TDMS Study 88031-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02
EXPERIMENT: 88031 TEST: 05 TIME: 10:28:09
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: MISSING CAS: 25265-71-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#3
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02
EXPERIMENT: 88031 TEST: 05 TIME: 10:28:09
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: MISSING CAS: 25265-71-8
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
Pancreas
Parathyroid Gland
Pituitary Gland
Prostate
Salivary Glands
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 02/04/02
EXPERIMENT: 88031 TEST: 05 TIME: 10:28:09
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: MISSING CAS: 25265-71-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIPROPYLENE GLYCOL
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma Malignant
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Carcinoma or Adenoma
Islets, Pancreatic Carcinoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Testes Adenoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Clitoral/Preputial Gland Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
All Organs Hemangiosarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 2/49 (4%) 0/50 (0%) 0/48 (0%) |1/49 (2%) 0/47 (0%) 1/47 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/37.58 2/42.09 0/42.10 0/24.30 |1/42.75 0/41.25 1/44.49 0/42.03 |
|POLY-3 PERCENT (g) | 0.0% 4.8% 0.0% 0.0% |2.3% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/23 (0%) 1/27 (4%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | --- 698 --- --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.971N P=0.287 (e) (e) |P=0.480N P=0.493N P=0.708N P=0.493N |
|POLY 3 | P=0.420N P=0.263 (e) (e) |P=0.481N P=0.507N P=0.752N P=0.503N |
|POLY 1.5 | P=0.411N P=0.257 (e) (e) |P=0.481N P=0.507N P=0.758N P=0.504N |
|POLY 6 | P=0.392N P=0.271 (e) (e) |P=0.482N P=0.508N P=0.745N P=0.504N |
|LOGISTIC REGRESSION| P=0.737N P=0.270 (e) (e) |P=0.480N (e) P=0.708N (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.258 (e) (e) |P=0.483N P=0.510N P=0.742 P=0.510N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/47 (9%) 7/49 (14%) 12/50 (24%) 1/47 (2%) |0/49 (0%) 3/47 (6%) 1/46 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 4/37.88 7/42.10 12/43.89 1/24.31 |0/42.75 3/41.63 1/43.84 0/42.03 |
|POLY-3 PERCENT (g) | 10.6% 16.6% 27.3% 4.1% |0.0% 7.2% 2.3% 0.0% |
|TERMINAL (d) | 1/23 (4%) 4/27 (15%) 8/27 (30%) 0/0 (0%) |0/30 (0%) 2/31 (7%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 697 711 340 614 |--- 622 725 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.146 P=0.388 P=0.063 P=0.335 |P=0.265N P=0.127 P=0.546 (e) |
|POLY 3 | P=0.308N P=0.323 P=0.049 * P=0.339N |P=0.263N P=0.113 P=0.505 (e) |
|POLY 1.5 | P=0.140N P=0.310 P=0.045 * P=0.250N |P=0.263N P=0.113 P=0.499 (e) |
|POLY 6 | P=0.424 P=0.339 P=0.051 P=0.512N |P=0.265N P=0.114 P=0.512 (e) |
|LOGISTIC REGRESSION| P=0.296N P=0.367 P=0.042 * P=0.700N |P=0.267N P=0.114 P=0.521 (e) |
|COCH-ARM / FISHERS | P=0.050N P=0.287 P=0.036 * P=0.181N |P=0.268N P=0.113 P=0.484 (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/47 (11%) 0/49 (0%) 2/50 (4%) 0/47 (0%) |2/49 (4%) 0/47 (0%) 0/46 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 5/38.29 0/41.97 2/43.00 0/23.91 |2/42.86 0/41.25 0/43.82 0/42.03 |
|POLY-3 PERCENT (g) | 13.1% 0.0% 4.7% 0.0% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/23 (13%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 511 --- 340 --- |702 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.307N P=0.024N* P=0.172N P=0.537N |P=0.311N P=0.237N P=0.201N P=0.240N |
|POLY 3 | P=0.161N P=0.023N* P=0.170N P=0.094N |P=0.316N P=0.245N P=0.232N P=0.241N |
|POLY 1.5 | P=0.125N P=0.024N* P=0.175N P=0.054N |P=0.315N P=0.245N P=0.239N P=0.242N |
|POLY 6 | P=0.199N P=0.021N* P=0.167N P=0.213N |P=0.318N P=0.247N P=0.225N P=0.242N |
|LOGISTIC REGRESSION| P=0.058N P=0.027N* P=0.218N P=0.106N |P=0.309N P=0.246N P=0.230N P=0.241N |
|COCH-ARM / FISHERS | P=0.087N P=0.025N* P=0.193N P=0.028N* |P=0.312N P=0.258N P=0.263N P=0.258N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/47 (19%) 7/49 (14%) 13/50 (26%) 1/47 (2%) |2/49 (4%) 3/47 (6%) 1/46 (2%) 0/47 (0%) |
|POLY-3 RATE (b) | 9/38.58 7/42.10 13/43.89 1/24.31 |2/42.86 3/41.63 1/43.84 0/42.03 |
|POLY-3 PERCENT (g) | 23.3% 16.6% 29.6% 4.1% |4.7% 7.2% 2.3% 0.0% |
|TERMINAL (d) | 4/23 (17%) 4/27 (15%) 9/27 (33%) 0/0 (0%) |0/30 (0%) 2/31 (7%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 511 711 340 614 |702 622 725 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387 P=0.264N P=0.374 P=0.648 |P=0.117N P=0.508 P=0.432N P=0.240N |
|POLY 3 | P=0.121N P=0.317N P=0.346 P=0.050N |P=0.118N P=0.487 P=0.492N P=0.241N |
|POLY 1.5 | P=0.039N* P=0.330N P=0.330 P=0.020N* |P=0.117N P=0.486 P=0.503N P=0.242N |
|POLY 6 | P=0.408N P=0.302N P=0.353 P=0.178N |P=0.120N P=0.487 P=0.480N P=0.242N |
|LOGISTIC REGRESSION| P=0.092N P=0.285N P=0.313 P=0.129N |P=0.116N P=0.483 P=0.483N P=0.241N |
|COCH-ARM / FISHERS | P=0.009N** P=0.358N P=0.288 P=0.008N** |P=0.118N P=0.480 P=0.524N P=0.258N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/47 (2%) 3/50 (6%) 1/50 (2%) |6/48 (13%) 9/44 (20%) 4/48 (8%) 4/48 (8%) |
|POLY-3 RATE (b) | 3/40.37 1/41.26 3/42.10 1/25.88 |6/41.42 9/38.95 4/44.12 4/42.17 |
|POLY-3 PERCENT (g) | 7.4% 2.4% 7.1% 3.9% |14.5% 23.1% 9.1% 9.5% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 3/27 (11%) 0/0 (0%) |6/29 (21%) 8/30 (27%) 4/37 (11%) 3/30 (10%) |
|FIRST INCIDENCE | 654 586 729 (T) 484 |729 (T) 585 729 (T) 725 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.389 P=0.266N P=0.609N P=0.579 |P=0.182N P=0.307 P=0.224N P=0.346N |
|POLY 3 | P=0.543N P=0.297N P=0.644N P=0.475N |P=0.164N P=0.240 P=0.330N P=0.357N |
|POLY 1.5 | P=0.447N P=0.308N P=0.648N P=0.386N |P=0.162N P=0.237 P=0.345N P=0.358N |
|POLY 6 | P=0.505 P=0.281N P=0.642N P=0.624N |P=0.170N P=0.244 P=0.313N P=0.362N |
|LOGISTIC REGRESSION| P=0.405N P=0.338N P=0.631N P=0.360N |P=0.173N P=0.233 P=0.224N P=0.358N |
|COCH-ARM / FISHERS | P=0.336N P=0.332N P=0.661N P=0.309N |P=0.167N P=0.227 P=0.370N P=0.370N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/47 (2%) 2/50 (4%) 0/50 (0%) |5/48 (10%) 5/44 (11%) 2/48 (4%) 1/48 (2%) |
|POLY-3 RATE (b) | 3/41.08 1/41.53 2/42.51 0/25.17 |5/41.79 5/38.49 2/44.12 1/42.74 |
|POLY-3 PERCENT (g) | 7.3% 2.4% 4.7% 0.0% |12.0% 13.0% 4.5% 2.3% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |4/29 (14%) 4/30 (13%) 2/37 (5%) 0/30 (0%) |
|FIRST INCIDENCE | 511 456 627 --- |626 725 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312N P=0.293N P=0.456N P=0.305N |P=0.065N P=0.613N P=0.139N P=0.100N |
|POLY 3 | P=0.258N P=0.301N P=0.484N P=0.230N |P=0.059N P=0.578 P=0.194N P=0.095N |
|POLY 1.5 | P=0.199N P=0.310N P=0.488N P=0.167N |P=0.059N P=0.579 P=0.202N P=0.096N |
|POLY 6 | P=0.337N P=0.287N P=0.480N P=0.361N |P=0.060N P=0.576 P=0.186N P=0.096N |
|LOGISTIC REGRESSION| P=0.070N P=0.452N P=0.547N P=0.085N |P=0.060N P=0.586 P=0.187N P=0.105N |
|COCH-ARM / FISHERS | P=0.137N P=0.332N P=0.500N P=0.121N |P=0.061N P=0.573 P=0.218N P=0.102N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/47 (4%) 5/50 (10%) 1/50 (2%) |10/48 (21%) 14/44 (32%) 6/48 (13%) 5/48 (10%) |
|POLY-3 RATE (b) | 6/41.55 2/42.01 5/42.51 1/25.88 |10/41.79 14/38.97 6/44.12 5/42.76 |
|POLY-3 PERCENT (g) | 14.4% 4.8% 11.8% 3.9% |23.9% 35.9% 13.6% 11.7% |
|TERMINAL (d) | 2/23 (9%) 0/27 (0%) 3/27 (11%) 0/0 (0%) |9/29 (31%) 12/30 (40%) 6/37 (16%) 3/30 (10%) |
|FIRST INCIDENCE | 511 456 627 484 |626 585 729 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.581N P=0.118N P=0.429N P=0.509N |P=0.037N* P=0.261 P=0.086N P=0.117N |
|POLY 3 | P=0.284N P=0.128N P=0.484N P=0.175N |P=0.027N* P=0.172 P=0.170N P=0.116N |
|POLY 1.5 | P=0.181N P=0.137N P=0.486N P=0.102N |P=0.027N* P=0.173 P=0.183N P=0.118N |
|POLY 6 | P=0.457N P=0.116N P=0.485N P=0.357N |P=0.028N* P=0.171 P=0.157N P=0.117N |
|LOGISTIC REGRESSION| P=0.051N P=0.214N P=0.497N P=0.044N* |P=0.032N* P=0.171 P=0.141N P=0.123N |
|COCH-ARM / FISHERS | P=0.094N P=0.155N P=0.500N P=0.056N |P=0.033N* P=0.168 P=0.206N P=0.130N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/40.56 3/42.41 1/42.17 0/24.59 |0/43.16 2/43.38 4/45.88 1/43.66 |
|POLY-3 PERCENT (g) | 4.9% 7.1% 2.4% 0.0% |0.0% 4.6% 8.7% 2.3% |
|TERMINAL (d) | 0/23 (0%) 3/27 (11%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 4/38 (11%) 1/31 (3%) |
|FIRST INCIDENCE | 565 729 (T) 712 --- |--- 634 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.495N P=0.556 P=0.459N P=0.576N |P=0.584N P=0.243 P=0.096 P=0.507 |
|POLY 3 | P=0.198N P=0.520 P=0.486N P=0.361N |P=0.573N P=0.238 P=0.068 P=0.502 |
|POLY 1.5 | P=0.160N P=0.514 P=0.490N P=0.298N |P=0.571N P=0.238 P=0.065 P=0.503 |
|POLY 6 | P=0.233N P=0.531 P=0.484N P=0.474N |P=0.579N P=0.238 P=0.072 P=0.500 |
|LOGISTIC REGRESSION| P=0.210N P=0.518 P=0.511N P=0.241N |P=0.581N P=0.237 P=0.096 P=0.507 |
|COCH-ARM / FISHERS | P=0.118N P=0.500 P=0.500N P=0.253N |P=0.578N P=0.247 P=0.059 P=0.500 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/44 (5%) 3/48 (6%) 0/50 (0%) 0/47 (0%) |0/47 (0%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/36.11 3/41.84 0/42.10 0/23.65 |0/41.03 1/41.49 0/45.05 0/42.76 |
|POLY-3 PERCENT (g) | 5.5% 7.2% 0.0% 0.0% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 2/23 (9%) 2/27 (7%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 649 --- --- |--- 717 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.488N P=0.566 P=0.203N P=1.000 |P=0.616N P=0.518 (e) (e) |
|POLY 3 | P=0.145N P=0.567 P=0.203N P=0.342N |P=0.612N P=0.502 (e) (e) |
|POLY 1.5 | P=0.130N P=0.558 P=0.204N P=0.277N |P=0.609N P=0.504 (e) (e) |
|POLY 6 | P=0.136N P=0.579 P=0.204N P=0.460N |P=0.616N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.274N P=0.573 (e) (e) |P=0.606N P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.106N P=0.542 P=0.216N P=0.231N |P=0.607N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/44 (0%) 4/48 (8%) 0/50 (0%) 2/47 (4%) |0/47 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/36.11 4/41.62 0/42.10 2/24.37 |0/41.03 0/41.44 0/45.05 0/42.76 |
|POLY-3 PERCENT (g) | 0.0% 9.6% 0.0% 8.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 3/27 (11%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 709 --- 564 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * P=0.092 (e) P=0.032 * |(e) (e) (e) (e) |
|POLY 3 | P=0.409 P=0.079 (e) P=0.163 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.469 P=0.077 (e) P=0.203 |(e) (e) (e) (e) |
|POLY 6 | P=0.350 P=0.082 (e) P=0.114 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.252 P=0.090 (e) P=0.210 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.546 P=0.070 (e) P=0.264 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/44 (5%) 7/48 (15%) 0/50 (0%) 2/47 (4%) |0/47 (0%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/36.11 7/41.92 0/42.10 2/24.37 |0/41.03 1/41.49 0/45.05 0/42.76 |
|POLY-3 PERCENT (g) | 5.5% 16.7% 0.0% 8.2% |0.0% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 2/23 (9%) 5/27 (19%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 649 --- 564 |--- 717 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.111 P=0.127 P=0.203N P=0.032 * |P=0.616N P=0.518 (e) (e) |
|POLY 3 | P=0.379N P=0.117 P=0.203N P=0.545 |P=0.612N P=0.502 (e) (e) |
|POLY 1.5 | P=0.327N P=0.112 P=0.204N P=0.635 |P=0.609N P=0.504 (e) (e) |
|POLY 6 | P=0.395N P=0.125 P=0.204N P=0.394 |P=0.616N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.614 P=0.125 (e) P=0.363 |P=0.606N P=0.500 (e) (e) |
|COCH-ARM / FISHERS | P=0.259N P=0.101 P=0.216N P=0.666N |P=0.607N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Lipoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/50 (0%) 2/50 (4%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/47 (0%) |
|POLY-3 RATE (b) | 0/37.91 0/42.41 2/42.31 0/24.20 |0/42.42 0/42.07 0/45.12 0/42.03 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- 674 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.710 (e) P=0.264 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.630 (e) P=0.262 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.730N (e) P=0.259 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.354 (e) P=0.264 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.793 (e) P=0.261 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.655N (e) P=0.263 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/49 (6%) 0/50 (0%) 1/49 (2%) |0/50 (0%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/40.21 3/42.45 0/42.10 1/25.37 |0/43.16 2/43.04 0/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 5.0% 7.1% 0.0% 3.9% |0.0% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 2/31 (7%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 645 586 --- 438 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.661 P=0.555 P=0.225N P=0.589 |P=0.390N P=0.245 (e) (e) |
|POLY 3 | P=0.422N P=0.525 P=0.227N P=0.652N |P=0.396N P=0.236 (e) (e) |
|POLY 1.5 | P=0.393N P=0.512 P=0.230N P=0.581N |P=0.394N P=0.237 (e) (e) |
|POLY 6 | P=0.408N P=0.543 P=0.224N P=0.659 |P=0.400N P=0.235 (e) (e) |
|LOGISTIC REGRESSION| P=0.299N P=0.503 P=0.230N P=0.469N |(e) P=0.245 (e) (e) |
|COCH-ARM / FISHERS | P=0.341N P=0.490 P=0.247N P=0.508N |P=0.394N P=0.247 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/49 (4%) 2/50 (4%) 1/49 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/39.90 2/42.06 2/42.59 1/24.98 |1/43.16 1/43.04 1/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 2.5% 4.8% 4.7% 4.0% |2.3% 2.3% 2.2% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 711 583 617 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251 P=0.577 P=0.553 P=0.310 |P=0.331N P=0.755N P=0.708N P=0.493N |
|POLY 3 | P=0.582 P=0.518 P=0.523 P=0.647 |P=0.336N P=0.760 P=0.747N P=0.500N |
|POLY 1.5 | P=0.608N P=0.509 P=0.515 P=0.705 |P=0.335N P=0.760N P=0.752N P=0.500N |
|POLY 6 | P=0.424 P=0.533 P=0.532 P=0.542 |P=0.338N P=0.759 P=0.741N P=0.501N |
|LOGISTIC REGRESSION| P=0.647 P=0.560 P=0.507 P=0.596 |P=0.331N P=0.755N P=0.708N (e) |
|COCH-ARM / FISHERS | P=0.518N P=0.492 P=0.500 P=0.747 |P=0.337N P=0.753N P=0.753N P=0.505N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/49 (10%) 2/50 (4%) 2/49 (4%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 3/40.21 5/42.54 2/42.59 2/25.76 |1/43.16 3/43.04 1/45.88 0/43.15 |
|POLY-3 PERCENT (g) | 7.5% 11.8% 4.7% 7.8% |2.3% 7.0% 2.2% 0.0% |
|TERMINAL (d) | 2/23 (9%) 2/27 (7%) 1/27 (4%) 0/0 (0%) |1/30 (3%) 3/31 (10%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 645 586 583 438 |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277 P=0.448 P=0.446N P=0.219 |P=0.169N P=0.316 P=0.708N P=0.493N |
|POLY 3 | P=0.474N P=0.387 P=0.474N P=0.660 |P=0.175N P=0.304 P=0.747N P=0.500N |
|POLY 1.5 | P=0.392N P=0.371 P=0.482N P=0.602N |P=0.175N P=0.306 P=0.752N P=0.500N |
|POLY 6 | P=0.554N P=0.411 P=0.465N P=0.499 |P=0.178N P=0.302 P=0.741N P=0.501N |
|LOGISTIC REGRESSION| P=0.356N P=0.381 P=0.488N P=0.590N |P=0.169N P=0.316 P=0.708N (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.346 P=0.500N P=0.510N |P=0.177N P=0.309 P=0.753N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |4/43.75 4/43.04 2/45.88 2/43.85 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |9.1% 9.3% 4.4% 4.6% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |3/30 (10%) 4/31 (13%) 2/38 (5%) 1/31 (3%) |
|FIRST INCIDENCE | --- --- --- --- |542 729 (T) 729 (T) 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.272N P=0.627N P=0.248N P=0.330N |
|POLY 3 | (e) (e) (e) (e) |P=0.273N P=0.635 P=0.315N P=0.336N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.271N P=0.640 P=0.323N P=0.333N |
|POLY 6 | (e) (e) (e) (e) |P=0.279N P=0.628 P=0.306N P=0.342N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.269N P=0.643 P=0.329N P=0.335N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.272N P=0.643N P=0.339N P=0.339N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 1/50 (2%) 0/50 (0%) |36/50 (72%) 35/50 (70%) 30/50 (60%) 22/50 (44%) |
|POLY-3 RATE (b) | 1/39.90 7/42.41 1/42.69 0/25.17 |36/46.35 35/44.40 30/46.63 22/44.99 |
|POLY-3 PERCENT (g) | 2.5% 16.5% 2.3% 0.0% |77.7% 78.8% 64.3% 48.9% |
|TERMINAL (d) | 1/23 (4%) 7/27 (26%) 0/27 (0%) 0/0 (0%) |25/30 (83%) 27/31 (87%) 26/38 (68%) 14/31 (45%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 543 --- |247 585 597 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413N P=0.047 * P=0.735N P=1.000 |P=0.003N** P=0.444N P=0.013N* P=0.010N* |
|POLY 3 | P=0.106N P=0.036 * P=0.746N P=0.588N |P<0.001N** P=0.551 P=0.107N P=0.002N** |
|POLY 1.5 | P=0.076N P=0.034 * P=0.751N P=0.544N |P<0.001N** P=0.593N P=0.122N P=0.002N** |
|POLY 6 | P=0.143N P=0.039 * P=0.740N P=0.654N |P<0.001N** P=0.476 P=0.096N P=0.003N** |
|LOGISTIC REGRESSION| P=0.206N P=0.047 * P=0.746 (e) |P<0.001N** P=0.512N P=0.073N P=0.003N** |
|COCH-ARM / FISHERS | P=0.053N P=0.030 * P=0.753N P=0.500N |P<0.001N** P=0.500N P=0.146N P=0.004N** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 1/50 (2%) 0/50 (0%) |37/50 (74%) 37/50 (74%) 30/50 (60%) 23/50 (46%) |
|POLY-3 RATE (b) | 1/39.90 7/42.41 1/42.69 0/25.17 |37/46.94 37/44.40 30/46.63 23/44.99 |
|POLY-3 PERCENT (g) | 2.5% 16.5% 2.3% 0.0% |78.8% 83.3% 64.3% 51.1% |
|TERMINAL (d) | 1/23 (4%) 7/27 (26%) 0/27 (0%) 0/0 (0%) |25/30 (83%) 29/31 (94%) 26/38 (68%) 15/31 (48%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 543 --- |247 585 597 626 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413N P=0.047 * P=0.735N P=1.000N |P=0.003N** P=0.518N P=0.008N** P=0.010N* |
|POLY 3 | P=0.106N P=0.036 * P=0.746N P=0.588N |P<0.001N** P=0.379 P=0.083N P=0.003N** |
|POLY 1.5 | P=0.076N P=0.034 * P=0.751N P=0.544N |P<0.001N** P=0.473 P=0.090N P=0.003N** |
|POLY 6 | P=0.143N P=0.039 * P=0.740N P=0.654N |P<0.001N** P=0.261 P=0.081N P=0.004N** |
|LOGISTIC REGRESSION| P=0.206N P=0.047 * P=0.746 (e) |P<0.001N** P=0.591 P=0.054N P=0.002N** |
|COCH-ARM / FISHERS | P=0.053N P=0.030 * P=0.753N P=0.500N |P<0.001N** P=0.590N P=0.101N P=0.004N** |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |0/43.16 0/43.04 1/46.21 2/44.41 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.2% 4.5% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 638 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.098 (e) P=0.519 P=0.238 |
|POLY 3 | (e) (e) (e) (e) |P=0.102 (e) P=0.514 P=0.243 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.101 (e) P=0.508 P=0.242 |
|POLY 6 | (e) (e) (e) (e) |P=0.102 (e) P=0.520 P=0.243 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.071 (e) P=0.475 P=0.180 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.097 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Mixed Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/44 (5%) 0/49 (0%) 0/50 (0%) 0/47 (0%) |0/47 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 2/36.72 0/41.98 0/42.10 0/23.65 |0/41.03 0/41.44 0/45.05 0/42.76 |
|POLY-3 PERCENT (g) | 5.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 584 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.504N P=0.214N P=0.216N P=0.578N |(e) (e) (e) (e) |
|POLY 3 | P=0.309N P=0.207N P=0.207N P=0.346N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.319N P=0.208N P=0.206N P=0.280N |(e) (e) (e) (e) |
|POLY 6 | P=0.238N P=0.207N P=0.210N P=0.466N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.268N P=0.228N P=0.222N P=0.236N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.305N P=0.221N P=0.216N P=0.231N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/45 (2%) 2/48 (4%) 0/49 (0%) 0/50 (0%) |0/49 (0%) 0/47 (0%) 0/47 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/36.39 2/40.78 0/41.10 0/25.17 |0/42.42 0/40.75 0/43.81 0/43.15 |
|POLY-3 PERCENT (g) | 2.8% 4.9% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/26 (4%) 0/26 (0%) 0/0 (0%) |0/30 (0%) 0/30 (0%) 0/36 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 649 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.728N P=0.548 P=0.467N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.270N P=0.540 P=0.476N P=0.571N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.255N P=0.533 P=0.478N P=0.525N |(e) (e) (e) (e) |
|POLY 6 | P=0.249N P=0.551 P=0.474N P=0.641N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.401N P=0.540 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.226N P=0.524 P=0.479N P=0.474N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/47 (32%) 21/49 (43%) 18/50 (36%) 7/49 (14%) |20/48 (42%) 18/45 (40%) 20/50 (40%) 13/47 (28%) |
|POLY-3 RATE (b) | 15/40.01 21/44.40 18/45.08 7/27.83 |20/43.11 18/41.74 20/46.97 13/43.05 |
|POLY-3 PERCENT (g) | 37.5% 47.3% 39.9% 25.2% |46.4% 43.1% 42.6% 30.2% |
|TERMINAL (d) | 9/23 (39%) 12/27 (44%) 9/27 (33%) 0/0 (0%) |15/30 (50%) 10/31 (32%) 16/38 (42%) 9/31 (29%) |
|FIRST INCIDENCE | 582 417 562 431 |413 542 598 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * P=0.342 P=0.504 P=0.002 ** |P=0.099N P=0.402N P=0.273N P=0.100N |
|POLY 3 | P=0.100N P=0.242 P=0.497 P=0.209N |P=0.068N P=0.466N P=0.439N P=0.089N |
|POLY 1.5 | P=0.024N* P=0.221 P=0.468 P=0.091N |P=0.068N P=0.487N P=0.470N P=0.094N |
|POLY 6 | P=0.367N P=0.272 P=0.532 P=0.535N |P=0.072N P=0.430N P=0.401N P=0.084N |
|LOGISTIC REGRESSION| P=0.058N P=0.214 P=0.441 P=0.451N |P=0.067N P=0.509N P=0.443N P=0.094N |
|COCH-ARM / FISHERS | P=0.003N** P=0.185 P=0.417 P=0.034N* |P=0.076N P=0.519N P=0.515N P=0.111N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/47 (32%) 21/49 (43%) 19/50 (38%) 7/49 (14%) |21/48 (44%) 18/45 (40%) 21/50 (42%) 13/47 (28%) |
|POLY-3 RATE (b) | 15/40.01 21/44.40 19/45.67 7/27.83 |21/43.69 18/41.74 21/47.42 13/43.05 |
|POLY-3 PERCENT (g) | 37.5% 47.3% 41.6% 25.2% |48.1% 43.1% 44.3% 30.2% |
|TERMINAL (d) | 9/23 (39%) 12/27 (44%) 9/27 (33%) 0/0 (0%) |15/30 (50%) 10/31 (32%) 16/38 (42%) 9/31 (29%) |
|FIRST INCIDENCE | 582 417 543 431 |413 542 597 577 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.014 * P=0.342 P=0.431 P=0.002 ** |P=0.079N P=0.332N P=0.273N P=0.072N |
|POLY 3 | P=0.104N P=0.242 P=0.433 P=0.209N |P=0.054N P=0.404N P=0.440N P=0.065N |
|POLY 1.5 | P=0.025N* P=0.221 P=0.397 P=0.091N |P=0.053N P=0.417N P=0.469N P=0.067N |
|POLY 6 | P=0.384N P=0.272 P=0.477 P=0.535N |P=0.060N P=0.378N P=0.402N P=0.064N |
|LOGISTIC REGRESSION| P=0.043N* P=0.214 P=0.356 P=0.451N |P=0.052N P=0.430N P=0.471N P=0.067N |
|COCH-ARM / FISHERS | P=0.003N** P=0.185 P=0.340 P=0.034N* |P=0.057N P=0.438N P=0.512N P=0.077N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 RATE (b) | 1/38.81 1/42.41 2/42.10 0/25.17 | |
|POLY-3 PERCENT (g) | 2.6% 2.4% 4.8% 0.0% | |
|TERMINAL (d) | 0/23 (0%) 1/27 (4%) 2/27 (7%) 0/0 (0%) | |
|FIRST INCIDENCE | 676 729 (T) 729 (T) --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.860 P=0.726N P=0.541 P=0.970N | |
|POLY 3 | P=0.471N P=0.741N P=0.528 P=0.582N | |
|POLY 1.5 | P=0.394N P=0.744N P=0.525 P=0.537N | |
|POLY 6 | P=0.588N P=0.736N P=0.530 P=0.651N | |
|LOGISTIC REGRESSION| P=0.811N P=0.741N P=0.535 P=0.722N | |
|COCH-ARM / FISHERS | P=0.312N P=0.742N P=0.515 P=0.490N | |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 3/50 (6%) 0/50 (0%) |0/49 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/38.94 1/41.82 3/42.48 0/25.17 |0/42.42 1/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 7.1% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 1/27 (4%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 614 627 --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.664 P=0.510 P=0.148 (e) |P=0.612N P=0.507 (e) (e) |
|POLY 3 | P=0.646N P=0.514 P=0.134 (e) |P=0.611N P=0.503 (e) (e) |
|POLY 1.5 | P=0.539N P=0.509 P=0.130 (e) |P=0.608N P=0.504 (e) (e) |
|POLY 6 | P=0.388 P=0.522 P=0.139 (e) |P=0.615N P=0.501 (e) (e) |
|LOGISTIC REGRESSION| P=0.552N P=0.470 P=0.132 (e) |(e) P=0.507 (e) (e) |
|COCH-ARM / FISHERS | P=0.431N P=0.500 P=0.125 (e) |P=0.607N P=0.505 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/38.94 2/42.56 0/42.10 0/25.17 |0/42.42 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 505 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.250 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.416N P=0.257 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.407N P=0.250 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.387N P=0.268 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.285N P=0.146 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.386N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/39.90 5/42.97 4/42.36 0/25.17 |0/43.16 1/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 2.5% 11.6% 9.4% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 4/27 (15%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 554 674 --- |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.759 P=0.134 P=0.231 P=1.000N |P=0.612N P=0.507 (e) (e) |
|POLY 3 | P=0.262N P=0.118 P=0.196 P=0.588N |P=0.612N P=0.499 (e) (e) |
|POLY 1.5 | P=0.167N P=0.112 P=0.191 P=0.544N |P=0.610N P=0.500 (e) (e) |
|POLY 6 | P=0.453N P=0.128 P=0.203 P=0.654N |P=0.616N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.395N P=0.117 P=0.205 (e) |(e) P=0.507 (e) (e) |
|COCH-ARM / FISHERS | P=0.097N P=0.102 P=0.181 P=0.500N |P=0.608N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 3/50 (6%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/40.71 5/42.95 3/42.15 1/25.33 |1/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 14.7% 11.6% 7.1% 4.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/23 (13%) 4/27 (15%) 2/27 (7%) 0/0 (0%) |1/30 (3%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 569 564 718 690 |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.680 P=0.409N P=0.180N P=0.481 |P=0.550N P=0.493N P=0.453N P=0.493N |
|POLY 3 | P=0.143N P=0.462N P=0.223N P=0.175N |P=0.551N P=0.501N P=0.488N P=0.498N |
|POLY 1.5 | P=0.091N P=0.475N P=0.228N P=0.102N |P=0.550N P=0.500N P=0.492N P=0.497N |
|POLY 6 | P=0.218N P=0.444N P=0.220N P=0.361N |P=0.553N P=0.502N P=0.483N P=0.500N |
|LOGISTIC REGRESSION| P=0.242N P=0.467N P=0.212N P=0.450N |P=0.550N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047N* P=0.500N P=0.243N P=0.056N |P=0.547N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 7/50 (14%) 1/50 (2%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 9/41.54 5/42.95 7/42.15 1/25.33 |1/43.16 2/43.21 2/46.12 0/43.66 |
|POLY-3 PERCENT (g) | 21.7% 11.6% 16.6% 4.0% |2.3% 4.6% 4.3% 0.0% |
|TERMINAL (d) | 3/23 (13%) 4/27 (15%) 6/27 (22%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 511 564 718 690 |729 (T) 683 665 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.627 P=0.138N P=0.283N P=0.717 |P=0.237N P=0.498 P=0.566 P=0.493N |
|POLY 3 | P=0.107N P=0.171N P=0.378N P=0.058N |P=0.232N P=0.500 P=0.523 P=0.498N |
|POLY 1.5 | P=0.047N* P=0.177N P=0.378N P=0.023N* |P=0.231N P=0.501 P=0.514 P=0.497N |
|POLY 6 | P=0.258N P=0.161N P=0.385N P=0.205N |P=0.237N P=0.500 P=0.534 P=0.500N |
|LOGISTIC REGRESSION| P=0.136N P=0.180N P=0.348N P=0.068N |P=0.231N P=0.498 P=0.516 (e) |
|COCH-ARM / FISHERS | P=0.016N* P=0.194N P=0.393N P=0.008N** |P=0.233N P=0.500 P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/39.90 3/42.97 4/42.36 0/25.17 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 2.5% 7.0% 9.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 554 674 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.704 P=0.347 P=0.231 P=1.000 |(e) (e) (e) (e) |
|POLY 3 | P=0.378N P=0.332 P=0.196 P=0.588N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.264N P=0.322 P=0.191 P=0.544N |(e) (e) (e) (e) |
|POLY 6 | P=0.578 P=0.347 P=0.203 P=0.654N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.448N P=0.315 P=0.205 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.168N P=0.309 P=0.181 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 5/50 (10%) 0/50 (0%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/40.73 0/42.41 5/42.15 0/25.17 |0/43.16 2/43.21 2/46.12 0/43.66 |
|POLY-3 PERCENT (g) | 7.4% 0.0% 11.9% 0.0% |0.0% 4.6% 4.3% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 4/27 (15%) 0/0 (0%) |0/30 (0%) 1/31 (3%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | 511 --- 718 --- |--- 683 665 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.658 P=0.101N P=0.444 P=0.537N |P=0.352N P=0.234 P=0.277 (e) |
|POLY 3 | P=0.425N P=0.111N P=0.374 P=0.228N |P=0.343N P=0.237 P=0.252 (e) |
|POLY 1.5 | P=0.293N P=0.114N P=0.371 P=0.166N |P=0.342N P=0.238 P=0.246 (e) |
|POLY 6 | P=0.504 P=0.107N P=0.377 P=0.357N |P=0.348N P=0.237 P=0.259 (e) |
|LOGISTIC REGRESSION| P=0.433N P=0.130N P=0.382 P=0.127N |P=0.344N P=0.237 P=0.239 (e) |
|COCH-ARM / FISHERS | P=0.183N P=0.121N P=0.357 P=0.121N |P=0.346N P=0.247 P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.90 2/42.41 0/42.10 0/25.17 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 2/27 (7%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.970N P=0.274 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.423N P=0.251 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.413N P=0.246 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.395N P=0.258 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.274 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/39.90 5/42.97 4/42.36 0/25.17 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 2.5% 11.6% 9.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 4/27 (15%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 729 (T) 554 674 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.759 P=0.134 P=0.231 P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.262N P=0.118 P=0.196 P=0.588N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.167N P=0.112 P=0.191 P=0.544N |(e) (e) (e) (e) |
|POLY 6 | P=0.453N P=0.128 P=0.203 P=0.654N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.395N P=0.117 P=0.205 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097N P=0.102 P=0.181 P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |2/44.12 1/43.04 0/45.88 1/43.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | --- --- --- --- |247 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.566N P=0.492N P=0.214N P=0.492N |
|POLY 3 | (e) (e) (e) (e) |P=0.566N P=0.509N P=0.229N P=0.504N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.563N P=0.506N P=0.233N P=0.501N |
|POLY 6 | (e) (e) (e) (e) |P=0.570N P=0.511N P=0.223N P=0.508N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.631N P=0.549N P=0.308N P=0.647N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.563N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |2/44.12 1/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- --- |247 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.211N P=0.492N P=0.214N P=0.236N |
|POLY 3 | (e) (e) (e) (e) |P=0.214N P=0.509N P=0.229N P=0.239N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.213N P=0.506N P=0.233N P=0.238N |
|POLY 6 | (e) (e) (e) (e) |P=0.217N P=0.511N P=0.223N P=0.242N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.266N P=0.549N P=0.308N P=0.414N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.212N P=0.500N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 45/50 (90%) 43/50 (86%) 48/50 (96%) | |
|POLY-3 RATE (b) | 45/46.66 45/47.76 43/46.59 48/48.38 | |
|POLY-3 PERCENT (g) | 96.5% 94.2% 92.3% 99.2% | |
|TERMINAL (d) | 23/23 (100%) 25/27 (93%) 27/27 (100%) 0/0 (0%) | |
|FIRST INCIDENCE | 511 528 562 398 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.221N P=0.151N P<0.001 ** | |
|POLY 3 | P=0.145 P=0.488N P=0.297N P=0.385 | |
|POLY 1.5 | P=0.140 P=0.517N P=0.278N P=0.310 | |
|POLY 6 | P=0.168 P=0.474N P=0.477N P=0.496 | |
|LOGISTIC REGRESSION| P=0.002 ** P=0.429N P=0.101N P=0.038 * | |
|COCH-ARM / FISHERS | P=0.139 P=0.630N P=0.380N P=0.218 | |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/42 (10%) 4/47 (9%) 6/48 (13%) 0/47 (0%) |6/45 (13%) 8/45 (18%) 3/46 (7%) 3/46 (7%) |
|POLY-3 RATE (b) | 4/36.69 4/40.42 6/42.61 0/23.82 |6/39.85 8/39.85 3/44.27 3/41.30 |
|POLY-3 PERCENT (g) | 10.9% 9.9% 14.1% 0.0% |15.1% 20.1% 6.8% 7.3% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 3/27 (11%) 0/0 (0%) |5/30 (17%) 6/31 (19%) 2/38 (5%) 1/31 (3%) |
|FIRST INCIDENCE | 568 649 562 --- |626 721 598 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.570N P=0.422 P=0.461N |P=0.129N P=0.411 P=0.157N P=0.237N |
|POLY 3 | P=0.175N P=0.590N P=0.466 P=0.138N |P=0.117N P=0.385 P=0.192N P=0.223N |
|POLY 1.5 | P=0.090N P=0.587N P=0.463 P=0.083N |P=0.115N P=0.389 P=0.204N P=0.222N |
|POLY 6 | P=0.376N P=0.589N P=0.467 P=0.275N |P=0.122N P=0.377 P=0.180N P=0.228N |
|LOGISTIC REGRESSION| P=0.043N* P=0.581N P=0.427 P=0.054N |P=0.115N P=0.387 P=0.222N P=0.223N |
|COCH-ARM / FISHERS | P=0.036N* P=0.578N P=0.458 P=0.046N* |P=0.117N P=0.386 P=0.231N P=0.231N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/42 (5%) 3/47 (6%) 2/48 (4%) 0/47 (0%) |1/45 (2%) 1/45 (2%) 2/46 (4%) 1/46 (2%) |
|POLY-3 RATE (b) | 2/36.20 3/40.10 2/41.39 0/23.82 |1/39.48 1/39.80 2/43.82 1/41.10 |
|POLY-3 PERCENT (g) | 5.5% 7.5% 4.8% 0.0% |2.5% 2.5% 4.6% 2.4% |
|TERMINAL (d) | 1/23 (4%) 2/27 (7%) 1/27 (4%) 0/0 (0%) |1/30 (3%) 1/31 (3%) 2/38 (5%) 1/31 (3%) |
|FIRST INCIDENCE | 569 717 726 --- |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.617N P=0.566 P=0.637N P=0.574N |P=0.639N P=0.755N P=0.583 P=0.755N |
|POLY 3 | P=0.222N P=0.547 P=0.646N P=0.341N |P=0.622N P=0.759N P=0.536 P=0.752N |
|POLY 1.5 | P=0.164N P=0.548 P=0.644N P=0.274N |P=0.620N P=0.759N P=0.527 P=0.752N |
|POLY 6 | P=0.307N P=0.551 P=0.649N P=0.460N |P=0.626N P=0.760N P=0.546 P=0.754N |
|LOGISTIC REGRESSION| P=0.295N P=0.552 P=0.646N P=0.233N |P=0.639N P=0.755N P=0.583 P=0.755N |
|COCH-ARM / FISHERS | P=0.106N P=0.554 P=0.640N P=0.220N |P=0.625N P=0.753N P=0.508 P=0.747N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/42 (14%) 7/47 (15%) 8/48 (17%) 0/47 (0%) |7/45 (16%) 9/45 (20%) 5/46 (11%) 4/46 (9%) |
|POLY-3 RATE (b) | 6/37.21 7/40.47 8/42.62 0/23.82 |7/39.85 9/39.85 5/44.27 4/41.30 |
|POLY-3 PERCENT (g) | 16.1% 17.3% 18.8% 0.0% |17.6% 22.6% 11.3% 9.7% |
|TERMINAL (d) | 2/23 (9%) 4/27 (15%) 4/27 (15%) 0/0 (0%) |6/30 (20%) 7/31 (23%) 4/38 (11%) 2/31 (7%) |
|FIRST INCIDENCE | 568 649 562 --- |626 721 598 681 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.426N P=0.598 P=0.466 P=0.277N |P=0.143N P=0.419 P=0.244N P=0.252N |
|POLY 3 | P=0.077N P=0.566 P=0.494 P=0.059N |P=0.128N P=0.390 P=0.307N P=0.238N |
|POLY 1.5 | P=0.027N* P=0.573 P=0.496 P=0.026N* |P=0.126N P=0.395 P=0.325N P=0.238N |
|POLY 6 | P=0.246N P=0.563 P=0.489 P=0.176N |P=0.133N P=0.382 P=0.289N P=0.244N |
|LOGISTIC REGRESSION| P=0.017N* P=0.587 P=0.471 P=0.010N* |P=0.127N P=0.392 P=0.330N P=0.240N |
|COCH-ARM / FISHERS | P=0.007N** P=0.588 P=0.494 P=0.009N** |P=0.129N P=0.392 P=0.363N P=0.248N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 12/50 (24%) 6/50 (12%) 12/50 (24%) |
|POLY-3 RATE (b) | |8/43.19 12/44.68 6/46.50 12/45.31 |
|POLY-3 PERCENT (g) | |18.5% 26.9% 12.9% 26.5% |
|TERMINAL (d) | |6/30 (20%) 7/31 (23%) 4/38 (11%) 7/31 (23%) |
|FIRST INCIDENCE | |724 585 600 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.258 P=0.256 P=0.245N P=0.259 |
|POLY 3 | |P=0.281 P=0.249 P=0.330N P=0.260 |
|POLY 1.5 | |P=0.279 P=0.240 P=0.352N P=0.251 |
|POLY 6 | |P=0.277 P=0.263 P=0.303N P=0.267 |
|LOGISTIC REGRESSION| |P=0.267 P=0.223 P=0.327N P=0.234 |
|COCH-ARM / FISHERS | |P=0.262 P=0.227 P=0.387N P=0.227 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/43.16 0/43.04 2/46.31 0/43.66 |
|POLY-3 PERCENT (g) | |2.3% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |1/30 (3%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | |729 (T) --- 604 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.441N P=0.493N P=0.562 P=0.493N |
|POLY 3 | |P=0.432N P=0.501N P=0.524 P=0.498N |
|POLY 1.5 | |P=0.432N P=0.500N P=0.515 P=0.497N |
|POLY 6 | |P=0.435N P=0.502N P=0.536 P=0.500N |
|LOGISTIC REGRESSION| |P=0.437N (e) P=0.495 (e) |
|COCH-ARM / FISHERS | |P=0.437N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |9/50 (18%) 12/50 (24%) 8/50 (16%) 12/50 (24%) |
|POLY-3 RATE (b) | |9/43.19 12/44.68 8/46.93 12/45.31 |
|POLY-3 PERCENT (g) | |20.8% 26.9% 17.1% 26.5% |
|TERMINAL (d) | |7/30 (23%) 7/31 (23%) 5/38 (13%) 7/31 (23%) |
|FIRST INCIDENCE | |724 585 600 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.336 P=0.342 P=0.328N P=0.346 |
|POLY 3 | |P=0.367 P=0.340 P=0.425N P=0.354 |
|POLY 1.5 | |P=0.364 P=0.330 P=0.455N P=0.342 |
|POLY 6 | |P=0.362 P=0.358 P=0.388N P=0.363 |
|LOGISTIC REGRESSION| |P=0.348 P=0.307 P=0.448N P=0.320 |
|COCH-ARM / FISHERS | |P=0.343 P=0.312 P=0.500N P=0.312 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/41.42 2/43.08 1/42.17 1/25.96 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 7.2% 4.6% 2.4% 3.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 376 558 712 438 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.601N P=0.460N P=0.272N P=0.533N |(e) (e) (e) (e) |
|POLY 3 | P=0.423N P=0.482N P=0.298N P=0.484N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.371N P=0.489N P=0.300N P=0.392N |(e) (e) (e) (e) |
|POLY 6 | P=0.456N P=0.470N P=0.297N P=0.632N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.147N P=0.615N P=0.383N P=0.180N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.299N P=0.500N P=0.309N P=0.309N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/39.90 1/42.42 0/42.10 0/25.17 |0/43.16 0/43.04 0/45.88 2/44.11 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 1/31 (3%) |
|FIRST INCIDENCE | --- 726 --- --- |--- --- --- 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.999N P=0.546 (e) (e) |P=0.040 * (e) (e) P=0.246 |
|POLY 3 | P=0.605N P=0.512 (e) (e) |P=0.042 * (e) (e) P=0.242 |
|POLY 1.5 | P=0.614N P=0.508 (e) (e) |P=0.042 * (e) (e) P=0.242 |
|POLY 6 | P=0.541N P=0.519 (e) (e) |P=0.042 * (e) (e) P=0.241 |
|LOGISTIC REGRESSION| P=0.995N P=0.543 (e) (e) |P=0.038 * (e) (e) P=0.224 |
|COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.042 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/39.90 0/42.41 0/42.10 0/25.17 |0/43.16 0/43.04 2/46.32 0/43.66 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.3% 0.0% |
|TERMINAL (d) | 0/23 (0%) 0/27 (0%) 0/27 (0%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 1/38 (3%) 0/31 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 600 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.659N (e) P=0.276 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.646N (e) P=0.253 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.647N (e) P=0.247 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.649N (e) P=0.261 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.662N (e) P=0.220 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.652N (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 20/50 (40%) 22/50 (44%) 5/50 (10%) |10/50 (20%) 10/50 (20%) 4/50 (8%) 13/50 (26%) |
|POLY-3 RATE (b) | 16/42.81 20/44.92 22/44.59 5/27.46 |10/44.54 10/46.53 4/47.17 13/46.05 |
|POLY-3 PERCENT (g) | 37.4% 44.5% 49.3% 18.2% |22.5% 21.5% 8.5% 28.2% |
|TERMINAL (d) | 6/23 (26%) 8/27 (30%) 12/27 (44%) 0/0 (0%) |5/30 (17%) 4/31 (13%) 2/38 (5%) 4/31 (13%) |
|FIRST INCIDENCE | 564 550 584 408 |543 417 295 597 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.467 P=0.307 P=0.154 |P=0.175 P=0.577N P=0.046N* P=0.335 |
|POLY 3 | P=0.055N P=0.320 P=0.176 P=0.075N |P=0.166 P=0.556N P=0.056N P=0.348 |
|POLY 1.5 | P=0.007N** P=0.301 P=0.171 P=0.022N* |P=0.167 P=0.568N P=0.061N P=0.341 |
|POLY 6 | P=0.384N P=0.354 P=0.179 P=0.320N |P=0.166 P=0.548N P=0.052N P=0.356 |
|LOGISTIC REGRESSION| P=0.022N* P=0.305 P=0.184 P=0.042N* |P=0.131 P=0.590 P=0.095N P=0.310 |
|COCH-ARM / FISHERS | P<0.001N** P=0.266 P=0.151 P=0.006N** |P=0.168 P=0.598N P=0.074N P=0.318 |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/41.07 2/43.51 2/42.10 2/25.99 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 14.6% 4.6% 4.8% 7.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/23 (9%) 0/27 (0%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 569 554 729 (T) 610 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.120N P=0.111N P=0.396 |(e) (e) (e) (e) |
|POLY 3 | P=0.412N P=0.113N P=0.123N P=0.328N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.338N P=0.120N P=0.125N P=0.217N |(e) (e) (e) (e) |
|POLY 6 | P=0.473N P=0.105N P=0.123N P=0.546N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.241N P=0.151N P=0.123N P=0.315N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242N P=0.134N P=0.134N P=0.134N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/41.07 2/43.51 2/42.10 2/25.99 |0/43.16 0/43.04 0/45.88 0/43.66 |
|POLY-3 PERCENT (g) | 14.6% 4.6% 4.8% 7.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/23 (9%) 0/27 (0%) 2/27 (7%) 0/0 (0%) |0/30 (0%) 0/31 (0%) 0/38 (0%) 0/31 (0%) |
|FIRST INCIDENCE | 569 554 729 (T) 610 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.432 P=0.120N P=0.111N P=0.396 |(e) (e) (e) (e) |
|POLY 3 | P=0.412N P=0.113N P=0.123N P=0.328N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.338N P=0.120N P=0.125N P=0.217N |(e) (e) (e) (e) |
|POLY 6 | P=0.473N P=0.105N P=0.123N P=0.546N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.241N P=0.151N P=0.123N P=0.315N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.242N P=0.134N P=0.134N P=0.134N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 25
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 47/50 (94%) 49/50 (98%) 50/50 (100%) 49/50 (98%) |44/50 (88%) 45/50 (90%) 40/50 (80%) 36/50 (72%) |
|POLY-3 RATE (b) | 47/47.27 49/49.25 50/50.00 49/49.18 |44/47.54 45/47.12 40/47.71 36/46.69 |
|POLY-3 PERCENT (g) | 99.4% 99.5% 100.0% 99.6% |92.6% 95.5% 83.8% 77.1% |
|TERMINAL (d) | 23/23 (100%) 27/27 (100%) 27/27 (100%) 0/0 (0%) |30/30 (100%) 30/31 (97%) 33/38 (87%) 25/31 (81%) |
|FIRST INCIDENCE | 511 417 340 398 |247 542 597 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.306N P=0.405N P<0.001 ** |P=0.061N P=0.562 P=0.012N* P=0.080N |
|POLY 3 | P=0.993 P=0.999 P=1.000 P=1.000 |P=0.003N** P=0.417 P=0.137N P=0.021N* |
|POLY 1.5 | P=0.763 P=0.792 P=0.577 P=0.778 |P=0.004N** P=0.425 P=0.174N P=0.027N* |
|POLY 6 | P=1.000 P=1.000N P=1.000 P=1.000N |P=0.003N** P=0.507 P=0.095N P=0.019N* |
|LOGISTIC REGRESSION| P=0.376 P=0.895 P=0.274 P=0.980 |P=0.004N** P=0.516 P=0.104N P=0.022N* |
|COCH-ARM / FISHERS | P=0.409 P=0.309 P=0.121 P=0.309 |P=0.010N* P=0.500 P=0.207N P=0.039N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 34/50 (68%) 35/50 (70%) 13/50 (26%) |25/50 (50%) 24/50 (48%) 20/50 (40%) 21/50 (42%) |
|POLY-3 RATE (b) | 35/48.06 34/49.10 35/47.55 13/31.09 |25/46.20 24/47.47 20/49.30 21/47.92 |
|POLY-3 PERCENT (g) | 72.8% 69.2% 73.6% 41.8% |54.1% 50.6% 40.6% 43.8% |
|TERMINAL (d) | 12/23 (52%) 14/27 (52%) 18/27 (67%) 0/0 (0%) |15/30 (50%) 13/31 (42%) 12/38 (32%) 8/31 (26%) |
|FIRST INCIDENCE | 323 456 340 408 |540 417 295 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.287N P=0.344N P=0.044 * |P=0.326N P=0.468N P=0.085N P=0.294N |
|POLY 3 | P=0.004N** P=0.434N P=0.559 P=0.003N** |P=0.245N P=0.445N P=0.130N P=0.212N |
|POLY 1.5 | P<0.001N** P=0.455N P=0.587 P<0.001N** |P=0.253N P=0.458N P=0.154N P=0.229N |
|POLY 6 | P=0.193N P=0.405N P=0.505 P=0.127N |P=0.237N P=0.436N P=0.107N P=0.197N |
|LOGISTIC REGRESSION| P<0.001N** P=0.565N P=0.561 P<0.001N** |P=0.295N P=0.501N P=0.244N P=0.284N |
|COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.586N P<0.001N** |P=0.277N P=0.500N P=0.211N P=0.274N |
|=================================================================================================================================|
Date: 02/04/02 EXPERIMENT: 88031 TEST: 05 Page 26
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 0.25% 1.0% 4.0% |0.0% 0.25% 1.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|50/50 (100%) 49/50 (98%) 46/50 (92%) 46/50 (92%) |
|POLY-3 RATE (b) | 49/49.05 50/50.00 50/50.00 50/50.00 |50/50.00 49/49.20 46/50.00 46/49.51 |
|POLY-3 PERCENT (g) | 99.9% 100.0% 100.0% 100.0% |100.0% 99.6% 92.0% 92.9% |
|TERMINAL (d) | 23/23 (100%) 27/27 (100%) 27/27 (100%) 0/0 (0%) |30/30 (100%) 31/31 (100%) 34/38 (90%) 28/31 (90%) |
|FIRST INCIDENCE | 323 417 340 398 |247 417 295 533 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.261N P=0.299N P<0.001 ** |P=0.342N P=0.443N P=0.022N* P=0.274N |
|POLY 3 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.061N P=1.000N P=0.061N P=0.075N |
|POLY 1.5 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.058N P=0.891N P=0.061N P=0.067N |
|POLY 6 | P=1.000 P=1.000 P=1.000 P=1.000 |P=0.073N P=1.000N P=0.061N P=0.091N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.066N P=0.363N (e) P=0.063N |
|COCH-ARM / FISHERS | P=0.547 P=0.500 P=0.500 P=0.500 |P=0.069N P=0.500N P=0.059N P=0.059N |
|=================================================================================================================================|
(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).