TDMS Study 90004-07 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 11/14/01
EXPERIMENT: 90004 TEST: 07 TIME: 10:00:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 11/14/01
EXPERIMENT: 90004 TEST: 07 TIME: 10:00:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest PROPYLENE GLYCOL MONO-T-BUTYL ETHER DATE: 11/14/01
EXPERIMENT: 90004 TEST: 07 TIME: 10:00:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C90004
PATHOLOGIST: RENNE, ROGER CAS: 57018-52-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF PROPYLENE GLYCOL MONO-T-BUTYL ETHER
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Islets, Pancreatic Adenoma
Liver Hepatocellular Adenoma
Skin Basal Cell Adenoma
Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, malignant or NOS), or Trichoepithelioma
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Mammary Gland Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
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) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/49 (4%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |2/42.54 2/46.42 1/42.02 4/45.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.7% 4.3% 2.4% 8.8% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |2/33 (6%) 2/34 (6%) 1/28 (4%) 3/36 (8%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) 730 (T) 730 (T) 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.226 P=0.685N P=0.558N P=0.375 |
|POLY 3 | (e) (e) (e) (e) |P=0.196 P=0.662N P=0.504N P=0.367 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.194 P=0.668N P=0.495N P=0.362 |
|POLY 6 | (e) (e) (e) (e) |P=0.200 P=0.659N P=0.520N P=0.372 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.208 P=0.685N P=0.558N P=0.369 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.189 P=0.684N P=0.492N P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |0/42.54 2/46.74 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |--- 642 --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.648 P=0.260 (e) P=0.517 |
|POLY 3 | (e) (e) (e) (e) |P=0.653 P=0.259 (e) P=0.512 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.648 P=0.254 (e) P=0.510 |
|POLY 6 | (e) (e) (e) (e) |P=0.657 P=0.262 (e) P=0.513 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.638 P=0.231 (e) P=0.517 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.636 P=0.253 (e) P=0.505 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 8/50 (16%) 11/49 (22%) 7/50 (14%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 12/42.68 8/44.59 11/38.15 7/40.75 |2/42.65 1/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 28.1% 17.9% 28.8% 17.2% |4.7% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 9/27 (33%) 3/29 (10%) 3/16 (19%) 5/22 (23%) |1/33 (3%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 409 621 565 724 |702 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360N P=0.190N P=0.250 P=0.281N |P=0.204N P=0.487N P=0.278N P=0.225N |
|POLY 3 | P=0.247N P=0.189N P=0.570 P=0.173N |P=0.209N P=0.471N P=0.240N P=0.224N |
|POLY 1.5 | P=0.224N P=0.204N P=0.578N P=0.163N |P=0.211N P=0.476N P=0.234N P=0.226N |
|POLY 6 | P=0.294N P=0.167N P=0.506 P=0.195N |P=0.206N P=0.468N P=0.251N P=0.223N |
|LOGISTIC REGRESSION| P=0.235N P=0.208N P=0.508 P=0.190N |P=0.208N P=0.467N P=0.249N P=0.224N |
|COCH-ARM / FISHERS | P=0.201N P=0.227N P=0.522N P=0.154N |P=0.211N P=0.492N P=0.242N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.04 0/43.38 0/36.82 2/40.96 |0/42.54 0/46.42 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 0.0% 4.9% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 656 --- --- 663 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.308 P=0.220N P=0.324N P=0.647 |P=0.248 (e) (e) P=0.517 |
|POLY 3 | P=0.337 P=0.230N P=0.267N P=0.685 |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.341 P=0.232N P=0.254N P=0.690 |P=0.231 (e) (e) P=0.510 |
|POLY 6 | P=0.329 P=0.228N P=0.289N P=0.674 |P=0.231 (e) (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.338 P=0.233N P=0.265N P=0.688 |(e) (e) (e) P=0.517 |
|COCH-ARM / FISHERS | P=0.347 P=0.247N P=0.253N P=0.691N |P=0.229 (e) (e) P=0.505 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 9/50 (18%) 11/49 (22%) 9/50 (18%) |2/49 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 14/42.96 9/44.59 11/38.15 9/41.00 |2/42.65 1/46.42 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 32.6% 20.2% 28.8% 22.0% |4.7% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 10/27 (37%) 4/29 (14%) 3/16 (19%) 6/22 (27%) |1/33 (3%) 1/34 (3%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 409 621 565 663 |702 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.140N P=0.386 P=0.318N |P=0.533N P=0.487N P=0.278N P=0.474N |
|POLY 3 | P=0.321N P=0.138N P=0.450N P=0.195N |P=0.557N P=0.471N P=0.240N P=0.480N |
|POLY 1.5 | P=0.295N P=0.151N P=0.398N P=0.182N |P=0.559N P=0.476N P=0.234N P=0.482N |
|POLY 6 | P=0.374N P=0.121N P=0.526N P=0.221N |P=0.552N P=0.468N P=0.251N P=0.478N |
|LOGISTIC REGRESSION| P=0.311N P=0.152N P=0.505N P=0.206N |P=0.546N P=0.467N P=0.249N P=0.476N |
|COCH-ARM / FISHERS | P=0.268N P=0.171N P=0.343N P=0.171N |P=0.560N P=0.492N P=0.242N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/49 (2%) 2/50 (4%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 2/43.67 1/36.82 2/40.99 |2/42.84 2/46.42 1/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 2.7% 4.9% |4.7% 4.3% 2.4% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |1/33 (3%) 2/34 (6%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 648 729 (T) 656 |702 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430 P=0.526 P=0.641 P=0.449 |P=0.145N P=0.681N P=0.558N P=0.225N |
|POLY 3 | P=0.479 P=0.516 P=0.732 P=0.493 |P=0.151N P=0.665N P=0.507N P=0.225N |
|POLY 1.5 | P=0.484 P=0.510 P=0.744 P=0.497 |P=0.153N P=0.672N P=0.499N P=0.228N |
|POLY 6 | P=0.467 P=0.522 P=0.712 P=0.484 |P=0.148N P=0.661N P=0.522N P=0.223N |
|LOGISTIC REGRESSION| P=0.467 P=0.512 P=0.641 P=0.483 |P=0.149N P=0.661N P=0.531N P=0.224N |
|COCH-ARM / FISHERS | P=0.488 P=0.500 P=0.747 P=0.500 |P=0.156N P=0.691N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/49 (2%) 2/50 (4%) |3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.00 2/43.67 1/36.82 2/40.99 |3/42.84 2/46.42 1/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.8% 4.6% 2.7% 4.9% |7.0% 4.3% 2.4% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |2/33 (6%) 2/34 (6%) 1/28 (4%) 0/36 (0%) |
|FIRST INCIDENCE | 668 648 729 (T) 656 |702 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.551 P=0.665N P=0.650N P=0.642 |P=0.095N P=0.484N P=0.368N P=0.110N |
|POLY 3 | P=0.601 P=0.680N P=0.546N P=0.686 |P=0.100N P=0.464N P=0.312N P=0.109N |
|POLY 1.5 | P=0.607 P=0.684N P=0.527N P=0.690 |P=0.101N P=0.473N P=0.304N P=0.112N |
|POLY 6 | P=0.588 P=0.676N P=0.576N P=0.675 |P=0.097N P=0.459N P=0.328N P=0.108N |
|LOGISTIC REGRESSION| P=0.597 P=0.688N P=0.587N P=0.687 |P=0.097N P=0.457N P=0.341N P=0.108N |
|COCH-ARM / FISHERS | P=0.614 P=0.691N P=0.508N P=0.691N |P=0.103N P=0.500N P=0.309N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 5/49 (10%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/41.84 4/43.39 5/37.75 0/40.72 |0/42.54 1/46.42 1/42.02 2/45.19 |
|POLY-3 PERCENT (g) | 9.6% 9.2% 13.3% 0.0% |0.0% 2.2% 2.4% 4.4% |
|TERMINAL (d) | 3/27 (11%) 3/29 (10%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 1/34 (3%) 1/28 (4%) 2/36 (6%) |
|FIRST INCIDENCE | 712 726 642 --- |--- 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075N P=0.604N P=0.268 P=0.093N |P=0.246 P=0.506 P=0.467 P=0.258 |
|POLY 3 | P=0.046N* P=0.624N P=0.435 P=0.063N |P=0.224 P=0.517 P=0.498 P=0.251 |
|POLY 1.5 | P=0.044N* P=0.629N P=0.461 P=0.061N |P=0.223 P=0.514 P=0.503 P=0.249 |
|POLY 6 | P=0.052N P=0.618N P=0.397 P=0.067N |P=0.226 P=0.519 P=0.488 P=0.252 |
|LOGISTIC REGRESSION| P=0.052N P=0.599N P=0.386 P=0.080N |(e) P=0.506 P=0.467 P=0.258 |
|COCH-ARM / FISHERS | P=0.043N* P=0.643N P=0.487 P=0.059N |P=0.217 P=0.505 P=0.505 P=0.253 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 4/50 (8%) 6/49 (12%) 1/50 (2%) |1/49 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/41.84 4/43.39 6/37.75 1/40.72 |1/42.54 1/46.42 1/42.02 2/45.19 |
|POLY-3 PERCENT (g) | 9.6% 9.2% 15.9% 2.5% |2.4% 2.2% 2.4% 4.4% |
|TERMINAL (d) | 3/27 (11%) 3/29 (10%) 2/16 (13%) 1/22 (5%) |1/33 (3%) 1/34 (3%) 1/28 (4%) 2/36 (6%) |
|FIRST INCIDENCE | 712 726 642 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181N P=0.604N P=0.156 P=0.247N |P=0.406 P=0.755N P=0.725 P=0.530 |
|POLY 3 | P=0.124N P=0.624N P=0.304 P=0.186N |P=0.377 P=0.741N P=0.758 P=0.521 |
|POLY 1.5 | P=0.118N P=0.629N P=0.330 P=0.182N |P=0.376 P=0.745N P=0.757N P=0.518 |
|POLY 6 | P=0.137N P=0.618N P=0.268 P=0.196N |P=0.379 P=0.739N P=0.748 P=0.523 |
|LOGISTIC REGRESSION| P=0.138N P=0.599N P=0.246 P=0.224N |P=0.406 P=0.755N P=0.725 P=0.530 |
|COCH-ARM / FISHERS | P=0.113N P=0.643N P=0.357 P=0.181N |P=0.372 P=0.747N P=0.747N P=0.508 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/49 (6%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.04 1/43.38 3/37.04 2/40.89 |0/42.54 0/46.42 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 8.1% 4.9% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 655 729 (T) 681 683 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385 P=0.747N P=0.182 P=0.459 |P=0.248 (e) (e) P=0.517 |
|POLY 3 | P=0.423 P=0.754N P=0.260 P=0.490 |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.435 P=0.756N P=0.279 P=0.496 |P=0.231 (e) (e) P=0.510 |
|POLY 6 | P=0.402 P=0.753N P=0.233 P=0.478 |P=0.231 (e) (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.423 P=0.759N P=0.245 P=0.495 |(e) (e) (e) P=0.517 |
|COCH-ARM / FISHERS | P=0.447 P=0.753N P=0.301 P=0.500 |P=0.229 (e) (e) P=0.505 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
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) | 1/50 (2%) 1/50 (2%) 3/49 (6%) 3/50 (6%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.04 1/43.38 3/37.04 3/40.89 |0/42.54 0/46.42 0/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 8.1% 7.3% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 1/16 (6%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 655 729 (T) 681 683 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 P=0.747N P=0.182 P=0.259 |P=0.248 (e) (e) P=0.517 |
|POLY 3 | P=0.214 P=0.754N P=0.260 P=0.295 |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.223 P=0.756N P=0.279 P=0.301 |P=0.231 (e) (e) P=0.510 |
|POLY 6 | P=0.198 P=0.753N P=0.233 P=0.282 |P=0.231 (e) (e) P=0.513 |
|LOGISTIC REGRESSION| P=0.209 P=0.759N P=0.245 P=0.293 |(e) (e) (e) P=0.517 |
|COCH-ARM / FISHERS | P=0.232 P=0.753N P=0.301 P=0.309 |P=0.229 (e) (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 2/49 (4%) 6/50 (12%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/41.84 0/43.38 2/37.00 6/41.90 |1/42.54 0/46.42 0/42.02 2/45.21 |
|POLY-3 PERCENT (g) | 7.2% 0.0% 5.4% 14.3% |2.4% 0.0% 0.0% 4.4% |
|TERMINAL (d) | 2/27 (7%) 0/29 (0%) 1/16 (6%) 2/22 (9%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 712 --- 684 537 |730 (T) --- --- 726 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.113N P=0.654 P=0.183 |P=0.204 P=0.494N P=0.533N P=0.533 |
|POLY 3 | P=0.022 * P=0.112N P=0.556N P=0.241 |P=0.176 P=0.483N P=0.502N P=0.521 |
|POLY 1.5 | P=0.023 * P=0.114N P=0.533N P=0.243 |P=0.176 P=0.486N P=0.497N P=0.518 |
|POLY 6 | P=0.021 * P=0.109N P=0.592N P=0.233 |P=0.177 P=0.481N P=0.512N P=0.524 |
|LOGISTIC REGRESSION| P=0.023 * P=0.106N P=0.644N P=0.235 |P=0.197 (e) (e) P=0.532 |
|COCH-ARM / FISHERS | P=0.026 * P=0.121N P=0.510N P=0.243 |P=0.177 P=0.495N P=0.495N P=0.508 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 1/36.95 2/41.10 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.7% 4.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 697 662 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203 P=0.486N P=0.656 P=0.457 |(e) (e) (e) (e) |
|POLY 3 | P=0.229 P=0.492N P=0.733 P=0.494 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.234 P=0.495N P=0.745 P=0.498 |(e) (e) (e) (e) |
|POLY 6 | P=0.220 P=0.490N P=0.714 P=0.486 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.231 (e) P=0.701 P=0.491 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.239 P=0.500N P=0.747 P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 1/36.95 3/41.10 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.7% 7.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 1/22 (5%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- 697 662 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 P=0.486N P=0.656 P=0.258 |(e) (e) (e) (e) |
|POLY 3 | P=0.075 P=0.492N P=0.733 P=0.299 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.078 P=0.495N P=0.745 P=0.303 |(e) (e) (e) (e) |
|POLY 6 | P=0.071 P=0.490N P=0.714 P=0.290 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.074 (e) P=0.701 P=0.287 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.081 P=0.500N P=0.747 P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |0/42.73 0/46.42 2/43.15 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 471 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.647N (e) P=0.246 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.648N (e) P=0.239 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.649N (e) P=0.242 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.648N (e) P=0.233 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.708N (e) P=0.141 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.652N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 0/43.38 0/36.82 0/40.72 |0/42.73 2/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 2/34 (6%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.373N P=0.245 (e) (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.366N P=0.256 (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.373N P=0.251 (e) (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.358N P=0.259 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) P=0.245 (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.390N P=0.247 (e) (e) |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |5/50 (10%) 4/50 (8%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 2/43.69 2/37.46 1/40.84 |5/42.73 4/46.87 1/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 5.3% 2.5% |11.7% 8.5% 2.4% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |5/33 (15%) 2/34 (6%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | --- 642 593 698 |730 (T) 656 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.627 P=0.256 P=0.191 P=0.465 |P=0.077N P=0.473N P=0.142N P=0.083N |
|POLY 3 | P=0.658 P=0.247 P=0.213 P=0.495 |P=0.083N P=0.442N P=0.104N P=0.089N |
|POLY 1.5 | P=0.661N P=0.244 P=0.223 P=0.498 |P=0.085N P=0.458N P=0.100N P=0.092N |
|POLY 6 | P=0.643 P=0.251 P=0.199 P=0.490 |P=0.081N P=0.429N P=0.114N P=0.086N |
|LOGISTIC REGRESSION| P=0.659N P=0.238 P=0.246 P=0.494 |P=0.083N P=0.446N P=0.142N P=0.083N |
|COCH-ARM / FISHERS | P=0.658N P=0.247 P=0.247 P=0.500 |P=0.089N P=0.500N P=0.102N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |5/50 (10%) 6/50 (12%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/41.77 2/43.69 2/37.46 1/40.84 |5/42.73 6/46.87 1/42.02 1/45.19 |
|POLY-3 PERCENT (g) | 0.0% 4.6% 5.3% 2.5% |11.7% 12.8% 2.4% 2.2% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 0/22 (0%) |5/33 (15%) 4/34 (12%) 1/28 (4%) 1/36 (3%) |
|FIRST INCIDENCE | --- 642 593 698 |730 (T) 656 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.627 P=0.256 P=0.191 P=0.465 |P=0.044N* P=0.529 P=0.142N P=0.083N |
|POLY 3 | P=0.658 P=0.247 P=0.213 P=0.495 |P=0.045N* P=0.565 P=0.104N P=0.089N |
|POLY 1.5 | P=0.661N P=0.244 P=0.223 P=0.498 |P=0.046N* P=0.546 P=0.100N P=0.092N |
|POLY 6 | P=0.643 P=0.251 P=0.199 P=0.490 |P=0.042N* P=0.579 P=0.114N P=0.086N |
|LOGISTIC REGRESSION| P=0.659N P=0.238 P=0.246 P=0.494 |P=0.047N* P=0.565 P=0.142N P=0.083N |
|COCH-ARM / FISHERS | P=0.658N P=0.247 P=0.247 P=0.500 |P=0.052N P=0.500 P=0.102N P=0.102N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |25/50 (50%) 29/50 (58%) 21/50 (42%) 29/50 (58%) |
|POLY-3 RATE (b) | 2/41.77 2/43.69 3/37.52 3/41.24 |25/43.37 29/47.72 21/43.87 29/46.02 |
|POLY-3 PERCENT (g) | 4.8% 4.6% 8.0% 7.3% |57.7% 60.8% 47.9% 63.0% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |23/33 (70%) 21/34 (62%) 12/28 (43%) 23/36 (64%) |
|FIRST INCIDENCE | 729 (T) 642 621 656 |558 642 610 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364 P=0.668N P=0.320 P=0.439 |P=0.496 P=0.357 P=0.528N P=0.446 |
|POLY 3 | P=0.413 P=0.678N P=0.451 P=0.494 |P=0.321 P=0.464 P=0.236N P=0.378 |
|POLY 1.5 | P=0.422 P=0.683N P=0.471 P=0.498 |P=0.312 P=0.402 P=0.233N P=0.347 |
|POLY 6 | P=0.397 P=0.671N P=0.421 P=0.485 |P=0.334 P=0.526 P=0.249N P=0.414 |
|LOGISTIC REGRESSION| P=0.421 P=0.680N P=0.442 P=0.483 |P=0.348 P=0.473 P=0.343N P=0.396 |
|COCH-ARM / FISHERS | P=0.429 P=0.691N P=0.500 P=0.500 |P=0.290 P=0.274 P=0.274N P=0.274 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |25/50 (50%) 30/50 (60%) 21/50 (42%) 29/50 (58%) |
|POLY-3 RATE (b) | 2/41.77 2/43.69 3/37.52 3/41.24 |25/43.37 30/47.72 21/43.87 29/46.02 |
|POLY-3 PERCENT (g) | 4.8% 4.6% 8.0% 7.3% |57.7% 62.9% 47.9% 63.0% |
|TERMINAL (d) | 2/27 (7%) 1/29 (3%) 1/16 (6%) 1/22 (5%) |23/33 (70%) 22/34 (65%) 12/28 (43%) 23/36 (64%) |
|FIRST INCIDENCE | 729 (T) 642 621 656 |558 642 610 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364 P=0.668N P=0.320 P=0.439 |P=0.532 P=0.285 P=0.528N P=0.446 |
|POLY 3 | P=0.413 P=0.678N P=0.451 P=0.494 |P=0.360 P=0.382 P=0.236N P=0.378 |
|POLY 1.5 | P=0.422 P=0.683N P=0.471 P=0.498 |P=0.349 P=0.325 P=0.233N P=0.347 |
|POLY 6 | P=0.397 P=0.671N P=0.421 P=0.485 |P=0.376 P=0.442 P=0.249N P=0.414 |
|LOGISTIC REGRESSION| P=0.421 P=0.680N P=0.442 P=0.483 |P=0.386 P=0.394 P=0.343N P=0.396 |
|COCH-ARM / FISHERS | P=0.429 P=0.691N P=0.500 P=0.500 |P=0.323 P=0.211 P=0.274N P=0.274 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |27/50 (54%) 32/50 (64%) 21/50 (42%) 29/50 (58%) |
|POLY-3 RATE (b) | 2/41.77 3/43.69 5/38.16 4/41.36 |27/43.37 32/47.90 21/43.87 29/46.02 |
|POLY-3 PERCENT (g) | 4.8% 6.9% 13.1% 9.7% |62.3% 66.8% 47.9% 63.0% |
|TERMINAL (d) | 2/27 (7%) 2/29 (7%) 1/16 (6%) 1/22 (5%) |25/33 (76%) 23/34 (68%) 12/28 (43%) 23/36 (64%) |
|FIRST INCIDENCE | 729 (T) 642 593 656 |558 642 610 642 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301 P=0.533 P=0.104 P=0.278 |P=0.405N P=0.289 P=0.385N P=0.547N |
|POLY 3 | P=0.354 P=0.521 P=0.179 P=0.332 |P=0.540 P=0.405 P=0.120N P=0.559 |
|POLY 1.5 | P=0.363 P=0.514 P=0.193 P=0.336 |P=0.524 P=0.337 P=0.121N P=0.518 |
|POLY 6 | P=0.336 P=0.529 P=0.159 P=0.323 |P=0.559 P=0.482 P=0.125N P=0.580N |
|LOGISTIC REGRESSION| P=0.365 P=0.523 P=0.190 P=0.319 |P=0.548N P=0.411 P=0.206N P=0.579 |
|COCH-ARM / FISHERS | P=0.372 P=0.500 P=0.218 P=0.339 |P=0.484 P=0.208 P=0.158N P=0.420 |
|=================================================================================================================================|
| | | |
| | 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) | 35/50 (70%) 27/50 (54%) 26/49 (53%) 32/50 (64%) |30/49 (61%) 36/50 (72%) 32/50 (64%) 22/49 (45%) |
|POLY-3 RATE (b) | 35/46.77 27/46.42 26/42.14 32/45.38 |30/44.48 36/49.68 32/45.65 22/46.71 |
|POLY-3 PERCENT (g) | 74.8% 58.2% 61.7% 70.5% |67.4% 72.5% 70.1% 47.1% |
|TERMINAL (d) | 21/27 (78%) 16/29 (55%) 9/16 (56%) 15/22 (68%) |23/33 (70%) 21/34 (62%) 20/28 (71%) 15/36 (42%) |
|FIRST INCIDENCE | 296 509 431 518 |537 410 528 586 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193 P=0.070N P=0.406 P=0.456 |P=0.008N** P=0.294 P=0.176 P=0.051N |
|POLY 3 | P=0.382 P=0.060N P=0.121N P=0.404N |P=0.003N** P=0.379 P=0.482 P=0.036N* |
|POLY 1.5 | P=0.401 P=0.064N P=0.089N P=0.378N |P=0.004N** P=0.312 P=0.506 P=0.043N* |
|POLY 6 | P=0.357 P=0.060N P=0.182N P=0.444N |P=0.003N** P=0.450 P=0.438 P=0.031N* |
|LOGISTIC REGRESSION| P=0.412 P=0.063N P=0.091N P=0.345N |P=0.005N** P=0.256 P=0.424 P=0.043N* |
|COCH-ARM / FISHERS | P=0.444 P=0.074N P=0.063N P=0.335N |P=0.008N** P=0.178 P=0.469 P=0.078N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 1/43.38 0/36.82 3/40.84 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 7.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 698 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029 * P=0.514 (e) P=0.090 |(e) (e) (e) (e) |
|POLY 3 | P=0.038 * P=0.508 (e) P=0.114 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.039 * P=0.505 (e) P=0.117 |(e) (e) (e) (e) |
|POLY 6 | P=0.037 * P=0.510 (e) P=0.108 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.032 * P=0.514 (e) P=0.100 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.041 * P=0.500 (e) P=0.121 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/41.77 1/43.38 0/36.82 4/40.86 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 9.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 698 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.514 (e) P=0.045 * |(e) (e) (e) (e) |
|POLY 3 | P=0.009 ** P=0.508 (e) P=0.057 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.009 ** P=0.505 (e) P=0.059 |(e) (e) (e) (e) |
|POLY 6 | P=0.008 ** P=0.510 (e) P=0.053 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.007 ** P=0.514 (e) P=0.047 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010 * P=0.500 (e) P=0.059 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.12 1/43.38 1/36.88 5/41.10 |0/42.73 0/46.42 0/42.02 1/45.42 |
|POLY-3 PERCENT (g) | 4.8% 2.3% 2.7% 12.2% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 631 729 (T) 716 666 |--- --- --- 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.032 * P=0.481N P=0.635N P=0.168 |P=0.241 (e) (e) P=0.514 |
|POLY 3 | P=0.040 * P=0.490N P=0.546N P=0.205 |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.042 * P=0.492N P=0.527N P=0.211 |P=0.231 (e) (e) P=0.509 |
|POLY 6 | P=0.037 * P=0.487N P=0.577N P=0.192 |P=0.232 (e) (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.038 * P=0.491N P=0.548N P=0.200 |P=0.222 (e) (e) P=0.492 |
|COCH-ARM / FISHERS | P=0.045 * P=0.500N P=0.500N P=0.218 |P=0.228 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/41.84 4/44.26 2/36.95 4/40.99 |1/42.95 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.8% 9.0% 5.4% 9.8% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 2/29 (7%) 1/16 (6%) 3/22 (14%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 712 513 697 655 |670 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.290 P=0.369 P=0.512 P=0.259 |P=0.541N P=0.486N P=0.521N P=0.490N |
|POLY 3 | P=0.359 P=0.363 P=0.649 P=0.327 |P=0.553N P=0.485N P=0.504N P=0.490N |
|POLY 1.5 | P=0.367 P=0.354 P=0.668 P=0.333 |P=0.553N P=0.488N P=0.500N P=0.492N |
|POLY 6 | P=0.341 P=0.374 P=0.618 P=0.313 |P=0.551N P=0.483N P=0.514N P=0.489N |
|LOGISTIC REGRESSION| P=0.355 P=0.334 P=0.578 P=0.296 |P=0.552N P=0.518N P=0.501N P=0.508N |
|COCH-ARM / FISHERS | P=0.372 P=0.339 P=0.691N P=0.339 |P=0.547N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 3/50 (6%) 4/50 (8%) 2/50 (4%) 5/50 (10%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/41.84 4/44.26 2/36.95 5/41.32 |3/43.12 0/46.42 0/42.02 1/45.37 |
|POLY-3 PERCENT (g) | 7.2% 9.0% 5.4% 12.1% |7.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 2/27 (7%) 2/29 (7%) 1/16 (6%) 3/22 (14%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 712 513 697 639 |670 --- --- 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218 P=0.534 P=0.646 P=0.270 |P=0.513N P=0.117N P=0.148N P=0.290N |
|POLY 3 | P=0.283 P=0.531 P=0.557N P=0.348 |P=0.540N P=0.106N P=0.123N P=0.287N |
|POLY 1.5 | P=0.290 P=0.520 P=0.533N P=0.354 |P=0.540N P=0.109N P=0.119N P=0.291N |
|POLY 6 | P=0.269 P=0.544 P=0.593N P=0.336 |P=0.535N P=0.105N P=0.132N P=0.285N |
|LOGISTIC REGRESSION| P=0.279 P=0.505 P=0.655N P=0.325 |P=0.531N P=0.115N P=0.121N P=0.299N |
|COCH-ARM / FISHERS | P=0.294 P=0.500 P=0.500N P=0.357 |P=0.532N P=0.121N P=0.121N P=0.309N |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/41.77 0/43.38 0/36.82 1/41.04 |2/42.89 0/46.42 0/42.02 1/45.37 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 0.0% 2.4% |4.7% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- 639 |687 --- --- 684 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491 P=0.486N P=0.604N P=0.729 |P=0.694N P=0.234N P=0.270N P=0.481N |
|POLY 3 | P=0.514 P=0.492N P=0.525N P=0.757 |P=0.695 P=0.220N P=0.242N P=0.480N |
|POLY 1.5 | P=0.517 P=0.495N P=0.515N P=0.759 |P=0.695 P=0.224N P=0.236N P=0.485N |
|POLY 6 | P=0.506 P=0.490N P=0.542N P=0.752 |P=0.696 P=0.218N P=0.252N P=0.477N |
|LOGISTIC REGRESSION| P=0.519 (e) (e) P=0.761 |P=0.702 P=0.223N P=0.243N P=0.490N |
|COCH-ARM / FISHERS | P=0.522 P=0.500N P=0.500N P=0.753N |P=0.700 P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/41.77 2/43.47 1/36.82 0/40.72 |0/42.73 0/46.42 1/42.25 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.6% 2.7% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 729 (T) 705 729 (T) --- |--- --- 670 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.293N P=0.527 P=0.641 P=0.541N |P=0.764N (e) P=0.479 (e) |
|POLY 3 | P=0.241N P=0.514 P=0.732 P=0.505N |P=0.770N (e) P=0.498 (e) |
|POLY 1.5 | P=0.239N P=0.509 P=0.744 P=0.502N |P=0.770N (e) P=0.502 (e) |
|POLY 6 | P=0.247N P=0.519 P=0.712 P=0.512N |P=0.769N (e) P=0.490 (e) |
|LOGISTIC REGRESSION| P=0.274N P=0.525 P=0.641 (e) |P=0.777N (e) P=0.499 (e) |
|COCH-ARM / FISHERS | P=0.238N P=0.500 P=0.753N P=0.500N |P=0.772N (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.12 0/43.38 1/36.88 1/40.95 |0/42.73 0/46.42 0/42.02 1/45.42 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 2.7% 2.4% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 631 --- 716 666 |--- --- --- 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.674 P=0.229N P=0.635N P=0.537N |P=0.241 (e) (e) P=0.514 |
|POLY 3 | P=0.662N P=0.230N P=0.546N P=0.510N |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.658N P=0.232N P=0.527N P=0.504N |P=0.231 (e) (e) P=0.509 |
|POLY 6 | P=0.670N P=0.229N P=0.577N P=0.522N |P=0.232 (e) (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.658N P=0.238N P=0.548N P=0.500N |P=0.222 (e) (e) P=0.492 |
|COCH-ARM / FISHERS | P=0.654N P=0.247N P=0.500N P=0.500N |P=0.228 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.12 0/43.38 1/36.88 1/40.95 |0/42.73 0/46.42 0/42.02 1/45.42 |
|POLY-3 PERCENT (g) | 4.8% 0.0% 2.7% 2.4% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/27 (4%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 631 --- 716 666 |--- --- --- 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.674 P=0.229N P=0.635N P=0.537N |P=0.241 (e) (e) P=0.514 |
|POLY 3 | P=0.662N P=0.230N P=0.546N P=0.510N |P=0.231 (e) (e) P=0.512 |
|POLY 1.5 | P=0.658N P=0.232N P=0.527N P=0.504N |P=0.231 (e) (e) P=0.509 |
|POLY 6 | P=0.670N P=0.229N P=0.577N P=0.522N |P=0.232 (e) (e) P=0.515 |
|LOGISTIC REGRESSION| P=0.658N P=0.238N P=0.548N P=0.500N |P=0.222 (e) (e) P=0.492 |
|COCH-ARM / FISHERS | P=0.654N P=0.247N P=0.500N P=0.500N |P=0.228 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 41/50 (82%) 45/50 (90%) 40/49 (82%) 42/50 (84%) | |
|POLY-3 RATE (b) | 41/45.93 45/48.37 40/45.72 42/46.78 | |
|POLY-3 PERCENT (g) | 89.3% 93.0% 87.5% 89.8% | |
|TERMINAL (d) | 25/27 (93%) 28/29 (97%) 16/16 (100%) 22/22 (100%)| |
|FIRST INCIDENCE | 458 464 431 509 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 P=0.498 P=0.020 * P=0.158 | |
|POLY 3 | P=0.529N P=0.377 P=0.527N P=0.616 | |
|POLY 1.5 | P=0.510N P=0.298 P=0.532N P=0.576 | |
|POLY 6 | P=0.615N P=0.474 P=0.580N P=0.617 | |
|LOGISTIC REGRESSION| P=0.530N P=0.286 P=0.467 P=0.504 | |
|COCH-ARM / FISHERS | P=0.499N P=0.194 P=0.584N P=0.500 | |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 3/49 (6%) 5/50 (10%) |8/49 (16%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/41.90 4/43.50 3/37.30 5/40.74 |8/43.38 2/46.43 3/42.48 4/45.42 |
|POLY-3 PERCENT (g) | 7.2% 9.2% 8.0% 12.3% |18.4% 4.3% 7.1% 8.8% |
|TERMINAL (d) | 1/27 (4%) 3/29 (10%) 1/16 (6%) 4/22 (18%) |5/33 (15%) 1/34 (3%) 2/28 (7%) 3/36 (8%) |
|FIRST INCIDENCE | 712 697 634 724 |537 726 593 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224 P=0.536 P=0.455 P=0.257 |P=0.367N P=0.046N* P=0.156N P=0.148N |
|POLY 3 | P=0.299 P=0.520 P=0.608 P=0.340 |P=0.411N P=0.034N* P=0.103N P=0.154N |
|POLY 1.5 | P=0.310 P=0.514 P=0.631 P=0.350 |P=0.412N P=0.036N* P=0.095N P=0.156N |
|POLY 6 | P=0.276 P=0.527 P=0.572 P=0.319 |P=0.404N P=0.034N* P=0.119N P=0.153N |
|LOGISTIC REGRESSION| P=0.260 P=0.537 P=0.571 P=0.275 |P=0.404N P=0.039N* P=0.096N P=0.156N |
|COCH-ARM / FISHERS | P=0.320 P=0.500 P=0.651 P=0.357 |P=0.410N P=0.043N* P=0.094N P=0.168N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/49 (6%) 3/50 (6%) |2/49 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.00 1/43.76 3/38.07 3/40.90 |2/43.01 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 7.9% 7.3% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 2/22 (9%) |1/33 (3%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 668 621 509 681 |593 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.200 P=0.751N P=0.241 P=0.254 |P=0.303N P=0.222N P=0.258N P=0.225N |
|POLY 3 | P=0.213 P=0.752N P=0.270 P=0.295 |P=0.310N P=0.220N P=0.242N P=0.226N |
|POLY 1.5 | P=0.222 P=0.754N P=0.284 P=0.301 |P=0.311N P=0.223N P=0.235N P=0.227N |
|POLY 6 | P=0.196 P=0.749N P=0.247 P=0.283 |P=0.307N P=0.220N P=0.254N P=0.226N |
|LOGISTIC REGRESSION| P=0.238 P=0.745 P=0.324 P=0.290 |P=0.311N P=0.253N P=0.236N P=0.243N |
|COCH-ARM / FISHERS | P=0.232 P=0.753N P=0.301 P=0.309 |P=0.306N P=0.242N P=0.242N P=0.242N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 6/49 (12%) 7/50 (14%) |9/49 (18%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/42.14 5/43.88 6/38.54 7/40.92 |9/43.85 2/46.43 3/42.48 4/45.42 |
|POLY-3 PERCENT (g) | 9.5% 11.4% 15.6% 17.1% |20.5% 4.3% 7.1% 8.8% |
|TERMINAL (d) | 1/27 (4%) 3/29 (10%) 1/16 (6%) 5/22 (23%) |5/33 (15%) 1/34 (3%) 2/28 (7%) 3/36 (8%) |
|FIRST INCIDENCE | 668 621 509 681 |537 726 593 669 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168 P=0.537 P=0.195 P=0.175 |P=0.300N P=0.026N* P=0.103N P=0.098N |
|POLY 3 | P=0.216 P=0.526 P=0.313 P=0.241 |P=0.335N P=0.019N* P=0.065N P=0.101N |
|POLY 1.5 | P=0.232 P=0.517 P=0.335 P=0.253 |P=0.337N P=0.020N* P=0.058N P=0.101N |
|POLY 6 | P=0.189 P=0.534 P=0.277 P=0.219 |P=0.329N P=0.019N* P=0.079N P=0.102N |
|LOGISTIC REGRESSION| P=0.230 P=0.523 P=0.350 P=0.205 |P=0.333N P=0.024N* P=0.057N P=0.105N |
|COCH-ARM / FISHERS | P=0.247 P=0.500 P=0.357 P=0.262 |P=0.335N P=0.023N* P=0.056N P=0.109N |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 1/50 (2%) 0/49 (0%) 2/50 (4%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.04 1/43.47 0/36.82 2/41.38 |0/42.54 1/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 2.3% 0.0% 4.8% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/27 (0%) 0/29 (0%) 0/16 (0%) 0/22 (0%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 656 705 --- 582 |--- 730 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289 P=0.738N P=0.545N P=0.481 |P=0.589N P=0.506 (e) (e) |
|POLY 3 | P=0.316 P=0.753N P=0.526N P=0.494 |P=0.591N P=0.517 (e) (e) |
|POLY 1.5 | P=0.318 P=0.755N P=0.515N P=0.498 |P=0.596N P=0.514 (e) (e) |
|POLY 6 | P=0.310 P=0.751N P=0.544N P=0.486 |P=0.586N P=0.519 (e) (e) |
|LOGISTIC REGRESSION| P=0.322 P=0.763 P=0.500N P=0.502 |(e) P=0.506 (e) (e) |
|COCH-ARM / FISHERS | P=0.318 P=0.753N P=0.505N P=0.500 |P=0.607N P=0.505 (e) (e) |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 7/50 (14%) 12/50 (24%) 6/50 (12%) |
|POLY-3 RATE (b) | |5/42.73 7/46.42 12/43.19 6/45.77 |
|POLY-3 PERCENT (g) | |11.7% 15.1% 27.8% 13.1% |
|TERMINAL (d) | |5/33 (15%) 7/34 (21%) 8/28 (29%) 4/36 (11%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 559 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.413N P=0.398 P=0.029 * P=0.559 |
|POLY 3 | |P=0.453N P=0.438 P=0.052 P=0.548 |
|POLY 1.5 | |P=0.466N P=0.423 P=0.056 P=0.535 |
|POLY 6 | |P=0.438N P=0.447 P=0.045 * P=0.560 |
|LOGISTIC REGRESSION| |P=0.468N P=0.398 P=0.044 * P=0.539 |
|COCH-ARM / FISHERS | |P=0.494N P=0.380 P=0.054 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |5/50 (10%) 7/50 (14%) 12/50 (24%) 6/50 (12%) |
|POLY-3 RATE (b) | |5/42.73 7/46.42 12/43.19 6/45.77 |
|POLY-3 PERCENT (g) | |11.7% 15.1% 27.8% 13.1% |
|TERMINAL (d) | |5/33 (15%) 7/34 (21%) 8/28 (29%) 4/36 (11%) |
|FIRST INCIDENCE | |730 (T) 730 (T) 559 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.413N P=0.398 P=0.029 * P=0.559 |
|POLY 3 | |P=0.453N P=0.438 P=0.052 P=0.548 |
|POLY 1.5 | |P=0.466N P=0.423 P=0.056 P=0.535 |
|POLY 6 | |P=0.438N P=0.447 P=0.045 * P=0.560 |
|LOGISTIC REGRESSION| |P=0.468N P=0.398 P=0.044 * P=0.539 |
|COCH-ARM / FISHERS | |P=0.494N P=0.380 P=0.054 P=0.500 |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.52 2/44.12 0/36.82 2/40.72 |2/44.48 1/46.42 1/42.44 0/45.19 |
|POLY-3 PERCENT (g) | 2.4% 4.5% 0.0% 4.9% |4.5% 2.2% 2.4% 0.0% |
|TERMINAL (d) | 0/27 (0%) 1/29 (3%) 0/16 (0%) 2/22 (9%) |0/33 (0%) 1/34 (3%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 458 464 --- 729 (T) |284 730 (T) 610 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410 P=0.520 P=0.504N P=0.455 |P=0.212N P=0.489N P=0.491N P=0.235N |
|POLY 3 | P=0.441 P=0.513 P=0.529N P=0.485 |P=0.215N P=0.485N P=0.516N P=0.234N |
|POLY 1.5 | P=0.447 P=0.509 P=0.517N P=0.492 |P=0.216N P=0.489N P=0.507N P=0.234N |
|POLY 6 | P=0.429 P=0.517 P=0.546N P=0.471 |P=0.213N P=0.483N P=0.531N P=0.233N |
|LOGISTIC REGRESSION| P=0.454 P=0.342 P=0.391N P=0.502 |P=0.267N P=0.706 P=0.735 P=0.442N |
|COCH-ARM / FISHERS | P=0.451 P=0.500 P=0.500N P=0.500 |P=0.214N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 31/50 (62%) 35/50 (70%) 27/50 (54%) |24/50 (48%) 24/50 (48%) 28/50 (56%) 20/50 (40%) |
|POLY-3 RATE (b) | 33/47.19 31/46.27 35/45.61 27/45.69 |24/45.04 24/47.68 28/47.24 20/47.78 |
|POLY-3 PERCENT (g) | 69.9% 67.0% 76.7% 59.1% |53.3% 50.3% 59.3% 41.9% |
|TERMINAL (d) | 16/27 (59%) 19/29 (66%) 12/16 (75%) 13/22 (59%) |15/33 (46%) 17/34 (50%) 13/28 (46%) 13/36 (36%) |
|FIRST INCIDENCE | 296 569 361 254 |380 642 507 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.437N P=0.317N P=0.034 * P=0.443N |P=0.133N P=0.490N P=0.163 P=0.205N |
|POLY 3 | P=0.121N P=0.466N P=0.300 P=0.183N |P=0.123N P=0.469N P=0.354 P=0.184N |
|POLY 1.5 | P=0.108N P=0.444N P=0.329 P=0.162N |P=0.139N P=0.494N P=0.340 P=0.207N |
|POLY 6 | P=0.169N P=0.496N P=0.248 P=0.241N |P=0.109N P=0.459N P=0.357 P=0.167N |
|LOGISTIC REGRESSION| P=0.118N P=0.381N P=0.368 P=0.153N |P=0.170N P=0.468N P=0.281 P=0.245N |
|COCH-ARM / FISHERS | P=0.114N P=0.418N P=0.415 P=0.154N |P=0.176N P=0.579N P=0.274 P=0.273N |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.09 2/44.04 3/37.84 4/41.21 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.8% 4.5% 7.9% 9.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 639 509 561 662 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205 P=0.670N P=0.368 P=0.283 |(e) (e) (e) (e) |
|POLY 3 | P=0.227 P=0.678N P=0.451 P=0.327 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.236 P=0.683N P=0.471 P=0.333 |(e) (e) (e) (e) |
|POLY 6 | P=0.212 P=0.673N P=0.420 P=0.313 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.245 P=0.671 P=0.510 P=0.328 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.244 P=0.691N P=0.500 P=0.339 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 75 PPM 300 PPM 1200 PPM |CONTROL 75 PPM 300 PPM 1200 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.09 2/44.04 3/37.84 4/41.21 |0/42.73 0/46.42 0/42.02 0/45.19 |
|POLY-3 PERCENT (g) | 4.8% 4.5% 7.9% 9.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/27 (4%) 1/29 (3%) 1/16 (6%) 2/22 (9%) |0/33 (0%) 0/34 (0%) 0/28 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 639 509 561 662 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.205 P=0.670N P=0.368 P=0.283 |(e) (e) (e) (e) |
|POLY 3 | P=0.227 P=0.678N P=0.451 P=0.327 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.236 P=0.683N P=0.471 P=0.333 |(e) (e) (e) (e) |
|POLY 6 | P=0.212 P=0.673N P=0.420 P=0.313 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.245 P=0.671 P=0.510 P=0.328 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.244 P=0.691N P=0.500 P=0.339 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | 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) | 50/50 (100%) 50/50 (100%) 48/50 (96%) 49/50 (98%) |41/50 (82%) 45/50 (90%) 42/50 (84%) 41/50 (82%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 48/48.12 49/49.04 |41/45.13 45/50.00 42/46.79 41/47.85 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 99.8% 99.9% |90.8% 90.0% 89.8% 85.7% |
|TERMINAL (d) | 27/27 (100%) 29/29 (100%) 16/16 (100%) 22/22 (100%)|31/33 (94%) 29/34 (85%) 26/28 (93%) 30/36 (83%) |
|FIRST INCIDENCE | 296 464 431 509 |537 410 528 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.211 (e) P=0.027 * P=0.259 |P=0.179N P=0.436 P=0.145 P=0.327N |
|POLY 3 | P=1.000N (e) P=1.000N P=1.000N |P=0.245N P=0.586N P=0.580N P=0.317N |
|POLY 1.5 | P=0.945N (e) P=0.967N P=1.000N |P=0.272N P=0.524 P=0.587N P=0.402N |
|POLY 6 | P=1.000N (e) P=1.000N P=1.000N |P=0.222N P=0.438N P=0.610N P=0.247N |
|LOGISTIC REGRESSION| P=0.598N (e) P=0.328N (e) |P=0.237N P=0.494 P=0.533 P=0.350N |
|COCH-ARM / FISHERS | P=0.419N (e) P=0.247N P=0.500N |P=0.354N P=0.194 P=0.500 P=0.602N |
|=================================================================================================================================|
| | | |
| | 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) | 35/50 (70%) 34/50 (68%) 40/50 (80%) 40/50 (80%) |33/50 (66%) 27/50 (54%) 32/50 (64%) 23/50 (46%) |
|POLY-3 RATE (b) | 35/47.94 34/48.06 40/46.78 40/47.51 |33/47.86 27/47.68 32/48.46 23/47.78 |
|POLY-3 PERCENT (g) | 73.0% 70.8% 85.5% 84.2% |69.0% 56.6% 66.0% 48.1% |
|TERMINAL (d) | 17/27 (63%) 19/29 (66%) 13/16 (81%) 20/22 (91%) |20/33 (61%) 20/34 (59%) 14/28 (50%) 16/36 (44%) |
|FIRST INCIDENCE | 296 464 361 254 |284 642 471 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066 P=0.372N P=0.010 * P=0.093 |P=0.045N* P=0.144N P=0.405 P=0.034N* |
|POLY 3 | P=0.079 P=0.492N P=0.096 P=0.128 |P=0.040N* P=0.147N P=0.465N P=0.028N* |
|POLY 1.5 | P=0.100 P=0.495N P=0.110 P=0.153 |P=0.042N* P=0.141N P=0.463N P=0.029N* |
|POLY 6 | P=0.049 * P=0.490N P=0.078 P=0.090 |P=0.038N* P=0.160N P=0.472N P=0.029N* |
|LOGISTIC REGRESSION| P=0.120 P=0.517N P=0.152 P=0.178 |P=0.050N P=0.140N P=0.505N P=0.038N* |
|COCH-ARM / FISHERS | P=0.122 P=0.500N P=0.178 P=0.178 |P=0.047N* P=0.154N P=0.500N P=0.035N* |
|=================================================================================================================================|
Date: 11/14/01 EXPERIMENT: 90004 TEST: 07 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - PROPYLENE GLYCOL MONO-T-BUTYL ETHER
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 and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 49/50 (98%) 50/50 (100%)|49/50 (98%) 48/50 (96%) 50/50 (100%) 45/50 (90%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 49/49.00 50/50.00 |49/49.01 48/50.00 50/50.00 45/49.06 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |100.0% 96.0% 100.0% 91.7% |
|TERMINAL (d) | 27/27 (100%) 29/29 (100%) 16/16 (100%) 22/22 (100%)|33/33 (100%) 32/34 (94%) 28/28 (100%) 32/36 (89%) |
|FIRST INCIDENCE | 296 464 361 254 |284 410 471 519 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.173 (e) P=0.021 * (e) |P=0.092N P=0.339N P=0.163 P=0.120N |
|POLY 3 | P=1.000 (e) P=1.000N (e) |P=0.028N* P=0.245N P=1.000 P=0.058N |
|POLY 1.5 | P=1.000 (e) P=1.000N (e) |P=0.023N* P=0.269N P=1.000 P=0.055N |
|POLY 6 | P=1.000 (e) P=1.000N (e) |P=0.030N* P=0.242N P=1.000 P=0.061N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.016N* P=0.273N (e) P=0.038N* |
|COCH-ARM / FISHERS | P=0.772 (e) P=0.500N (e) |P=0.027N* P=0.500N P=0.500 P=0.102N |
|=================================================================================================================================|
(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).