TDMS Study 91001-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus O-CHLOROANILINE DATE: 10/20/04
EXPERIMENT: 91001 TEST: 01 TIME: 13:23:01
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: C91001
PATHOLOGIST: R. PERSING ELWELL, MICHAEL LE CAS: 95-51-2
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 10 MG/KG
INCLUDE 004 10 MG/KG
INCLUDE 005 20 MG/KG
INCLUDE 006 20 MG/KG
INCLUDE 007 40 MG/KG
INCLUDE 008 40 MG/KG
INCLUDE 009 80 MG/KG
INCLUDE 010 80 MG/KG
INCLUDE 011 160 MG/KG
INCLUDE 012 160 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus O-CHLOROANILINE DATE: 10/20/04
EXPERIMENT: 91001 TEST: 01 TIME: 13:23:01
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-15320 ROUTE: GAVAGE NTP C#: C91001
PATHOLOGIST: R. PERSING ELWELL, MICHAEL LE CAS: 95-51-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF O-CHLOROANILINE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Bone Marrow: Erythroid Cell Hyperplasia
Kidney: Cortex Pigmentation Diffuse Hemosiderin
Liver Pigmentation Hemosiderin
Spleen Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
Spleen: Capsule Fibrosis
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Bone Marrow: Erythroid Cell Hyperplasia
Kidney: Cortex Pigmentation Diffuse Hemosiderin
Liver Pigmentation Hemosiderin
Spleen Hematopoietic Cell Proliferation
Pigmentation Hemosiderin
Spleen: Capsule Fibrosis
===============================================================
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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%) 1/10 (10%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 1/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 12 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.500 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.500 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) P=0.500 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: Erythroid Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 0/9.09 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% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | |
|POLY-3 RATE (b) | |
|POLY-3 PERCENT (g) | |
|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 |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 3/10 (30%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 3/10.00 0/0.00 0/0.09 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 30.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 3/10 (30%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.207N P=1.000N P=1.000 P=1.000N P=1.000N P=0.293N |
|POLY 3 | (e) (e) P=0.838N (e) (e) P=0.292N |
|POLY 1.5 | (e) (e) P=0.809N (e) (e) P=0.292N |
|POLY 6 | (e) (e) P=0.849N (e) (e) P=0.292N |
|LOGISTIC REGRESSION| P=0.207N (e) (e) (e) (e) P=0.293N |
|COCH-ARM / FISHERS | P=0.223N P=1.000 P=0.727N P=1.000 P=1.000 P=0.291N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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: Myocardium |
| Degeneration Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 0/0.00 0/0.00 0/0.00 2/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/10 (20%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.607 P=1.000N P=1.000N P=1.000N P=1.000N P=0.707 |
|POLY 3 | (e) (e) (e) P=0.882N (e) P=0.702 |
|POLY 1.5 | (e) (e) (e) P=0.879N (e) P=0.702 |
|POLY 6 | (e) (e) (e) P=0.882N (e) P=0.702 |
|LOGISTIC REGRESSION| P=0.607 (e) (e) (e) (e) P=0.707 |
|COCH-ARM / FISHERS | P=0.591 P=1.000 P=1.000 P=0.818N P=1.000 P=0.709N |
|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: Myocardium |
| Degeneration Chronic Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.09 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.309 (e) (e) (e) (e) P=0.500 |
|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| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.289 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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 Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 9/10.00 10/10.00 10/10.00 10/10.00 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 90.0% 100.0% 100.0% 100.0% 100.0% 90.0% |
|TERMINAL (d) | 9/10 (90%) 10/10 (100%) 10/10 (100%) 9/9 (100%) 10/10 (100%) 9/10 (90%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 12 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.384N P=0.500 P=0.500 P=0.251 P=0.500 P=0.766 |
|POLY 3 | P=0.415N P=0.500 P=0.500 P=0.500 P=0.500 P=0.760 |
|POLY 1.5 | P=0.415N P=0.500 P=0.500 P=0.500 P=0.500 P=0.760 |
|POLY 6 | P=0.415N P=0.500 P=0.500 P=0.500 P=0.500 P=0.760 |
|LOGISTIC REGRESSION| P=0.384N P=0.500 P=0.500 (e) P=0.500 P=0.766 |
|COCH-ARM / FISHERS | P=0.414N P=0.500 P=0.500 P=0.500 P=0.500 P=0.763N |
|ORDER RESTRICTED | P=0.292 (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 Diffuse |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 9/10.00 10/10.00 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 90.0% 100.0% 100.0% 90.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 8/9 (89%) 10/10 (100%) 10/10 (100%) 9/10 (90%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 42 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.239N (e) P=0.749N (e) (e) P=0.500N |
|POLY 3 | P=0.318N (e) P=0.500N (e) (e) P=0.500N |
|POLY 1.5 | P=0.318N (e) P=0.500N (e) (e) P=0.500N |
|POLY 6 | P=0.318N (e) P=0.500N (e) (e) P=0.500N |
|LOGISTIC REGRESSION| P=0.239N (e) (e) (e) (e) P=0.500N |
|COCH-ARM / FISHERS | P=0.315N (e) P=0.500N (e) (e) P=0.500N |
|ORDER RESTRICTED | P=0.191N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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 Diffuse Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | 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 |
|=================================================================================================================================|
| |
|Kidney: Cortex |
| Pigmentation Diffuse Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.09 0/10.00 0/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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 Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 0/0.00 0/0.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|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 |
| Pigmentation Hemosiderin |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.09 0/0.00 0/0.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|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) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/1 (0%) 0/0 (0%) 6/10 (60%) |
|POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 0/0.00 0/0.00 6/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 60.0% |
|TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 6/10 (60%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.588 P=1.000N P=1.000N P=1.000N P=1.000N P=0.672 |
|POLY 3 | (e) (e) (e) P=0.833N (e) P=0.667 |
|POLY 1.5 | (e) (e) (e) P=0.821N (e) P=0.667 |
|POLY 6 | (e) (e) (e) P=0.834N (e) P=0.667 |
|LOGISTIC REGRESSION| P=0.588 (e) (e) (e) (e) P=0.672 |
|COCH-ARM / FISHERS | P=0.538 P=1.000 P=1.000 P=0.455N P=1.000 P=0.675N |
|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) | |
|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: 91001 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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%) 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 0/9.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | 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%) 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 0/9.09 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% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 0/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 90.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 9/10 (90%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | 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%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 9/10 (90%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.09 0/10.00 9/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 90.0% 90.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (0%) 0/10 (0%) 9/10 (90%) 9/10 (90%) |
|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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/20/04 EXPERIMENT: 91001 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - O-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%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 10/10 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/9.00 10/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 100.0% 90.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) 10/10 (100%) 9/10 (90%) |
|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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | 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%) 0/10 (0%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/9.09 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% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/9 (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<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (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 | 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).