TDMS Study 61529-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus M-CHLOROANILINE DATE: 10/20/04
EXPERIMENT: 61529 TEST: 01 TIME: 08:47:58
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: 61529B
PATHOLOGIST: YARRINGTON, J. 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: 01 TIME: 08:47:58
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: 61529B
PATHOLOGIST: YARRINGTON, J. CAS: 108-42-09
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF M-CHLOROANILINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Bone Marrow Pigmentation Hemosiderin
Bone Marrow: Erythroid Cell Hyperplasia
Heart Cardiomyopathy
Kidney: Cortex Pigmentation Hemosiderin
Kidney: Renal Tubule Regeneration Focal
Liver Hematopoietic Cell Proliferation
Liver: Kupffer Cell Pigmentation
Preputial Gland Inflammation Chronic Focal
Spleen Congestion
Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
Spleen: Capsule Fibrosis
Infiltration Cellular
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Bone Marrow Myelofibrosis
Pigmentation Hemosiderin
Bone Marrow: Erythroid Cell Hyperplasia
Kidney: Cortex Pigmentation Hemosiderin
Kidney: Renal Tubule Regeneration Focal
Liver Hematopoietic Cell Proliferation
Pigmentation
Liver: Kupffer Cell Pigmentation
Spleen Congestion
Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
Spleen: Capsule Fibrosis
Infiltration Cellular
===============================================================
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 3/10 (30%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 2/10.00 3/10.00 0/10.00 0/9.59 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 20.0% 30.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 2/10 (20%) 3/10 (30%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239N P=0.500 P=0.234 P=0.111 (e) (e) |
|POLY 3 | P=0.220N P=0.500 P=0.227 P=0.095 (e) (e) |
|POLY 1.5 | P=0.216N P=0.500 P=0.227 P=0.095 (e) (e) |
|POLY 6 | P=0.225N P=0.500 P=0.227 P=0.095 (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.500 P=0.234 P=0.111 (e) (e) |
|COCH-ARM / FISHERS | P=0.217N P=0.500 P=0.237 P=0.105 (e) (e) |
|ORDER RESTRICTED | P=0.228N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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 |
|=================================================================================================================================|
| |
|Bone Marrow |
| Myelofibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/10.00 1/10.00 0/10.00 0/10.00 1/10.00 1/9.59 |
|POLY-3 PERCENT (g) | 30.0% 10.0% 0.0% 0.0% 10.0% 10.4% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 1/9 (11%) |
|FIRST INCIDENCE | 93 (T) 93 (T) --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.471N P=0.293N P=0.111N P=0.111N P=0.293N P=0.333N |
|POLY 3 | P=0.442N P=0.292N P=0.095N P=0.095N P=0.292N P=0.308N |
|POLY 1.5 | P=0.440N P=0.292N P=0.095N P=0.095N P=0.292N P=0.301N |
|POLY 6 | P=0.445N P=0.292N P=0.095N P=0.095N P=0.292N P=0.318N |
|LOGISTIC REGRESSION| P=0.471N P=0.293N (e) (e) P=0.293N P=0.333N |
|COCH-ARM / FISHERS | P=0.438N P=0.291N P=0.105N P=0.105N P=0.291N P=0.291N |
|ORDER RESTRICTED | P=0.049N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (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 | P<0.001N** (e) (e) (e) P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** (e) (e) (e) P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** (e) (e) (e) P<0.001N** P<0.001N** |
|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 | 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%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 3/10.00 10/10.00 9/9.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 30.0% 100.0% 93.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 3/10 (30%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.111 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.095 P<0.001N** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.095 P<0.001N** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.095 P<0.001N** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.111 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.105 P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 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% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (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| P<0.001 ** (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=0.831 (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%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 6/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 60.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.009 ** 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=0.009 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
| | |
| | Females |
|Dose | 0 MG/KG 10 MG/KG 20 MG/KG 40 MG/KG 80 MG/KG 160 |
| | MG/KG |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 7/10 (70%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 7/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 70.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/9 (67%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.146 P=1.000 P=1.000 P=1.000N P=1.000N P=0.257 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.329 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.329 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.329 |
|LOGISTIC REGRESSION| P=0.146 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247 P=1.000 P=1.000 P=1.000 P=1.000 P=0.325 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 10/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 100.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 10/10 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012N* (e) (e) (e) (e) P=0.022N* |
|POLY 3 | (e) (e) (e) (e) (e) P=0.008N** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.008N** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.008N** |
|LOGISTIC REGRESSION| P=0.012N* (e) (e) (e) (e) P=0.022N* |
|COCH-ARM / FISHERS | P=0.010N* (e) (e) (e) (e) P=0.016N* |
|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 |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 4/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/9 (44%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.291 P=1.000N P=1.000N P=1.000N P=1.000N P=0.431 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| P=0.291 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.411 P=1.000 P=1.000 P=1.000 P=1.000 P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 9/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 90.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.560 (e) P=0.500N (e) (e) (e) |
|POLY 3 | P=0.560 (e) P=0.500N (e) (e) (e) |
|POLY 1.5 | P=0.560 (e) P=0.500N (e) (e) (e) |
|POLY 6 | P=0.560 (e) P=0.500N (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.560 (e) P=0.500N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.561 (e) P=0.500N (e) (e) (e) |
|ORDER RESTRICTED | P=0.513 (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 |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 9/9.59 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 93.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=1.000N (e) (e) (e) (e) P=1.000N |
|POLY 3 | P=0.221N (e) (e) (e) (e) P=0.745N |
|POLY 1.5 | P=0.150N (e) (e) (e) (e) P=0.613N |
|POLY 6 | P=0.508N (e) (e) (e) (e) P=0.962N |
|LOGISTIC REGRESSION| P=1.000N (e) (e) (e) (e) P=1.000N |
|COCH-ARM / FISHERS | P=0.105N (e) (e) (e) (e) P=0.500N |
|ORDER RESTRICTED | P=0.060N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Cortex |
| 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) | 0/10.00 0/10.00 0/10.00 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% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (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<0.001N** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001 ** (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=0.831 (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: Cortex |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 1/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 10.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.500 P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Renal Tubule |
| Regeneration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 8/10 (80%) 7/10 (70%) 3/10 (30%) 2/10 (20%) 0/10 (0%) |
|POLY-3 RATE (b) | 9/10.00 8/10.00 7/10.00 3/10.00 2/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 90.0% 80.0% 70.0% 30.0% 20.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 9/10 (90%) 8/10 (80%) 7/10 (70%) 3/10 (30%) 2/10 (20%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=0.500N P=0.293N P=0.013N* P=0.004N** P<0.001N** |
|POLY 3 | P<0.001N** P=0.500N P=0.292N P=0.003N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P=0.500N P=0.292N P=0.003N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P=0.500N P=0.292N P=0.003N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** P=0.500N P=0.293N P=0.013N* P=0.004N** (e) |
|COCH-ARM / FISHERS | P<0.001N** P=0.500N P=0.291N P=0.010N* P=0.003N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (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: Renal Tubule |
| Regeneration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/10.00 1/10.00 0/10.00 0/10.00 0/9.59 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 10.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) --- 93 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.163N P=0.234N P=0.500N P=0.234N P=0.234N P=0.257N |
|POLY 3 | P=0.149N P=0.227N P=0.500N P=0.227N P=0.227N P=0.236N |
|POLY 1.5 | P=0.149N P=0.227N P=0.500N P=0.227N P=0.227N P=0.232N |
|POLY 6 | P=0.148N P=0.227N P=0.500N P=0.227N P=0.227N P=0.243N |
|LOGISTIC REGRESSION| P=0.163N (e) P=0.500N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.237N P=0.500N P=0.237N P=0.237N P=0.237N |
|ORDER RESTRICTED | P=0.029N* (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 0/10.00 0/10.00 9/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 0.0% 0.0% 90.0% 90.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 9/10 (90%) |
|FIRST INCIDENCE | --- 93 (T) --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 (e) (e) P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 (e) (e) P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.500 (e) (e) P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 (e) (e) 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 |
|=================================================================================================================================|
| |
|Liver |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 2/10.00 0/10.00 1/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 10.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/10 (0%) 1/10 (10%) 10/10 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | 93 (T) --- 93 (T) 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.234N P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.227N P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.227N P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.227N P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.500N P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.237N P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 2/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 20.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- 93 (T) --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.287N P=0.234 (e) (e) (e) (e) |
|POLY 3 | P=0.277N P=0.227 (e) (e) (e) (e) |
|POLY 1.5 | P=0.277N P=0.227 (e) (e) (e) (e) |
|POLY 6 | P=0.277N P=0.227 (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.234 (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.285N P=0.237 (e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.165N (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 |
| Necrosis Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.59 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (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 |
|=================================================================================================================================|
| |
|Liver |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 3/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/9.59 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.115N P=0.111N P=0.111N P=0.111N P=0.111N P=0.129N |
|POLY 3 | P=0.083N P=0.095N P=0.095N P=0.095N P=0.095N P=0.103N |
|POLY 1.5 | P=0.084N P=0.095N P=0.095N P=0.095N P=0.095N P=0.099N |
|POLY 6 | P=0.082N P=0.095N P=0.095N P=0.095N P=0.095N P=0.108N |
|LOGISTIC REGRESSION| P=0.115N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.107N P=0.105N P=0.105N P=0.105N P=0.105N P=0.105N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 9/10.00 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 90.0% 100.0% 90.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 9/10 (90%) |
|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 |
|=================================================================================================================================|
| |
|Liver: Kupffer Cell |
| Pigmentation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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) | 0/10.00 0/10.00 0/10.00 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% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 78 |
|-------------------| |
|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 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P=0.831 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.413N P=1.000N P=1.000N P=1.000N P=1.000N P=0.500N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.500N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.413N (e) (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.411N P=1.000 P=1.000 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: Artery |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/9 (44%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.163 P=1.000N P=1.000N P=1.000N P=1.000N P=0.282 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.329 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.329 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.329 |
|LOGISTIC REGRESSION| P=0.163 (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247 P=1.000 P=1.000 P=1.000 P=1.000 P=0.325 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.127 P=1.000N P=1.000 P=1.000N P=1.000N P=0.180 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.174 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.174 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.174 |
|LOGISTIC REGRESSION| P=0.127 (e) (e) (e) (e) P=0.180 |
|COCH-ARM / FISHERS | P=0.121 P=1.000 P=1.000 P=1.000 P=1.000 P=0.175 |
|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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.012N* P=1.000N P=1.000N P=1.000N P=1.000N P=0.022N* |
|POLY 3 | (e) (e) (e) (e) (e) P=0.008N** |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.008N** |
|POLY 6 | (e) (e) (e) (e) (e) P=0.008N** |
|LOGISTIC REGRESSION| P=0.012N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.010N* P=1.000 P=1.000 P=1.000 P=1.000 P=0.016N* |
|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 |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|INT SACRIFICE 1 (c)| |
|TERMINAL (d) | |
|FIRST INCIDENCE | |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | |
|POLY 3 | |
|POLY 1.5 | |
|POLY 6 | |
|LOGISTIC REGRESSION| |
|COCH-ARM / FISHERS | |
|ORDER RESTRICTED | |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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 |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 1/10 (10%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 1/10.00 9/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 10.0% 90.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/10 (10%) 9/10 (90%) 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=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** 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 |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 8/10 (80%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 8/10.00 9/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 80.0% 90.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 8/10 (80%) 9/10 (90%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- --- 93 (T) 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 7/10 (70%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 7/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 70.0% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 7/10 (70%) 10/10 (100%) 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=0.003 ** 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=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** 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%) 5/10 (50%) 8/10 (80%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 5/10.00 8/10.00 10/10.00 10/10.00 9/9.59 |
|POLY-3 PERCENT (g) | 0.0% 50.0% 80.0% 100.0% 100.0% 93.9% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 5/10 (50%) 8/10 (80%) 10/10 (100%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** P<0.001N** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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%) 6/10 (60%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 6/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 60.0% 100.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 6/10 (60%) 10/10 (100%) 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=0.009 ** 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=0.009 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.005 ** P<0.001 ** 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%) 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 10/10.00 10/10.00 9/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 100.0% 100.0% 90.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 9/9 (100%) |
|FIRST INCIDENCE | --- 93 (T) 93 (T) 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001N** P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001N** 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 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** 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) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Capsule |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/10 (20%) 2/10 (20%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 2/10.00 2/10.00 8/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 20.0% 20.0% 80.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 2/10 (20%) 2/10 (20%) 8/10 (80%) 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=0.234 P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.227 P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.227 P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.227 P=0.227 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) P=0.234 P=0.234 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.237 P=0.237 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: Capsule |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 6/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 60.0% 100.0% 80.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) 7/9 (78%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.009 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P<0.001 ** P<0.001N** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P<0.001 ** P<0.001N** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P<0.001 ** P<0.001N** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.009 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.005 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 61529 TEST: 01 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 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: Capsule |
| Infiltration Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 2/10 (20%) 2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 1/10.00 2/10.00 2/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 10.0% 20.0% 20.0% 100.0% 100.0% 100.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/10 (10%) 2/10 (20%) 2/10 (20%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.500 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.500 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.500 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.500 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.500 P=0.500 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.500 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: Capsule |
| Infiltration Cellular |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 8/10 (80%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 0/10.00 9/10.00 10/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 0.0% 90.0% 100.0% 80.0% |
|INT SACRIFICE 1 (c)| 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|TERMINAL (d) | 1/10 (10%) 1/10 (10%) 0/10 (0%) 9/10 (90%) 10/10 (100%) 7/9 (78%) |
|FIRST INCIDENCE | 93 (T) 93 (T) --- 93 (T) 93 (T) 78 |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.766 P=0.500N P<0.001 ** P<0.001 ** P=0.004 ** |
|POLY 3 | P<0.001 ** P=0.760 P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.760 P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.760 P=0.500N P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.766 (e) P<0.001 ** P<0.001 ** (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.763N P=0.500N P<0.001 ** P<0.001 ** P=0.003 ** |
|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).