TDMS Study 96001-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 01/08/03
EXPERIMENT: 96001 TEST: 05 TIME: 12:11:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: RENNE, ROGER CAS: 64742-88-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 01/08/03
EXPERIMENT: 96001 TEST: 05 TIME: 12:11:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: RENNE, ROGER CAS: 64742-88-7
Rats(FISCHER 344)
-----------------------------
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
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pituitary Gland
Prostate
Salivary Glands
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 01/08/03
EXPERIMENT: 96001 TEST: 05 TIME: 12:11:39
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: RENNE, ROGER CAS: 64742-88-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF STODDARD SOLVENT (TYPE IIC)
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Bone Osteosarcoma
Clitoral/Preputial Gland Carcinoma or Adenoma
Skin Basal Cell Carcinoma
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Osteosarcoma
Osteosarcoma or Osteoma
Benign Tumors
Malignant Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Brain Glioma Malignant
Oligodendroglioma, Glioma, or Astrocytoma
Clitoral/Preputial Gland Adenoma
Carcinoma or Adenoma
Mammary Gland Carcinoma
Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 9/50 (18%) 13/50 (26%) 17/50 (34%) |2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 5/45.63 9/39.38 13/43.53 17/40.82 |2/44.62 4/43.89 2/44.80 2/41.23 |
|POLY-3 PERCENT (g) | 11.0% 22.9% 29.9% 41.6% |4.5% 9.1% 4.5% 4.9% |
|TERMINAL (d) | 3/29 (10%) 5/19 (26%) 5/21 (24%) 7/16 (44%) |2/36 (6%) 2/30 (7%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | 626 605 541 652 |730 (T) 726 730 (T) 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.050 P=0.015 * P<0.001 ** |P=0.585 P=0.269 P=0.652 P=0.599 |
|POLY 3 | P<0.001 ** P=0.117 P=0.022 * P<0.001 ** |P=0.490N P=0.329 P=0.693N P=0.665 |
|POLY 1.5 | P<0.001 ** P=0.148 P=0.026 * P<0.001 ** |P=0.478N P=0.334 P=0.693N P=0.677 |
|POLY 6 | P<0.001 ** P=0.081 P=0.019 * P<0.001 ** |P=0.507N P=0.321 P=0.693N P=0.650 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.099 P=0.035 * P<0.001 ** |P=0.511N P=0.286 P=0.652 P=0.688 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.194 P=0.033 * P=0.004 ** |P=0.456N P=0.339 P=0.691N P=0.691N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.531N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.22 0/38.44 0/41.34 2/40.07 |1/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 5.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 684 --- --- 565 |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.192 P=0.628N P=0.528N P=0.409 |P=0.343N P=0.536N P=0.523N P=0.573N |
|POLY 3 | P=0.216 P=0.532N P=0.518N P=0.458 |P=0.293N P=0.503N P=0.499N P=0.519N |
|POLY 1.5 | P=0.215 P=0.518N P=0.510N P=0.476 |P=0.299N P=0.502N P=0.500N P=0.511N |
|POLY 6 | P=0.216 P=0.553N P=0.527N P=0.431 |P=0.284N P=0.507N P=0.499N P=0.529N |
|LOGISTIC REGRESSION| P=0.230 P=0.508N P=0.495N P=0.594 |P=0.343N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.214 P=0.500N P=0.500N P=0.500 |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.108 (e) (e) (e) |P=0.137N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 13/50 (26%) 19/50 (38%) |3/50 (6%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/45.81 9/39.38 13/43.53 19/41.48 |3/44.62 4/43.89 2/44.80 2/41.23 |
|POLY-3 PERCENT (g) | 13.1% 22.9% 29.9% 45.8% |6.7% 9.1% 4.5% 4.9% |
|TERMINAL (d) | 3/29 (10%) 5/19 (26%) 5/21 (24%) 7/16 (44%) |3/36 (8%) 2/30 (7%) 2/32 (6%) 0/25 (0%) |
|FIRST INCIDENCE | 626 605 541 565 |730 (T) 726 730 (T) 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.081 P=0.029 * P<0.001 ** |P=0.454N P=0.412 P=0.554N P=0.623N |
|POLY 3 | P<0.001 ** P=0.185 P=0.044 * P<0.001 ** |P=0.348N P=0.491 P=0.498N P=0.536N |
|POLY 1.5 | P<0.001 ** P=0.228 P=0.050 P<0.001 ** |P=0.337N P=0.496 P=0.499N P=0.522N |
|POLY 6 | P<0.001 ** P=0.133 P=0.038 * P<0.001 ** |P=0.362N P=0.482 P=0.498N P=0.555N |
|LOGISTIC REGRESSION| P<0.001 ** P=0.168 P=0.066 P<0.001 ** |P=0.372N P=0.439 P=0.554N P=0.527N |
|COCH-ARM / FISHERS | P<0.001 ** P=0.288 P=0.062 P=0.002 ** |P=0.319N P=0.500 P=0.500N P=0.500N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.427N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.04 0/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.335N P=0.311N P=0.376N |(e) (e) (e) (e) |
|POLY 3 | P=0.133N P=0.274N P=0.257N P=0.268N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.140N P=0.257N P=0.249N P=0.254N |(e) (e) (e) (e) |
|POLY 6 | P=0.123N P=0.300N P=0.267N P=0.289N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.205N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain |
| Glioma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 0/39.41 |0/44.22 0/43.87 0/44.80 2/40.80 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.031 * (e) (e) P=0.178 |
|POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.220 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.228 |
|POLY 6 | (e) (e) (e) (e) |P=0.041 * (e) (e) P=0.208 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.038 * (e) (e) P=0.210 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.047 * (e) (e) P=0.253 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 0/41.34 0/39.41 |0/44.22 0/43.87 0/44.80 2/40.80 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405N P=0.584N P=0.564N P=0.619N |P=0.031 * (e) (e) P=0.178 |
|POLY 3 | P=0.318N P=0.531N P=0.517N P=0.527N |P=0.043 * (e) (e) P=0.220 |
|POLY 1.5 | P=0.329N P=0.518N P=0.510N P=0.515N |P=0.044 * (e) (e) P=0.228 |
|POLY 6 | P=0.302N P=0.552N P=0.526N P=0.543N |P=0.041 * (e) (e) P=0.208 |
|LOGISTIC REGRESSION| P=0.405N (e) (e) (e) |P=0.038 * (e) (e) P=0.210 |
|COCH-ARM / FISHERS | P=0.343N P=0.500N P=0.500N P=0.500N |P=0.047 * (e) (e) P=0.253 |
|ORDER RESTRICTED | P=0.145N (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 3/50 (6%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/45.04 1/38.94 2/41.34 1/39.41 |0/43.62 3/43.87 5/44.98 6/41.15 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 4.8% 2.5% |0.0% 6.8% 11.1% 14.6% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 2/21 (10%) 1/16 (6%) |0/35 (0%) 3/30 (10%) 4/32 (13%) 4/25 (16%) |
|FIRST INCIDENCE | --- 579 729 (T) 729 (T) |--- 730 (T) 682 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265 P=0.487 P=0.170 P=0.381 |P=0.005 ** P=0.095 P=0.029 * P=0.007 ** |
|POLY 3 | P=0.323 P=0.471 P=0.218 P=0.473 |P=0.011 * P=0.119 P=0.033 * P=0.012 * |
|POLY 1.5 | P=0.346 P=0.484 P=0.226 P=0.485 |P=0.012 * P=0.121 P=0.033 * P=0.014 * |
|POLY 6 | P=0.290 P=0.452 P=0.209 P=0.456 |P=0.009 ** P=0.116 P=0.033 * P=0.010 * |
|LOGISTIC REGRESSION| P=0.353 P=0.660 P=0.170 P=0.381 |P=0.008 ** P=0.095 P=0.035 * P=0.013 * |
|COCH-ARM / FISHERS | P=0.373 P=0.500 P=0.247 P=0.500 |P=0.016 * P=0.125 P=0.030 * P=0.014 * |
|ORDER RESTRICTED | P=0.209 (e) (e) (e) |P=0.009 ** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.04 1/38.82 3/42.30 0/39.41 |1/43.62 2/43.87 1/44.80 1/41.03 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 7.1% 0.0% |2.3% 4.6% 2.2% 2.4% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |1/35 (3%) 2/30 (7%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- 621 396 --- |730 (T) 730 (T) 730 (T) 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.568 P=0.477 P=0.099 (e) |P=0.618N P=0.446 P=0.742 P=0.709 |
|POLY 3 | P=0.562 P=0.470 P=0.108 (e) |P=0.546N P=0.502 P=0.755N P=0.747 |
|POLY 1.5 | P=0.593 P=0.483 P=0.112 (e) |P=0.538N P=0.505 P=0.755N P=0.754 |
|POLY 6 | P=0.514 P=0.452 P=0.101 (e) |P=0.557N P=0.497 P=0.755N P=0.737 |
|LOGISTIC REGRESSION| P=0.574N P=0.596 P=0.197 (e) |P=0.556N P=0.446 P=0.742 P=0.757N |
|COCH-ARM / FISHERS | P=0.627N P=0.500 P=0.121 (e) |P=0.525N P=0.508 P=0.747N P=0.747N |
|ORDER RESTRICTED | P=0.209 (e) (e) (e) |P=0.598N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |1/49 (2%) 5/50 (10%) 6/50 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | 0/45.04 2/39.32 5/42.30 1/39.41 |1/43.62 5/43.87 6/44.98 7/41.52 |
|POLY-3 PERCENT (g) | 0.0% 5.1% 11.8% 2.5% |2.3% 11.4% 13.3% 16.9% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 3/21 (14%) 1/16 (6%) |1/35 (3%) 5/30 (17%) 5/32 (16%) 4/25 (16%) |
|FIRST INCIDENCE | --- 579 396 729 (T) |730 (T) 730 (T) 682 606 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290 P=0.220 P=0.019 * P=0.381 |P=0.012 * P=0.070 P=0.049 * P=0.013 * |
|POLY 3 | P=0.327 P=0.208 P=0.025 * P=0.473 |P=0.029 * P=0.102 P=0.060 P=0.024 * |
|POLY 1.5 | P=0.363 P=0.220 P=0.028 * P=0.485 |P=0.034 * P=0.104 P=0.060 P=0.027 * |
|POLY 6 | P=0.275 P=0.191 P=0.022 * P=0.456 |P=0.025 * P=0.098 P=0.061 P=0.021 * |
|LOGISTIC REGRESSION| P=0.443 P=0.365 P=0.045 * P=0.381 |P=0.024 * P=0.070 P=0.061 P=0.027 * |
|COCH-ARM / FISHERS | P=0.408 P=0.247 P=0.028 * P=0.500 |P=0.042 * P=0.107 P=0.059 P=0.032 * |
|ORDER RESTRICTED | P=0.082 (e) (e) (e) |P=0.021 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |1/49 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.30 2/38.66 1/41.43 3/40.22 |1/44.22 0/43.87 1/44.85 0/40.65 |
|POLY-3 PERCENT (g) | 6.6% 5.2% 2.4% 7.5% |2.3% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 1/16 (6%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 674 670 708 578 |730 (T) --- 718 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.431 P=0.643 P=0.391N P=0.477 |P=0.466N P=0.536N P=0.741 P=0.573N |
|POLY 3 | P=0.535 P=0.572N P=0.338N P=0.606 |P=0.413N P=0.502N P=0.758N P=0.517N |
|POLY 1.5 | P=0.544 P=0.540N P=0.324N P=0.631 |P=0.409N P=0.499N P=0.757N P=0.508N |
|POLY 6 | P=0.520 P=0.617N P=0.355N P=0.570 |P=0.418N P=0.506N P=0.759N P=0.528N |
|LOGISTIC REGRESSION| P=0.534 P=0.611N P=0.342N P=0.654N |P=0.443N (e) P=0.762 (e) |
|COCH-ARM / FISHERS | P=0.555 P=0.500N P=0.309N P=0.661N |P=0.402N P=0.495N P=0.747N P=0.495N |
|ORDER RESTRICTED | P=0.460 (e) (e) (e) |P=0.268N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 3/41.79 0/39.41 |0/44.22 0/43.87 1/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 7.2% 0.0% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- 621 --- |--- --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589 P=0.584N P=0.223 P=0.619N |P=0.657 (e) P=0.477 (e) |
|POLY 3 | P=0.589N P=0.531N P=0.279 P=0.527N |P=0.652 (e) P=0.503 (e) |
|POLY 1.5 | P=0.577N P=0.518N P=0.289 P=0.515N |P=0.671 (e) P=0.503 (e) |
|POLY 6 | P=0.608N P=0.552N P=0.266 P=0.543N |P=0.626 (e) P=0.501 (e) |
|LOGISTIC REGRESSION| P=0.593N (e) P=0.284 (e) |(e) (e) P=0.477 (e) |
|COCH-ARM / FISHERS | P=0.564N P=0.500N P=0.309 P=0.500N |P=0.697 (e) P=0.505 (e) |
|ORDER RESTRICTED | P=0.266N (e) (e) (e) |P=0.384 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 4/50 (8%) 3/50 (6%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/45.30 2/38.66 4/41.88 3/40.22 |1/44.22 0/43.87 2/44.85 0/40.65 |
|POLY-3 PERCENT (g) | 8.8% 5.2% 9.6% 7.5% |2.3% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 2/29 (7%) 1/19 (5%) 1/21 (5%) 1/16 (6%) |1/36 (3%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 674 670 621 578 |730 (T) --- 718 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.419 P=0.570N P=0.506 P=0.589 |P=0.541N P=0.536N P=0.466 P=0.573N |
|POLY 3 | P=0.555 P=0.412N P=0.600 P=0.565N |P=0.485N P=0.502N P=0.505 P=0.517N |
|POLY 1.5 | P=0.568 P=0.379N P=0.617 P=0.536N |P=0.474N P=0.499N P=0.506 P=0.508N |
|POLY 6 | P=0.533 P=0.464N P=0.578 P=0.605N |P=0.500N P=0.506N P=0.503 P=0.528N |
|LOGISTIC REGRESSION| P=0.550 P=0.473N P=0.601 P=0.514N |P=0.518N (e) P=0.495 (e) |
|COCH-ARM / FISHERS | P=0.564N P=0.339N P=0.643N P=0.500N |P=0.457N P=0.495N P=0.508 P=0.495N |
|ORDER RESTRICTED | P=0.630 (e) (e) (e) |P=0.342N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.04 0/38.44 2/41.34 0/38.70 |0/44.22 0/43.87 0/44.80 1/40.84 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.8% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 2/21 (10%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.642N P=0.584N P=0.387 P=0.619N |P=0.179 (e) (e) P=0.468 |
|POLY 3 | P=0.536N P=0.531N P=0.470 P=0.530N |P=0.189 (e) (e) P=0.484 |
|POLY 1.5 | P=0.530N P=0.518N P=0.482 P=0.519N |P=0.193 (e) (e) P=0.492 |
|POLY 6 | P=0.547N P=0.552N P=0.455 P=0.546N |P=0.183 (e) (e) P=0.473 |
|LOGISTIC REGRESSION| P=0.642N (e) P=0.387 (e) |P=0.202 (e) (e) P=0.506 |
|COCH-ARM / FISHERS | P=0.524N P=0.500N P=0.500 P=0.505N |P=0.200 (e) (e) P=0.505 |
|ORDER RESTRICTED | P=0.326N (e) (e) (e) |P=0.107 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 3/50 (6%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.04 0/38.44 3/41.34 0/38.70 |0/44.22 0/43.87 1/44.98 1/40.84 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 7.3% 0.0% |0.0% 0.0% 2.2% 2.5% |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 3/21 (14%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- 682 682 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.525N P=0.335N P=0.353 P=0.376N |P=0.209 (e) P=0.514 P=0.468 |
|POLY 3 | P=0.389N P=0.274N P=0.461 P=0.272N |P=0.213 (e) P=0.503 P=0.484 |
|POLY 1.5 | P=0.383N P=0.257N P=0.477 P=0.259N |P=0.223 (e) P=0.504 P=0.492 |
|POLY 6 | P=0.401N P=0.300N P=0.441 P=0.293N |P=0.200 (e) P=0.503 P=0.473 |
|LOGISTIC REGRESSION| P=0.525N (e) P=0.353 (e) |P=0.242 (e) P=0.506 P=0.506 |
|COCH-ARM / FISHERS | P=0.378N P=0.247N P=0.500 P=0.253N |P=0.238 (e) P=0.505 P=0.505 |
|ORDER RESTRICTED | P=0.182N (e) (e) (e) |P=0.237 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |4/50 (8%) 2/50 (4%) 10/50 (20%) 8/50 (16%) |
|POLY-3 RATE (b) | 0/45.04 1/38.44 2/41.34 0/39.41 |4/44.62 2/44.08 10/46.61 8/42.08 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 4.8% 0.0% |9.0% 4.5% 21.5% 19.0% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 2/21 (10%) 0/16 (0%) |4/36 (11%) 1/30 (3%) 6/32 (19%) 3/25 (12%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |730 (T) 675 401 537 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.590 P=0.416 P=0.170 (e) |P=0.019 * P=0.413N P=0.058 P=0.080 |
|POLY 3 | P=0.636N P=0.469 P=0.218 (e) |P=0.037 * P=0.343N P=0.085 P=0.148 |
|POLY 1.5 | P=0.617N P=0.482 P=0.226 (e) |P=0.042 * P=0.340N P=0.080 P=0.159 |
|POLY 6 | P=0.603 P=0.448 P=0.209 (e) |P=0.033 * P=0.348N P=0.089 P=0.134 |
|LOGISTIC REGRESSION| (e) P=0.416 P=0.170 (e) |P=0.056 P=0.356N P=0.074 P=0.154 |
|COCH-ARM / FISHERS | P=0.592N P=0.500 P=0.247 (e) |P=0.053 P=0.339N P=0.074 P=0.178 |
|ORDER RESTRICTED | P=0.304 (e) (e) (e) |P=0.046 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |19/50 (38%) 26/50 (52%) 22/50 (44%) 24/50 (48%) |
|POLY-3 RATE (b) | 3/45.04 1/38.44 2/41.34 4/39.68 |19/47.60 26/45.52 22/45.47 24/42.64 |
|POLY-3 PERCENT (g) | 6.7% 2.6% 4.8% 10.1% |39.9% 57.1% 48.4% 56.3% |
|TERMINAL (d) | 3/29 (10%) 1/19 (5%) 2/21 (10%) 2/16 (13%) |12/36 (33%) 18/30 (60%) 16/32 (50%) 16/25 (64%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 691 |481 481 689 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 P=0.465N P=0.647N P=0.230 |P=0.040 * P=0.054 P=0.248 P=0.030 * |
|POLY 3 | P=0.236 P=0.364N P=0.539N P=0.431 |P=0.126 P=0.069 P=0.269 P=0.085 |
|POLY 1.5 | P=0.243 P=0.338N P=0.523N P=0.461 |P=0.182 P=0.087 P=0.297 P=0.126 |
|POLY 6 | P=0.225 P=0.405N P=0.559N P=0.389 |P=0.075 P=0.049 * P=0.236 P=0.049 * |
|LOGISTIC REGRESSION| P=0.153 P=0.465N P=0.647N P=0.304 |P=0.174 P=0.111 P=0.344 P=0.151 |
|COCH-ARM / FISHERS | P=0.249 P=0.309N P=0.500N P=0.500 |P=0.290 P=0.114 P=0.342 P=0.210 |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.086 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |19/50 (38%) 26/50 (52%) 23/50 (46%) 24/50 (48%) |
|POLY-3 RATE (b) | 3/45.04 1/38.44 2/41.34 4/39.68 |19/47.60 26/45.52 23/45.49 24/42.64 |
|POLY-3 PERCENT (g) | 6.7% 2.6% 4.8% 10.1% |39.9% 57.1% 50.6% 56.3% |
|TERMINAL (d) | 3/29 (10%) 1/19 (5%) 2/21 (10%) 2/16 (13%) |12/36 (33%) 18/30 (60%) 16/32 (50%) 16/25 (64%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 691 |481 481 689 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 P=0.465N P=0.647N P=0.230 |P=0.038 * P=0.054 P=0.196 P=0.030 * |
|POLY 3 | P=0.236 P=0.364N P=0.539N P=0.431 |P=0.118 P=0.069 P=0.203 P=0.085 |
|POLY 1.5 | P=0.243 P=0.338N P=0.523N P=0.461 |P=0.173 P=0.087 P=0.229 P=0.126 |
|POLY 6 | P=0.225 P=0.405N P=0.559N P=0.389 |P=0.069 P=0.049 * P=0.174 P=0.049 * |
|LOGISTIC REGRESSION| P=0.153 P=0.465N P=0.647N P=0.304 |P=0.165 P=0.111 P=0.273 P=0.151 |
|COCH-ARM / FISHERS | P=0.249 P=0.309N P=0.500N P=0.500 |P=0.282 P=0.114 P=0.272 P=0.210 |
|ORDER RESTRICTED | P=0.241 (e) (e) (e) |P=0.086 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 4/50 (8%) 4/50 (8%) |23/50 (46%) 27/50 (54%) 28/50 (56%) 29/50 (58%) |
|POLY-3 RATE (b) | 3/45.04 2/38.44 4/41.34 4/39.68 |23/47.60 27/45.73 28/47.28 29/43.52 |
|POLY-3 PERCENT (g) | 6.7% 5.2% 9.7% 10.1% |48.3% 59.1% 59.2% 66.6% |
|TERMINAL (d) | 3/29 (10%) 2/19 (11%) 4/21 (19%) 2/16 (13%) |16/36 (44%) 18/30 (60%) 18/32 (56%) 18/25 (72%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 691 |481 481 401 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.120 P=0.677 P=0.324 P=0.230 |P=0.013 * P=0.132 P=0.151 P=0.014 * |
|POLY 3 | P=0.265 P=0.572N P=0.453 P=0.431 |P=0.054 P=0.200 P=0.193 P=0.054 |
|POLY 1.5 | P=0.281 P=0.540N P=0.473 P=0.461 |P=0.083 P=0.231 P=0.201 P=0.086 |
|POLY 6 | P=0.241 P=0.618N P=0.429 P=0.389 |P=0.031 * P=0.160 P=0.181 P=0.029 * |
|LOGISTIC REGRESSION| P=0.169 P=0.677 P=0.324 P=0.304 |P=0.088 P=0.265 P=0.212 P=0.098 |
|COCH-ARM / FISHERS | P=0.298 P=0.500N P=0.500 P=0.500 |P=0.151 P=0.274 P=0.212 P=0.158 |
|ORDER RESTRICTED | P=0.383 (e) (e) (e) |P=0.051 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 38/50 (76%) 36/50 (72%) 35/50 (70%) 31/50 (62%) |27/49 (55%) 34/50 (68%) 33/50 (66%) 28/50 (56%) |
|POLY-3 RATE (b) | 38/48.92 36/46.13 35/46.55 31/44.67 |27/45.49 34/47.79 33/47.01 28/44.86 |
|POLY-3 PERCENT (g) | 77.7% 78.1% 75.2% 69.4% |59.4% 71.2% 70.2% 62.4% |
|TERMINAL (d) | 21/29 (72%) 14/19 (74%) 15/21 (71%) 12/16 (75%) |22/36 (61%) 19/30 (63%) 23/32 (72%) 16/25 (64%) |
|FIRST INCIDENCE | 476 403 529 522 |509 481 565 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307 P=0.056 P=0.248 P=0.136 |P=0.103 P=0.042 * P=0.079 P=0.069 |
|POLY 3 | P=0.162N P=0.584 P=0.481N P=0.239N |P=0.525 P=0.157 P=0.185 P=0.466 |
|POLY 1.5 | P=0.116N P=0.531N P=0.420N P=0.166N |P=0.516N P=0.146 P=0.179 P=0.494 |
|POLY 6 | P=0.249N P=0.484 P=0.546N P=0.370N |P=0.471 P=0.172 P=0.199 P=0.427 |
|LOGISTIC REGRESSION| P=0.108N P=0.495N P=0.400N P=0.183N |P=0.495 P=0.114 P=0.167 P=0.397 |
|COCH-ARM / FISHERS | P=0.075N P=0.410N P=0.326N P=0.097N |P=0.438N P=0.133 P=0.183 P=0.545 |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.298 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 36/50 (72%) 35/50 (70%) 31/50 (62%) |27/49 (55%) 35/50 (70%) 33/50 (66%) 29/50 (58%) |
|POLY-3 RATE (b) | 39/49.14 36/46.13 35/46.55 31/44.67 |27/45.49 35/47.79 33/47.01 29/44.91 |
|POLY-3 PERCENT (g) | 79.4% 78.1% 75.2% 69.4% |59.4% 73.2% 70.2% 64.6% |
|TERMINAL (d) | 21/29 (72%) 14/19 (74%) 15/21 (71%) 12/16 (75%) |22/36 (61%) 20/30 (67%) 23/32 (72%) 16/25 (64%) |
|FIRST INCIDENCE | 476 403 529 522 |509 481 565 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.346 P=0.072 P=0.294 P=0.169 |P=0.079 P=0.028 * P=0.079 P=0.048 * |
|POLY 3 | P=0.125N P=0.539N P=0.401N P=0.180N |P=0.463 P=0.108 P=0.185 P=0.381 |
|POLY 1.5 | P=0.086N P=0.443N P=0.337N P=0.116N |P=0.505 P=0.100 P=0.179 P=0.410 |
|POLY 6 | P=0.206N P=0.556 P=0.477N P=0.306N |P=0.410 P=0.118 P=0.199 P=0.343 |
|LOGISTIC REGRESSION| P=0.079N P=0.395N P=0.307N P=0.124N |P=0.428 P=0.077 P=0.167 P=0.314 |
|COCH-ARM / FISHERS | P=0.054N P=0.322N P=0.247N P=0.063N |P=0.496N P=0.093 P=0.183 P=0.465 |
|ORDER RESTRICTED | P=0.183N (e) (e) (e) |P=0.237 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.44 1/41.34 3/39.65 |0/44.62 0/43.87 1/44.90 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 2.4% 7.6% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 1/21 (5%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 684 |--- --- 703 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.416 P=0.436 P=0.055 |P=0.665 (e) P=0.495 (e) |
|POLY 3 | P=0.048 * P=0.469 P=0.483 P=0.097 |P=0.653 (e) P=0.501 (e) |
|POLY 1.5 | P=0.053 P=0.482 P=0.490 P=0.106 |P=0.670 (e) P=0.501 (e) |
|POLY 6 | P=0.043 * P=0.448 P=0.474 P=0.085 |P=0.628 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.038 * P=0.416 P=0.436 P=0.079 |P=0.689 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.059 P=0.500 P=0.500 P=0.121 |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P=0.383 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.04 1/38.44 1/41.34 3/39.65 |0/44.62 0/43.87 1/44.90 1/41.29 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 2.4% 7.6% |0.0% 0.0% 2.2% 2.4% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 1/21 (5%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) 684 |--- --- 703 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.416 P=0.436 P=0.055 |P=0.209 (e) P=0.495 P=0.496 |
|POLY 3 | P=0.048 * P=0.469 P=0.483 P=0.097 |P=0.216 (e) P=0.501 P=0.485 |
|POLY 1.5 | P=0.053 P=0.482 P=0.490 P=0.106 |P=0.224 (e) P=0.501 P=0.491 |
|POLY 6 | P=0.043 * P=0.448 P=0.474 P=0.085 |P=0.205 (e) P=0.502 P=0.476 |
|LOGISTIC REGRESSION| P=0.038 * P=0.416 P=0.436 P=0.079 |P=0.301 (e) P=0.500 P=0.646 |
|COCH-ARM / FISHERS | P=0.059 P=0.500 P=0.500 P=0.121 |P=0.236 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P=0.237 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|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) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 5/50 (10%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.04 3/38.78 1/41.34 5/39.65 |1/44.62 0/43.87 1/44.90 1/41.29 |
|POLY-3 PERCENT (g) | 2.2% 7.7% 2.4% 12.6% |2.2% 0.0% 2.2% 2.4% |
|TERMINAL (d) | 1/29 (3%) 2/19 (11%) 1/21 (5%) 3/16 (19%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 636 729 (T) 684 |730 (T) --- 703 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035 * P=0.188 P=0.689 P=0.024 * |P=0.488 P=0.536N P=0.744 P=0.718 |
|POLY 3 | P=0.075 P=0.253 P=0.741 P=0.074 |P=0.517 P=0.503N P=0.759N P=0.743 |
|POLY 1.5 | P=0.084 P=0.276 P=0.749 P=0.086 |P=0.525 P=0.502N P=0.760N P=0.750 |
|POLY 6 | P=0.064 P=0.223 P=0.731 P=0.060 |P=0.505 P=0.507N P=0.759N P=0.733 |
|LOGISTIC REGRESSION| P=0.060 P=0.210 P=0.689 P=0.038 * |P=0.582 (e) P=0.762N P=0.721N |
|COCH-ARM / FISHERS | P=0.096 P=0.309 P=0.753N P=0.102 |P=0.539 P=0.500N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.029 * (e) (e) (e) |P=0.511 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.04 4/39.26 2/41.34 2/39.46 |0/44.62 0/43.87 0/44.80 2/41.04 |
|POLY-3 PERCENT (g) | 4.4% 10.2% 4.8% 5.1% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 2/29 (7%) 2/19 (11%) 2/21 (10%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) 579 729 (T) 717 |--- --- --- 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.583N P=0.201 P=0.575 P=0.472 |P=0.034 * (e) (e) P=0.190 |
|POLY 3 | P=0.451N P=0.276 P=0.663 P=0.646 |P=0.043 * (e) (e) P=0.219 |
|POLY 1.5 | P=0.427N P=0.302 P=0.676 P=0.667 |P=0.044 * (e) (e) P=0.226 |
|POLY 6 | P=0.487N P=0.239 P=0.647 P=0.613 |P=0.041 * (e) (e) P=0.209 |
|LOGISTIC REGRESSION| P=0.455N P=0.289 P=0.575 P=0.506 |P=0.049 * (e) (e) P=0.240 |
|COCH-ARM / FISHERS | P=0.397N P=0.339 P=0.691N P=0.691N |P=0.046 * (e) (e) P=0.247 |
|ORDER RESTRICTED | P=0.525 (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/45.04 5/39.26 2/41.34 2/39.46 |0/44.62 0/43.87 4/45.47 2/41.04 |
|POLY-3 PERCENT (g) | 6.7% 12.7% 4.8% 5.1% |0.0% 0.0% 8.8% 4.9% |
|TERMINAL (d) | 3/29 (10%) 3/19 (16%) 2/21 (10%) 1/16 (6%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 1/25 (4%) |
|FIRST INCIDENCE | 729 (T) 579 729 (T) 717 |--- --- 610 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.402N P=0.185 P=0.647N P=0.609 |P=0.071 (e) P=0.064 P=0.190 |
|POLY 3 | P=0.266N P=0.283 P=0.539N P=0.560N |P=0.079 (e) P=0.063 P=0.219 |
|POLY 1.5 | P=0.246N P=0.314 P=0.523N P=0.534N |P=0.087 (e) P=0.062 P=0.226 |
|POLY 6 | P=0.297N P=0.240 P=0.559N P=0.598N |P=0.069 (e) P=0.064 P=0.209 |
|LOGISTIC REGRESSION| P=0.280N P=0.251 P=0.647N P=0.643 |P=0.109 (e) P=0.063 P=0.240 |
|COCH-ARM / FISHERS | P=0.222N P=0.357 P=0.500N P=0.500N |P=0.104 (e) P=0.059 P=0.247 |
|ORDER RESTRICTED | P=0.331N (e) (e) (e) |P=0.057 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 1/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 2/45.37 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 2.6% 0.0% 0.0% |0.0% 0.0% 4.4% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280N P=0.665 P=0.564N P=0.619N |P=0.570 (e) P=0.247 (e) |
|POLY 3 | P=0.219N P=0.724 P=0.517N P=0.527N |P=0.541 (e) P=0.241 (e) |
|POLY 1.5 | P=0.216N P=0.741 P=0.510N P=0.515N |P=0.563 (e) P=0.239 (e) |
|POLY 6 | P=0.223N P=0.699 P=0.526N P=0.543N |P=0.508 (e) P=0.243 (e) |
|LOGISTIC REGRESSION| P=0.280N P=0.665 (e) (e) |P=0.631 (e) P=0.240 (e) |
|COCH-ARM / FISHERS | P=0.212N P=0.753N P=0.500N P=0.500N |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.252 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 1/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 4/45.47 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 2.6% 0.0% 0.0% |0.0% 0.0% 8.8% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280N P=0.665 P=0.564N P=0.619N |P=0.438 (e) P=0.064 (e) |
|POLY 3 | P=0.219N P=0.724 P=0.517N P=0.527N |P=0.427 (e) P=0.063 (e) |
|POLY 1.5 | P=0.216N P=0.741 P=0.510N P=0.515N |P=0.457 (e) P=0.062 (e) |
|POLY 6 | P=0.223N P=0.699 P=0.526N P=0.543N |P=0.387 (e) P=0.064 (e) |
|LOGISTIC REGRESSION| P=0.280N P=0.665 (e) (e) |P=0.507 (e) P=0.063 (e) |
|COCH-ARM / FISHERS | P=0.212N P=0.753N P=0.500N P=0.500N |P=0.500 (e) P=0.059 (e) |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.113 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.04 0/38.44 0/41.34 1/39.48 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 2.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 712 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.630N P=0.335N P=0.311N P=0.694N |(e) (e) (e) (e) |
|POLY 3 | P=0.493N P=0.274N P=0.257N P=0.546N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.504N P=0.257N P=0.249N P=0.526N |(e) (e) (e) (e) |
|POLY 6 | P=0.478N P=0.300N P=0.267N P=0.575N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.591N (e) (e) P=0.653N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.518N P=0.247N P=0.247N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.165N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 0/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 2/44.90 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/29 (0%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 1/32 (3%) 0/25 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 705 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.537 (e) P=0.221 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.542 (e) P=0.238 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.564 (e) P=0.238 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.510 (e) P=0.239 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.568 (e) P=0.238 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.595 (e) P=0.247 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.250 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 2/38.78 0/41.34 2/39.41 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 5.2% 0.0% 5.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 2/16 (13%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 636 --- 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382 P=0.383 P=0.564N P=0.296 |(e) (e) (e) (e) |
|POLY 3 | P=0.479 P=0.448 P=0.517N P=0.454 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.495 P=0.471 P=0.510N P=0.474 |(e) (e) (e) (e) |
|POLY 6 | P=0.455 P=0.415 P=0.526N P=0.424 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.461 P=0.437 (e) P=0.296 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.514 P=0.500 P=0.500N P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 2/38.78 0/41.34 2/39.41 |1/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 5.2% 0.0% 5.1% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 2/16 (13%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 636 --- 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382 P=0.383 P=0.564N P=0.296 |P=0.343N P=0.536N P=0.523N P=0.573N |
|POLY 3 | P=0.479 P=0.448 P=0.517N P=0.454 |P=0.293N P=0.503N P=0.499N P=0.519N |
|POLY 1.5 | P=0.495 P=0.471 P=0.510N P=0.474 |P=0.299N P=0.502N P=0.500N P=0.511N |
|POLY 6 | P=0.455 P=0.415 P=0.526N P=0.424 |P=0.284N P=0.507N P=0.499N P=0.529N |
|LOGISTIC REGRESSION| P=0.461 P=0.437 (e) P=0.296 |P=0.343N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.514 P=0.500 P=0.500N P=0.500 |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |P=0.137N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 2/38.78 0/41.34 2/39.41 |1/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 5.2% 0.0% 5.1% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 0/21 (0%) 2/16 (13%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 636 --- 729 (T) |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.382 P=0.383 P=0.564N P=0.296 |P=0.343N P=0.536N P=0.523N P=0.573N |
|POLY 3 | P=0.479 P=0.448 P=0.517N P=0.454 |P=0.293N P=0.503N P=0.499N P=0.519N |
|POLY 1.5 | P=0.495 P=0.471 P=0.510N P=0.474 |P=0.299N P=0.502N P=0.500N P=0.511N |
|POLY 6 | P=0.455 P=0.415 P=0.526N P=0.424 |P=0.284N P=0.507N P=0.499N P=0.529N |
|LOGISTIC REGRESSION| P=0.461 P=0.437 (e) P=0.296 |P=0.343N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.514 P=0.500 P=0.500N P=0.500 |P=0.306N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.353 (e) (e) (e) |P=0.137N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.47 1/38.44 1/41.34 0/39.41 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 6.6% 2.6% 2.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/29 (3%) 1/19 (5%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 670 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133N P=0.499N P=0.395N P=0.198N |(e) (e) (e) (e) |
|POLY 3 | P=0.090N P=0.368N P=0.340N P=0.146N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.089N P=0.339N P=0.325N P=0.134N |(e) (e) (e) (e) |
|POLY 6 | P=0.092N P=0.412N P=0.360N P=0.167N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.106N P=0.374N P=0.328N P=0.125N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.309N P=0.309N P=0.121N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.053N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 39/50 (78%) 38/50 (76%) 42/50 (84%) | |
|POLY-3 RATE (b) | 41/47.99 39/45.35 38/47.00 42/46.31 | |
|POLY-3 PERCENT (g) | 85.4% 86.0% 80.9% 90.7% | |
|TERMINAL (d) | 27/29 (93%) 18/19 (95%) 16/21 (76%) 15/16 (94%) | |
|FIRST INCIDENCE | 476 537 509 522 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P=0.020 * P=0.185 P=0.002 ** | |
|POLY 3 | P=0.293 P=0.596 P=0.365N P=0.300 | |
|POLY 1.5 | P=0.327 P=0.556N P=0.352N P=0.375 | |
|POLY 6 | P=0.282 P=0.508 P=0.351N P=0.243 | |
|LOGISTIC REGRESSION| P=0.193 P=0.327 P=0.499N P=0.124 | |
|COCH-ARM / FISHERS | P=0.388 P=0.402N P=0.312N P=0.500 | |
|ORDER RESTRICTED | P=0.243 (e) (e) (e) | |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 6/50 (12%) 4/50 (8%) |3/49 (6%) 5/50 (10%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 7/45.57 6/39.56 6/41.86 4/39.93 |3/44.34 5/43.87 2/44.92 4/41.79 |
|POLY-3 PERCENT (g) | 15.4% 15.2% 14.3% 10.0% |6.8% 11.4% 4.5% 9.6% |
|TERMINAL (d) | 4/29 (14%) 4/19 (21%) 3/21 (14%) 2/16 (13%) |2/36 (6%) 5/30 (17%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | 670 421 589 652 |698 730 (T) 698 509 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.449N P=0.424 P=0.533 P=0.563N |P=0.382 P=0.266 P=0.536N P=0.361 |
|POLY 3 | P=0.269N P=0.609N P=0.566N P=0.341N |P=0.506 P=0.350 P=0.494N P=0.468 |
|POLY 1.5 | P=0.248N P=0.559N P=0.538N P=0.305N |P=0.522 P=0.359 P=0.493N P=0.485 |
|POLY 6 | P=0.304N P=0.553 P=0.601N P=0.396N |P=0.484 P=0.336 P=0.497N P=0.443 |
|LOGISTIC REGRESSION| P=0.263N P=0.559N P=0.580N P=0.370N |P=0.519 P=0.317 P=0.496N P=0.537 |
|COCH-ARM / FISHERS | P=0.222N P=0.500N P=0.500N P=0.262N |P=0.547 P=0.369 P=0.490N P=0.511 |
|ORDER RESTRICTED | P=0.374N (e) (e) (e) |P=0.500 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/45.45 3/38.44 2/41.45 0/39.41 |1/44.22 2/44.13 0/44.80 1/40.65 |
|POLY-3 PERCENT (g) | 4.4% 7.8% 4.8% 0.0% |2.3% 4.5% 0.0% 2.5% |
|TERMINAL (d) | 1/29 (3%) 3/19 (16%) 1/21 (5%) 0/16 (0%) |1/36 (3%) 0/30 (0%) 0/32 (0%) 1/25 (4%) |
|FIRST INCIDENCE | 611 729 (T) 702 --- |730 (T) 691 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200N P=0.335 P=0.605 P=0.333N |P=0.583N P=0.461 P=0.523N P=0.678 |
|POLY 3 | P=0.140N P=0.424 P=0.661 P=0.270N |P=0.510N P=0.499 P=0.497N P=0.742 |
|POLY 1.5 | P=0.128N P=0.458 P=0.674 P=0.255N |P=0.504N P=0.503 P=0.497N P=0.751 |
|POLY 6 | P=0.161N P=0.375 P=0.643 P=0.293N |P=0.516N P=0.494 P=0.499N P=0.728 |
|LOGISTIC REGRESSION| P=0.141N P=0.381 P=0.689 P=0.205N |P=0.533N P=0.500 (e) P=0.678 |
|COCH-ARM / FISHERS | P=0.114N P=0.500 P=0.691N P=0.247N |P=0.495N P=0.508 P=0.495N P=0.747N |
|ORDER RESTRICTED | P=0.131N (e) (e) (e) |P=0.398N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 9/50 (18%) 8/50 (16%) 4/50 (8%) |4/49 (8%) 7/50 (14%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 9/45.98 9/39.56 8/41.97 4/39.93 |4/44.34 7/44.13 2/44.92 4/41.79 |
|POLY-3 PERCENT (g) | 19.6% 22.8% 19.1% 10.0% |9.0% 15.9% 4.5% 9.6% |
|TERMINAL (d) | 5/29 (17%) 7/19 (37%) 4/21 (19%) 2/16 (13%) |3/36 (8%) 5/30 (17%) 1/32 (3%) 2/25 (8%) |
|FIRST INCIDENCE | 611 421 589 652 |698 691 698 509 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.252 P=0.481 P=0.372N |P=0.551N P=0.184 P=0.379N P=0.486 |
|POLY 3 | P=0.108N P=0.463 P=0.583N P=0.176N |P=0.410N P=0.257 P=0.331N P=0.611 |
|POLY 1.5 | P=0.093N P=0.527 P=0.548N P=0.147N |P=0.395N P=0.265 P=0.330N P=0.628 |
|POLY 6 | P=0.137N P=0.364 P=0.587 P=0.223N |P=0.431N P=0.245 P=0.333N P=0.585 |
|LOGISTIC REGRESSION| P=0.105N P=0.492 P=0.577N P=0.167N |P=0.405N P=0.237 P=0.333N P=0.626N |
|COCH-ARM / FISHERS | P=0.076N P=0.602N P=0.500N P=0.117N |P=0.372N P=0.274 P=0.329N P=0.631N |
|ORDER RESTRICTED | P=0.137N (e) (e) (e) |P=0.309N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/49 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.04 1/38.45 2/41.92 1/39.72 |0/44.22 0/43.87 1/44.81 0/40.65 |
|POLY-3 PERCENT (g) | 2.2% 2.6% 4.8% 2.5% |0.0% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/29 (3%) 0/19 (0%) 1/21 (5%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) 726 546 645 |--- --- 726 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.665 P=0.418 P=0.671 |P=0.656 (e) P=0.483 (e) |
|POLY 3 | P=0.537 P=0.724 P=0.475 P=0.732 |P=0.652 (e) P=0.503 (e) |
|POLY 1.5 | P=0.553 P=0.741 P=0.485 P=0.745 |P=0.671 (e) P=0.503 (e) |
|POLY 6 | P=0.512 P=0.699 P=0.462 P=0.713 |P=0.626 (e) P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.573 P=0.655 P=0.542 P=0.763 |P=0.671 (e) P=0.497 (e) |
|COCH-ARM / FISHERS | P=0.572 P=0.753N P=0.500 P=0.753N |P=0.697 (e) P=0.505 (e) |
|ORDER RESTRICTED | P=0.546 (e) (e) (e) |P=0.384 (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |10/50 (20%) 9/50 (18%) 10/50 (20%) 9/50 (18%) |
|POLY-3 RATE (b) | |10/45.46 9/44.98 10/45.00 9/41.73 |
|POLY-3 PERCENT (g) | |22.0% 20.0% 22.2% 21.6% |
|TERMINAL (d) | |8/36 (22%) 6/30 (20%) 8/32 (25%) 4/25 (16%) |
|FIRST INCIDENCE | |582 593 689 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.356 P=0.570 P=0.504 P=0.421 |
|POLY 3 | |P=0.535 P=0.510N P=0.590 P=0.583N |
|POLY 1.5 | |P=0.526N P=0.505N P=0.593 P=0.550N |
|POLY 6 | |P=0.491 P=0.522N P=0.582 P=0.578 |
|LOGISTIC REGRESSION| |P=0.549 P=0.505N P=0.595N P=0.567N |
|COCH-ARM / FISHERS | |P=0.476N P=0.500N P=0.598N P=0.500N |
|ORDER RESTRICTED | |P=0.699 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |11/50 (22%) 10/50 (20%) 10/50 (20%) 10/50 (20%) |
|POLY-3 RATE (b) | |11/45.53 10/44.99 10/45.00 10/42.00 |
|POLY-3 PERCENT (g) | |24.2% 22.2% 22.2% 23.8% |
|TERMINAL (d) | |8/36 (22%) 6/30 (20%) 8/32 (25%) 4/25 (16%) |
|FIRST INCIDENCE | |582 593 689 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.355 P=0.556 P=0.594 P=0.405 |
|POLY 3 | |P=0.544N P=0.512N P=0.512N P=0.584N |
|POLY 1.5 | |P=0.513N P=0.506N P=0.507N P=0.550N |
|POLY 6 | |P=0.507 P=0.526N P=0.522N P=0.571 |
|LOGISTIC REGRESSION| |P=0.540N P=0.507N P=0.496N P=0.564N |
|COCH-ARM / FISHERS | |P=0.465N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | |P=0.671N (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 29/50 (58%) 30/50 (60%) 30/50 (60%) |26/50 (52%) 28/50 (56%) 26/50 (52%) 29/50 (58%) |
|POLY-3 RATE (b) | 25/47.99 29/44.73 30/47.32 30/45.98 |26/47.29 28/48.20 26/48.19 29/47.32 |
|POLY-3 PERCENT (g) | 52.1% 64.8% 63.4% 65.3% |55.0% 58.1% 54.0% 61.3% |
|TERMINAL (d) | 12/29 (41%) 10/19 (53%) 8/21 (38%) 8/16 (50%) |18/36 (50%) 14/30 (47%) 14/32 (44%) 10/25 (40%) |
|FIRST INCIDENCE | 476 421 509 432 |495 506 433 451 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.048 * P=0.022 * P=0.072 P=0.013 * |P=0.084 P=0.243 P=0.433 P=0.080 |
|POLY 3 | P=0.175 P=0.144 P=0.178 P=0.133 |P=0.329 P=0.460 P=0.542N P=0.339 |
|POLY 1.5 | P=0.196 P=0.192 P=0.187 P=0.163 |P=0.328 P=0.442 P=0.558N P=0.334 |
|POLY 6 | P=0.155 P=0.097 P=0.179 P=0.103 |P=0.334 P=0.483 P=0.523N P=0.348 |
|LOGISTIC REGRESSION| P=0.244 P=0.283 P=0.277 P=0.282 |P=0.401 P=0.426 P=0.579 P=0.383 |
|COCH-ARM / FISHERS | P=0.224 P=0.274 P=0.211 P=0.211 |P=0.342 P=0.421 P=0.579N P=0.344 |
|ORDER RESTRICTED | P=0.136 (e) (e) (e) |P=0.424 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.44 0/41.34 2/40.13 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 563 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133 P=0.416 (e) P=0.201 |(e) (e) (e) (e) |
|POLY 3 | P=0.146 P=0.469 (e) P=0.212 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.153 P=0.482 (e) P=0.223 |(e) (e) (e) (e) |
|POLY 6 | P=0.135 P=0.448 (e) P=0.198 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.172 P=0.416 (e) P=0.327 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.059 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.04 1/38.44 0/41.34 2/40.13 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 0.0% 2.6% 0.0% 5.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/29 (0%) 1/19 (5%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 563 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133 P=0.416 (e) P=0.201 |(e) (e) (e) (e) |
|POLY 3 | P=0.146 P=0.469 (e) P=0.212 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.153 P=0.482 (e) P=0.223 |(e) (e) (e) (e) |
|POLY 6 | P=0.135 P=0.448 (e) P=0.198 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.172 P=0.416 (e) P=0.327 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.059 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.04 0/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.335N P=0.311N P=0.376N |(e) (e) (e) (e) |
|POLY 3 | P=0.133N P=0.274N P=0.257N P=0.268N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.140N P=0.257N P=0.249N P=0.254N |(e) (e) (e) (e) |
|POLY 6 | P=0.123N P=0.300N P=0.267N P=0.289N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.205N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.04 0/38.44 0/41.34 0/39.41 |0/44.62 0/43.87 0/44.80 0/40.65 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/29 (7%) 0/19 (0%) 0/21 (0%) 0/16 (0%) |0/36 (0%) 0/30 (0%) 0/32 (0%) 0/25 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205N P=0.335N P=0.311N P=0.376N |(e) (e) (e) (e) |
|POLY 3 | P=0.133N P=0.274N P=0.257N P=0.268N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.140N P=0.257N P=0.249N P=0.254N |(e) (e) (e) (e) |
|POLY 6 | P=0.123N P=0.300N P=0.267N P=0.289N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.205N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.041N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 49/50 (98%) 48/50 (96%) |37/50 (74%) 47/50 (94%) 42/50 (84%) 43/50 (86%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 49/49.16 48/48.47 |37/48.40 47/49.21 42/47.34 43/47.07 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 99.7% 99.0% |76.4% 95.5% 88.7% 91.4% |
|TERMINAL (d) | 29/29 (100%) 19/19 (100%) 21/21 (100%) 16/16 (100%)|27/36 (75%) 29/30 (97%) 29/32 (91%) 24/25 (96%) |
|FIRST INCIDENCE | 476 403 509 522 |481 481 565 506 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 (e) P=0.080 P=0.007 ** |P=0.007 ** P=0.008 ** P=0.098 P=0.004 ** |
|POLY 3 | P=0.366N (e) P=1.000N P=0.942N |P=0.058 P=0.005 ** P=0.085 P=0.036 * |
|POLY 1.5 | P=0.117N (e) P=0.931N P=0.514N |P=0.092 P=0.005 ** P=0.107 P=0.052 |
|POLY 6 | P=1.000N (e) P=1.000N P=1.000N |P=0.037 * P=0.004 ** P=0.071 P=0.026 * |
|LOGISTIC REGRESSION| P=0.020N* (e) (e) (e) |P=0.095 P=0.007 ** P=0.159 P=0.054 |
|COCH-ARM / FISHERS | P=0.062N (e) P=0.500N P=0.247N |P=0.205 P=0.006 ** P=0.163 P=0.105 |
|ORDER RESTRICTED | P=0.050N (e) (e) (e) |P=0.008 ** (e) (e) (e) |
|=================================================================================================================================|
Date: 01/08/03 EXPERIMENT: 96001 TEST: 05 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 33/50 (66%) 35/50 (70%) 35/50 (70%) |30/50 (60%) 30/50 (60%) 36/50 (72%) 37/50 (74%) |
|POLY-3 RATE (b) | 33/48.45 33/44.73 35/48.27 35/47.54 |30/48.15 30/48.40 36/49.24 37/48.01 |
|POLY-3 PERCENT (g) | 68.1% 73.8% 72.5% 73.6% |62.3% 62.0% 73.1% 77.1% |
|TERMINAL (d) | 17/29 (59%) 14/19 (74%) 11/21 (52%) 8/16 (50%) |20/36 (56%) 15/30 (50%) 21/32 (66%) 15/25 (60%) |
|FIRST INCIDENCE | 476 421 396 432 |495 506 401 451 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 P=0.037 * P=0.117 P=0.022 * |P=0.008 ** P=0.341 P=0.121 P=0.015 * |
|POLY 3 | P=0.364 P=0.348 P=0.399 P=0.352 |P=0.041 * P=0.570N P=0.175 P=0.084 |
|POLY 1.5 | P=0.351 P=0.448 P=0.404 P=0.378 |P=0.041 * P=0.576N P=0.164 P=0.085 |
|POLY 6 | P=0.384 P=0.229 P=0.400 P=0.323 |P=0.042 * P=0.560N P=0.184 P=0.088 |
|LOGISTIC REGRESSION| P=0.339 P=0.434 P=0.499 P=0.524 |P=0.065 P=0.572N P=0.143 P=0.111 |
|COCH-ARM / FISHERS | P=0.331 P=0.583N P=0.415 P=0.415 |P=0.050 P=0.581N P=0.146 P=0.101 |
|ORDER RESTRICTED | P=0.420 (e) (e) (e) |P=0.083 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 138 550 1100 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|44/50 (88%) 50/50 (100%) 50/50 (100%) 48/50 (96%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 50/50.00 50/50.00 |44/50.00 50/50.00 50/50.00 48/49.06 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |88.0% 100.0% 100.0% 97.8% |
|TERMINAL (d) | 29/29 (100%) 19/19 (100%) 21/21 (100%) 16/16 (100%)|30/36 (83%) 30/30 (100%) 32/32 (100%) 24/25 (96%) |
|FIRST INCIDENCE | 476 403 396 432 |481 481 401 451 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.009 ** P=0.038 * P=0.075 P=0.010 * |
|POLY 3 | (e) (e) (e) (e) |P=0.029 * P=0.016 * P=0.016 * P=0.063 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.037 * P=0.016 * P=0.016 * P=0.073 |
|POLY 6 | (e) (e) (e) (e) |P=0.026 * P=0.016 * P=0.016 * P=0.060 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.098 (e) (e) P=0.121 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.111 P=0.013 * P=0.013 * P=0.134 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P<0.001 ** (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).