TDMS Study 56111-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/18/01
EXPERIMENT: 56111 TEST: 03 TIME: 13:39:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: TOFT, JOHN CAS: 14371-10-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANS-CINNAMALDEHYDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Brain Hemorrhage
Liver Mixed Cell Focus
Liver: Hepatocyte Vacuolization Cytoplasmic
Lung Inflammation Chronic
Oral Mucosa: Gingival Inflammation Chronic
Pancreas: Acinus Atrophy
Preputial Gland Hyperplasia
Inflammation Chronic
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy
Mesentery: Fat Inflammation Chronic
Pancreas: Duct Cyst
Thyroid Gland: C-Cell Hyperplasia
===============================================================
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Accessory Adrenal Cortical Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.58 0/41.64 | 1/45.04 2/45.91 |
|POLY-3 PERCENT (g) | 2.2% 0.0% | 2.2% 4.4% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 1/34 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 696 --- | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.528N | P=0.520 |
|POLY 3 | P=0.528N | P=0.504 |
|POLY 1.5 | P=0.517N | P=0.504 |
|POLY 6 | P=0.540N | P=0.506 |
|LOGISTIC REGRESSION| P=0.506N | P=0.520 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.44 2/41.64 | 2/45.55 1/45.91 |
|POLY-3 PERCENT (g) | 2.3% 4.8% | 4.4% 2.2% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 597 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 | P=0.488N |
|POLY 3 | P=0.485 | P=0.496N |
|POLY 1.5 | P=0.491 | P=0.496N |
|POLY 6 | P=0.480 | P=0.498N |
|LOGISTIC REGRESSION| P=0.523 | P=0.519N |
|COCH-ARM / FISHERS | P=0.500 | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 9/50 (18%) | 10/50 (20%) 17/50 (34%) |
|POLY-3 RATE (b) | 12/45.05 9/42.63 | 10/45.31 17/46.54 |
|POLY-3 PERCENT (g) | 26.6% 21.1% | 22.1% 36.5% |
|TERMINAL (d) | 9/29 (31%) 6/31 (19%) | 8/34 (24%) 14/36 (39%) |
|FIRST INCIDENCE | 603 577 | 676 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.287N | P=0.120 |
|POLY 3 | P=0.363N | P=0.095 |
|POLY 1.5 | P=0.344N | P=0.094 |
|POLY 6 | P=0.381N | P=0.098 |
|LOGISTIC REGRESSION| P=0.379N | P=0.097 |
|COCH-ARM / FISHERS | P=0.312N | P=0.088 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.60 3/42.09 | 1/45.04 4/45.91 |
|POLY-3 PERCENT (g) | 4.5% 7.1% | 2.2% 8.7% |
|TERMINAL (d) | 0/29 (0%) 2/31 (7%) | 1/34 (3%) 4/36 (11%) |
|FIRST INCIDENCE | 710 598 | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.498 | P=0.196 |
|POLY 3 | P=0.479 | P=0.183 |
|POLY 1.5 | P=0.487 | P=0.183 |
|POLY 6 | P=0.472 | P=0.184 |
|LOGISTIC REGRESSION| P=0.487 | P=0.196 |
|COCH-ARM / FISHERS | P=0.500 | P=0.181 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.44 2/42.04 | 0/45.04 1/46.16 |
|POLY-3 PERCENT (g) | 0.0% 4.8% | 0.0% 2.2% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 647 | --- 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.214 | P=0.514 |
|POLY 3 | P=0.231 | P=0.500 |
|POLY 1.5 | P=0.233 | P=0.500 |
|POLY 6 | P=0.229 | P=0.500 |
|LOGISTIC REGRESSION| P=0.245 | P=0.480 |
|COCH-ARM / FISHERS | P=0.247 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 27/50 (54%) | 20/50 (40%) 18/50 (36%) |
|POLY-3 RATE (b) | 30/49.18 27/47.35 | 20/46.17 18/46.75 |
|POLY-3 PERCENT (g) | 61.0% 57.0% | 43.3% 38.5% |
|TERMINAL (d) | 14/29 (48%) 13/31 (42%) | 13/34 (38%) 13/36 (36%) |
|FIRST INCIDENCE | 508 499 | 660 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415N | P=0.361N |
|POLY 3 | P=0.426N | P=0.396N |
|POLY 1.5 | P=0.396N | P=0.398N |
|POLY 6 | P=0.454N | P=0.397N |
|LOGISTIC REGRESSION| P=0.242N | P=0.386N |
|COCH-ARM / FISHERS | P=0.343N | P=0.418N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 9/50 (18%) | 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 8/44.47 9/42.82 | 3/45.37 6/45.91 |
|POLY-3 PERCENT (g) | 18.0% 21.0% | 6.6% 13.1% |
|TERMINAL (d) | 7/29 (24%) 7/31 (23%) | 1/34 (3%) 6/36 (17%) |
|FIRST INCIDENCE | 724 505 | 660 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 | P=0.270 |
|POLY 3 | P=0.467 | P=0.247 |
|POLY 1.5 | P=0.479 | P=0.248 |
|POLY 6 | P=0.459 | P=0.245 |
|LOGISTIC REGRESSION| P=0.436 | P=0.254 |
|COCH-ARM / FISHERS | P=0.500 | P=0.243 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 33/50 (66%) | 15/50 (30%) 16/50 (32%) |
|POLY-3 RATE (b) | 29/48.19 33/49.34 | 15/47.73 16/48.78 |
|POLY-3 PERCENT (g) | 60.2% 66.9% | 31.4% 32.8% |
|TERMINAL (d) | 15/29 (52%) 16/31 (52%) | 4/34 (12%) 6/36 (17%) |
|FIRST INCIDENCE | 524 429 | 576 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 | P=0.541 |
|POLY 3 | P=0.315 | P=0.528 |
|POLY 1.5 | P=0.295 | P=0.524 |
|POLY 6 | P=0.342 | P=0.529 |
|LOGISTIC REGRESSION| P=0.382 | P=0.450 |
|COCH-ARM / FISHERS | P=0.268 | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.44 0/41.64 | 3/45.80 2/46.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 6.6% 4.3% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- | 649 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.488N |
|POLY 3 | (e) | P=0.497N |
|POLY 1.5 | (e) | P=0.495N |
|POLY 6 | (e) | P=0.500N |
|LOGISTIC REGRESSION| (e) | P=0.524N |
|COCH-ARM / FISHERS | (e) | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Compression |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/44.88 2/41.64 | 2/45.91 3/46.28 |
|POLY-3 PERCENT (g) | 6.7% 4.8% | 4.4% 6.5% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 0/34 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 631 731 (T) | 557 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495N | P=0.512 |
|POLY 3 | P=0.541N | P=0.503 |
|POLY 1.5 | P=0.525N | P=0.503 |
|POLY 6 | P=0.559N | P=0.502 |
|LOGISTIC REGRESSION| P=0.530N | P=0.446 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 1/50 (2%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/46.35 1/42.30 | 2/46.33 0/45.91 |
|POLY-3 PERCENT (g) | 12.9% 2.4% | 4.3% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 508 508 | 203 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081N | P=0.240N |
|POLY 3 | P=0.075N | P=0.240N |
|POLY 1.5 | P=0.067N | P=0.239N |
|POLY 6 | P=0.084N | P=0.241N |
|LOGISTIC REGRESSION| P=0.013N* | P=0.440N |
|COCH-ARM / FISHERS | P=0.056N | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) | 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | 4/44.88 3/42.07 | 2/45.91 5/46.45 |
|POLY-3 PERCENT (g) | 8.9% 7.1% | 4.4% 10.8% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 0/34 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 631 606 | 557 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.496N | P=0.236 |
|POLY 3 | P=0.541N | P=0.220 |
|POLY 1.5 | P=0.525N | P=0.221 |
|POLY 6 | P=0.556N | P=0.220 |
|LOGISTIC REGRESSION| P=0.515N | P=0.184 |
|COCH-ARM / FISHERS | P=0.500N | P=0.218 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.11 0/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.7% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 508 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.118N | (e) |
|POLY 3 | P=0.139N | (e) |
|POLY 1.5 | P=0.131N | (e) |
|POLY 6 | P=0.147N | (e) |
|LOGISTIC REGRESSION| P=0.091N | (e) |
|COCH-ARM / FISHERS | P=0.121N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 11/49 (22%) 11/50 (22%) |
|POLY-3 RATE (b) | | 11/44.15 11/45.91 |
|POLY-3 PERCENT (g) | | 24.9% 24.0% |
|TERMINAL (d) | | 10/33 (30%) 11/36 (31%) |
|FIRST INCIDENCE | | 708 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.509N |
|POLY 3 | | P=0.554N |
|POLY 1.5 | | P=0.556N |
|POLY 6 | | P=0.550N |
|LOGISTIC REGRESSION| | P=0.520N |
|COCH-ARM / FISHERS | | P=0.574N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 13/49 (27%) 9/50 (18%) |
|POLY-3 RATE (b) | | 13/44.76 9/45.91 |
|POLY-3 PERCENT (g) | | 29.0% 19.6% |
|TERMINAL (d) | | 11/33 (33%) 9/36 (25%) |
|FIRST INCIDENCE | | 597 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.167N |
|POLY 3 | | P=0.209N |
|POLY 1.5 | | P=0.209N |
|POLY 6 | | P=0.211N |
|LOGISTIC REGRESSION| | P=0.192N |
|COCH-ARM / FISHERS | | P=0.218N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral Gland: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 11/49 (22%) 16/50 (32%) |
|POLY-3 RATE (b) | | 11/44.04 16/45.91 |
|POLY-3 PERCENT (g) | | 25.0% 34.9% |
|TERMINAL (d) | | 11/33 (33%) 16/36 (44%) |
|FIRST INCIDENCE | | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.244 |
|POLY 3 | | P=0.211 |
|POLY 1.5 | | P=0.211 |
|POLY 6 | | P=0.213 |
|LOGISTIC REGRESSION| | P=0.244 |
|COCH-ARM / FISHERS | | P=0.200 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Epididymis |
| Granuloma Sperm |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | |
|POLY-3 RATE (b) | 3/44.93 1/41.92 | |
|POLY-3 PERCENT (g) | 6.7% 2.4% | |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | |
|FIRST INCIDENCE | 659 655 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.363N | |
|POLY 3 | P=0.337N | |
|POLY 1.5 | P=0.324N | |
|POLY 6 | P=0.350N | |
|LOGISTIC REGRESSION| P=0.288N | |
|COCH-ARM / FISHERS | P=0.309N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Eye: Retina |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 1/1 (100%) | 1/1 (100%) 0/0 (0%) |
|POLY-3 RATE (b) | 2/2.00 1/1.00 | 1/1.00 0/0.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% | 100.0% 0.0% |
|TERMINAL (d) | 2/2 (100%) 1/1 (100%) | 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | (e) |
|POLY 3 | (e) | (e) |
|POLY 1.5 | (e) | (e) |
|POLY 6 | (e) | (e) |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | (e) |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 46/50 (92%) | 36/50 (72%) 45/50 (90%) |
|POLY-3 RATE (b) | 44/48.53 46/50.00 | 36/46.67 45/48.97 |
|POLY-3 PERCENT (g) | 90.7% 92.0% | 77.1% 91.9% |
|TERMINAL (d) | 27/29 (93%) 27/31 (87%) | 28/34 (82%) 35/36 (97%) |
|FIRST INCIDENCE | 508 429 | 624 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.451 | P=0.114 |
|POLY 3 | P=0.549 | P=0.031 * |
|POLY 1.5 | P=0.465 | P=0.028 * |
|POLY 6 | P=0.628N | P=0.033 * |
|LOGISTIC REGRESSION| P=0.367 | P=0.022 * |
|COCH-ARM / FISHERS | P=0.370 | P=0.020 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.44 3/42.74 | 1/45.09 0/45.91 |
|POLY-3 PERCENT (g) | 2.3% 7.0% | 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) 429 | 723 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.306 | P=0.495N |
|POLY 3 | P=0.295 | P=0.493N |
|POLY 1.5 | P=0.299 | P=0.494N |
|POLY 6 | P=0.291 | P=0.492N |
|LOGISTIC REGRESSION| P=0.396 | P=0.495N |
|COCH-ARM / FISHERS | P=0.309 | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) | 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/45.01 4/42.07 | 1/45.30 5/45.91 |
|POLY-3 PERCENT (g) | 6.7% 9.5% | 2.2% 10.9% |
|TERMINAL (d) | 1/29 (3%) 3/31 (10%) | 0/34 (0%) 5/36 (14%) |
|FIRST INCIDENCE | 586 606 | 666 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.497 | P=0.118 |
|POLY 3 | P=0.469 | P=0.104 |
|POLY 1.5 | P=0.481 | P=0.104 |
|POLY 6 | P=0.457 | P=0.103 |
|LOGISTIC REGRESSION| P=0.499 | P=0.108 |
|COCH-ARM / FISHERS | P=0.500 | P=0.102 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/50 (8%) | 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 10/44.74 4/42.07 | 0/45.04 4/46.07 |
|POLY-3 PERCENT (g) | 22.4% 9.5% | 0.0% 8.7% |
|TERMINAL (d) | 8/29 (28%) 3/31 (10%) | 0/34 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 676 606 | --- 695 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.068N | P=0.071 |
|POLY 3 | P=0.090N | P=0.062 |
|POLY 1.5 | P=0.084N | P=0.062 |
|POLY 6 | P=0.097N | P=0.063 |
|LOGISTIC REGRESSION| P=0.100N | P=0.066 |
|COCH-ARM / FISHERS | P=0.074N | P=0.059 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 31/50 (62%) | 30/50 (60%) 38/50 (76%) |
|POLY-3 RATE (b) | 38/46.97 31/46.41 | 30/47.37 38/48.65 |
|POLY-3 PERCENT (g) | 80.9% 66.8% | 63.3% 78.1% |
|TERMINAL (d) | 26/29 (90%) 20/31 (65%) | 19/34 (56%) 29/36 (81%) |
|FIRST INCIDENCE | 508 499 | 557 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129N | P=0.181 |
|POLY 3 | P=0.082N | P=0.079 |
|POLY 1.5 | P=0.091N | P=0.079 |
|POLY 6 | P=0.065N | P=0.075 |
|LOGISTIC REGRESSION| P=0.158N | P=0.077 |
|COCH-ARM / FISHERS | P=0.097N | P=0.066 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 47/50 (94%) | 39/50 (78%) 43/50 (86%) |
|POLY-3 RATE (b) | 47/48.44 47/48.89 | 39/46.76 43/49.75 |
|POLY-3 PERCENT (g) | 97.0% 96.1% | 83.4% 86.4% |
|TERMINAL (d) | 29/29 (100%) 31/31 (100%) | 31/34 (91%) 31/36 (86%) |
|FIRST INCIDENCE | 524 429 | 576 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N | P=0.424 |
|POLY 3 | P=0.657N | P=0.443 |
|POLY 1.5 | P=0.650N | P=0.353 |
|POLY 6 | P=0.738N | P=0.574 |
|LOGISTIC REGRESSION| P=0.437 | P=0.261 |
|COCH-ARM / FISHERS | P=0.661N | P=0.218 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 26/50 (52%) | 42/50 (84%) 44/50 (88%) |
|POLY-3 RATE (b) | 25/45.49 26/43.54 | 42/47.35 44/48.51 |
|POLY-3 PERCENT (g) | 55.0% 59.7% | 88.7% 90.7% |
|TERMINAL (d) | 21/29 (72%) 21/31 (68%) | 32/34 (94%) 34/36 (94%) |
|FIRST INCIDENCE | 508 577 | 557 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.575N | P=0.571N |
|POLY 3 | P=0.404 | P=0.504 |
|POLY 1.5 | P=0.439 | P=0.469 |
|POLY 6 | P=0.380 | P=0.569 |
|LOGISTIC REGRESSION| P=0.304 | P=0.450 |
|COCH-ARM / FISHERS | P=0.500 | P=0.387 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.44 1/41.64 | 1/45.04 2/45.91 |
|POLY-3 PERCENT (g) | 2.3% 2.4% | 2.2% 4.4% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 1/34 (3%) 2/36 (6%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.747N | P=0.520 |
|POLY 3 | P=0.754 | P=0.504 |
|POLY 1.5 | P=0.756 | P=0.504 |
|POLY 6 | P=0.752 | P=0.506 |
|LOGISTIC REGRESSION| P=0.747N | P=0.520 |
|COCH-ARM / FISHERS | P=0.753N | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.44 1/42.07 | 0/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 4.5% 2.4% | 0.0% 2.2% |
|TERMINAL (d) | 2/29 (7%) 0/31 (0%) | 0/34 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 731 (T) 606 | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.493N | P=0.511 |
|POLY 3 | P=0.526N | P=0.500 |
|POLY 1.5 | P=0.516N | P=0.500 |
|POLY 6 | P=0.534N | P=0.500 |
|LOGISTIC REGRESSION| P=0.501N | P=0.511 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) | 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.44 1/41.64 | 3/46.07 2/45.91 |
|POLY-3 PERCENT (g) | 2.3% 2.4% | 6.5% 4.4% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 0/34 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 576 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.747N | P=0.485N |
|POLY 3 | P=0.754 | P=0.502N |
|POLY 1.5 | P=0.756 | P=0.498N |
|POLY 6 | P=0.752 | P=0.507N |
|LOGISTIC REGRESSION| P=0.747N | P=0.539N |
|COCH-ARM / FISHERS | P=0.753N | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/44.44 2/41.64 | 4/45.04 5/46.41 |
|POLY-3 PERCENT (g) | 4.5% 4.8% | 8.9% 10.8% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 4/34 (12%) 3/36 (8%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 735 (T) 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.672N | P=0.529 |
|POLY 3 | P=0.677 | P=0.517 |
|POLY 1.5 | P=0.683 | P=0.512 |
|POLY 6 | P=0.671 | P=0.524 |
|LOGISTIC REGRESSION| P=0.672N | P=0.512 |
|COCH-ARM / FISHERS | P=0.691N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 38/50 (76%) | 44/50 (88%) 41/50 (82%) |
|POLY-3 RATE (b) | 33/46.73 38/45.03 | 44/48.18 41/47.63 |
|POLY-3 PERCENT (g) | 70.6% 84.4% | 91.3% 86.1% |
|TERMINAL (d) | 24/29 (83%) 30/31 (97%) | 32/34 (94%) 34/36 (94%) |
|FIRST INCIDENCE | 508 499 | 557 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.274 | P=0.197N |
|POLY 3 | P=0.074 | P=0.301N |
|POLY 1.5 | P=0.114 | P=0.268N |
|POLY 6 | P=0.041 * | P=0.359N |
|LOGISTIC REGRESSION| P=0.051 | P=0.206N |
|COCH-ARM / FISHERS | P=0.189 | P=0.288N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 29/50 (58%) | 26/50 (52%) 25/50 (50%) |
|POLY-3 RATE (b) | 18/44.52 29/42.61 | 26/46.17 25/46.88 |
|POLY-3 PERCENT (g) | 40.4% 68.1% | 56.3% 53.3% |
|TERMINAL (d) | 17/29 (59%) 26/31 (84%) | 23/34 (68%) 21/36 (58%) |
|FIRST INCIDENCE | 711 577 | 557 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * | P=0.392N |
|POLY 3 | P=0.005 ** | P=0.467N |
|POLY 1.5 | P=0.010 * | P=0.473N |
|POLY 6 | P=0.003 ** | P=0.449N |
|LOGISTIC REGRESSION| P=0.002 ** | P=0.456N |
|COCH-ARM / FISHERS | P=0.022 * | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) | 5/50 (10%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/44.52 5/43.41 | 5/45.67 3/46.16 |
|POLY-3 PERCENT (g) | 4.5% 11.5% | 11.0% 6.5% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 2/34 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 711 429 | 652 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 | P=0.335N |
|POLY 3 | P=0.207 | P=0.350N |
|POLY 1.5 | P=0.211 | P=0.350N |
|POLY 6 | P=0.203 | P=0.351N |
|LOGISTIC REGRESSION| P=0.305 | P=0.357N |
|COCH-ARM / FISHERS | P=0.218 | P=0.357N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) | 21/50 (42%) 25/50 (50%) |
|POLY-3 RATE (b) | 45/47.68 46/48.14 | 21/46.11 25/47.53 |
|POLY-3 PERCENT (g) | 94.4% 95.6% | 45.5% 52.6% |
|TERMINAL (d) | 29/29 (100%) 31/31 (100%) | 16/34 (47%) 19/36 (53%) |
|FIRST INCIDENCE | 508 429 | 597 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.546 | P=0.365 |
|POLY 3 | P=0.603 | P=0.315 |
|POLY 1.5 | P=0.543 | P=0.304 |
|POLY 6 | P=0.763 | P=0.332 |
|LOGISTIC REGRESSION| P=0.196 | P=0.299 |
|COCH-ARM / FISHERS | P=0.500 | P=0.274 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/44.68 7/41.73 | 1/45.61 1/46.31 |
|POLY-3 PERCENT (g) | 9.0% 16.8% | 2.2% 2.2% |
|TERMINAL (d) | 2/29 (7%) 6/31 (19%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 690 707 | 557 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.275 | P=0.760N |
|POLY 3 | P=0.225 | P=0.755N |
|POLY 1.5 | P=0.239 | P=0.756N |
|POLY 6 | P=0.211 | P=0.754N |
|LOGISTIC REGRESSION| P=0.208 | P=0.691 |
|COCH-ARM / FISHERS | P=0.262 | P=0.753N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 37/50 (74%) | 31/50 (62%) 32/50 (64%) |
|POLY-3 RATE (b) | 23/47.84 37/45.78 | 31/47.03 32/47.61 |
|POLY-3 PERCENT (g) | 48.1% 80.8% | 65.9% 67.2% |
|TERMINAL (d) | 13/29 (45%) 26/31 (84%) | 24/34 (71%) 26/36 (72%) |
|FIRST INCIDENCE | 508 505 | 557 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.015 * | P=0.528N |
|POLY 3 | P<0.001 ** | P=0.533 |
|POLY 1.5 | P<0.001 ** | P=0.534 |
|POLY 6 | P<0.001 ** | P=0.525 |
|LOGISTIC REGRESSION| P=0.003 ** | P=0.546 |
|COCH-ARM / FISHERS | P=0.004 ** | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 32/50 (64%) | 31/50 (62%) 36/50 (72%) |
|POLY-3 RATE (b) | 26/45.30 32/44.20 | 31/47.41 36/46.90 |
|POLY-3 PERCENT (g) | 57.4% 72.4% | 65.4% 76.8% |
|TERMINAL (d) | 21/29 (72%) 27/31 (87%) | 24/34 (71%) 32/36 (89%) |
|FIRST INCIDENCE | 603 499 | 557 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 | P=0.312 |
|POLY 3 | P=0.090 | P=0.152 |
|POLY 1.5 | P=0.113 | P=0.180 |
|POLY 6 | P=0.069 | P=0.117 |
|LOGISTIC REGRESSION| P=0.041 * | P=0.224 |
|COCH-ARM / FISHERS | P=0.156 | P=0.198 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) | 45/50 (90%) 45/50 (90%) |
|POLY-3 RATE (b) | 45/48.99 46/48.78 | 45/49.02 45/49.83 |
|POLY-3 PERCENT (g) | 91.9% 94.3% | 91.8% 90.3% |
|TERMINAL (d) | 27/29 (93%) 30/31 (97%) | 30/34 (88%) 32/36 (89%) |
|FIRST INCIDENCE | 508 429 | 557 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522 | P=0.426N |
|POLY 3 | P=0.466 | P=0.536N |
|POLY 1.5 | P=0.483 | P=0.541N |
|POLY 6 | P=0.435 | P=0.552N |
|LOGISTIC REGRESSION| P=0.416 | P=0.588N |
|COCH-ARM / FISHERS | P=0.500 | P=0.630N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 35/50 (70%) | 44/50 (88%) 47/50 (94%) |
|POLY-3 RATE (b) | 30/46.22 35/44.21 | 44/47.96 47/49.18 |
|POLY-3 PERCENT (g) | 64.9% 79.2% | 91.7% 95.6% |
|TERMINAL (d) | 22/29 (76%) 29/31 (94%) | 33/34 (97%) 36/36 (100%) |
|FIRST INCIDENCE | 583 505 | 557 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.264 | P=0.520 |
|POLY 3 | P=0.086 | P=0.347 |
|POLY 1.5 | P=0.128 | P=0.319 |
|POLY 6 | P=0.047 * | P=0.398 |
|LOGISTIC REGRESSION| P=0.051 | P=0.303 |
|COCH-ARM / FISHERS | P=0.201 | P=0.243 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 10/50 (20%) | 12/50 (24%) 12/50 (24%) |
|POLY-3 RATE (b) | 9/44.98 10/42.66 | 12/45.51 12/45.91 |
|POLY-3 PERCENT (g) | 20.0% 23.4% | 26.4% 26.1% |
|TERMINAL (d) | 7/29 (24%) 8/31 (26%) | 11/34 (32%) 12/36 (33%) |
|FIRST INCIDENCE | 598 577 | 597 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534 | P=0.532N |
|POLY 3 | P=0.451 | P=0.584N |
|POLY 1.5 | P=0.470 | P=0.581N |
|POLY 6 | P=0.434 | P=0.587N |
|LOGISTIC REGRESSION| P=0.436 | P=0.560N |
|COCH-ARM / FISHERS | P=0.500 | P=0.592N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 36/50 (72%) | 44/50 (88%) 47/50 (94%) |
|POLY-3 RATE (b) | 31/46.70 36/44.90 | 44/47.96 47/49.18 |
|POLY-3 PERCENT (g) | 66.4% 80.2% | 91.7% 95.6% |
|TERMINAL (d) | 22/29 (76%) 29/31 (94%) | 33/34 (97%) 36/36 (100%) |
|FIRST INCIDENCE | 583 499 | 557 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268 | P=0.520 |
|POLY 3 | P=0.090 | P=0.347 |
|POLY 1.5 | P=0.130 | P=0.319 |
|POLY 6 | P=0.050 | P=0.398 |
|LOGISTIC REGRESSION| P=0.071 | P=0.303 |
|COCH-ARM / FISHERS | P=0.198 | P=0.243 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/24 (8%) 0/20 (0%) | 0/30 (0%) 0/25 (0%) |
|POLY-3 RATE (b) | 2/22.15 0/16.32 | 0/28.35 0/23.04 |
|POLY-3 PERCENT (g) | 9.0% 0.0% | 0.0% 0.0% |
|TERMINAL (d) | 1/13 (8%) 0/11 (0%) | 0/21 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 711 --- | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254N | (e) |
|POLY 3 | P=0.352N | (e) |
|POLY 1.5 | P=0.329N | (e) |
|POLY 6 | P=0.379N | (e) |
|LOGISTIC REGRESSION| P=0.320N | (e) |
|COCH-ARM / FISHERS | P=0.292N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mandibular |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/2 (100%) 0/0 (0%) | 1/1 (100%) 0/2 (0%) |
|POLY-3 RATE (b) | 2/2.00 0/0.00 | 1/1.00 0/2.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% | 100.0% 0.0% |
|TERMINAL (d) | 2/2 (100%) 0/0 (0%) | 1/1 (100%) 0/2 (0%) |
|FIRST INCIDENCE | 731 (T) --- | 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.362N |
|POLY 3 | (e) | P=1.000 |
|POLY 1.5 | (e) | P=1.000 |
|POLY 6 | (e) | P=1.000 |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | (e) | P=0.333N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 10/50 (20%) | 15/50 (30%) 17/50 (34%) |
|POLY-3 RATE (b) | 6/44.44 10/43.05 | 15/45.47 17/46.09 |
|POLY-3 PERCENT (g) | 13.5% 23.2% | 33.0% 36.9% |
|TERMINAL (d) | 6/29 (21%) 7/31 (23%) | 13/34 (38%) 16/36 (44%) |
|FIRST INCIDENCE | 731 (T) 499 | 652 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228 | P=0.487 |
|POLY 3 | P=0.184 | P=0.431 |
|POLY 1.5 | P=0.192 | P=0.431 |
|POLY 6 | P=0.180 | P=0.429 |
|LOGISTIC REGRESSION| P=0.172 | P=0.457 |
|COCH-ARM / FISHERS | P=0.207 | P=0.415 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) | 19/50 (38%) 20/50 (40%) |
|POLY-3 RATE (b) | 7/44.66 10/42.91 | 19/45.52 20/46.39 |
|POLY-3 PERCENT (g) | 15.7% 23.3% | 41.7% 43.1% |
|TERMINAL (d) | 6/29 (21%) 7/31 (23%) | 16/34 (47%) 18/36 (50%) |
|FIRST INCIDENCE | 673 499 | 652 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 | P=0.581N |
|POLY 3 | P=0.265 | P=0.530 |
|POLY 1.5 | P=0.277 | P=0.525 |
|POLY 6 | P=0.256 | P=0.537 |
|LOGISTIC REGRESSION| P=0.251 | P=0.549 |
|COCH-ARM / FISHERS | P=0.298 | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/44.44 0/41.64 | 2/45.20 1/46.04 |
|POLY-3 PERCENT (g) | 4.5% 0.0% | 4.4% 2.2% |
|TERMINAL (d) | 2/29 (7%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) --- | 708 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223N | P=0.497N |
|POLY 3 | P=0.260N | P=0.491N |
|POLY 1.5 | P=0.251N | P=0.493N |
|POLY 6 | P=0.268N | P=0.490N |
|LOGISTIC REGRESSION| (e) | P=0.497N |
|COCH-ARM / FISHERS | P=0.247N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/24 (13%) 0/20 (0%) | 1/30 (3%) 0/25 (0%) |
|POLY-3 RATE (b) | 3/22.40 0/16.32 | 1/28.46 0/23.04 |
|POLY-3 PERCENT (g) | 13.4% 0.0% | 3.5% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/11 (0%) | 0/21 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 690 --- | 708 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.137N | P=0.500N |
|POLY 3 | P=0.207N | P=0.585N |
|POLY 1.5 | P=0.186N | P=0.580N |
|POLY 6 | P=0.234N | P=0.589N |
|LOGISTIC REGRESSION| P=0.162N | P=0.526N |
|COCH-ARM / FISHERS | P=0.153N | P=0.545N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lymph Node: Deep Cervical |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/24 (13%) 1/20 (5%) | 0/30 (0%) 0/25 (0%) |
|POLY-3 RATE (b) | 3/22.53 1/16.32 | 0/28.35 0/23.04 |
|POLY-3 PERCENT (g) | 13.3% 6.1% | 0.0% 0.0% |
|TERMINAL (d) | 0/13 (0%) 1/11 (9%) | 0/21 (0%) 0/19 (0%) |
|FIRST INCIDENCE | 659 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352N | (e) |
|POLY 3 | P=0.464N | (e) |
|POLY 1.5 | P=0.431N | (e) |
|POLY 6 | P=0.505N | (e) |
|LOGISTIC REGRESSION| P=0.393N | (e) |
|COCH-ARM / FISHERS | P=0.376N | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/44.44 0/41.64 | 5/45.39 4/46.28 |
|POLY-3 PERCENT (g) | 2.3% 0.0% | 11.0% 8.6% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 3/34 (9%) 3/36 (8%) |
|FIRST INCIDENCE | 731 (T) --- | 652 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.487N | P=0.472N |
|POLY 3 | P=0.527N | P=0.487N |
|POLY 1.5 | P=0.516N | P=0.489N |
|POLY 6 | P=0.537N | P=0.484N |
|LOGISTIC REGRESSION| (e) | P=0.493N |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 47/50 (94%) | 43/50 (86%) 47/50 (94%) |
|POLY-3 RATE (b) | 45/49.48 47/49.57 | 43/48.02 47/49.06 |
|POLY-3 PERCENT (g) | 90.9% 94.8% | 89.6% 95.8% |
|TERMINAL (d) | 26/29 (90%) 29/31 (94%) | 31/34 (91%) 35/36 (97%) |
|FIRST INCIDENCE | 508 429 | 557 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442 | P=0.440 |
|POLY 3 | P=0.355 | P=0.195 |
|POLY 1.5 | P=0.355 | P=0.194 |
|POLY 6 | P=0.360 | P=0.197 |
|LOGISTIC REGRESSION| P=0.373 | P=0.197 |
|COCH-ARM / FISHERS | P=0.357 | P=0.159 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/14 (79%) 2/5 (40%) | 4/11 (36%) 8/9 (89%) |
|POLY-3 RATE (b) | 11/12.88 2/4.43 | 4/10.05 8/8.83 |
|POLY-3 PERCENT (g) | 85.4% 45.1% | 39.8% 90.6% |
|TERMINAL (d) | 7/8 (88%) 2/3 (67%) | 3/7 (43%) 6/6 (100%) |
|FIRST INCIDENCE | 676 731 (T) | 666 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053N | P=0.068 |
|POLY 3 | P=0.207N | P=0.019 * |
|POLY 1.5 | P=0.202N | P=0.018 * |
|POLY 6 | P=0.265N | P=0.021 * |
|LOGISTIC REGRESSION| P=0.140N | P=0.028 * |
|COCH-ARM / FISHERS | P=0.151N | P=0.025 * |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/14 (57%) 2/5 (40%) | 8/11 (73%) 5/9 (56%) |
|POLY-3 RATE (b) | 8/12.79 2/4.43 | 8/10.62 5/8.36 |
|POLY-3 PERCENT (g) | 62.6% 45.1% | 75.4% 59.8% |
|TERMINAL (d) | 5/8 (63%) 2/3 (67%) | 6/7 (86%) 4/6 (67%) |
|FIRST INCIDENCE | 676 731 (T) | 576 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.231N | P=0.294N |
|POLY 3 | P=0.579N | P=0.434N |
|POLY 1.5 | P=0.555N | P=0.416N |
|POLY 6 | P=0.639N | P=0.458N |
|LOGISTIC REGRESSION| P=0.483N | P=0.348N |
|COCH-ARM / FISHERS | P=0.444N | P=0.370N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/14 (79%) 2/5 (40%) | 9/11 (82%) 7/9 (78%) |
|POLY-3 RATE (b) | 11/12.88 2/4.43 | 9/11.00 7/8.83 |
|POLY-3 PERCENT (g) | 85.4% 45.1% | 81.8% 79.3% |
|TERMINAL (d) | 7/8 (88%) 2/3 (67%) | 5/7 (71%) 5/6 (83%) |
|FIRST INCIDENCE | 676 731 (T) | 576 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053N | P=0.458N |
|POLY 3 | P=0.207N | P=0.683N |
|POLY 1.5 | P=0.202N | P=0.665N |
|POLY 6 | P=0.265N | P=0.715N |
|LOGISTIC REGRESSION| P=0.140N | P=0.652N |
|COCH-ARM / FISHERS | P=0.151N | P=0.625N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 2/42.52 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 4.7% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 598 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 | (e) |
|POLY 3 | P=0.232 | (e) |
|POLY 1.5 | P=0.234 | (e) |
|POLY 6 | P=0.231 | (e) |
|LOGISTIC REGRESSION| P=0.330 | (e) |
|COCH-ARM / FISHERS | P=0.247 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) | 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.07 4/42.86 | 4/45.43 1/46.16 |
|POLY-3 PERCENT (g) | 4.4% 9.3% | 8.8% 2.2% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 2/34 (6%) 0/36 (0%) |
|FIRST INCIDENCE | 615 598 | 666 670 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.299 | P=0.171N |
|POLY 3 | P=0.318 | P=0.173N |
|POLY 1.5 | P=0.325 | P=0.174N |
|POLY 6 | P=0.312 | P=0.172N |
|LOGISTIC REGRESSION| P=0.434 | P=0.181N |
|COCH-ARM / FISHERS | P=0.339 | P=0.181N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.55 2/42.43 | 2/45.71 3/47.16 |
|POLY-3 PERCENT (g) | 2.2% 4.7% | 4.4% 6.4% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 703 577 | 624 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.458 | P=0.510 |
|POLY 3 | P=0.489 | P=0.511 |
|POLY 1.5 | P=0.493 | P=0.508 |
|POLY 6 | P=0.486 | P=0.515 |
|LOGISTIC REGRESSION| P=0.574 | P=0.389 |
|COCH-ARM / FISHERS | P=0.500 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 6/50 (12%) | 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 12/47.10 6/42.35 | 4/45.04 5/46.55 |
|POLY-3 PERCENT (g) | 25.5% 14.2% | 8.9% 10.7% |
|TERMINAL (d) | 5/29 (17%) 3/31 (10%) | 4/34 (12%) 4/36 (11%) |
|FIRST INCIDENCE | 508 637 | 735 (T) 523 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.130N | P=0.533 |
|POLY 3 | P=0.145N | P=0.518 |
|POLY 1.5 | P=0.124N | P=0.513 |
|POLY 6 | P=0.171N | P=0.524 |
|LOGISTIC REGRESSION| P=0.072N | P=0.506 |
|COCH-ARM / FISHERS | P=0.096N | P=0.500 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/13 (100%) 12/13 (92%) | 11/12 (92%) 9/11 (82%) |
|POLY-3 RATE (b) | 13/13.00 12/13.00 | 11/12.00 9/11.00 |
|POLY-3 PERCENT (g) | 100.0% 92.3% | 91.7% 81.8% |
|TERMINAL (d) | 9/9 (100%) 10/11 (91%) | 8/9 (89%) 8/10 (80%) |
|FIRST INCIDENCE | 696 429 | 597 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.257N | P=0.234N |
|POLY 3 | P=0.500N | P=0.479N |
|POLY 1.5 | P=0.500N | P=0.479N |
|POLY 6 | P=0.500N | P=0.479N |
|LOGISTIC REGRESSION| (e) | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.466N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Oral Mucosa: Gingival |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/13 (69%) 4/13 (31%) | 5/12 (42%) 8/11 (73%) |
|POLY-3 RATE (b) | 9/12.86 4/11.90 | 5/12.00 8/11.00 |
|POLY-3 PERCENT (g) | 70.0% 33.6% | 41.7% 72.7% |
|TERMINAL (d) | 6/9 (67%) 4/11 (36%) | 2/9 (22%) 7/10 (70%) |
|FIRST INCIDENCE | 709 731 (T) | 597 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.040N* | P=0.308 |
|POLY 3 | P=0.074N | P=0.143 |
|POLY 1.5 | P=0.065N | P=0.143 |
|POLY 6 | P=0.083N | P=0.143 |
|LOGISTIC REGRESSION| P=0.076N | (e) |
|COCH-ARM / FISHERS | P=0.058N | P=0.140 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 9/50 (18%) 5/50 (10%) |
|POLY-3 RATE (b) | | 9/45.82 5/46.05 |
|POLY-3 PERCENT (g) | | 19.6% 10.9% |
|TERMINAL (d) | | 7/34 (21%) 3/36 (8%) |
|FIRST INCIDENCE | | 576 702 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.173N |
|POLY 3 | | P=0.189N |
|POLY 1.5 | | P=0.188N |
|POLY 6 | | P=0.190N |
|LOGISTIC REGRESSION| | P=0.185N |
|COCH-ARM / FISHERS | | P=0.194N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 25/50 (50%) | 12/50 (24%) 14/50 (28%) |
|POLY-3 RATE (b) | 13/45.13 25/45.12 | 12/45.39 14/46.46 |
|POLY-3 PERCENT (g) | 28.8% 55.4% | 26.4% 30.1% |
|TERMINAL (d) | 9/29 (31%) 16/31 (52%) | 10/34 (29%) 12/36 (33%) |
|FIRST INCIDENCE | 603 499 | 690 652 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.023 * | P=0.473 |
|POLY 3 | P=0.007 ** | P=0.435 |
|POLY 1.5 | P=0.008 ** | P=0.430 |
|POLY 6 | P=0.007 ** | P=0.442 |
|LOGISTIC REGRESSION| P=0.007 ** | P=0.438 |
|COCH-ARM / FISHERS | P=0.011 * | P=0.410 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pancreas: Duct |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) | 0/50 (0%) 8/50 (16%) |
|POLY-3 RATE (b) | 2/44.47 3/42.07 | 0/45.04 8/46.61 |
|POLY-3 PERCENT (g) | 4.5% 7.1% | 0.0% 17.2% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 0/34 (0%) 6/36 (17%) |
|FIRST INCIDENCE | 724 606 | --- 620 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517 | P=0.007 ** |
|POLY 3 | P=0.480 | P=0.004 ** |
|POLY 1.5 | P=0.487 | P=0.004 ** |
|POLY 6 | P=0.474 | P=0.004 ** |
|LOGISTIC REGRESSION| P=0.473 | P=0.005 ** |
|COCH-ARM / FISHERS | P=0.500 | P=0.003 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.44 1/42.09 | 2/45.63 2/45.91 |
|POLY-3 PERCENT (g) | 0.0% 2.4% | 4.4% 4.4% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 0/34 (0%) 2/36 (6%) |
|FIRST INCIDENCE | --- 598 | 597 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.482 | P=0.680N |
|POLY 3 | P=0.501 | P=0.691N |
|POLY 1.5 | P=0.500 | P=0.690N |
|POLY 6 | P=0.501 | P=0.694N |
|LOGISTIC REGRESSION| P=0.599 | P=0.685 |
|COCH-ARM / FISHERS | P=0.500 | P=0.691N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) | 30/50 (60%) 27/50 (54%) |
|POLY-3 RATE (b) | 2/44.52 4/42.82 | 30/47.80 27/48.21 |
|POLY-3 PERCENT (g) | 4.5% 9.3% | 62.8% 56.0% |
|TERMINAL (d) | 1/29 (3%) 2/31 (7%) | 20/34 (59%) 19/36 (53%) |
|FIRST INCIDENCE | 710 505 | 203 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343 | P=0.290N |
|POLY 3 | P=0.322 | P=0.319N |
|POLY 1.5 | P=0.328 | P=0.331N |
|POLY 6 | P=0.317 | P=0.301N |
|LOGISTIC REGRESSION| P=0.385 | P=0.347N |
|COCH-ARM / FISHERS | P=0.339 | P=0.343N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 13/50 (26%) | 24/50 (48%) 19/50 (38%) |
|POLY-3 RATE (b) | 16/46.00 13/43.99 | 24/46.05 19/46.53 |
|POLY-3 PERCENT (g) | 34.8% 29.6% | 52.1% 40.8% |
|TERMINAL (d) | 9/29 (31%) 8/31 (26%) | 20/34 (59%) 17/36 (47%) |
|FIRST INCIDENCE | 583 499 | 597 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.350N | P=0.145N |
|POLY 3 | P=0.382N | P=0.186N |
|POLY 1.5 | P=0.361N | P=0.189N |
|POLY 6 | P=0.404N | P=0.183N |
|LOGISTIC REGRESSION| P=0.336N | P=0.174N |
|COCH-ARM / FISHERS | P=0.330N | P=0.210N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.44 2/41.64 | 2/45.51 0/45.91 |
|POLY-3 PERCENT (g) | 4.5% 4.8% | 4.4% 0.0% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 597 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.672N | P=0.231N |
|POLY 3 | P=0.677 | P=0.234N |
|POLY 1.5 | P=0.683 | P=0.234N |
|POLY 6 | P=0.671 | P=0.235N |
|LOGISTIC REGRESSION| P=0.672N | P=0.257N |
|COCH-ARM / FISHERS | P=0.691N | P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 0/50 (0%) | |
|POLY-3 RATE (b) | 7/44.80 0/41.64 | |
|POLY-3 PERCENT (g) | 15.6% 0.0% | |
|TERMINAL (d) | 4/29 (14%) 0/31 (0%) | |
|FIRST INCIDENCE | 673 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011N* | |
|POLY 3 | P=0.010N* | |
|POLY 1.5 | P=0.009N** | |
|POLY 6 | P=0.012N* | |
|LOGISTIC REGRESSION| P=0.012N* | |
|COCH-ARM / FISHERS | P=0.006N** | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 43/50 (86%) | |
|POLY-3 RATE (b) | 49/50.00 43/46.74 | |
|POLY-3 PERCENT (g) | 98.0% 92.0% | |
|TERMINAL (d) | 28/29 (97%) 30/31 (97%) | |
|FIRST INCIDENCE | 508 505 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187N | |
|POLY 3 | P=0.153N | |
|POLY 1.5 | P=0.073N | |
|POLY 6 | P=0.361N | |
|LOGISTIC REGRESSION| P=0.087N | |
|COCH-ARM / FISHERS | P=0.030N* | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/44.60 0/41.64 | |
|POLY-3 PERCENT (g) | 4.5% 0.0% | |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | |
|FIRST INCIDENCE | 690 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.250N | |
|POLY 3 | P=0.261N | |
|POLY 1.5 | P=0.251N | |
|POLY 6 | P=0.271N | |
|LOGISTIC REGRESSION| P=0.254N | |
|COCH-ARM / FISHERS | P=0.247N | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Preputial Gland: Duct |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) | |
|POLY-3 RATE (b) | 5/44.64 7/42.98 | |
|POLY-3 PERCENT (g) | 11.2% 16.3% | |
|TERMINAL (d) | 3/29 (10%) 4/31 (13%) | |
|FIRST INCIDENCE | 703 577 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380 | |
|POLY 3 | P=0.354 | |
|POLY 1.5 | P=0.363 | |
|POLY 6 | P=0.349 | |
|LOGISTIC REGRESSION| P=0.364 | |
|COCH-ARM / FISHERS | P=0.380 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) | |
|POLY-3 RATE (b) | 1/44.44 3/42.58 | |
|POLY-3 PERCENT (g) | 2.3% 7.1% | |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | |
|FIRST INCIDENCE | 731 (T) 508 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 | |
|POLY 3 | P=0.294 | |
|POLY 1.5 | P=0.298 | |
|POLY 6 | P=0.291 | |
|LOGISTIC REGRESSION| P=0.355 | |
|COCH-ARM / FISHERS | P=0.309 | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 23/50 (46%) | |
|POLY-3 RATE (b) | 21/45.39 23/46.81 | |
|POLY-3 PERCENT (g) | 46.3% 49.1% | |
|TERMINAL (d) | 16/29 (55%) 13/31 (42%) | |
|FIRST INCIDENCE | 586 499 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.455 | |
|POLY 3 | P=0.472 | |
|POLY 1.5 | P=0.446 | |
|POLY 6 | P=0.516 | |
|LOGISTIC REGRESSION| P=0.423 | |
|COCH-ARM / FISHERS | P=0.420 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Prostate: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) | |
|POLY-3 RATE (b) | 2/44.53 4/42.20 | |
|POLY-3 PERCENT (g) | 4.5% 9.5% | |
|TERMINAL (d) | 1/29 (3%) 3/31 (10%) | |
|FIRST INCIDENCE | 709 554 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 | |
|POLY 3 | P=0.316 | |
|POLY 1.5 | P=0.325 | |
|POLY 6 | P=0.309 | |
|LOGISTIC REGRESSION| P=0.320 | |
|COCH-ARM / FISHERS | P=0.339 | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) | 11/50 (22%) 19/50 (38%) |
|POLY-3 RATE (b) | 8/45.02 5/41.64 | 11/45.74 19/46.66 |
|POLY-3 PERCENT (g) | 17.8% 12.0% | 24.1% 40.7% |
|TERMINAL (d) | 6/29 (21%) 5/31 (16%) | 8/34 (24%) 16/36 (44%) |
|FIRST INCIDENCE | 583 731 (T) | 576 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248N | P=0.090 |
|POLY 3 | P=0.331N | P=0.065 |
|POLY 1.5 | P=0.309N | P=0.065 |
|POLY 6 | P=0.356N | P=0.065 |
|LOGISTIC REGRESSION| P=0.335N | P=0.070 |
|COCH-ARM / FISHERS | P=0.277N | P=0.063 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Salivary Glands |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 19/50 (38%) | 10/50 (20%) 7/50 (14%) |
|POLY-3 RATE (b) | 16/45.09 19/42.07 | 10/45.39 7/45.91 |
|POLY-3 PERCENT (g) | 35.5% 45.2% | 22.0% 15.3% |
|TERMINAL (d) | 13/29 (45%) 18/31 (58%) | 8/34 (24%) 7/36 (19%) |
|FIRST INCIDENCE | 586 606 | 676 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.399 | P=0.256N |
|POLY 3 | P=0.239 | P=0.286N |
|POLY 1.5 | P=0.278 | P=0.287N |
|POLY 6 | P=0.201 | P=0.287N |
|LOGISTIC REGRESSION| P=0.196 | P=0.269N |
|COCH-ARM / FISHERS | P=0.338 | P=0.298N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) | 12/50 (24%) 5/50 (10%) |
|POLY-3 RATE (b) | 2/44.44 5/42.66 | 12/46.18 5/46.09 |
|POLY-3 PERCENT (g) | 4.5% 11.7% | 26.0% 10.9% |
|TERMINAL (d) | 2/29 (7%) 2/31 (7%) | 8/34 (24%) 4/36 (11%) |
|FIRST INCIDENCE | 731 (T) 499 | 576 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.230 | P=0.050N |
|POLY 3 | P=0.201 | P=0.052N |
|POLY 1.5 | P=0.207 | P=0.051N |
|POLY 6 | P=0.197 | P=0.053N |
|LOGISTIC REGRESSION| P=0.220 | P=0.052N |
|COCH-ARM / FISHERS | P=0.218 | P=0.054N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hyperplasia Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.44 2/41.64 | 2/45.04 1/45.91 |
|POLY-3 PERCENT (g) | 6.8% 4.8% | 4.4% 2.2% |
|TERMINAL (d) | 3/29 (10%) 2/31 (7%) | 2/34 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469N | P=0.480N |
|POLY 3 | P=0.536N | P=0.491N |
|POLY 1.5 | P=0.522N | P=0.493N |
|POLY 6 | P=0.549N | P=0.489N |
|LOGISTIC REGRESSION| P=0.469N | P=0.480N |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.15 3/42.48 | 1/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 8.9% 7.1% | 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 583 554 | 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.530N | P=0.489N |
|POLY 3 | P=0.538N | P=0.492N |
|POLY 1.5 | P=0.523N | P=0.494N |
|POLY 6 | P=0.552N | P=0.491N |
|LOGISTIC REGRESSION| P=0.444N | (e) |
|COCH-ARM / FISHERS | P=0.500N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.96 1/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 4.5% 2.4% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 603 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503N | (e) |
|POLY 3 | P=0.536N | (e) |
|POLY 1.5 | P=0.522N | (e) |
|POLY 6 | P=0.552N | (e) |
|LOGISTIC REGRESSION| P=0.489N | (e) |
|COCH-ARM / FISHERS | P=0.500N | (e) |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/45.59 3/42.48 | 1/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 11.0% 7.1% | 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 583 554 | 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394N | P=0.489N |
|POLY 3 | P=0.401N | P=0.492N |
|POLY 1.5 | P=0.383N | P=0.494N |
|POLY 6 | P=0.419N | P=0.491N |
|LOGISTIC REGRESSION| P=0.278N | (e) |
|COCH-ARM / FISHERS | P=0.357N | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) | 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/45.78 2/42.48 | 1/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 10.9% 4.7% | 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/31 (0%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 524 554 | 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255N | P=0.489N |
|POLY 3 | P=0.252N | P=0.492N |
|POLY 1.5 | P=0.238N | P=0.494N |
|POLY 6 | P=0.266N | P=0.491N |
|LOGISTIC REGRESSION| P=0.119N | (e) |
|COCH-ARM / FISHERS | P=0.218N | P=0.500N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.44 2/41.92 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 2.3% 4.8% | 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) 655 | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 | (e) |
|POLY 3 | P=0.487 | (e) |
|POLY 1.5 | P=0.492 | (e) |
|POLY 6 | P=0.483 | (e) |
|LOGISTIC REGRESSION| P=0.478 | (e) |
|COCH-ARM / FISHERS | P=0.500 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 4/42.92 | 2/46.02 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 9.3% | 4.4% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/31 (0%) | 1/34 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- 554 | 203 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 | P=0.233N |
|POLY 3 | P=0.057 | P=0.238N |
|POLY 1.5 | P=0.058 | P=0.238N |
|POLY 6 | P=0.056 | P=0.237N |
|LOGISTIC REGRESSION| P=0.088 | P=0.415N |
|COCH-ARM / FISHERS | P=0.059 | P=0.247N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 42
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Stomach, Glandular: Glands |
| Ectasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 34/50 (68%) | 39/50 (78%) 36/50 (72%) |
|POLY-3 RATE (b) | 34/47.37 34/46.25 | 39/47.37 36/47.98 |
|POLY-3 PERCENT (g) | 71.8% 73.5% | 82.3% 75.0% |
|TERMINAL (d) | 21/29 (72%) 23/31 (74%) | 29/34 (85%) 28/36 (78%) |
|FIRST INCIDENCE | 583 499 | 576 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.539N | P=0.236N |
|POLY 3 | P=0.519 | P=0.259N |
|POLY 1.5 | P=0.547 | P=0.269N |
|POLY 6 | P=0.484 | P=0.254N |
|LOGISTIC REGRESSION| P=0.473 | P=0.263N |
|COCH-ARM / FISHERS | P=0.585N | P=0.322N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 38/50 (76%) | |
|POLY-3 RATE (b) | 42/48.25 38/45.85 | |
|POLY-3 PERCENT (g) | 87.1% 82.9% | |
|TERMINAL (d) | 27/29 (93%) 28/31 (90%) | |
|FIRST INCIDENCE | 524 499 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.255N | |
|POLY 3 | P=0.385N | |
|POLY 1.5 | P=0.311N | |
|POLY 6 | P=0.480N | |
|LOGISTIC REGRESSION| P=0.414N | |
|COCH-ARM / FISHERS | P=0.227N | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 43
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) | |
|POLY-3 RATE (b) | 4/44.44 1/41.64 | |
|POLY-3 PERCENT (g) | 9.0% 2.4% | |
|TERMINAL (d) | 4/29 (14%) 1/31 (3%) | |
|FIRST INCIDENCE | 731 (T) 731 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.158N | |
|POLY 3 | P=0.203N | |
|POLY 1.5 | P=0.194N | |
|POLY 6 | P=0.212N | |
|LOGISTIC REGRESSION| P=0.158N | |
|COCH-ARM / FISHERS | P=0.181N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) | |
|POLY-3 RATE (b) | 10/46.93 8/44.86 | |
|POLY-3 PERCENT (g) | 21.3% 17.8% | |
|TERMINAL (d) | 3/29 (10%) 1/31 (3%) | |
|FIRST INCIDENCE | 508 499 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.434N | |
|POLY 3 | P=0.441N | |
|POLY 1.5 | P=0.425N | |
|POLY 6 | P=0.454N | |
|LOGISTIC REGRESSION| P=0.175N | |
|COCH-ARM / FISHERS | P=0.398N | |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 44
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thymus |
| Ectopic Parathyroid Gland |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 2/44 (5%) | 4/43 (9%) 4/49 (8%) |
|POLY-3 RATE (b) | 0/38.48 2/36.92 | 4/40.36 4/45.55 |
|POLY-3 PERCENT (g) | 0.0% 5.4% | 9.9% 8.8% |
|TERMINAL (d) | 0/28 (0%) 1/28 (4%) | 3/31 (10%) 4/36 (11%) |
|FIRST INCIDENCE | --- 554 | 203 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235 | P=0.570N |
|POLY 3 | P=0.232 | P=0.567N |
|POLY 1.5 | P=0.235 | P=0.564N |
|POLY 6 | P=0.230 | P=0.570N |
|LOGISTIC REGRESSION| P=0.285 | P=0.642N |
|COCH-ARM / FISHERS | P=0.253 | P=0.567N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland |
| Ultimobranchial Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/44.44 1/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 6.8% 2.4% | 0.0% 0.0% |
|TERMINAL (d) | 3/29 (10%) 1/31 (3%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 731 (T) 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280N | (e) |
|POLY 3 | P=0.335N | (e) |
|POLY 1.5 | P=0.323N | (e) |
|POLY 6 | P=0.346N | (e) |
|LOGISTIC REGRESSION| P=0.280N | (e) |
|COCH-ARM / FISHERS | P=0.309N | (e) |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 45
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 22/50 (44%) | 23/50 (46%) 33/50 (66%) |
|POLY-3 RATE (b) | 17/45.23 22/44.11 | 23/46.20 33/47.68 |
|POLY-3 PERCENT (g) | 37.6% 49.9% | 49.8% 69.2% |
|TERMINAL (d) | 12/29 (41%) 15/31 (48%) | 18/34 (53%) 28/36 (78%) |
|FIRST INCIDENCE | 659 554 | 597 526 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235 | P=0.068 |
|POLY 3 | P=0.165 | P=0.038 * |
|POLY 1.5 | P=0.178 | P=0.038 * |
|POLY 6 | P=0.159 | P=0.037 * |
|LOGISTIC REGRESSION| P=0.129 | P=0.039 * |
|COCH-ARM / FISHERS | P=0.206 | P=0.035 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicle |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.68 2/42.07 | 0/45.04 2/45.91 |
|POLY-3 PERCENT (g) | 4.5% 4.8% | 0.0% 4.4% |
|TERMINAL (d) | 0/29 (0%) 1/31 (3%) | 0/34 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 690 606 | --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.671 | P=0.251 |
|POLY 3 | P=0.678 | P=0.239 |
|POLY 1.5 | P=0.684 | P=0.239 |
|POLY 6 | P=0.673 | P=0.240 |
|LOGISTIC REGRESSION| P=0.690N | P=0.251 |
|COCH-ARM / FISHERS | P=0.691N | P=0.247 |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 46
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) | 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.44 3/41.64 | 0/45.04 0/45.91 |
|POLY-3 PERCENT (g) | 0.0% 7.2% | 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 3/31 (10%) | 0/34 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 731 (T) | --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.132 | (e) |
|POLY 3 | P=0.111 | (e) |
|POLY 1.5 | P=0.114 | (e) |
|POLY 6 | P=0.108 | (e) |
|LOGISTIC REGRESSION| P=0.132 | (e) |
|COCH-ARM / FISHERS | P=0.121 | (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Hydrometra |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | | 2/45.04 2/45.91 |
|POLY-3 PERCENT (g) | | 4.4% 4.4% |
|TERMINAL (d) | | 2/34 (6%) 2/36 (6%) |
|FIRST INCIDENCE | | 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.675N |
|POLY 3 | | P=0.685N |
|POLY 1.5 | | P=0.687N |
|POLY 6 | | P=0.684N |
|LOGISTIC REGRESSION| | P=0.675N |
|COCH-ARM / FISHERS | | P=0.691N |
|=================================================================================================================================|
Date: 06/18/01 EXPERIMENT: 56111 TEST: 03 Page 47
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Uterus: Endometrium |
| Hyperplasia Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 5/50 (10%) |
|POLY-3 RATE (b) | | 2/45.09 5/45.91 |
|POLY-3 PERCENT (g) | | 4.4% 10.9% |
|TERMINAL (d) | | 1/34 (3%) 5/36 (14%) |
|FIRST INCIDENCE | | 723 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.239 |
|POLY 3 | | P=0.222 |
|POLY 1.5 | | P=0.222 |
|POLY 6 | | P=0.223 |
|LOGISTIC REGRESSION| | P=0.232 |
|COCH-ARM / FISHERS | | P=0.218 |
|=================================================================================================================================|
(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).