TDMS Study 88031-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 06/26/02
EXPERIMENT: 88031 TEST: 06 TIME: 14:00:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: RYAN, MICHAEL CAS: 25265-71-8
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1, REVISION #3
REASONS FOR REMOVAL: 25022 Accidently Killed
25018 Dosing Accident
25019 Moribund Sacrifice
25020 Natural Death
25026 Other
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 06/26/02
EXPERIMENT: 88031 TEST: 06 TIME: 14:00:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: RYAN, MICHAEL CAS: 25265-71-8
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Medulla
Bone Marrow
Clitoral/Preputial Gland
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus DIPROPYLENE GLYCOL DATE: 06/26/02
EXPERIMENT: 88031 TEST: 06 TIME: 14:00:57
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED WATER NTP C#: C88031
PATHOLOGIST: RYAN, MICHAEL CAS: 25265-71-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DIPROPYLENE GLYCOL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
All Organs Benign Tumors
Malignant Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Hemangiosarcoma
===============================================================
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/43.93 0/45.14 0/41.99 |0/45.83 0/45.33 2/44.15 1/40.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 2.4% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/37 (0%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 693 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.220 (e) P=0.237 P=0.496 |
|POLY 3 | (e) (e) (e) (e) |P=0.203 (e) P=0.229 P=0.477 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.216 (e) P=0.231 P=0.485 |
|POLY 6 | (e) (e) (e) (e) |P=0.192 (e) P=0.228 P=0.471 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.337 (e) P=0.230 P=0.652 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.247 (e) P=0.242 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 4/50 (8%) 1/49 (2%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/45.94 3/44.17 4/45.14 1/41.99 |1/45.83 2/46.65 2/44.12 3/40.09 |
|POLY-3 PERCENT (g) | 4.4% 6.8% 8.9% 2.4% |2.2% 4.3% 4.5% 7.5% |
|TERMINAL (d) | 2/40 (5%) 2/39 (5%) 4/35 (11%) 1/34 (3%) |1/37 (3%) 1/38 (3%) 2/38 (5%) 3/33 (9%) |
|FIRST INCIDENCE | 729 (T) 710 729 (T) 729 (T) |728 (T) 641 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.451N P=0.489 P=0.277 P=0.557N |P=0.186 P=0.509 P=0.509 P=0.265 |
|POLY 3 | P=0.416N P=0.482 P=0.329 P=0.531N |P=0.184 P=0.506 P=0.487 P=0.259 |
|POLY 1.5 | P=0.402N P=0.486 P=0.334 P=0.522N |P=0.199 P=0.505 P=0.492 P=0.274 |
|POLY 6 | P=0.432N P=0.482 P=0.320 P=0.540N |P=0.172 P=0.507 P=0.483 P=0.246 |
|LOGISTIC REGRESSION| P=0.437N P=0.481 P=0.277 P=0.557N |P=0.175 P=0.498 P=0.509 P=0.265 |
|COCH-ARM / FISHERS | P=0.380N P=0.500 P=0.339 P=0.508N |P=0.232 P=0.500 P=0.500 P=0.309 |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 1/49 (2%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 3/45.94 3/44.17 4/45.14 1/41.99 |1/45.83 3/46.65 2/44.12 3/40.09 |
|POLY-3 PERCENT (g) | 6.5% 6.8% 8.9% 2.4% |2.2% 6.4% 4.5% 7.5% |
|TERMINAL (d) | 3/40 (8%) 2/39 (5%) 4/35 (11%) 1/34 (3%) |1/37 (3%) 2/38 (5%) 2/38 (5%) 3/33 (9%) |
|FIRST INCIDENCE | 729 (T) 710 729 (T) 729 (T) |728 (T) 641 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320N P=0.650 P=0.427 P=0.365N |P=0.248 P=0.316 P=0.509 P=0.265 |
|POLY 3 | P=0.285N P=0.644 P=0.490 P=0.338N |P=0.242 P=0.312 P=0.487 P=0.259 |
|POLY 1.5 | P=0.273N P=0.648 P=0.496 P=0.329N |P=0.261 P=0.311 P=0.492 P=0.274 |
|POLY 6 | P=0.297N P=0.644 P=0.480 P=0.347N |P=0.226 P=0.312 P=0.483 P=0.246 |
|LOGISTIC REGRESSION| P=0.307N P=0.645 P=0.427 P=0.365N |P=0.231 P=0.307 P=0.509 P=0.265 |
|COCH-ARM / FISHERS | P=0.255N P=0.661N P=0.500 P=0.316N |P=0.302 P=0.309 P=0.500 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.94 2/44.10 0/45.14 0/41.99 |0/45.83 1/46.33 1/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 0.0% 0.0% |0.0% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/39 (5%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 1/38 (3%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218N P=0.491 P=0.527N P=0.532N |P=0.622N P=0.505 P=0.505 (e) |
|POLY 3 | P=0.200N P=0.486 P=0.504N P=0.518N |P=0.629N P=0.502 P=0.492 (e) |
|POLY 1.5 | P=0.196N P=0.489 P=0.502N P=0.513N |P=0.618N P=0.502 P=0.496 (e) |
|POLY 6 | P=0.203N P=0.485 P=0.507N P=0.523N |P=0.639N P=0.502 P=0.490 (e) |
|LOGISTIC REGRESSION| P=0.218N P=0.491 (e) (e) |(e) P=0.505 P=0.505 (e) |
|COCH-ARM / FISHERS | P=0.191N P=0.500 P=0.500N P=0.505N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.94 2/44.10 3/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 6.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/39 (5%) 3/35 (9%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.491 P=0.258 P=0.532N |(e) (e) (e) (e) |
|POLY 3 | P=0.375N P=0.486 P=0.299 P=0.518N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.363N P=0.489 P=0.303 P=0.513N |(e) (e) (e) (e) |
|POLY 6 | P=0.387N P=0.485 P=0.292 P=0.523N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.396N P=0.491 P=0.258 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.344N P=0.500 P=0.309 P=0.505N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 0/49 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/45.94 2/44.10 3/45.14 0/41.99 |0/45.83 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 2.2% 4.5% 6.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/39 (5%) 3/35 (9%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.491 P=0.258 P=0.532N |(e) (e) (e) (e) |
|POLY 3 | P=0.375N P=0.486 P=0.299 P=0.518N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.363N P=0.489 P=0.303 P=0.513N |(e) (e) (e) (e) |
|POLY 6 | P=0.387N P=0.485 P=0.292 P=0.523N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.396N P=0.491 P=0.258 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.344N P=0.500 P=0.309 P=0.505N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/45.94 3/44.10 0/45.14 0/41.99 |0/45.83 1/46.33 1/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 4.4% 6.8% 0.0% 0.0% |0.0% 2.2% 2.3% 0.0% |
|TERMINAL (d) | 2/40 (5%) 3/39 (8%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 1/38 (3%) 1/38 (3%) 0/33 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- 728 (T) 728 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.093N P=0.488 P=0.268N P=0.275N |P=0.622N P=0.505 P=0.505 (e) |
|POLY 3 | P=0.079N P=0.481 P=0.241N P=0.258N |P=0.629N P=0.502 P=0.492 (e) |
|POLY 1.5 | P=0.077N P=0.485 P=0.239N P=0.252N |P=0.618N P=0.502 P=0.496 (e) |
|POLY 6 | P=0.082N P=0.481 P=0.245N P=0.263N |P=0.639N P=0.502 P=0.490 (e) |
|LOGISTIC REGRESSION| P=0.093N P=0.488 (e) (e) |(e) P=0.505 P=0.505 (e) |
|COCH-ARM / FISHERS | P=0.075N P=0.500 P=0.247N P=0.253N |P=0.595N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 1/45.45 0/41.99 |2/45.83 0/46.33 0/44.12 1/40.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |4.4% 0.0% 0.0% 2.4% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |2/37 (5%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 645 --- |728 (T) --- --- 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.688 (e) P=0.505 (e) |P=0.483N P=0.232N P=0.232N P=0.529N |
|POLY 3 | P=0.665 (e) P=0.498 (e) |P=0.461N P=0.235N P=0.246N P=0.539N |
|POLY 1.5 | P=0.676 (e) P=0.499 (e) |P=0.462N P=0.235N P=0.242N P=0.527N |
|POLY 6 | P=0.655 (e) P=0.495 (e) |P=0.459N P=0.235N P=0.248N P=0.551N |
|LOGISTIC REGRESSION| P=0.702 (e) P=0.493 (e) |P=0.375N (e) (e) P=0.439N |
|COCH-ARM / FISHERS | P=0.692 (e) P=0.500 (e) |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 0/49 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.94 1/44.10 2/45.14 0/41.99 |1/45.83 0/46.33 1/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 2.2% 2.3% 4.4% 0.0% |2.2% 0.0% 2.3% 2.5% |
|TERMINAL (d) | 1/40 (3%) 1/39 (3%) 2/35 (6%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 1/38 (3%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |728 (T) --- 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.415N P=0.756 P=0.453 P=0.532N |P=0.509 P=0.495N P=0.756N P=0.736 |
|POLY 3 | P=0.393N P=0.751 P=0.494 P=0.518N |P=0.495 P=0.498N P=0.752 P=0.730 |
|POLY 1.5 | P=0.385N P=0.753 P=0.497 P=0.513N |P=0.508 P=0.498N P=0.756 P=0.740 |
|POLY 6 | P=0.402N P=0.751 P=0.487 P=0.523N |P=0.483 P=0.498N P=0.750 P=0.721 |
|LOGISTIC REGRESSION| P=0.415N P=0.756 P=0.453 (e) |P=0.509 (e) P=0.756N P=0.736 |
|COCH-ARM / FISHERS | P=0.372N P=0.753N P=0.500 P=0.505N |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 2/49 (4%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 3/44.10 1/45.15 2/41.99 |2/45.83 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 6.8% 2.2% 4.8% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 3/39 (8%) 0/35 (0%) 2/34 (6%) |2/37 (5%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 727 729 (T) |728 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280 P=0.117 P=0.479 P=0.203 |P=0.122N P=0.232N P=0.232N P=0.264N |
|POLY 3 | P=0.299 P=0.111 P=0.497 P=0.218 |P=0.111N P=0.235N P=0.246N P=0.268N |
|POLY 1.5 | P=0.310 P=0.113 P=0.498 P=0.223 |P=0.112N P=0.235N P=0.242N P=0.258N |
|POLY 6 | P=0.289 P=0.111 P=0.493 P=0.212 |P=0.109N P=0.235N P=0.248N P=0.278N |
|LOGISTIC REGRESSION| P=0.278 P=0.117 P=0.482 P=0.203 |P=0.122N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.330 P=0.121 P=0.500 P=0.242 |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 4/50 (8%) 1/49 (2%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 4/46.37 1/42.22 |0/45.83 0/46.33 1/44.26 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 8.6% 2.4% |0.0% 0.0% 2.3% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 616 668 |--- --- 693 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.223 (e) P=0.068 P=0.480 |P=0.671 (e) P=0.490 (e) |
|POLY 3 | P=0.207 (e) P=0.061 P=0.483 |P=0.634 (e) P=0.493 (e) |
|POLY 1.5 | P=0.218 (e) P=0.061 P=0.488 |P=0.654 (e) P=0.496 (e) |
|POLY 6 | P=0.197 (e) P=0.061 P=0.479 |P=0.616 (e) P=0.492 (e) |
|LOGISTIC REGRESSION| P=0.261 (e) P=0.056 P=0.514 |P=0.693 (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.239 (e) P=0.059 P=0.495 |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 17/50 (34%) 20/50 (40%) 6/49 (12%) |11/50 (22%) 14/50 (28%) 12/50 (24%) 11/50 (22%) |
|POLY-3 RATE (b) | 17/46.41 17/44.10 20/46.26 6/42.99 |11/46.08 14/46.65 12/44.12 11/40.68 |
|POLY-3 PERCENT (g) | 36.6% 38.6% 43.2% 14.0% |23.9% 30.0% 27.2% 27.0% |
|TERMINAL (d) | 16/40 (40%) 17/39 (44%) 17/35 (49%) 4/34 (12%) |9/37 (24%) 12/38 (32%) 12/38 (32%) 10/33 (30%) |
|FIRST INCIDENCE | 592 729 (T) 542 464 |693 687 728 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.548 P=0.187 P=0.025N* |P=0.485 P=0.347 P=0.522 P=0.466 |
|POLY 3 | P=0.011N* P=0.511 P=0.330 P=0.012N* |P=0.468 P=0.333 P=0.452 P=0.464 |
|POLY 1.5 | P=0.010N* P=0.530 P=0.337 P=0.010N* |P=0.520 P=0.334 P=0.472 P=0.507 |
|POLY 6 | P=0.013N* P=0.501 P=0.314 P=0.013N* |P=0.421 P=0.330 P=0.434 P=0.424 |
|LOGISTIC REGRESSION| P=0.015N* P=0.528 P=0.305 P=0.014N* |P=0.412 P=0.327 P=0.452 P=0.421 |
|COCH-ARM / FISHERS | P=0.010N* P=0.583N P=0.339 P=0.009N** |P=0.455N P=0.322 P=0.500 P=0.595N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 11/50 (22%) 16/49 (33%) |7/50 (14%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/49.44 10/46.13 11/46.50 16/45.31 |7/46.24 2/46.33 2/44.12 2/40.68 |
|POLY-3 PERCENT (g) | 28.3% 21.7% 23.7% 35.3% |15.1% 4.3% 4.5% 4.9% |
|TERMINAL (d) | 5/40 (13%) 5/39 (13%) 6/35 (17%) 7/34 (21%) |5/37 (14%) 2/38 (5%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 416 501 616 451 |621 728 (T) 728 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.299N P=0.410N P=0.286 |P=0.090N P=0.079N P=0.082N P=0.121N |
|POLY 3 | P=0.200 P=0.306N P=0.388N P=0.306 |P=0.081N P=0.078N P=0.090N P=0.113N |
|POLY 1.5 | P=0.217 P=0.287N P=0.360N P=0.334 |P=0.076N P=0.077N P=0.086N P=0.101N |
|POLY 6 | P=0.183 P=0.319N P=0.425N P=0.282 |P=0.085N P=0.080N P=0.094N P=0.125N |
|LOGISTIC REGRESSION| P=0.303 P=0.160N P=0.288N P=0.549 |P=0.081N P=0.078N P=0.090N P=0.095N |
|COCH-ARM / FISHERS | P=0.243 P=0.241N P=0.322N P=0.388 |P=0.066N P=0.080N P=0.080N P=0.080N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 13/50 (26%) 16/49 (33%) |7/50 (14%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/49.44 10/46.13 13/47.02 16/45.31 |7/46.24 2/46.33 3/44.26 2/40.68 |
|POLY-3 PERCENT (g) | 28.3% 21.7% 27.7% 35.3% |15.1% 4.3% 6.8% 4.9% |
|TERMINAL (d) | 5/40 (13%) 5/39 (13%) 6/35 (17%) 7/34 (21%) |5/37 (14%) 2/38 (5%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 416 501 616 451 |621 728 (T) 693 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.165 P=0.299N P=0.572N P=0.286 |P=0.111N P=0.079N P=0.163N P=0.121N |
|POLY 3 | P=0.186 P=0.306N P=0.561N P=0.306 |P=0.101N P=0.078N P=0.175N P=0.113N |
|POLY 1.5 | P=0.202 P=0.287N P=0.536N P=0.334 |P=0.095N P=0.077N P=0.168N P=0.101N |
|POLY 6 | P=0.169 P=0.319N P=0.588 P=0.282 |P=0.107N P=0.080N P=0.181N P=0.125N |
|LOGISTIC REGRESSION| P=0.289 P=0.160N P=0.463N P=0.549 |P=0.097N P=0.078N P=0.172N P=0.095N |
|COCH-ARM / FISHERS | P=0.228 P=0.241N P=0.500N P=0.388 |P=0.080N P=0.080N P=0.159N P=0.080N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 25/50 (50%) 28/50 (56%) 21/49 (43%) |17/50 (34%) 15/50 (30%) 13/50 (26%) 13/50 (26%) |
|POLY-3 RATE (b) | 29/49.44 25/46.13 28/47.61 21/46.31 |17/46.49 15/46.65 13/44.12 13/41.27 |
|POLY-3 PERCENT (g) | 58.7% 54.2% 58.8% 45.4% |36.6% 32.2% 29.5% 31.5% |
|TERMINAL (d) | 20/40 (50%) 20/39 (51%) 20/35 (57%) 10/34 (29%) |13/37 (35%) 13/38 (34%) 13/38 (34%) 11/33 (33%) |
|FIRST INCIDENCE | 416 501 542 451 |621 687 728 (T) 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.356N P=0.443 P=0.286N |P=0.355N P=0.391N P=0.241N P=0.406N |
|POLY 3 | P=0.126N P=0.408N P=0.576 P=0.135N |P=0.345N P=0.409N P=0.310N P=0.392N |
|POLY 1.5 | P=0.116N P=0.368N P=0.552N P=0.120N |P=0.301N P=0.404N P=0.286N P=0.346N |
|POLY 6 | P=0.137N P=0.437N P=0.532 P=0.148N |P=0.387N P=0.419N P=0.335N P=0.438N |
|LOGISTIC REGRESSION| P=0.102N P=0.284N P=0.489N P=0.059N |P=0.408N P=0.402N P=0.306N P=0.410N |
|COCH-ARM / FISHERS | P=0.104N P=0.274N P=0.500N P=0.096N |P=0.215N P=0.415N P=0.257N P=0.257N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 25/50 (50%) 28/50 (56%) 21/49 (43%) |17/50 (34%) 15/50 (30%) 14/50 (28%) 13/50 (26%) |
|POLY-3 RATE (b) | 29/49.44 25/46.13 28/47.61 21/46.31 |17/46.49 15/46.65 14/44.26 13/41.27 |
|POLY-3 PERCENT (g) | 58.7% 54.2% 58.8% 45.4% |36.6% 32.2% 31.6% 31.5% |
|TERMINAL (d) | 20/40 (50%) 20/39 (51%) 20/35 (57%) 10/34 (29%) |13/37 (35%) 13/38 (34%) 13/38 (34%) 11/33 (33%) |
|FIRST INCIDENCE | 416 501 542 451 |621 687 693 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.356N P=0.443 P=0.286N |P=0.371N P=0.391N P=0.319N P=0.406N |
|POLY 3 | P=0.126N P=0.408N P=0.576 P=0.135N |P=0.360N P=0.409N P=0.392N P=0.392N |
|POLY 1.5 | P=0.116N P=0.368N P=0.552N P=0.120N |P=0.315N P=0.404N P=0.366N P=0.346N |
|POLY 6 | P=0.137N P=0.437N P=0.532 P=0.148N |P=0.403N P=0.419N P=0.416N P=0.438N |
|LOGISTIC REGRESSION| P=0.102N P=0.284N P=0.489N P=0.059N |P=0.420N P=0.402N P=0.392N P=0.410N |
|COCH-ARM / FISHERS | P=0.104N P=0.274N P=0.500N P=0.096N |P=0.224N P=0.415N P=0.333N P=0.257N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 9/50 (18%) 5/50 (10%) 4/49 (8%) |2/50 (4%) 0/50 (0%) 4/49 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.30 9/44.10 5/46.15 4/41.99 |2/45.83 0/46.33 4/44.07 1/40.09 |
|POLY-3 PERCENT (g) | 6.5% 20.4% 10.8% 9.5% |4.4% 0.0% 9.1% 2.5% |
|TERMINAL (d) | 2/40 (5%) 9/39 (23%) 2/35 (6%) 4/34 (12%) |2/37 (5%) 0/38 (0%) 3/38 (8%) 1/33 (3%) |
|FIRST INCIDENCE | 629 729 (T) 542 729 (T) |728 (T) --- 576 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.557 P=0.056 P=0.322 P=0.417 |P=0.577 P=0.232N P=0.345 P=0.540N |
|POLY 3 | P=0.526N P=0.048 * P=0.355 P=0.447 |P=0.543 P=0.235N P=0.319 P=0.546N |
|POLY 1.5 | P=0.504N P=0.051 P=0.357 P=0.463 |P=0.569 P=0.235N P=0.323 P=0.531N |
|POLY 6 | P=0.551N P=0.047 * P=0.348 P=0.431 |P=0.520 P=0.235N P=0.319 P=0.560N |
|LOGISTIC REGRESSION| P=0.503N P=0.052 P=0.359 P=0.448 |P=0.588 (e) P=0.322 P=0.540N |
|COCH-ARM / FISHERS | P=0.468N P=0.061 P=0.357 P=0.489 |P=0.578N P=0.247N P=0.329 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 5/50 (10%) 8/50 (16%) 4/49 (8%) |2/50 (4%) 2/50 (4%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/45.94 5/44.35 8/46.56 4/41.99 |2/45.83 2/46.33 2/43.84 2/40.09 |
|POLY-3 PERCENT (g) | 6.5% 11.3% 17.2% 9.5% |4.4% 4.3% 4.6% 5.0% |
|TERMINAL (d) | 3/40 (8%) 4/39 (10%) 5/35 (14%) 4/34 (12%) |2/37 (5%) 2/38 (5%) 1/38 (3%) 2/33 (6%) |
|FIRST INCIDENCE | 729 (T) 661 494 729 (T) |728 (T) 728 (T) 654 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.332 P=0.344 P=0.076 P=0.411 |P=0.544 P=0.686N P=0.688N P=0.654 |
|POLY 3 | P=0.366 P=0.337 P=0.102 P=0.451 |P=0.529 P=0.690N P=0.678 P=0.645 |
|POLY 1.5 | P=0.388 P=0.341 P=0.102 P=0.465 |P=0.550 P=0.689N P=0.681 P=0.661 |
|POLY 6 | P=0.343 P=0.339 P=0.100 P=0.438 |P=0.512 P=0.691N P=0.678 P=0.630 |
|LOGISTIC REGRESSION| P=0.404 P=0.333 P=0.102 P=0.411 |P=0.524 P=0.686N P=0.681 P=0.654 |
|COCH-ARM / FISHERS | P=0.422 P=0.357 P=0.100 P=0.489 |P=0.595 P=0.691N P=0.684 P=0.691N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 14/50 (28%) 13/50 (26%) 8/49 (16%) |3/50 (6%) 2/50 (4%) 6/49 (12%) 3/50 (6%) |
|POLY-3 RATE (b) | 6/46.30 14/44.35 13/47.56 8/41.99 |3/45.83 2/46.33 6/44.34 3/40.09 |
|POLY-3 PERCENT (g) | 13.0% 31.6% 27.3% 19.1% |6.6% 4.3% 13.5% 7.5% |
|TERMINAL (d) | 5/40 (13%) 13/39 (33%) 7/35 (20%) 8/34 (24%) |3/37 (8%) 2/38 (5%) 4/38 (11%) 3/33 (9%) |
|FIRST INCIDENCE | 629 661 494 729 (T) |728 (T) 728 (T) 576 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370 P=0.035 * P=0.048 * P=0.270 |P=0.386 P=0.488N P=0.252 P=0.610 |
|POLY 3 | P=0.422 P=0.028 * P=0.068 P=0.312 |P=0.359 P=0.495N P=0.226 P=0.599 |
|POLY 1.5 | P=0.458 P=0.030 * P=0.066 P=0.334 |P=0.390 P=0.495N P=0.228 P=0.620 |
|POLY 6 | P=0.384 P=0.027 * P=0.068 P=0.291 |P=0.333 P=0.496N P=0.228 P=0.580 |
|LOGISTIC REGRESSION| P=0.474 P=0.030 * P=0.064 P=0.297 |P=0.381 P=0.488N P=0.227 P=0.610 |
|COCH-ARM / FISHERS | P=0.514 P=0.039 * P=0.062 P=0.371 |P=0.461 P=0.500N P=0.233 P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |2/45.84 1/46.33 0/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 2.2% 0.0% 2.5% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 1/38 (3%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- --- --- |725 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.400N P=0.491N P=0.237N P=0.543N |
|POLY 3 | (e) (e) (e) (e) |P=0.378N P=0.496N P=0.246N P=0.546N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.375N P=0.496N P=0.242N P=0.531N |
|POLY 6 | (e) (e) (e) (e) |P=0.380N P=0.497N P=0.248N P=0.560N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.413N P=0.496N P=0.244N P=0.560N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |2/45.84 1/46.33 0/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 2.2% 0.0% 2.5% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 1/38 (3%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- --- --- |725 728 (T) --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.400N P=0.491N P=0.237N P=0.543N |
|POLY 3 | (e) (e) (e) (e) |P=0.378N P=0.496N P=0.246N P=0.546N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.375N P=0.496N P=0.242N P=0.531N |
|POLY 6 | (e) (e) (e) (e) |P=0.380N P=0.497N P=0.248N P=0.560N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.413N P=0.496N P=0.244N P=0.560N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.366N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |0/45.83 2/46.78 1/44.56 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.3% 2.2% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |0/37 (0%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 643 599 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.515N P=0.240 P=0.482 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.505N P=0.242 P=0.494 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.490N P=0.241 P=0.497 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.517N P=0.243 P=0.494 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.408N P=0.216 P=0.500 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.461N P=0.247 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/45.83 2/46.33 2/44.12 1/40.09 |
|POLY-3 PERCENT (g) | |0.0% 4.3% 4.5% 2.5% |
|TERMINAL (d) | |0/37 (0%) 2/38 (5%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | |--- 728 (T) 728 (T) 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.428 P=0.244 P=0.244 P=0.477 |
|POLY 3 | |P=0.395 P=0.240 P=0.229 P=0.473 |
|POLY 1.5 | |P=0.419 P=0.240 P=0.232 P=0.482 |
|POLY 6 | |P=0.374 P=0.239 P=0.226 P=0.466 |
|LOGISTIC REGRESSION| |(e) P=0.244 P=0.244 P=0.477 |
|COCH-ARM / FISHERS | |P=0.469 P=0.247 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |1/49 (2%) 3/49 (6%) 3/49 (6%) 3/49 (6%) |
|POLY-3 RATE (b) | 0/45.41 0/42.52 0/44.14 0/41.99 |1/45.81 3/45.47 3/43.56 3/39.37 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 6.6% 6.9% 7.6% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/34 (0%) 0/34 (0%) |1/37 (3%) 3/38 (8%) 3/38 (8%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) 728 (T) 728 (T) 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.226 P=0.314 P=0.314 P=0.254 |
|POLY 3 | (e) (e) (e) (e) |P=0.218 P=0.303 P=0.287 P=0.253 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.238 P=0.304 P=0.293 P=0.268 |
|POLY 6 | (e) (e) (e) (e) |P=0.203 P=0.302 P=0.285 P=0.242 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.206 P=0.314 P=0.314 P=0.249 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.292 P=0.309 P=0.309 P=0.309 |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 1/45.83 0/41.99 |2/46.15 0/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.2% 0.0% |4.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 0/38 (0%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- --- 494 --- |641 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.688 (e) P=0.504 (e) |P=0.127N P=0.234N P=0.244N P=0.274N |
|POLY 3 | P=0.665 (e) P=0.500 (e) |P=0.110N P=0.236N P=0.247N P=0.270N |
|POLY 1.5 | P=0.675 (e) P=0.500 (e) |P=0.112N P=0.235N P=0.243N P=0.259N |
|POLY 6 | P=0.654 (e) P=0.497 (e) |P=0.108N P=0.238N P=0.251N P=0.281N |
|LOGISTIC REGRESSION| P=0.706 (e) P=0.358 (e) |P=0.110N P=0.244N P=0.235N P=0.241N |
|COCH-ARM / FISHERS | P=0.692 (e) P=0.500 (e) |P=0.115N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |3/50 (6%) 7/50 (14%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |3/46.67 7/47.51 2/44.90 3/40.63 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |6.4% 14.7% 4.5% 7.4% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |1/37 (3%) 2/38 (5%) 0/38 (0%) 2/33 (6%) |
|FIRST INCIDENCE | --- --- --- --- |570 561 576 565 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.444N P=0.177 P=0.516N P=0.579 |
|POLY 3 | (e) (e) (e) (e) |P=0.417N P=0.165 P=0.518N P=0.597 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.392N P=0.164 P=0.510N P=0.619 |
|POLY 6 | (e) (e) (e) (e) |P=0.440N P=0.166 P=0.522N P=0.576 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.277N P=0.129 P=0.484N P=0.644N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.341N P=0.159 P=0.500N P=0.661N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.94 0/44.10 0/45.14 0/41.99 |2/45.83 1/46.40 0/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |4.4% 2.2% 0.0% 2.5% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |2/37 (5%) 0/38 (0%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |728 (T) 711 --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.505N P=0.527N P=0.532N |P=0.402N P=0.491N P=0.232N P=0.540N |
|POLY 3 | P=0.298N P=0.508N P=0.504N P=0.518N |P=0.378N P=0.496N P=0.246N P=0.546N |
|POLY 1.5 | P=0.301N P=0.506N P=0.502N P=0.513N |P=0.375N P=0.496N P=0.242N P=0.531N |
|POLY 6 | P=0.296N P=0.508N P=0.507N P=0.523N |P=0.380N P=0.496N P=0.248N P=0.560N |
|LOGISTIC REGRESSION| P=0.327N (e) (e) (e) |P=0.418N P=0.497N (e) P=0.540N |
|COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.500N P=0.505N |P=0.366N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.94 0/44.10 0/45.14 0/41.99 |2/45.83 0/46.33 0/44.12 1/40.09 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/40 (0%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |2/37 (5%) 0/38 (0%) 0/38 (0%) 1/33 (3%) |
|FIRST INCIDENCE | --- --- --- --- |728 (T) --- --- 728 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.491N P=0.232N P=0.232N P=0.540N |
|POLY 3 | (e) (e) (e) (e) |P=0.460N P=0.235N P=0.246N P=0.546N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.461N P=0.235N P=0.242N P=0.531N |
|POLY 6 | (e) (e) (e) (e) |P=0.457N P=0.235N P=0.248N P=0.560N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.491N (e) (e) P=0.540N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/49 (2%) | |
|POLY-3 RATE (b) | 3/46.03 0/44.10 0/45.14 1/41.99 | |
|POLY-3 PERCENT (g) | 6.5% 0.0% 0.0% 2.4% | |
|TERMINAL (d) | 2/40 (5%) 0/39 (0%) 0/35 (0%) 1/34 (3%) | |
|FIRST INCIDENCE | 708 --- --- 729 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288N P=0.129N P=0.147N P=0.365N | |
|POLY 3 | P=0.243N P=0.127N P=0.122N P=0.339N | |
|POLY 1.5 | P=0.245N P=0.125N P=0.120N P=0.329N | |
|POLY 6 | P=0.244N P=0.127N P=0.126N P=0.348N | |
|LOGISTIC REGRESSION| P=0.274N P=0.127N P=0.128N P=0.350N | |
|COCH-ARM / FISHERS | P=0.251N P=0.121N P=0.121N P=0.316N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/49 (0%) |2/50 (4%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.94 1/44.10 2/45.14 0/41.99 |2/45.83 0/46.33 2/44.12 2/40.76 |
|POLY-3 PERCENT (g) | 4.4% 2.3% 4.4% 0.0% |4.4% 0.0% 4.5% 4.9% |
|TERMINAL (d) | 2/40 (5%) 1/39 (3%) 2/35 (6%) 0/34 (0%) |2/37 (5%) 0/38 (0%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |728 (T) --- 728 (T) 504 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.240N P=0.509N P=0.646 P=0.275N |P=0.401 P=0.232N P=0.686N P=0.654 |
|POLY 3 | P=0.218N P=0.514N P=0.688 P=0.258N |P=0.396 P=0.235N P=0.680 P=0.651 |
|POLY 1.5 | P=0.212N P=0.511N P=0.691 P=0.252N |P=0.410 P=0.235N P=0.686 P=0.665 |
|POLY 6 | P=0.225N P=0.515N P=0.681 P=0.263N |P=0.385 P=0.235N P=0.677 P=0.639 |
|LOGISTIC REGRESSION| P=0.240N P=0.509N P=0.646 (e) |P=0.434 (e) P=0.686N P=0.695N |
|COCH-ARM / FISHERS | P=0.204N P=0.500N P=0.691N P=0.253N |P=0.444 P=0.247N P=0.691N P=0.691N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 2/50 (4%) 3/49 (6%) |3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.94 4/44.10 2/45.15 3/42.41 |3/46.21 1/46.33 0/44.12 0/40.09 |
|POLY-3 PERCENT (g) | 0.0% 9.1% 4.4% 7.1% |6.5% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 4/39 (10%) 1/35 (3%) 2/34 (6%) |2/37 (5%) 1/38 (3%) 0/38 (0%) 0/33 (0%) |
|FIRST INCIDENCE | --- 729 (T) 727 610 |621 728 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.175 P=0.060 P=0.214 P=0.101 |P=0.051N P=0.300N P=0.125N P=0.151N |
|POLY 3 | P=0.193 P=0.055 P=0.233 P=0.105 |P=0.046N* P=0.304N P=0.127N P=0.146N |
|POLY 1.5 | P=0.202 P=0.056 P=0.236 P=0.108 |P=0.045N* P=0.303N P=0.124N P=0.137N |
|POLY 6 | P=0.185 P=0.055 P=0.229 P=0.102 |P=0.046N* P=0.307N P=0.130N P=0.156N |
|LOGISTIC REGRESSION| P=0.195 P=0.060 P=0.214 P=0.116 |P=0.046N* P=0.305N P=0.120N P=0.128N |
|COCH-ARM / FISHERS | P=0.219 P=0.059 P=0.247 P=0.117 |P=0.044N* P=0.309N P=0.121N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 5/50 (10%) 4/50 (8%) 3/49 (6%) |5/50 (10%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/45.94 5/44.10 4/45.15 3/42.41 |5/46.21 1/46.33 2/44.12 2/40.76 |
|POLY-3 PERCENT (g) | 4.4% 11.3% 8.9% 7.1% |10.8% 2.2% 4.5% 4.9% |
|TERMINAL (d) | 2/40 (5%) 5/39 (13%) 3/35 (9%) 2/34 (6%) |4/37 (11%) 1/38 (3%) 2/38 (5%) 1/33 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 727 610 |621 728 (T) 728 (T) 504 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.443 P=0.206 P=0.281 P=0.435 |P=0.266N P=0.100N P=0.214N P=0.273N |
|POLY 3 | P=0.486 P=0.200 P=0.329 P=0.464 |P=0.253N P=0.101N P=0.235N P=0.270N |
|POLY 1.5 | P=0.500 P=0.203 P=0.334 P=0.473 |P=0.243N P=0.100N P=0.227N P=0.252N |
|POLY 6 | P=0.472 P=0.199 P=0.320 P=0.456 |P=0.260N P=0.102N P=0.242N P=0.287N |
|LOGISTIC REGRESSION| P=0.476 P=0.206 P=0.282 P=0.471 |P=0.233N P=0.101N P=0.230N P=0.220N |
|COCH-ARM / FISHERS | P=0.526 P=0.218 P=0.339 P=0.490 |P=0.221N P=0.102N P=0.218N P=0.218N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |5/50 (10%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/45.94 0/44.10 0/45.14 0/41.99 |5/46.82 2/46.55 2/44.20 4/40.21 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |10.7% 4.3% 4.5% 10.0% |
|TERMINAL (d) | 1/40 (3%) 0/39 (0%) 0/35 (0%) 0/34 (0%) |3/37 (8%) 1/38 (3%) 1/38 (3%) 3/33 (9%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |193 671 708 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.505N P=0.527N P=0.532N |P=0.564 P=0.213N P=0.216N P=0.570N |
|POLY 3 | P=0.298N P=0.508N P=0.504N P=0.518N |P=0.568 P=0.219N P=0.240N P=0.594N |
|POLY 1.5 | P=0.301N P=0.506N P=0.502N P=0.513N |P=0.558N P=0.218N P=0.233N P=0.566N |
|POLY 6 | P=0.296N P=0.508N P=0.507N P=0.523N |P=0.553 P=0.218N P=0.244N P=0.617N |
|LOGISTIC REGRESSION| P=0.327N (e) (e) (e) |P=0.497N P=0.267N P=0.200N P=0.479N |
|COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.500N P=0.505N |P=0.519N P=0.218N P=0.218N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 23/50 (46%) 26/50 (52%) 11/49 (22%) |22/50 (44%) 24/50 (48%) 22/50 (44%) 21/50 (42%) |
|POLY-3 RATE (b) | 27/46.85 23/44.17 26/46.67 11/42.99 |22/46.09 24/46.96 22/44.76 21/43.05 |
|POLY-3 PERCENT (g) | 57.6% 52.1% 55.7% 25.6% |47.7% 51.1% 49.2% 48.8% |
|TERMINAL (d) | 24/40 (60%) 22/39 (56%) 21/35 (60%) 9/34 (27%) |19/37 (51%) 21/38 (55%) 20/38 (53%) 16/33 (49%) |
|FIRST INCIDENCE | 592 710 542 464 |693 641 576 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008N** P=0.316N P=0.415 P=0.006N** |P=0.446 P=0.464 P=0.547N P=0.458 |
|POLY 3 | P<0.001N** P=0.372N P=0.509N P<0.001N** |P=0.534 P=0.453 P=0.530 P=0.545 |
|POLY 1.5 | P<0.001N** P=0.342N P=0.501N P<0.001N** |P=0.504N P=0.448 P=0.551 P=0.576 |
|POLY 6 | P=0.002N** P=0.396N P=0.531N P=0.002N** |P=0.504 P=0.458 P=0.518 P=0.522 |
|LOGISTIC REGRESSION| P=0.002N** P=0.337N P=0.541N P=0.002N** |P=0.410 P=0.431 P=0.488 P=0.484 |
|COCH-ARM / FISHERS | P<0.001N** P=0.274N P=0.500N P<0.001N** |P=0.396N P=0.421 P=0.580N P=0.500N |
|=================================================================================================================================|
Date: 06/26/02 EXPERIMENT: 88031 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DIPROPYLENE GLYCOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 19/50 (38%) 26/50 (52%) 25/49 (51%) |18/50 (36%) 18/50 (36%) 14/50 (28%) 14/50 (28%) |
|POLY-3 RATE (b) | 19/49.44 19/46.96 26/48.45 25/46.47 |18/48.75 18/48.25 14/46.34 14/42.33 |
|POLY-3 PERCENT (g) | 38.4% 40.5% 53.7% 53.8% |36.9% 37.3% 30.2% 33.1% |
|TERMINAL (d) | 10/40 (25%) 13/39 (33%) 15/35 (43%) 14/34 (41%) |11/37 (30%) 9/38 (24%) 7/38 (18%) 9/33 (27%) |
|FIRST INCIDENCE | 416 405 494 451 |193 561 576 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.043 * P=0.525 P=0.095 P=0.091 |P=0.359N P=0.546N P=0.287N P=0.426N |
|POLY 3 | P=0.050 P=0.502 P=0.094 P=0.095 |P=0.331N P=0.567 P=0.318N P=0.435N |
|POLY 1.5 | P=0.056 P=0.523 P=0.102 P=0.107 |P=0.282N P=0.571 P=0.302N P=0.380N |
|POLY 6 | P=0.044 * P=0.486 P=0.083 P=0.086 |P=0.375N P=0.574 P=0.319N P=0.485N |
|LOGISTIC REGRESSION| P=0.092 P=0.513N P=0.128 P=0.210 |P=0.147N P=0.554 P=0.224N P=0.234N |
|COCH-ARM / FISHERS | P=0.070 P=0.582N P=0.114 P=0.135 |P=0.178N P=0.582N P=0.260N P=0.260N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0.0% 1.0% 2.0% 4.0% |0.0% 1.0% 2.0% 4.0% |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 37/50 (74%) 39/50 (78%) 33/49 (67%) |32/50 (64%) 35/50 (70%) 30/50 (60%) 29/50 (58%) |
|POLY-3 RATE (b) | 39/49.44 37/47.03 39/49.03 33/46.72 |32/49.00 35/48.25 30/46.34 29/44.45 |
|POLY-3 PERCENT (g) | 78.9% 78.7% 79.5% 70.6% |65.3% 72.5% 64.7% 65.2% |
|TERMINAL (d) | 30/40 (75%) 30/39 (77%) 27/35 (77%) 21/34 (62%) |23/37 (62%) 26/38 (68%) 23/38 (61%) 20/33 (61%) |
|FIRST INCIDENCE | 416 405 494 451 |193 561 576 395 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521 P=0.509N P=0.300 P=0.517N |P=0.527N P=0.414 P=0.413N P=0.513 |
|POLY 3 | P=0.187N P=0.589N P=0.567 P=0.242N |P=0.435N P=0.289 P=0.563N P=0.584N |
|POLY 1.5 | P=0.173N P=0.540N P=0.581 P=0.216N |P=0.368N P=0.304 P=0.520N P=0.521N |
|POLY 6 | P=0.197N P=0.578 P=0.539 P=0.258N |P=0.485N P=0.284 P=0.579N P=0.546 |
|LOGISTIC REGRESSION| P=0.174N P=0.471N P=0.587N P=0.168N |P=0.333N P=0.335 P=0.435N P=0.416N |
|COCH-ARM / FISHERS | P=0.152N P=0.408N P=0.595N P=0.168N |P=0.200N P=0.335 P=0.418N P=0.341N |
|=================================================================================================================================|
(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).