TDMS Study 05197-12 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/18/98
EXPERIMENT: 05197 TEST: 12 TIME: 09:11:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D
PATHOLOGIST: MILLER, RODNEY CAS: 111-76-0002
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 NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Gland
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest 2-BUTOXYETHANOL DATE: 02/18/98
EXPERIMENT: 05197 TEST: 12 TIME: 09:11:28
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE:
CONT: NO1-ES-15318 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 62077D
PATHOLOGIST: MILLER, RODNEY CAS: 111-76-0002
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 2-BUTOXYETHANOL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hemangiosarcoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Testes Adenoma
All Organs Hemangiosarcoma
Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Carcinoma
Skin Sarcoma
Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/49 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 4.2% 5.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/39 (5%) 1/39 (3%) 1/27 (4%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 670 583 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251N P=0.681N P=0.583 P=0.331N |(e) (e) (e) (e) |
|POLY 3 | P=0.207N P=0.675N P=0.653 P=0.267N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.192N P=0.681N P=0.668 P=0.257N |(e) (e) (e) (e) |
|POLY 6 | P=0.225N P=0.669N P=0.631 P=0.279N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.177N P=0.681N P=0.675 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.164N P=0.691N P=0.684 P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |3/50 (6%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |7.0% 2.4% 2.4% 2.3% |
|TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |2/29 (7%) 0/31 (0%) 1/33 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |713 592 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.203N P=0.299N P=0.268N P=0.248N |
|POLY 3 | (e) (e) (e) (e) |P=0.238N P=0.311N P=0.321N P=0.297N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.240N P=0.312N P=0.324N P=0.301N |
|POLY 6 | (e) (e) (e) (e) |P=0.236N P=0.304N P=0.310N P=0.291N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.237N P=0.310N P=0.292N P=0.280N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.243N P=0.309N P=0.316N P=0.309N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/50 (2%) 0/49 (0%) 0/49 (0%) |3/50 (6%) 1/50 (2%) 1/49 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 0.0% |7.0% 2.4% 2.4% 2.3% |
|TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |2/29 (7%) 0/31 (0%) 1/33 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- 549 --- --- |713 592 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588N P=0.508 (e) (e) |P=0.203N P=0.299N P=0.268N P=0.248N |
|POLY 3 | P=0.578N P=0.517 (e) (e) |P=0.238N P=0.311N P=0.321N P=0.297N |
|POLY 1.5 | P=0.573N P=0.512 (e) (e) |P=0.240N P=0.312N P=0.324N P=0.301N |
|POLY 6 | P=0.587N P=0.520 (e) (e) |P=0.236N P=0.304N P=0.310N P=0.291N |
|LOGISTIC REGRESSION| P=0.430N P=0.263 (e) (e) |P=0.237N P=0.310N P=0.292N P=0.280N |
|COCH-ARM / FISHERS | P=0.568N P=0.505 (e) (e) |P=0.243N P=0.309N P=0.316N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 0.0% 5.0% |2.3% 0.0% 2.4% 2.3% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 1/26 (4%) |0/29 (0%) 0/31 (0%) 1/33 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- 670 --- 454 |689 --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.102 P=0.529 (e) P=0.185 |P=0.576 P=0.505N P=0.743N P=0.737N |
|POLY 3 | P=0.121 P=0.511 (e) P=0.213 |P=0.551 P=0.506N P=0.755 P=0.756N |
|POLY 1.5 | P=0.127 P=0.507 (e) P=0.221 |P=0.547 P=0.505N P=0.753 P=0.758N |
|POLY 6 | P=0.114 P=0.514 (e) P=0.204 |P=0.554 P=0.504N P=0.760 P=0.753N |
|LOGISTIC REGRESSION| P=0.200 P=0.460 (e) P=0.292 |P=0.550 P=0.502N P=0.759 P=0.757N |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |4/50 (8%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.7% 6.4% 5.0% 5.1% |9.3% 7.2% 4.8% 6.8% |
|TERMINAL (d) | 3/39 (8%) 3/39 (8%) 2/27 (7%) 2/26 (8%) |4/29 (14%) 3/31 (10%) 2/33 (6%) 2/36 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N P=0.664 P=0.665N P=0.681 |P=0.319N P=0.463N P=0.277N P=0.392N |
|POLY 3 | P=0.440N P=0.640N P=0.555N P=0.559N |P=0.405N P=0.514N P=0.348N P=0.484N |
|POLY 1.5 | P=0.416N P=0.647N P=0.531N P=0.540N |P=0.412N P=0.514N P=0.352N P=0.492N |
|POLY 6 | P=0.470N P=0.634N P=0.586N P=0.582N |P=0.396N P=0.508N P=0.335N P=0.471N |
|LOGISTIC REGRESSION| P=0.587N P=0.664 P=0.665N P=0.681 |P=0.387N P=0.463N P=0.277N P=0.474N |
|COCH-ARM / FISHERS | P=0.371N P=0.661N P=0.500N P=0.500N |P=0.420N P=0.500N P=0.339N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |2.3% 2.4% 2.4% 4.5% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 1/31 (3%) 1/33 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) 731 (T) 731 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.406 P=0.747N P=0.733N P=0.549 |
|POLY 3 | (e) (e) (e) (e) |P=0.366 P=0.755 P=0.755 P=0.512 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.360 P=0.755 P=0.753 P=0.506 |
|POLY 6 | (e) (e) (e) (e) |P=0.376 P=0.758 P=0.761N P=0.522 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.358 P=0.747N P=0.733N P=0.497 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.351 P=0.753N P=0.753N P=0.500 |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |5/50 (10%) 4/50 (8%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 6.7% 6.4% 5.0% 5.1% |11.6% 9.5% 7.1% 9.0% |
|TERMINAL (d) | 3/39 (8%) 3/39 (8%) 2/27 (7%) 2/26 (8%) |5/29 (17%) 4/31 (13%) 3/33 (9%) 2/36 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |731 (T) 731 (T) 731 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.587N P=0.664 P=0.665N P=0.681 |P=0.314N P=0.457N P=0.284N P=0.383N |
|POLY 3 | P=0.440N P=0.640N P=0.555N P=0.559N |P=0.408N P=0.516N P=0.369N P=0.478N |
|POLY 1.5 | P=0.416N P=0.647N P=0.531N P=0.540N |P=0.418N P=0.516N P=0.374N P=0.488N |
|POLY 6 | P=0.470N P=0.634N P=0.586N P=0.582N |P=0.393N P=0.509N P=0.354N P=0.460N |
|LOGISTIC REGRESSION| P=0.587N P=0.664 P=0.665N P=0.681 |P=0.397N P=0.457N P=0.284N P=0.479N |
|COCH-ARM / FISHERS | P=0.371N P=0.661N P=0.500N P=0.500N |P=0.430N P=0.500N P=0.357N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/47 (0%) 0/46 (0%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 0.0% |4.6% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |2/29 (7%) 1/31 (3%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 669 --- --- --- |731 (T) 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150N P=0.227N P=0.307N P=0.308N |P=0.080N P=0.477N P=0.210N P=0.192N |
|POLY 3 | P=0.124N P=0.228N P=0.270N P=0.284N |P=0.100N P=0.509N P=0.242N P=0.232N |
|POLY 1.5 | P=0.123N P=0.231N P=0.261N P=0.275N |P=0.100N P=0.509N P=0.245N P=0.234N |
|POLY 6 | P=0.127N P=0.226N P=0.285N P=0.295N |P=0.099N P=0.505N P=0.236N P=0.228N |
|LOGISTIC REGRESSION| P=0.126N P=0.241N P=0.259N P=0.272N |P=0.080N P=0.477N (e) (e) |
|COCH-ARM / FISHERS | P=0.123N P=0.247N P=0.263N P=0.269N |P=0.101N P=0.500N P=0.253N P=0.247N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/47 (0%) 1/46 (2%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.4% 0.0% 0.0% 2.7% |4.6% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 1/25 (4%) |2/29 (7%) 1/31 (3%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 669 --- --- 729 (T) |731 (T) 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.566N P=0.227N P=0.307N P=0.620N |P=0.080N P=0.477N P=0.210N P=0.192N |
|POLY 3 | P=0.495N P=0.228N P=0.270N P=0.570N |P=0.100N P=0.509N P=0.242N P=0.232N |
|POLY 1.5 | P=0.490N P=0.231N P=0.261N P=0.557N |P=0.100N P=0.509N P=0.245N P=0.234N |
|POLY 6 | P=0.501N P=0.226N P=0.285N P=0.585N |P=0.099N P=0.505N P=0.236N P=0.228N |
|LOGISTIC REGRESSION| P=0.521N P=0.241N P=0.259N P=0.571N |P=0.080N P=0.477N (e) (e) |
|COCH-ARM / FISHERS | P=0.484N P=0.247N P=0.263N P=0.532N |P=0.101N P=0.500N P=0.253N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/49 (4%) 4/49 (8%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 5.0% 10.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 1/27 (4%) 2/26 (8%) |0/29 (0%) 1/31 (3%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 670 704 454 |--- 731 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.529 P=0.170 P=0.037 * |P=0.535N P=0.513 (e) (e) |
|POLY 3 | P=0.014 * P=0.511 P=0.211 P=0.046 * |P=0.569N P=0.495 (e) (e) |
|POLY 1.5 | P=0.016 * P=0.507 P=0.220 P=0.049 * |P=0.570N P=0.495 (e) (e) |
|POLY 6 | P=0.012 * P=0.514 P=0.198 P=0.043 * |P=0.566N P=0.497 (e) (e) |
|LOGISTIC REGRESSION| P=0.022 * P=0.460 P=0.191 P=0.067 |(e) P=0.513 (e) (e) |
|COCH-ARM / FISHERS | P=0.021 * P=0.500 P=0.242 P=0.056 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 18/50 (36%) 18/49 (37%) 17/49 (35%) |16/50 (32%) 8/50 (16%) 7/49 (14%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 48.6% 37.2% 43.8% 40.3% |35.8% 18.7% 16.7% 18.0% |
|TERMINAL (d) | 21/39 (54%) 13/39 (33%) 14/27 (52%) 10/26 (39%) |9/29 (31%) 5/31 (16%) 6/33 (18%) 7/36 (19%) |
|FIRST INCIDENCE | 642 549 582 368 |586 456 715 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280 P=0.262N P=0.347 P=0.446 |P=0.026N* P=0.053N P=0.020N* P=0.023N* |
|POLY 3 | P=0.345N P=0.180N P=0.407N P=0.283N |P=0.048N* P=0.057N P=0.035N* P=0.045N* |
|POLY 1.5 | P=0.313N P=0.212N P=0.355N P=0.275N |P=0.050N P=0.055N P=0.035N* P=0.047N* |
|POLY 6 | P=0.382N P=0.152N P=0.485N P=0.292N |P=0.046N* P=0.057N P=0.033N* P=0.044N* |
|LOGISTIC REGRESSION| P=0.410N P=0.196N P=0.586N P=0.342N |P=0.048N* P=0.056N P=0.031N* P=0.045N* |
|COCH-ARM / FISHERS | P=0.235N P=0.270N P=0.298N P=0.229N |P=0.056N P=0.050N P=0.031N* P=0.050N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 11/50 (22%) 16/49 (33%) 21/49 (43%) |10/50 (20%) 12/50 (24%) 13/49 (27%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 20.8% 22.9% 35.9% 45.9% |22.3% 27.5% 29.8% 21.9% |
|TERMINAL (d) | 3/39 (8%) 7/39 (18%) 5/27 (19%) 7/26 (27%) |5/29 (17%) 5/31 (16%) 10/33 (30%) 5/36 (14%) |
|FIRST INCIDENCE | 374 621 430 312 |376 592 537 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.534 P=0.060 P=0.007 ** |P=0.364N P=0.435 P=0.402 P=0.460N |
|POLY 3 | P=0.002 ** P=0.500 P=0.080 P=0.007 ** |P=0.483N P=0.375 P=0.288 P=0.583N |
|POLY 1.5 | P=0.002 ** P=0.502 P=0.094 P=0.008 ** |P=0.498N P=0.375 P=0.279 P=0.593N |
|POLY 6 | P=0.002 ** P=0.492 P=0.063 P=0.006 ** |P=0.458N P=0.395 P=0.312 P=0.561N |
|LOGISTIC REGRESSION| P=0.031 * P=0.301 P=0.280 P=0.045 * |P=0.511N P=0.404 P=0.298 P=0.588 |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500 P=0.115 P=0.012 * |P=0.514N P=0.405 P=0.298 P=0.598N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 24/50 (48%) 31/49 (63%) 30/49 (61%) |22/50 (44%) 16/50 (32%) 18/49 (37%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 61.9% 48.9% 67.5% 64.8% |47.8% 36.1% 41.2% 39.1% |
|TERMINAL (d) | 22/39 (56%) 17/39 (44%) 16/27 (59%) 14/26 (54%) |13/29 (45%) 8/31 (26%) 14/33 (42%) 12/36 (33%) |
|FIRST INCIDENCE | 374 549 430 312 |376 456 537 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * P=0.174N P=0.082 P=0.110 |P=0.170N P=0.158N P=0.188N P=0.134N |
|POLY 3 | P=0.225 P=0.137N P=0.362 P=0.469 |P=0.307N P=0.175N P=0.336N P=0.260N |
|POLY 1.5 | P=0.242 P=0.143N P=0.401 P=0.478 |P=0.318N P=0.175N P=0.339N P=0.269N |
|POLY 6 | P=0.203 P=0.135N P=0.309 P=0.450 |P=0.291N P=0.163N P=0.317N P=0.241N |
|LOGISTIC REGRESSION| P=0.422 P=0.198N P=0.503 P=0.567N |P=0.317N P=0.158N P=0.311N P=0.267N |
|COCH-ARM / FISHERS | P=0.306 P=0.158N P=0.449 P=0.532 |P=0.331N P=0.151N P=0.298N P=0.270N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 24/50 (48%) 31/49 (63%) 30/49 (61%) |22/50 (44%) 16/50 (32%) 18/49 (37%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 61.9% 48.9% 67.5% 64.8% |47.8% 36.1% 41.2% 39.1% |
|TERMINAL (d) | 22/39 (56%) 17/39 (44%) 16/27 (59%) 14/26 (54%) |13/29 (45%) 8/31 (26%) 14/33 (42%) 12/36 (33%) |
|FIRST INCIDENCE | 374 549 430 312 |376 456 537 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * P=0.174N P=0.082 P=0.110 |P=0.170N P=0.158N P=0.188N P=0.134N |
|POLY 3 | P=0.225 P=0.137N P=0.362 P=0.469 |P=0.307N P=0.175N P=0.336N P=0.260N |
|POLY 1.5 | P=0.242 P=0.143N P=0.401 P=0.478 |P=0.318N P=0.175N P=0.339N P=0.269N |
|POLY 6 | P=0.203 P=0.135N P=0.309 P=0.450 |P=0.291N P=0.163N P=0.317N P=0.241N |
|LOGISTIC REGRESSION| P=0.422 P=0.198N P=0.503 P=0.567N |P=0.317N P=0.158N P=0.311N P=0.267N |
|COCH-ARM / FISHERS | P=0.306 P=0.158N P=0.449 P=0.532 |P=0.331N P=0.151N P=0.298N P=0.270N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 459 --- --- --- |577 --- --- 489 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322N P=0.496N P=0.508N P=0.526N |P=0.442N P=0.237N P=0.235N P=0.475N |
|POLY 3 | P=0.306N P=0.494N P=0.528N P=0.532N |P=0.456N P=0.245N P=0.245N P=0.491N |
|POLY 1.5 | P=0.305N P=0.496N P=0.518N P=0.523N |P=0.458N P=0.244N P=0.247N P=0.495N |
|POLY 6 | P=0.307N P=0.492N P=0.542N P=0.542N |P=0.456N P=0.244N P=0.241N P=0.485N |
|LOGISTIC REGRESSION| P=0.106N P=0.933N P=0.531N P=0.328N |P=0.474N P=0.223N P=0.229N P=0.524N |
|COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.505N P=0.505N |P=0.462N P=0.247N P=0.253N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 7/50 (14%) 10/49 (20%) 8/50 (16%) |7/50 (14%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 19.9% 14.7% 24.2% 19.5% |16.3% 4.8% 9.5% 2.3% |
|TERMINAL (d) | 8/39 (21%) 6/39 (15%) 5/27 (19%) 4/26 (15%) |7/29 (24%) 2/31 (7%) 2/33 (6%) 1/36 (3%) |
|FIRST INCIDENCE | 642 649 537 402 |731 (T) 731 (T) 715 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.246 P=0.383N P=0.236 P=0.417 |P=0.020N* P=0.061N P=0.194N P=0.014N* |
|POLY 3 | P=0.445 P=0.353N P=0.413 P=0.591N |P=0.032N* P=0.083N P=0.272N P=0.027N* |
|POLY 1.5 | P=0.485 P=0.366N P=0.443 P=0.564N |P=0.033N* P=0.084N P=0.279N P=0.029N* |
|POLY 6 | P=0.400 P=0.343N P=0.373 P=0.590 |P=0.030N* P=0.079N P=0.254N P=0.025N* |
|LOGISTIC REGRESSION| P=0.500 P=0.347N P=0.415 P=0.574N |P=0.026N* P=0.061N P=0.221N P=0.014N* |
|COCH-ARM / FISHERS | P=0.527N P=0.393N P=0.480 P=0.500N |P=0.038N* P=0.080N P=0.262N P=0.030N* |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/49 (6%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.1% 4.2% 7.6% 7.6% |0.0% 4.7% 2.4% 0.0% |
|TERMINAL (d) | 5/39 (13%) 1/39 (3%) 3/27 (11%) 3/26 (12%) |0/29 (0%) 1/31 (3%) 1/33 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 649 729 (T) 729 (T) |--- 676 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.554 P=0.212N P=0.569N P=0.591N |P=0.423N P=0.247 P=0.526 (e) |
|POLY 3 | P=0.446N P=0.195N P=0.427N P=0.429N |P=0.455N P=0.232 P=0.495 (e) |
|POLY 1.5 | P=0.419N P=0.202N P=0.400N P=0.406N |P=0.459N P=0.232 P=0.494 (e) |
|POLY 6 | P=0.477N P=0.188N P=0.466N P=0.459N |P=0.447N P=0.236 P=0.500 (e) |
|LOGISTIC REGRESSION| P=0.532N P=0.196N P=0.569N P=0.591N |P=0.452N P=0.233 P=0.526 (e) |
|COCH-ARM / FISHERS | P=0.369N P=0.218N P=0.369N P=0.357N |P=0.461N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 8/50 (16%) 12/49 (24%) 11/50 (22%) |7/50 (14%) 4/50 (8%) 5/50 (10%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 30.9% 16.9% 29.0% 26.9% |16.3% 9.5% 11.9% 2.3% |
|TERMINAL (d) | 13/39 (33%) 7/39 (18%) 7/27 (26%) 7/26 (27%) |7/29 (24%) 3/31 (10%) 3/33 (9%) 1/36 (3%) |
|FIRST INCIDENCE | 642 649 537 402 |731 (T) 676 715 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248 P=0.108N P=0.397 P=0.463 |P=0.017N* P=0.224N P=0.293N P=0.014N* |
|POLY 3 | P=0.524 P=0.087N P=0.515N P=0.430N |P=0.027N* P=0.271N P=0.394N P=0.027N* |
|POLY 1.5 | P=0.520N P=0.095N P=0.478N P=0.397N |P=0.029N* P=0.273N P=0.401N P=0.029N* |
|POLY 6 | P=0.472 P=0.081N P=0.566N P=0.472N |P=0.026N* P=0.261N P=0.373N P=0.025N* |
|LOGISTIC REGRESSION| P=0.520 P=0.083N P=0.567N P=0.459N |P=0.024N* P=0.256N P=0.330N P=0.014N* |
|COCH-ARM / FISHERS | P=0.423N P=0.114N P=0.433N P=0.322N |P=0.033N* P=0.262N P=0.380N P=0.030N* |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 2.4% 0.0% 6.7% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 694 --- 621 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.054 P=0.500 (e) P=0.145 |
|POLY 3 | (e) (e) (e) (e) |P=0.045 * P=0.495 (e) P=0.125 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044 * P=0.495 (e) P=0.122 |
|POLY 6 | (e) (e) (e) (e) |P=0.046 * P=0.498 (e) P=0.129 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.045 * P=0.497 (e) P=0.120 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * P=0.500 (e) P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/49 (2%) 3/49 (6%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |4.6% 2.4% 7.3% 0.0% |
|TERMINAL (d) | |1/29 (3%) 1/31 (3%) 3/32 (9%) 0/35 (0%) |
|FIRST INCIDENCE | |721 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.197N P=0.485N P=0.546 P=0.207N |
|POLY 3 | |P=0.236N P=0.514N P=0.477 P=0.237N |
|POLY 1.5 | |P=0.240N P=0.515N P=0.475 P=0.239N |
|POLY 6 | |P=0.232N P=0.508N P=0.488 P=0.233N |
|LOGISTIC REGRESSION| |P=0.223N P=0.499N P=0.518 P=0.228N |
|COCH-ARM / FISHERS | |P=0.247N P=0.508N P=0.490 P=0.253N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Teratoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/49 (0%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | |0/29 (0%) 0/31 (0%) 1/32 (3%) 0/35 (0%) |
|FIRST INCIDENCE | |--- --- 196 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.612 (e) P=0.248 (e) |
|POLY 3 | |P=0.607 (e) P=0.231 (e) |
|POLY 1.5 | |P=0.602 (e) P=0.229 (e) |
|POLY 6 | |P=0.612 (e) P=0.237 (e) |
|LOGISTIC REGRESSION| |P=0.604 (e) P=0.372 (e) |
|COCH-ARM / FISHERS | |P=0.592 (e) P=0.242 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/46 (0%) 0/48 (0%) |5/50 (10%) 8/49 (16%) 8/48 (17%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |11.5% 19.6% 18.9% 9.2% |
|TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |3/29 (10%) 8/30 (27%) 7/33 (21%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- --- --- |565 731 (T) 570 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.236N P=0.289 P=0.343 P=0.425N |
|POLY 3 | (e) (e) (e) (e) |P=0.334N P=0.233 P=0.255 P=0.502N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.345N P=0.240 P=0.246 P=0.507N |
|POLY 6 | (e) (e) (e) (e) |P=0.316N P=0.232 P=0.271 P=0.491N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.332N P=0.248 P=0.252 P=0.508N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.359N P=0.264 P=0.250 P=0.513N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/46 (0%) 0/48 (0%) |6/50 (12%) 8/49 (16%) 8/48 (17%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |13.7% 19.6% 18.9% 9.2% |
|TERMINAL (d) | 0/38 (0%) 0/39 (0%) 0/27 (0%) 0/25 (0%) |3/29 (10%) 8/30 (27%) 7/33 (21%) 2/35 (6%) |
|FIRST INCIDENCE | --- --- --- --- |565 731 (T) 570 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.170N P=0.399 P=0.461 P=0.306N |
|POLY 3 | (e) (e) (e) (e) |P=0.251N P=0.335 P=0.361 P=0.372N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.260N P=0.343 P=0.351 P=0.377N |
|POLY 6 | (e) (e) (e) (e) |P=0.236N P=0.334 P=0.381 P=0.361N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.249N P=0.354 P=0.359 P=0.376N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.274N P=0.371 P=0.355 P=0.383N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.8% 4.6% 0.0% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |0/29 (0%) 0/31 (0%) 0/33 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |521 369 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.039N* P=0.505N P=0.124N P=0.119N |
|POLY 3 | (e) (e) (e) (e) |P=0.039N* P=0.510N P=0.127N P=0.118N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.039N* P=0.509N P=0.127N P=0.119N |
|POLY 6 | (e) (e) (e) (e) |P=0.038N* P=0.507N P=0.125N P=0.117N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.032N* P=0.373N P=0.095N P=0.126N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.039N* P=0.500N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 2.2% 2.1% 5.0% 5.0% |0.0% 2.4% 4.8% 13.4% |
|TERMINAL (d) | 1/39 (3%) 1/39 (3%) 2/27 (7%) 1/26 (4%) |0/29 (0%) 1/31 (3%) 2/33 (6%) 4/36 (11%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 402 |--- 731 (T) 731 (T) 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.762 P=0.372 P=0.400 |P=0.005 ** P=0.513 P=0.267 P=0.030 * |
|POLY 3 | P=0.285 P=0.750N P=0.458 P=0.462 |P=0.002 ** P=0.495 P=0.231 P=0.017 * |
|POLY 1.5 | P=0.302 P=0.753N P=0.477 P=0.474 |P=0.002 ** P=0.495 P=0.230 P=0.016 * |
|POLY 6 | P=0.266 P=0.747N P=0.434 P=0.447 |P=0.003 ** P=0.497 P=0.237 P=0.019 * |
|LOGISTIC REGRESSION| P=0.348 P=0.762 P=0.372 P=0.570 |P=0.003 ** P=0.513 P=0.267 P=0.018 * |
|COCH-ARM / FISHERS | P=0.337 P=0.753N P=0.500 P=0.500 |P=0.002 ** P=0.500 P=0.247 P=0.013 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 2.2% 2.1% 5.0% 5.0% |0.0% 2.4% 4.8% 11.2% |
|TERMINAL (d) | 1/39 (3%) 1/39 (3%) 2/27 (7%) 1/26 (4%) |0/29 (0%) 1/31 (3%) 2/33 (6%) 3/36 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 402 |--- 731 (T) 731 (T) 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212 P=0.762 P=0.372 P=0.400 |P=0.013 * P=0.513 P=0.267 P=0.049 * |
|POLY 3 | P=0.285 P=0.750N P=0.458 P=0.462 |P=0.008 ** P=0.495 P=0.231 P=0.034 * |
|POLY 1.5 | P=0.302 P=0.753N P=0.477 P=0.474 |P=0.007 ** P=0.495 P=0.230 P=0.032 * |
|POLY 6 | P=0.266 P=0.747N P=0.434 P=0.447 |P=0.008 ** P=0.497 P=0.237 P=0.036 * |
|LOGISTIC REGRESSION| P=0.348 P=0.762 P=0.372 P=0.570 |P=0.008 ** P=0.513 P=0.267 P=0.033 * |
|COCH-ARM / FISHERS | P=0.337 P=0.753N P=0.500 P=0.500 |P=0.007 ** P=0.500 P=0.247 P=0.028 * |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 5.1% | |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 0/27 (0%) 2/26 (8%) | |
|FIRST INCIDENCE | --- --- --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.024 * (e) (e) P=0.154 | |
|POLY 3 | P=0.039 * (e) (e) P=0.209 | |
|POLY 1.5 | P=0.041 * (e) (e) P=0.218 | |
|POLY 6 | P=0.037 * (e) (e) P=0.199 | |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.154 | |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/48 (2%) 1/49 (2%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 5/50 (10%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.2% 2.5% 2.5% |2.3% 4.8% 11.9% 2.3% |
|TERMINAL (d) | 2/39 (5%) 1/38 (3%) 1/27 (4%) 0/26 (0%) |1/29 (3%) 1/31 (3%) 5/33 (15%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 604 |731 (T) 712 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.509N P=0.628N P=0.601N |P=0.538N P=0.515 P=0.132 P=0.720N |
|POLY 3 | P=0.446N P=0.497N P=0.543N P=0.541N |P=0.581 P=0.492 P=0.095 P=0.761N |
|POLY 1.5 | P=0.432N P=0.503N P=0.527N P=0.529N |P=0.573 P=0.492 P=0.094 P=0.758 |
|POLY 6 | P=0.462N P=0.492N P=0.567N P=0.556N |P=0.591 P=0.496 P=0.100 P=0.757N |
|LOGISTIC REGRESSION| P=0.451N P=0.509N P=0.628N P=0.518N |P=0.587N P=0.500 P=0.132 P=0.720N |
|COCH-ARM / FISHERS | P=0.406N P=0.515N P=0.508N P=0.500N |P=0.560 P=0.500 P=0.102 P=0.747 |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/48 (2%) 1/49 (2%) 1/50 (2%) |1/50 (2%) 3/50 (6%) 5/50 (10%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.4% 2.2% 2.5% 2.5% |2.3% 7.1% 11.9% 2.3% |
|TERMINAL (d) | 2/39 (5%) 1/38 (3%) 1/27 (4%) 0/26 (0%) |1/29 (3%) 2/31 (7%) 5/33 (15%) 1/35 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 604 |731 (T) 712 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.536N P=0.509N P=0.628N P=0.601N |P=0.462N P=0.324 P=0.132 P=0.720N |
|POLY 3 | P=0.446N P=0.497N P=0.543N P=0.541N |P=0.537N P=0.296 P=0.095 P=0.761N |
|POLY 1.5 | P=0.432N P=0.503N P=0.527N P=0.529N |P=0.544N P=0.297 P=0.094 P=0.758 |
|POLY 6 | P=0.462N P=0.492N P=0.567N P=0.556N |P=0.526N P=0.301 P=0.100 P=0.757N |
|LOGISTIC REGRESSION| P=0.451N P=0.509N P=0.628N P=0.518N |P=0.513N P=0.305 P=0.132 P=0.720N |
|COCH-ARM / FISHERS | P=0.406N P=0.515N P=0.508N P=0.500N |P=0.554N P=0.309 P=0.102 P=0.747 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 4.8% 0.0% |
|TERMINAL (d) | |0/29 (0%) 0/31 (0%) 2/33 (6%) 0/36 (0%) |
|FIRST INCIDENCE | |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.637 (e) P=0.267 (e) |
|POLY 3 | |P=0.614 (e) P=0.231 (e) |
|POLY 1.5 | |P=0.608 (e) P=0.230 (e) |
|POLY 6 | |P=0.621 (e) P=0.237 (e) |
|LOGISTIC REGRESSION| |(e) (e) P=0.267 (e) |
|COCH-ARM / FISHERS | |P=0.595 (e) P=0.247 (e) |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |2.3% 4.8% 9.5% 4.5% |
|TERMINAL (d) | |1/29 (3%) 2/31 (7%) 3/33 (9%) 2/36 (6%) |
|FIRST INCIDENCE | |731 (T) 731 (T) 723 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.480 P=0.523 P=0.223 P=0.576 |
|POLY 3 | |P=0.406 P=0.491 P=0.171 P=0.508 |
|POLY 1.5 | |P=0.399 P=0.491 P=0.169 P=0.504 |
|POLY 6 | |P=0.416 P=0.495 P=0.178 P=0.514 |
|LOGISTIC REGRESSION| |P=0.438 P=0.523 P=0.199 P=0.576 |
|COCH-ARM / FISHERS | |P=0.387 P=0.500 P=0.181 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 2/50 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |2.3% 4.8% 9.5% 4.5% |
|TERMINAL (d) | |1/29 (3%) 2/31 (7%) 3/33 (9%) 2/36 (6%) |
|FIRST INCIDENCE | |731 (T) 731 (T) 723 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.480 P=0.523 P=0.223 P=0.576 |
|POLY 3 | |P=0.406 P=0.491 P=0.171 P=0.508 |
|POLY 1.5 | |P=0.399 P=0.491 P=0.169 P=0.504 |
|POLY 6 | |P=0.416 P=0.495 P=0.178 P=0.514 |
|LOGISTIC REGRESSION| |P=0.438 P=0.523 P=0.199 P=0.576 |
|COCH-ARM / FISHERS | |P=0.387 P=0.500 P=0.181 P=0.500 |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 5.0% 0.0% |6.9% 0.0% 4.7% 0.0% |
|TERMINAL (d) | 0/39 (0%) 0/39 (0%) 2/27 (7%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 1/33 (3%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |572 --- 591 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502 (e) P=0.162 (e) |P=0.113N P=0.126N P=0.485N P=0.110N |
|POLY 3 | P=0.525 (e) P=0.211 (e) |P=0.118N P=0.126N P=0.513N P=0.117N |
|POLY 1.5 | P=0.545 (e) P=0.222 (e) |P=0.120N P=0.125N P=0.516N P=0.118N |
|POLY 6 | P=0.504 (e) P=0.197 (e) |P=0.116N P=0.125N P=0.503N P=0.115N |
|LOGISTIC REGRESSION| (e) (e) P=0.162 (e) |P=0.125N P=0.115N P=0.489N P=0.124N |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.125N P=0.121N P=0.500N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 5/50 (10%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.2% 2.1% 5.0% 12.4% |4.6% 4.7% 7.1% 2.3% |
|TERMINAL (d) | 1/39 (3%) 0/39 (0%) 1/27 (4%) 3/26 (12%) |1/29 (3%) 1/31 (3%) 3/33 (9%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 670 704 454 |689 670 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.745N P=0.382 P=0.049 * |P=0.339N P=0.678N P=0.549 P=0.450N |
|POLY 3 | P=0.019 * P=0.749N P=0.459 P=0.079 |P=0.392N P=0.686 P=0.487 P=0.493N |
|POLY 1.5 | P=0.022 * P=0.753N P=0.477 P=0.085 |P=0.397N P=0.685 P=0.484 P=0.496N |
|POLY 6 | P=0.016 * P=0.745N P=0.436 P=0.071 |P=0.386N P=0.690 P=0.497 P=0.488N |
|LOGISTIC REGRESSION| P=0.025 * P=0.760 P=0.416 P=0.099 |P=0.385N P=0.688 P=0.509 P=0.486N |
|COCH-ARM / FISHERS | P=0.029 * P=0.753N P=0.500 P=0.102 |P=0.404N P=0.691N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 5/50 (10%) |5/50 (10%) 2/50 (4%) 5/50 (10%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.2% 2.1% 10.0% 12.4% |11.4% 4.7% 11.8% 2.3% |
|TERMINAL (d) | 1/39 (3%) 0/39 (0%) 3/27 (11%) 3/26 (12%) |2/29 (7%) 1/31 (3%) 4/33 (12%) 1/36 (3%) |
|FIRST INCIDENCE | 729 (T) 670 704 454 |572 670 591 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.745N P=0.092 P=0.049 * |P=0.101N P=0.216N P=0.583N P=0.084N |
|POLY 3 | P=0.020 * P=0.749N P=0.145 P=0.079 |P=0.124N P=0.231N P=0.611 P=0.100N |
|POLY 1.5 | P=0.023 * P=0.753N P=0.159 P=0.085 |P=0.126N P=0.229N P=0.607 P=0.101N |
|POLY 6 | P=0.017 * P=0.745N P=0.127 P=0.071 |P=0.122N P=0.230N P=0.623 P=0.098N |
|LOGISTIC REGRESSION| P=0.025 * P=0.760 P=0.105 P=0.099 |P=0.129N P=0.221N P=0.618 P=0.103N |
|COCH-ARM / FISHERS | P=0.033 * P=0.753N P=0.181 P=0.102 |P=0.132N P=0.218N P=0.630N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.2% 0.0% 0.0% 5.0% |2.3% 2.4% 4.7% 0.0% |
|TERMINAL (d) | 1/39 (3%) 0/39 (0%) 0/27 (0%) 0/26 (0%) |1/29 (3%) 0/31 (0%) 1/33 (3%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 629 |731 (T) 606 666 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178 P=0.500N P=0.573N P=0.402 |P=0.334N P=0.756N P=0.536 P=0.457N |
|POLY 3 | P=0.222 P=0.490N P=0.524N P=0.459 |P=0.357N P=0.757 P=0.493 P=0.495N |
|POLY 1.5 | P=0.230 P=0.494N P=0.513N P=0.471 |P=0.361N P=0.756 P=0.490 P=0.498N |
|POLY 6 | P=0.214 P=0.488N P=0.538N P=0.445 |P=0.352N P=0.760N P=0.504 P=0.492N |
|LOGISTIC REGRESSION| P=0.234 (e) (e) P=0.483 |P=0.366N P=0.759N P=0.494 (e) |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.366N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |7/50 (14%) 9/50 (18%) 10/50 (20%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 2.2% 6.3% 0.0% 0.0% |16.1% 20.8% 23.0% 15.2% |
|TERMINAL (d) | 0/39 (0%) 1/39 (3%) 0/27 (0%) 0/26 (0%) |5/29 (17%) 5/31 (16%) 5/33 (15%) 3/36 (8%) |
|FIRST INCIDENCE | 621 611 --- --- |572 544 397 437 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.208N P=0.330 P=0.546N P=0.524N |P=0.387N P=0.425 P=0.381 P=0.503N |
|POLY 3 | P=0.179N P=0.324 P=0.526N P=0.527N |P=0.448N P=0.384 P=0.292 P=0.568N |
|POLY 1.5 | P=0.168N P=0.318 P=0.514N P=0.518N |P=0.474N P=0.379 P=0.282 P=0.587N |
|POLY 6 | P=0.196N P=0.329 P=0.541N P=0.539N |P=0.417N P=0.402 P=0.317 P=0.543N |
|LOGISTIC REGRESSION| P=0.129N P=0.219 P=0.458N P=0.461N |P=0.516N P=0.376 P=0.283 P=0.598 |
|COCH-ARM / FISHERS | P=0.153N P=0.309 P=0.500N P=0.500N |P=0.513N P=0.393 P=0.298 P=0.613N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 28/50 (56%) 26/50 (52%) 28/50 (56%) |31/50 (62%) 23/50 (46%) 27/50 (54%) 18/50 (36%) |
|POLY-3 ADJUSTED (b)| 65.9% 57.2% 60.2% 63.4% |67.4% 53.0% 61.3% 39.8% |
|TERMINAL (d) | 28/39 (72%) 21/39 (54%) 17/27 (63%) 17/26 (65%) |19/29 (66%) 18/31 (58%) 22/33 (67%) 14/36 (39%) |
|FIRST INCIDENCE | 642 549 537 368 |565 456 196 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047 * P=0.394N P=0.205 P=0.091 |P=0.002N** P=0.075N P=0.149N P=0.003N** |
|POLY 3 | P=0.534N P=0.252N P=0.361N P=0.487N |P=0.007N** P=0.112N P=0.345N P=0.005N** |
|POLY 1.5 | P=0.496N P=0.313N P=0.321N P=0.482N |P=0.008N** P=0.101N P=0.334N P=0.006N** |
|POLY 6 | P=0.507 P=0.195N P=0.415N P=0.492N |P=0.006N** P=0.123N P=0.345N P=0.005N** |
|LOGISTIC REGRESSION| P=0.410 P=0.286N P=0.588 P=0.526 |P=0.008N** P=0.095N P=0.333N P=0.005N** |
|COCH-ARM / FISHERS | P=0.386N P=0.420N P=0.273N P=0.420N |P=0.013N* P=0.080N P=0.272N P=0.008N** |
|=================================================================================================================================|
Date: 02/18/98 EXPERIMENT: 05197 TEST: 12 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - 2-BUTOXYETHANOL
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 16/50 (32%) 19/50 (38%) 28/50 (56%) |27/50 (54%) 26/50 (52%) 28/50 (56%) 22/50 (44%) |
|POLY-3 ADJUSTED (b)| 38.6% 32.4% 42.4% 59.4% |56.9% 56.4% 60.2% 45.3% |
|TERMINAL (d) | 10/39 (26%) 8/39 (21%) 7/27 (26%) 12/26 (46%) |12/29 (41%) 12/31 (39%) 17/33 (52%) 11/36 (31%) |
|FIRST INCIDENCE | 374 549 430 312 |376 369 72 437 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.320N P=0.263 P=0.012 * |P=0.105N P=0.461N P=0.495N P=0.129N |
|POLY 3 | P=0.008 ** P=0.332N P=0.435 P=0.031 * |P=0.132N P=0.563N P=0.456 P=0.172N |
|POLY 1.5 | P=0.010 * P=0.334N P=0.496 P=0.036 * |P=0.151N P=0.559N P=0.454 P=0.189N |
|POLY 6 | P=0.005 ** P=0.331N P=0.362 P=0.024 * |P=0.113N P=0.538N P=0.479 P=0.149N |
|LOGISTIC REGRESSION| P=0.086 P=0.529N P=0.357N P=0.138 |P=0.196N P=0.499N P=0.516 P=0.234N |
|COCH-ARM / FISHERS | P=0.018 * P=0.338N P=0.582N P=0.054 |P=0.188N P=0.500N P=0.500 P=0.212N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPM 125 PPM 250 PPM |CONTROL 62.5 PPM 125 PPM 250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 33/50 (66%) 36/50 (72%) 41/50 (82%) |43/50 (86%) 38/50 (76%) 38/50 (76%) 35/50 (70%) |
|POLY-3 ADJUSTED (b)| 84.9% 66.4% 76.1% 85.3% |87.7% 81.1% 80.0% 71.0% |
|TERMINAL (d) | 32/39 (82%) 24/39 (62%) 18/27 (67%) 21/26 (81%) |24/29 (83%) 23/31 (74%) 26/33 (79%) 22/36 (61%) |
|FIRST INCIDENCE | 374 549 430 312 |376 369 72 437 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.070N P=0.253 P=0.045 * |P=0.023N* P=0.212N P=0.125N P=0.029N* |
|POLY 3 | P=0.278 P=0.025N* P=0.192N P=0.596 |P=0.023N* P=0.268N P=0.219N P=0.033N* |
|POLY 1.5 | P=0.306 P=0.027N* P=0.156N P=0.608N |P=0.029N* P=0.236N P=0.194N P=0.037N* |
|POLY 6 | P=0.242 P=0.024N* P=0.242N P=0.563 |P=0.018N* P=0.274N P=0.241N P=0.027N* |
|LOGISTIC REGRESSION| P=0.448 P=0.044N* P=0.108N P=0.529N |P=0.047N* P=0.187N P=0.160N P=0.049N* |
|COCH-ARM / FISHERS | P=0.411 P=0.032N* P=0.114N P=0.500N |P=0.050N P=0.154N P=0.154N P=0.045N* |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).