TDMS Study 90004-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 11/04/02
EXPERIMENT: 90004 TEST: 06 TIME: 15:15:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: MISSING CAS: 57018-52-7
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
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Prostate
Spleen
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 11/04/02
EXPERIMENT: 90004 TEST: 06 TIME: 15:15:40
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: MISSING CAS: 57018-52-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PROPYLENE GLYCOL MONO-T-BUTYL ET
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Sarcoma
All Organs Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/49 (2%) 1/50 (2%) 4/50 (8%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/44.56 1/44.95 1/45.18 4/44.78 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 2.2% 8.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 1/40 (3%) 3/37 (8%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 711 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 P=0.732N P=0.732N P=0.195 |(e) (e) (e) (e) |
|POLY 3 | P=0.057 P=0.759N P=0.758N P=0.180 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.059 P=0.760N P=0.755N P=0.185 |(e) (e) (e) (e) |
|POLY 6 | P=0.054 P=0.756N P=0.759N P=0.175 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.050 P=0.732N P=0.732N P=0.175 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.061 P=0.747N P=0.742N P=0.194 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/44.56 2/44.95 0/45.18 0/44.71 |1/47.12 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 0.0% 4.5% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |624 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.268 (e) (e) |P=0.558N P=0.513N P=0.500N P=0.517N |
|POLY 3 | P=0.389N P=0.239 (e) (e) |P=0.548N P=0.503N P=0.496N P=0.509N |
|POLY 1.5 | P=0.389N P=0.238 (e) (e) |P=0.550N P=0.500N P=0.496N P=0.507N |
|POLY 6 | P=0.389N P=0.242 (e) (e) |P=0.546N P=0.507N P=0.496N P=0.510N |
|LOGISTIC REGRESSION| (e) P=0.268 (e) (e) |P=0.406N P=0.340N P=0.574N P=0.374N |
|COCH-ARM / FISHERS | P=0.384N P=0.253 (e) (e) |P=0.553N P=0.495N P=0.495N P=0.505N |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |3/50 (6%) 4/50 (8%) 5/50 (10%) 4/49 (8%) |
|POLY-3 RATE (b) | 6/46.18 4/45.45 4/45.18 4/45.06 |3/47.55 4/46.71 5/48.81 4/45.40 |
|POLY-3 PERCENT (g) | 13.0% 8.8% 8.9% 8.9% |6.3% 8.6% 10.2% 8.8% |
|TERMINAL (d) | 5/35 (14%) 3/40 (8%) 4/40 (10%) 3/37 (8%) |3/39 (8%) 2/36 (6%) 2/42 (5%) 4/39 (10%) |
|FIRST INCIDENCE | 671 663 729 (T) 632 |731 (T) 643 600 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.445N P=0.307N P=0.297N P=0.348N |P=0.537 P=0.462 P=0.393 P=0.500 |
|POLY 3 | P=0.440N P=0.379N P=0.383N P=0.385N |P=0.503 P=0.490 P=0.371 P=0.475 |
|POLY 1.5 | P=0.433N P=0.384N P=0.378N P=0.379N |P=0.507 P=0.494 P=0.365 P=0.479 |
|POLY 6 | P=0.449N P=0.368N P=0.384N P=0.388N |P=0.504 P=0.486 P=0.382 P=0.475 |
|LOGISTIC REGRESSION| P=0.447N P=0.377N P=0.369N P=0.385N |P=0.526 P=0.490 P=0.331 P=0.500 |
|COCH-ARM / FISHERS | P=0.431N P=0.370N P=0.370N P=0.370N |P=0.519 P=0.500 P=0.357 P=0.489 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 1/45.96 1/45.21 0/45.18 2/44.78 |0/47.55 2/46.83 0/48.03 2/45.40 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 0.0% 4.5% |0.0% 4.3% 0.0% 4.4% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 0/40 (0%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 711 |--- 630 --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.310 P=0.732N P=0.473N P=0.513 |P=0.290 P=0.230 (e) P=0.238 |
|POLY 3 | P=0.313 P=0.757 P=0.503N P=0.491 |P=0.275 P=0.234 (e) P=0.227 |
|POLY 1.5 | P=0.316 P=0.756 P=0.502N P=0.494 |P=0.277 P=0.235 (e) P=0.229 |
|POLY 6 | P=0.310 P=0.761N P=0.503N P=0.489 |P=0.274 P=0.233 (e) P=0.227 |
|LOGISTIC REGRESSION| P=0.304 P=0.732N (e) P=0.490 |P=0.308 P=0.299 (e) P=0.238 |
|COCH-ARM / FISHERS | P=0.317 P=0.753N P=0.500N P=0.500 |P=0.283 P=0.247 (e) P=0.242 |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 4/50 (8%) 6/50 (12%) |3/50 (6%) 6/50 (12%) 5/50 (10%) 5/49 (10%) |
|POLY-3 RATE (b) | 7/46.18 5/45.45 4/45.18 6/45.13 |3/47.55 6/47.17 5/48.81 5/45.40 |
|POLY-3 PERCENT (g) | 15.2% 11.0% 8.9% 13.3% |6.3% 12.7% 10.2% 11.0% |
|TERMINAL (d) | 6/35 (17%) 4/40 (10%) 4/40 (10%) 4/37 (11%) |3/39 (8%) 2/36 (6%) 2/42 (5%) 5/39 (13%) |
|FIRST INCIDENCE | 671 663 729 (T) 632 |731 (T) 630 600 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548 P=0.306N P=0.196N P=0.472N |P=0.500 P=0.219 P=0.393 P=0.355 |
|POLY 3 | P=0.554 P=0.390N P=0.273N P=0.518N |P=0.460 P=0.238 P=0.371 P=0.332 |
|POLY 1.5 | P=0.561 P=0.395N P=0.269N P=0.511N |P=0.466 P=0.240 P=0.365 P=0.336 |
|POLY 6 | P=0.545 P=0.378N P=0.274N P=0.521N |P=0.459 P=0.238 P=0.382 P=0.331 |
|LOGISTIC REGRESSION| P=0.542 P=0.385N P=0.257N P=0.523N |P=0.503 P=0.260 P=0.331 P=0.355 |
|COCH-ARM / FISHERS | P=0.563 P=0.380N P=0.262N P=0.500N |P=0.481 P=0.243 P=0.357 P=0.346 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 2/45.21 1/45.18 0/44.71 |0/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 2.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 1/40 (3%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.369N P=0.268 P=0.527 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.374N P=0.234 P=0.497 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.372N P=0.232 P=0.498 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.375N P=0.237 P=0.497 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.268 P=0.527 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.247 P=0.500 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/46.03 1/45.21 1/45.18 1/44.71 |0/47.55 0/46.36 0/48.03 1/45.40 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 2.2% 2.2% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 1/40 (3%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 1/39 (3%) |
|FIRST INCIDENCE | 711 729 (T) 729 (T) 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.460N P=0.463N P=0.487N |P=0.230 (e) (e) P=0.500 |
|POLY 3 | P=0.526N P=0.506N P=0.507N P=0.510N |P=0.222 (e) (e) P=0.491 |
|POLY 1.5 | P=0.522N P=0.508N P=0.504N P=0.506N |P=0.223 (e) (e) P=0.492 |
|POLY 6 | P=0.531N P=0.501N P=0.506N P=0.513N |P=0.223 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.536N P=0.495N P=0.500N P=0.510N |(e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.521N P=0.500N P=0.500N P=0.500N |P=0.224 (e) (e) P=0.495 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/46.03 1/45.21 2/45.18 1/44.71 |1/47.74 0/46.36 0/48.03 1/45.40 |
|POLY-3 PERCENT (g) | 4.4% 2.2% 4.4% 2.2% |2.1% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 2/40 (5%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 1/39 (3%) |
|FIRST INCIDENCE | 711 729 (T) 729 (T) 729 (T) |680 --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495N P=0.460N P=0.652N P=0.487N |P=0.520 P=0.513N P=0.509N P=0.753 |
|POLY 3 | P=0.494N P=0.506N P=0.687 P=0.510N |P=0.516 P=0.506N P=0.499N P=0.749 |
|POLY 1.5 | P=0.489N P=0.508N P=0.690 P=0.506N |P=0.516 P=0.503N P=0.499N P=0.751 |
|POLY 6 | P=0.501N P=0.501N P=0.688 P=0.513N |P=0.518 P=0.509N P=0.498N P=0.749 |
|LOGISTIC REGRESSION| P=0.503N P=0.495N P=0.693N P=0.510N |P=0.528 P=0.455N P=0.523N P=0.762N |
|COCH-ARM / FISHERS | P=0.487N P=0.500N P=0.691N P=0.500N |P=0.517 P=0.500N P=0.500N P=0.747 |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/45.96 2/45.21 2/45.18 1/44.71 |0/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 2.2% 4.4% 4.4% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 2/40 (5%) 2/40 (5%) 1/37 (3%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.519N P=0.547 P=0.547 P=0.749N |(e) (e) (e) (e) |
|POLY 3 | P=0.522N P=0.494 P=0.494 P=0.755 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.517N P=0.492 P=0.496 P=0.757 |(e) (e) (e) (e) |
|POLY 6 | P=0.527N P=0.500 P=0.495 P=0.753 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.519N P=0.547 P=0.547 P=0.749N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.513N P=0.500 P=0.500 P=0.753N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/44.56 0/44.95 0/45.18 0/44.71 |1/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 4.5% 0.0% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.209N P=0.209N P=0.226N |P=0.543N P=0.516N P=0.485N P=0.500N |
|POLY 3 | P=0.300N P=0.235N P=0.234N P=0.236N |P=0.550N P=0.502N P=0.495N P=0.507N |
|POLY 1.5 | P=0.299N P=0.237N P=0.232N P=0.233N |P=0.551N P=0.499N P=0.495N P=0.507N |
|POLY 6 | P=0.304N P=0.232N P=0.235N P=0.240N |P=0.548N P=0.505N P=0.494N P=0.507N |
|LOGISTIC REGRESSION| P=0.309N (e) (e) (e) |P=0.543N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.303N P=0.242N P=0.237N P=0.237N |P=0.553N P=0.495N P=0.495N P=0.505N |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/45.96 0/44.95 0/45.18 0/44.71 |0/46.74 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 4.4% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/35 (6%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.309N P=0.209N P=0.209N P=0.226N |(e) (e) (e) (e) |
|POLY 3 | P=0.306N P=0.242N P=0.241N P=0.243N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.304N P=0.245N P=0.240N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.311N P=0.237N P=0.240N P=0.245N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.309N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.307N P=0.253N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/46.27 0/44.95 1/45.60 1/44.78 |0/46.74 2/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 2.2% 2.2% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 2/36 (6%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 668 --- 606 711 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.671N P=0.239N P=0.518N P=0.514N |P=0.385N P=0.221 (e) (e) |
|POLY 3 | P=0.656N P=0.244N P=0.505N P=0.511N |P=0.401N P=0.235 (e) (e) |
|POLY 1.5 | P=0.651N P=0.246N P=0.503N P=0.507N |P=0.398N P=0.238 (e) (e) |
|POLY 6 | P=0.663N P=0.240N P=0.504N P=0.515N |P=0.405N P=0.232 (e) (e) |
|LOGISTIC REGRESSION| P=0.653N P=0.238N P=0.497N P=0.498N |(e) P=0.221 (e) (e) |
|COCH-ARM / FISHERS | P=0.651N P=0.253N P=0.500N P=0.500N |P=0.392N P=0.253 (e) (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 5/50 (10%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 0/44.95 1/45.18 5/44.71 |0/46.74 0/46.36 0/48.03 2/45.40 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 11.2% |0.0% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 1/40 (3%) 5/37 (14%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 2/39 (5%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |--- --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.527 P=0.038 * |P=0.043 * (e) (e) P=0.238 |
|POLY 3 | P<0.001 ** (e) P=0.497 P=0.028 * |P=0.039 * (e) (e) P=0.231 |
|POLY 1.5 | P<0.001 ** (e) P=0.498 P=0.029 * |P=0.039 * (e) (e) P=0.233 |
|POLY 6 | P<0.001 ** (e) P=0.497 P=0.027 * |P=0.039 * (e) (e) P=0.230 |
|LOGISTIC REGRESSION| (e) (e) P=0.527 P=0.038 * |(e) (e) (e) P=0.238 |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P=0.028 * |P=0.041 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 23/49 (47%) 26/50 (52%) 36/50 (72%) |14/49 (29%) 8/50 (16%) 10/50 (20%) 37/49 (76%) |
|POLY-3 RATE (b) | 18/46.93 23/45.11 26/45.60 36/46.93 |14/46.96 8/46.80 10/48.03 37/46.66 |
|POLY-3 PERCENT (g) | 38.4% 51.0% 57.0% 76.7% |29.8% 17.1% 20.8% 79.3% |
|TERMINAL (d) | 13/35 (37%) 21/40 (53%) 24/40 (60%) 29/37 (78%) |12/39 (31%) 7/36 (19%) 10/42 (24%) 32/39 (82%) |
|FIRST INCIDENCE | 622 705 642 527 |680 602 731 (T) 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.376 P=0.187 P=0.002 ** |P<0.001 ** P=0.158N P=0.185N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.154 P=0.052 P<0.001 ** |P<0.001 ** P=0.112N P=0.220N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.154 P=0.062 P<0.001 ** |P<0.001 ** P=0.108N P=0.222N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.159 P=0.045 * P<0.001 ** |P<0.001 ** P=0.118N P=0.218N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.196 P=0.059 P<0.001 ** |P<0.001 ** P=0.123N P=0.200N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.184 P=0.079 P<0.001 ** |P<0.001 ** P=0.103N P=0.224N P<0.001 ** |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/49 (16%) 13/50 (26%) 11/50 (22%) |4/49 (8%) 8/50 (16%) 7/50 (14%) 10/49 (20%) |
|POLY-3 RATE (b) | 9/46.90 8/45.11 13/48.04 11/46.52 |4/47.39 8/47.98 7/48.48 10/47.16 |
|POLY-3 PERCENT (g) | 19.2% 17.7% 27.1% 23.7% |8.4% 16.7% 14.4% 21.2% |
|TERMINAL (d) | 5/35 (14%) 6/40 (15%) 7/40 (18%) 5/37 (14%) |1/39 (3%) 3/36 (8%) 6/42 (14%) 6/39 (15%) |
|FIRST INCIDENCE | 630 705 463 560 |624 586 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329 P=0.417N P=0.305 P=0.418 |P=0.125 P=0.167 P=0.300 P=0.081 |
|POLY 3 | P=0.348 P=0.535N P=0.253 P=0.393 |P=0.109 P=0.183 P=0.275 P=0.071 |
|POLY 1.5 | P=0.354 P=0.538N P=0.247 P=0.396 |P=0.110 P=0.185 P=0.275 P=0.072 |
|POLY 6 | P=0.346 P=0.527N P=0.266 P=0.396 |P=0.111 P=0.181 P=0.274 P=0.071 |
|LOGISTIC REGRESSION| P=0.355 P=0.525N P=0.254 P=0.414 |P=0.190 P=0.296 P=0.249 P=0.130 |
|COCH-ARM / FISHERS | P=0.352 P=0.518N P=0.235 P=0.402 |P=0.111 P=0.188 P=0.274 P=0.074 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 8/49 (16%) 13/50 (26%) 12/50 (24%) |4/49 (8%) 8/50 (16%) 7/50 (14%) 12/49 (24%) |
|POLY-3 RATE (b) | 9/46.90 8/45.11 13/48.04 12/46.52 |4/47.39 8/47.98 7/48.48 12/47.16 |
|POLY-3 PERCENT (g) | 19.2% 17.7% 27.1% 25.8% |8.4% 16.7% 14.4% 25.4% |
|TERMINAL (d) | 5/35 (14%) 6/40 (15%) 7/40 (18%) 6/37 (16%) |1/39 (3%) 3/36 (8%) 6/42 (14%) 8/39 (21%) |
|FIRST INCIDENCE | 630 705 463 560 |624 586 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237 P=0.417N P=0.305 P=0.336 |P=0.041 * P=0.167 P=0.300 P=0.033 * |
|POLY 3 | P=0.248 P=0.535N P=0.253 P=0.303 |P=0.031 * P=0.183 P=0.275 P=0.025 * |
|POLY 1.5 | P=0.253 P=0.538N P=0.247 P=0.306 |P=0.031 * P=0.185 P=0.275 P=0.025 * |
|POLY 6 | P=0.246 P=0.527N P=0.266 P=0.306 |P=0.031 * P=0.181 P=0.274 P=0.025 * |
|LOGISTIC REGRESSION| P=0.254 P=0.525N P=0.254 P=0.321 |P=0.059 P=0.296 P=0.249 P=0.048 * |
|COCH-ARM / FISHERS | P=0.252 P=0.518N P=0.235 P=0.312 |P=0.032 * P=0.188 P=0.274 P=0.027 * |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 26/49 (53%) 33/50 (66%) 41/50 (82%) |18/49 (37%) 14/50 (28%) 16/50 (32%) 41/49 (84%) |
|POLY-3 RATE (b) | 25/47.87 26/45.11 33/48.04 41/48.25 |18/47.61 14/47.98 16/48.48 41/47.59 |
|POLY-3 PERCENT (g) | 52.2% 57.6% 68.7% 85.0% |37.8% 29.2% 33.0% 86.2% |
|TERMINAL (d) | 16/35 (46%) 24/40 (60%) 27/40 (68%) 31/37 (84%) |13/39 (33%) 9/36 (25%) 15/42 (36%) 34/39 (87%) |
|FIRST INCIDENCE | 622 705 463 527 |624 586 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.442N P=0.233 P=0.009 ** |P<0.001 ** P=0.354N P=0.336N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.375 P=0.071 P<0.001 ** |P<0.001 ** P=0.249N P=0.391N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.390 P=0.075 P<0.001 ** |P<0.001 ** P=0.245N P=0.389N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.359 P=0.068 P<0.001 ** |P<0.001 ** P=0.256N P=0.395N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.451 P=0.074 P<0.001 ** |P<0.001 ** P=0.208N P=0.385N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.459 P=0.078 P<0.001 ** |P<0.001 ** P=0.238N P=0.388N P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 26/49 (53%) 33/50 (66%) 41/50 (82%) |18/49 (37%) 14/50 (28%) 16/50 (32%) 41/49 (84%) |
|POLY-3 RATE (b) | 25/47.87 26/45.11 33/48.04 41/48.25 |18/47.61 14/47.98 16/48.48 41/47.59 |
|POLY-3 PERCENT (g) | 52.2% 57.6% 68.7% 85.0% |37.8% 29.2% 33.0% 86.2% |
|TERMINAL (d) | 16/35 (46%) 24/40 (60%) 27/40 (68%) 31/37 (84%) |13/39 (33%) 9/36 (25%) 15/42 (36%) 34/39 (87%) |
|FIRST INCIDENCE | 622 705 463 527 |624 586 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.442N P=0.233 P=0.009 ** |P<0.001 ** P=0.354N P=0.336N P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.375 P=0.071 P<0.001 ** |P<0.001 ** P=0.249N P=0.391N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.390 P=0.075 P<0.001 ** |P<0.001 ** P=0.245N P=0.389N P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.359 P=0.068 P<0.001 ** |P<0.001 ** P=0.256N P=0.395N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.451 P=0.074 P<0.001 ** |P<0.001 ** P=0.208N P=0.385N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.459 P=0.078 P<0.001 ** |P<0.001 ** P=0.238N P=0.388N P<0.001 ** |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 7/50 (14%) 0/50 (0%) 7/50 (14%) |2/50 (4%) 2/50 (4%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 13/46.56 7/45.37 0/45.18 7/45.47 |2/47.55 2/46.72 2/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 27.9% 15.4% 0.0% 15.4% |4.2% 4.3% 4.2% 0.0% |
|TERMINAL (d) | 11/35 (31%) 5/40 (13%) 0/40 (0%) 5/37 (14%) |2/39 (5%) 1/36 (3%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | 622 705 --- 599 |731 (T) 630 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.067N P<0.001N** P=0.095N |P=0.154N P=0.668 P=0.668N P=0.238N |
|POLY 3 | P=0.286N P=0.114N P<0.001N** P=0.113N |P=0.167N P=0.687 P=0.690N P=0.248N |
|POLY 1.5 | P=0.283N P=0.116N P<0.001N** P=0.110N |P=0.166N P=0.690 P=0.692N P=0.246N |
|POLY 6 | P=0.290N P=0.108N P<0.001N** P=0.114N |P=0.166N P=0.685 P=0.687N P=0.247N |
|LOGISTIC REGRESSION| P=0.305N P=0.108N P<0.001N** P=0.114N |P=0.161N P=0.681N P=0.668N (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.105N P<0.001N** P=0.105N |P=0.161N P=0.691N P=0.691N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 6/46.41 3/45.21 1/45.18 4/44.71 |1/47.55 3/46.47 1/48.03 1/45.40 |
|POLY-3 PERCENT (g) | 12.9% 6.6% 2.2% 9.0% |2.1% 6.5% 2.1% 2.2% |
|TERMINAL (d) | 4/35 (11%) 3/40 (8%) 1/40 (3%) 4/37 (11%) |1/39 (3%) 2/36 (6%) 1/42 (2%) 1/39 (3%) |
|FIRST INCIDENCE | 669 729 (T) 729 (T) 729 (T) |731 (T) 705 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.574N P=0.199N P=0.049N* P=0.352N |P=0.427N P=0.281 P=0.745N P=0.762 |
|POLY 3 | P=0.569N P=0.255N P=0.060N P=0.393N |P=0.454N P=0.297 P=0.758N P=0.750 |
|POLY 1.5 | P=0.562N P=0.256N P=0.059N P=0.383N |P=0.451N P=0.301 P=0.759N P=0.752 |
|POLY 6 | P=0.578N P=0.250N P=0.061N P=0.403N |P=0.454N P=0.293 P=0.757N P=0.750 |
|LOGISTIC REGRESSION| P=0.581N P=0.249N P=0.060N P=0.389N |P=0.443N P=0.289 P=0.745N P=0.762 |
|COCH-ARM / FISHERS | P=0.560N P=0.243N P=0.056N P=0.370N |P=0.444N P=0.309 P=0.753N P=0.747 |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 10/50 (20%) 1/50 (2%) 10/50 (20%) |3/50 (6%) 5/50 (10%) 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 17/47.01 10/45.37 1/45.18 10/45.47 |3/47.55 5/46.83 3/48.03 1/45.40 |
|POLY-3 PERCENT (g) | 36.2% 22.0% 2.2% 22.0% |6.3% 10.7% 6.3% 2.2% |
|TERMINAL (d) | 13/35 (37%) 8/40 (20%) 1/40 (3%) 8/37 (22%) |3/39 (8%) 3/36 (8%) 3/42 (7%) 1/39 (3%) |
|FIRST INCIDENCE | 622 705 729 (T) 599 |731 (T) 630 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313N P=0.053N P<0.001N** P=0.081N |P=0.127N P=0.320 P=0.629N P=0.305N |
|POLY 3 | P=0.284N P=0.102N P<0.001N** P=0.100N |P=0.144N P=0.348 P=0.657N P=0.322N |
|POLY 1.5 | P=0.280N P=0.101N P<0.001N** P=0.094N |P=0.143N P=0.352 P=0.659N P=0.320N |
|POLY 6 | P=0.291N P=0.099N P<0.001N** P=0.106N |P=0.144N P=0.345 P=0.654N P=0.322N |
|LOGISTIC REGRESSION| P=0.308N P=0.093N P<0.001N** P=0.097N |P=0.140N P=0.352 P=0.629N P=0.305N |
|COCH-ARM / FISHERS | P=0.291N P=0.088N P<0.001N** P=0.088N |P=0.137N P=0.357 P=0.661N P=0.316N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 2/45.21 0/45.18 0/44.71 |1/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 0.0% 0.0% |2.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 0/40 (0%) 0/37 (0%) |1/39 (3%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392N P=0.268 (e) (e) |P=0.543N P=0.516N P=0.485N P=0.500N |
|POLY 3 | P=0.395N P=0.234 (e) (e) |P=0.549N P=0.505N P=0.498N P=0.509N |
|POLY 1.5 | P=0.395N P=0.232 (e) (e) |P=0.549N P=0.503N P=0.499N P=0.508N |
|POLY 6 | P=0.394N P=0.237 (e) (e) |P=0.548N P=0.508N P=0.496N P=0.509N |
|LOGISTIC REGRESSION| (e) P=0.268 (e) (e) |P=0.543N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |P=0.551N P=0.500N P=0.500N P=0.505N |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/49 (2%) 3/49 (6%) 1/48 (2%) |
|POLY-3 RATE (b) | |2/47.55 1/45.91 3/47.03 1/45.05 |
|POLY-3 PERCENT (g) | |4.2% 2.2% 6.4% 2.2% |
|TERMINAL (d) | |2/39 (5%) 0/36 (0%) 3/41 (7%) 1/39 (3%) |
|FIRST INCIDENCE | |731 (T) 705 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.448N P=0.524N P=0.523 P=0.500N |
|POLY 3 | |P=0.475N P=0.512N P=0.495 P=0.519N |
|POLY 1.5 | |P=0.475N P=0.510N P=0.493 P=0.518N |
|POLY 6 | |P=0.471N P=0.514N P=0.498 P=0.517N |
|LOGISTIC REGRESSION| |P=0.463N P=0.515N P=0.523 P=0.500N |
|COCH-ARM / FISHERS | |P=0.471N P=0.508N P=0.490 P=0.515N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Luteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 0/49 (0%) 1/49 (2%) 1/48 (2%) |
|POLY-3 RATE (b) | |2/47.55 0/45.80 1/47.03 1/45.05 |
|POLY-3 PERCENT (g) | |4.2% 0.0% 2.1% 2.2% |
|TERMINAL (d) | |2/39 (5%) 0/36 (0%) 1/41 (2%) 1/39 (3%) |
|FIRST INCIDENCE | |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.646N P=0.256N P=0.483N P=0.500N |
|POLY 3 | |P=0.664N P=0.246N P=0.504N P=0.519N |
|POLY 1.5 | |P=0.664N P=0.244N P=0.505N P=0.518N |
|POLY 6 | |P=0.661N P=0.247N P=0.501N P=0.517N |
|LOGISTIC REGRESSION| |P=0.646N (e) P=0.483N P=0.500N |
|COCH-ARM / FISHERS | |P=0.664N P=0.253N P=0.508N P=0.515N |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/43 (0%) 0/48 (0%) 0/50 (0%) 0/48 (0%) |9/48 (19%) 11/49 (22%) 12/47 (26%) 8/46 (17%) |
|POLY-3 RATE (b) | 0/40.90 0/43.95 0/45.18 0/42.78 |9/46.12 11/46.14 12/45.31 8/43.26 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |19.5% 23.8% 26.5% 18.5% |
|TERMINAL (d) | 0/34 (0%) 0/39 (0%) 0/40 (0%) 0/36 (0%) |8/38 (21%) 8/36 (22%) 11/39 (28%) 6/38 (16%) |
|FIRST INCIDENCE | --- --- --- --- |680 669 656 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.306N P=0.353 P=0.332 P=0.501N |
|POLY 3 | (e) (e) (e) (e) |P=0.386N P=0.401 P=0.294 P=0.558N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.383N P=0.410 P=0.293 P=0.552N |
|POLY 6 | (e) (e) (e) (e) |P=0.380N P=0.392 P=0.296 P=0.557N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.366N P=0.384 P=0.294 P=0.545N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.369N P=0.421 P=0.292 P=0.539N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 8/50 (16%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 4/45.57 2/45.18 0/44.71 |1/47.83 8/47.26 1/48.03 2/45.55 |
|POLY-3 PERCENT (g) | 0.0% 8.8% 4.4% 0.0% |2.1% 16.9% 2.1% 4.4% |
|TERMINAL (d) | 0/35 (0%) 3/40 (8%) 2/40 (5%) 0/37 (0%) |0/39 (0%) 5/36 (14%) 1/42 (2%) 1/39 (3%) |
|FIRST INCIDENCE | --- 627 729 (T) --- |653 533 731 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.077 P=0.268 (e) |P=0.274N P=0.017 * P=0.750N P=0.492 |
|POLY 3 | P=0.196N P=0.059 P=0.233 (e) |P=0.291N P=0.015 * P=0.760N P=0.483 |
|POLY 1.5 | P=0.193N P=0.058 P=0.235 (e) |P=0.287N P=0.015 * P=0.760N P=0.486 |
|POLY 6 | P=0.197N P=0.062 P=0.234 (e) |P=0.292N P=0.014 * P=0.759N P=0.483 |
|LOGISTIC REGRESSION| P=0.193N P=0.061 P=0.268 (e) |P=0.238N P=0.025 * P=0.748 P=0.530 |
|COCH-ARM / FISHERS | P=0.190N P=0.059 P=0.247 (e) |P=0.281N P=0.015 * P=0.753N P=0.492 |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 8/50 (16%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 4/45.57 2/45.18 0/44.71 |1/47.83 8/47.26 1/48.03 2/45.55 |
|POLY-3 PERCENT (g) | 0.0% 8.8% 4.4% 0.0% |2.1% 16.9% 2.1% 4.4% |
|TERMINAL (d) | 0/35 (0%) 3/40 (8%) 2/40 (5%) 0/37 (0%) |0/39 (0%) 5/36 (14%) 1/42 (2%) 1/39 (3%) |
|FIRST INCIDENCE | --- 627 729 (T) --- |653 533 731 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.077 P=0.268 (e) |P=0.274N P=0.017 * P=0.750N P=0.492 |
|POLY 3 | P=0.196N P=0.059 P=0.233 (e) |P=0.291N P=0.015 * P=0.760N P=0.483 |
|POLY 1.5 | P=0.193N P=0.058 P=0.235 (e) |P=0.287N P=0.015 * P=0.760N P=0.486 |
|POLY 6 | P=0.197N P=0.062 P=0.234 (e) |P=0.292N P=0.014 * P=0.759N P=0.483 |
|LOGISTIC REGRESSION| P=0.193N P=0.061 P=0.268 (e) |P=0.238N P=0.025 * P=0.748 P=0.530 |
|COCH-ARM / FISHERS | P=0.190N P=0.059 P=0.247 (e) |P=0.281N P=0.015 * P=0.753N P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/45.96 2/45.21 2/45.18 0/44.71 |0/47.55 0/46.36 0/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 0.0% 4.4% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/35 (0%) 2/40 (5%) 2/40 (5%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.349N P=0.268 P=0.268 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.355N P=0.234 P=0.233 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.351N P=0.232 P=0.235 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.358N P=0.237 P=0.234 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.268 P=0.268 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.346N P=0.247 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 8/50 (16%) 1/50 (2%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.96 1/45.57 0/45.18 0/44.71 |1/47.83 8/47.26 1/48.03 2/45.55 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |2.1% 16.9% 2.1% 4.4% |
|TERMINAL (d) | 0/35 (0%) 0/40 (0%) 0/40 (0%) 0/37 (0%) |0/39 (0%) 5/36 (14%) 1/42 (2%) 1/39 (3%) |
|FIRST INCIDENCE | --- 627 --- --- |653 533 731 (T) 694 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.615N P=0.491 (e) (e) |P=0.274N P=0.017 * P=0.750N P=0.492 |
|POLY 3 | P=0.610N P=0.498 (e) (e) |P=0.291N P=0.015 * P=0.760N P=0.483 |
|POLY 1.5 | P=0.611N P=0.496 (e) (e) |P=0.287N P=0.015 * P=0.760N P=0.486 |
|POLY 6 | P=0.608N P=0.503 (e) (e) |P=0.292N P=0.014 * P=0.759N P=0.483 |
|LOGISTIC REGRESSION| P=0.620N P=0.529 (e) (e) |P=0.238N P=0.025 * P=0.748 P=0.530 |
|COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.281N P=0.015 * P=0.753N P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/44.79 1/44.30 1/45.18 0/44.71 |0/46.74 1/46.37 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 4.5% 2.3% 2.2% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 1/40 (3%) 1/40 (3%) 0/37 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 668 729 (T) 729 (T) --- |--- 730 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.220N P=0.475N P=0.477N P=0.244N |P=0.607N P=0.489 (e) (e) |
|POLY 3 | P=0.213N P=0.504N P=0.497N P=0.237N |P=0.620N P=0.498 (e) (e) |
|POLY 1.5 | P=0.209N P=0.506N P=0.492N P=0.234N |P=0.617N P=0.501 (e) (e) |
|POLY 6 | P=0.218N P=0.499N P=0.501N P=0.242N |P=0.622N P=0.495 (e) (e) |
|LOGISTIC REGRESSION| P=0.211N P=0.503N P=0.490N P=0.227N |P=0.607N P=0.490 (e) (e) |
|COCH-ARM / FISHERS | P=0.206N P=0.500N P=0.485N P=0.237N |P=0.614N P=0.505 (e) (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 2/46.18 0/45.21 2/45.18 0/44.71 | |
|POLY-3 PERCENT (g) | 4.3% 0.0% 4.4% 0.0% | |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 2/40 (5%) 0/37 (0%) | |
|FIRST INCIDENCE | 669 --- 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.296N P=0.228N P=0.662N P=0.241N | |
|POLY 3 | P=0.293N P=0.242N P=0.686 P=0.244N | |
|POLY 1.5 | P=0.289N P=0.243N P=0.689 P=0.242N | |
|POLY 6 | P=0.300N P=0.239N P=0.685 P=0.247N | |
|LOGISTIC REGRESSION| P=0.294N P=0.238N P=0.690 P=0.237N | |
|COCH-ARM / FISHERS | P=0.290N P=0.247N P=0.691N P=0.247N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 0/48 (0%) 2/49 (4%) 0/49 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 1/44.56 0/44.31 2/44.18 0/43.71 |0/46.83 0/46.36 0/48.03 0/45.05 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/35 (3%) 0/40 (0%) 2/39 (5%) 0/36 (0%) |0/39 (0%) 0/36 (0%) 0/42 (0%) 0/39 (0%) |
|FIRST INCIDENCE | 729 (T) --- 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.447N P=0.473N P=0.538 P=0.494N |(e) (e) (e) (e) |
|POLY 3 | P=0.444N P=0.501N P=0.497 P=0.504N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.436N P=0.503N P=0.501 P=0.501N |(e) (e) (e) (e) |
|POLY 6 | P=0.453N P=0.498N P=0.494 P=0.507N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.447N (e) P=0.538 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.431N P=0.500N P=0.508 P=0.495N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | |0/47.55 0/46.36 2/48.03 0/45.40 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | |0/39 (0%) 0/36 (0%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.647N (e) P=0.255 (e) |
|POLY 3 | |P=0.662N (e) P=0.240 (e) |
|POLY 1.5 | |P=0.661N (e) P=0.239 (e) |
|POLY 6 | |P=0.660N (e) P=0.241 (e) |
|LOGISTIC REGRESSION| |(e) (e) P=0.255 (e) |
|COCH-ARM / FISHERS | |P=0.657N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | |0/47.55 0/46.36 2/48.03 0/45.40 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.2% 0.0% |
|TERMINAL (d) | |0/39 (0%) 0/36 (0%) 2/42 (5%) 0/39 (0%) |
|FIRST INCIDENCE | |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.647N (e) P=0.255 (e) |
|POLY 3 | |P=0.662N (e) P=0.240 (e) |
|POLY 1.5 | |P=0.661N (e) P=0.239 (e) |
|POLY 6 | |P=0.660N (e) P=0.241 (e) |
|LOGISTIC REGRESSION| |(e) (e) P=0.255 (e) |
|COCH-ARM / FISHERS | |P=0.657N (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/46.27 3/45.21 2/45.60 1/44.78 |1/47.55 3/46.37 3/48.03 0/45.40 |
|POLY-3 PERCENT (g) | 6.5% 6.6% 4.4% 2.2% |2.1% 6.5% 6.3% 0.0% |
|TERMINAL (d) | 1/35 (3%) 3/40 (8%) 1/40 (3%) 0/37 (0%) |1/39 (3%) 2/36 (6%) 3/42 (7%) 0/39 (0%) |
|FIRST INCIDENCE | 668 729 (T) 606 711 |731 (T) 730 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.237N P=0.619N P=0.490N P=0.314N |P=0.165N P=0.281 P=0.332 P=0.500N |
|POLY 3 | P=0.232N P=0.652 P=0.507N P=0.317N |P=0.183N P=0.296 P=0.309 P=0.509N |
|POLY 1.5 | P=0.227N P=0.650 P=0.504N P=0.312N |P=0.181N P=0.300 P=0.308 P=0.508N |
|POLY 6 | P=0.237N P=0.657 P=0.506N P=0.321N |P=0.182N P=0.292 P=0.312 P=0.509N |
|LOGISTIC REGRESSION| P=0.224N P=0.657 P=0.496N P=0.308N |P=0.164N P=0.285 P=0.332 (e) |
|COCH-ARM / FISHERS | P=0.223N P=0.661N P=0.500N P=0.309N |P=0.176N P=0.309 P=0.309 P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 3/50 (6%) 1/49 (2%) |
|POLY-3 RATE (b) | 4/46.27 3/45.21 3/45.60 1/44.78 |1/47.55 3/46.37 3/48.03 1/45.89 |
|POLY-3 PERCENT (g) | 8.6% 6.6% 6.6% 2.2% |2.1% 6.5% 6.3% 2.2% |
|TERMINAL (d) | 2/35 (6%) 3/40 (8%) 2/40 (5%) 0/37 (0%) |1/39 (3%) 2/36 (6%) 3/42 (7%) 0/39 (0%) |
|FIRST INCIDENCE | 668 729 (T) 606 711 |731 (T) 730 731 (T) 585 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.449N P=0.471N P=0.185N |P=0.385N P=0.281 P=0.332 P=0.751 |
|POLY 3 | P=0.164N P=0.513N P=0.508N P=0.189N |P=0.403N P=0.296 P=0.309 P=0.753 |
|POLY 1.5 | P=0.159N P=0.514N P=0.505N P=0.185N |P=0.403N P=0.300 P=0.308 P=0.753 |
|POLY 6 | P=0.169N P=0.507N P=0.507N P=0.192N |P=0.399N P=0.292 P=0.312 P=0.754 |
|LOGISTIC REGRESSION| P=0.159N P=0.506N P=0.499N P=0.184N |P=0.395N P=0.285 P=0.332 P=0.704N |
|COCH-ARM / FISHERS | P=0.156N P=0.500N P=0.500N P=0.181N |P=0.398N P=0.309 P=0.309 P=0.747 |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 6/50 (12%) 3/50 (6%) |13/50 (26%) 15/50 (30%) 10/50 (20%) 7/49 (14%) |
|POLY-3 RATE (b) | 3/46.18 1/45.21 6/45.92 3/44.71 |13/47.87 15/47.00 10/48.03 7/45.68 |
|POLY-3 PERCENT (g) | 6.5% 2.2% 13.1% 6.7% |27.2% 31.9% 20.8% 15.3% |
|TERMINAL (d) | 2/35 (6%) 1/40 (3%) 4/40 (10%) 3/37 (8%) |10/39 (26%) 13/36 (36%) 10/42 (24%) 5/39 (13%) |
|FIRST INCIDENCE | 669 729 (T) 606 729 (T) |680 533 731 (T) 666 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.507 P=0.274N P=0.281 P=0.646N |P=0.043N* P=0.329 P=0.258N P=0.117N |
|POLY 3 | P=0.507 P=0.313N P=0.239 P=0.647 |P=0.057N P=0.389 P=0.313N P=0.126N |
|POLY 1.5 | P=0.518 P=0.314N P=0.240 P=0.653 |P=0.056N P=0.400 P=0.316N P=0.123N |
|POLY 6 | P=0.493 P=0.308N P=0.243 P=0.642 |P=0.055N P=0.372 P=0.310N P=0.125N |
|LOGISTIC REGRESSION| P=0.517 P=0.310N P=0.243 P=0.649 |P=0.055N P=0.373 P=0.286N P=0.126N |
|COCH-ARM / FISHERS | P=0.522 P=0.309N P=0.243 P=0.661N |P=0.052N P=0.412 P=0.318N P=0.115N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 28/50 (56%) 30/50 (60%) 39/50 (78%) |25/50 (50%) 24/50 (48%) 28/50 (56%) 39/49 (80%) |
|POLY-3 RATE (b) | 30/47.38 28/45.62 30/45.60 39/47.37 |25/47.96 24/47.85 28/48.81 39/47.15 |
|POLY-3 PERCENT (g) | 63.3% 61.4% 65.8% 82.3% |52.1% 50.2% 57.4% 82.7% |
|TERMINAL (d) | 23/35 (66%) 25/40 (63%) 28/40 (70%) 31/37 (84%) |22/39 (56%) 17/36 (47%) 25/42 (60%) 33/39 (85%) |
|FIRST INCIDENCE | 622 663 642 527 |680 602 600 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.010 * P=0.205N P=0.319N P=0.102 |P=0.002 ** P=0.514 P=0.483 P=0.004 ** |
|POLY 3 | P=0.009 ** P=0.508N P=0.487 P=0.027 * |P<0.001 ** P=0.505N P=0.376 P<0.001 ** |
|POLY 1.5 | P=0.010 * P=0.497N P=0.531 P=0.030 * |P<0.001 ** P=0.504N P=0.362 P<0.001 ** |
|POLY 6 | P=0.009 ** P=0.508N P=0.447 P=0.025 * |P<0.001 ** P=0.500N P=0.398 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.004 ** P=0.440N P=0.515 P=0.022 * |P<0.001 ** P=0.560N P=0.377 P<0.001 ** |
|COCH-ARM / FISHERS | P=0.011 * P=0.420N P=0.581N P=0.041 * |P<0.001 ** P=0.500N P=0.344 P=0.002 ** |
|=================================================================================================================================|
Date: 11/04/02 EXPERIMENT: 90004 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - PROPYLENE GLYCOL MONO-T-BUTYL ET
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 20/50 (40%) 26/50 (52%) 18/50 (36%) |23/50 (46%) 30/50 (60%) 21/50 (42%) 23/49 (47%) |
|POLY-3 RATE (b) | 22/48.48 20/46.26 26/49.55 18/46.52 |23/49.00 30/49.37 21/48.89 23/47.44 |
|POLY-3 PERCENT (g) | 45.4% 43.2% 52.5% 38.7% |46.9% 60.8% 43.0% 48.5% |
|TERMINAL (d) | 11/35 (31%) 16/40 (40%) 17/40 (43%) 12/37 (32%) |15/39 (39%) 18/36 (50%) 17/42 (41%) 17/39 (44%) |
|FIRST INCIDENCE | 610 568 451 560 |624 533 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290N P=0.311N P=0.409 P=0.286N |P=0.329N P=0.105 P=0.337N P=0.552 |
|POLY 3 | P=0.263N P=0.499N P=0.309 P=0.326N |P=0.389N P=0.119 P=0.424N P=0.521 |
|POLY 1.5 | P=0.239N P=0.483N P=0.301 P=0.301N |P=0.379N P=0.117 P=0.422N P=0.528 |
|POLY 6 | P=0.294N P=0.514N P=0.317 P=0.357N |P=0.396N P=0.122 P=0.429N P=0.516 |
|LOGISTIC REGRESSION| P=0.226N P=0.442N P=0.307 P=0.269N |P=0.323N P=0.144 P=0.431N P=0.576 |
|COCH-ARM / FISHERS | P=0.227N P=0.420N P=0.274 P=0.270N |P=0.360N P=0.115 P=0.420N P=0.543 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 38/50 (76%) 41/50 (82%) 43/50 (86%) |37/50 (74%) 39/50 (78%) 37/50 (74%) 47/49 (96%) |
|POLY-3 RATE (b) | 41/49.06 38/46.51 41/49.55 43/48.25 |37/49.00 39/49.60 37/49.17 47/48.32 |
|POLY-3 PERCENT (g) | 83.6% 81.7% 82.8% 89.1% |75.5% 78.6% 75.3% 97.3% |
|TERMINAL (d) | 27/35 (77%) 33/40 (83%) 32/40 (80%) 33/37 (89%) |29/39 (74%) 26/36 (72%) 32/42 (76%) 38/39 (97%) |
|FIRST INCIDENCE | 610 568 451 527 |624 533 600 440 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 P=0.140N P=0.329N P=0.508 |P=0.036 * P=0.269 P=0.393N P=0.035 * |
|POLY 3 | P=0.199 P=0.512N P=0.563N P=0.306 |P<0.001 ** P=0.448 P=0.582N P<0.001 ** |
|POLY 1.5 | P=0.216 P=0.461N P=0.562N P=0.343 |P<0.001 ** P=0.430 P=0.584N P<0.001 ** |
|POLY 6 | P=0.182 P=0.570N P=0.581N P=0.265 |P<0.001 ** P=0.477 P=0.582N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.200 P=0.400N P=0.599 P=0.339 |P=0.002 ** P=0.410 P=0.567N P<0.001 ** |
|COCH-ARM / FISHERS | P=0.210 P=0.312N P=0.602N P=0.393 |P=0.002 ** P=0.408 P=0.590N P=0.002 ** |
|=================================================================================================================================|
(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).