TDMS Study 93026-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest DECALIN DATE: 08/28/01
EXPERIMENT: 93026 TEST: 07 TIME: 09:21:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: RENNE, ROGER CAS: 91-17-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 002 CONTROL
INCLUDE 004 25 PPM
INCLUDE 007 100 PPM
INCLUDE 009 400 PPM
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest DECALIN DATE: 08/28/01
EXPERIMENT: 93026 TEST: 07 TIME: 09:21:58
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: RENNE, ROGER CAS: 91-17-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DECALIN
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Brain Hemorrhage
Eye Atrophy
Eye: Lens Cataract
Kidney Nephropathy Chronic
Kidney: Pelvis Mineralization
Larynx Foreign Body
Inflammation
Lung: Alveolus Infiltration Cellular Histiocyte
Proteinosis
Lung: Interstitium Fibrosis
Pleura Inflammation Chronic
Spleen Fibrosis
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/48 (0%) 2/49 (4%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/44.73 0/45.50 2/46.14 2/40.74 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 4.3% 4.9% |
|TERMINAL (d) | 2/32 (6%) 0/35 (0%) 2/39 (5%) 2/28 (7%) |
|FIRST INCIDENCE | 680 --- 734 (T) 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.486 P=0.107N P=0.420N P=0.558N |
|POLY 3 | P=0.510 P=0.116N P=0.486N P=0.543N |
|POLY 1.5 | P=0.533 P=0.120N P=0.496N P=0.527N |
|POLY 6 | P=0.480 P=0.110N P=0.472N P=0.563N |
|LOGISTIC REGRESSION| P=0.486 P=0.118N P=0.472N P=0.566N |
|COCH-ARM / FISHERS | P=0.565 P=0.129N P=0.510N P=0.510N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 7/48 (15%) 11/49 (22%) 8/49 (16%) |
|POLY-3 RATE (b) | 7/44.73 7/45.91 11/46.14 8/41.55 |
|POLY-3 PERCENT (g) | 15.7% 15.3% 23.8% 19.3% |
|TERMINAL (d) | 6/32 (19%) 4/35 (11%) 11/39 (28%) 5/28 (18%) |
|FIRST INCIDENCE | 680 638 734 (T) 634 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309 P=0.536N P=0.367 P=0.389 |
|POLY 3 | P=0.405 P=0.593N P=0.237 P=0.438 |
|POLY 1.5 | P=0.446 P=0.613 P=0.222 P=0.458 |
|POLY 6 | P=0.357 P=0.566N P=0.258 P=0.415 |
|LOGISTIC REGRESSION| P=0.348 P=0.585N P=0.309 P=0.403 |
|COCH-ARM / FISHERS | P=0.501 P=0.581 P=0.204 P=0.483 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/48 (4%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/44.85 2/45.50 0/46.14 0/40.74 |
|POLY-3 PERCENT (g) | 6.7% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/35 (6%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 666 734 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.121N P=0.464N P=0.103N P=0.160N |
|POLY 3 | P=0.109N P=0.493N P=0.114N P=0.136N |
|POLY 1.5 | P=0.104N P=0.503N P=0.117N P=0.130N |
|POLY 6 | P=0.115N P=0.482N P=0.109N P=0.146N |
|LOGISTIC REGRESSION| P=0.105N P=0.498N P=0.124N P=0.132N |
|COCH-ARM / FISHERS | P=0.098N P=0.520N P=0.125N P=0.125N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/50 (12%) 5/49 (10%) 6/49 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/46.18 5/45.84 6/46.58 3/42.76 |
|POLY-3 PERCENT (g) | 13.0% 10.9% 12.9% 7.0% |
|TERMINAL (d) | 2/32 (6%) 4/35 (11%) 4/39 (10%) 0/28 (0%) |
|FIRST INCIDENCE | 525 728 665 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309N P=0.448N P=0.527N P=0.311N |
|POLY 3 | P=0.254N P=0.505N P=0.615N P=0.281N |
|POLY 1.5 | P=0.232N P=0.508N P=0.617 P=0.264N |
|POLY 6 | P=0.283N P=0.500N P=0.600N P=0.304N |
|LOGISTIC REGRESSION| P=0.156N P=0.570N P=0.554 P=0.175N |
|COCH-ARM / FISHERS | P=0.203N P=0.514N P=0.606 P=0.243N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/49 (2%) 3/49 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/44.52 1/46.08 3/47.21 6/43.72 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 6.4% 13.7% |
|TERMINAL (d) | 1/32 (3%) 0/35 (0%) 1/39 (3%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 663 349 492 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.008 ** P=0.745N P=0.351 P=0.048 * |
|POLY 3 | P=0.011 * P=0.753N P=0.327 P=0.052 |
|POLY 1.5 | P=0.013 * P=0.758N P=0.315 P=0.054 |
|POLY 6 | P=0.010 * P=0.746N P=0.341 P=0.051 |
|LOGISTIC REGRESSION| P=0.040 * P=0.753 P=0.237 P=0.073 |
|COCH-ARM / FISHERS | P=0.015 * P=0.747 P=0.301 P=0.056 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 3/49 (6%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/43.41 3/45.92 2/46.14 1/41.60 |
|POLY-3 PERCENT (g) | 4.6% 6.5% 4.3% 2.4% |
|TERMINAL (d) | 2/31 (7%) 2/35 (6%) 2/39 (5%) 1/28 (4%) |
|FIRST INCIDENCE | 734 (T) 708 734 (T) 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.376N P=0.558 P=0.610N P=0.536N |
|POLY 3 | P=0.334N P=0.526 P=0.672N P=0.515N |
|POLY 1.5 | P=0.317N P=0.518 P=0.679N P=0.503N |
|POLY 6 | P=0.354N P=0.539 P=0.660N P=0.529N |
|LOGISTIC REGRESSION| P=0.379N P=0.555 P=0.610N P=0.536N |
|COCH-ARM / FISHERS | P=0.293N P=0.510 P=0.684N P=0.485N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 3/49 (6%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/43.66 3/45.84 1/46.14 3/41.60 |
|POLY-3 PERCENT (g) | 6.9% 6.6% 2.2% 7.2% |
|TERMINAL (d) | 2/31 (7%) 2/35 (6%) 1/39 (3%) 3/28 (11%) |
|FIRST INCIDENCE | 666 728 734 (T) 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.476 P=0.610N P=0.242N P=0.609 |
|POLY 3 | P=0.537 P=0.640N P=0.286N P=0.640 |
|POLY 1.5 | P=0.557 P=0.646N P=0.292N P=0.657 |
|POLY 6 | P=0.511 P=0.629N P=0.276N P=0.619 |
|LOGISTIC REGRESSION| P=0.487 P=0.632N P=0.288N P=0.617 |
|COCH-ARM / FISHERS | P=0.586 P=0.651N P=0.301N P=0.641N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Eye |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 2/2 (100%) 0/5 (0%) 0/4 (0%) |
|POLY-3 RATE (b) | 0/1.00 2/2.00 0/4.75 0/3.46 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 0.0% |
|TERMINAL (d) | 0/1 (0%) 0/0 (0%) 0/4 (0%) 0/3 (0%) |
|FIRST INCIDENCE | --- 638 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.434N P=0.253 (e) (e) |
|POLY 3 | P<0.001N** P=1.000N (e) (e) |
|POLY 1.5 | P<0.001N** P=1.000N (e) (e) |
|POLY 6 | P<0.001N** P=1.000N (e) (e) |
|LOGISTIC REGRESSION| P=0.129N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.221N P=0.333 (e) (e) |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Eye: Lens |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/1 (100%) 0/2 (0%) 3/5 (60%) 2/4 (50%) |
|POLY-3 RATE (b) | 1/1.00 0/1.39 3/5.00 2/3.46 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 60.0% 57.8% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 2/4 (50%) 2/3 (67%) |
|FIRST INCIDENCE | 734 (T) --- 666 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.683N P=1.000N P=0.743 P=0.718N |
|POLY 3 | P=0.710 P<0.001N** P=0.631N P=0.652N |
|POLY 1.5 | P=0.690 P<0.001N** P=0.631N P=0.618N |
|POLY 6 | P=0.700N P=0.574N P=0.631N P=0.691N |
|LOGISTIC REGRESSION| P=0.732 (e) (e) P=0.718N |
|COCH-ARM / FISHERS | P=0.674 P=0.333N P=0.667N P=0.600N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.52 2/46.62 1/46.35 0/41.60 |
|POLY-3 PERCENT (g) | 4.5% 4.3% 2.2% 0.0% |
|TERMINAL (d) | 2/32 (6%) 0/35 (0%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 722 680 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.192N P=0.642N P=0.443N P=0.268N |
|POLY 3 | P=0.175N P=0.677N P=0.486N P=0.252N |
|POLY 1.5 | P=0.167N P=0.684N P=0.495N P=0.245N |
|POLY 6 | P=0.185N P=0.668N P=0.473N P=0.262N |
|LOGISTIC REGRESSION| P=0.171N P=0.661N P=0.494N (e) |
|COCH-ARM / FISHERS | P=0.156N P=0.691N P=0.508N P=0.247N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/46 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.52 2/43.79 1/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 2.3% 4.6% 2.2% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/35 (6%) 1/39 (3%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 734 (T) 734 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.275N P=0.531 P=0.717N P=0.527N |
|POLY 3 | P=0.251N P=0.494 P=0.753N P=0.514N |
|POLY 1.5 | P=0.242N P=0.485 P=0.758N P=0.507N |
|POLY 6 | P=0.262N P=0.507 P=0.745N P=0.522N |
|LOGISTIC REGRESSION| P=0.275N P=0.531 P=0.717N (e) |
|COCH-ARM / FISHERS | P=0.231N P=0.468 P=0.747 P=0.500N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 43/50 (86%) 45/46 (98%) 48/49 (98%) 48/50 (96%) |
|POLY-3 RATE (b) | 43/47.48 45/46.00 48/48.11 48/49.14 |
|POLY-3 PERCENT (g) | 90.6% 97.8% 99.8% 97.7% |
|TERMINAL (d) | 31/32 (97%) 34/35 (97%) 39/39 (100%) 28/28 (100%) |
|FIRST INCIDENCE | 561 533 617 492 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** P=0.421N P=0.343N P=0.042 * |
|POLY 3 | P=0.245 P=0.122 P=0.029 * P=0.114 |
|POLY 1.5 | P=0.231 P=0.076 P=0.024 * P=0.094 |
|POLY 6 | P=0.273 P=0.218 P=0.052 P=0.156 |
|LOGISTIC REGRESSION| P=0.057 P=0.110 P=0.068 P=0.027 * |
|COCH-ARM / FISHERS | P=0.223 P=0.039 * P=0.032 * P=0.080 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Cortex, Renal Tubule |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/46 (9%) 4/49 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.52 4/43.79 4/46.19 2/41.60 |
|POLY-3 PERCENT (g) | 2.3% 9.1% 8.7% 4.8% |
|TERMINAL (d) | 1/32 (3%) 4/35 (11%) 3/39 (8%) 2/28 (7%) |
|FIRST INCIDENCE | 734 (T) 734 (T) 722 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.617N P=0.206 P=0.245 P=0.453 |
|POLY 3 | P=0.537N P=0.173 P=0.190 P=0.476 |
|POLY 1.5 | P=0.514N P=0.166 P=0.182 P=0.487 |
|POLY 6 | P=0.567N P=0.184 P=0.201 P=0.462 |
|LOGISTIC REGRESSION| P=0.621 P=0.206 P=0.220 P=0.453 |
|COCH-ARM / FISHERS | P=0.485N P=0.156 P=0.175 P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Papilla |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 2/46 (4%) 4/49 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/44.95 2/43.79 4/46.14 4/41.92 |
|POLY-3 PERCENT (g) | 6.7% 4.6% 8.7% 9.5% |
|TERMINAL (d) | 1/32 (3%) 2/35 (6%) 4/39 (10%) 3/28 (11%) |
|FIRST INCIDENCE | 666 734 (T) 734 (T) 644 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.254 P=0.463N P=0.588 P=0.426 |
|POLY 3 | P=0.324 P=0.512N P=0.514 P=0.462 |
|POLY 1.5 | P=0.351 P=0.522N P=0.503 P=0.479 |
|POLY 6 | P=0.291 P=0.499N P=0.528 P=0.439 |
|LOGISTIC REGRESSION| P=0.315 P=0.534N P=0.514 P=0.472 |
|COCH-ARM / FISHERS | P=0.385 P=0.540N P=0.489 P=0.500 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Pelvis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 16/46 (35%) 19/49 (39%) 18/50 (36%) |
|POLY-3 RATE (b) | 11/46.35 16/43.97 19/46.19 18/43.66 |
|POLY-3 PERCENT (g) | 23.7% 36.4% 41.1% 41.2% |
|TERMINAL (d) | 5/32 (16%) 13/35 (37%) 18/39 (46%) 14/28 (50%) |
|FIRST INCIDENCE | 525 706 722 478 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.048 * P=0.279 P=0.176 P=0.053 |
|POLY 3 | P=0.135 P=0.138 P=0.056 P=0.057 |
|POLY 1.5 | P=0.173 P=0.132 P=0.055 P=0.072 |
|POLY 6 | P=0.092 P=0.145 P=0.057 P=0.039 * |
|LOGISTIC REGRESSION| P=0.138 P=0.130 P=0.066 P=0.091 |
|COCH-ARM / FISHERS | P=0.224 P=0.122 P=0.055 P=0.093 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Pelvis, Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/46 (4%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.52 2/43.86 2/46.14 2/41.60 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 4.3% 4.8% |
|TERMINAL (d) | 0/32 (0%) 0/35 (0%) 2/39 (5%) 2/28 (7%) |
|FIRST INCIDENCE | --- 722 734 (T) 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.300 P=0.274 P=0.283 P=0.209 |
|POLY 3 | P=0.361 P=0.234 P=0.245 P=0.222 |
|POLY 1.5 | P=0.378 P=0.228 P=0.240 P=0.229 |
|POLY 6 | P=0.339 P=0.242 P=0.253 P=0.213 |
|LOGISTIC REGRESSION| P=0.302 P=0.241 P=0.283 P=0.209 |
|COCH-ARM / FISHERS | P=0.400 P=0.227 P=0.242 P=0.247 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/49 (2%) 0/49 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 0/44.52 1/45.86 0/46.14 3/41.05 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 7.3% |
|TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/39 (0%) 1/28 (4%) |
|FIRST INCIDENCE | --- 722 --- 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.027 * P=0.538 (e) P=0.110 |
|POLY 3 | P=0.033 * P=0.506 (e) P=0.104 |
|POLY 1.5 | P=0.035 * P=0.502 (e) P=0.108 |
|POLY 6 | P=0.031 * P=0.512 (e) P=0.101 |
|LOGISTIC REGRESSION| P=0.057 P=0.509 (e) P=0.128 |
|COCH-ARM / FISHERS | P=0.038 * P=0.495 (e) P=0.114 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/49 (0%) 4/48 (8%) |
|POLY-3 RATE (b) | 0/44.52 2/45.86 0/46.14 4/41.05 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 9.7% |
|TERMINAL (d) | 0/32 (0%) 1/35 (3%) 0/39 (0%) 2/28 (7%) |
|FIRST INCIDENCE | --- 722 --- 580 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.018 * P=0.271 (e) P=0.054 |
|POLY 3 | P=0.024 * P=0.244 (e) P=0.050 |
|POLY 1.5 | P=0.026 * P=0.239 (e) P=0.052 |
|POLY 6 | P=0.023 * P=0.250 (e) P=0.048 * |
|LOGISTIC REGRESSION| P=0.039 * P=0.256 (e) P=0.066 |
|COCH-ARM / FISHERS | P=0.029 * P=0.242 (e) P=0.054 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Larynx |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 4/49 (8%) 2/49 (4%) 2/48 (4%) |
|POLY-3 RATE (b) | 2/44.70 4/45.81 2/46.14 2/40.17 |
|POLY-3 PERCENT (g) | 4.5% 8.7% 4.3% 5.0% |
|TERMINAL (d) | 1/32 (3%) 4/35 (11%) 2/39 (5%) 1/28 (4%) |
|FIRST INCIDENCE | 688 734 (T) 734 (T) 706 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.550N P=0.382 P=0.630N P=0.647 |
|POLY 3 | P=0.506N P=0.349 P=0.682N P=0.655 |
|POLY 1.5 | P=0.488N P=0.340 P=0.690N P=0.666 |
|POLY 6 | P=0.526N P=0.360 P=0.672N P=0.642 |
|LOGISTIC REGRESSION| P=0.553N P=0.370 P=0.676N P=0.650 |
|COCH-ARM / FISHERS | P=0.466N P=0.329 P=0.684 P=0.676 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/48 (4%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.52 2/45.08 0/46.14 1/41.60 |
|POLY-3 PERCENT (g) | 2.3% 4.4% 0.0% 2.4% |
|TERMINAL (d) | 1/32 (3%) 2/35 (6%) 0/39 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 734 (T) 734 (T) --- 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.662N P=0.531 P=0.461N P=0.732 |
|POLY 3 | P=0.605N P=0.504 P=0.493N P=0.746 |
|POLY 1.5 | P=0.598N P=0.497 P=0.498N P=0.752 |
|POLY 6 | P=0.614N P=0.515 P=0.486N P=0.736 |
|LOGISTIC REGRESSION| P=0.662N P=0.531 (e) P=0.732 |
|COCH-ARM / FISHERS | P=0.587N P=0.485 P=0.505N P=0.753N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/49 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.52 2/45.08 1/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 0.0% |
|TERMINAL (d) | 0/32 (0%) 2/35 (6%) 1/39 (3%) 0/28 (0%) |
|FIRST INCIDENCE | --- 734 (T) 734 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.411N P=0.258 P=0.539 (e) |
|POLY 3 | P=0.379N P=0.240 P=0.507 (e) |
|POLY 1.5 | P=0.371N P=0.235 P=0.502 (e) |
|POLY 6 | P=0.390N P=0.247 P=0.514 (e) |
|LOGISTIC REGRESSION| (e) P=0.258 P=0.539 (e) |
|COCH-ARM / FISHERS | P=0.362N P=0.237 P=0.495 (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 5/48 (10%) 4/49 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/44.52 5/45.49 4/46.14 2/42.27 |
|POLY-3 PERCENT (g) | 15.7% 11.0% 8.7% 4.7% |
|TERMINAL (d) | 7/32 (22%) 4/35 (11%) 4/39 (10%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 613 734 (T) 566 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.132N P=0.317N P=0.156N P=0.115N |
|POLY 3 | P=0.104N P=0.364N P=0.240N P=0.091N |
|POLY 1.5 | P=0.093N P=0.382N P=0.255N P=0.085N |
|POLY 6 | P=0.119N P=0.337N P=0.221N P=0.097N |
|LOGISTIC REGRESSION| P=0.099N P=0.348N P=0.156N P=0.099N |
|COCH-ARM / FISHERS | P=0.080N P=0.409N P=0.274N P=0.080N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 6/48 (13%) 6/49 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | 9/45.08 6/45.21 6/46.40 7/42.53 |
|POLY-3 PERCENT (g) | 20.0% 13.3% 12.9% 16.5% |
|TERMINAL (d) | 7/32 (22%) 4/35 (11%) 5/39 (13%) 5/28 (18%) |
|FIRST INCIDENCE | 652 706 665 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.469 P=0.233N P=0.180N P=0.510N |
|POLY 3 | P=0.570N P=0.284N P=0.266N P=0.441N |
|POLY 1.5 | P=0.537N P=0.298N P=0.282N P=0.419N |
|POLY 6 | P=0.536 P=0.266N P=0.246N P=0.473N |
|LOGISTIC REGRESSION| P=0.572N P=0.266N P=0.261N P=0.441N |
|COCH-ARM / FISHERS | P=0.495N P=0.318N P=0.303N P=0.393N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/48 (4%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.52 2/45.12 0/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 4.5% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 2/32 (6%) 1/35 (3%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 722 --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178N P=0.652N P=0.196N P=0.268N |
|POLY 3 | P=0.161N P=0.689N P=0.229N P=0.252N |
|POLY 1.5 | P=0.156N P=0.690 P=0.235N P=0.245N |
|POLY 6 | P=0.168N P=0.677N P=0.222N P=0.262N |
|LOGISTIC REGRESSION| P=0.178N P=0.656N (e) (e) |
|COCH-ARM / FISHERS | P=0.149N P=0.676 P=0.253N P=0.247N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/48 (0%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.23 0/45.08 2/47.04 0/41.60 |
|POLY-3 PERCENT (g) | 6.6% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/35 (0%) 1/39 (3%) 0/28 (0%) |
|FIRST INCIDENCE | 525 --- 349 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.220N P=0.110N P=0.454N P=0.145N |
|POLY 3 | P=0.218N P=0.119N P=0.482N P=0.134N |
|POLY 1.5 | P=0.205N P=0.122N P=0.493N P=0.127N |
|POLY 6 | P=0.237N P=0.115N P=0.469N P=0.144N |
|LOGISTIC REGRESSION| P=0.137N P=0.157N P=0.600N P=0.106N |
|COCH-ARM / FISHERS | P=0.189N P=0.129N P=0.510N P=0.121N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/50 (18%) 14/50 (28%) 8/49 (16%) 14/50 (28%) |
|POLY-3 RATE (b) | 9/45.38 14/47.00 8/46.40 14/42.17 |
|POLY-3 PERCENT (g) | 19.8% 29.8% 17.2% 33.2% |
|TERMINAL (d) | 6/32 (19%) 11/35 (31%) 7/39 (18%) 11/28 (39%) |
|FIRST INCIDENCE | 561 638 666 634 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.083 P=0.247 P=0.353N P=0.096 |
|POLY 3 | P=0.154 P=0.193 P=0.480N P=0.117 |
|POLY 1.5 | P=0.186 P=0.184 P=0.497N P=0.139 |
|POLY 6 | P=0.120 P=0.206 P=0.456N P=0.092 |
|LOGISTIC REGRESSION| P=0.118 P=0.198 P=0.490N P=0.105 |
|COCH-ARM / FISHERS | P=0.233 P=0.171 P=0.518N P=0.171 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.52 0/46.53 1/46.14 2/41.70 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.8% |
|TERMINAL (d) | 0/32 (0%) 0/35 (0%) 1/39 (3%) 1/28 (4%) |
|FIRST INCIDENCE | --- --- 734 (T) 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.062 (e) P=0.539 P=0.206 |
|POLY 3 | P=0.085 (e) P=0.507 P=0.223 |
|POLY 1.5 | P=0.090 (e) P=0.502 P=0.229 |
|POLY 6 | P=0.078 (e) P=0.514 P=0.214 |
|LOGISTIC REGRESSION| P=0.068 (e) P=0.539 P=0.211 |
|COCH-ARM / FISHERS | P=0.098 (e) P=0.495 P=0.247 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 21/50 (42%) 26/50 (52%) 29/49 (59%) 29/50 (58%) |
|POLY-3 RATE (b) | 21/46.95 26/47.15 29/46.85 29/45.24 |
|POLY-3 PERCENT (g) | 44.7% 55.2% 61.9% 64.1% |
|TERMINAL (d) | 13/32 (41%) 21/35 (60%) 26/39 (67%) 18/28 (64%) |
|FIRST INCIDENCE | 359 638 617 492 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.017 * P=0.365 P=0.308 P=0.039 * |
|POLY 3 | P=0.078 P=0.207 P=0.068 P=0.043 * |
|POLY 1.5 | P=0.102 P=0.208 P=0.064 P=0.056 |
|POLY 6 | P=0.057 P=0.212 P=0.075 P=0.032 * |
|LOGISTIC REGRESSION| P=0.070 P=0.243 P=0.080 P=0.069 |
|COCH-ARM / FISHERS | P=0.143 P=0.212 P=0.065 P=0.081 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Proteinosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 11/50 (22%) 16/50 (32%) 15/49 (31%) 23/50 (46%) |
|POLY-3 RATE (b) | 11/45.13 16/46.76 15/46.19 23/43.02 |
|POLY-3 PERCENT (g) | 24.4% 34.2% 32.5% 53.5% |
|TERMINAL (d) | 9/32 (28%) 13/35 (37%) 14/39 (36%) 18/28 (64%) |
|FIRST INCIDENCE | 561 708 722 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.273 P=0.450 P=0.002 ** |
|POLY 3 | P=0.004 ** P=0.209 P=0.265 P=0.003 ** |
|POLY 1.5 | P=0.006 ** P=0.199 P=0.248 P=0.005 ** |
|POLY 6 | P=0.002 ** P=0.225 P=0.291 P=0.002 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.245 P=0.330 P=0.003 ** |
|COCH-ARM / FISHERS | P=0.011 * P=0.184 P=0.228 P=0.010 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 16/50 (32%) 24/50 (48%) 23/49 (47%) 28/50 (56%) |
|POLY-3 RATE (b) | 16/45.52 24/47.12 23/46.85 28/44.51 |
|POLY-3 PERCENT (g) | 35.2% 50.9% 49.1% 62.9% |
|TERMINAL (d) | 10/32 (31%) 20/35 (57%) 20/39 (51%) 19/28 (68%) |
|FIRST INCIDENCE | 652 638 617 492 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.003 ** P=0.160 P=0.310 P=0.005 ** |
|POLY 3 | P=0.017 * P=0.089 P=0.123 P=0.005 ** |
|POLY 1.5 | P=0.024 * P=0.084 P=0.109 P=0.008 ** |
|POLY 6 | P=0.011 * P=0.096 P=0.143 P=0.003 ** |
|LOGISTIC REGRESSION| P=0.008 ** P=0.115 P=0.146 P=0.005 ** |
|COCH-ARM / FISHERS | P=0.038 * P=0.076 P=0.094 P=0.013 * |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 6/49 (12%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/44.57 6/46.65 6/46.19 4/41.71 |
|POLY-3 PERCENT (g) | 2.2% 12.9% 13.0% 9.6% |
|TERMINAL (d) | 0/32 (0%) 4/35 (11%) 5/39 (13%) 3/28 (11%) |
|FIRST INCIDENCE | 722 708 722 706 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.375 P=0.085 P=0.099 P=0.143 |
|POLY 3 | P=0.456 P=0.063 P=0.062 P=0.158 |
|POLY 1.5 | P=0.485 P=0.061 P=0.058 P=0.168 |
|POLY 6 | P=0.418 P=0.068 P=0.067 P=0.147 |
|LOGISTIC REGRESSION| P=0.380 P=0.073 P=0.078 P=0.139 |
|COCH-ARM / FISHERS | P=0.521 P=0.056 P=0.053 P=0.181 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/2 (0%) 2/10 (20%) 0/7 (0%) 1/5 (20%) |
|POLY-3 RATE (b) | 0/1.88 2/8.95 0/6.49 1/4.29 |
|POLY-3 PERCENT (g) | 0.0% 22.4% 0.0% 23.3% |
|TERMINAL (d) | 0/0 (0%) 1/5 (20%) 0/4 (0%) 1/3 (33%) |
|FIRST INCIDENCE | --- 728 --- 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.663 P=0.523 (e) P=1.000 |
|POLY 3 | P=0.594 P=0.618 (e) P=0.662 |
|POLY 1.5 | P=0.600 P=0.621 (e) P=0.666 |
|POLY 6 | P=0.591 P=0.618 (e) P=0.660 |
|LOGISTIC REGRESSION| P=0.649 P=0.842 (e) P=1.000 |
|COCH-ARM / FISHERS | P=0.614 P=0.682 (e) P=0.714 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/45 (2%) 2/46 (4%) 0/49 (0%) 1/44 (2%) |
|POLY-3 RATE (b) | 1/41.74 2/43.54 0/46.14 1/36.55 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 0.0% 2.7% |
|TERMINAL (d) | 0/31 (0%) 1/33 (3%) 0/39 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 561 533 --- 700 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.635N P=0.510 P=0.500N P=0.743 |
|POLY 3 | P=0.631N P=0.515 P=0.480N P=0.730 |
|POLY 1.5 | P=0.622N P=0.512 P=0.481N P=0.741 |
|POLY 6 | P=0.640N P=0.519 P=0.478N P=0.717 |
|LOGISTIC REGRESSION| P=0.511N P=0.414 P=0.498N P=0.728N |
|COCH-ARM / FISHERS | P=0.609N P=0.508 P=0.479N P=0.747 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 5/49 (10%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.52 1/46.57 5/46.14 1/41.73 |
|POLY-3 PERCENT (g) | 6.7% 2.2% 10.8% 2.4% |
|TERMINAL (d) | 3/32 (9%) 0/35 (0%) 5/39 (13%) 0/28 (0%) |
|FIRST INCIDENCE | 734 (T) 722 734 (T) 700 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.403N P=0.267N P=0.468 P=0.353N |
|POLY 3 | P=0.366N P=0.289N P=0.376 P=0.329N |
|POLY 1.5 | P=0.342N P=0.296N P=0.363 P=0.318N |
|POLY 6 | P=0.397N P=0.280N P=0.395 P=0.342N |
|LOGISTIC REGRESSION| P=0.404N P=0.263N P=0.468 P=0.354N |
|COCH-ARM / FISHERS | P=0.314N P=0.309N P=0.346 P=0.309N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Mesentery |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 26/26 (100%) 20/20 (100%) 20/20 (100%) 16/17 (94%) |
|POLY-3 RATE (b) | 26/26.00 20/20.00 20/20.00 16/17.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 94.1% |
|TERMINAL (d) | 18/18 (100%) 14/14 (100%) 17/17 (100%) 10/11 (91%) |
|FIRST INCIDENCE | 525 706 349 478 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.467N (e) (e) P=0.361N |
|POLY 3 | P=0.179N (e) (e) P=0.415N |
|POLY 1.5 | P=0.179N (e) (e) P=0.415N |
|POLY 6 | P=0.179N (e) (e) P=0.415N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.179N (e) (e) P=0.395N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/48 (8%) 3/49 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/44.57 4/45.08 3/46.14 1/41.09 |
|POLY-3 PERCENT (g) | 2.2% 8.9% 6.5% 2.4% |
|TERMINAL (d) | 0/32 (0%) 4/35 (11%) 3/39 (8%) 0/28 (0%) |
|FIRST INCIDENCE | 722 734 (T) 734 (T) 634 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.394N P=0.216 P=0.379 P=0.723 |
|POLY 3 | P=0.346N P=0.182 P=0.318 P=0.742 |
|POLY 1.5 | P=0.331N P=0.176 P=0.309 P=0.749 |
|POLY 6 | P=0.366N P=0.191 P=0.330 P=0.735 |
|LOGISTIC REGRESSION| P=0.367N P=0.214 P=0.351 P=0.760N |
|COCH-ARM / FISHERS | P=0.311N P=0.168 P=0.301 P=0.747 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 5/48 (10%) 7/49 (14%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/44.64 5/45.08 7/46.30 3/41.85 |
|POLY-3 PERCENT (g) | 6.7% 11.1% 15.1% 7.2% |
|TERMINAL (d) | 1/32 (3%) 5/35 (14%) 6/39 (15%) 0/28 (0%) |
|FIRST INCIDENCE | 716 734 (T) 694 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.516N P=0.416 P=0.245 P=0.597 |
|POLY 3 | P=0.438N P=0.362 P=0.172 P=0.633 |
|POLY 1.5 | P=0.416N P=0.351 P=0.162 P=0.642 |
|POLY 6 | P=0.467N P=0.377 P=0.187 P=0.622 |
|LOGISTIC REGRESSION| P=0.424N P=0.411 P=0.195 P=0.650N |
|COCH-ARM / FISHERS | P=0.387N P=0.335 P=0.151 P=0.651 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Goblet Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 1/48 (2%) 5/49 (10%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/44.52 1/45.08 5/46.30 2/41.34 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 10.8% 4.8% |
|TERMINAL (d) | 1/32 (3%) 1/35 (3%) 4/39 (10%) 1/28 (4%) |
|FIRST INCIDENCE | 734 (T) 734 (T) 694 538 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.421 P=0.742N P=0.151 P=0.469 |
|POLY 3 | P=0.452 P=0.758N P=0.111 P=0.474 |
|POLY 1.5 | P=0.475 P=0.758 P=0.105 P=0.483 |
|POLY 6 | P=0.420 P=0.751N P=0.119 P=0.463 |
|LOGISTIC REGRESSION| P=0.490 P=0.742N P=0.124 P=0.514 |
|COCH-ARM / FISHERS | P=0.504 P=0.742 P=0.098 P=0.492 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 1/48 (2%) 1/49 (2%) 3/49 (6%) |
|POLY-3 RATE (b) | 3/44.82 1/45.08 1/46.19 3/40.74 |
|POLY-3 PERCENT (g) | 6.7% 2.2% 2.2% 7.4% |
|TERMINAL (d) | 2/32 (6%) 1/35 (3%) 0/39 (0%) 3/28 (11%) |
|FIRST INCIDENCE | 652 734 (T) 722 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.292 P=0.285N P=0.252N P=0.592 |
|POLY 3 | P=0.343 P=0.303N P=0.295N P=0.618 |
|POLY 1.5 | P=0.363 P=0.310N P=0.303N P=0.634 |
|POLY 6 | P=0.320 P=0.294N P=0.284N P=0.596 |
|LOGISTIC REGRESSION| P=0.318 P=0.309N P=0.307N P=0.600 |
|COCH-ARM / FISHERS | P=0.388 P=0.324N P=0.316N P=0.651 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 1/48 (2%) 1/49 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/44.52 1/45.08 1/46.14 2/41.22 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 4.9% |
|TERMINAL (d) | 0/32 (0%) 1/35 (3%) 1/39 (3%) 1/28 (4%) |
|FIRST INCIDENCE | --- 734 (T) 734 (T) 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.164 P=0.518 P=0.539 P=0.215 |
|POLY 3 | P=0.195 P=0.502 P=0.507 P=0.220 |
|POLY 1.5 | P=0.203 P=0.498 P=0.502 P=0.226 |
|POLY 6 | P=0.184 P=0.509 P=0.514 P=0.213 |
|LOGISTIC REGRESSION| P=0.220 P=0.518 P=0.539 P=0.248 |
|COCH-ARM / FISHERS | P=0.214 P=0.490 P=0.495 P=0.242 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 2/48 (4%) 2/49 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/44.60 2/45.08 2/46.14 1/40.89 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 4.3% 2.5% |
|TERMINAL (d) | 0/32 (0%) 2/35 (6%) 2/39 (5%) 0/28 (0%) |
|FIRST INCIDENCE | 716 734 (T) 734 (T) 694 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.597N P=0.533 P=0.558 P=0.723 |
|POLY 3 | P=0.549N P=0.504 P=0.512 P=0.741 |
|POLY 1.5 | P=0.533N P=0.496 P=0.504 P=0.748 |
|POLY 6 | P=0.568N P=0.514 P=0.523 P=0.733 |
|LOGISTIC REGRESSION| P=0.582N P=0.527 P=0.535 P=0.748 |
|COCH-ARM / FISHERS | P=0.514N P=0.485 P=0.492 P=0.747 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Oral Mucosa: Pharyngeal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/1 (0%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |
|POLY-3 RATE (b) | 0/0.93 0/0.00 0/0.00 2/2.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- 492 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183 (e) (e) P=0.468 |
|POLY 3 | (e) (e) (e) P=1.000 |
|POLY 1.5 | (e) (e) (e) P=1.000 |
|POLY 6 | (e) (e) (e) P=1.000 |
|LOGISTIC REGRESSION| P=0.317 (e) (e) P=0.448 |
|COCH-ARM / FISHERS | P=0.224 (e) (e) P=0.333 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 6/49 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/44.52 4/46.53 6/46.40 3/42.69 |
|POLY-3 PERCENT (g) | 6.7% 8.6% 12.9% 7.0% |
|TERMINAL (d) | 3/32 (9%) 4/35 (11%) 5/39 (13%) 1/28 (4%) |
|FIRST INCIDENCE | 734 (T) 734 (T) 665 561 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.586N P=0.549 P=0.343 P=0.613 |
|POLY 3 | P=0.513N P=0.524 P=0.263 P=0.643 |
|POLY 1.5 | P=0.492N P=0.514 P=0.249 P=0.652 |
|POLY 6 | P=0.540N P=0.537 P=0.282 P=0.632 |
|LOGISTIC REGRESSION| P=0.490N P=0.549 P=0.284 P=0.645N |
|COCH-ARM / FISHERS | P=0.466N P=0.500 P=0.233 P=0.661N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 4/49 (8%) 3/49 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.57 4/45.81 3/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 2.2% 8.7% 6.5% 0.0% |
|TERMINAL (d) | 0/32 (0%) 4/35 (11%) 3/39 (8%) 0/28 (0%) |
|FIRST INCIDENCE | 722 734 (T) 734 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.167N P=0.216 P=0.379 P=0.533N |
|POLY 3 | P=0.149N P=0.187 P=0.318 P=0.514N |
|POLY 1.5 | P=0.138N P=0.181 P=0.309 P=0.507N |
|POLY 6 | P=0.163N P=0.195 P=0.330 P=0.522N |
|LOGISTIC REGRESSION| P=0.171N P=0.215 P=0.351 P=0.525N |
|COCH-ARM / FISHERS | P=0.127N P=0.175 P=0.301 P=0.500N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.57 0/45.81 0/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 722 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.344N P=0.209N P=0.198N P=0.273N |
|POLY 3 | P=0.323N P=0.231N P=0.230N P=0.253N |
|POLY 1.5 | P=0.316N P=0.235N P=0.235N P=0.246N |
|POLY 6 | P=0.331N P=0.225N P=0.222N P=0.262N |
|LOGISTIC REGRESSION| P=0.337N P=0.218N P=0.214N P=0.269N |
|COCH-ARM / FISHERS | P=0.307N P=0.253N P=0.253N P=0.247N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/50 (14%) 9/49 (18%) 8/49 (16%) 5/50 (10%) |
|POLY-3 RATE (b) | 7/45.03 9/45.97 8/46.80 5/42.08 |
|POLY-3 PERCENT (g) | 15.6% 19.6% 17.1% 11.9% |
|TERMINAL (d) | 5/32 (16%) 7/35 (20%) 6/39 (15%) 4/28 (14%) |
|FIRST INCIDENCE | 666 706 617 590 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.356N P=0.473 P=0.585N P=0.479N |
|POLY 3 | P=0.271N P=0.409 P=0.532 P=0.427N |
|POLY 1.5 | P=0.242N P=0.396 P=0.511 P=0.405N |
|POLY 6 | P=0.313N P=0.428 P=0.561 P=0.458N |
|LOGISTIC REGRESSION| P=0.269N P=0.435 P=0.500 P=0.432N |
|COCH-ARM / FISHERS | P=0.207N P=0.376 P=0.483 P=0.380N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pleura |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/20 (75%) 17/25 (68%) 23/25 (92%) 27/28 (96%) |
|POLY-3 RATE (b) | 15/18.82 17/24.66 23/25.00 27/27.30 |
|POLY-3 PERCENT (g) | 79.7% 69.0% 92.0% 98.9% |
|TERMINAL (d) | 11/13 (85%) 13/20 (65%) 20/22 (91%) 19/19 (100%) |
|FIRST INCIDENCE | 561 708 617 589 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P=0.252N P=0.582N P=0.044 * |
|POLY 3 | P=0.005 ** P=0.326N P=0.227 P=0.028 * |
|POLY 1.5 | P=0.006 ** P=0.355N P=0.186 P=0.029 * |
|POLY 6 | P=0.005 ** P=0.305N P=0.271 P=0.029 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.278N P=0.223 P=0.039 * |
|COCH-ARM / FISHERS | P=0.011 * P=0.429N P=0.126 P=0.039 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Pleura: Mesothelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/20 (10%) 7/25 (28%) 8/25 (32%) 2/28 (7%) |
|POLY-3 RATE (b) | 2/18.17 7/24.38 8/24.34 2/25.65 |
|POLY-3 PERCENT (g) | 11.0% 28.7% 32.9% 7.8% |
|TERMINAL (d) | 0/13 (0%) 7/20 (35%) 7/22 (32%) 0/19 (0%) |
|FIRST INCIDENCE | 652 734 (T) 722 634 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.166N P=0.185 P=0.151 P=0.629 |
|POLY 3 | P=0.095N P=0.154 P=0.096 P=0.566N |
|POLY 1.5 | P=0.090N P=0.146 P=0.089 P=0.564N |
|POLY 6 | P=0.102N P=0.161 P=0.101 P=0.571N |
|LOGISTIC REGRESSION| P=0.102N P=0.156 P=0.098 P=0.590N |
|COCH-ARM / FISHERS | P=0.093N P=0.130 P=0.078 P=0.558N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.52 0/45.79 0/46.14 3/42.51 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 734 (T) --- --- 561 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032 * P=0.482N P=0.461N P=0.267 |
|POLY 3 | P=0.042 * P=0.494N P=0.493N P=0.288 |
|POLY 1.5 | P=0.045 * P=0.498N P=0.498N P=0.296 |
|POLY 6 | P=0.039 * P=0.489N P=0.486N P=0.279 |
|LOGISTIC REGRESSION| P=0.070 (e) (e) P=0.327 |
|COCH-ARM / FISHERS | P=0.050 P=0.505N P=0.505N P=0.309 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.78 0/45.79 1/46.19 2/42.08 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 2.2% 4.8% |
|TERMINAL (d) | 0/32 (0%) 0/35 (0%) 0/39 (0%) 1/28 (4%) |
|FIRST INCIDENCE | 666 --- 722 589 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.184 P=0.495N P=0.731N P=0.456 |
|POLY 3 | P=0.217 P=0.496N P=0.754N P=0.478 |
|POLY 1.5 | P=0.228 P=0.499N P=0.759N P=0.488 |
|POLY 6 | P=0.203 P=0.491N P=0.747N P=0.465 |
|LOGISTIC REGRESSION| P=0.276 P=0.537N P=0.750 P=0.524 |
|COCH-ARM / FISHERS | P=0.242 P=0.505N P=0.747 P=0.500 |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/50 (6%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.91 0/45.79 0/46.14 0/41.60 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 0/35 (0%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 639 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.216N P=0.108N P=0.100N P=0.155N |
|POLY 3 | P=0.198N P=0.115N P=0.114N P=0.133N |
|POLY 1.5 | P=0.192N P=0.118N P=0.118N P=0.126N |
|POLY 6 | P=0.206N P=0.111N P=0.109N P=0.142N |
|LOGISTIC REGRESSION| P=0.179N P=0.128N P=0.128N P=0.123N |
|COCH-ARM / FISHERS | P=0.186N P=0.125N P=0.125N P=0.121N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/50 (4%) 2/47 (4%) 1/49 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/44.95 2/44.79 1/47.04 0/40.74 |
|POLY-3 PERCENT (g) | 4.5% 4.5% 2.1% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/35 (3%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | 609 728 349 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183N P=0.659N P=0.475N P=0.273N |
|POLY 3 | P=0.177N P=0.693 P=0.484N P=0.260N |
|POLY 1.5 | P=0.168N P=0.684 P=0.493N P=0.251N |
|POLY 6 | P=0.188N P=0.684N P=0.474N P=0.270N |
|LOGISTIC REGRESSION| P=0.109N P=0.657 P=0.585N P=0.229N |
|COCH-ARM / FISHERS | P=0.155N P=0.668 P=0.508N P=0.253N |
|=================================================================================================================================|
Date: 08/28/01 EXPERIMENT: 93026 TEST: 07 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 15/50 (30%) 7/49 (14%) 6/49 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 15/44.90 7/46.33 6/46.30 6/41.60 |
|POLY-3 PERCENT (g) | 33.4% 15.1% 13.0% 14.4% |
|TERMINAL (d) | 12/32 (38%) 5/35 (14%) 5/39 (13%) 6/28 (21%) |
|FIRST INCIDENCE | 666 613 694 734 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.183N P=0.029N* P=0.008N** P=0.051N |
|POLY 3 | P=0.128N P=0.034N* P=0.017N* P=0.032N* |
|POLY 1.5 | P=0.107N P=0.039N* P=0.020N* P=0.027N* |
|POLY 6 | P=0.161N P=0.027N* P=0.013N* P=0.041N* |
|LOGISTIC REGRESSION| P=0.162N P=0.032N* P=0.012N* P=0.047N* |
|COCH-ARM / FISHERS | P=0.086N P=0.050N P=0.027N* P=0.024N* |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |
| | |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/50 (0%) 3/49 (6%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.52 3/45.81 0/46.14 1/41.70 |
|POLY-3 PERCENT (g) | 0.0% 6.6% 0.0% 2.4% |
|TERMINAL (d) | 0/32 (0%) 3/35 (9%) 0/39 (0%) 0/28 (0%) |
|FIRST INCIDENCE | --- 734 (T) --- 708 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.691 P=0.137 (e) P=0.464 |
|POLY 3 | P=0.634N P=0.124 (e) P=0.487 |
|POLY 1.5 | P=0.629N P=0.120 (e) P=0.493 |
|POLY 6 | P=0.640N P=0.129 (e) P=0.479 |
|LOGISTIC REGRESSION| P=0.687N P=0.137 (e) P=0.487 |
|COCH-ARM / FISHERS | P=0.620N P=0.117 (e) P=0.500 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(d) Observed incidence at terminal kill.
(f) Beneath the control incidence are the P-values associated with the trend
test. Beneath the dosed group incidence are the P-values corresponding to
pairwise comparisons between the controls and that dosed group. The life
table analysis regards tumors in animals dying prior to terminal kill as
being (directly or indirectly) the cause of death.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers exact tests compare directly the overall incidence rates
For all tests a negative trend is indicated by N
(e) Value of Statistic cannot be computed.
(g) Poly-3 adjusted lifetime tumor incidence.
(I) Interim sacrifice
(T) Terminal sacrifice
# Tumor rates based on number of animals necropsied.
* To the right of any statistical result, indicates significance at (P<=0.05).
** To the right of any statistical result, indicates significance at (P<=0.01).