TDMS Study 93029-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/19/03
EXPERIMENT: 93029 TEST: 04 TIME: 07:04:52
TEST TYPE: CHRONIC PAGE: 1
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029
PATHOLOGIST: MISSING CAS: 129-73-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/19/03
EXPERIMENT: 93029 TEST: 04 TIME: 07:04:52
TEST TYPE: CHRONIC
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029
PATHOLOGIST: MISSING CAS: 129-73-7
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.
---------------
Bone Marrow
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/19/03
EXPERIMENT: 93029 TEST: 04 TIME: 07:04:52
TEST TYPE: CHRONIC
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029
PATHOLOGIST: MISSING CAS: 129-73-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF LEUKOMALACHITE GREEN
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Ovary Teratoma Benign
Spleen Hemangiosarcoma
Uterus Sarcoma Stromal
===============================================================
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/48 (4%) 2/48 (4%) 4/48 (8%) 5/48 (10%) |
|POLY-3 RATE (b) | 2/43.52 2/46.24 4/44.56 5/45.09 |
|POLY-3 PERCENT (g) | 4.6% 4.3% 9.0% 11.1% |
|TERMINAL (d) | 2/37 (5%) 2/41 (5%) 3/39 (8%) 5/39 (13%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 675 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.113 P=0.658N P=0.358 P=0.237 |
|POLY 3 | P=0.114 P=0.672N P=0.348 P=0.231 |
|POLY 1.5 | P=0.114 P=0.676N P=0.347 P=0.230 |
|POLY 6 | P=0.113 P=0.668N P=0.350 P=0.232 |
|LOGISTIC REGRESSION| P=0.113 P=0.658N P=0.345 P=0.237 |
|COCH-ARM / FISHERS | P=0.110 P=0.692N P=0.339 P=0.218 |
|ORDER RESTRICTED | P=0.181 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 3/48 (6%) 2/48 (4%) 4/48 (8%) 6/48 (13%) |
|POLY-3 RATE (b) | 3/43.67 2/46.24 4/44.56 6/45.09 |
|POLY-3 PERCENT (g) | 6.9% 4.3% 9.0% 13.3% |
|TERMINAL (d) | 2/37 (5%) 2/41 (5%) 3/39 (8%) 6/39 (15%) |
|FIRST INCIDENCE | 695 733 (T) 675 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.111 P=0.454N P=0.522 P=0.271 |
|POLY 3 | P=0.107 P=0.474N P=0.511 P=0.258 |
|POLY 1.5 | P=0.109 P=0.479N P=0.510 P=0.257 |
|POLY 6 | P=0.106 P=0.470N P=0.512 P=0.257 |
|LOGISTIC REGRESSION| P=0.109 P=0.472N P=0.509 P=0.262 |
|COCH-ARM / FISHERS | P=0.106 P=0.500N P=0.500 P=0.243 |
|ORDER RESTRICTED | P=0.147 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/47 (6%) 6/48 (13%) 5/47 (11%) 9/47 (19%) |
|POLY-3 RATE (b) | 3/43.40 6/46.93 5/43.97 9/44.65 |
|POLY-3 PERCENT (g) | 6.9% 12.8% 11.4% 20.2% |
|TERMINAL (d) | 2/37 (5%) 5/41 (12%) 5/39 (13%) 9/39 (23%) |
|FIRST INCIDENCE | 682 498 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.058 P=0.293 P=0.381 P=0.073 |
|POLY 3 | P=0.055 P=0.282 P=0.363 P=0.065 |
|POLY 1.5 | P=0.056 P=0.277 P=0.364 P=0.065 |
|POLY 6 | P=0.054 P=0.286 P=0.361 P=0.065 |
|LOGISTIC REGRESSION| P=0.056 P=0.235 P=0.365 P=0.069 |
|COCH-ARM / FISHERS | P=0.053 P=0.254 P=0.357 P=0.060 |
|ORDER RESTRICTED | P=0.046 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/47 (0%) 0/48 (0%) 1/47 (2%) 2/47 (4%) |
|POLY-3 RATE (b) | 0/43.21 0/46.24 1/43.97 2/44.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 4.5% |
|TERMINAL (d) | 0/37 (0%) 0/41 (0%) 1/39 (3%) 2/39 (5%) |
|FIRST INCIDENCE | --- --- 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 (e) P=0.511 P=0.250 |
|POLY 3 | P=0.068 (e) P=0.504 P=0.245 |
|POLY 1.5 | P=0.068 (e) P=0.503 P=0.244 |
|POLY 6 | P=0.068 (e) P=0.504 P=0.245 |
|LOGISTIC REGRESSION| (e) (e) P=0.511 P=0.250 |
|COCH-ARM / FISHERS | P=0.067 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.079 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/47 (6%) 6/48 (13%) 6/47 (13%) 11/47 (23%) |
|POLY-3 RATE (b) | 3/43.40 6/46.93 6/43.97 11/44.65 |
|POLY-3 PERCENT (g) | 6.9% 12.8% 13.6% 24.6% |
|TERMINAL (d) | 2/37 (5%) 5/41 (12%) 6/39 (15%) 11/39 (28%) |
|FIRST INCIDENCE | 682 498 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.293 P=0.265 P=0.027 * |
|POLY 3 | P=0.013 * P=0.282 P=0.248 P=0.022 * |
|POLY 1.5 | P=0.014 * P=0.277 P=0.249 P=0.022 * |
|POLY 6 | P=0.013 * P=0.286 P=0.246 P=0.021 * |
|LOGISTIC REGRESSION| P=0.014 * P=0.235 P=0.250 P=0.025 * |
|COCH-ARM / FISHERS | P=0.013 * P=0.254 P=0.243 P=0.020 * |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/47 (6%) 6/48 (13%) 6/47 (13%) 11/47 (23%) |
|POLY-3 RATE (b) | 3/43.40 6/46.93 6/43.97 11/44.65 |
|POLY-3 PERCENT (g) | 6.9% 12.8% 13.6% 24.6% |
|TERMINAL (d) | 2/37 (5%) 5/41 (12%) 6/39 (15%) 11/39 (28%) |
|FIRST INCIDENCE | 682 498 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.293 P=0.265 P=0.027 * |
|POLY 3 | P=0.013 * P=0.282 P=0.248 P=0.022 * |
|POLY 1.5 | P=0.014 * P=0.277 P=0.249 P=0.022 * |
|POLY 6 | P=0.013 * P=0.286 P=0.246 P=0.021 * |
|LOGISTIC REGRESSION| P=0.014 * P=0.235 P=0.250 P=0.025 * |
|COCH-ARM / FISHERS | P=0.013 * P=0.254 P=0.243 P=0.020 * |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/47 (2%) 1/48 (2%) 0/47 (0%) 2/47 (4%) |
|POLY-3 RATE (b) | 1/43.34 1/46.41 0/43.97 2/46.00 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 0.0% 4.4% |
|TERMINAL (d) | 0/37 (0%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 700 690 --- 444 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.379 P=0.734N P=0.490N P=0.521 |
|POLY 3 | P=0.375 P=0.745N P=0.497N P=0.521 |
|POLY 1.5 | P=0.373 P=0.747N P=0.497N P=0.517 |
|POLY 6 | P=0.376 P=0.744N P=0.498N P=0.524 |
|LOGISTIC REGRESSION| P=0.268 P=0.761 P=0.501N P=0.340 |
|COCH-ARM / FISHERS | P=0.365 P=0.747N P=0.500N P=0.500 |
|ORDER RESTRICTED | P=0.290 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/47 (6%) 1/48 (2%) 2/47 (4%) 1/47 (2%) |
|POLY-3 RATE (b) | 3/43.21 1/46.24 2/44.66 1/44.65 |
|POLY-3 PERCENT (g) | 6.9% 2.2% 4.5% 2.2% |
|TERMINAL (d) | 3/37 (8%) 1/41 (2%) 1/39 (3%) 1/39 (3%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 498 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.280N P=0.269N P=0.477N P=0.286N |
|POLY 3 | P=0.290N P=0.281N P=0.485N P=0.294N |
|POLY 1.5 | P=0.289N P=0.284N P=0.488N P=0.295N |
|POLY 6 | P=0.290N P=0.279N P=0.482N P=0.292N |
|LOGISTIC REGRESSION| P=0.298N P=0.269N P=0.509N P=0.286N |
|COCH-ARM / FISHERS | P=0.290N P=0.301N P=0.500N P=0.308N |
|ORDER RESTRICTED | P=0.206N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/47 (4%) 0/48 (0%) 0/47 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 2/43.21 0/46.24 0/43.97 0/44.65 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/37 (5%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 733 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.119N P=0.216N P=0.227N P=0.227N |
|POLY 3 | P=0.126N P=0.222N P=0.233N P=0.230N |
|POLY 1.5 | P=0.125N P=0.224N P=0.233N P=0.230N |
|POLY 6 | P=0.127N P=0.221N P=0.233N P=0.229N |
|LOGISTIC REGRESSION| P=0.119N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.123N P=0.242N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 5/47 (11%) 1/48 (2%) 2/47 (4%) 1/47 (2%) |
|POLY-3 RATE (b) | 5/43.21 1/46.24 2/44.66 1/44.65 |
|POLY-3 PERCENT (g) | 11.6% 2.2% 4.5% 2.2% |
|TERMINAL (d) | 5/37 (14%) 1/41 (2%) 1/39 (3%) 1/39 (3%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 498 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.095N P=0.081N P=0.198N P=0.091N |
|POLY 3 | P=0.100N P=0.086N P=0.203N P=0.094N |
|POLY 1.5 | P=0.100N P=0.088N P=0.205N P=0.094N |
|POLY 6 | P=0.100N P=0.085N P=0.200N P=0.093N |
|LOGISTIC REGRESSION| P=0.102N P=0.081N P=0.217N P=0.091N |
|COCH-ARM / FISHERS | P=0.101N P=0.097N P=0.217N P=0.102N |
|ORDER RESTRICTED | P=0.032N* (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/48 (4%) 0/48 (0%) 1/48 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/43.69 0/46.24 1/45.03 0/45.09 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 688 --- 498 --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.197N P=0.219N P=0.489N P=0.229N |
|POLY 3 | P=0.204N P=0.225N P=0.489N P=0.230N |
|POLY 1.5 | P=0.202N P=0.227N P=0.491N P=0.230N |
|POLY 6 | P=0.205N P=0.223N P=0.489N P=0.230N |
|LOGISTIC REGRESSION| P=0.227N P=0.233N P=0.525N P=0.234N |
|COCH-ARM / FISHERS | P=0.199N P=0.247N P=0.500N P=0.247N |
|ORDER RESTRICTED | P=0.070N (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/48 (2%) 1/48 (2%) 2/48 (4%) 4/48 (8%) |
|POLY-3 RATE (b) | 1/43.52 1/46.24 2/44.34 4/45.15 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 4.5% 8.9% |
|TERMINAL (d) | 1/37 (3%) 1/41 (2%) 2/39 (5%) 3/39 (8%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.074 P=0.739N P=0.518 P=0.202 |
|POLY 3 | P=0.072 P=0.747N P=0.507 P=0.190 |
|POLY 1.5 | P=0.072 P=0.750N P=0.506 P=0.189 |
|POLY 6 | P=0.071 P=0.744N P=0.506 P=0.191 |
|LOGISTIC REGRESSION| P=0.072 P=0.739N P=0.518 P=0.193 |
|COCH-ARM / FISHERS | P=0.070 P=0.753N P=0.500 P=0.181 |
|ORDER RESTRICTED | P=0.101 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary |
| Teratoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/46 (4%) 0/48 (0%) 0/47 (0%) 0/44 (0%) |
|POLY-3 RATE (b) | 2/44.82 0/46.24 0/43.97 0/43.49 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 122 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.125N P=0.235N P=0.240N P=0.242N |
|POLY 3 | P=0.125N P=0.230N P=0.241N P=0.244N |
|POLY 1.5 | P=0.124N P=0.230N P=0.239N P=0.245N |
|POLY 6 | P=0.125N P=0.230N P=0.243N P=0.241N |
|LOGISTIC REGRESSION| P=0.173N P=0.389N P=0.197N (e) |
|COCH-ARM / FISHERS | P=0.125N P=0.237N P=0.242N P=0.258N |
|ORDER RESTRICTED | P=0.031N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/41 (7%) 0/45 (0%) 1/44 (2%) 2/46 (4%) |
|POLY-3 RATE (b) | 3/38.52 0/43.24 1/41.14 2/43.65 |
|POLY-3 PERCENT (g) | 7.8% 0.0% 2.4% 4.6% |
|TERMINAL (d) | 2/32 (6%) 0/38 (0%) 1/37 (3%) 2/38 (5%) |
|FIRST INCIDENCE | 639 --- 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.536N P=0.101N P=0.271N P=0.438N |
|POLY 3 | P=0.545N P=0.098N P=0.281N P=0.443N |
|POLY 1.5 | P=0.544N P=0.099N P=0.280N P=0.442N |
|POLY 6 | P=0.546N P=0.098N P=0.282N P=0.443N |
|LOGISTIC REGRESSION| P=0.538N P=0.107N P=0.279N P=0.445N |
|COCH-ARM / FISHERS | P=0.540N P=0.104N P=0.282N P=0.445N |
|ORDER RESTRICTED | P=0.147N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/43.52 2/46.34 0/44.34 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 4.4% |
|TERMINAL (d) | 0/37 (0%) 1/41 (2%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 708 --- 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.276 P=0.268 (e) P=0.259 |
|POLY 3 | P=0.272 P=0.251 (e) P=0.246 |
|POLY 1.5 | P=0.271 P=0.248 (e) P=0.245 |
|POLY 6 | P=0.273 P=0.255 (e) P=0.247 |
|LOGISTIC REGRESSION| P=0.264 P=0.246 (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.261 P=0.247 (e) P=0.247 |
|ORDER RESTRICTED | P=0.123 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/43.52 2/46.34 0/44.34 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 4.4% |
|TERMINAL (d) | 0/37 (0%) 1/41 (2%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 708 --- 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.276 P=0.268 (e) P=0.259 |
|POLY 3 | P=0.272 P=0.251 (e) P=0.246 |
|POLY 1.5 | P=0.271 P=0.248 (e) P=0.245 |
|POLY 6 | P=0.273 P=0.255 (e) P=0.247 |
|LOGISTIC REGRESSION| P=0.264 P=0.246 (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.261 P=0.247 (e) P=0.247 |
|ORDER RESTRICTED | P=0.123 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/43.52 1/46.34 0/44.34 2/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 4.4% |
|TERMINAL (d) | 0/37 (0%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 708 --- 718 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.156 P=0.529 (e) P=0.259 |
|POLY 3 | P=0.149 P=0.513 (e) P=0.246 |
|POLY 1.5 | P=0.149 P=0.510 (e) P=0.245 |
|POLY 6 | P=0.149 P=0.515 (e) P=0.247 |
|LOGISTIC REGRESSION| P=0.146 P=0.500 (e) P=0.244 |
|COCH-ARM / FISHERS | P=0.144 P=0.500 (e) P=0.247 |
|ORDER RESTRICTED | P=0.080 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/45 (4%) 0/48 (0%) 0/47 (0%) 0/45 (0%) |
|POLY-3 RATE (b) | 2/42.32 0/46.24 0/43.97 0/44.00 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 639 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.124N P=0.227N P=0.239N P=0.237N |
|POLY 3 | P=0.124N P=0.218N P=0.229N P=0.229N |
|POLY 1.5 | P=0.124N P=0.217N P=0.227N P=0.229N |
|POLY 6 | P=0.123N P=0.219N P=0.231N P=0.229N |
|LOGISTIC REGRESSION| P=0.127N P=0.235N P=0.231N P=0.253N |
|COCH-ARM / FISHERS | P=0.122N P=0.231N P=0.237N P=0.247N |
|ORDER RESTRICTED | P=0.026N* (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/43.52 2/46.26 2/44.34 1/45.09 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 4.5% 2.2% |
|TERMINAL (d) | 0/37 (0%) 1/41 (2%) 2/39 (5%) 1/39 (3%) |
|FIRST INCIDENCE | --- 729 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.484 P=0.262 P=0.250 P=0.511 |
|POLY 3 | P=0.496 P=0.251 P=0.241 P=0.507 |
|POLY 1.5 | P=0.495 P=0.248 P=0.241 P=0.506 |
|POLY 6 | P=0.497 P=0.254 P=0.241 P=0.508 |
|LOGISTIC REGRESSION| P=0.491 P=0.257 P=0.250 P=0.511 |
|COCH-ARM / FISHERS | P=0.480 P=0.247 P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.236 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/48 (0%) 2/48 (4%) 1/48 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/43.52 2/46.26 1/44.34 1/45.09 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.3% 2.2% |
|TERMINAL (d) | 0/37 (0%) 1/41 (2%) 1/39 (3%) 1/39 (3%) |
|FIRST INCIDENCE | --- 729 733 (T) 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.519 P=0.262 P=0.511 P=0.511 |
|POLY 3 | P=0.530 P=0.251 P=0.504 P=0.507 |
|POLY 1.5 | P=0.529 P=0.248 P=0.504 P=0.506 |
|POLY 6 | P=0.532 P=0.254 P=0.504 P=0.508 |
|LOGISTIC REGRESSION| P=0.524 P=0.257 P=0.511 P=0.511 |
|COCH-ARM / FISHERS | P=0.515 P=0.247 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.280 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/48 (4%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/43.52 0/46.24 0/44.34 0/45.09 |
|POLY-3 PERCENT (g) | 4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/41 (0%) 0/39 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 732 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.121N P=0.220N P=0.231N P=0.231N |
|POLY 3 | P=0.127N P=0.224N P=0.233N P=0.229N |
|POLY 1.5 | P=0.126N P=0.227N P=0.233N P=0.230N |
|POLY 6 | P=0.129N P=0.221N P=0.233N P=0.229N |
|LOGISTIC REGRESSION| P=0.118N P=0.215N P=0.230N P=0.223N |
|COCH-ARM / FISHERS | P=0.122N P=0.247N P=0.247N P=0.247N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 6/48 (13%) 5/48 (10%) 12/48 (25%) 6/48 (13%) |
|POLY-3 RATE (b) | 6/44.64 5/46.24 12/45.54 6/45.69 |
|POLY-3 PERCENT (g) | 13.4% 10.8% 26.4% 13.1% |
|TERMINAL (d) | 4/37 (11%) 5/41 (12%) 7/39 (18%) 3/39 (8%) |
|FIRST INCIDENCE | 225 733 (T) 620 584 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.442 P=0.435N P=0.127 P=0.577N |
|POLY 3 | P=0.431 P=0.475N P=0.101 P=0.604N |
|POLY 1.5 | P=0.430 P=0.480N P=0.098 P=0.607N |
|POLY 6 | P=0.436 P=0.470N P=0.107 P=0.600N |
|LOGISTIC REGRESSION| P=0.401 P=0.562N P=0.089 P=0.567 |
|COCH-ARM / FISHERS | P=0.420 P=0.500N P=0.095 P=0.621N |
|ORDER RESTRICTED | P=0.255 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 16/48 (33%) 14/48 (29%) 13/48 (27%) 19/48 (40%) |
|POLY-3 RATE (b) | 16/45.97 14/46.94 13/45.25 19/45.09 |
|POLY-3 PERCENT (g) | 34.8% 29.8% 28.7% 42.1% |
|TERMINAL (d) | 10/37 (27%) 12/41 (29%) 11/39 (28%) 19/39 (49%) |
|FIRST INCIDENCE | 122 498 498 733 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.272 P=0.314N P=0.296N P=0.409 |
|POLY 3 | P=0.212 P=0.386N P=0.346N P=0.308 |
|POLY 1.5 | P=0.228 P=0.389N P=0.338N P=0.326 |
|POLY 6 | P=0.194 P=0.390N P=0.359N P=0.283 |
|LOGISTIC REGRESSION| P=0.244 P=0.493N P=0.342N P=0.333 |
|COCH-ARM / FISHERS | P=0.246 P=0.413N P=0.329N P=0.336 |
|ORDER RESTRICTED | P=0.210 (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 16/48 (33%) 11/48 (23%) 18/48 (38%) 17/48 (35%) |
|POLY-3 RATE (b) | 16/45.28 11/46.52 18/47.37 17/47.13 |
|POLY-3 PERCENT (g) | 35.3% 23.7% 38.0% 36.1% |
|TERMINAL (d) | 10/37 (27%) 8/41 (20%) 10/39 (26%) 10/39 (26%) |
|FIRST INCIDENCE | 225 690 193 444 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.316 P=0.133N P=0.477 P=0.568 |
|POLY 3 | P=0.308 P=0.159N P=0.480 P=0.557 |
|POLY 1.5 | P=0.298 P=0.162N P=0.464 P=0.545 |
|POLY 6 | P=0.318 P=0.157N P=0.497 P=0.567 |
|LOGISTIC REGRESSION| P=0.234 P=0.191N P=0.385 P=0.458 |
|COCH-ARM / FISHERS | P=0.268 P=0.182N P=0.416 P=0.500 |
|ORDER RESTRICTED | P=0.349 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/19/03 EXPERIMENT: 93029 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Mice(C57BL/6NXC3H/HEN MTN-NCTR) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 PPM 91 PPM 204 PPM 408 PPM |
| | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 28/48 (58%) 22/48 (46%) 26/48 (54%) 32/48 (67%) |
|POLY-3 RATE (b) | 28/47.12 22/47.21 26/47.37 32/47.13 |
|POLY-3 PERCENT (g) | 59.4% 46.6% 54.9% 67.9% |
|TERMINAL (d) | 19/37 (51%) 18/41 (44%) 18/39 (46%) 25/39 (64%) |
|FIRST INCIDENCE | 122 498 193 444 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.178 P=0.098N P=0.362N P=0.404 |
|POLY 3 | P=0.107 P=0.148N P=0.407N P=0.261 |
|POLY 1.5 | P=0.108 P=0.149N P=0.412N P=0.263 |
|POLY 6 | P=0.105 P=0.150N P=0.400N P=0.255 |
|LOGISTIC REGRESSION| P=0.096 P=0.210N P=0.448N P=0.228 |
|COCH-ARM / FISHERS | P=0.111 P=0.154N P=0.419N P=0.264 |
|ORDER RESTRICTED | P=0.107 (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).