TDMS Study 88031-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02
EXPERIMENT: 88031 TEST: 05 TIME: 13:39:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: MISSING CAS: 25265-71-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIPROPYLENE GLYCOL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Hypertrophy
Adrenal Medulla Hyperplasia
Eye: Retina Atrophy
Heart Cardiomyopathy
Mineralization
Heart: Atrium Thrombosis
Intestine Large, Rectum Parasite Metazoan
Kidney Nephropathy
Kidney: Transitional Epithelium Hyperplasia
Liver Angiectasis
Basophilic Focus
Clear Cell Focus
Degeneration Cystic
Fatty Change
Hepatodiaphragmatic Nodule
Inflammation Focal Granulomatous
Inflammation Focal Histiocytic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Necrosis
Lung Infiltration Cellular Histiocyte
Inflammation Chronic
Thrombosis
Lung: Alveolar Epithelium Hyperplasia
Mesentery: Fat Necrosis
Nose Inflammation
Thrombosis
Nose: Olfactory Epithelium Atrophy
Degeneration
Metaplasia
Pancreas Atrophy
Hyperplasia
Parathyroid Gland Hyperplasia
Pituitary Gland: Pars Distalis Hyperplasia
Preputial Gland Cyst
Prostate Hyperplasia
Inflammation Chronic
Salivary Glands Inflammation
Spleen Hematopoietic Cell Proliferation
Hyperplasia Focal Lymphoid
Stomach, Forestomach Hyperplasia
Hyperplasia Basal Cell
Ulcer
Stomach, Glandular Necrosis
Testes Atrophy
Thyroid Gland: C-Cell Hyperplasia
Thyroid Gland: Follicular Cell Hyperplasia
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02
EXPERIMENT: 88031 TEST: 05 TIME: 13:39:24
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: MISSING CAS: 25265-71-8
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Degeneration Cystic
Hyperplasia
Adrenal Medulla Necrosis
Heart Cardiomyopathy
Liver Clear Cell Focus
Eosinophilic Focus
Inflammation Focal Histiocytic
Mixed Cell Focus
Liver: Bile Duct Hyperplasia
Mesentery: Fat Necrosis
Nose: Olfactory Epithelium Degeneration
Nose: Respiratory Epithelium Accumulation, Hyaline Droplet
Parathyroid Gland Hyperplasia
Skin Inflammation Chronic
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/49 (0%) 0/50 (0%) 0/48 (0%) |5/49 (10%) 2/47 (4%) 0/47 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/37.58 0/41.97 0/42.10 0/24.30 |5/42.75 2/41.30 0/44.49 0/42.03 |
|POLY-3 PERCENT (g) | 2.7% 0.0% 0.0% 0.0% |11.7% 4.8% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |5/30 (17%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |729 (T) 717 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.994N P=0.468N P=0.468N P=1.000N |P=0.039N* P=0.200N P=0.017N* P=0.029N* |
|POLY 3 | P=0.532N P=0.478N P=0.477N P=0.583N |P=0.041N* P=0.229N P=0.027N* P=0.031N* |
|POLY 1.5 | P=0.552N P=0.483N P=0.480N P=0.539N |P=0.041N* P=0.230N P=0.029N* P=0.032N* |
|POLY 6 | P=0.433N P=0.472N P=0.475N P=0.651N |P=0.042N* P=0.229N P=0.025N* P=0.031N* |
|LOGISTIC REGRESSION| P=0.994N (e) (e) (e) |P=0.039N* P=0.218N (e) (e) |
|COCH-ARM / FISHERS | P=0.548N P=0.490N P=0.485N P=0.495N |P=0.043N* P=0.235N P=0.031N* P=0.031N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/47 (32%) 22/49 (45%) 26/50 (52%) 8/48 (17%) |18/49 (37%) 24/47 (51%) 25/47 (53%) 13/47 (28%) |
|POLY-3 RATE (b) | 15/38.16 22/44.73 26/44.77 8/27.72 |18/43.83 24/42.21 25/44.82 13/42.74 |
|POLY-3 PERCENT (g) | 39.3% 49.2% 58.1% 28.9% |41.1% 56.9% 55.8% 30.4% |
|TERMINAL (d) | 13/23 (57%) 15/27 (56%) 17/27 (63%) 0/0 (0%) |15/30 (50%) 21/31 (68%) 24/38 (63%) 10/31 (32%) |
|FIRST INCIDENCE | 565 417 543 483 |542 542 638 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.238 P=0.074 P<0.001 ** |P=0.025N* P=0.169 P=0.391 P=0.169N |
|POLY 3 | P=0.149N P=0.244 P=0.061 P=0.265N |P=0.024N* P=0.100 P=0.116 P=0.207N |
|POLY 1.5 | P=0.032N* P=0.198 P=0.050 P=0.137N |P=0.026N* P=0.108 P=0.103 P=0.210N |
|POLY 6 | P=0.526 P=0.316 P=0.077 P=0.582N |P=0.024N* P=0.089 P=0.131 P=0.209N |
|LOGISTIC REGRESSION| P=0.295N P=0.191 P=0.049 * P=0.410 |P=0.028N* P=0.105 P=0.163 P=0.205N |
|COCH-ARM / FISHERS | P=0.004N** P=0.136 P=0.036 * P=0.067N |P=0.037N* P=0.113 P=0.078 P=0.232N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/47 (11%) 4/49 (8%) 6/50 (12%) 5/48 (10%) |11/49 (22%) 14/47 (30%) 12/47 (26%) 9/47 (19%) |
|POLY-3 RATE (b) | 5/38.52 4/42.00 6/43.30 5/25.86 |11/43.26 14/41.45 12/44.74 9/43.22 |
|POLY-3 PERCENT (g) | 13.0% 9.5% 13.9% 19.3% |25.4% 33.8% 26.8% 20.8% |
|TERMINAL (d) | 2/23 (9%) 3/27 (11%) 3/27 (11%) 0/0 (0%) |8/30 (27%) 12/31 (39%) 10/38 (26%) 5/31 (16%) |
|FIRST INCIDENCE | 565 721 562 617 |659 683 667 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.412N P=0.558 P<0.001 ** |P=0.231N P=0.338 P=0.468N P=0.396N |
|POLY 3 | P=0.239 P=0.445N P=0.582 P=0.371 |P=0.201N P=0.272 P=0.537 P=0.400N |
|POLY 1.5 | P=0.367 P=0.454N P=0.571 P=0.509 |P=0.211N P=0.279 P=0.510 P=0.411N |
|POLY 6 | P=0.114 P=0.436N P=0.591 P=0.184 |P=0.196N P=0.259 P=0.565 P=0.396N |
|LOGISTIC REGRESSION| P=0.247 P=0.435N P=0.546 P=0.277 |P=0.223N P=0.273 P=0.581 P=0.422N |
|COCH-ARM / FISHERS | P=0.542 P=0.473N P=0.544 P=0.616N |P=0.237N P=0.279 P=0.454 P=0.442N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 4/49 (8%) 1/50 (2%) 0/48 (0%) |1/49 (2%) 2/47 (4%) 0/47 (0%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/37.86 4/42.37 1/42.31 0/24.30 |1/42.83 2/41.78 0/44.49 2/42.39 |
|POLY-3 PERCENT (g) | 2.6% 9.4% 2.4% 0.0% |2.3% 4.8% 0.0% 4.7% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 653 649 674 --- |709 634 --- 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.670N P=0.234 P=0.758 P=0.912N |P=0.441 P=0.501 P=0.462N P=0.491 |
|POLY 3 | P=0.210N P=0.214 P=0.736N P=0.584N |P=0.447 P=0.491 P=0.492N P=0.496 |
|POLY 1.5 | P=0.169N P=0.206 P=0.739N P=0.540N |P=0.447 P=0.490 P=0.498N P=0.494 |
|POLY 6 | P=0.258N P=0.225 P=0.734N P=0.653N |P=0.445 P=0.493 P=0.487N P=0.498 |
|LOGISTIC REGRESSION| P=0.204N P=0.206 P=0.754N P=0.601N |P=0.426 P=0.481 P=0.498N P=0.484 |
|COCH-ARM / FISHERS | P=0.127N P=0.194 P=0.737N P=0.495N |P=0.443 P=0.484 P=0.510N P=0.484 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/47 (49%) 23/49 (47%) 24/50 (48%) 4/47 (9%) |12/49 (24%) 8/47 (17%) 10/46 (22%) 7/47 (15%) |
|POLY-3 RATE (b) | 23/40.09 23/43.83 24/44.51 4/25.78 |12/43.24 8/42.57 10/43.89 7/42.55 |
|POLY-3 PERCENT (g) | 57.4% 52.5% 53.9% 15.5% |27.8% 18.8% 22.8% 16.5% |
|TERMINAL (d) | 13/23 (57%) 15/27 (56%) 16/27 (59%) 0/0 (0%) |10/30 (33%) 3/31 (10%) 8/38 (21%) 4/31 (13%) |
|FIRST INCIDENCE | 565 456 564 564 |626 542 717 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.322N P=0.420N P=0.238 |P=0.224N P=0.220N P=0.206N P=0.149N |
|POLY 3 | P<0.001N** P=0.406N P=0.459N P<0.001N** |P=0.218N P=0.233N P=0.387N P=0.157N |
|POLY 1.5 | P<0.001N** P=0.433N P=0.478N P<0.001N** |P=0.217N P=0.241N P=0.416N P=0.162N |
|POLY 6 | P=0.042N* P=0.385N P=0.462N P=0.018N* |P=0.223N P=0.225N P=0.357N P=0.156N |
|LOGISTIC REGRESSION| P=0.005N** P=0.377N P=0.443N P=0.012N* |P=0.213N P=0.253N P=0.326N P=0.161N |
|COCH-ARM / FISHERS | P<0.001N** P=0.503N P=0.544N P<0.001N** |P=0.224N P=0.259N P=0.471N P=0.178N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/49 (0%) 0/50 (0%) 1/47 (2%) |0/49 (0%) 0/47 (0%) 0/46 (0%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/38.12 0/41.97 0/42.10 1/24.73 |0/42.75 0/41.25 0/43.82 2/42.16 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 4.0% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | 564 --- --- 408 |--- --- --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490 P=0.513N P=0.496N P=0.729 |P=0.039 * (e) (e) P=0.234 |
|POLY 3 | P=0.432 P=0.481N P=0.480N P=0.656 |P=0.041 * (e) (e) P=0.234 |
|POLY 1.5 | P=0.468 P=0.484N P=0.482N P=0.712 |P=0.041 * (e) (e) P=0.233 |
|POLY 6 | P=0.395 P=0.476N P=0.480N P=0.549 |P=0.041 * (e) (e) P=0.234 |
|LOGISTIC REGRESSION| P=0.625 P=0.563N P=0.553N P=0.722N |P=0.041 * (e) (e) P=0.233 |
|COCH-ARM / FISHERS | P=0.517 P=0.490N P=0.485N P=0.753N |P=0.041 * (e) (e) P=0.237 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |1/43.29 3/43.04 1/45.88 1/43.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 7.0% 2.2% 2.3% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 3/31 (10%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- --- |697 729 (T) 729 (T) 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.442N P=0.308 P=0.728N P=0.748 |
|POLY 3 | (e) (e) (e) (e) |P=0.435N P=0.303 P=0.748N P=0.757N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.433N P=0.305 P=0.752N P=0.757N |
|POLY 6 | (e) (e) (e) (e) |P=0.440N P=0.299 P=0.742N P=0.760N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.435N P=0.301 P=0.749N P=0.759 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.435N P=0.309 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |5/48 (10%) 2/44 (5%) 3/48 (6%) 3/48 (6%) |
|POLY-3 RATE (b) | |5/42.38 2/38.47 3/44.35 3/42.15 |
|POLY-3 PERCENT (g) | |11.8% 5.2% 6.8% 7.1% |
|TERMINAL (d) | |3/29 (10%) 2/30 (7%) 2/37 (5%) 3/30 (10%) |
|FIRST INCIDENCE | |543 729 (T) 667 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.500N P=0.210N P=0.267N P=0.341N |
|POLY 3 | |P=0.479N P=0.256N P=0.331N P=0.359N |
|POLY 1.5 | |P=0.474N P=0.253N P=0.340N P=0.353N |
|POLY 6 | |P=0.490N P=0.261N P=0.321N P=0.371N |
|LOGISTIC REGRESSION| |P=0.471N P=0.251N P=0.366N P=0.352N |
|COCH-ARM / FISHERS | |P=0.475N P=0.255N P=0.357N P=0.357N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/48 (4%) 0/44 (0%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | |2/41.55 0/38.47 0/44.12 1/42.15 |
|POLY-3 PERCENT (g) | |4.8% 0.0% 0.0% 2.4% |
|TERMINAL (d) | |1/29 (3%) 0/30 (0%) 0/37 (0%) 1/30 (3%) |
|FIRST INCIDENCE | |697 --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.695 P=0.245N P=0.208N P=0.505N |
|POLY 3 | |P=0.706 P=0.254N P=0.224N P=0.495N |
|POLY 1.5 | |P=0.707 P=0.254N P=0.229N P=0.494N |
|POLY 6 | |P=0.702 P=0.254N P=0.219N P=0.499N |
|LOGISTIC REGRESSION| |P=0.707 P=0.253N P=0.222N P=0.499N |
|COCH-ARM / FISHERS | |P=0.706N P=0.269N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 1/2 (50%) 2/3 (67%) 1/1 (100%) |2/2 (100%) 0/1 (0%) 2/2 (100%) 1/3 (33%) |
|POLY-3 RATE (b) | 2/2.00 1/1.45 2/3.00 1/1.00 |2/2.00 0/0.95 2/2.00 1/3.00 |
|POLY-3 PERCENT (g) | 100.0% 69.0% 66.7% 100.0% |100.0% 0.0% 100.0% 33.3% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 1/2 (50%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 1/1 (100%) 0/2 (0%) |
|FIRST INCIDENCE | 582 729 (T) 584 627 |624 --- 598 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344 P=0.495N P=0.564N (e) |P=0.397N P=0.521N (e) P=0.424N |
|POLY 3 | P=0.785 P=0.819N P=0.577N (e) |P=0.229N P=1.000N (e) P=0.281N |
|POLY 1.5 | P=0.744 P=0.644N P=0.577N (e) |P=0.236N P=1.000N (e) P=0.281N |
|POLY 6 | P=0.824 P=0.998N P=0.577N (e) |P=0.215N P=1.000N (e) P=0.281N |
|LOGISTIC REGRESSION| P=0.708 P=0.495N (e) (e) |P=0.364N P=0.424N (e) (e) |
|COCH-ARM / FISHERS | P=0.719 P=0.500N P=0.600N (e) |P=0.279N P=0.333N (e) P=0.300N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/2 (0%) 1/3 (33%) 0/1 (0%) |0/2 (0%) 0/1 (0%) 0/2 (0%) 2/3 (67%) |
|POLY-3 RATE (b) | 0/1.51 0/1.45 1/2.51 0/0.64 |0/1.63 0/0.95 0/1.55 2/2.82 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 39.8% 0.0% |0.0% 0.0% 0.0% 71.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 1/2 (50%) 0/0 (0%) |0/1 (0%) 0/0 (0%) 0/1 (0%) 2/2 (100%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.991 (e) P=0.638 (e) |P=0.166 (e) (e) P=0.362 |
|POLY 3 | P=0.815 (e) P=0.600 (e) |P=0.078 (e) (e) P=0.314 |
|POLY 1.5 | P=0.835 (e) P=0.589 (e) |P=0.076 (e) (e) P=0.298 |
|POLY 6 | P=0.731 (e) P=0.616 (e) |P=0.080 (e) (e) P=0.341 |
|LOGISTIC REGRESSION| (e) (e) P=0.638 (e) |(e) (e) (e) P=0.362 |
|COCH-ARM / FISHERS | P=0.894 (e) P=0.600 (e) |P=0.086 (e) (e) P=0.300 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 1/2 (50%) 2/3 (67%) 1/1 (100%) |2/2 (100%) 0/1 (0%) 1/2 (50%) 2/3 (67%) |
|POLY-3 RATE (b) | 1/1.51 1/1.45 2/3.00 1/1.00 |2/2.00 0/0.95 1/1.55 2/3.00 |
|POLY-3 PERCENT (g) | 66.3% 69.0% 66.7% 100.0% |100.0% 0.0% 64.4% 66.7% |
|TERMINAL (d) | 1/1 (100%) 1/1 (100%) 1/2 (50%) 0/0 (0%) |1/1 (100%) 0/0 (0%) 1/1 (100%) 1/2 (50%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 584 627 |624 --- 729 (T) 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084 P=1.000N P=0.689 P=0.011 * |P=0.657N P=0.521N P=0.495N P=0.580N |
|POLY 3 | P=0.635 P=0.852 P=0.795 P=0.799 |P=0.689N P=1.000 P=0.727N P=0.577N |
|POLY 1.5 | P=0.566 P=0.800 P=0.741 P=0.698 |P=0.706N P=1.000 P=0.602N P=0.577N |
|POLY 6 | P=0.727 P=0.964 P=0.751N P=0.971 |P=0.658N P=1.000N P=0.953N P=0.577N |
|LOGISTIC REGRESSION| P=0.457 P=1.000N P=0.740 (e) |P=0.713N P=0.424N P=0.495N (e) |
|COCH-ARM / FISHERS | P=0.485 P=0.833N P=0.700 P=0.667 |P=0.721 P=0.333N P=0.500N P=0.600N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 42/50 (84%) 43/50 (86%) 22/49 (45%) |33/50 (66%) 42/50 (84%) 32/50 (64%) 26/50 (52%) |
|POLY-3 RATE (b) | 41/46.44 42/47.54 43/48.23 22/34.56 |33/44.97 42/46.83 32/47.48 26/44.64 |
|POLY-3 PERCENT (g) | 88.3% 88.4% 89.2% 63.7% |73.4% 89.7% 67.4% 58.3% |
|TERMINAL (d) | 22/23 (96%) 25/27 (93%) 25/27 (93%) 0/0 (0%) |24/30 (80%) 31/31 (100%) 26/38 (68%) 21/31 (68%) |
|FIRST INCIDENCE | 261 417 340 431 |543 417 597 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.273N P=0.380N P<0.001 ** |P=0.013N* P=0.078 P=0.105N P=0.097N |
|POLY 3 | P<0.001N** P=0.635 P=0.583 P=0.002N** |P=0.003N** P=0.026 * P=0.339N P=0.087N |
|POLY 1.5 | P<0.001N** P=0.596 P=0.518 P<0.001N** |P=0.003N** P=0.030 * P=0.400N P=0.087N |
|POLY 6 | P=0.032N* P=0.658N P=0.649 P=0.047N* |P=0.005N** P=0.019 * P=0.278N P=0.101N |
|LOGISTIC REGRESSION| P<0.001N** P=0.598N P=0.505 P=0.010N* |P=0.003N** P=0.019 * P=0.306N P=0.086N |
|COCH-ARM / FISHERS | P<0.001N** P=0.500 P=0.393 P<0.001N** |P=0.006N** P=0.032 * P=0.500N P=0.111N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 7/49 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 7/28.95 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 24.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- 398 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.002 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.003 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.024 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.006 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 2/50 (4%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.90 5/43.41 2/42.77 0/24.59 |0/43.16 2/43.22 0/45.88 1/44.11 |
|POLY-3 PERCENT (g) | 0.0% 11.5% 4.7% 0.0% |0.0% 4.6% 0.0% 2.3% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 614 584 --- |--- 680 --- 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577N P=0.056 P=0.263 (e) |P=0.631 P=0.238 (e) P=0.505 |
|POLY 3 | P=0.276N P=0.038 * P=0.253 (e) |P=0.637 P=0.237 (e) P=0.504 |
|POLY 1.5 | P=0.206N P=0.035 * P=0.247 (e) |P=0.638 P=0.238 (e) P=0.504 |
|POLY 6 | P=0.388N P=0.043 * P=0.259 (e) |P=0.635 P=0.237 (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.151N P=0.033 * P=0.213 (e) |P=0.625 P=0.237 (e) P=0.439 |
|COCH-ARM / FISHERS | P=0.146N P=0.028 * P=0.247 (e) |P=0.634 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/41 (10%) 1/49 (2%) 3/48 (6%) 0/43 (0%) |4/48 (8%) 4/47 (9%) 1/48 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 4/34.61 1/41.97 3/41.97 0/21.83 |4/41.63 4/40.49 1/44.45 2/41.10 |
|POLY-3 PERCENT (g) | 11.6% 2.4% 7.2% 0.0% |9.6% 9.9% 2.3% 4.9% |
|TERMINAL (d) | 3/23 (13%) 1/27 (4%) 1/27 (4%) 0/0 (0%) |3/30 (10%) 3/30 (10%) 1/38 (3%) 2/31 (7%) |
|FIRST INCIDENCE | 568 729 (T) 586 --- |626 717 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.489N P=0.144N P=0.429N P=0.579N |P=0.280N P=0.638N P=0.126N P=0.325N |
|POLY 3 | P=0.218N P=0.123N P=0.395N P=0.143N |P=0.293N P=0.629 P=0.159N P=0.342N |
|POLY 1.5 | P=0.158N P=0.124N P=0.399N P=0.089N |P=0.293N P=0.632 P=0.166N P=0.345N |
|POLY 6 | P=0.308N P=0.121N P=0.394N P=0.276N |P=0.296N P=0.625 P=0.151N P=0.343N |
|LOGISTIC REGRESSION| P=0.146N P=0.123N P=0.417N P=0.188N |P=0.283N P=0.633 P=0.161N P=0.338N |
|COCH-ARM / FISHERS | P=0.101N P=0.130N P=0.411N P=0.052N |P=0.299N P=0.631 P=0.181N P=0.359N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/40 (15%) 3/50 (6%) 6/48 (13%) 0/44 (0%) |7/48 (15%) 5/47 (11%) 13/49 (27%) 3/46 (7%) |
|POLY-3 RATE (b) | 6/33.76 3/42.41 6/41.49 0/22.24 |7/41.76 5/40.78 13/45.12 3/41.10 |
|POLY-3 PERCENT (g) | 17.8% 7.1% 14.5% 0.0% |16.8% 12.3% 28.8% 7.3% |
|TERMINAL (d) | 5/22 (23%) 3/27 (11%) 4/27 (15%) 0/0 (0%) |5/30 (17%) 5/31 (16%) 13/38 (34%) 3/31 (10%) |
|FIRST INCIDENCE | 565 729 (T) 712 --- |626 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.676N P=0.158N P=0.480N P=0.576N |P=0.120N P=0.366N P=0.235 P=0.153N |
|POLY 3 | P=0.123N P=0.139N P=0.471N P=0.052N |P=0.118N P=0.395N P=0.139 P=0.162N |
|POLY 1.5 | P=0.063N P=0.139N P=0.472N P=0.024N* |P=0.122N P=0.392N P=0.130 P=0.164N |
|POLY 6 | P=0.268N P=0.137N P=0.476N P=0.160N |P=0.119N P=0.398N P=0.150 P=0.163N |
|LOGISTIC REGRESSION| P=0.352N P=0.132N P=0.462N P=0.163N |P=0.124N P=0.382N P=0.174 P=0.156N |
|COCH-ARM / FISHERS | P=0.027N* P=0.145N P=0.486N P=0.009N** |P=0.140N P=0.395N P=0.114 P=0.176N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/44 (0%) 0/48 (0%) 2/50 (4%) 0/47 (0%) |0/47 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/36.11 0/41.54 2/42.10 0/23.65 |0/41.03 0/41.44 0/45.05 0/42.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.736 (e) P=0.274 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.628 (e) P=0.272 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.728N (e) P=0.272 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.352 (e) P=0.270 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.274 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.649N (e) P=0.280 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 3/50 (6%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/37.91 0/42.41 3/42.10 0/24.20 |0/42.42 0/42.07 1/45.12 0/42.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 7.1% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 3/27 (11%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399 (e) P=0.149 (e) |P=0.779N (e) P=0.547 (e) |
|POLY 3 | P=0.568 (e) P=0.138 (e) |P=0.773N (e) P=0.512 (e) |
|POLY 1.5 | P=0.690N (e) P=0.136 (e) |P=0.775N (e) P=0.508 (e) |
|POLY 6 | P=0.263 (e) P=0.138 (e) |P=0.773N (e) P=0.518 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.149 (e) |(e) (e) P=0.547 (e) |
|COCH-ARM / FISHERS | P=0.585N (e) P=0.133 (e) |P=0.780N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 6/50 (12%) 3/50 (6%) 2/48 (4%) |3/49 (6%) 2/49 (4%) 1/49 (2%) 4/47 (9%) |
|POLY-3 RATE (b) | 3/38.74 6/43.58 3/42.98 2/24.80 |3/42.44 2/42.86 1/45.55 4/42.76 |
|POLY-3 PERCENT (g) | 7.7% 13.8% 7.0% 8.1% |7.1% 4.7% 2.2% 9.4% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |2/30 (7%) 1/31 (3%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | 511 614 586 640 |724 435 604 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 P=0.340 P=0.613N P=0.123 |P=0.275 P=0.491N P=0.245N P=0.499 |
|POLY 3 | P=0.442N P=0.302 P=0.614N P=0.659 |P=0.271 P=0.496N P=0.280N P=0.504 |
|POLY 1.5 | P=0.341N P=0.292 P=0.619N P=0.594N |P=0.267 P=0.495N P=0.290N P=0.496 |
|POLY 6 | P=0.558N P=0.319 P=0.611N P=0.489 |P=0.274 P=0.498N P=0.269N P=0.511 |
|LOGISTIC REGRESSION| P=0.248N P=0.264 P=0.665 P=0.645N |P=0.229 P=0.502N P=0.301N P=0.487 |
|COCH-ARM / FISHERS | P=0.227N P=0.275 P=0.631N P=0.490N |P=0.258 P=0.500N P=0.309N P=0.476 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/50 (4%) 1/50 (2%) 2/48 (4%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/37.91 2/42.97 1/42.55 2/25.83 |1/42.42 0/42.07 0/45.12 0/42.03 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.4% 7.7% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 558 598 398 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 P=0.260 P=0.519 P=0.249 |P=0.550N P=0.493N P=0.453N P=0.493N |
|POLY 3 | P=0.211 P=0.266 P=0.523 P=0.164 |P=0.557N P=0.502N P=0.488N P=0.502N |
|POLY 1.5 | P=0.267 P=0.261 P=0.520 P=0.200 |P=0.556N P=0.500N P=0.492N P=0.503N |
|POLY 6 | P=0.145 P=0.272 P=0.526 P=0.116 |P=0.558N P=0.504N P=0.482N P=0.502N |
|LOGISTIC REGRESSION| P=0.561 P=0.233 P=0.472 P=0.160 |P=0.550N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.337 P=0.263 P=0.515 P=0.253 |P=0.554N P=0.500N P=0.500N P=0.510N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/47 (87%) 47/50 (94%) 50/50 (100%) 48/48 (100%)|43/49 (88%) 45/49 (92%) 47/49 (96%) 46/47 (98%) |
|POLY-3 RATE (b) | 41/44.55 47/48.68 50/50.00 48/48.00 |43/47.12 45/47.28 47/47.62 46/47.00 |
|POLY-3 PERCENT (g) | 92.0% 96.6% 100.0% 100.0% |91.3% 95.2% 98.7% 97.9% |
|TERMINAL (d) | 23/23 (100%) 27/27 (100%) 27/27 (100%) 0/0 (0%) |30/30 (100%) 31/31 (100%) 38/38 (100%) 30/31 (97%) |
|FIRST INCIDENCE | 261 417 340 398 |247 425 597 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.561N P=0.352 P<0.001 ** |P=0.345 P=0.483 P=0.200N P=0.412 |
|POLY 3 | P=0.047 * P=0.278 P=0.038 * P=0.042 * |P=0.168 P=0.350 P=0.090 P=0.151 |
|POLY 1.5 | P=0.030 * P=0.257 P=0.022 * P=0.025 * |P=0.109 P=0.358 P=0.091 P=0.104 |
|POLY 6 | P=0.092 P=0.310 P=0.075 P=0.081 |P=0.280 P=0.339 P=0.102 P=0.229 |
|LOGISTIC REGRESSION| P=0.006 ** P=0.302 P=0.022 * P=0.005 ** |P=0.123 P=0.385 P=0.210 P=0.089 |
|COCH-ARM / FISHERS | P=0.020 * P=0.213 P=0.011 * P=0.012 * |P=0.068 P=0.370 P=0.134 P=0.062 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 2/50 (4%) 1/50 (2%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 1/38.11 2/43.03 1/42.29 0/24.20 |0/42.42 0/42.07 0/45.12 0/42.03 |
|POLY-3 PERCENT (g) | 2.6% 4.7% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 676 564 682 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602N P=0.544 P=0.746N P=0.970N |(e) (e) (e) (e) |
|POLY 3 | P=0.340N P=0.542 P=0.738N P=0.586N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.294N P=0.535 P=0.740N P=0.541N |(e) (e) (e) (e) |
|POLY 6 | P=0.388N P=0.551 P=0.737N P=0.655N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.233N P=0.504 P=0.747N P=0.719N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.523 P=0.737N P=0.495N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 2/50 (4%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/37.91 0/42.41 2/42.95 0/24.20 |0/42.42 0/42.07 0/45.12 0/42.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 586 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.766 (e) P=0.253 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.629 (e) P=0.265 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.730N (e) P=0.261 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.351 (e) P=0.270 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.570N (e) P=0.207 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.655N (e) P=0.263 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 3/50 (6%) 7/50 (14%) 9/48 (19%) |0/49 (0%) 1/49 (2%) 1/49 (2%) 1/47 (2%) |
|POLY-3 RATE (b) | 1/37.91 3/42.41 7/42.56 9/27.58 |0/42.42 1/42.55 1/45.12 1/42.03 |
|POLY-3 PERCENT (g) | 2.6% 7.1% 16.5% 32.6% |0.0% 2.4% 2.2% 2.4% |
|TERMINAL (d) | 1/23 (4%) 3/27 (11%) 5/27 (19%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 1/31 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 598 564 |--- 585 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.362 P=0.053 P<0.001 ** |P=0.523 P=0.509 P=0.547 P=0.507 |
|POLY 3 | P<0.001 ** P=0.346 P=0.043 * P<0.001 ** |P=0.527 P=0.501 P=0.512 P=0.498 |
|POLY 1.5 | P=0.002 ** P=0.340 P=0.041 * P=0.003 ** |P=0.524 P=0.501 P=0.508 P=0.497 |
|POLY 6 | P<0.001 ** P=0.354 P=0.043 * P<0.001 ** |P=0.527 P=0.500 P=0.518 P=0.498 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.362 P=0.044 * P<0.001 ** |P=0.508 P=0.476 P=0.547 P=0.507 |
|COCH-ARM / FISHERS | P=0.008 ** P=0.332 P=0.036 * P=0.008 ** |P=0.515 P=0.500 P=0.500 P=0.490 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/48 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.00 2/25.18 |0/43.16 2/43.04 0/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.9% |0.0% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 2/31 (7%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- 449 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.053 |P=0.390N P=0.245 (e) (e) |
|POLY 3 | P=0.023 * (e) (e) P=0.151 |P=0.396N P=0.236 (e) (e) |
|POLY 1.5 | P=0.029 * (e) (e) P=0.186 |P=0.394N P=0.237 (e) (e) |
|POLY 6 | P=0.019 * (e) (e) P=0.107 |P=0.400N P=0.235 (e) (e) |
|LOGISTIC REGRESSION| P=0.105 (e) (e) P=0.295 |(e) P=0.245 (e) (e) |
|COCH-ARM / FISHERS | P=0.039 * (e) (e) P=0.237 |P=0.394N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 35/50 (70%) 26/49 (53%) 45/48 (94%) |46/50 (92%) 46/50 (92%) 49/50 (98%) 46/49 (94%) |
|POLY-3 RATE (b) | 24/41.13 35/45.03 26/44.36 45/46.57 |46/47.92 46/48.28 49/49.07 46/47.84 |
|POLY-3 PERCENT (g) | 58.4% 77.7% 58.6% 96.6% |96.0% 95.3% 99.9% 96.2% |
|TERMINAL (d) | 18/23 (78%) 25/27 (93%) 18/27 (67%) 0/0 (0%) |30/30 (100%) 31/31 (100%) 38/38 (100%) 31/31 (100%) |
|FIRST INCIDENCE | 565 456 543 398 |413 425 597 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.125 P=0.452N P<0.001 ** |P=0.531 P=0.509N P=0.156N P=0.519N |
|POLY 3 | P<0.001 ** P=0.031 * P=0.581 P<0.001 ** |P=0.677N P=0.651N P=0.221 P=0.715 |
|POLY 1.5 | P<0.001 ** P=0.026 * P=0.510 P<0.001 ** |P=0.623 P=0.621N P=0.175 P=0.656 |
|POLY 6 | P<0.001 ** P=0.039 * P=0.534N P<0.001 ** |P=0.684N P=0.735N P=0.356 P=0.765N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.031 * P=0.550 P<0.001 ** |P=0.518N P=0.625N P=0.299 P=0.611N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.021 * P=0.381 P<0.001 ** |P=0.493 P=0.643N P=0.181 P=0.511 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 22/50 (44%) 23/49 (47%) 2/48 (4%) |10/50 (20%) 16/50 (32%) 20/50 (40%) 17/49 (35%) |
|POLY-3 RATE (b) | 22/40.34 22/42.41 23/42.12 2/25.35 |10/43.29 16/43.58 20/45.88 17/43.15 |
|POLY-3 PERCENT (g) | 54.5% 51.9% 54.6% 7.9% |23.1% 36.7% 43.6% 39.4% |
|TERMINAL (d) | 19/23 (83%) 22/27 (82%) 21/27 (78%) 0/0 (0%) |9/30 (30%) 14/31 (45%) 20/38 (53%) 17/31 (55%) |
|FIRST INCIDENCE | 654 729 (T) 712 438 |697 626 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.214N P=0.329N P=0.167 |P=0.185 P=0.130 P=0.093 P=0.081 |
|POLY 3 | P<0.001N** P=0.491N P=0.589 P<0.001N** |P=0.204 P=0.121 P=0.031 * P=0.076 |
|POLY 1.5 | P<0.001N** P=0.522N P=0.551 P<0.001N** |P=0.211 P=0.125 P=0.028 * P=0.080 |
|POLY 6 | P=0.013N* P=0.440N P=0.580N P=0.002N** |P=0.184 P=0.119 P=0.035 * P=0.068 |
|LOGISTIC REGRESSION| P=0.583 P=0.132N P=0.370N P=0.281N |P=0.174 P=0.110 P=0.060 P=0.069 |
|COCH-ARM / FISHERS | P<0.001N** P=0.580N P=0.463 P<0.001N** |P=0.203 P=0.127 P=0.024 * P=0.078 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 6/49 (12%) 2/48 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/40.18 3/42.71 6/42.59 2/24.96 |0/43.16 0/43.04 0/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 10.0% 7.0% 14.1% 8.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/23 (13%) 1/27 (4%) 4/27 (15%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 654 684 649 561 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.411N P=0.436 P=0.073 |(e) (e) (e) (e) |
|POLY 3 | P=0.579 P=0.467N P=0.406 P=0.567N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.457N P=0.479N P=0.391 P=0.460N |(e) (e) (e) (e) |
|POLY 6 | P=0.338 P=0.447N P=0.422 P=0.581 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.505 P=0.453N P=0.409 P=0.592 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.302N P=0.500N P=0.357 P=0.359N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/49 (4%) 0/48 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/39.90 0/42.41 2/42.05 0/24.20 |0/43.16 0/43.04 1/45.88 4/43.74 |
|POLY-3 PERCENT (g) | 2.5% 0.0% 4.8% 0.0% |0.0% 0.0% 2.2% 9.1% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 3/31 (10%) |
|FIRST INCIDENCE | 729 (T) --- 718 --- |--- --- 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.869 P=0.468N P=0.563 P=1.000N |P=0.005 ** (e) P=0.547 P=0.069 |
|POLY 3 | P=0.604N P=0.488N P=0.518 P=0.595N |P=0.005 ** (e) P=0.512 P=0.062 |
|POLY 1.5 | P=0.530N P=0.492N P=0.511 P=0.552N |P=0.005 ** (e) P=0.508 P=0.061 |
|POLY 6 | P=0.546 P=0.481N P=0.526 P=0.659N |P=0.005 ** (e) P=0.517 P=0.061 |
|LOGISTIC REGRESSION| P=0.843 (e) P=0.551 (e) |P=0.005 ** (e) P=0.547 P=0.058 |
|COCH-ARM / FISHERS | P=0.447N P=0.500N P=0.492 P=0.510N |P=0.005 ** (e) P=0.500 P=0.056 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 3/49 (6%) 5/48 (10%) |6/50 (12%) 9/50 (18%) 6/50 (12%) 4/49 (8%) |
|POLY-3 RATE (b) | 6/41.34 5/43.03 3/43.35 5/27.08 |6/43.97 9/46.83 6/48.13 4/44.22 |
|POLY-3 PERCENT (g) | 14.5% 11.6% 6.9% 18.5% |13.6% 19.2% 12.5% 9.1% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 564 614 583 398 |596 417 597 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.396N P=0.208N P=0.093 |P=0.194N P=0.301 P=0.536N P=0.385N |
|POLY 3 | P=0.368 P=0.472N P=0.217N P=0.462 |P=0.184N P=0.334 P=0.556N P=0.366N |
|POLY 1.5 | P=0.470 P=0.480N P=0.227N P=0.595 |P=0.181N P=0.318 P=0.582N P=0.368N |
|POLY 6 | P=0.261 P=0.458N P=0.209N P=0.253 |P=0.193N P=0.351 P=0.525N P=0.367N |
|LOGISTIC REGRESSION| P=0.372N P=0.493N P=0.321N P=0.430N |P=0.246N P=0.267 P=0.558 P=0.397N |
|COCH-ARM / FISHERS | P=0.579N P=0.500N P=0.254N P=0.529N |P=0.182N P=0.288 P=0.620N P=0.383N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/49 (8%) 5/48 (10%) |4/50 (8%) 7/50 (14%) 6/50 (12%) 6/49 (12%) |
|POLY-3 RATE (b) | 3/40.56 5/43.14 4/43.28 5/27.01 |4/43.29 7/43.29 6/47.29 6/43.69 |
|POLY-3 PERCENT (g) | 7.4% 11.6% 9.2% 18.5% |9.2% 16.2% 12.7% 13.7% |
|TERMINAL (d) | 2/23 (9%) 3/27 (11%) 1/27 (4%) 0/0 (0%) |2/30 (7%) 4/31 (13%) 3/38 (8%) 5/31 (16%) |
|FIRST INCIDENCE | 511 564 562 408 |697 683 295 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * P=0.424 P=0.545 P=0.030 * |P=0.482 P=0.276 P=0.483 P=0.383 |
|POLY 3 | P=0.174 P=0.390 P=0.536 P=0.164 |P=0.497 P=0.259 P=0.426 P=0.375 |
|POLY 1.5 | P=0.259 P=0.378 P=0.520 P=0.241 |P=0.495 P=0.262 P=0.406 P=0.372 |
|POLY 6 | P=0.094 P=0.411 P=0.553 P=0.077 |P=0.492 P=0.257 P=0.447 P=0.373 |
|LOGISTIC REGRESSION| P=0.570 P=0.360 P=0.422 P=0.467 |P=0.481 P=0.253 P=0.330 P=0.367 |
|COCH-ARM / FISHERS | P=0.382 P=0.357 P=0.489 P=0.335 |P=0.479 P=0.262 P=0.370 P=0.357 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 26/50 (52%) 42/49 (86%) 27/48 (56%) |30/50 (60%) 33/50 (66%) 37/50 (74%) 26/49 (53%) |
|POLY-3 RATE (b) | 22/41.38 26/43.29 42/47.70 27/37.84 |30/45.32 33/44.70 37/47.21 26/45.05 |
|POLY-3 PERCENT (g) | 50.8% 60.1% 88.1% 71.4% |66.2% 73.8% 78.4% 57.7% |
|TERMINAL (d) | 18/23 (78%) 22/27 (82%) 25/27 (93%) 0/0 (0%) |22/30 (73%) 27/31 (87%) 32/38 (84%) 20/31 (65%) |
|FIRST INCIDENCE | 376 564 543 398 |413 425 597 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.451 P<0.001 ** P<0.001 ** |P=0.104N P=0.395 P=0.579 P=0.248N |
|POLY 3 | P=0.078 P=0.250 P<0.001 ** P=0.034 * |P=0.064N P=0.277 P=0.129 P=0.263N |
|POLY 1.5 | P=0.160 P=0.235 P<0.001 ** P=0.066 |P=0.077N P=0.311 P=0.115 P=0.273N |
|POLY 6 | P=0.020 * P=0.289 P<0.001 ** P=0.010 * |P=0.056N P=0.235 P=0.151 P=0.261N |
|LOGISTIC REGRESSION| P=0.007 ** P=0.340 P<0.001 ** P=0.031 * |P=0.081N P=0.315 P=0.188 P=0.262N |
|COCH-ARM / FISHERS | P=0.300 P=0.212 P<0.001 ** P=0.113 |P=0.116N P=0.339 P=0.101 P=0.311N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Focal Histiocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 27/50 (54%) 46/49 (94%) 48/48 (100%)|39/50 (78%) 37/50 (74%) 36/50 (72%) 28/49 (57%) |
|POLY-3 RATE (b) | 18/42.07 27/45.35 46/47.59 48/48.00 |39/47.86 37/45.45 36/47.19 28/44.68 |
|POLY-3 PERCENT (g) | 42.8% 59.5% 96.7% 100.0% |81.5% 81.4% 76.3% 62.7% |
|TERMINAL (d) | 12/23 (52%) 17/27 (63%) 27/27 (100%) 0/0 (0%) |26/30 (87%) 29/31 (94%) 31/38 (82%) 23/31 (74%) |
|FIRST INCIDENCE | 376 505 543 398 |247 425 597 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.180 P<0.001 ** P<0.001 ** |P=0.014N* P=0.369N P=0.036N* P=0.021N* |
|POLY 3 | P<0.001 ** P=0.080 P<0.001 ** P<0.001 ** |P=0.009N** P=0.609N P=0.350N P=0.028N* |
|POLY 1.5 | P<0.001 ** P=0.068 P<0.001 ** P<0.001 ** |P=0.009N** P=0.520N P=0.346N P=0.023N* |
|POLY 6 | P<0.001 ** P=0.106 P<0.001 ** P<0.001 ** |P=0.011N* P=0.508 P=0.359N P=0.042N* |
|LOGISTIC REGRESSION| P<0.001 ** P=0.074 P<0.001 ** P<0.001 ** |P=0.006N** P=0.396N P=0.241N P=0.015N* |
|COCH-ARM / FISHERS | P<0.001 ** P=0.054 P<0.001 ** P<0.001 ** |P=0.012N* P=0.408N P=0.322N P=0.022N* |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/49 (4%) 2/48 (4%) |1/50 (2%) 7/50 (14%) 7/50 (14%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/39.90 2/42.41 2/42.00 2/25.25 |1/43.29 7/43.04 7/46.11 4/43.66 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 4.8% 7.9% |2.3% 16.3% 15.2% 9.2% |
|TERMINAL (d) | 0/23 (0%) 2/27 (7%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 7/31 (23%) 6/38 (16%) 3/31 (10%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 398 |697 729 (T) 667 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.274 P=0.274 P=0.057 |P=0.592N P=0.034 * P=0.061 P=0.184 |
|POLY 3 | P=0.203 P=0.251 P=0.248 P=0.151 |P=0.574N P=0.029 * P=0.037 * P=0.181 |
|POLY 1.5 | P=0.278 P=0.246 P=0.244 P=0.187 |P=0.577N P=0.030 * P=0.034 * P=0.180 |
|POLY 6 | P=0.114 P=0.258 P=0.253 P=0.107 |P=0.577N P=0.027 * P=0.040 * P=0.180 |
|LOGISTIC REGRESSION| P=0.272 P=0.274 P=0.274 P=0.304 |P=0.590N P=0.030 * P=0.041 * P=0.175 |
|COCH-ARM / FISHERS | P=0.369 P=0.247 P=0.242 P=0.237 |P=0.586 P=0.030 * P=0.030 * P=0.175 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/40.95 0/42.41 0/42.00 0/24.20 |0/43.16 0/43.04 0/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 7.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 565 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353N P=0.117N P=0.121N P=0.425N |(e) (e) (e) (e) |
|POLY 3 | P=0.207N P=0.112N P=0.114N P=0.239N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.210N P=0.114N P=0.115N P=0.176N |(e) (e) (e) (e) |
|POLY 6 | P=0.157N P=0.109N P=0.113N P=0.369N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.144N P=0.136N P=0.149N P=0.113N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.193N P=0.121N P=0.125N P=0.129N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 38/50 (76%) 43/49 (88%) 44/48 (92%) |2/50 (4%) 3/50 (6%) 7/50 (14%) 18/49 (37%) |
|POLY-3 RATE (b) | 34/45.22 38/45.81 43/48.11 44/46.58 |2/43.16 3/43.84 7/46.11 18/44.26 |
|POLY-3 PERCENT (g) | 75.2% 83.0% 89.4% 94.5% |4.6% 6.8% 15.2% 40.7% |
|TERMINAL (d) | 17/23 (74%) 22/27 (82%) 24/27 (89%) 0/0 (0%) |2/30 (7%) 1/31 (3%) 5/38 (13%) 14/31 (45%) |
|FIRST INCIDENCE | 564 417 543 398 |729 (T) 585 681 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.492N P=0.296 P<0.001 ** |P<0.001 ** P=0.511 P=0.145 P<0.001 ** |
|POLY 3 | P=0.009 ** P=0.243 P=0.052 P=0.005 ** |P<0.001 ** P=0.507 P=0.095 P<0.001 ** |
|POLY 1.5 | P=0.008 ** P=0.265 P=0.036 * P=0.005 ** |P<0.001 ** P=0.505 P=0.089 P<0.001 ** |
|POLY 6 | P=0.010 * P=0.215 P=0.071 P=0.004 ** |P<0.001 ** P=0.511 P=0.103 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.357 P=0.035 * P<0.001 ** |P<0.001 ** P=0.500 P=0.106 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.005 ** P=0.252 P=0.016 * P=0.003 ** |P<0.001 ** P=0.500 P=0.080 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 11/50 (22%) 12/49 (24%) 3/48 (6%) |6/50 (12%) 8/50 (16%) 2/50 (4%) 6/49 (12%) |
|POLY-3 RATE (b) | 15/43.85 11/44.78 12/44.55 3/25.63 |6/44.68 8/45.73 2/46.21 6/44.90 |
|POLY-3 PERCENT (g) | 34.2% 24.6% 26.9% 11.7% |13.4% 17.5% 4.3% 13.4% |
|TERMINAL (d) | 2/23 (9%) 1/27 (4%) 3/27 (11%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 511 550 584 408 |540 417 638 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560 P=0.187N P=0.272N P=0.624 |P=0.541N P=0.406 P=0.101N P=0.611N |
|POLY 3 | P=0.070N P=0.221N P=0.304N P=0.040N* |P=0.545N P=0.404 P=0.122N P=0.618N |
|POLY 1.5 | P=0.019N* P=0.227N P=0.311N P=0.010N* |P=0.545N P=0.401 P=0.126N P=0.620N |
|POLY 6 | P=0.239N P=0.215N P=0.306N P=0.222N |P=0.548N P=0.405 P=0.118N P=0.619N |
|LOGISTIC REGRESSION| P=0.002N** P=0.273N P=0.409N P=0.003N** |P=0.537 P=0.366 P=0.157N P=0.540 |
|COCH-ARM / FISHERS | P=0.003N** P=0.247N P=0.349N P=0.002N** |P=0.552N P=0.387 P=0.134N P=0.606 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 35/49 (71%) 39/50 (78%) 34/49 (69%) |46/50 (92%) 47/50 (94%) 46/50 (92%) 45/49 (92%) |
|POLY-3 RATE (b) | 32/43.43 35/46.15 39/47.51 34/40.73 |46/48.75 47/48.77 46/48.38 45/48.43 |
|POLY-3 PERCENT (g) | 73.7% 75.8% 82.1% 83.5% |94.4% 96.4% 95.1% 92.9% |
|TERMINAL (d) | 20/23 (87%) 22/27 (82%) 23/27 (85%) 0/0 (0%) |30/30 (100%) 31/31 (100%) 37/38 (97%) 31/31 (100%) |
|FIRST INCIDENCE | 564 456 543 438 |247 425 597 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.451N P=0.394 P<0.001 ** |P=0.467N P=0.561 P=0.057N P=0.431N |
|POLY 3 | P=0.171 P=0.504 P=0.223 P=0.172 |P=0.367N P=0.503 P=0.630 P=0.554N |
|POLY 1.5 | P=0.311 P=0.418 P=0.161 P=0.265 |P=0.421N P=0.487 P=0.611 P=0.587N |
|POLY 6 | P=0.062 P=0.607N P=0.320 P=0.076 |P=0.325N P=0.565 P=0.689 P=0.521N |
|LOGISTIC REGRESSION| P=0.046 * P=0.406 P=0.150 P=0.028 * |P=0.415N P=0.527 P=0.529N P=0.602N |
|COCH-ARM / FISHERS | P=0.514 P=0.283 P=0.093 P=0.361 |P=0.516N P=0.500 P=0.643N P=0.631N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/49 (4%) 4/50 (8%) 1/49 (2%) |8/50 (16%) 4/50 (8%) 8/50 (16%) 11/49 (22%) |
|POLY-3 RATE (b) | 3/39.90 2/41.97 4/42.58 1/24.74 |8/43.79 4/43.04 8/45.89 11/43.58 |
|POLY-3 PERCENT (g) | 7.5% 4.8% 9.4% 4.0% |18.3% 9.3% 17.4% 25.2% |
|TERMINAL (d) | 3/23 (13%) 2/27 (7%) 3/27 (11%) 0/0 (0%) |7/30 (23%) 4/31 (13%) 7/38 (18%) 9/31 (29%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 586 690 |527 729 (T) 725 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.426N P=0.585 P=0.005 ** |P=0.082 P=0.160N P=0.416N P=0.325 |
|POLY 3 | P=0.504N P=0.477N P=0.536 P=0.488N |P=0.087 P=0.183N P=0.568N P=0.297 |
|POLY 1.5 | P=0.389N P=0.489N P=0.524 P=0.397N |P=0.087 P=0.180N P=0.582N P=0.299 |
|POLY 6 | P=0.486 P=0.459N P=0.550 P=0.637N |P=0.085 P=0.188N P=0.551N P=0.292 |
|LOGISTIC REGRESSION| P=0.455 P=0.426N P=0.539 P=0.199 |P=0.080 P=0.179N P=0.542N P=0.299 |
|COCH-ARM / FISHERS | P=0.267N P=0.510N P=0.500 P=0.316N |P=0.083 P=0.178N P=0.607N P=0.288 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/50 (6%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/40.18 1/41.97 3/42.10 0/24.59 |0/43.16 0/43.04 1/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 2.5% 2.4% 7.1% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/27 (4%) 3/27 (11%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 653 729 (T) 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.679 P=0.740N P=0.341 P=0.912N |P=0.779N (e) P=0.547 (e) |
|POLY 3 | P=0.515N P=0.751N P=0.322 P=0.593N |P=0.772N (e) P=0.512 (e) |
|POLY 1.5 | P=0.411N P=0.756N P=0.317 P=0.549N |P=0.772N (e) P=0.508 (e) |
|POLY 6 | P=0.518 P=0.744N P=0.325 P=0.659N |P=0.773N (e) P=0.517 (e) |
|LOGISTIC REGRESSION| P=0.791 P=0.758N P=0.331 P=0.614N |(e) (e) P=0.547 (e) |
|COCH-ARM / FISHERS | P=0.307N P=0.747 P=0.309 P=0.505N |P=0.776N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/50 (2%) 3/49 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/39.90 2/42.98 1/42.29 3/26.60 |1/44.12 0/43.04 0/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.4% 11.3% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 456 682 398 |247 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.257 P=0.519 P=0.098 |P=0.547N P=0.500N P=0.500N P=0.500N |
|POLY 3 | P=0.070 P=0.254 P=0.512 P=0.062 |P=0.550N P=0.505N P=0.492N P=0.504N |
|POLY 1.5 | P=0.097 P=0.246 P=0.508 P=0.085 |P=0.550N P=0.503N P=0.496N P=0.504N |
|POLY 6 | P=0.045 * P=0.266 P=0.516 P=0.037 * |P=0.552N P=0.507N P=0.487N P=0.506N |
|LOGISTIC REGRESSION| P=0.349 P=0.148 P=0.505 P=0.164 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.138 P=0.242 P=0.500 P=0.117 |P=0.551N P=0.500N P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 18/49 (37%) 10/50 (20%) 5/49 (10%) |11/50 (22%) 15/50 (30%) 17/50 (34%) 8/49 (16%) |
|POLY-3 RATE (b) | 11/40.86 18/43.97 10/42.12 5/26.59 |11/44.58 15/44.26 17/45.92 8/43.76 |
|POLY-3 PERCENT (g) | 26.9% 40.9% 23.7% 18.8% |24.7% 33.9% 37.0% 18.3% |
|TERMINAL (d) | 7/23 (30%) 12/27 (44%) 9/27 (33%) 0/0 (0%) |7/30 (23%) 12/31 (39%) 16/38 (42%) 7/31 (23%) |
|FIRST INCIDENCE | 653 558 725 586 |413 585 717 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.195 P=0.365N P=0.006 ** |P=0.099N P=0.274 P=0.325 P=0.291N |
|POLY 3 | P=0.112N P=0.125 P=0.468N P=0.321N |P=0.101N P=0.234 P=0.146 P=0.318N |
|POLY 1.5 | P=0.041N* P=0.106 P=0.473N P=0.182N |P=0.100N P=0.240 P=0.141 P=0.315N |
|POLY 6 | P=0.307N P=0.156 P=0.472N P=0.609N |P=0.109N P=0.229 P=0.152 P=0.330N |
|LOGISTIC REGRESSION| P=0.390N P=0.115 P=0.408N P=0.560 |P=0.099N P=0.246 P=0.172 P=0.315N |
|COCH-ARM / FISHERS | P=0.011N* P=0.082 P=0.500N P=0.093N |P=0.110N P=0.247 P=0.133 P=0.323N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung: Bronchiole |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 2/50 (4%) 3/50 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/39.90 0/41.97 0/42.10 0/24.59 |1/43.27 2/43.04 3/45.88 2/43.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.7% 6.5% 4.6% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 2/31 (7%) 3/38 (8%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- --- --- |702 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.540 P=0.511 P=0.387 P=0.508 |
|POLY 3 | (e) (e) (e) (e) |P=0.545 P=0.498 P=0.326 P=0.499 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.545 P=0.500 P=0.319 P=0.499 |
|POLY 6 | (e) (e) (e) (e) |P=0.542 P=0.495 P=0.335 P=0.496 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.533 P=0.497 P=0.342 P=0.496 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.536 P=0.500 P=0.309 P=0.492 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/39.90 0/42.41 1/42.17 2/26.66 |0/43.16 1/43.04 0/45.88 1/43.66 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 2.4% 7.5% |0.0% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 2/23 (9%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | 729 (T) --- 712 438 |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061 P=0.203N P=0.438N P=0.233 |P=0.475 P=0.507 (e) P=0.507 |
|POLY 3 | P=0.264 P=0.223N P=0.481N P=0.541 |P=0.479 P=0.499 (e) P=0.502 |
|POLY 1.5 | P=0.320 P=0.228N P=0.487N P=0.622 |P=0.480 P=0.500 (e) P=0.503 |
|POLY 6 | P=0.202 P=0.216N P=0.474N P=0.401 |P=0.475 P=0.498 (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.500 (e) P=0.456N P=0.644N |(e) P=0.507 (e) P=0.507 |
|COCH-ARM / FISHERS | P=0.395 P=0.247N P=0.500N P=0.691N |P=0.478 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/18 (0%) 0/14 (0%) 0/21 (0%) 0/9 (0%) |0/15 (0%) 0/11 (0%) 2/8 (25%) 0/14 (0%) |
|POLY-3 RATE (b) | 0/15.01 0/11.89 0/18.44 0/4.53 |0/12.41 0/8.32 2/5.93 0/12.98 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 33.7% 0.0% |
|TERMINAL (d) | 0/7 (0%) 0/6 (0%) 0/10 (0%) 0/0 (0%) |0/6 (0%) 0/6 (0%) 2/4 (50%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.529N (e) P=0.142 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.580N (e) P=0.075 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.596N (e) P=0.082 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.564N (e) P=0.067 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.142 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.619N (e) P=0.111 (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/41 (0%) 1/47 (2%) 0/44 (0%) |3/50 (6%) 3/49 (6%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/38.11 0/36.12 1/39.85 0/22.54 |3/43.42 3/42.79 1/45.88 1/43.27 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 2.5% 0.0% |6.9% 7.0% 2.2% 2.3% |
|TERMINAL (d) | 1/22 (5%) 0/25 (0%) 0/26 (0%) 0/0 (0%) |2/30 (7%) 2/31 (7%) 1/38 (3%) 1/31 (3%) |
|FIRST INCIDENCE | 729 (T) --- 725 --- |659 622 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.989 P=0.475N P=0.715N P=1.000N |P=0.232N P=0.655N P=0.240N P=0.300N |
|POLY 3 | P=0.575N P=0.511N P=0.751N P=0.599N |P=0.235N P=0.656 P=0.286N P=0.306N |
|POLY 1.5 | P=0.536N P=0.519N P=0.756N P=0.559N |P=0.233N P=0.656 P=0.293N P=0.306N |
|POLY 6 | P=0.611N P=0.500N P=0.746N P=0.662N |P=0.240N P=0.657 P=0.278N P=0.310N |
|LOGISTIC REGRESSION| P=0.982 (e) P=0.725N (e) |P=0.230N P=0.655 P=0.283N P=0.305N |
|COCH-ARM / FISHERS | P=0.484N P=0.539N P=0.747 P=0.522N |P=0.235N P=0.651 P=0.309N P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/14 (86%) 9/11 (82%) 5/6 (83%) 4/4 (100%) |14/15 (93%) 13/13 (100%) 11/13 (85%) 8/11 (73%) |
|POLY-3 RATE (b) | 12/13.52 9/9.90 5/6.00 4/4.00 |14/14.41 13/13.00 11/12.23 8/10.02 |
|POLY-3 PERCENT (g) | 88.8% 90.9% 83.3% 100.0% |97.2% 100.0% 90.0% 79.8% |
|TERMINAL (d) | 4/4 (100%) 4/4 (100%) 3/4 (75%) 0/0 (0%) |9/9 (100%) 8/8 (100%) 6/6 (100%) 5/5 (100%) |
|FIRST INCIDENCE | 376 649 340 598 |659 417 295 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171 P=0.223N P=0.026N* P=0.219 |P=0.291N P=0.622 P=0.549N P=0.376N |
|POLY 3 | P=0.544 P=0.726 P=0.660N P=0.633 |P=0.048N* P=0.930 P=0.518N P=0.193N |
|POLY 1.5 | P=0.481 P=0.736N P=0.680N P=0.583 |P=0.049N* P=0.732 P=0.470N P=0.184N |
|POLY 6 | P=0.658 P=0.715 P=0.616N P=0.743 |P=0.056N P=1.000 P=0.708N P=0.243N |
|LOGISTIC REGRESSION| P=0.403 P=0.525N P=0.741N P=0.578 |P=0.050N P=0.275 P=0.645N P=0.386N |
|COCH-ARM / FISHERS | P=0.417 P=0.604N P=0.681N P=0.595 |P=0.056N P=0.536 P=0.444N P=0.188N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/48 (0%) 0/48 (0%) 0/46 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/37.87 2/42.41 0/42.10 0/24.79 |0/42.01 0/41.44 0/43.82 0/43.15 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/27 (7%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.970N P=0.274 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.425N P=0.262 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.413N P=0.260 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.399N P=0.267 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.274 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.386N P=0.269 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/46 (24%) 17/50 (34%) 15/50 (30%) 6/49 (12%) |10/48 (21%) 5/48 (10%) 7/46 (15%) 4/49 (8%) |
|POLY-3 RATE (b) | 11/40.99 17/44.82 15/45.27 6/27.31 |10/43.93 5/41.67 7/43.82 4/44.11 |
|POLY-3 PERCENT (g) | 26.8% 37.9% 33.1% 22.0% |22.8% 12.0% 16.0% 9.1% |
|TERMINAL (d) | 6/23 (26%) 8/27 (30%) 5/27 (19%) 0/0 (0%) |3/30 (10%) 3/31 (10%) 7/38 (18%) 2/31 (7%) |
|FIRST INCIDENCE | 376 554 562 561 |413 683 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 P=0.242 P=0.372 P=0.178 |P=0.147N P=0.146N P=0.189N P=0.088N |
|POLY 3 | P=0.254N P=0.191 P=0.343 P=0.434N |P=0.118N P=0.152N P=0.297N P=0.069N |
|POLY 1.5 | P=0.095N P=0.190 P=0.336 P=0.252N |P=0.118N P=0.141N P=0.306N P=0.066N |
|POLY 6 | P=0.522 P=0.208 P=0.362 P=0.482 |P=0.123N P=0.166N P=0.290N P=0.076N |
|LOGISTIC REGRESSION| P=0.020N* P=0.182 P=0.294 P=0.087N |P=0.125N P=0.130N P=0.363N P=0.079N |
|COCH-ARM / FISHERS | P=0.018N* P=0.195 P=0.330 P=0.112N |P=0.124N P=0.130N P=0.331N P=0.068N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 5/50 (10%) 4/50 (8%) 9/49 (18%) |1/48 (2%) 4/48 (8%) 0/46 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | 2/38.23 5/43.57 4/43.28 9/29.79 |1/42.09 4/43.71 0/43.82 3/44.59 |
|POLY-3 PERCENT (g) | 5.2% 11.5% 9.2% 30.2% |2.4% 9.2% 0.0% 6.7% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 676 554 584 408 |709 417 --- 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.296 P=0.367 P<0.001 ** |P=0.413 P=0.191 P=0.462N P=0.321 |
|POLY 3 | P=0.004 ** P=0.271 P=0.395 P=0.006 ** |P=0.430 P=0.190 P=0.492N P=0.326 |
|POLY 1.5 | P=0.010 * P=0.263 P=0.389 P=0.014 * |P=0.430 P=0.187 P=0.498N P=0.323 |
|POLY 6 | P<0.001 ** P=0.285 P=0.403 P<0.001 ** |P=0.428 P=0.192 P=0.486N P=0.327 |
|LOGISTIC REGRESSION| P=0.135 P=0.246 P=0.364 P=0.114 |P=0.251 P=0.141 P=0.499N P=0.232 |
|COCH-ARM / FISHERS | P=0.025 * P=0.254 P=0.379 P=0.032 * |P=0.423 P=0.181 P=0.511N P=0.316 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/46 (9%) 3/50 (6%) 3/50 (6%) 34/49 (69%) |0/48 (0%) 0/48 (0%) 1/46 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 4/39.22 3/42.49 3/42.65 34/41.78 |0/42.01 0/41.44 1/43.82 0/43.15 |
|POLY-3 PERCENT (g) | 10.2% 7.1% 7.0% 81.4% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 564 709 627 398 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.447N P=0.470N P<0.001 ** |P=0.779N (e) P=0.547 (e) |
|POLY 3 | P<0.001 ** P=0.456N P=0.454N P<0.001 ** |P=0.764N (e) P=0.508 (e) |
|POLY 1.5 | P<0.001 ** P=0.454N P=0.452N P<0.001 ** |P=0.764N (e) P=0.503 (e) |
|POLY 6 | P<0.001 ** P=0.456N P=0.458N P<0.001 ** |P=0.766N (e) P=0.515 (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.460N P=0.475N P<0.001 ** |(e) (e) P=0.547 (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.453N P=0.453N P<0.001 ** |P=0.767N (e) P=0.489 (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/50 (0%) 0/50 (0%) 7/49 (14%) |0/48 (0%) 0/48 (0%) 0/46 (0%) 9/49 (18%) |
|POLY-3 RATE (b) | 0/37.87 0/42.41 0/42.10 7/28.36 |0/42.01 0/41.44 0/43.82 9/45.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 24.7% |0.0% 0.0% 0.0% 19.9% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 3/31 (10%) |
|FIRST INCIDENCE | --- --- --- 398 |--- --- --- 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P=0.004 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.002 ** |P<0.001 ** (e) (e) P=0.002 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.004 ** |P<0.001 ** (e) (e) P=0.002 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** |P<0.001 ** (e) (e) P=0.003 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.037 * |P<0.001 ** (e) (e) P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.008 ** |P<0.001 ** (e) (e) P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/46 (9%) 1/50 (2%) 0/50 (0%) 2/49 (4%) |0/48 (0%) 0/48 (0%) 2/46 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/38.40 1/42.41 0/42.10 2/25.72 |0/42.01 0/41.44 2/43.82 1/43.74 |
|POLY-3 PERCENT (g) | 10.4% 2.4% 0.0% 7.8% |0.0% 0.0% 4.6% 2.3% |
|TERMINAL (d) | 3/23 (13%) 1/27 (4%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 2/38 (5%) 0/31 (0%) |
|FIRST INCIDENCE | 564 729 (T) --- 561 |--- --- 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226 P=0.147N P=0.049N* P=0.324 |P=0.419 (e) P=0.292 P=0.513 |
|POLY 3 | P=0.624 P=0.148N P=0.048N* P=0.531N |P=0.443 (e) P=0.247 P=0.508 |
|POLY 1.5 | P=0.603N P=0.151N P=0.049N* P=0.419N |P=0.439 (e) P=0.240 P=0.508 |
|POLY 6 | P=0.590N P=0.144N P=0.048N* P=0.608 |P=0.443 (e) P=0.254 P=0.507 |
|LOGISTIC REGRESSION| P=0.651N P=0.148N P=0.051N P=0.535N |P=0.411 (e) P=0.292 P=0.384 |
|COCH-ARM / FISHERS | P=0.545N P=0.156N P=0.049N* P=0.309N |P=0.427 (e) P=0.237 P=0.505 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |40/48 (83%) 36/48 (75%) 37/46 (80%) 46/49 (94%) |
|POLY-3 RATE (b) | 0/37.87 0/42.41 0/42.10 0/24.79 |40/45.54 36/46.14 37/45.55 46/47.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |87.8% 78.0% 81.2% 96.7% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |27/30 (90%) 24/31 (77%) 30/38 (79%) 31/31 (100%) |
|FIRST INCIDENCE | --- --- --- --- |413 417 598 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.045 * P=0.259N P=0.037N* P=0.221 |
|POLY 3 | (e) (e) (e) (e) |P=0.014 * P=0.155N P=0.275N P=0.087 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.017 * P=0.171N P=0.332N P=0.097 |
|POLY 6 | (e) (e) (e) (e) |P=0.012 * P=0.143N P=0.220N P=0.074 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.025 * P=0.222N P=0.289N P=0.133 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.020 * P=0.226N P=0.461N P=0.093 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 6/50 (12%) 7/49 (14%) 8/48 (17%) |
|POLY-3 RATE (b) | |4/43.75 6/43.46 7/45.57 8/43.15 |
|POLY-3 PERCENT (g) | |9.1% 13.8% 15.4% 18.5% |
|TERMINAL (d) | |3/30 (10%) 4/31 (13%) 6/38 (16%) 6/31 (19%) |
|FIRST INCIDENCE | |542 624 597 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.196 P=0.391 P=0.394 P=0.195 |
|POLY 3 | |P=0.191 P=0.365 P=0.284 P=0.168 |
|POLY 1.5 | |P=0.189 P=0.368 P=0.271 P=0.167 |
|POLY 6 | |P=0.191 P=0.361 P=0.301 P=0.168 |
|LOGISTIC REGRESSION| |P=0.185 P=0.369 P=0.260 P=0.163 |
|COCH-ARM / FISHERS | |P=0.178 P=0.370 P=0.251 P=0.159 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/44 (39%) 20/49 (41%) 12/50 (24%) 9/47 (19%) |7/47 (15%) 10/48 (21%) 6/48 (13%) 10/48 (21%) |
|POLY-3 RATE (b) | 17/38.51 20/44.71 12/42.23 9/28.60 |7/41.16 10/42.16 6/45.38 10/43.82 |
|POLY-3 PERCENT (g) | 44.2% 44.7% 28.4% 31.5% |17.0% 23.7% 13.2% 22.8% |
|TERMINAL (d) | 8/23 (35%) 12/27 (44%) 11/27 (41%) 0/0 (0%) |6/30 (20%) 8/31 (26%) 5/38 (13%) 6/31 (19%) |
|FIRST INCIDENCE | 564 528 698 438 |697 585 638 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.535 P=0.099N P=0.012 * |P=0.318 P=0.315 P=0.342N P=0.317 |
|POLY 3 | P=0.141N P=0.567 P=0.102N P=0.207N |P=0.364 P=0.313 P=0.425N P=0.346 |
|POLY 1.5 | P=0.053N P=0.551 P=0.091N P=0.086N |P=0.359 P=0.315 P=0.444N P=0.338 |
|POLY 6 | P=0.383N P=0.578 P=0.131N P=0.558N |P=0.363 P=0.311 P=0.405N P=0.349 |
|LOGISTIC REGRESSION| P=0.089N P=0.531 P=0.078N P=0.084N |P=0.352 P=0.296 P=0.410N P=0.327 |
|COCH-ARM / FISHERS | P=0.015N* P=0.499 P=0.095N P=0.034N* |P=0.339 P=0.314 P=0.483N P=0.314 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/44 (2%) 2/49 (4%) 2/50 (4%) 0/47 (0%) |3/47 (6%) 2/48 (4%) 3/48 (6%) 3/48 (6%) |
|POLY-3 RATE (b) | 1/36.11 2/41.98 2/42.50 0/23.65 |3/41.03 2/41.44 3/45.05 3/42.76 |
|POLY-3 PERCENT (g) | 2.8% 4.8% 4.7% 0.0% |7.3% 4.8% 6.7% 7.0% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 1/27 (4%) 0/0 (0%) |3/30 (10%) 2/31 (7%) 3/38 (8%) 3/31 (10%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 617 --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.837N P=0.556 P=0.546 P=1.000N |P=0.529 P=0.485N P=0.550N P=0.650N |
|POLY 3 | P=0.380N P=0.553 P=0.557 P=0.581N |P=0.551 P=0.495N P=0.619N P=0.644N |
|POLY 1.5 | P=0.306N P=0.548 P=0.555 P=0.534N |P=0.549 P=0.492N P=0.630N P=0.644N |
|POLY 6 | P=0.491N P=0.558 P=0.557 P=0.651N |P=0.547 P=0.500N P=0.608N P=0.648N |
|LOGISTIC REGRESSION| P=0.551N P=0.556 P=0.552 (e) |P=0.529 P=0.485N P=0.550N P=0.650N |
|COCH-ARM / FISHERS | P=0.229N P=0.541 P=0.548 P=0.484N |P=0.540 P=0.490N P=0.651N P=0.651N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/44 (16%) 6/49 (12%) 4/50 (8%) 5/47 (11%) |2/47 (4%) 1/48 (2%) 4/48 (8%) 3/48 (6%) |
|POLY-3 RATE (b) | 7/36.44 6/42.08 4/42.40 5/25.56 |2/41.03 1/41.44 4/45.05 3/42.76 |
|POLY-3 PERCENT (g) | 19.2% 14.3% 9.4% 19.6% |4.9% 2.4% 8.9% 7.0% |
|TERMINAL (d) | 4/23 (17%) 3/27 (11%) 3/27 (11%) 0/0 (0%) |2/30 (7%) 1/31 (3%) 4/38 (11%) 3/31 (10%) |
|FIRST INCIDENCE | 687 709 649 565 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.360N P=0.191N P<0.001 ** |P=0.361 P=0.488N P=0.450 P=0.515 |
|POLY 3 | P=0.501 P=0.388N P=0.177N P=0.612 |P=0.391 P=0.497N P=0.381 P=0.519 |
|POLY 1.5 | P=0.540N P=0.395N P=0.179N P=0.483N |P=0.388 P=0.494N P=0.370 P=0.518 |
|POLY 6 | P=0.360 P=0.382N P=0.180N P=0.362 |P=0.387 P=0.500N P=0.392 P=0.515 |
|LOGISTIC REGRESSION| P=0.172 P=0.353N P=0.181N P=0.264 |P=0.361 P=0.488N P=0.450 P=0.515 |
|COCH-ARM / FISHERS | P=0.388N P=0.416N P=0.193N P=0.333N |P=0.376 P=0.492N P=0.349 P=0.510 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/45 (0%) 4/48 (8%) 1/49 (2%) 5/50 (10%) |0/49 (0%) 0/47 (0%) 0/47 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/36.39 4/40.87 1/41.55 5/27.64 |0/42.42 0/40.75 0/43.81 2/43.15 |
|POLY-3 PERCENT (g) | 0.0% 9.8% 2.4% 18.1% |0.0% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/22 (0%) 1/26 (4%) 0/26 (0%) 0/0 (0%) |0/30 (0%) 0/30 (0%) 0/36 (0%) 2/31 (7%) |
|FIRST INCIDENCE | --- 661 598 431 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.094 P=0.519 P=0.003 ** |P=0.040 * (e) (e) P=0.245 |
|POLY 3 | P=0.031 * P=0.075 P=0.526 P=0.013 * |P=0.044 * (e) (e) P=0.241 |
|POLY 1.5 | P=0.048 * P=0.072 P=0.523 P=0.023 * |P=0.044 * (e) (e) P=0.241 |
|POLY 6 | P=0.018 * P=0.080 P=0.530 P=0.005 ** |P=0.043 * (e) (e) P=0.238 |
|LOGISTIC REGRESSION| P=0.128 P=0.077 P=0.483 P=0.075 |(e) (e) (e) P=0.245 |
|COCH-ARM / FISHERS | P=0.082 P=0.067 P=0.521 P=0.037 * |P=0.044 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 0/49 (0%) 0/50 (0%) 1/49 (2%) |0/48 (0%) 0/45 (0%) 3/50 (6%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/38.55 0/41.97 0/42.10 1/25.11 |0/41.77 0/39.44 3/46.45 2/42.03 |
|POLY-3 PERCENT (g) | 2.6% 0.0% 0.0% 4.0% |0.0% 0.0% 6.5% 4.8% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 2/31 (7%) |
|FIRST INCIDENCE | 729 (T) --- --- 640 |--- --- 638 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078 P=0.468N P=0.468N P=0.171 |P=0.197 (e) P=0.150 P=0.245 |
|POLY 3 | P=0.436 P=0.483N P=0.482N P=0.656 |P=0.210 (e) P=0.139 P=0.238 |
|POLY 1.5 | P=0.474 P=0.486N P=0.484N P=0.716 |P=0.208 (e) P=0.134 P=0.237 |
|POLY 6 | P=0.399 P=0.477N P=0.481N P=0.548 |P=0.210 (e) P=0.145 P=0.238 |
|LOGISTIC REGRESSION| P=0.383 (e) (e) P=0.526 |P=0.202 (e) P=0.119 P=0.245 |
|COCH-ARM / FISHERS | P=0.526 P=0.490N P=0.485N P=0.742N |P=0.200 (e) P=0.129 P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 4/49 (8%) 1/50 (2%) 0/49 (0%) |0/48 (0%) 1/45 (2%) 0/50 (0%) 1/47 (2%) |
|POLY-3 RATE (b) | 0/38.55 4/42.04 1/42.10 0/24.79 |0/41.77 1/39.44 0/45.88 1/42.03 |
|POLY-3 PERCENT (g) | 0.0% 9.5% 2.4% 0.0% |0.0% 2.5% 0.0% 2.4% |
|TERMINAL (d) | 0/23 (0%) 3/27 (11%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | --- 711 729 (T) --- |--- 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.919N P=0.090 P=0.532 (e) |P=0.475 P=0.507 (e) P=0.507 |
|POLY 3 | P=0.294N P=0.071 P=0.518 (e) |P=0.483 P=0.489 (e) P=0.501 |
|POLY 1.5 | P=0.241N P=0.069 P=0.516 (e) |P=0.482 P=0.489 (e) P=0.500 |
|POLY 6 | P=0.362N P=0.075 P=0.519 (e) |P=0.481 P=0.488 (e) P=0.501 |
|LOGISTIC REGRESSION| P=0.838N P=0.088 P=0.532 (e) |(e) P=0.507 (e) P=0.507 |
|COCH-ARM / FISHERS | P=0.187N P=0.064 P=0.515 (e) |P=0.477 P=0.484 (e) P=0.495 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/47 (19%) 16/49 (33%) 16/50 (32%) 6/49 (12%) |19/48 (40%) 15/45 (33%) 22/50 (44%) 19/47 (40%) |
|POLY-3 RATE (b) | 9/39.09 16/43.94 16/44.04 6/27.56 |19/42.52 15/39.92 22/46.52 19/43.48 |
|POLY-3 PERCENT (g) | 23.0% 36.4% 36.3% 21.8% |44.7% 37.6% 47.3% 43.7% |
|TERMINAL (d) | 8/23 (35%) 10/27 (37%) 9/27 (33%) 0/0 (0%) |15/30 (50%) 14/31 (45%) 19/38 (50%) 14/31 (45%) |
|FIRST INCIDENCE | 564 456 586 564 |626 585 627 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.162 P=0.165 P=0.007 ** |P=0.407 P=0.229N P=0.475N P=0.556N |
|POLY 3 | P=0.329N P=0.135 P=0.136 P=0.569N |P=0.502 P=0.331N P=0.487 P=0.550N |
|POLY 1.5 | P=0.143N P=0.120 P=0.126 P=0.408N |P=0.480 P=0.329N P=0.457 P=0.568N |
|POLY 6 | P=0.429 P=0.164 P=0.155 P=0.405 |P=0.519 P=0.339N P=0.518 P=0.539N |
|LOGISTIC REGRESSION| P=0.338N P=0.118 P=0.124 P=0.511 |P=0.457 P=0.327N P=0.534 P=0.577N |
|COCH-ARM / FISHERS | P=0.039N* P=0.101 P=0.112 P=0.258N |P=0.431 P=0.341N P=0.406 P=0.550 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/39.90 0/40.78 0/42.10 2/25.87 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 7.7% | |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- --- --- 610 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.030 * | |
|POLY 3 | P=0.026 * (e) (e) P=0.156 | |
|POLY 1.5 | P=0.032 * (e) (e) P=0.193 | |
|POLY 6 | P=0.021 * (e) (e) P=0.111 | |
|LOGISTIC REGRESSION| P=0.048 * (e) (e) P=0.167 | |
|COCH-ARM / FISHERS | P=0.044 * (e) (e) P=0.247 | |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/47 (6%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 1/39.90 3/41.31 3/42.59 1/25.58 | |
|POLY-3 PERCENT (g) | 2.5% 7.3% 7.0% 3.9% | |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 2/27 (7%) 0/0 (0%) | |
|FIRST INCIDENCE | 729 (T) 564 583 614 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346 P=0.343 P=0.363 P=0.335 | |
|POLY 3 | P=0.593N P=0.317 P=0.328 P=0.653 | |
|POLY 1.5 | P=0.492N P=0.304 P=0.321 P=0.710 | |
|POLY 6 | P=0.437 P=0.337 P=0.337 P=0.547 | |
|LOGISTIC REGRESSION| P=0.552N P=0.296 P=0.320 P=0.610 | |
|COCH-ARM / FISHERS | P=0.378N P=0.285 P=0.309 P=0.753N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/48 (23%) 11/50 (22%) 10/50 (20%) 5/50 (10%) | |
|POLY-3 RATE (b) | 11/40.03 11/42.67 10/42.17 5/27.43 | |
|POLY-3 PERCENT (g) | 27.5% 25.8% 23.7% 18.2% | |
|TERMINAL (d) | 8/23 (35%) 10/27 (37%) 9/27 (33%) 0/0 (0%) | |
|FIRST INCIDENCE | 323 661 712 561 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.441N P=0.355N P=0.040 * | |
|POLY 3 | P=0.255N P=0.530N P=0.445N P=0.281N | |
|POLY 1.5 | P=0.129N P=0.537N P=0.445N P=0.152N | |
|POLY 6 | P=0.497N P=0.514N P=0.450N P=0.567N | |
|LOGISTIC REGRESSION| P=0.562N P=0.496N P=0.408N P=0.248N | |
|COCH-ARM / FISHERS | P=0.046N* P=0.553N P=0.458N P=0.072N | |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/48 (17%) 8/50 (16%) 12/50 (24%) 0/50 (0%) | |
|POLY-3 RATE (b) | 8/39.25 8/42.58 12/43.99 0/25.17 | |
|POLY-3 PERCENT (g) | 20.4% 18.8% 27.3% 0.0% | |
|TERMINAL (d) | 6/23 (26%) 5/27 (19%) 7/27 (26%) 0/0 (0%) | |
|FIRST INCIDENCE | 569 709 564 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.572N P=0.455N P=0.344 P=0.574N | |
|POLY 3 | P=0.057N P=0.539N P=0.316 P=0.023N* | |
|POLY 1.5 | P=0.014N* P=0.549N P=0.296 P=0.008N** | |
|POLY 6 | P=0.272N P=0.523N P=0.339 P=0.099N | |
|LOGISTIC REGRESSION| P=0.067N P=0.494N P=0.286 P=0.147N | |
|COCH-ARM / FISHERS | P=0.003N** P=0.572N P=0.259 P=0.002N** | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 5/49 (10%) 0/50 (0%) 0/50 (0%) |3/49 (6%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/38.94 5/41.59 0/42.10 0/25.17 |3/42.42 4/43.04 3/45.88 1/43.89 |
|POLY-3 PERCENT (g) | 2.6% 12.0% 0.0% 0.0% |7.1% 9.3% 6.5% 2.3% |
|TERMINAL (d) | 1/23 (4%) 4/27 (15%) 0/27 (0%) 0/0 (0%) |3/30 (10%) 4/31 (13%) 3/38 (8%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 684 --- --- |729 (T) 729 (T) 729 (T) 668 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.538N P=0.144 P=0.468N P=1.000N |P=0.166N P=0.518 P=0.550N P=0.300N |
|POLY 3 | P=0.129N P=0.116 P=0.484N P=0.583N |P=0.163N P=0.508 P=0.626N P=0.293N |
|POLY 1.5 | P=0.109N P=0.110 P=0.488N P=0.540N |P=0.162N P=0.511 P=0.636N P=0.293N |
|POLY 6 | P=0.134N P=0.124 P=0.481N P=0.651N |P=0.166N P=0.503 P=0.615N P=0.296N |
|LOGISTIC REGRESSION| P=0.390N P=0.140 (e) (e) |P=0.169N P=0.518 P=0.550N P=0.298N |
|COCH-ARM / FISHERS | P=0.089N P=0.102 P=0.495N P=0.495N |P=0.165N P=0.511 P=0.651N P=0.301N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |1/49 (2%) 3/50 (6%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/38.94 1/41.42 1/42.10 0/25.17 |1/42.42 3/43.04 5/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 2.6% 2.4% 2.4% 0.0% |2.4% 7.0% 10.9% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/27 (4%) 1/27 (4%) 0/0 (0%) |1/30 (3%) 3/31 (10%) 5/38 (13%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.976N P=0.726N P=0.726N P=1.000N |P=0.159N P=0.316 P=0.163 P=0.493N |
|POLY 3 | P=0.428N P=0.747N P=0.743N P=0.583N |P=0.155N P=0.310 P=0.120 P=0.494N |
|POLY 1.5 | P=0.384N P=0.752N P=0.747N P=0.540N |P=0.154N P=0.312 P=0.115 P=0.493N |
|POLY 6 | P=0.472N P=0.740N P=0.739N P=0.651N |P=0.160N P=0.306 P=0.126 P=0.497N |
|LOGISTIC REGRESSION| P=0.976N P=0.726N P=0.726N (e) |P=0.159N P=0.316 P=0.163 (e) |
|COCH-ARM / FISHERS | P=0.328N P=0.753N P=0.747N P=0.495N |P=0.162N P=0.316 P=0.107 P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/50 (0%) 22/50 (44%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/38.94 1/41.59 0/42.10 22/35.70 |0/42.42 1/43.52 1/46.11 1/43.71 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 61.6% |0.0% 2.3% 2.2% 2.3% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 684 --- 431 |--- 585 667 718 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.536 (e) P<0.001 ** |P=0.522 P=0.509 P=0.515 P=0.506 |
|POLY 3 | P<0.001 ** P=0.513 (e) P<0.001 ** |P=0.533 P=0.505 P=0.517 P=0.506 |
|POLY 1.5 | P<0.001 ** P=0.508 (e) P<0.001 ** |P=0.534 P=0.505 P=0.512 P=0.507 |
|POLY 6 | P<0.001 ** P=0.521 (e) P<0.001 ** |P=0.528 P=0.505 P=0.522 P=0.503 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.506 (e) P<0.001 ** |P=0.513 P=0.479 P=0.491 P=0.502 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) P<0.001 ** |P=0.530 P=0.505 P=0.505 P=0.505 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 2/48 (4%) 0/49 (0%) 0/46 (0%) | |
|POLY-3 RATE (b) | 0/35.63 2/41.09 0/42.00 0/23.53 | |
|POLY-3 PERCENT (g) | 0.0% 4.9% 0.0% 0.0% | |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- 716 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.969N P=0.295 (e) (e) | |
|POLY 3 | P=0.423N P=0.269 (e) (e) | |
|POLY 1.5 | P=0.414N P=0.266 (e) (e) | |
|POLY 6 | P=0.395N P=0.274 (e) (e) | |
|LOGISTIC REGRESSION| P=0.840N P=0.280 (e) (e) | |
|COCH-ARM / FISHERS | P=0.388N P=0.275 (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 4/48 (8%) 0/49 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/39.34 4/40.49 0/41.10 0/24.65 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 2.5% 9.9% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 3/25 (12%) 0/26 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 709 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.633N P=0.219 P=0.476N P=1.000 |(e) (e) (e) (e) |
|POLY 3 | P=0.172N P=0.186 P=0.491N P=0.589N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.150N P=0.183 P=0.493N P=0.544N |(e) (e) (e) (e) |
|POLY 6 | P=0.174N P=0.193 P=0.490N P=0.655N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.547N P=0.220 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.121N P=0.181 P=0.495N P=0.495N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/48 (2%) 0/49 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/39.39 1/40.46 0/41.10 0/24.65 |0/43.16 0/43.04 0/45.88 2/43.66 |
|POLY-3 PERCENT (g) | 2.5% 2.5% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/23 (0%) 0/25 (0%) 0/26 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 2/31 (7%) |
|FIRST INCIDENCE | 718 717 --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.926N P=0.711N P=0.455N P=1.000N |P=0.038 * (e) (e) P=0.245 |
|POLY 3 | P=0.370N P=0.755N P=0.491N P=0.589N |P=0.041 * (e) (e) P=0.240 |
|POLY 1.5 | P=0.367N P=0.757N P=0.493N P=0.544N |P=0.042 * (e) (e) P=0.240 |
|POLY 6 | P=0.324N P=0.750N P=0.490N P=0.655N |P=0.041 * (e) (e) P=0.237 |
|LOGISTIC REGRESSION| P=0.722N P=0.746N P=0.486N P=0.994N |(e) (e) (e) P=0.245 |
|COCH-ARM / FISHERS | P=0.345N P=0.753N P=0.495N P=0.495N |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/43 (14%) 5/50 (10%) 4/49 (8%) 2/47 (4%) |0/48 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 6/37.67 5/42.93 4/42.97 2/24.16 |0/41.44 0/41.12 0/45.12 0/42.76 |
|POLY-3 PERCENT (g) | 15.9% 11.7% 9.3% 8.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 564 661 586 629 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.319 P=0.407N P=0.315N P=0.332 |(e) (e) (e) (e) |
|POLY 3 | P=0.297N P=0.408N P=0.288N P=0.322N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.202N P=0.400N P=0.284N P=0.197N |(e) (e) (e) (e) |
|POLY 6 | P=0.414N P=0.414N P=0.297N P=0.558N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.153N P=0.396N P=0.323N P=0.232N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.109N P=0.393N P=0.289N P=0.106N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 5/50 (10%) 2/49 (4%) 0/47 (0%) |7/48 (15%) 7/48 (15%) 4/49 (8%) 2/48 (4%) |
|POLY-3 RATE (b) | 2/36.86 5/44.83 2/42.90 0/23.65 |7/44.73 7/42.06 4/45.93 2/43.49 |
|POLY-3 PERCENT (g) | 5.4% 11.2% 4.7% 0.0% |15.7% 16.6% 8.7% 4.6% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 2/31 (7%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 564 456 564 --- |247 626 604 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164N P=0.255 P=0.673N P=0.566N |P=0.060N P=0.606 P=0.220N P=0.091N |
|POLY 3 | P=0.156N P=0.301 P=0.639N P=0.347N |P=0.052N P=0.566 P=0.246N P=0.085N |
|POLY 1.5 | P=0.107N P=0.295 P=0.639N P=0.279N |P=0.051N P=0.584 P=0.249N P=0.082N |
|POLY 6 | P=0.229N P=0.311 P=0.642N P=0.468N |P=0.055N P=0.546 P=0.242N P=0.091N |
|LOGISTIC REGRESSION| P=0.011N* P=0.221 P=0.667 P=0.196N |P=0.081N P=0.605 P=0.388N P=0.174N |
|COCH-ARM / FISHERS | P=0.062N P=0.285 P=0.641N P=0.225N |P=0.052N P=0.613N P=0.250N P=0.079N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 0/50 (0%) 0/49 (0%) 0/47 (0%) |1/48 (2%) 0/48 (0%) 0/49 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/36.72 0/42.41 0/42.00 0/23.65 |1/41.44 0/41.12 0/45.12 1/43.03 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 0.0% 0.0% |2.4% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 568 --- --- --- |729 (T) --- --- 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494N P=0.222N P=0.213N P=0.574N |P=0.521 P=0.493N P=0.453N P=0.757N |
|POLY 3 | P=0.302N P=0.205N P=0.207N P=0.346N |P=0.529 P=0.502N P=0.483N P=0.752N |
|POLY 1.5 | P=0.314N P=0.204N P=0.206N P=0.278N |P=0.527 P=0.500N P=0.488N P=0.754N |
|POLY 6 | P=0.230N P=0.205N P=0.210N P=0.466N |P=0.530 P=0.503N P=0.478N P=0.752N |
|LOGISTIC REGRESSION| P=0.266N P=0.210N P=0.225N P=0.242N |P=0.523 (e) (e) P=0.761N |
|COCH-ARM / FISHERS | P=0.305N P=0.211N P=0.216N P=0.225N |P=0.522 P=0.500N P=0.495N P=0.753N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/43 (9%) 4/50 (8%) 9/49 (18%) 2/47 (4%) |0/48 (0%) 0/48 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 4/36.20 4/42.42 9/42.00 2/24.47 |0/41.44 0/41.12 0/45.12 0/42.76 |
|POLY-3 PERCENT (g) | 11.1% 9.4% 21.4% 8.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/23 (17%) 3/27 (11%) 9/27 (33%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 728 729 (T) 564 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.551N P=0.172 P=0.044 * |(e) (e) (e) (e) |
|POLY 3 | P=0.559N P=0.554N P=0.176 P=0.527N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.372N P=0.554N P=0.179 P=0.410N |(e) (e) (e) (e) |
|POLY 6 | P=0.283 P=0.551N P=0.169 P=0.608 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.055 (e) P=0.172 P=0.511 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.197N P=0.555N P=0.173 P=0.297N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 0/50 (0%) 0/49 (0%) 0/47 (0%) |0/48 (0%) 1/48 (2%) 1/49 (2%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/36.20 0/42.41 0/42.00 0/23.65 |0/41.44 1/41.12 1/45.12 3/42.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.4% 2.2% 7.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 1/38 (3%) 3/31 (10%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.064 P=0.507 P=0.547 P=0.126 |
|POLY 3 | (e) (e) (e) (e) |P=0.073 P=0.498 P=0.517 P=0.124 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.072 P=0.500 P=0.512 P=0.123 |
|POLY 6 | (e) (e) (e) (e) |P=0.072 P=0.497 P=0.522 P=0.123 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.507 P=0.547 P=0.126 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.069 P=0.500 P=0.505 P=0.121 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 3/50 (6%) 2/49 (4%) 0/47 (0%) |1/48 (2%) 1/48 (2%) 1/49 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/36.20 3/42.99 2/42.18 0/23.65 |1/41.90 1/41.46 1/45.48 0/42.76 |
|POLY-3 PERCENT (g) | 0.0% 7.0% 4.7% 0.0% |2.4% 2.4% 2.2% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/27 (4%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 614 682 --- |596 634 627 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.815 P=0.150 P=0.268 (e) |P=0.334N P=0.758 P=0.735N P=0.500N |
|POLY 3 | P=0.424N P=0.151 P=0.272 (e) |P=0.331N P=0.758 P=0.742N P=0.496N |
|POLY 1.5 | P=0.338N P=0.150 P=0.271 (e) |P=0.330N P=0.760 P=0.747N P=0.496N |
|POLY 6 | P=0.556N P=0.154 P=0.270 (e) |P=0.334N P=0.756 P=0.736N P=0.498N |
|LOGISTIC REGRESSION| P=0.392N P=0.148 P=0.270 (e) |P=0.383N P=0.752 P=0.731 P=0.577N |
|COCH-ARM / FISHERS | P=0.251N P=0.151 P=0.281 (e) |P=0.333N P=0.753N P=0.747N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 5/49 (10%) |4/50 (8%) 3/49 (6%) 3/50 (6%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/39.90 1/42.59 3/42.52 5/27.30 |4/44.59 3/43.03 3/46.06 2/42.80 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 7.1% 18.3% |9.0% 7.0% 6.5% 4.7% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 2/38 (5%) 0/31 (0%) |
|FIRST INCIDENCE | --- 684 649 431 |413 585 681 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.536 P=0.142 P=0.011 * |P=0.327N P=0.485N P=0.423N P=0.332N |
|POLY 3 | P=0.003 ** P=0.513 P=0.130 P=0.009 ** |P=0.336N P=0.519N P=0.482N P=0.356N |
|POLY 1.5 | P=0.007 ** P=0.508 P=0.126 P=0.017 * |P=0.335N P=0.516N P=0.489N P=0.354N |
|POLY 6 | P<0.001 ** P=0.521 P=0.134 P=0.004 ** |P=0.340N P=0.522N P=0.473N P=0.359N |
|LOGISTIC REGRESSION| P=0.037 * P=0.505 P=0.127 P=0.062 |P=0.382N P=0.535N P=0.558N P=0.438N |
|COCH-ARM / FISHERS | P=0.015 * P=0.500 P=0.121 P=0.027 * |P=0.337N P=0.511N P=0.500N P=0.359N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia Basal Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/49 (4%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 1/42.29 2/25.24 |0/43.16 0/42.07 0/45.88 0/42.42 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 7.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 682 614 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.519 P=0.019 * |(e) (e) (e) (e) |
|POLY 3 | P=0.044 * (e) P=0.512 P=0.152 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.063 (e) P=0.508 P=0.188 |(e) (e) (e) (e) |
|POLY 6 | P=0.024 * (e) P=0.516 P=0.108 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.056 (e) P=0.505 P=0.124 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.093 (e) P=0.500 P=0.242 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/40.31 0/42.41 1/42.65 1/25.10 |0/43.16 0/42.07 0/45.88 0/42.42 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 2.3% 4.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 653 --- 562 589 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426 P=0.216N P=0.493N P=0.485 |(e) (e) (e) (e) |
|POLY 3 | P=0.563 P=0.226N P=0.480N P=0.656N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.630 P=0.229N P=0.486N P=0.583N |(e) (e) (e) (e) |
|POLY 6 | P=0.469 P=0.220N P=0.475N P=0.654 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.590N P=0.235N P=0.530N P=0.648N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.661N P=0.247N P=0.500N P=0.508N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 8/50 (16%) 10/49 (20%) |2/50 (4%) 6/49 (12%) 2/50 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/40.61 5/43.83 8/44.67 10/28.71 |2/43.62 6/44.13 2/46.69 1/42.92 |
|POLY-3 PERCENT (g) | 7.4% 11.4% 17.9% 34.8% |4.6% 13.6% 4.3% 2.3% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 645 550 562 564 |624 435 597 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.430 P=0.141 P<0.001 ** |P=0.153N P=0.143 P=0.648N P=0.497N |
|POLY 3 | P=0.003 ** P=0.398 P=0.129 P=0.004 ** |P=0.148N P=0.136 P=0.669N P=0.506N |
|POLY 1.5 | P=0.009 ** P=0.383 P=0.118 P=0.012 * |P=0.148N P=0.133 P=0.678N P=0.507N |
|POLY 6 | P<0.001 ** P=0.422 P=0.144 P<0.001 ** |P=0.151N P=0.140 P=0.658N P=0.507N |
|LOGISTIC REGRESSION| P=0.064 P=0.333 P=0.078 P=0.014 * |P=0.202N P=0.116 P=0.653 P=0.568N |
|COCH-ARM / FISHERS | P=0.032 * P=0.357 P=0.100 P=0.033 * |P=0.154N P=0.128 P=0.691N P=0.515N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 1/49 (2%) 0/50 (0%) 2/48 (4%) |1/49 (2%) 1/47 (2%) 0/49 (0%) 1/47 (2%) |
|POLY-3 RATE (b) | 0/38.21 1/41.98 0/42.10 2/25.87 |1/42.88 1/40.49 0/45.32 1/42.03 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 7.7% |2.3% 2.5% 0.0% 2.4% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | --- 726 --- 398 |596 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.546 (e) P=0.249 |P=0.668 P=0.759N P=0.479N P=0.757N |
|POLY 3 | P=0.100 P=0.519 (e) P=0.163 |P=0.665 P=0.748 P=0.489N P=0.756 |
|POLY 1.5 | P=0.121 P=0.516 (e) P=0.200 |P=0.665 P=0.750 P=0.493N P=0.756 |
|POLY 6 | P=0.082 P=0.524 (e) P=0.116 |P=0.663 P=0.745 P=0.485N P=0.755 |
|LOGISTIC REGRESSION| P=0.377 P=0.544 (e) P=0.214 |P=0.658 P=0.752 P=0.544N P=0.739 |
|COCH-ARM / FISHERS | P=0.152 P=0.516 (e) P=0.258 |P=0.662 P=0.742 P=0.500N P=0.742 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/46 (11%) 7/49 (14%) 2/50 (4%) 5/48 (10%) |3/49 (6%) 2/47 (4%) 2/49 (4%) 4/47 (9%) |
|POLY-3 RATE (b) | 5/40.25 7/43.16 2/42.77 5/26.55 |3/42.98 2/40.86 2/45.89 4/43.52 |
|POLY-3 PERCENT (g) | 12.4% 16.2% 4.7% 18.8% |7.0% 4.9% 4.4% 9.2% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 323 614 584 431 |596 680 638 564 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.481 P=0.202N P=0.082 |P=0.304 P=0.509N P=0.439N P=0.503 |
|POLY 3 | P=0.414 P=0.428 P=0.190N P=0.361 |P=0.319 P=0.523N P=0.470N P=0.507 |
|POLY 1.5 | P=0.521 P=0.424 P=0.188N P=0.502 |P=0.312 P=0.520N P=0.481N P=0.498 |
|POLY 6 | P=0.307 P=0.444 P=0.194N P=0.182 |P=0.324 P=0.526N P=0.457N P=0.514 |
|LOGISTIC REGRESSION| P=0.267N P=0.389 P=0.213N P=0.343N |P=0.241 P=0.520N P=0.534N P=0.395 |
|COCH-ARM / FISHERS | P=0.513N P=0.425 P=0.185N P=0.602N |P=0.295 P=0.520N P=0.500N P=0.476 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 2/40.02 4/43.17 1/42.47 3/26.78 | |
|POLY-3 PERCENT (g) | 5.0% 9.3% 2.4% 11.2% | |
|TERMINAL (d) | 1/23 (4%) 3/27 (11%) 0/27 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | 698 456 627 431 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.052 P=0.412 P=0.462N P=0.049 * | |
|POLY 3 | P=0.376 P=0.372 P=0.479N P=0.325 | |
|POLY 1.5 | P=0.452 P=0.360 P=0.486N P=0.411 | |
|POLY 6 | P=0.299 P=0.389 P=0.472N P=0.204 | |
|LOGISTIC REGRESSION| P=0.624N P=0.343 P=0.490N P=0.498 | |
|COCH-ARM / FISHERS | P=0.551 P=0.339 P=0.500N P=0.500 | |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/50 (4%) 1/50 (2%) | |
|POLY-3 RATE (b) | 3/40.56 2/43.17 2/42.47 1/25.54 | |
|POLY-3 PERCENT (g) | 7.4% 4.6% 4.7% 3.9% | |
|TERMINAL (d) | 1/23 (4%) 1/27 (4%) 1/27 (4%) 0/0 (0%) | |
|FIRST INCIDENCE | 565 456 627 627 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.586 P=0.449N P=0.452N P=0.586 | |
|POLY 3 | P=0.453N P=0.472N P=0.479N P=0.482N | |
|POLY 1.5 | P=0.378N P=0.481N P=0.485N P=0.390N | |
|POLY 6 | P=0.529N P=0.458N P=0.473N P=0.631N | |
|LOGISTIC REGRESSION| P=0.250N P=0.540N P=0.502N P=0.474N | |
|COCH-ARM / FISHERS | P=0.286N P=0.500N P=0.500N P=0.309N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/42 (57%) 26/47 (55%) 31/48 (65%) 3/47 (6%) |36/45 (80%) 36/45 (80%) 38/46 (83%) 28/46 (61%) |
|POLY-3 RATE (b) | 24/38.21 26/41.87 31/45.04 3/24.78 |36/42.95 36/42.33 38/45.12 28/43.74 |
|POLY-3 PERCENT (g) | 62.8% 62.1% 68.8% 12.1% |83.8% 85.1% 84.2% 64.0% |
|TERMINAL (d) | 16/23 (70%) 21/27 (78%) 19/27 (70%) 0/0 (0%) |25/30 (83%) 29/31 (94%) 32/38 (84%) 21/31 (68%) |
|FIRST INCIDENCE | 564 456 543 610 |413 542 597 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.300 P=0.454N P=0.330 P=0.367 |P=0.038N* P=0.518N P=0.186N P=0.080N |
|POLY 3 | P<0.001N** P=0.568N P=0.360 P<0.001N** |P=0.003N** P=0.559 P=0.597 P=0.026N* |
|POLY 1.5 | P<0.001N** P=0.544N P=0.340 P<0.001N** |P=0.004N** P=0.591 P=0.569 P=0.026N* |
|POLY 6 | P=0.027N* P=0.599N P=0.387 P=0.005N** |P=0.003N** P=0.517 P=0.616 P=0.030N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.521N P=0.329 P=0.007N** |P=0.005N** P=0.568N P=0.565N P=0.029N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.516N P=0.306 P<0.001N** |P=0.008N** P=0.604N P=0.480 P=0.038N* |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/42 (2%) 1/47 (2%) 1/48 (2%) 2/47 (4%) |0/45 (0%) 1/45 (2%) 0/46 (0%) 0/46 (0%) |
|POLY-3 RATE (b) | 1/35.67 1/40.06 1/41.38 2/24.68 |0/39.48 1/39.80 0/43.82 0/41.10 |
|POLY-3 PERCENT (g) | 2.8% 2.5% 2.4% 8.1% |0.0% 2.5% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 1/27 (4%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 574 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.726N P=0.726N P=0.070 |P=0.612N P=0.507 (e) (e) |
|POLY 3 | P=0.244 P=0.735N P=0.728N P=0.376 |P=0.609N P=0.502 (e) (e) |
|POLY 1.5 | P=0.303 P=0.736N P=0.728N P=0.453 |P=0.607N P=0.502 (e) (e) |
|POLY 6 | P=0.180 P=0.732N P=0.727N P=0.268 |P=0.612N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.200 P=0.726N P=0.726N P=0.419 |(e) P=0.507 (e) (e) |
|COCH-ARM / FISHERS | P=0.386 P=0.724N P=0.718N P=0.543 |P=0.605N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 3/3 (100%) 0/0 (0%) |6/6 (100%) 2/2 (100%) 1/1 (100%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/1.00 0/0.00 3/3.00 0/0.00 |6/6.00 2/2.00 1/1.00 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 0.0% |100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 3/3 (100%) 0/0 (0%) |3/3 (100%) 1/1 (100%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |247 683 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
(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).