TDMS Study 93005-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR MALACHITE GREEN DATE: 06/19/03
EXPERIMENT: 93005 TEST: 04 TIME: 07:21:51
TEST TYPE: CHRONIC PAGE: 1
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93005
PATHOLOGIST: TROTTER, RONALD CAS: 569-64-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR MALACHITE GREEN DATE: 06/19/03
EXPERIMENT: 93005 TEST: 04 TIME: 07:21:51
TEST TYPE: CHRONIC
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93005
PATHOLOGIST: TROTTER, RONALD CAS: 569-64-2
Mice(C57BL/6NXC3H/HEN MTN-NCTR)
-----------------------------
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
Islets, Pancreatic
Liver
Lung
Ovary
Pituitary Gland
Spleen
Thyroid Gland
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 2/46 (4%) 1/44 (2%) 1/46 (2%) |
|POLY-3 RATE (b) | 0/44.14 2/45.38 1/41.40 1/43.08 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.4% 2.3% |
|TERMINAL (d) | 0/39 (0%) 2/43 (5%) 1/39 (3%) 1/39 (3%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.504 P=0.260 P=0.500 P=0.500 |
|POLY 3 | P=0.507 P=0.243 P=0.487 P=0.495 |
|POLY 1.5 | P=0.503 P=0.239 P=0.486 P=0.494 |
|POLY 6 | P=0.513 P=0.249 P=0.490 P=0.498 |
|LOGISTIC REGRESSION| (e) P=0.260 P=0.500 P=0.500 |
|COCH-ARM / FISHERS | P=0.508 P=0.242 P=0.484 P=0.495 |
|ORDER RESTRICTED | P=0.269 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/48 (6%) 0/48 (0%) 2/48 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 3/45.14 0/46.93 2/43.58 3/45.08 |
|POLY-3 PERCENT (g) | 6.7% 0.0% 4.6% 6.7% |
|TERMINAL (d) | 3/40 (8%) 0/44 (0%) 2/40 (5%) 3/41 (7%) |
|FIRST INCIDENCE | 727 (T) --- 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379 P=0.105N P=0.500N P=0.652N |
|POLY 3 | P=0.370 P=0.112N P=0.516N P=0.662 |
|POLY 1.5 | P=0.372 P=0.114N P=0.515N P=0.658 |
|POLY 6 | P=0.371 P=0.109N P=0.512N P=0.657N |
|LOGISTIC REGRESSION| P=0.379 (e) P=0.500N P=0.652N |
|COCH-ARM / FISHERS | P=0.384 P=0.121N P=0.500N P=0.661N |
|ORDER RESTRICTED | P=0.345 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 2/48 (4%) 2/46 (4%) 2/48 (4%) |
|POLY-3 RATE (b) | 3/45.14 2/46.93 2/43.32 2/45.08 |
|POLY-3 PERCENT (g) | 6.7% 4.3% 4.6% 4.4% |
|TERMINAL (d) | 3/40 (8%) 2/44 (5%) 2/40 (5%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.439N P=0.456N P=0.500N P=0.489N |
|POLY 3 | P=0.446N P=0.482N P=0.519N P=0.501N |
|POLY 1.5 | P=0.446N P=0.489N P=0.522N P=0.504N |
|POLY 6 | P=0.443N P=0.475N P=0.513N P=0.494N |
|LOGISTIC REGRESSION| P=0.439N P=0.456N P=0.500N P=0.489N |
|COCH-ARM / FISHERS | P=0.437N P=0.500N P=0.520N P=0.500N |
|ORDER RESTRICTED | P=0.498N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/48 (2%) 2/48 (4%) 0/46 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 1/45.14 2/47.23 0/43.32 1/45.08 |
|POLY-3 PERCENT (g) | 2.2% 4.2% 0.0% 2.2% |
|TERMINAL (d) | 1/40 (3%) 1/44 (2%) 0/40 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 644 --- 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.491N P=0.527 P=0.500N P=0.756N |
|POLY 3 | P=0.487N P=0.516 P=0.508N P=0.760 |
|POLY 1.5 | P=0.489N P=0.510 P=0.509N P=0.758 |
|POLY 6 | P=0.484N P=0.523 P=0.506N P=0.758N |
|LOGISTIC REGRESSION| P=0.485N P=0.466 (e) P=0.756N |
|COCH-ARM / FISHERS | P=0.487N P=0.500 P=0.511N P=0.753N |
|ORDER RESTRICTED | P=0.395N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 4/48 (8%) 2/46 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 3/45.14 4/47.23 2/43.32 3/45.08 |
|POLY-3 PERCENT (g) | 6.7% 8.5% 4.6% 6.7% |
|TERMINAL (d) | 3/40 (8%) 3/44 (7%) 2/40 (5%) 3/41 (7%) |
|FIRST INCIDENCE | 727 (T) 644 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499N P=0.548 P=0.500N P=0.652N |
|POLY 3 | P=0.501N P=0.525 P=0.519N P=0.662 |
|POLY 1.5 | P=0.503N P=0.515 P=0.522N P=0.658 |
|POLY 6 | P=0.497N P=0.536 P=0.513N P=0.657N |
|LOGISTIC REGRESSION| P=0.501N P=0.503 P=0.500N P=0.652N |
|COCH-ARM / FISHERS | P=0.494N P=0.500 P=0.520N P=0.661N |
|ORDER RESTRICTED | P=0.561N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/48 (6%) 4/48 (8%) 2/46 (4%) 3/48 (6%) |
|POLY-3 RATE (b) | 3/45.14 4/47.23 2/43.32 3/45.08 |
|POLY-3 PERCENT (g) | 6.7% 8.5% 4.6% 6.7% |
|TERMINAL (d) | 3/40 (8%) 3/44 (7%) 2/40 (5%) 3/41 (7%) |
|FIRST INCIDENCE | 727 (T) 644 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.499N P=0.548 P=0.500N P=0.652N |
|POLY 3 | P=0.501N P=0.525 P=0.519N P=0.662 |
|POLY 1.5 | P=0.503N P=0.515 P=0.522N P=0.658 |
|POLY 6 | P=0.497N P=0.536 P=0.513N P=0.657N |
|LOGISTIC REGRESSION| P=0.501N P=0.503 P=0.500N P=0.652N |
|COCH-ARM / FISHERS | P=0.494N P=0.500 P=0.520N P=0.661N |
|ORDER RESTRICTED | P=0.561N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 4/48 (8%) 3/48 (6%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/45.14 4/46.93 3/43.58 0/45.08 |
|POLY-3 PERCENT (g) | 4.4% 8.5% 6.9% 0.0% |
|TERMINAL (d) | 2/40 (5%) 4/44 (9%) 3/40 (8%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.131N P=0.382 P=0.500 P=0.233N |
|POLY 3 | P=0.132N P=0.355 P=0.484 P=0.237N |
|POLY 1.5 | P=0.133N P=0.349 P=0.485 P=0.239N |
|POLY 6 | P=0.128N P=0.363 P=0.488 P=0.234N |
|LOGISTIC REGRESSION| P=0.131N P=0.382 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.129N P=0.339 P=0.500 P=0.247N |
|ORDER RESTRICTED | P=0.112N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/48 (4%) 5/48 (10%) 4/48 (8%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/45.14 5/46.93 4/43.58 0/45.08 |
|POLY-3 PERCENT (g) | 4.4% 10.7% 9.2% 0.0% |
|TERMINAL (d) | 2/40 (5%) 5/44 (11%) 4/40 (10%) 0/41 (0%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128N P=0.256 P=0.337 P=0.233N |
|POLY 3 | P=0.128N P=0.232 P=0.321 P=0.237N |
|POLY 1.5 | P=0.130N P=0.227 P=0.323 P=0.239N |
|POLY 6 | P=0.123N P=0.239 P=0.325 P=0.234N |
|LOGISTIC REGRESSION| P=0.128N P=0.256 P=0.337 (e) |
|COCH-ARM / FISHERS | P=0.126N P=0.218 P=0.339 P=0.247N |
|ORDER RESTRICTED | P=0.079N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 1/48 (2%) 4/48 (8%) |
|POLY-3 RATE (b) | 2/45.14 1/46.93 1/43.58 4/45.78 |
|POLY-3 PERCENT (g) | 4.4% 2.1% 2.3% 8.7% |
|TERMINAL (d) | 2/40 (5%) 1/44 (2%) 1/40 (3%) 2/41 (5%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 626 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.159 P=0.467N P=0.500N P=0.349 |
|POLY 3 | P=0.157 P=0.486N P=0.512N P=0.344 |
|POLY 1.5 | P=0.156 P=0.491N P=0.511N P=0.337 |
|POLY 6 | P=0.160 P=0.481N P=0.509N P=0.355 |
|LOGISTIC REGRESSION| P=0.161 P=0.467N P=0.500N P=0.342 |
|COCH-ARM / FISHERS | P=0.160 P=0.500N P=0.500N P=0.339 |
|ORDER RESTRICTED | P=0.138 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/46 (4%) 0/46 (0%) 0/45 (0%) |
|POLY-3 RATE (b) | 0/45.14 2/45.38 0/43.32 0/43.07 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 0/40 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 727 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.385N P=0.254 (e) (e) |
|POLY 3 | P=0.377N P=0.238 (e) (e) |
|POLY 1.5 | P=0.381N P=0.234 (e) (e) |
|POLY 6 | P=0.371N P=0.243 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.254 (e) (e) |
|COCH-ARM / FISHERS | P=0.387N P=0.237 (e) (e) |
|ORDER RESTRICTED | P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/47 (4%) 2/46 (4%) 0/45 (0%) |
|POLY-3 RATE (b) | 0/45.14 2/45.93 2/41.58 0/42.08 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 4.8% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/43 (5%) 2/38 (5%) 0/38 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.511N P=0.254 P=0.227 (e) |
|POLY 3 | P=0.508N P=0.241 P=0.219 (e) |
|POLY 1.5 | P=0.510N P=0.238 P=0.220 (e) |
|POLY 6 | P=0.502N P=0.245 P=0.221 (e) |
|LOGISTIC REGRESSION| (e) P=0.254 P=0.227 (e) |
|COCH-ARM / FISHERS | P=0.504N P=0.242 P=0.237 (e) |
|ORDER RESTRICTED | P=0.267 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/45.14 1/46.93 2/43.58 1/45.17 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 4.6% 2.2% |
|TERMINAL (d) | 0/40 (0%) 1/44 (2%) 2/40 (5%) 0/41 (0%) |
|FIRST INCIDENCE | --- 727 (T) 727 (T) 704 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.368 P=0.519 P=0.238 P=0.514 |
|POLY 3 | P=0.365 P=0.508 P=0.229 P=0.500 |
|POLY 1.5 | P=0.362 P=0.505 P=0.230 P=0.498 |
|POLY 6 | P=0.371 P=0.511 P=0.231 P=0.503 |
|LOGISTIC REGRESSION| P=0.363 P=0.519 P=0.238 P=0.500 |
|COCH-ARM / FISHERS | P=0.368 P=0.500 P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.217 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/45.97 1/46.93 2/43.58 1/45.08 |
|POLY-3 PERCENT (g) | 4.4% 2.1% 4.6% 2.2% |
|TERMINAL (d) | 0/40 (0%) 1/44 (2%) 2/40 (5%) 1/41 (2%) |
|FIRST INCIDENCE | 562 727 (T) 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459N P=0.484N P=0.682 P=0.502N |
|POLY 3 | P=0.464N P=0.493N P=0.674 P=0.507N |
|POLY 1.5 | P=0.463N P=0.495N P=0.678 P=0.507N |
|POLY 6 | P=0.464N P=0.491N P=0.674 P=0.506N |
|LOGISTIC REGRESSION| P=0.433N P=0.660N P=0.666N P=0.457N |
|COCH-ARM / FISHERS | P=0.451N P=0.500N P=0.692N P=0.500N |
|ORDER RESTRICTED | P=0.452N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/48 (2%) 2/48 (4%) 1/48 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 1/45.14 2/46.93 1/43.58 1/45.08 |
|POLY-3 PERCENT (g) | 2.2% 4.3% 2.3% 2.2% |
|TERMINAL (d) | 1/40 (3%) 2/44 (5%) 1/40 (3%) 1/41 (2%) |
|FIRST INCIDENCE | 727 (T) 727 (T) 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.524N P=0.533 P=0.762 P=0.756N |
|POLY 3 | P=0.525N P=0.514 P=0.753 P=0.760 |
|POLY 1.5 | P=0.526N P=0.509 P=0.753 P=0.758 |
|POLY 6 | P=0.521N P=0.519 P=0.755 P=0.758N |
|LOGISTIC REGRESSION| P=0.524N P=0.533 P=0.762 P=0.756N |
|COCH-ARM / FISHERS | P=0.520N P=0.500 P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.596N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/48 (6%) 0/48 (0%) 1/48 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/46.00 0/46.93 1/43.71 1/45.08 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/44 (0%) 0/40 (0%) 1/41 (2%) |
|FIRST INCIDENCE | 562 --- 694 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.317N P=0.115N P=0.312N P=0.304N |
|POLY 3 | P=0.323N P=0.115N P=0.324N P=0.313N |
|POLY 1.5 | P=0.321N P=0.116N P=0.320N P=0.313N |
|POLY 6 | P=0.324N P=0.114N P=0.324N P=0.312N |
|LOGISTIC REGRESSION| P=0.282N P=0.186N P=0.258N P=0.276N |
|COCH-ARM / FISHERS | P=0.313N P=0.121N P=0.308N P=0.308N |
|ORDER RESTRICTED | P=0.106N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 7/48 (15%) 10/48 (21%) 6/48 (13%) 13/48 (27%) |
|POLY-3 RATE (b) | 7/45.54 10/47.70 6/44.83 13/47.21 |
|POLY-3 PERCENT (g) | 15.4% 21.0% 13.4% 27.5% |
|TERMINAL (d) | 5/40 (13%) 7/44 (16%) 3/40 (8%) 9/41 (22%) |
|FIRST INCIDENCE | 673 596 252 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.117 P=0.371 P=0.504N P=0.126 |
|POLY 3 | P=0.117 P=0.334 P=0.512N P=0.120 |
|POLY 1.5 | P=0.115 P=0.320 P=0.512N P=0.114 |
|POLY 6 | P=0.120 P=0.351 P=0.506N P=0.126 |
|LOGISTIC REGRESSION| P=0.144 P=0.263 P=0.456N P=0.119 |
|COCH-ARM / FISHERS | P=0.110 P=0.297 P=0.500N P=0.104 |
|ORDER RESTRICTED | P=0.105 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 12/48 (25%) 11/48 (23%) 11/48 (23%) 8/48 (17%) |
|POLY-3 RATE (b) | 12/45.97 11/46.93 11/43.58 8/45.08 |
|POLY-3 PERCENT (g) | 26.1% 23.4% 25.2% 17.8% |
|TERMINAL (d) | 10/40 (25%) 11/44 (25%) 11/40 (28%) 8/41 (20%) |
|FIRST INCIDENCE | 562 727 (T) 727 (T) 727 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.196N P=0.405N P=0.505N P=0.213N |
|POLY 3 | P=0.215N P=0.477N P=0.559N P=0.240N |
|POLY 1.5 | P=0.212N P=0.485N P=0.546N P=0.240N |
|POLY 6 | P=0.213N P=0.471N P=0.562N P=0.236N |
|LOGISTIC REGRESSION| P=0.200N P=0.486N P=0.535N P=0.229N |
|COCH-ARM / FISHERS | P=0.189N P=0.500N P=0.500N P=0.226N |
|ORDER RESTRICTED | P=0.274N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 18/48 (38%) 15/48 (31%) 12/48 (25%) 20/48 (42%) |
|POLY-3 RATE (b) | 18/47.56 15/48.00 12/44.96 20/48.00 |
|POLY-3 PERCENT (g) | 37.9% 31.3% 26.7% 41.7% |
|TERMINAL (d) | 11/40 (28%) 11/44 (25%) 8/40 (20%) 13/41 (32%) |
|FIRST INCIDENCE | 378 596 252 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.330 P=0.264N P=0.166N P=0.453 |
|POLY 3 | P=0.322 P=0.323N P=0.178N P=0.432 |
|POLY 1.5 | P=0.322 P=0.328N P=0.166N P=0.426 |
|POLY 6 | P=0.324 P=0.316N P=0.186N P=0.440 |
|LOGISTIC REGRESSION| P=0.384 P=0.521N P=0.105N P=0.343 |
|COCH-ARM / FISHERS | P=0.327 P=0.334N P=0.135N P=0.417 |
|ORDER RESTRICTED | P=0.253 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93005 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - MALACHITE GREEN
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 100 PPM 225 PPM 450 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 25/48 (52%) 23/48 (48%) 20/48 (42%) 25/48 (52%) |
|POLY-3 RATE (b) | 25/47.56 23/48.00 20/44.96 25/48.00 |
|POLY-3 PERCENT (g) | 52.6% 47.9% 44.5% 52.1% |
|TERMINAL (d) | 18/40 (45%) 19/44 (43%) 16/40 (40%) 18/41 (44%) |
|FIRST INCIDENCE | 378 596 252 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.504 P=0.297N P=0.241N P=0.535N |
|POLY 3 | P=0.524 P=0.402N P=0.285N P=0.562N |
|POLY 1.5 | P=0.523 P=0.410N P=0.263N P=0.570N |
|POLY 6 | P=0.529 P=0.392N P=0.299N P=0.552N |
|LOGISTIC REGRESSION| P=0.514N P=0.550N P=0.199N P=0.540 |
|COCH-ARM / FISHERS | P=0.528 P=0.419N P=0.207N P=0.581N |
|ORDER RESTRICTED | P=0.528N (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).