TDMS Study 97013-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 08 TIME: 10:50:01
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013G
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 25 MG/KG
INCLUDE 004 25 MG/KG
INCLUDE 005 50 MG/KG
INCLUDE 006 50 MG/KG
INCLUDE 007 100 MG/KG
INCLUDE 008 100 MG/KG
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) DATE: 06/11/04
EXPERIMENT: 97013 TEST: 08 TIME: 10:50:01
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013G
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: 08 TIME: 10:50:01
TEST TYPE: SUBCHRON 26-WEEK CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-65406 ROUTE: GAVAGE NTP C#: 97013G
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
----- ----------
Skin Squamous Cell Papilloma
Stomach, Forestomach Squamous Cell Papilloma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Stomach, Forestomach Squamous Cell Papilloma
Tooth Odontogenic Tumor
All Organs Benign Tumors
===============================================================
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 1
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 1/15 (7%) 0/15 (0%) 5/15 (33%) |1/15 (7%) 3/15 (20%) 5/15 (33%) 2/15 (13%) |
|POLY-3 RATE (b) | 1/13.17 1/14.49 0/12.95 5/15.00 |1/13.13 3/14.48 5/14.18 2/13.35 |
|POLY-3 PERCENT (g) | 7.6% 6.9% 0.0% 33.3% |7.6% 20.7% 35.3% 15.0% |
|TERMINAL (d) | 1/13 (8%) 1/14 (7%) 0/12 (0%) 5/15 (33%) |1/11 (9%) 3/14 (21%) 4/13 (31%) 2/13 (15%) |
|FIRST INCIDENCE | 182 (T) 182 (T) --- 182 (T) |183 (T) 183 (T) 126 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.027 * P=0.748N P=0.516N P=0.122 |P=0.480 P=0.390 P=0.126 P=0.560 |
|POLY 3 | P=0.015 * P=0.739N P=0.503N P=0.112 |P=0.428 P=0.334 P=0.095 P=0.506 |
|POLY 1.5 | P=0.015 * P=0.742N P=0.498N P=0.105 |P=0.423 P=0.326 P=0.091 P=0.501 |
|POLY 6 | P=0.016 * P=0.741N P=0.511N P=0.115 |P=0.448 P=0.346 P=0.105 P=0.517 |
|LOGISTIC REGRESSION| P=0.027 * P=0.748N (e) P=0.122 |P=0.425 P=0.390 P=0.087 P=0.560 |
|COCH-ARM / FISHERS | P=0.018 * P=0.759N P=0.500N P=0.084 |P=0.433 P=0.299 P=0.084 P=0.500 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.205 (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 |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/15 (60%) 5/15 (33%) 11/15 (73%) 12/15 (80%) |6/15 (40%) 8/15 (53%) 10/15 (67%) 11/15 (73%) |
|POLY-3 RATE (b) | 9/13.17 5/15.00 11/13.48 12/15.00 |6/13.47 8/14.48 10/13.51 11/13.35 |
|POLY-3 PERCENT (g) | 68.4% 33.3% 81.6% 80.0% |44.6% 55.3% 74.0% 82.4% |
|TERMINAL (d) | 9/13 (69%) 4/14 (29%) 10/12 (83%) 12/15 (80%) |5/11 (46%) 8/14 (57%) 10/13 (77%) 11/13 (85%) |
|FIRST INCIDENCE | 182 (T) 143 142 182 (T) |160 183 (T) 183 (T) 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.117 P=0.104N P=0.231 P=0.415 |P=0.062 P=0.582 P=0.247 P=0.145 |
|POLY 3 | P=0.057 P=0.065N P=0.365 P=0.394 |P=0.020 * P=0.427 P=0.115 P=0.041 * |
|POLY 1.5 | P=0.055 P=0.075N P=0.388 P=0.353 |P=0.024 * P=0.417 P=0.127 P=0.045 * |
|POLY 6 | P=0.059 P=0.061N P=0.336 P=0.413 |P=0.020 * P=0.440 P=0.112 P=0.041 * |
|LOGISTIC REGRESSION| P=0.083 P=0.090N P=0.288 P=0.415 |P=0.030 * P=0.471 P=0.140 P=0.064 |
|COCH-ARM / FISHERS | P=0.048 * P=0.136N P=0.350 P=0.213 |P=0.042 * P=0.358 P=0.136 P=0.070 |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |P=0.025 * (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 2
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 26 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 |
|=================================================================================================================================|
| |
|Tooth |
| Odontogenic Tumor |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/15 (13%) 2/15 (13%) 3/15 (20%) 2/15 (13%) |4/15 (27%) 0/15 (0%) 3/15 (20%) 2/15 (13%) |
|POLY-3 RATE (b) | 2/13.17 2/15.00 3/15.00 2/15.00 |4/13.36 0/14.48 3/13.51 2/14.01 |
|POLY-3 PERCENT (g) | 15.2% 13.3% 20.0% 13.3% |29.9% 0.0% 22.2% 14.3% |
|TERMINAL (d) | 2/13 (15%) 1/14 (7%) 0/12 (0%) 2/15 (13%) |3/11 (27%) 0/14 (0%) 3/13 (23%) 1/13 (8%) |
|FIRST INCIDENCE | 182 (T) 143 113 182 (T) |168 --- 183 (T) 127 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.563N P=0.663N P=0.511 P=0.648N |P=0.393N P=0.037N* P=0.410N P=0.278N |
|POLY 3 | P=0.573N P=0.650N P=0.562 P=0.650N |P=0.435N P=0.035N* P=0.493N P=0.302N |
|POLY 1.5 | P=0.581N P=0.660N P=0.550 P=0.660N |P=0.438N P=0.037N* P=0.489N P=0.313N |
|POLY 6 | P=0.570N P=0.646N P=0.567 P=0.646N |P=0.427N P=0.033N* P=0.489N P=0.285N |
|LOGISTIC REGRESSION| P=0.407 P=0.704 P=0.443 P=0.648N |P=0.430N P=0.044N* P=0.477N P=0.324N |
|COCH-ARM / FISHERS | P=0.573 P=0.701N P=0.500 P=0.701N |P=0.427N P=0.050N P=0.500N P=0.326N |
|ORDER RESTRICTED | P=0.649N (e) (e) (e) |P=0.153N (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 |
| Leukemia: Erythrocytic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/15 (7%) 0/15 (0%) 0/15 (0%) 1/15 (7%) |2/15 (13%) 2/15 (13%) 1/15 (7%) 0/15 (0%) |
|POLY-3 RATE (b) | 1/14.01 0/14.49 0/12.95 1/15.00 |2/13.47 2/15.00 1/14.18 0/13.35 |
|POLY-3 PERCENT (g) | 7.1% 0.0% 0.0% 6.7% |14.9% 13.3% 7.1% 0.0% |
|TERMINAL (d) | 0/13 (0%) 0/14 (0%) 0/12 (0%) 1/15 (7%) |1/11 (9%) 1/14 (7%) 0/13 (0%) 0/13 (0%) |
|FIRST INCIDENCE | 98 --- --- 182 (T) |160 143 126 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.611 P=0.486N P=0.486N P=0.737N |P=0.126N P=0.644N P=0.489N P=0.229N |
|POLY 3 | P=0.599 P=0.493N P=0.516N P=0.745N |P=0.125N P=0.659N P=0.482N P=0.232N |
|POLY 1.5 | P=0.598 P=0.492N P=0.506N P=0.747N |P=0.124N P=0.668N P=0.484N P=0.233N |
|POLY 6 | P=0.601 P=0.497N P=0.525N P=0.745N |P=0.124N P=0.647N P=0.474N P=0.229N |
|LOGISTIC REGRESSION| P=0.427 P=0.828N P=0.689N P=0.642 |P=0.110N P=0.667 P=0.536N P=0.232N |
|COCH-ARM / FISHERS | P=0.596 P=0.500N P=0.500N P=0.759N |P=0.118N P=0.701N P=0.500N P=0.241N |
|ORDER RESTRICTED | P=0.388N (e) (e) (e) |P=0.149N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 3
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 26 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) | 9/15 (60%) 5/15 (33%) 11/15 (73%) 13/15 (87%) |7/15 (47%) 9/15 (60%) 12/15 (80%) 12/15 (80%) |
|POLY-3 RATE (b) | 9/13.17 5/15.00 11/13.48 13/15.00 |7/13.47 9/14.48 12/14.18 12/13.35 |
|POLY-3 PERCENT (g) | 68.4% 33.3% 81.6% 86.7% |52.0% 62.2% 84.6% 89.9% |
|TERMINAL (d) | 9/13 (69%) 4/14 (29%) 10/12 (83%) 13/15 (87%) |6/11 (55%) 9/14 (64%) 11/13 (85%) 12/13 (92%) |
|FIRST INCIDENCE | 182 (T) 143 142 182 (T) |160 183 (T) 126 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.056 P=0.104N P=0.231 P=0.259 |P=0.055 P=0.618 P=0.163 P=0.143 |
|POLY 3 | P=0.018 * P=0.065N P=0.365 P=0.238 |P=0.011 * P=0.437 P=0.065 P=0.029 * |
|POLY 1.5 | P=0.017 * P=0.075N P=0.388 P=0.202 |P=0.014 * P=0.425 P=0.065 P=0.034 * |
|POLY 6 | P=0.018 * P=0.061N P=0.336 P=0.256 |P=0.012 * P=0.452 P=0.072 P=0.029 * |
|LOGISTIC REGRESSION| P=0.035 * P=0.090N P=0.288 P=0.259 |P=0.016 * P=0.497 P=0.064 P=0.053 |
|COCH-ARM / FISHERS | P=0.019 * P=0.136N P=0.350 P=0.107 |P=0.032 * P=0.358 P=0.064 P=0.064 |
|ORDER RESTRICTED | P=0.015 * (e) (e) (e) |P=0.015 * (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) | 2/15 (13%) 1/15 (7%) 0/15 (0%) 1/15 (7%) |3/15 (20%) 2/15 (13%) 1/15 (7%) 1/15 (7%) |
|POLY-3 RATE (b) | 2/14.01 1/15.00 0/12.95 1/15.00 |3/13.47 2/15.00 1/14.18 1/13.35 |
|POLY-3 PERCENT (g) | 14.3% 6.7% 0.0% 6.7% |22.3% 13.3% 7.1% 7.5% |
|TERMINAL (d) | 1/13 (8%) 0/14 (0%) 0/12 (0%) 1/15 (7%) |2/11 (18%) 1/14 (7%) 0/13 (0%) 1/13 (8%) |
|FIRST INCIDENCE | 98 143 --- 182 (T) |160 143 126 183 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343N P=0.467N P=0.241N P=0.459N |P=0.189N P=0.428N P=0.284N P=0.265N |
|POLY 3 | P=0.372N P=0.476N P=0.249N P=0.476N |P=0.202N P=0.449N P=0.278N P=0.300N |
|POLY 1.5 | P=0.369N P=0.478N P=0.238N P=0.478N |P=0.200N P=0.461N P=0.281N P=0.300N |
|POLY 6 | P=0.375N P=0.476N P=0.261N P=0.476N |P=0.202N P=0.434N P=0.270N P=0.294N |
|LOGISTIC REGRESSION| P=0.510N P=0.701N P=0.267N P=0.642N |P=0.181N P=0.535N P=0.312N P=0.293N |
|COCH-ARM / FISHERS | P=0.363N P=0.500N P=0.241N P=0.500N |P=0.188N P=0.500N P=0.299N P=0.299N |
|ORDER RESTRICTED | P=0.207N (e) (e) (e) |P=0.203N (e) (e) (e) |
|=================================================================================================================================|
Date: 06/11/04 EXPERIMENT: 97013 TEST: 08 Page 4
Statistical Analysis of Primary Tumors in Mice(TG.AC HETEROZYGOUS TRANSGENIC) - WATER DISINFECTION MODEL (BROMODICHLOR
Terminal Sacrifice at 26 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) | 11/15 (73%) 6/15 (40%) 13/15 (87%) 14/15 (93%) |10/15 (67%) 10/15 (67%) 12/15 (80%) 13/15 (87%) |
|POLY-3 RATE (b) | 11/14.01 6/15.00 13/15.00 14/15.00 |10/13.69 10/15.00 12/14.18 13/14.01 |
|POLY-3 PERCENT (g) | 78.5% 40.0% 86.7% 93.3% |73.0% 66.7% 84.6% 92.8% |
|TERMINAL (d) | 10/13 (77%) 5/14 (36%) 10/12 (83%) 14/15 (93%) |8/11 (73%) 9/14 (64%) 11/13 (85%) 12/13 (92%) |
|FIRST INCIDENCE | 98 143 113 182 (T) |160 143 126 127 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.115 P=0.059N P=0.284 P=0.453 |P=0.219 P=0.347N P=0.587 P=0.448 |
|POLY 3 | P=0.023 * P=0.035N* P=0.465 P=0.271 |P=0.075 P=0.514N P=0.388 P=0.185 |
|POLY 1.5 | P=0.022 * P=0.038N* P=0.450 P=0.256 |P=0.076 P=0.541N P=0.390 P=0.173 |
|POLY 6 | P=0.023 * P=0.035N* P=0.467 P=0.273 |P=0.081 P=0.487N P=0.398 P=0.206 |
|LOGISTIC REGRESSION| P=0.025 * P=0.057N P=0.343 P=0.275 |P=0.072 P=0.559N P=0.357 P=0.159 |
|COCH-ARM / FISHERS | P=0.024 * P=0.070N P=0.326 P=0.165 |P=0.104 P=0.650N P=0.341 P=0.195 |
|ORDER RESTRICTED | P=0.012 * (e) (e) (e) |P=0.103 (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).