (e) (e) |P=0.324N P=0.687N P=0.483N P=0.483N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.329N P=0.687N P=0.488N P=0.488N |
|POLY 6 | (e) (e) (e) (e) |P=0.319N P=0.693N P=0.478N P=0.479N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.305N P=0.695 P=0.478N P=0.478N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.336N P=0.691N P=0.492N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.420N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 3/48 (6%) 1/50 (2%) 1/48 (2%) |3/49 (6%) 2/49 (4%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/45.74 3/44.38 1/44.84 1/41.93 |3/41.96 2/42.91 1/44.22 1/44.17 |
|POLY-3 PERCENT (g) | 4.4% 6.8% 2.2% 2.4% |7.2% 4.7% 2.3% 2.3% |
|TERMINAL (d) | 2/39 (5%) 3/40 (8%) 1/38 (3%) 1/36 (3%) |3/33 (9%) 2/33 (6%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308N P=0.512 P=0.509N P=0.528N |P=0.145N P=0.500N P=0.247N P=0.239N |
|POLY 3 | P=0.305N P=0.486 P=0.507N P=0.530N |P=0.189N P=0.490N P=0.286N P=0.287N |
|POLY 1.5 | P=0.299N P=0.488 P=0.504N P=0.524N |P=0.193N P=0.490N P=0.292N P=0.292N |
|POLY 6 | P=0.310N P=0.485 P=0.511N P=0.536N |P=0.184N P=0.496N P=0.281N P=0.281N |
|LOGISTIC REGRESSION| P=0.308N P=0.512 P=0.509N P=0.528N |P=0.145N P=0.500N P=0.247N P=0.239N |
|COCH-ARM / FISHERS | P=0.276N P=0.500 P=0.485N P=0.500N |P=0.198N P=0.500N P=0.301N P=0.309N |
|ORDER RESTRICTED | P=0.352N (e) (e) (e) |P=0.198N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/50 (0%) 3/48 (6%) |1/49 (2%) 1/49 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.74 0/44.38 0/44.84 3/43.00 |1/42.35 1/42.91 0/44.22 0/44.17 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% |2.4% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 558 |619 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * (e) (e) P=0.112 |P=0.219N P=0.758N P=0.500N P=0.495N |
|POLY 3 | P=0.010 * (e) (e) P=0.108 |P=0.233N P=0.758N P=0.491N P=0.492N |
|POLY 1.5 | P=0.010 * (e) (e) P=0.109 |P=0.234N P=0.757N P=0.494N P=0.494N |
|POLY 6 | P=0.010 * (e) (e) P=0.107 |P=0.232N P=0.759 P=0.490N P=0.490N |
|LOGISTIC REGRESSION| P=0.014 * (e) (e) P=0.151 |P=0.235N P=0.762 P=0.496N P=0.516N |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.235N P=0.753N P=0.495N P=0.500N |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P=0.242N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Focal Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 2/48 (4%) 1/50 (2%) 0/48 (0%) |5/49 (10%) 2/49 (4%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/45.74 2/44.53 1/44.90 0/41.93 |5/42.40 2/42.91 0/44.22 1/44.17 |
|POLY-3 PERCENT (g) | 8.8% 4.5% 2.2% 0.0% |11.8% 4.7% 0.0% 2.3% |
|TERMINAL (d) | 4/39 (10%) 1/40 (3%) 0/38 (0%) 0/36 (0%) |3/33 (9%) 2/33 (6%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 691 715 --- |619 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037N* P=0.330N P=0.191N P=0.073N |P=0.030N* P=0.222N P=0.026N* P=0.075N |
|POLY 3 | P=0.032N* P=0.350N P=0.184N P=0.072N |P=0.040N* P=0.210N P=0.027N* P=0.092N |
|POLY 1.5 | P=0.031N* P=0.349N P=0.182N P=0.070N |P=0.041N* P=0.209N P=0.028N* P=0.094N |
|POLY 6 | P=0.033N* P=0.349N P=0.187N P=0.074N |P=0.038N* P=0.218N P=0.026N* P=0.090N |
|LOGISTIC REGRESSION| P=0.034N* P=0.351N P=0.192N (e) |P=0.038N* P=0.209N P=0.030N* P=0.093N |
|COCH-ARM / FISHERS | P=0.029N* P=0.339N P=0.168N P=0.059N |P=0.043N* P=0.218N P=0.027N* P=0.102N |
|ORDER RESTRICTED | P=0.024N* (e) (e) (e) |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/48 (96%) 44/48 (92%) 41/50 (82%) 40/48 (83%) |13/49 (27%) 8/49 (16%) 11/50 (22%) 18/49 (37%) |
|POLY-3 RATE (b) | 46/47.64 44/45.63 41/47.04 40/43.37 |13/42.72 8/43.99 11/44.22 18/44.17 |
|POLY-3 PERCENT (g) | 96.6% 96.4% 87.2% 92.2% |30.4% 18.2% 24.9% 40.8% |
|TERMINAL (d) | 39/39 (100%) 39/40 (98%) 34/38 (90%) 34/36 (94%) |11/33 (33%) 6/33 (18%) 11/39 (28%) 18/40 (45%) |
|FIRST INCIDENCE | 515 603 493 558 |521 555 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.337N P=0.302N P=0.263N P=0.356N |P=0.188 P=0.159N P=0.244N P=0.400 |
|POLY 3 | P=0.152N P=0.721N P=0.084N P=0.310N |P=0.068 P=0.138N P=0.367N P=0.216 |
|POLY 1.5 | P=0.105N P=0.632N P=0.079N P=0.208N |P=0.068 P=0.143N P=0.378N P=0.211 |
|POLY 6 | P=0.213N P=0.729 P=0.091N P=0.429N |P=0.071 P=0.141N P=0.359N P=0.220 |
|LOGISTIC REGRESSION| P=0.153N P=0.565N P=0.088N P=0.259N |P=0.092 P=0.150N P=0.336N P=0.251 |
|COCH-ARM / FISHERS | P=0.028N* P=0.339N P=0.030N* P=0.045N* |P=0.068 P=0.162N P=0.385N P=0.193 |
|ORDER RESTRICTED | P=0.119N (e) (e) (e) |P=0.062 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) |3/49 (6%) 1/49 (2%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.74 0/44.38 0/44.84 0/41.93 |3/43.32 1/43.30 0/44.22 2/44.99 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.9% 2.3% 0.0% 4.5% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |488 617 --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.424N P=0.295N P=0.113N P=0.469N |
|POLY 3 | (e) (e) (e) (e) |P=0.439N P=0.305N P=0.115N P=0.483N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.442N P=0.303N P=0.116N P=0.488N |
|POLY 6 | (e) (e) (e) (e) |P=0.434N P=0.312N P=0.114N P=0.476N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.469N P=0.324N P=0.112N P=0.553N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.443N P=0.309N P=0.117N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.174N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 3/48 (6%) 0/50 (0%) 1/48 (2%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/45.74 3/44.38 0/44.84 1/41.93 |0/41.96 0/42.91 0/44.22 0/44.17 |
|POLY-3 PERCENT (g) | 4.4% 6.8% 0.0% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 3/40 (8%) 0/38 (0%) 1/36 (3%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266N P=0.512 P=0.244N P=0.528N |(e) (e) (e) (e) |
|POLY 3 | P=0.258N P=0.486 P=0.242N P=0.530N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.255N P=0.488 P=0.240N P=0.524N |(e) (e) (e) (e) |
|POLY 6 | P=0.262N P=0.485 P=0.244N P=0.536N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.266N P=0.512 (e) P=0.528N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.500 P=0.237N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.203N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/42.71 |1/42.68 2/43.91 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 653 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.165N P=0.500 P=0.467N P=0.462N |
|POLY 3 | (e) (e) (e) (e) |P=0.180N P=0.510 P=0.493N P=0.489N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.183N P=0.508 P=0.497N P=0.492N |
|POLY 6 | (e) (e) (e) (e) |P=0.177N P=0.507 P=0.489N P=0.485N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.182N P=0.506 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.188N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.163N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.83 1/46.01 1/44.84 2/42.71 |0/42.68 0/43.63 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 2.2% 4.7% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/39 (5%) 1/40 (3%) 1/38 (3%) 2/36 (6%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522 P=0.491N P=0.509N P=0.666 |P=0.224 (e) (e) P=0.538 |
|POLY 3 | P=0.525 P=0.506N P=0.515N P=0.660 |P=0.206 (e) (e) P=0.511 |
|POLY 1.5 | P=0.529 P=0.507N P=0.515N P=0.665 |P=0.203 (e) (e) P=0.508 |
|POLY 6 | P=0.521 P=0.505N P=0.515N P=0.657 |P=0.209 (e) (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.522 P=0.491N P=0.509N P=0.666 |(e) (e) (e) P=0.538 |
|COCH-ARM / FISHERS | P=0.548 P=0.500N P=0.500N P=0.684 |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.506 (e) (e) (e) |P=0.131 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 4/49 (8%) |6/50 (12%) 1/50 (2%) 6/50 (12%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.01 1/46.01 1/44.84 4/42.71 |6/42.72 1/43.63 6/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 2.2% 9.4% |14.1% 2.3% 13.6% 0.0% |
|TERMINAL (d) | 1/39 (3%) 1/40 (3%) 1/38 (3%) 4/36 (11%) |5/33 (15%) 1/33 (3%) 6/39 (15%) 0/40 (0%) |
|FIRST INCIDENCE | 682 729 (T) 729 (T) 729 (T) |720 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137 P=0.497N P=0.514N P=0.297 |P=0.024N* P=0.060N P=0.502N P=0.010N* |
|POLY 3 | P=0.144 P=0.507N P=0.516N P=0.294 |P=0.035N* P=0.052N P=0.597N P=0.012N* |
|POLY 1.5 | P=0.147 P=0.507N P=0.515N P=0.300 |P=0.038N* P=0.052N P=0.609N P=0.013N* |
|POLY 6 | P=0.141 P=0.508N P=0.518N P=0.288 |P=0.031N* P=0.053N P=0.584N P=0.011N* |
|LOGISTIC REGRESSION| P=0.135 P=0.505N P=0.513N P=0.291 |P=0.025N* P=0.060N P=0.536N P=0.011N* |
|COCH-ARM / FISHERS | P=0.158 P=0.500N P=0.500N P=0.329 |P=0.045N* P=0.056N P=0.620N P=0.013N* |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) |P=0.006N** (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/42.71 |0/42.68 2/44.15 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.5% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 625 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.569 P=0.239 (e) P=0.538 |
|POLY 3 | (e) (e) (e) (e) |P=0.561 P=0.245 (e) P=0.511 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.554 P=0.243 (e) P=0.508 |
|POLY 6 | (e) (e) (e) (e) |P=0.568 P=0.244 (e) P=0.515 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.539 P=0.234 (e) P=0.538 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 P=0.247 (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.330 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 0/42.71 |0/42.68 1/43.63 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.3% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.561N P=0.500 P=0.276 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.594N P=0.504 P=0.245 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.602N P=0.504 P=0.241 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.586N P=0.502 P=0.249 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.500 P=0.276 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.616N P=0.500 P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.322N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 5/50 (10%) 6/49 (12%) |16/50 (32%) 9/50 (18%) 10/50 (20%) 22/50 (44%) |
|POLY-3 RATE (b) | 8/46.94 5/46.01 5/45.27 6/43.28 |16/43.97 9/46.01 10/45.06 22/45.62 |
|POLY-3 PERCENT (g) | 17.0% 10.9% 11.0% 13.9% |36.4% 19.6% 22.2% 48.2% |
|TERMINAL (d) | 7/39 (18%) 5/40 (13%) 3/38 (8%) 4/36 (11%) |12/33 (36%) 4/33 (12%) 8/39 (21%) 21/40 (53%) |
|FIRST INCIDENCE | 702 729 (T) 653 642 |603 12 603 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454N P=0.263N P=0.300N P=0.452N |P=0.139 P=0.095N P=0.069N P=0.358 |
|POLY 3 | P=0.436N P=0.289N P=0.299N P=0.450N |P=0.039 * P=0.058N P=0.106N P=0.176 |
|POLY 1.5 | P=0.432N P=0.289N P=0.301N P=0.445N |P=0.038 * P=0.061N P=0.115N P=0.171 |
|POLY 6 | P=0.436N P=0.287N P=0.296N P=0.452N |P=0.040 * P=0.061N P=0.099N P=0.177 |
|LOGISTIC REGRESSION| P=0.451N P=0.282N P=0.303N P=0.457N |P=0.048 * P=0.085N P=0.111N P=0.205 |
|COCH-ARM / FISHERS | P=0.399N P=0.277N P=0.277N P=0.403N |P=0.043 * P=0.083N P=0.127N P=0.151 |
|ORDER RESTRICTED | P=0.377N (e) (e) (e) |P=0.013 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 17/50 (34%) 12/50 (24%) 8/49 (16%) |3/50 (6%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 19/46.83 17/46.01 12/44.84 8/42.71 |3/43.07 2/43.63 0/44.22 1/45.62 |
|POLY-3 PERCENT (g) | 40.6% 37.0% 26.8% 18.7% |7.0% 4.6% 0.0% 2.2% |
|TERMINAL (d) | 19/39 (49%) 17/40 (43%) 12/38 (32%) 8/36 (22%) |2/33 (6%) 2/33 (6%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |619 729 (T) --- 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008N** P=0.372N P=0.098N P=0.016N* |P=0.134N P=0.498N P=0.104N P=0.269N |
|POLY 3 | P=0.009N** P=0.442N P=0.118N P=0.019N* |P=0.157N P=0.494N P=0.114N P=0.285N |
|POLY 1.5 | P=0.009N** P=0.445N P=0.119N P=0.018N* |P=0.160N P=0.493N P=0.116N P=0.291N |
|POLY 6 | P=0.010N* P=0.436N P=0.116N P=0.020N* |P=0.153N P=0.503N P=0.111N P=0.278N |
|LOGISTIC REGRESSION| P=0.008N** P=0.372N P=0.098N P=0.016N* |P=0.162N P=0.492N P=0.119N P=0.313N |
|COCH-ARM / FISHERS | P=0.006N** P=0.418N P=0.097N P=0.014N* |P=0.163N P=0.500N P=0.121N P=0.309N |
|ORDER RESTRICTED | P=0.016N* (e) (e) (e) |P=0.097N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.83 0/46.01 0/44.84 0/42.71 |0/42.68 0/43.63 4/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 9.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 4/39 (10%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.122N P=0.233N P=0.244N P=0.256N |P=0.564 (e) P=0.086 (e) |
|POLY 3 | P=0.113N P=0.241N P=0.247N P=0.258N |P=0.536 (e) P=0.065 (e) |
|POLY 1.5 | P=0.113N P=0.242N P=0.247N P=0.256N |P=0.524 (e) P=0.062 (e) |
|POLY 6 | P=0.113N P=0.240N P=0.247N P=0.260N |P=0.553 (e) P=0.067 (e) |
|LOGISTIC REGRESSION| P=0.122N (e) (e) (e) |(e) (e) P=0.086 (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N |P=0.500 (e) P=0.059 (e) |
|ORDER RESTRICTED | P=0.037N* (e) (e) (e) |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/46.83 2/46.01 0/44.84 2/42.71 |2/42.96 0/43.63 1/44.22 6/45.62 |
|POLY-3 PERCENT (g) | 2.1% 4.4% 0.0% 4.7% |4.7% 0.0% 2.3% 13.2% |
|TERMINAL (d) | 1/39 (3%) 2/40 (5%) 0/38 (0%) 2/36 (6%) |1/33 (3%) 0/33 (0%) 1/39 (3%) 5/40 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 729 (T) |653 --- 729 (T) 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.438 P=0.509 P=0.505N P=0.472 |P=0.028 * P=0.240N P=0.459N P=0.192 |
|POLY 3 | P=0.440 P=0.494 P=0.509N P=0.468 |P=0.016 * P=0.234N P=0.490N P=0.153 |
|POLY 1.5 | P=0.443 P=0.493 P=0.508N P=0.472 |P=0.016 * P=0.233N P=0.495N P=0.147 |
|POLY 6 | P=0.437 P=0.495 P=0.509N P=0.464 |P=0.018 * P=0.237N P=0.485N P=0.160 |
|LOGISTIC REGRESSION| P=0.438 P=0.509 (e) P=0.472 |P=0.018 * P=0.235N P=0.493N P=0.143 |
|COCH-ARM / FISHERS | P=0.462 P=0.500 P=0.500N P=0.492 |P=0.016 * P=0.247N P=0.500N P=0.134 |
|ORDER RESTRICTED | P=0.371 (e) (e) (e) |P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 2/50 (4%) 7/49 (14%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/46.83 3/47.17 2/45.80 7/42.97 |3/42.86 3/44.19 1/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 10.7% 6.4% 4.4% 16.3% |7.0% 6.8% 2.3% 2.2% |
|TERMINAL (d) | 5/39 (13%) 1/40 (3%) 0/38 (0%) 5/36 (14%) |2/33 (6%) 0/33 (0%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 435 496 679 |681 653 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.195 P=0.350N P=0.233N P=0.322 |P=0.133N P=0.651 P=0.259N P=0.253N |
|POLY 3 | P=0.196 P=0.353N P=0.225N P=0.320 |P=0.155N P=0.648N P=0.294N P=0.287N |
|POLY 1.5 | P=0.201 P=0.359N P=0.229N P=0.326 |P=0.159N P=0.651N P=0.300N P=0.292N |
|POLY 6 | P=0.193 P=0.346N P=0.221N P=0.317 |P=0.151N P=0.651N P=0.288N P=0.281N |
|LOGISTIC REGRESSION| P=0.230 P=0.324N P=0.201N P=0.307 |P=0.156N P=0.657N P=0.288N P=0.281N |
|COCH-ARM / FISHERS | P=0.222 P=0.357N P=0.218N P=0.365 |P=0.165N P=0.661N P=0.309N P=0.309N |
|ORDER RESTRICTED | P=0.106 (e) (e) (e) |P=0.223N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 17/50 (34%) 17/50 (34%) 18/49 (37%) |5/50 (10%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 18/46.83 17/46.60 17/44.90 18/42.71 |5/43.04 3/44.10 1/44.22 5/46.58 |
|POLY-3 PERCENT (g) | 38.4% 36.5% 37.9% 42.1% |11.6% 6.8% 2.3% 10.7% |
|TERMINAL (d) | 18/39 (46%) 16/40 (40%) 16/38 (42%) 18/36 (50%) |3/33 (9%) 2/33 (6%) 1/39 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 545 715 729 (T) |681 588 729 (T) 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370 P=0.462N P=0.541N P=0.460 |P=0.529N P=0.359N P=0.079N P=0.549N |
|POLY 3 | P=0.371 P=0.507N P=0.563N P=0.444 |P=0.567 P=0.343N P=0.095N P=0.580N |
|POLY 1.5 | P=0.393 P=0.517N P=0.561N P=0.462 |P=0.555 P=0.344N P=0.098N P=0.597N |
|POLY 6 | P=0.351 P=0.494N P=0.563N P=0.427 |P=0.573N P=0.350N P=0.092N P=0.561N |
|LOGISTIC REGRESSION| P=0.346 P=0.520N P=0.577N P=0.460 |P=0.537 P=0.347N P=0.094N P=0.625 |
|COCH-ARM / FISHERS | P=0.488 P=0.500N P=0.500N P=0.553 |P=0.537 P=0.357N P=0.102N P=0.630N |
|ORDER RESTRICTED | P=0.512 (e) (e) (e) |P=0.299N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.92 0/46.01 1/45.29 0/43.48 |2/43.53 0/43.63 1/45.22 1/46.12 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.2% 0.0% |4.6% 0.0% 2.2% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 706 --- 597 --- |506 --- 15 105 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.505N P=0.753 P=0.520N |P=0.491N P=0.236N P=0.492N P=0.487N |
|POLY 3 | P=0.415N P=0.504N P=0.753 P=0.515N |P=0.490N P=0.236N P=0.487N P=0.480N |
|POLY 1.5 | P=0.413N P=0.504N P=0.752 P=0.512N |P=0.493N P=0.235N P=0.490N P=0.484N |
|POLY 6 | P=0.417N P=0.504N P=0.753 P=0.518N |P=0.482N P=0.242N P=0.483N P=0.476N |
|LOGISTIC REGRESSION| P=0.383N P=0.501N P=0.743N P=0.509N |P=0.576N P=0.247N P=0.456N P=0.605N |
|COCH-ARM / FISHERS | P=0.405N P=0.500N P=0.753N P=0.500N |P=0.500N P=0.247N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.267N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.83 1/46.01 4/44.84 0/43.48 |0/42.68 1/43.91 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 8.9% 0.0% |0.0% 2.3% 0.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 1/40 (3%) 4/38 (11%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- 653 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.756N P=0.171 P=0.516N |P=0.431 P=0.500 (e) P=0.538 |
|POLY 3 | P=0.484N P=0.757 P=0.166 P=0.515N |P=0.421 P=0.506 (e) P=0.511 |
|POLY 1.5 | P=0.476N P=0.756 P=0.167 P=0.512N |P=0.416 P=0.505 (e) P=0.508 |
|POLY 6 | P=0.493N P=0.757 P=0.165 P=0.517N |P=0.427 P=0.504 (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.478N P=0.756N P=0.171 (e) |P=0.407 P=0.496 (e) P=0.538 |
|COCH-ARM / FISHERS | P=0.444N P=0.753N P=0.181 P=0.500N |P=0.405 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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) | 0/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 2/43.80 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 683 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.376N P=0.240 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.390N P=0.243 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.394N P=0.242 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.387N P=0.241 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.397N P=0.241 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/46.83 2/46.01 1/44.84 3/43.48 |1/43.38 2/43.63 1/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 8.5% 4.4% 2.2% 6.9% |2.3% 4.6% 2.3% 4.4% |
|TERMINAL (d) | 4/39 (10%) 2/40 (5%) 1/38 (3%) 3/36 (8%) |0/33 (0%) 2/33 (6%) 1/39 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |488 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.501N P=0.325N P=0.187N P=0.544N |P=0.511 P=0.505 P=0.742N P=0.547 |
|POLY 3 | P=0.477N P=0.345N P=0.192N P=0.540N |P=0.461 P=0.502 P=0.756N P=0.514 |
|POLY 1.5 | P=0.473N P=0.346N P=0.192N P=0.533N |P=0.456 P=0.504 P=0.759N P=0.510 |
|POLY 6 | P=0.481N P=0.344N P=0.192N P=0.548N |P=0.468 P=0.495 P=0.754N P=0.519 |
|LOGISTIC REGRESSION| P=0.501N P=0.325N P=0.187N P=0.544N |P=0.448 P=0.493 P=0.762N P=0.484 |
|COCH-ARM / FISHERS | P=0.456N P=0.339N P=0.181N P=0.500N |P=0.444 P=0.500 P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.317N (e) (e) (e) |P=0.460 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lung: Mediastinum |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 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) | 1/46.83 0/46.01 0/44.84 0/43.48 |0/42.68 2/43.63 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 2/33 (6%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.495N P=0.505N P=0.516N |P=0.363N P=0.238 (e) (e) |
|POLY 3 | P=0.299N P=0.504N P=0.509N P=0.515N |P=0.391N P=0.242 (e) (e) |
|POLY 1.5 | P=0.300N P=0.504N P=0.508N P=0.512N |P=0.394N P=0.242 (e) (e) |
|POLY 6 | P=0.298N P=0.503N P=0.509N P=0.517N |P=0.388N P=0.239 (e) (e) |
|LOGISTIC REGRESSION| P=0.316N (e) (e) (e) |(e) P=0.238 (e) (e) |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.134N (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/48 (2%) 0/47 (0%) 1/47 (2%) |6/47 (13%) 4/49 (8%) 2/49 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/44.40 1/44.16 0/42.29 1/40.67 |6/40.17 4/43.97 2/43.67 1/43.13 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 2.5% |14.9% 9.1% 4.6% 2.3% |
|TERMINAL (d) | 0/38 (0%) 1/39 (3%) 0/36 (0%) 1/34 (3%) |4/30 (13%) 2/33 (6%) 1/39 (3%) 1/38 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |603 555 653 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.378 P=0.505 (e) P=0.478 |P=0.018N* P=0.334N P=0.089N P=0.035N* |
|POLY 3 | P=0.380 P=0.499 (e) P=0.483 |P=0.024N* P=0.313N P=0.106N P=0.044N* |
|POLY 1.5 | P=0.384 P=0.499 (e) P=0.486 |P=0.025N* P=0.321N P=0.113N P=0.047N* |
|POLY 6 | P=0.375 P=0.499 (e) P=0.479 |P=0.023N* P=0.312N P=0.100N P=0.042N* |
|LOGISTIC REGRESSION| (e) P=0.505 (e) P=0.478 |P=0.027N* P=0.339N P=0.112N P=0.046N* |
|COCH-ARM / FISHERS | P=0.403 P=0.505 (e) P=0.500 |P=0.027N* P=0.344N P=0.121N P=0.052N |
|ORDER RESTRICTED | P=0.235 (e) (e) (e) |P=0.021N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 1/49 (2%) 0/48 (0%) |1/47 (2%) 1/48 (2%) 5/49 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.83 0/44.12 1/44.57 0/41.62 |1/39.89 1/42.00 5/43.71 2/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |2.5% 2.4% 11.4% 4.4% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/38 (0%) 0/36 (0%) |1/32 (3%) 0/32 (0%) 5/39 (13%) 2/40 (5%) |
|FIRST INCIDENCE | --- --- 653 --- |729 (T) 707 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.686 (e) P=0.496 (e) |P=0.406 P=0.757 P=0.153 P=0.578 |
|POLY 3 | P=0.659 (e) P=0.490 (e) |P=0.361 P=0.749N P=0.123 P=0.543 |
|POLY 1.5 | P=0.666 (e) P=0.489 (e) |P=0.349 P=0.750N P=0.117 P=0.536 |
|POLY 6 | P=0.652 (e) P=0.492 (e) |P=0.376 P=0.752N P=0.129 P=0.550 |
|LOGISTIC REGRESSION| P=0.706 (e) P=0.520 (e) |P=0.384 P=0.756N P=0.153 P=0.578 |
|COCH-ARM / FISHERS | P=0.691 (e) P=0.495 (e) |P=0.327 P=0.747N P=0.112 P=0.523 |
|ORDER RESTRICTED | P=0.373 (e) (e) (e) |P=0.207 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/48 (2%) 3/49 (6%) 0/48 (0%) |0/47 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.97 1/44.12 3/44.54 0/41.62 |0/39.89 0/41.91 0/43.71 1/45.13 |
|POLY-3 PERCENT (g) | 6.4% 2.3% 6.7% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 1/39 (3%) 1/38 (3%) 0/36 (0%) |0/32 (0%) 0/32 (0%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 702 729 (T) 681 --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.160N P=0.314N P=0.638 P=0.145N |P=0.228 (e) (e) P=0.545 |
|POLY 3 | P=0.159N P=0.328N P=0.638 P=0.142N |P=0.213 (e) (e) P=0.525 |
|POLY 1.5 | P=0.155N P=0.328N P=0.636 P=0.139N |P=0.211 (e) (e) P=0.521 |
|POLY 6 | P=0.163N P=0.328N P=0.641 P=0.145N |P=0.217 (e) (e) P=0.528 |
|LOGISTIC REGRESSION| P=0.154N P=0.325N P=0.640 P=0.142N |(e) (e) (e) P=0.545 |
|COCH-ARM / FISHERS | P=0.141N P=0.324N P=0.651 P=0.129N |P=0.205 (e) (e) P=0.515 |
|ORDER RESTRICTED | P=0.094N (e) (e) (e) |P=0.144 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/48 (4%) 4/49 (8%) 2/48 (4%) |3/47 (6%) 6/48 (13%) 2/49 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/46.83 2/44.12 4/44.72 2/41.62 |3/40.33 6/42.88 2/43.71 5/45.13 |
|POLY-3 PERCENT (g) | 6.4% 4.5% 8.9% 4.8% |7.4% 14.0% 4.6% 11.1% |
|TERMINAL (d) | 3/39 (8%) 2/39 (5%) 2/38 (5%) 2/36 (6%) |2/32 (6%) 3/32 (9%) 2/39 (5%) 5/40 (13%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 653 729 (T) |603 555 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523N P=0.500N P=0.485 P=0.537N |P=0.553 P=0.249 P=0.429N P=0.469 |
|POLY 3 | P=0.533N P=0.527N P=0.475 P=0.553N |P=0.497 P=0.272 P=0.463N P=0.419 |
|POLY 1.5 | P=0.526N P=0.528N P=0.471 P=0.547N |P=0.488 P=0.268 P=0.472N P=0.412 |
|POLY 6 | P=0.540N P=0.525N P=0.482 P=0.559N |P=0.506 P=0.270 P=0.455N P=0.426 |
|LOGISTIC REGRESSION| P=0.534N P=0.500N P=0.473 P=0.537N |P=0.489 P=0.255 P=0.468N P=0.425 |
|COCH-ARM / FISHERS | P=0.494N P=0.520N P=0.489 P=0.520N |P=0.467 P=0.254 P=0.480N P=0.393 |
|ORDER RESTRICTED | P=0.567N (e) (e) (e) |P=0.447 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/5 (0%) 0/5 (0%) 0/4 (0%) |0/11 (0%) 1/13 (8%) 1/10 (10%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/5.50 0/5.00 0/5.00 0/3.13 |0/8.74 1/10.61 1/8.86 3/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 9.4% 11.3% 31.5% |
|TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/5 (0%) 0/1 (0%) |0/5 (0%) 0/5 (0%) 1/7 (14%) 3/8 (38%) |
|FIRST INCIDENCE | --- --- --- --- |--- 707 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.106 P=0.494 P=0.567 P=0.198 |
|POLY 3 | (e) (e) (e) (e) |P=0.042 * P=0.539 P=0.503 P=0.109 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.035 * P=0.538 P=0.494 P=0.096 |
|POLY 6 | (e) (e) (e) (e) |P=0.053 P=0.534 P=0.513 P=0.129 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.085 P=0.524 P=0.567 P=0.198 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.030 * P=0.542 P=0.476 P=0.090 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.034 * (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/5 (0%) 0/5 (0%) 0/4 (0%) |2/11 (18%) 0/13 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/5.50 0/5.00 0/5.00 0/3.13 |2/9.44 0/10.52 0/8.86 0/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |21.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/5 (0%) 0/1 (0%) |1/5 (20%) 0/5 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |488 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.093N P=0.235N P=0.203N P=0.187N |
|POLY 3 | (e) (e) (e) (e) |P=0.111N P=0.199N P=0.239N P=0.223N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.114N P=0.194N P=0.244N P=0.234N |
|POLY 6 | (e) (e) (e) (e) |P=0.104N P=0.213N P=0.233N P=0.208N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.201N P=0.246N P=0.340N P=0.440N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.123N P=0.199N P=0.262N P=0.262N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.022N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Iliac |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/5 (0%) 0/5 (0%) 1/4 (25%) |2/11 (18%) 2/13 (15%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/5.50 0/5.00 0/5.00 1/3.68 |2/8.79 2/10.67 2/9.29 2/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 27.2% |22.8% 18.7% 21.5% 21.0% |
|TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/5 (0%) 0/1 (0%) |1/5 (20%) 1/5 (20%) 1/7 (14%) 2/8 (25%) |
|FIRST INCIDENCE | --- --- --- 558 |715 690 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194 (e) (e) P=0.491 |P=0.436N P=0.686 P=0.622N P=0.550N |
|POLY 3 | P=0.144 (e) (e) P=0.416 |P=0.606N P=0.632N P=0.686N P=0.676N |
|POLY 1.5 | P=0.146 (e) (e) P=0.416 |P=0.579 P=0.631N P=0.702 P=0.702N |
|POLY 6 | P=0.141 (e) (e) P=0.417 |P=0.563N P=0.646N P=0.657N P=0.641N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.570N P=0.698N P=0.707 P=0.584N |
|COCH-ARM / FISHERS | P=0.149 (e) (e) P=0.400 |P=0.529 P=0.637N P=0.669 P=0.669 |
|ORDER RESTRICTED | P=0.066 (e) (e) (e) |P=0.691N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Inguinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/6 (33%) 3/5 (60%) 4/5 (80%) 1/4 (25%) |1/11 (9%) 0/13 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/5.78 3/5.00 4/5.00 1/3.68 |1/8.74 0/10.52 0/8.86 0/9.52 |
|POLY-3 PERCENT (g) | 34.6% 60.0% 80.0% 27.2% |11.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/3 (0%) 3/5 (60%) 4/5 (80%) 0/1 (0%) |1/5 (20%) 0/5 (0%) 0/7 (0%) 0/8 (0%) |
|FIRST INCIDENCE | 682 729 (T) 729 (T) 558 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.573 P=0.637 P=0.486 P=0.534N |P=0.245N P=0.500N P=0.433N P=0.406N |
|POLY 3 | P=0.600N P=0.417 P=0.182 P=0.667N |P=0.339N P=0.462N P=0.497N P=0.483N |
|POLY 1.5 | P=0.581N P=0.408 P=0.175 P=0.658N |P=0.334N P=0.462N P=0.506N P=0.498N |
|POLY 6 | P=0.597 P=0.433 P=0.195 P=0.683N |P=0.342N P=0.469N P=0.486N P=0.463N |
|LOGISTIC REGRESSION| P=0.478N P=0.275 P=0.124 P=0.346N |P=0.245N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.562N P=0.392 P=0.175 P=0.667N |P=0.322N P=0.458N P=0.524N P=0.524N |
|ORDER RESTRICTED | P=0.319N (e) (e) (e) |P=0.104N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/5 (0%) 1/5 (20%) 0/4 (0%) |1/11 (9%) 2/13 (15%) 1/10 (10%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/5.50 0/5.00 1/5.00 0/3.13 |1/8.74 2/10.52 1/9.29 3/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 20.0% 0.0% |11.5% 19.0% 10.8% 31.5% |
|TERMINAL (d) | 0/3 (0%) 0/5 (0%) 1/5 (20%) 0/1 (0%) |1/5 (20%) 2/5 (40%) 0/7 (0%) 3/8 (38%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |729 (T) 729 (T) 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.634 (e) P=0.602 (e) |P=0.392 P=0.500 P=0.721N P=0.482 |
|POLY 3 | P=0.545 (e) P=0.481 (e) |P=0.225 P=0.568 P=0.749N P=0.322 |
|POLY 1.5 | P=0.594 (e) P=0.472 (e) |P=0.201 P=0.567 P=0.761 P=0.293 |
|POLY 6 | P=0.468 (e) P=0.497 (e) |P=0.262 P=0.556 P=0.730N P=0.362 |
|LOGISTIC REGRESSION| (e) (e) P=0.602 (e) |P=0.261 P=0.500 P=0.739 P=0.482 |
|COCH-ARM / FISHERS | P=0.653 (e) P=0.455 (e) |P=0.167 P=0.565 P=0.738 P=0.256 |
|ORDER RESTRICTED | P=0.397 (e) (e) (e) |P=0.225 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Renal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/6 (0%) 0/5 (0%) 0/5 (0%) 0/4 (0%) |1/11 (9%) 1/13 (8%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/5.50 0/5.00 0/5.00 0/3.13 |1/9.02 1/10.52 2/8.86 0/9.52 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |11.1% 9.5% 22.6% 0.0% |
|TERMINAL (d) | 0/3 (0%) 0/5 (0%) 0/5 (0%) 0/1 (0%) |0/5 (0%) 1/5 (20%) 2/7 (29%) 0/8 (0%) |
|FIRST INCIDENCE | --- --- --- --- |653 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.255N P=0.760 P=0.588 P=0.485N |
|POLY 3 | (e) (e) (e) (e) |P=0.349N P=0.730N P=0.493 P=0.489N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.376N P=0.724N P=0.483 P=0.501N |
|POLY 6 | (e) (e) (e) (e) |P=0.315N P=0.747N P=0.502 P=0.476N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.321N P=0.730N P=0.510 P=0.600N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.409N P=0.717N P=0.462 P=0.524N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.265N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 1/50 (2%) |3/23 (13%) 5/20 (25%) 0/14 (0%) 1/18 (6%) |
|POLY-3 RATE (b) | 0/45.83 1/45.09 0/44.84 1/43.48 |3/19.63 5/18.04 0/12.80 1/16.08 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.3% |15.3% 27.7% 0.0% 6.2% |
|TERMINAL (d) | 0/38 (0%) 1/40 (3%) 0/38 (0%) 1/36 (3%) |3/15 (20%) 3/12 (25%) 0/11 (0%) 1/13 (8%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |729 (T) 683 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389 P=0.510 (e) P=0.489 |P=0.105N P=0.258 P=0.174N P=0.352N |
|POLY 3 | P=0.390 P=0.497 (e) P=0.490 |P=0.129N P=0.297 P=0.195N P=0.375N |
|POLY 1.5 | P=0.393 P=0.496 (e) P=0.492 |P=0.135N P=0.291 P=0.201N P=0.380N |
|POLY 6 | P=0.387 P=0.498 (e) P=0.487 |P=0.126N P=0.295 P=0.190N P=0.374N |
|LOGISTIC REGRESSION| (e) P=0.510 (e) P=0.489 |P=0.132N P=0.263 (e) P=0.352N |
|COCH-ARM / FISHERS | P=0.410 P=0.500 (e) P=0.505 |P=0.151N P=0.270 P=0.228N P=0.402N |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.081N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 2/49 (4%) 4/50 (8%) 4/50 (8%) |17/23 (74%) 13/20 (65%) 9/14 (64%) 15/18 (83%) |
|POLY-3 RATE (b) | 4/46.14 2/45.09 4/44.84 4/43.72 |17/21.33 13/18.51 9/12.80 15/17.52 |
|POLY-3 PERCENT (g) | 8.7% 4.4% 8.9% 9.2% |79.7% 70.2% 70.3% 85.6% |
|TERMINAL (d) | 2/38 (5%) 2/40 (5%) 4/38 (11%) 3/36 (8%) |12/15 (80%) 9/12 (75%) 9/11 (82%) 12/13 (92%) |
|FIRST INCIDENCE | 672 729 (T) 729 (T) 664 |488 653 729 (T) 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.329N P=0.634 P=0.602 |P=0.478N P=0.430N P=0.100N P=0.554N |
|POLY 3 | P=0.435 P=0.348N P=0.627 P=0.613 |P=0.336 P=0.369N P=0.415N P=0.476 |
|POLY 1.5 | P=0.443 P=0.348N P=0.630 P=0.621 |P=0.315 P=0.357N P=0.393N P=0.444 |
|POLY 6 | P=0.427 P=0.348N P=0.624 P=0.606 |P=0.350 P=0.425N P=0.475N P=0.488 |
|LOGISTIC REGRESSION| P=0.431 P=0.344N P=0.633 P=0.624 |P=0.339 P=0.278N P=0.275N P=0.443 |
|COCH-ARM / FISHERS | P=0.476 P=0.339N P=0.631N P=0.631N |P=0.270 P=0.381N P=0.397N P=0.370 |
|ORDER RESTRICTED | P=0.512 (e) (e) (e) |P=0.282 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.84 0/46.01 1/44.84 0/43.48 |0/42.68 0/43.63 1/43.54 0/45.13 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/40 (0%) 1/38 (3%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 725 --- 729 (T) --- |--- --- 690 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.201N P=0.234N P=0.506N P=0.257N |P=0.708 (e) P=0.516 (e) |
|POLY 3 | P=0.191N P=0.236N P=0.508N P=0.249N |P=0.713 (e) P=0.504 (e) |
|POLY 1.5 | P=0.190N P=0.237N P=0.507N P=0.246N |P=0.706 (e) P=0.500 (e) |
|POLY 6 | P=0.193N P=0.235N P=0.508N P=0.252N |P=0.721 (e) P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.201N P=0.234N P=0.509N P=0.255N |P=0.695 (e) P=0.497 (e) |
|COCH-ARM / FISHERS | P=0.185N P=0.242N P=0.492N P=0.242N |P=0.694 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.082N (e) (e) (e) |P=0.384 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.83 2/46.01 1/44.84 0/43.48 |0/42.68 0/43.63 0/43.39 0/45.13 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 2/40 (5%) 1/38 (3%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.262N P=0.518 P=0.762 P=0.511N |(e) (e) (e) (e) |
|POLY 3 | P=0.263N P=0.501 P=0.756 P=0.510N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.260N P=0.501 P=0.756 P=0.508N |(e) (e) (e) (e) |
|POLY 6 | P=0.266N P=0.503 P=0.756 P=0.513N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.262N P=0.518 P=0.762 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.243N P=0.508 P=0.747N P=0.495N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.237N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.83 0/46.01 2/45.29 3/43.92 |1/43.38 0/43.63 1/43.79 0/45.13 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.4% 6.8% |2.3% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/40 (0%) 1/38 (3%) 1/36 (3%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) --- 597 664 |488 --- 614 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091 P=0.490N P=0.498 P=0.282 |P=0.401N P=0.492N P=0.758N P=0.496N |
|POLY 3 | P=0.096 P=0.499N P=0.496 P=0.290 |P=0.400N P=0.499N P=0.759N P=0.492N |
|POLY 1.5 | P=0.097 P=0.500N P=0.495 P=0.293 |P=0.403N P=0.498N P=0.759 P=0.494N |
|POLY 6 | P=0.095 P=0.498N P=0.498 P=0.289 |P=0.395N P=0.503N P=0.754N P=0.489N |
|LOGISTIC REGRESSION| P=0.106 (e) P=0.517 P=0.301 |P=0.425N P=0.516N P=0.763N P=0.545N |
|COCH-ARM / FISHERS | P=0.106 P=0.495N P=0.508 P=0.316 |P=0.406N P=0.500N P=0.747 P=0.500N |
|ORDER RESTRICTED | P=0.099 (e) (e) (e) |P=0.243N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 3/50 (6%) 1/49 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | |2/41.68 3/43.91 1/43.71 1/44.17 |
|POLY-3 PERCENT (g) | |4.8% 6.8% 2.3% 2.3% |
|TERMINAL (d) | |2/32 (6%) 2/33 (6%) 1/39 (3%) 1/40 (3%) |
|FIRST INCIDENCE | |729 (T) 653 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.215N P=0.511 P=0.431N P=0.422N |
|POLY 3 | |P=0.264N P=0.524 P=0.483N P=0.480N |
|POLY 1.5 | |P=0.271N P=0.521 P=0.492N P=0.486N |
|POLY 6 | |P=0.257N P=0.521 P=0.474N P=0.472N |
|LOGISTIC REGRESSION| |P=0.255N P=0.517 P=0.431N P=0.422N |
|COCH-ARM / FISHERS | |P=0.281N P=0.510 P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.320N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |14/49 (29%) 16/50 (32%) 14/49 (29%) 18/49 (37%) |
|POLY-3 RATE (b) | |14/42.50 16/45.16 14/44.02 18/45.05 |
|POLY-3 PERCENT (g) | |32.9% 35.4% 31.8% 40.0% |
|TERMINAL (d) | |12/32 (38%) 12/33 (36%) 12/39 (31%) 16/40 (40%) |
|FIRST INCIDENCE | |603 540 687 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.526 P=0.454 P=0.372N P=0.515 |
|POLY 3 | |P=0.293 P=0.492 P=0.546N P=0.323 |
|POLY 1.5 | |P=0.275 P=0.480 P=0.569N P=0.302 |
|POLY 6 | |P=0.321 P=0.489 P=0.522N P=0.347 |
|LOGISTIC REGRESSION| |P=0.302 P=0.469 P=0.514N P=0.324 |
|COCH-ARM / FISHERS | |P=0.242 P=0.440 P=0.588N P=0.259 |
|ORDER RESTRICTED | |P=0.392 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | |2/41.68 0/43.63 0/43.71 0/44.17 |
|POLY-3 PERCENT (g) | |4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |2/32 (6%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.094N P=0.231N P=0.196N P=0.191N |
|POLY 3 | |P=0.116N P=0.227N P=0.227N P=0.224N |
|POLY 1.5 | |P=0.116N P=0.227N P=0.232N P=0.228N |
|POLY 6 | |P=0.115N P=0.229N P=0.221N P=0.220N |
|LOGISTIC REGRESSION| |P=0.094N (e) (e) (e) |
|COCH-ARM / FISHERS | |P=0.115N P=0.242N P=0.247N P=0.247N |
|ORDER RESTRICTED | |P=0.025N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/49 (6%) 2/50 (4%) 0/49 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | |3/41.68 2/43.78 0/43.71 3/44.17 |
|POLY-3 PERCENT (g) | |7.2% 4.6% 0.0% 6.8% |
|TERMINAL (d) | |3/32 (9%) 1/33 (3%) 0/39 (0%) 3/40 (8%) |
|FIRST INCIDENCE | |729 (T) 690 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.501N P=0.491N P=0.088N P=0.556N |
|POLY 3 | |P=0.590N P=0.478N P=0.110N P=0.636N |
|POLY 1.5 | |P=0.594N P=0.479N P=0.114N P=0.644N |
|POLY 6 | |P=0.583N P=0.481N P=0.105N P=0.626N |
|LOGISTIC REGRESSION| |P=0.550N P=0.491N (e) P=0.556N |
|COCH-ARM / FISHERS | |P=0.594 P=0.490N P=0.121N P=0.661N |
|ORDER RESTRICTED | |P=0.322N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 1/50 (2%) 1/49 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | |2/41.68 1/43.63 1/43.71 0/44.17 |
|POLY-3 PERCENT (g) | |4.8% 2.3% 2.3% 0.0% |
|TERMINAL (d) | |2/32 (6%) 1/33 (3%) 1/39 (3%) 0/40 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.116N P=0.489N P=0.431N P=0.191N |
|POLY 3 | |P=0.147N P=0.484N P=0.483N P=0.224N |
|POLY 1.5 | |P=0.150N P=0.485N P=0.492N P=0.228N |
|POLY 6 | |P=0.143N P=0.488N P=0.474N P=0.220N |
|LOGISTIC REGRESSION| |P=0.116N P=0.489N P=0.431N (e) |
|COCH-ARM / FISHERS | |P=0.154N P=0.492N P=0.500N P=0.247N |
|ORDER RESTRICTED | |P=0.108N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Oviduct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/3 (100%) 0/1 (0%) 0/0 (0%) 0/0 (0%) |
|POLY-3 RATE (b) | |3/3.00 0/0.47 0/0.00 0/0.00 |
|POLY-3 PERCENT (g) | |100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |3/3 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=1.000 P=1.000N (e) (e) |
|POLY 3 | |(e) P=0.250 (e) (e) |
|POLY 1.5 | |(e) P=0.250 (e) (e) |
|POLY 6 | |(e) P=0.250 (e) (e) |
|LOGISTIC REGRESSION| |P=1.000 (e) (e) (e) |
|COCH-ARM / FISHERS | |P=0.748N P=0.250N (e) (e) |
|ORDER RESTRICTED | |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |0/50 (0%) 2/48 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.29 0/42.69 |0/42.68 2/42.26 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 684 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.373N P=0.240 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.387N P=0.235 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.391N P=0.234 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.383N P=0.234 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.395N P=0.233 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.403N P=0.237 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.235N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 3/49 (6%) |1/50 (2%) 2/48 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.29 3/42.93 |1/42.68 2/42.09 1/44.66 3/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.0% |2.3% 4.8% 2.2% 6.7% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 2/36 (6%) |1/33 (3%) 2/33 (6%) 0/39 (0%) 3/40 (8%) |
|FIRST INCIDENCE | --- --- --- 664 |729 (T) 729 (T) 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * (e) (e) P=0.110 |P=0.301 P=0.500 P=0.742N P=0.376 |
|POLY 3 | P=0.010 * (e) (e) P=0.106 |P=0.260 P=0.495 P=0.751N P=0.325 |
|POLY 1.5 | P=0.010 * (e) (e) P=0.108 |P=0.255 P=0.494 P=0.756N P=0.319 |
|POLY 6 | P=0.010 * (e) (e) P=0.104 |P=0.268 P=0.493 P=0.745N P=0.333 |
|LOGISTIC REGRESSION| P=0.010 * (e) (e) P=0.111 |P=0.257 P=0.500 P=0.762 P=0.376 |
|COCH-ARM / FISHERS | P=0.012 * (e) (e) P=0.121 |P=0.242 P=0.485 P=0.753N P=0.309 |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |0/50 (0%) 2/48 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.29 0/42.69 |0/42.68 2/42.26 0/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.7% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 684 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.585 P=0.240 (e) P=0.538 |
|POLY 3 | (e) (e) (e) (e) |P=0.564 P=0.235 (e) P=0.511 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.557 P=0.234 (e) P=0.508 |
|POLY 6 | (e) (e) (e) (e) |P=0.571 P=0.234 (e) P=0.515 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.557 P=0.233 (e) P=0.538 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.543 P=0.237 (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.325 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/46 (4%) 1/47 (2%) |2/46 (4%) 2/43 (5%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/45.83 0/46.01 2/41.18 1/41.95 |2/40.35 2/37.56 0/43.22 1/44.13 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.9% 2.4% |5.0% 5.3% 0.0% 2.3% |
|TERMINAL (d) | 1/38 (3%) 0/40 (0%) 1/35 (3%) 0/36 (0%) |2/31 (7%) 2/29 (7%) 0/38 (0%) 1/39 (3%) |
|FIRST INCIDENCE | 729 (T) --- 653 498 |729 (T) 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.490N P=0.478 P=0.745 |P=0.222N P=0.672 P=0.195N P=0.420N |
|POLY 3 | P=0.466 P=0.499N P=0.463 P=0.741 |P=0.267N P=0.669 P=0.222N P=0.469N |
|POLY 1.5 | P=0.467 P=0.500N P=0.463 P=0.741 |P=0.269N P=0.668 P=0.225N P=0.473N |
|POLY 6 | P=0.466 P=0.498N P=0.464 P=0.741 |P=0.263N P=0.665 P=0.218N P=0.463N |
|LOGISTIC REGRESSION| P=0.512 (e) P=0.470 P=0.731N |P=0.222N P=0.672 (e) P=0.420N |
|COCH-ARM / FISHERS | P=0.483 P=0.495N P=0.476 P=0.742 |P=0.270N P=0.666 P=0.232N P=0.476N |
|ORDER RESTRICTED | P=0.343 (e) (e) (e) |P=0.222N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/50 (0%) 0/49 (0%) |3/48 (6%) 1/50 (2%) 1/50 (2%) 3/46 (7%) |
|POLY-3 RATE (b) | 0/44.84 0/43.75 0/44.84 0/42.71 |3/40.81 1/43.63 1/44.22 3/42.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |7.4% 2.3% 2.3% 7.1% |
|TERMINAL (d) | 0/38 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |3/32 (9%) 1/33 (3%) 1/39 (3%) 3/38 (8%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.579 P=0.293N P=0.237N P=0.582N |
|POLY 3 | (e) (e) (e) (e) |P=0.497 P=0.281N P=0.277N P=0.648N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.489 P=0.282N P=0.283N P=0.659N |
|POLY 6 | (e) (e) (e) (e) |P=0.511 P=0.285N P=0.270N P=0.635N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.579 P=0.293N P=0.237N P=0.582N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.478 P=0.293N P=0.293N P=0.641 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.363N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 3/50 (6%) 3/49 (6%) |0/48 (0%) 0/50 (0%) 1/50 (2%) 0/46 (0%) |
|POLY-3 RATE (b) | 1/44.84 2/43.75 3/44.84 3/42.71 |0/40.81 0/43.63 1/44.22 0/42.13 |
|POLY-3 PERCENT (g) | 2.2% 4.6% 6.7% 7.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/38 (3%) 2/40 (5%) 3/38 (8%) 3/36 (8%) |0/32 (0%) 0/33 (0%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.518 P=0.305 P=0.286 |P=0.718 (e) P=0.539 (e) |
|POLY 3 | P=0.209 P=0.491 P=0.305 P=0.288 |P=0.716 (e) P=0.516 (e) |
|POLY 1.5 | P=0.214 P=0.488 P=0.306 P=0.292 |P=0.707 (e) P=0.512 (e) |
|POLY 6 | P=0.203 P=0.497 P=0.305 P=0.285 |P=0.729 (e) P=0.520 (e) |
|LOGISTIC REGRESSION| P=0.199 P=0.518 P=0.305 P=0.286 |(e) (e) P=0.539 (e) |
|COCH-ARM / FISHERS | P=0.238 P=0.492 P=0.324 P=0.316 |P=0.690 (e) P=0.510 (e) |
|ORDER RESTRICTED | P=0.248 (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cytoplasmic Alteration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/47 (0%) 5/50 (10%) 0/49 (0%) |2/48 (4%) 0/50 (0%) 4/50 (8%) 1/46 (2%) |
|POLY-3 RATE (b) | 1/44.84 0/43.75 5/44.99 0/42.71 |2/41.24 0/43.63 4/44.22 1/42.13 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 11.1% 0.0% |4.9% 0.0% 9.0% 2.4% |
|TERMINAL (d) | 1/38 (3%) 0/40 (0%) 4/38 (11%) 0/36 (0%) |1/32 (3%) 0/33 (0%) 4/39 (10%) 1/38 (3%) |
|FIRST INCIDENCE | 729 (T) --- 690 --- |603 --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.586N P=0.490N P=0.103 P=0.511N |P=0.514N P=0.236N P=0.416 P=0.460N |
|POLY 3 | P=0.588N P=0.505N P=0.102 P=0.510N |P=0.572N P=0.224N P=0.370 P=0.493N |
|POLY 1.5 | P=0.579N P=0.507N P=0.102 P=0.508N |P=0.583N P=0.224N P=0.363 P=0.500N |
|POLY 6 | P=0.597N P=0.502N P=0.102 P=0.511N |P=0.556N P=0.229N P=0.375 P=0.485N |
|LOGISTIC REGRESSION| P=0.576N (e) P=0.102 (e) |P=0.574N P=0.230N P=0.369 P=0.512N |
|COCH-ARM / FISHERS | P=0.544N P=0.505N P=0.112 P=0.495N |P=0.599N P=0.237N P=0.359 P=0.516N |
|ORDER RESTRICTED | P=0.179 (e) (e) (e) |P=0.343 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/47 (0%) 0/50 (0%) 0/49 (0%) |3/48 (6%) 2/50 (4%) 7/50 (14%) 3/46 (7%) |
|POLY-3 RATE (b) | 1/44.84 0/43.75 0/44.84 0/42.71 |3/40.86 2/43.63 7/44.22 3/42.13 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |7.3% 4.6% 15.8% 7.1% |
|TERMINAL (d) | 1/38 (3%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |2/32 (6%) 2/33 (6%) 7/39 (18%) 3/38 (8%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |715 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.490N P=0.500N P=0.511N |P=0.557 P=0.494N P=0.245 P=0.582N |
|POLY 3 | P=0.297N P=0.505N P=0.500N P=0.510N |P=0.466 P=0.470N P=0.190 P=0.649N |
|POLY 1.5 | P=0.297N P=0.507N P=0.500N P=0.508N |P=0.446 P=0.471N P=0.182 P=0.660N |
|POLY 6 | P=0.297N P=0.502N P=0.500N P=0.511N |P=0.494 P=0.477N P=0.198 P=0.636N |
|LOGISTIC REGRESSION| P=0.313N (e) (e) (e) |P=0.534 P=0.492N P=0.217 P=0.615N |
|COCH-ARM / FISHERS | P=0.301N P=0.505N P=0.490N P=0.495N |P=0.414 P=0.480N P=0.176 P=0.641 |
|ORDER RESTRICTED | P=0.130N (e) (e) (e) |P=0.292 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 2/43.48 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% | |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 2/36 (6%) | |
|FIRST INCIDENCE | --- --- --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) (e) P=0.221 | |
|POLY 3 | P=0.043 * (e) (e) P=0.221 | |
|POLY 1.5 | P=0.043 * (e) (e) P=0.224 | |
|POLY 6 | P=0.042 * (e) (e) P=0.218 | |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.221 | |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 | |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 4/50 (8%) | |
|POLY-3 RATE (b) | 3/47.54 1/46.09 1/45.29 4/44.27 | |
|POLY-3 PERCENT (g) | 6.3% 2.2% 2.2% 9.0% | |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 2/36 (6%) | |
|FIRST INCIDENCE | 592 710 597 558 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.317N P=0.327N P=0.449 | |
|POLY 3 | P=0.285 P=0.317N P=0.323N P=0.461 | |
|POLY 1.5 | P=0.288 P=0.315N P=0.322N P=0.468 | |
|POLY 6 | P=0.282 P=0.319N P=0.325N P=0.454 | |
|LOGISTIC REGRESSION| P=0.329 P=0.277N P=0.248N P=0.543 | |
|COCH-ARM / FISHERS | P=0.302 P=0.309N P=0.309N P=0.500 | |
|ORDER RESTRICTED | P=0.177 (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 10/50 (20%) 6/50 (12%) | |
|POLY-3 RATE (b) | 11/47.24 8/46.16 10/44.90 6/43.71 | |
|POLY-3 PERCENT (g) | 23.3% 17.3% 22.3% 13.7% | |
|TERMINAL (d) | 7/39 (18%) 7/40 (18%) 9/38 (24%) 5/36 (14%) | |
|FIRST INCIDENCE | 682 691 715 667 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213N P=0.302N P=0.535N P=0.204N | |
|POLY 3 | P=0.195N P=0.324N P=0.553N P=0.184N | |
|POLY 1.5 | P=0.186N P=0.324N P=0.547N P=0.176N | |
|POLY 6 | P=0.206N P=0.325N P=0.561N P=0.194N | |
|LOGISTIC REGRESSION| P=0.202N P=0.317N P=0.546N P=0.187N | |
|COCH-ARM / FISHERS | P=0.150N P=0.306N P=0.500N P=0.143N | |
|ORDER RESTRICTED | P=0.194N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/46.83 1/46.24 0/44.84 2/44.70 | |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 4.5% | |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) | |
|FIRST INCIDENCE | --- 670 --- 484 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.496 (e) P=0.224 | |
|POLY 3 | P=0.132 P=0.497 (e) P=0.227 | |
|POLY 1.5 | P=0.133 P=0.497 (e) P=0.228 | |
|POLY 6 | P=0.132 P=0.499 (e) P=0.227 | |
|LOGISTIC REGRESSION| P=0.178 P=0.516 (e) P=0.341 | |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 | |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) | |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/46.83 1/46.01 0/44.84 0/43.48 | |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% | |
|TERMINAL (d) | 2/39 (5%) 1/40 (3%) 0/38 (0%) 0/36 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109N P=0.491N P=0.244N P=0.256N | |
|POLY 3 | P=0.103N P=0.506N P=0.247N P=0.254N | |
|POLY 1.5 | P=0.103N P=0.507N P=0.247N P=0.251N | |
|POLY 6 | P=0.104N P=0.505N P=0.247N P=0.257N | |
|LOGISTIC REGRESSION| P=0.109N P=0.491N (e) (e) | |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.247N P=0.247N | |
|ORDER RESTRICTED | P=0.086N (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Site of Application |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 1/46.45 1/45.12 0/43.48 |2/43.17 1/43.63 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 0.0% |4.6% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 603 653 --- |603 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611N P=0.504 P=0.496 (e) |P=0.089N P=0.507N P=0.228N P=0.220N |
|POLY 3 | P=0.615N P=0.498 P=0.493 (e) |P=0.099N P=0.496N P=0.232N P=0.227N |
|POLY 1.5 | P=0.611N P=0.497 P=0.492 (e) |P=0.100N P=0.495N P=0.235N P=0.230N |
|POLY 6 | P=0.618N P=0.500 P=0.493 (e) |P=0.097N P=0.504N P=0.229N P=0.225N |
|LOGISTIC REGRESSION| P=0.562N P=0.558 P=0.525 (e) |P=0.100N P=0.499N P=0.238N P=0.244N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.101N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.400 (e) (e) (e) |P=0.068N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Site of Application - Dermis |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 9/50 (18%) 1/50 (2%) |3/50 (6%) 2/50 (4%) 7/50 (14%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.83 2/46.67 9/45.12 1/43.48 |3/43.78 2/43.63 7/44.22 2/45.13 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 20.0% 2.3% |6.9% 4.6% 15.8% 4.4% |
|TERMINAL (d) | 2/39 (5%) 0/40 (0%) 8/38 (21%) 1/36 (3%) |1/33 (3%) 2/33 (6%) 7/39 (18%) 2/40 (5%) |
|FIRST INCIDENCE | 729 (T) 603 653 729 (T) |506 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559 P=0.688N P=0.025 * P=0.528N |P=0.430N P=0.494N P=0.221 P=0.442N |
|POLY 3 | P=0.540 P=0.692 P=0.021 * P=0.526N |P=0.513N P=0.502N P=0.161 P=0.486N |
|POLY 1.5 | P=0.556 P=0.690 P=0.021 * P=0.521N |P=0.521N P=0.497N P=0.158 P=0.489N |
|POLY 6 | P=0.522 P=0.690N P=0.021 * P=0.531N |P=0.500N P=0.513N P=0.162 P=0.483N |
|LOGISTIC REGRESSION| P=0.568N P=0.680N P=0.022 * P=0.528N |P=0.518N P=0.506N P=0.162 P=0.515N |
|COCH-ARM / FISHERS | P=0.537N P=0.691N P=0.026 * P=0.500N |P=0.537N P=0.500N P=0.159 P=0.500N |
|ORDER RESTRICTED | P=0.153N (e) (e) (e) |P=0.324N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Site of Application - Epidermis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 10/50 (20%) 1/50 (2%) |5/50 (10%) 3/50 (6%) 7/50 (14%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/46.83 3/46.45 10/45.12 1/43.48 |5/44.12 3/44.15 7/44.22 7/46.32 |
|POLY-3 PERCENT (g) | 4.3% 6.5% 22.2% 2.3% |11.3% 6.8% 15.8% 15.1% |
|TERMINAL (d) | 2/39 (5%) 2/40 (5%) 9/38 (24%) 1/36 (3%) |1/33 (3%) 2/33 (6%) 7/39 (18%) 5/40 (13%) |
|FIRST INCIDENCE | 729 (T) 603 653 729 (T) |506 568 729 (T) 528 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556N P=0.511 P=0.014 * P=0.528N |P=0.302 P=0.356N P=0.469 P=0.474 |
|POLY 3 | P=0.565 P=0.496 P=0.011 * P=0.526N |P=0.228 P=0.356N P=0.380 P=0.414 |
|POLY 1.5 | P=0.559N P=0.494 P=0.011 * P=0.521N |P=0.218 P=0.351N P=0.378 P=0.404 |
|POLY 6 | P=0.547 P=0.500 P=0.011 * P=0.531N |P=0.243 P=0.369N P=0.380 P=0.422 |
|LOGISTIC REGRESSION| P=0.544N P=0.500 P=0.012 * P=0.528N |P=0.202 P=0.366N P=0.385 P=0.357 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.014 * P=0.500N |P=0.200 P=0.357N P=0.380 P=0.380 |
|ORDER RESTRICTED | P=0.108N (e) (e) (e) |P=0.280 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 39
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.83 0/46.01 0/44.84 2/44.11 |1/43.38 2/44.01 0/44.22 1/45.56 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.5% |2.3% 4.5% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 558 |488 619 --- 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042 * (e) (e) P=0.224 |P=0.478N P=0.508 P=0.500N P=0.750N |
|POLY 3 | P=0.043 * (e) (e) P=0.224 |P=0.491N P=0.505 P=0.496N P=0.750N |
|POLY 1.5 | P=0.043 * (e) (e) P=0.226 |P=0.494N P=0.505 P=0.499N P=0.753N |
|POLY 6 | P=0.043 * (e) (e) P=0.223 |P=0.487N P=0.501 P=0.494N P=0.745N |
|LOGISTIC REGRESSION| P=0.051 (e) (e) P=0.267 |P=0.519N P=0.485 P=0.486N P=0.731 |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.500N P=0.500 P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.025 * (e) (e) (e) |P=0.367N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 13/50 (26%) 14/50 (28%) 13/47 (28%) |24/49 (49%) 21/49 (43%) 18/50 (36%) 13/50 (26%) |
|POLY-3 RATE (b) | 15/48.35 13/46.82 14/46.50 13/42.78 |24/45.14 21/47.08 18/46.88 13/45.83 |
|POLY-3 PERCENT (g) | 31.0% 27.8% 30.1% 30.4% |53.2% 44.6% 38.4% 28.4% |
|TERMINAL (d) | 9/39 (23%) 10/40 (25%) 9/38 (24%) 7/35 (20%) |15/33 (46%) 10/33 (30%) 13/39 (33%) 10/40 (25%) |
|FIRST INCIDENCE | 515 603 496 474 |305 12 67 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.533 P=0.406N P=0.541N P=0.538N |P=0.005N** P=0.366N P=0.086N P=0.008N** |
|POLY 3 | P=0.533 P=0.451N P=0.550N P=0.564N |P=0.009N** P=0.269N P=0.110N P=0.012N* |
|POLY 1.5 | P=0.538N P=0.436N P=0.540N P=0.546N |P=0.009N** P=0.280N P=0.116N P=0.012N* |
|POLY 6 | P=0.522 P=0.465N P=0.559N P=0.577N |P=0.009N** P=0.267N P=0.109N P=0.012N* |
|LOGISTIC REGRESSION| P=0.470N P=0.369N P=0.446N P=0.428N |P=0.010N* P=0.356N P=0.135N P=0.013N* |
|COCH-ARM / FISHERS | P=0.463N P=0.387N P=0.474N P=0.463N |P=0.009N** P=0.343N P=0.135N P=0.015N* |
|ORDER RESTRICTED | P=0.666N (e) (e) (e) |P=0.010N* (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 40
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 5/50 (10%) 1/50 (2%) 1/47 (2%) |6/49 (12%) 12/49 (24%) 12/50 (24%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/46.28 5/46.01 1/44.99 1/40.78 |6/42.08 12/42.91 12/44.22 6/45.13 |
|POLY-3 PERCENT (g) | 4.3% 10.9% 2.2% 2.5% |14.3% 28.0% 27.1% 13.3% |
|TERMINAL (d) | 2/39 (5%) 5/40 (13%) 0/38 (0%) 1/35 (3%) |5/33 (15%) 12/33 (36%) 12/39 (31%) 6/40 (15%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 690 729 (T) |698 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230N P=0.226 P=0.512N P=0.538N |P=0.213N P=0.088 P=0.172 P=0.485N |
|POLY 3 | P=0.234N P=0.214 P=0.510N P=0.544N |P=0.321N P=0.098 P=0.112 P=0.571N |
|POLY 1.5 | P=0.229N P=0.215 P=0.509N P=0.538N |P=0.339N P=0.100 P=0.107 P=0.581N |
|POLY 6 | P=0.239N P=0.213 P=0.511N P=0.549N |P=0.301N P=0.089 P=0.117 P=0.562N |
|LOGISTIC REGRESSION| P=0.239N P=0.226 P=0.509N P=0.538N |P=0.243N P=0.077 P=0.134 P=0.538N |
|COCH-ARM / FISHERS | P=0.206N P=0.226 P=0.492N P=0.516N |P=0.380N P=0.096 P=0.104 P=0.606N |
|ORDER RESTRICTED | P=0.211N (e) (e) (e) |P=0.193N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 1/46.01 0/44.84 0/43.48 |2/43.35 0/42.91 2/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |4.6% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/39 (0%) 1/40 (3%) 0/38 (0%) 0/36 (0%) |1/33 (3%) 0/33 (0%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |506 --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.582N P=0.505 (e) (e) |P=0.212N P=0.233N P=0.646N P=0.214N |
|POLY 3 | P=0.575N P=0.496 (e) (e) |P=0.237N P=0.239N P=0.687N P=0.228N |
|POLY 1.5 | P=0.574N P=0.496 (e) (e) |P=0.241N P=0.239N P=0.691N P=0.231N |
|POLY 6 | P=0.575N P=0.497 (e) (e) |P=0.231N P=0.243N P=0.682N P=0.225N |
|LOGISTIC REGRESSION| (e) P=0.505 (e) (e) |P=0.248N P=0.250N P=0.695 P=0.254N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.246N P=0.253N P=0.691N P=0.247N |
|ORDER RESTRICTED | P=0.391N (e) (e) (e) |P=0.109N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 41
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/49 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.83 1/46.27 0/44.84 0/43.48 |1/43.61 1/43.44 0/44.22 2/46.08 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.3% 2.3% 0.0% 4.3% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 660 --- --- |305 568 --- 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579N P=0.500 (e) (e) |P=0.373 P=0.753N P=0.504N P=0.510 |
|POLY 3 | P=0.574N P=0.498 (e) (e) |P=0.381 P=0.760 P=0.497N P=0.519 |
|POLY 1.5 | P=0.574N P=0.497 (e) (e) |P=0.376 P=0.759 P=0.500N P=0.512 |
|POLY 6 | P=0.574N P=0.499 (e) (e) |P=0.389 P=0.759 P=0.494N P=0.529 |
|LOGISTIC REGRESSION| P=0.556N P=0.522 (e) (e) |P=0.325 P=0.748 P=0.451N P=0.419 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.369 P=0.747 P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.392N (e) (e) (e) |P=0.293 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 4/49 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.83 2/46.27 3/45.07 2/43.71 |4/43.35 4/43.72 2/44.22 1/45.70 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 6.7% 4.6% |9.2% 9.2% 4.5% 2.2% |
|TERMINAL (d) | 2/39 (5%) 1/40 (3%) 2/38 (5%) 1/36 (3%) |3/33 (9%) 2/33 (6%) 2/39 (5%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 660 669 667 |506 568 729 (T) 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527 P=0.686N P=0.486 P=0.663 |P=0.071N P=0.634N P=0.275N P=0.145N |
|POLY 3 | P=0.530 P=0.689 P=0.483 P=0.669 |P=0.085N P=0.639N P=0.328N P=0.163N |
|POLY 1.5 | P=0.537 P=0.688 P=0.482 P=0.673 |P=0.088N P=0.641N P=0.334N P=0.168N |
|POLY 6 | P=0.524 P=0.692 P=0.484 P=0.666 |P=0.080N P=0.641N P=0.321N P=0.157N |
|LOGISTIC REGRESSION| P=0.548 P=0.691 P=0.481 P=0.672 |P=0.096N P=0.630 P=0.333N P=0.192N |
|COCH-ARM / FISHERS | P=0.569 P=0.691N P=0.500 P=0.691N |P=0.094N P=0.631 P=0.339N P=0.181N |
|ORDER RESTRICTED | P=0.598 (e) (e) (e) |P=0.130N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 42
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/47 (2%) 1/48 (2%) 0/47 (0%) |0/49 (0%) 0/48 (0%) 0/47 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/48.14 1/44.22 1/43.09 0/40.99 |0/41.96 0/42.09 0/43.26 1/46.12 |
|POLY-3 PERCENT (g) | 8.3% 2.3% 2.3% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/39 (3%) 0/40 (0%) 1/38 (3%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 515 545 729 (T) --- |--- --- --- 105 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042N* P=0.189N P=0.200N P=0.081N |P=0.202 (e) (e) P=0.504 |
|POLY 3 | P=0.042N* P=0.206N P=0.214N P=0.083N |P=0.213 (e) (e) P=0.519 |
|POLY 1.5 | P=0.040N* P=0.206N P=0.211N P=0.080N |P=0.211 (e) (e) P=0.515 |
|POLY 6 | P=0.043N* P=0.205N P=0.218N P=0.087N |P=0.217 (e) (e) P=0.522 |
|LOGISTIC REGRESSION| P=0.025N* P=0.118N P=0.144N P=0.038N* |P=0.099 (e) (e) P=0.369 |
|COCH-ARM / FISHERS | P=0.038N* P=0.201N P=0.194N P=0.066N |P=0.203 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.020N* (e) (e) (e) |P=0.138 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 1/44 (2%) 2/47 (4%) 0/46 (0%) |0/46 (0%) 0/48 (0%) 0/44 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 2/44.38 1/40.97 2/42.02 0/40.71 |0/38.72 0/42.72 0/38.87 0/42.13 |
|POLY-3 PERCENT (g) | 4.5% 2.4% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/38 (5%) 0/36 (0%) 2/36 (6%) 0/34 (0%) |0/30 (0%) 0/33 (0%) 0/35 (0%) 0/37 (0%) |
|FIRST INCIDENCE | 729 (T) 670 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N P=0.515N P=0.676 P=0.263N |(e) (e) (e) (e) |
|POLY 3 | P=0.217N P=0.528N P=0.674 P=0.257N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.213N P=0.529N P=0.676 P=0.253N |(e) (e) (e) (e) |
|POLY 6 | P=0.223N P=0.526N P=0.672 P=0.261N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.214N P=0.526N P=0.676 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.200N P=0.525N P=0.692N P=0.253N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.171N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 43
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/44 (0%) 0/47 (0%) 0/46 (0%) |5/46 (11%) 4/48 (8%) 4/44 (9%) 1/47 (2%) |
|POLY-3 RATE (b) | 1/44.38 0/40.74 0/42.02 0/40.71 |5/38.72 4/42.72 4/39.31 1/42.13 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |12.9% 9.4% 10.2% 2.4% |
|TERMINAL (d) | 1/38 (3%) 0/36 (0%) 0/36 (0%) 0/34 (0%) |5/30 (17%) 4/33 (12%) 3/35 (9%) 1/37 (3%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |729 (T) 729 (T) 603 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.511N P=0.511N P=0.522N |P=0.047N* P=0.439N P=0.414N P=0.061N |
|POLY 3 | P=0.302N P=0.517N P=0.511N P=0.517N |P=0.069N P=0.438N P=0.490N P=0.082N |
|POLY 1.5 | P=0.303N P=0.517N P=0.510N P=0.514N |P=0.073N P=0.447N P=0.510N P=0.086N |
|POLY 6 | P=0.300N P=0.517N P=0.512N P=0.521N |P=0.063N P=0.436N P=0.467N P=0.077N |
|LOGISTIC REGRESSION| P=0.318N (e) (e) (e) |P=0.063N P=0.439N P=0.492N P=0.061N |
|COCH-ARM / FISHERS | P=0.306N P=0.516N P=0.500N P=0.505N |P=0.080N P=0.473N P=0.529N P=0.097N |
|ORDER RESTRICTED | P=0.136N (e) (e) (e) |P=0.068N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.28 0/46.01 0/44.84 0/43.48 |0/42.68 2/43.63 3/44.22 1/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 6.8% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 2/33 (6%) 3/39 (8%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.524 P=0.238 P=0.152 P=0.538 |
|POLY 3 | (e) (e) (e) (e) |P=0.479 P=0.242 P=0.125 P=0.511 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.468 P=0.242 P=0.122 P=0.508 |
|POLY 6 | (e) (e) (e) (e) |P=0.493 P=0.239 P=0.128 P=0.515 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.238 P=0.152 P=0.538 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.444 P=0.247 P=0.121 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.191 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 44
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.28 3/46.01 0/44.84 0/43.48 |0/42.68 2/44.10 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 2.2% 6.5% 0.0% 0.0% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 3/40 (8%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 1/33 (3%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 588 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.314 P=0.505N P=0.516N |P=0.383N P=0.242 (e) (e) |
|POLY 3 | P=0.163N P=0.303 P=0.506N P=0.512N |P=0.389N P=0.244 (e) (e) |
|POLY 1.5 | P=0.161N P=0.304 P=0.505N P=0.509N |P=0.394N P=0.243 (e) (e) |
|POLY 6 | P=0.166N P=0.302 P=0.507N P=0.516N |P=0.386N P=0.243 (e) (e) |
|LOGISTIC REGRESSION| P=0.167N P=0.314 (e) (e) |P=0.410N P=0.234 (e) (e) |
|COCH-ARM / FISHERS | P=0.150N P=0.316 P=0.495N P=0.495N |P=0.405N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) |P=0.243N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Degeneration Cystic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 6/50 (12%) 8/50 (16%) 6/50 (12%) |14/50 (28%) 14/50 (28%) 18/50 (36%) 12/50 (24%) |
|POLY-3 RATE (b) | 4/46.49 6/46.24 8/45.46 6/44.22 |14/45.53 14/45.20 18/45.16 12/45.70 |
|POLY-3 PERCENT (g) | 8.6% 13.0% 17.6% 13.6% |30.8% 31.0% 39.9% 26.3% |
|TERMINAL (d) | 3/39 (8%) 4/40 (10%) 5/38 (13%) 4/36 (11%) |7/33 (21%) 8/33 (24%) 15/39 (39%) 11/40 (28%) |
|FIRST INCIDENCE | 672 691 653 558 |365 568 579 551 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268 P=0.381 P=0.170 P=0.320 |P=0.215N P=0.577N P=0.424 P=0.263N |
|POLY 3 | P=0.284 P=0.366 P=0.166 P=0.338 |P=0.386N P=0.581 P=0.245 P=0.404N |
|POLY 1.5 | P=0.294 P=0.368 P=0.167 P=0.346 |P=0.386N P=0.588N P=0.245 P=0.401N |
|POLY 6 | P=0.275 P=0.365 P=0.166 P=0.331 |P=0.385N P=0.558 P=0.245 P=0.411N |
|LOGISTIC REGRESSION| P=0.305 P=0.367 P=0.170 P=0.363 |P=0.369N P=0.587N P=0.267 P=0.404N |
|COCH-ARM / FISHERS | P=0.341 P=0.383 P=0.188 P=0.383 |P=0.396N P=0.588N P=0.260 P=0.410N |
|ORDER RESTRICTED | P=0.259 (e) (e) (e) |P=0.345N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 45
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 7/50 (14%) 8/50 (16%) 3/50 (6%) |1/50 (2%) 11/50 (22%) 9/50 (18%) 4/50 (8%) |
|POLY-3 RATE (b) | 7/46.28 7/46.01 8/44.90 3/43.80 |1/42.68 11/43.96 9/44.51 4/45.17 |
|POLY-3 PERCENT (g) | 15.1% 15.2% 17.8% 6.9% |2.3% 25.0% 20.2% 8.9% |
|TERMINAL (d) | 7/39 (18%) 7/40 (18%) 7/38 (18%) 2/36 (6%) |1/33 (3%) 9/33 (27%) 8/39 (21%) 3/40 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 713 642 |729 (T) 683 653 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.595N P=0.478 P=0.192N |P=0.472N P=0.003 ** P=0.018 * P=0.243 |
|POLY 3 | P=0.159N P=0.609 P=0.475 P=0.181N |P=0.554 P=0.002 ** P=0.009 ** P=0.196 |
|POLY 1.5 | P=0.153N P=0.610 P=0.479 P=0.175N |P=0.531 P=0.002 ** P=0.009 ** P=0.191 |
|POLY 6 | P=0.166N P=0.608 P=0.471 P=0.186N |P=0.543N P=0.002 ** P=0.010 * P=0.203 |
|LOGISTIC REGRESSION| P=0.171N P=0.595N P=0.458 P=0.189N |P=0.554N P=0.002 ** P=0.012 * P=0.215 |
|COCH-ARM / FISHERS | P=0.124N P=0.597N P=0.517 P=0.151N |P=0.486 P=0.002 ** P=0.008 ** P=0.181 |
|ORDER RESTRICTED | P=0.160N (e) (e) (e) |P=0.021 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/18 (100%) 11/11 (100%) 15/15 (100%) 12/12 (100%)|0/1 (0%) 1/1 (100%) 0/1 (0%) 1/2 (50%) |
|POLY-3 RATE (b) | 18/18.00 11/11.00 15/15.00 12/12.00 |0/0.30 1/1.00 0/1.00 1/1.57 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |0.0% 100.0% 0.0% 63.7% |
|TERMINAL (d) | 16/16 (100%) 10/10 (100%) 13/13 (100%) 10/10 (100%)|0/0 (0%) 0/0 (0%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 640 710 690 573 |--- 653 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.685 P=0.506 (e) P=1.000N |
|POLY 3 | (e) (e) (e) (e) |P=0.703N P=1.000N (e) P=0.764 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.690 P=1.000N (e) P=0.691 |
|POLY 6 | (e) (e) (e) (e) |P=0.752N P=1.000N (e) P=0.896 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.710N (e) (e) P=1.000N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.590 P=0.500 (e) P=0.667 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.566 (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 46
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.83 1/46.24 0/44.29 2/44.70 |0/42.68 0/43.63 0/44.22 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 4.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/40 (0%) 0/38 (0%) 0/36 (0%) |0/33 (0%) 0/33 (0%) 0/39 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- 670 --- 484 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.128 P=0.496 (e) P=0.224 |(e) (e) (e) (e) |
|POLY 3 | P=0.133 P=0.497 (e) P=0.227 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.133 P=0.497 (e) P=0.228 |(e) (e) (e) (e) |
|POLY 6 | P=0.133 P=0.499 (e) P=0.227 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.179 P=0.516 (e) P=0.341 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.068 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 8/50 (16%) 6/50 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | |5/43.07 8/45.24 6/44.39 2/45.84 |
|POLY-3 PERCENT (g) | |11.6% 17.7% 13.5% 4.4% |
|TERMINAL (d) | |4/33 (12%) 3/33 (9%) 5/39 (13%) 1/40 (3%) |
|FIRST INCIDENCE | |619 568 687 481 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.075N P=0.289 P=0.600 P=0.166N |
|POLY 3 | |P=0.090N P=0.307 P=0.521 P=0.191N |
|POLY 1.5 | |P=0.097N P=0.299 P=0.510 P=0.199N |
|POLY 6 | |P=0.083N P=0.311 P=0.533 P=0.184N |
|LOGISTIC REGRESSION| |P=0.110N P=0.279 P=0.529 P=0.218N |
|COCH-ARM / FISHERS | |P=0.113N P=0.277 P=0.500 P=0.218N |
|ORDER RESTRICTED | |P=0.098N (e) (e) (e) |
|=================================================================================================================================|
Date: 07/19/04 EXPERIMENT: 93020 TEST: 08 Page 47
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIISOPROPYLCARBODIIMIDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |46/50 (92%) 44/50 (88%) 47/50 (94%) 49/50 (98%) |
|POLY-3 RATE (b) | |46/48.88 44/47.67 47/47.19 49/49.00 |
|POLY-3 PERCENT (g) | |94.1% 92.3% 99.6% 100.0% |
|TERMINAL (d) | |31/33 (94%) 32/33 (97%) 39/39 (100%) 40/40 (100%) |
|FIRST INCIDENCE | |305 555 560 481 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.192N P=0.421N P=0.196N P=0.243N |
|POLY 3 | |P=0.026 * P=0.522N P=0.160 P=0.125 |
|POLY 1.5 | |P=0.029 * P=0.445N P=0.202 P=0.127 |
|POLY 6 | |P=0.027 * P=0.643N P=0.144 P=0.130 |
|LOGISTIC REGRESSION| |P=0.090 P=0.282N P=0.485 P=0.238 |
|COCH-ARM / FISHERS | |P=0.080 P=0.370N P=0.500 P=0.181 |
|ORDER RESTRICTED | |P=0.030 * (e) (e) (e) |
|=================================================================================================================================|
(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).