TDMS Study 61529-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus M-CHLOROANILINE DATE: 10/20/04
EXPERIMENT: 61529 TEST: 02 TIME: 11:22:27
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: 61529B
PATHOLOGIST: RYAN, M. CAS: 108-42-09
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus M-CHLOROANILINE DATE: 10/20/04
EXPERIMENT: 61529 TEST: 02 TIME: 11:22:27
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: 61529B
PATHOLOGIST: RYAN, M. CAS: 108-42-09
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF M-CHLOROANILINE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Bone Marrow Pigmentation Hemosiderin
Bone Marrow: Erythroid Cell Hyperplasia
Heart Inflammation
Liver Hematopoietic Cell Proliferation
Liver: Kupffer Cell Pigmentation
Lung: Serosa Inflammation
Spleen Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Bone Marrow Pigmentation Hemosiderin
Bone Marrow: Erythroid Cell Hyperplasia
Kidney Pigmentation
Liver Hematopoietic Cell Proliferation
Liver: Kupffer Cell Pigmentation
Lung Foreign Body
Lung: Serosa Inflammation
Spleen Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
===============================================================
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/9.00 0/10.00 0/7.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/7 (0%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 4/10 (40%) 8/10 (80%) 7/10 (70%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/9.00 4/9.00 8/10.00 7/8.00 10/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 44.4% 80.0% 87.5% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 4/9 (44%) 8/10 (80%) 7/8 (88%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.049 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.049 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.043 * P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow: Erythroid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 0/9.00 0/10.00 0/7.00 0/10.00 0/10.00 4/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 0/7 (0%) 0/10 (0%) 0/10 (0%) 4/10 (40%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P=0.063 |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P=0.045 * |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P=0.045 * |
|POLY 6 | P<0.001 ** (e) (e) (e) (e) P=0.045 * |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.063 |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.043 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow: Erythroid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/9.00 0/9.00 0/10.00 0/8.00 0/10.00 2/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 22.2% |
|TERMINAL (d) | 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/8 (0%) 0/10 (0%) 2/9 (22%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.011 * (e) (e) (e) (e) P=0.233 |
|POLY 3 | P=0.008 ** (e) (e) (e) (e) P=0.225 |
|POLY 1.5 | P=0.008 ** (e) (e) (e) (e) P=0.225 |
|POLY 6 | P=0.008 ** (e) (e) (e) (e) P=0.225 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.227 |
|COCH-ARM / FISHERS | P=0.010 * (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 2/2.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- 9 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.376N (e) P=0.210 (e) (e) (e) |
|POLY 3 | (e) (e) P<0.001 ** (e) (e) (e) |
|POLY 1.5 | (e) (e) P<0.001 ** (e) (e) (e) |
|POLY 6 | (e) (e) P<0.001 ** (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.979 (e) P=0.498 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.269N (e) P=0.038 * (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Heart |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 0/0.00 0/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/3 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Kidney |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 0/0 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 0/0.00 6/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 66.7% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/9 (67%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.004 ** (e) (e) (e) (e) P=0.008 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.008 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P=0.005 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/3 (0%) 0/0 (0%) 0/3 (0%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 0/3.00 8/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 80.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/3 (0%) 8/10 (80%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 1/9 (11%) 7/10 (70%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 1/9.00 7/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 11.1% 77.8% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) 7/9 (78%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.500 P=0.002 ** |
|POLY 3 | (e) (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.500 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.500 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.500 P=0.002 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.474 P=0.002 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/3 (0%) 0/0 (0%) 3/3 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 3/3.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 90.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 3/3 (100%) 9/10 (90%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.005 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) (e) (e) P=0.005 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.003 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 0/2 (0%) 9/9 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 0/0.00 9/9.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/9 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 7
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 1/3 (33%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 1/1.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 99.9% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 9 --- 9 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.283N P=0.500N P=0.743 P=0.500N P=0.500N P=0.500N |
|POLY 3 | (e) (e) P=0.285 (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) P=0.289 (e) (e) P=0.500N |
|POLY 6 | (e) (e) P=0.285 (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.960N (e) P=0.502N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.210N P=1.000 P=0.423 P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/9.00 0/0.00 0/0.00 2/2.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 0.0% 10.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- --- --- 7 --- 7 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.316 (e) (e) P=0.240 (e) P=0.500 |
|POLY 3 | (e) (e) (e) P<0.001 ** (e) P=0.521 |
|POLY 1.5 | (e) (e) (e) P<0.001 ** (e) P=0.520 |
|POLY 6 | (e) (e) (e) P<0.001 ** (e) P=0.521 |
|LOGISTIC REGRESSION| P=0.215 (e) (e) P=0.323 (e) P=0.250 |
|COCH-ARM / FISHERS | P=0.566 (e) (e) P=0.015 * (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 8
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 3/3 (100%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 3/3.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 100.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 9 --- 5 --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.160N P=0.500N P=0.272 P=0.500N P=0.500N P=0.500N |
|POLY 3 | (e) (e) P<0.001 ** (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) P<0.001 ** (e) (e) P=0.500N |
|POLY 6 | (e) (e) P<0.001 ** (e) (e) P=0.500N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.090N P=1.000 P=0.014 * P=1.000 P=1.000 P=0.500N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Lung: Serosa |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/9.00 1/1.00 0/0.00 2/2.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 0.0% 100.0% 0.0% 10.0% |
|TERMINAL (d) | 0/9 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- 7 --- 7 --- 7 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.487 P=0.500 (e) P=0.240 (e) P=0.500 |
|POLY 3 | (e) P<0.001 ** (e) P<0.001 ** (e) P=0.521 |
|POLY 1.5 | (e) P<0.001 ** (e) P<0.001 ** (e) P=0.520 |
|POLY 6 | (e) P<0.001 ** (e) P<0.001 ** (e) P=0.521 |
|LOGISTIC REGRESSION| P=0.424 P=0.250 (e) P=0.323 (e) P=0.250 |
|COCH-ARM / FISHERS | P=0.489N P=0.091 (e) P=0.015 * (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 9
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/9.00 0/10.00 3/8.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 37.5% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) 2/7 (29%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 9 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.086 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.071 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.071 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.071 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.123 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.105 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 7/10 (70%) 7/10 (70%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/9.00 2/9.00 7/10.00 7/8.00 10/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 22.2% 70.0% 87.5% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 2/9 (22%) 7/10 (70%) 7/8 (88%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.233 P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.225 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.225 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.225 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.227 P=0.005 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.237 P=0.002 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 02 Page 10
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - M-CHLOROANILINE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 4/10 (40%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/9.00 1/10.00 4/7.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 57.1% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 1/10 (10%) 4/7 (57%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.521 P=0.024 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.521 P=0.010 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.520 P=0.010 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.521 P=0.010 * P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.521 P=0.024 * P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.043 * P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Spleen |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 9/10 (90%) 10/10 (100%) 8/10 (80%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/9.00 9/9.00 10/10.00 8/8.00 10/10.00 9/9.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/9 (0%) 9/9 (100%) 10/10 (100%) 8/8 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (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).