TDMS Study 88031-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 05/15/01
EXPERIMENT: 88031 TEST: 06 TIME: 09:44:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: RYAN, MICHAEL CAS: 25265-71-8
------------------------------------------------------------------------------------------------------------------------------------
Final#1/Mice
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 05/15/01
EXPERIMENT: 88031 TEST: 06 TIME: 09:44:35
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: RYAN, MICHAEL CAS: 25265-71-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIPROPYLENE GLYCOL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia Focal
Hypertrophy Focal
Islets, Pancreatic Hyperplasia
Kidney Metaplasia Osseous
Liver Clear Cell Focus
Eosinophilic Focus
Mixed Cell Focus
Preputial Gland Inflammation
Seminal Vesicle Atrophy
Stomach, Glandular Inflammation Chronic
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Blood Vessel: Aorta Inflammation Chronic
Brain Hydrocephalus
Liver Infiltration Cellular Lymphocyte
Lung Thrombosis
Lung: Bronchus Foreign Body
Inflammation Acute
Nose Inflammation Acute
===============================================================
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 1/50 (2%) 0/49 (0%) |1/50 (2%) 1/50 (2%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/45.94 4/44.10 1/45.14 0/41.99 |1/45.83 1/46.33 2/44.02 0/40.09 |
|POLY-3 PERCENT (g) | 15.2% 9.1% 2.2% 0.0% |2.2% 2.2% 4.5% 0.0% |
|TERMINAL (d) | 7/40 (18%) 4/39 (10%) 1/35 (3%) 0/34 (0%) |1/37 (3%) 1/38 (3%) 2/38 (5%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |728 (T) 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004N** P=0.274N P=0.048N* P=0.016N* |P=0.398N P=0.756N P=0.509 P=0.523N |
|POLY 3 | P=0.002N** P=0.285N P=0.032N* P=0.011N* |P=0.417N P=0.758N P=0.486 P=0.527N |
|POLY 1.5 | P=0.002N** P=0.280N P=0.031N* P=0.010N* |P=0.402N P=0.758N P=0.490 P=0.518N |
|POLY 6 | P=0.003N** P=0.285N P=0.034N* P=0.012N* |P=0.431N P=0.759N P=0.483 P=0.534N |
|LOGISTIC REGRESSION| P=0.004N** P=0.274N P=0.048N* (e) |P=0.398N P=0.756N P=0.509 (e) |
|COCH-ARM / FISHERS | P=0.003N** P=0.262N P=0.030N* P=0.007N** |P=0.367N P=0.753N P=0.492 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 24/50 (48%) 23/50 (46%) 15/49 (31%) |3/50 (6%) 3/50 (6%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 28/45.94 24/44.49 23/46.38 15/42.07 |3/45.83 3/46.33 2/44.02 1/40.09 |
|POLY-3 PERCENT (g) | 61.0% 54.0% 49.6% 35.7% |6.6% 6.5% 4.5% 2.5% |
|TERMINAL (d) | 28/40 (70%) 23/39 (59%) 20/35 (57%) 14/34 (41%) |3/37 (8%) 3/38 (8%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 619 518 710 |728 (T) 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027N* P=0.297N P=0.431N P=0.026N* |P=0.226N P=0.651N P=0.488N P=0.346N |
|POLY 3 | P=0.009N** P=0.320N P=0.182N P=0.012N* |P=0.237N P=0.657N P=0.518N P=0.355N |
|POLY 1.5 | P=0.008N** P=0.315N P=0.191N P=0.010N* |P=0.224N P=0.657N P=0.513N P=0.338N |
|POLY 6 | P=0.010N* P=0.306N P=0.179N P=0.014N* |P=0.249N P=0.659N P=0.522N P=0.370N |
|LOGISTIC REGRESSION| P=0.014N* P=0.327N P=0.257N P=0.026N* |P=0.226N P=0.651N P=0.488N P=0.346N |
|COCH-ARM / FISHERS | P=0.007N** P=0.274N P=0.212N P=0.009N** |P=0.195N P=0.661N P=0.510N P=0.309N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 46/50 (92%) 44/50 (88%) 42/49 (86%) |48/50 (96%) 49/50 (98%) 49/49 (100%) 48/50 (96%) |
|POLY-3 RATE (b) | 47/49.12 46/48.55 44/49.09 42/47.13 |48/49.72 49/49.46 49/49.00 48/49.84 |
|POLY-3 PERCENT (g) | 95.7% 94.7% 89.6% 89.1% |96.6% 99.1% 100.0% 96.3% |
|TERMINAL (d) | 40/40 (100%) 37/39 (95%) 31/35 (89%) 31/34 (91%) |36/37 (97%) 38/38 (100%) 38/38 (100%) 32/33 (97%) |
|FIRST INCIDENCE | 416 405 518 416 |193 494 406 20 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390 P=0.563 P=0.421 P=0.447 |P=0.121 P=0.576N P=0.542 P=0.192 |
|POLY 3 | P=0.103N P=0.609N P=0.209N P=0.182N |P=0.531N P=0.424 P=0.282 P=0.689N |
|POLY 1.5 | P=0.093N P=0.605N P=0.226N P=0.170N |P=0.557N P=0.455 P=0.261 P=0.691N |
|POLY 6 | P=0.112N P=0.574N P=0.179N P=0.188N |P=0.496N P=0.397 P=0.326 P=0.688N |
|LOGISTIC REGRESSION| P=0.128N P=0.663N P=0.241N P=0.224N |P=0.621N P=0.551 P=0.241 P=0.667N |
|COCH-ARM / FISHERS | P=0.094N P=0.500N P=0.243N P=0.151N |P=0.590N P=0.500 P=0.253 P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 2/44.00 0/45.14 0/41.99 |1/45.83 0/45.33 1/44.02 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 0.0% 0.0% |2.2% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 0/37 (0%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 710 --- --- |728 (T) --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.440N P=0.234 (e) (e) |P=0.426N P=0.500N P=0.756N P=0.523N |
|POLY 3 | P=0.422N P=0.228 (e) (e) |P=0.426N P=0.502N P=0.752 P=0.527N |
|POLY 1.5 | P=0.417N P=0.228 (e) (e) |P=0.420N P=0.502N P=0.754 P=0.518N |
|POLY 6 | P=0.427N P=0.228 (e) (e) |P=0.431N P=0.503N P=0.750 P=0.534N |
|LOGISTIC REGRESSION| P=0.425N P=0.228 (e) (e) |P=0.426N (e) P=0.756N (e) |
|COCH-ARM / FISHERS | P=0.408N P=0.242 (e) (e) |P=0.405N P=0.505N P=0.747 P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 2/40.09 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 5.0% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.505N P=0.527N P=0.532N |P=0.037 * (e) (e) P=0.213 |
|POLY 3 | P=0.298N P=0.508N P=0.504N P=0.518N |P=0.040 * (e) (e) P=0.209 |
|POLY 1.5 | P=0.301N P=0.506N P=0.502N P=0.513N |P=0.042 * (e) (e) P=0.218 |
|POLY 6 | P=0.296N P=0.508N P=0.507N P=0.523N |P=0.039 * (e) (e) P=0.201 |
|LOGISTIC REGRESSION| P=0.327N (e) (e) (e) |(e) (e) (e) P=0.213 |
|COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.500N P=0.505N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel: Aorta |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |1/45.83 3/46.98 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 6.4% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 585 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.181N P=0.318 P=0.495N P=0.523N |
|POLY 3 | (e) (e) (e) (e) |P=0.171N P=0.314 P=0.508N P=0.527N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.164N P=0.312 P=0.504N P=0.518N |
|POLY 6 | (e) (e) (e) (e) |P=0.176N P=0.317 P=0.510N P=0.534N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.144N P=0.288 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.153N P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |4/50 (8%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.94 0/44.10 0/45.14 0/41.99 |4/46.32 4/46.33 4/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |8.6% 8.6% 9.1% 0.0% |
|TERMINAL (d) | 2/39 (5%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |2/37 (5%) 4/38 (11%) 4/38 (11%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |641 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129N P=0.238N P=0.262N P=0.269N |P=0.072N P=0.629N P=0.640N P=0.088N |
|POLY 3 | P=0.108N P=0.241N P=0.236N P=0.253N |P=0.083N P=0.643N P=0.616 P=0.081N |
|POLY 1.5 | P=0.109N P=0.240N P=0.234N P=0.247N |P=0.072N P=0.639N P=0.628 P=0.074N |
|POLY 6 | P=0.108N P=0.241N P=0.240N P=0.258N |P=0.094N P=0.637 P=0.606 P=0.089N |
|LOGISTIC REGRESSION| P=0.129N (e) (e) (e) |P=0.076N P=0.639N P=0.627 P=0.069N |
|COCH-ARM / FISHERS | P=0.114N P=0.242N P=0.242N P=0.247N |P=0.054N P=0.643N P=0.643N P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 0/45.47 0/43.56 2/41.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.218 |
|POLY 3 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.214 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.221 |
|POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.208 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.098 (e) (e) P=0.319 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Brain: Hypothalamus |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 1/45.47 0/43.56 2/41.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 4.9% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 1/38 (3%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 728 (T) --- 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.121 P=0.505 (e) P=0.218 |
|POLY 3 | (e) (e) (e) (e) |P=0.126 P=0.498 (e) P=0.214 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.131 P=0.498 (e) P=0.221 |
|POLY 6 | (e) (e) (e) (e) |P=0.123 P=0.498 (e) P=0.208 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.214 P=0.505 (e) P=0.319 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.141 P=0.495 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/49 (2%) | |
|POLY-3 RATE (b) | 2/46.50 1/44.10 0/45.14 1/42.07 | |
|POLY-3 PERCENT (g) | 4.3% 2.3% 0.0% 2.4% | |
|TERMINAL (d) | 1/40 (3%) 1/39 (3%) 0/35 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 556 729 (T) --- 710 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.411N P=0.513N P=0.257N P=0.552N | |
|POLY 3 | P=0.374N P=0.518N P=0.244N P=0.535N | |
|POLY 1.5 | P=0.373N P=0.514N P=0.241N P=0.525N | |
|POLY 6 | P=0.378N P=0.521N P=0.250N P=0.545N | |
|LOGISTIC REGRESSION| P=0.364N P=0.478N P=0.242N P=0.472N | |
|COCH-ARM / FISHERS | P=0.372N P=0.500N P=0.247N P=0.508N | |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Gallbladder: Epithelium |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/49 (0%) 2/48 (4%) |5/50 (10%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.18 1/42.35 0/44.14 2/41.64 |5/45.97 1/46.33 1/43.56 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 4.8% |10.9% 2.2% 2.3% 2.5% |
|TERMINAL (d) | 0/39 (0%) 1/38 (3%) 0/34 (0%) 2/34 (6%) |4/37 (11%) 1/38 (3%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |693 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.119 P=0.495 (e) P=0.209 |P=0.087N P=0.101N P=0.102N P=0.137N |
|POLY 3 | P=0.131 P=0.492 (e) P=0.224 |P=0.082N P=0.100N P=0.114N P=0.136N |
|POLY 1.5 | P=0.134 P=0.493 (e) P=0.229 |P=0.079N P=0.099N P=0.111N P=0.124N |
|POLY 6 | P=0.128 P=0.491 (e) P=0.219 |P=0.084N P=0.100N P=0.116N P=0.148N |
|LOGISTIC REGRESSION| (e) P=0.495 (e) P=0.209 |P=0.097N P=0.101N P=0.115N P=0.147N |
|COCH-ARM / FISHERS | P=0.139 P=0.500 (e) P=0.247 |P=0.072N P=0.102N P=0.107N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Gallbladder: Epithelium |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 0/49 (0%) 0/48 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.18 1/42.35 0/44.14 0/41.64 |1/45.83 0/46.33 0/43.56 0/40.09 |
|POLY-3 PERCENT (g) | 4.5% 2.4% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/38 (3%) 0/34 (0%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117N P=0.509N P=0.269N P=0.269N |P=0.317N P=0.495N P=0.495N P=0.523N |
|POLY 3 | P=0.100N P=0.515N P=0.237N P=0.250N |P=0.294N P=0.498N P=0.510N P=0.527N |
|POLY 1.5 | P=0.100N P=0.512N P=0.235N P=0.246N |P=0.299N P=0.498N P=0.508N P=0.518N |
|POLY 6 | P=0.101N P=0.515N P=0.242N P=0.255N |P=0.289N P=0.498N P=0.511N P=0.534N |
|LOGISTIC REGRESSION| P=0.117N P=0.509N (e) (e) |P=0.317N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.100N P=0.500N P=0.242N P=0.247N |P=0.306N P=0.500N P=0.505N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.94 0/44.10 1/45.14 0/41.99 |1/45.83 0/46.33 0/43.56 0/40.09 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 2.2% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/40 (8%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106N P=0.126N P=0.354N P=0.151N |P=0.317N P=0.495N P=0.495N P=0.523N |
|POLY 3 | P=0.087N P=0.126N P=0.312N P=0.135N |P=0.294N P=0.498N P=0.510N P=0.527N |
|POLY 1.5 | P=0.086N P=0.125N P=0.308N P=0.131N |P=0.299N P=0.498N P=0.508N P=0.518N |
|POLY 6 | P=0.088N P=0.126N P=0.318N P=0.140N |P=0.289N P=0.498N P=0.511N P=0.534N |
|LOGISTIC REGRESSION| P=0.106N (e) P=0.354N (e) |P=0.317N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.088N P=0.121N P=0.309N P=0.125N |P=0.306N P=0.500N P=0.505N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.94 1/44.10 1/45.14 1/41.99 |2/45.83 0/46.33 0/43.56 1/40.25 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 2.2% 2.4% |4.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/40 (5%) 1/39 (3%) 1/35 (3%) 1/34 (3%) |2/37 (5%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |728 (T) --- --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466N P=0.509N P=0.547N P=0.557N |P=0.498N P=0.232N P=0.232N P=0.547N |
|POLY 3 | P=0.426N P=0.514N P=0.506N P=0.531N |P=0.460N P=0.235N P=0.249N P=0.545N |
|POLY 1.5 | P=0.422N P=0.511N P=0.503N P=0.522N |P=0.462N P=0.235N P=0.246N P=0.531N |
|POLY 6 | P=0.432N P=0.515N P=0.513N P=0.540N |P=0.457N P=0.235N P=0.250N P=0.557N |
|LOGISTIC REGRESSION| P=0.466N P=0.509N P=0.547N P=0.557N |P=0.500N (e) (e) P=0.554N |
|COCH-ARM / FISHERS | P=0.416N P=0.500N P=0.500N P=0.508N |P=0.462N P=0.247N P=0.253N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 1/50 (2%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.96 0/44.10 1/45.45 0/41.99 |2/46.36 1/46.49 1/43.70 2/40.74 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 0.0% |4.3% 2.2% 2.3% 4.9% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 724 --- 645 --- |570 687 693 565 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.213N P=0.248N P=0.528N P=0.279N |P=0.481 P=0.497N P=0.513N P=0.617 |
|POLY 3 | P=0.193N P=0.247N P=0.504N P=0.258N |P=0.510 P=0.499N P=0.521N P=0.646 |
|POLY 1.5 | P=0.191N P=0.245N P=0.502N P=0.252N |P=0.523 P=0.498N P=0.515N P=0.662 |
|POLY 6 | P=0.195N P=0.247N P=0.509N P=0.264N |P=0.499 P=0.501N P=0.524N P=0.633 |
|LOGISTIC REGRESSION| P=0.193N P=0.246N P=0.499N P=0.268N |P=0.611 P=0.536N P=0.500N P=0.660N |
|COCH-ARM / FISHERS | P=0.191N P=0.247N P=0.500N P=0.253N |P=0.555 P=0.500N P=0.508N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.94 1/44.10 3/45.14 0/41.99 |0/45.83 0/46.33 2/44.82 2/40.09 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 6.7% 0.0% |0.0% 0.0% 4.5% 5.0% |
|TERMINAL (d) | 1/40 (3%) 1/39 (3%) 3/35 (9%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 1/38 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- 484 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.466N P=0.756 P=0.258 P=0.532N |P=0.071 (e) P=0.240 P=0.213 |
|POLY 3 | P=0.444N P=0.751 P=0.299 P=0.518N |P=0.064 (e) P=0.232 P=0.209 |
|POLY 1.5 | P=0.433N P=0.753 P=0.303 P=0.513N |P=0.070 (e) P=0.234 P=0.218 |
|POLY 6 | P=0.456N P=0.751 P=0.292 P=0.523N |P=0.058 (e) P=0.231 P=0.201 |
|LOGISTIC REGRESSION| P=0.466N P=0.756 P=0.258 (e) |P=0.095 (e) P=0.238 P=0.213 |
|COCH-ARM / FISHERS | P=0.416N P=0.753N P=0.309 P=0.505N |P=0.086 (e) P=0.247 P=0.247 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 40/50 (80%) 41/50 (82%) 39/50 (78%) 43/49 (88%) |31/50 (62%) 29/50 (58%) 29/50 (58%) 33/50 (66%) |
|POLY-3 RATE (b) | 40/47.02 41/47.38 39/47.99 43/47.00 |31/46.78 29/47.87 29/45.99 33/45.82 |
|POLY-3 PERCENT (g) | 85.1% 86.5% 81.3% 91.5% |66.3% 60.6% 63.1% 72.0% |
|TERMINAL (d) | 37/40 (93%) 35/39 (90%) 30/35 (86%) 31/34 (91%) |27/37 (73%) 25/38 (66%) 25/38 (66%) 23/33 (70%) |
|FIRST INCIDENCE | 556 224 494 416 |570 494 543 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.393 P=0.274 P=0.035 * |P=0.111 P=0.361N P=0.377N P=0.186 |
|POLY 3 | P=0.230 P=0.539 P=0.407N P=0.241 |P=0.243 P=0.357N P=0.457N P=0.351 |
|POLY 1.5 | P=0.214 P=0.517 P=0.442N P=0.223 |P=0.253 P=0.370N P=0.441N P=0.355 |
|POLY 6 | P=0.273 P=0.578 P=0.377N P=0.298 |P=0.246 P=0.345N P=0.457N P=0.362 |
|LOGISTIC REGRESSION| P=0.121 P=0.345 P=0.538N P=0.078 |P=0.154 P=0.392N P=0.519N P=0.258 |
|COCH-ARM / FISHERS | P=0.205 P=0.500 P=0.500N P=0.220 |P=0.330 P=0.419N P=0.419N P=0.418 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Hydronephrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 2/44.57 1/45.65 0/41.99 |0/45.83 0/46.33 2/45.02 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 2.2% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- 588 575 --- |--- --- 340 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.492N P=0.232 P=0.500 (e) |P=0.581 (e) P=0.245 (e) |
|POLY 3 | P=0.490N P=0.230 P=0.499 (e) |P=0.515 (e) P=0.233 (e) |
|POLY 1.5 | P=0.482N P=0.231 P=0.500 (e) |P=0.541 (e) P=0.236 (e) |
|POLY 6 | P=0.499N P=0.231 P=0.496 (e) |P=0.492 (e) P=0.231 (e) |
|LOGISTIC REGRESSION| P=0.440N P=0.256 P=0.455 (e) |P=0.636N (e) P=0.216 (e) |
|COCH-ARM / FISHERS | P=0.466N P=0.247 P=0.500 (e) |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 14/50 (28%) 10/50 (20%) 9/49 (18%) |4/50 (8%) 7/50 (14%) 9/50 (18%) 8/50 (16%) |
|POLY-3 RATE (b) | 7/45.94 14/45.32 10/45.78 9/42.93 |4/45.83 7/46.64 9/44.84 8/40.09 |
|POLY-3 PERCENT (g) | 15.2% 30.9% 21.8% 21.0% |8.7% 15.0% 20.1% 20.0% |
|TERMINAL (d) | 7/40 (18%) 11/39 (28%) 7/35 (20%) 6/34 (18%) |4/37 (11%) 6/38 (16%) 7/38 (18%) 8/33 (24%) |
|FIRST INCIDENCE | 729 (T) 501 645 533 |728 (T) 643 599 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385 P=0.064 P=0.216 P=0.274 |P=0.102 P=0.277 P=0.125 P=0.123 |
|POLY 3 | P=0.472 P=0.061 P=0.293 P=0.336 |P=0.092 P=0.271 P=0.106 P=0.118 |
|POLY 1.5 | P=0.492 P=0.061 P=0.296 P=0.349 |P=0.113 P=0.270 P=0.110 P=0.136 |
|POLY 6 | P=0.456 P=0.064 P=0.286 P=0.326 |P=0.077 P=0.272 P=0.105 P=0.103 |
|LOGISTIC REGRESSION| P=0.482 P=0.059 P=0.270 P=0.322 |P=0.085 P=0.265 P=0.104 P=0.123 |
|COCH-ARM / FISHERS | P=0.526 P=0.070 P=0.298 P=0.376 |P=0.167 P=0.262 P=0.117 P=0.178 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.94 0/44.10 0/45.14 0/41.99 |1/45.83 3/46.65 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 0.0% |2.2% 6.4% 0.0% 0.0% |
|TERMINAL (d) | 3/40 (8%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 2/38 (5%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |728 (T) 641 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.126N P=0.146N P=0.151N |P=0.174N P=0.316 P=0.495N P=0.523N |
|POLY 3 | P=0.043N* P=0.126N P=0.122N P=0.135N |P=0.171N P=0.312 P=0.508N P=0.527N |
|POLY 1.5 | P=0.044N* P=0.125N P=0.120N P=0.131N |P=0.164N P=0.311 P=0.504N P=0.518N |
|POLY 6 | P=0.043N* P=0.126N P=0.125N P=0.140N |P=0.177N P=0.312 P=0.510N P=0.534N |
|LOGISTIC REGRESSION| P=0.058N (e) (e) (e) |P=0.167N P=0.307 (e) (e) |
|COCH-ARM / FISHERS | P=0.048N* P=0.121N P=0.121N P=0.125N |P=0.153N P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 37/50 (74%) 34/50 (68%) 36/49 (73%) |12/50 (24%) 8/50 (16%) 15/50 (30%) 12/50 (24%) |
|POLY-3 RATE (b) | 38/46.76 37/44.60 34/45.79 36/44.72 |12/46.00 8/46.33 15/45.81 12/40.84 |
|POLY-3 PERCENT (g) | 81.3% 83.0% 74.3% 80.5% |26.1% 17.3% 32.8% 29.4% |
|TERMINAL (d) | 37/40 (93%) 34/39 (87%) 32/35 (91%) 29/34 (85%) |11/37 (30%) 8/38 (21%) 12/38 (32%) 10/33 (30%) |
|FIRST INCIDENCE | 416 661 616 451 |683 728 (T) 406 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168 P=0.613N P=0.556 P=0.243 |P=0.244 P=0.203N P=0.347 P=0.458 |
|POLY 3 | P=0.435N P=0.526 P=0.272N P=0.573N |P=0.241 P=0.219N P=0.319 P=0.459 |
|POLY 1.5 | P=0.429N P=0.560 P=0.262N P=0.549N |P=0.278 P=0.218N P=0.324 P=0.502 |
|POLY 6 | P=0.421N P=0.549 P=0.295N P=0.558N |P=0.213 P=0.222N P=0.319 P=0.424 |
|LOGISTIC REGRESSION| P=0.416 P=0.550 P=0.302N P=0.461 |P=0.239 P=0.215N P=0.305 P=0.407 |
|COCH-ARM / FISHERS | P=0.410N P=0.500N P=0.252N P=0.477N |P=0.378 P=0.227N P=0.326 P=0.592N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 0/44.10 0/45.14 0/41.99 |0/45.83 0/46.33 1/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 575 --- --- --- |--- --- 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.250N P=0.254N P=0.270N |P=0.683 (e) P=0.505 (e) |
|POLY 3 | P=0.109N P=0.249N P=0.244N P=0.260N |P=0.635 (e) P=0.492 (e) |
|POLY 1.5 | P=0.111N P=0.246N P=0.240N P=0.253N |P=0.654 (e) P=0.496 (e) |
|POLY 6 | P=0.109N P=0.251N P=0.249N P=0.267N |P=0.617 (e) P=0.490 (e) |
|LOGISTIC REGRESSION| P=0.109N P=0.205N P=0.240N P=0.204N |(e) (e) P=0.505 (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.94 1/44.10 2/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/39 (3%) 2/35 (6%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240N P=0.509N P=0.646 P=0.275N |(e) (e) (e) (e) |
|POLY 3 | P=0.218N P=0.514N P=0.688 P=0.258N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.212N P=0.511N P=0.691 P=0.252N |(e) (e) (e) (e) |
|POLY 6 | P=0.225N P=0.515N P=0.681 P=0.263N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.240N P=0.509N P=0.646 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.204N P=0.500N P=0.691N P=0.253N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/49 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.94 4/44.10 2/45.14 2/42.90 |0/45.83 1/46.65 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 4.4% 9.1% 4.4% 4.7% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 4/39 (10%) 2/35 (6%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 582 |--- 641 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.325 P=0.646 P=0.648 |P=0.600N P=0.504 (e) (e) |
|POLY 3 | P=0.487N P=0.318 P=0.688 P=0.669 |P=0.573N P=0.504 (e) (e) |
|POLY 1.5 | P=0.480N P=0.323 P=0.691 P=0.675 |P=0.570N P=0.503 (e) (e) |
|POLY 6 | P=0.494N P=0.317 P=0.681 P=0.665 |P=0.574N P=0.504 (e) (e) |
|LOGISTIC REGRESSION| P=0.478N P=0.325 P=0.646 P=0.666N |P=0.535N P=0.466 (e) (e) |
|COCH-ARM / FISHERS | P=0.466N P=0.339 P=0.691N P=0.684 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 2/45.36 1/41.99 |3/45.83 1/46.33 2/44.39 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 2.4% |6.6% 2.2% 4.5% 2.5% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 1/35 (3%) 1/34 (3%) |3/37 (8%) 1/38 (3%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- 672 729 (T) |728 (T) 728 (T) 654 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.214 (e) P=0.220 P=0.468 |P=0.320N P=0.295N P=0.492N P=0.346N |
|POLY 3 | P=0.219 (e) P=0.234 P=0.482 |P=0.319N P=0.301N P=0.514N P=0.355N |
|POLY 1.5 | P=0.227 (e) P=0.236 P=0.487 |P=0.308N P=0.301N P=0.509N P=0.338N |
|POLY 6 | P=0.210 (e) P=0.231 P=0.477 |P=0.329N P=0.302N P=0.517N P=0.370N |
|LOGISTIC REGRESSION| P=0.229 (e) P=0.238 P=0.468 |P=0.334N P=0.295N P=0.516N P=0.346N |
|COCH-ARM / FISHERS | P=0.241 (e) P=0.247 P=0.495 |P=0.279N P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 3/49 (6%) |2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.94 1/44.10 0/45.14 3/42.57 |2/45.83 0/46.33 1/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 0.0% 7.1% |4.4% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 2/40 (5%) 1/39 (3%) 0/35 (0%) 1/34 (3%) |2/37 (5%) 0/38 (0%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 610 |728 (T) --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289 P=0.509N P=0.268N P=0.439 |P=0.536N P=0.232N P=0.491N P=0.540N |
|POLY 3 | P=0.323 P=0.514N P=0.241N P=0.465 |P=0.522N P=0.235N P=0.513N P=0.546N |
|POLY 1.5 | P=0.326 P=0.511N P=0.239N P=0.474 |P=0.516N P=0.235N P=0.508N P=0.531N |
|POLY 6 | P=0.319 P=0.515N P=0.245N P=0.459 |P=0.526N P=0.235N P=0.517N P=0.560N |
|LOGISTIC REGRESSION| P=0.320 P=0.509N (e) P=0.483 |P=0.536N (e) P=0.491N P=0.540N |
|COCH-ARM / FISHERS | P=0.330 P=0.500N P=0.247N P=0.490 |P=0.500N P=0.247N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 24/50 (48%) 31/50 (62%) 12/49 (24%) |5/50 (10%) 5/50 (10%) 2/50 (4%) 8/50 (16%) |
|POLY-3 RATE (b) | 26/46.76 24/45.34 31/46.76 12/42.07 |5/45.83 5/46.33 2/44.12 8/42.20 |
|POLY-3 PERCENT (g) | 55.6% 52.9% 66.3% 28.5% |10.9% 10.8% 4.5% 19.0% |
|TERMINAL (d) | 25/40 (63%) 22/39 (56%) 27/35 (77%) 11/34 (32%) |5/37 (14%) 5/38 (13%) 2/38 (5%) 5/33 (15%) |
|FIRST INCIDENCE | 416 491 494 710 |728 (T) 728 (T) 728 (T) 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024N* P=0.472N P=0.052 P=0.014N* |P=0.156 P=0.615N P=0.205N P=0.218 |
|POLY 3 | P=0.009N** P=0.481N P=0.192 P=0.007N** |P=0.175 P=0.623N P=0.232N P=0.223 |
|POLY 1.5 | P=0.007N** P=0.474N P=0.200 P=0.005N** |P=0.185 P=0.622N P=0.226N P=0.238 |
|POLY 6 | P=0.013N* P=0.467N P=0.176 P=0.008N** |P=0.168 P=0.625N P=0.236N P=0.211 |
|LOGISTIC REGRESSION| P=0.009N** P=0.499N P=0.177 P=0.009N** |P=0.194 P=0.615N P=0.205N P=0.279 |
|COCH-ARM / FISHERS | P=0.005N** P=0.421N P=0.210 P=0.004N** |P=0.213 P=0.630N P=0.218N P=0.277 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 28/50 (56%) 18/50 (36%) 11/49 (22%) |21/50 (42%) 13/50 (26%) 16/50 (32%) 17/50 (34%) |
|POLY-3 RATE (b) | 15/46.03 28/46.05 18/46.69 11/43.50 |21/46.37 13/46.49 16/45.32 17/42.13 |
|POLY-3 PERCENT (g) | 32.6% 60.8% 38.6% 25.3% |45.3% 28.0% 35.3% 40.4% |
|TERMINAL (d) | 14/40 (35%) 23/39 (59%) 15/35 (43%) 9/34 (27%) |19/37 (51%) 12/38 (32%) 12/38 (32%) 13/33 (39%) |
|FIRST INCIDENCE | 708 491 518 451 |599 689 484 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145N P=0.007 ** P=0.198 P=0.409N |P=0.525 P=0.055N P=0.192N P=0.442N |
|POLY 3 | P=0.059N P=0.004 ** P=0.351 P=0.298N |P=0.502N P=0.062N P=0.222N P=0.399N |
|POLY 1.5 | P=0.054N P=0.004 ** P=0.347 P=0.286N |P=0.467N P=0.062N P=0.213N P=0.359N |
|POLY 6 | P=0.067N P=0.005 ** P=0.345 P=0.313N |P=0.524N P=0.063N P=0.223N P=0.429N |
|LOGISTIC REGRESSION| P=0.067N P=0.004 ** P=0.312 P=0.315N |P=0.518 P=0.061N P=0.243N P=0.441N |
|COCH-ARM / FISHERS | P=0.053N P=0.007 ** P=0.335 P=0.266N |P=0.371N P=0.069N P=0.204N P=0.268N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |30/50 (60%) 39/50 (78%) 35/50 (70%) 30/50 (60%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |30/46.26 39/48.30 35/45.82 30/41.72 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |64.9% 80.7% 76.4% 71.9% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |27/37 (73%) 34/38 (90%) 31/38 (82%) 27/33 (82%) |
|FIRST INCIDENCE | --- --- --- --- |683 494 484 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.381 P=0.053 P=0.227 P=0.275 |
|POLY 3 | (e) (e) (e) (e) |P=0.380 P=0.058 P=0.153 P=0.308 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.507 P=0.053 P=0.172 P=0.397 |
|POLY 6 | (e) (e) (e) (e) |P=0.269 P=0.060 P=0.143 P=0.229 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.260 P=0.038 * P=0.096 P=0.159 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.324N P=0.041 * P=0.201 P=0.581N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 21/50 (42%) 20/50 (40%) 20/49 (41%) |36/50 (72%) 33/50 (66%) 35/50 (70%) 34/50 (68%) |
|POLY-3 RATE (b) | 23/45.96 21/44.17 20/45.40 20/43.97 |36/45.83 33/47.06 35/45.21 34/43.06 |
|POLY-3 PERCENT (g) | 50.0% 47.5% 44.1% 45.5% |78.6% 70.1% 77.4% 79.0% |
|TERMINAL (d) | 22/40 (55%) 20/39 (51%) 19/35 (54%) 16/34 (47%) |36/37 (97%) 31/38 (82%) 33/38 (87%) 29/33 (88%) |
|FIRST INCIDENCE | 724 710 661 416 |728 (T) 543 543 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.474 P=0.463N P=0.571N P=0.557 |P=0.212 P=0.171N P=0.375N P=0.383 |
|POLY 3 | P=0.360N P=0.489N P=0.356N P=0.412N |P=0.397 P=0.233N P=0.552N P=0.591 |
|POLY 1.5 | P=0.353N P=0.475N P=0.347N P=0.401N |P=0.463 P=0.261N P=0.530N P=0.568N |
|POLY 6 | P=0.367N P=0.489N P=0.379N P=0.416N |P=0.354 P=0.198N P=0.548N P=0.572 |
|LOGISTIC REGRESSION| P=0.486N P=0.491N P=0.493N P=0.496N |P=0.112 P=0.275N P=0.494 P=0.243 |
|COCH-ARM / FISHERS | P=0.347N P=0.420N P=0.343N P=0.376N |P=0.438N P=0.333N P=0.500N P=0.414N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 20/50 (40%) 21/50 (42%) 7/49 (14%) |14/50 (28%) 19/50 (38%) 21/50 (42%) 15/50 (30%) |
|POLY-3 RATE (b) | 15/46.88 20/44.79 21/45.91 7/41.99 |14/46.24 19/46.64 21/44.12 15/42.53 |
|POLY-3 PERCENT (g) | 32.0% 44.7% 45.7% 16.7% |30.3% 40.7% 47.6% 35.3% |
|TERMINAL (d) | 13/40 (33%) 19/39 (49%) 18/35 (51%) 7/34 (21%) |11/37 (30%) 18/38 (47%) 21/38 (55%) 11/33 (33%) |
|FIRST INCIDENCE | 546 491 575 729 (T) |683 643 728 (T) 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.171 P=0.070 P=0.099N |P=0.342 P=0.221 P=0.112 P=0.355 |
|POLY 3 | P=0.049N* P=0.149 P=0.123 P=0.075N |P=0.369 P=0.200 P=0.067 P=0.392 |
|POLY 1.5 | P=0.038N* P=0.162 P=0.135 P=0.064N |P=0.412 P=0.205 P=0.081 P=0.422 |
|POLY 6 | P=0.066N P=0.141 P=0.105 P=0.089N |P=0.334 P=0.192 P=0.055 P=0.367 |
|LOGISTIC REGRESSION| P=0.043N* P=0.160 P=0.129 P=0.073N |P=0.298 P=0.199 P=0.066 P=0.399 |
|COCH-ARM / FISHERS | P=0.028N* P=0.201 P=0.149 P=0.050N |P=0.530 P=0.198 P=0.104 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 5/50 (10%) 5/49 (10%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/46.63 5/44.35 5/45.86 5/42.95 |2/46.13 2/46.40 2/44.12 1/40.77 |
|POLY-3 PERCENT (g) | 15.0% 11.3% 10.9% 11.6% |4.3% 4.3% 4.5% 2.5% |
|TERMINAL (d) | 4/40 (10%) 4/39 (10%) 3/35 (9%) 1/34 (3%) |0/37 (0%) 1/38 (3%) 2/38 (5%) 0/33 (0%) |
|FIRST INCIDENCE | 603 661 616 582 |651 711 728 (T) 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.404N P=0.441N P=0.482N |P=0.423N P=0.685N P=0.691N P=0.544N |
|POLY 3 | P=0.392N P=0.415N P=0.391N P=0.438N |P=0.421N P=0.692N P=0.678 P=0.543N |
|POLY 1.5 | P=0.381N P=0.406N P=0.385N P=0.422N |P=0.406N P=0.690N P=0.684 P=0.529N |
|POLY 6 | P=0.403N P=0.420N P=0.404N P=0.451N |P=0.435N P=0.694 P=0.672 P=0.556N |
|LOGISTIC REGRESSION| P=0.370N P=0.398N P=0.376N P=0.387N |P=0.361N P=0.695N P=0.687 P=0.448N |
|COCH-ARM / FISHERS | P=0.365N P=0.380N P=0.380N P=0.394N |P=0.373N P=0.691N P=0.691N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 2/49 (4%) |4/50 (8%) 10/50 (20%) 9/50 (18%) 10/50 (20%) |
|POLY-3 RATE (b) | 3/45.94 3/44.10 4/45.14 2/42.41 |4/45.94 10/46.93 9/45.08 10/43.28 |
|POLY-3 PERCENT (g) | 6.5% 6.8% 8.9% 4.7% |8.7% 21.3% 20.0% 23.1% |
|TERMINAL (d) | 3/40 (8%) 3/39 (8%) 4/35 (11%) 1/34 (3%) |3/37 (8%) 8/38 (21%) 7/38 (18%) 5/33 (15%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 610 |699 543 406 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.506N P=0.652 P=0.427 P=0.565N |P=0.072 P=0.086 P=0.127 P=0.056 |
|POLY 3 | P=0.459N P=0.643 P=0.490 P=0.536N |P=0.083 P=0.078 P=0.107 P=0.055 |
|POLY 1.5 | P=0.448N P=0.647 P=0.496 P=0.527N |P=0.090 P=0.078 P=0.111 P=0.059 |
|POLY 6 | P=0.470N P=0.643 P=0.480 P=0.544N |P=0.078 P=0.078 P=0.104 P=0.053 |
|LOGISTIC REGRESSION| P=0.472N P=0.652 P=0.427 P=0.529N |P=0.131 P=0.077 P=0.114 P=0.093 |
|COCH-ARM / FISHERS | P=0.431N P=0.661N P=0.500 P=0.510N |P=0.117 P=0.074 P=0.117 P=0.074 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |3/50 (6%) 2/50 (4%) 4/49 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.94 1/44.10 1/45.23 1/42.15 |3/46.35 2/46.33 4/43.84 2/40.93 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.2% 2.4% |6.5% 4.3% 9.1% 4.9% |
|TERMINAL (d) | 0/40 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |2/37 (5%) 2/38 (5%) 3/38 (8%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) 708 688 |570 728 (T) 654 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.495 P=0.475 P=0.475 |P=0.545N P=0.492N P=0.503 P=0.556N |
|POLY 3 | P=0.355 P=0.492 P=0.497 P=0.483 |P=0.549N P=0.500N P=0.470 P=0.556N |
|POLY 1.5 | P=0.364 P=0.494 P=0.499 P=0.488 |P=0.527N P=0.498N P=0.477 P=0.538N |
|POLY 6 | P=0.347 P=0.492 P=0.493 P=0.479 |P=0.567N P=0.504N P=0.466 P=0.574N |
|LOGISTIC REGRESSION| P=0.367 P=0.495 P=0.498 P=0.499 |P=0.454N P=0.505N P=0.489 P=0.437N |
|COCH-ARM / FISHERS | P=0.379 P=0.500 P=0.500 P=0.495 |P=0.480N P=0.500N P=0.489 P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |1/50 (2%) 3/50 (6%) 0/49 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.94 1/44.10 1/45.14 1/41.99 |1/45.83 3/46.65 0/43.56 2/41.06 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.2% 2.4% |2.2% 6.4% 0.0% 4.9% |
|TERMINAL (d) | 0/40 (0%) 1/39 (3%) 1/35 (3%) 1/34 (3%) |1/37 (3%) 2/38 (5%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 729 (T) |728 (T) 641 --- 228 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341 P=0.495 P=0.473 P=0.468 |P=0.514 P=0.316 P=0.495N P=0.474 |
|POLY 3 | P=0.354 P=0.492 P=0.496 P=0.482 |P=0.515 P=0.312 P=0.510N P=0.462 |
|POLY 1.5 | P=0.363 P=0.494 P=0.498 P=0.487 |P=0.529 P=0.311 P=0.508N P=0.475 |
|POLY 6 | P=0.344 P=0.492 P=0.493 P=0.477 |P=0.503 P=0.312 P=0.511N P=0.449 |
|LOGISTIC REGRESSION| (e) P=0.495 P=0.473 P=0.468 |P=0.567N P=0.307 (e) P=0.612 |
|COCH-ARM / FISHERS | P=0.379 P=0.500 P=0.500 P=0.495 |P=0.555 P=0.309 P=0.505N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Metaplasia Focal Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 2/45.54 1/41.99 |0/45.83 0/46.33 0/43.56 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 1/35 (3%) 1/34 (3%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 616 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 (e) P=0.230 P=0.468 |(e) (e) (e) (e) |
|POLY 3 | P=0.218 (e) P=0.235 P=0.482 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.227 (e) P=0.237 P=0.487 |(e) (e) (e) (e) |
|POLY 6 | P=0.210 (e) P=0.232 P=0.477 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.241 (e) P=0.237 P=0.468 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.241 (e) P=0.247 P=0.495 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |3/50 (6%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.41 0/44.10 1/45.14 0/41.99 |3/46.91 0/46.33 0/43.56 0/40.09 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 0.0% |6.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 592 --- 729 (T) --- |193 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432N P=0.513N P=0.746 P=0.523N |P=0.053N P=0.123N P=0.124N P=0.144N |
|POLY 3 | P=0.415N P=0.510N P=0.754 P=0.520N |P=0.044N* P=0.121N P=0.132N P=0.150N |
|POLY 1.5 | P=0.412N P=0.508N P=0.757 P=0.514N |P=0.045N* P=0.120N P=0.130N P=0.140N |
|POLY 6 | P=0.419N P=0.512N P=0.749 P=0.526N |P=0.044N* P=0.122N P=0.134N P=0.159N |
|LOGISTIC REGRESSION| P=0.396N P=0.429N P=0.762 P=0.424N |P=0.016N* P=0.187N P=0.110N P=0.056N |
|COCH-ARM / FISHERS | P=0.409N P=0.500N P=0.753N P=0.505N |P=0.048N* P=0.121N P=0.125N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 3/49 (6%) |3/50 (6%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.52 3/44.10 4/45.14 3/42.25 |3/46.15 1/46.33 1/43.56 1/40.09 |
|POLY-3 PERCENT (g) | 6.5% 6.8% 8.9% 7.1% |6.5% 2.2% 2.3% 2.5% |
|TERMINAL (d) | 2/40 (5%) 3/39 (8%) 4/35 (11%) 2/34 (6%) |2/37 (5%) 1/38 (3%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 546 729 (T) 729 (T) 661 |641 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469 P=0.645 P=0.435 P=0.592 |P=0.277N P=0.298N P=0.306N P=0.356N |
|POLY 3 | P=0.506 P=0.637 P=0.484 P=0.617 |P=0.269N P=0.304N P=0.326N P=0.357N |
|POLY 1.5 | P=0.522 P=0.644 P=0.492 P=0.630 |P=0.261N P=0.303N P=0.321N P=0.340N |
|POLY 6 | P=0.490 P=0.634 P=0.470 P=0.605 |P=0.274N P=0.306N P=0.330N P=0.374N |
|LOGISTIC REGRESSION| P=0.520 P=0.660 P=0.499 P=0.664 |P=0.282N P=0.303N P=0.318N P=0.346N |
|COCH-ARM / FISHERS | P=0.547 P=0.661N P=0.500 P=0.651 |P=0.243N P=0.309N P=0.316N P=0.309N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung: Bronchus |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 0/46.33 0/43.56 4/42.44 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 9.4% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.002 ** (e) (e) P=0.051 |
|POLY 3 | (e) (e) (e) (e) |P=0.002 ** (e) (e) P=0.051 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.002 ** (e) (e) P=0.053 |
|POLY 6 | (e) (e) (e) (e) |P=0.002 ** (e) (e) P=0.050 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.012 * (e) (e) P=0.103 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.003 ** (e) (e) P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung: Bronchus |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |1/45.93 0/46.33 0/43.56 4/42.44 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 0.0% 0.0% 9.4% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |704 --- --- 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.020 * P=0.500N P=0.505N P=0.146 |
|POLY 3 | (e) (e) (e) (e) |P=0.024 * P=0.498N P=0.511N P=0.156 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.024 * P=0.498N P=0.508N P=0.161 |
|POLY 6 | (e) (e) (e) (e) |P=0.023 * P=0.499N P=0.512N P=0.152 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.068 P=0.500N P=0.507N P=0.262 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.028 * P=0.500N P=0.505N P=0.181 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) |0/48 (0%) 1/48 (2%) 0/49 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/44.61 0/44.10 1/44.38 0/41.60 |0/43.86 1/44.33 0/43.82 2/39.79 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |0.0% 2.3% 0.0% 5.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |0/36 (0%) 1/36 (3%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- 728 (T) --- 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.673 (e) P=0.473 (e) |P=0.119 P=0.500 (e) P=0.211 |
|POLY 3 | P=0.670 (e) P=0.499 (e) |P=0.127 P=0.502 (e) P=0.216 |
|POLY 1.5 | P=0.679 (e) P=0.502 (e) |P=0.132 P=0.502 (e) P=0.224 |
|POLY 6 | P=0.660 (e) P=0.494 (e) |P=0.124 P=0.501 (e) P=0.210 |
|LOGISTIC REGRESSION| (e) (e) P=0.473 (e) |P=0.119 P=0.500 (e) P=0.216 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.505 (e) |P=0.143 P=0.500 (e) P=0.253 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 1/49 (2%) 0/48 (0%) |2/48 (4%) 0/48 (0%) 1/49 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/44.61 0/44.10 1/44.38 0/41.60 |2/43.86 0/44.33 1/44.47 0/39.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.6% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 1/35 (3%) 0/34 (0%) |2/36 (6%) 0/36 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |728 (T) --- 515 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.673 (e) P=0.473 (e) |P=0.201N P=0.238N P=0.490N P=0.258N |
|POLY 3 | P=0.670 (e) P=0.499 (e) |P=0.197N P=0.235N P=0.495N P=0.260N |
|POLY 1.5 | P=0.679 (e) P=0.502 (e) |P=0.194N P=0.235N P=0.494N P=0.252N |
|POLY 6 | P=0.660 (e) P=0.494 (e) |P=0.199N P=0.235N P=0.495N P=0.268N |
|LOGISTIC REGRESSION| (e) (e) P=0.473 (e) |P=0.158N (e) P=0.491N (e) |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.505 (e) |P=0.184N P=0.247N P=0.492N P=0.242N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lymph Node: Lumbar |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |2/5 (40%) 0/3 (0%) 0/1 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/0.98 0/0.00 0/0.00 0/0.00 |2/4.99 0/2.47 0/0.29 0/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |40.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |1/3 (33%) 0/1 (0%) 0/0 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |704 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.175N P=0.353N P=0.505N P=0.304N |
|POLY 3 | (e) (e) (e) (e) |P=0.320N P=0.396N P=0.772N P=0.451N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.296N P=0.369N P=0.725N P=0.451N |
|POLY 6 | (e) (e) (e) (e) |P=0.336N P=0.442N P=0.807N P=0.450N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.258N P=0.447N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.234N P=0.357N P=0.667N P=0.476N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/8 (88%) 9/10 (90%) 1/1 (100%) 0/0 (0%) |11/11 (100%) 13/18 (72%) 11/13 (85%) 13/14 (93%) |
|POLY-3 RATE (b) | 7/8.00 9/9.03 1/1.00 0/0.00 |11/11.00 13/17.55 11/12.56 13/14.00 |
|POLY-3 PERCENT (g) | 87.5% 99.7% 100.0% 0.0% |100.0% 74.1% 87.6% 92.9% |
|TERMINAL (d) | 7/8 (88%) 8/8 (100%) 0/0 (0%) 0/0 (0%) |9/9 (100%) 10/13 (77%) 7/8 (88%) 9/10 (90%) |
|FIRST INCIDENCE | 729 (T) 710 727 --- |570 494 515 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.649 P=0.240 P=0.479 P=1.000 |P=0.250 P=0.433N P=0.499 P=0.427 |
|POLY 3 | (e) P=0.487 P=0.878 (e) |P=0.499 P=0.080N P=0.342N P=0.548N |
|POLY 1.5 | (e) P=0.536 P=0.878 (e) |P=0.484 P=0.075N P=0.304N P=0.548N |
|POLY 6 | (e) P=0.477 P=0.878 (e) |P=0.525 P=0.090N P=0.409N P=0.548N |
|LOGISTIC REGRESSION| P=0.747 P=0.469 (e) (e) |P=0.478 P=0.071N P=0.317N (e) |
|COCH-ARM / FISHERS | P=0.828 P=0.706 P=0.889 P=1.000 |P=0.470 P=0.072N P=0.283N P=0.560N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 0/45.47 0/44.12 3/41.94 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 7.2% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.108 |
|POLY 3 | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.103 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.108 |
|POLY 6 | (e) (e) (e) (e) |P=0.010 * (e) (e) P=0.101 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.035 * (e) (e) P=0.183 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.012 * (e) (e) P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | |3/46.00 0/46.33 5/44.12 2/40.09 |
|POLY-3 PERCENT (g) | |6.5% 0.0% 11.3% 5.0% |
|TERMINAL (d) | |2/37 (5%) 0/38 (0%) 5/38 (13%) 2/33 (6%) |
|FIRST INCIDENCE | |683 --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.482 P=0.120N P=0.365 P=0.560N |
|POLY 3 | |P=0.453 P=0.117N P=0.334 P=0.562N |
|POLY 1.5 | |P=0.481 P=0.117N P=0.343 P=0.542N |
|POLY 6 | |P=0.428 P=0.118N P=0.326 P=0.581N |
|LOGISTIC REGRESSION| |P=0.452 P=0.119N P=0.330 P=0.579N |
|COCH-ARM / FISHERS | |P=0.544 P=0.121N P=0.357 P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 11/50 (22%) 15/50 (30%) 14/50 (28%) |
|POLY-3 RATE (b) | |12/45.83 11/46.92 15/45.21 14/41.04 |
|POLY-3 PERCENT (g) | |26.2% 23.5% 33.2% 34.1% |
|TERMINAL (d) | |12/37 (32%) 10/38 (26%) 13/38 (34%) 12/33 (36%) |
|FIRST INCIDENCE | |728 (T) 543 543 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.164 P=0.470N P=0.347 P=0.279 |
|POLY 3 | |P=0.169 P=0.474N P=0.308 P=0.284 |
|POLY 1.5 | |P=0.202 P=0.479N P=0.315 P=0.321 |
|POLY 6 | |P=0.146 P=0.470N P=0.309 P=0.255 |
|LOGISTIC REGRESSION| |P=0.153 P=0.491N P=0.280 P=0.231 |
|COCH-ARM / FISHERS | |P=0.293 P=0.500N P=0.326 P=0.410 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | |2/46.56 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | |599 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.133N P=0.242N P=0.255N P=0.289N |
|POLY 3 | |P=0.110N P=0.238N P=0.249N P=0.272N |
|POLY 1.5 | |P=0.111N P=0.237N P=0.244N P=0.260N |
|POLY 6 | |P=0.107N P=0.241N P=0.254N P=0.284N |
|LOGISTIC REGRESSION| |P=0.085N P=0.276N P=0.231N P=0.199N |
|COCH-ARM / FISHERS | |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/48 (6%) 2/49 (4%) 1/49 (2%) |6/49 (12%) 8/49 (16%) 6/49 (12%) 5/49 (10%) |
|POLY-3 RATE (b) | 3/45.41 3/42.52 2/44.14 1/41.99 |6/46.13 8/45.47 6/43.56 5/40.44 |
|POLY-3 PERCENT (g) | 6.6% 7.1% 4.5% 2.4% |13.0% 17.6% 13.8% 12.4% |
|TERMINAL (d) | 3/40 (8%) 3/39 (8%) 2/34 (6%) 1/34 (3%) |5/37 (14%) 8/38 (21%) 6/38 (16%) 3/32 (9%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |641 728 (T) 728 (T) 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251N P=0.652 P=0.574N P=0.365N |P=0.455N P=0.407 P=0.608N P=0.594N |
|POLY 3 | P=0.213N P=0.632 P=0.513N P=0.334N |P=0.450N P=0.375 P=0.580 P=0.591N |
|POLY 1.5 | P=0.205N P=0.636 P=0.506N P=0.323N |P=0.420N P=0.380 P=0.593 P=0.565N |
|POLY 6 | P=0.224N P=0.632 P=0.525N P=0.345N |P=0.475N P=0.370 P=0.572 P=0.614N |
|LOGISTIC REGRESSION| P=0.251N P=0.652 P=0.574N P=0.365N |P=0.433N P=0.380 P=0.583 P=0.495N |
|COCH-ARM / FISHERS | P=0.192N P=0.651 P=0.500N P=0.309N |P=0.345N P=0.387 P=0.620N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 32/50 (64%) 34/50 (68%) 34/49 (69%) | |
|POLY-3 RATE (b) | 31/47.25 32/45.40 34/49.31 34/44.74 | |
|POLY-3 PERCENT (g) | 65.6% 70.5% 69.0% 76.0% | |
|TERMINAL (d) | 27/40 (68%) 28/39 (72%) 22/35 (63%) 28/34 (82%) | |
|FIRST INCIDENCE | 556 501 494 416 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.061 P=0.431 P=0.170 P=0.078 | |
|POLY 3 | P=0.176 P=0.388 P=0.446 P=0.186 | |
|POLY 1.5 | P=0.197 P=0.414 P=0.405 P=0.220 | |
|POLY 6 | P=0.157 P=0.378 P=0.487 P=0.159 | |
|LOGISTIC REGRESSION| P=0.150 P=0.383 P=0.333 P=0.154 | |
|COCH-ARM / FISHERS | P=0.232 P=0.500 P=0.338 P=0.287 | |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 0/50 (0%) 0/49 (0%) | |
|POLY-3 RATE (b) | 5/46.76 3/44.10 0/45.14 0/41.99 | |
|POLY-3 PERCENT (g) | 10.7% 6.8% 0.0% 0.0% | |
|TERMINAL (d) | 4/40 (10%) 3/39 (8%) 0/35 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 416 729 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* P=0.374N P=0.045N* P=0.047N* | |
|POLY 3 | P=0.008N** P=0.389N P=0.034N* P=0.041N* | |
|POLY 1.5 | P=0.007N** P=0.381N P=0.032N* P=0.038N* | |
|POLY 6 | P=0.008N** P=0.392N P=0.036N* P=0.044N* | |
|LOGISTIC REGRESSION| P=0.007N** P=0.349N P=0.032N* P=0.025N* | |
|COCH-ARM / FISHERS | P=0.008N** P=0.357N P=0.028N* P=0.030N* | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |
|POLY-3 RATE (b) | 1/46.03 0/44.10 0/45.14 2/41.99 | |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.8% | |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 2/34 (6%) | |
|FIRST INCIDENCE | 708 --- --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.510N P=0.525N P=0.445 | |
|POLY 3 | P=0.237 P=0.509N P=0.504N P=0.468 | |
|POLY 1.5 | P=0.239 P=0.507N P=0.502N P=0.477 | |
|POLY 6 | P=0.233 P=0.509N P=0.508N P=0.459 | |
|LOGISTIC REGRESSION| P=0.220 P=0.506N P=0.502N P=0.458 | |
|COCH-ARM / FISHERS | P=0.241 P=0.500N P=0.500N P=0.492 | |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) | |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 2/42.07 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% | |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 1/34 (3%) | |
|FIRST INCIDENCE | --- --- --- 710 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.038 * (e) (e) P=0.205 | |
|POLY 3 | P=0.042 * (e) (e) P=0.218 | |
|POLY 1.5 | P=0.043 * (e) (e) P=0.223 | |
|POLY 6 | P=0.041 * (e) (e) P=0.213 | |
|LOGISTIC REGRESSION| P=0.039 * (e) (e) P=0.213 | |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) 1/49 (2%) | |
|POLY-3 RATE (b) | 0/45.94 4/44.57 0/45.14 1/41.99 | |
|POLY-3 PERCENT (g) | 0.0% 9.0% 0.0% 2.4% | |
|TERMINAL (d) | 0/40 (0%) 3/39 (8%) 0/35 (0%) 1/34 (3%) | |
|FIRST INCIDENCE | --- 588 --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.583N P=0.061 (e) P=0.468 | |
|POLY 3 | P=0.564N P=0.056 (e) P=0.482 | |
|POLY 1.5 | P=0.555N P=0.057 (e) P=0.487 | |
|POLY 6 | P=0.572N P=0.057 (e) P=0.477 | |
|LOGISTIC REGRESSION| P=0.545N P=0.062 (e) P=0.468 | |
|COCH-ARM / FISHERS | P=0.538N P=0.059 (e) P=0.495 | |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) | |
|POLY-3 RATE (b) | 1/45.94 1/44.10 2/45.45 0/41.99 | |
|POLY-3 PERCENT (g) | 2.2% 2.3% 4.4% 0.0% | |
|TERMINAL (d) | 1/40 (3%) 1/39 (3%) 1/35 (3%) 0/34 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) 645 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.756 P=0.472 P=0.532N | |
|POLY 3 | P=0.393N P=0.751 P=0.496 P=0.518N | |
|POLY 1.5 | P=0.385N P=0.753 P=0.499 P=0.513N | |
|POLY 6 | P=0.402N P=0.751 P=0.491 P=0.523N | |
|LOGISTIC REGRESSION| P=0.383N P=0.756 P=0.500 (e) | |
|COCH-ARM / FISHERS | P=0.372N P=0.753N P=0.500 P=0.505N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 17/50 (34%) 14/50 (28%) 12/49 (24%) |29/50 (58%) 24/50 (48%) 25/50 (50%) 24/50 (48%) |
|POLY-3 RATE (b) | 15/47.45 17/46.24 14/46.14 12/43.97 |29/46.21 24/47.19 25/46.76 24/44.38 |
|POLY-3 PERCENT (g) | 31.6% 36.8% 30.3% 27.3% |62.8% 50.9% 53.5% 54.1% |
|TERMINAL (d) | 11/40 (28%) 12/39 (31%) 12/35 (34%) 7/34 (21%) |28/37 (76%) 19/38 (50%) 20/38 (53%) 17/33 (52%) |
|FIRST INCIDENCE | 416 224 494 451 |621 641 484 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.391N P=0.386 P=0.535 P=0.492N |P=0.477N P=0.168N P=0.234N P=0.416N |
|POLY 3 | P=0.289N P=0.379 P=0.536N P=0.412N |P=0.307N P=0.166N P=0.239N P=0.262N |
|POLY 1.5 | P=0.269N P=0.388 P=0.519N P=0.391N |P=0.295N P=0.177N P=0.252N P=0.253N |
|POLY 6 | P=0.308N P=0.380 P=0.566N P=0.428N |P=0.312N P=0.151N P=0.213N P=0.263N |
|LOGISTIC REGRESSION| P=0.225N P=0.442 P=0.499N P=0.325N |P=0.392N P=0.187N P=0.327N P=0.348N |
|COCH-ARM / FISHERS | P=0.234N P=0.415 P=0.500N P=0.349N |P=0.237N P=0.212N P=0.274N P=0.212N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 12/50 (24%) 11/50 (22%) 13/49 (27%) |12/50 (24%) 10/50 (20%) 10/50 (20%) 12/50 (24%) |
|POLY-3 RATE (b) | 11/47.71 12/46.96 11/48.72 13/45.05 |12/47.34 10/48.76 10/47.08 12/46.58 |
|POLY-3 PERCENT (g) | 23.1% 25.6% 22.6% 28.9% |25.4% 20.5% 21.2% 25.8% |
|TERMINAL (d) | 5/40 (13%) 6/39 (15%) 2/35 (6%) 6/34 (18%) |8/37 (22%) 3/38 (8%) 5/38 (13%) 1/33 (3%) |
|FIRST INCIDENCE | 556 224 494 464 |497 494 406 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266 P=0.467 P=0.526 P=0.287 |P=0.361 P=0.399N P=0.411N P=0.461 |
|POLY 3 | P=0.324 P=0.483 P=0.573N P=0.345 |P=0.469 P=0.375N P=0.410N P=0.575 |
|POLY 1.5 | P=0.335 P=0.487 P=0.579N P=0.359 |P=0.470 P=0.382N P=0.406N P=0.572 |
|POLY 6 | P=0.312 P=0.482 P=0.575N P=0.333 |P=0.475 P=0.365N P=0.412N P=0.585 |
|LOGISTIC REGRESSION| P=0.476 P=0.596N P=0.563N P=0.485 |P=0.256N P=0.448N P=0.357N P=0.387N |
|COCH-ARM / FISHERS | P=0.355 P=0.500 P=0.595N P=0.385 |P=0.500 P=0.405N P=0.405N P=0.592N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 3/50 (6%) 1/49 (2%) |7/50 (14%) 8/50 (16%) 6/50 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/45.94 1/44.10 3/45.14 1/41.99 |7/45.83 8/46.33 6/44.70 7/40.85 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 6.7% 2.4% |15.3% 17.3% 13.4% 17.1% |
|TERMINAL (d) | 2/40 (5%) 1/39 (3%) 3/35 (9%) 1/34 (3%) |7/37 (19%) 8/38 (21%) 5/38 (13%) 6/33 (18%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |728 (T) 728 (T) 543 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543N P=0.509N P=0.439 P=0.557N |P=0.508 P=0.523 P=0.483N P=0.528 |
|POLY 3 | P=0.506N P=0.514N P=0.492 P=0.531N |P=0.509 P=0.509 P=0.519N P=0.523 |
|POLY 1.5 | P=0.496N P=0.511N P=0.496 P=0.522N |P=0.539 P=0.510 P=0.511N P=0.552 |
|POLY 6 | P=0.517N P=0.515N P=0.483 P=0.540N |P=0.483 P=0.507 P=0.522N P=0.496 |
|LOGISTIC REGRESSION| P=0.543N P=0.509N P=0.439 P=0.557N |P=0.493 P=0.523 P=0.528N P=0.514 |
|COCH-ARM / FISHERS | P=0.482N P=0.500N P=0.500 P=0.508N |P=0.500N P=0.500 P=0.500N P=0.613N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/49 (6%) |4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.94 0/44.10 1/45.45 3/41.99 |4/47.52 1/46.33 1/44.12 2/40.09 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 7.1% |8.4% 2.2% 2.3% 5.0% |
|TERMINAL (d) | 2/40 (5%) 0/39 (0%) 0/35 (0%) 3/34 (9%) |1/37 (3%) 1/38 (3%) 1/38 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) --- 645 729 (T) |193 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198 P=0.244N P=0.528N P=0.426 |P=0.353N P=0.182N P=0.186N P=0.386N |
|POLY 3 | P=0.227 P=0.246N P=0.504N P=0.459 |P=0.344N P=0.187N P=0.202N P=0.418N |
|POLY 1.5 | P=0.231 P=0.245N P=0.501N P=0.471 |P=0.335N P=0.184N P=0.195N P=0.393N |
|POLY 6 | P=0.221 P=0.247N P=0.509N P=0.448 |P=0.351N P=0.189N P=0.208N P=0.441N |
|LOGISTIC REGRESSION| P=0.215 (e) P=0.500N P=0.426 |P=0.215N P=0.258N P=0.147N P=0.234N |
|COCH-ARM / FISHERS | P=0.235 P=0.247N P=0.500N P=0.490 |P=0.313N P=0.181N P=0.181N P=0.339N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.03 0/44.10 0/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 708 --- --- --- |--- --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132N P=0.248N P=0.269N P=0.275N |P=0.181 (e) (e) P=0.477 |
|POLY 3 | P=0.110N P=0.247N P=0.241N P=0.258N |P=0.181 (e) (e) P=0.473 |
|POLY 1.5 | P=0.111N P=0.245N P=0.239N P=0.252N |P=0.187 (e) (e) P=0.482 |
|POLY 6 | P=0.109N P=0.247N P=0.246N P=0.264N |P=0.177 (e) (e) P=0.466 |
|LOGISTIC REGRESSION| P=0.122N P=0.246N P=0.244N P=0.261N |(e) (e) (e) P=0.477 |
|COCH-ARM / FISHERS | P=0.116N P=0.247N P=0.247N P=0.253N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 2/45.97 2/42.49 |3/46.84 0/46.33 1/44.26 1/40.25 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 4.7% |6.4% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 575 610 |193 --- 693 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 (e) P=0.245 P=0.215 |P=0.337N P=0.123N P=0.313N P=0.352N |
|POLY 3 | P=0.075 (e) P=0.237 P=0.220 |P=0.314N P=0.121N P=0.326N P=0.362N |
|POLY 1.5 | P=0.078 (e) P=0.238 P=0.224 |P=0.309N P=0.120N P=0.320N P=0.345N |
|POLY 6 | P=0.072 (e) P=0.236 P=0.217 |P=0.317N P=0.121N P=0.329N P=0.376N |
|LOGISTIC REGRESSION| P=0.095 (e) P=0.207 P=0.256 |P=0.189N P=0.185N P=0.286N P=0.208N |
|COCH-ARM / FISHERS | P=0.083 (e) P=0.247 P=0.242 |P=0.296N P=0.121N P=0.309N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.94 0/44.10 0/45.14 0/41.99 |1/45.83 1/46.33 1/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 0.0% |2.2% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 3/40 (8%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 1/38 (3%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |728 (T) 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.058N P=0.126N P=0.146N P=0.151N |P=0.335N P=0.756N P=0.756N P=0.523N |
|POLY 3 | P=0.043N* P=0.126N P=0.122N P=0.135N |P=0.343N P=0.758N P=0.752 P=0.527N |
|POLY 1.5 | P=0.044N* P=0.125N P=0.120N P=0.131N |P=0.333N P=0.758N P=0.756 P=0.518N |
|POLY 6 | P=0.043N* P=0.126N P=0.125N P=0.140N |P=0.351N P=0.759N P=0.750 P=0.534N |
|LOGISTIC REGRESSION| P=0.058N (e) (e) (e) |P=0.335N P=0.756N P=0.756N (e) |
|COCH-ARM / FISHERS | P=0.048N* P=0.121N P=0.121N P=0.125N |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/49 (4%) |4/50 (8%) 2/50 (4%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 3/44.10 0/45.14 2/41.99 |4/45.83 2/46.33 5/44.90 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 0.0% 4.8% |8.7% 4.3% 11.1% 0.0% |
|TERMINAL (d) | 0/40 (0%) 3/39 (8%) 0/35 (0%) 2/34 (6%) |4/37 (11%) 2/38 (5%) 3/38 (8%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |728 (T) 728 (T) 576 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.297 P=0.117 (e) P=0.203 |P=0.122N P=0.324N P=0.508 P=0.078N |
|POLY 3 | P=0.317 P=0.111 (e) P=0.218 |P=0.135N P=0.332N P=0.487 P=0.079N |
|POLY 1.5 | P=0.327 P=0.113 (e) P=0.223 |P=0.121N P=0.332N P=0.492 P=0.073N |
|POLY 6 | P=0.308 P=0.111 (e) P=0.212 |P=0.148N P=0.333N P=0.488 P=0.085N |
|LOGISTIC REGRESSION| (e) P=0.117 (e) P=0.203 |P=0.116N P=0.324N P=0.491 (e) |
|COCH-ARM / FISHERS | P=0.344 P=0.121 (e) P=0.242 |P=0.095N P=0.339N P=0.500 P=0.059N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 1/47.02 0/44.12 2/41.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.1% 0.0% 4.9% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 494 --- 504 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.122 P=0.504 (e) P=0.212 |
|POLY 3 | (e) (e) (e) (e) |P=0.124 P=0.505 (e) P=0.213 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.129 P=0.504 (e) P=0.221 |
|POLY 6 | (e) (e) (e) (e) |P=0.121 P=0.506 (e) P=0.208 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.251 P=0.337 (e) P=0.291 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 2/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 2/35 (6%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560 (e) P=0.209 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.557 (e) P=0.233 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.571 (e) P=0.236 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.545 (e) P=0.229 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.209 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.591 (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) | |
|POLY-3 RATE (b) | 1/45.94 2/44.10 0/45.14 0/41.99 | |
|POLY-3 PERCENT (g) | 2.2% 4.5% 0.0% 0.0% | |
|TERMINAL (d) | 1/40 (3%) 2/39 (5%) 0/35 (0%) 0/34 (0%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218N P=0.491 P=0.527N P=0.532N | |
|POLY 3 | P=0.200N P=0.486 P=0.504N P=0.518N | |
|POLY 1.5 | P=0.196N P=0.489 P=0.502N P=0.513N | |
|POLY 6 | P=0.203N P=0.485 P=0.507N P=0.523N | |
|LOGISTIC REGRESSION| P=0.218N P=0.491 (e) (e) | |
|COCH-ARM / FISHERS | P=0.191N P=0.500 P=0.500N P=0.505N | |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thymus |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 1/45 (2%) 0/47 (0%) 0/44 (0%) |5/49 (10%) 1/49 (2%) 4/48 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/42.38 1/39.10 0/42.70 0/37.65 |5/45.35 1/45.88 4/44.04 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 0.0% |11.0% 2.2% 9.1% 2.5% |
|TERMINAL (d) | 0/37 (0%) 1/34 (3%) 0/34 (0%) 0/30 (0%) |5/37 (14%) 1/38 (3%) 3/38 (8%) 1/33 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |728 (T) 728 (T) 543 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.483 (e) (e) |P=0.168N P=0.096N P=0.488N P=0.130N |
|POLY 3 | P=0.581N P=0.484 (e) (e) |P=0.173N P=0.099N P=0.518N P=0.132N |
|POLY 1.5 | P=0.579N P=0.487 (e) (e) |P=0.159N P=0.099N P=0.514N P=0.120N |
|POLY 6 | P=0.584N P=0.482 (e) (e) |P=0.185N P=0.099N P=0.520N P=0.145N |
|LOGISTIC REGRESSION| (e) P=0.483 (e) (e) |P=0.164N P=0.096N P=0.518N P=0.130N |
|COCH-ARM / FISHERS | P=0.573N P=0.495 (e) (e) |P=0.132N P=0.102N P=0.513N P=0.098N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |1/49 (2%) 1/48 (2%) 0/49 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/45.94 1/44.10 0/45.14 0/41.99 |1/45.27 1/45.01 0/43.56 2/40.06 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |2.2% 2.2% 0.0% 5.0% |
|TERMINAL (d) | 0/40 (0%) 1/39 (3%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 1/38 (3%) 0/38 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |728 (T) 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.593N P=0.495 (e) (e) |P=0.329 P=0.756N P=0.495N P=0.460 |
|POLY 3 | P=0.578N P=0.492 (e) (e) |P=0.339 P=0.759 P=0.508N P=0.457 |
|POLY 1.5 | P=0.576N P=0.494 (e) (e) |P=0.348 P=0.759 P=0.505N P=0.473 |
|POLY 6 | P=0.580N P=0.492 (e) (e) |P=0.330 P=0.759 P=0.510N P=0.443 |
|LOGISTIC REGRESSION| (e) P=0.495 (e) (e) |P=0.329 P=0.756N (e) P=0.460 |
|COCH-ARM / FISHERS | P=0.571N P=0.500 (e) (e) |P=0.362 P=0.747 P=0.500N P=0.492 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/26 (100%) 22/22 (100%) 20/20 (100%) 7/7 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |
|POLY-3 RATE (b) | 26/26.00 22/22.00 20/20.00 7/7.00 |0/0.00 0/0.00 0/0.00 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 24/24 (100%) 19/19 (100%) 13/13 (100%) 6/6 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 556 491 575 668 |--- --- --- 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/45.83 1/46.33 2/44.12 1/40.09 |
|POLY-3 PERCENT (g) | |0.0% 2.2% 4.5% 2.5% |
|TERMINAL (d) | |0/37 (0%) 1/38 (3%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.329 P=0.505 P=0.244 P=0.477 |
|POLY 3 | |P=0.302 P=0.502 P=0.229 P=0.473 |
|POLY 1.5 | |P=0.322 P=0.502 P=0.232 P=0.482 |
|POLY 6 | |P=0.284 P=0.502 P=0.226 P=0.466 |
|LOGISTIC REGRESSION| |(e) P=0.505 P=0.244 P=0.477 |
|COCH-ARM / FISHERS | |P=0.366 P=0.500 P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 05/15/01 EXPERIMENT: 88031 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |38/50 (76%) 38/50 (76%) 39/50 (78%) 39/50 (78%) |
|POLY-3 RATE (b) | |38/47.63 38/48.38 39/46.06 39/44.91 |
|POLY-3 PERCENT (g) | |79.8% 78.6% 84.7% 86.8% |
|TERMINAL (d) | |31/37 (84%) 32/38 (84%) 36/38 (95%) 30/33 (91%) |
|FIRST INCIDENCE | |570 494 484 452 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.093 P=0.511N P=0.561 P=0.167 |
|POLY 3 | |P=0.156 P=0.542N P=0.356 P=0.254 |
|POLY 1.5 | |P=0.223 P=0.539N P=0.429 P=0.321 |
|POLY 6 | |P=0.101 P=0.566N P=0.266 P=0.191 |
|LOGISTIC REGRESSION| |P=0.089 P=0.553N P=0.339 P=0.180 |
|COCH-ARM / FISHERS | |P=0.432 P=0.592N P=0.500 P=0.500 |
|=================================================================================================================================|
(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).