TDMS Study 97013-98 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/04/03
EXPERIMENT: 97013 TEST: 98 TIME: 14:17:58
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013K
PATHOLOGIST: MISSING CAS: 75-27-4
------------------------------------------------------------------------------------------------------------------------------------
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 WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/04/03
EXPERIMENT: 97013 TEST: 98 TIME: 14:17:58
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013K
PATHOLOGIST: MISSING CAS: 75-27-4
Mice(P53 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.
---------------
Adrenal Cortex
Liver
Lung
Pituitary Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 11/04/03
EXPERIMENT: 97013 TEST: 98 TIME: 14:17:58
TEST TYPE: 26-39 WEEKS CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013K
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
----- ----------
Liver Hepatocellular Adenoma
===============================================================
Date: 11/04/03 EXPERIMENT: 97013 TEST: 98 Page 1
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/9.02 0/10.00 0/10.00 |1/10.00 2/10.00 0/8.66 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.0% 20.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |0/9 (0%) 1/9 (11%) 0/8 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- |258 275 --- 260 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.502N P=0.512 P=0.545N P=0.749N |
|POLY 3 | (e) (e) (e) (e) |P=0.512N P=0.500 P=0.528N P=0.760 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.510N P=0.500 P=0.525N P=0.760 |
|POLY 6 | (e) (e) (e) (e) |P=0.514N P=0.500 P=0.534N P=0.760 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.495N (e) P=0.477N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.500 P=0.500N P=0.763N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.384N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/9.02 0/10.00 0/10.00 |0/9.71 0/9.86 0/8.66 0/9.73 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |0/9 (0%) 0/9 (0%) 0/8 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 288 (T) --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.112N P=0.257N P=0.234N P=0.234N |(e) (e) (e) (e) |
|POLY 3 | P=0.095N P=0.252N P=0.227N P=0.227N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.096N P=0.248N P=0.227N P=0.227N |(e) (e) (e) (e) |
|POLY 6 | P=0.095N P=0.252N P=0.227N P=0.227N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.112N P=0.251N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.110N P=0.237N P=0.237N P=0.237N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.023N* (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 98 Page 2
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |0/10 (0%) 1/10 (10%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/9.02 1/10.00 1/10.00 |0/9.71 1/9.86 2/8.66 0/9.73 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 10.0% 10.0% |0.0% 10.1% 23.1% 0.0% |
|TERMINAL (d) | 1/10 (10%) 0/9 (0%) 1/10 (10%) 1/10 (10%) |0/9 (0%) 1/9 (11%) 2/8 (25%) 0/9 (0%) |
|FIRST INCIDENCE | 288 (T) --- 288 (T) 288 (T) |--- 289 (T) 289 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.549 P=0.521N P=0.766 P=0.766 |P=0.620N P=0.500 P=0.207 (e) |
|POLY 3 | P=0.556 P=0.521N P=0.760 P=0.760 |P=0.620N P=0.503 P=0.199 (e) |
|POLY 1.5 | P=0.554 P=0.518N P=0.760 P=0.760 |P=0.620N P=0.502 P=0.200 (e) |
|POLY 6 | P=0.557 P=0.521N P=0.760 P=0.760 |P=0.620N P=0.505 P=0.197 (e) |
|LOGISTIC REGRESSION| P=0.549 (e) P=0.766 P=0.766 |(e) P=0.500 P=0.207 (e) |
|COCH-ARM / FISHERS | P=0.540 P=0.500N P=0.763N P=0.763N |P=0.620N P=0.500 P=0.237 (e) |
|ORDER RESTRICTED | P=0.548 (e) (e) (e) |P=0.291 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |1/10 (10%) 2/10 (20%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/9.02 0/10.00 0/10.00 |1/10.00 2/10.00 0/8.66 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |10.0% 20.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |0/9 (0%) 1/9 (11%) 0/8 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- |258 275 --- 260 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.502N P=0.512 P=0.545N P=0.749N |
|POLY 3 | (e) (e) (e) (e) |P=0.512N P=0.500 P=0.528N P=0.760 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.510N P=0.500 P=0.525N P=0.760 |
|POLY 6 | (e) (e) (e) (e) |P=0.514N P=0.500 P=0.534N P=0.760 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.495N (e) P=0.477N (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.500N P=0.500 P=0.500N P=0.763N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.384N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 98 Page 3
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |0/10 (0%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/9.02 0/10.00 3/10.00 |0/9.71 2/9.86 1/8.66 0/9.73 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 30.0% |0.0% 20.3% 11.5% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/9 (0%) 0/10 (0%) 3/10 (30%) |0/9 (0%) 2/9 (22%) 1/8 (13%) 0/9 (0%) |
|FIRST INCIDENCE | 288 (T) --- --- 288 (T) |--- 289 (T) 289 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248 P=0.257N P=0.234N P=0.500 |P=0.464N P=0.233 P=0.477 (e) |
|POLY 3 | P=0.244 P=0.252N P=0.227N P=0.500 |P=0.462N P=0.230 P=0.477 (e) |
|POLY 1.5 | P=0.242 P=0.248N P=0.227N P=0.500 |P=0.463N P=0.228 P=0.478 (e) |
|POLY 6 | P=0.245 P=0.252N P=0.227N P=0.500 |P=0.462N P=0.232 P=0.476 (e) |
|LOGISTIC REGRESSION| P=0.248 P=0.251N (e) P=0.500 |(e) P=0.233 P=0.477 (e) |
|COCH-ARM / FISHERS | P=0.234 P=0.237N P=0.237N P=0.500 |P=0.460N P=0.237 P=0.500 (e) |
|ORDER RESTRICTED | P=0.081 (e) (e) (e) |P=0.300N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 1/10 (10%) 1/10 (10%) |1/10 (10%) 2/10 (20%) 3/10 (30%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 2/10.00 1/10.00 1/10.00 |1/10.00 2/10.00 3/9.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 20.0% 10.0% 10.0% |10.0% 20.0% 33.3% 10.0% |
|TERMINAL (d) | 1/10 (10%) 1/9 (11%) 1/10 (10%) 1/10 (10%) |0/9 (0%) 1/9 (11%) 2/8 (25%) 0/9 (0%) |
|FIRST INCIDENCE | 288 (T) 77 288 (T) 288 (T) |258 275 252 260 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.521N P=0.475 P=0.766 P=0.766 |P=0.579N P=0.512 P=0.257 P=0.749N |
|POLY 3 | P=0.531N P=0.500 P=0.760 P=0.760 |P=0.584N P=0.500 P=0.251 P=0.760 |
|POLY 1.5 | P=0.531N P=0.500 P=0.760 P=0.760 |P=0.584N P=0.500 P=0.251 P=0.760 |
|POLY 6 | P=0.531N P=0.500 P=0.760 P=0.760 |P=0.584N P=0.500 P=0.251 P=0.760 |
|LOGISTIC REGRESSION| P=0.521N (e) P=0.766 P=0.766 |P=0.580N (e) P=0.282 (e) |
|COCH-ARM / FISHERS | P=0.532N P=0.500 P=0.763N P=0.763N |P=0.584N P=0.500 P=0.291 P=0.763N |
|ORDER RESTRICTED | P=0.583N (e) (e) (e) |P=0.414 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/04/03 EXPERIMENT: 97013 TEST: 98 Page 4
Statistical Analysis of Primary Tumors in Mice(P53 Heterozygous Transgenic) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 42 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 25 MG/KG 50 MG/KG 100 |0 MG/KG 25 MG/KG 50 MG/KG 100 |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/10 (30%) 2/10 (20%) 1/10 (10%) 4/10 (40%) |1/10 (10%) 4/10 (40%) 4/10 (40%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/10.00 2/10.00 1/10.00 4/10.00 |1/10.00 4/10.00 4/9.00 1/10.00 |
|POLY-3 PERCENT (g) | 30.0% 20.0% 10.0% 40.0% |10.0% 40.0% 44.4% 10.0% |
|TERMINAL (d) | 3/10 (30%) 1/9 (11%) 1/10 (10%) 4/10 (40%) |0/9 (0%) 3/9 (33%) 3/8 (38%) 0/9 (0%) |
|FIRST INCIDENCE | 288 (T) 77 288 (T) 288 (T) |258 275 252 260 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.540N P=0.293N P=0.500 |P=0.461N P=0.183 P=0.138 P=0.749N |
|POLY 3 | P=0.358 P=0.500N P=0.292N P=0.500 |P=0.453N P=0.148 P=0.114 P=0.760 |
|POLY 1.5 | P=0.358 P=0.500N P=0.292N P=0.500 |P=0.453N P=0.148 P=0.114 P=0.760 |
|POLY 6 | P=0.358 P=0.500N P=0.292N P=0.500 |P=0.453N P=0.148 P=0.114 P=0.760 |
|LOGISTIC REGRESSION| P=0.377 (e) P=0.293N P=0.500 |P=0.449N (e) P=0.137 (e) |
|COCH-ARM / FISHERS | P=0.356 P=0.500N P=0.291N P=0.500 |P=0.451N P=0.152 P=0.152 P=0.763N |
|ORDER RESTRICTED | P=0.246 (e) (e) (e) |P=0.209 (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).