TDMS Study 05109-14 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 06/06/02
EXPERIMENT: 05109 TEST: 14 TIME: 08:39:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85427 ROUTE: SKIN APPLICATION NTP C#: 61621E
PATHOLOGIST: MISSING CAS: 102-71-6
------------------------------------------------------------------------------------------------------------------------------------
FINAL #1/MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 06/06/02
EXPERIMENT: 05109 TEST: 14 TIME: 08:39:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85427 ROUTE: SKIN APPLICATION NTP C#: 61621E
PATHOLOGIST: MISSING CAS: 102-71-6
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Salivary Glands
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIETHANOLAMINE DATE: 06/06/02
EXPERIMENT: 05109 TEST: 14 TIME: 08:39:59
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85427 ROUTE: SKIN APPLICATION NTP C#: 61621E
PATHOLOGIST: MISSING CAS: 102-71-6
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRIETHANOLAMINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hemangiosarcoma
All Organs Hemangiosarcoma
Benign Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Thyroid Gland: Follicular Cell Adenoma
All Organs Benign Tumors
Malignant Tumors
===============================================================
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 6/50 (12%) 5/50 (10%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/47.21 3/46.90 6/43.61 5/46.42 |0/44.21 0/43.59 0/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 6.4% 6.4% 13.8% 10.8% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 3/37 (8%) 3/43 (7%) 4/34 (12%) 4/40 (10%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 676 618 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.305 P=0.592N P=0.199 P=0.392 |P=0.201 (e) (e) P=0.482 |
|POLY 3 | P=0.285 P=0.659 P=0.204 P=0.347 |P=0.222 (e) (e) P=0.500 |
|POLY 1.5 | P=0.289 P=0.658 P=0.218 P=0.350 |P=0.221 (e) (e) P=0.499 |
|POLY 6 | P=0.281 P=0.660N P=0.193 P=0.347 |P=0.223 (e) (e) P=0.502 |
|LOGISTIC REGRESSION| P=0.281 P=0.592N P=0.186 P=0.346 |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.294 P=0.661N P=0.243 P=0.357 |P=0.221 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 2/50 (4%) 2/50 (4%) 6/50 (12%) |5/50 (10%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/47.86 2/46.90 2/43.35 6/46.04 |5/44.45 5/44.29 3/44.71 3/44.92 |
|POLY-3 PERCENT (g) | 14.6% 4.3% 4.6% 13.0% |11.3% 11.3% 6.7% 6.7% |
|TERMINAL (d) | 6/37 (16%) 2/43 (5%) 2/34 (6%) 6/40 (15%) |4/35 (11%) 3/34 (9%) 3/41 (7%) 2/32 (6%) |
|FIRST INCIDENCE | 511 726 (T) 726 (T) 726 (T) |666 594 729 (T) 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394 P=0.055N P=0.104N P=0.446N |P=0.319N P=0.625 P=0.276N P=0.390N |
|POLY 3 | P=0.369 P=0.084N P=0.105N P=0.530N |P=0.279N P=0.628 P=0.353N P=0.350N |
|POLY 1.5 | P=0.374 P=0.083N P=0.095N P=0.519N |P=0.283N P=0.624 P=0.361N P=0.356N |
|POLY 6 | P=0.361 P=0.082N P=0.115N P=0.539N |P=0.278N P=0.626N P=0.337N P=0.344N |
|LOGISTIC REGRESSION| P=0.367 P=0.078N P=0.086N P=0.509N |P=0.285N P=0.623 P=0.328N P=0.358N |
|COCH-ARM / FISHERS | P=0.379 P=0.080N P=0.080N P=0.500N |P=0.285N P=0.630N P=0.357N P=0.357N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 1/46.39 |2/45.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 2.2% |4.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- 628 |532 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.464 P=0.530 (e) P=0.491 |P=0.265N P=0.247N P=0.247N P=0.245N |
|POLY 3 | P=0.460 P=0.499 (e) P=0.497 |P=0.255N P=0.245N P=0.240N P=0.242N |
|POLY 1.5 | P=0.461 P=0.498 (e) P=0.498 |P=0.256N P=0.244N P=0.241N P=0.241N |
|POLY 6 | P=0.460 P=0.501 (e) P=0.496 |P=0.255N P=0.247N P=0.235N P=0.243N |
|LOGISTIC REGRESSION| P=0.468 P=0.530 (e) P=0.572 |P=0.244N P=0.178N P=0.181N P=0.186N |
|COCH-ARM / FISHERS | P=0.464 P=0.500 (e) P=0.500 |P=0.262N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 3/50 (6%) 2/50 (4%) 7/50 (14%) |7/50 (14%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |
|POLY-3 RATE (b) | 7/47.86 3/46.90 2/43.35 7/46.39 |7/45.45 5/44.29 3/44.71 3/44.92 |
|POLY-3 PERCENT (g) | 14.6% 6.4% 4.6% 15.1% |15.4% 11.3% 6.7% 6.7% |
|TERMINAL (d) | 6/37 (16%) 3/43 (7%) 2/34 (6%) 6/40 (15%) |4/35 (11%) 3/34 (9%) 3/41 (7%) 2/32 (6%) |
|FIRST INCIDENCE | 511 726 (T) 726 (T) 628 |532 594 729 (T) 527 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311 P=0.112N P=0.104N P=0.564N |P=0.188N P=0.390N P=0.121N P=0.187N |
|POLY 3 | P=0.289 P=0.166N P=0.105N P=0.589 |P=0.161N P=0.397N P=0.164N P=0.162N |
|POLY 1.5 | P=0.292 P=0.165N P=0.095N P=0.597 |P=0.163N P=0.395N P=0.166N P=0.163N |
|POLY 6 | P=0.285 P=0.163N P=0.115N P=0.584 |P=0.162N P=0.397N P=0.157N P=0.162N |
|LOGISTIC REGRESSION| P=0.289 P=0.156N P=0.086N P=0.609N |P=0.163N P=0.374N P=0.159N P=0.151N |
|COCH-ARM / FISHERS | P=0.296 P=0.159N P=0.080N P=0.613N |P=0.163N P=0.380N P=0.159N P=0.159N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.21 1/46.90 0/43.35 1/46.04 |0/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 6.4% 2.1% 0.0% 2.2% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/37 (8%) 1/43 (2%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.253N P=0.136N P=0.278N |P=0.619N P=0.494 (e) (e) |
|POLY 3 | P=0.352N P=0.308N P=0.135N P=0.314N |P=0.603N P=0.497 (e) (e) |
|POLY 1.5 | P=0.351N P=0.309N P=0.129N P=0.311N |P=0.603N P=0.497 (e) (e) |
|POLY 6 | P=0.354N P=0.304N P=0.141N P=0.317N |P=0.604N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.347N P=0.253N (e) P=0.278N |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.352N P=0.309N P=0.121N P=0.309N |P=0.601N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.21 1/46.90 0/43.35 1/46.04 |0/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 6.4% 2.1% 0.0% 2.2% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/37 (8%) 1/43 (2%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.253N P=0.136N P=0.278N |P=0.619N P=0.494 (e) (e) |
|POLY 3 | P=0.352N P=0.308N P=0.135N P=0.314N |P=0.603N P=0.497 (e) (e) |
|POLY 1.5 | P=0.351N P=0.309N P=0.129N P=0.311N |P=0.603N P=0.497 (e) (e) |
|POLY 6 | P=0.354N P=0.304N P=0.141N P=0.317N |P=0.604N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.347N P=0.253N (e) P=0.278N |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.352N P=0.309N P=0.121N P=0.309N |P=0.601N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/47.21 1/46.90 0/43.35 2/46.88 |0/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 6.4% 2.1% 0.0% 4.3% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 3/37 (8%) 1/43 (2%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 399 |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624N P=0.253N P=0.136N P=0.472N |P=0.619N P=0.494 (e) (e) |
|POLY 3 | P=0.629N P=0.308N P=0.135N P=0.503N |P=0.603N P=0.497 (e) (e) |
|POLY 1.5 | P=0.630N P=0.309N P=0.129N P=0.502N |P=0.603N P=0.497 (e) (e) |
|POLY 6 | P=0.631N P=0.304N P=0.141N P=0.504N |P=0.604N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.625N P=0.253N (e) P=0.419N |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.633N P=0.309N P=0.121N P=0.500N |P=0.601N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/43.35 2/46.21 |0/44.21 0/43.59 0/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.3% 4.3% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 1/34 (3%) 1/40 (3%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) 683 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.470N P=0.743 P=0.513 |P=0.201 (e) (e) P=0.482 |
|POLY 3 | P=0.232 P=0.501N P=0.741 P=0.493 |P=0.222 (e) (e) P=0.500 |
|POLY 1.5 | P=0.234 P=0.502N P=0.748 P=0.495 |P=0.221 (e) (e) P=0.499 |
|POLY 6 | P=0.229 P=0.499N P=0.734 P=0.491 |P=0.223 (e) (e) P=0.502 |
|LOGISTIC REGRESSION| P=0.231 (e) P=0.743 P=0.494 |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.235 P=0.500N P=0.753N P=0.500 |P=0.221 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/47.21 1/46.90 0/43.35 2/46.04 |1/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 4.3% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/37 (0%) 1/43 (2%) 0/34 (0%) 2/40 (5%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.157 P=0.530 (e) P=0.256 |P=0.515N P=0.506N P=0.468N P=0.518N |
|POLY 3 | P=0.146 P=0.499 (e) P=0.232 |P=0.499N P=0.503N P=0.498N P=0.500N |
|POLY 1.5 | P=0.148 P=0.498 (e) P=0.234 |P=0.498N P=0.503N P=0.501N P=0.501N |
|POLY 6 | P=0.145 P=0.501 (e) P=0.230 |P=0.501N P=0.502N P=0.491N P=0.498N |
|LOGISTIC REGRESSION| (e) P=0.530 (e) P=0.256 |P=0.515N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.150 P=0.500 (e) P=0.247 |P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 6/50 (12%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 6/44.45 1/46.04 |0/44.21 1/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 13.5% 2.2% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 3/34 (9%) 1/40 (3%) |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- 517 726 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.603 P=0.470N P=0.047 * P=0.744N |P=0.619N P=0.494 (e) (e) |
|POLY 3 | P=0.587 P=0.501N P=0.047 * P=0.755 |P=0.603N P=0.497 (e) (e) |
|POLY 1.5 | P=0.595 P=0.502N P=0.050 P=0.757 |P=0.603N P=0.497 (e) (e) |
|POLY 6 | P=0.578 P=0.499N P=0.044 * P=0.754 |P=0.604N P=0.498 (e) (e) |
|LOGISTIC REGRESSION| P=0.611 (e) P=0.071 P=0.744N |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.603 P=0.500N P=0.056 P=0.753N |P=0.601N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 1/46.90 2/43.35 3/46.42 |0/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 4.6% 6.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 1/43 (2%) 2/34 (6%) 2/40 (5%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 618 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193 P=0.728N P=0.470 P=0.324 |(e) (e) (e) (e) |
|POLY 3 | P=0.181 P=0.759 P=0.470 P=0.299 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.183 P=0.759 P=0.481 P=0.301 |(e) (e) (e) (e) |
|POLY 6 | P=0.179 P=0.760N P=0.460 P=0.299 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.181 P=0.728N P=0.470 P=0.312 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.184 P=0.753N P=0.500 P=0.309 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/50 (38%) 18/50 (36%) 23/50 (46%) 20/50 (40%) |9/50 (18%) 18/50 (36%) 20/50 (40%) 33/50 (66%) |
|POLY-3 RATE (b) | 19/47.48 18/46.90 23/43.94 20/46.78 |9/45.13 18/43.96 20/45.98 33/45.59 |
|POLY-3 PERCENT (g) | 40.0% 38.4% 52.4% 42.8% |19.9% 41.0% 43.5% 72.4% |
|TERMINAL (d) | 17/37 (46%) 18/43 (42%) 20/34 (59%) 18/40 (45%) |6/35 (17%) 16/34 (47%) 18/41 (44%) 25/32 (78%) |
|FIRST INCIDENCE | 688 726 (T) 659 618 |617 665 444 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.470 P=0.285N P=0.155 P=0.561N |P<0.001 ** P=0.033 * P=0.041 * P<0.001 ** |
|POLY 3 | P=0.425 P=0.519N P=0.162 P=0.476 |P<0.001 ** P=0.024 * P=0.012 * P<0.001 ** |
|POLY 1.5 | P=0.431 P=0.517N P=0.199 P=0.483 |P<0.001 ** P=0.026 * P=0.011 * P<0.001 ** |
|POLY 6 | P=0.419 P=0.511N P=0.133 P=0.474 |P<0.001 ** P=0.022 * P=0.015 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.378 P=0.446N P=0.111 P=0.446 |P<0.001 ** P=0.031 * P=0.013 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.441 P=0.500N P=0.272 P=0.500 |P<0.001 ** P=0.035 * P=0.013 * P<0.001 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 14/50 (28%) 14/50 (28%) 11/50 (22%) |6/50 (12%) 8/50 (16%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 17/49.44 14/48.17 14/47.23 11/46.72 |6/45.00 8/44.74 4/45.19 5/44.40 |
|POLY-3 PERCENT (g) | 34.4% 29.1% 29.6% 23.6% |13.3% 17.9% 8.9% 11.3% |
|TERMINAL (d) | 8/37 (22%) 11/43 (26%) 5/34 (15%) 9/40 (23%) |3/35 (9%) 4/34 (12%) 3/41 (7%) 4/32 (13%) |
|FIRST INCIDENCE | 511 554 439 572 |595 601 586 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167N P=0.254N P=0.469N P=0.136N |P=0.386N P=0.377 P=0.315N P=0.537N |
|POLY 3 | P=0.177N P=0.365N P=0.390N P=0.172N |P=0.354N P=0.382 P=0.367N P=0.509N |
|POLY 1.5 | P=0.162N P=0.357N P=0.367N P=0.156N |P=0.352N P=0.378 P=0.375N P=0.509N |
|POLY 6 | P=0.200N P=0.368N P=0.418N P=0.193N |P=0.359N P=0.390 P=0.350N P=0.511N |
|LOGISTIC REGRESSION| P=0.121N P=0.303N P=0.118N P=0.110N |P=0.345N P=0.384 P=0.371N P=0.501N |
|COCH-ARM / FISHERS | P=0.142N P=0.333N P=0.333N P=0.133N |P=0.346N P=0.387 P=0.370N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 15/50 (30%) 15/50 (30%) 13/50 (26%) |6/50 (12%) 8/50 (16%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 18/49.44 15/48.17 15/47.23 13/47.10 |6/45.00 8/44.74 4/45.19 5/44.40 |
|POLY-3 PERCENT (g) | 36.4% 31.1% 31.8% 27.6% |13.3% 17.9% 8.9% 11.3% |
|TERMINAL (d) | 9/37 (24%) 12/43 (28%) 6/34 (18%) 10/40 (25%) |3/35 (9%) 4/34 (12%) 3/41 (7%) 4/32 (13%) |
|FIRST INCIDENCE | 511 554 439 572 |595 601 586 701 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238N P=0.249N P=0.476N P=0.192N |P=0.386N P=0.377 P=0.315N P=0.537N |
|POLY 3 | P=0.253N P=0.369N P=0.395N P=0.240N |P=0.354N P=0.382 P=0.367N P=0.509N |
|POLY 1.5 | P=0.237N P=0.360N P=0.371N P=0.222N |P=0.352N P=0.378 P=0.375N P=0.509N |
|POLY 6 | P=0.276N P=0.373N P=0.425N P=0.261N |P=0.359N P=0.390 P=0.350N P=0.511N |
|LOGISTIC REGRESSION| P=0.190N P=0.308N P=0.133N P=0.161N |P=0.345N P=0.384 P=0.371N P=0.501N |
|COCH-ARM / FISHERS | P=0.214N P=0.335N P=0.335N P=0.194N |P=0.346N P=0.387 P=0.370N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 27/50 (54%) 33/50 (66%) 25/50 (50%) |12/50 (24%) 23/50 (46%) 24/50 (48%) 34/50 (68%) |
|POLY-3 RATE (b) | 33/49.59 27/48.17 33/47.69 25/47.46 |12/45.63 23/45.10 24/46.46 34/45.59 |
|POLY-3 PERCENT (g) | 66.6% 56.1% 69.2% 52.7% |26.3% 51.0% 51.7% 74.6% |
|TERMINAL (d) | 23/37 (62%) 24/43 (56%) 22/34 (65%) 21/40 (53%) |7/35 (20%) 17/34 (50%) 21/41 (51%) 26/32 (81%) |
|FIRST INCIDENCE | 511 554 439 572 |595 601 444 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.138N P=0.067N P=0.365 P=0.072N |P<0.001 ** P=0.023 * P=0.042 * P<0.001 ** |
|POLY 3 | P=0.148N P=0.195N P=0.475 P=0.116N |P<0.001 ** P=0.011 * P=0.009 ** P<0.001 ** |
|POLY 1.5 | P=0.130N P=0.183N P=0.518 P=0.099N |P<0.001 ** P=0.012 * P=0.008 ** P<0.001 ** |
|POLY 6 | P=0.173N P=0.203N P=0.425 P=0.136N |P<0.001 ** P=0.012 * P=0.012 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.114N P=0.155N P=0.544N P=0.081N |P<0.001 ** P=0.015 * P=0.010 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.112N P=0.154N P=0.583N P=0.078N |P<0.001 ** P=0.018 * P=0.011 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 27/50 (54%) 34/50 (68%) 26/50 (52%) |12/50 (24%) 23/50 (46%) 24/50 (48%) 34/50 (68%) |
|POLY-3 RATE (b) | 33/49.59 27/48.17 34/47.69 26/47.46 |12/45.63 23/45.10 24/46.46 34/45.59 |
|POLY-3 PERCENT (g) | 66.6% 56.1% 71.3% 54.8% |26.3% 51.0% 51.7% 74.6% |
|TERMINAL (d) | 23/37 (62%) 24/43 (56%) 23/34 (68%) 22/40 (55%) |7/35 (20%) 17/34 (50%) 21/41 (51%) 26/32 (81%) |
|FIRST INCIDENCE | 511 554 439 572 |595 601 444 604 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N P=0.067N P=0.303 P=0.097N |P<0.001 ** P=0.023 * P=0.042 * P<0.001 ** |
|POLY 3 | P=0.208N P=0.195N P=0.386 P=0.162N |P<0.001 ** P=0.011 * P=0.009 ** P<0.001 ** |
|POLY 1.5 | P=0.185N P=0.183N P=0.431 P=0.141N |P<0.001 ** P=0.012 * P=0.008 ** P<0.001 ** |
|POLY 6 | P=0.240N P=0.203N P=0.337 P=0.189N |P<0.001 ** P=0.012 * P=0.012 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.163N P=0.155N P=0.534 P=0.117N |P<0.001 ** P=0.015 * P=0.010 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.159N P=0.154N P=0.500 P=0.111N |P<0.001 ** P=0.018 * P=0.011 * P<0.001 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 7/50 (14%) 12/50 (24%) 9/50 (18%) |3/50 (6%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 6/47.21 7/46.90 12/44.82 9/46.04 |3/44.21 1/43.59 2/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 12.7% 14.9% 26.8% 19.6% |6.8% 2.3% 4.5% 2.3% |
|TERMINAL (d) | 6/37 (16%) 7/43 (16%) 7/34 (21%) 9/40 (23%) |3/35 (9%) 1/34 (3%) 2/41 (5%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 487 726 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.312 P=0.616 P=0.071 P=0.343 |P=0.378N P=0.315N P=0.428N P=0.337N |
|POLY 3 | P=0.272 P=0.495 P=0.074 P=0.269 |P=0.344N P=0.310N P=0.495N P=0.304N |
|POLY 1.5 | P=0.282 P=0.494 P=0.081 P=0.276 |P=0.345N P=0.311N P=0.502N P=0.307N |
|POLY 6 | P=0.260 P=0.503 P=0.069 P=0.264 |P=0.343N P=0.308N P=0.480N P=0.301N |
|LOGISTIC REGRESSION| P=0.281 P=0.616 P=0.082 P=0.343 |P=0.378N P=0.315N P=0.428N P=0.337N |
|COCH-ARM / FISHERS | P=0.296 P=0.500 P=0.096 P=0.288 |P=0.347N P=0.309N P=0.500N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 6/50 (12%) 8/50 (16%) 4/50 (8%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/48.09 6/46.90 8/44.97 4/46.04 |2/44.21 2/43.59 3/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 14.6% 12.8% 17.8% 8.7% |4.5% 4.6% 6.7% 2.3% |
|TERMINAL (d) | 5/37 (14%) 6/43 (14%) 5/34 (15%) 4/40 (10%) |2/35 (6%) 2/34 (6%) 3/41 (7%) 1/32 (3%) |
|FIRST INCIDENCE | 511 726 (T) 503 726 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.408N P=0.425 P=0.233N |P=0.409N P=0.685 P=0.572 P=0.531N |
|POLY 3 | P=0.246N P=0.519N P=0.444 P=0.287N |P=0.370N P=0.689 P=0.505 P=0.499N |
|POLY 1.5 | P=0.237N P=0.515N P=0.464 P=0.278N |P=0.373N P=0.688 P=0.498 P=0.502N |
|POLY 6 | P=0.257N P=0.518N P=0.427 P=0.296N |P=0.368N P=0.691 P=0.520 P=0.496N |
|LOGISTIC REGRESSION| P=0.220N P=0.496N P=0.609N P=0.251N |P=0.409N P=0.685 P=0.572 P=0.531N |
|COCH-ARM / FISHERS | P=0.225N P=0.500N P=0.500 P=0.262N |P=0.373N P=0.691N P=0.500 P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 13/50 (26%) 19/50 (38%) 13/50 (26%) |5/50 (10%) 3/50 (6%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 12/48.09 13/46.90 19/46.44 13/46.04 |5/44.21 3/43.59 4/44.71 2/44.29 |
|POLY-3 PERCENT (g) | 25.0% 27.7% 40.9% 28.2% |11.3% 6.9% 9.0% 4.5% |
|TERMINAL (d) | 10/37 (27%) 13/43 (30%) 11/34 (32%) 13/40 (33%) |5/35 (14%) 3/34 (9%) 4/41 (10%) 2/32 (6%) |
|FIRST INCIDENCE | 511 726 (T) 487 726 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.552N P=0.528N P=0.068 P=0.579 |P=0.262N P=0.371N P=0.401N P=0.252N |
|POLY 3 | P=0.481 P=0.471 P=0.074 P=0.450 |P=0.224N P=0.364N P=0.493N P=0.215N |
|POLY 1.5 | P=0.504 P=0.478 P=0.080 P=0.468 |P=0.227N P=0.365N P=0.503N P=0.218N |
|POLY 6 | P=0.454 P=0.472 P=0.072 P=0.431 |P=0.222N P=0.360N P=0.472N P=0.211N |
|LOGISTIC REGRESSION| P=0.528 P=0.492 P=0.131 P=0.471 |P=0.262N P=0.371N P=0.401N P=0.252N |
|COCH-ARM / FISHERS | P=0.535 P=0.500 P=0.097 P=0.500 |P=0.228N P=0.357N P=0.500N P=0.218N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |8/50 (16%) 5/50 (10%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 0/47.21 0/46.22 1/42.35 0/46.04 |8/44.88 5/43.59 5/44.71 5/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 0.0% |17.8% 11.5% 11.2% 11.3% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/33 (3%) 0/40 (0%) |6/35 (17%) 5/34 (15%) 5/41 (12%) 5/32 (16%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |619 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.775N (e) P=0.477 (e) |P=0.406N P=0.291N P=0.198N P=0.327N |
|POLY 3 | P=0.784N (e) P=0.478 (e) |P=0.344N P=0.294N P=0.277N P=0.283N |
|POLY 1.5 | P=0.782N (e) P=0.485 (e) |P=0.345N P=0.291N P=0.284N P=0.284N |
|POLY 6 | P=0.786N (e) P=0.472 (e) |P=0.345N P=0.297N P=0.263N P=0.284N |
|LOGISTIC REGRESSION| (e) (e) P=0.477 (e) |P=0.335N P=0.281N P=0.263N P=0.271N |
|COCH-ARM / FISHERS | P=0.780N (e) P=0.495 (e) |P=0.346N P=0.277N P=0.277N P=0.277N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |8/50 (16%) 5/50 (10%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/47.21 0/46.22 1/42.35 0/46.04 |8/44.88 5/43.59 5/44.71 6/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.4% 0.0% |17.8% 11.5% 11.2% 13.6% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/33 (3%) 0/40 (0%) |6/35 (17%) 5/34 (15%) 5/41 (12%) 6/32 (19%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |619 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.775N (e) P=0.477 (e) |P=0.561N P=0.291N P=0.198N P=0.447N |
|POLY 3 | P=0.784N (e) P=0.478 (e) |P=0.488N P=0.294N P=0.277N P=0.396N |
|POLY 1.5 | P=0.782N (e) P=0.485 (e) |P=0.489N P=0.291N P=0.284N P=0.397N |
|POLY 6 | P=0.786N (e) P=0.472 (e) |P=0.490N P=0.297N P=0.263N P=0.398N |
|LOGISTIC REGRESSION| (e) (e) P=0.477 (e) |P=0.479N P=0.281N P=0.263N P=0.380N |
|COCH-ARM / FISHERS | P=0.780N (e) P=0.495 (e) |P=0.489N P=0.277N P=0.277N P=0.387N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 0/49 (0%) 1/50 (2%) |0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 0/46.22 0/42.35 1/46.60 |0/44.21 3/43.59 1/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 2.2% |0.0% 6.9% 2.2% 0.0% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 0/33 (0%) 0/40 (0%) |0/35 (0%) 3/34 (9%) 1/41 (2%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) --- --- 554 |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.540 P=0.470N P=0.523N P=0.752N |P=0.298N P=0.116 P=0.532 (e) |
|POLY 3 | P=0.537 P=0.504N P=0.522N P=0.758 |P=0.280N P=0.116 P=0.502 (e) |
|POLY 1.5 | P=0.538 P=0.505N P=0.515N P=0.758 |P=0.282N P=0.116 P=0.499 (e) |
|POLY 6 | P=0.534 P=0.501N P=0.528N P=0.758 |P=0.278N P=0.117 P=0.509 (e) |
|LOGISTIC REGRESSION| P=0.550 (e) (e) P=0.709N |(e) P=0.116 P=0.532 (e) |
|COCH-ARM / FISHERS | P=0.538 P=0.505N P=0.505N P=0.753N |P=0.280N P=0.121 P=0.500 (e) |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Rhabdomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 0/46.04 |1/44.21 2/44.05 0/44.71 2/44.29 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 4.5% 0.0% 4.5% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |1/35 (3%) 1/34 (3%) 0/41 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 594 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.426 P=0.491 P=0.468N P=0.469 |
|POLY 3 | (e) (e) (e) (e) |P=0.454 P=0.499 P=0.498N P=0.501 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.453 P=0.496 P=0.501N P=0.498 |
|POLY 6 | (e) (e) (e) (e) |P=0.455 P=0.503 P=0.491N P=0.504 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.454 P=0.501 (e) P=0.469 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.454 P=0.500 P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 0/43.35 0/46.04 |1/44.45 1/43.84 2/44.71 1/44.57 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.3% 2.3% 4.5% 2.2% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 2/41 (5%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |666 665 729 (T) 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.644N P=0.741N P=0.551 P=0.746N |
|POLY 3 | (e) (e) (e) (e) |P=0.632N P=0.758 P=0.502 P=0.760N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.634N P=0.757 P=0.497 P=0.760 |
|POLY 6 | (e) (e) (e) (e) |P=0.631N P=0.759 P=0.512 P=0.758N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.636N P=0.757N P=0.501 P=0.757N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.636N P=0.753N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/46.88 2/46.90 2/43.60 0/46.04 |1/44.21 0/43.59 1/44.71 1/44.29 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 4.6% 0.0% |2.3% 0.0% 2.2% 2.3% |
|TERMINAL (d) | 0/37 (0%) 2/43 (5%) 1/34 (3%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 624 726 (T) 659 --- |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.166N P=0.667N P=0.648 P=0.255N |P=0.536 P=0.506N P=0.726N P=0.742 |
|POLY 3 | P=0.161N P=0.693N P=0.667 P=0.241N |P=0.563 P=0.503N P=0.758N P=0.760N |
|POLY 1.5 | P=0.158N P=0.692N P=0.680 P=0.238N |P=0.561 P=0.503N P=0.759 P=0.759 |
|POLY 6 | P=0.165N P=0.694N P=0.654 P=0.245N |P=0.564 P=0.502N P=0.751N P=0.759N |
|LOGISTIC REGRESSION| P=0.151N P=0.674N P=0.642N P=0.182N |P=0.536 (e) P=0.726N P=0.742 |
|COCH-ARM / FISHERS | P=0.154N P=0.684N P=0.684N P=0.242N |P=0.560 P=0.500N P=0.747 P=0.753N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/47.21 2/46.90 0/43.35 1/46.04 |2/44.21 0/43.59 3/44.71 4/44.36 |
|POLY-3 PERCENT (g) | 2.1% 4.3% 0.0% 2.2% |4.5% 0.0% 6.7% 9.0% |
|TERMINAL (d) | 1/37 (3%) 2/43 (5%) 0/34 (0%) 1/40 (3%) |2/35 (6%) 0/34 (0%) 3/41 (7%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |729 (T) --- 729 (T) 712 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.558N P=0.552 P=0.517N P=0.744N |P=0.086 P=0.245N P=0.572 P=0.304 |
|POLY 3 | P=0.567N P=0.498 P=0.517N P=0.755 |P=0.113 P=0.240N P=0.505 P=0.338 |
|POLY 1.5 | P=0.566N P=0.497 P=0.511N P=0.757 |P=0.111 P=0.241N P=0.498 P=0.335 |
|POLY 6 | P=0.568N P=0.501 P=0.523N P=0.754 |P=0.114 P=0.239N P=0.520 P=0.343 |
|LOGISTIC REGRESSION| P=0.558N P=0.552 (e) P=0.744N |P=0.108 (e) P=0.572 P=0.341 |
|COCH-ARM / FISHERS | P=0.566N P=0.500 P=0.500N P=0.753N |P=0.111 P=0.247N P=0.500 P=0.339 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/42.55 0/46.04 |0/44.21 0/43.59 1/44.86 3/44.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.4% 0.0% |0.0% 0.0% 2.2% 6.7% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 1/34 (3%) 0/40 (0%) |0/35 (0%) 0/34 (0%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) --- |--- --- 692 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.470N P=0.743 P=0.484N |P=0.022 * (e) P=0.525 P=0.122 |
|POLY 3 | P=0.467N P=0.501N P=0.737 P=0.505N |P=0.023 * (e) P=0.503 P=0.120 |
|POLY 1.5 | P=0.465N P=0.502N P=0.744 P=0.503N |P=0.022 * (e) P=0.499 P=0.119 |
|POLY 6 | P=0.470N P=0.499N P=0.731 P=0.506N |P=0.023 * (e) P=0.510 P=0.123 |
|LOGISTIC REGRESSION| P=0.459N (e) P=0.743 (e) |P=0.023 * (e) P=0.500 P=0.120 |
|COCH-ARM / FISHERS | P=0.464N P=0.500N P=0.747 P=0.500N |P=0.022 * (e) P=0.500 P=0.121 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/49 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/47.21 0/46.90 1/42.55 0/46.04 |1/44.21 0/43.59 1/44.86 3/44.64 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.4% 0.0% |2.3% 0.0% 2.2% 6.7% |
|TERMINAL (d) | 1/37 (3%) 0/43 (0%) 1/34 (3%) 0/40 (0%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) --- |729 (T) --- 692 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.459N P=0.470N P=0.743 P=0.484N |P=0.078 P=0.506N P=0.728N P=0.296 |
|POLY 3 | P=0.467N P=0.501N P=0.737 P=0.505N |P=0.084 P=0.503N P=0.757N P=0.309 |
|POLY 1.5 | P=0.465N P=0.502N P=0.744 P=0.503N |P=0.083 P=0.503N P=0.760 P=0.305 |
|POLY 6 | P=0.470N P=0.499N P=0.731 P=0.506N |P=0.085 P=0.502N P=0.750N P=0.314 |
|LOGISTIC REGRESSION| P=0.459N (e) P=0.743 (e) |P=0.082 (e) P=0.761N P=0.304 |
|COCH-ARM / FISHERS | P=0.464N P=0.500N P=0.747 P=0.500N |P=0.082 P=0.500N P=0.753N P=0.309 |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/44.21 1/43.59 0/44.71 2/44.76 |
|POLY-3 PERCENT (g) | |0.0% 2.3% 0.0% 4.5% |
|TERMINAL (d) | |0/35 (0%) 1/34 (3%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | |--- 729 (T) --- 595 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.140 P=0.494 (e) P=0.234 |
|POLY 3 | |P=0.150 P=0.497 (e) P=0.240 |
|POLY 1.5 | |P=0.149 P=0.497 (e) P=0.237 |
|POLY 6 | |P=0.152 P=0.498 (e) P=0.243 |
|LOGISTIC REGRESSION| |P=0.149 P=0.494 (e) P=0.243 |
|COCH-ARM / FISHERS | |P=0.149 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |1/44.21 0/43.59 3/44.71 1/44.68 |
|POLY-3 PERCENT (g) | |2.3% 0.0% 6.7% 2.2% |
|TERMINAL (d) | |1/35 (3%) 0/34 (0%) 3/41 (7%) 0/32 (0%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.567 P=0.506N P=0.363 P=0.748 |
|POLY 3 | |P=0.602 P=0.503N P=0.309 P=0.758N |
|POLY 1.5 | |P=0.596 P=0.503N P=0.303 P=0.760 |
|POLY 6 | |P=0.609 P=0.502N P=0.321 P=0.755N |
|LOGISTIC REGRESSION| |P=0.593 (e) P=0.363 P=0.760N |
|COCH-ARM / FISHERS | |P=0.592 P=0.500N P=0.309 P=0.753N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/47.21 1/46.90 0/43.35 2/46.04 |1/44.21 0/43.59 0/44.71 0/44.29 |
|POLY-3 PERCENT (g) | 2.1% 2.1% 0.0% 4.3% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/37 (3%) 1/43 (2%) 0/34 (0%) 2/40 (5%) |1/35 (3%) 0/34 (0%) 0/41 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338 P=0.728N P=0.517N P=0.527 |P=0.515N P=0.506N P=0.468N P=0.518N |
|POLY 3 | P=0.325 P=0.759 P=0.517N P=0.491 |P=0.499N P=0.503N P=0.498N P=0.500N |
|POLY 1.5 | P=0.327 P=0.759 P=0.511N P=0.494 |P=0.498N P=0.503N P=0.501N P=0.501N |
|POLY 6 | P=0.323 P=0.760N P=0.523N P=0.489 |P=0.501N P=0.502N P=0.491N P=0.498N |
|LOGISTIC REGRESSION| P=0.338 P=0.728N (e) P=0.527 |P=0.515N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.329 P=0.753N P=0.500N P=0.500 |P=0.500N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 9/50 (18%) 2/50 (4%) |3/50 (6%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 3/47.72 2/46.90 9/44.70 2/46.42 |3/44.60 1/43.59 1/44.71 2/44.34 |
|POLY-3 PERCENT (g) | 6.3% 4.3% 20.1% 4.3% |6.7% 2.3% 2.2% 4.5% |
|TERMINAL (d) | 1/37 (3%) 2/43 (5%) 5/34 (15%) 1/40 (3%) |2/35 (6%) 1/34 (3%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 624 726 (T) 517 618 |619 729 (T) 729 (T) 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.430N P=0.461N P=0.048 * P=0.502N |P=0.628 P=0.316N P=0.268N P=0.529N |
|POLY 3 | P=0.442N P=0.508N P=0.046 * P=0.513N |P=0.613N P=0.313N P=0.304N P=0.503N |
|POLY 1.5 | P=0.434N P=0.506N P=0.051 P=0.508N |P=0.614N P=0.313N P=0.309N P=0.504N |
|POLY 6 | P=0.451N P=0.507N P=0.042 * P=0.517N |P=0.613N P=0.313N P=0.295N P=0.501N |
|LOGISTIC REGRESSION| P=0.415N P=0.491N P=0.080 P=0.449N |P=0.614N P=0.309N P=0.306N P=0.501N |
|COCH-ARM / FISHERS | P=0.425N P=0.500N P=0.061 P=0.500N |P=0.616N P=0.309N P=0.309N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 9/50 (18%) 4/50 (8%) |4/50 (8%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/47.72 3/46.90 9/44.70 4/46.42 |4/44.60 1/43.59 1/44.71 2/44.34 |
|POLY-3 PERCENT (g) | 8.4% 6.4% 20.1% 8.6% |9.0% 2.3% 2.2% 4.5% |
|TERMINAL (d) | 2/37 (5%) 3/43 (7%) 5/34 (15%) 3/40 (8%) |3/35 (9%) 1/34 (3%) 1/41 (2%) 1/32 (3%) |
|FIRST INCIDENCE | 624 726 (T) 517 618 |619 729 (T) 729 (T) 717 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.566 P=0.444N P=0.092 P=0.626N |P=0.515N P=0.190N P=0.147N P=0.371N |
|POLY 3 | P=0.550 P=0.509N P=0.092 P=0.628 |P=0.477N P=0.185N P=0.178N P=0.340N |
|POLY 1.5 | P=0.557 P=0.508N P=0.100 P=0.633 |P=0.478N P=0.185N P=0.182N P=0.342N |
|POLY 6 | P=0.540 P=0.508N P=0.085 P=0.623 |P=0.478N P=0.185N P=0.169N P=0.338N |
|LOGISTIC REGRESSION| P=0.573 P=0.499N P=0.141 P=0.625N |P=0.478N P=0.183N P=0.178N P=0.336N |
|COCH-ARM / FISHERS | P=0.568 P=0.500N P=0.117 P=0.643N |P=0.482N P=0.181N P=0.181N P=0.339N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |4/50 (8%) 5/50 (10%) 0/50 (0%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/47.21 1/46.96 0/43.35 2/46.20 |4/45.59 5/45.24 0/44.71 3/45.07 |
|POLY-3 PERCENT (g) | 0.0% 2.1% 0.0% 4.3% |8.8% 11.1% 0.0% 6.7% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 0/34 (0%) 1/40 (3%) |0/35 (0%) 2/34 (6%) 0/41 (0%) 1/32 (3%) |
|FIRST INCIDENCE | --- 710 --- 684 |617 444 --- 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150 P=0.514 (e) P=0.241 |P=0.409N P=0.498 P=0.067N P=0.515N |
|POLY 3 | P=0.147 P=0.499 (e) P=0.232 |P=0.396N P=0.495 P=0.063N P=0.506N |
|POLY 1.5 | P=0.148 P=0.498 (e) P=0.234 |P=0.396N P=0.494 P=0.063N P=0.507N |
|POLY 6 | P=0.146 P=0.501 (e) P=0.232 |P=0.398N P=0.494 P=0.061N P=0.507N |
|LOGISTIC REGRESSION| P=0.149 P=0.499 (e) P=0.237 |P=0.381N P=0.565 P=0.050N P=0.470N |
|COCH-ARM / FISHERS | P=0.150 P=0.500 (e) P=0.247 |P=0.395N P=0.500 P=0.059N P=0.500N |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |8/50 (16%) 9/50 (18%) 6/50 (12%) 8/50 (16%) |
|POLY-3 RATE (b) | 0/47.21 0/46.90 1/43.35 1/46.04 |8/44.21 9/44.42 6/45.55 8/44.90 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 2.2% |18.1% 20.3% 13.2% 17.8% |
|TERMINAL (d) | 0/37 (0%) 0/43 (0%) 1/34 (3%) 1/40 (3%) |8/35 (23%) 6/34 (18%) 3/41 (7%) 6/32 (19%) |
|FIRST INCIDENCE | --- --- 726 (T) 726 (T) |729 (T) 610 586 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322 (e) P=0.483 P=0.516 |P=0.541 P=0.483 P=0.288N P=0.541 |
|POLY 3 | P=0.307 (e) P=0.483 P=0.495 |P=0.530N P=0.504 P=0.363N P=0.595N |
|POLY 1.5 | P=0.311 (e) P=0.489 P=0.497 |P=0.536N P=0.494 P=0.383N P=0.606N |
|POLY 6 | P=0.303 (e) P=0.477 P=0.494 |P=0.527N P=0.523 P=0.329N P=0.581N |
|LOGISTIC REGRESSION| (e) (e) P=0.483 P=0.516 |P=0.536N P=0.491 P=0.378N P=0.600N |
|COCH-ARM / FISHERS | P=0.315 (e) P=0.500 P=0.500 |P=0.540N P=0.500 P=0.387N P=0.607N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/50 (60%) 25/50 (50%) 32/50 (64%) 32/50 (64%) |24/50 (48%) 28/50 (56%) 27/50 (54%) 38/50 (76%) |
|POLY-3 RATE (b) | 30/48.13 25/46.90 32/45.49 32/48.33 |24/45.52 28/44.74 27/46.13 38/47.60 |
|POLY-3 PERCENT (g) | 62.3% 53.3% 70.4% 66.2% |52.7% 62.6% 58.5% 79.8% |
|TERMINAL (d) | 27/37 (73%) 25/43 (58%) 23/34 (68%) 27/40 (68%) |20/35 (57%) 23/34 (68%) 24/41 (59%) 27/32 (84%) |
|FIRST INCIDENCE | 511 726 (T) 487 399 |617 594 444 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.043N* P=0.231 P=0.578 |P<0.001 ** P=0.241 P=0.536N P=0.003 ** |
|POLY 3 | P=0.241 P=0.245N P=0.269 P=0.426 |P=0.003 ** P=0.226 P=0.362 P=0.003 ** |
|POLY 1.5 | P=0.232 P=0.237N P=0.317 P=0.421 |P=0.003 ** P=0.232 P=0.335 P=0.003 ** |
|POLY 6 | P=0.252 P=0.240N P=0.247 P=0.440 |P=0.004 ** P=0.225 P=0.410 P=0.004 ** |
|LOGISTIC REGRESSION| P=0.179 P=0.199N P=0.209 P=0.390 |P=0.002 ** P=0.248 P=0.348 P=0.003 ** |
|COCH-ARM / FISHERS | P=0.215 P=0.211N P=0.418 P=0.418 |P=0.003 ** P=0.274 P=0.345 P=0.004 ** |
|=================================================================================================================================|
Date: 06/06/02 EXPERIMENT: 05109 TEST: 14 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - TRIETHANOLAMINE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 24/50 (48%) 27/50 (54%) 21/50 (42%) |27/50 (54%) 26/50 (52%) 16/50 (32%) 21/50 (42%) |
|POLY-3 RATE (b) | 28/50.00 24/48.24 27/48.83 21/48.31 |27/48.01 26/47.70 16/46.06 21/46.59 |
|POLY-3 PERCENT (g) | 56.0% 49.8% 55.3% 43.5% |56.2% 54.5% 34.7% 45.1% |
|TERMINAL (d) | 16/37 (43%) 20/43 (47%) 14/34 (41%) 14/40 (35%) |16/35 (46%) 14/34 (41%) 12/41 (29%) 12/32 (38%) |
|FIRST INCIDENCE | 511 554 439 566 |532 444 573 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174N P=0.169N P=0.454 P=0.135N |P=0.261N P=0.521N P=0.015N* P=0.270N |
|POLY 3 | P=0.150N P=0.339N P=0.552N P=0.149N |P=0.179N P=0.514N P=0.027N* P=0.188N |
|POLY 1.5 | P=0.141N P=0.318N P=0.532N P=0.136N |P=0.170N P=0.521N P=0.026N* P=0.181N |
|POLY 6 | P=0.160N P=0.357N P=0.574N P=0.163N |P=0.196N P=0.505N P=0.028N* P=0.203N |
|LOGISTIC REGRESSION| P=0.112N P=0.263N P=0.291N P=0.088N |P=0.159N P=0.495N P=0.022N* P=0.160N |
|COCH-ARM / FISHERS | P=0.128N P=0.274N P=0.500N P=0.115N |P=0.158N P=0.500N P=0.021N* P=0.158N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 200 630 2000 |0 MG/KG 100 300 1000 |
| | MG/KG MG/KG MG/KG | MG/KG MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 35/50 (70%) 43/50 (86%) 41/50 (82%) |38/50 (76%) 41/50 (82%) 35/50 (70%) 44/50 (88%) |
|POLY-3 RATE (b) | 45/50.00 35/48.24 43/49.23 41/49.70 |38/48.01 41/48.06 35/47.33 44/49.06 |
|POLY-3 PERCENT (g) | 90.0% 72.6% 87.4% 82.5% |79.2% 85.3% 74.0% 89.7% |
|TERMINAL (d) | 33/37 (89%) 31/43 (72%) 28/34 (82%) 32/40 (80%) |27/35 (77%) 27/34 (79%) 29/41 (71%) 29/32 (91%) |
|FIRST INCIDENCE | 511 554 439 399 |532 444 444 70 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516N P=0.005N** P=0.421 P=0.180N |P=0.084 P=0.332 P=0.123N P=0.104 |
|POLY 3 | P=0.518N P=0.022N* P=0.460N P=0.212N |P=0.122 P=0.300 P=0.359N P=0.119 |
|POLY 1.5 | P=0.530N P=0.017N* P=0.433N P=0.204N |P=0.115 P=0.278 P=0.370N P=0.109 |
|POLY 6 | P=0.518N P=0.027N* P=0.479N P=0.225N |P=0.125 P=0.337 P=0.339N P=0.129 |
|LOGISTIC REGRESSION| P=0.556 P=0.014N* P=0.353N P=0.175N |P=0.088 P=0.260 P=0.352N P=0.088 |
|COCH-ARM / FISHERS | P=0.559 P=0.011N* P=0.380N P=0.194N |P=0.095 P=0.312 P=0.326N P=0.096 |
|=================================================================================================================================|
(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).