TDMS Study 56111-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02
EXPERIMENT: 56111 TEST: 04 TIME: 10:51:11
TEST TYPE: CHRONIC PAGE: 1
CONT: N01-ES-55384 ROUTE: DOSED FEED NTP C#: 56111B
PATHOLOGIST: MARIT, GARY CAS: 14371-10-9
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25020 Natural Death
25017 Scheduled Sacrifice
25021 Terminal Sacrifice
25007 Wrong Sex
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 UNTREATDCONTROL
INCLUDE 002 UNTREATDCONTROL
INCLUDE 005 .312%
INCLUDE 006 .312%
INCLUDE 007 .625%
INCLUDE 008 .625%
INCLUDE 009 1.25%
INCLUDE 010 1.25%
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02
EXPERIMENT: 56111 TEST: 04 TIME: 10:51:11
TEST TYPE: CHRONIC
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
Heart
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRANS-CINNAMALDEHYDE DATE: 12/11/02
EXPERIMENT: 56111 TEST: 04 TIME: 10:51:11
TEST TYPE: CHRONIC
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
----- ----------
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Skin Hemangioma
All Organs Hemangioma
Hemangiosarcoma or Hemangioma
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/50 (4%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.43 2/48.13 0/44.02 1/49.55 |0/47.03 0/45.42 0/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 2.2% 4.2% 0.0% 2.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/44 (2%) 2/46 (4%) 0/39 (0%) 1/49 (2%) |0/43 (0%) 0/37 (0%) 0/44 (0%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- 728 (T) |--- --- --- 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475N P=0.516 P=0.524N P=0.737N |P=0.207 (e) (e) P=0.500 |
|POLY 3 | P=0.492N P=0.512 P=0.511N P=0.746N |P=0.199 (e) (e) P=0.498 |
|POLY 1.5 | P=0.493N P=0.509 P=0.506N P=0.749N |P=0.198 (e) (e) P=0.498 |
|POLY 6 | P=0.491N P=0.515 P=0.516N P=0.743N |P=0.202 (e) (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.475N P=0.516 (e) P=0.737N |(e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.496N P=0.508 P=0.500N P=0.747N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.376N (e) (e) (e) |P=0.118 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/46.45 3/48.13 1/44.90 2/49.55 |1/47.03 3/45.79 3/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 8.6% 6.2% 2.2% 4.0% |2.1% 6.6% 6.3% 0.0% |
|TERMINAL (d) | 4/44 (9%) 3/46 (7%) 1/39 (3%) 2/49 (4%) |1/43 (2%) 2/37 (5%) 3/44 (7%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 628 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198N P=0.476N P=0.218N P=0.289N |P=0.268N P=0.264 P=0.314 P=0.500N |
|POLY 3 | P=0.212N P=0.481N P=0.189N P=0.308N |P=0.282N P=0.296 P=0.311 P=0.502N |
|POLY 1.5 | P=0.214N P=0.488N P=0.183N P=0.316N |P=0.284N P=0.300 P=0.309 P=0.502N |
|POLY 6 | P=0.211N P=0.477N P=0.199N P=0.302N |P=0.278N P=0.291 P=0.315 P=0.501N |
|LOGISTIC REGRESSION| P=0.198N P=0.476N P=0.218N P=0.289N |P=0.279N P=0.306 P=0.314 (e) |
|COCH-ARM / FISHERS | P=0.221N P=0.500N P=0.181N P=0.339N |P=0.279N P=0.309 P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.181N (e) (e) (e) |P=0.157N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 1/48.13 0/44.90 0/49.55 |1/47.03 1/45.42 2/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 0.0% |2.1% 2.2% 4.2% 0.0% |
|TERMINAL (d) | 0/44 (0%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |1/43 (2%) 1/37 (3%) 2/44 (5%) 0/43 (0%) |
|FIRST INCIDENCE | --- 728 (T) --- --- |733 (T) 733 (T) 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.553N P=0.509 (e) (e) |P=0.353N P=0.728 P=0.508 P=0.500N |
|POLY 3 | P=0.562N P=0.507 (e) (e) |P=0.367N P=0.753 P=0.506 P=0.502N |
|POLY 1.5 | P=0.563N P=0.505 (e) (e) |P=0.369N P=0.756 P=0.503 P=0.502N |
|POLY 6 | P=0.561N P=0.509 (e) (e) |P=0.362N P=0.749 P=0.509 P=0.501N |
|LOGISTIC REGRESSION| (e) P=0.509 (e) (e) |P=0.353N P=0.728 P=0.508 (e) |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.366N P=0.753N P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.376N (e) (e) (e) |P=0.272N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |2/50 (4%) 4/50 (8%) 5/50 (10%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/46.45 3/48.13 1/44.90 2/49.55 |2/47.03 4/45.79 5/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 8.6% 6.2% 2.2% 4.0% |4.3% 8.7% 10.5% 0.0% |
|TERMINAL (d) | 4/44 (9%) 3/46 (7%) 1/39 (3%) 2/49 (4%) |2/43 (5%) 3/37 (8%) 5/44 (11%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 728 (T) 728 (T) |733 (T) 628 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198N P=0.476N P=0.218N P=0.289N |P=0.174N P=0.280 P=0.226 P=0.238N |
|POLY 3 | P=0.212N P=0.481N P=0.189N P=0.308N |P=0.188N P=0.325 P=0.223 P=0.240N |
|POLY 1.5 | P=0.214N P=0.488N P=0.183N P=0.316N |P=0.190N P=0.330 P=0.221 P=0.240N |
|POLY 6 | P=0.211N P=0.477N P=0.199N P=0.302N |P=0.182N P=0.319 P=0.227 P=0.238N |
|LOGISTIC REGRESSION| P=0.198N P=0.476N P=0.218N P=0.289N |P=0.184N P=0.328 P=0.226 (e) |
|COCH-ARM / FISHERS | P=0.221N P=0.500N P=0.181N P=0.339N |P=0.186N P=0.339 P=0.218 P=0.247N |
|ORDER RESTRICTED | P=0.181N (e) (e) (e) |P=0.079N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) 5/50 (10%) 4/50 (8%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/47.13 5/48.13 5/46.06 4/49.55 |4/47.03 4/45.52 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 10.6% 10.4% 10.9% 8.1% |8.5% 8.8% 4.2% 2.2% |
|TERMINAL (d) | 4/44 (9%) 5/46 (11%) 3/39 (8%) 4/49 (8%) |4/43 (9%) 3/37 (8%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 498 728 (T) 498 728 (T) |733 (T) 708 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.603N P=0.574 P=0.438N |P=0.087N P=0.564 P=0.326N P=0.180N |
|POLY 3 | P=0.392N P=0.617N P=0.615 P=0.469N |P=0.095N P=0.625 P=0.330N P=0.182N |
|POLY 1.5 | P=0.398N P=0.621N P=0.626 P=0.476N |P=0.096N P=0.632 P=0.333N P=0.183N |
|POLY 6 | P=0.387N P=0.615N P=0.601 P=0.463N |P=0.092N P=0.616 P=0.325N P=0.180N |
|LOGISTIC REGRESSION| P=0.444N P=0.630N P=0.628 P=0.530N |P=0.087N P=0.603 P=0.326N P=0.180N |
|COCH-ARM / FISHERS | P=0.419N P=0.630N P=0.630N P=0.500N |P=0.095N P=0.643N P=0.339N P=0.181N |
|ORDER RESTRICTED | P=0.532N (e) (e) (e) |P=0.141N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 4/50 (8%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/47.28 7/48.13 4/46.06 3/49.55 |1/47.03 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 12.7% 14.5% 8.7% 6.1% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/44 (9%) 7/46 (15%) 2/39 (5%) 3/49 (6%) |1/43 (2%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 538 728 (T) 498 728 (T) |733 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.114N P=0.532 P=0.429N P=0.202N |P=0.301N P=0.530N P=0.495N P=0.500N |
|POLY 3 | P=0.118N P=0.514 P=0.386N P=0.220N |P=0.301N P=0.507N P=0.497N P=0.502N |
|POLY 1.5 | P=0.121N P=0.510 P=0.375N P=0.225N |P=0.302N P=0.504N P=0.498N P=0.502N |
|POLY 6 | P=0.117N P=0.512 P=0.404N P=0.218N |P=0.299N P=0.511N P=0.495N P=0.501N |
|LOGISTIC REGRESSION| P=0.143N P=0.504 P=0.372N P=0.266N |P=0.301N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.132N P=0.500 P=0.370N P=0.243N |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.172N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 7/50 (14%) 7/50 (14%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 10/47.96 12/48.13 7/46.06 7/49.55 |4/47.03 4/45.52 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 20.9% 24.9% 15.2% 14.1% |8.5% 8.8% 4.2% 2.2% |
|TERMINAL (d) | 7/44 (16%) 12/46 (26%) 5/39 (13%) 7/49 (14%) |4/43 (9%) 3/37 (8%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 498 728 (T) 498 728 (T) |733 (T) 708 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.450 P=0.379N P=0.232N |P=0.087N P=0.564 P=0.326N P=0.180N |
|POLY 3 | P=0.144N P=0.408 P=0.329N P=0.273N |P=0.095N P=0.625 P=0.330N P=0.182N |
|POLY 1.5 | P=0.145N P=0.408 P=0.311N P=0.276N |P=0.096N P=0.632 P=0.333N P=0.183N |
|POLY 6 | P=0.144N P=0.402 P=0.356N P=0.273N |P=0.092N P=0.616 P=0.325N P=0.180N |
|LOGISTIC REGRESSION| P=0.164N P=0.407 P=0.295N P=0.343N |P=0.087N P=0.603 P=0.326N P=0.180N |
|COCH-ARM / FISHERS | P=0.160N P=0.405 P=0.298N P=0.298N |P=0.095N P=0.643N P=0.339N P=0.181N |
|ORDER RESTRICTED | P=0.208N (e) (e) (e) |P=0.141N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 12/50 (24%) 7/50 (14%) 7/50 (14%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 10/47.96 12/48.13 7/46.06 7/49.55 |4/47.03 4/45.52 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 20.9% 24.9% 15.2% 14.1% |8.5% 8.8% 4.2% 2.2% |
|TERMINAL (d) | 7/44 (16%) 12/46 (26%) 5/39 (13%) 7/49 (14%) |4/43 (9%) 3/37 (8%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 498 728 (T) 498 728 (T) |733 (T) 708 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.126N P=0.450 P=0.379N P=0.232N |P=0.087N P=0.564 P=0.326N P=0.180N |
|POLY 3 | P=0.144N P=0.408 P=0.329N P=0.273N |P=0.095N P=0.625 P=0.330N P=0.182N |
|POLY 1.5 | P=0.145N P=0.408 P=0.311N P=0.276N |P=0.096N P=0.632 P=0.333N P=0.183N |
|POLY 6 | P=0.144N P=0.402 P=0.356N P=0.273N |P=0.092N P=0.616 P=0.325N P=0.180N |
|LOGISTIC REGRESSION| P=0.164N P=0.407 P=0.295N P=0.343N |P=0.087N P=0.603 P=0.326N P=0.180N |
|COCH-ARM / FISHERS | P=0.160N P=0.405 P=0.298N P=0.298N |P=0.095N P=0.643N P=0.339N P=0.181N |
|ORDER RESTRICTED | P=0.208N (e) (e) (e) |P=0.141N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/50 (14%) 2/50 (4%) 7/50 (14%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/46.45 7/48.44 2/45.02 7/49.55 |1/47.03 1/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 6.5% 14.5% 4.4% 14.1% |2.1% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 3/44 (7%) 6/46 (13%) 1/39 (3%) 7/49 (14%) |1/43 (2%) 1/37 (3%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 644 699 728 (T) |733 (T) 733 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.271 P=0.180 P=0.550N P=0.206 |P=0.230N P=0.728 P=0.495N P=0.500N |
|POLY 3 | P=0.245 P=0.176 P=0.514N P=0.186 |P=0.235N P=0.753 P=0.497N P=0.502N |
|POLY 1.5 | P=0.238 P=0.169 P=0.505N P=0.178 |P=0.236N P=0.756 P=0.498N P=0.502N |
|POLY 6 | P=0.249 P=0.181 P=0.527N P=0.192 |P=0.235N P=0.749 P=0.495N P=0.501N |
|LOGISTIC REGRESSION| P=0.248 P=0.168 P=0.528N P=0.206 |P=0.230N P=0.728 (e) (e) |
|COCH-ARM / FISHERS | P=0.220 P=0.159 P=0.500N P=0.159 |P=0.235N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.160 (e) (e) (e) |P=0.247N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 6/50 (12%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.45 1/48.13 2/45.30 6/50.00 |2/47.03 2/45.44 1/48.34 1/46.74 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 4.4% 12.0% |4.3% 4.4% 2.1% 2.1% |
|TERMINAL (d) | 2/44 (5%) 1/46 (2%) 0/39 (0%) 5/49 (10%) |2/43 (5%) 1/37 (3%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 728 (T) 652 596 |733 (T) 728 568 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * P=0.484N P=0.658 P=0.173 |P=0.324N P=0.641 P=0.492N P=0.495N |
|POLY 3 | P=0.037 * P=0.488N P=0.685 P=0.159 |P=0.335N P=0.681 P=0.490N P=0.502N |
|POLY 1.5 | P=0.036 * P=0.492N P=0.691 P=0.152 |P=0.338N P=0.686 P=0.495N P=0.504N |
|POLY 6 | P=0.038 * P=0.485N P=0.677 P=0.166 |P=0.330N P=0.675 P=0.485N P=0.498N |
|LOGISTIC REGRESSION| P=0.032 * P=0.484N P=0.694 P=0.129 |P=0.329N P=0.663 P=0.515N P=0.502N |
|COCH-ARM / FISHERS | P=0.033 * P=0.500N P=0.691N P=0.134 |P=0.337N P=0.691N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.042 * (e) (e) (e) |P=0.430N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 3/50 (6%) 13/50 (26%) |3/50 (6%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/46.45 8/48.44 3/45.30 13/50.00 |3/47.03 3/45.44 1/48.34 1/46.74 |
|POLY-3 PERCENT (g) | 8.6% 16.5% 6.6% 26.0% |6.4% 6.6% 2.1% 2.1% |
|TERMINAL (d) | 4/44 (9%) 7/46 (15%) 1/39 (3%) 12/49 (25%) |3/43 (7%) 2/37 (5%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) 644 652 596 |733 (T) 728 568 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.026 * P=0.202 P=0.557N P=0.030 * |P=0.157N P=0.593 P=0.299N P=0.303N |
|POLY 3 | P=0.016 * P=0.199 P=0.514N P=0.023 * |P=0.163N P=0.646 P=0.296N P=0.308N |
|POLY 1.5 | P=0.015 * P=0.191 P=0.504N P=0.020 * |P=0.165N P=0.652 P=0.300N P=0.309N |
|POLY 6 | P=0.017 * P=0.205 P=0.526N P=0.025 * |P=0.159N P=0.638 P=0.290N P=0.303N |
|LOGISTIC REGRESSION| P=0.017 * P=0.191 P=0.513N P=0.020 * |P=0.163N P=0.619 P=0.315N P=0.308N |
|COCH-ARM / FISHERS | P=0.014 * P=0.178 P=0.500N P=0.016 * |P=0.164N P=0.661N P=0.309N P=0.309N |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) |P=0.234N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 0/48.13 0/44.90 0/49.55 |0/47.03 0/45.42 2/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/43 (0%) 0/37 (0%) 2/44 (5%) 0/43 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.604 (e) P=0.244 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.593 (e) P=0.241 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.590 (e) P=0.239 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.600 (e) P=0.243 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.244 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.251 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 2/50 (4%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/47.25 2/45.52 1/46.83 1/46.54 |
|POLY-3 PERCENT (g) | |4.2% 4.4% 2.1% 2.2% |
|TERMINAL (d) | |1/43 (2%) 1/37 (3%) 1/44 (2%) 1/43 (2%) |
|FIRST INCIDENCE | |675 708 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.322N P=0.650 P=0.490N P=0.497N |
|POLY 3 | |P=0.339N P=0.680 P=0.503N P=0.505N |
|POLY 1.5 | |P=0.341N P=0.686 P=0.505N P=0.505N |
|POLY 6 | |P=0.336N P=0.673 P=0.501N P=0.504N |
|LOGISTIC REGRESSION| |P=0.338N P=0.692 P=0.509N P=0.502N |
|COCH-ARM / FISHERS | |P=0.338N P=0.691N P=0.508N P=0.500N |
|ORDER RESTRICTED | |P=0.438N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |5/48 (10%) 1/50 (2%) 4/49 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.05 0/47.13 0/44.90 0/48.55 |5/45.70 1/45.94 4/46.80 2/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.9% 2.2% 8.6% 4.3% |
|TERMINAL (d) | 0/43 (0%) 0/45 (0%) 0/39 (0%) 0/48 (0%) |4/42 (10%) 0/37 (0%) 4/43 (9%) 2/43 (5%) |
|FIRST INCIDENCE | --- --- --- --- |652 575 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.253N P=0.130N P=0.487N P=0.212N |
|POLY 3 | (e) (e) (e) (e) |P=0.259N P=0.100N P=0.485N P=0.209N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.262N P=0.097N P=0.486N P=0.208N |
|POLY 6 | (e) (e) (e) (e) |P=0.254N P=0.105N P=0.485N P=0.209N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.261N P=0.083N P=0.482N P=0.205N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.260N P=0.093N P=0.487N P=0.201N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.151N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 0/48.13 0/44.90 0/49.55 |2/47.03 3/45.66 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.3% 6.6% 0.0% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |2/43 (5%) 2/37 (5%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- --- --- --- |733 (T) 668 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.070N P=0.442 P=0.233N P=0.238N |
|POLY 3 | (e) (e) (e) (e) |P=0.072N P=0.487 P=0.234N P=0.240N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.072N P=0.492 P=0.235N P=0.240N |
|POLY 6 | (e) (e) (e) (e) |P=0.071N P=0.480 P=0.232N P=0.238N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.073N P=0.485 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.073N P=0.500 P=0.247N P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.078N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 0/48.13 0/44.90 0/49.55 |0/47.03 0/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/44 (5%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/43 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.229N P=0.265N P=0.215N |(e) (e) (e) (e) |
|POLY 3 | P=0.119N P=0.229N P=0.245N P=0.223N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.117N P=0.232N P=0.240N P=0.227N |(e) (e) (e) (e) |
|POLY 6 | P=0.121N P=0.228N P=0.252N P=0.220N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.113N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.025N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |0/48 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.45 1/48.13 0/44.51 0/49.55 |0/45.75 0/45.42 2/47.80 1/46.54 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 0.0% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 1/44 (2%) 1/46 (2%) 0/39 (0%) 0/49 (0%) |0/43 (0%) 0/37 (0%) 2/44 (5%) 1/43 (2%) |
|FIRST INCIDENCE | 728 (T) 728 (T) --- --- |--- --- 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228N P=0.752N P=0.524N P=0.479N |P=0.259 (e) P=0.244 P=0.500 |
|POLY 3 | P=0.236N P=0.753N P=0.508N P=0.487N |P=0.248 (e) P=0.247 P=0.503 |
|POLY 1.5 | P=0.236N P=0.755N P=0.505N P=0.491N |P=0.247 (e) P=0.247 P=0.504 |
|POLY 6 | P=0.236N P=0.751N P=0.513N P=0.484N |P=0.251 (e) P=0.247 P=0.503 |
|LOGISTIC REGRESSION| P=0.228N P=0.752N (e) (e) |(e) (e) P=0.244 P=0.500 |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.505N P=0.500N |P=0.252 (e) P=0.258 P=0.510 |
|ORDER RESTRICTED | P=0.239N (e) (e) (e) |P=0.176 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 0/48.13 2/45.01 1/49.55 |1/47.03 0/45.42 4/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 2.0% |2.1% 0.0% 8.4% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 1/39 (3%) 1/49 (2%) |1/43 (2%) 0/37 (0%) 4/44 (9%) 0/43 (0%) |
|FIRST INCIDENCE | --- --- 702 728 (T) |733 (T) --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.270 (e) P=0.216 P=0.521 |P=0.513N P=0.530N P=0.187 P=0.500N |
|POLY 3 | P=0.268 (e) P=0.230 P=0.513 |P=0.530N P=0.507N P=0.184 P=0.502N |
|POLY 1.5 | P=0.262 (e) P=0.235 P=0.509 |P=0.534N P=0.504N P=0.182 P=0.502N |
|POLY 6 | P=0.274 (e) P=0.224 P=0.516 |P=0.521N P=0.511N P=0.187 P=0.501N |
|LOGISTIC REGRESSION| P=0.256 (e) P=0.230 P=0.521 |P=0.513N (e) P=0.187 (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.531N P=0.500N P=0.181 P=0.500N |
|ORDER RESTRICTED | P=0.163 (e) (e) (e) |P=0.219N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 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 .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 0/48.13 1/44.90 1/49.55 |1/47.03 0/45.42 3/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 2.0% |2.1% 0.0% 6.3% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 1/39 (3%) 1/49 (2%) |1/43 (2%) 0/37 (0%) 3/44 (7%) 0/43 (0%) |
|FIRST INCIDENCE | --- --- 728 (T) 728 (T) |733 (T) --- 733 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256 (e) P=0.476 P=0.521 |P=0.485N P=0.530N P=0.314 P=0.500N |
|POLY 3 | P=0.253 (e) P=0.493 P=0.513 |P=0.498N P=0.507N P=0.311 P=0.502N |
|POLY 1.5 | P=0.249 (e) P=0.497 P=0.509 |P=0.502N P=0.504N P=0.309 P=0.502N |
|POLY 6 | P=0.257 (e) P=0.487 P=0.516 |P=0.491N P=0.511N P=0.315 P=0.501N |
|LOGISTIC REGRESSION| (e) (e) P=0.476 P=0.521 |P=0.485N (e) P=0.314 (e) |
|COCH-ARM / FISHERS | P=0.235 (e) P=0.500 P=0.500 |P=0.500N P=0.500N P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.246 (e) (e) (e) |P=0.268N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.45 0/48.13 0/44.90 0/49.55 |2/47.03 1/45.42 0/47.80 0/46.54 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |4.3% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/44 (5%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |2/43 (5%) 1/37 (3%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | 728 (T) --- --- --- |733 (T) 733 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113N P=0.229N P=0.265N P=0.215N |P=0.097N P=0.552N P=0.233N P=0.238N |
|POLY 3 | P=0.119N P=0.229N P=0.245N P=0.223N |P=0.099N P=0.512N P=0.234N P=0.240N |
|POLY 1.5 | P=0.117N P=0.232N P=0.240N P=0.227N |P=0.100N P=0.507N P=0.235N P=0.240N |
|POLY 6 | P=0.121N P=0.228N P=0.252N P=0.220N |P=0.098N P=0.519N P=0.232N P=0.238N |
|LOGISTIC REGRESSION| P=0.113N (e) (e) (e) |P=0.097N P=0.552N (e) (e) |
|COCH-ARM / FISHERS | P=0.115N P=0.247N P=0.247N P=0.247N |P=0.101N P=0.500N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.025N* (e) (e) (e) |P=0.076N (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 EXPERIMENT: 56111 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.45 2/48.44 1/44.90 0/49.55 |0/47.03 0/45.42 3/47.80 2/46.54 |
|POLY-3 PERCENT (g) | 2.2% 4.1% 2.2% 0.0% |0.0% 0.0% 6.3% 4.3% |
|TERMINAL (d) | 1/44 (2%) 1/46 (2%) 1/39 (3%) 0/49 (0%) |0/43 (0%) 0/37 (0%) 3/44 (7%) 2/43 (5%) |
|FIRST INCIDENCE | 728 (T) 644 728 (T) --- |--- --- 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.236N P=0.515 P=0.735 P=0.479N |P=0.107 (e) P=0.125 P=0.238 |
|POLY 3 | P=0.234N P=0.515 P=0.753 P=0.487N |P=0.095 (e) P=0.122 P=0.235 |
|POLY 1.5 | P=0.238N P=0.509 P=0.758 P=0.491N |P=0.094 (e) P=0.121 P=0.235 |
|POLY 6 | P=0.232N P=0.519 P=0.746 P=0.484N |P=0.099 (e) P=0.124 P=0.237 |
|LOGISTIC REGRESSION| P=0.246N P=0.499 P=0.735 (e) |(e) (e) P=0.125 P=0.238 |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |P=0.096 (e) P=0.121 P=0.247 |
|ORDER RESTRICTED | P=0.221N (e) (e) (e) |P=0.083 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/46.45 2/48.44 1/44.90 0/49.55 |2/47.03 1/45.42 3/47.80 2/46.54 |
|POLY-3 PERCENT (g) | 6.5% 4.1% 2.2% 0.0% |4.3% 2.2% 6.3% 4.3% |
|TERMINAL (d) | 3/44 (7%) 1/46 (2%) 1/39 (3%) 0/49 (0%) |2/43 (5%) 1/37 (3%) 3/44 (7%) 2/43 (5%) |
|FIRST INCIDENCE | 728 (T) 644 728 (T) --- |733 (T) 733 (T) 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.059N P=0.480N P=0.349N P=0.103N |P=0.522 P=0.552N P=0.511 P=0.695 |
|POLY 3 | P=0.058N P=0.481N P=0.318N P=0.108N |P=0.502 P=0.512N P=0.507 P=0.690 |
|POLY 1.5 | P=0.059N P=0.488N P=0.310N P=0.111N |P=0.498 P=0.507N P=0.504 P=0.689 |
|POLY 6 | P=0.058N P=0.476N P=0.328N P=0.106N |P=0.510 P=0.519N P=0.512 P=0.693 |
|LOGISTIC REGRESSION| P=0.059N P=0.496N P=0.349N (e) |P=0.522 P=0.552N P=0.511 P=0.695 |
|COCH-ARM / FISHERS | P=0.062N P=0.500N P=0.309N P=0.121N |P=0.500 P=0.500N P=0.500 P=0.691N |
|ORDER RESTRICTED | P=0.049N* (e) (e) (e) |P=0.493 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 EXPERIMENT: 56111 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.45 1/48.24 2/45.72 0/49.55 |0/47.03 1/45.98 1/48.13 0/46.54 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 4.4% 0.0% |0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 0/44 (0%) 0/46 (0%) 0/39 (0%) 0/49 (0%) |0/43 (0%) 0/37 (0%) 0/44 (0%) 0/43 (0%) |
|FIRST INCIDENCE | --- 701 566 --- |--- 558 642 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.597N P=0.513 P=0.230 (e) |P=0.595N P=0.500 P=0.504 (e) |
|POLY 3 | P=0.592N P=0.508 P=0.234 (e) |P=0.597N P=0.495 P=0.505 (e) |
|POLY 1.5 | P=0.598N P=0.505 P=0.237 (e) |P=0.597N P=0.497 P=0.503 (e) |
|POLY 6 | P=0.586N P=0.509 P=0.230 (e) |P=0.594N P=0.493 P=0.507 (e) |
|LOGISTIC REGRESSION| P=0.642 P=0.499 P=0.209 (e) |P=0.516N P=0.588 P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.616N P=0.500 P=0.247 (e) |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.316N (e) (e) (e) |P=0.401 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |13/50 (26%) 6/50 (12%) 8/50 (16%) 14/50 (28%) |
|POLY-3 RATE (b) | 4/47.05 1/48.13 2/45.73 2/49.55 |13/47.03 6/45.46 8/49.11 14/47.59 |
|POLY-3 PERCENT (g) | 8.5% 2.1% 4.4% 4.0% |27.6% 13.2% 16.3% 29.4% |
|TERMINAL (d) | 3/44 (7%) 1/46 (2%) 0/39 (0%) 2/49 (4%) |13/43 (30%) 5/37 (14%) 5/44 (11%) 11/43 (26%) |
|FIRST INCIDENCE | 538 728 (T) 561 728 (T) |733 (T) 723 425 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.318N P=0.169N P=0.375N P=0.294N |P=0.315 P=0.118N P=0.154N P=0.500 |
|POLY 3 | P=0.335N P=0.172N P=0.351N P=0.314N |P=0.292 P=0.070N P=0.135N P=0.514 |
|POLY 1.5 | P=0.336N P=0.175N P=0.342N P=0.320N |P=0.277 P=0.067N P=0.146N P=0.500 |
|POLY 6 | P=0.333N P=0.172N P=0.362N P=0.310N |P=0.317 P=0.075N P=0.123N P=0.538 |
|LOGISTIC REGRESSION| P=0.381N P=0.183N P=0.344N P=0.369N |P=0.265 P=0.093N P=0.167N P=0.488 |
|COCH-ARM / FISHERS | P=0.343N P=0.181N P=0.339N P=0.339N |P=0.267 P=0.062N P=0.163N P=0.500 |
|ORDER RESTRICTED | P=0.190N (e) (e) (e) |P=0.169 (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 EXPERIMENT: 56111 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 16/50 (32%) 9/50 (18%) 15/50 (30%) |17/50 (34%) 10/50 (20%) 14/50 (28%) 7/50 (14%) |
|POLY-3 RATE (b) | 14/47.13 16/48.44 9/46.17 15/49.55 |17/47.55 10/46.96 14/47.80 7/46.54 |
|POLY-3 PERCENT (g) | 29.7% 33.0% 19.5% 30.3% |35.8% 21.3% 29.3% 15.0% |
|TERMINAL (d) | 13/44 (30%) 15/46 (33%) 6/39 (15%) 15/49 (31%) |15/43 (35%) 6/37 (16%) 14/44 (32%) 7/43 (16%) |
|FIRST INCIDENCE | 498 644 498 728 (T) |652 558 733 (T) 733 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419N P=0.470 P=0.258N P=0.541N |P=0.023N* P=0.178N P=0.306N P=0.018N* |
|POLY 3 | P=0.477N P=0.449 P=0.183N P=0.563 |P=0.029N* P=0.090N P=0.325N P=0.017N* |
|POLY 1.5 | P=0.485N P=0.435 P=0.173N P=0.548 |P=0.030N* P=0.089N P=0.328N P=0.017N* |
|POLY 6 | P=0.471N P=0.458 P=0.198N P=0.575 |P=0.028N* P=0.093N P=0.323N P=0.017N* |
|LOGISTIC REGRESSION| P=0.487N P=0.439 P=0.172N P=0.552 |P=0.028N* P=0.090N P=0.300N P=0.017N* |
|COCH-ARM / FISHERS | P=0.521N P=0.414 P=0.171N P=0.500 |P=0.029N* P=0.088N P=0.333N P=0.017N* |
|ORDER RESTRICTED | P=0.389N (e) (e) (e) |P=0.013N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 14/50 (28%) 11/50 (22%) 12/50 (24%) |24/50 (48%) 13/50 (26%) 16/50 (32%) 16/50 (32%) |
|POLY-3 RATE (b) | 12/47.28 14/48.54 11/47.91 12/50.00 |24/48.84 13/46.65 16/50.00 16/47.79 |
|POLY-3 PERCENT (g) | 25.4% 28.8% 23.0% 24.0% |49.1% 27.9% 32.0% 33.5% |
|TERMINAL (d) | 10/44 (23%) 12/46 (26%) 3/39 (8%) 11/49 (22%) |20/43 (47%) 8/37 (22%) 10/44 (23%) 12/43 (28%) |
|FIRST INCIDENCE | 538 644 498 596 |429 558 425 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.383N P=0.463 P=0.584 P=0.479N |P=0.131N P=0.072N P=0.087N P=0.096N |
|POLY 3 | P=0.408N P=0.440 P=0.486N P=0.531N |P=0.133N P=0.025N* P=0.062N P=0.086N |
|POLY 1.5 | P=0.421N P=0.430 P=0.485N P=0.546N |P=0.140N P=0.022N* P=0.067N P=0.086N |
|POLY 6 | P=0.399N P=0.446 P=0.488N P=0.520N |P=0.121N P=0.029N* P=0.055N P=0.083N |
|LOGISTIC REGRESSION| P=0.499N P=0.425 P=0.495N P=0.593 |P=0.134N P=0.018N* P=0.089N P=0.075N |
|COCH-ARM / FISHERS | P=0.467N P=0.410 P=0.500N P=0.592N |P=0.140N P=0.019N* P=0.076N P=0.076N |
|ORDER RESTRICTED | P=0.534N (e) (e) (e) |P=0.044N* (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/02 EXPERIMENT: 56111 TEST: 04 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRANS-CINNAMALDEHYDE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | UNTREATD .312% .625% 1.25% |UNTREATD .312% .625% 1.25% |
| | CONTROL |CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 27/50 (54%) 17/50 (34%) 22/50 (44%) |33/50 (66%) 21/50 (42%) 24/50 (48%) 21/50 (42%) |
|POLY-3 RATE (b) | 23/47.96 27/48.54 17/47.91 22/50.00 |33/49.36 21/47.27 24/50.00 21/47.79 |
|POLY-3 PERCENT (g) | 48.0% 55.6% 35.5% 44.0% |66.9% 44.4% 48.0% 43.9% |
|TERMINAL (d) | 20/44 (46%) 25/46 (54%) 9/39 (23%) 21/49 (43%) |27/43 (63%) 14/37 (38%) 18/44 (41%) 17/43 (40%) |
|FIRST INCIDENCE | 498 644 498 596 |429 558 425 568 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.197N P=0.359 P=0.290N P=0.327N |P=0.036N* P=0.095N P=0.069N P=0.026N* |
|POLY 3 | P=0.231N P=0.292 P=0.151N P=0.425N |P=0.034N* P=0.019N* P=0.043N* P=0.017N* |
|POLY 1.5 | P=0.241N P=0.286 P=0.146N P=0.440N |P=0.035N* P=0.016N* P=0.046N* P=0.016N* |
|POLY 6 | P=0.224N P=0.292 P=0.158N P=0.416N |P=0.031N* P=0.025N* P=0.041N* P=0.018N* |
|LOGISTIC REGRESSION| P=0.275N P=0.300 P=0.152N P=0.480N |P=0.032N* P=0.014N* P=0.061N P=0.014N* |
|COCH-ARM / FISHERS | P=0.290N P=0.274 P=0.154N P=0.500N |P=0.033N* P=0.013N* P=0.053N P=0.013N* |
|ORDER RESTRICTED | P=0.179N (e) (e) (e) |P=0.014N* (e) (e) (e) |
|=================================================================================================================================|
(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).