TDMS Study 97013-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 06 TIME: 10:46:16
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 64 MG/KG
INCLUDE 004 64 MG/KG
INCLUDE 005 128 MG/KG
INCLUDE 006 128 MG/KG
INCLUDE 007 256 MG/KG
INCLUDE 008 256 MG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 06 TIME: 10:46:16
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
PATHOLOGIST: MISSING CAS: 75-27-4
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 WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 06 TIME: 10:46:16
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-65406 ROUTE: SKIN APPLICATION NTP C#: 97013F
PATHOLOGIST: MISSING CAS: 75-27-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF WATER DISINFECTION MODEL (BROMODICHLOR
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Tooth Odontogenic Tumor
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
All Organs Benign Tumors
===============================================================
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 3/15 (20%) 3/15 (20%) 4/15 (27%) |1/15 (7%) 5/15 (33%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.69 3/14.38 3/15.00 4/13.85 |1/12.19 5/12.21 2/12.88 1/11.87 |
|POLY-3 PERCENT (g) | 7.3% 20.9% 20.0% 28.9% |8.2% 40.9% 15.5% 8.4% |
|TERMINAL (d) | 1/13 (8%) 3/14 (21%) 3/15 (20%) 4/13 (31%) |1/11 (9%) 5/10 (50%) 2/12 (17%) 1/10 (10%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 183 (T) |184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.133 P=0.325 P=0.352 P=0.165 |P=0.352N P=0.060 P=0.532 P=0.744 |
|POLY 3 | P=0.147 P=0.316 P=0.333 P=0.163 |P=0.337N P=0.072 P=0.520 P=0.757 |
|POLY 1.5 | P=0.146 P=0.309 P=0.320 P=0.163 |P=0.331N P=0.076 P=0.516 P=0.760 |
|POLY 6 | P=0.147 P=0.321 P=0.345 P=0.163 |P=0.351N P=0.066 P=0.521 P=0.751 |
|LOGISTIC REGRESSION| P=0.133 P=0.325 P=0.352 P=0.165 |P=0.352N P=0.060 P=0.532 P=0.744 |
|COCH-ARM / FISHERS | P=0.142 P=0.299 P=0.299 P=0.165 |P=0.334N P=0.084 P=0.500 P=0.759N |
|ORDER RESTRICTED | P=0.127 (e) (e) (e) |P=0.237N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/15 (27%) 4/15 (27%) 6/15 (40%) 6/15 (40%) |2/15 (13%) 4/15 (27%) 5/15 (33%) 4/15 (27%) |
|POLY-3 RATE (b) | 4/13.69 4/14.38 6/15.00 6/14.24 |2/12.19 4/12.21 5/12.88 4/11.87 |
|POLY-3 PERCENT (g) | 29.2% 27.8% 40.0% 42.1% |16.4% 32.8% 38.8% 33.7% |
|TERMINAL (d) | 4/13 (31%) 4/14 (29%) 6/15 (40%) 5/13 (39%) |2/11 (18%) 4/10 (40%) 5/12 (42%) 4/10 (40%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 155 |184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.224 P=0.615N P=0.456 P=0.359 |P=0.244 P=0.272 P=0.226 P=0.272 |
|POLY 3 | P=0.252 P=0.628N P=0.418 P=0.378 |P=0.266 P=0.321 P=0.210 P=0.306 |
|POLY 1.5 | P=0.244 P=0.638N P=0.393 P=0.367 |P=0.278 P=0.329 P=0.208 P=0.317 |
|POLY 6 | P=0.262 P=0.619N P=0.441 P=0.392 |P=0.248 P=0.310 P=0.210 P=0.291 |
|LOGISTIC REGRESSION| P=0.228 P=0.615N P=0.456 P=0.355 |P=0.244 P=0.272 P=0.226 P=0.272 |
|COCH-ARM / FISHERS | P=0.229 P=0.659N P=0.350 P=0.350 |P=0.290 P=0.326 P=0.195 P=0.326 |
|ORDER RESTRICTED | P=0.369 (e) (e) (e) |P=0.235 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|Tooth |
| Odontogenic Tumor |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/15 (20%) 3/15 (20%) 0/15 (0%) 0/15 (0%) |2/15 (13%) 3/15 (20%) 2/15 (13%) 1/15 (7%) |
|POLY-3 RATE (b) | 3/14.46 3/14.38 0/15.00 0/13.85 |2/12.54 3/13.32 2/13.50 1/11.87 |
|POLY-3 PERCENT (g) | 20.8% 20.9% 0.0% 0.0% |16.0% 22.5% 14.8% 8.4% |
|TERMINAL (d) | 2/13 (15%) 3/14 (21%) 0/15 (0%) 0/13 (0%) |1/11 (9%) 1/10 (10%) 1/12 (8%) 1/10 (10%) |
|FIRST INCIDENCE | 113 183 (T) --- --- |160 126 133 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.639N P=0.105N P=0.121N |P=0.324N P=0.475 P=0.671N P=0.532N |
|POLY 3 | P=0.027N* P=0.669 P=0.099N P=0.113N |P=0.326N P=0.529 P=0.673N P=0.520N |
|POLY 1.5 | P=0.027N* P=0.669 P=0.102N P=0.111N |P=0.316N P=0.523 P=0.678N P=0.509N |
|POLY 6 | P=0.027N* P=0.670 P=0.096N P=0.116N |P=0.343N P=0.530 P=0.672N P=0.537N |
|LOGISTIC REGRESSION| P=0.032N* P=0.631 P=0.231N P=0.110N |P=0.303N P=0.494 P=0.698 P=0.508N |
|COCH-ARM / FISHERS | P=0.029N* P=0.674N P=0.112N P=0.112N |P=0.304N P=0.500 P=0.701N P=0.500N |
|ORDER RESTRICTED | P=0.046N* (e) (e) (e) |P=0.380N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/15 (33%) 7/15 (47%) 8/15 (53%) 8/15 (53%) |3/15 (20%) 8/15 (53%) 7/15 (47%) 5/15 (33%) |
|POLY-3 RATE (b) | 5/13.69 7/14.38 8/15.00 8/14.24 |3/12.19 8/12.21 7/12.88 5/11.87 |
|POLY-3 PERCENT (g) | 36.5% 48.7% 53.3% 56.2% |24.6% 65.5% 54.4% 42.1% |
|TERMINAL (d) | 5/13 (39%) 7/14 (50%) 8/15 (53%) 7/13 (54%) |3/11 (27%) 8/10 (80%) 7/12 (58%) 5/10 (50%) |
|FIRST INCIDENCE | 183 (T) 183 (T) 183 (T) 155 |184 (T) 184 (T) 184 (T) 184 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181 P=0.416 P=0.345 P=0.240 |P=0.384 P=0.027 * P=0.145 P=0.272 |
|POLY 3 | P=0.218 P=0.396 P=0.302 P=0.255 |P=0.411 P=0.041 * P=0.127 P=0.316 |
|POLY 1.5 | P=0.207 P=0.382 P=0.275 P=0.245 |P=0.430 P=0.049 * P=0.128 P=0.329 |
|POLY 6 | P=0.232 P=0.409 P=0.329 P=0.270 |P=0.379 P=0.033 * P=0.127 P=0.296 |
|LOGISTIC REGRESSION| P=0.187 P=0.416 P=0.345 P=0.234 |P=0.384 P=0.027 * P=0.145 P=0.272 |
|COCH-ARM / FISHERS | P=0.191 P=0.355 P=0.231 P=0.231 |P=0.446 P=0.064 P=0.123 P=0.341 |
|ORDER RESTRICTED | P=0.248 (e) (e) (e) |P=0.104 (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 27 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 0/15 (0%) |1/15 (7%) 2/15 (13%) 0/15 (0%) 1/15 (7%) |
|POLY-3 RATE (b) | 1/13.69 1/15.00 0/15.00 0/13.85 |1/12.19 2/12.97 0/12.88 1/12.38 |
|POLY-3 PERCENT (g) | 7.3% 6.7% 0.0% 0.0% |8.2% 15.4% 0.0% 8.1% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/15 (0%) 0/13 (0%) |1/11 (9%) 0/10 (0%) 0/12 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 183 (T) 133 --- --- |184 (T) 126 --- 145 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234N P=0.744N P=0.471N P=0.500N |P=0.510N P=0.489 P=0.483N P=0.750 |
|POLY 3 | P=0.232N P=0.740N P=0.482N P=0.498N |P=0.493N P=0.522 P=0.489N P=0.759N |
|POLY 1.5 | P=0.234N P=0.748N P=0.489N P=0.498N |P=0.494N P=0.517 P=0.491N P=0.759N |
|POLY 6 | P=0.231N P=0.733N P=0.475N P=0.498N |P=0.493N P=0.525 P=0.488N P=0.760N |
|LOGISTIC REGRESSION| P=0.248N P=0.705 (e) (e) |P=0.498N P=0.497 (e) P=0.768N |
|COCH-ARM / FISHERS | P=0.233N P=0.759N P=0.500N P=0.500N |P=0.500N P=0.500 P=0.500N P=0.759N |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.379N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 64 MG/KG 128 256 |0 MG/KG 64 MG/KG 128 256 |
| | MG/KG MG/KG | MG/KG MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/15 (60%) 9/15 (60%) 8/15 (53%) 8/15 (53%) |6/15 (40%) 11/15 (73%) 8/15 (53%) 6/15 (40%) |
|POLY-3 RATE (b) | 9/14.46 9/15.00 8/15.00 8/14.24 |6/12.54 11/13.40 8/13.50 6/12.38 |
|POLY-3 PERCENT (g) | 62.3% 60.0% 53.3% 56.2% |47.9% 82.1% 59.3% 48.5% |
|TERMINAL (d) | 8/13 (62%) 8/14 (57%) 8/15 (53%) 7/13 (54%) |5/11 (46%) 8/10 (80%) 7/12 (58%) 5/10 (50%) |
|FIRST INCIDENCE | 113 133 183 (T) 155 |160 126 133 145 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.408N P=0.550N P=0.344N P=0.495N |P=0.404N P=0.062 P=0.438 P=0.570 |
|POLY 3 | P=0.424N P=0.597N P=0.455N P=0.519N |P=0.352N P=0.067 P=0.426 P=0.642 |
|POLY 1.5 | P=0.418N P=0.615N P=0.473N P=0.516N |P=0.340N P=0.065 P=0.411 P=0.649 |
|POLY 6 | P=0.423N P=0.575N P=0.433N P=0.514N |P=0.383N P=0.069 P=0.430 P=0.623 |
|LOGISTIC REGRESSION| P=0.396N P=0.623 P=0.518N P=0.496N |P=0.354N P=0.058 P=0.401 P=0.629 |
|COCH-ARM / FISHERS | P=0.396N P=0.645N P=0.500N P=0.500N |P=0.347N P=0.070 P=0.358 P=0.645N |
|ORDER RESTRICTED | P=0.544N (e) (e) (e) |P=0.300N (e) (e) (e) |
|=================================================================================================================================|
(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).