TDMS Study 96001-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 09/25/02
EXPERIMENT: 96001 TEST: 06 TIME: 11:17:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: GRUMBEIN, SONDR CAS: 64742-88-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1 MICE
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: 09/25/02
EXPERIMENT: 96001 TEST: 06 TIME: 11:17:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: GRUMBEIN, SONDR CAS: 64742-88-7
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Clitoral/Preputial Gland
Islets, Pancreatic
Liver
Lung
Nose
Ovary
Pancreas
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest STODDARD SOLVENT (TYPE IIC) DATE: 09/25/02
EXPERIMENT: 96001 TEST: 06 TIME: 11:17:13
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-75410 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C96001
PATHOLOGIST: GRUMBEIN, SONDR CAS: 64742-88-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF STODDARD SOLVENT (TYPE IIC)
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Intestine Small: Ileum Carcinoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Carcinoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
===============================================================
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 3/50 (6%) 1/49 (2%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/43.20 3/43.68 1/40.73 1/42.54 |1/45.92 1/43.40 0/42.07 0/44.68 |
|POLY-3 PERCENT (g) | 9.3% 6.9% 2.5% 2.4% |2.2% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 4/34 (12%) 2/32 (6%) 1/27 (4%) 1/32 (3%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 618 729 (T) 729 (T) |530 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110N P=0.527N P=0.253N P=0.197N |P=0.248N P=0.752 P=0.500N P=0.508N |
|POLY 3 | P=0.096N P=0.494N P=0.196N P=0.183N |P=0.242N P=0.748 P=0.517N P=0.505N |
|POLY 1.5 | P=0.094N P=0.493N P=0.192N P=0.179N |P=0.240N P=0.753 P=0.513N P=0.504N |
|POLY 6 | P=0.098N P=0.493N P=0.200N P=0.187N |P=0.243N P=0.742 P=0.525N P=0.506N |
|LOGISTIC REGRESSION| P=0.100N P=0.501N P=0.253N P=0.197N |P=0.220N P=0.732N P=0.411N P=0.391N |
|COCH-ARM / FISHERS | P=0.090N P=0.489N P=0.181N P=0.175N |P=0.236N P=0.753N P=0.505N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 0/48 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |2/49 (4%) 0/50 (0%) 0/48 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/42.82 0/42.68 0/40.73 0/42.54 |2/45.07 0/43.40 0/41.34 1/43.90 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |1/36 (3%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |594 --- --- 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.469N P=0.251N P=0.276N P=0.509N |
|POLY 3 | (e) (e) (e) (e) |P=0.458N P=0.246N P=0.257N P=0.509N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.460N P=0.240N P=0.252N P=0.507N |
|POLY 6 | (e) (e) (e) (e) |P=0.456N P=0.253N P=0.266N P=0.510N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.460N P=0.213N P=0.222N P=0.488N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.463N P=0.242N P=0.253N P=0.500N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 5/50 (10%) 4/50 (8%) |4/50 (8%) 2/50 (4%) 6/50 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/44.05 6/43.68 5/41.65 4/42.54 |4/45.81 2/43.40 6/43.16 3/44.68 |
|POLY-3 PERCENT (g) | 15.9% 13.7% 12.0% 9.4% |8.7% 4.6% 13.9% 6.7% |
|TERMINAL (d) | 5/34 (15%) 5/32 (16%) 4/27 (15%) 4/32 (13%) |2/36 (6%) 2/34 (6%) 4/27 (15%) 3/34 (9%) |
|FIRST INCIDENCE | 651 618 644 729 (T) |618 730 (T) 673 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240N P=0.534N P=0.509N P=0.297N |P=0.563 P=0.371N P=0.250 P=0.520N |
|POLY 3 | P=0.219N P=0.507N P=0.419N P=0.280N |P=0.558N P=0.362N P=0.332 P=0.514N |
|POLY 1.5 | P=0.212N P=0.505N P=0.409N P=0.272N |P=0.560N P=0.352N P=0.345 P=0.511N |
|POLY 6 | P=0.229N P=0.509N P=0.429N P=0.291N |P=0.554N P=0.376N P=0.309 P=0.515N |
|LOGISTIC REGRESSION| P=0.220N P=0.506N P=0.422N P=0.281N |P=0.555N P=0.350N P=0.340 P=0.506N |
|COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.380N P=0.262N |P=0.554N P=0.339N P=0.370 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.60 4/43.52 3/41.96 3/42.91 |1/45.50 1/43.40 1/43.05 0/44.68 |
|POLY-3 PERCENT (g) | 0.0% 9.2% 7.2% 7.0% |2.2% 2.3% 2.3% 0.0% |
|TERMINAL (d) | 0/34 (0%) 2/32 (6%) 2/27 (7%) 2/32 (6%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 675 527 626 |681 730 (T) 664 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.207 P=0.061 P=0.093 P=0.113 |P=0.319N P=0.737 P=0.726 P=0.500N |
|POLY 3 | P=0.211 P=0.060 P=0.112 P=0.115 |P=0.315N P=0.750 P=0.748 P=0.504N |
|POLY 1.5 | P=0.214 P=0.060 P=0.113 P=0.117 |P=0.315N P=0.754 P=0.752 P=0.503N |
|POLY 6 | P=0.208 P=0.060 P=0.110 P=0.114 |P=0.315N P=0.745 P=0.740 P=0.503N |
|LOGISTIC REGRESSION| P=0.217 P=0.061 P=0.125 P=0.118 |P=0.312N P=0.757 P=0.756N P=0.495N |
|COCH-ARM / FISHERS | P=0.221 P=0.059 P=0.121 P=0.121 |P=0.311N P=0.753N P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 10/50 (20%) 8/50 (16%) 7/50 (14%) |5/50 (10%) 3/50 (6%) 7/50 (14%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/44.05 10/43.91 8/42.27 7/42.91 |5/46.00 3/43.40 7/43.40 3/44.68 |
|POLY-3 PERCENT (g) | 15.9% 22.8% 18.9% 16.3% |10.9% 6.9% 16.1% 6.7% |
|TERMINAL (d) | 5/34 (15%) 7/32 (22%) 6/27 (22%) 6/32 (19%) |2/36 (6%) 3/34 (9%) 4/27 (15%) 3/34 (9%) |
|FIRST INCIDENCE | 651 618 527 626 |618 730 (T) 664 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507N P=0.270 P=0.356 P=0.566 |P=0.428N P=0.402N P=0.255 P=0.377N |
|POLY 3 | P=0.477N P=0.292 P=0.465 P=0.594 |P=0.408N P=0.389N P=0.338 P=0.373N |
|POLY 1.5 | P=0.466N P=0.293 P=0.472 P=0.601 |P=0.409N P=0.375N P=0.353 P=0.368N |
|POLY 6 | P=0.491N P=0.292 P=0.458 P=0.584 |P=0.405N P=0.407N P=0.314 P=0.376N |
|LOGISTIC REGRESSION| P=0.477N P=0.290 P=0.461 P=0.589 |P=0.405N P=0.372N P=0.359 P=0.361N |
|COCH-ARM / FISHERS | P=0.448N P=0.298 P=0.500 P=0.613N |P=0.401N P=0.357N P=0.380 P=0.357N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Intestine Small: Ileum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 0/41.34 2/43.37 |0/45.31 0/43.40 1/43.36 0/44.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.6% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- 593 |--- --- 557 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.045 * (e) (e) P=0.229 |P=0.689 (e) P=0.500 (e) |
|POLY 3 | P=0.045 * (e) (e) P=0.236 |P=0.695 (e) P=0.491 (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.236 |P=0.693 (e) P=0.494 (e) |
|POLY 6 | P=0.045 * (e) (e) P=0.236 |P=0.701 (e) P=0.485 (e) |
|LOGISTIC REGRESSION| P=0.044 * (e) (e) P=0.264 |P=0.728 (e) P=0.575 (e) |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.60 3/43.29 0/41.34 0/42.54 |0/45.31 1/43.40 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 3/32 (9%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331N P=0.110 (e) (e) |P=0.576N P=0.489 (e) (e) |
|POLY 3 | P=0.319N P=0.117 (e) (e) |P=0.576N P=0.491 (e) (e) |
|POLY 1.5 | P=0.316N P=0.118 (e) (e) |P=0.573N P=0.495 (e) (e) |
|POLY 6 | P=0.323N P=0.117 (e) (e) |P=0.580N P=0.487 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.110 (e) (e) |(e) P=0.489 (e) (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.121 (e) (e) |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 3/43.29 0/41.34 2/43.37 |0/45.31 1/43.40 1/43.36 1/44.68 |
|POLY-3 PERCENT (g) | 0.0% 6.9% 0.0% 4.6% |0.0% 2.3% 2.3% 2.2% |
|TERMINAL (d) | 0/34 (0%) 3/32 (9%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 593 |--- 730 (T) 557 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.336 P=0.110 (e) P=0.229 |P=0.371 P=0.489 P=0.500 P=0.489 |
|POLY 3 | P=0.345 P=0.117 (e) P=0.236 |P=0.381 P=0.491 P=0.491 P=0.497 |
|POLY 1.5 | P=0.346 P=0.118 (e) P=0.236 |P=0.381 P=0.495 P=0.494 P=0.497 |
|POLY 6 | P=0.345 P=0.117 (e) P=0.236 |P=0.384 P=0.487 P=0.485 P=0.498 |
|LOGISTIC REGRESSION| P=0.351 P=0.110 (e) P=0.264 |P=0.388 P=0.489 P=0.575 P=0.489 |
|COCH-ARM / FISHERS | P=0.351 P=0.121 (e) P=0.247 |P=0.384 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 4/43.29 0/41.34 2/43.37 |0/45.31 1/43.40 1/43.36 1/44.68 |
|POLY-3 PERCENT (g) | 0.0% 9.2% 0.0% 4.6% |0.0% 2.3% 2.3% 2.2% |
|TERMINAL (d) | 0/34 (0%) 4/32 (13%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | --- 729 (T) --- 593 |--- 730 (T) 557 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424 P=0.055 (e) P=0.229 |P=0.371 P=0.489 P=0.500 P=0.489 |
|POLY 3 | P=0.437 P=0.059 (e) P=0.236 |P=0.381 P=0.491 P=0.491 P=0.497 |
|POLY 1.5 | P=0.438 P=0.059 (e) P=0.236 |P=0.381 P=0.495 P=0.494 P=0.497 |
|POLY 6 | P=0.437 P=0.058 (e) P=0.236 |P=0.384 P=0.487 P=0.485 P=0.498 |
|LOGISTIC REGRESSION| P=0.441 P=0.055 (e) P=0.264 |P=0.388 P=0.489 P=0.575 P=0.489 |
|COCH-ARM / FISHERS | P=0.444 P=0.059 (e) P=0.247 |P=0.384 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 1/43.47 3/41.88 0/42.54 |0/45.31 1/43.40 0/42.80 1/44.70 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 7.2% 0.0% |0.0% 2.3% 0.0% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 683 628 --- |--- 730 (T) --- 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.617 P=0.495 P=0.109 (e) |P=0.395 P=0.489 (e) P=0.489 |
|POLY 3 | P=0.621 P=0.499 P=0.111 (e) |P=0.400 P=0.491 (e) P=0.497 |
|POLY 1.5 | P=0.627 P=0.499 P=0.113 (e) |P=0.401 P=0.495 (e) P=0.497 |
|POLY 6 | P=0.614 P=0.500 P=0.111 (e) |P=0.401 P=0.487 (e) P=0.498 |
|LOGISTIC REGRESSION| P=0.634N P=0.501 P=0.118 (e) |P=0.408 P=0.489 (e) P=0.499 |
|COCH-ARM / FISHERS | P=0.634 P=0.500 P=0.121 (e) |P=0.405 P=0.500 (e) P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 28/50 (56%) 21/50 (42%) 29/50 (58%) |9/50 (18%) 12/50 (24%) 15/50 (30%) 18/50 (36%) |
|POLY-3 RATE (b) | 23/44.70 28/46.14 21/43.49 29/46.13 |9/46.16 12/43.90 15/44.44 18/46.35 |
|POLY-3 PERCENT (g) | 51.5% 60.7% 48.3% 62.9% |19.5% 27.3% 33.8% 38.8% |
|TERMINAL (d) | 21/34 (62%) 20/32 (63%) 14/27 (52%) 21/32 (66%) |5/36 (14%) 11/34 (32%) 7/27 (26%) 13/34 (38%) |
|FIRST INCIDENCE | 458 398 509 506 |590 578 600 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.147 P=0.151 P=0.395 P=0.103 |P=0.025 * P=0.260 P=0.053 P=0.037 * |
|POLY 3 | P=0.225 P=0.244 P=0.466N P=0.180 |P=0.023 * P=0.264 P=0.095 P=0.032 * |
|POLY 1.5 | P=0.214 P=0.225 P=0.467N P=0.166 |P=0.022 * P=0.284 P=0.102 P=0.032 * |
|POLY 6 | P=0.246 P=0.280 P=0.448N P=0.206 |P=0.024 * P=0.238 P=0.083 P=0.033 * |
|LOGISTIC REGRESSION| P=0.180 P=0.197 P=0.513N P=0.131 |P=0.022 * P=0.272 P=0.104 P=0.035 * |
|COCH-ARM / FISHERS | P=0.215 P=0.212 P=0.420N P=0.158 |P=0.023 * P=0.312 P=0.121 P=0.035 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 15/50 (30%) 17/50 (34%) 10/50 (20%) |6/50 (12%) 7/50 (14%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 16/48.66 15/48.38 17/46.19 10/44.77 |6/45.65 7/44.40 5/43.64 6/44.86 |
|POLY-3 PERCENT (g) | 32.9% 31.0% 36.8% 22.3% |13.1% 15.8% 11.5% 13.4% |
|TERMINAL (d) | 6/34 (18%) 4/32 (13%) 3/27 (11%) 4/32 (13%) |4/36 (11%) 4/34 (12%) 2/27 (7%) 4/34 (12%) |
|FIRST INCIDENCE | 458 398 478 563 |668 620 639 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.520N P=0.377 P=0.186N |P=0.523N P=0.452 P=0.606 P=0.596 |
|POLY 3 | P=0.181N P=0.508N P=0.427 P=0.182N |P=0.512N P=0.479 P=0.532N P=0.609 |
|POLY 1.5 | P=0.154N P=0.504N P=0.443 P=0.160N |P=0.511N P=0.486 P=0.522N P=0.610 |
|POLY 6 | P=0.211N P=0.513N P=0.416 P=0.207N |P=0.511N P=0.470 P=0.550N P=0.611 |
|LOGISTIC REGRESSION| P=0.071N P=0.504N P=0.541N P=0.083N |P=0.505N P=0.487 P=0.520N P=0.614 |
|COCH-ARM / FISHERS | P=0.113N P=0.500N P=0.500 P=0.127N |P=0.500N P=0.500 P=0.500N P=0.620N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 15/50 (30%) 17/50 (34%) 11/50 (22%) |6/50 (12%) 7/50 (14%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 16/48.66 15/48.38 17/46.19 11/44.77 |6/45.65 7/44.40 5/43.64 6/44.86 |
|POLY-3 PERCENT (g) | 32.9% 31.0% 36.8% 24.6% |13.1% 15.8% 11.5% 13.4% |
|TERMINAL (d) | 6/34 (18%) 4/32 (13%) 3/27 (11%) 5/32 (16%) |4/36 (11%) 4/34 (12%) 2/27 (7%) 4/34 (12%) |
|FIRST INCIDENCE | 458 398 478 563 |668 620 639 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.246N P=0.520N P=0.377 P=0.249N |P=0.523N P=0.452 P=0.606 P=0.596 |
|POLY 3 | P=0.253N P=0.508N P=0.427 P=0.256N |P=0.512N P=0.479 P=0.532N P=0.609 |
|POLY 1.5 | P=0.219N P=0.504N P=0.443 P=0.227N |P=0.511N P=0.486 P=0.522N P=0.610 |
|POLY 6 | P=0.290N P=0.513N P=0.416 P=0.287N |P=0.511N P=0.470 P=0.550N P=0.611 |
|LOGISTIC REGRESSION| P=0.114N P=0.504N P=0.541N P=0.132N |P=0.505N P=0.487 P=0.520N P=0.614 |
|COCH-ARM / FISHERS | P=0.166N P=0.500N P=0.500 P=0.184N |P=0.500N P=0.500 P=0.500N P=0.620N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 37/50 (74%) 30/50 (60%) 32/50 (64%) |13/50 (26%) 17/50 (34%) 18/50 (36%) 21/50 (42%) |
|POLY-3 RATE (b) | 34/49.01 37/49.49 30/46.27 32/46.59 |13/46.39 17/44.91 18/44.71 21/46.44 |
|POLY-3 PERCENT (g) | 69.4% 74.8% 64.8% 68.7% |28.0% 37.9% 40.3% 45.2% |
|TERMINAL (d) | 23/34 (68%) 21/32 (66%) 15/27 (56%) 22/32 (69%) |8/36 (22%) 13/34 (38%) 9/27 (33%) 15/34 (44%) |
|FIRST INCIDENCE | 458 398 478 506 |590 578 600 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.306 P=0.489 P=0.545N |P=0.065 P=0.209 P=0.076 P=0.069 |
|POLY 3 | P=0.402N P=0.355 P=0.399N P=0.560N |P=0.059 P=0.217 P=0.154 P=0.063 |
|POLY 1.5 | P=0.342N P=0.343 P=0.366N P=0.505N |P=0.058 P=0.232 P=0.165 P=0.064 |
|POLY 6 | P=0.470N P=0.374 P=0.426N P=0.566 |P=0.060 P=0.200 P=0.136 P=0.064 |
|LOGISTIC REGRESSION| P=0.245N P=0.333 P=0.265N P=0.412N |P=0.059 P=0.227 P=0.161 P=0.065 |
|COCH-ARM / FISHERS | P=0.247N P=0.330 P=0.266N P=0.417N |P=0.063 P=0.257 P=0.194 P=0.069 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 37/50 (74%) 30/50 (60%) 32/50 (64%) |13/50 (26%) 17/50 (34%) 18/50 (36%) 21/50 (42%) |
|POLY-3 RATE (b) | 34/49.01 37/49.49 30/46.27 32/46.59 |13/46.39 17/44.91 18/44.71 21/46.44 |
|POLY-3 PERCENT (g) | 69.4% 74.8% 64.8% 68.7% |28.0% 37.9% 40.3% 45.2% |
|TERMINAL (d) | 23/34 (68%) 21/32 (66%) 15/27 (56%) 22/32 (69%) |8/36 (22%) 13/34 (38%) 9/27 (33%) 15/34 (44%) |
|FIRST INCIDENCE | 458 398 478 506 |590 578 600 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.306 P=0.489 P=0.545N |P=0.065 P=0.209 P=0.076 P=0.069 |
|POLY 3 | P=0.402N P=0.355 P=0.399N P=0.560N |P=0.059 P=0.217 P=0.154 P=0.063 |
|POLY 1.5 | P=0.342N P=0.343 P=0.366N P=0.505N |P=0.058 P=0.232 P=0.165 P=0.064 |
|POLY 6 | P=0.470N P=0.374 P=0.426N P=0.566 |P=0.060 P=0.200 P=0.136 P=0.064 |
|LOGISTIC REGRESSION| P=0.245N P=0.333 P=0.265N P=0.412N |P=0.059 P=0.227 P=0.161 P=0.065 |
|COCH-ARM / FISHERS | P=0.247N P=0.330 P=0.266N P=0.417N |P=0.063 P=0.257 P=0.194 P=0.069 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 0/41.34 0/42.54 |0/45.31 2/43.89 0/42.80 1/44.82 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.6% 0.0% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 653 --- 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.547 P=0.224 (e) P=0.510 |
|POLY 3 | (e) (e) (e) (e) |P=0.532 P=0.230 (e) P=0.498 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.533 P=0.233 (e) P=0.498 |
|POLY 6 | (e) (e) (e) (e) |P=0.533 P=0.227 (e) P=0.499 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.543 P=0.251 (e) P=0.501 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/49 (4%) 3/50 (6%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/43.60 2/42.55 3/41.44 1/42.54 |2/45.31 2/43.90 3/42.80 1/44.68 |
|POLY-3 PERCENT (g) | 13.8% 4.7% 7.2% 2.4% |4.4% 4.6% 7.0% 2.2% |
|TERMINAL (d) | 6/34 (18%) 2/32 (6%) 2/27 (7%) 1/32 (3%) |2/36 (6%) 1/34 (3%) 3/27 (11%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 702 729 (T) |730 (T) 578 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066N P=0.151N P=0.353N P=0.066N |P=0.434N P=0.676 P=0.369 P=0.520N |
|POLY 3 | P=0.055N P=0.140N P=0.266N P=0.059N |P=0.408N P=0.683 P=0.474 P=0.505N |
|POLY 1.5 | P=0.054N P=0.141N P=0.262N P=0.058N |P=0.409N P=0.687 P=0.483 P=0.505N |
|POLY 6 | P=0.056N P=0.138N P=0.270N P=0.060N |P=0.404N P=0.678 P=0.457 P=0.503N |
|LOGISTIC REGRESSION| P=0.060N P=0.151N P=0.297N P=0.066N |P=0.406N P=0.694N P=0.369 P=0.520N |
|COCH-ARM / FISHERS | P=0.053N P=0.141N P=0.243N P=0.056N |P=0.404N P=0.691N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/49 (4%) 4/50 (8%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 7/44.15 2/42.76 4/41.52 5/43.21 |0/45.31 0/43.40 0/42.80 2/45.42 |
|POLY-3 PERCENT (g) | 15.9% 4.7% 9.6% 11.6% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 5/34 (15%) 1/32 (3%) 2/27 (7%) 3/32 (9%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 628 675 702 506 |--- --- --- 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.505N P=0.097N P=0.369N P=0.420N |P=0.047 * (e) (e) P=0.231 |
|POLY 3 | P=0.475N P=0.085N P=0.296N P=0.394N |P=0.046 * (e) (e) P=0.238 |
|POLY 1.5 | P=0.470N P=0.086N P=0.287N P=0.388N |P=0.046 * (e) (e) P=0.237 |
|POLY 6 | P=0.483N P=0.085N P=0.306N P=0.403N |P=0.047 * (e) (e) P=0.240 |
|LOGISTIC REGRESSION| P=0.479N P=0.086N P=0.295N P=0.390N |P=0.046 * (e) (e) P=0.284 |
|COCH-ARM / FISHERS | P=0.462N P=0.085N P=0.262N P=0.380N |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 13/50 (26%) 4/49 (8%) 6/50 (12%) 6/50 (12%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 13/44.15 4/42.76 6/41.52 6/43.21 |2/45.31 2/43.90 3/42.80 3/45.42 |
|POLY-3 PERCENT (g) | 29.5% 9.4% 14.5% 13.9% |4.4% 4.6% 7.0% 6.6% |
|TERMINAL (d) | 11/34 (32%) 3/32 (9%) 4/27 (15%) 4/32 (13%) |2/36 (6%) 1/34 (3%) 3/27 (11%) 2/34 (6%) |
|FIRST INCIDENCE | 628 675 702 506 |730 (T) 578 730 (T) 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.124N P=0.023N* P=0.145N P=0.084N |P=0.346 P=0.676 P=0.369 P=0.477 |
|POLY 3 | P=0.091N P=0.016N* P=0.076N P=0.063N |P=0.377 P=0.683 P=0.474 P=0.501 |
|POLY 1.5 | P=0.090N P=0.016N* P=0.073N P=0.062N |P=0.372 P=0.687 P=0.483 P=0.499 |
|POLY 6 | P=0.094N P=0.015N* P=0.081N P=0.066N |P=0.384 P=0.678 P=0.457 P=0.506 |
|LOGISTIC REGRESSION| P=0.103N P=0.017N* P=0.081N P=0.070N |P=0.372 P=0.694N P=0.369 P=0.515 |
|COCH-ARM / FISHERS | P=0.091N P=0.017N* P=0.062N P=0.062N |P=0.371 P=0.691N P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 2/50 (4%) 1/48 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | |1/44.31 2/43.60 1/41.15 1/44.45 |
|POLY-3 PERCENT (g) | |2.3% 4.6% 2.4% 2.3% |
|TERMINAL (d) | |1/35 (3%) 1/34 (3%) 1/27 (4%) 0/34 (0%) |
|FIRST INCIDENCE | |730 (T) 677 730 (T) 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.538N P=0.479 P=0.703 P=0.755 |
|POLY 3 | |P=0.534N P=0.494 P=0.744 P=0.760N |
|POLY 1.5 | |P=0.535N P=0.499 P=0.748 P=0.760 |
|POLY 6 | |P=0.530N P=0.489 P=0.737 P=0.757N |
|LOGISTIC REGRESSION| |P=0.529N P=0.492 P=0.703 P=0.728N |
|COCH-ARM / FISHERS | |P=0.534N P=0.508 P=0.747 P=0.753N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) |10/47 (21%) 8/49 (16%) 10/49 (20%) 10/48 (21%) |
|POLY-3 RATE (b) | 0/43.28 0/42.55 0/40.08 0/39.42 |10/43.41 8/42.40 10/43.26 10/43.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |23.0% 18.9% 23.1% 23.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/29 (0%) |10/35 (29%) 8/33 (24%) 7/27 (26%) 8/34 (24%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 590 554 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.442 P=0.449N P=0.372 P=0.573 |
|POLY 3 | (e) (e) (e) (e) |P=0.490 P=0.417N P=0.597 P=0.597N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.482 P=0.395N P=0.591N P=0.596N |
|POLY 6 | (e) (e) (e) (e) |P=0.511 P=0.445N P=0.578 P=0.587N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.472 P=0.449N P=0.563 P=0.591 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.488 P=0.360N P=0.558N P=0.578N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/46 (0%) |10/47 (21%) 9/49 (18%) 10/49 (20%) 10/48 (21%) |
|POLY-3 RATE (b) | 0/43.28 0/42.55 0/40.08 0/39.42 |10/43.41 9/42.53 10/43.26 10/43.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |23.0% 21.2% 23.1% 23.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/29 (0%) |10/35 (29%) 8/33 (24%) 7/27 (26%) 8/34 (24%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 695 590 554 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.481 P=0.561N P=0.372 P=0.573 |
|POLY 3 | (e) (e) (e) (e) |P=0.525 P=0.520N P=0.597 P=0.597N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.517 P=0.497N P=0.591N P=0.596N |
|POLY 6 | (e) (e) (e) (e) |P=0.544 P=0.546N P=0.578 P=0.587N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.509 P=0.597N P=0.563 P=0.591 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.524 P=0.459N P=0.558N P=0.578N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.23 0/43.29 0/41.34 1/42.54 |1/45.39 0/43.40 5/44.25 2/44.70 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.4% |2.2% 0.0% 11.3% 4.5% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 1/34 (3%) |
|FIRST INCIDENCE | 525 --- --- 729 (T) |708 --- 506 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.504N P=0.517N P=0.751 |P=0.230 P=0.522N P=0.077 P=0.487 |
|POLY 3 | P=0.590 P=0.504N P=0.513N P=0.752 |P=0.231 P=0.509N P=0.095 P=0.495 |
|POLY 1.5 | P=0.592 P=0.503N P=0.510N P=0.755 |P=0.228 P=0.505N P=0.097 P=0.495 |
|POLY 6 | P=0.588 P=0.506N P=0.517N P=0.748 |P=0.237 P=0.514N P=0.090 P=0.496 |
|LOGISTIC REGRESSION| P=0.609 P=0.409N P=0.396N P=0.743N |P=0.237 P=0.507N P=0.121 P=0.497 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.232 P=0.500N P=0.102 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.23 0/43.29 0/41.34 1/42.54 |1/45.39 0/43.40 5/44.25 2/44.70 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.4% |2.2% 0.0% 11.3% 4.5% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 1/34 (3%) |
|FIRST INCIDENCE | 525 --- --- 729 (T) |708 --- 506 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.504N P=0.517N P=0.751 |P=0.230 P=0.522N P=0.077 P=0.487 |
|POLY 3 | P=0.590 P=0.504N P=0.513N P=0.752 |P=0.231 P=0.509N P=0.095 P=0.495 |
|POLY 1.5 | P=0.592 P=0.503N P=0.510N P=0.755 |P=0.228 P=0.505N P=0.097 P=0.495 |
|POLY 6 | P=0.588 P=0.506N P=0.517N P=0.748 |P=0.237 P=0.514N P=0.090 P=0.496 |
|LOGISTIC REGRESSION| P=0.609 P=0.409N P=0.396N P=0.743N |P=0.237 P=0.507N P=0.121 P=0.497 |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.232 P=0.500N P=0.102 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 2/41.42 1/42.55 |0/45.31 1/43.56 0/42.80 0/44.68 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.4% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 709 728 |--- 688 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.243 (e) P=0.199 P=0.494 |P=0.554N P=0.479 (e) (e) |
|POLY 3 | P=0.238 (e) P=0.226 P=0.495 |P=0.576N P=0.492 (e) (e) |
|POLY 1.5 | P=0.241 (e) P=0.228 P=0.497 |P=0.573N P=0.495 (e) (e) |
|POLY 6 | P=0.234 (e) P=0.223 P=0.493 |P=0.579N P=0.489 (e) (e) |
|LOGISTIC REGRESSION| P=0.236 (e) P=0.220 P=0.492 |P=0.567N P=0.503 (e) (e) |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.23 0/43.29 0/41.34 0/42.54 |1/45.39 0/43.40 5/44.25 2/44.70 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |2.2% 0.0% 11.3% 4.5% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 0/27 (0%) 0/32 (0%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 1/34 (3%) |
|FIRST INCIDENCE | 525 --- --- --- |708 --- 506 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.504N P=0.517N P=0.504N |P=0.230 P=0.522N P=0.077 P=0.487 |
|POLY 3 | P=0.304N P=0.504N P=0.513N P=0.508N |P=0.231 P=0.509N P=0.095 P=0.495 |
|POLY 1.5 | P=0.305N P=0.503N P=0.510N P=0.505N |P=0.228 P=0.505N P=0.097 P=0.495 |
|POLY 6 | P=0.303N P=0.506N P=0.517N P=0.511N |P=0.237 P=0.514N P=0.090 P=0.496 |
|LOGISTIC REGRESSION| P=0.266N P=0.409N P=0.396N P=0.412N |P=0.237 P=0.507N P=0.121 P=0.497 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.232 P=0.500N P=0.102 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 2/41.46 2/42.83 |0/45.31 0/43.40 1/42.80 1/44.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 4.7% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 698 653 |--- --- 730 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 (e) P=0.215 P=0.233 |P=0.238 (e) P=0.443 P=0.500 |
|POLY 3 | P=0.083 (e) P=0.226 P=0.233 |P=0.238 (e) P=0.489 P=0.498 |
|POLY 1.5 | P=0.084 (e) P=0.228 P=0.234 |P=0.236 (e) P=0.493 P=0.497 |
|POLY 6 | P=0.082 (e) P=0.224 P=0.232 |P=0.242 (e) P=0.481 P=0.499 |
|LOGISTIC REGRESSION| P=0.083 (e) P=0.223 P=0.236 |P=0.240 (e) P=0.443 P=0.498 |
|COCH-ARM / FISHERS | P=0.086 (e) P=0.247 P=0.247 |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.60 0/43.29 2/41.46 1/42.54 |0/45.31 0/43.40 1/42.80 1/44.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 2.4% |0.0% 0.0% 2.3% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 1/32 (3%) |0/36 (0%) 0/34 (0%) 1/27 (4%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 698 729 (T) |--- --- 730 (T) 709 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240 (e) P=0.215 P=0.488 |P=0.238 (e) P=0.443 P=0.500 |
|POLY 3 | P=0.238 (e) P=0.226 P=0.495 |P=0.238 (e) P=0.489 P=0.498 |
|POLY 1.5 | P=0.241 (e) P=0.228 P=0.497 |P=0.236 (e) P=0.493 P=0.497 |
|POLY 6 | P=0.234 (e) P=0.224 P=0.493 |P=0.242 (e) P=0.481 P=0.499 |
|LOGISTIC REGRESSION| P=0.237 (e) P=0.223 P=0.488 |P=0.240 (e) P=0.443 P=0.498 |
|COCH-ARM / FISHERS | P=0.246 (e) P=0.247 P=0.500 |P=0.236 (e) P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) | |
|POLY-3 RATE (b) | 1/43.60 2/43.29 0/41.34 2/42.62 | |
|POLY-3 PERCENT (g) | 2.3% 4.6% 0.0% 4.7% | |
|TERMINAL (d) | 1/34 (3%) 2/32 (6%) 0/27 (0%) 1/32 (3%) | |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 710 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.450 P=0.479 P=0.546N P=0.483 | |
|POLY 3 | P=0.460 P=0.497 P=0.511N P=0.492 | |
|POLY 1.5 | P=0.463 P=0.498 P=0.508N P=0.495 | |
|POLY 6 | P=0.456 P=0.497 P=0.513N P=0.489 | |
|LOGISTIC REGRESSION| P=0.454 P=0.479 (e) P=0.485 | |
|COCH-ARM / FISHERS | P=0.469 P=0.500 P=0.500N P=0.500 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/48 (0%) 0/47 (0%) 0/50 (0%) |2/50 (4%) 0/49 (0%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/43.38 0/41.78 0/38.85 0/42.54 |2/45.31 0/42.95 0/40.23 0/43.38 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/31 (0%) 0/26 (0%) 0/32 (0%) |2/36 (6%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 681 --- --- --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.511N P=0.511N P=0.516N |P=0.129N P=0.251N P=0.303N P=0.251N |
|POLY 3 | P=0.303N P=0.507N P=0.522N P=0.504N |P=0.118N P=0.249N P=0.264N P=0.247N |
|POLY 1.5 | P=0.304N P=0.506N P=0.518N P=0.501N |P=0.118N P=0.246N P=0.260N P=0.248N |
|POLY 6 | P=0.302N P=0.509N P=0.526N P=0.508N |P=0.117N P=0.253N P=0.272N P=0.244N |
|LOGISTIC REGRESSION| P=0.304N P=0.502N P=0.509N P=0.493N |P=0.129N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.505N P=0.510N P=0.495N |P=0.120N P=0.253N P=0.263N P=0.258N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 1/49 (2%) 0/48 (0%) 0/47 (0%) 0/50 (0%) |2/50 (4%) 1/49 (2%) 0/47 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/43.38 0/41.78 0/38.85 0/42.54 |2/45.31 1/42.95 0/40.23 0/43.38 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |4.4% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/31 (0%) 0/26 (0%) 0/32 (0%) |2/36 (6%) 1/34 (3%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 681 --- --- --- |730 (T) 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315N P=0.511N P=0.511N P=0.516N |P=0.116N P=0.520N P=0.303N P=0.251N |
|POLY 3 | P=0.303N P=0.507N P=0.522N P=0.504N |P=0.107N P=0.519N P=0.264N P=0.247N |
|POLY 1.5 | P=0.304N P=0.506N P=0.518N P=0.501N |P=0.107N P=0.514N P=0.260N P=0.248N |
|POLY 6 | P=0.302N P=0.509N P=0.526N P=0.508N |P=0.106N P=0.524N P=0.272N P=0.244N |
|LOGISTIC REGRESSION| P=0.304N P=0.502N P=0.509N P=0.493N |P=0.116N P=0.520N (e) (e) |
|COCH-ARM / FISHERS | P=0.304N P=0.505N P=0.510N P=0.495N |P=0.106N P=0.508N P=0.263N P=0.258N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | |2/45.31 0/43.40 0/42.80 1/45.01 |
|POLY-3 PERCENT (g) | |4.4% 0.0% 0.0% 2.2% |
|TERMINAL (d) | |2/36 (6%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | |730 (T) --- --- 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.473N P=0.251N P=0.303N P=0.513N |
|POLY 3 | |P=0.457N P=0.247N P=0.250N P=0.502N |
|POLY 1.5 | |P=0.459N P=0.243N P=0.246N P=0.503N |
|POLY 6 | |P=0.456N P=0.252N P=0.258N P=0.499N |
|LOGISTIC REGRESSION| |P=0.462N (e) (e) P=0.501N |
|COCH-ARM / FISHERS | |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | |3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | |3/45.31 1/43.88 0/42.80 1/45.01 |
|POLY-3 PERCENT (g) | |6.6% 2.3% 0.0% 2.2% |
|TERMINAL (d) | |3/36 (8%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | |730 (T) 586 --- 639 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.217N P=0.326N P=0.176N P=0.322N |
|POLY 3 | |P=0.200N P=0.317N P=0.129N P=0.308N |
|POLY 1.5 | |P=0.200N P=0.313N P=0.126N P=0.309N |
|POLY 6 | |P=0.199N P=0.322N P=0.136N P=0.304N |
|LOGISTIC REGRESSION| |P=0.198N P=0.304N (e) P=0.308N |
|COCH-ARM / FISHERS | |P=0.200N P=0.309N P=0.121N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |1/50 (2%) 4/50 (8%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.00 1/43.47 5/41.96 2/42.73 |1/45.77 4/44.06 0/42.80 3/44.70 |
|POLY-3 PERCENT (g) | 2.3% 2.3% 11.9% 4.7% |2.2% 9.1% 0.0% 6.7% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 0/32 (0%) |0/36 (0%) 2/34 (6%) 0/27 (0%) 2/34 (6%) |
|FIRST INCIDENCE | 617 683 628 681 |594 578 --- 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286 P=0.757 P=0.085 P=0.479 |P=0.390 P=0.168 P=0.509N P=0.291 |
|POLY 3 | P=0.285 P=0.758 P=0.090 P=0.490 |P=0.388 P=0.167 P=0.513N P=0.297 |
|POLY 1.5 | P=0.292 P=0.759 P=0.093 P=0.494 |P=0.392 P=0.172 P=0.509N P=0.299 |
|POLY 6 | P=0.277 P=0.758 P=0.088 P=0.485 |P=0.384 P=0.162 P=0.522N P=0.296 |
|LOGISTIC REGRESSION| P=0.299 P=0.755N P=0.100 P=0.505 |P=0.404 P=0.199 P=0.448N P=0.306 |
|COCH-ARM / FISHERS | P=0.302 P=0.753N P=0.102 P=0.500 |P=0.404 P=0.181 P=0.500N P=0.309 |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 5/50 (10%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.00 1/43.47 5/41.96 2/42.73 |2/46.16 5/44.06 1/42.80 4/45.44 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 11.9% 4.7% |4.3% 11.4% 2.3% 8.8% |
|TERMINAL (d) | 1/34 (3%) 0/32 (0%) 1/27 (4%) 0/32 (0%) |0/36 (0%) 3/34 (9%) 1/27 (4%) 2/34 (6%) |
|FIRST INCIDENCE | 617 683 628 681 |594 578 730 (T) 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.510N P=0.175 P=0.670 |P=0.403 P=0.202 P=0.543N P=0.325 |
|POLY 3 | P=0.439 P=0.504N P=0.196 P=0.684 |P=0.408 P=0.197 P=0.526N P=0.330 |
|POLY 1.5 | P=0.446 P=0.503N P=0.201 P=0.687 |P=0.411 P=0.205 P=0.517N P=0.331 |
|POLY 6 | P=0.431 P=0.505N P=0.194 P=0.679 |P=0.404 P=0.188 P=0.543N P=0.329 |
|LOGISTIC REGRESSION| P=0.451 P=0.497N P=0.206 P=0.694 |P=0.430 P=0.241 P=0.462N P=0.383 |
|COCH-ARM / FISHERS | P=0.456 P=0.500N P=0.218 P=0.691N |P=0.420 P=0.218 P=0.500N P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.60 1/43.68 3/41.68 0/42.54 |2/46.11 2/44.61 1/43.15 2/45.64 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 7.2% 0.0% |4.3% 4.5% 2.3% 4.4% |
|TERMINAL (d) | 0/34 (0%) 0/32 (0%) 1/27 (4%) 0/32 (0%) |1/36 (3%) 0/34 (0%) 0/27 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 618 667 --- |424 455 634 408 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.617 P=0.505 P=0.108 (e) |P=0.577N P=0.683 P=0.538N P=0.685 |
|POLY 3 | P=0.621 P=0.500 P=0.110 (e) |P=0.581N P=0.682 P=0.523N P=0.690 |
|POLY 1.5 | P=0.627 P=0.500 P=0.112 (e) |P=0.581N P=0.686 P=0.516N P=0.690 |
|POLY 6 | P=0.614 P=0.502 P=0.109 (e) |P=0.580N P=0.677 P=0.535N P=0.693 |
|LOGISTIC REGRESSION| P=0.633N P=0.521 P=0.113 (e) |P=0.507N P=0.581N P=0.413N P=0.580N |
|COCH-ARM / FISHERS | P=0.634 P=0.500 P=0.121 (e) |P=0.577N P=0.691N P=0.500N P=0.691N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |5/50 (10%) 9/50 (18%) 11/50 (22%) 8/50 (16%) |
|POLY-3 RATE (b) | 3/43.74 1/43.29 0/41.34 2/42.54 |5/46.01 9/43.64 11/43.84 8/45.01 |
|POLY-3 PERCENT (g) | 6.9% 2.3% 0.0% 4.7% |10.9% 20.6% 25.1% 17.8% |
|TERMINAL (d) | 2/34 (6%) 1/32 (3%) 0/27 (0%) 2/32 (6%) |3/36 (8%) 8/34 (24%) 5/27 (19%) 5/34 (15%) |
|FIRST INCIDENCE | 694 729 (T) --- 729 (T) |492 666 652 672 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469N P=0.325N P=0.153N P=0.527N |P=0.270 P=0.165 P=0.040 * P=0.255 |
|POLY 3 | P=0.451N P=0.309N P=0.129N P=0.513N |P=0.276 P=0.163 P=0.066 P=0.261 |
|POLY 1.5 | P=0.449N P=0.308N P=0.126N P=0.508N |P=0.276 P=0.174 P=0.072 P=0.263 |
|POLY 6 | P=0.453N P=0.310N P=0.131N P=0.519N |P=0.284 P=0.150 P=0.059 P=0.264 |
|LOGISTIC REGRESSION| P=0.462N P=0.308N P=0.132N P=0.519N |P=0.288 P=0.174 P=0.079 P=0.270 |
|COCH-ARM / FISHERS | P=0.444N P=0.309N P=0.121N P=0.500N |P=0.292 P=0.194 P=0.086 P=0.277 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 31/50 (62%) 30/50 (60%) 33/50 (66%) |27/50 (54%) 24/50 (48%) 30/50 (60%) 27/50 (54%) |
|POLY-3 RATE (b) | 32/45.34 31/46.14 30/44.74 33/46.43 |27/47.63 24/44.10 30/45.54 27/47.42 |
|POLY-3 PERCENT (g) | 70.6% 67.2% 67.1% 71.1% |56.7% 54.4% 65.9% 56.9% |
|TERMINAL (d) | 27/34 (79%) 23/32 (72%) 19/27 (70%) 23/32 (72%) |20/36 (56%) 22/34 (65%) 18/27 (67%) 18/34 (53%) |
|FIRST INCIDENCE | 458 398 484 506 |530 578 590 465 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309 P=0.536 P=0.304 P=0.369 |P=0.341 P=0.465N P=0.074 P=0.492 |
|POLY 3 | P=0.484 P=0.448N P=0.445N P=0.574 |P=0.462 P=0.497N P=0.239 P=0.572 |
|POLY 1.5 | P=0.457 P=0.475N P=0.462N P=0.535 |P=0.436 P=0.430N P=0.268 P=0.567 |
|POLY 6 | P=0.528 P=0.409N P=0.404N P=0.571N |P=0.504 P=0.586 P=0.200 P=0.583N |
|LOGISTIC REGRESSION| P=0.380 P=0.517N P=0.549N P=0.441 |P=0.402 P=0.428N P=0.267 P=0.568 |
|COCH-ARM / FISHERS | P=0.441 P=0.500N P=0.418N P=0.500 |P=0.424 P=0.345N P=0.343 P=0.579N |
|=================================================================================================================================|
Date: 09/25/02 EXPERIMENT: 96001 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - STODDARD SOLVENT (TYPE IIC)
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |CONTROL 550 1100 2200 |
| | MG/M3 MG/M3 MG/M3 | MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 23/50 (46%) 25/50 (50%) 23/50 (46%) |19/50 (38%) 26/50 (52%) 23/50 (46%) 23/50 (46%) |
|POLY-3 RATE (b) | 23/48.98 23/48.61 25/46.63 23/46.55 |19/48.29 26/47.35 23/47.02 23/48.31 |
|POLY-3 PERCENT (g) | 47.0% 47.3% 53.6% 49.4% |39.3% 54.9% 48.9% 47.6% |
|TERMINAL (d) | 11/34 (32%) 10/32 (31%) 9/27 (33%) 12/32 (38%) |10/36 (28%) 15/34 (44%) 8/27 (30%) 12/34 (35%) |
|FIRST INCIDENCE | 458 398 478 506 |424 455 506 282 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.433 P=0.522 P=0.259 P=0.494 |P=0.343 P=0.109 P=0.125 P=0.269 |
|POLY 3 | P=0.406 P=0.566 P=0.328 P=0.486 |P=0.362 P=0.091 P=0.231 P=0.269 |
|POLY 1.5 | P=0.444 P=0.572 P=0.347 P=0.519 |P=0.359 P=0.097 P=0.237 P=0.270 |
|POLY 6 | P=0.376 P=0.557 P=0.315 P=0.458 |P=0.367 P=0.090 P=0.223 P=0.273 |
|LOGISTIC REGRESSION| P=0.514N P=0.580N P=0.498 P=0.537N |P=0.374 P=0.137 P=0.313 P=0.296 |
|COCH-ARM / FISHERS | P=0.519 P=0.579N P=0.421 P=0.579N |P=0.359 P=0.114 P=0.272 P=0.272 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 550 1100 2200 |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) | 42/50 (84%) 43/50 (86%) 41/50 (82%) 41/50 (82%) |39/50 (78%) 41/50 (82%) 41/50 (82%) 39/50 (78%) |
|POLY-3 RATE (b) | 42/49.49 43/49.70 41/47.07 41/48.00 |39/49.56 41/47.55 41/48.29 39/49.66 |
|POLY-3 PERCENT (g) | 84.9% 86.5% 87.1% 85.4% |78.7% 86.2% 84.9% 78.5% |
|TERMINAL (d) | 28/34 (82%) 26/32 (81%) 23/27 (85%) 26/32 (81%) |27/36 (75%) 29/34 (85%) 21/27 (78%) 24/34 (71%) |
|FIRST INCIDENCE | 458 398 478 506 |424 455 506 282 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.467 P=0.398 P=0.227 P=0.491 |P=0.450 P=0.280 P=0.073 P=0.466 |
|POLY 3 | P=0.539 P=0.520 P=0.490 P=0.584 |P=0.444N P=0.235 P=0.295 P=0.590N |
|POLY 1.5 | P=0.513N P=0.512 P=0.539 P=0.597N |P=0.467N P=0.287 P=0.305 P=0.593N |
|POLY 6 | P=0.498 P=0.531 P=0.455 P=0.556 |P=0.420N P=0.199 P=0.291 P=0.583N |
|LOGISTIC REGRESSION| P=0.407N P=0.506 P=0.585N P=0.509N |P=0.510N P=0.369 P=0.370 P=0.587N |
|COCH-ARM / FISHERS | P=0.386N P=0.500 P=0.500N P=0.500N |P=0.500N P=0.402 P=0.402 P=0.595N |
|=================================================================================================================================|
(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).