TDMS Study 88133-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE DATE: 10/30/02
EXPERIMENT: 88133 TEST: 06 TIME: 10:08:39
TEST TYPE: SUBCHRON 26-WEEK PAGE: 1
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B
PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5
------------------------------------------------------------------------------------------------------------------------------------
Final#3
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 0.75 MG/KG
INCLUDE 004 0.75 MG/KG
INCLUDE 005 1.5 MG/KG
INCLUDE 006 1.5 MG/KG
INCLUDE 007 3 MG/KG
INCLUDE 008 3 MG/KG
INCLUDE 009 6 MG/KG
INCLUDE 010 6 MG/KG
INCLUDE 011 12 MG/KG
INCLUDE 012 12 MG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE DATE: 10/30/02
EXPERIMENT: 88133 TEST: 06 TIME: 10:08:39
TEST TYPE: SUBCHRON 26-WEEK
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B
PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5
Mice(TG.AC HETEROZYGOUS TRANSGENIC)
-----------------------------
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.
---------------
Lung
Salivary Glands
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus TRIMETHYLOLPROPANE TRIACRYLATE DATE: 10/30/02
EXPERIMENT: 88133 TEST: 06 TIME: 10:08:39
TEST TYPE: SUBCHRON 26-WEEK
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 88133B
PATHOLOGIST: TOFT, JOHN CAS: 15625-89-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF TRIMETHYLOLPROPANE TRIACRYLATE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Squamous Cell Papilloma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Squamous Cell Papilloma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Stomach, Forestomach Squamous Cell Papilloma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 2/14.33 12/14.11 13/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 14.0% 85.1% 86.7% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 2/14 (14%) 11/13 (85%) 9/11 (82%) |
|FIRST INCIDENCE | --- --- --- 192 (T) 180 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.232 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 2/15 (13%) 11/15 (73%) 15/15 (100%) |
|POLY-3 RATE (b) | 0/15.00 1/14.85 1/12.32 2/14.27 11/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 8.1% 14.0% 73.3% 100.0% |
|TERMINAL (d) | 0/15 (0%) 1/14 (7%) 1/12 (8%) 2/14 (14%) 10/14 (71%) 12/12 (100%) |
|FIRST INCIDENCE | --- 193 (T) 193 (T) 193 (T) 162 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.486 P=0.455 P=0.221 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.498 P=0.461 P=0.220 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.499 P=0.470 P=0.224 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.496 P=0.457 P=0.217 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.486 P=0.455 P=0.221 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 2/14.33 12/14.11 13/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 14.0% 85.1% 86.7% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 2/14 (14%) 11/13 (85%) 9/11 (82%) |
|FIRST INCIDENCE | --- --- --- 192 (T) 180 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.232 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 2/15 (13%) 11/15 (73%) 15/15 (100%) |
|POLY-3 RATE (b) | 0/15.00 1/14.85 0/12.32 2/14.27 11/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 14.0% 73.3% 100.0% |
|TERMINAL (d) | 0/15 (0%) 1/14 (7%) 0/12 (0%) 2/14 (14%) 10/14 (71%) 12/12 (100%) |
|FIRST INCIDENCE | --- 193 (T) --- 193 (T) 162 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.486 (e) P=0.221 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.498 (e) P=0.220 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.499 (e) P=0.224 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.496 (e) P=0.217 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.486 (e) P=0.221 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 2/15 (13%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 2/14.33 12/14.11 13/15.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 14.0% 85.1% 86.7% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 2/14 (14%) 11/13 (85%) 9/11 (82%) |
|FIRST INCIDENCE | --- --- --- 192 (T) 180 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.234 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.232 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) P=0.236 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 1/15 (7%) 2/15 (13%) 11/15 (73%) 15/15 (100%) |
|POLY-3 RATE (b) | 0/15.00 1/14.85 1/12.32 2/14.27 11/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 8.1% 14.0% 73.3% 100.0% |
|TERMINAL (d) | 0/15 (0%) 1/14 (7%) 1/12 (8%) 2/14 (14%) 10/14 (71%) 12/12 (100%) |
|FIRST INCIDENCE | --- 193 (T) 193 (T) 193 (T) 162 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.486 P=0.455 P=0.221 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.498 P=0.461 P=0.220 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.499 P=0.470 P=0.224 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.496 P=0.457 P=0.217 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.486 P=0.455 P=0.221 (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 P=0.241 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 5/15 (33%) 7/15 (47%) 1/15 (7%) 4/15 (27%) 3/15 (20%) 2/15 (13%) |
|POLY-3 RATE (b) | 5/15.00 7/15.00 1/12.73 4/14.33 3/13.93 2/14.02 |
|POLY-3 PERCENT (g) | 33.3% 46.7% 7.9% 27.9% 21.5% 14.3% |
|TERMINAL (d) | 4/14 (29%) 7/15 (47%) 1/12 (8%) 4/14 (29%) 3/13 (23%) 2/11 (18%) |
|FIRST INCIDENCE | 101 192 (T) 192 (T) 192 (T) 192 (T) 192 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.176N P=0.413 P=0.132N P=0.500N P=0.390N P=0.296N |
|POLY 3 | P=0.095N P=0.358 P=0.121N P=0.532N P=0.387N P=0.224N |
|POLY 1.5 | P=0.092N P=0.358 P=0.108N P=0.520N P=0.374N P=0.211N |
|POLY 6 | P=0.105N P=0.358 P=0.131N P=0.543N P=0.398N P=0.245N |
|LOGISTIC REGRESSION| P=0.099N P=0.413 P=0.073N P=0.521N P=0.332N P=0.206N |
|COCH-ARM / FISHERS | P=0.100N P=0.355 P=0.084N P=0.500N P=0.341N P=0.195N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 4/15 (27%) 5/15 (33%) 4/15 (27%) 2/15 (13%) 5/15 (33%) 9/15 (60%) |
|POLY-3 RATE (b) | 4/15.00 5/14.85 4/12.32 2/14.27 5/14.59 9/13.93 |
|POLY-3 PERCENT (g) | 26.7% 33.7% 32.5% 14.0% 34.3% 64.6% |
|TERMINAL (d) | 4/15 (27%) 5/14 (36%) 4/12 (33%) 2/14 (14%) 5/14 (36%) 9/12 (75%) |
|FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) 193 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.006 ** P=0.451 P=0.518 P=0.360N P=0.451 P=0.019 * |
|POLY 3 | P=0.014 * P=0.493 P=0.535 P=0.352N P=0.481 P=0.040 * |
|POLY 1.5 | P=0.015 * P=0.496 P=0.563 P=0.343N P=0.489 P=0.048 * |
|POLY 6 | P=0.012 * P=0.487 P=0.521 P=0.359N P=0.469 P=0.032 * |
|LOGISTIC REGRESSION| P=0.006 ** P=0.451 P=0.518 P=0.360N P=0.451 P=0.019 * |
|COCH-ARM / FISHERS | P=0.018 * P=0.500 P=0.659N P=0.326N P=0.500 P=0.070 |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Odontogenic Tumor |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/15 (7%) 3/15 (20%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/14.15 3/15.00 1/13.18 0/14.33 1/14.11 1/14.02 |
|POLY-3 PERCENT (g) | 7.1% 20.0% 7.6% 0.0% 7.1% 7.1% |
|TERMINAL (d) | 1/14 (7%) 3/15 (20%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) |
|FIRST INCIDENCE | 192 (T) 192 (T) 157 --- 180 192 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.469N P=0.324 P=0.735 P=0.500N P=0.752 P=0.710 |
|POLY 3 | P=0.403N P=0.320 P=0.745 P=0.497N P=0.760 P=0.759 |
|POLY 1.5 | P=0.402N P=0.314 P=0.748 P=0.497N P=0.760 P=0.760N |
|POLY 6 | P=0.408N P=0.324 P=0.744 P=0.499N P=0.761 P=0.751 |
|LOGISTIC REGRESSION| P=0.410N P=0.324 P=0.758N (e) P=0.768 P=0.710 |
|COCH-ARM / FISHERS | P=0.410N P=0.299 P=0.759N P=0.500N P=0.759N P=0.759N |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Odontogenic Tumor |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/15 (7%) 4/15 (27%) 2/15 (13%) 0/15 (0%) 3/15 (20%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/15.00 4/14.85 2/12.32 0/14.27 3/15.00 1/13.93 |
|POLY-3 PERCENT (g) | 6.7% 26.9% 16.2% 0.0% 20.0% 7.2% |
|TERMINAL (d) | 1/15 (7%) 4/14 (29%) 2/12 (17%) 0/14 (0%) 2/14 (14%) 1/12 (8%) |
|FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) --- 162 193 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.446N P=0.147 P=0.420 P=0.514N P=0.285 P=0.714 |
|POLY 3 | P=0.397N P=0.160 P=0.431 P=0.510N P=0.298 P=0.744 |
|POLY 1.5 | P=0.390N P=0.161 P=0.446 P=0.507N P=0.298 P=0.750 |
|POLY 6 | P=0.408N P=0.157 P=0.423 P=0.513N P=0.298 P=0.737 |
|LOGISTIC REGRESSION| P=0.391N P=0.147 P=0.420 (e) (e) P=0.714 |
|COCH-ARM / FISHERS | P=0.389N P=0.165 P=0.500 P=0.500N P=0.299 P=0.759N |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Erythrocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 0/14.15 0/15.00 0/12.73 0/14.33 0/13.93 1/14.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 7.1% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 0/12 (0%) 0/14 (0%) 0/13 (0%) 1/11 (9%) |
|FIRST INCIDENCE | --- --- --- --- --- 192 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.082 (e) (e) (e) (e) P=0.452 |
|POLY 3 | P=0.106 (e) (e) (e) (e) P=0.498 |
|POLY 1.5 | P=0.107 (e) (e) (e) (e) P=0.501 |
|POLY 6 | P=0.103 (e) (e) (e) (e) P=0.491 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.452 |
|COCH-ARM / FISHERS | P=0.105 (e) (e) (e) (e) P=0.500 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Erythrocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 1/15 (7%) 0/15 (0%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/15.00 1/14.85 0/12.32 1/14.27 0/14.59 2/14.94 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 7.0% 0.0% 13.4% |
|TERMINAL (d) | 0/15 (0%) 1/14 (7%) 0/12 (0%) 1/14 (7%) 0/14 (0%) 0/12 (0%) |
|FIRST INCIDENCE | --- 193 (T) --- 193 (T) --- 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.118 P=0.486 (e) P=0.486 (e) P=0.232 |
|POLY 3 | P=0.137 P=0.498 (e) P=0.490 (e) P=0.231 |
|POLY 1.5 | P=0.135 P=0.499 (e) P=0.493 (e) P=0.231 |
|POLY 6 | P=0.137 P=0.496 (e) P=0.487 (e) P=0.230 |
|LOGISTIC REGRESSION| P=0.107 P=0.486 (e) P=0.486 (e) (e) |
|COCH-ARM / FISHERS | P=0.125 P=0.500 (e) P=0.500 (e) P=0.241 |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 5/15 (33%) 7/15 (47%) 1/15 (7%) 5/15 (33%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 5/15.00 7/15.00 1/12.73 5/14.33 12/14.11 13/15.00 |
|POLY-3 PERCENT (g) | 33.3% 46.7% 7.9% 34.9% 85.1% 86.7% |
|TERMINAL (d) | 4/14 (29%) 7/15 (47%) 1/12 (8%) 5/14 (36%) 11/13 (85%) 9/11 (82%) |
|FIRST INCIDENCE | 101 192 (T) 192 (T) 192 (T) 180 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.413 P=0.132N P=0.644 P=0.014 * P=0.005 ** |
|POLY 3 | P<0.001 ** P=0.358 P=0.121N P=0.614 P=0.003 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.358 P=0.108N P=0.626 P=0.004 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.358 P=0.131N P=0.603 P=0.002 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.413 P=0.073N P=0.636 P=0.013 * (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.355 P=0.084N P=0.650N P=0.013 * P=0.004 ** |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 5/15 (33%) 5/15 (33%) 4/15 (27%) 4/15 (27%) 11/15 (73%) 15/15 (100%) |
|POLY-3 RATE (b) | 5/15.00 5/14.85 4/12.32 4/14.27 11/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 33.3% 33.7% 32.5% 28.0% 73.3% 100.0% |
|TERMINAL (d) | 5/15 (33%) 5/14 (36%) 4/12 (33%) 4/14 (29%) 10/14 (71%) 12/12 (100%) |
|FIRST INCIDENCE | 193 (T) 193 (T) 193 (T) 193 (T) 162 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.599 P=0.657 P=0.549N P=0.029 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.639 P=0.635N P=0.535N P=0.027 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.642 P=0.606N P=0.523N P=0.027 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.633 P=0.649N P=0.544N P=0.027 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.599 P=0.657 P=0.549N (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.650N P=0.500N P=0.500N P=0.033 * P<0.001 ** |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 0/15 (0%) 0/15 (0%) 2/15 (13%) 1/15 (7%) 0/15 (0%) 2/15 (13%) |
|POLY-3 RATE (b) | 0/14.15 0/15.00 2/13.60 1/15.00 0/13.93 2/14.02 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 14.7% 6.7% 0.0% 14.3% |
|TERMINAL (d) | 0/14 (0%) 0/15 (0%) 1/12 (8%) 0/14 (0%) 0/13 (0%) 2/11 (18%) |
|FIRST INCIDENCE | --- --- 95 132 --- 192 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.170 (e) P=0.216 P=0.514 (e) P=0.183 |
|POLY 3 | P=0.182 (e) P=0.222 P=0.512 (e) P=0.229 |
|POLY 1.5 | P=0.189 (e) P=0.224 P=0.508 (e) P=0.232 |
|POLY 6 | P=0.173 (e) P=0.219 P=0.513 (e) P=0.220 |
|LOGISTIC REGRESSION| P=0.139 (e) P=0.316 P=0.324 (e) P=0.183 |
|COCH-ARM / FISHERS | P=0.197 (e) P=0.241 P=0.500 (e) P=0.241 |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 1/15 (7%) 2/15 (13%) 1/15 (7%) 1/15 (7%) 1/15 (7%) 3/15 (20%) |
|POLY-3 RATE (b) | 1/15.00 2/15.00 1/12.32 1/14.27 1/14.59 3/14.94 |
|POLY-3 PERCENT (g) | 6.7% 13.3% 8.1% 7.0% 6.9% 20.1% |
|TERMINAL (d) | 1/15 (7%) 1/14 (7%) 1/12 (8%) 1/14 (7%) 1/14 (7%) 1/12 (8%) |
|FIRST INCIDENCE | 193 (T) 183 193 (T) 193 (T) 193 (T) 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.169 P=0.484 P=0.714 P=0.749 P=0.749 P=0.262 |
|POLY 3 | P=0.213 P=0.500 P=0.715 P=0.749 P=0.754 P=0.297 |
|POLY 1.5 | P=0.211 P=0.500 P=0.726 P=0.753 P=0.757 P=0.298 |
|POLY 6 | P=0.213 P=0.500 P=0.710 P=0.746 P=0.751 P=0.295 |
|LOGISTIC REGRESSION| P=0.189 (e) P=0.714 P=0.749 P=0.749 P=0.763 |
|COCH-ARM / FISHERS | P=0.194 P=0.500 P=0.759N P=0.759N P=0.759N P=0.299 |
|=================================================================================================================================|
Date: 10/30/02 EXPERIMENT: 88133 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - TRIMETHYLOLPROPANE TRIACRYLATE
Terminal Sacrifice at 28 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 6/15 (40%) 8/15 (53%) 4/15 (27%) 6/15 (40%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 6/15.00 8/15.00 4/14.06 6/15.00 12/14.11 13/15.00 |
|POLY-3 PERCENT (g) | 40.0% 53.3% 28.5% 40.0% 85.1% 86.7% |
|TERMINAL (d) | 5/14 (36%) 8/15 (53%) 2/12 (17%) 5/14 (36%) 11/13 (85%) 9/11 (82%) |
|FIRST INCIDENCE | 101 192 (T) 95 132 180 161 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.425 P=0.456N P=0.629N P=0.029 * P=0.011 * |
|POLY 3 | P<0.001 ** P=0.361 P=0.399N P=0.641 P=0.011 * P=0.006 ** |
|POLY 1.5 | P<0.001 ** P=0.361 P=0.389N P=0.641 P=0.013 * P=0.006 ** |
|POLY 6 | P<0.001 ** P=0.361 P=0.402N P=0.641 P=0.010 * P=0.006 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.425 P=0.260N (e) P=0.030 * (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.358 P=0.350N P=0.645N P=0.030 * P=0.010 * |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 0.75 1.5 3 MG/KG 6 MG/KG 12 MG/KG |
| | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # # # |
|----------- | |
|OVERALL (a) | 6/15 (40%) 9/15 (60%) 6/15 (40%) 5/15 (33%) 12/15 (80%) 15/15 (100%) |
|POLY-3 RATE (b) | 6/15.00 9/15.00 6/12.32 5/14.27 12/15.00 15/15.00 |
|POLY-3 PERCENT (g) | 40.0% 60.0% 48.7% 35.1% 80.0% 100.0% |
|TERMINAL (d) | 6/15 (40%) 8/14 (57%) 6/12 (50%) 5/14 (36%) 11/14 (79%) 12/12 (100%) |
|FIRST INCIDENCE | 193 (T) 183 193 (T) 193 (T) 162 118 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.197 P=0.449 P=0.557N P=0.026 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.236 P=0.474 P=0.541N P=0.024 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.236 P=0.513 P=0.527N P=0.024 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.236 P=0.455 P=0.552N P=0.024 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.449 P=0.557N (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.233 P=0.645N P=0.500N P=0.030 * P<0.001 ** |
|=================================================================================================================================|
(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).