TDMS Study 61938-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest 1-NITROPYRENE DATE: 10/18/04
EXPERIMENT: 61938 TEST: 01 TIME: 08:36:31
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-85232 ROUTE: RESPIRATORY EXPOSURE NASAL NTP C#: C61938
PATHOLOGIST: R. MILLER R. RENNE P. CAS: 5522-43-0
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest 1-NITROPYRENE DATE: 10/18/04
EXPERIMENT: 61938 TEST: 01 TIME: 08:36:31
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-85232 ROUTE: RESPIRATORY EXPOSURE NASAL NTP C#: C61938
PATHOLOGIST: R. MILLER R. RENNE P. CAS: 5522-43-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF 1-NITROPYRENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Larynx: Epiglottis Metaplasia
Liver Hepatodiaphragmatic Nodule
Lung: Bronchus Metaplasia
Nose: Respiratory Epithelium Cytoplasmic Alteration
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Larynx: Epiglottis Metaplasia
Liver Hepatodiaphragmatic Nodule
Lung Hemorrhage
Inflammation Chronic
Lung: Bronchus Metaplasia
Nose: Respiratory Epithelium Cytoplasmic Alteration
===============================================================
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/9 (100%) 10/10 (100%) 10/10 (100%) 9/9 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 9/9.00 10/10.00 10/10.00 9/9.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 9/9 (100%) 10/10 (100%) 10/10 (100%) 9/9 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|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 | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Epididymis |
| Hypospermia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 6/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 6/10 (60%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 91 (T) --- --- --- --- 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.271N P=1.000 P=1.000 P=1.000 P=1.000N P=0.331N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.333N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.333N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.333N |
|LOGISTIC REGRESSION| P=0.271N (e) (e) (e) (e) P=0.331N |
|COCH-ARM / FISHERS | P=0.266N P=1.000 P=1.000 P=1.000 P=1.000 P=0.328N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 4/10.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 4/10 (40%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 91 (T) --- --- --- --- 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.605 P=1.000 P=1.000 P=1.000 P=1.000 P=0.672 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.667 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.667 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.667 |
|LOGISTIC REGRESSION| P=0.605 (e) (e) (e) (e) P=0.672 |
|COCH-ARM / FISHERS | P=0.608 P=1.000 P=1.000 P=1.000 P=1.000 P=0.675N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 5/10.00 0/0.00 0/0.00 0/0.00 0/0.00 5/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 5/10 (50%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 91 (T) --- --- --- --- 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.603 P=1.000N P=1.000N P=1.000N P=1.000N P=0.669 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.664 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.664 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.664 |
|LOGISTIC REGRESSION| P=0.603 (e) (e) (e) (e) P=0.669 |
|COCH-ARM / FISHERS | P=0.606 P=1.000 P=1.000 P=1.000 P=1.000 P=0.672N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 1/10 (10%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 91 (T) --- --- --- --- 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.669 P=1.000N P=1.000N P=1.000N P=1.000N P=0.766 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.760 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.760 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.760 |
|LOGISTIC REGRESSION| P=0.669 (e) (e) (e) (e) P=0.766 |
|COCH-ARM / FISHERS | P=0.673 P=1.000 P=1.000 P=1.000 P=1.000 P=0.763N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 5/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 50.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 5/10 (50%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.008 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) P=0.022 * P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.016 * P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 4/10 (40%) 4/10 (40%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 4/10.00 4/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 40.0% 40.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 4/10 (40%) 4/10 (40%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** P=0.051 P=0.051 P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.033 * P=0.033 * P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 1.5 | P<0.001 ** P=0.033 * P=0.033 * P<0.001 ** P<0.001 ** P<0.001N** |
|POLY 6 | P<0.001 ** P=0.033 * P=0.033 * P<0.001 ** P<0.001 ** P<0.001N** |
|LOGISTIC REGRESSION| (e) P=0.051 P=0.051 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.043 * P=0.043 * P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 2/2 (100%) 4/4 (100%) 1/1 (100%) 1/1 (100%) 1/10 (10%) |
|POLY-3 RATE (b) | 2/10.00 2/2.00 4/4.00 1/1.00 1/1.00 1/10.00 |
|POLY-3 PERCENT (g) | 20.0% 100.0% 100.0% 100.0% 100.0% 10.0% |
|TERMINAL (d) | 2/10 (20%) 2/2 (100%) 4/4 (100%) 1/1 (100%) 1/1 (100%) 1/10 (10%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.038N* P=0.095 P=0.020 * P=0.305 P=0.305 P=0.500N |
|POLY 3 | P=0.004N** P=0.053 P=0.002 ** P=0.286 P=0.286 P=0.500N |
|POLY 1.5 | P=0.004N** P=0.053 P=0.002 ** P=0.286 P=0.286 P=0.500N |
|POLY 6 | P=0.004N** P=0.053 P=0.002 ** P=0.286 P=0.286 P=0.500N |
|LOGISTIC REGRESSION| P=0.038N* P=0.095 P=0.020 * P=0.305 P=0.305 P=0.500N |
|COCH-ARM / FISHERS | P=0.035N* P=0.091 P=0.015 * P=0.273 P=0.273 P=0.500N |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 2/3 (67%) 1/1 (100%) 4/4 (100%) 1/1 (100%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 2/3.00 1/1.00 4/4.00 1/1.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 66.7% 100.0% 100.0% 100.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 2/3 (67%) 1/1 (100%) 4/4 (100%) 1/1 (100%) 1/10 (10%) |
|FIRST INCIDENCE | --- 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182N P=0.034 * P=0.077 P<0.001 ** P=0.077 P=0.500 |
|POLY 3 | P=0.051N P=0.003 ** P=0.091 P<0.001 ** P=0.091 P=0.500 |
|POLY 1.5 | P=0.051N P=0.003 ** P=0.091 P<0.001 ** P=0.091 P=0.500 |
|POLY 6 | P=0.051N P=0.003 ** P=0.091 P<0.001 ** P=0.091 P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.034 * P=0.077 P<0.001 ** P=0.077 P=0.500 |
|COCH-ARM / FISHERS | P=0.178N P=0.038 * P=0.091 P<0.001 ** P=0.091 P=0.500 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 8/8 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 8/8.00 10/10.00 9/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 90.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 8/8 (100%) 10/10 (100%) 9/10 (90%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.695 (e) (e) P=0.500N (e) (e) |
|POLY 3 | P=0.695 (e) (e) P=0.500N (e) (e) |
|POLY 1.5 | P=0.695 (e) (e) P=0.500N (e) (e) |
|POLY 6 | P=0.695 (e) (e) P=0.500N (e) (e) |
|LOGISTIC REGRESSION| P=0.695 (e) (e) P=0.500N (e) (e) |
|COCH-ARM / FISHERS | P=0.697 (e) (e) P=0.500N (e) (e) |
|ORDER RESTRICTED | P=0.513N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 8/10 (80%) 6/10 (60%) 9/10 (90%) 7/10 (70%) 9/10 (90%) |
|POLY-3 RATE (b) | 10/10.00 8/10.00 6/10.00 9/10.00 7/10.00 9/10.00 |
|POLY-3 PERCENT (g) | 100.0% 80.0% 60.0% 90.0% 70.0% 90.0% |
|TERMINAL (d) | 10/10 (100%) 8/10 (80%) 6/10 (60%) 9/10 (90%) 7/10 (70%) 9/10 (90%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.459 P=0.234N P=0.051N P=0.500N P=0.111N P=0.500N |
|POLY 3 | P=0.458 P=0.227N P=0.033N* P=0.500N P=0.095N P=0.500N |
|POLY 1.5 | P=0.458 P=0.227N P=0.033N* P=0.500N P=0.095N P=0.500N |
|POLY 6 | P=0.458 P=0.227N P=0.033N* P=0.500N P=0.095N P=0.500N |
|LOGISTIC REGRESSION| P=0.459 P=0.234N P=0.051N P=0.500N P=0.111N P=0.500N |
|COCH-ARM / FISHERS | P=0.458 P=0.237N P=0.043N* P=0.500N P=0.105N P=0.500N |
|ORDER RESTRICTED | P=0.159N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 3/8 (38%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 3/8.00 1/10.00 2/10.00 1/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 37.5% 10.0% 20.0% 10.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 3/8 (38%) 1/10 (10%) 2/10 (20%) 1/10 (10%) 0/10 (0%) |
|FIRST INCIDENCE | --- 91 (T) 91 (T) 91 (T) 91 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.171N P=0.074 P=0.500 P=0.234 P=0.500 (e) |
|POLY 3 | P=0.163N P=0.053 P=0.500 P=0.227 P=0.500 (e) |
|POLY 1.5 | P=0.163N P=0.053 P=0.500 P=0.227 P=0.500 (e) |
|POLY 6 | P=0.163N P=0.053 P=0.500 P=0.227 P=0.500 (e) |
|LOGISTIC REGRESSION| (e) P=0.074 P=0.500 P=0.234 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.169N P=0.069 P=0.500 P=0.237 P=0.500 (e) |
|ORDER RESTRICTED | P=0.205N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 5/10 (50%) 2/10 (20%) 0/10 (0%) 2/10 (20%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 5/10.00 2/10.00 0/10.00 2/10.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 50.0% 20.0% 0.0% 20.0% 20.0% |
|TERMINAL (d) | 0/10 (0%) 5/10 (50%) 2/10 (20%) 0/10 (0%) 2/10 (20%) 2/10 (20%) |
|FIRST INCIDENCE | --- 91 (T) 91 (T) --- 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.602N P=0.022 * P=0.234 (e) P=0.234 P=0.234 |
|POLY 3 | P=0.609N P=0.008 ** P=0.227 (e) P=0.227 P=0.227 |
|POLY 1.5 | P=0.609N P=0.008 ** P=0.227 (e) P=0.227 P=0.227 |
|POLY 6 | P=0.609N P=0.008 ** P=0.227 (e) P=0.227 P=0.227 |
|LOGISTIC REGRESSION| (e) P=0.022 * P=0.234 (e) P=0.234 P=0.234 |
|COCH-ARM / FISHERS | P=0.603N P=0.016 * P=0.237 (e) P=0.237 P=0.237 |
|ORDER RESTRICTED | P=0.152 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Bronchus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 5/10 (50%) |
|POLY-3 RATE (b) | 0/10.00 0/8.00 0/10.00 1/10.00 2/10.00 5/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 10.0% 20.0% 50.0% |
|TERMINAL (d) | 0/10 (0%) 0/8 (0%) 0/10 (0%) 1/10 (10%) 2/10 (20%) 5/10 (50%) |
|FIRST INCIDENCE | --- --- --- 91 (T) 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.500 P=0.234 P=0.022 * |
|POLY 3 | P<0.001 ** (e) (e) P=0.500 P=0.227 P=0.008 ** |
|POLY 1.5 | P<0.001 ** (e) (e) P=0.500 P=0.227 P=0.008 ** |
|POLY 6 | P<0.001 ** (e) (e) P=0.500 P=0.227 P=0.008 ** |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.500 P=0.234 P=0.022 * |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) P=0.500 P=0.237 P=0.016 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Lung: Bronchus |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 3/10 (30%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 0/10.00 2/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 20.0% 30.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 3/10 (30%) |
|FIRST INCIDENCE | --- --- --- --- 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) (e) P=0.234 P=0.111 |
|POLY 3 | P<0.001 ** (e) (e) (e) P=0.227 P=0.095 |
|POLY 1.5 | P<0.001 ** (e) (e) (e) P=0.227 P=0.095 |
|POLY 6 | P<0.001 ** (e) (e) (e) P=0.227 P=0.095 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.234 P=0.111 |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) (e) P=0.237 P=0.105 |
|ORDER RESTRICTED | P=0.007 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|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 | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|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: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/10.00 0/10.00 8/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 80.0% 100.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 8/10 (80%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 91 (T) 91 (T) 91 (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 | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Cytoplasmic Alteration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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% |
|TERMINAL (d) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 6/10 (60%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 91 (T) 91 (T) 91 (T) |
|-------------------| |
|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<0.001N** |
|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| (e) (e) (e) P=0.009 ** P<0.001 ** P<0.001 ** |
|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: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|POLY-3 RATE (b) | 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) 10/10 (100%) |
|FIRST INCIDENCE | 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) 91 (T) |
|-------------------| |
|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 | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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: 10/18/04 EXPERIMENT: 61938 TEST: 01 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - 1-NITROPYRENE
Terminal Sacrifice at 13 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 0/10.00 0/10.00 2/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 0.0% 0.0% 20.0% 10.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 2/10 (20%) 1/10 (10%) |
|FIRST INCIDENCE | 91 (T) --- --- --- 91 (T) 91 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.269 P=0.500N P=0.500N P=0.500N P=0.500 P=0.766 |
|POLY 3 | P=0.268 P=0.500N P=0.500N P=0.500N P=0.500 P=0.760 |
|POLY 1.5 | P=0.268 P=0.500N P=0.500N P=0.500N P=0.500 P=0.760 |
|POLY 6 | P=0.268 P=0.500N P=0.500N P=0.500N P=0.500 P=0.760 |
|LOGISTIC REGRESSION| P=0.269 (e) (e) (e) P=0.500 P=0.766 |
|COCH-ARM / FISHERS | P=0.267 P=0.500N P=0.500N P=0.500N P=0.500 P=0.763N |
|ORDER RESTRICTED | P=0.232 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 0.5 2.0 8.0 20.0 50.0 |
| | MG/M3 MG/M3 MG/M3 MG/M3 MG/M3 |
|=================================================================================================================================|
| |
|Testes |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 | |
|=================================================================================================================================|
(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).