TDMS Study 90004-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 03/04/03
EXPERIMENT: 90004 TEST: 07 TIME: 10:25:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL#2/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 03/04/03
EXPERIMENT: 90004 TEST: 07 TIME: 10:25:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PROPYLENE GLYCOL MONO-T-BUTYL ET
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Eye: Anterior Chamber, Cornea Inflammation
Kidney Nephropathy Chronic
Kidney: Cortex Infarct
Kidney: Cortex, Renal Tubule Accumulation, Hyaline Droplet
Hyperplasia
Kidney: Papilla Mineralization
Kidney: Pelvis, Transitional Epithelium
Hyperplasia
Larynx Inflammation Chronic
Liver Basophilic Focus
Clear Cell Focus
Fatty Change
Hepatodiaphragmatic Nodule
Lung: Alveolar Epithelium Metaplasia
Lung: Alveolus Foreign Body
Infiltration Cellular Histiocyte
Lymph Node, Bronchial Hyperplasia Lymphoid
Mesentery Necrosis
Nose Inflammation Chronic
Nose: Glands Dilatation
Nose: Goblet Cell Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Pleura: Mesothelium Hyperplasia
Preputial Gland Inflammation
Skin Inflammation Granulomatous
Urinary Bladder: Transitional Epithelium
Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Eye: Cornea Mineralization
Kidney: Pelvis Mineralization
Liver Basophilic Focus
Clear Cell Focus
Lung Inflammation Chronic
Lung: Alveolus Infiltration Cellular Histiocyte
Lymph Node, Mediastinal Pigmentation
Mammary Gland Galactocele
Nose Inflammation
Nose: Glands Dilatation
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 03/04/03
EXPERIMENT: 90004 TEST: 07 TIME: 10:25:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
Nose: Goblet Cell Hyperplasia
Nose: Olfactory Epithelium Degeneration Hyaline
Spleen Fibrosis
Necrosis
===============================================================
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |2/49 (4%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 1/43.38 0/36.82 3/40.72 |2/42.54 0/46.42 2/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 7.4% |4.7% 0.0% 4.8% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 3/22 (14%) |2/33 (6%) 0/34 (0%) 2/28 (7%) 1/36 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.514 (e) P=0.086 |P=0.567N P=0.232N P=0.635 P=0.470N |
|POLY 3 | P=0.039 * P=0.508 (e) P=0.113 |P=0.605N P=0.218N P=0.690 P=0.479N |
|POLY 1.5 | P=0.040 * P=0.505 (e) P=0.117 |P=0.604N P=0.222N P=0.689N P=0.482N |
|POLY 6 | P=0.036 * P=0.510 (e) P=0.107 |P=0.604N P=0.216N P=0.674 P=0.476N |
|LOGISTIC REGRESSION| (e) P=0.514 (e) P=0.086 |P=0.567N (e) P=0.635 P=0.470N |
|COCH-ARM / FISHERS | P=0.041 * P=0.500 (e) P=0.121 |P=0.601N P=0.242N P=0.684N P=0.492N |
|ORDER RESTRICTED | P=0.019 * (e) (e) (e) |P=0.386N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 6/50 (12%) 14/50 (28%) 6/49 (12%) 9/50 (18%) |15/49 (31%) 10/50 (20%) 6/50 (12%) 5/50 (10%) |
|POLY-3 RATE (b) | 6/42.39 14/44.05 6/37.49 9/41.11 |15/43.81 10/46.63 6/42.61 5/45.42 |
|POLY-3 PERCENT (g) | 14.2% 31.8% 16.0% 21.9% |34.2% 21.4% 14.1% 11.0% |
|TERMINAL (d) | 3/27 (11%) 9/29 (31%) 3/16 (19%) 6/22 (27%) |12/33 (36%) 7/34 (21%) 2/28 (7%) 4/36 (11%) |
|FIRST INCIDENCE | 625 642 611 662 |380 684 646 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413 P=0.069 P=0.318 P=0.187 |P=0.018N* P=0.154N P=0.061N P=0.008N** |
|POLY 3 | P=0.567 P=0.042 * P=0.533 P=0.261 |P=0.018N* P=0.129N P=0.024N* P=0.007N** |
|POLY 1.5 | P=0.559N P=0.041 * P=0.570 P=0.276 |P=0.019N* P=0.136N P=0.020N* P=0.007N** |
|POLY 6 | P=0.531 P=0.044 * P=0.473 P=0.234 |P=0.017N* P=0.125N P=0.030N* P=0.007N** |
|LOGISTIC REGRESSION| P=0.511 P=0.049 * P=0.492 P=0.234 |P=0.020N* P=0.128N P=0.023N* P=0.009N** |
|COCH-ARM / FISHERS | P=0.547N P=0.039 * P=0.606 P=0.288 |P=0.022N* P=0.163N P=0.021N* P=0.010N* |
|ORDER RESTRICTED | P=0.218 (e) (e) (e) |P=0.003N** (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 11/49 (22%) 9/50 (18%) |1/49 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/42.59 4/43.66 11/37.99 9/41.56 |1/42.54 1/46.42 2/42.14 0/45.19 |
|POLY-3 PERCENT (g) | 14.1% 9.2% 29.0% 21.7% |2.4% 2.2% 4.8% 0.0% |
|TERMINAL (d) | 2/27 (7%) 2/29 (7%) 6/16 (38%) 5/22 (23%) |1/33 (3%) 1/34 (3%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 642 689 634 648 |730 (T) 730 (T) 698 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114 P=0.325N P=0.029 * P=0.205 |P=0.299N P=0.755N P=0.449 P=0.483N |
|POLY 3 | P=0.157 P=0.353N P=0.084 P=0.266 |P=0.311N P=0.741N P=0.497 P=0.488N |
|POLY 1.5 | P=0.172 P=0.357N P=0.105 P=0.278 |P=0.312N P=0.745N P=0.506 P=0.490N |
|POLY 6 | P=0.133 P=0.351N P=0.057 P=0.243 |P=0.309N P=0.739N P=0.482 P=0.487N |
|LOGISTIC REGRESSION| P=0.159 P=0.349N P=0.068 P=0.263 |P=0.307N P=0.755N P=0.472 (e) |
|COCH-ARM / FISHERS | P=0.190 P=0.370N P=0.133 P=0.288 |P=0.315N P=0.747N P=0.508 P=0.495N |
|ORDER RESTRICTED | P=0.073 (e) (e) (e) |P=0.271N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 4/50 (8%) 5/49 (10%) 3/50 (6%) |5/49 (10%) 9/50 (18%) 8/50 (16%) 4/50 (8%) |
|POLY-3 RATE (b) | 7/43.43 4/44.37 5/37.69 3/41.41 |5/43.47 9/48.13 8/44.67 4/46.08 |
|POLY-3 PERCENT (g) | 16.1% 9.0% 13.3% 7.3% |11.5% 18.7% 17.9% 8.7% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 2/16 (13%) 1/22 (5%) |3/33 (9%) 2/34 (6%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | 465 509 605 631 |558 410 528 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275N P=0.238N P=0.612 P=0.213N |P=0.190N P=0.253 P=0.242 P=0.461N |
|POLY 3 | P=0.228N P=0.247N P=0.481N P=0.175N |P=0.184N P=0.254 P=0.292 P=0.464N |
|POLY 1.5 | P=0.218N P=0.251N P=0.439N P=0.166N |P=0.187N P=0.241 P=0.299 P=0.469N |
|POLY 6 | P=0.249N P=0.245N P=0.546N P=0.193N |P=0.180N P=0.263 P=0.282 P=0.458N |
|LOGISTIC REGRESSION| P=0.199N P=0.297N P=0.396N P=0.156N |P=0.210N P=0.151 P=0.270 P=0.509N |
|COCH-ARM / FISHERS | P=0.205N P=0.262N P=0.394N P=0.159N |P=0.194N P=0.205 P=0.290 P=0.487N |
|ORDER RESTRICTED | P=0.150N (e) (e) (e) |P=0.252N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 4/49 (8%) 2/50 (4%) |4/49 (8%) 3/50 (6%) 6/50 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/44.04 4/44.11 4/38.32 2/41.85 |4/44.43 3/46.79 6/44.66 2/46.53 |
|POLY-3 PERCENT (g) | 9.1% 9.1% 10.4% 4.8% |9.0% 6.4% 13.4% 4.3% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 0/22 (0%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 296 509 431 254 |284 683 507 283 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301N P=0.608N P=0.533 P=0.363N |P=0.271N P=0.475N P=0.353 P=0.321N |
|POLY 3 | P=0.270N P=0.643N P=0.565 P=0.360N |P=0.268N P=0.472N P=0.372 P=0.316N |
|POLY 1.5 | P=0.260N P=0.643N P=0.596 P=0.349N |P=0.270N P=0.476N P=0.381 P=0.319N |
|POLY 6 | P=0.290N P=0.641N P=0.518 P=0.380N |P=0.266N P=0.467N P=0.360 P=0.313N |
|LOGISTIC REGRESSION| P=0.206N P=0.507 P=0.598N P=0.374N |P=0.318N P=0.643 P=0.267 P=0.518N |
|COCH-ARM / FISHERS | P=0.250N P=0.643N P=0.631 P=0.339N |P=0.276N P=0.489N P=0.383 P=0.329N |
|ORDER RESTRICTED | P=0.338N (e) (e) (e) |P=0.287N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | |2/42.90 3/46.42 1/42.02 4/45.19 |
|POLY-3 PERCENT (g) | |4.7% 6.5% 2.4% 8.9% |
|TERMINAL (d) | |1/33 (3%) 3/34 (9%) 1/28 (4%) 4/36 (11%) |
|FIRST INCIDENCE | |684 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.311 P=0.513 P=0.554N P=0.375 |
|POLY 3 | |P=0.276 P=0.536 P=0.507N P=0.361 |
|POLY 1.5 | |P=0.272 P=0.527 P=0.499N P=0.356 |
|POLY 6 | |P=0.280 P=0.540 P=0.523N P=0.364 |
|LOGISTIC REGRESSION| |P=0.291 P=0.543 P=0.519N P=0.369 |
|COCH-ARM / FISHERS | |P=0.262 P=0.500 P=0.500N P=0.339 |
|ORDER RESTRICTED | |P=0.306 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | |3/43.69 3/46.42 2/42.02 2/45.37 |
|POLY-3 PERCENT (g) | |6.9% 6.5% 4.8% 4.4% |
|TERMINAL (d) | |0/33 (0%) 3/34 (9%) 2/28 (7%) 1/36 (3%) |
|FIRST INCIDENCE | |593 730 (T) 730 (T) 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.396N P=0.629N P=0.548N P=0.473N |
|POLY 3 | |P=0.419N P=0.634N P=0.518N P=0.483N |
|POLY 1.5 | |P=0.423N P=0.639N P=0.503N P=0.485N |
|POLY 6 | |P=0.415N P=0.636N P=0.544N P=0.484N |
|LOGISTIC REGRESSION| |P=0.425N P=0.653 P=0.501N P=0.521N |
|COCH-ARM / FISHERS | |P=0.429N P=0.661N P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.486N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/42.73 1/46.42 2/42.33 1/45.19 |
|POLY-3 PERCENT (g) | |0.0% 2.2% 4.7% 2.2% |
|TERMINAL (d) | |0/33 (0%) 1/34 (3%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | |--- 730 (T) 646 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.586 P=0.506 P=0.216 P=0.517 |
|POLY 3 | |P=0.576 P=0.517 P=0.235 P=0.511 |
|POLY 1.5 | |P=0.573 P=0.512 P=0.239 P=0.508 |
|POLY 6 | |P=0.577 P=0.519 P=0.227 P=0.513 |
|LOGISTIC REGRESSION| |P=0.570 P=0.506 P=0.238 P=0.517 |
|COCH-ARM / FISHERS | |P=0.563 P=0.500 P=0.247 P=0.500 |
|ORDER RESTRICTED | |P=0.223 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 0/36.82 1/40.99 |0/42.54 0/46.42 2/42.44 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.4% |0.0% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 656 |--- --- 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224 (e) (e) P=0.494 |P=0.637N (e) P=0.222 (e) |
|POLY 3 | P=0.223 (e) (e) P=0.496 |P=0.649N (e) P=0.236 (e) |
|POLY 1.5 | P=0.227 (e) (e) P=0.499 |P=0.649N (e) P=0.241 (e) |
|POLY 6 | P=0.217 (e) (e) P=0.491 |P=0.650N (e) P=0.228 (e) |
|LOGISTIC REGRESSION| P=0.232 (e) (e) P=0.501 |P=0.655N (e) P=0.240 (e) |
|COCH-ARM / FISHERS | P=0.230 (e) (e) P=0.500 |P=0.649N (e) P=0.253 (e) |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.247 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Anterior Chamber, Cornea |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 0/36.82 2/40.73 |0/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 725 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * (e) (e) P=0.201 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.231 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.224 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.033 * (e) (e) P=0.200 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 10/50 (20%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 0/36.82 0/40.72 |0/42.54 0/46.42 0/42.02 10/46.15 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 21.7% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 6/36 (17%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P<0.001 ** (e) (e) P=0.003 ** |
|POLY 3 | (e) (e) (e) (e) |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P<0.001 ** (e) (e) P=0.002 ** |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P<0.001 ** (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 0/36.82 0/40.72 |1/42.54 4/47.01 3/42.44 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 8.5% 7.1% 2.2% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |1/33 (3%) 2/34 (6%) 2/28 (7%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 621 610 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.288N P=0.204 P=0.264 P=0.742N |
|POLY 3 | (e) (e) (e) (e) |P=0.291N P=0.211 P=0.304 P=0.747N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.295N P=0.204 P=0.312 P=0.749N |
|POLY 6 | (e) (e) (e) (e) |P=0.288N P=0.216 P=0.290 P=0.746N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.304N P=0.186 P=0.305 P=0.742N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.306N P=0.187 P=0.316 P=0.747N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.329N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 4/49 (8%) 7/50 (14%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 7/42.11 6/43.70 4/36.98 7/41.54 |0/42.73 3/46.93 1/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 16.6% 13.7% 10.8% 16.9% |0.0% 6.4% 2.4% 0.0% |
|TERMINAL (d) | 5/27 (19%) 2/29 (7%) 3/16 (19%) 4/22 (18%) |0/33 (0%) 1/34 (3%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 642 689 690 635 |--- 642 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.335 P=0.438N P=0.576N P=0.488 |P=0.254N P=0.140 P=0.467 (e) |
|POLY 3 | P=0.461 P=0.471N P=0.338N P=0.605 |P=0.239N P=0.136 P=0.497 (e) |
|POLY 1.5 | P=0.468 P=0.480N P=0.305N P=0.610 |P=0.245N P=0.131 P=0.501 (e) |
|POLY 6 | P=0.443 P=0.460N P=0.395N P=0.589 |P=0.232N P=0.141 P=0.488 (e) |
|LOGISTIC REGRESSION| P=0.408 P=0.456N P=0.463N P=0.573 |P=0.262N P=0.110 P=0.467 (e) |
|COCH-ARM / FISHERS | P=0.475 P=0.500N P=0.274N P=0.613N |P=0.263N P=0.121 P=0.500 (e) |
|ORDER RESTRICTED | P=0.545 (e) (e) (e) |P=0.230N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.84 0/43.38 1/36.90 0/40.72 |0/42.73 2/46.69 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.7% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 712 --- 709 --- |--- 681 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.524N P=0.494N P=0.654 P=0.543N |P=0.382N P=0.257 (e) (e) |
|POLY 3 | P=0.488N P=0.493N P=0.732 P=0.505N |P=0.365N P=0.258 (e) (e) |
|POLY 1.5 | P=0.483N P=0.495N P=0.744 P=0.502N |P=0.373N P=0.252 (e) (e) |
|POLY 6 | P=0.497N P=0.491N P=0.713 P=0.512N |P=0.357N P=0.262 (e) (e) |
|LOGISTIC REGRESSION| P=0.495N P=0.490N P=0.706 P=0.516N |P=0.389N P=0.236 (e) (e) |
|COCH-ARM / FISHERS | P=0.477N P=0.500N P=0.747 P=0.500N |P=0.390N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |0/42.54 2/46.71 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 676 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.383N P=0.259 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.366N P=0.259 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.373N P=0.254 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.359N P=0.262 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.388N P=0.237 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.388N P=0.253 (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.254N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 50/50 (100%) 49/49 (100%) 50/50 (100%)|45/49 (92%) 45/50 (90%) 45/50 (90%) 49/50 (98%) |
|POLY-3 RATE (b) | 46/47.07 50/50.00 49/49.00 50/50.00 |45/47.07 45/50.00 45/48.46 49/49.06 |
|POLY-3 PERCENT (g) | 97.7% 100.0% 100.0% 100.0% |95.6% 90.0% 92.9% 99.9% |
|TERMINAL (d) | 27/27 (100%) 29/29 (100%) 16/16 (100%) 22/22 (100%)|31/33 (94%) 29/34 (85%) 26/28 (93%) 36/36 (100%) |
|FIRST INCIDENCE | 458 464 361 254 |380 410 507 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099 P=0.518 P=0.004 ** P=0.081 |P=0.511 P=0.413N P=0.215 P=0.558 |
|POLY 3 | P=0.552 P=0.437 P=0.443 P=0.437 |P=0.058 P=0.252N P=0.444N P=0.225 |
|POLY 1.5 | P=0.268 P=0.169 P=0.173 P=0.169 |P=0.064 P=0.287N P=0.399N P=0.210 |
|POLY 6 | P=0.967 P=0.953 P=0.954 P=0.953 |P=0.057 P=0.243N P=0.552N P=0.228 |
|LOGISTIC REGRESSION| P=0.046 * P=0.153 P=0.033 * P=0.038 * |P=0.097 P=0.331N P=0.391N P=0.321 |
|COCH-ARM / FISHERS | P=0.118 P=0.059 P=0.061 P=0.059 |P=0.088 P=0.513N P=0.513N P=0.175 |
|ORDER RESTRICTED | P=0.010 * (e) (e) (e) |P=0.082 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Cortex |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/43.16 0/43.38 0/36.82 2/41.96 |0/42.54 0/46.42 0/42.02 1/45.76 |
|POLY-3 PERCENT (g) | 9.3% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 409 --- --- 518 |--- --- --- 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.617 P=0.060N P=0.103N P=0.366N |P=0.234 (e) (e) P=0.513 |
|POLY 3 | P=0.641 P=0.059N P=0.082N P=0.350N |P=0.233 (e) (e) P=0.515 |
|POLY 1.5 | P=0.641 P=0.059N P=0.073N P=0.343N |P=0.232 (e) (e) P=0.512 |
|POLY 6 | P=0.637 P=0.059N P=0.100N P=0.365N |P=0.234 (e) (e) P=0.517 |
|LOGISTIC REGRESSION| P=0.636N P=0.082N P=0.054N P=0.334N |P=0.199 (e) (e) P=0.439 |
|COCH-ARM / FISHERS | P=0.640 P=0.059N P=0.061N P=0.339N |P=0.229 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.036N* (e) (e) (e) |P=0.134 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Accumulation, Hyaline Droplet |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 9/49 (18%) 17/50 (34%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.77 2/44.12 9/39.56 17/43.68 |1/42.54 2/46.60 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.5% 22.8% 38.9% |2.4% 4.3% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 2/16 (13%) 8/22 (36%) |1/33 (3%) 1/34 (3%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 464 509 509 |730 (T) 684 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.524 P=0.003 ** P<0.001 ** |P=0.563N P=0.510 P=0.533N P=0.742N |
|POLY 3 | P<0.001 ** P=0.519 P=0.005 ** P<0.001 ** |P=0.578N P=0.532 P=0.502N P=0.747N |
|POLY 1.5 | P<0.001 ** P=0.513 P=0.006 ** P<0.001 ** |P=0.582N P=0.525 P=0.497N P=0.749N |
|POLY 6 | P<0.001 ** P=0.526 P=0.004 ** P<0.001 ** |P=0.572N P=0.536 P=0.512N P=0.746N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.463 P=0.010 * P<0.001 ** |P=0.581N P=0.529 (e) P=0.742N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.007 ** P<0.001 ** |P=0.591N P=0.508 P=0.495N P=0.747N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.389N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Cortex, Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 7/49 (14%) 19/50 (38%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 3/44.04 7/37.38 19/42.97 |0/42.54 0/46.42 1/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 18.7% 44.2% |0.0% 0.0% 2.4% 2.2% |
|TERMINAL (d) | 0/27 (0%) 2/29 (7%) 2/16 (13%) 11/22 (50%) |0/33 (0%) 0/34 (0%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | --- 509 646 537 |--- --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.135 P=0.002 ** P<0.001 ** |P=0.375 (e) P=0.467 P=0.517 |
|POLY 3 | P<0.001 ** P=0.128 P=0.004 ** P<0.001 ** |P=0.352 (e) P=0.498 P=0.512 |
|POLY 1.5 | P<0.001 ** P=0.125 P=0.005 ** P<0.001 ** |P=0.353 (e) P=0.503 P=0.510 |
|POLY 6 | P<0.001 ** P=0.131 P=0.003 ** P<0.001 ** |P=0.351 (e) P=0.488 P=0.513 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.107 P=0.003 ** P<0.001 ** |(e) (e) P=0.467 P=0.517 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P=0.006 ** P<0.001 ** |P=0.351 (e) P=0.505 P=0.505 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.249 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 8/50 (16%) 28/49 (57%) 41/50 (82%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 8/45.03 28/44.48 41/48.81 |0/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 17.8% 63.0% 84.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 4/29 (14%) 8/16 (50%) 17/22 (77%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 509 361 254 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Pelvis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |13/49 (27%) 5/50 (10%) 7/50 (14%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |13/43.31 5/47.52 7/42.02 3/45.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |30.0% 10.5% 16.7% 6.6% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |11/33 (33%) 3/34 (9%) 7/28 (25%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |537 410 730 (T) 675 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.020N* P=0.030N* P=0.184N P=0.005N** |
|POLY 3 | (e) (e) (e) (e) |P=0.025N* P=0.017N* P=0.112N P=0.004N** |
|POLY 1.5 | (e) (e) (e) (e) |P=0.025N* P=0.020N* P=0.098N P=0.004N** |
|POLY 6 | (e) (e) (e) (e) |P=0.024N* P=0.016N* P=0.140N P=0.003N** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.025N* P=0.029N* P=0.133N P=0.005N** |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.026N* P=0.030N* P=0.096N P=0.005N** |
|ORDER RESTRICTED | (e) (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 6/49 (12%) 15/50 (30%) |0/49 (0%) 4/50 (8%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.04 1/43.38 6/36.90 15/42.80 |0/42.54 4/47.00 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.8% 2.3% 16.3% 35.1% |0.0% 8.5% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 4/16 (25%) 8/22 (36%) |0/33 (0%) 2/34 (6%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 655 729 (T) 718 509 |--- 642 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.477N P=0.033 * P<0.001 ** |P=0.186N P=0.077 (e) (e) |
|POLY 3 | P<0.001 ** P=0.489N P=0.092 P<0.001 ** |P=0.164N P=0.074 (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.492N P=0.108 P<0.001 ** |P=0.170N P=0.071 (e) (e) |
|POLY 6 | P<0.001 ** P=0.487N P=0.071 P<0.001 ** |P=0.157N P=0.077 (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.487N P=0.050 P<0.001 ** |P=0.190N P=0.061 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.128 P<0.001 ** |P=0.190N P=0.061 (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.116N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.70 0/43.38 0/36.82 0/40.72 |0/42.54 0/46.42 2/43.15 0/45.19 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 296 --- --- --- |--- --- 471 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.550N P=0.500N P=0.504N P=0.504N |P=0.647N (e) P=0.246 (e) |
|POLY 3 | P=0.542N P=0.497N P=0.529N P=0.510N |P=0.649N (e) P=0.240 (e) |
|POLY 1.5 | P=0.544N P=0.498N P=0.518N P=0.505N |P=0.648N (e) P=0.244 (e) |
|POLY 6 | P=0.541N P=0.495N P=0.547N P=0.517N |P=0.649N (e) P=0.233 (e) |
|LOGISTIC REGRESSION| P=0.277N (e) (e) P=0.422N |P=0.698N (e) P=0.150 (e) |
|COCH-ARM / FISHERS | P=0.546N P=0.500N P=0.505N P=0.500N |P=0.649N (e) P=0.253 (e) |
|ORDER RESTRICTED | P=0.129N (e) (e) (e) |P=0.250 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 2/37.29 0/40.72 |0/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 5.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 590 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475N P=0.486N P=0.364 P=0.541N |(e) (e) (e) (e) |
|POLY 3 | P=0.454N P=0.492N P=0.460 P=0.505N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.446N P=0.495N P=0.477 P=0.502N |(e) (e) (e) (e) |
|POLY 6 | P=0.469N P=0.490N P=0.435 P=0.512N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.439N (e) P=0.469 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.436N P=0.500N P=0.492 P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.320N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 1/48 (2%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 2/43.52 1/35.95 1/40.97 |1/42.54 1/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 2.8% 2.4% |2.4% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/16 (6%) 0/22 (0%) |1/33 (3%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 621 729 (T) 662 |730 (T) 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.592N P=0.521 P=0.641 P=0.734 |P=0.333N P=0.755N P=0.533N P=0.483N |
|POLY 3 | P=0.549N P=0.514 P=0.727 P=0.757 |P=0.341N P=0.741N P=0.502N P=0.488N |
|POLY 1.5 | P=0.546N P=0.506 P=0.739 P=0.759 |P=0.344N P=0.745N P=0.497N P=0.490N |
|POLY 6 | P=0.558N P=0.525 P=0.706 P=0.751 |P=0.337N P=0.739N P=0.512N P=0.487N |
|LOGISTIC REGRESSION| P=0.548N P=0.483 P=0.641 P=0.757 |P=0.333N P=0.755N (e) (e) |
|COCH-ARM / FISHERS | P=0.544N P=0.492 P=0.742 P=0.753N |P=0.346N P=0.747N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.605N (e) (e) (e) |P=0.240N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 1/48 (2%) 0/50 (0%) |4/49 (8%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.77 2/43.28 1/36.08 0/40.72 |4/43.48 2/46.42 1/42.02 2/45.21 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 2.8% 0.0% |9.2% 4.3% 2.4% 4.4% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |3/33 (9%) 2/34 (6%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | --- 621 697 --- |284 730 (T) 730 (T) 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N P=0.248 P=0.422 (e) |P=0.392N P=0.325N P=0.221N P=0.305N |
|POLY 3 | P=0.364N P=0.245 P=0.471 (e) |P=0.424N P=0.307N P=0.189N P=0.319N |
|POLY 1.5 | P=0.362N P=0.241 P=0.481 (e) |P=0.426N P=0.313N P=0.179N P=0.321N |
|POLY 6 | P=0.371N P=0.251 P=0.455 (e) |P=0.419N P=0.304N P=0.204N P=0.317N |
|LOGISTIC REGRESSION| P=0.367N P=0.227 P=0.462 (e) |P=0.432N P=0.390N P=0.184N P=0.357N |
|COCH-ARM / FISHERS | P=0.363N P=0.242 P=0.490 (e) |P=0.426N P=0.329N P=0.175N P=0.329N |
|ORDER RESTRICTED | P=0.314 (e) (e) (e) |P=0.168N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/48 (0%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/42.90 0/35.95 3/41.57 |0/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 7.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 635 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.486N P=0.604N P=0.274 |(e) (e) (e) (e) |
|POLY 3 | P=0.047 * P=0.495N P=0.530N P=0.303 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.048 * P=0.498N P=0.519N P=0.305 |(e) (e) (e) (e) |
|POLY 6 | P=0.046 * P=0.491N P=0.547N P=0.297 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.050 (e) (e) P=0.305 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.050 P=0.505N P=0.510N P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.038 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/48 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 1/35.95 0/40.72 |0/42.54 0/46.42 1/42.02 2/45.21 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.8% 0.0% |0.0% 0.0% 2.4% 4.4% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |--- --- 730 (T) 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.796N (e) P=0.396 (e) |P=0.119 (e) P=0.467 P=0.262 |
|POLY 3 | P=0.777N (e) P=0.470 (e) |P=0.099 (e) P=0.498 P=0.251 |
|POLY 1.5 | P=0.773N (e) P=0.481 (e) |P=0.099 (e) P=0.503 P=0.249 |
|POLY 6 | P=0.784N (e) P=0.453 (e) |P=0.099 (e) P=0.488 P=0.252 |
|LOGISTIC REGRESSION| (e) (e) P=0.396 (e) |P=0.114 (e) P=0.467 P=0.256 |
|COCH-ARM / FISHERS | P=0.769N (e) P=0.490 (e) |P=0.098 (e) P=0.505 P=0.253 |
|ORDER RESTRICTED | P=0.355 (e) (e) (e) |P=0.083 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |1/42.54 0/46.42 3/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 0.0% 7.1% 2.2% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |1/33 (3%) 0/34 (0%) 3/28 (11%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.649 P=0.494N P=0.247 P=0.742N |
|POLY 3 | (e) (e) (e) (e) |P=0.620 P=0.483N P=0.300 P=0.747N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.622 P=0.486N P=0.310 P=0.749N |
|POLY 6 | (e) (e) (e) (e) |P=0.619 P=0.481N P=0.284 P=0.746N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.649 (e) P=0.247 P=0.742N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.622 P=0.495N P=0.316 P=0.747N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.261 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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%) 18/50 (36%) 15/49 (31%) 17/50 (34%) |39/49 (80%) 45/50 (90%) 43/50 (86%) 40/50 (80%) |
|POLY-3 RATE (b) | 6/42.12 18/44.18 15/37.71 17/42.84 |39/44.81 45/48.66 43/47.26 40/46.57 |
|POLY-3 PERCENT (g) | 14.2% 40.7% 39.8% 39.7% |87.0% 92.5% 91.0% 85.9% |
|TERMINAL (d) | 5/27 (19%) 14/29 (48%) 13/16 (81%) 9/22 (41%) |32/33 (97%) 34/34 (100%) 27/28 (96%) 32/36 (89%) |
|FIRST INCIDENCE | 630 642 550 550 |537 621 471 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.008 ** P<0.001 ** P=0.004 ** |P=0.128N P=0.238 P=0.044 * P=0.384N |
|POLY 3 | P=0.101 P=0.004 ** P=0.007 ** P=0.006 ** |P=0.291N P=0.285 P=0.382 P=0.562N |
|POLY 1.5 | P=0.104 P=0.004 ** P=0.012 * P=0.007 ** |P=0.271N P=0.232 P=0.382 P=0.555N |
|POLY 6 | P=0.093 P=0.005 ** P=0.003 ** P=0.005 ** |P=0.323N P=0.330 P=0.353 P=0.586N |
|LOGISTIC REGRESSION| P=0.065 P=0.006 ** P=0.002 ** P=0.006 ** |P=0.201N P=0.360 P=0.234 P=0.454N |
|COCH-ARM / FISHERS | P=0.110 P=0.005 ** P=0.021 * P=0.008 ** |P=0.292N P=0.122 P=0.282 P=0.579 |
|ORDER RESTRICTED | P=0.005 ** (e) (e) (e) |P=0.373N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 11/50 (22%) 11/49 (22%) 9/50 (18%) |12/49 (24%) 13/50 (26%) 11/50 (22%) 27/50 (54%) |
|POLY-3 RATE (b) | 8/41.77 11/43.38 11/36.82 9/41.77 |12/43.47 13/46.89 11/43.06 27/45.63 |
|POLY-3 PERCENT (g) | 19.2% 25.4% 29.9% 21.6% |27.6% 27.7% 25.5% 59.2% |
|TERMINAL (d) | 8/27 (30%) 11/29 (38%) 11/16 (69%) 5/22 (23%) |10/33 (30%) 10/34 (29%) 6/28 (21%) 23/36 (64%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 612 |558 656 610 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413 P=0.356 P=0.016 * P=0.344 |P<0.001 ** P=0.550 P=0.542 P=0.005 ** |
|POLY 3 | P=0.506N P=0.334 P=0.196 P=0.500 |P<0.001 ** P=0.588 P=0.511N P=0.002 ** |
|POLY 1.5 | P=0.502N P=0.325 P=0.240 P=0.502 |P<0.001 ** P=0.574 P=0.483N P=0.002 ** |
|POLY 6 | P=0.519N P=0.343 P=0.135 P=0.491 |P<0.001 ** P=0.593N P=0.553N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.481 P=0.356 P=0.016 * P=0.430 |P<0.001 ** P=0.590N P=0.511N P=0.003 ** |
|COCH-ARM / FISHERS | P=0.500N P=0.306 P=0.288 P=0.500 |P<0.001 ** P=0.523 P=0.478N P=0.002 ** |
|ORDER RESTRICTED | P=0.390 (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 1/37.00 3/41.32 |0/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.7% 7.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 684 635 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.068 P=0.486N P=0.668 P=0.270 |(e) (e) (e) (e) |
|POLY 3 | P=0.076 P=0.492N P=0.733 P=0.301 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.078 P=0.495N P=0.745 P=0.304 |(e) (e) (e) (e) |
|POLY 6 | P=0.072 P=0.490N P=0.715 P=0.293 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.079 (e) P=0.714 P=0.300 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.081 P=0.500N P=0.747 P=0.309 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.077 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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) | 0/50 (0%) 1/50 (2%) 1/49 (2%) 2/50 (4%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 1/43.38 1/36.82 2/40.96 |1/42.54 0/46.42 0/42.02 1/45.42 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 2.7% 4.9% |2.4% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 663 |730 (T) --- --- 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.176 P=0.514 P=0.396 P=0.211 |P=0.539 P=0.494N P=0.533N P=0.743N |
|POLY 3 | P=0.208 P=0.508 P=0.475 P=0.232 |P=0.522 P=0.483N P=0.502N P=0.746N |
|POLY 1.5 | P=0.212 P=0.505 P=0.485 P=0.235 |P=0.522 P=0.486N P=0.497N P=0.748N |
|POLY 6 | P=0.199 P=0.510 P=0.458 P=0.226 |P=0.524 P=0.481N P=0.512N P=0.744N |
|LOGISTIC REGRESSION| P=0.194 P=0.514 P=0.396 P=0.231 |P=0.526 (e) (e) P=0.755N |
|COCH-ARM / FISHERS | P=0.215 P=0.500 P=0.495 P=0.247 |P=0.525 P=0.495N P=0.495N P=0.747N |
|ORDER RESTRICTED | P=0.114 (e) (e) (e) |P=0.382N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.34 0/43.38 0/36.82 1/41.01 |0/42.54 1/46.68 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 2.4% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 630 --- --- 648 |--- 660 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561N P=0.113N P=0.191N P=0.342N |P=0.599N P=0.519 (e) (e) |
|POLY 3 | P=0.534N P=0.114N P=0.145N P=0.316N |P=0.591N P=0.518 (e) (e) |
|POLY 1.5 | P=0.533N P=0.115N P=0.133N P=0.310N |P=0.596N P=0.515 (e) (e) |
|POLY 6 | P=0.537N P=0.113N P=0.166N P=0.330N |P=0.585N P=0.521 (e) (e) |
|LOGISTIC REGRESSION| P=0.530N P=0.121N P=0.129N P=0.304N |P=0.613N P=0.478 (e) (e) |
|COCH-ARM / FISHERS | P=0.531N P=0.121N P=0.125N P=0.309N |P=0.607N P=0.505 (e) (e) |
|ORDER RESTRICTED | P=0.042N* (e) (e) (e) |P=0.388N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 11/49 (22%) 5/50 (10%) |8/49 (16%) 10/50 (20%) 9/50 (18%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/41.77 6/44.33 11/39.71 5/42.18 |8/43.23 10/46.42 9/43.72 7/45.90 |
|POLY-3 PERCENT (g) | 2.4% 13.5% 27.7% 11.9% |18.5% 21.5% 20.6% 15.3% |
|TERMINAL (d) | 1/27 (4%) 4/29 (14%) 4/16 (25%) 0/22 (0%) |6/33 (18%) 10/34 (29%) 5/28 (18%) 5/36 (14%) |
|FIRST INCIDENCE | 729 (T) 509 431 598 |593 730 (T) 507 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381 P=0.073 P<0.001 ** P=0.094 |P=0.268N P=0.431 P=0.397 P=0.437N |
|POLY 3 | P=0.445 P=0.065 P<0.001 ** P=0.102 |P=0.302N P=0.462 P=0.510 P=0.450N |
|POLY 1.5 | P=0.451 P=0.062 P<0.001 ** P=0.103 |P=0.310N P=0.454 P=0.526 P=0.457N |
|POLY 6 | P=0.431 P=0.069 P<0.001 ** P=0.100 |P=0.290N P=0.460 P=0.479 P=0.444N |
|LOGISTIC REGRESSION| P=0.467 P=0.059 P=0.003 ** P=0.104 |P=0.317N P=0.484 P=0.518 P=0.463N |
|COCH-ARM / FISHERS | P=0.457 P=0.056 P=0.002 ** P=0.102 |P=0.325N P=0.416 P=0.518 P=0.483N |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.435N (e) (e) (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) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |1/42.54 0/46.42 1/42.02 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.4% 0.0% 2.4% 4.4% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |1/33 (3%) 0/34 (0%) 1/28 (4%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.271 P=0.494N P=0.725 P=0.530 |
|POLY 3 | (e) (e) (e) (e) |P=0.240 P=0.483N P=0.758 P=0.521 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.241 P=0.486N P=0.757N P=0.518 |
|POLY 6 | (e) (e) (e) (e) |P=0.241 P=0.481N P=0.748 P=0.523 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.271 (e) P=0.725 P=0.530 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.241 P=0.495N P=0.747N P=0.508 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.240 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) 1/50 (2%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 3/37.72 1/41.36 |0/42.54 1/46.61 1/42.02 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.0% 2.4% |0.0% 2.2% 2.4% 4.4% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 1/28 (4%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- 590 518 |--- 681 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454 (e) P=0.081 P=0.508 |P=0.243 P=0.515 P=0.467 P=0.258 |
|POLY 3 | P=0.449 (e) P=0.100 P=0.498 |P=0.224 P=0.518 P=0.498 P=0.251 |
|POLY 1.5 | P=0.459 (e) P=0.108 P=0.500 |P=0.223 P=0.515 P=0.503 P=0.249 |
|POLY 6 | P=0.429 (e) P=0.090 P=0.493 |P=0.225 P=0.521 P=0.488 P=0.252 |
|LOGISTIC REGRESSION| P=0.487 (e) P=0.124 P=0.502 |P=0.226 P=0.494 P=0.467 P=0.258 |
|COCH-ARM / FISHERS | P=0.469 (e) P=0.117 P=0.500 |P=0.217 P=0.505 P=0.505 P=0.253 |
|ORDER RESTRICTED | P=0.098 (e) (e) (e) |P=0.130 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/49 (4%) 1/50 (2%) |3/49 (6%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.78 1/44.04 2/37.35 1/41.29 |3/44.82 4/46.94 3/42.86 0/45.19 |
|POLY-3 PERCENT (g) | 7.0% 2.3% 5.4% 2.4% |6.7% 8.5% 7.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 465 509 646 550 |284 660 528 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386N P=0.289N P=0.609N P=0.326N |P=0.062N P=0.530 P=0.643 P=0.122N |
|POLY 3 | P=0.380N P=0.295N P=0.562N P=0.318N |P=0.060N P=0.525 P=0.642 P=0.117N |
|POLY 1.5 | P=0.373N P=0.298N P=0.537N P=0.311N |P=0.060N P=0.522 P=0.657 P=0.116N |
|POLY 6 | P=0.395N P=0.291N P=0.598N P=0.330N |P=0.061N P=0.528 P=0.621 P=0.118N |
|LOGISTIC REGRESSION| P=0.336N P=0.400N P=0.481N P=0.301N |P=0.065N P=0.261 P=0.523 P=0.206N |
|COCH-ARM / FISHERS | P=0.364N P=0.309N P=0.510N P=0.309N |P=0.059N P=0.511 P=0.651N P=0.117N |
|ORDER RESTRICTED | P=0.233N (e) (e) (e) |P=0.086N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.70 2/43.38 1/36.82 1/40.72 |1/42.79 2/46.60 0/42.02 1/45.59 |
|POLY-3 PERCENT (g) | 2.3% 4.6% 2.7% 2.5% |2.3% 4.3% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 2/29 (7%) 1/16 (6%) 1/22 (5%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 296 729 (T) 729 (T) 729 (T) |715 683 --- 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.608N P=0.517 P=0.701 P=0.735 |P=0.570N P=0.519 P=0.545N P=0.741N |
|POLY 3 | P=0.558N P=0.505 P=0.727 P=0.750 |P=0.576N P=0.530 P=0.504N P=0.746N |
|POLY 1.5 | P=0.554N P=0.503 P=0.740 P=0.755 |P=0.583N P=0.522 P=0.499N P=0.750N |
|POLY 6 | P=0.569N P=0.509 P=0.706 P=0.742 |P=0.568N P=0.535 P=0.512N P=0.743N |
|LOGISTIC REGRESSION| P=0.539N P=0.393 P=0.767 P=0.772 |P=0.596N P=0.522 P=0.511N P=0.755 |
|COCH-ARM / FISHERS | P=0.548N P=0.500 P=0.747 P=0.753N |P=0.594N P=0.500 P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.610N (e) (e) (e) |P=0.387N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 1/37.37 2/40.94 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.7% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 561 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087 (e) P=0.486 P=0.209 |(e) (e) (e) (e) |
|POLY 3 | P=0.091 (e) P=0.478 P=0.232 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.094 (e) P=0.487 P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.086 (e) P=0.463 P=0.226 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.099 (e) P=0.506 P=0.229 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.098 (e) P=0.495 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.071 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 5/49 (10%) 4/50 (8%) |9/50 (18%) 2/50 (4%) 7/50 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | 5/42.87 2/43.38 5/37.19 4/41.52 |9/43.26 2/46.42 7/42.22 6/45.19 |
|POLY-3 PERCENT (g) | 11.7% 4.6% 13.4% 9.6% |20.8% 4.3% 16.6% 13.3% |
|TERMINAL (d) | 3/27 (11%) 2/29 (7%) 2/16 (13%) 2/22 (9%) |7/33 (21%) 2/34 (6%) 5/28 (18%) 6/36 (17%) |
|FIRST INCIDENCE | 458 729 (T) 656 550 |587 730 (T) 698 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.195N P=0.375 P=0.574N |P=0.503N P=0.024N* P=0.524N P=0.230N |
|POLY 3 | P=0.543 P=0.210N P=0.539 P=0.520N |P=0.580 P=0.018N* P=0.412N P=0.255N |
|POLY 1.5 | P=0.553 P=0.212N P=0.577 P=0.510N |P=0.580 P=0.019N* P=0.391N P=0.262N |
|POLY 6 | P=0.521 P=0.209N P=0.481 P=0.540N |P=0.582N P=0.017N* P=0.450N P=0.252N |
|LOGISTIC REGRESSION| P=0.557 P=0.220N P=0.577 P=0.497N |P=0.545N P=0.019N* P=0.447N P=0.241N |
|COCH-ARM / FISHERS | P=0.566 P=0.218N P=0.617 P=0.500N |P=0.581 P=0.026N* P=0.393N P=0.288N |
|ORDER RESTRICTED | P=0.475 (e) (e) (e) |P=0.142N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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%) 2/50 (4%) 5/49 (10%) 6/50 (12%) |6/50 (12%) 4/50 (8%) 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 6/42.47 2/44.04 5/36.88 6/41.16 |6/42.79 4/46.42 5/42.20 4/45.19 |
|POLY-3 PERCENT (g) | 14.1% 4.5% 13.6% 14.6% |14.0% 8.6% 11.9% 8.9% |
|TERMINAL (d) | 4/27 (15%) 1/29 (3%) 4/16 (25%) 5/22 (23%) |5/33 (15%) 4/34 (12%) 4/28 (14%) 4/36 (11%) |
|FIRST INCIDENCE | 630 509 716 598 |715 730 (T) 682 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.227 P=0.122N P=0.434 P=0.504 |P=0.348N P=0.347N P=0.614N P=0.314N |
|POLY 3 | P=0.290 P=0.120N P=0.599N P=0.600 |P=0.403N P=0.319N P=0.510N P=0.335N |
|POLY 1.5 | P=0.305 P=0.124N P=0.557N P=0.612 |P=0.407N P=0.332N P=0.496N P=0.344N |
|POLY 6 | P=0.262 P=0.117N P=0.591 P=0.573 |P=0.397N P=0.312N P=0.537N P=0.329N |
|LOGISTIC REGRESSION| P=0.295 P=0.137N P=0.580 P=0.594 |P=0.369N P=0.316N P=0.580N P=0.312N |
|COCH-ARM / FISHERS | P=0.324 P=0.134N P=0.514N P=0.620N |P=0.414N P=0.370N P=0.500N P=0.370N |
|ORDER RESTRICTED | P=0.350 (e) (e) (e) |P=0.347N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 0/36.82 4/42.33 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 9.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 518 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.486N P=0.604N P=0.171 |(e) (e) (e) (e) |
|POLY 3 | P=0.011 * P=0.492N P=0.525N P=0.182 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.011 * P=0.495N P=0.515N P=0.182 |(e) (e) (e) (e) |
|POLY 6 | P=0.011 * P=0.490N P=0.542N P=0.179 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.013 * (e) (e) P=0.180 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.012 * P=0.500N P=0.505N P=0.181 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 2/40.89 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 684 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033 * (e) (e) P=0.203 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.232 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.225 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.039 * (e) (e) P=0.224 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 3/50 (6%) 8/49 (16%) 8/50 (16%) |15/50 (30%) 9/50 (18%) 13/50 (26%) 20/50 (40%) |
|POLY-3 RATE (b) | 11/43.73 3/43.38 8/37.65 8/41.58 |15/43.93 9/46.70 13/42.71 20/45.99 |
|POLY-3 PERCENT (g) | 25.2% 6.9% 21.3% 19.2% |34.1% 19.3% 30.4% 43.5% |
|TERMINAL (d) | 7/27 (26%) 3/29 (10%) 4/16 (25%) 6/22 (27%) |11/33 (33%) 7/34 (21%) 11/28 (39%) 18/36 (50%) |
|FIRST INCIDENCE | 296 729 (T) 593 550 |587 660 528 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.018N* P=0.516 P=0.440N |P=0.068 P=0.104N P=0.584 P=0.296 |
|POLY 3 | P=0.472 P=0.019N* P=0.439N P=0.345N |P=0.031 * P=0.084N P=0.444N P=0.243 |
|POLY 1.5 | P=0.488 P=0.019N* P=0.384N P=0.327N |P=0.031 * P=0.091N P=0.411N P=0.236 |
|POLY 6 | P=0.441 P=0.019N* P=0.525N P=0.381N |P=0.031 * P=0.083N P=0.513N P=0.241 |
|LOGISTIC REGRESSION| P=0.489 P=0.022N* P=0.365N P=0.307N |P=0.038 * P=0.080N P=0.449N P=0.257 |
|COCH-ARM / FISHERS | P=0.509 P=0.020N* P=0.323N P=0.306N |P=0.031 * P=0.121N P=0.412N P=0.201 |
|ORDER RESTRICTED | P=0.181N (e) (e) (e) |P=0.055 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Proteinosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/41.77 1/43.38 0/36.82 0/40.72 |4/43.21 0/46.42 3/42.02 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |9.3% 0.0% 7.1% 4.4% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |3/33 (9%) 0/34 (0%) 3/28 (11%) 2/36 (6%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |587 --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.639N P=0.514 (e) (e) |P=0.515N P=0.058N P=0.578N P=0.303N |
|POLY 3 | P=0.598N P=0.508 (e) (e) |P=0.565N P=0.052N P=0.515N P=0.316N |
|POLY 1.5 | P=0.601N P=0.505 (e) (e) |P=0.564N P=0.054N P=0.501N P=0.321N |
|POLY 6 | P=0.595N P=0.510 (e) (e) |P=0.564N P=0.051N P=0.542N P=0.314N |
|LOGISTIC REGRESSION| (e) P=0.514 (e) (e) |P=0.544N P=0.059N P=0.518N P=0.318N |
|COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.558N P=0.059N P=0.500N P=0.339N |
|ORDER RESTRICTED | P=0.392N (e) (e) (e) |P=0.184N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 4/49 (8%) 6/50 (12%) |4/50 (8%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/42.53 1/43.38 4/36.92 6/41.04 |4/42.73 1/46.42 4/42.14 2/45.19 |
|POLY-3 PERCENT (g) | 11.8% 2.3% 10.8% 14.6% |9.4% 2.2% 9.5% 4.4% |
|TERMINAL (d) | 3/27 (11%) 1/29 (3%) 2/16 (13%) 4/22 (18%) |4/33 (12%) 1/34 (3%) 3/28 (11%) 2/36 (6%) |
|FIRST INCIDENCE | 604 729 (T) 716 656 |730 (T) 730 (T) 698 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115 P=0.095N P=0.508 P=0.393 |P=0.398N P=0.169N P=0.554 P=0.296N |
|POLY 3 | P=0.154 P=0.096N P=0.589N P=0.475 |P=0.446N P=0.154N P=0.636 P=0.311N |
|POLY 1.5 | P=0.163 P=0.097N P=0.551N P=0.489 |P=0.446N P=0.161N P=0.640N P=0.318N |
|POLY 6 | P=0.138 P=0.095N P=0.631 P=0.447 |P=0.443N P=0.151N P=0.615 P=0.306N |
|LOGISTIC REGRESSION| P=0.144 P=0.098N P=0.626N P=0.473 |P=0.411N P=0.169N P=0.573 P=0.296N |
|COCH-ARM / FISHERS | P=0.175 P=0.102N P=0.513N P=0.500 |P=0.447N P=0.181N P=0.643N P=0.339N |
|ORDER RESTRICTED | P=0.180 (e) (e) (e) |P=0.270N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/24 (0%) 0/7 (0%) 0/9 (0%) 2/21 (10%) |0/9 (0%) 0/4 (0%) 0/10 (0%) 0/5 (0%) |
|POLY-3 RATE (b) | 0/22.07 0/6.46 0/6.49 2/16.51 |0/7.10 0/3.68 0/7.79 0/4.28 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 12.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/16 (0%) 0/4 (0%) 0/1 (0%) 1/7 (14%) |0/4 (0%) 0/3 (0%) 0/2 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- --- --- 631 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041 * (e) (e) P=0.153 |(e) (e) (e) (e) |
|POLY 3 | P=0.070 (e) (e) P=0.172 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.076 (e) (e) P=0.184 |(e) (e) (e) (e) |
|POLY 6 | P=0.063 (e) (e) P=0.159 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.078 (e) (e) P=0.195 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.088 (e) (e) P=0.212 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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, Mediastinal |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/38 (0%) 1/41 (2%) 1/46 (2%) 0/45 (0%) |3/43 (7%) 1/46 (2%) 1/45 (2%) 2/43 (5%) |
|POLY-3 RATE (b) | 0/30.56 1/35.62 1/35.14 0/36.79 |3/37.24 1/42.68 1/37.71 2/39.50 |
|POLY-3 PERCENT (g) | 0.0% 2.8% 2.9% 0.0% |8.1% 2.3% 2.7% 5.1% |
|TERMINAL (d) | 0/17 (0%) 1/23 (4%) 0/16 (0%) 0/21 (0%) |2/28 (7%) 1/32 (3%) 1/26 (4%) 2/32 (6%) |
|FIRST INCIDENCE | --- 729 (T) 722 --- |284 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528N P=0.560 P=0.400 (e) |P=0.612N P=0.270N P=0.324N P=0.451N |
|POLY 3 | P=0.489N P=0.530 P=0.528 (e) |P=0.629 P=0.257N P=0.300N P=0.473N |
|POLY 1.5 | P=0.491N P=0.525 P=0.533 (e) |P=0.627 P=0.264N P=0.291N P=0.479N |
|POLY 6 | P=0.487N P=0.539 P=0.520 (e) |P=0.632 P=0.253N P=0.315N P=0.468N |
|LOGISTIC REGRESSION| P=0.501N P=0.560 P=0.506 (e) |P=0.594 P=0.379N P=0.325N P=0.588N |
|COCH-ARM / FISHERS | P=0.495N P=0.519 P=0.548 (e) |P=0.623 P=0.283N P=0.291N P=0.500N |
|ORDER RESTRICTED | P=0.404N (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/38 (0%) 0/41 (0%) 0/46 (0%) 0/45 (0%) |1/43 (2%) 2/46 (4%) 4/45 (9%) 0/43 (0%) |
|POLY-3 RATE (b) | 0/30.56 0/35.62 0/35.11 0/36.79 |1/36.30 2/42.96 4/38.13 0/39.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.8% 4.7% 10.5% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/16 (0%) 0/21 (0%) |1/28 (4%) 1/32 (3%) 3/26 (12%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 656 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.205N P=0.547 P=0.163 P=0.473N |
|POLY 3 | (e) (e) (e) (e) |P=0.209N P=0.558 P=0.192 P=0.483N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.213N P=0.549 P=0.197 P=0.487N |
|POLY 6 | (e) (e) (e) (e) |P=0.207N P=0.565 P=0.181 P=0.480N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.221N P=0.545 P=0.187 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.229N P=0.526 P=0.195 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.166N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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, Mediastinal |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/38 (0%) 0/41 (0%) 0/46 (0%) 0/45 (0%) |3/43 (7%) 1/46 (2%) 0/45 (0%) 0/43 (0%) |
|POLY-3 RATE (b) | 0/30.56 0/35.62 0/35.11 0/36.79 |3/36.30 1/43.07 0/37.71 0/39.50 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/17 (0%) 0/23 (0%) 0/16 (0%) 0/21 (0%) |3/28 (11%) 0/32 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 621 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.129N P=0.258N P=0.133N P=0.098N |
|POLY 3 | (e) (e) (e) (e) |P=0.137N P=0.246N P=0.110N P=0.103N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.137N P=0.256N P=0.108N P=0.107N |
|POLY 6 | (e) (e) (e) (e) |P=0.136N P=0.239N P=0.117N P=0.101N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.133N P=0.261N (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.137N P=0.283N P=0.112N P=0.121N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.016N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 2/49 (4%) 1/50 (2%) |0/49 (0%) 7/50 (14%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/42.00 2/43.74 2/36.87 1/40.97 |0/42.54 7/46.77 2/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 7.1% 4.6% 5.4% 2.4% |0.0% 15.0% 4.8% 2.2% |
|TERMINAL (d) | 2/27 (7%) 0/29 (0%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 5/34 (15%) 2/28 (7%) 1/36 (3%) |
|FIRST INCIDENCE | 668 656 718 662 |--- 660 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.353N P=0.462N P=0.657 P=0.359N |P=0.190N P=0.012 * P=0.202 P=0.517 |
|POLY 3 | P=0.298N P=0.481N P=0.559N P=0.314N |P=0.182N P=0.011 * P=0.234 P=0.512 |
|POLY 1.5 | P=0.292N P=0.487N P=0.534N P=0.309N |P=0.189N P=0.010 * P=0.240 P=0.510 |
|POLY 6 | P=0.310N P=0.474N P=0.599N P=0.325N |P=0.175N P=0.011 * P=0.224 P=0.513 |
|LOGISTIC REGRESSION| P=0.302N P=0.487N P=0.636N P=0.314N |P=0.202N P=0.013 * P=0.202 P=0.517 |
|COCH-ARM / FISHERS | P=0.285N P=0.500N P=0.510N P=0.309N |P=0.211N P=0.007 ** P=0.253 P=0.505 |
|ORDER RESTRICTED | P=0.254N (e) (e) (e) |P=0.094 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/13 (100%) 9/9 (100%) 10/10 (100%) 5/7 (71%) |17/17 (100%) 21/23 (91%) 9/10 (90%) 17/17 (100%) |
|POLY-3 RATE (b) | 13/13.00 9/9.00 10/10.00 5/6.98 |17/17.00 21/22.68 9/9.54 17/17.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 71.6% |100.0% 92.6% 94.4% 100.0% |
|TERMINAL (d) | 10/10 (100%) 5/5 (100%) 2/2 (100%) 1/2 (50%) |11/11 (100%) 14/15 (93%) 7/7 (100%) 15/15 (100%) |
|FIRST INCIDENCE | 655 513 565 598 |415 621 509 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.463N (e) (e) P=0.587N |P=0.117N P=0.557N P=0.164N (e) |
|POLY 3 | P=0.008N** (e) (e) P=0.093N |P=0.441 P=0.355N P=0.727N (e) |
|POLY 1.5 | P=0.007N** (e) (e) P=0.092N |P=0.416 P=0.329N P=0.539N (e) |
|POLY 6 | P=0.008N** (e) (e) P=0.094N |P=0.491 P=0.405N P=0.987N (e) |
|LOGISTIC REGRESSION| P=0.003N** (e) (e) P=0.025N* |P=0.487 P=0.282N P=0.395N (e) |
|COCH-ARM / FISHERS | P=0.013N* (e) (e) P=0.111N |P=0.393 P=0.324N P=0.370N (e) |
|ORDER RESTRICTED | P=0.005N** (e) (e) (e) |P=0.323 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 6/49 (12%) 4/49 (8%) 3/50 (6%) |2/49 (4%) 2/49 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/43.21 6/43.99 4/37.98 3/40.89 |2/42.54 2/45.60 2/42.68 0/45.19 |
|POLY-3 PERCENT (g) | 13.9% 13.6% 10.5% 7.3% |4.7% 4.4% 4.7% 0.0% |
|TERMINAL (d) | 2/27 (7%) 3/29 (10%) 0/16 (0%) 1/22 (5%) |2/33 (6%) 2/34 (6%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 539 591 593 698 |730 (T) 730 (T) 509 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259N P=0.587N P=0.564N P=0.320N |P=0.144N P=0.685N P=0.653 P=0.219N |
|POLY 3 | P=0.206N P=0.609N P=0.452N P=0.268N |P=0.150N P=0.669N P=0.693N P=0.224N |
|POLY 1.5 | P=0.193N P=0.617N P=0.418N P=0.255N |P=0.151N P=0.675N P=0.685N P=0.226N |
|POLY 6 | P=0.232N P=0.600N P=0.505N P=0.294N |P=0.148N P=0.665N P=0.682 P=0.222N |
|LOGISTIC REGRESSION| P=0.179N P=0.579 P=0.365N P=0.243N |P=0.153N P=0.685N P=0.689N (e) |
|COCH-ARM / FISHERS | P=0.180N P=0.606 P=0.383N P=0.243N |P=0.153N P=0.691N P=0.684N P=0.242N |
|ORDER RESTRICTED | P=0.273N (e) (e) (e) |P=0.176N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 10/49 (20%) 11/49 (22%) 4/50 (8%) |4/49 (8%) 2/49 (4%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/43.45 10/44.34 11/40.21 4/40.90 |4/42.86 2/45.60 5/43.14 0/45.19 |
|POLY-3 PERCENT (g) | 13.8% 22.6% 27.4% 9.8% |9.3% 4.4% 11.6% 0.0% |
|TERMINAL (d) | 1/27 (4%) 5/29 (17%) 2/16 (13%) 2/22 (9%) |3/33 (9%) 2/34 (6%) 3/28 (11%) 0/36 (0%) |
|FIRST INCIDENCE | 539 591 509 696 |642 730 (T) 509 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.255 P=0.064 P=0.456N |P=0.067N P=0.314N P=0.431 P=0.055N |
|POLY 3 | P=0.148N P=0.216 P=0.100 P=0.407N |P=0.069N P=0.309N P=0.504 P=0.054N |
|POLY 1.5 | P=0.129N P=0.209 P=0.115 P=0.388N |P=0.069N P=0.315N P=0.516 P=0.054N |
|POLY 6 | P=0.187N P=0.224 P=0.080 P=0.443N |P=0.069N P=0.306N P=0.481 P=0.053N |
|LOGISTIC REGRESSION| P=0.109N P=0.177 P=0.159 P=0.370N |P=0.071N P=0.306N P=0.513 P=0.056N |
|COCH-ARM / FISHERS | P=0.113N P=0.194 P=0.133 P=0.370N |P=0.071N P=0.339N P=0.513 P=0.056N |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |P=0.049N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 4/50 (8%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/42.90 0/36.82 4/41.05 |0/42.54 0/45.60 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 9.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 3/22 (14%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 635 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.045 * |(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=0.059 |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** (e) (e) P=0.054 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) P=0.055 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Glands |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 7/49 (14%) 15/50 (30%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/41.77 2/42.90 7/37.35 15/43.59 |0/42.54 0/45.60 0/42.02 4/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 18.7% 34.4% |0.0% 0.0% 0.0% 8.9% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 4/16 (25%) 5/22 (23%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 4/36 (11%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 656 518 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.525 P=0.006 ** P<0.001 ** |P=0.003 ** (e) (e) P=0.074 |
|POLY 3 | P<0.001 ** P=0.509 P=0.019 * P<0.001 ** |P=0.002 ** (e) (e) P=0.068 |
|POLY 1.5 | P<0.001 ** P=0.504 P=0.023 * P<0.001 ** |P=0.002 ** (e) (e) P=0.067 |
|POLY 6 | P<0.001 ** P=0.516 P=0.013 * P<0.001 ** |P=0.002 ** (e) (e) P=0.069 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.525 P=0.010 * P<0.001 ** |(e) (e) (e) P=0.074 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.492 P=0.028 * P<0.001 ** |P=0.002 ** (e) (e) P=0.061 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.002 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Goblet Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 2/49 (4%) 15/50 (30%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/42.12 1/42.90 2/37.58 15/42.99 |0/42.54 0/45.60 0/42.02 3/45.19 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 5.3% 34.9% |0.0% 0.0% 0.0% 6.6% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 7/22 (32%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 631 729 (T) 565 509 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.750N P=0.434 P<0.001 ** |P=0.012 * (e) (e) P=0.136 |
|POLY 3 | P<0.001 ** P=0.757N P=0.460 P<0.001 ** |P=0.008 ** (e) (e) P=0.130 |
|POLY 1.5 | P<0.001 ** P=0.759N P=0.476 P<0.001 ** |P=0.008 ** (e) (e) P=0.128 |
|POLY 6 | P<0.001 ** P=0.754N P=0.435 P<0.001 ** |P=0.008 ** (e) (e) P=0.131 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.757 P=0.518 P<0.001 ** |(e) (e) (e) P=0.136 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.747 P=0.492 P<0.001 ** |P=0.009 ** (e) (e) P=0.125 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.010 * (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 1/50 (2%) |1/49 (2%) 1/49 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 1/42.90 0/36.82 1/40.72 |1/42.54 1/45.60 4/42.44 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 2.5% |2.4% 2.2% 9.4% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 1/22 (5%) |1/33 (3%) 1/34 (3%) 3/28 (11%) 1/36 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 729 (T) |730 (T) 730 (T) 610 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.514 (e) P=0.459 |P=0.516N P=0.755N P=0.143 P=0.742N |
|POLY 3 | P=0.476 P=0.505 (e) P=0.495 |P=0.542N P=0.745N P=0.177 P=0.747N |
|POLY 1.5 | P=0.479 P=0.502 (e) P=0.498 |P=0.542N P=0.749N P=0.184 P=0.749N |
|POLY 6 | P=0.469 P=0.509 (e) P=0.488 |P=0.542N P=0.742N P=0.165 P=0.746N |
|LOGISTIC REGRESSION| (e) P=0.514 (e) P=0.459 |P=0.538N P=0.755N P=0.173 P=0.742N |
|COCH-ARM / FISHERS | P=0.480 P=0.495 (e) P=0.500 |P=0.546N P=0.753N P=0.187 P=0.747N |
|ORDER RESTRICTED | P=0.246 (e) (e) (e) |P=0.325 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 25/49 (51%) 45/49 (92%) 50/50 (100%)|10/49 (20%) 22/49 (45%) 48/50 (96%) 50/50 (100%) |
|POLY-3 RATE (b) | 0/41.77 25/45.91 45/47.80 50/50.00 |10/44.00 22/47.76 48/49.87 50/50.00 |
|POLY-3 PERCENT (g) | 0.0% 54.5% 94.2% 100.0% |22.7% 46.1% 96.2% 100.0% |
|TERMINAL (d) | 0/27 (0%) 17/29 (59%) 16/16 (100%) 22/22 (100%)|6/33 (18%) 15/34 (44%) 27/28 (96%) 36/36 (100%) |
|FIRST INCIDENCE | --- 464 361 254 |380 410 471 283 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.015 * P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P<0.001 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 4/49 (8%) 3/50 (6%) |2/49 (4%) 1/49 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.55 2/43.28 4/37.88 3/40.77 |2/42.86 1/45.60 1/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 4.7% 4.6% 10.6% 7.4% |4.7% 2.2% 2.4% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |1/33 (3%) 1/34 (3%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | 604 621 619 716 |642 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400 P=0.685N P=0.242 P=0.444 |P=0.491N P=0.475N P=0.547N P=0.472N |
|POLY 3 | P=0.425 P=0.688N P=0.284 P=0.480 |P=0.513N P=0.478N P=0.507N P=0.482N |
|POLY 1.5 | P=0.443 P=0.692N P=0.305 P=0.491 |P=0.514N P=0.483N P=0.496N P=0.483N |
|POLY 6 | P=0.393 P=0.684N P=0.254 P=0.460 |P=0.510N P=0.476N P=0.525N P=0.481N |
|LOGISTIC REGRESSION| P=0.463 P=0.653 P=0.348 P=0.497 |P=0.508N P=0.493N P=0.500N P=0.486N |
|COCH-ARM / FISHERS | P=0.462 P=0.684 P=0.329 P=0.500 |P=0.514N P=0.500N P=0.492N P=0.492N |
|ORDER RESTRICTED | P=0.347 (e) (e) (e) |P=0.391N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 5/50 (10%) 3/50 (6%) 8/50 (16%) |
|POLY-3 RATE (b) | |6/42.73 5/47.04 3/42.33 8/45.24 |
|POLY-3 PERCENT (g) | |14.0% 10.6% 7.1% 17.7% |
|TERMINAL (d) | |6/33 (18%) 2/34 (6%) 2/28 (7%) 6/36 (17%) |
|FIRST INCIDENCE | |730 (T) 642 646 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.268 P=0.458N P=0.321N P=0.460 |
|POLY 3 | |P=0.209 P=0.433N P=0.245N P=0.431 |
|POLY 1.5 | |P=0.207 P=0.452N P=0.237N P=0.420 |
|POLY 6 | |P=0.211 P=0.417N P=0.262N P=0.440 |
|LOGISTIC REGRESSION| |P=0.225 P=0.443N P=0.284N P=0.461 |
|COCH-ARM / FISHERS | |P=0.203 P=0.500N P=0.243N P=0.387 |
|ORDER RESTRICTED | |P=0.250 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/49 (2%) 0/50 (0%) |4/49 (8%) 4/50 (8%) 1/50 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 1/41.77 3/43.38 1/37.13 0/40.72 |4/42.54 4/46.42 1/42.14 4/45.31 |
|POLY-3 PERCENT (g) | 2.4% 6.9% 2.7% 0.0% |9.4% 8.6% 2.4% 8.8% |
|TERMINAL (d) | 1/27 (4%) 3/29 (10%) 0/16 (0%) 0/22 (0%) |4/33 (12%) 4/34 (12%) 0/28 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 646 --- |730 (T) 730 (T) 698 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.215N P=0.330 P=0.678 P=0.541N |P=0.593 P=0.629N P=0.230N P=0.598N |
|POLY 3 | P=0.174N P=0.318 P=0.734 P=0.505N |P=0.558 P=0.595N P=0.181N P=0.608N |
|POLY 1.5 | P=0.173N P=0.315 P=0.745 P=0.502N |P=0.550 P=0.604N P=0.174N P=0.616N |
|POLY 6 | P=0.179N P=0.323 P=0.716 P=0.512N |P=0.567 P=0.590N P=0.193N P=0.602N |
|LOGISTIC REGRESSION| P=0.194N P=0.330 P=0.741 (e) |P=0.570 P=0.629N P=0.211N P=0.604N |
|COCH-ARM / FISHERS | P=0.173N P=0.309 P=0.747 P=0.500N |P=0.534 P=0.631N P=0.175N P=0.643N |
|ORDER RESTRICTED | P=0.165N (e) (e) (e) |P=0.404N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/49 (4%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/42.36 1/43.90 2/36.95 0/40.72 |1/42.72 0/46.42 1/42.02 0/45.13 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 5.4% 0.0% |2.3% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 539 569 696 --- |684 --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.345N P=0.758N P=0.396 P=0.500N |P=0.461N P=0.495N P=0.727 P=0.490N |
|POLY 3 | P=0.334N P=0.753N P=0.452 P=0.508N |P=0.480N P=0.483N P=0.757 P=0.489N |
|POLY 1.5 | P=0.326N P=0.755N P=0.472 P=0.504N |P=0.480N P=0.486N P=0.758N P=0.491N |
|POLY 6 | P=0.349N P=0.750N P=0.422 P=0.516N |P=0.478N P=0.482N P=0.746 P=0.488N |
|LOGISTIC REGRESSION| P=0.306N P=0.677 P=0.501 P=0.498N |P=0.474N P=0.504N P=0.760 P=0.507N |
|COCH-ARM / FISHERS | P=0.317N P=0.753N P=0.492 P=0.500N |P=0.480N P=0.495N P=0.747N P=0.500N |
|ORDER RESTRICTED | P=0.267N (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 4/49 (8%) 2/50 (4%) |3/49 (6%) 6/50 (12%) 3/50 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/42.58 2/43.69 4/37.66 2/40.72 |3/43.02 6/46.74 3/42.67 3/45.13 |
|POLY-3 PERCENT (g) | 11.7% 4.6% 10.6% 4.9% |7.0% 12.8% 7.0% 6.7% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 2/16 (13%) 2/22 (9%) |2/33 (6%) 5/34 (15%) 1/28 (4%) 3/36 (8%) |
|FIRST INCIDENCE | 604 642 509 729 (T) |587 642 593 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373N P=0.202N P=0.554 P=0.291N |P=0.347N P=0.271 P=0.612 P=0.627N |
|POLY 3 | P=0.317N P=0.205N P=0.577N P=0.233N |P=0.370N P=0.284 P=0.659 P=0.640N |
|POLY 1.5 | P=0.304N P=0.208N P=0.545N P=0.224N |P=0.376N P=0.277 P=0.655N P=0.644N |
|POLY 6 | P=0.342N P=0.202N P=0.629N P=0.253N |P=0.366N P=0.288 P=0.641 P=0.640N |
|LOGISTIC REGRESSION| P=0.297N P=0.215N P=0.534N P=0.226N |P=0.383N P=0.267 P=0.655N P=0.647N |
|COCH-ARM / FISHERS | P=0.290N P=0.218N P=0.513N P=0.218N |P=0.394N P=0.254 P=0.651N P=0.661N |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.451N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 2/50 (4%) 3/49 (6%) 7/50 (14%) |15/50 (30%) 10/50 (20%) 11/49 (22%) 17/50 (34%) |
|POLY-3 RATE (b) | 6/42.17 2/43.38 3/37.14 7/41.54 |15/43.75 10/46.43 11/41.56 17/45.99 |
|POLY-3 PERCENT (g) | 14.2% 4.6% 8.1% 16.9% |34.3% 21.5% 26.5% 37.0% |
|TERMINAL (d) | 3/27 (11%) 2/29 (7%) 1/16 (6%) 4/22 (18%) |11/33 (33%) 9/34 (27%) 9/28 (32%) 15/36 (42%) |
|FIRST INCIDENCE | 458 729 (T) 656 550 |587 726 634 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.109 P=0.119N P=0.464N P=0.394 |P=0.238 P=0.150N P=0.406N P=0.527 |
|POLY 3 | P=0.153 P=0.122N P=0.307N P=0.488 |P=0.162 P=0.130N P=0.290N P=0.482 |
|POLY 1.5 | P=0.160 P=0.123N P=0.275N P=0.503 |P=0.157 P=0.139N P=0.265N P=0.468 |
|POLY 6 | P=0.140 P=0.123N P=0.359N P=0.460 |P=0.170 P=0.131N P=0.342N P=0.487 |
|LOGISTIC REGRESSION| P=0.157 P=0.127N P=0.264N P=0.511 |P=0.176 P=0.113N P=0.311N P=0.489 |
|COCH-ARM / FISHERS | P=0.168 P=0.128N P=0.243N P=0.516 |P=0.149 P=0.178N P=0.266N P=0.415 |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) |P=0.247 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Pleura: Mesothelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.04 0/43.38 0/36.82 2/40.72 |0/42.73 0/46.42 0/41.14 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * (e) (e) P=0.194 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.239 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.227 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.194 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.253 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/49 (6%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/42.26 3/43.38 3/38.13 0/40.72 | |
|POLY-3 PERCENT (g) | 4.7% 6.9% 7.9% 0.0% | |
|TERMINAL (d) | 0/27 (0%) 3/29 (10%) 0/16 (0%) 0/22 (0%) | |
|FIRST INCIDENCE | 642 729 (T) 361 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.155N P=0.536 P=0.409 P=0.263N | |
|POLY 3 | P=0.127N P=0.512 P=0.453 P=0.245N | |
|POLY 1.5 | P=0.122N P=0.509 P=0.473 P=0.241N | |
|POLY 6 | P=0.137N P=0.513 P=0.419 P=0.255N | |
|LOGISTIC REGRESSION| P=0.113N P=0.516 P=0.529 P=0.237N | |
|COCH-ARM / FISHERS | P=0.117N P=0.500 P=0.490 P=0.247N | |
|ORDER RESTRICTED | P=0.131N (e) (e) (e) | |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 4/49 (8%) 0/50 (0%) | |
|POLY-3 RATE (b) | 4/42.40 0/43.38 4/37.28 0/40.72 | |
|POLY-3 PERCENT (g) | 9.4% 0.0% 10.7% 0.0% | |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 1/16 (6%) 0/22 (0%) | |
|FIRST INCIDENCE | 655 --- 656 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.057N P=0.440 P=0.084N | |
|POLY 3 | P=0.141N P=0.057N P=0.571 P=0.065N | |
|POLY 1.5 | P=0.134N P=0.058N P=0.602 P=0.062N | |
|POLY 6 | P=0.154N P=0.057N P=0.522 P=0.071N | |
|LOGISTIC REGRESSION| P=0.136N P=0.061N P=0.565 P=0.064N | |
|COCH-ARM / FISHERS | P=0.129N P=0.059N P=0.631 P=0.059N | |
|ORDER RESTRICTED | P=0.028N* (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 24/50 (48%) 27/49 (55%) 27/50 (54%) | |
|POLY-3 RATE (b) | 31/46.04 24/45.85 27/43.15 27/45.25 | |
|POLY-3 PERCENT (g) | 67.3% 52.4% 62.6% 59.7% | |
|TERMINAL (d) | 16/27 (59%) 15/29 (52%) 9/16 (56%) 10/22 (46%) | |
|FIRST INCIDENCE | 465 509 431 509 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344 P=0.097N P=0.207 P=0.550N | |
|POLY 3 | P=0.501N P=0.098N P=0.398N P=0.288N | |
|POLY 1.5 | P=0.492N P=0.097N P=0.346N P=0.275N | |
|POLY 6 | P=0.516N P=0.112N P=0.498N P=0.322N | |
|LOGISTIC REGRESSION| P=0.497N P=0.091N P=0.374N P=0.282N | |
|COCH-ARM / FISHERS | P=0.474N P=0.114N P=0.311N P=0.272N | |
|ORDER RESTRICTED | P=0.276N (e) (e) (e) | |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 3/49 (6%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.77 5/43.53 3/37.41 1/40.72 |0/42.73 1/46.42 1/42.57 0/45.19 |
|POLY-3 PERCENT (g) | 7.2% 11.5% 8.0% 2.5% |0.0% 2.2% 2.4% 0.0% |
|TERMINAL (d) | 3/27 (11%) 4/29 (14%) 1/16 (6%) 1/22 (5%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 689 561 729 (T) |--- 730 (T) 559 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.401 P=0.450 P=0.379N |P=0.511N P=0.506 P=0.504 (e) |
|POLY 3 | P=0.137N P=0.379 P=0.611 P=0.314N |P=0.508N P=0.517 P=0.499 (e) |
|POLY 1.5 | P=0.134N P=0.372 P=0.632 P=0.309N |P=0.512N P=0.512 P=0.502 (e) |
|POLY 6 | P=0.147N P=0.388 P=0.577 P=0.325N |P=0.505N P=0.519 P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.155N P=0.399 P=0.580 P=0.379N |P=0.538N P=0.506 P=0.432 (e) |
|COCH-ARM / FISHERS | P=0.131N P=0.357 P=0.651 P=0.309N |P=0.522N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.174N (e) (e) (e) |P=0.400N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 6/49 (12%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.84 1/43.38 6/36.90 1/40.72 |0/42.73 0/46.42 1/42.14 0/45.19 |
|POLY-3 PERCENT (g) | 7.2% 2.3% 16.3% 2.5% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 5/16 (31%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 712 729 (T) 709 729 (T) |--- --- 698 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.284N P=0.061 P=0.382N |P=0.761N (e) P=0.477 (e) |
|POLY 3 | P=0.327N P=0.292N P=0.181 P=0.314N |P=0.770N (e) P=0.497 (e) |
|POLY 1.5 | P=0.313N P=0.296N P=0.206 P=0.309N |P=0.770N (e) P=0.501 (e) |
|POLY 6 | P=0.353N P=0.287N P=0.145 P=0.326N |P=0.769N (e) P=0.490 (e) |
|LOGISTIC REGRESSION| P=0.379N P=0.275N P=0.078 P=0.357N |P=0.771N (e) P=0.499 (e) |
|COCH-ARM / FISHERS | P=0.300N P=0.309N P=0.233 P=0.309N |P=0.772N (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.229N (e) (e) (e) |P=0.379 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 2/41.01 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- 648 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * (e) (e) P=0.217 |(e) (e) (e) (e) |
|POLY 3 | P=0.040 * (e) (e) P=0.233 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.041 * (e) (e) P=0.235 |(e) (e) (e) (e) |
|POLY 6 | P=0.038 * (e) (e) P=0.227 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.042 * (e) (e) P=0.234 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.028 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 0/36.82 2/41.29 |1/43.05 0/46.42 0/42.02 1/45.51 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 4.8% |2.3% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 648 |642 --- --- 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.164 P=0.486N P=0.604N P=0.470 |P=0.525 P=0.469N P=0.515N P=0.746N |
|POLY 3 | P=0.171 P=0.492N P=0.525N P=0.496 |P=0.520 P=0.485N P=0.505N P=0.748N |
|POLY 1.5 | P=0.173 P=0.495N P=0.515N P=0.499 |P=0.520 P=0.488N P=0.500N P=0.751N |
|POLY 6 | P=0.167 P=0.490N P=0.542N P=0.489 |P=0.522 P=0.484N P=0.514N P=0.746N |
|LOGISTIC REGRESSION| P=0.175 (e) (e) P=0.499 |P=0.507 P=0.541N P=0.512N P=0.743 |
|COCH-ARM / FISHERS | P=0.176 P=0.500N P=0.505N P=0.500 |P=0.522 P=0.500N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.130 (e) (e) (e) |P=0.385N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/49 (8%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.22 3/43.51 4/38.47 1/40.72 |1/42.86 2/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.7% 6.9% 10.4% 2.5% |2.3% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 2/34 (6%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 656 697 431 729 (T) |642 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344N P=0.544 P=0.253 P=0.538N |P=0.232N P=0.525 P=0.515N P=0.486N |
|POLY 3 | P=0.300N P=0.514 P=0.294 P=0.513N |P=0.228N P=0.528 P=0.504N P=0.489N |
|POLY 1.5 | P=0.289N P=0.510 P=0.312 P=0.506N |P=0.232N P=0.523 P=0.498N P=0.490N |
|POLY 6 | P=0.322N P=0.517 P=0.264 P=0.528N |P=0.224N P=0.529 P=0.514N P=0.489N |
|LOGISTIC REGRESSION| P=0.272N P=0.513 P=0.363 P=0.505N |P=0.237N P=0.514 P=0.506N P=0.515N |
|COCH-ARM / FISHERS | P=0.279N P=0.500 P=0.329 P=0.500N |P=0.238N P=0.508 P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.285N (e) (e) (e) |P=0.172N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 7/49 (14%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/42.15 1/43.38 7/38.20 4/40.87 |0/42.54 0/46.42 0/42.02 2/45.21 |
|POLY-3 PERCENT (g) | 11.9% 2.3% 18.3% 9.8% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 3/27 (11%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 642 729 (T) 611 696 |--- --- --- 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434 P=0.092N P=0.166 P=0.606N |P=0.055 (e) (e) P=0.262 |
|POLY 3 | P=0.498 P=0.094N P=0.309 P=0.520N |P=0.042 * (e) (e) P=0.251 |
|POLY 1.5 | P=0.516 P=0.096N P=0.336 P=0.508N |P=0.042 * (e) (e) P=0.249 |
|POLY 6 | P=0.464 P=0.092N P=0.270 P=0.543N |P=0.043 * (e) (e) P=0.252 |
|LOGISTIC REGRESSION| P=0.510 P=0.091N P=0.297 P=0.552N |P=0.051 (e) (e) P=0.256 |
|COCH-ARM / FISHERS | P=0.537 P=0.102N P=0.365 P=0.500N |P=0.043 * (e) (e) P=0.253 |
|ORDER RESTRICTED | P=0.234 (e) (e) (e) |P=0.034 * (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 3/50 (6%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.70 0/43.38 1/37.13 3/41.72 |1/42.54 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.7% 7.2% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 296 --- 646 582 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.079 P=0.500N P=0.736 P=0.294 |P=0.529N P=0.494N P=0.533N P=0.483N |
|POLY 3 | P=0.076 P=0.497N P=0.729 P=0.296 |P=0.550N P=0.483N P=0.502N P=0.488N |
|POLY 1.5 | P=0.078 P=0.498N P=0.741 P=0.300 |P=0.550N P=0.486N P=0.497N P=0.490N |
|POLY 6 | P=0.073 P=0.495N P=0.710 P=0.290 |P=0.548N P=0.481N P=0.512N P=0.487N |
|LOGISTIC REGRESSION| P=0.089 (e) P=0.754 P=0.289 |P=0.529N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.081 P=0.500N P=0.747 P=0.309 |P=0.545N P=0.495N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.076 (e) (e) (e) |P=0.109N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 5/49 (10%) 1/50 (2%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/42.20 2/43.46 5/39.08 1/40.77 |0/42.54 1/46.60 0/42.02 3/46.32 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 12.8% 2.5% |0.0% 2.2% 0.0% 6.5% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 604 709 509 716 |--- 684 --- 550 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.468N P=0.513 P=0.083 P=0.739 |P=0.049 * P=0.505 (e) P=0.136 |
|POLY 3 | P=0.459N P=0.510 P=0.083 P=0.753 |P=0.045 * P=0.518 (e) P=0.135 |
|POLY 1.5 | P=0.444N P=0.507 P=0.090 P=0.757 |P=0.043 * P=0.515 (e) P=0.131 |
|POLY 6 | P=0.485N P=0.513 P=0.073 P=0.745 |P=0.047 * P=0.521 (e) P=0.138 |
|LOGISTIC REGRESSION| P=0.413N P=0.499 P=0.115 P=0.761N |P=0.034 * P=0.496 (e) P=0.090 |
|COCH-ARM / FISHERS | P=0.430N P=0.500 P=0.098 P=0.753N |P=0.042 * P=0.505 (e) P=0.125 |
|ORDER RESTRICTED | P=0.236 (e) (e) (e) |P=0.026 * (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/49 (4%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/42.47 1/43.38 2/37.61 4/42.11 |0/42.54 0/46.42 0/42.02 0/45.13 |
|POLY-3 PERCENT (g) | 4.7% 2.3% 5.3% 9.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 604 729 (T) 537 550 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 P=0.488N P=0.621 P=0.331 |(e) (e) (e) (e) |
|POLY 3 | P=0.142 P=0.493N P=0.650 P=0.332 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.145 P=0.494N P=0.668 P=0.336 |(e) (e) (e) (e) |
|POLY 6 | P=0.137 P=0.493N P=0.619 P=0.323 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.154 P=0.516N P=0.677N P=0.339 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.147 P=0.500N P=0.684 P=0.339 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.169 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/49 (6%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 4/50 (8%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/43.20 0/43.38 3/37.43 4/42.28 |0/42.54 0/46.42 4/42.93 0/45.13 |
|POLY-3 PERCENT (g) | 6.9% 0.0% 8.0% 9.5% |0.0% 0.0% 9.3% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 296 --- 646 550 |--- --- 528 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 P=0.124N P=0.536 P=0.477 |P=0.510N (e) P=0.054 (e) |
|POLY 3 | P=0.179 P=0.118N P=0.595 P=0.488 |P=0.524N (e) P=0.061 (e) |
|POLY 1.5 | P=0.182 P=0.118N P=0.621 P=0.493 |P=0.525N (e) P=0.064 (e) |
|POLY 6 | P=0.172 P=0.117N P=0.556 P=0.479 |P=0.525N (e) P=0.057 (e) |
|LOGISTIC REGRESSION| P=0.201 P=0.195N P=0.634N P=0.494 |P=0.569N (e) P=0.063 (e) |
|COCH-ARM / FISHERS | P=0.188 P=0.121N P=0.651 P=0.500 |P=0.535N (e) P=0.061 (e) |
|ORDER RESTRICTED | P=0.183 (e) (e) (e) |P=0.110 (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 3/49 (6%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 3/37.59 0/40.72 |0/42.54 0/46.42 0/42.02 0/45.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 509 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610N (e) P=0.075 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.605N (e) P=0.100 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.594N (e) P=0.107 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.625N (e) P=0.089 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.574N (e) P=0.123 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.580N (e) P=0.117 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.144 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 19/50 (38%) 18/49 (37%) 20/50 (40%) | |
|POLY-3 RATE (b) | 20/44.56 19/46.37 18/40.71 20/43.92 | |
|POLY-3 PERCENT (g) | 44.9% 41.0% 44.2% 45.5% | |
|TERMINAL (d) | 9/27 (33%) 10/29 (35%) 4/16 (25%) 7/22 (32%) | |
|FIRST INCIDENCE | 625 509 509 550 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 P=0.411N P=0.252 P=0.398 | |
|POLY 3 | P=0.449 P=0.434N P=0.563N P=0.561 | |
|POLY 1.5 | P=0.471 P=0.450N P=0.503N P=0.576 | |
|POLY 6 | P=0.412 P=0.435N P=0.520 P=0.524 | |
|LOGISTIC REGRESSION| P=0.481 P=0.489N P=0.525N P=0.566 | |
|COCH-ARM / FISHERS | P=0.498 P=0.500N P=0.449N P=0.581N | |
|ORDER RESTRICTED | P=0.620 (e) (e) (e) | |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 8/49 (16%) 8/50 (16%) | |
|POLY-3 RATE (b) | 4/41.79 3/43.96 8/39.07 8/42.23 | |
|POLY-3 PERCENT (g) | 9.6% 6.8% 20.5% 18.9% | |
|TERMINAL (d) | 3/27 (11%) 1/29 (3%) 1/16 (6%) 3/22 (14%) | |
|FIRST INCIDENCE | 723 642 509 550 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.076 P=0.459N P=0.065 P=0.126 | |
|POLY 3 | P=0.095 P=0.472N P=0.141 P=0.179 | |
|POLY 1.5 | P=0.099 P=0.482N P=0.154 P=0.180 | |
|POLY 6 | P=0.087 P=0.459N P=0.123 P=0.174 | |
|LOGISTIC REGRESSION| P=0.104 P=0.478N P=0.152 P=0.168 | |
|COCH-ARM / FISHERS | P=0.105 P=0.500N P=0.168 P=0.178 | |
|ORDER RESTRICTED | P=0.092 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 4/50 (8%) 7/49 (14%) 7/50 (14%) |9/49 (18%) 8/50 (16%) 7/50 (14%) 5/50 (10%) |
|POLY-3 RATE (b) | 8/42.18 4/43.69 7/38.44 7/41.55 |9/43.24 8/47.24 7/42.33 5/45.83 |
|POLY-3 PERCENT (g) | 19.0% 9.2% 18.2% 16.9% |20.8% 16.9% 16.5% 10.9% |
|TERMINAL (d) | 6/27 (22%) 3/29 (10%) 2/16 (13%) 4/22 (18%) |7/33 (21%) 5/34 (15%) 6/28 (21%) 4/36 (11%) |
|FIRST INCIDENCE | 625 642 565 639 |625 621 646 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355 P=0.151N P=0.397 P=0.581 |P=0.136N P=0.451N P=0.517N P=0.155N |
|POLY 3 | P=0.455 P=0.158N P=0.579N P=0.513N |P=0.155N P=0.420N P=0.409N P=0.160N |
|POLY 1.5 | P=0.467 P=0.164N P=0.548N P=0.505N |P=0.158N P=0.435N P=0.384N P=0.164N |
|POLY 6 | P=0.430 P=0.150N P=0.604 P=0.532N |P=0.152N P=0.410N P=0.453N P=0.158N |
|LOGISTIC REGRESSION| P=0.455 P=0.152N P=0.607N P=0.545N |P=0.158N P=0.449N P=0.425N P=0.171N |
|COCH-ARM / FISHERS | P=0.482 P=0.178N P=0.517N P=0.500N |P=0.165N P=0.482N P=0.376N P=0.183N |
|ORDER RESTRICTED | P=0.455N (e) (e) (e) |P=0.159N (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Tongue: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) 3/3 (100%) 1/1 (100%) |1/2 (50%) 0/0 (0%) 0/0 (0%) 0/1 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 3/3.00 1/1.00 |1/2.00 0/0.00 0/0.00 0/0.97 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 100.0% |50.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/2 (100%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |1/2 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 729 (T) --- 537 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=1.000 P=1.000 P=1.000 P=1.000 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) P=0.618N |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) P=0.616N |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) P=0.623N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=1.000 (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.543N P=1.000 P=1.000 P=0.667N |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Urethra: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/1.00 0/0.00 1/1.00 2/2.00 |0/0.00 0/0.00 0/0.00 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 100.0% |0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | 729 (T) --- 722 724 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/04/03 EXPERIMENT: 90004 TEST: 07 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/49 (2%) 3/49 (6%) 6/50 (12%) |1/49 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/42.22 1/42.90 3/37.80 6/41.77 |1/42.71 1/46.62 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 7.1% 2.3% 7.9% 14.4% |2.3% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 656 729 (T) 565 582 |687 676 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049 * P=0.278N P=0.517 P=0.201 |P=0.346N P=0.747N P=0.522N P=0.495N |
|POLY 3 | P=0.055 P=0.299N P=0.611 P=0.235 |P=0.341N P=0.741N P=0.503N P=0.489N |
|POLY 1.5 | P=0.058 P=0.303N P=0.632 P=0.240 |P=0.344N P=0.744N P=0.498N P=0.490N |
|POLY 6 | P=0.050 P=0.296N P=0.576 P=0.222 |P=0.337N P=0.739N P=0.513N P=0.488N |
|LOGISTIC REGRESSION| P=0.061 P=0.299N P=0.659 P=0.239 |P=0.348N P=0.761 P=0.496N P=0.497N |
|COCH-ARM / FISHERS | P=0.062 P=0.316N P=0.651 P=0.243 |P=0.346N P=0.747N P=0.495N P=0.495N |
|ORDER RESTRICTED | P=0.071 (e) (e) (e) |P=0.241N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/42.73 0/46.42 1/42.02 2/45.19 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 2.4% 4.4% |
|TERMINAL (d) | |0/33 (0%) 0/34 (0%) 1/28 (4%) 2/36 (6%) |
|FIRST INCIDENCE | |--- --- 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.118 (e) P=0.467 P=0.258 |
|POLY 3 | |P=0.099 (e) P=0.497 P=0.250 |
|POLY 1.5 | |P=0.099 (e) P=0.501 P=0.247 |
|POLY 6 | |P=0.099 (e) P=0.488 P=0.252 |
|LOGISTIC REGRESSION| |(e) (e) P=0.467 P=0.258 |
|COCH-ARM / FISHERS | |P=0.097 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | |P=0.082 (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).