TDMS Study 93029-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/18/03
EXPERIMENT: 93029 TEST: 03 TIME: 14:55:01
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: 06/18/03
EXPERIMENT: 93029 TEST: 03 TIME: 14:55:01
TEST TYPE: CHRONIC
CONT: 224-93-00001 ROUTE: DOSED FEED NTP C#: C93029
PATHOLOGIST: MISSING CAS: 129-73-7
Rats(FISCHER344)
-----------------------------
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
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Pancreas
Pituitary Gland
Salivary Glands
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: NCTR LEUKOMALACHITE GREEN DATE: 06/18/03
EXPERIMENT: 93029 TEST: 03 TIME: 14:55:01
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
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Malignant
Clitoral/Preputial Gland Carcinoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Sarcoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Carcinoma or Adenoma
Fibroadenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
Zymbal's Gland Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
===============================================================
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 6/46 (13%) 2/47 (4%) 3/47 (6%) |0/47 (0%) 0/48 (0%) 1/46 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 3/40.66 6/41.48 2/42.02 3/42.42 |0/42.64 0/44.68 1/41.67 0/42.63 |
|POLY-3 PERCENT (g) | 7.4% 14.5% 4.8% 7.1% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 2/23 (9%) 5/29 (17%) 2/33 (6%) 3/30 (10%) |0/32 (0%) 0/36 (0%) 1/33 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 659 615 733 (T) 733 (T) |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237N P=0.341 P=0.361N P=0.549N |P=0.670 (e) P=0.506 (e) |
|POLY 3 | P=0.311N P=0.250 P=0.485N P=0.643N |P=0.655 (e) P=0.495 (e) |
|POLY 1.5 | P=0.321N P=0.241 P=0.494N P=0.652N |P=0.661 (e) P=0.493 (e) |
|POLY 6 | P=0.295N P=0.267 P=0.465N P=0.629N |P=0.649 (e) P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.294N P=0.254 P=0.458N P=0.613N |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.331N P=0.232 P=0.500N P=0.661N |P=0.669 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.324N (e) (e) (e) |P=0.376 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/46 (4%) 0/47 (0%) 3/47 (6%) |0/47 (0%) 0/48 (0%) 1/46 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/40.39 2/41.21 0/42.02 3/42.70 |0/42.64 0/44.68 1/41.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 0.0% 7.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/29 (3%) 0/33 (0%) 1/30 (3%) |0/32 (0%) 0/36 (0%) 1/33 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- 697 --- 676 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.279 (e) P=0.155 |P=0.670 (e) P=0.506 (e) |
|POLY 3 | P=0.127 P=0.241 (e) P=0.128 |P=0.655 (e) P=0.495 (e) |
|POLY 1.5 | P=0.123 P=0.237 (e) P=0.124 |P=0.661 (e) P=0.493 (e) |
|POLY 6 | P=0.135 P=0.250 (e) P=0.137 |P=0.649 (e) P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.125 P=0.246 (e) P=0.127 |(e) (e) P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.119 P=0.242 (e) P=0.121 |P=0.669 (e) P=0.495 (e) |
|ORDER RESTRICTED | P=0.041 * (e) (e) (e) |P=0.376 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 8/46 (17%) 2/47 (4%) 7/47 (15%) |0/47 (0%) 0/48 (0%) 2/46 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 3/40.66 8/41.62 2/42.02 7/43.02 |0/42.64 0/44.68 2/41.67 0/42.63 |
|POLY-3 PERCENT (g) | 7.4% 19.2% 4.8% 16.3% |0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | 2/23 (9%) 6/29 (21%) 2/33 (6%) 4/30 (13%) |0/32 (0%) 0/36 (0%) 2/33 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 659 615 733 (T) 645 |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.439 P=0.170 P=0.361N P=0.260 |P=0.563 (e) P=0.245 (e) |
|POLY 3 | P=0.357 P=0.103 P=0.485N P=0.179 |P=0.545 (e) P=0.232 (e) |
|POLY 1.5 | P=0.341 P=0.097 P=0.494N P=0.169 |P=0.553 (e) P=0.230 (e) |
|POLY 6 | P=0.384 P=0.114 P=0.465N P=0.198 |P=0.537 (e) P=0.236 (e) |
|LOGISTIC REGRESSION| P=0.355 P=0.107 P=0.458N P=0.176 |(e) (e) P=0.245 (e) |
|COCH-ARM / FISHERS | P=0.327 P=0.092 P=0.500N P=0.158 |P=0.562 (e) P=0.242 (e) |
|ORDER RESTRICTED | P=0.159 (e) (e) (e) |P=0.242 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 2/47 (4%) 7/48 (15%) 3/47 (6%) |7/47 (15%) 8/47 (17%) 3/46 (7%) 6/47 (13%) |
|POLY-3 RATE (b) | 5/41.45 2/42.07 7/43.02 3/42.73 |7/43.16 8/43.85 3/41.83 6/42.84 |
|POLY-3 PERCENT (g) | 12.1% 4.8% 16.3% 7.0% |16.2% 18.2% 7.2% 14.0% |
|TERMINAL (d) | 4/24 (17%) 2/30 (7%) 7/34 (21%) 1/30 (3%) |7/33 (21%) 8/36 (22%) 3/35 (9%) 4/34 (12%) |
|FIRST INCIDENCE | 718 733 (T) 733 (T) 658 |734 (T) 734 (T) 734 (T) 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.137N P=0.623N P=0.264N |P=0.297N P=0.575 P=0.131N P=0.478N |
|POLY 3 | P=0.482N P=0.209N P=0.405 P=0.339N |P=0.310N P=0.514 P=0.169N P=0.506N |
|POLY 1.5 | P=0.494N P=0.217N P=0.389 P=0.353N |P=0.308N P=0.500 P=0.173N P=0.505N |
|POLY 6 | P=0.464N P=0.195N P=0.438 P=0.317N |P=0.309N P=0.536 P=0.160N P=0.501N |
|LOGISTIC REGRESSION| P=0.448N P=0.151N P=0.556 P=0.312N |P=0.326N P=0.575 P=0.131N P=0.514N |
|COCH-ARM / FISHERS | P=0.508N P=0.226N P=0.379 P=0.369N |P=0.302N P=0.500 P=0.167N P=0.500N |
|ORDER RESTRICTED | P=0.351N (e) (e) (e) |P=0.298N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/48 (13%) 0/47 (0%) 4/48 (8%) 9/47 (19%) |2/47 (4%) 1/47 (2%) 2/46 (4%) 2/47 (4%) |
|POLY-3 RATE (b) | 6/42.20 0/42.07 4/43.89 9/43.15 |2/43.65 1/43.89 2/42.05 2/42.13 |
|POLY-3 PERCENT (g) | 14.2% 0.0% 9.1% 20.9% |4.6% 2.3% 4.8% 4.8% |
|TERMINAL (d) | 4/24 (17%) 0/30 (0%) 1/34 (3%) 7/30 (23%) |1/33 (3%) 0/36 (0%) 1/35 (3%) 2/34 (6%) |
|FIRST INCIDENCE | 564 --- 543 505 |585 725 676 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 P=0.011N* P=0.248N P=0.418 |P=0.493 P=0.474N P=0.672N P=0.692N |
|POLY 3 | P=0.035 * P=0.015N* P=0.344N P=0.301 |P=0.480 P=0.498N P=0.681 P=0.681 |
|POLY 1.5 | P=0.034 * P=0.016N* P=0.359N P=0.288 |P=0.488 P=0.502N P=0.679 P=0.685 |
|POLY 6 | P=0.036 * P=0.014N* P=0.315N P=0.322 |P=0.473 P=0.491N P=0.687 P=0.679 |
|LOGISTIC REGRESSION| P=0.033 * P=0.019N* P=0.374N P=0.276 |P=0.499 P=0.484N P=0.687N P=0.687N |
|COCH-ARM / FISHERS | P=0.035 * P=0.014N* P=0.370N P=0.272 |P=0.499 P=0.500N P=0.683 P=0.692N |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P=0.592 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/48 (23%) 2/47 (4%) 10/48 (21%) 12/47 (26%) |9/47 (19%) 9/47 (19%) 5/46 (11%) 8/47 (17%) |
|POLY-3 RATE (b) | 11/42.26 2/42.07 10/43.89 12/43.47 |9/43.65 9/43.89 5/42.05 8/42.84 |
|POLY-3 PERCENT (g) | 26.0% 4.8% 22.8% 27.6% |20.6% 20.5% 11.9% 18.7% |
|TERMINAL (d) | 8/24 (33%) 2/30 (7%) 7/34 (21%) 8/30 (27%) |8/33 (24%) 8/36 (22%) 4/35 (11%) 6/34 (18%) |
|FIRST INCIDENCE | 564 733 (T) 543 505 |585 725 676 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185 P=0.003N** P=0.237N P=0.501N |P=0.368N P=0.525N P=0.163N P=0.479N |
|POLY 3 | P=0.116 P=0.006N** P=0.460N P=0.532 |P=0.386N P=0.599N P=0.212N P=0.517N |
|POLY 1.5 | P=0.109 P=0.007N** P=0.484N P=0.506 |P=0.379N P=0.597 P=0.216N P=0.512N |
|POLY 6 | P=0.127 P=0.005N** P=0.412N P=0.571 |P=0.390N P=0.581N P=0.201N P=0.518N |
|LOGISTIC REGRESSION| P=0.115 P=0.007N** P=0.470N P=0.515 |P=0.392N P=0.568N P=0.208N P=0.510N |
|COCH-ARM / FISHERS | P=0.105 P=0.008N** P=0.500N P=0.477 |P=0.368N P=0.603N P=0.205N P=0.500N |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.412N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/47 (0%) |0/48 (0%) 0/48 (0%) 2/48 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/41.39 0/42.07 0/43.02 0/42.42 |0/43.64 0/44.68 2/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 2/35 (6%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.561 (e) P=0.251 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.542 (e) P=0.237 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.551 (e) P=0.235 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.534 (e) P=0.242 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.251 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.561 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.247 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/48 (10%) 2/47 (4%) 1/48 (2%) 4/47 (9%) |0/48 (0%) 0/48 (0%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 5/41.59 2/42.21 1/43.02 4/42.68 |0/43.64 0/44.68 0/42.77 0/42.63 |
|POLY-3 PERCENT (g) | 12.0% 4.7% 2.3% 9.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/24 (13%) 1/30 (3%) 1/34 (3%) 3/30 (10%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 698 697 733 (T) 661 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.154N P=0.050N P=0.389N |(e) (e) (e) (e) |
|POLY 3 | P=0.525N P=0.209N P=0.093N P=0.484N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.528N P=0.217N P=0.098N P=0.498N |(e) (e) (e) (e) |
|POLY 6 | P=0.519N P=0.195N P=0.083N P=0.461N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.497N P=0.186N P=0.071N P=0.454N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.532N P=0.226N P=0.102N P=0.514N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.188N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 2/47 (4%) 3/48 (6%) 2/47 (4%) |1/48 (2%) 3/48 (6%) 0/48 (0%) 3/48 (6%) |
|POLY-3 RATE (b) | 2/41.86 2/42.07 3/43.02 2/42.42 |1/43.64 3/44.68 0/43.67 3/42.63 |
|POLY-3 PERCENT (g) | 4.8% 4.8% 7.0% 4.7% |2.3% 6.7% 0.0% 7.0% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 3/34 (9%) 2/30 (7%) |1/33 (3%) 3/36 (8%) 0/35 (0%) 3/34 (9%) |
|FIRST INCIDENCE | 639 733 (T) 733 (T) 733 (T) |734 (T) 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548N P=0.647N P=0.617 P=0.633N |P=0.367 P=0.336 P=0.488N P=0.315 |
|POLY 3 | P=0.568 P=0.692N P=0.512 P=0.690N |P=0.360 P=0.314 P=0.500N P=0.297 |
|POLY 1.5 | P=0.561 P=0.691 P=0.504 P=0.693 |P=0.362 P=0.307 P=0.502N P=0.299 |
|POLY 6 | P=0.578 P=0.684N P=0.530 P=0.681N |P=0.361 P=0.324 P=0.495N P=0.296 |
|LOGISTIC REGRESSION| P=0.581 P=0.691 P=0.512 P=0.691 |P=0.367 P=0.336 (e) P=0.315 |
|COCH-ARM / FISHERS | P=0.553 P=0.684 P=0.500 P=0.684 |P=0.368 P=0.308 P=0.500N P=0.308 |
|ORDER RESTRICTED | P=0.640 (e) (e) (e) |P=0.206 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/47 (2%) 3/48 (6%) 4/47 (9%) |1/48 (2%) 2/48 (4%) 3/48 (6%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/41.39 1/42.07 3/43.02 4/42.89 |1/43.64 2/44.72 3/43.96 0/42.63 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 7.0% 9.3% |2.3% 4.5% 6.8% 0.0% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 3/34 (9%) 2/30 (7%) |1/33 (3%) 1/36 (3%) 2/35 (6%) 0/34 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 660 |734 (T) 725 657 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092 P=0.712N P=0.436 P=0.241 |P=0.331N P=0.536 P=0.327 P=0.494N |
|POLY 3 | P=0.073 P=0.757N P=0.319 P=0.189 |P=0.340N P=0.508 P=0.308 P=0.505N |
|POLY 1.5 | P=0.070 P=0.760 P=0.311 P=0.181 |P=0.335N P=0.502 P=0.303 P=0.503N |
|POLY 6 | P=0.079 P=0.750N P=0.336 P=0.203 |P=0.343N P=0.519 P=0.317 P=0.505N |
|LOGISTIC REGRESSION| P=0.074 P=0.712N P=0.436 P=0.182 |P=0.336N P=0.533 P=0.303 (e) |
|COCH-ARM / FISHERS | P=0.066 P=0.747 P=0.308 P=0.174 |P=0.326N P=0.500 P=0.308 P=0.500N |
|ORDER RESTRICTED | P=0.121 (e) (e) (e) |P=0.196N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/47 (0%) |0/48 (0%) 1/48 (2%) 1/48 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/41.39 0/42.07 0/43.02 0/42.42 |0/43.64 1/44.76 1/43.71 2/43.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 2.2% 2.3% 4.6% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 714 724 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.156 P=0.516 P=0.517 P=0.238 |
|POLY 3 | (e) (e) (e) (e) |P=0.157 P=0.505 P=0.500 P=0.234 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.158 P=0.501 P=0.498 P=0.235 |
|POLY 6 | (e) (e) (e) (e) |P=0.157 P=0.511 P=0.505 P=0.236 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.163 P=0.501 P=0.504 P=0.268 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.160 P=0.500 P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.115 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 1/48 (2%) 0/47 (0%) |0/48 (0%) 1/48 (2%) 2/48 (4%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/41.39 0/42.07 1/43.02 0/42.42 |0/43.64 1/44.85 2/43.96 2/42.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |0.0% 2.2% 4.6% 4.7% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/34 (3%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 1/35 (3%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |--- 690 657 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.695 (e) P=0.569 (e) |P=0.153 P=0.525 P=0.252 P=0.245 |
|POLY 3 | P=0.679 (e) P=0.508 (e) |P=0.152 P=0.505 P=0.239 P=0.232 |
|POLY 1.5 | P=0.674 (e) P=0.503 (e) |P=0.156 P=0.501 P=0.236 P=0.233 |
|POLY 6 | P=0.687 (e) P=0.517 (e) |P=0.150 P=0.512 P=0.245 P=0.232 |
|LOGISTIC REGRESSION| (e) (e) P=0.569 (e) |P=0.158 P=0.504 P=0.239 P=0.245 |
|COCH-ARM / FISHERS | P=0.667 (e) P=0.500 (e) |P=0.161 P=0.500 P=0.247 P=0.247 |
|ORDER RESTRICTED | P=0.388 (e) (e) (e) |P=0.151 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 1/48 (2%) 0/47 (0%) |0/48 (0%) 2/48 (4%) 3/48 (6%) 4/48 (8%) |
|POLY-3 RATE (b) | 0/41.39 0/42.07 1/43.02 0/42.42 |0/43.64 2/44.93 3/44.00 4/43.13 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 0.0% |0.0% 4.5% 6.8% 9.3% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 1/34 (3%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 1/35 (3%) 3/34 (9%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |--- 690 657 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.695 (e) P=0.569 (e) |P=0.048 * P=0.262 P=0.136 P=0.066 |
|POLY 3 | P=0.679 (e) P=0.508 (e) |P=0.047 * P=0.244 P=0.120 P=0.058 |
|POLY 1.5 | P=0.674 (e) P=0.503 (e) |P=0.048 * P=0.239 P=0.117 P=0.059 |
|POLY 6 | P=0.687 (e) P=0.517 (e) |P=0.047 * P=0.251 P=0.125 P=0.059 |
|LOGISTIC REGRESSION| (e) (e) P=0.569 (e) |P=0.051 P=0.238 P=0.120 P=0.064 |
|COCH-ARM / FISHERS | P=0.667 (e) P=0.500 (e) |P=0.050 P=0.247 P=0.121 P=0.059 |
|ORDER RESTRICTED | P=0.388 (e) (e) (e) |P=0.035 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 1/48 (2%) 4/47 (9%) |20/48 (42%) 12/48 (25%) 12/48 (25%) 13/48 (27%) |
|POLY-3 RATE (b) | 1/41.39 2/42.31 1/43.02 4/42.42 |20/44.43 12/45.62 12/44.43 13/44.18 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 2.3% 9.4% |45.0% 26.3% 27.0% 29.4% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 1/34 (3%) 4/30 (13%) |17/33 (52%) 8/36 (22%) 8/35 (23%) 9/34 (27%) |
|FIRST INCIDENCE | 733 (T) 667 733 (T) 733 (T) |589 625 599 570 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.568 P=0.682N P=0.250 |P=0.170N P=0.041N* P=0.049N* P=0.095N |
|POLY 3 | P=0.122 P=0.508 P=0.752N P=0.185 |P=0.160N P=0.048N* P=0.058N P=0.094N |
|POLY 1.5 | P=0.119 P=0.500 P=0.757N P=0.179 |P=0.155N P=0.058N P=0.065N P=0.098N |
|POLY 6 | P=0.128 P=0.521 P=0.741N P=0.196 |P=0.161N P=0.036N* P=0.047N* P=0.084N |
|LOGISTIC REGRESSION| P=0.131 P=0.508 P=0.682N P=0.250 |P=0.164N P=0.056N P=0.060N P=0.110N |
|COCH-ARM / FISHERS | P=0.115 P=0.492 P=0.753N P=0.174 |P=0.150N P=0.065N P=0.065N P=0.098N |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.054N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 1/48 (2%) 4/47 (9%) |20/48 (42%) 13/48 (27%) 13/48 (27%) 15/48 (31%) |
|POLY-3 RATE (b) | 1/41.39 2/42.31 1/43.02 4/42.42 |20/44.43 13/45.70 13/44.47 15/44.67 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 2.3% 9.4% |45.0% 28.5% 29.2% 33.6% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 1/34 (3%) 4/30 (13%) |17/33 (52%) 8/36 (22%) 8/35 (23%) 10/34 (29%) |
|FIRST INCIDENCE | 733 (T) 667 733 (T) 733 (T) |589 625 599 570 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.568 P=0.682N P=0.250 |P=0.297N P=0.066N P=0.077N P=0.192N |
|POLY 3 | P=0.122 P=0.508 P=0.752N P=0.185 |P=0.278N P=0.076N P=0.090N P=0.185N |
|POLY 1.5 | P=0.119 P=0.500 P=0.757N P=0.179 |P=0.275N P=0.090N P=0.100N P=0.195N |
|POLY 6 | P=0.128 P=0.521 P=0.741N P=0.196 |P=0.274N P=0.058N P=0.074N P=0.164N |
|LOGISTIC REGRESSION| P=0.131 P=0.508 P=0.682N P=0.250 |P=0.288N P=0.087N P=0.092N P=0.213N |
|COCH-ARM / FISHERS | P=0.115 P=0.492 P=0.753N P=0.174 |P=0.271N P=0.098N P=0.098N P=0.198N |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.108N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 2/47 (4%) 2/48 (4%) 4/47 (9%) |20/48 (42%) 13/48 (27%) 14/48 (29%) 17/48 (35%) |
|POLY-3 RATE (b) | 1/41.39 2/42.31 2/43.02 4/42.42 |20/44.43 13/45.70 14/44.75 17/44.67 |
|POLY-3 PERCENT (g) | 2.4% 4.7% 4.7% 9.4% |45.0% 28.5% 31.3% 38.1% |
|TERMINAL (d) | 1/24 (4%) 1/30 (3%) 2/34 (6%) 4/30 (13%) |17/33 (52%) 8/36 (22%) 8/35 (23%) 12/34 (35%) |
|FIRST INCIDENCE | 733 (T) 667 733 (T) 733 (T) |589 625 599 570 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.151 P=0.568 P=0.621 P=0.250 |P=0.481N P=0.066N P=0.115N P=0.320N |
|POLY 3 | P=0.122 P=0.508 P=0.514 P=0.185 |P=0.472N P=0.076N P=0.130N P=0.325N |
|POLY 1.5 | P=0.118 P=0.500 P=0.505 P=0.179 |P=0.467N P=0.090N P=0.144N P=0.336N |
|POLY 6 | P=0.128 P=0.521 P=0.530 P=0.196 |P=0.468N P=0.058N P=0.105N P=0.297N |
|LOGISTIC REGRESSION| P=0.130 P=0.508 P=0.621 P=0.250 |P=0.481N P=0.087N P=0.140N P=0.362N |
|COCH-ARM / FISHERS | P=0.113 P=0.492 P=0.500 P=0.174 |P=0.459N P=0.098N P=0.143N P=0.338N |
|ORDER RESTRICTED | P=0.119 (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/45 (67%) 19/46 (41%) 21/48 (44%) 13/45 (29%) |26/47 (55%) 23/47 (49%) 17/45 (38%) 20/46 (43%) |
|POLY-3 RATE (b) | 30/43.12 19/44.24 21/44.24 13/41.49 |26/44.34 23/45.02 17/42.82 20/41.59 |
|POLY-3 PERCENT (g) | 69.6% 43.0% 47.5% 31.3% |58.6% 51.1% 39.7% 48.1% |
|TERMINAL (d) | 15/23 (65%) 10/30 (33%) 16/34 (47%) 11/30 (37%) |19/33 (58%) 18/35 (51%) 12/35 (34%) 17/32 (53%) |
|FIRST INCIDENCE | 541 487 599 645 |627 561 599 632 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.011N* P=0.005N** P<0.001N** |P=0.166N P=0.259N P=0.044N* P=0.199N |
|POLY 3 | P<0.001N** P=0.008N** P=0.026N* P<0.001N** |P=0.170N P=0.306N P=0.056N P=0.218N |
|POLY 1.5 | P<0.001N** P=0.010N* P=0.024N* P<0.001N** |P=0.151N P=0.335N P=0.062N P=0.202N |
|POLY 6 | P=0.002N** P=0.007N** P=0.026N* P<0.001N** |P=0.190N P=0.271N P=0.048N* P=0.236N |
|LOGISTIC REGRESSION| P<0.001N** P=0.016N* P=0.020N* P<0.001N** |P=0.167N P=0.328N P=0.059N P=0.223N |
|COCH-ARM / FISHERS | P<0.001N** P=0.013N* P=0.022N* P<0.001N** |P=0.131N P=0.340N P=0.070N P=0.175N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.130N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 5/47 (11%) 1/48 (2%) 4/47 (9%) |2/48 (4%) 2/48 (4%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 2/41.65 5/42.57 1/43.75 4/42.42 |2/43.64 2/44.68 0/43.67 2/42.63 |
|POLY-3 PERCENT (g) | 4.8% 11.7% 2.3% 9.4% |4.6% 4.5% 0.0% 4.7% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 0/34 (0%) 4/30 (13%) |2/33 (6%) 2/36 (6%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 662 579 477 733 (T) |734 (T) 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.543 P=0.292 P=0.450N P=0.430 |P=0.536N P=0.664N P=0.225N P=0.685N |
|POLY 3 | P=0.488 P=0.224 P=0.483N P=0.345 |P=0.541N P=0.685N P=0.237N P=0.686 |
|POLY 1.5 | P=0.478 P=0.216 P=0.492N P=0.337 |P=0.540N P=0.692N P=0.239N P=0.688 |
|POLY 6 | P=0.504 P=0.238 P=0.466N P=0.358 |P=0.541N P=0.675N P=0.232N P=0.686 |
|LOGISTIC REGRESSION| P=0.460 P=0.211 P=0.445N P=0.374 |P=0.536N P=0.664N (e) P=0.685N |
|COCH-ARM / FISHERS | P=0.467 P=0.209 P=0.500N P=0.329 |P=0.535N P=0.692N P=0.247N P=0.692N |
|ORDER RESTRICTED | P=0.324 (e) (e) (e) |P=0.448N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 1/47 (2%) 1/48 (2%) 5/47 (11%) |0/48 (0%) 1/48 (2%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 4/41.77 1/42.07 1/43.02 5/42.78 |0/43.64 1/44.68 0/43.67 1/43.13 |
|POLY-3 PERCENT (g) | 9.6% 2.4% 2.3% 11.7% |0.0% 2.2% 0.0% 2.3% |
|TERMINAL (d) | 3/24 (13%) 1/30 (3%) 1/34 (3%) 2/30 (7%) |0/33 (0%) 1/36 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 623 733 (T) 733 (T) 687 |--- 734 (T) --- 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 P=0.132N P=0.105N P=0.605 |P=0.433 P=0.517 (e) P=0.491 |
|POLY 3 | P=0.250 P=0.176N P=0.169N P=0.515 |P=0.435 P=0.505 (e) P=0.498 |
|POLY 1.5 | P=0.246 P=0.181N P=0.175N P=0.501 |P=0.435 P=0.501 (e) P=0.498 |
|POLY 6 | P=0.255 P=0.167N P=0.157N P=0.538 |P=0.438 P=0.510 (e) P=0.499 |
|LOGISTIC REGRESSION| P=0.261 P=0.171N P=0.165N P=0.517 |P=0.442 P=0.517 (e) P=0.637 |
|COCH-ARM / FISHERS | P=0.244 P=0.187N P=0.181N P=0.486 |P=0.438 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.148 (e) (e) (e) |P=0.249 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 5/47 (11%) 2/48 (4%) 10/47 (21%) |0/48 (0%) 3/48 (6%) 1/48 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | 4/41.77 5/42.52 2/43.02 10/42.78 |0/43.64 3/44.85 1/44.41 1/43.13 |
|POLY-3 PERCENT (g) | 9.6% 11.8% 4.7% 23.4% |0.0% 6.7% 2.3% 2.3% |
|TERMINAL (d) | 3/24 (13%) 3/30 (10%) 2/34 (6%) 7/30 (23%) |0/33 (0%) 1/36 (3%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 623 604 733 (T) 687 |--- 709 470 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071 P=0.607 P=0.211N P=0.147 |P=0.589N P=0.141 P=0.496 P=0.491 |
|POLY 3 | P=0.042 * P=0.511 P=0.323N P=0.076 |P=0.579N P=0.123 P=0.503 P=0.498 |
|POLY 1.5 | P=0.040 * P=0.499 P=0.332N P=0.071 |P=0.582N P=0.120 P=0.500 P=0.498 |
|POLY 6 | P=0.045 * P=0.533 P=0.304N P=0.086 |P=0.573N P=0.129 P=0.509 P=0.499 |
|LOGISTIC REGRESSION| P=0.049 * P=0.503 P=0.307N P=0.092 |P=0.571N P=0.123 P=0.675 P=0.637 |
|COCH-ARM / FISHERS | P=0.041 * P=0.486 P=0.339N P=0.067 |P=0.579N P=0.121 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.025 * (e) (e) (e) |P=0.232 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 4/47 (9%) 1/48 (2%) 5/47 (11%) |0/48 (0%) 2/48 (4%) 1/48 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/41.39 4/42.52 1/43.02 5/42.42 |0/43.64 2/44.85 1/44.41 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 9.4% 2.3% 11.8% |0.0% 4.5% 2.3% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 1/34 (3%) 5/30 (17%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 604 733 (T) 733 (T) |--- 709 470 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.090 P=0.091 P=0.569 P=0.053 |P=0.409N P=0.260 P=0.496 (e) |
|POLY 3 | P=0.071 P=0.063 P=0.508 P=0.032 * |P=0.404N P=0.243 P=0.503 (e) |
|POLY 1.5 | P=0.067 P=0.060 P=0.503 P=0.030 * |P=0.405N P=0.239 P=0.500 (e) |
|POLY 6 | P=0.077 P=0.068 P=0.517 P=0.035 * |P=0.401N P=0.251 P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.075 P=0.060 P=0.569 P=0.053 |P=0.392N P=0.238 P=0.675 (e) |
|COCH-ARM / FISHERS | P=0.066 P=0.056 P=0.500 P=0.026 * |P=0.400N P=0.247 P=0.500 (e) |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) |P=0.332 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 3/47 (6%) 0/48 (0%) 2/47 (4%) |0/48 (0%) 1/48 (2%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/41.65 3/42.57 0/43.02 2/42.42 |0/43.64 1/44.68 0/43.67 1/42.63 |
|POLY-3 PERCENT (g) | 4.8% 7.1% 0.0% 4.7% |0.0% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 1/24 (4%) 2/30 (7%) 0/34 (0%) 2/30 (7%) |0/33 (0%) 1/36 (3%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 662 579 --- 733 (T) |--- 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.381N P=0.567 P=0.189N P=0.628N |P=0.438 P=0.517 (e) P=0.506 |
|POLY 3 | P=0.428N P=0.510 P=0.230N P=0.688N |P=0.433 P=0.505 (e) P=0.495 |
|POLY 1.5 | P=0.433N P=0.501 P=0.234N P=0.694 |P=0.434 P=0.501 (e) P=0.497 |
|POLY 6 | P=0.420N P=0.526 P=0.220N P=0.677N |P=0.433 P=0.510 (e) P=0.495 |
|LOGISTIC REGRESSION| P=0.437N P=0.480 P=0.237N P=0.678N |(e) P=0.517 (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.438N P=0.490 P=0.247N P=0.684 |P=0.438 P=0.500 (e) P=0.500 |
|ORDER RESTRICTED | P=0.325N (e) (e) (e) |P=0.247 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 3/47 (6%) 1/48 (2%) 0/47 (0%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/41.39 3/42.07 1/43.16 0/42.42 |0/43.64 0/44.68 0/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 3/30 (10%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 733 (T) 698 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251N P=0.162 P=0.539 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.274N P=0.121 P=0.508 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.283N P=0.118 P=0.503 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.259N P=0.127 P=0.519 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.272N P=0.162 P=0.501 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.294N P=0.117 P=0.500 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.218N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 3/47 (6%) 0/48 (0%) 4/47 (9%) |0/48 (0%) 2/48 (4%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/41.39 3/42.51 0/43.02 4/42.42 |0/43.64 2/44.85 0/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 0.0% 9.4% |0.0% 4.5% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 0/34 (0%) 4/30 (13%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 604 --- 733 (T) |--- 709 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 P=0.151 (e) P=0.093 |P=0.328N P=0.260 (e) (e) |
|POLY 3 | P=0.092 P=0.123 (e) P=0.063 |P=0.318N P=0.243 (e) (e) |
|POLY 1.5 | P=0.088 P=0.119 (e) P=0.060 |P=0.322N P=0.239 (e) (e) |
|POLY 6 | P=0.098 P=0.130 (e) P=0.067 |P=0.312N P=0.251 (e) (e) |
|LOGISTIC REGRESSION| P=0.093 P=0.113 (e) P=0.093 |P=0.324N P=0.238 (e) (e) |
|COCH-ARM / FISHERS | P=0.087 P=0.117 (e) P=0.056 |P=0.321N P=0.247 (e) (e) |
|ORDER RESTRICTED | P=0.019 * (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/47 (4%) 0/48 (0%) 0/47 (0%) |1/48 (2%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/41.39 2/42.07 0/43.02 0/42.42 |1/43.64 0/44.68 0/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 0/34 (0%) 0/30 (0%) |1/33 (3%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |734 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285N P=0.288 (e) (e) |P=0.329N P=0.483N P=0.488N P=0.494N |
|POLY 3 | P=0.309N P=0.240 (e) (e) |P=0.331N P=0.495N P=0.500N P=0.505N |
|POLY 1.5 | P=0.316N P=0.237 (e) (e) |P=0.330N P=0.499N P=0.502N P=0.503N |
|POLY 6 | P=0.297N P=0.248 (e) (e) |P=0.333N P=0.490N P=0.495N P=0.505N |
|LOGISTIC REGRESSION| (e) P=0.288 (e) (e) |P=0.329N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.323N P=0.242 (e) (e) |P=0.330N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.245N (e) (e) (e) |P=0.125N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 5/47 (11%) 0/48 (0%) 3/47 (6%) |1/48 (2%) 1/48 (2%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/41.65 5/42.57 0/43.02 3/42.42 |1/43.64 1/44.68 0/43.67 1/42.63 |
|POLY-3 PERCENT (g) | 4.8% 11.7% 0.0% 7.1% |2.3% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 0/34 (0%) 3/30 (10%) |1/33 (3%) 1/36 (3%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 662 579 --- 733 (T) |734 (T) 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.403N P=0.292 P=0.189N P=0.586 |P=0.600N P=0.742N P=0.488N P=0.755N |
|POLY 3 | P=0.461N P=0.224 P=0.230N P=0.508 |P=0.602N P=0.755N P=0.500N P=0.755 |
|POLY 1.5 | P=0.470N P=0.216 P=0.234N P=0.500 |P=0.601N P=0.760N P=0.502N P=0.757 |
|POLY 6 | P=0.447N P=0.238 P=0.220N P=0.522 |P=0.601N P=0.749N P=0.495N P=0.756 |
|LOGISTIC REGRESSION| P=0.463N P=0.211 P=0.237N P=0.532 |P=0.600N P=0.742N (e) P=0.755N |
|COCH-ARM / FISHERS | P=0.477N P=0.209 P=0.247N P=0.490 |P=0.600N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.277N (e) (e) (e) |P=0.540N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 5/47 (11%) 0/48 (0%) 2/47 (4%) |1/48 (2%) 1/48 (2%) 0/48 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 2/41.65 5/42.57 0/43.02 2/42.42 |1/43.64 1/44.68 0/43.67 1/42.63 |
|POLY-3 PERCENT (g) | 4.8% 11.7% 0.0% 4.7% |2.3% 2.2% 0.0% 2.4% |
|TERMINAL (d) | 1/24 (4%) 4/30 (13%) 0/34 (0%) 2/30 (7%) |1/33 (3%) 1/36 (3%) 0/35 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 662 579 --- 733 (T) |734 (T) 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.292 P=0.189N P=0.628N |P=0.600N P=0.742N P=0.488N P=0.755N |
|POLY 3 | P=0.264N P=0.224 P=0.230N P=0.688N |P=0.602N P=0.755N P=0.500N P=0.755 |
|POLY 1.5 | P=0.271N P=0.216 P=0.234N P=0.694 |P=0.601N P=0.760N P=0.502N P=0.757 |
|POLY 6 | P=0.252N P=0.238 P=0.220N P=0.677N |P=0.601N P=0.749N P=0.495N P=0.756 |
|LOGISTIC REGRESSION| P=0.271N P=0.211 P=0.237N P=0.678N |P=0.600N P=0.742N (e) P=0.755N |
|COCH-ARM / FISHERS | P=0.280N P=0.209 P=0.247N P=0.684 |P=0.600N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.540N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 37/48 (77%) 42/47 (89%) 43/48 (90%) 45/47 (96%) | |
|POLY-3 RATE (b) | 37/44.86 42/45.01 43/46.62 45/47.00 | |
|POLY-3 PERCENT (g) | 82.5% 93.3% 92.2% 95.7% | |
|TERMINAL (d) | 23/24 (96%) 29/30 (97%) 32/34 (94%) 28/30 (93%) | |
|FIRST INCIDENCE | 564 579 435 475 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.444 P=0.428N P=0.223N P=0.503 | |
|POLY 3 | P=0.036 * P=0.078 P=0.115 P=0.029 * | |
|POLY 1.5 | P=0.018 * P=0.080 P=0.092 P=0.015 * | |
|POLY 6 | P=0.104 P=0.090 P=0.182 P=0.078 | |
|LOGISTIC REGRESSION| P=0.010 * P=0.113 P=0.074 P=0.012 * | |
|COCH-ARM / FISHERS | P=0.010 * P=0.092 P=0.085 P=0.008 ** | |
|ORDER RESTRICTED | P=0.009 ** (e) (e) (e) | |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/47 (13%) 7/47 (15%) 7/48 (15%) 4/46 (9%) |4/46 (9%) 7/46 (15%) 5/47 (11%) 5/48 (10%) |
|POLY-3 RATE (b) | 6/41.54 7/42.50 7/43.43 4/41.55 |4/42.42 7/43.27 5/42.73 5/42.85 |
|POLY-3 PERCENT (g) | 14.4% 16.5% 16.1% 9.6% |9.4% 16.2% 11.7% 11.7% |
|TERMINAL (d) | 3/24 (13%) 6/30 (20%) 5/34 (15%) 4/30 (13%) |3/33 (9%) 6/35 (17%) 4/34 (12%) 3/34 (9%) |
|FIRST INCIDENCE | 613 606 629 733 (T) |589 725 719 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.182N P=0.604N P=0.532N P=0.264N |P=0.538N P=0.300 P=0.518 P=0.513 |
|POLY 3 | P=0.266N P=0.518 P=0.535 P=0.368N |P=0.536N P=0.271 P=0.505 P=0.506 |
|POLY 1.5 | P=0.273N P=0.509 P=0.522 P=0.376N |P=0.525N P=0.262 P=0.502 P=0.513 |
|POLY 6 | P=0.256N P=0.534 P=0.563 P=0.357N |P=0.544N P=0.285 P=0.513 P=0.503 |
|LOGISTIC REGRESSION| P=0.254N P=0.517 P=0.533 P=0.352N |P=0.542N P=0.272 P=0.510 P=0.516 |
|COCH-ARM / FISHERS | P=0.279N P=0.500 P=0.517 P=0.384N |P=0.507N P=0.261 P=0.514 P=0.527 |
|ORDER RESTRICTED | P=0.344N (e) (e) (e) |P=0.472 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/47 (2%) 2/47 (4%) 0/48 (0%) 0/46 (0%) |0/46 (0%) 1/46 (2%) 1/47 (2%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/40.81 2/42.08 0/43.02 0/41.55 |0/41.94 1/43.68 1/42.67 0/42.63 |
|POLY-3 PERCENT (g) | 2.5% 4.8% 0.0% 0.0% |0.0% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/30 (3%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/35 (0%) 1/34 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 731 729 --- --- |--- 605 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.134N P=0.573 P=0.446N P=0.471N |P=0.566N P=0.509 P=0.506 (e) |
|POLY 3 | P=0.151N P=0.511 P=0.489N P=0.496N |P=0.558N P=0.508 P=0.503 (e) |
|POLY 1.5 | P=0.154N P=0.505 P=0.493N P=0.500N |P=0.557N P=0.503 P=0.502 (e) |
|POLY 6 | P=0.146N P=0.521 P=0.481N P=0.490N |P=0.558N P=0.515 P=0.507 (e) |
|LOGISTIC REGRESSION| P=0.138N P=0.558 P=0.454N P=0.476N |P=0.547N P=0.547 P=0.506 (e) |
|COCH-ARM / FISHERS | P=0.156N P=0.500 P=0.495N P=0.505N |P=0.552N P=0.500 P=0.505 (e) |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.403N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/47 (15%) 9/47 (19%) 7/48 (15%) 4/46 (9%) |4/46 (9%) 8/46 (17%) 6/47 (13%) 5/48 (10%) |
|POLY-3 RATE (b) | 7/41.55 9/42.52 7/43.43 4/41.55 |4/42.42 8/43.71 6/42.73 5/42.85 |
|POLY-3 PERCENT (g) | 16.9% 21.2% 16.1% 9.6% |9.4% 18.3% 14.0% 11.7% |
|TERMINAL (d) | 3/24 (13%) 7/30 (23%) 5/34 (15%) 4/30 (13%) |3/33 (9%) 6/35 (17%) 5/34 (15%) 3/34 (9%) |
|FIRST INCIDENCE | 613 606 629 733 (T) |589 605 719 676 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084N P=0.544 P=0.405N P=0.175N |P=0.499N P=0.213 P=0.389 P=0.513 |
|POLY 3 | P=0.135N P=0.410 P=0.580N P=0.259N |P=0.499N P=0.190 P=0.374 P=0.506 |
|POLY 1.5 | P=0.141N P=0.401 P=0.592N P=0.266N |P=0.487N P=0.180 P=0.371 P=0.513 |
|POLY 6 | P=0.126N P=0.428 P=0.551N P=0.247N |P=0.509N P=0.205 P=0.381 P=0.503 |
|LOGISTIC REGRESSION| P=0.124N P=0.422 P=0.577N P=0.240N |P=0.491N P=0.177 P=0.380 P=0.516 |
|COCH-ARM / FISHERS | P=0.146N P=0.392 P=0.597N P=0.274N |P=0.465N P=0.177 P=0.384 P=0.527 |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) |P=0.380 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/47 (4%) 0/48 (0%) 1/46 (2%) |0/46 (0%) 0/46 (0%) 0/47 (0%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/40.80 2/42.07 0/43.02 1/41.55 |0/41.94 0/43.24 0/42.67 1/42.63 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 2.4% |0.0% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 0/34 (0%) 1/30 (3%) |0/33 (0%) 0/35 (0%) 0/34 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- 733 (T) --- 733 (T) |--- --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.645 P=0.288 (e) P=0.545 |P=0.192 (e) (e) P=0.506 |
|POLY 3 | P=0.610 P=0.244 (e) P=0.504 |P=0.191 (e) (e) P=0.503 |
|POLY 1.5 | P=0.603 P=0.240 (e) P=0.500 |P=0.194 (e) (e) P=0.505 |
|POLY 6 | P=0.623 P=0.250 (e) P=0.510 |P=0.189 (e) (e) P=0.503 |
|LOGISTIC REGRESSION| (e) P=0.288 (e) P=0.545 |(e) (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.596 P=0.247 (e) P=0.495 |P=0.197 (e) (e) P=0.511 |
|ORDER RESTRICTED | P=0.329 (e) (e) (e) |P=0.123 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/47 (0%) 1/48 (2%) 2/46 (4%) |0/46 (0%) 1/46 (2%) 2/47 (4%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/40.80 0/42.07 1/43.28 2/41.55 |0/41.94 1/43.25 2/42.67 0/42.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 4.8% |0.0% 2.3% 4.7% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/34 (0%) 2/30 (7%) |0/33 (0%) 0/35 (0%) 2/34 (6%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 662 733 (T) |--- 732 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072 (e) P=0.526 P=0.288 |P=0.598N P=0.523 P=0.245 (e) |
|POLY 3 | P=0.064 (e) P=0.512 P=0.241 |P=0.601N P=0.506 P=0.241 (e) |
|POLY 1.5 | P=0.062 (e) P=0.507 P=0.237 |P=0.597N P=0.502 P=0.239 (e) |
|POLY 6 | P=0.066 (e) P=0.521 P=0.248 |P=0.605N P=0.512 P=0.245 (e) |
|LOGISTIC REGRESSION| P=0.063 (e) P=0.512 P=0.288 |P=0.601N P=0.519 P=0.245 (e) |
|COCH-ARM / FISHERS | P=0.061 (e) P=0.505 P=0.242 |P=0.589N P=0.500 P=0.253 (e) |
|ORDER RESTRICTED | P=0.076 (e) (e) (e) |P=0.328N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/47 (4%) 1/48 (2%) 3/46 (7%) |0/46 (0%) 1/46 (2%) 2/47 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 0/40.80 2/42.07 1/43.28 3/41.55 |0/41.94 1/43.25 2/42.67 1/42.63 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 2.3% 7.2% |0.0% 2.3% 4.7% 2.4% |
|TERMINAL (d) | 0/24 (0%) 2/30 (7%) 0/34 (0%) 3/30 (10%) |0/33 (0%) 0/35 (0%) 2/34 (6%) 1/34 (3%) |
|FIRST INCIDENCE | --- 733 (T) 662 733 (T) |--- 732 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145 P=0.288 P=0.526 P=0.162 |P=0.373 P=0.523 P=0.245 P=0.506 |
|POLY 3 | P=0.122 P=0.244 P=0.512 P=0.121 |P=0.367 P=0.506 P=0.241 P=0.503 |
|POLY 1.5 | P=0.118 P=0.240 P=0.507 P=0.118 |P=0.374 P=0.502 P=0.239 P=0.505 |
|POLY 6 | P=0.129 P=0.250 P=0.521 P=0.127 |P=0.361 P=0.512 P=0.245 P=0.503 |
|LOGISTIC REGRESSION| P=0.125 P=0.288 P=0.512 P=0.162 |P=0.370 P=0.519 P=0.245 P=0.506 |
|COCH-ARM / FISHERS | P=0.115 P=0.247 P=0.505 P=0.117 |P=0.384 P=0.500 P=0.253 P=0.511 |
|ORDER RESTRICTED | P=0.058 (e) (e) (e) |P=0.229 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |10/48 (21%) 12/48 (25%) 19/48 (40%) 17/48 (35%) |
|POLY-3 RATE (b) | |10/44.43 12/44.69 19/45.15 17/43.63 |
|POLY-3 PERCENT (g) | |22.5% 26.9% 42.1% 39.0% |
|TERMINAL (d) | |8/33 (24%) 11/36 (31%) 14/35 (40%) 13/34 (38%) |
|FIRST INCIDENCE | |585 732 482 570 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.047 * P=0.491 P=0.062 P=0.103 |
|POLY 3 | |P=0.035 * P=0.409 P=0.037 * P=0.071 |
|POLY 1.5 | |P=0.039 * P=0.398 P=0.034 * P=0.075 |
|POLY 6 | |P=0.034 * P=0.426 P=0.044 * P=0.071 |
|LOGISTIC REGRESSION| |P=0.037 * P=0.448 P=0.036 * P=0.075 |
|COCH-ARM / FISHERS | |P=0.046 * P=0.404 P=0.037 * P=0.086 |
|ORDER RESTRICTED | |P=0.049 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |11/48 (23%) 12/48 (25%) 19/48 (40%) 18/48 (38%) |
|POLY-3 RATE (b) | |11/44.43 12/44.69 19/45.15 18/44.24 |
|POLY-3 PERCENT (g) | |24.8% 26.9% 42.1% 40.7% |
|TERMINAL (d) | |9/33 (27%) 11/36 (31%) 14/35 (40%) 13/34 (38%) |
|FIRST INCIDENCE | |585 732 482 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.043 * P=0.590 P=0.095 P=0.110 |
|POLY 3 | |P=0.035 * P=0.506 P=0.062 P=0.082 |
|POLY 1.5 | |P=0.037 * P=0.494 P=0.057 P=0.083 |
|POLY 6 | |P=0.036 * P=0.525 P=0.073 P=0.085 |
|LOGISTIC REGRESSION| |P=0.035 * P=0.550 P=0.059 P=0.084 |
|COCH-ARM / FISHERS | |P=0.041 * P=0.500 P=0.061 P=0.091 |
|ORDER RESTRICTED | |P=0.070 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/47 (0%) 0/48 (0%) 0/47 (0%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/41.39 0/42.07 0/43.02 0/42.42 |0/43.64 0/44.68 0/43.67 2/42.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.245 |
|POLY 3 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.232 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.233 |
|POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.245 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/47 (0%) 0/48 (0%) 1/47 (2%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 2/48 (4%) |
|POLY-3 RATE (b) | 1/41.75 0/42.07 0/43.02 1/42.74 |0/43.64 0/44.68 0/43.67 2/42.63 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 2.3% |0.0% 0.0% 0.0% 4.7% |
|TERMINAL (d) | 0/24 (0%) 0/30 (0%) 0/34 (0%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 632 --- --- 645 |--- --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590 P=0.505N P=0.490N P=0.733N |P=0.043 * (e) (e) P=0.245 |
|POLY 3 | P=0.563 P=0.498N P=0.494N P=0.756N |P=0.041 * (e) (e) P=0.232 |
|POLY 1.5 | P=0.561 P=0.501N P=0.498N P=0.760N |P=0.042 * (e) (e) P=0.233 |
|POLY 6 | P=0.565 P=0.493N P=0.486N P=0.748N |P=0.041 * (e) (e) P=0.232 |
|LOGISTIC REGRESSION| P=0.559 P=0.509N P=0.473N P=0.751 |(e) (e) (e) P=0.245 |
|COCH-ARM / FISHERS | P=0.560 P=0.505N P=0.500N P=0.747 |P=0.044 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.393N (e) (e) (e) |P=0.027 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 29/48 (60%) 16/47 (34%) 19/48 (40%) 7/47 (15%) |17/48 (35%) 8/48 (17%) 5/48 (10%) 8/48 (17%) |
|POLY-3 RATE (b) | 29/45.63 16/43.73 19/45.63 7/43.71 |17/45.99 8/44.96 5/45.33 8/44.06 |
|POLY-3 PERCENT (g) | 63.6% 36.6% 41.6% 16.0% |37.0% 17.8% 11.0% 18.2% |
|TERMINAL (d) | 12/24 (50%) 9/30 (30%) 9/34 (27%) 2/30 (7%) |8/33 (24%) 6/36 (17%) 1/35 (3%) 3/34 (9%) |
|FIRST INCIDENCE | 564 579 435 601 |552 683 482 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.006N** P=0.011N* P<0.001N** |P=0.053N P=0.029N* P=0.007N** P=0.048N* |
|POLY 3 | P<0.001N** P=0.007N** P=0.026N* P<0.001N** |P=0.038N* P=0.033N* P=0.003N** P=0.037N* |
|POLY 1.5 | P<0.001N** P=0.007N** P=0.029N* P<0.001N** |P=0.036N* P=0.033N* P=0.003N** P=0.034N* |
|POLY 6 | P<0.001N** P=0.008N** P=0.022N* P<0.001N** |P=0.039N* P=0.032N* P=0.003N** P=0.040N* |
|LOGISTIC REGRESSION| P<0.001N** P=0.009N** P=0.035N* P<0.001N** |P=0.033N* P=0.031N* P=0.002N** P=0.023N* |
|COCH-ARM / FISHERS | P<0.001N** P=0.009N** P=0.033N* P<0.001N** |P=0.037N* P=0.031N* P=0.003N** P=0.031N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/47 (0%) 1/48 (2%) 1/47 (2%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/41.80 0/42.07 1/43.02 1/43.14 |0/43.64 0/44.68 0/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 2.3% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 1/34 (3%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 613 --- 733 (T) 475 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517N P=0.218N P=0.420N P=0.474N |(e) (e) (e) (e) |
|POLY 3 | P=0.543N P=0.235N P=0.490N P=0.489N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.544N P=0.239N P=0.496N P=0.497N |(e) (e) (e) (e) |
|POLY 6 | P=0.541N P=0.229N P=0.476N P=0.477N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.554N P=0.251N P=0.501N P=0.511N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.547N P=0.253N P=0.500N P=0.508N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.261N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/47 (0%) 1/48 (2%) 1/47 (2%) |0/48 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/41.80 0/42.07 1/43.02 1/43.14 |0/43.64 0/44.68 0/43.67 0/42.63 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 2.3% 2.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/30 (0%) 1/34 (3%) 0/30 (0%) |0/33 (0%) 0/36 (0%) 0/35 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 613 --- 733 (T) 475 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517N P=0.218N P=0.420N P=0.474N |(e) (e) (e) (e) |
|POLY 3 | P=0.543N P=0.235N P=0.490N P=0.489N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.544N P=0.239N P=0.496N P=0.497N |(e) (e) (e) (e) |
|POLY 6 | P=0.541N P=0.229N P=0.476N P=0.477N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.554N P=0.251N P=0.501N P=0.511N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.547N P=0.253N P=0.500N P=0.508N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.261N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/48 (94%) 47/47 (100%) 47/48 (98%) 47/47 (100%)|41/48 (85%) 43/48 (90%) 37/48 (77%) 38/48 (79%) |
|POLY-3 RATE (b) | 45/47.39 47/47.00 47/47.22 47/47.00 |41/46.56 43/46.81 37/45.89 38/45.85 |
|POLY-3 PERCENT (g) | 95.0% 100.0% 99.6% 100.0% |88.1% 91.9% 80.6% 82.9% |
|TERMINAL (d) | 24/24 (100%) 30/30 (100%) 34/34 (100%) 30/30 (100%)|29/33 (88%) 33/36 (92%) 27/35 (77%) 29/34 (85%) |
|FIRST INCIDENCE | 541 487 435 475 |585 561 482 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.241N P=0.064N P=0.230N |P=0.235N P=0.468N P=0.181N P=0.313N |
|POLY 3 | P=0.094 P=0.166 P=0.208 P=0.166 |P=0.140N P=0.390 P=0.237N P=0.334N |
|POLY 1.5 | P=0.092 P=0.143 P=0.231 P=0.143 |P=0.126N P=0.340 P=0.254N P=0.323N |
|POLY 6 | P=0.116 P=0.209 P=0.219 P=0.209 |P=0.155N P=0.461 P=0.208N P=0.342N |
|LOGISTIC REGRESSION| P=0.096 P=0.131 P=0.226 P=0.134 |P=0.170N P=0.366 P=0.258N P=0.381N |
|COCH-ARM / FISHERS | P=0.113 P=0.125 P=0.308 P=0.125 |P=0.121N P=0.379 P=0.217N P=0.297N |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.187N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/18/03 EXPERIMENT: 93029 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER344) - LEUKOMALACHITE GREEN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 34/48 (71%) 23/47 (49%) 25/48 (52%) 26/47 (55%) |21/48 (44%) 16/48 (33%) 19/48 (40%) 15/48 (31%) |
|POLY-3 RATE (b) | 34/46.06 23/44.59 25/47.22 26/46.40 |21/47.00 16/46.06 19/47.60 15/44.67 |
|POLY-3 PERCENT (g) | 73.8% 51.6% 53.0% 56.0% |44.7% 34.7% 39.9% 33.6% |
|TERMINAL (d) | 15/24 (63%) 13/30 (43%) 12/34 (35%) 13/30 (43%) |10/33 (30%) 7/36 (19%) 10/35 (29%) 9/34 (27%) |
|FIRST INCIDENCE | 564 579 435 475 |552 605 102 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111N P=0.014N* P=0.015N* P=0.044N* |P=0.253N P=0.175N P=0.383N P=0.179N |
|POLY 3 | P=0.132N P=0.020N* P=0.027N* P=0.054N |P=0.242N P=0.221N P=0.397N P=0.190N |
|POLY 1.5 | P=0.156N P=0.021N* P=0.035N* P=0.066N |P=0.220N P=0.223N P=0.407N P=0.172N |
|POLY 6 | P=0.110N P=0.020N* P=0.019N* P=0.043N* |P=0.269N P=0.214N P=0.383N P=0.212N |
|LOGISTIC REGRESSION| P=0.232N P=0.025N* P=0.056N P=0.119N |P=0.159N P=0.198N P=0.515N P=0.114N |
|COCH-ARM / FISHERS | P=0.195N P=0.024N* P=0.046N* P=0.088N |P=0.198N P=0.201N P=0.418N P=0.146N |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |P=0.218N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 91 PPM 272 PPM 543 PPM |0 PPM 91 PPM 272 PPM 543 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 48/48 (100%) 47/47 (100%) 47/48 (98%) 47/47 (100%)|46/48 (96%) 46/48 (96%) 42/48 (88%) 43/48 (90%) |
|POLY-3 RATE (b) | 48/48.00 47/47.00 47/47.22 47/47.00 |46/48.00 46/47.00 42/48.00 43/47.17 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 99.6% 100.0% |95.8% 97.9% 87.5% 91.2% |
|TERMINAL (d) | 24/24 (100%) 30/30 (100%) 34/34 (100%) 30/30 (100%)|31/33 (94%) 35/36 (97%) 29/35 (83%) 30/34 (88%) |
|FIRST INCIDENCE | 541 487 435 475 |552 561 102 484 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.125N (e) P=0.023N* (e) |P=0.307N P=0.310N P=0.190N P=0.331N |
|POLY 3 | P=0.998N (e) P=1.000N (e) |P=0.111N P=0.507 P=0.134N P=0.305N |
|POLY 1.5 | P=0.883N (e) P=0.874N (e) |P=0.096N P=0.513 P=0.134N P=0.274N |
|POLY 6 | P=1.000N (e) P=1.000N (e) |P=0.122N P=0.507 P=0.134N P=0.324N |
|LOGISTIC REGRESSION| P=0.999 (e) (e) (e) |P=0.104N P=0.591 (e) P=0.234N |
|COCH-ARM / FISHERS | P=0.667N (e) P=0.500N (e) |P=0.098N P=0.692N P=0.134N P=0.218N |
|ORDER RESTRICTED | P=0.380N (e) (e) (e) |P=0.109N (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).