TDMS Study 56111-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/14/01
EXPERIMENT: 56111 TEST: 04 TIME: 09:37:06
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: MARIT, GARY CAS: 14371-10-9
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Clitoral/Preputial Gland
Epididymis
Heart
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 06/14/01
EXPERIMENT: 56111 TEST: 04 TIME: 09:37:06
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: MARIT, GARY CAS: 14371-10-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRANS-CINNAMALDEHYDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) | 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.45 4/48.41 | 1/47.03 1/46.06 |
|POLY-3 PERCENT (g) | 8.6% 8.3% | 2.1% 2.2% |
|TERMINAL (d) | 4/44 (9%) 4/47 (9%) | 1/43 (2%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607N | P=0.751 |
|POLY 3 | P=0.617N | P=0.758 |
|POLY 1.5 | P=0.627N | P=0.759 |
|POLY 6 | P=0.610N | P=0.758 |
|LOGISTIC REGRESSION| P=0.607N | P=0.751 |
|COCH-ARM / FISHERS | P=0.643N | P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) | 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.45 4/48.41 | 2/47.03 1/46.06 |
|POLY-3 PERCENT (g) | 8.6% 8.3% | 4.3% 2.2% |
|TERMINAL (d) | 4/44 (9%) 4/47 (9%) | 2/43 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607N | P=0.517N |
|POLY 3 | P=0.617N | P=0.510N |
|POLY 1.5 | P=0.627N | P=0.507N |
|POLY 6 | P=0.610N | P=0.512N |
|LOGISTIC REGRESSION| P=0.607N | P=0.517N |
|COCH-ARM / FISHERS | P=0.643N | P=0.500N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) | 4/50 (8%) 3/49 (6%) |
|POLY-3 RATE (b) | 5/47.13 9/48.41 | 4/47.03 3/45.21 |
|POLY-3 PERCENT (g) | 10.6% 18.6% | 8.5% 6.6% |
|TERMINAL (d) | 4/44 (9%) 9/47 (19%) | 4/43 (9%) 3/41 (7%) |
|FIRST INCIDENCE | 498 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.232 | P=0.526N |
|POLY 3 | P=0.208 | P=0.525N |
|POLY 1.5 | P=0.203 | P=0.521N |
|POLY 6 | P=0.211 | P=0.525N |
|LOGISTIC REGRESSION| P=0.198 | P=0.526N |
|COCH-ARM / FISHERS | P=0.194 | P=0.511N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) | 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 6/47.28 7/48.49 | 1/47.03 2/45.21 |
|POLY-3 PERCENT (g) | 12.7% 14.4% | 2.1% 4.4% |
|TERMINAL (d) | 4/44 (9%) 6/47 (13%) | 1/43 (2%) 2/41 (5%) |
|FIRST INCIDENCE | 538 708 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 | P=0.483 |
|POLY 3 | P=0.518 | P=0.491 |
|POLY 1.5 | P=0.512 | P=0.492 |
|POLY 6 | P=0.521 | P=0.491 |
|LOGISTIC REGRESSION| P=0.502 | P=0.483 |
|COCH-ARM / FISHERS | P=0.500 | P=0.492 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 16/50 (32%) | 4/50 (8%) 5/49 (10%) |
|POLY-3 RATE (b) | 10/47.96 16/48.49 | 4/47.03 5/45.21 |
|POLY-3 PERCENT (g) | 20.9% 33.0% | 8.5% 11.1% |
|TERMINAL (d) | 7/44 (16%) 15/47 (32%) | 4/43 (9%) 5/41 (12%) |
|FIRST INCIDENCE | 498 708 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 | P=0.470 |
|POLY 3 | P=0.132 | P=0.478 |
|POLY 1.5 | P=0.131 | P=0.481 |
|POLY 6 | P=0.132 | P=0.477 |
|LOGISTIC REGRESSION| P=0.130 | P=0.470 |
|COCH-ARM / FISHERS | P=0.127 | P=0.487 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 16/50 (32%) | 4/50 (8%) 5/49 (10%) |
|POLY-3 RATE (b) | 10/47.96 16/48.49 | 4/47.03 5/45.21 |
|POLY-3 PERCENT (g) | 20.9% 33.0% | 8.5% 11.1% |
|TERMINAL (d) | 7/44 (16%) 15/47 (32%) | 4/43 (9%) 5/41 (12%) |
|FIRST INCIDENCE | 498 708 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180 | P=0.470 |
|POLY 3 | P=0.132 | P=0.478 |
|POLY 1.5 | P=0.131 | P=0.481 |
|POLY 6 | P=0.132 | P=0.477 |
|LOGISTIC REGRESSION| P=0.130 | P=0.470 |
|COCH-ARM / FISHERS | P=0.127 | P=0.487 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 6/50 (12%) | 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/46.45 6/48.92 | 1/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 6.5% 12.3% | 2.1% 4.3% |
|TERMINAL (d) | 3/44 (7%) 5/47 (11%) | 1/43 (2%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 572 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.278 | P=0.483 |
|POLY 3 | P=0.266 | P=0.495 |
|POLY 1.5 | P=0.257 | P=0.497 |
|POLY 6 | P=0.274 | P=0.494 |
|LOGISTIC REGRESSION| P=0.246 | P=0.483 |
|COCH-ARM / FISHERS | P=0.243 | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 5/48.49 | 2/47.03 0/46.06 |
|POLY-3 PERCENT (g) | 4.3% 10.3% | 4.3% 0.0% |
|TERMINAL (d) | 2/44 (5%) 4/47 (9%) | 2/43 (5%) 0/41 (0%) |
|FIRST INCIDENCE | 728 (T) 708 | 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248 | P=0.249N |
|POLY 3 | P=0.232 | P=0.244N |
|POLY 1.5 | P=0.226 | P=0.242N |
|POLY 6 | P=0.237 | P=0.246N |
|LOGISTIC REGRESSION| P=0.236 | (e) |
|COCH-ARM / FISHERS | P=0.218 | P=0.247N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 10/50 (20%) | 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/46.45 10/49.00 | 3/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 8.6% 20.4% | 6.4% 4.3% |
|TERMINAL (d) | 4/44 (9%) 8/47 (17%) | 3/43 (7%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 572 | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 | P=0.522N |
|POLY 3 | P=0.088 | P=0.511N |
|POLY 1.5 | P=0.082 | P=0.508N |
|POLY 6 | P=0.094 | P=0.514N |
|LOGISTIC REGRESSION| P=0.079 | P=0.522N |
|COCH-ARM / FISHERS | P=0.074 | P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | | 2/47.25 0/46.06 |
|POLY-3 PERCENT (g) | | 4.2% 0.0% |
|TERMINAL (d) | | 1/43 (2%) 0/41 (0%) |
|FIRST INCIDENCE | | 675 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | | P=0.245N |
|POLY 3 | | P=0.246N |
|POLY 1.5 | | P=0.243N |
|POLY 6 | | P=0.249N |
|LOGISTIC REGRESSION| | P=0.234N |
|COCH-ARM / FISHERS | | P=0.247N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) | 5/48 (10%) 6/49 (12%) |
|POLY-3 RATE (b) | 0/45.05 0/48.41 | 5/45.70 6/45.22 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 10.9% 13.3% |
|TERMINAL (d) | 0/43 (0%) 0/47 (0%) | 4/42 (10%) 5/41 (12%) |
|FIRST INCIDENCE | --- --- | 652 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.482 |
|POLY 3 | (e) | P=0.493 |
|POLY 1.5 | (e) | P=0.501 |
|POLY 6 | (e) | P=0.487 |
|LOGISTIC REGRESSION| (e) | P=0.497 |
|COCH-ARM / FISHERS | (e) | P=0.515 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.45 0/48.41 | 2/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 4.3% 4.3% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 2/43 (5%) 2/41 (5%) |
|FIRST INCIDENCE | --- --- | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.678 |
|POLY 3 | (e) | P=0.688 |
|POLY 1.5 | (e) | P=0.690 |
|POLY 6 | (e) | P=0.687 |
|LOGISTIC REGRESSION| (e) | P=0.678 |
|COCH-ARM / FISHERS | (e) | P=0.691N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) | 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.45 0/48.41 | 0/47.03 1/46.06 |
|POLY-3 PERCENT (g) | 4.3% 0.0% | 0.0% 2.2% |
|TERMINAL (d) | 2/44 (5%) 0/47 (0%) | 0/43 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 728 (T) --- | --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224N | P=0.490 |
|POLY 3 | P=0.224N | P=0.500 |
|POLY 1.5 | P=0.229N | P=0.500 |
|POLY 6 | P=0.220N | P=0.500 |
|LOGISTIC REGRESSION| (e) | P=0.490 |
|COCH-ARM / FISHERS | P=0.247N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/46.45 1/48.41 | 2/47.03 2/46.06 |
|POLY-3 PERCENT (g) | 4.3% 2.1% | 4.3% 4.3% |
|TERMINAL (d) | 2/44 (5%) 1/47 (2%) | 2/43 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 728 (T) | 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.477N | P=0.678 |
|POLY 3 | P=0.481N | P=0.688 |
|POLY 1.5 | P=0.488N | P=0.690 |
|POLY 6 | P=0.475N | P=0.687 |
|LOGISTIC REGRESSION| P=0.477N | P=0.678 |
|COCH-ARM / FISHERS | P=0.500N | P=0.691N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) | 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/46.45 2/48.92 | 2/47.03 3/46.19 |
|POLY-3 PERCENT (g) | 6.5% 4.1% | 4.3% 6.5% |
|TERMINAL (d) | 3/44 (7%) 1/47 (2%) | 2/43 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 728 (T) 572 | 733 (T) 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470N | P=0.483 |
|POLY 3 | P=0.472N | P=0.493 |
|POLY 1.5 | P=0.482N | P=0.495 |
|POLY 6 | P=0.463N | P=0.493 |
|LOGISTIC REGRESSION| P=0.505N | P=0.490 |
|COCH-ARM / FISHERS | P=0.500N | P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.45 0/48.41 | 0/47.03 2/46.82 |
|POLY-3 PERCENT (g) | 0.0% 0.0% | 0.0% 4.3% |
|TERMINAL (d) | 0/44 (0%) 0/47 (0%) | 0/43 (0%) 1/41 (2%) |
|FIRST INCIDENCE | --- --- | --- 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) | P=0.237 |
|POLY 3 | (e) | P=0.237 |
|POLY 1.5 | (e) | P=0.237 |
|POLY 6 | (e) | P=0.237 |
|LOGISTIC REGRESSION| (e) | P=0.282 |
|COCH-ARM / FISHERS | (e) | P=0.247 |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) | 13/50 (26%) 10/50 (20%) |
|POLY-3 RATE (b) | 4/47.05 4/48.41 | 13/47.03 10/46.51 |
|POLY-3 PERCENT (g) | 8.5% 8.3% | 27.6% 21.5% |
|TERMINAL (d) | 3/44 (7%) 4/47 (9%) | 13/43 (30%) 8/41 (20%) |
|FIRST INCIDENCE | 538 728 (T) | 733 (T) 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.607N | P=0.365N |
|POLY 3 | P=0.625N | P=0.327N |
|POLY 1.5 | P=0.631N | P=0.326N |
|POLY 6 | P=0.621N | P=0.324N |
|LOGISTIC REGRESSION| P=0.643 | P=0.339N |
|COCH-ARM / FISHERS | P=0.643N | P=0.318N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 23/50 (46%) | 17/50 (34%) 15/50 (30%) |
|POLY-3 RATE (b) | 14/47.13 23/48.92 | 17/47.55 15/46.61 |
|POLY-3 PERCENT (g) | 29.7% 47.0% | 35.8% 32.2% |
|TERMINAL (d) | 13/44 (30%) 22/47 (47%) | 15/43 (35%) 13/41 (32%) |
|FIRST INCIDENCE | 498 572 | 652 614 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.081 | P=0.477N |
|POLY 3 | P=0.061 | P=0.442N |
|POLY 1.5 | P=0.055 | P=0.433N |
|POLY 6 | P=0.067 | P=0.447N |
|LOGISTIC REGRESSION| P=0.056 | P=0.444N |
|COCH-ARM / FISHERS | P=0.048 * | P=0.415N |
|=================================================================================================================================|
Date: 06/14/01 EXPERIMENT: 56111 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 16/50 (32%) | 24/50 (48%) 22/50 (44%) |
|POLY-3 RATE (b) | 12/47.28 16/49.00 | 24/48.84 22/48.50 |
|POLY-3 PERCENT (g) | 25.4% 32.7% | 49.1% 45.4% |
|TERMINAL (d) | 10/44 (23%) 14/47 (30%) | 20/43 (47%) 15/41 (37%) |
|FIRST INCIDENCE | 538 572 | 429 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327 | P=0.499N |
|POLY 3 | P=0.287 | P=0.433N |
|POLY 1.5 | P=0.275 | P=0.432N |
|POLY 6 | P=0.297 | P=0.424N |
|LOGISTIC REGRESSION| P=0.263 | P=0.397N |
|COCH-ARM / FISHERS | P=0.252 | P=0.421N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD VEHICLE | UNTREATD VEHICLE |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 34/50 (68%) | 33/50 (66%) 29/50 (58%) |
|POLY-3 RATE (b) | 23/47.96 34/49.00 | 33/49.36 29/48.50 |
|POLY-3 PERCENT (g) | 48.0% 69.4% | 66.9% 59.8% |
|TERMINAL (d) | 20/44 (46%) 32/47 (68%) | 27/43 (63%) 22/41 (54%) |
|FIRST INCIDENCE | 498 572 | 429 456 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.060 | P=0.387N |
|POLY 3 | P=0.024 * | P=0.304N |
|POLY 1.5 | P=0.022 * | P=0.293N |
|POLY 6 | P=0.026 * | P=0.311N |
|LOGISTIC REGRESSION| P=0.026 * | P=0.262N |
|COCH-ARM / FISHERS | P=0.021 * | P=0.268N |
|=================================================================================================================================|
(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).