TDMS Study 56111-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/14/01
EXPERIMENT: 56111 TEST: 04 TIME: 09:30:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: MARIT, GARY CAS: 14371-10-9
------------------------------------------------------------------------------------------------------------------------------------
Final#1/Mice
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 003 VEHICLE CONTROL
INCLUDE 004 VEHICLE CONTROL
INCLUDE 005 .312%
INCLUDE 006 .312%
INCLUDE 007 .625%
INCLUDE 008 .625%
INCLUDE 009 1.25%
INCLUDE 010 1.25%
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/14/01
EXPERIMENT: 56111 TEST: 04 TIME: 09:30:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: MARIT, GARY CAS: 14371-10-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANS-CINNAMALDEHYDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Heart Mineralization
Kidney Infarct
Infiltration Cellular Lymphocyte
Mineralization
Nephropathy
Liver Inflammation
Liver: Portal Infiltration Cellular Lymphocyte
Nose: Olfactory Epithelium Pigmentation
Preputial Gland Inflammation
Preputial Gland: Duct Ectasia
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Myelofibrosis
Kidney Infiltration Cellular Lymphocyte
Nephropathy
Liver Clear Cell Focus
Mesentery: Fat Mineralization
Nose: Olfactory Epithelium Degeneration Hyaline
Pigmentation
Stomach, Forestomach Ulcer
Thyroid Gland: Follicle Cyst
Urinary Bladder Inflammation
Uterus: Endometrium Hyperplasia Cystic
===============================================================
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |2/50 (4%) 6/50 (12%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 1/44.02 0/49.55 |2/46.06 6/45.42 2/47.80 2/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |4.3% 13.2% 4.2% 4.3% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 1/39 (3%) 0/49 (0%) |2/41 (5%) 6/37 (16%) 2/44 (5%) 2/43 (5%) |
|FIRST INCIDENCE | --- --- 728 (T) --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.693 (e) P=0.463 (e) |P=0.301N P=0.103 P=0.669N P=0.678N |
|POLY 3 | P=0.708 (e) P=0.481 (e) |P=0.334N P=0.128 P=0.680N P=0.690N |
|POLY 1.5 | P=0.705 (e) P=0.488 (e) |P=0.340N P=0.131 P=0.685N P=0.693N |
|POLY 6 | P=0.711 (e) P=0.473 (e) |P=0.328N P=0.123 P=0.676N P=0.686N |
|LOGISTIC REGRESSION| (e) (e) P=0.463 (e) |P=0.301N P=0.103 P=0.669N P=0.678N |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.495 (e) |P=0.343N P=0.134 P=0.691N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 22/50 (44%) 24/49 (49%) 19/50 (38%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 23/48.41 22/48.44 24/44.12 19/49.55 |4/46.06 2/45.42 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 47.5% 45.4% 54.4% 38.4% |8.7% 4.4% 4.2% 2.2% |
|TERMINAL (d) | 23/47 (49%) 21/46 (46%) 23/39 (59%) 19/49 (39%) |4/41 (10%) 2/37 (5%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 644 702 728 (T) |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207N P=0.538N P=0.178 P=0.214N |P=0.117N P=0.385N P=0.305N P=0.166N |
|POLY 3 | P=0.222N P=0.499N P=0.325 P=0.239N |P=0.132N P=0.344N P=0.320N P=0.176N |
|POLY 1.5 | P=0.223N P=0.500N P=0.389 P=0.242N |P=0.135N P=0.341N P=0.327N P=0.179N |
|POLY 6 | P=0.221N P=0.500N P=0.258 P=0.236N |P=0.128N P=0.351N P=0.314N P=0.172N |
|LOGISTIC REGRESSION| P=0.226N P=0.516N P=0.182 P=0.214N |P=0.117N P=0.385N P=0.305N P=0.166N |
|COCH-ARM / FISHERS | P=0.254N P=0.500N P=0.462 P=0.272N |P=0.137N P=0.339N P=0.339N P=0.181N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |34/50 (68%) 26/50 (52%) 32/50 (64%) 29/50 (58%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/44.02 0/49.55 |34/46.48 26/45.66 32/48.34 29/47.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |73.2% 56.9% 66.2% 61.7% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |33/41 (81%) 25/37 (68%) 31/44 (71%) 28/43 (65%) |
|FIRST INCIDENCE | --- --- --- --- |609 668 568 587 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.124N P=0.167N P=0.218N P=0.104N |
|POLY 3 | (e) (e) (e) (e) |P=0.254N P=0.071N P=0.301N P=0.162N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.292N P=0.070N P=0.344N P=0.185N |
|POLY 6 | (e) (e) (e) (e) |P=0.208N P=0.080N P=0.263N P=0.138N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.215N P=0.098N P=0.272N P=0.147N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.321N P=0.076N P=0.417N P=0.204N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |34/50 (68%) 31/50 (62%) 37/50 (74%) 33/50 (66%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/44.02 0/49.55 |34/46.19 31/46.33 37/47.80 33/47.51 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |73.6% 66.9% 77.4% 69.5% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |33/41 (81%) 30/37 (81%) 37/44 (84%) 32/43 (74%) |
|FIRST INCIDENCE | --- --- --- --- |698 325 733 (T) 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.274N P=0.577 P=0.553 P=0.352N |
|POLY 3 | (e) (e) (e) (e) |P=0.473N P=0.310N P=0.423 P=0.412N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.518N P=0.310N P=0.385 P=0.448N |
|POLY 6 | (e) (e) (e) (e) |P=0.413N P=0.344N P=0.458 P=0.379N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.486N P=0.386N P=0.518 P=0.462N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.510 P=0.338N P=0.330 P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 43/50 (86%) 44/49 (90%) 42/50 (84%) |49/50 (98%) 50/50 (100%) 50/50 (100%) 49/50 (98%) |
|POLY-3 RATE (b) | 46/50.00 43/48.89 44/48.47 42/50.00 |49/49.24 50/50.00 50/50.00 49/49.97 |
|POLY-3 PERCENT (g) | 92.0% 88.0% 90.8% 84.0% |99.5% 100.0% 100.0% 98.1% |
|TERMINAL (d) | 43/47 (92%) 41/46 (89%) 35/39 (90%) 41/49 (84%) |41/41 (100%) 37/37 (100%) 44/44 (100%) 43/43 (100%) |
|FIRST INCIDENCE | 100 594 365 596 |463 325 425 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146N P=0.384N P=0.141 P=0.105N |P=0.165N P=0.176 P=0.365N P=0.387N |
|POLY 3 | P=0.156N P=0.369N P=0.557N P=0.179N |P=0.304N P=0.999 P=0.999 P=0.609N |
|POLY 1.5 | P=0.158N P=0.361N P=0.528N P=0.179N |P=0.413N P=0.848 P=0.848 P=0.679N |
|POLY 6 | P=0.154N P=0.379N P=0.591N P=0.179N |P=0.234N P=1.000 P=1.000 P=0.552N |
|LOGISTIC REGRESSION| P=0.162N P=0.265N P=0.474N (e) |P=0.655N P=0.396 P=0.597 P=0.726 |
|COCH-ARM / FISHERS | P=0.188N P=0.262N P=0.487N P=0.178N |P=0.595N P=0.500 P=0.500 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.41 1/48.13 0/44.02 0/49.55 |1/46.06 3/45.42 2/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |2.2% 6.6% 4.2% 0.0% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |1/41 (2%) 3/37 (8%) 2/44 (5%) 0/43 (0%) |
|FIRST INCIDENCE | --- 728 (T) --- --- |733 (T) 733 (T) 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.560N P=0.496 (e) (e) |P=0.218N P=0.269 P=0.525 P=0.490N |
|POLY 3 | P=0.571N P=0.499 (e) (e) |P=0.236N P=0.300 P=0.513 P=0.498N |
|POLY 1.5 | P=0.569N P=0.499 (e) (e) |P=0.240N P=0.303 P=0.508 P=0.500N |
|POLY 6 | P=0.573N P=0.498 (e) (e) |P=0.232N P=0.295 P=0.518 P=0.496N |
|LOGISTIC REGRESSION| (e) P=0.496 (e) (e) |P=0.218N P=0.269 P=0.525 (e) |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.242N P=0.309 P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |27/50 (54%) 23/50 (46%) 34/50 (68%) 38/50 (76%) |
|POLY-3 RATE (b) | 1/48.41 1/48.13 0/44.90 1/49.55 |27/46.62 23/46.23 34/48.36 38/46.54 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 2.0% |57.9% 49.8% 70.3% 81.7% |
|TERMINAL (d) | 1/47 (2%) 1/46 (2%) 0/39 (0%) 1/49 (2%) |25/41 (61%) 21/37 (57%) 32/44 (73%) 38/43 (88%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- 728 (T) |609 575 568 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605N P=0.757 P=0.537N P=0.752N |P=0.009 ** P=0.450N P=0.209 P=0.023 * |
|POLY 3 | P=0.618N P=0.759 P=0.515N P=0.755N |P<0.001 ** P=0.278N P=0.144 P=0.008 ** |
|POLY 1.5 | P=0.616N P=0.760 P=0.508N P=0.756N |P<0.001 ** P=0.274N P=0.129 P=0.010 * |
|POLY 6 | P=0.620N P=0.758 P=0.523N P=0.755N |P<0.001 ** P=0.297N P=0.157 P=0.008 ** |
|LOGISTIC REGRESSION| P=0.605N P=0.757 (e) P=0.752N |P=0.003 ** P=0.304N P=0.163 P=0.016 * |
|COCH-ARM / FISHERS | P=0.616N P=0.753N P=0.500N P=0.753N |P=0.003 ** P=0.274N P=0.109 P=0.018 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 19/50 (38%) 20/50 (40%) 13/50 (26%) |10/50 (20%) 10/50 (20%) 12/50 (24%) 12/50 (24%) |
|POLY-3 RATE (b) | 14/49.92 19/48.13 20/47.30 13/49.55 |10/46.92 10/47.53 12/48.93 12/47.97 |
|POLY-3 PERCENT (g) | 28.0% 39.5% 42.3% 26.2% |21.3% 21.0% 24.5% 25.0% |
|TERMINAL (d) | 12/47 (26%) 19/46 (41%) 15/39 (39%) 13/49 (27%) |7/41 (17%) 4/37 (11%) 10/44 (23%) 9/43 (21%) |
|FIRST INCIDENCE | 100 728 (T) 365 728 (T) |609 325 425 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329N P=0.182 P=0.063 P=0.454N |P=0.404 P=0.527 P=0.474 P=0.449 |
|POLY 3 | P=0.364N P=0.163 P=0.103 P=0.509N |P=0.345 P=0.586N P=0.448 P=0.427 |
|POLY 1.5 | P=0.359N P=0.170 P=0.119 P=0.505N |P=0.333 P=0.587N P=0.434 P=0.416 |
|POLY 6 | P=0.368N P=0.154 P=0.087 P=0.513N |P=0.358 P=0.593N P=0.458 P=0.436 |
|LOGISTIC REGRESSION| P=0.380N P=0.199 P=0.202 P=0.574N |P=0.319 P=0.588N P=0.374 P=0.407 |
|COCH-ARM / FISHERS | P=0.361N P=0.198 P=0.146 P=0.500N |P=0.322 P=0.598N P=0.405 P=0.405 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |35/49 (71%) 30/50 (60%) 36/49 (73%) 33/50 (66%) |
|POLY-3 RATE (b) | |35/45.24 30/47.39 36/47.96 33/47.72 |
|POLY-3 PERCENT (g) | |77.4% 63.3% 75.1% 69.2% |
|TERMINAL (d) | |34/41 (83%) 23/37 (62%) 34/44 (77%) 31/43 (72%) |
|FIRST INCIDENCE | |693 551 425 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.278N P=0.423N P=0.457N P=0.272N |
|POLY 3 | |P=0.383N P=0.098N P=0.493N P=0.249N |
|POLY 1.5 | |P=0.421N P=0.121N P=0.564N P=0.291N |
|POLY 6 | |P=0.343N P=0.080N P=0.424N P=0.209N |
|LOGISTIC REGRESSION| |P=0.440N P=0.166N P=0.534N P=0.315N |
|COCH-ARM / FISHERS | |P=0.479N P=0.162N P=0.500 P=0.358N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Epididymis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 RATE (b) | 3/48.41 0/48.13 2/44.90 2/49.55 | |
|POLY-3 PERCENT (g) | 6.2% 0.0% 4.5% 4.0% | |
|TERMINAL (d) | 3/47 (6%) 0/46 (0%) 2/39 (5%) 2/49 (4%) | |
|FIRST INCIDENCE | 728 (T) --- 728 (T) 728 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.125N P=0.585N P=0.481N | |
|POLY 3 | P=0.573N P=0.120N P=0.534N P=0.489N | |
|POLY 1.5 | P=0.572N P=0.120N P=0.518N P=0.490N | |
|POLY 6 | P=0.572N P=0.121N P=0.553N P=0.489N | |
|LOGISTIC REGRESSION| P=0.563N (e) P=0.585N P=0.481N | |
|COCH-ARM / FISHERS | P=0.578N P=0.121N P=0.500N P=0.500N | |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Esophagus |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 4/50 (8%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/48.92 2/48.69 4/47.54 0/49.55 |1/46.82 2/45.70 1/48.14 1/46.57 |
|POLY-3 PERCENT (g) | 4.1% 4.1% 8.4% 0.0% |2.1% 4.4% 2.1% 2.2% |
|TERMINAL (d) | 1/47 (2%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 572 594 365 --- |456 663 638 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233N P=0.690 P=0.313 P=0.233N |P=0.517N P=0.486 P=0.753N P=0.760N |
|POLY 3 | P=0.226N P=0.692 P=0.324 P=0.235N |P=0.529N P=0.492 P=0.754N P=0.759 |
|POLY 1.5 | P=0.225N P=0.692 P=0.334 P=0.234N |P=0.531N P=0.495 P=0.757N P=0.758 |
|POLY 6 | P=0.227N P=0.691 P=0.312 P=0.235N |P=0.526N P=0.486 P=0.751N P=0.760N |
|LOGISTIC REGRESSION| P=0.354N P=0.690N P=0.414 P=0.277N |P=0.494N P=0.523 P=0.678 P=0.726N |
|COCH-ARM / FISHERS | P=0.232N P=0.691N P=0.339 P=0.247N |P=0.530N P=0.500 P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Gallbladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 2/50 (4%) 4/49 (8%) |6/50 (12%) 5/50 (10%) 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/48.41 2/48.13 2/44.90 4/48.55 |6/46.06 5/45.42 5/47.80 3/46.54 |
|POLY-3 PERCENT (g) | 8.3% 4.2% 4.5% 8.2% |13.0% 11.0% 10.5% 6.5% |
|TERMINAL (d) | 4/47 (9%) 2/46 (4%) 2/39 (5%) 4/48 (8%) |6/41 (15%) 5/37 (14%) 5/44 (11%) 3/43 (7%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.505 P=0.347N P=0.426N P=0.632N |P=0.156N P=0.572N P=0.450N P=0.219N |
|POLY 3 | P=0.496 P=0.340N P=0.373N P=0.641N |P=0.187N P=0.510N P=0.474N P=0.237N |
|POLY 1.5 | P=0.497 P=0.339N P=0.356N P=0.642N |P=0.194N P=0.505N P=0.484N P=0.242N |
|POLY 6 | P=0.496 P=0.343N P=0.393N P=0.640N |P=0.179N P=0.520N P=0.465N P=0.231N |
|LOGISTIC REGRESSION| P=0.505 P=0.347N P=0.426N P=0.632N |P=0.156N P=0.572N P=0.450N P=0.219N |
|COCH-ARM / FISHERS | P=0.489 P=0.339N P=0.339N P=0.631 |P=0.196N P=0.500N P=0.500N P=0.243N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/4 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) |0/1 (0%) 1/4 (25%) 2/5 (40%) 0/0 (0%) |
|POLY-3 RATE (b) | 0/4.00 0/4.00 0/1.00 0/3.00 |0/1.00 1/3.63 2/5.00 0/0.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 27.6% 40.0% 0.0% |
|TERMINAL (d) | 0/4 (0%) 0/4 (0%) 0/1 (0%) 0/3 (0%) |0/1 (0%) 1/3 (33%) 2/5 (40%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 733 (T) 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.627 P=0.718 P=0.638 (e) |
|POLY 3 | (e) (e) (e) (e) |(e) P=0.742 P=0.631 (e) |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=0.745 P=0.631 (e) |
|POLY 6 | (e) (e) (e) (e) |(e) P=0.736 P=0.631 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.718 P=0.638 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.582 P=0.800 P=0.667 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/48.41 1/48.13 2/46.04 1/50.00 |1/46.19 1/45.46 0/47.80 2/47.08 |
|POLY-3 PERCENT (g) | 4.1% 2.1% 4.3% 2.0% |2.2% 2.2% 0.0% 4.3% |
|TERMINAL (d) | 2/47 (4%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 533 596 |698 723 --- 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437N P=0.508N P=0.649 P=0.486N |P=0.386 P=0.744 P=0.491N P=0.511 |
|POLY 3 | P=0.434N P=0.502N P=0.676 P=0.489N |P=0.374 P=0.757 P=0.493N P=0.507 |
|POLY 1.5 | P=0.436N P=0.501N P=0.685 P=0.491N |P=0.370 P=0.759 P=0.496N P=0.502 |
|POLY 6 | P=0.432N P=0.504N P=0.665 P=0.486N |P=0.379 P=0.753 P=0.491N P=0.512 |
|LOGISTIC REGRESSION| P=0.508N P=0.508N P=0.694N P=0.540N |P=0.374 P=0.762 P=0.509N P=0.514 |
|COCH-ARM / FISHERS | P=0.444N P=0.500N P=0.691N P=0.500N |P=0.366 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.41 1/48.13 1/45.58 0/49.55 |1/46.80 2/45.42 1/47.80 2/47.40 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 0.0% |2.1% 4.4% 2.1% 4.2% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 2/37 (5%) 1/44 (2%) 1/43 (2%) |
|FIRST INCIDENCE | --- 728 (T) 498 --- |463 733 (T) 733 (T) 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N P=0.496 P=0.500 (e) |P=0.465 P=0.476 P=0.752N P=0.501 |
|POLY 3 | P=0.589N P=0.499 P=0.488 (e) |P=0.453 P=0.490 P=0.756N P=0.504 |
|POLY 1.5 | P=0.589N P=0.499 P=0.494 (e) |P=0.448 P=0.494 P=0.758N P=0.501 |
|POLY 6 | P=0.590N P=0.498 P=0.481 (e) |P=0.459 P=0.483 P=0.754N P=0.508 |
|LOGISTIC REGRESSION| P=0.663N P=0.496 P=0.436 (e) |P=0.494 P=0.515 P=0.701 P=0.627 |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.444 P=0.500 P=0.753N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 5/50 (10%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 5/47.31 0/49.55 |1/46.82 0/45.42 1/48.14 1/46.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.6% 0.0% |2.1% 0.0% 2.1% 2.2% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- --- 365 --- |456 --- 638 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 (e) P=0.031 * (e) |P=0.546 P=0.504N P=0.753N P=0.760N |
|POLY 3 | P=0.492 (e) P=0.029 * (e) |P=0.542 P=0.506N P=0.754N P=0.759 |
|POLY 1.5 | P=0.488 (e) P=0.030 * (e) |P=0.539 P=0.504N P=0.757N P=0.758 |
|POLY 6 | P=0.496 (e) P=0.027 * (e) |P=0.548 P=0.510N P=0.751N P=0.760N |
|LOGISTIC REGRESSION| P=0.309 (e) P=0.023 * (e) |P=0.598 P=0.396N P=0.678 P=0.726N |
|COCH-ARM / FISHERS | P=0.469 (e) P=0.028 * (e) |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Heart: Artery |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 1/44.90 2/49.55 |1/46.80 0/45.42 0/47.80 2/47.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 4.0% |2.1% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 1/39 (3%) 2/49 (4%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | --- --- 728 (T) 728 (T) |463 --- --- 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.079 (e) P=0.463 P=0.248 |P=0.254 P=0.500N P=0.500N P=0.506 |
|POLY 3 | P=0.073 (e) P=0.485 P=0.243 |P=0.251 P=0.506N P=0.496N P=0.502 |
|POLY 1.5 | P=0.073 (e) P=0.492 P=0.242 |P=0.248 P=0.504N P=0.497N P=0.499 |
|POLY 6 | P=0.074 (e) P=0.477 P=0.243 |P=0.255 P=0.510N P=0.494N P=0.506 |
|LOGISTIC REGRESSION| (e) (e) P=0.463 P=0.248 |P=0.308 P=0.402N P=0.603N P=0.571 |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.247 |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 3/50 (6%) 4/50 (8%) |3/50 (6%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/48.41 5/48.13 3/44.90 4/49.55 |3/46.06 4/45.42 0/47.80 2/46.54 |
|POLY-3 PERCENT (g) | 8.3% 10.4% 6.7% 8.1% |6.5% 8.8% 0.0% 4.3% |
|TERMINAL (d) | 4/47 (9%) 5/46 (11%) 3/39 (8%) 4/49 (8%) |3/41 (7%) 4/37 (11%) 0/44 (0%) 2/43 (5%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 733 (T) --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480N P=0.487 P=0.601N P=0.620N |P=0.231N P=0.444 P=0.109N P=0.478N |
|POLY 3 | P=0.492N P=0.496 P=0.541N P=0.630N |P=0.256N P=0.492 P=0.112N P=0.495N |
|POLY 1.5 | P=0.491N P=0.498 P=0.521N P=0.631N |P=0.260N P=0.496 P=0.115N P=0.499N |
|POLY 6 | P=0.493N P=0.493 P=0.563N P=0.629N |P=0.252N P=0.484 P=0.110N P=0.490N |
|LOGISTIC REGRESSION| P=0.480N P=0.487 P=0.601N P=0.620N |P=0.231N P=0.444 (e) P=0.478N |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.643N |P=0.263N P=0.500 P=0.121N P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/48.41 0/48.13 3/44.90 3/49.55 |0/46.06 0/45.42 0/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 6.7% 6.1% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 3/47 (6%) 0/46 (0%) 3/39 (8%) 3/49 (6%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) --- 728 (T) 728 (T) |--- --- --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403 P=0.125N P=0.574 P=0.643N |P=0.210 (e) (e) P=0.510 |
|POLY 3 | P=0.398 P=0.120N P=0.627 P=0.651N |P=0.201 (e) (e) P=0.502 |
|POLY 1.5 | P=0.397 P=0.120N P=0.644 P=0.652N |P=0.200 (e) (e) P=0.500 |
|POLY 6 | P=0.399 P=0.121N P=0.607 P=0.650N |P=0.204 (e) (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.403 (e) P=0.574 P=0.643N |(e) (e) (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.386 P=0.121N P=0.661N P=0.661N |P=0.198 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/48.41 2/48.13 2/44.90 0/49.55 |1/46.06 0/45.42 0/47.80 2/47.08 |
|POLY-3 PERCENT (g) | 10.3% 4.2% 4.5% 0.0% |2.2% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 5/47 (11%) 2/46 (4%) 2/39 (5%) 0/49 (0%) |1/41 (2%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) --- |733 (T) --- --- 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023N* P=0.226N P=0.298N P=0.030N* |P=0.262 P=0.520N P=0.486N P=0.513 |
|POLY 3 | P=0.020N* P=0.219N P=0.248N P=0.029N* |P=0.251 P=0.503N P=0.493N P=0.508 |
|POLY 1.5 | P=0.020N* P=0.218N P=0.233N P=0.029N* |P=0.248 P=0.501N P=0.495N P=0.503 |
|POLY 6 | P=0.020N* P=0.221N P=0.267N P=0.029N* |P=0.256 P=0.506N P=0.490N P=0.514 |
|LOGISTIC REGRESSION| P=0.023N* P=0.226N P=0.298N (e) |P=0.253 (e) (e) P=0.508 |
|COCH-ARM / FISHERS | P=0.022N* P=0.218N P=0.218N P=0.028N* |P=0.246 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 11
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 42/50 (84%) 40/50 (80%) 44/50 (88%) |9/50 (18%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 29/48.92 42/48.13 40/46.70 44/49.55 |9/49.41 0/48.13 0/44.90 0/49.55 |
|POLY-3 PERCENT (g) | 59.3% 87.3% 85.7% 88.8% |18.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 28/47 (60%) 42/46 (91%) 36/39 (92%) 44/49 (90%) |8/47 (17%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 572 728 (T) 498 728 (T) |100 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.002 ** P<0.001 ** P=0.002 ** |P<0.001N** P=0.003N** P=0.006N** P=0.002N** |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.003 ** P<0.001 ** |P<0.001N** P=0.002N** P=0.003N** P=0.002N** |
|POLY 1.5 | P<0.001 ** P=0.002 ** P=0.006 ** P<0.001 ** |P<0.001N** P=0.002N** P=0.002N** P=0.002N** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001N** P=0.002N** P=0.004N** P=0.002N** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.003 ** P=0.003 ** P<0.001 ** |P<0.001N** P=0.002N** P=0.002N** P=0.004N** |
|COCH-ARM / FISHERS | P=0.002 ** P=0.004 ** P=0.015 * P<0.001 ** |P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 2/44.90 1/49.55 |1/46.06 1/45.52 1/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 2.0% |2.2% 2.2% 2.1% 2.2% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 2/39 (5%) 1/49 (2%) |1/41 (2%) 0/37 (0%) 1/44 (2%) 1/43 (2%) |
|FIRST INCIDENCE | --- --- 728 (T) 728 (T) |733 (T) 708 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259 (e) P=0.198 P=0.508 |P=0.608N P=0.743 P=0.746N P=0.751N |
|POLY 3 | P=0.258 (e) P=0.221 P=0.505 |P=0.627N P=0.758 P=0.752N P=0.758N |
|POLY 1.5 | P=0.256 (e) P=0.229 P=0.504 |P=0.630N P=0.759 P=0.755N P=0.760N |
|POLY 6 | P=0.260 (e) P=0.212 P=0.505 |P=0.623N P=0.755 P=0.749N P=0.756N |
|LOGISTIC REGRESSION| (e) (e) P=0.198 P=0.508 |P=0.624N P=0.759 P=0.746N P=0.751N |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.634 P=0.753N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 12
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.41 1/48.13 3/44.90 2/49.55 |1/46.48 1/45.42 3/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 6.7% 4.0% |2.2% 2.2% 6.3% 2.2% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 3/39 (8%) 2/49 (4%) |0/41 (0%) 1/37 (3%) 3/44 (7%) 1/43 (2%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) 728 (T) |609 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178 P=0.496 P=0.091 P=0.248 |P=0.583 P=0.747 P=0.330 P=0.755N |
|POLY 3 | P=0.173 P=0.499 P=0.106 P=0.243 |P=0.560 P=0.755 P=0.316 P=0.760N |
|POLY 1.5 | P=0.172 P=0.499 P=0.112 P=0.242 |P=0.555 P=0.758 P=0.312 P=0.760 |
|POLY 6 | P=0.175 P=0.498 P=0.099 P=0.243 |P=0.566 P=0.751 P=0.318 P=0.759N |
|LOGISTIC REGRESSION| (e) P=0.496 P=0.091 P=0.248 |P=0.556 P=0.758N P=0.292 P=0.757N |
|COCH-ARM / FISHERS | P=0.163 P=0.500 P=0.121 P=0.247 |P=0.556 P=0.753N P=0.309 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 49/50 (98%) 45/50 (90%) 46/50 (92%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | 44/49.00 49/49.00 45/47.56 46/49.55 |4/47.00 1/45.42 2/47.83 6/46.54 |
|POLY-3 PERCENT (g) | 89.8% 100.0% 94.6% 92.8% |8.5% 2.2% 4.2% 12.9% |
|TERMINAL (d) | 42/47 (89%) 46/46 (100%) 38/39 (97%) 46/49 (94%) |2/41 (5%) 1/37 (3%) 1/44 (2%) 6/43 (14%) |
|FIRST INCIDENCE | 572 594 533 728 (T) |570 733 (T) 726 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.431N P=0.056 P=0.019 * P=0.610 |P=0.186 P=0.202N P=0.313N P=0.397 |
|POLY 3 | P=0.574 P=0.031 * P=0.299 P=0.428 |P=0.157 P=0.189N P=0.329N P=0.364 |
|POLY 1.5 | P=0.555N P=0.030 * P=0.411 P=0.448 |P=0.154 P=0.185N P=0.332N P=0.364 |
|POLY 6 | P=0.514 P=0.031 * P=0.199 P=0.396 |P=0.162 P=0.198N P=0.328N P=0.364 |
|LOGISTIC REGRESSION| P=0.514N P=0.034 * P=0.226 P=0.505 |P=0.154 P=0.173N P=0.375N P=0.370 |
|COCH-ARM / FISHERS | P=0.500 P=0.056 P=0.500 P=0.370 |P=0.154 P=0.181N P=0.339N P=0.370 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 13
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 46/50 (92%) 38/50 (76%) 42/50 (84%) |11/50 (22%) 4/50 (8%) 12/50 (24%) 8/50 (16%) |
|POLY-3 RATE (b) | 47/49.92 46/48.44 38/45.45 42/49.55 |11/47.69 4/45.79 12/47.80 8/47.23 |
|POLY-3 PERCENT (g) | 94.2% 95.0% 83.6% 84.8% |23.1% 8.7% 25.1% 16.9% |
|TERMINAL (d) | 45/47 (96%) 45/46 (98%) 37/39 (95%) 42/49 (86%) |8/41 (20%) 3/37 (8%) 12/44 (27%) 6/43 (14%) |
|FIRST INCIDENCE | 100 644 561 728 (T) |463 628 733 (T) 587 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.656N P=0.456N P=0.034N* |P=0.415N P=0.071N P=0.567 P=0.283N |
|POLY 3 | P=0.032N* P=0.608 P=0.073N P=0.112N |P=0.477N P=0.052N P=0.503 P=0.313N |
|POLY 1.5 | P=0.034N* P=0.640 P=0.032N* P=0.106N |P=0.488N P=0.049N* P=0.501 P=0.316N |
|POLY 6 | P=0.032N* P=0.564 P=0.183N P=0.118N |P=0.457N P=0.057N P=0.504 P=0.305N |
|LOGISTIC REGRESSION| P=0.018N* P=0.513N P=0.023N* P=0.094N |P=0.488N P=0.043N* P=0.483 P=0.300N |
|COCH-ARM / FISHERS | P=0.050N P=0.500N P=0.011N* P=0.100N |P=0.488N P=0.045N* P=0.500 P=0.306N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 8/50 (16%) 9/50 (18%) |25/50 (50%) 30/50 (60%) 22/50 (44%) 32/50 (64%) |
|POLY-3 RATE (b) | 7/48.41 5/48.13 8/44.90 9/49.55 |25/47.88 30/48.65 22/48.13 32/47.08 |
|POLY-3 PERCENT (g) | 14.5% 10.4% 17.8% 18.2% |52.2% 61.7% 45.7% 68.0% |
|TERMINAL (d) | 7/47 (15%) 5/46 (11%) 8/39 (21%) 9/49 (18%) |20/41 (49%) 22/37 (60%) 21/44 (48%) 31/43 (72%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |456 325 642 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265 P=0.394N P=0.346 P=0.428 |P=0.316 P=0.132 P=0.250N P=0.176 |
|POLY 3 | P=0.252 P=0.384N P=0.437 P=0.413 |P=0.126 P=0.231 P=0.332N P=0.084 |
|POLY 1.5 | P=0.252 P=0.382N P=0.467 P=0.411 |P=0.131 P=0.224 P=0.338N P=0.088 |
|POLY 6 | P=0.253 P=0.387N P=0.403 P=0.414 |P=0.124 P=0.233 P=0.326N P=0.083 |
|LOGISTIC REGRESSION| P=0.265 P=0.394N P=0.346 P=0.428 |P=0.166 P=0.214 P=0.317N P=0.112 |
|COCH-ARM / FISHERS | P=0.238 P=0.380N P=0.500 P=0.393 |P=0.163 P=0.211 P=0.344N P=0.113 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 14
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |4/49 (8%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/48.41 3/48.13 1/44.90 0/49.55 |4/45.21 2/45.42 1/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 6.2% 6.2% 2.2% 0.0% |8.9% 4.4% 2.1% 0.0% |
|TERMINAL (d) | 3/47 (6%) 3/46 (7%) 1/39 (3%) 0/49 (0%) |4/41 (10%) 2/37 (5%) 1/44 (2%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) --- |733 (T) 733 (T) 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054N P=0.653 P=0.374N P=0.114N |P=0.025N* P=0.385N P=0.159N P=0.057N |
|POLY 3 | P=0.051N P=0.659 P=0.333N P=0.115N |P=0.027N* P=0.335N P=0.162N P=0.057N |
|POLY 1.5 | P=0.051N P=0.660 P=0.320N P=0.115N |P=0.027N* P=0.332N P=0.166N P=0.058N |
|POLY 6 | P=0.051N P=0.657 P=0.349N P=0.115N |P=0.026N* P=0.343N P=0.159N P=0.055N |
|LOGISTIC REGRESSION| P=0.054N P=0.653 P=0.374N (e) |P=0.025N* P=0.385N P=0.159N (e) |
|COCH-ARM / FISHERS | P=0.052N P=0.661N P=0.309N P=0.121N |P=0.028N* P=0.329N P=0.175N P=0.056N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.41 3/48.13 2/44.90 1/49.55 |1/45.21 2/45.64 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 2.1% 6.2% 4.5% 2.0% |2.2% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 1/47 (2%) 3/46 (7%) 2/39 (5%) 1/49 (2%) |1/41 (2%) 1/37 (3%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 673 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.462N P=0.298 P=0.435 P=0.752N |P=0.177N P=0.468 P=0.486N P=0.490N |
|POLY 3 | P=0.466N P=0.304 P=0.474 P=0.755N |P=0.183N P=0.503 P=0.489N P=0.494N |
|POLY 1.5 | P=0.466N P=0.304 P=0.486 P=0.756N |P=0.184N P=0.505 P=0.491N P=0.496N |
|POLY 6 | P=0.467N P=0.302 P=0.459 P=0.755N |P=0.181N P=0.499 P=0.487N P=0.492N |
|LOGISTIC REGRESSION| P=0.462N P=0.298 P=0.435 P=0.752N |P=0.184N P=0.505 (e) (e) |
|COCH-ARM / FISHERS | P=0.474N P=0.309 P=0.500 P=0.753N |P=0.185N P=0.508 P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 15
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 2/50 (4%) |4/49 (8%) 8/50 (16%) 4/50 (8%) 7/50 (14%) |
|POLY-3 RATE (b) | 3/48.41 4/48.59 4/44.90 2/49.55 |4/46.11 8/45.99 4/47.80 7/46.54 |
|POLY-3 PERCENT (g) | 6.2% 8.2% 8.9% 4.0% |8.7% 17.4% 8.4% 15.0% |
|TERMINAL (d) | 3/47 (6%) 3/46 (7%) 4/39 (10%) 2/49 (4%) |2/41 (5%) 7/37 (19%) 4/44 (9%) 7/43 (16%) |
|FIRST INCIDENCE | 728 (T) 594 728 (T) 728 (T) |456 551 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.355N P=0.492 P=0.399 P=0.481N |P=0.399 P=0.147 P=0.611N P=0.286 |
|POLY 3 | P=0.358N P=0.502 P=0.459 P=0.489N |P=0.348 P=0.175 P=0.623N P=0.267 |
|POLY 1.5 | P=0.358N P=0.501 P=0.479 P=0.490N |P=0.346 P=0.181 P=0.626N P=0.266 |
|POLY 6 | P=0.358N P=0.502 P=0.436 P=0.489N |P=0.352 P=0.166 P=0.621N P=0.267 |
|LOGISTIC REGRESSION| P=0.361N P=0.500 P=0.399 P=0.481N |P=0.352 P=0.191 P=0.625 P=0.273 |
|COCH-ARM / FISHERS | P=0.367N P=0.500 P=0.500 P=0.500N |P=0.351 P=0.188 P=0.631N P=0.274 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |6/49 (12%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/48.41 1/48.24 1/45.19 0/49.55 |6/46.10 3/45.89 2/47.80 5/47.08 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 0.0% |13.0% 6.5% 4.2% 10.6% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |4/41 (10%) 1/37 (3%) 2/44 (5%) 4/43 (9%) |
|FIRST INCIDENCE | --- 701 652 --- |463 628 733 (T) 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590N P=0.496 P=0.478 (e) |P=0.457N P=0.283N P=0.121N P=0.475N |
|POLY 3 | P=0.590N P=0.499 P=0.486 (e) |P=0.482N P=0.244N P=0.122N P=0.485N |
|POLY 1.5 | P=0.590N P=0.500 P=0.493 (e) |P=0.487N P=0.240N P=0.124N P=0.489N |
|POLY 6 | P=0.590N P=0.499 P=0.479 (e) |P=0.474N P=0.252N P=0.121N P=0.480N |
|LOGISTIC REGRESSION| P=0.616N P=0.501 P=0.502 (e) |P=0.488N P=0.225N P=0.143N P=0.480N |
|COCH-ARM / FISHERS | P=0.595N P=0.500 P=0.500 (e) |P=0.490N P=0.233N P=0.128N P=0.486N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 16
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 34/50 (68%) 28/50 (56%) 27/50 (54%) |42/49 (86%) 36/50 (72%) 38/50 (76%) 41/50 (82%) |
|POLY-3 RATE (b) | 33/48.92 34/48.13 28/45.58 27/49.55 |42/47.80 36/47.22 38/48.13 41/49.11 |
|POLY-3 PERCENT (g) | 67.5% 70.6% 61.4% 54.5% |87.9% 76.2% 79.0% 83.5% |
|TERMINAL (d) | 32/47 (68%) 34/46 (74%) 27/39 (69%) 27/49 (55%) |37/41 (90%) 30/37 (81%) 37/44 (84%) 37/43 (86%) |
|FIRST INCIDENCE | 572 728 (T) 498 728 (T) |463 575 642 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.438 P=0.540 P=0.101N |P=0.289N P=0.375N P=0.075N P=0.338N |
|POLY 3 | P=0.060N P=0.452 P=0.344N P=0.133N |P=0.468N P=0.104N P=0.177N P=0.370N |
|POLY 1.5 | P=0.059N P=0.472 P=0.268N P=0.131N |P=0.491N P=0.091N P=0.170N P=0.380N |
|POLY 6 | P=0.061N P=0.422 P=0.449N P=0.137N |P=0.452N P=0.125N P=0.191N P=0.371N |
|LOGISTIC REGRESSION| P=0.058N P=0.483 P=0.393N P=0.123N |P=0.537N P=0.075N P=0.100N P=0.414N |
|COCH-ARM / FISHERS | P=0.078N P=0.500 P=0.206N P=0.154N |P=0.541N P=0.077N P=0.166N P=0.410N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 6/50 (12%) |1/49 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/48.41 3/48.13 3/44.90 6/49.55 |1/45.21 3/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 10.3% 6.2% 6.7% 12.1% |2.2% 6.6% 0.0% 0.0% |
|TERMINAL (d) | 5/47 (11%) 3/46 (7%) 3/39 (8%) 6/49 (12%) |1/41 (2%) 3/37 (8%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 733 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373 P=0.368N P=0.462N P=0.529 |P=0.139N P=0.269 P=0.486N P=0.490N |
|POLY 3 | P=0.359 P=0.360N P=0.399N P=0.516 |P=0.146N P=0.307 P=0.489N P=0.494N |
|POLY 1.5 | P=0.359 P=0.359N P=0.378N P=0.515 |P=0.147N P=0.310 P=0.491N P=0.496N |
|POLY 6 | P=0.359 P=0.363N P=0.423N P=0.517 |P=0.145N P=0.300 P=0.487N P=0.492N |
|LOGISTIC REGRESSION| P=0.373 P=0.368N P=0.462N P=0.529 |P=0.139N P=0.269 (e) (e) |
|COCH-ARM / FISHERS | P=0.350 P=0.357N P=0.357N P=0.500 |P=0.150N P=0.316 P=0.495N P=0.495N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 17
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 3/50 (6%) |2/49 (4%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/48.92 4/48.44 4/45.29 3/49.55 |2/45.21 2/46.03 1/47.80 3/47.40 |
|POLY-3 PERCENT (g) | 12.3% 8.3% 8.8% 6.1% |4.4% 4.3% 2.1% 6.3% |
|TERMINAL (d) | 5/47 (11%) 3/46 (7%) 2/39 (5%) 3/49 (6%) |2/41 (5%) 0/37 (0%) 1/44 (2%) 2/43 (5%) |
|FIRST INCIDENCE | 572 644 652 728 (T) |733 (T) 551 733 (T) 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206N P=0.383N P=0.481N P=0.226N |P=0.433 P=0.671 P=0.475N P=0.515 |
|POLY 3 | P=0.206N P=0.376N P=0.419N P=0.237N |P=0.423 P=0.687N P=0.481N P=0.522 |
|POLY 1.5 | P=0.204N P=0.374N P=0.396N P=0.236N |P=0.417 P=0.686N P=0.485N P=0.516 |
|POLY 6 | P=0.208N P=0.380N P=0.445N P=0.239N |P=0.430 P=0.691N P=0.477N P=0.527 |
|LOGISTIC REGRESSION| P=0.209N P=0.368N P=0.367N P=0.253N |P=0.431 P=0.684N P=0.475N P=0.529 |
|COCH-ARM / FISHERS | P=0.208N P=0.370N P=0.370N P=0.243N |P=0.410 P=0.684N P=0.492N P=0.510 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |3/49 (6%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/48.41 1/48.13 1/44.90 1/49.55 |3/45.64 4/45.46 2/47.80 4/47.08 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 2.0% |6.6% 8.8% 4.2% 8.5% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 1/39 (3%) 1/49 (2%) |2/41 (5%) 3/37 (8%) 2/44 (5%) 3/43 (7%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) 728 (T) |609 723 733 (T) 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.395 P=0.496 P=0.463 P=0.508 |P=0.524 P=0.453 P=0.471N P=0.520 |
|POLY 3 | P=0.395 P=0.499 P=0.485 P=0.505 |P=0.501 P=0.498 P=0.479N P=0.517 |
|POLY 1.5 | P=0.394 P=0.499 P=0.492 P=0.504 |P=0.494 P=0.504 P=0.483N P=0.512 |
|POLY 6 | P=0.396 P=0.498 P=0.477 P=0.505 |P=0.509 P=0.486 P=0.477N P=0.522 |
|LOGISTIC REGRESSION| (e) P=0.496 P=0.463 P=0.508 |P=0.490 P=0.507 P=0.497N P=0.515 |
|COCH-ARM / FISHERS | P=0.384 P=0.500 P=0.500 P=0.500 |P=0.490 P=0.511 P=0.490N P=0.511 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 18
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/44.90 1/49.55 |1/45.21 2/45.52 0/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.0% |2.2% 4.4% 0.0% 2.2% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 1/49 (2%) |1/41 (2%) 1/37 (3%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | --- --- --- 728 (T) |733 (T) 708 --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 (e) (e) P=0.508 |P=0.474N P=0.471 P=0.486N P=0.751N |
|POLY 3 | P=0.202 (e) (e) P=0.505 |P=0.491N P=0.502 P=0.489N P=0.754N |
|POLY 1.5 | P=0.202 (e) (e) P=0.504 |P=0.493N P=0.505 P=0.491N P=0.756N |
|POLY 6 | P=0.203 (e) (e) P=0.505 |P=0.489N P=0.497 P=0.487N P=0.752N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.508 |P=0.486N P=0.497 (e) P=0.751N |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.495N P=0.508 P=0.495N P=0.747N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver: Portal |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 8/50 (16%) 3/50 (6%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.41 6/48.13 8/44.90 3/49.55 |2/48.41 0/48.13 0/44.90 0/49.55 |
|POLY-3 PERCENT (g) | 2.1% 12.5% 17.8% 6.1% |4.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/47 (2%) 6/46 (13%) 8/39 (21%) 3/49 (6%) |2/47 (4%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424 P=0.056 P=0.008 ** P=0.321 |P=0.119N P=0.243N P=0.280N P=0.229N |
|POLY 3 | P=0.424 P=0.055 P=0.011 * P=0.314 |P=0.116N P=0.239N P=0.254N P=0.232N |
|POLY 1.5 | P=0.422 P=0.056 P=0.013 * P=0.313 |P=0.115N P=0.238N P=0.246N P=0.233N |
|POLY 6 | P=0.427 P=0.055 P=0.009 ** P=0.315 |P=0.117N P=0.240N P=0.264N P=0.232N |
|LOGISTIC REGRESSION| P=0.424 P=0.056 P=0.008 ** P=0.321 |P=0.119N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.401 P=0.056 P=0.015 * P=0.309 |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 19
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.41 1/48.13 3/44.90 1/50.00 |1/46.19 0/45.42 3/48.34 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 6.7% 2.0% |2.2% 0.0% 6.2% 0.0% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 3/39 (8%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 2/44 (5%) 0/43 (0%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) 596 |698 --- 568 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.365 P=0.496 P=0.091 P=0.508 |P=0.481N P=0.514N P=0.328 P=0.495N |
|POLY 3 | P=0.373 P=0.499 P=0.106 P=0.506 |P=0.494N P=0.503N P=0.322 P=0.498N |
|POLY 1.5 | P=0.368 P=0.499 P=0.112 P=0.505 |P=0.499N P=0.502N P=0.316 P=0.500N |
|POLY 6 | P=0.379 P=0.498 P=0.099 P=0.508 |P=0.486N P=0.507N P=0.328 P=0.497N |
|LOGISTIC REGRESSION| P=0.343 P=0.496 P=0.091 P=0.412 |P=0.494N P=0.499N P=0.271 P=0.499N |
|COCH-ARM / FISHERS | P=0.351 P=0.500 P=0.121 P=0.500 |P=0.500N P=0.500N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 7/50 (14%) 0/50 (0%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/48.41 7/48.13 0/44.90 5/49.55 |1/46.06 0/45.42 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 4.1% 14.5% 0.0% 10.1% |2.2% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 2/47 (4%) 7/46 (15%) 0/39 (0%) 5/49 (10%) |1/41 (2%) 0/37 (0%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- 728 (T) |733 (T) --- 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410 P=0.076 P=0.280N P=0.234 |P=0.527 P=0.520N P=0.525 P=0.751N |
|POLY 3 | P=0.392 P=0.078 P=0.254N P=0.227 |P=0.507 P=0.503N P=0.513 P=0.758N |
|POLY 1.5 | P=0.394 P=0.079 P=0.246N P=0.226 |P=0.502 P=0.501N P=0.508 P=0.760N |
|POLY 6 | P=0.389 P=0.077 P=0.264N P=0.227 |P=0.515 P=0.506N P=0.518 P=0.756N |
|LOGISTIC REGRESSION| P=0.410 P=0.076 (e) P=0.234 |P=0.527 (e) P=0.525 P=0.751N |
|COCH-ARM / FISHERS | P=0.390 P=0.080 P=0.247N P=0.218 |P=0.500 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 20
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/46 (0%) 2/46 (4%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.92 0/45.59 2/41.91 0/49.55 |1/45.59 0/45.42 0/46.80 0/46.54 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 4.8% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/47 (2%) 0/44 (0%) 1/37 (3%) 0/49 (0%) |1/41 (2%) 0/37 (0%) 0/43 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) --- 652 --- |733 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.454N P=0.513N P=0.430 P=0.492N |P=0.297N P=0.520N P=0.490N P=0.490N |
|POLY 3 | P=0.450N P=0.510N P=0.453 P=0.493N |P=0.301N P=0.501N P=0.495N P=0.496N |
|POLY 1.5 | P=0.450N P=0.510N P=0.465 P=0.493N |P=0.302N P=0.499N P=0.497N P=0.497N |
|POLY 6 | P=0.450N P=0.511N P=0.441 P=0.494N |P=0.299N P=0.505N P=0.493N P=0.495N |
|LOGISTIC REGRESSION| P=0.460N (e) P=0.480 (e) |P=0.297N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.453N P=0.516N P=0.476 P=0.495N |P=0.304N P=0.495N P=0.500N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/46 (0%) 1/46 (2%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.92 0/45.59 1/41.63 1/49.55 |0/45.59 0/45.42 0/46.80 0/46.54 |
|POLY-3 PERCENT (g) | 4.2% 0.0% 2.4% 2.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/47 (4%) 0/44 (0%) 1/37 (3%) 1/49 (2%) |0/41 (0%) 0/37 (0%) 0/43 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) --- 728 (T) 728 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488N P=0.253N P=0.583N P=0.485N |(e) (e) (e) (e) |
|POLY 3 | P=0.493N P=0.249N P=0.549N P=0.488N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.492N P=0.248N P=0.536N P=0.488N |(e) (e) (e) (e) |
|POLY 6 | P=0.494N P=0.250N P=0.563N P=0.490N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.488N (e) P=0.583N P=0.485N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.490N P=0.263N P=0.524N P=0.492N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 21
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |0/4 (0%) 2/5 (40%) 0/4 (0%) 1/1 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.90 0/0.00 |0/3.59 2/4.40 0/3.48 1/1.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 45.5% 0.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/3 (0%) 2/3 (67%) 0/1 (0%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |--- 733 (T) --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.191 P=0.215 (e) P=0.282 |
|POLY 3 | (e) (e) (e) (e) |P=0.162 P=0.251 (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) |P=0.164 P=0.255 (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) |P=0.161 P=0.248 (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.215 (e) P=0.282 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.207 P=0.278 (e) P=0.200 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) |3/4 (75%) 2/5 (40%) 1/4 (25%) 1/1 (100%) |
|POLY-3 RATE (b) | 0/0.00 0/0.00 0/0.90 0/0.00 |3/3.59 2/4.40 1/3.48 1/1.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |83.6% 45.5% 28.7% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |3/3 (100%) 2/3 (67%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | --- --- --- --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.755 P=0.500N P=1.000 P=1.000 |
|POLY 3 | (e) (e) (e) (e) |P=0.642N P=0.352N P=0.215N P=0.903 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.618N P=0.358N P=0.225N P=0.827 |
|POLY 6 | (e) (e) (e) (e) |P=0.684N P=0.337N P=0.208N P=0.991 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.755 P=0.500N P=1.000 P=1.000 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.598N P=0.357N P=0.243N P=0.800 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 22
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 3/48 (6%) 0/48 (0%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.92 3/46.69 0/44.04 3/50.00 |1/46.06 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 2.1% 6.4% 0.0% 6.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/46 (2%) 3/46 (7%) 0/39 (0%) 2/49 (4%) |1/41 (2%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- 596 |733 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.306 P=0.533N P=0.328 |P=0.296N P=0.520N P=0.486N P=0.490N |
|POLY 3 | P=0.345 P=0.304 P=0.513N P=0.329 |P=0.304N P=0.503N P=0.493N P=0.498N |
|POLY 1.5 | P=0.346 P=0.304 P=0.506N P=0.328 |P=0.304N P=0.501N P=0.495N P=0.500N |
|POLY 6 | P=0.344 P=0.303 P=0.520N P=0.329 |P=0.303N P=0.506N P=0.490N P=0.496N |
|LOGISTIC REGRESSION| P=0.337 P=0.306 (e) P=0.289 |P=0.296N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.341 P=0.308 P=0.500N P=0.324 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 6/48 (13%) 0/48 (0%) 4/50 (8%) |5/50 (10%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.92 6/46.69 0/44.04 4/49.55 |5/46.06 3/45.42 4/48.34 2/46.54 |
|POLY-3 PERCENT (g) | 4.3% 12.9% 0.0% 8.1% |10.9% 6.6% 8.3% 4.3% |
|TERMINAL (d) | 2/46 (4%) 6/46 (13%) 0/39 (0%) 4/49 (8%) |5/41 (12%) 3/37 (8%) 3/44 (7%) 2/43 (5%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- 728 (T) |733 (T) 733 (T) 568 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.526 P=0.135 P=0.276N P=0.367 |P=0.169N P=0.413N P=0.458N P=0.198N |
|POLY 3 | P=0.524 P=0.132 P=0.252N P=0.363 |P=0.192N P=0.364N P=0.470N P=0.212N |
|POLY 1.5 | P=0.527 P=0.132 P=0.244N P=0.364 |P=0.197N P=0.361N P=0.481N P=0.216N |
|POLY 6 | P=0.519 P=0.131 P=0.260N P=0.361 |P=0.184N P=0.372N P=0.458N P=0.207N |
|LOGISTIC REGRESSION| P=0.526 P=0.135 (e) P=0.367 |P=0.192N P=0.413N P=0.496N P=0.198N |
|COCH-ARM / FISHERS | P=0.523 P=0.134 P=0.247N P=0.359 |P=0.200N P=0.357N P=0.500N P=0.218N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 23
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 1/48 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.92 2/46.69 1/44.04 0/49.55 |0/46.06 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 2/46 (4%) 1/39 (3%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.239 P=0.467 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.448N P=0.236 P=0.487 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.446N P=0.237 P=0.494 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.450N P=0.236 P=0.480 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.239 P=0.467 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.450N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/48 (4%) 1/48 (2%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.92 2/46.69 1/44.04 3/49.55 |1/46.06 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 2.3% 6.1% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/46 (4%) 2/46 (4%) 1/39 (3%) 3/49 (6%) |1/41 (2%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.427 P=0.694 P=0.558N P=0.529 |P=0.296N P=0.520N P=0.486N P=0.490N |
|POLY 3 | P=0.425 P=0.692 P=0.522N P=0.525 |P=0.304N P=0.503N P=0.493N P=0.498N |
|POLY 1.5 | P=0.427 P=0.692 P=0.511N P=0.526 |P=0.304N P=0.501N P=0.495N P=0.500N |
|POLY 6 | P=0.423 P=0.691 P=0.535N P=0.523 |P=0.303N P=0.506N P=0.490N P=0.496N |
|LOGISTIC REGRESSION| P=0.427 P=0.694 P=0.558N P=0.529 |P=0.296N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.422 P=0.692N P=0.500N P=0.520 |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 24
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 0/48 (0%) 0/50 (0%) |23/50 (46%) 25/50 (50%) 22/50 (44%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.92 1/46.69 0/44.04 0/49.55 |23/47.64 25/47.38 22/49.64 0/46.54 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 0.0% 0.0% |48.3% 52.8% 44.3% 0.0% |
|TERMINAL (d) | 2/46 (4%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |20/41 (49%) 19/37 (51%) 18/44 (41%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- --- |463 325 425 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102N P=0.500N P=0.276N P=0.225N |P<0.001N** P=0.279 P=0.390N P<0.001N** |
|POLY 3 | P=0.098N P=0.502N P=0.252N P=0.225N |P<0.001N** P=0.408 P=0.426N P<0.001N** |
|POLY 1.5 | P=0.098N P=0.501N P=0.244N P=0.225N |P<0.001N** P=0.418 P=0.453N P<0.001N** |
|POLY 6 | P=0.099N P=0.503N P=0.260N P=0.226N |P<0.001N** P=0.385 P=0.400N P<0.001N** |
|LOGISTIC REGRESSION| P=0.102N P=0.500N (e) (e) |P<0.001N** P=0.417 P=0.527N P<0.001N** |
|COCH-ARM / FISHERS | P=0.097N P=0.500N P=0.247N P=0.237N |P<0.001N** P=0.421 P=0.500N P<0.001N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 3/48 (6%) 26/50 (52%) |0/50 (0%) 0/50 (0%) 8/50 (16%) 46/50 (92%) |
|POLY-3 RATE (b) | 0/46.92 0/46.69 3/44.04 26/49.55 |0/46.06 0/45.42 8/47.80 46/48.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 6.8% 52.5% |0.0% 0.0% 16.7% 94.8% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 3/39 (8%) 26/49 (53%) |0/41 (0%) 0/37 (0%) 8/44 (18%) 41/43 (95%) |
|FIRST INCIDENCE | --- --- 728 (T) 728 (T) |--- --- 733 (T) 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.094 P<0.001 ** |P<0.001 ** (e) P=0.007 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.108 P<0.001 ** |P<0.001 ** (e) P=0.004 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.113 P<0.001 ** |P<0.001 ** (e) P=0.004 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.102 P<0.001 ** |P<0.001 ** (e) P=0.005 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.094 P<0.001 ** |P<0.001 ** (e) P=0.007 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.121 P<0.001 ** |P<0.001 ** (e) P=0.003 ** P<0.001 ** |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 25
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 8/50 (16%) 11/49 (22%) 11/50 (22%) |
|POLY-3 RATE (b) | |10/46.19 8/46.50 11/47.36 11/47.28 |
|POLY-3 PERCENT (g) | |21.7% 17.2% 23.2% 23.3% |
|TERMINAL (d) | |9/41 (22%) 5/37 (14%) 10/44 (23%) 9/43 (21%) |
|FIRST INCIDENCE | |698 575 568 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.444 P=0.477N P=0.569 P=0.544 |
|POLY 3 | |P=0.383 P=0.391N P=0.526 P=0.524 |
|POLY 1.5 | |P=0.368 P=0.393N P=0.508 P=0.509 |
|POLY 6 | |P=0.405 P=0.394N P=0.543 P=0.542 |
|LOGISTIC REGRESSION| |P=0.361 P=0.403N P=0.514 P=0.507 |
|COCH-ARM / FISHERS | |P=0.358 P=0.398N P=0.479 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/50 (2%) 1/49 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | |2/46.06 1/45.42 1/46.83 3/47.08 |
|POLY-3 PERCENT (g) | |4.3% 2.2% 2.1% 6.4% |
|TERMINAL (d) | |2/41 (5%) 1/37 (3%) 1/44 (2%) 2/43 (5%) |
|FIRST INCIDENCE | |733 (T) 733 (T) 733 (T) 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.356 P=0.536N P=0.475N P=0.519 |
|POLY 3 | |P=0.335 P=0.505N P=0.494N P=0.510 |
|POLY 1.5 | |P=0.329 P=0.502N P=0.499N P=0.504 |
|POLY 6 | |P=0.344 P=0.510N P=0.490N P=0.518 |
|LOGISTIC REGRESSION| |P=0.324 P=0.536N P=0.475N P=0.501 |
|COCH-ARM / FISHERS | |P=0.324 P=0.500N P=0.508N P=0.500 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 26
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 14/50 (28%) 10/50 (20%) |25/50 (50%) 16/50 (32%) 24/50 (48%) 18/50 (36%) |
|POLY-3 RATE (b) | 10/48.41 8/48.13 14/45.01 10/49.55 |25/46.80 16/45.75 24/47.80 18/46.54 |
|POLY-3 PERCENT (g) | 20.7% 16.6% 31.1% 20.2% |53.4% 35.0% 50.2% 38.7% |
|TERMINAL (d) | 10/47 (21%) 8/46 (17%) 13/39 (33%) 10/49 (20%) |24/41 (59%) 14/37 (38%) 24/44 (55%) 18/43 (42%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 702 728 (T) |463 652 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.465 P=0.417N P=0.108 P=0.558N |P=0.108N P=0.103N P=0.359N P=0.069N |
|POLY 3 | P=0.457 P=0.403N P=0.179 P=0.576N |P=0.195N P=0.054N P=0.458N P=0.108N |
|POLY 1.5 | P=0.455 P=0.401N P=0.208 P=0.578N |P=0.208N P=0.052N P=0.474N P=0.114N |
|POLY 6 | P=0.460 P=0.407N P=0.150 P=0.574N |P=0.176N P=0.058N P=0.440N P=0.100N |
|LOGISTIC REGRESSION| P=0.452 P=0.417N P=0.118 P=0.558N |P=0.154N P=0.057N P=0.406N P=0.093N |
|COCH-ARM / FISHERS | P=0.430 P=0.398N P=0.241 P=0.598N |P=0.212N P=0.052N P=0.500N P=0.113N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/49 (6%) 0/50 (0%) 0/49 (0%) |0/49 (0%) 1/50 (2%) 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.41 3/47.13 0/44.90 0/48.55 |0/45.09 1/45.42 2/46.80 0/46.54 |
|POLY-3 PERCENT (g) | 2.1% 6.4% 0.0% 0.0% |0.0% 2.2% 4.3% 0.0% |
|TERMINAL (d) | 1/47 (2%) 3/45 (7%) 0/39 (0%) 0/48 (0%) |0/41 (0%) 1/37 (3%) 2/43 (5%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- --- |--- 733 (T) 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157N P=0.290 P=0.537N P=0.496N |P=0.593N P=0.480 P=0.249 (e) |
|POLY 3 | P=0.154N P=0.296 P=0.515N P=0.499N |P=0.607N P=0.501 P=0.246 (e) |
|POLY 1.5 | P=0.152N P=0.297 P=0.508N P=0.500N |P=0.611N P=0.503 P=0.243 (e) |
|POLY 6 | P=0.155N P=0.294 P=0.523N P=0.499N |P=0.601N P=0.498 P=0.249 (e) |
|LOGISTIC REGRESSION| P=0.157N P=0.290 (e) (e) |(e) P=0.480 P=0.249 (e) |
|COCH-ARM / FISHERS | P=0.155N P=0.301 P=0.500N P=0.505N |P=0.612N P=0.505 P=0.247 (e) |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 27
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 6/49 (12%) 4/50 (8%) 5/49 (10%) |5/49 (10%) 6/50 (12%) 2/49 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/48.41 6/47.13 4/44.90 5/48.55 |5/45.09 6/45.94 2/46.80 4/46.54 |
|POLY-3 PERCENT (g) | 10.3% 12.7% 8.9% 10.3% |11.1% 13.1% 4.3% 8.6% |
|TERMINAL (d) | 5/47 (11%) 6/45 (13%) 4/39 (10%) 5/48 (10%) |5/41 (12%) 5/37 (14%) 2/43 (5%) 4/43 (9%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 575 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488N P=0.470 P=0.616N P=0.617N |P=0.273N P=0.436 P=0.198N P=0.470N |
|POLY 3 | P=0.500N P=0.481 P=0.547N P=0.628N |P=0.302N P=0.513 P=0.201N P=0.480N |
|POLY 1.5 | P=0.499N P=0.483 P=0.524N P=0.629N |P=0.308N P=0.514 P=0.207N P=0.486N |
|POLY 6 | P=0.501N P=0.478 P=0.573N P=0.627N |P=0.294N P=0.507 P=0.196N P=0.473N |
|LOGISTIC REGRESSION| P=0.488N P=0.470 P=0.616N P=0.617N |P=0.297N P=0.506 P=0.198N P=0.470N |
|COCH-ARM / FISHERS | P=0.510N P=0.486 P=0.500N P=0.617 |P=0.311N P=0.514 P=0.218N P=0.487N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 31/50 (62%) 27/50 (54%) 22/50 (44%) | |
|POLY-3 RATE (b) | 29/48.41 31/49.00 27/48.26 22/49.55 | |
|POLY-3 PERCENT (g) | 59.9% 63.3% 56.0% 44.4% | |
|TERMINAL (d) | 29/47 (62%) 28/46 (61%) 20/39 (51%) 22/49 (45%) | |
|FIRST INCIDENCE | 728 (T) 594 498 728 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.049N* P=0.374 P=0.367 P=0.075N | |
|POLY 3 | P=0.039N* P=0.448 P=0.426N P=0.090N | |
|POLY 1.5 | P=0.040N* P=0.434 P=0.412N P=0.093N | |
|POLY 6 | P=0.039N* P=0.464 P=0.441N P=0.088N | |
|LOGISTIC REGRESSION| P=0.046N* P=0.409 P=0.453N P=0.075N | |
|COCH-ARM / FISHERS | P=0.054N P=0.419 P=0.420N P=0.115N | |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 28
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 27/50 (54%) 17/50 (34%) 13/50 (26%) | |
|POLY-3 RATE (b) | 20/48.49 27/49.00 17/47.65 13/50.00 | |
|POLY-3 PERCENT (g) | 41.3% 55.1% 35.7% 26.0% | |
|TERMINAL (d) | 19/47 (40%) 24/46 (52%) 11/39 (28%) 12/49 (25%) | |
|FIRST INCIDENCE | 708 594 498 596 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023N* P=0.108 P=0.567 P=0.083N | |
|POLY 3 | P=0.014N* P=0.122 P=0.363N P=0.082N | |
|POLY 1.5 | P=0.014N* P=0.117 P=0.346N P=0.085N | |
|POLY 6 | P=0.013N* P=0.127 P=0.383N P=0.079N | |
|LOGISTIC REGRESSION| P=0.020N* P=0.110 P=0.342N P=0.091N | |
|COCH-ARM / FISHERS | P=0.021N* P=0.115 P=0.339N P=0.101N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/48.49 0/48.13 1/44.51 0/49.55 |0/46.06 0/44.01 0/47.61 1/47.08 |
|POLY-3 PERCENT (g) | 6.2% 0.0% 2.3% 0.0% |0.0% 0.0% 0.0% 2.1% |
|TERMINAL (d) | 2/47 (4%) 0/46 (0%) 1/39 (3%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 708 --- 728 (T) --- |--- --- --- 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.091N P=0.128N P=0.377N P=0.117N |P=0.201 (e) (e) P=0.504 |
|POLY 3 | P=0.085N P=0.120N P=0.337N P=0.115N |P=0.205 (e) (e) P=0.504 |
|POLY 1.5 | P=0.085N P=0.120N P=0.325N P=0.116N |P=0.203 (e) (e) P=0.502 |
|POLY 6 | P=0.084N P=0.122N P=0.351N P=0.115N |P=0.208 (e) (e) P=0.508 |
|LOGISTIC REGRESSION| P=0.087N P=0.121N P=0.343N P=0.118N |P=0.255 (e) (e) P=0.560 |
|COCH-ARM / FISHERS | P=0.087N P=0.121N P=0.316N P=0.121N |P=0.201 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 29
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 33/50 (66%) 26/49 (53%) 29/50 (58%) |32/50 (64%) 27/48 (56%) 27/49 (55%) 27/50 (54%) |
|POLY-3 RATE (b) | 31/48.41 33/48.44 26/44.62 29/49.55 |32/47.52 27/45.60 27/47.77 27/47.28 |
|POLY-3 PERCENT (g) | 64.0% 68.1% 58.3% 58.5% |67.3% 59.2% 56.5% 57.1% |
|TERMINAL (d) | 31/47 (66%) 32/46 (70%) 25/39 (64%) 29/49 (59%) |28/41 (68%) 22/37 (60%) 26/44 (59%) 25/43 (58%) |
|FIRST INCIDENCE | 728 (T) 644 702 728 (T) |463 558 691 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203N P=0.359 P=0.561 P=0.318N |P=0.111N P=0.405N P=0.115N P=0.148N |
|POLY 3 | P=0.233N P=0.417 P=0.359N P=0.363N |P=0.200N P=0.272N P=0.188N P=0.205N |
|POLY 1.5 | P=0.234N P=0.415 P=0.296N P=0.369N |P=0.211N P=0.277N P=0.206N P=0.215N |
|POLY 6 | P=0.234N P=0.415 P=0.441N P=0.358N |P=0.183N P=0.273N P=0.175N P=0.190N |
|LOGISTIC REGRESSION| P=0.228N P=0.384 P=0.588N P=0.318N |P=0.180N P=0.280N P=0.154N P=0.193N |
|COCH-ARM / FISHERS | P=0.276N P=0.418 P=0.243N P=0.419N |P=0.206N P=0.282N P=0.243N P=0.208N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 2/44.99 0/49.55 |0/46.06 0/44.01 0/47.61 1/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 1/39 (3%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | --- --- 588 --- |--- --- --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.598 (e) P=0.210 (e) |P=0.210 (e) (e) P=0.510 |
|POLY 3 | P=0.612 (e) P=0.221 (e) |P=0.203 (e) (e) P=0.502 |
|POLY 1.5 | P=0.609 (e) P=0.227 (e) |P=0.202 (e) (e) P=0.500 |
|POLY 6 | P=0.616 (e) P=0.215 (e) |P=0.206 (e) (e) P=0.504 |
|LOGISTIC REGRESSION| P=0.567 (e) P=0.232 (e) |(e) (e) (e) P=0.510 |
|COCH-ARM / FISHERS | P=0.594 (e) P=0.242 (e) |P=0.201 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 30
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Edema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.41 1/48.24 2/45.73 0/49.55 |0/46.06 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- 701 561 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.610N P=0.496 P=0.221 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.606N P=0.499 P=0.225 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.607N P=0.500 P=0.231 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.605N P=0.499 P=0.218 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.651 P=0.501 P=0.222 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 10/50 (20%) 8/49 (16%) 5/50 (10%) |16/49 (33%) 15/50 (30%) 9/50 (18%) 11/50 (22%) |
|POLY-3 RATE (b) | 8/48.92 10/48.89 8/46.45 5/49.55 |16/47.49 15/47.80 9/48.13 11/48.91 |
|POLY-3 PERCENT (g) | 16.4% 20.5% 17.2% 10.1% |33.7% 31.4% 18.7% 22.5% |
|TERMINAL (d) | 7/47 (15%) 8/46 (17%) 4/39 (10%) 5/49 (10%) |10/41 (24%) 9/37 (24%) 8/44 (18%) 8/43 (19%) |
|FIRST INCIDENCE | 572 594 365 728 (T) |463 325 642 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.386 P=0.478 P=0.254N |P=0.090N P=0.568 P=0.071N P=0.179N |
|POLY 3 | P=0.165N P=0.397 P=0.563 P=0.269N |P=0.091N P=0.491N P=0.074N P=0.159N |
|POLY 1.5 | P=0.163N P=0.397 P=0.581 P=0.268N |P=0.094N P=0.479N P=0.073N P=0.161N |
|POLY 6 | P=0.168N P=0.397 P=0.540 P=0.271N |P=0.091N P=0.516N P=0.078N P=0.164N |
|LOGISTIC REGRESSION| P=0.192N P=0.398 P=0.594N P=0.280N |P=0.101N P=0.459N P=0.090N P=0.167N |
|COCH-ARM / FISHERS | P=0.171N P=0.398 P=0.590 P=0.277N |P=0.099N P=0.473N P=0.074N P=0.168N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 31
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/48.49 1/49.13 1/44.99 1/50.00 |0/45.09 2/45.98 2/48.36 0/46.54 |
|POLY-3 PERCENT (g) | 2.1% 2.0% 2.2% 2.0% |0.0% 4.4% 4.1% 0.0% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 708 50 588 596 |--- 596 568 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.625N P=0.756 P=0.727 P=0.753N |P=0.484N P=0.234 P=0.255 (e) |
|POLY 3 | P=0.629N P=0.757N P=0.744 P=0.753N |P=0.489N P=0.242 P=0.253 (e) |
|POLY 1.5 | P=0.630N P=0.757N P=0.750 P=0.755N |P=0.493N P=0.242 P=0.249 (e) |
|POLY 6 | P=0.628N P=0.759N P=0.736 P=0.752N |P=0.483N P=0.240 P=0.258 (e) |
|LOGISTIC REGRESSION| P=0.417 P=0.775N P=0.759 P=0.724 |P=0.468N P=0.248 P=0.195 (e) |
|COCH-ARM / FISHERS | P=0.633 P=0.753N P=0.747 P=0.753N |P=0.495N P=0.253 P=0.253 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |4/49 (8%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/44.51 0/49.55 |4/45.09 1/45.42 0/47.80 4/47.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |8.9% 2.2% 0.0% 8.4% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |4/41 (10%) 1/37 (3%) 0/44 (0%) 3/43 (7%) |
|FIRST INCIDENCE | --- --- --- --- |733 (T) 733 (T) --- 379 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.513 P=0.211N P=0.055N P=0.621N |
|POLY 3 | (e) (e) (e) (e) |P=0.497 P=0.176N P=0.053N P=0.615N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.491 P=0.175N P=0.055N P=0.623N |
|POLY 6 | (e) (e) (e) (e) |P=0.505 P=0.181N P=0.052N P=0.607N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.486 P=0.211N (e) P=0.629N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.484 P=0.175N P=0.056N P=0.631N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 32
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 3/48 (6%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/48.41 2/49.24 3/45.17 0/49.55 |1/46.82 1/45.44 2/48.30 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 4.1% 6.6% 0.0% |2.1% 2.2% 4.1% 0.0% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- 50 533 --- |456 728 638 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.525N P=0.237 P=0.113 (e) |P=0.360N P=0.750 P=0.513 P=0.508N |
|POLY 3 | P=0.519N P=0.241 P=0.107 (e) |P=0.365N P=0.754 P=0.511 P=0.501N |
|POLY 1.5 | P=0.521N P=0.241 P=0.110 (e) |P=0.368N P=0.757 P=0.506 P=0.502N |
|POLY 6 | P=0.518N P=0.241 P=0.104 (e) |P=0.361N P=0.750 P=0.517 P=0.500N |
|LOGISTIC REGRESSION| P=0.490 P=0.224 P=0.084 (e) |P=0.324N P=0.747N P=0.375 P=0.344N |
|COCH-ARM / FISHERS | P=0.532N P=0.247 P=0.114 (e) |P=0.366N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/48 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/43.55 0/49.55 |0/46.06 0/45.42 0/47.80 2/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.3% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/41 (0%) 0/37 (0%) 0/44 (0%) 2/43 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.053 (e) (e) P=0.249 |
|POLY 3 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.240 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.238 |
|POLY 6 | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.242 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.249 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 33
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/48.41 0/48.13 0/44.90 1/49.55 |2/46.06 1/45.42 1/47.80 3/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.0% |4.3% 2.2% 2.1% 6.5% |
|TERMINAL (d) | 0/47 (0%) 0/46 (0%) 0/39 (0%) 1/49 (2%) |2/41 (5%) 1/37 (3%) 1/44 (2%) 3/43 (7%) |
|FIRST INCIDENCE | --- --- --- 728 (T) |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 (e) (e) P=0.508 |P=0.359 P=0.536N P=0.475N P=0.522 |
|POLY 3 | P=0.202 (e) (e) P=0.505 |P=0.332 P=0.505N P=0.487N P=0.505 |
|POLY 1.5 | P=0.202 (e) (e) P=0.504 |P=0.328 P=0.502N P=0.492N P=0.501 |
|POLY 6 | P=0.203 (e) (e) P=0.505 |P=0.339 P=0.510N P=0.482N P=0.510 |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.508 |P=0.359 P=0.536N P=0.475N P=0.522 |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.324 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 0/48.41 3/48.13 3/44.90 1/49.55 | |
|POLY-3 PERCENT (g) | 0.0% 6.2% 6.7% 2.0% | |
|TERMINAL (d) | 0/47 (0%) 3/46 (7%) 3/39 (8%) 1/49 (2%) | |
|FIRST INCIDENCE | --- 728 (T) 728 (T) 728 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.538 P=0.118 P=0.091 P=0.508 | |
|POLY 3 | P=0.543 P=0.118 P=0.106 P=0.505 | |
|POLY 1.5 | P=0.541 P=0.118 P=0.112 P=0.504 | |
|POLY 6 | P=0.544 P=0.117 P=0.099 P=0.505 | |
|LOGISTIC REGRESSION| (e) P=0.118 P=0.091 P=0.508 | |
|COCH-ARM / FISHERS | P=0.526 P=0.121 P=0.121 P=0.500 | |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 34
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/43 (5%) 3/44 (7%) 3/44 (7%) 1/49 (2%) |2/47 (4%) 3/46 (7%) 2/47 (4%) 1/47 (2%) |
|POLY-3 RATE (b) | 2/41.92 3/44.00 3/42.53 1/48.55 |2/44.05 3/42.28 2/45.16 1/43.74 |
|POLY-3 PERCENT (g) | 4.8% 6.8% 7.1% 2.1% |4.5% 7.1% 4.4% 2.3% |
|TERMINAL (d) | 2/41 (5%) 0/41 (0%) 0/37 (0%) 1/48 (2%) |0/39 (0%) 1/35 (3%) 0/41 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 50 498 728 (T) |609 668 642 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.323N P=0.500 P=0.470 P=0.445N |P=0.296N P=0.471 P=0.672N P=0.492N |
|POLY 3 | P=0.289N P=0.522 P=0.507 P=0.449N |P=0.311N P=0.481 P=0.685N P=0.502N |
|POLY 1.5 | P=0.288N P=0.521 P=0.512 P=0.448N |P=0.313N P=0.485 P=0.688N P=0.503N |
|POLY 6 | P=0.291N P=0.523 P=0.499 P=0.450N |P=0.309N P=0.474 P=0.683N P=0.502N |
|LOGISTIC REGRESSION| P=0.474N P=0.530 P=0.466 P=0.445N |P=0.303N P=0.501 P=0.655 P=0.491N |
|COCH-ARM / FISHERS | P=0.292N P=0.511 P=0.511 P=0.451N |P=0.310N P=0.490 P=0.692N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.49 1/48.13 1/44.90 0/49.55 |2/46.19 0/44.99 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 2.2% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/47 (0%) 1/46 (2%) 1/39 (3%) 0/49 (0%) |1/41 (2%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- 728 (T) 728 (T) --- |698 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585N P=0.496 P=0.463 (e) |P=0.110N P=0.259N P=0.227N P=0.232N |
|POLY 3 | P=0.587N P=0.503 P=0.489 (e) |P=0.112N P=0.243N P=0.230N P=0.236N |
|POLY 1.5 | P=0.586N P=0.503 P=0.496 (e) |P=0.112N P=0.242N P=0.233N P=0.237N |
|POLY 6 | P=0.587N P=0.501 P=0.480 (e) |P=0.111N P=0.246N P=0.227N P=0.234N |
|LOGISTIC REGRESSION| (e) P=0.496 P=0.463 (e) |P=0.114N P=0.242N P=0.235N P=0.237N |
|COCH-ARM / FISHERS | P=0.592N P=0.505 P=0.505 (e) |P=0.115N P=0.253N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 35
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 4/50 (8%) 5/50 (10%) 5/50 (10%) |3/50 (6%) 4/49 (8%) 10/50 (20%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/47.49 4/48.13 5/45.01 5/49.55 |3/46.06 4/44.99 10/47.80 4/46.54 |
|POLY-3 PERCENT (g) | 8.4% 8.3% 11.1% 10.1% |6.5% 8.9% 20.9% 8.6% |
|TERMINAL (d) | 4/47 (9%) 4/46 (9%) 4/39 (10%) 5/49 (10%) |3/41 (7%) 4/37 (11%) 10/44 (23%) 4/43 (9%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 702 728 (T) |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425 P=0.632 P=0.387 P=0.526 |P=0.426 P=0.444 P=0.048 * P=0.526 |
|POLY 3 | P=0.426 P=0.635N P=0.467 P=0.526 |P=0.378 P=0.487 P=0.041 * P=0.506 |
|POLY 1.5 | P=0.426 P=0.634N P=0.489 P=0.525 |P=0.368 P=0.489 P=0.039 * P=0.501 |
|POLY 6 | P=0.426 P=0.639N P=0.441 P=0.527 |P=0.392 P=0.482 P=0.043 * P=0.512 |
|LOGISTIC REGRESSION| P=0.422 P=0.632 P=0.427 P=0.526 |P=0.426 P=0.444 P=0.048 * P=0.526 |
|COCH-ARM / FISHERS | P=0.411 P=0.631N P=0.513 P=0.513 |P=0.368 P=0.489 P=0.036 * P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 1/1 (100%) 2/2 (100%) |1/2 (50%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |
|POLY-3 RATE (b) | 1/1.00 0/0.00 1/1.00 2/2.00 |1/2.00 0/0.00 1/1.00 1/1.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 100.0% 100.0% |50.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 2/2 (100%) |1/2 (50%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |
|FIRST INCIDENCE | 728 (T) --- 365 728 (T) |733 (T) --- 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.382 P=1.000 P=0.638 P=0.638 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) P=0.614 P=0.614 |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) P=0.614 P=0.614 |
|POLY 6 | (e) (e) (e) (e) |(e) (e) P=0.614 P=0.614 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.382 (e) P=0.638 P=0.638 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.364 P=1.000 P=0.667 P=0.667 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 36
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 20/50 (40%) 18/50 (36%) 21/50 (42%) |33/50 (66%) 39/50 (78%) 33/50 (66%) 33/50 (66%) |
|POLY-3 RATE (b) | 16/48.41 20/48.13 18/46.06 21/50.00 |33/47.37 39/47.39 33/48.83 33/47.65 |
|POLY-3 PERCENT (g) | 33.1% 41.6% 39.1% 42.0% |69.7% 82.3% 67.6% 69.3% |
|TERMINAL (d) | 16/47 (34%) 20/46 (44%) 16/39 (41%) 20/49 (41%) |30/41 (73%) 32/37 (87%) 30/44 (68%) 30/43 (70%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 365 596 |463 551 568 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268 P=0.237 P=0.196 P=0.254 |P=0.167N P=0.041 * P=0.400N P=0.461N |
|POLY 3 | P=0.260 P=0.258 P=0.347 P=0.241 |P=0.319N P=0.107 P=0.500N P=0.571N |
|POLY 1.5 | P=0.255 P=0.261 P=0.385 P=0.234 |P=0.351N P=0.114 P=0.535N P=0.581 |
|POLY 6 | P=0.268 P=0.251 P=0.301 P=0.249 |P=0.272N P=0.099 P=0.461N P=0.534N |
|LOGISTIC REGRESSION| P=0.243 P=0.237 P=0.355 P=0.223 |P=0.319N P=0.111 P=0.504N P=0.571N |
|COCH-ARM / FISHERS | P=0.222 P=0.266 P=0.417 P=0.204 |P=0.358N P=0.133 P=0.583N P=0.583N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/50 (14%) 3/50 (6%) 2/50 (4%) 6/50 (12%) |
|POLY-3 RATE (b) | |7/46.47 3/45.64 2/47.80 6/46.54 |
|POLY-3 PERCENT (g) | |15.1% 6.6% 4.2% 12.9% |
|TERMINAL (d) | |6/41 (15%) 2/37 (5%) 2/44 (5%) 6/43 (14%) |
|FIRST INCIDENCE | |614 673 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.477N P=0.201N P=0.067N P=0.465N |
|POLY 3 | |P=0.524N P=0.165N P=0.072N P=0.499N |
|POLY 1.5 | |P=0.530N P=0.162N P=0.075N P=0.503N |
|POLY 6 | |P=0.516N P=0.171N P=0.071N P=0.494N |
|LOGISTIC REGRESSION| |P=0.520N P=0.162N P=0.075N P=0.491N |
|COCH-ARM / FISHERS | |P=0.533N P=0.159N P=0.080N P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 37
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | VEHICLE .312% .625% 1.25% |VEHICLE .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |42/50 (84%) 46/50 (92%) 41/50 (82%) 48/50 (96%) |
|POLY-3 RATE (b) | |42/48.12 46/48.70 41/48.36 48/49.80 |
|POLY-3 PERCENT (g) | |87.3% 94.5% 84.8% 96.4% |
|TERMINAL (d) | |38/41 (93%) 37/37 (100%) 39/44 (89%) 42/43 (98%) |
|FIRST INCIDENCE | |463 325 568 226 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.446 P=0.040 * P=0.220N P=0.206 |
|POLY 3 | |P=0.133 P=0.171 P=0.474N P=0.086 |
|POLY 1.5 | |P=0.107 P=0.176 P=0.486N P=0.065 |
|POLY 6 | |P=0.175 P=0.160 P=0.461N P=0.117 |
|LOGISTIC REGRESSION| |P=0.073 P=0.160 P=0.357N P=0.041 * |
|COCH-ARM / FISHERS | |P=0.083 P=0.178 P=0.500N P=0.046 * |
|=================================================================================================================================|
(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).