TDMS Study 90004-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 01/09/02
EXPERIMENT: 90004 TEST: 06 TIME: 09:32:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: MISSING CAS: 57018-52-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PROPYLENE GLYCOL MONO-T-BUTYL ET
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Eye: Cornea Mineralization
Harderian Gland Hyperplasia
Kidney Metaplasia Osseous
Kidney: Transitional Epithelium Hyperplasia
Liver Basophilic Focus
Eosinophilic Focus
Inflammation Granulomatous
Mixed Cell Focus
Liver: Hepatocyte Multinucleated
Lung: Alveolar Epithelium Hyperplasia
Mesentery: Artery Inflammation
Nose Inflammation
Stomach, Forestomach Inflammation
Stomach, Forestomach: Epithelium Hyperplasia
Tooth Inflammation Chronic
Malformation
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Hypertrophy
Eye Cataract
Eye: Cornea Erosion
Mineralization
Intestine Small, Ileum Necrosis
Liver Eosinophilic Focus
Inflammation Granulomatous
Lung Inflammation Granulomatous
Lung: Artery Inflammation Acute
Mesentery: Fat Necrosis
Tooth Inflammation Chronic
===============================================================
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/48 (23%) 9/49 (18%) 14/50 (28%) 7/50 (14%) |8/49 (16%) 3/50 (6%) 3/50 (6%) 4/48 (8%) |
|POLY-3 RATE (b) | 11/45.10 9/44.95 14/45.28 7/45.04 |8/46.92 3/46.72 3/48.03 4/45.05 |
|POLY-3 PERCENT (g) | 24.4% 20.0% 30.9% 15.5% |17.1% 6.4% 6.3% 8.9% |
|TERMINAL (d) | 9/35 (26%) 9/40 (23%) 13/40 (33%) 6/37 (16%) |7/39 (18%) 2/36 (6%) 3/42 (7%) 4/39 (10%) |
|FIRST INCIDENCE | 641 729 (T) 702 637 |683 630 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198N P=0.292N P=0.450 P=0.195N |P=0.346N P=0.128N P=0.082N P=0.180N |
|POLY 3 | P=0.186N P=0.404N P=0.323 P=0.215N |P=0.379N P=0.100N P=0.092N P=0.197N |
|POLY 1.5 | P=0.173N P=0.405N P=0.342 P=0.204N |P=0.380N P=0.097N P=0.092N P=0.195N |
|POLY 6 | P=0.202N P=0.400N P=0.308 P=0.228N |P=0.375N P=0.103N P=0.090N P=0.197N |
|LOGISTIC REGRESSION| P=0.204N P=0.381N P=0.327 P=0.214N |P=0.377N P=0.099N P=0.088N P=0.189N |
|COCH-ARM / FISHERS | P=0.166N P=0.381N P=0.365 P=0.190N |P=0.377N P=0.094N P=0.094N P=0.188N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/48 (71%) 32/49 (65%) 29/50 (58%) 18/50 (36%) |7/49 (14%) 7/50 (14%) 1/50 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | 34/45.63 32/45.31 29/45.74 18/46.09 |7/46.74 7/46.77 1/48.03 2/45.05 |
|POLY-3 PERCENT (g) | 74.5% 70.6% 63.4% 39.1% |15.0% 15.0% 2.1% 4.4% |
|TERMINAL (d) | 28/35 (80%) 31/40 (78%) 27/40 (68%) 15/37 (41%) |7/39 (18%) 3/36 (8%) 1/42 (2%) 2/39 (5%) |
|FIRST INCIDENCE | 634 627 596 527 |731 (T) 669 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.131N P=0.054N P<0.001N** |P=0.054N P=0.556 P=0.025N* P=0.079N |
|POLY 3 | P<0.001N** P=0.427N P=0.170N P<0.001N** |P=0.059N P=0.613N P=0.027N* P=0.088N |
|POLY 1.5 | P<0.001N** P=0.424N P=0.149N P<0.001N** |P=0.059N P=0.606N P=0.028N* P=0.087N |
|POLY 6 | P<0.001N** P=0.427N P=0.196N P<0.001N** |P=0.058N P=0.608 P=0.027N* P=0.087N |
|LOGISTIC REGRESSION| P<0.001N** P=0.349N P=0.188N P<0.001N** |P=0.057N P=0.594 P=0.025N* P=0.079N |
|COCH-ARM / FISHERS | P<0.001N** P=0.357N P=0.132N P<0.001N** |P=0.060N P=0.597N P=0.028N* P=0.084N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 3/50 (6%) 3/50 (6%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 0/44.71 |0/46.74 3/46.36 3/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 6.5% 6.3% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 3/36 (8%) 3/42 (7%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.239N P=0.107 P=0.135 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.261N P=0.117 P=0.124 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.259N P=0.120 P=0.123 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.259N P=0.114 P=0.125 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.107 P=0.135 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.256N P=0.125 P=0.125 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 1/49 (2%) 1/49 (2%) 2/49 (4%) |2/47 (4%) 4/49 (8%) 1/50 (2%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/43.63 1/44.95 1/45.48 2/44.37 |2/45.27 4/45.56 1/48.03 3/45.40 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 4.5% |4.4% 8.8% 2.1% 6.6% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 0/37 (0%) |1/38 (3%) 3/35 (9%) 1/42 (2%) 2/39 (5%) |
|FIRST INCIDENCE | --- 729 (T) 564 632 |691 680 731 (T) 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 P=0.527 P=0.487 P=0.235 |P=0.563 P=0.308 P=0.474N P=0.499 |
|POLY 3 | P=0.214 P=0.506 P=0.508 P=0.241 |P=0.544 P=0.340 P=0.479N P=0.501 |
|POLY 1.5 | P=0.217 P=0.505 P=0.509 P=0.243 |P=0.545 P=0.347 P=0.479N P=0.503 |
|POLY 6 | P=0.212 P=0.508 P=0.509 P=0.240 |P=0.546 P=0.330 P=0.480N P=0.502 |
|LOGISTIC REGRESSION| P=0.215 P=0.527 P=0.441 P=0.254 |P=0.555 P=0.351 P=0.478N P=0.539 |
|COCH-ARM / FISHERS | P=0.220 P=0.510 P=0.510 P=0.258 |P=0.549 P=0.359 P=0.477N P=0.510 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 0/44.71 |0/47.55 0/46.36 0/48.03 2/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.238 |
|POLY 3 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.225 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.037 * (e) (e) P=0.226 |
|POLY 6 | (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.226 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.238 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.237 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 1/45.06 |0/47.55 0/46.36 0/48.03 3/45.53 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |0.0% 0.0% 0.0% 6.6% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | --- --- --- 632 |--- --- --- 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227 (e) (e) P=0.491 |P=0.008 ** (e) (e) P=0.118 |
|POLY 3 | P=0.229 (e) (e) P=0.502 |P=0.007 ** (e) (e) P=0.111 |
|POLY 1.5 | P=0.231 (e) (e) P=0.505 |P=0.007 ** (e) (e) P=0.111 |
|POLY 6 | P=0.226 (e) (e) P=0.500 |P=0.007 ** (e) (e) P=0.113 |
|LOGISTIC REGRESSION| P=0.223 (e) (e) P=0.518 |P=0.011 * (e) (e) P=0.133 |
|COCH-ARM / FISHERS | P=0.232 (e) (e) P=0.510 |P=0.007 ** (e) (e) P=0.114 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 1/44.56 0/44.95 0/45.18 1/44.71 |1/47.55 2/46.68 0/48.03 2/45.05 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 2.2% |2.1% 4.3% 0.0% 4.4% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/40 (0%) 1/37 (3%) |1/39 (3%) 1/36 (3%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | 729 (T) --- --- 729 (T) |731 (T) 643 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519 P=0.473N P=0.473N P=0.749N |P=0.453 P=0.476 P=0.485N P=0.500 |
|POLY 3 | P=0.523 P=0.498N P=0.497N P=0.760N |P=0.431 P=0.494 P=0.498N P=0.481 |
|POLY 1.5 | P=0.528 P=0.499N P=0.495N P=0.756N |P=0.432 P=0.496 P=0.499N P=0.482 |
|POLY 6 | P=0.518 P=0.496N P=0.498N P=0.758 |P=0.432 P=0.491 P=0.496N P=0.483 |
|LOGISTIC REGRESSION| P=0.519 (e) (e) P=0.749N |P=0.436 P=0.524 (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.529 P=0.495N P=0.490N P=0.742N |P=0.435 P=0.500 P=0.500N P=0.485 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 4/48 (8%) |
|POLY-3 RATE (b) | 1/44.56 0/44.95 1/45.18 1/44.71 |1/47.55 2/46.68 0/48.03 4/45.05 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 2.2% |2.1% 4.3% 0.0% 8.9% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 1/40 (3%) 1/37 (3%) |1/39 (3%) 1/36 (3%) 0/42 (0%) 4/39 (10%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) 729 (T) |731 (T) 643 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560 P=0.473N P=0.732N P=0.749N |P=0.082 P=0.476 P=0.485N P=0.179 |
|POLY 3 | P=0.561 P=0.498N P=0.758N P=0.760N |P=0.069 P=0.494 P=0.498N P=0.163 |
|POLY 1.5 | P=0.568 P=0.499N P=0.755N P=0.756N |P=0.070 P=0.496 P=0.499N P=0.164 |
|POLY 6 | P=0.553 P=0.496N P=0.759N P=0.758 |P=0.070 P=0.491 P=0.496N P=0.164 |
|LOGISTIC REGRESSION| P=0.560 (e) P=0.732N P=0.749N |P=0.071 P=0.524 (e) P=0.179 |
|COCH-ARM / FISHERS | P=0.571 P=0.495N P=0.742N P=0.742N |P=0.072 P=0.500 P=0.500N P=0.168 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 20/48 (42%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 3/45.28 |1/47.55 2/46.68 0/48.03 20/45.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.6% |2.1% 4.3% 0.0% 43.9% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 1/37 (3%) |1/39 (3%) 1/36 (3%) 0/42 (0%) 17/39 (44%) |
|FIRST INCIDENCE | --- --- --- 632 |731 (T) 643 --- 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** (e) (e) P=0.125 |P<0.001 ** P=0.476 P=0.485N P<0.001 ** |
|POLY 3 | P=0.008 ** (e) (e) P=0.121 |P<0.001 ** P=0.494 P=0.498N P<0.001 ** |
|POLY 1.5 | P=0.008 ** (e) (e) P=0.123 |P<0.001 ** P=0.496 P=0.499N P<0.001 ** |
|POLY 6 | P=0.008 ** (e) (e) P=0.120 |P<0.001 ** P=0.491 P=0.496N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.009 ** (e) (e) P=0.133 |P<0.001 ** P=0.524 (e) P<0.001 ** |
|COCH-ARM / FISHERS | P=0.009 ** (e) (e) P=0.129 |P<0.001 ** P=0.500 P=0.500N P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Gallbladder |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/38 (0%) 1/41 (2%) 2/39 (5%) 0/40 (0%) |0/40 (0%) 0/39 (0%) 0/43 (0%) 0/33 (0%) |
|POLY-3 RATE (b) | 0/37.41 1/37.55 2/36.29 0/37.01 |0/38.42 0/36.72 0/41.99 0/31.44 |
|POLY-3 PERCENT (g) | 0.0% 2.7% 5.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 1/34 (3%) 1/33 (3%) 0/31 (0%) |0/33 (0%) 0/31 (0%) 0/38 (0%) 0/29 (0%) |
|FIRST INCIDENCE | --- 729 (T) 642 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493N P=0.500 P=0.234 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.485N P=0.501 P=0.230 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.476N P=0.503 P=0.234 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.497N P=0.498 P=0.226 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.468N P=0.500 P=0.285 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.468N P=0.519 P=0.253 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 3/50 (6%) 5/50 (10%) 1/50 (2%) |3/50 (6%) 3/50 (6%) 4/50 (8%) 4/49 (8%) |
|POLY-3 RATE (b) | 10/46.66 3/45.21 5/45.28 1/44.71 |3/47.55 3/47.04 4/48.03 4/46.08 |
|POLY-3 PERCENT (g) | 21.4% 6.6% 11.0% 2.2% |6.3% 6.4% 8.3% 8.7% |
|TERMINAL (d) | 7/35 (20%) 3/40 (8%) 4/40 (10%) 1/37 (3%) |3/39 (8%) 1/36 (3%) 4/42 (10%) 3/39 (8%) |
|FIRST INCIDENCE | 610 729 (T) 702 729 (T) |731 (T) 586 731 (T) 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021N* P=0.026N* P=0.100N P=0.006N** |P=0.443 P=0.629 P=0.541 P=0.497 |
|POLY 3 | P=0.018N* P=0.039N* P=0.143N P=0.005N** |P=0.422 P=0.657 P=0.506 P=0.483 |
|POLY 1.5 | P=0.017N* P=0.040N* P=0.137N P=0.005N** |P=0.422 P=0.659 P=0.503 P=0.484 |
|POLY 6 | P=0.020N* P=0.038N* P=0.145N P=0.005N** |P=0.426 P=0.656 P=0.510 P=0.486 |
|LOGISTIC REGRESSION| P=0.021N* P=0.039N* P=0.137N P=0.006N** |P=0.474 P=0.624N P=0.541 P=0.529 |
|COCH-ARM / FISHERS | P=0.019N* P=0.036N* P=0.131N P=0.004N** |P=0.426 P=0.661N P=0.500 P=0.489 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/50 (16%) 11/50 (22%) 7/50 (14%) |5/50 (10%) 4/50 (8%) 8/50 (16%) 3/49 (6%) |
|POLY-3 RATE (b) | 9/46.31 8/45.21 11/45.50 7/45.50 |5/47.66 4/46.51 8/48.26 3/45.44 |
|POLY-3 PERCENT (g) | 19.4% 17.7% 24.2% 15.4% |10.5% 8.6% 16.6% 6.6% |
|TERMINAL (d) | 8/35 (23%) 8/40 (20%) 10/40 (25%) 4/37 (11%) |4/39 (10%) 3/36 (8%) 7/42 (17%) 2/39 (5%) |
|FIRST INCIDENCE | 630 729 (T) 641 527 |701 694 669 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.361N P=0.390N P=0.513 P=0.366N |P=0.280N P=0.545N P=0.321 P=0.358N |
|POLY 3 | P=0.349N P=0.522N P=0.383 P=0.407N |P=0.315N P=0.515N P=0.284 P=0.383N |
|POLY 1.5 | P=0.342N P=0.524N P=0.391 P=0.402N |P=0.313N P=0.509N P=0.281 P=0.379N |
|POLY 6 | P=0.356N P=0.512N P=0.384 P=0.409N |P=0.312N P=0.523N P=0.290 P=0.384N |
|LOGISTIC REGRESSION| P=0.366N P=0.486N P=0.385 P=0.404N |P=0.308N P=0.526N P=0.286 P=0.377N |
|COCH-ARM / FISHERS | P=0.344N P=0.500N P=0.402 P=0.393N |P=0.303N P=0.500N P=0.277 P=0.369N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/46.98 0/45.21 0/45.18 0/44.71 |0/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 281 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.239N P=0.237N P=0.243N |(e) (e) (e) (e) |
|POLY 3 | P=0.301N P=0.246N P=0.246N P=0.248N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.301N P=0.246N P=0.243N P=0.245N |(e) (e) (e) (e) |
|POLY 6 | P=0.304N P=0.243N P=0.246N P=0.251N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.362N P=0.118N P=0.254N P=0.202N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.308N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/45.21 3/45.63 0/44.71 |1/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.6% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 2/40 (5%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 596 --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N (e) P=0.134 (e) |P=0.543N P=0.516N P=0.485N P=0.500N |
|POLY 3 | P=0.591N (e) P=0.117 (e) |P=0.549N P=0.505N P=0.498N P=0.509N |
|POLY 1.5 | P=0.585N (e) P=0.118 (e) |P=0.549N P=0.503N P=0.499N P=0.508N |
|POLY 6 | P=0.598N (e) P=0.119 (e) |P=0.548N P=0.508N P=0.496N P=0.509N |
|LOGISTIC REGRESSION| P=0.582N (e) P=0.122 (e) |P=0.543N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.581N (e) P=0.121 (e) |P=0.551N P=0.500N P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/43 (2%) 1/47 (2%) 0/48 (0%) 0/48 (0%) |0/49 (0%) 0/48 (0%) 2/49 (4%) 0/46 (0%) |
|POLY-3 RATE (b) | 1/40.70 1/43.90 0/44.33 0/43.70 |0/46.74 0/44.86 2/47.36 0/43.38 |
|POLY-3 PERCENT (g) | 2.5% 2.3% 0.0% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 1/41 (2%) 0/39 (0%) |
|FIRST INCIDENCE | 711 568 --- --- |--- --- 641 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.759N P=0.490N P=0.500N |P=0.654N (e) P=0.250 (e) |
|POLY 3 | P=0.339N P=0.744N P=0.483N P=0.486N |P=0.667N (e) P=0.240 (e) |
|POLY 1.5 | P=0.337N P=0.745N P=0.480N P=0.482N |P=0.668N (e) P=0.239 (e) |
|POLY 6 | P=0.340N P=0.742N P=0.485N P=0.490N |P=0.663N (e) P=0.242 (e) |
|LOGISTIC REGRESSION| P=0.345N P=0.721N P=0.479N P=0.481N |P=0.626N (e) P=0.217 (e) |
|COCH-ARM / FISHERS | P=0.336N P=0.730N P=0.473N P=0.473N |P=0.666N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/43 (9%) 2/47 (4%) 2/46 (4%) 1/46 (2%) |2/49 (4%) 1/48 (2%) 3/48 (6%) 1/45 (2%) |
|POLY-3 RATE (b) | 4/40.63 2/43.37 2/43.20 1/42.64 |2/46.74 1/44.98 3/46.31 1/42.63 |
|POLY-3 PERCENT (g) | 9.8% 4.6% 4.6% 2.4% |4.3% 2.2% 6.5% 2.4% |
|TERMINAL (d) | 4/35 (11%) 2/40 (5%) 2/40 (5%) 1/37 (3%) |2/39 (5%) 1/36 (3%) 3/41 (7%) 1/39 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209N P=0.277N P=0.277N P=0.162N |P=0.447N P=0.528N P=0.523 P=0.500N |
|POLY 3 | P=0.200N P=0.307N P=0.309N P=0.163N |P=0.490N P=0.513N P=0.496 P=0.532N |
|POLY 1.5 | P=0.198N P=0.307N P=0.307N P=0.161N |P=0.492N P=0.511N P=0.493 P=0.532N |
|POLY 6 | P=0.203N P=0.305N P=0.311N P=0.166N |P=0.483N P=0.516N P=0.500 P=0.528N |
|LOGISTIC REGRESSION| P=0.209N P=0.277N P=0.277N P=0.162N |P=0.447N P=0.528N P=0.523 P=0.500N |
|COCH-ARM / FISHERS | P=0.199N P=0.297N P=0.306N P=0.160N |P=0.491N P=0.508N P=0.490 P=0.532N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Ileum |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 0/47 (0%) 1/46 (2%) 0/46 (0%) |0/49 (0%) 0/48 (0%) 0/48 (0%) 2/45 (4%) |
|POLY-3 RATE (b) | 0/40.63 0/43.37 1/43.20 0/42.64 |0/46.74 0/44.98 0/46.31 2/43.90 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |0.0% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/40 (3%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/41 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- --- 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.777N (e) P=0.527 (e) |P=0.039 * (e) (e) P=0.228 |
|POLY 3 | P=0.770N (e) P=0.512 (e) |P=0.036 * (e) (e) P=0.223 |
|POLY 1.5 | P=0.768N (e) P=0.513 (e) |P=0.036 * (e) (e) P=0.221 |
|POLY 6 | P=0.772N (e) P=0.511 (e) |P=0.038 * (e) (e) P=0.228 |
|LOGISTIC REGRESSION| (e) (e) P=0.527 (e) |P=0.319 (e) (e) P=0.704 |
|COCH-ARM / FISHERS | P=0.769N (e) P=0.517 (e) |P=0.036 * (e) (e) P=0.226 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/42 (5%) 0/47 (0%) 2/47 (4%) 0/45 (0%) |0/49 (0%) 0/48 (0%) 1/48 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 2/39.71 0/43.37 2/44.10 0/41.86 |0/46.74 0/44.98 1/46.36 0/44.24 |
|POLY-3 PERCENT (g) | 5.0% 0.0% 4.5% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/40 (0%) 2/40 (5%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 1/42 (2%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.292N P=0.209N P=0.646N P=0.226N |P=0.770N (e) P=0.515 (e) |
|POLY 3 | P=0.284N P=0.217N P=0.656N P=0.225N |P=0.778N (e) P=0.498 (e) |
|POLY 1.5 | P=0.281N P=0.217N P=0.653N P=0.224N |P=0.778N (e) P=0.497 (e) |
|POLY 6 | P=0.286N P=0.217N P=0.659N P=0.227N |P=0.776N (e) P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.292N (e) P=0.646N (e) |(e) (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.286N P=0.220N P=0.648N P=0.230N |P=0.778N (e) P=0.495 (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/45.96 1/44.95 2/45.18 0/44.71 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 2/40 (5%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320N P=0.732N P=0.547 P=0.489N |(e) (e) (e) (e) |
|POLY 3 | P=0.324N P=0.756 P=0.494 P=0.505N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.319N P=0.753 P=0.496 P=0.503N |(e) (e) (e) (e) |
|POLY 6 | P=0.330N P=0.760 P=0.495 P=0.507N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.320N P=0.732N P=0.547 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.315N P=0.747 P=0.500 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/49 (6%) 3/50 (6%) 7/50 (14%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 3/46.26 3/44.95 3/45.18 7/45.03 |1/46.74 0/46.36 2/48.03 3/45.05 |
|POLY-3 PERCENT (g) | 6.5% 6.7% 6.6% 15.6% |2.1% 0.0% 4.2% 6.7% |
|TERMINAL (d) | 1/35 (3%) 3/40 (8%) 3/40 (8%) 6/37 (16%) |1/39 (3%) 0/36 (0%) 2/42 (5%) 3/39 (8%) |
|FIRST INCIDENCE | 669 729 (T) 729 (T) 643 |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 P=0.615N P=0.619N P=0.174 |P=0.118 P=0.516N P=0.526 P=0.305 |
|POLY 3 | P=0.062 P=0.649 P=0.651 P=0.146 |P=0.106 P=0.502N P=0.509 P=0.292 |
|POLY 1.5 | P=0.065 P=0.645 P=0.656 P=0.151 |P=0.106 P=0.499N P=0.508 P=0.294 |
|POLY 6 | P=0.059 P=0.656 P=0.650 P=0.142 |P=0.109 P=0.505N P=0.511 P=0.293 |
|LOGISTIC REGRESSION| P=0.058 P=0.653 P=0.656 P=0.148 |P=0.118 (e) P=0.526 P=0.305 |
|COCH-ARM / FISHERS | P=0.067 P=0.651 P=0.661N P=0.159 |P=0.106 P=0.495N P=0.508 P=0.301 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/49 (12%) 2/50 (4%) 0/50 (0%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/46.02 6/45.31 2/45.28 0/44.71 |2/46.74 1/46.36 1/48.03 1/45.05 |
|POLY-3 PERCENT (g) | 6.5% 13.2% 4.4% 0.0% |4.3% 2.2% 2.1% 2.2% |
|TERMINAL (d) | 2/35 (6%) 5/40 (13%) 1/40 (3%) 0/37 (0%) |2/39 (5%) 1/36 (3%) 1/42 (2%) 1/39 (3%) |
|FIRST INCIDENCE | 714 627 702 --- |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035N* P=0.300 P=0.453N P=0.116N |P=0.513N P=0.528N P=0.474N P=0.500N |
|POLY 3 | P=0.033N* P=0.234 P=0.507N P=0.124N |P=0.534N P=0.503N P=0.491N P=0.513N |
|POLY 1.5 | P=0.032N* P=0.228 P=0.504N P=0.122N |P=0.534N P=0.499N P=0.492N P=0.511N |
|POLY 6 | P=0.034N* P=0.246 P=0.506N P=0.125N |P=0.530N P=0.508N P=0.489N P=0.512N |
|LOGISTIC REGRESSION| P=0.034N* P=0.231 P=0.505N P=0.124N |P=0.513N P=0.528N P=0.474N P=0.500N |
|COCH-ARM / FISHERS | P=0.033N* P=0.233 P=0.500N P=0.121N |P=0.533N P=0.492N P=0.492N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 40/49 (82%) 44/50 (88%) 36/50 (72%) |34/49 (69%) 34/50 (68%) 32/50 (64%) 34/48 (71%) |
|POLY-3 RATE (b) | 41/48.49 40/46.25 44/50.00 36/47.18 |34/49.00 34/49.15 32/49.43 34/47.32 |
|POLY-3 PERCENT (g) | 84.6% 86.5% 88.0% 76.3% |69.4% 69.2% 64.7% 71.9% |
|TERMINAL (d) | 33/35 (94%) 35/40 (88%) 34/40 (85%) 29/37 (78%) |24/39 (62%) 23/36 (64%) 27/42 (64%) 26/39 (67%) |
|FIRST INCIDENCE | 281 568 451 527 |588 533 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.151N P=0.484N P=0.134N |P=0.539N P=0.413 P=0.299N P=0.543 |
|POLY 3 | P=0.092N P=0.510 P=0.417 P=0.213N |P=0.407 P=0.577N P=0.392N P=0.484 |
|POLY 1.5 | P=0.079N P=0.492 P=0.353 P=0.205N |P=0.412 P=0.555N P=0.378N P=0.499 |
|POLY 6 | P=0.098N P=0.576 P=0.535 P=0.197N |P=0.409 P=0.562 P=0.415N P=0.470 |
|LOGISTIC REGRESSION| P=0.077N P=0.553 P=0.288 P=0.202N |P=0.435 P=0.465N P=0.380N P=0.547 |
|COCH-ARM / FISHERS | P=0.076N P=0.584N P=0.288 P=0.171N |P=0.428 P=0.527N P=0.361N P=0.527 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 2/45.63 1/44.71 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/40 (3%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 596 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413 (e) P=0.245 P=0.511 |(e) (e) (e) (e) |
|POLY 3 | P=0.409 (e) P=0.236 P=0.495 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.416 (e) P=0.236 P=0.497 |(e) (e) (e) (e) |
|POLY 6 | P=0.402 (e) P=0.237 P=0.493 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.421 (e) P=0.238 P=0.511 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.421 (e) P=0.247 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 1/45.18 2/44.71 |0/46.74 0/46.36 1/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.5% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/40 (3%) 2/37 (5%) |0/39 (0%) 0/36 (0%) 1/42 (2%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092 (e) P=0.527 P=0.251 |P=0.770N (e) P=0.515 (e) |
|POLY 3 | P=0.094 (e) P=0.497 P=0.231 |P=0.778N (e) P=0.505 (e) |
|POLY 1.5 | P=0.096 (e) P=0.498 P=0.234 |P=0.778N (e) P=0.505 (e) |
|POLY 6 | P=0.091 (e) P=0.497 P=0.229 |P=0.777N (e) P=0.506 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.527 P=0.251 |(e) (e) P=0.515 (e) |
|COCH-ARM / FISHERS | P=0.098 (e) P=0.500 P=0.247 |P=0.778N (e) P=0.505 (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/45.96 0/44.95 1/45.18 0/44.71 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/40 (0%) 1/40 (3%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.302N P=0.209N P=0.453N P=0.226N |(e) (e) (e) (e) |
|POLY 3 | P=0.303N P=0.242N P=0.506N P=0.243N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.299N P=0.245N P=0.504N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.309N P=0.237N P=0.505N P=0.245N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.302N (e) P=0.453N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.298N P=0.253N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 0/45.18 2/45.03 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- 643 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040 * (e) (e) P=0.238 |(e) (e) (e) (e) |
|POLY 3 | P=0.041 * (e) (e) P=0.233 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.234 |(e) (e) (e) (e) |
|POLY 6 | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.043 * (e) (e) P=0.241 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 11/49 (22%) 16/50 (32%) 4/50 (8%) |3/49 (6%) 4/50 (8%) 4/50 (8%) 2/49 (4%) |
|POLY-3 RATE (b) | 6/45.96 11/45.45 16/46.39 4/44.93 |3/46.86 4/46.94 4/48.31 2/45.44 |
|POLY-3 PERCENT (g) | 13.1% 24.2% 34.5% 8.9% |6.4% 8.5% 8.3% 4.4% |
|TERMINAL (d) | 6/35 (17%) 9/40 (23%) 14/40 (35%) 3/37 (8%) |2/39 (5%) 2/36 (6%) 3/42 (7%) 1/39 (3%) |
|FIRST INCIDENCE | 729 (T) 611 451 672 |701 616 655 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085N P=0.213 P=0.030 * P=0.338N |P=0.321N P=0.465 P=0.535 P=0.500N |
|POLY 3 | P=0.082N P=0.135 P=0.013 * P=0.384N |P=0.343N P=0.501 P=0.517 P=0.514N |
|POLY 1.5 | P=0.076N P=0.128 P=0.013 * P=0.379N |P=0.339N P=0.505 P=0.514 P=0.510N |
|POLY 6 | P=0.088N P=0.148 P=0.013 * P=0.385N |P=0.344N P=0.496 P=0.521 P=0.516N |
|LOGISTIC REGRESSION| P=0.083N P=0.138 P=0.014 * P=0.386N |P=0.316N P=0.545 P=0.507 P=0.513N |
|COCH-ARM / FISHERS | P=0.077N P=0.133 P=0.014 * P=0.370N |P=0.328N P=0.511 P=0.511 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 18/49 (37%) 16/50 (32%) 17/50 (34%) |4/49 (8%) 4/50 (8%) 6/50 (12%) 5/49 (10%) |
|POLY-3 RATE (b) | 20/46.18 18/44.95 16/45.79 17/44.71 |4/46.92 4/47.12 6/48.30 5/45.93 |
|POLY-3 PERCENT (g) | 43.3% 40.1% 34.9% 38.0% |8.5% 8.5% 12.4% 10.9% |
|TERMINAL (d) | 19/35 (54%) 18/40 (45%) 15/40 (38%) 17/37 (46%) |3/39 (8%) 2/36 (6%) 5/42 (12%) 3/39 (8%) |
|FIRST INCIDENCE | 671 729 (T) 531 729 (T) |683 616 658 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.218N P=0.124N P=0.248N |P=0.470 P=0.604 P=0.409 P=0.493 |
|POLY 3 | P=0.414N P=0.459N P=0.270N P=0.381N |P=0.446 P=0.641N P=0.388 P=0.487 |
|POLY 1.5 | P=0.389N P=0.473N P=0.268N P=0.364N |P=0.448 P=0.637N P=0.386 P=0.490 |
|POLY 6 | P=0.445N P=0.431N P=0.261N P=0.396N |P=0.449 P=0.641 P=0.392 P=0.487 |
|LOGISTIC REGRESSION| P=0.452N P=0.305N P=0.277N P=0.330N |P=0.493 P=0.580N P=0.382 P=0.513 |
|COCH-ARM / FISHERS | P=0.371N P=0.449N P=0.266N P=0.339N |P=0.458 P=0.631N P=0.383 P=0.500 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 14/49 (29%) 11/50 (22%) 29/50 (58%) |11/49 (22%) 10/50 (20%) 9/50 (18%) 27/49 (55%) |
|POLY-3 RATE (b) | 9/45.96 14/45.01 11/45.18 29/46.40 |11/47.08 10/47.46 9/48.03 27/46.53 |
|POLY-3 PERCENT (g) | 19.6% 31.1% 24.4% 62.5% |23.4% 21.1% 18.7% 58.0% |
|TERMINAL (d) | 9/35 (26%) 13/40 (33%) 11/40 (28%) 25/37 (68%) |10/39 (26%) 6/36 (17%) 9/42 (21%) 23/39 (59%) |
|FIRST INCIDENCE | 729 (T) 712 729 (T) 526 |638 602 731 (T) 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.272 P=0.535 P<0.001 ** |P<0.001 ** P=0.571N P=0.333N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.152 P=0.384 P<0.001 ** |P<0.001 ** P=0.492N P=0.382N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.146 P=0.391 P<0.001 ** |P<0.001 ** P=0.487N P=0.382N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.165 P=0.385 P<0.001 ** |P<0.001 ** P=0.495N P=0.381N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.231 P=0.535 P<0.001 ** |P<0.001 ** P=0.467N P=0.365N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.157 P=0.402 P<0.001 ** |P<0.001 ** P=0.479N P=0.382N P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/50 (0%) 2/50 (4%) |2/49 (4%) 1/50 (2%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/45.96 1/44.95 0/45.18 2/44.71 |2/47.24 1/46.97 1/48.11 1/46.19 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 4.5% |4.2% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 2/37 (5%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |588 533 711 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.527 (e) P=0.251 |P=0.534N P=0.511N P=0.483N P=0.517N |
|POLY 3 | P=0.150 P=0.496 (e) P=0.231 |P=0.527N P=0.502N P=0.494N P=0.508N |
|POLY 1.5 | P=0.152 P=0.493 (e) P=0.234 |P=0.527N P=0.498N P=0.493N P=0.505N |
|POLY 6 | P=0.148 P=0.500 (e) P=0.229 |P=0.526N P=0.508N P=0.494N P=0.509N |
|LOGISTIC REGRESSION| (e) P=0.527 (e) P=0.251 |P=0.128N P=0.217N P=0.533N P=0.146N |
|COCH-ARM / FISHERS | P=0.154 P=0.495 (e) P=0.247 |P=0.525N P=0.492N P=0.492N P=0.500N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 1/50 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/46.36 1/45.31 1/45.18 3/45.04 |0/46.74 0/46.36 1/48.11 0/45.40 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 2.2% 6.7% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/40 (3%) 2/37 (5%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 634 627 729 (T) 637 |--- --- 711 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260 P=0.504N P=0.483N P=0.500 |P=0.768N (e) P=0.519 (e) |
|POLY 3 | P=0.264 P=0.508N P=0.509N P=0.487 |P=0.776N (e) P=0.506 (e) |
|POLY 1.5 | P=0.269 P=0.512N P=0.505N P=0.492 |P=0.776N (e) P=0.505 (e) |
|POLY 6 | P=0.257 P=0.501N P=0.511N P=0.483 |P=0.776N (e) P=0.507 (e) |
|LOGISTIC REGRESSION| P=0.272 P=0.484N P=0.498N P=0.507 |P=0.773N (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.271 P=0.508N P=0.500N P=0.500 |P=0.775N (e) P=0.505 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 12/49 (24%) 11/50 (22%) 3/50 (6%) |23/49 (47%) 9/50 (18%) 17/50 (34%) 12/49 (24%) |
|POLY-3 RATE (b) | 9/45.96 12/45.01 11/45.18 3/44.71 |23/46.74 9/46.60 17/48.03 12/46.12 |
|POLY-3 PERCENT (g) | 17.4% 26.7% 24.4% 6.7% |49.2% 19.3% 35.4% 26.0% |
|TERMINAL (d) | 9/35 (26%) 11/40 (28%) 11/40 (28%) 3/37 (8%) |23/39 (59%) 8/36 (22%) 17/42 (41%) 10/39 (26%) |
|FIRST INCIDENCE | 729 (T) 712 729 (T) 729 (T) |731 (T) 669 731 (T) 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020N* P=0.334 P=0.423 P=0.081N |P=0.113N P=0.004N** P=0.076N P=0.015N* |
|POLY 3 | P=0.022N* P=0.208 P=0.289 P=0.107N |P=0.137N P<0.001N** P=0.122N P=0.016N* |
|POLY 1.5 | P=0.020N* P=0.201 P=0.296 P=0.104N |P=0.141N P<0.001N** P=0.127N P=0.016N* |
|POLY 6 | P=0.024N* P=0.223 P=0.289 P=0.108N |P=0.125N P=0.002N** P=0.114N P=0.014N* |
|LOGISTIC REGRESSION| P=0.022N* P=0.290 P=0.423 P=0.081N |P=0.147N P=0.003N** P=0.076N P=0.022N* |
|COCH-ARM / FISHERS | P=0.021N* P=0.212 P=0.306 P=0.100N |P=0.146N P=0.002N** P=0.134N P=0.017N* |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 0/45.18 4/44.71 |0/46.74 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 4/37 (11%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.070 |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** (e) (e) P=0.057 |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.058 |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P=0.056 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.070 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.059 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Tension Lipidosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 4/50 (8%) 2/50 (4%) |4/49 (8%) 3/50 (6%) 6/50 (12%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/45.96 2/45.31 4/45.28 2/45.33 |4/47.22 3/46.97 6/48.39 4/46.57 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 8.8% 4.4% |8.5% 6.4% 12.4% 8.6% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 3/40 (8%) 1/37 (3%) |3/39 (8%) 2/36 (6%) 4/42 (10%) 2/39 (5%) |
|FIRST INCIDENCE | 729 (T) 627 702 527 |588 533 656 501 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560 P=0.526 P=0.218 P=0.510 |P=0.564 P=0.534N P=0.412 P=0.625 |
|POLY 3 | P=0.563 P=0.495 P=0.174 P=0.495 |P=0.558 P=0.503N P=0.385 P=0.635 |
|POLY 1.5 | P=0.569 P=0.490 P=0.176 P=0.497 |P=0.556 P=0.497N P=0.384 P=0.637 |
|POLY 6 | P=0.556 P=0.504 P=0.175 P=0.495 |P=0.566 P=0.511N P=0.389 P=0.637 |
|LOGISTIC REGRESSION| P=0.574 P=0.494 P=0.179 P=0.513 |P=0.488N P=0.377N P=0.365 P=0.488N |
|COCH-ARM / FISHERS | P=0.573 P=0.492 P=0.181 P=0.500 |P=0.560 P=0.489N P=0.383 P=0.643N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 3/50 (6%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/46.90 1/45.30 1/45.60 0/44.71 |0/46.74 3/46.70 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 2.1% 2.2% 2.2% 0.0% |0.0% 6.4% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 281 630 606 --- |--- 680 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341N P=0.748 P=0.748 P=0.500N |P=0.271N P=0.116 (e) (e) |
|POLY 3 | P=0.341N P=0.753 P=0.754 P=0.510N |P=0.277N P=0.119 (e) (e) |
|POLY 1.5 | P=0.337N P=0.750 P=0.756 P=0.506N |P=0.274N P=0.120 (e) (e) |
|POLY 6 | P=0.345N P=0.758 P=0.756 P=0.511N |P=0.279N P=0.117 (e) (e) |
|LOGISTIC REGRESSION| P=0.392N P=0.653N P=0.777 (e) |P=0.253N P=0.134 (e) (e) |
|COCH-ARM / FISHERS | P=0.331N P=0.747 P=0.753N P=0.500N |P=0.271N P=0.125 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Multinucleated |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 23/49 (47%) 24/50 (48%) 46/50 (92%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 27/46.94 23/45.71 24/47.02 46/48.69 |0/46.74 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 57.5% 50.3% 51.0% 94.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 23/35 (66%) 21/40 (53%) 20/40 (50%) 36/37 (97%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 630 611 463 325 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.118N P=0.177N P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.312N P=0.334N P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.330N P=0.336N P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.279N P=0.321N P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.298N P=0.372N P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.308N P=0.345N P<0.001 ** |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 1/45.21 0/45.18 1/44.71 |0/47.55 0/46.36 0/48.03 2/45.40 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 2.2% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.474 P=0.527 (e) P=0.511 |P=0.043 * (e) (e) P=0.238 |
|POLY 3 | P=0.471 P=0.497 (e) P=0.495 |P=0.039 * (e) (e) P=0.227 |
|POLY 1.5 | P=0.474 P=0.496 (e) P=0.497 |P=0.039 * (e) (e) P=0.229 |
|POLY 6 | P=0.470 P=0.500 (e) P=0.493 |P=0.039 * (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) P=0.527 (e) P=0.511 |(e) (e) (e) P=0.238 |
|COCH-ARM / FISHERS | P=0.478 P=0.500 (e) P=0.500 |P=0.040 * (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 3/46.27 0/45.18 0/44.71 |1/47.74 0/46.36 0/48.03 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 6.5% 0.0% 0.0% |2.1% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 137 --- --- |680 --- --- 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274N P=0.138 (e) (e) |P=0.170 P=0.513N P=0.509N P=0.482 |
|POLY 3 | P=0.269N P=0.120 (e) (e) |P=0.170 P=0.506N P=0.499N P=0.487 |
|POLY 1.5 | P=0.269N P=0.119 (e) (e) |P=0.170 P=0.503N P=0.499N P=0.488 |
|POLY 6 | P=0.267N P=0.123 (e) (e) |P=0.173 P=0.509N P=0.498N P=0.489 |
|LOGISTIC REGRESSION| P=0.314N P=0.177 (e) (e) |P=0.255 P=0.455N P=0.523N P=0.601 |
|COCH-ARM / FISHERS | P=0.269N P=0.121 (e) (e) |P=0.170 P=0.500N P=0.500N P=0.492 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 4/50 (8%) 3/49 (6%) |
|POLY-3 RATE (b) | 6/46.30 4/45.45 4/45.18 0/44.71 |3/47.55 2/46.36 4/48.54 3/45.44 |
|POLY-3 PERCENT (g) | 13.0% 8.8% 8.9% 0.0% |6.3% 4.3% 8.2% 6.6% |
|TERMINAL (d) | 5/35 (14%) 3/40 (8%) 4/40 (10%) 0/37 (0%) |3/39 (8%) 2/36 (6%) 2/42 (5%) 2/39 (5%) |
|FIRST INCIDENCE | 634 663 729 (T) --- |731 (T) 731 (T) 656 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020N* P=0.312N P=0.301N P=0.016N* |P=0.563 P=0.537N P=0.528 P=0.660N |
|POLY 3 | P=0.020N* P=0.381N P=0.385N P=0.017N* |P=0.535 P=0.511N P=0.511 P=0.641 |
|POLY 1.5 | P=0.019N* P=0.384N P=0.379N P=0.016N* |P=0.536 P=0.507N P=0.506 P=0.644 |
|POLY 6 | P=0.022N* P=0.371N P=0.387N P=0.018N* |P=0.539 P=0.517N P=0.520 P=0.642 |
|LOGISTIC REGRESSION| P=0.021N* P=0.379N P=0.377N P=0.019N* |P=0.536 P=0.537N P=0.488 P=0.659 |
|COCH-ARM / FISHERS | P=0.020N* P=0.370N P=0.370N P=0.013N* |P=0.544 P=0.500N P=0.500 P=0.651 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 3/49 (6%) |
|POLY-3 RATE (b) | 1/46.18 0/45.21 0/45.18 2/45.16 |2/47.55 1/46.36 0/48.03 3/45.60 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.4% |4.2% 2.2% 0.0% 6.6% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |2/39 (5%) 1/36 (3%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | 669 --- --- 632 |731 (T) 731 (T) --- 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169 P=0.505N P=0.510N P=0.487 |P=0.233 P=0.528N P=0.222N P=0.498 |
|POLY 3 | P=0.174 P=0.504N P=0.504N P=0.492 |P=0.217 P=0.509N P=0.235N P=0.481 |
|POLY 1.5 | P=0.176 P=0.505N P=0.503N P=0.495 |P=0.218 P=0.505N P=0.236N P=0.483 |
|POLY 6 | P=0.172 P=0.502N P=0.505N P=0.491 |P=0.219 P=0.513N P=0.233N P=0.483 |
|LOGISTIC REGRESSION| P=0.172 P=0.490N P=0.498N P=0.511 |P=0.215 P=0.528N (e) P=0.480 |
|COCH-ARM / FISHERS | P=0.175 P=0.500N P=0.500N P=0.500 |P=0.220 P=0.500N P=0.247N P=0.490 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Artery |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 0/45.21 0/45.18 0/44.71 |0/47.55 0/46.36 0/48.03 2/45.95 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.230 |
|POLY 3 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.230 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.230 |
|POLY 6 | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.070 (e) (e) P=0.299 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.040 * (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/2 (0%) 0/1 (0%) 0/4 (0%) 0/1 (0%) |0/4 (0%) 2/8 (25%) 0/6 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/1.77 0/1.00 0/2.92 0/1.00 |0/4.00 2/7.98 0/6.00 0/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 25.1% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/1 (0%) 0/2 (0%) 0/1 (0%) |0/4 (0%) 0/5 (0%) 0/6 (0%) 0/2 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 630 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.393N P=0.237 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.602N P=0.395 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.602N P=0.396 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.602N P=0.394 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.604N P=0.424 (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |1/48 (2%) 2/48 (4%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/45.12 0/44.95 1/44.49 0/44.71 |1/45.55 2/44.68 2/46.39 1/45.05 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |2.2% 4.5% 4.3% 2.2% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/39 (0%) 0/37 (0%) |1/37 (3%) 2/35 (6%) 2/42 (5%) 1/39 (3%) |
|FIRST INCIDENCE | --- --- 642 --- |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.777N (e) P=0.491 (e) |P=0.489N P=0.481 P=0.544 P=0.750N |
|POLY 3 | P=0.773N (e) P=0.497 (e) |P=0.516N P=0.493 P=0.506 P=0.758 |
|POLY 1.5 | P=0.770N (e) P=0.499 (e) |P=0.516N P=0.496 P=0.503 P=0.758 |
|POLY 6 | P=0.776N (e) P=0.498 (e) |P=0.513N P=0.490 P=0.512 P=0.760 |
|LOGISTIC REGRESSION| P=0.770N (e) P=0.604 (e) |P=0.489N P=0.481 P=0.544 P=0.750N |
|COCH-ARM / FISHERS | P=0.767N (e) P=0.505 (e) |P=0.513N P=0.500 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Infiltration Cellular Plasma Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/49 (2%) 4/49 (8%) 0/50 (0%) |0/48 (0%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/45.12 1/44.95 4/44.18 0/44.71 |0/45.55 1/44.68 0/46.39 0/45.05 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 9.1% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 1/40 (3%) 4/39 (10%) 0/37 (0%) |0/37 (0%) 1/35 (3%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.204N P=0.453N P=0.387 P=0.226N |P=0.599N P=0.489 (e) (e) |
|POLY 3 | P=0.208N P=0.501N P=0.327 P=0.239N |P=0.613N P=0.496 (e) (e) |
|POLY 1.5 | P=0.200N P=0.503N P=0.334 P=0.236N |P=0.611N P=0.498 (e) (e) |
|POLY 6 | P=0.215N P=0.496N P=0.326 P=0.242N |P=0.615N P=0.495 (e) (e) |
|LOGISTIC REGRESSION| P=0.204N P=0.453N P=0.387 (e) |(e) P=0.489 (e) (e) |
|COCH-ARM / FISHERS | P=0.195N P=0.492N P=0.349 P=0.237N |P=0.608N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/14 (14%) 1/16 (6%) 4/13 (31%) 1/11 (9%) |0/17 (0%) 0/21 (0%) 0/13 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 2/13.38 1/15.65 4/11.68 1/9.75 |0/16.70 0/18.97 0/12.32 0/1.81 |
|POLY-3 PERCENT (g) | 15.0% 6.4% 34.3% 10.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/11 (18%) 1/15 (7%) 4/10 (40%) 1/8 (13%) |0/15 (0%) 0/12 (0%) 0/10 (0%) 0/1 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.649N P=0.389N P=0.272 P=0.616N |(e) (e) (e) (e) |
|POLY 3 | P=0.622N P=0.444N P=0.257 P=0.612N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.601N P=0.448N P=0.267 P=0.601N |(e) (e) (e) (e) |
|POLY 6 | P=0.647 P=0.437N P=0.250 P=0.624N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.649N P=0.389N P=0.272 P=0.616N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.572N P=0.448N P=0.286 P=0.593N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/14 (0%) 0/16 (0%) 1/13 (8%) 2/11 (18%) |0/17 (0%) 0/21 (0%) 0/13 (0%) 0/2 (0%) |
|POLY-3 RATE (b) | 0/13.38 0/15.65 1/12.13 2/10.37 |0/16.70 0/18.97 0/12.32 0/1.81 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.2% 19.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/11 (0%) 0/15 (0%) 0/10 (0%) 1/8 (13%) |0/15 (0%) 0/12 (0%) 0/10 (0%) 0/1 (0%) |
|FIRST INCIDENCE | --- --- 596 527 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 (e) P=0.487 P=0.201 |(e) (e) (e) (e) |
|POLY 3 | P=0.046 * (e) P=0.480 P=0.171 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.048 * (e) P=0.481 P=0.172 |(e) (e) (e) (e) |
|POLY 6 | P=0.045 * (e) P=0.483 P=0.168 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.102 (e) P=0.701 P=0.374 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.051 (e) P=0.481 P=0.183 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/14 (71%) 14/16 (88%) 7/13 (54%) 7/11 (64%) |14/17 (82%) 19/21 (90%) 12/13 (92%) 2/2 (100%) |
|POLY-3 RATE (b) | 10/13.61 14/16.00 7/11.78 7/10.38 |14/16.81 19/21.00 12/12.92 2/2.00 |
|POLY-3 PERCENT (g) | 73.5% 87.5% 59.4% 67.5% |83.3% 90.5% 92.9% 100.0% |
|TERMINAL (d) | 9/11 (82%) 13/15 (87%) 6/10 (60%) 5/8 (63%) |13/15 (87%) 10/12 (83%) 10/10 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 669 630 702 642 |705 586 641 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.446N P=0.568 P=0.300N P=0.541N |P=0.160N P=0.033 * P=0.240 P=0.685 |
|POLY 3 | P=0.323N P=0.309 P=0.371N P=0.551N |P=0.519 P=0.435 P=0.412 P=0.662 |
|POLY 1.5 | P=0.305N P=0.287 P=0.344N P=0.536N |P=0.513 P=0.419 P=0.407 P=0.652 |
|POLY 6 | P=0.336N P=0.348 P=0.390N P=0.556N |P=0.530 P=0.463 P=0.418 P=0.679 |
|LOGISTIC REGRESSION| P=0.432N P=0.288 P=0.378N P=0.628N |P=0.517 P=0.454 P=0.316 P=0.456 |
|COCH-ARM / FISHERS | P=0.280N P=0.261 P=0.293N P=0.504N |P=0.506 P=0.396 P=0.409 P=0.702 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/49 (0%) 4/50 (8%) 6/50 (12%) |3/50 (6%) 0/50 (0%) 1/49 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 5/46.18 0/44.95 4/46.03 6/45.76 |3/47.55 0/46.36 1/47.03 1/45.40 |
|POLY-3 PERCENT (g) | 10.8% 0.0% 8.7% 13.1% |6.3% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 4/35 (11%) 0/40 (0%) 2/40 (5%) 3/37 (8%) |3/39 (8%) 0/36 (0%) 1/41 (2%) 1/39 (3%) |
|FIRST INCIDENCE | 669 --- 463 526 |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.026N* P=0.445N P=0.517 |P=0.484N P=0.135N P=0.287N P=0.305N |
|POLY 3 | P=0.125 P=0.033N* P=0.502N P=0.494 |P=0.501N P=0.123N P=0.309N P=0.322N |
|POLY 1.5 | P=0.129 P=0.034N* P=0.501N P=0.496 |P=0.501N P=0.122N P=0.311N P=0.320N |
|POLY 6 | P=0.121 P=0.031N* P=0.499N P=0.495 |P=0.497N P=0.126N P=0.307N P=0.322N |
|LOGISTIC REGRESSION| P=0.129 P=0.035N* P=0.495N P=0.505 |P=0.484N (e) P=0.287N P=0.305N |
|COCH-ARM / FISHERS | P=0.129 P=0.030N* P=0.500N P=0.500 |P=0.500N P=0.121N P=0.316N P=0.316N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 0/45.18 1/44.81 |2/47.57 0/46.36 0/47.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |4.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/41 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- --- 705 |725 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 (e) (e) P=0.500 |P=0.307N P=0.254N P=0.229N P=0.243N |
|POLY 3 | P=0.226 (e) (e) P=0.495 |P=0.309N P=0.243N P=0.240N P=0.248N |
|POLY 1.5 | P=0.228 (e) (e) P=0.497 |P=0.310N P=0.241N P=0.241N P=0.246N |
|POLY 6 | P=0.223 (e) (e) P=0.494 |P=0.307N P=0.246N P=0.238N P=0.248N |
|LOGISTIC REGRESSION| P=0.228 (e) (e) P=0.498 |P=0.308N P=0.249N P=0.234N P=0.243N |
|COCH-ARM / FISHERS | P=0.229 (e) (e) P=0.500 |P=0.311N P=0.247N P=0.253N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 1/45.92 1/44.81 |2/47.57 0/46.36 0/47.03 1/45.89 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 2.2% |4.2% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/41 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 463 705 |725 --- --- 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 (e) P=0.500 P=0.500 |P=0.695 P=0.254N P=0.229N P=0.513N |
|POLY 3 | P=0.343 (e) P=0.500 P=0.495 |P=0.698 P=0.243N P=0.240N P=0.513N |
|POLY 1.5 | P=0.348 (e) P=0.500 P=0.497 |P=0.696 P=0.241N P=0.241N P=0.511N |
|POLY 6 | P=0.338 (e) P=0.501 P=0.494 |P=0.702 P=0.246N P=0.238N P=0.510N |
|LOGISTIC REGRESSION| P=0.318 (e) P=0.386 P=0.498 |P=0.656N P=0.249N P=0.234N P=0.441N |
|COCH-ARM / FISHERS | P=0.350 (e) P=0.500 P=0.500 |P=0.696 P=0.247N P=0.253N P=0.508N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |12/50 (24%) 12/49 (24%) 12/49 (24%) 11/48 (23%) |
|POLY-3 RATE (b) | |12/47.55 12/46.30 12/47.66 11/45.68 |
|POLY-3 PERCENT (g) | |25.2% 25.9% 25.2% 24.1% |
|TERMINAL (d) | |12/39 (31%) 10/36 (28%) 9/41 (22%) 9/39 (23%) |
|FIRST INCIDENCE | |731 (T) 630 656 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.428N P=0.507 P=0.538N P=0.504N |
|POLY 3 | |P=0.490N P=0.564 P=0.590N P=0.544N |
|POLY 1.5 | |P=0.494N P=0.566 P=0.583 P=0.548N |
|POLY 6 | |P=0.474N P=0.565 P=0.571N P=0.528N |
|LOGISTIC REGRESSION| |P=0.499N P=0.538 P=0.588 P=0.557N |
|COCH-ARM / FISHERS | |P=0.490N P=0.570 P=0.570 P=0.545N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/44.56 1/44.95 0/45.18 0/44.71 |1/46.74 0/46.36 2/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.1% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.612N P=0.527 (e) (e) |P=0.430N P=0.516N P=0.526 P=0.500N |
|POLY 3 | P=0.606N P=0.502 (e) (e) |P=0.444N P=0.502N P=0.509 P=0.507N |
|POLY 1.5 | P=0.606N P=0.501 (e) (e) |P=0.445N P=0.499N P=0.508 P=0.507N |
|POLY 6 | P=0.605N P=0.504 (e) (e) |P=0.439N P=0.505N P=0.511 P=0.507N |
|LOGISTIC REGRESSION| (e) P=0.527 (e) (e) |P=0.430N (e) P=0.526 (e) |
|COCH-ARM / FISHERS | P=0.604N P=0.505 (e) (e) |P=0.445N P=0.495N P=0.508 P=0.505N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 1/48 (2%) 4/50 (8%) 1/48 (2%) |16/48 (33%) 11/49 (22%) 16/47 (34%) 11/46 (24%) |
|POLY-3 RATE (b) | 0/40.90 1/44.01 4/46.03 1/42.78 |16/46.36 11/45.80 16/45.68 11/43.79 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 8.7% 2.3% |34.5% 24.0% 35.0% 25.1% |
|TERMINAL (d) | 0/34 (0%) 0/39 (0%) 2/40 (5%) 1/36 (3%) |12/38 (32%) 11/36 (31%) 13/39 (33%) 9/38 (24%) |
|FIRST INCIDENCE | --- 712 564 729 (T) |680 731 (T) 641 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.602 P=0.520 P=0.073 P=0.511 |P=0.244N P=0.234N P=0.545N P=0.200N |
|POLY 3 | P=0.604 P=0.515 P=0.076 P=0.509 |P=0.307N P=0.189N P=0.566 P=0.229N |
|POLY 1.5 | P=0.618 P=0.515 P=0.077 P=0.514 |P=0.313N P=0.179N P=0.562 P=0.227N |
|POLY 6 | P=0.589 P=0.516 P=0.076 P=0.505 |P=0.288N P=0.205N P=0.573 P=0.224N |
|LOGISTIC REGRESSION| P=0.639 P=0.517 P=0.114 P=0.511 |P=0.317N P=0.199N P=0.559 P=0.231N |
|COCH-ARM / FISHERS | P=0.634 P=0.527 P=0.079 P=0.527 |P=0.310N P=0.166N P=0.557 P=0.218N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/45.96 1/45.45 1/45.60 0/44.71 | |
|POLY-3 PERCENT (g) | 4.4% 2.2% 2.2% 0.0% | |
|TERMINAL (d) | 2/35 (6%) 0/40 (0%) 0/40 (0%) 0/37 (0%) | |
|FIRST INCIDENCE | 729 (T) 663 606 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225N P=0.472N P=0.482N P=0.226N | |
|POLY 3 | P=0.219N P=0.504N P=0.503N P=0.243N | |
|POLY 1.5 | P=0.216N P=0.507N P=0.502N P=0.241N | |
|POLY 6 | P=0.223N P=0.496N P=0.500N P=0.245N | |
|LOGISTIC REGRESSION| P=0.215N P=0.505N P=0.497N (e) | |
|COCH-ARM / FISHERS | P=0.214N P=0.500N P=0.500N P=0.247N | |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/45.96 0/45.21 0/45.18 2/45.15 | |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.4% | |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/40 (0%) 1/37 (3%) | |
|FIRST INCIDENCE | 729 (T) --- --- 600 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169 P=0.473N P=0.473N P=0.503 | |
|POLY 3 | P=0.174 P=0.503N P=0.503N P=0.494 | |
|POLY 1.5 | P=0.176 P=0.504N P=0.502N P=0.496 | |
|POLY 6 | P=0.172 P=0.500N P=0.503N P=0.494 | |
|LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.506 | |
|COCH-ARM / FISHERS | P=0.175 P=0.500N P=0.500N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 RATE (b) | 0/45.96 3/46.09 2/45.95 2/44.71 | |
|POLY-3 PERCENT (g) | 0.0% 6.5% 4.4% 4.5% | |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 0/40 (0%) 2/37 (5%) | |
|FIRST INCIDENCE | --- 568 596 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.483 P=0.125 P=0.225 P=0.251 | |
|POLY 3 | P=0.480 P=0.119 P=0.237 P=0.231 | |
|POLY 1.5 | P=0.486 P=0.117 P=0.237 P=0.234 | |
|POLY 6 | P=0.474 P=0.124 P=0.240 P=0.229 | |
|LOGISTIC REGRESSION| P=0.486 P=0.134 P=0.224 P=0.251 | |
|COCH-ARM / FISHERS | P=0.494 P=0.121 P=0.247 P=0.247 | |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/45.96 2/45.21 2/45.18 0/44.71 | |
|POLY-3 PERCENT (g) | 0.0% 4.4% 4.4% 0.0% | |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 2/40 (5%) 0/37 (0%) | |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.268 P=0.268 (e) | |
|POLY 3 | P=0.355N P=0.234 P=0.233 (e) | |
|POLY 1.5 | P=0.351N P=0.232 P=0.235 (e) | |
|POLY 6 | P=0.358N P=0.237 P=0.234 (e) | |
|LOGISTIC REGRESSION| (e) P=0.268 P=0.268 (e) | |
|COCH-ARM / FISHERS | P=0.346N P=0.247 P=0.247 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/49 (4%) 1/49 (2%) 0/49 (0%) | |
|POLY-3 RATE (b) | 0/43.55 2/44.95 1/44.79 0/43.93 | |
|POLY-3 PERCENT (g) | 0.0% 4.5% 2.2% 0.0% | |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 1/40 (3%) 0/37 (0%) | |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369N P=0.268 P=0.527 (e) | |
|POLY 3 | P=0.370N P=0.244 P=0.506 (e) | |
|POLY 1.5 | P=0.367N P=0.243 P=0.507 (e) | |
|POLY 6 | P=0.373N P=0.247 P=0.505 (e) | |
|LOGISTIC REGRESSION| (e) P=0.268 P=0.527 (e) | |
|COCH-ARM / FISHERS | P=0.361N P=0.258 P=0.510 (e) | |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Infiltration Cellular Mixed Cell |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/44.96 1/45.45 0/45.18 0/44.71 |1/47.92 3/46.36 2/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.1% 6.5% 4.2% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 3/36 (8%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | --- 663 --- --- |624 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.622N P=0.495 (e) (e) |P=0.171N P=0.280 P=0.517 P=0.517N |
|POLY 3 | P=0.609N P=0.502 (e) (e) |P=0.186N P=0.294 P=0.501 P=0.511N |
|POLY 1.5 | P=0.609N P=0.500 (e) (e) |P=0.183N P=0.299 P=0.500 P=0.509N |
|POLY 6 | P=0.606N P=0.507 (e) (e) |P=0.187N P=0.287 P=0.502 P=0.512N |
|LOGISTIC REGRESSION| P=0.610N P=0.516 (e) (e) |P=0.176N P=0.322 P=0.477 P=0.366N |
|COCH-ARM / FISHERS | P=0.607N P=0.505 (e) (e) |P=0.177N P=0.309 P=0.500 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 1/50 (2%) 6/50 (12%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/44.96 1/46.20 6/45.50 5/45.35 |0/47.55 0/46.36 0/48.03 1/45.44 |
|POLY-3 PERCENT (g) | 8.9% 2.2% 13.2% 11.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 4/34 (12%) 0/40 (0%) 5/40 (13%) 2/37 (5%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 137 641 632 |--- --- --- 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.267 P=0.145N P=0.461 P=0.532 |P=0.234 (e) (e) P=0.505 |
|POLY 3 | P=0.265 P=0.170N P=0.377 P=0.505 |P=0.222 (e) (e) P=0.491 |
|POLY 1.5 | P=0.270 P=0.173N P=0.379 P=0.507 |P=0.223 (e) (e) P=0.492 |
|POLY 6 | P=0.260 P=0.165N P=0.382 P=0.509 |P=0.224 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.272 P=0.118N P=0.376 P=0.501 |P=0.221 (e) (e) P=0.491 |
|COCH-ARM / FISHERS | P=0.276 P=0.175N P=0.383 P=0.513 |P=0.224 (e) (e) P=0.495 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 2/48 (4%) 2/50 (4%) 2/50 (4%) |4/49 (8%) 4/50 (8%) 2/50 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 4/44.78 2/44.66 2/45.18 2/44.71 |4/47.39 4/46.97 2/48.03 3/45.19 |
|POLY-3 PERCENT (g) | 8.9% 4.5% 4.4% 4.5% |8.4% 8.5% 4.2% 6.6% |
|TERMINAL (d) | 2/35 (6%) 1/40 (3%) 2/40 (5%) 2/37 (5%) |1/39 (3%) 1/36 (3%) 2/42 (5%) 2/39 (5%) |
|FIRST INCIDENCE | 693 627 729 (T) 729 (T) |624 643 731 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.422N P=0.307N P=0.296N P=0.326N |P=0.460N P=0.607 P=0.319N P=0.510N |
|POLY 3 | P=0.407N P=0.338N P=0.333N P=0.338N |P=0.487N P=0.638 P=0.331N P=0.526N |
|POLY 1.5 | P=0.398N P=0.343N P=0.327N P=0.330N |P=0.485N P=0.641N P=0.330N P=0.521N |
|POLY 6 | P=0.420N P=0.330N P=0.338N P=0.347N |P=0.486N P=0.630 P=0.334N P=0.529N |
|LOGISTIC REGRESSION| P=0.402N P=0.338N P=0.331N P=0.340N |P=0.446N P=0.546N P=0.344N P=0.477N |
|COCH-ARM / FISHERS | P=0.391N P=0.339N P=0.319N P=0.319N |P=0.479N P=0.631N P=0.329N P=0.512N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |3/49 (6%) 5/50 (10%) 1/50 (2%) 6/48 (13%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 1/44.71 |3/47.69 5/47.53 1/48.11 6/45.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |6.3% 10.5% 2.1% 13.2% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 4/39 (10%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |588 533 711 666 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 (e) (e) P=0.511 |P=0.198 P=0.339 P=0.298N P=0.238 |
|POLY 3 | P=0.227 (e) (e) P=0.501 |P=0.171 P=0.355 P=0.302N P=0.218 |
|POLY 1.5 | P=0.230 (e) (e) P=0.504 |P=0.174 P=0.361 P=0.301N P=0.223 |
|POLY 6 | P=0.224 (e) (e) P=0.498 |P=0.170 P=0.347 P=0.305N P=0.215 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.511 |P=0.250 P=0.589 P=0.333N P=0.276 |
|COCH-ARM / FISHERS | P=0.232 (e) (e) P=0.510 |P=0.181 P=0.369 P=0.301N P=0.233 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 3/49 (6%) 9/50 (18%) 9/50 (18%) |2/49 (4%) 5/50 (10%) 2/50 (4%) 6/48 (13%) |
|POLY-3 RATE (b) | 2/44.63 3/44.95 9/46.76 9/46.40 |2/47.51 5/47.32 2/48.38 6/45.81 |
|POLY-3 PERCENT (g) | 4.5% 6.7% 19.3% 19.4% |4.2% 10.6% 4.1% 13.1% |
|TERMINAL (d) | 1/35 (3%) 3/40 (8%) 6/40 (15%) 6/37 (16%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 3/39 (8%) |
|FIRST INCIDENCE | 711 729 (T) 531 526 |588 616 658 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.555 P=0.041 * P=0.035 * |P=0.154 P=0.206 P=0.681N P=0.132 |
|POLY 3 | P=0.028 * P=0.503 P=0.030 * P=0.029 * |P=0.135 P=0.215 P=0.687N P=0.122 |
|POLY 1.5 | P=0.029 * P=0.501 P=0.030 * P=0.030 * |P=0.136 P=0.219 P=0.687N P=0.123 |
|POLY 6 | P=0.027 * P=0.508 P=0.031 * P=0.029 * |P=0.137 P=0.211 P=0.687N P=0.122 |
|LOGISTIC REGRESSION| P=0.030 * P=0.521 P=0.034 * P=0.036 * |P=0.210 P=0.364 P=0.666 P=0.182 |
|COCH-ARM / FISHERS | P=0.029 * P=0.510 P=0.030 * P=0.030 * |P=0.139 P=0.226 P=0.684N P=0.127 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 1/50 (2%) |2/49 (4%) 0/50 (0%) 1/50 (2%) 4/48 (8%) |
|POLY-3 RATE (b) | 0/44.56 0/44.95 0/45.18 1/44.71 |2/47.51 0/46.36 1/48.30 4/45.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |4.2% 0.0% 2.1% 8.8% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |588 --- 658 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 (e) (e) P=0.511 |P=0.062 P=0.252N P=0.498N P=0.324 |
|POLY 3 | P=0.227 (e) (e) P=0.501 |P=0.058 P=0.243N P=0.494N P=0.318 |
|POLY 1.5 | P=0.230 (e) (e) P=0.504 |P=0.057 P=0.238N P=0.494N P=0.321 |
|POLY 6 | P=0.224 (e) (e) P=0.498 |P=0.060 P=0.249N P=0.495N P=0.318 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.511 |P=0.105 P=0.073N P=0.592N P=0.438 |
|COCH-ARM / FISHERS | P=0.232 (e) (e) P=0.510 |P=0.058 P=0.242N P=0.492N P=0.329 |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 5/49 (10%) 9/50 (18%) 7/50 (14%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/44.63 5/44.95 9/46.76 7/45.78 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 4.5% 11.1% 19.3% 15.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 5/40 (13%) 6/40 (15%) 5/37 (14%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 711 729 (T) 531 527 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.172 P=0.271 P=0.041 * P=0.092 |(e) (e) (e) (e) |
|POLY 3 | P=0.187 P=0.219 P=0.030 * P=0.085 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.194 P=0.217 P=0.030 * P=0.087 |(e) (e) (e) (e) |
|POLY 6 | P=0.181 P=0.223 P=0.031 * P=0.083 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.199 P=0.238 P=0.034 * P=0.095 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.197 P=0.226 P=0.030 * P=0.090 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/49 (2%) 3/50 (6%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/44.63 1/44.95 3/45.18 3/45.33 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 6.6% 6.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 1/40 (3%) 3/40 (8%) 2/37 (5%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 711 729 (T) 729 (T) 527 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 P=0.737N P=0.348 P=0.316 |(e) (e) (e) (e) |
|POLY 3 | P=0.234 P=0.759N P=0.310 P=0.311 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.240 P=0.760N P=0.314 P=0.315 |(e) (e) (e) (e) |
|POLY 6 | P=0.227 P=0.757N P=0.307 P=0.307 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.241 P=0.760N P=0.311 P=0.332 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242 P=0.747N P=0.324 P=0.324 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 1/48 (2%) 1/50 (2%) 1/48 (2%) |2/49 (4%) 1/48 (2%) 1/50 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 1/42.93 1/44.71 1/45.49 1/43.78 |2/46.94 1/45.21 1/48.30 1/45.05 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 2.2% 2.3% |4.3% 2.2% 2.1% 2.2% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/42 (0%) 1/39 (3%) |
|FIRST INCIDENCE | 729 (T) 611 642 711 |680 669 658 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.672 P=0.748N P=0.751N P=0.754N |P=0.525N P=0.520N P=0.494N P=0.505N |
|POLY 3 | P=0.680 P=0.752N P=0.748N P=0.756N |P=0.531N P=0.513N P=0.490N P=0.514N |
|POLY 1.5 | P=0.678N P=0.754N P=0.745N P=0.754N |P=0.530N P=0.511N P=0.491N P=0.512N |
|POLY 6 | P=0.674 P=0.748N P=0.749N P=0.758N |P=0.530N P=0.516N P=0.488N P=0.515N |
|LOGISTIC REGRESSION| P=0.683N P=0.744N P=0.740N P=0.760N |P=0.478N P=0.468N P=0.518N P=0.506N |
|COCH-ARM / FISHERS | P=0.679N P=0.742N P=0.731N P=0.742N |P=0.527N P=0.508N P=0.492N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/46 (0%) 2/48 (4%) 1/50 (2%) 0/48 (0%) |0/49 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/42.93 2/44.92 1/45.28 0/43.70 |0/46.74 0/44.98 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 568 702 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.376N P=0.243 P=0.510 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.367N P=0.247 P=0.511 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.365N P=0.245 P=0.513 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.368N P=0.252 P=0.509 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.368N P=0.268 P=0.517 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.361N P=0.258 P=0.521 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 1/49 (2%) 0/49 (0%) |2/49 (4%) 1/50 (2%) 3/50 (6%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/44.56 0/44.31 1/44.18 0/43.71 |2/46.83 1/46.36 3/48.03 1/45.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.3% 2.2% 6.3% 2.2% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/39 (3%) 0/36 (0%) |2/39 (5%) 1/36 (3%) 3/42 (7%) 0/39 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |731 (T) 731 (T) 731 (T) 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.780N (e) P=0.522 (e) |P=0.447N P=0.528N P=0.534 P=0.497N |
|POLY 3 | P=0.775N (e) P=0.498 (e) |P=0.472N P=0.504N P=0.511 P=0.513N |
|POLY 1.5 | P=0.772N (e) P=0.501 (e) |P=0.474N P=0.499N P=0.510 P=0.512N |
|POLY 6 | P=0.779N (e) P=0.497 (e) |P=0.467N P=0.509N P=0.513 P=0.512N |
|LOGISTIC REGRESSION| (e) (e) P=0.522 (e) |P=0.455N P=0.528N P=0.534 P=0.508N |
|COCH-ARM / FISHERS | P=0.770N (e) P=0.505 (e) |P=0.472N P=0.492N P=0.510 P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 4/50 (8%) 15/50 (30%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 7/49 (14%) |
|POLY-3 RATE (b) | 3/45.96 5/46.45 4/45.18 15/45.67 |1/47.55 2/46.36 1/48.03 7/45.40 |
|POLY-3 PERCENT (g) | 6.5% 10.8% 8.9% 32.8% |2.1% 4.3% 2.1% 15.4% |
|TERMINAL (d) | 3/35 (9%) 3/40 (8%) 4/40 (10%) 12/37 (32%) |1/39 (3%) 2/36 (6%) 1/42 (2%) 7/39 (18%) |
|FIRST INCIDENCE | 729 (T) 137 729 (T) 560 |731 (T) 731 (T) 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.412 P=0.573 P=0.003 ** |P=0.004 ** P=0.472 P=0.745N P=0.032 * |
|POLY 3 | P<0.001 ** P=0.362 P=0.491 P<0.001 ** |P=0.003 ** P=0.491 P=0.758N P=0.025 * |
|POLY 1.5 | P<0.001 ** P=0.357 P=0.494 P<0.001 ** |P=0.003 ** P=0.495 P=0.759N P=0.026 * |
|POLY 6 | P<0.001 ** P=0.374 P=0.492 P<0.001 ** |P=0.003 ** P=0.487 P=0.757N P=0.025 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.406 P=0.573 P=0.002 ** |P=0.004 ** P=0.472 P=0.745N P=0.032 * |
|COCH-ARM / FISHERS | P<0.001 ** P=0.357 P=0.500 P=0.002 ** |P=0.004 ** P=0.500 P=0.753N P=0.028 * |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 24/50 (48%) 15/50 (30%) 15/50 (30%) 16/50 (32%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 24/47.03 15/45.21 15/45.28 16/45.57 |1/47.55 1/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 51.0% 33.2% 33.1% 35.1% |2.1% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 18/35 (51%) 15/40 (38%) 14/40 (35%) 13/37 (35%) |1/39 (3%) 1/36 (3%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 641 729 (T) 702 637 |731 (T) 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265N P=0.020N* P=0.022N* P=0.070N |P=0.343N P=0.744 P=0.485N P=0.500N |
|POLY 3 | P=0.240N P=0.061N P=0.059N P=0.087N |P=0.356N P=0.755 P=0.498N P=0.509N |
|POLY 1.5 | P=0.232N P=0.060N P=0.054N P=0.082N |P=0.355N P=0.757 P=0.499N P=0.508N |
|POLY 6 | P=0.248N P=0.060N P=0.065N P=0.092N |P=0.356N P=0.752 P=0.496N P=0.509N |
|LOGISTIC REGRESSION| P=0.282N P=0.044N* P=0.052N P=0.093N |P=0.343N P=0.744 (e) (e) |
|COCH-ARM / FISHERS | P=0.239N P=0.050N P=0.050N P=0.076N |P=0.352N P=0.753N P=0.500N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/50 (2%) 4/50 (8%) 2/48 (4%) |
|POLY-3 RATE (b) | |3/47.55 1/46.39 4/48.03 2/45.05 |
|POLY-3 PERCENT (g) | |6.3% 2.2% 8.3% 4.4% |
|TERMINAL (d) | |3/39 (8%) 0/36 (0%) 4/42 (10%) 2/39 (5%) |
|FIRST INCIDENCE | |731 (T) 725 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.541N P=0.333N P=0.541 P=0.500N |
|POLY 3 | |P=0.573N P=0.314N P=0.506 P=0.525N |
|POLY 1.5 | |P=0.574N P=0.311N P=0.503 P=0.523N |
|POLY 6 | |P=0.566N P=0.319N P=0.510 P=0.522N |
|LOGISTIC REGRESSION| |P=0.544N P=0.323N P=0.541 P=0.500N |
|COCH-ARM / FISHERS | |P=0.573N P=0.309N P=0.500 P=0.520N |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/48 (4%) |
|POLY-3 RATE (b) | |0/47.55 1/46.36 2/48.44 2/45.68 |
|POLY-3 PERCENT (g) | |0.0% 2.2% 4.1% 4.4% |
|TERMINAL (d) | |0/39 (0%) 1/36 (3%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | |--- 731 (T) 641 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.264 P=0.484 P=0.255 P=0.231 |
|POLY 3 | |P=0.257 P=0.495 P=0.241 P=0.228 |
|POLY 1.5 | |P=0.254 P=0.497 P=0.240 P=0.228 |
|POLY 6 | |P=0.264 P=0.492 P=0.245 P=0.231 |
|LOGISTIC REGRESSION| |P=0.341 P=0.484 P=0.204 P=0.315 |
|COCH-ARM / FISHERS | |P=0.253 P=0.500 P=0.247 P=0.237 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | |0/47.55 2/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | |0/39 (0%) 2/36 (6%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.385N P=0.221 (e) (e) |
|POLY 3 | |P=0.405N P=0.232 (e) (e) |
|POLY 1.5 | |P=0.403N P=0.234 (e) (e) |
|POLY 6 | |P=0.407N P=0.229 (e) (e) |
|LOGISTIC REGRESSION| |(e) P=0.221 (e) (e) |
|COCH-ARM / FISHERS | |P=0.399N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 01/09/02 EXPERIMENT: 90004 TEST: 06 Page 38
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |46/50 (92%) 48/50 (96%) 48/50 (96%) 45/48 (94%) |
|POLY-3 RATE (b) | |46/49.31 48/48.95 48/50.00 45/47.16 |
|POLY-3 PERCENT (g) | |93.3% 98.1% 96.0% 95.4% |
|TERMINAL (d) | |38/39 (97%) 36/36 (100%) 40/42 (95%) 38/39 (97%) |
|FIRST INCIDENCE | |588 586 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.286N P=0.166 P=0.491N P=0.525N |
|POLY 3 | |P=0.637N P=0.225 P=0.436 P=0.495 |
|POLY 1.5 | |P=0.614N P=0.270 P=0.387 P=0.505 |
|POLY 6 | |P=0.649 P=0.186 P=0.526 P=0.493 |
|LOGISTIC REGRESSION| |P=0.475 P=0.131 P=0.359 P=0.396 |
|COCH-ARM / FISHERS | |P=0.589N P=0.339 P=0.339 P=0.523 |
|=================================================================================================================================|
(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).