TDMS Study 05205-08 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst P-NITROTOLUENE DATE: 02/08/00
EXPERIMENT: 05205 TEST: 08 TIME: 09:26:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: FARNELL, D. CAS: 99-99-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 CHRONIC STUDY FOR MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst P-NITROTOLUENE DATE: 02/08/00
EXPERIMENT: 05205 TEST: 08 TIME: 09:26:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: FARNELL, D. CAS: 99-99-0
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
Bone Marrow
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst P-NITROTOLUENE DATE: 02/08/00
EXPERIMENT: 05205 TEST: 08 TIME: 09:26:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62537D
PATHOLOGIST: FARNELL, D. CAS: 99-99-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF P-NITROTOLUENE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Thyroid Gland: Follicular Cell Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 4/50 (8%) 3/49 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 6.3% 8.2% 6.3% 4.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/45 (7%) 4/46 (9%) 3/45 (7%) 2/42 (5%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.380N P=0.512 P=0.663 P=0.531N |(e) (e) (e) (e) |
|POLY 3 | P=0.352N P=0.510 P=0.659 P=0.503N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.345N P=0.509 P=0.661 P=0.497N |(e) (e) (e) (e) |
|POLY 6 | P=0.362N P=0.511 P=0.654 P=0.512N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.380N P=0.512 P=0.663 P=0.531N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.337N P=0.511 P=0.661N P=0.490N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 6/50 (12%) 1/50 (2%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.1% 6.2% 12.4% 2.1% |4.1% 4.1% 2.1% 6.1% |
|TERMINAL (d) | 3/46 (7%) 3/46 (7%) 6/45 (13%) 1/42 (2%) |2/46 (4%) 2/47 (4%) 1/43 (2%) 3/49 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.341N P=0.663 P=0.232 P=0.338N |P=0.426 P=0.687N P=0.524N P=0.529 |
|POLY 3 | P=0.314N P=0.660 P=0.238 P=0.315N |P=0.403 P=0.692 P=0.510N P=0.500 |
|POLY 1.5 | P=0.305N P=0.660 P=0.241 P=0.311N |P=0.402 P=0.692 P=0.506N P=0.497 |
|POLY 6 | P=0.327N P=0.662 P=0.232 P=0.322N |P=0.407 P=0.693 P=0.513N P=0.505 |
|LOGISTIC REGRESSION| P=0.341N P=0.663 P=0.232 P=0.338N |P=0.426 P=0.687N P=0.524N P=0.529 |
|COCH-ARM / FISHERS | P=0.297N P=0.661N P=0.243 P=0.309N |P=0.404 P=0.691N P=0.500N P=0.500 |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 6/50 (12%) 2/50 (4%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 6.1% 8.2% 12.4% 4.2% |4.1% 6.1% 4.2% 6.1% |
|TERMINAL (d) | 3/46 (7%) 4/46 (9%) 6/45 (13%) 1/42 (2%) |2/46 (4%) 3/47 (6%) 2/43 (5%) 3/49 (6%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 681 |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.464N P=0.500 P=0.232 P=0.537N |P=0.481 P=0.510 P=0.670 P=0.529 |
|POLY 3 | P=0.428N P=0.498 P=0.238 P=0.511N |P=0.455 P=0.498 P=0.683 P=0.500 |
|POLY 1.5 | P=0.419N P=0.497 P=0.241 P=0.506N |P=0.453 P=0.498 P=0.687 P=0.497 |
|POLY 6 | P=0.440N P=0.500 P=0.232 P=0.518N |P=0.461 P=0.499 P=0.680 P=0.505 |
|LOGISTIC REGRESSION| P=0.436N P=0.500 P=0.232 P=0.502N |P=0.481 P=0.510 P=0.670 P=0.529 |
|COCH-ARM / FISHERS | P=0.410N P=0.500 P=0.243 P=0.500N |P=0.456 P=0.500 P=0.691N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 2/46 (4%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.239 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.410N P=0.237 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.408N P=0.236 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.413N P=0.237 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.239 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 2.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 2/46 (4%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- 689 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517 P=0.239 (e) P=0.487 |(e) (e) (e) (e) |
|POLY 3 | P=0.531 P=0.237 (e) P=0.495 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.534 P=0.236 (e) P=0.497 |(e) (e) (e) (e) |
|POLY 6 | P=0.525 P=0.237 (e) P=0.492 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.541 P=0.239 (e) P=0.509 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.539 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 13/50 (26%) 15/50 (30%) 15/50 (30%) |6/49 (12%) 3/50 (6%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 28.6% 26.7% 31.0% 31.5% |12.3% 6.1% 4.2% 10.2% |
|TERMINAL (d) | 14/46 (30%) 13/46 (28%) 15/45 (33%) 15/42 (36%) |5/46 (11%) 3/47 (6%) 2/43 (5%) 5/49 (10%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |654 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.500N P=0.472 P=0.383 |P=0.471N P=0.236N P=0.158N P=0.460N |
|POLY 3 | P=0.370 P=0.504N P=0.487 P=0.465 |P=0.495N P=0.242N P=0.140N P=0.495N |
|POLY 1.5 | P=0.388 P=0.506N P=0.495 P=0.481 |P=0.495N P=0.238N P=0.135N P=0.495N |
|POLY 6 | P=0.342 P=0.500N P=0.473 P=0.441 |P=0.494N P=0.245N P=0.147N P=0.493N |
|LOGISTIC REGRESSION| P=0.285 P=0.500N P=0.472 P=0.383 |P=0.494N P=0.221N P=0.123N P=0.484N |
|COCH-ARM / FISHERS | P=0.406 P=0.500N P=0.500 P=0.500 |P=0.490N P=0.233N P=0.128N P=0.486N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/50 (24%) 11/50 (22%) 12/50 (24%) |3/49 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 16.1% 24.6% 22.3% 24.7% |6.2% 8.1% 0.0% 2.0% |
|TERMINAL (d) | 6/46 (13%) 12/46 (26%) 9/45 (20%) 9/42 (21%) |3/46 (7%) 3/47 (6%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | 453 729 (T) 597 585 |729 (T) 487 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.188 P=0.229 P=0.296 P=0.183 |P=0.107N P=0.510 P=0.134N P=0.283N |
|POLY 3 | P=0.233 P=0.213 P=0.298 P=0.209 |P=0.110N P=0.512 P=0.122N P=0.301N |
|POLY 1.5 | P=0.242 P=0.216 P=0.302 P=0.216 |P=0.109N P=0.512 P=0.119N P=0.302N |
|POLY 6 | P=0.222 P=0.212 P=0.293 P=0.200 |P=0.109N P=0.513 P=0.124N P=0.298N |
|LOGISTIC REGRESSION| P=0.268 P=0.232 P=0.337 P=0.271 |P=0.082N P=0.628 (e) P=0.283N |
|COCH-ARM / FISHERS | P=0.252 P=0.227 P=0.306 P=0.227 |P=0.108N P=0.511 P=0.117N P=0.301N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/50 (24%) 11/50 (22%) 13/50 (26%) |3/49 (6%) 4/50 (8%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 16.1% 24.6% 22.3% 26.8% |6.2% 8.1% 0.0% 2.0% |
|TERMINAL (d) | 6/46 (13%) 12/46 (26%) 9/45 (20%) 9/42 (21%) |3/46 (7%) 3/47 (6%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | 453 729 (T) 597 585 |729 (T) 487 --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129 P=0.229 P=0.296 P=0.131 |P=0.107N P=0.510 P=0.134N P=0.283N |
|POLY 3 | P=0.163 P=0.213 P=0.298 P=0.148 |P=0.110N P=0.512 P=0.122N P=0.301N |
|POLY 1.5 | P=0.170 P=0.216 P=0.302 P=0.154 |P=0.109N P=0.512 P=0.119N P=0.302N |
|POLY 6 | P=0.155 P=0.212 P=0.293 P=0.141 |P=0.109N P=0.513 P=0.124N P=0.298N |
|LOGISTIC REGRESSION| P=0.191 P=0.232 P=0.337 P=0.198 |P=0.082N P=0.628 (e) P=0.283N |
|COCH-ARM / FISHERS | P=0.178 P=0.227 P=0.306 P=0.163 |P=0.108N P=0.511 P=0.117N P=0.301N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 24/50 (48%) 25/50 (50%) 24/50 (48%) |8/49 (16%) 6/50 (12%) 2/50 (4%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 40.2% 49.2% 50.8% 49.5% |16.4% 12.1% 4.2% 12.2% |
|TERMINAL (d) | 18/46 (39%) 24/46 (52%) 23/45 (51%) 21/42 (50%) |7/46 (15%) 5/47 (11%) 2/43 (5%) 6/49 (12%) |
|FIRST INCIDENCE | 453 729 (T) 597 585 |654 487 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 P=0.273 P=0.194 P=0.173 |P=0.273N P=0.375N P=0.061N P=0.344N |
|POLY 3 | P=0.239 P=0.245 P=0.198 P=0.237 |P=0.296N P=0.374N P=0.049N* P=0.382N |
|POLY 1.5 | P=0.256 P=0.251 P=0.204 P=0.252 |P=0.294N P=0.373N P=0.046N* P=0.381N |
|POLY 6 | P=0.219 P=0.242 P=0.190 P=0.220 |P=0.296N P=0.376N P=0.052N P=0.379N |
|LOGISTIC REGRESSION| P=0.265 P=0.269 P=0.218 P=0.282 |P=0.270N P=0.289N P=0.044N* P=0.372N |
|COCH-ARM / FISHERS | P=0.275 P=0.273 P=0.211 P=0.273 |P=0.286N P=0.371N P=0.043N* P=0.371N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 24/50 (48%) 25/50 (50%) 25/50 (50%) |8/49 (16%) 6/50 (12%) 2/50 (4%) 6/50 (12%) |
|POLY-3 ADJUSTED (b)| 40.2% 49.2% 50.8% 51.5% |16.4% 12.1% 4.2% 12.2% |
|TERMINAL (d) | 18/46 (39%) 24/46 (52%) 23/45 (51%) 21/42 (50%) |7/46 (15%) 5/47 (11%) 2/43 (5%) 6/49 (12%) |
|FIRST INCIDENCE | 453 729 (T) 597 585 |654 487 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.108 P=0.273 P=0.194 P=0.131 |P=0.273N P=0.375N P=0.061N P=0.344N |
|POLY 3 | P=0.178 P=0.245 P=0.198 P=0.179 |P=0.296N P=0.374N P=0.049N* P=0.382N |
|POLY 1.5 | P=0.192 P=0.251 P=0.204 P=0.192 |P=0.294N P=0.373N P=0.046N* P=0.381N |
|POLY 6 | P=0.162 P=0.242 P=0.190 P=0.165 |P=0.296N P=0.376N P=0.052N P=0.379N |
|LOGISTIC REGRESSION| P=0.199 P=0.269 P=0.218 P=0.218 |P=0.270N P=0.289N P=0.044N* P=0.372N |
|COCH-ARM / FISHERS | P=0.208 P=0.273 P=0.211 P=0.211 |P=0.286N P=0.371N P=0.043N* P=0.371N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.1% 0.0% 2.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/46 (4%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) --- 597 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199N P=0.239N P=0.503N P=0.259N |(e) (e) (e) (e) |
|POLY 3 | P=0.191N P=0.238N P=0.500N P=0.244N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.189N P=0.238N P=0.500N P=0.241N |(e) (e) (e) (e) |
|POLY 6 | P=0.193N P=0.237N P=0.502N P=0.248N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.187N (e) P=0.531N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 9/50 (18%) 8/50 (16%) 13/50 (26%) |5/50 (10%) 2/50 (4%) 2/50 (4%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 12.2% 18.5% 16.5% 26.8% |10.2% 4.1% 4.2% 10.2% |
|TERMINAL (d) | 4/46 (9%) 9/46 (20%) 7/45 (16%) 11/42 (26%) |5/46 (11%) 2/47 (4%) 1/43 (2%) 5/49 (10%) |
|FIRST INCIDENCE | 665 729 (T) 693 505 |729 (T) 729 (T) 714 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.034 * P=0.290 P=0.369 P=0.048 * |P=0.493 P=0.209N P=0.244N P=0.590N |
|POLY 3 | P=0.049 * P=0.282 P=0.377 P=0.057 |P=0.461 P=0.219N P=0.228N P=0.629 |
|POLY 1.5 | P=0.051 P=0.283 P=0.383 P=0.059 |P=0.460 P=0.219N P=0.224N P=0.626 |
|POLY 6 | P=0.044 * P=0.281 P=0.367 P=0.052 |P=0.466 P=0.218N P=0.231N P=0.622N |
|LOGISTIC REGRESSION| P=0.053 P=0.285 P=0.387 P=0.070 |P=0.477 P=0.209N P=0.233N P=0.590N |
|COCH-ARM / FISHERS | P=0.053 P=0.288 P=0.387 P=0.062 |P=0.463 P=0.218N P=0.218N P=0.630N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 4/50 (8%) 6/50 (12%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 4.1% 12.2% 8.3% 12.3% |2.0% 0.0% 4.2% 6.1% |
|TERMINAL (d) | 2/46 (4%) 4/46 (9%) 4/45 (9%) 3/42 (7%) |1/46 (2%) 0/47 (0%) 2/43 (5%) 3/49 (6%) |
|FIRST INCIDENCE | 729 (T) 689 729 (T) 585 |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.148 P=0.140 P=0.327 P=0.119 |P=0.117 P=0.496N P=0.476 P=0.328 |
|POLY 3 | P=0.176 P=0.134 P=0.333 P=0.132 |P=0.104 P=0.501N P=0.490 P=0.305 |
|POLY 1.5 | P=0.178 P=0.133 P=0.336 P=0.133 |P=0.103 P=0.501N P=0.494 P=0.304 |
|POLY 6 | P=0.171 P=0.137 P=0.328 P=0.129 |P=0.106 P=0.500N P=0.487 P=0.310 |
|LOGISTIC REGRESSION| P=0.186 P=0.134 P=0.327 P=0.150 |P=0.117 (e) P=0.476 P=0.328 |
|COCH-ARM / FISHERS | P=0.179 P=0.134 P=0.339 P=0.134 |P=0.104 P=0.500N P=0.500 P=0.309 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 14/50 (28%) 12/50 (24%) 19/50 (38%) |6/50 (12%) 2/50 (4%) 4/50 (8%) 8/50 (16%) |
|POLY-3 ADJUSTED (b)| 16.3% 28.6% 24.7% 38.4% |12.2% 4.1% 8.4% 16.3% |
|TERMINAL (d) | 6/46 (13%) 12/46 (26%) 11/45 (24%) 14/42 (33%) |6/46 (13%) 2/47 (4%) 3/43 (7%) 8/49 (16%) |
|FIRST INCIDENCE | 665 689 693 505 |729 (T) 729 (T) 714 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.009 ** P=0.123 P=0.214 P=0.010 * |P=0.198 P=0.128N P=0.410N P=0.436 |
|POLY 3 | P=0.014 * P=0.111 P=0.217 P=0.011 * |P=0.168 P=0.135N P=0.387N P=0.387 |
|POLY 1.5 | P=0.014 * P=0.110 P=0.223 P=0.011 * |P=0.167 P=0.135N P=0.381N P=0.383 |
|POLY 6 | P=0.013 * P=0.112 P=0.207 P=0.010 * |P=0.172 P=0.134N P=0.392N P=0.396 |
|LOGISTIC REGRESSION| P=0.015 * P=0.112 P=0.222 P=0.016 * |P=0.185 P=0.128N P=0.397N P=0.436 |
|COCH-ARM / FISHERS | P=0.014 * P=0.114 P=0.227 P=0.012 * |P=0.169 P=0.134N P=0.370N P=0.387 |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |3/48 (6%) 1/50 (2%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |6.3% 2.0% 4.2% 0.0% |
|TERMINAL (d) | |3/45 (7%) 1/47 (2%) 2/43 (5%) 0/48 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.099N P=0.290N P=0.521N P=0.110N |
|POLY 3 | |P=0.101N P=0.295N P=0.497N P=0.117N |
|POLY 1.5 | |P=0.102N P=0.294N P=0.491N P=0.117N |
|POLY 6 | |P=0.100N P=0.296N P=0.504N P=0.115N |
|LOGISTIC REGRESSION| |P=0.099N P=0.290N P=0.521N (e) |
|COCH-ARM / FISHERS | |P=0.100N P=0.293N P=0.480N P=0.117N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.0% 0.0% 0.0% |4.1% 0.0% 8.1% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |1/46 (2%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 280 --- --- |682 --- 456 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.500 (e) (e) |P=0.336N P=0.240N P=0.327 P=0.231N |
|POLY 3 | P=0.567N P=0.503 (e) (e) |P=0.336N P=0.239N P=0.340 P=0.238N |
|POLY 1.5 | P=0.567N P=0.502 (e) (e) |P=0.338N P=0.239N P=0.339 P=0.239N |
|POLY 6 | P=0.568N P=0.504 (e) (e) |P=0.331N P=0.239N P=0.342 P=0.236N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.160N P=0.212N P=0.684 P=0.222N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.337N P=0.247N P=0.339 P=0.247N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.0% 0.0% 0.0% |2.0% 0.0% 8.1% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |0/46 (0%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 280 --- --- |682 --- 456 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.500 (e) (e) |P=0.528N P=0.504N P=0.178 P=0.496N |
|POLY 3 | P=0.567N P=0.503 (e) (e) |P=0.532N P=0.502N P=0.181 P=0.501N |
|POLY 1.5 | P=0.567N P=0.502 (e) (e) |P=0.534N P=0.501N P=0.180 P=0.502N |
|POLY 6 | P=0.568N P=0.504 (e) (e) |P=0.526N P=0.502N P=0.182 P=0.499N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.301N P=0.444N P=0.472 P=0.470N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.531N P=0.500N P=0.181 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.0% 0.0% 0.0% |4.1% 0.0% 8.1% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/45 (0%) 0/42 (0%) |1/46 (2%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 280 --- --- |682 --- 456 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567N P=0.500 (e) (e) |P=0.336N P=0.240N P=0.327 P=0.231N |
|POLY 3 | P=0.567N P=0.503 (e) (e) |P=0.336N P=0.239N P=0.340 P=0.238N |
|POLY 1.5 | P=0.567N P=0.502 (e) (e) |P=0.338N P=0.239N P=0.339 P=0.239N |
|POLY 6 | P=0.568N P=0.504 (e) (e) |P=0.331N P=0.239N P=0.342 P=0.236N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.160N P=0.212N P=0.684 P=0.222N |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.337N P=0.247N P=0.339 P=0.247N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.0% 4.1% 4.1% 6.2% |0.0% 6.1% 4.2% 2.0% |
|TERMINAL (d) | 1/46 (2%) 2/46 (4%) 2/45 (4%) 1/42 (2%) |0/46 (0%) 3/47 (6%) 1/43 (2%) 1/49 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 625 |--- 729 (T) 682 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206 P=0.500 P=0.492 P=0.285 |P=0.571 P=0.125 P=0.228 P=0.513 |
|POLY 3 | P=0.228 P=0.499 P=0.497 P=0.300 |P=0.555 P=0.118 P=0.232 P=0.500 |
|POLY 1.5 | P=0.231 P=0.498 P=0.499 P=0.303 |P=0.552 P=0.118 P=0.234 P=0.499 |
|POLY 6 | P=0.223 P=0.500 P=0.493 P=0.296 |P=0.562 P=0.119 P=0.231 P=0.502 |
|LOGISTIC REGRESSION| P=0.237 P=0.500 P=0.492 P=0.322 |P=0.555 P=0.125 P=0.254 P=0.513 |
|COCH-ARM / FISHERS | P=0.232 P=0.500 P=0.500 P=0.309 |P=0.556 P=0.121 P=0.247 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 2/49 (4%) |0/50 (0%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 4.3% |0.0% 2.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 0/46 (0%) 0/44 (0%) 2/41 (5%) |0/46 (0%) 1/47 (2%) 0/42 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |--- 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.039 * (e) (e) P=0.214 |P=0.559N P=0.504 (e) (e) |
|POLY 3 | P=0.043 * (e) (e) P=0.227 |P=0.570N P=0.499 (e) (e) |
|POLY 1.5 | P=0.044 * (e) (e) P=0.230 |P=0.569N P=0.499 (e) (e) |
|POLY 6 | P=0.042 * (e) (e) P=0.222 |P=0.569N P=0.500 (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.214 |(e) P=0.504 (e) (e) |
|COCH-ARM / FISHERS | P=0.045 * (e) (e) P=0.242 |P=0.567N P=0.500 (e) (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |6.1% 2.0% 8.4% 2.0% |
|TERMINAL (d) | |3/46 (7%) 1/47 (2%) 4/43 (9%) 1/49 (2%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.325N P=0.298N P=0.463 P=0.283N |
|POLY 3 | |P=0.343N P=0.307N P=0.485 P=0.306N |
|POLY 1.5 | |P=0.346N P=0.307N P=0.490 P=0.308N |
|POLY 6 | |P=0.338N P=0.306N P=0.480 P=0.302N |
|LOGISTIC REGRESSION| |P=0.325N P=0.298N P=0.463 P=0.283N |
|COCH-ARM / FISHERS | |P=0.343N P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |6.1% 2.0% 8.4% 2.0% |
|TERMINAL (d) | |3/46 (7%) 1/47 (2%) 4/43 (9%) 1/49 (2%) |
|FIRST INCIDENCE | |729 (T) 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.325N P=0.298N P=0.463 P=0.283N |
|POLY 3 | |P=0.343N P=0.307N P=0.485 P=0.306N |
|POLY 1.5 | |P=0.346N P=0.307N P=0.490 P=0.308N |
|POLY 6 | |P=0.338N P=0.306N P=0.480 P=0.302N |
|LOGISTIC REGRESSION| |P=0.325N P=0.298N P=0.463 P=0.283N |
|COCH-ARM / FISHERS | |P=0.343N P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 4.1% 0.0% 0.0% |2.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/46 (0%) 1/46 (2%) 0/45 (0%) 0/42 (0%) |1/46 (2%) 0/47 (0%) 0/43 (0%) 0/49 (0%) |
|FIRST INCIDENCE | --- 689 --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.422N P=0.242 (e) (e) |P=0.302N P=0.496N P=0.513N P=0.487N |
|POLY 3 | P=0.410N P=0.237 (e) (e) |P=0.307N P=0.501N P=0.506N P=0.500N |
|POLY 1.5 | P=0.408N P=0.237 (e) (e) |P=0.306N P=0.501N P=0.504N P=0.501N |
|POLY 6 | P=0.413N P=0.239 (e) (e) |P=0.309N P=0.500N P=0.507N P=0.498N |
|LOGISTIC REGRESSION| P=0.403N P=0.241 (e) (e) |P=0.302N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.0% 2.1% 6.2% 4.2% |2.0% 2.0% 0.0% 2.0% |
|TERMINAL (d) | 1/46 (2%) 1/46 (2%) 2/45 (4%) 2/42 (5%) |0/46 (0%) 1/47 (2%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 689 729 (T) |707 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.291 P=0.761 P=0.299 P=0.468 |P=0.602N P=0.758N P=0.509N P=0.749N |
|POLY 3 | P=0.312 P=0.760 P=0.303 P=0.490 |P=0.617N P=0.759 P=0.506N P=0.760 |
|POLY 1.5 | P=0.319 P=0.759 P=0.305 P=0.495 |P=0.617N P=0.759 P=0.504N P=0.759 |
|POLY 6 | P=0.302 P=0.760 P=0.300 P=0.484 |P=0.617N P=0.759 P=0.508N P=0.759N |
|LOGISTIC REGRESSION| P=0.316 P=0.761 P=0.305 P=0.468 |P=0.617N P=0.759N P=0.482N P=0.761N |
|COCH-ARM / FISHERS | P=0.324 P=0.753N P=0.309 P=0.500 |P=0.616N P=0.753N P=0.500N P=0.753N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.0% 6.1% 6.2% 4.2% |4.1% 2.0% 0.0% 2.0% |
|TERMINAL (d) | 1/46 (2%) 2/46 (4%) 2/45 (4%) 2/42 (5%) |1/46 (2%) 1/47 (2%) 0/43 (0%) 1/49 (2%) |
|FIRST INCIDENCE | 729 (T) 689 689 729 (T) |707 729 (T) --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.436 P=0.309 P=0.299 P=0.468 |P=0.356N P=0.495N P=0.252N P=0.481N |
|POLY 3 | P=0.460 P=0.306 P=0.303 P=0.490 |P=0.369N P=0.502N P=0.244N P=0.501N |
|POLY 1.5 | P=0.468 P=0.305 P=0.305 P=0.495 |P=0.368N P=0.502N P=0.242N P=0.502N |
|POLY 6 | P=0.447 P=0.308 P=0.300 P=0.484 |P=0.369N P=0.502N P=0.247N P=0.497N |
|LOGISTIC REGRESSION| P=0.475 P=0.305 P=0.305 P=0.468 |P=0.368N P=0.498N P=0.233N P=0.500N |
|COCH-ARM / FISHERS | P=0.477 P=0.309 P=0.309 P=0.500 |P=0.366N P=0.500N P=0.247N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.0% 0.0% 2.1% 4.2% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/46 (2%) 0/46 (0%) 0/45 (0%) 1/42 (2%) |0/46 (0%) 0/47 (0%) 1/43 (2%) 0/49 (0%) |
|FIRST INCIDENCE | 729 (T) --- 693 681 |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228 P=0.500N P=0.753 P=0.474 |P=0.698 (e) P=0.487 (e) |
|POLY 3 | P=0.243 P=0.501N P=0.759 P=0.492 |P=0.696 (e) P=0.494 (e) |
|POLY 1.5 | P=0.246 P=0.501N P=0.760 P=0.496 |P=0.693 (e) P=0.496 (e) |
|POLY 6 | P=0.239 P=0.500N P=0.757 P=0.486 |P=0.701 (e) P=0.493 (e) |
|LOGISTIC REGRESSION| P=0.251 (e) P=0.762 P=0.506 |(e) (e) P=0.487 (e) |
|COCH-ARM / FISHERS | P=0.247 P=0.500N P=0.753N P=0.500 |P=0.694 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |3/50 (6%) 5/50 (10%) 9/50 (18%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 6.1% 6.2% 2.1% 8.4% |6.1% 10.2% 18.8% 10.2% |
|TERMINAL (d) | 3/46 (7%) 3/46 (7%) 1/45 (2%) 3/42 (7%) |2/46 (4%) 4/47 (9%) 9/43 (21%) 5/49 (10%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 681 |707 680 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.392 P=0.663 P=0.313N P=0.455 |P=0.333 P=0.368 P=0.050 P=0.391 |
|POLY 3 | P=0.428 P=0.660 P=0.309N P=0.487 |P=0.294 P=0.356 P=0.053 P=0.356 |
|POLY 1.5 | P=0.433 P=0.660 P=0.307N P=0.493 |P=0.291 P=0.356 P=0.056 P=0.354 |
|POLY 6 | P=0.420 P=0.662 P=0.313N P=0.479 |P=0.302 P=0.358 P=0.051 P=0.362 |
|LOGISTIC REGRESSION| P=0.421 P=0.663 P=0.313N P=0.489 |P=0.298 P=0.361 P=0.052 P=0.356 |
|COCH-ARM / FISHERS | P=0.438 P=0.661N P=0.309N P=0.500 |P=0.296 P=0.357 P=0.061 P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 28/50 (56%) 30/50 (60%) 33/50 (66%) |17/50 (34%) 14/50 (28%) 14/50 (28%) 14/50 (28%) |
|POLY-3 ADJUSTED (b)| 50.8% 57.2% 61.8% 67.4% |34.4% 28.7% 29.2% 28.5% |
|TERMINAL (d) | 23/46 (50%) 27/46 (59%) 29/45 (64%) 29/42 (69%) |16/46 (35%) 14/47 (30%) 12/43 (28%) 14/49 (29%) |
|FIRST INCIDENCE | 665 689 693 505 |654 729 (T) 682 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P=0.347 P=0.179 P=0.035 * |P=0.274N P=0.308N P=0.416N P=0.264N |
|POLY 3 | P=0.054 P=0.332 P=0.186 P=0.069 |P=0.336N P=0.346N P=0.368N P=0.341N |
|POLY 1.5 | P=0.058 P=0.332 P=0.200 P=0.074 |P=0.338N P=0.342N P=0.355N P=0.344N |
|POLY 6 | P=0.046 * P=0.334 P=0.165 P=0.062 |P=0.326N P=0.348N P=0.379N P=0.331N |
|LOGISTIC REGRESSION| P=0.042 * P=0.339 P=0.165 P=0.069 |P=0.319N P=0.336N P=0.371N P=0.333N |
|COCH-ARM / FISHERS | P=0.061 P=0.344 P=0.211 P=0.078 |P=0.328N P=0.333N P=0.333N P=0.333N |
|=================================================================================================================================|
Date: 02/08/00 EXPERIMENT: 05205 TEST: 08 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - P-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 24/50 (48%) 20/50 (40%) 21/50 (42%) |9/50 (18%) 13/50 (26%) 23/50 (46%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 28.2% 48.0% 40.0% 42.7% |18.2% 26.1% 46.1% 24.5% |
|TERMINAL (d) | 12/46 (26%) 20/46 (44%) 15/45 (33%) 15/42 (36%) |7/46 (15%) 11/47 (23%) 17/43 (40%) 12/49 (25%) |
|FIRST INCIDENCE | 453 280 597 585 |682 487 456 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131 P=0.042 * P=0.148 P=0.076 |P=0.315 P=0.257 P=0.003 ** P=0.371 |
|POLY 3 | P=0.181 P=0.032 * P=0.151 P=0.096 |P=0.238 P=0.242 P=0.002 ** P=0.307 |
|POLY 1.5 | P=0.186 P=0.031 * P=0.148 P=0.099 |P=0.237 P=0.239 P=0.002 ** P=0.305 |
|POLY 6 | P=0.177 P=0.033 * P=0.154 P=0.094 |P=0.248 P=0.246 P=0.002 ** P=0.314 |
|LOGISTIC REGRESSION| P=0.288 P=0.029 * P=0.201 P=0.134 |P=0.273 P=0.253 P=0.005 ** P=0.309 |
|COCH-ARM / FISHERS | P=0.196 P=0.032 * P=0.146 P=0.104 |P=0.254 P=0.235 P=0.002 ** P=0.312 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 1250 2500 5000 |0 1250 2500 5000 |
| | PPM PPM PPM PPM |PPM PPM PPM PPM |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 38/50 (76%) 41/50 (82%) 44/50 (88%) |21/50 (42%) 23/50 (46%) 31/50 (62%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 62.0% 76.0% 82.0% 88.0% |42.3% 46.2% 62.0% 51.0% |
|TERMINAL (d) | 27/46 (59%) 34/46 (74%) 36/45 (80%) 36/42 (86%) |18/46 (39%) 21/47 (45%) 24/43 (56%) 25/49 (51%) |
|FIRST INCIDENCE | 453 280 597 505 |654 487 456 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.130 P=0.034 * P=0.003 ** |P=0.288 P=0.455 P=0.032 * P=0.378 |
|POLY 3 | P=0.002 ** P=0.097 P=0.021 * P=0.002 ** |P=0.174 P=0.425 P=0.037 * P=0.256 |
|POLY 1.5 | P=0.002 ** P=0.097 P=0.021 * P=0.002 ** |P=0.175 P=0.423 P=0.036 * P=0.256 |
|POLY 6 | P=0.002 ** P=0.097 P=0.021 * P=0.002 ** |P=0.180 P=0.426 P=0.039 * P=0.261 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.202 P=0.431 P=0.051 P=0.266 |
|COCH-ARM / FISHERS | P=0.002 ** P=0.097 P=0.022 * P=0.002 ** |P=0.195 P=0.420 P=0.036 * P=0.274 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).
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