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: 09:43:36
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
----- ----------
Kidney Infiltration Cellular Lymphocyte
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Mesentery: Fat Necrosis
Uterus Inflammation
===============================================================
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.43 0/48.41 | 2/47.03 1/46.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.3% 2.2% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 2/43 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- | 733 (T) 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.511N |
|POLY 3 | (e) | P=0.508N |
|POLY 1.5 | (e) | P=0.506N |
|POLY 6 | (e) | P=0.509N |
|LOGISTIC REGRESSION| (e) | P=0.506N |
|COCH-ARM / FISHERS | (e) | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.43 0/48.41 | 2/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.3% 4.3% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 2/43 (5%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.678 |
|POLY 3 | (e) | P=0.688 |
|POLY 1.5 | (e) | P=0.690 |
|POLY 6 | (e) | P=0.687 |
|LOGISTIC REGRESSION| (e) | P=0.678 |
|COCH-ARM / FISHERS | (e) | P=0.691N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 23/50 (46%) | 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 23/46.43 23/48.41 | 4/47.03 4/46.06 |
|POLY-3 PERCENT (g) | 49.5% 47.5% | 8.5% 8.7% |
|TERMINAL (d) | 23/44 (52%) 23/47 (49%) | 4/43 (9%) 4/41 (10%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.457N | P=0.618 |
|POLY 3 | P=0.502N | P=0.633 |
|POLY 1.5 | P=0.526N | P=0.636 |
|POLY 6 | P=0.479N | P=0.631 |
|LOGISTIC REGRESSION| P=0.457N | P=0.618 |
|COCH-ARM / FISHERS | P=0.543N | P=0.643N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) | 32/50 (64%) 34/50 (68%) |
|POLY-3 RATE (b) | 0/46.43 0/48.41 | 32/47.97 34/46.48 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 66.7% 73.2% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 30/43 (70%) 33/41 (81%) |
|FIRST INCIDENCE | --- --- | 520 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.278 |
|POLY 3 | (e) | P=0.321 |
|POLY 1.5 | (e) | P=0.355 |
|POLY 6 | (e) | P=0.295 |
|LOGISTIC REGRESSION| (e) | P=0.334 |
|COCH-ARM / FISHERS | (e) | P=0.417 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) | 36/50 (72%) 34/50 (68%) |
|POLY-3 RATE (b) | 0/46.43 0/48.41 | 36/47.33 34/46.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 76.1% 73.6% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 35/43 (81%) 33/41 (81%) |
|FIRST INCIDENCE | --- --- | 652 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.566N |
|POLY 3 | (e) | P=0.486N |
|POLY 1.5 | (e) | P=0.459N |
|POLY 6 | (e) | P=0.507N |
|LOGISTIC REGRESSION| (e) | P=0.456N |
|COCH-ARM / FISHERS | (e) | P=0.414N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex: Subcapsular |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/49 (80%) 46/50 (92%) | 50/50 (100%) 49/50 (98%) |
|POLY-3 RATE (b) | 39/47.94 46/50.00 | 50/50.00 49/49.24 |
|POLY-3 PERCENT (g) | 81.4% 92.0% | 100.0% 99.5% |
|TERMINAL (d) | 36/44 (82%) 43/47 (92%) | 43/43 (100%) 41/41 (100%) |
|FIRST INCIDENCE | 498 100 | 429 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.211 | P=0.479 |
|POLY 3 | P=0.101 | P=0.999N |
|POLY 1.5 | P=0.089 | P=0.850N |
|POLY 6 | P=0.110 | P=1.000N |
|LOGISTIC REGRESSION| P=0.069 | P=0.581N |
|COCH-ARM / FISHERS | P=0.068 | 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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) | 3/49 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.43 0/48.41 | 3/46.25 1/46.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 6.5% 2.2% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 3/43 (7%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.322N |
|POLY 3 | (e) | P=0.307N |
|POLY 1.5 | (e) | P=0.303N |
|POLY 6 | (e) | P=0.310N |
|LOGISTIC REGRESSION| (e) | P=0.322N |
|COCH-ARM / FISHERS | (e) | P=0.301N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 24/50 (48%) 27/50 (54%) |
|POLY-3 RATE (b) | 1/46.45 1/48.41 | 24/47.03 27/46.62 |
|POLY-3 PERCENT (g) | 2.2% 2.1% | 51.0% 57.9% |
|TERMINAL (d) | 1/44 (2%) 1/47 (2%) | 24/43 (56%) 25/41 (61%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.747N | P=0.251 |
|POLY 3 | P=0.747N | P=0.321 |
|POLY 1.5 | P=0.752N | P=0.326 |
|POLY 6 | P=0.743N | P=0.327 |
|LOGISTIC REGRESSION| P=0.747N | P=0.291 |
|COCH-ARM / FISHERS | P=0.753N | P=0.345 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/50 (28%) | 11/50 (22%) 10/50 (20%) |
|POLY-3 RATE (b) | 17/48.86 14/49.92 | 11/49.20 10/46.92 |
|POLY-3 PERCENT (g) | 34.8% 28.0% | 22.4% 21.3% |
|TERMINAL (d) | 13/44 (30%) 12/47 (26%) | 5/43 (12%) 7/41 (17%) |
|FIRST INCIDENCE | 340 100 | 520 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278N | P=0.545N |
|POLY 3 | P=0.307N | P=0.551N |
|POLY 1.5 | P=0.311N | P=0.531N |
|POLY 6 | P=0.305N | P=0.572N |
|LOGISTIC REGRESSION| P=0.395N | P=0.461N |
|COCH-ARM / FISHERS | P=0.333N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain: Meninges |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/49 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 0/48.41 | 2/46.41 0/46.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.3% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 2/43 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.249N |
|POLY 3 | (e) | P=0.240N |
|POLY 1.5 | (e) | P=0.236N |
|POLY 6 | (e) | P=0.243N |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | P=0.242N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 33/50 (66%) 35/49 (71%) |
|POLY-3 RATE (b) | | 33/49.36 35/45.24 |
|POLY-3 PERCENT (g) | | 66.9% 77.4% |
|TERMINAL (d) | | 28/43 (65%) 34/41 (83%) |
|FIRST INCIDENCE | | 429 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.295 |
|POLY 3 | | P=0.180 |
|POLY 1.5 | | P=0.241 |
|POLY 6 | | P=0.131 |
|LOGISTIC REGRESSION| | P=0.295 |
|COCH-ARM / FISHERS | | P=0.358 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Epididymis |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 0/46.45 3/48.41 | |
|POLY-3 PERCENT (g) | 0.0% 6.2% | |
|TERMINAL (d) | 0/44 (0%) 3/47 (6%) | |
|FIRST INCIDENCE | --- 728 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133 | |
|POLY 3 | P=0.124 | |
|POLY 1.5 | P=0.122 | |
|POLY 6 | P=0.126 | |
|LOGISTIC REGRESSION| P=0.133 | |
|COCH-ARM / FISHERS | P=0.121 | |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Esophagus |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/49.01 2/48.92 | 2/47.75 1/46.82 |
|POLY-3 PERCENT (g) | 8.2% 4.1% | 4.2% 2.1% |
|TERMINAL (d) | 1/44 (2%) 1/47 (2%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 188 572 | 627 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N | P=0.515N |
|POLY 3 | P=0.339N | P=0.509N |
|POLY 1.5 | P=0.342N | P=0.505N |
|POLY 6 | P=0.333N | P=0.514N |
|LOGISTIC REGRESSION| P=0.428N | P=0.390N |
|COCH-ARM / FISHERS | P=0.339N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Gallbladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) | 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 2/46.45 4/48.41 | 3/47.03 6/46.06 |
|POLY-3 PERCENT (g) | 4.3% 8.3% | 6.4% 13.0% |
|TERMINAL (d) | 2/44 (5%) 4/47 (9%) | 3/43 (7%) 6/41 (15%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.368 | P=0.219 |
|POLY 3 | P=0.354 | P=0.233 |
|POLY 1.5 | P=0.348 | P=0.236 |
|POLY 6 | P=0.359 | P=0.231 |
|LOGISTIC REGRESSION| P=0.368 | P=0.219 |
|COCH-ARM / FISHERS | P=0.339 | P=0.243 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/4 (25%) 0/4 (0%) | 2/2 (100%) 0/1 (0%) |
|POLY-3 RATE (b) | 1/4.00 0/4.00 | 2/2.00 0/1.00 |
|POLY-3 PERCENT (g) | 25.0% 0.0% | 100.0% 0.0% |
|TERMINAL (d) | 1/4 (25%) 0/4 (0%) | 2/2 (100%) 0/1 (0%) |
|FIRST INCIDENCE | 728 (T) --- | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N | P=0.362N |
|POLY 3 | P=0.500N | P=1.000N |
|POLY 1.5 | P=0.500N | P=1.000N |
|POLY 6 | P=0.500N | P=1.000N |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.333N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.45 2/48.41 | 0/46.41 1/46.19 |
|POLY-3 PERCENT (g) | 2.2% 4.1% | 0.0% 2.2% |
|TERMINAL (d) | 1/44 (2%) 2/47 (4%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | --- 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 | P=0.500 |
|POLY 3 | P=0.510 | P=0.500 |
|POLY 1.5 | P=0.506 | P=0.500 |
|POLY 6 | P=0.513 | P=0.500 |
|LOGISTIC REGRESSION| P=0.523 | P=0.510 |
|COCH-ARM / FISHERS | P=0.500 | P=0.505 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Small, Jejunum: Peyer's Patch |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 0/48.41 | 0/47.03 0/46.06 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | (e) |
|POLY 3 | P=0.224N | (e) |
|POLY 1.5 | P=0.229N | (e) |
|POLY 6 | P=0.220N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) | 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 4/47.05 4/48.41 | 1/47.03 3/46.06 |
|POLY-3 PERCENT (g) | 8.5% 8.3% | 2.1% 6.5% |
|TERMINAL (d) | 3/44 (7%) 4/47 (9%) | 1/43 (2%) 3/41 (7%) |
|FIRST INCIDENCE | 538 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607N | P=0.288 |
|POLY 3 | P=0.625N | P=0.300 |
|POLY 1.5 | P=0.631N | P=0.302 |
|POLY 6 | P=0.621N | P=0.299 |
|LOGISTIC REGRESSION| P=0.643 | P=0.288 |
|COCH-ARM / FISHERS | P=0.643N | P=0.309 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 3/48.41 | 0/47.03 0/46.06 |
|POLY-3 PERCENT (g) | 4.3% 6.2% | 0.0% 0.0% |
|TERMINAL (d) | 2/44 (5%) 3/47 (6%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530 | (e) |
|POLY 3 | P=0.515 | (e) |
|POLY 1.5 | P=0.510 | (e) |
|POLY 6 | P=0.520 | (e) |
|LOGISTIC REGRESSION| P=0.530 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.45 5/48.41 | 1/47.03 1/46.06 |
|POLY-3 PERCENT (g) | 4.3% 10.3% | 2.1% 2.2% |
|TERMINAL (d) | 2/44 (5%) 5/47 (11%) | 1/43 (2%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.244 | P=0.751 |
|POLY 3 | P=0.231 | P=0.758 |
|POLY 1.5 | P=0.226 | P=0.759 |
|POLY 6 | P=0.236 | P=0.758 |
|LOGISTIC REGRESSION| P=0.244 | P=0.751 |
|COCH-ARM / FISHERS | P=0.218 | P=0.753N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 39/50 (78%) | 6/50 (12%) 0/50 (0%) |
|POLY-3 RATE (b) | 32/46.61 39/49.92 | 6/47.13 0/48.41 |
|POLY-3 PERCENT (g) | 68.7% 78.1% | 12.7% 0.0% |
|TERMINAL (d) | 31/44 (71%) 37/47 (79%) | 5/44 (11%) 0/47 (0%) |
|FIRST INCIDENCE | 687 100 | 498 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 | P=0.016N* |
|POLY 3 | P=0.202 | P=0.014N* |
|POLY 1.5 | P=0.164 | P=0.014N* |
|POLY 6 | P=0.235 | P=0.013N* |
|LOGISTIC REGRESSION| P=0.111 | P=0.018N* |
|COCH-ARM / FISHERS | P=0.093 | P=0.013N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.45 0/48.41 | 1/47.67 1/46.06 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 2.1% 2.2% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 0/43 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) --- | 520 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | P=0.750 |
|POLY 3 | P=0.224N | P=0.757 |
|POLY 1.5 | P=0.229N | P=0.758 |
|POLY 6 | P=0.220N | P=0.756 |
|LOGISTIC REGRESSION| (e) | P=0.730N |
|COCH-ARM / FISHERS | P=0.247N | 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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Metaplasia Osseous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.45 0/48.41 | 0/47.03 1/46.48 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 0.0% 2.2% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) --- | --- 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | P=0.492 |
|POLY 3 | P=0.224N | P=0.500 |
|POLY 1.5 | P=0.229N | P=0.500 |
|POLY 6 | P=0.220N | P=0.500 |
|LOGISTIC REGRESSION| (e) | P=0.541 |
|COCH-ARM / FISHERS | P=0.247N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 44/50 (88%) | 4/50 (8%) 4/50 (8%) |
|POLY-3 RATE (b) | 42/47.52 44/49.00 | 4/47.03 4/47.00 |
|POLY-3 PERCENT (g) | 88.4% 89.8% | 8.5% 8.5% |
|TERMINAL (d) | 39/44 (89%) 42/47 (89%) | 4/43 (9%) 2/41 (5%) |
|FIRST INCIDENCE | 498 572 | 733 (T) 570 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520N | P=0.616 |
|POLY 3 | P=0.540 | P=0.643 |
|POLY 1.5 | P=0.480 | P=0.642 |
|POLY 6 | P=0.580 | P=0.639N |
|LOGISTIC REGRESSION| P=0.543 | P=0.631N |
|COCH-ARM / FISHERS | P=0.387 | P=0.643N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 47/50 (94%) | 7/50 (14%) 11/50 (22%) |
|POLY-3 RATE (b) | 46/48.42 47/49.92 | 7/47.33 11/47.69 |
|POLY-3 PERCENT (g) | 95.0% 94.2% | 14.8% 23.1% |
|TERMINAL (d) | 42/44 (96%) 45/47 (96%) | 6/43 (14%) 8/41 (20%) |
|FIRST INCIDENCE | 340 100 | 652 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.379N | P=0.199 |
|POLY 3 | P=0.602N | P=0.222 |
|POLY 1.5 | P=0.648N | P=0.220 |
|POLY 6 | P=0.571N | P=0.223 |
|LOGISTIC REGRESSION| P=0.539 | P=0.234 |
|COCH-ARM / FISHERS | P=0.500 | P=0.218 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Dilatation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) | 24/50 (48%) 25/50 (50%) |
|POLY-3 RATE (b) | 6/46.45 7/48.41 | 24/49.14 25/47.88 |
|POLY-3 PERCENT (g) | 12.9% 14.5% | 48.8% 52.2% |
|TERMINAL (d) | 6/44 (14%) 7/47 (15%) | 20/43 (47%) 20/41 (49%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 429 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551 | P=0.426 |
|POLY 3 | P=0.529 | P=0.450 |
|POLY 1.5 | P=0.519 | P=0.468 |
|POLY 6 | P=0.538 | P=0.436 |
|LOGISTIC REGRESSION| P=0.551 | P=0.517 |
|COCH-ARM / FISHERS | P=0.500 | P=0.500 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/47.05 1/48.41 | 1/47.03 0/45.21 |
|POLY-3 PERCENT (g) | 4.3% 2.1% | 2.1% 0.0% |
|TERMINAL (d) | 1/44 (2%) 1/47 (2%) | 1/43 (2%) 0/41 (0%) |
|FIRST INCIDENCE | 538 728 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480N | P=0.510N |
|POLY 3 | P=0.487N | P=0.516N |
|POLY 1.5 | P=0.491N | P=0.513N |
|POLY 6 | P=0.484N | P=0.516N |
|LOGISTIC REGRESSION| P=0.512N | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 1/50 (2%) 4/49 (8%) |
|POLY-3 RATE (b) | 2/46.45 3/48.41 | 1/47.03 4/45.21 |
|POLY-3 PERCENT (g) | 4.3% 6.2% | 2.1% 8.9% |
|TERMINAL (d) | 2/44 (5%) 3/47 (6%) | 1/43 (2%) 4/41 (10%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530 | P=0.166 |
|POLY 3 | P=0.515 | P=0.169 |
|POLY 1.5 | P=0.510 | P=0.171 |
|POLY 6 | P=0.520 | P=0.169 |
|LOGISTIC REGRESSION| P=0.530 | P=0.166 |
|COCH-ARM / FISHERS | P=0.500 | P=0.175 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/46.45 1/48.41 | 3/47.03 1/45.21 |
|POLY-3 PERCENT (g) | 6.5% 2.1% | 6.4% 2.2% |
|TERMINAL (d) | 3/44 (7%) 1/47 (2%) | 3/43 (7%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N | P=0.322N |
|POLY 3 | P=0.287N | P=0.323N |
|POLY 1.5 | P=0.294N | P=0.321N |
|POLY 6 | P=0.282N | P=0.324N |
|LOGISTIC REGRESSION| P=0.282N | P=0.322N |
|COCH-ARM / FISHERS | P=0.309N | P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) | 5/50 (10%) 4/49 (8%) |
|POLY-3 RATE (b) | 3/46.45 3/48.41 | 5/47.03 4/46.11 |
|POLY-3 PERCENT (g) | 6.5% 6.2% | 10.6% 8.7% |
|TERMINAL (d) | 3/44 (7%) 3/47 (6%) | 5/43 (12%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.632N | P=0.521N |
|POLY 3 | P=0.640N | P=0.514N |
|POLY 1.5 | P=0.648N | P=0.515N |
|POLY 6 | P=0.633N | P=0.510N |
|LOGISTIC REGRESSION| P=0.632N | P=0.498N |
|COCH-ARM / FISHERS | P=0.661N | P=0.513N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 4/50 (8%) 6/49 (12%) |
|POLY-3 RATE (b) | 1/46.45 0/48.41 | 4/47.55 6/46.10 |
|POLY-3 PERCENT (g) | 2.2% 0.0% | 8.4% 13.0% |
|TERMINAL (d) | 1/44 (2%) 0/47 (0%) | 2/43 (5%) 4/41 (10%) |
|FIRST INCIDENCE | 728 (T) --- | 652 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487N | P=0.352 |
|POLY 3 | P=0.484N | P=0.352 |
|POLY 1.5 | P=0.490N | P=0.355 |
|POLY 6 | P=0.479N | P=0.351 |
|LOGISTIC REGRESSION| (e) | P=0.382 |
|COCH-ARM / FISHERS | P=0.500N | P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 33/50 (66%) | 39/50 (78%) 42/49 (86%) |
|POLY-3 RATE (b) | 26/46.61 33/48.92 | 39/48.00 42/47.80 |
|POLY-3 PERCENT (g) | 55.8% 67.5% | 81.3% 87.9% |
|TERMINAL (d) | 25/44 (57%) 32/47 (68%) | 36/43 (84%) 37/41 (90%) |
|FIRST INCIDENCE | 687 572 | 627 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.201 | P=0.179 |
|POLY 3 | P=0.166 | P=0.264 |
|POLY 1.5 | P=0.142 | P=0.249 |
|POLY 6 | P=0.188 | P=0.285 |
|LOGISTIC REGRESSION| P=0.162 | P=0.172 |
|COCH-ARM / FISHERS | P=0.111 | P=0.232 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) | 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/46.45 5/48.41 | 2/47.03 1/45.21 |
|POLY-3 PERCENT (g) | 6.5% 10.3% | 4.3% 2.2% |
|TERMINAL (d) | 3/44 (7%) 5/47 (11%) | 2/43 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.393 | P=0.517N |
|POLY 3 | P=0.377 | P=0.518N |
|POLY 1.5 | P=0.370 | P=0.516N |
|POLY 6 | P=0.383 | P=0.519N |
|LOGISTIC REGRESSION| P=0.393 | P=0.517N |
|COCH-ARM / FISHERS | P=0.357 | P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) | 6/50 (12%) 2/49 (4%) |
|POLY-3 RATE (b) | 3/46.45 6/48.92 | 6/47.03 2/45.21 |
|POLY-3 PERCENT (g) | 6.5% 12.3% | 12.8% 4.4% |
|TERMINAL (d) | 3/44 (7%) 5/47 (11%) | 6/43 (14%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 572 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278 | P=0.150N |
|POLY 3 | P=0.266 | P=0.148N |
|POLY 1.5 | P=0.257 | P=0.146N |
|POLY 6 | P=0.274 | P=0.148N |
|LOGISTIC REGRESSION| P=0.246 | P=0.150N |
|COCH-ARM / FISHERS | P=0.243 | P=0.141N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 2/50 (4%) 3/49 (6%) |
|POLY-3 RATE (b) | 1/46.45 0/48.41 | 2/47.25 3/45.64 |
|POLY-3 PERCENT (g) | 2.2% 0.0% | 4.2% 6.6% |
|TERMINAL (d) | 1/44 (2%) 0/47 (0%) | 1/43 (2%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) --- | 675 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487N | P=0.481 |
|POLY 3 | P=0.484N | P=0.487 |
|POLY 1.5 | P=0.490N | P=0.489 |
|POLY 6 | P=0.479N | P=0.488 |
|LOGISTIC REGRESSION| (e) | P=0.503 |
|COCH-ARM / FISHERS | P=0.500N | P=0.490 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Portal |
| Infiltration Cellular Lymphocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | 26/50 (52%) 32/49 (65%) |
|POLY-3 RATE (b) | 1/46.45 3/48.41 | 26/47.41 32/45.96 |
|POLY-3 PERCENT (g) | 2.2% 6.2% | 54.9% 69.6% |
|TERMINAL (d) | 1/44 (2%) 3/47 (6%) | 25/43 (58%) 31/41 (76%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 627 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329 | P=0.081 |
|POLY 3 | P=0.317 | P=0.099 |
|POLY 1.5 | P=0.313 | P=0.109 |
|POLY 6 | P=0.320 | P=0.092 |
|LOGISTIC REGRESSION| P=0.329 | P=0.090 |
|COCH-ARM / FISHERS | P=0.309 | P=0.127 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.45 2/48.41 | 1/47.03 1/46.06 |
|POLY-3 PERCENT (g) | 8.6% 4.1% | 2.1% 2.2% |
|TERMINAL (d) | 4/44 (9%) 2/47 (4%) | 1/43 (2%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N | P=0.751 |
|POLY 3 | P=0.316N | P=0.758 |
|POLY 1.5 | P=0.324N | P=0.759 |
|POLY 6 | P=0.309N | P=0.758 |
|LOGISTIC REGRESSION| P=0.307N | P=0.751 |
|COCH-ARM / FISHERS | P=0.339N | P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) | 2/46 (4%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/45.45 0/47.41 | 2/45.19 0/44.98 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.4% 0.0% |
|TERMINAL (d) | 0/43 (0%) 0/46 (0%) | 1/42 (2%) 0/41 (0%) |
|FIRST INCIDENCE | --- --- | 520 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.247N |
|POLY 3 | (e) | P=0.239N |
|POLY 1.5 | (e) | P=0.236N |
|POLY 6 | (e) | P=0.242N |
|LOGISTIC REGRESSION| (e) | P=0.147N |
|COCH-ARM / FISHERS | (e) | P=0.242N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 1/49 (2%) | 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 3/45.36 1/47.92 | 0/46.33 1/45.59 |
|POLY-3 PERCENT (g) | 6.6% 2.1% | 0.0% 2.2% |
|TERMINAL (d) | 3/44 (7%) 1/47 (2%) | 0/43 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.282N | P=0.490 |
|POLY 3 | P=0.282N | P=0.500 |
|POLY 1.5 | P=0.287N | P=0.500 |
|POLY 6 | P=0.278N | P=0.500 |
|LOGISTIC REGRESSION| P=0.282N | P=0.490 |
|COCH-ARM / FISHERS | P=0.301N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) | 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.36 2/47.92 | 0/46.33 0/45.59 |
|POLY-3 PERCENT (g) | 0.0% 4.2% | 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/47 (4%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 728 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253 | (e) |
|POLY 3 | P=0.244 | (e) |
|POLY 1.5 | P=0.242 | (e) |
|POLY 6 | P=0.245 | (e) |
|LOGISTIC REGRESSION| P=0.253 | (e) |
|COCH-ARM / FISHERS | P=0.253 | (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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) | 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/45.36 0/47.92 | 0/46.33 0/45.59 |
|POLY-3 PERCENT (g) | 4.4% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | (e) |
|POLY 3 | P=0.220N | (e) |
|POLY 1.5 | P=0.223N | (e) |
|POLY 6 | P=0.217N | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.242N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/2 (50%) 0/0 (0%) | 0/3 (0%) 3/4 (75%) |
|POLY-3 RATE (b) | 1/2.00 0/0.00 | 0/2.70 3/3.59 |
|POLY-3 PERCENT (g) | 50.0% 0.0% | 0.0% 83.6% |
|TERMINAL (d) | 1/2 (50%) 0/0 (0%) | 0/2 (0%) 3/3 (100%) |
|FIRST INCIDENCE | 728 (T) --- | --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=1.000 | P=0.122 |
|POLY 3 | (e) | P=0.019 * |
|POLY 1.5 | (e) | P=0.029 * |
|POLY 6 | (e) | P=0.009 ** |
|LOGISTIC REGRESSION| (e) | P=0.122 |
|COCH-ARM / FISHERS | P=1.000 | P=0.114 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/48 (6%) 2/48 (4%) | 2/49 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/45.59 2/46.92 | 2/46.70 5/46.06 |
|POLY-3 PERCENT (g) | 6.6% 4.3% | 4.3% 10.9% |
|TERMINAL (d) | 3/44 (7%) 2/46 (4%) | 1/43 (2%) 5/41 (12%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 652 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.480N | P=0.200 |
|POLY 3 | P=0.484N | P=0.212 |
|POLY 1.5 | P=0.493N | P=0.216 |
|POLY 6 | P=0.477N | P=0.207 |
|LOGISTIC REGRESSION| P=0.480N | P=0.215 |
|COCH-ARM / FISHERS | P=0.500N | P=0.226 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) | 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.59 2/46.92 | 2/46.70 1/46.06 |
|POLY-3 PERCENT (g) | 0.0% 4.3% | 4.3% 2.2% |
|TERMINAL (d) | 0/44 (0%) 2/46 (4%) | 1/43 (2%) 1/41 (2%) |
|FIRST INCIDENCE | --- 728 (T) | 652 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248 | P=0.516N |
|POLY 3 | P=0.241 | P=0.507N |
|POLY 1.5 | P=0.239 | P=0.500N |
|POLY 6 | P=0.242 | P=0.513N |
|LOGISTIC REGRESSION| P=0.248 | P=0.489N |
|COCH-ARM / FISHERS | P=0.247 | P=0.492N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) | 17/49 (35%) 23/50 (46%) |
|POLY-3 RATE (b) | 0/45.59 2/46.92 | 17/46.41 23/47.64 |
|POLY-3 PERCENT (g) | 0.0% 4.3% | 36.6% 48.3% |
|TERMINAL (d) | 0/44 (0%) 2/46 (4%) | 17/43 (40%) 20/41 (49%) |
|FIRST INCIDENCE | --- 728 (T) | 733 (T) 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248 | P=0.113 |
|POLY 3 | P=0.241 | P=0.174 |
|POLY 1.5 | P=0.239 | P=0.172 |
|POLY 6 | P=0.242 | P=0.179 |
|LOGISTIC REGRESSION| P=0.248 | P=0.151 |
|COCH-ARM / FISHERS | P=0.247 | P=0.173 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 13/50 (26%) 10/50 (20%) |
|POLY-3 RATE (b) | | 13/47.33 10/46.19 |
|POLY-3 PERCENT (g) | | 27.5% 21.7% |
|TERMINAL (d) | | 12/43 (28%) 9/41 (22%) |
|FIRST INCIDENCE | | 652 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.364N |
|POLY 3 | | P=0.341N |
|POLY 1.5 | | P=0.333N |
|POLY 6 | | P=0.347N |
|LOGISTIC REGRESSION| | P=0.339N |
|COCH-ARM / FISHERS | | P=0.318N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | | 1/47.03 2/46.06 |
|POLY-3 PERCENT (g) | | 2.1% 4.3% |
|TERMINAL (d) | | 1/43 (2%) 2/41 (5%) |
|FIRST INCIDENCE | | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.483 |
|POLY 3 | | P=0.495 |
|POLY 1.5 | | P=0.497 |
|POLY 6 | | P=0.494 |
|LOGISTIC REGRESSION| | P=0.483 |
|COCH-ARM / FISHERS | | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 0/48.41 | 1/47.03 0/46.06 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 2.1% 0.0% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 1/43 (2%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) --- | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | P=0.510N |
|POLY 3 | P=0.224N | P=0.508N |
|POLY 1.5 | P=0.229N | P=0.506N |
|POLY 6 | P=0.220N | P=0.510N |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.247N | P=0.500N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 10/50 (20%) | 21/50 (42%) 25/50 (50%) |
|POLY-3 RATE (b) | 8/46.45 10/48.41 | 21/47.03 25/46.80 |
|POLY-3 PERCENT (g) | 17.2% 20.7% | 44.7% 53.4% |
|TERMINAL (d) | 8/44 (18%) 10/47 (21%) | 21/43 (49%) 24/41 (59%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.458 | P=0.193 |
|POLY 3 | P=0.433 | P=0.259 |
|POLY 1.5 | P=0.420 | P=0.264 |
|POLY 6 | P=0.444 | P=0.257 |
|LOGISTIC REGRESSION| P=0.458 | P=0.229 |
|COCH-ARM / FISHERS | P=0.398 | P=0.274 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/50 (2%) | 1/48 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/45.05 1/48.41 | 1/45.41 0/45.09 |
|POLY-3 PERCENT (g) | 4.4% 2.1% | 2.2% 0.0% |
|TERMINAL (d) | 2/43 (5%) 1/47 (2%) | 1/42 (2%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469N | P=0.505N |
|POLY 3 | P=0.467N | P=0.503N |
|POLY 1.5 | P=0.472N | P=0.499N |
|POLY 6 | P=0.463N | P=0.506N |
|LOGISTIC REGRESSION| P=0.469N | (e) |
|COCH-ARM / FISHERS | P=0.485N | P=0.495N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 5/50 (10%) | 5/48 (10%) 5/49 (10%) |
|POLY-3 RATE (b) | 5/45.05 5/48.41 | 5/45.41 5/45.09 |
|POLY-3 PERCENT (g) | 11.1% 10.3% | 11.0% 11.1% |
|TERMINAL (d) | 5/43 (12%) 5/47 (11%) | 5/42 (12%) 5/41 (12%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.574N | P=0.616 |
|POLY 3 | P=0.580N | P=0.626 |
|POLY 1.5 | P=0.587N | P=0.628N |
|POLY 6 | P=0.574N | P=0.622 |
|LOGISTIC REGRESSION| P=0.574N | P=0.616 |
|COCH-ARM / FISHERS | P=0.603N | P=0.617N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 29/50 (58%) | |
|POLY-3 RATE (b) | 26/47.35 29/48.41 | |
|POLY-3 PERCENT (g) | 54.9% 59.9% | |
|TERMINAL (d) | 25/44 (57%) 29/47 (62%) | |
|FIRST INCIDENCE | 340 728 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 | |
|POLY 3 | P=0.386 | |
|POLY 1.5 | P=0.366 | |
|POLY 6 | P=0.407 | |
|LOGISTIC REGRESSION| P=0.404 | |
|COCH-ARM / FISHERS | P=0.344 | |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 20/50 (40%) | |
|POLY-3 RATE (b) | 15/46.45 20/48.49 | |
|POLY-3 PERCENT (g) | 32.3% 41.3% | |
|TERMINAL (d) | 15/44 (34%) 19/47 (40%) | |
|FIRST INCIDENCE | 728 (T) 708 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 | |
|POLY 3 | P=0.244 | |
|POLY 1.5 | P=0.227 | |
|POLY 6 | P=0.260 | |
|LOGISTIC REGRESSION| P=0.270 | |
|COCH-ARM / FISHERS | P=0.201 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | 0/48 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 3/48.49 | 0/46.21 0/46.06 |
|POLY-3 PERCENT (g) | 0.0% 6.2% | 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 2/47 (4%) | 0/43 (0%) 0/41 (0%) |
|FIRST INCIDENCE | --- 708 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.136 | (e) |
|POLY 3 | P=0.124 | (e) |
|POLY 1.5 | P=0.122 | (e) |
|POLY 6 | P=0.126 | (e) |
|LOGISTIC REGRESSION| P=0.126 | (e) |
|COCH-ARM / FISHERS | P=0.121 | (e) |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 31/50 (62%) | 25/48 (52%) 32/50 (64%) |
|POLY-3 RATE (b) | 30/47.05 31/48.41 | 25/46.50 32/47.52 |
|POLY-3 PERCENT (g) | 63.8% 64.0% | 53.8% 67.3% |
|TERMINAL (d) | 29/44 (66%) 31/47 (66%) | 24/43 (56%) 28/41 (68%) |
|FIRST INCIDENCE | 538 728 (T) | 652 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.500N | P=0.073 |
|POLY 3 | P=0.572 | P=0.124 |
|POLY 1.5 | P=0.547 | P=0.135 |
|POLY 6 | P=0.577N | P=0.117 |
|LOGISTIC REGRESSION| P=0.551N | P=0.105 |
|COCH-ARM / FISHERS | P=0.500 | P=0.161 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 8/50 (16%) | 11/48 (23%) 16/49 (33%) |
|POLY-3 RATE (b) | 7/48.03 8/48.92 | 11/48.00 16/47.49 |
|POLY-3 PERCENT (g) | 14.6% 16.4% | 22.9% 33.7% |
|TERMINAL (d) | 5/44 (11%) 7/47 (15%) | 6/43 (14%) 10/41 (24%) |
|FIRST INCIDENCE | 340 572 | 429 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.547 | P=0.180 |
|POLY 3 | P=0.514 | P=0.174 |
|POLY 1.5 | P=0.507 | P=0.182 |
|POLY 6 | P=0.522 | P=0.168 |
|LOGISTIC REGRESSION| P=0.472 | P=0.281 |
|COCH-ARM / FISHERS | P=0.500 | P=0.200 |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen: Lymphoid Follicle |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/48 (4%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/46.45 0/48.41 | 2/45.75 4/45.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.4% 8.9% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 2/43 (5%) 4/41 (10%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.315 |
|POLY 3 | (e) | P=0.332 |
|POLY 1.5 | (e) | P=0.337 |
|POLY 6 | (e) | P=0.327 |
|LOGISTIC REGRESSION| (e) | P=0.315 |
|COCH-ARM / FISHERS | (e) | P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/50 (0%) | 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.71 0/48.41 | 3/48.21 1/46.82 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 6.2% 2.1% |
|TERMINAL (d) | 0/43 (0%) 0/47 (0%) | 1/43 (2%) 0/41 (0%) |
|FIRST INCIDENCE | 498 --- | 429 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233N | P=0.319N |
|POLY 3 | P=0.226N | P=0.319N |
|POLY 1.5 | P=0.226N | P=0.314N |
|POLY 6 | P=0.225N | P=0.323N |
|LOGISTIC REGRESSION| P=0.151N | P=0.158N |
|COCH-ARM / FISHERS | P=0.237N | P=0.309N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.45 0/48.41 | 1/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 2.1% 4.3% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 1/43 (2%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.483 |
|POLY 3 | (e) | P=0.495 |
|POLY 1.5 | (e) | P=0.497 |
|POLY 6 | (e) | P=0.494 |
|LOGISTIC REGRESSION| (e) | P=0.483 |
|COCH-ARM / FISHERS | (e) | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/44 (0%) 2/43 (5%) | 5/46 (11%) 2/47 (4%) |
|POLY-3 RATE (b) | 0/40.61 2/41.92 | 5/44.56 2/44.05 |
|POLY-3 PERCENT (g) | 0.0% 4.8% | 11.2% 4.5% |
|TERMINAL (d) | 0/39 (0%) 2/41 (5%) | 2/40 (5%) 0/39 (0%) |
|FIRST INCIDENCE | --- 728 (T) | 520 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.249 | P=0.233N |
|POLY 3 | P=0.241 | P=0.221N |
|POLY 1.5 | P=0.238 | P=0.216N |
|POLY 6 | P=0.243 | P=0.225N |
|LOGISTIC REGRESSION| P=0.249 | P=0.162N |
|COCH-ARM / FISHERS | P=0.241 | P=0.209N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) | 0/48 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.45 0/47.49 | 0/46.21 2/46.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 0.0% 4.3% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 0/43 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- | --- 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.235 |
|POLY 3 | (e) | P=0.237 |
|POLY 1.5 | (e) | P=0.239 |
|POLY 6 | (e) | P=0.236 |
|LOGISTIC REGRESSION| (e) | P=0.244 |
|COCH-ARM / FISHERS | (e) | P=0.258 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/49 (8%) | 7/48 (15%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/46.45 4/47.49 | 7/46.21 3/46.06 |
|POLY-3 PERCENT (g) | 12.9% 8.4% | 15.2% 6.5% |
|TERMINAL (d) | 6/44 (14%) 4/47 (9%) | 7/43 (16%) 3/41 (7%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329N | P=0.177N |
|POLY 3 | P=0.355N | P=0.159N |
|POLY 1.5 | P=0.366N | P=0.152N |
|POLY 6 | P=0.345N | P=0.164N |
|LOGISTIC REGRESSION| P=0.329N | P=0.177N |
|COCH-ARM / FISHERS | P=0.383N | P=0.142N |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 16/50 (32%) | 34/50 (68%) 33/50 (66%) |
|POLY-3 RATE (b) | 20/47.13 16/48.41 | 34/48.50 33/47.37 |
|POLY-3 PERCENT (g) | 42.4% 33.1% | 70.1% 69.7% |
|TERMINAL (d) | 19/44 (43%) 16/47 (34%) | 31/43 (72%) 30/41 (73%) |
|FIRST INCIDENCE | 498 728 (T) | 429 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.191N | P=0.538 |
|POLY 3 | P=0.231N | P=0.572N |
|POLY 1.5 | P=0.243N | P=0.548N |
|POLY 6 | P=0.221N | P=0.587N |
|LOGISTIC REGRESSION| P=0.224N | P=0.547N |
|COCH-ARM / FISHERS | P=0.266N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 1/50 (2%) 7/50 (14%) |
|POLY-3 RATE (b) | | 1/47.03 7/46.47 |
|POLY-3 PERCENT (g) | | 2.1% 15.1% |
|TERMINAL (d) | | 1/43 (2%) 6/41 (15%) |
|FIRST INCIDENCE | | 733 (T) 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.029 * |
|POLY 3 | | P=0.029 * |
|POLY 1.5 | | P=0.029 * |
|POLY 6 | | P=0.029 * |
|LOGISTIC REGRESSION| | P=0.031 * |
|COCH-ARM / FISHERS | | P=0.030 * |
|=================================================================================================================================|
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 | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 43/50 (86%) 42/50 (84%) |
|POLY-3 RATE (b) | | 43/47.92 42/48.12 |
|POLY-3 PERCENT (g) | | 89.7% 87.3% |
|TERMINAL (d) | | 40/43 (93%) 38/41 (93%) |
|FIRST INCIDENCE | | 627 463 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.506 |
|POLY 3 | | P=0.476N |
|POLY 1.5 | | P=0.483N |
|POLY 6 | | P=0.475N |
|LOGISTIC REGRESSION| | P=0.622N |
|COCH-ARM / FISHERS | | P=0.500N |
|=================================================================================================================================|
(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).