TDMS Study 05135-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 03 TIME: 13:06:20
TEST TYPE: SUBCHRON 90-DAY PAGE: 1
CONT: N01-ES-55105 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61825
PATHOLOGIST: HAILEY, JAMES R. CAS: 78-79-5
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 03 TIME: 13:06:20
TEST TYPE: SUBCHRON 90-DAY
CONT: N01-ES-55105 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C61825
PATHOLOGIST: HAILEY, JAMES R. CAS: 78-79-5
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ISOPRENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy Focal
Lung: Alveolar Epithelium Hyperplasia Focal
Lung: Alveolus Infiltration Cellular Focal Histiocyte
Inflammation Focal
Lung: Peribronchial Hyperplasia Focal Lymphoid
Lung: Perivascular Hyperplasia Focal Lymphoid
Lymph Node, Bronchial Hyperplasia
Lymph Node, Mediastinal Hyperplasia
Pancreas Accessory Spleen
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Heart Cardiomyopathy Focal
Kidney Mineralization Focal
Kidney: Bilateral Mineralization Focal
Lung: Alveolar Epithelium Hyperplasia Focal
Lung: Alveolus Infiltration Cellular Focal Histiocyte
Inflammation Focal
Lung: Peribronchial Hyperplasia Focal Lymphoid
Lung: Perivascular Hyperplasia Focal Lymphoid
Lymph Node, Bronchial Hyperplasia
===============================================================
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|POLY-3 RATE (b) | 5/10.00 0/10.00 0/10.00 0/10.00 0/10.00 5/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 50.0% |
|TERMINAL (d) | 5/10 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 5/10 (50%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.015 * P=0.022N* P=0.022N* P=0.022N* P=0.022N* P=0.669 |
|POLY 3 | P=0.004 ** P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.664 |
|POLY 1.5 | P=0.004 ** P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.664 |
|POLY 6 | P=0.004 ** P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.664 |
|LOGISTIC REGRESSION| P=0.015 * (e) (e) (e) (e) P=0.669 |
|COCH-ARM / FISHERS | P=0.015 * P=0.016N* P=0.016N* P=0.016N* P=0.016N* P=0.672N |
|ORDER RESTRICTED | P=0.002 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.387N P=0.234N P=0.234N P=0.234N P=0.234N P=0.234N |
|POLY 3 | P=0.382N P=0.227N P=0.227N P=0.227N P=0.227N P=0.227N |
|POLY 1.5 | P=0.382N P=0.227N P=0.227N P=0.227N P=0.227N P=0.227N |
|POLY 6 | P=0.382N P=0.227N P=0.227N P=0.227N P=0.227N P=0.227N |
|LOGISTIC REGRESSION| P=0.387N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.387N P=0.237N P=0.237N P=0.237N P=0.237N P=0.237N |
|ORDER RESTRICTED | P=0.007N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization 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 0/10.00 |
|POLY-3 PERCENT (g) | 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 | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|POLY-3 RATE (b) | 9/10.00 0/10.00 0/10.00 0/10.00 1/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 10.0% 80.0% |
|TERMINAL (d) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|FIRST INCIDENCE | 93 (T) --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 3 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 1.5 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 6 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) P<0.001N** P=0.500N |
|COCH-ARM / FISHERS | P=0.002 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral |
| Mineralization 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 0/10.00 |
|POLY-3 PERCENT (g) | 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 | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Kidney: Bilateral |
| Mineralization Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|POLY-3 RATE (b) | 9/10.00 0/10.00 0/10.00 0/10.00 1/10.00 8/10.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 10.0% 80.0% |
|TERMINAL (d) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) 8/10 (80%) |
|FIRST INCIDENCE | 93 (T) --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 3 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 1.5 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|POLY 6 | P<0.001 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|LOGISTIC REGRESSION| P=0.002 ** (e) (e) (e) P<0.001N** P=0.500N |
|COCH-ARM / FISHERS | P=0.002 ** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.500N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 1/10.00 0/10.00 2/10.00 1/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 10.0% 0.0% 20.0% 10.0% 0.0% 10.0% |
|TERMINAL (d) | 1/10 (10%) 0/10 (0%) 2/10 (20%) 1/10 (10%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 93 (T) --- 93 (T) 93 (T) --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.649N P=0.500N P=0.500 P=0.766 P=0.500N P=0.766 |
|POLY 3 | P=0.647N P=0.500N P=0.500 P=0.760 P=0.500N P=0.760 |
|POLY 1.5 | P=0.647N P=0.500N P=0.500 P=0.760 P=0.500N P=0.760 |
|POLY 6 | P=0.647N P=0.500N P=0.500 P=0.760 P=0.500N P=0.760 |
|LOGISTIC REGRESSION| P=0.649N (e) P=0.500 P=0.766 (e) P=0.766 |
|COCH-ARM / FISHERS | P=0.650N P=0.500N P=0.500 P=0.763N P=0.500N P=0.763N |
|ORDER RESTRICTED | P=0.622 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|POLY-3 RATE (b) | 1/10.00 1/10.00 1/10.00 0/10.00 0/10.00 3/10.00 |
|POLY-3 PERCENT (g) | 10.0% 10.0% 10.0% 0.0% 0.0% 30.0% |
|TERMINAL (d) | 1/10 (10%) 1/10 (10%) 1/10 (10%) 0/10 (0%) 0/10 (0%) 3/10 (30%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.068 P=0.766 P=0.766 P=0.500N P=0.500N P=0.293 |
|POLY 3 | P=0.065 P=0.760 P=0.760 P=0.500N P=0.500N P=0.292 |
|POLY 1.5 | P=0.065 P=0.760 P=0.760 P=0.500N P=0.500N P=0.292 |
|POLY 6 | P=0.065 P=0.760 P=0.760 P=0.500N P=0.500N P=0.292 |
|LOGISTIC REGRESSION| P=0.068 P=0.766 P=0.766 (e) (e) P=0.293 |
|COCH-ARM / FISHERS | P=0.066 P=0.763N P=0.763N P=0.500N P=0.500N P=0.291 |
|ORDER RESTRICTED | P=0.053 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (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 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung |
| Hemorrhage Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (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: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 9/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.032N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.030N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 8/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 8/10 (80%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.045N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.045N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.044N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Focal Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 9/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.032N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.030N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Focal Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 7/10.00 0/10.00 0/10.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 70.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 7/10 (70%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.263N P=0.003N** P=0.003N** P=0.003N** P=0.003N** P=0.013N* |
|POLY 3 | P=0.178N P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.003N** |
|POLY 1.5 | P=0.178N P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.003N** |
|POLY 6 | P=0.178N P<0.001N** P<0.001N** P<0.001N** P<0.001N** P=0.003N** |
|LOGISTIC REGRESSION| P=0.263N (e) (e) (e) (e) P=0.013N* |
|COCH-ARM / FISHERS | P=0.261N P=0.002N** P=0.002N** P=0.002N** P=0.002N** P=0.010N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 6/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091N P=0.009N** P=0.009N** P=0.009N** P=0.009N** P=0.009N** |
|POLY 3 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.091N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.005N** P=0.005N** P=0.005N** P=0.005N** P=0.005N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Inflammation Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 5/10 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 5/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 50.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 5/10 (50%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.128N P=0.022N* P=0.022N* P=0.022N* P=0.022N* P=0.022N* |
|POLY 3 | P=0.071N P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.008N** |
|POLY 1.5 | P=0.071N P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.008N** |
|POLY 6 | P=0.071N P=0.008N** P=0.008N** P=0.008N** P=0.008N** P=0.008N** |
|LOGISTIC REGRESSION| P=0.128N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.126N P=0.016N* P=0.016N* P=0.016N* P=0.016N* P=0.016N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Peribronchial |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 6/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091N P=0.009N** P=0.009N** P=0.009N** P=0.009N** P=0.009N** |
|POLY 3 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.091N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.005N** P=0.005N** P=0.005N** P=0.005N** P=0.005N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Peribronchial |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 4/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/10 (40%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.182N P=0.051N P=0.051N P=0.051N P=0.051N P=0.051N |
|POLY 3 | P=0.140N P=0.033N* P=0.033N* P=0.033N* P=0.033N* P=0.033N* |
|POLY 1.5 | P=0.140N P=0.033N* P=0.033N* P=0.033N* P=0.033N* P=0.033N* |
|POLY 6 | P=0.140N P=0.033N* P=0.033N* P=0.033N* P=0.033N* P=0.033N* |
|LOGISTIC REGRESSION| P=0.182N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.180N P=0.043N* P=0.043N* P=0.043N* P=0.043N* P=0.043N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 9/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 9/10 (90%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.032N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.032N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.030N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lung: Perivascular |
| Hyperplasia Focal Lymphoid |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 6/10.00 0/10.00 0/10.00 0/10.00 0/10.00 0/10.00 |
|POLY-3 PERCENT (g) | 60.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 6/10 (60%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.091N P=0.009N** P=0.009N** P=0.009N** P=0.009N** P=0.009N** |
|POLY 3 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P=0.027N* P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.091N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.089N P=0.005N** P=0.005N** P=0.005N** P=0.005N** P=0.005N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 9/9 (100%) 7/7 (100%) 7/7 (100%) 8/8 (100%) 8/9 (89%) |
|POLY-3 RATE (b) | 9/10.00 9/9.00 7/7.00 7/7.00 8/8.00 8/9.00 |
|POLY-3 PERCENT (g) | 90.0% 100.0% 100.0% 100.0% 100.0% 88.9% |
|TERMINAL (d) | 9/10 (90%) 9/9 (100%) 7/7 (100%) 7/7 (100%) 8/8 (100%) 8/9 (89%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.381N P=0.521 P=0.571 P=0.571 P=0.545 P=0.743N |
|POLY 3 | P=0.383N P=0.521 P=0.570 P=0.570 P=0.544 P=0.737N |
|POLY 1.5 | P=0.383N P=0.521 P=0.570 P=0.570 P=0.544 P=0.737N |
|POLY 6 | P=0.383N P=0.521 P=0.570 P=0.570 P=0.544 P=0.737N |
|LOGISTIC REGRESSION| P=0.381N P=0.521 P=0.571 P=0.571 P=0.545 P=0.743N |
|COCH-ARM / FISHERS | P=0.379N P=0.526 P=0.588 P=0.588 P=0.556 P=0.737N |
|ORDER RESTRICTED | P=0.281N (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/10 (70%) 4/4 (100%) 10/10 (100%) 7/7 (100%) 7/7 (100%) 7/10 (70%) |
|POLY-3 RATE (b) | 7/10.00 4/4.00 10/10.00 7/7.00 7/7.00 7/10.00 |
|POLY-3 PERCENT (g) | 70.0% 100.0% 100.0% 100.0% 100.0% 70.0% |
|TERMINAL (d) | 7/10 (70%) 4/4 (100%) 10/10 (100%) 7/7 (100%) 7/7 (100%) 7/10 (70%) |
|FIRST INCIDENCE | 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.131N P=0.310 P=0.111 P=0.178 P=0.178 P=0.683 |
|POLY 3 | P=0.118N P=0.307 P=0.095 P=0.166 P=0.166 P=0.678 |
|POLY 1.5 | P=0.118N P=0.307 P=0.095 P=0.166 P=0.166 P=0.678 |
|POLY 6 | P=0.118N P=0.307 P=0.095 P=0.166 P=0.166 P=0.678 |
|LOGISTIC REGRESSION| P=0.131N P=0.310 P=0.111 P=0.178 P=0.178 P=0.683 |
|COCH-ARM / FISHERS | P=0.128N P=0.330 P=0.105 P=0.176 P=0.176 P=0.686N |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 0/9 (0%) 0/7 (0%) 0/7 (0%) 0/8 (0%) 0/9 (0%) |
|POLY-3 RATE (b) | 8/10.00 0/9.00 0/7.00 0/7.00 0/8.00 0/9.00 |
|POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 8/10 (80%) 0/9 (0%) 0/7 (0%) 0/7 (0%) 0/8 (0%) 0/9 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.042N* P<0.001N** P=0.004N** P=0.004N** P=0.002N** P<0.001N** |
|POLY 3 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 1.5 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|POLY 6 | P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.042N* (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.040N* P<0.001N** P=0.002N** P=0.002N** P<0.001N** P<0.001N** |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Bronchial |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 4/10 (40%) 0/4 (0%) 0/10 (0%) 0/7 (0%) 0/7 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 4/10.00 0/4.00 0/10.00 0/7.00 0/7.00 0/10.00 |
|POLY-3 PERCENT (g) | 40.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 4/10 (40%) 0/4 (0%) 0/10 (0%) 0/7 (0%) 0/7 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.153N P=0.209N P=0.051N P=0.098N P=0.098N P=0.051N |
|POLY 3 | P=0.116N P=0.198N P=0.033N* P=0.079N P=0.079N P=0.033N* |
|POLY 1.5 | P=0.116N P=0.198N P=0.033N* P=0.079N P=0.079N P=0.033N* |
|POLY 6 | P=0.116N P=0.198N P=0.033N* P=0.079N P=0.079N P=0.033N* |
|LOGISTIC REGRESSION| P=0.153N (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.151N P=0.210N P=0.043N* P=0.088N P=0.088N P=0.043N* |
|ORDER RESTRICTED | P<0.001N** (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/10 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/9 (100%) |
|POLY-3 RATE (b) | 8/10.00 0/0.00 0/0.00 0/0.00 0/0.00 9/9.00 |
|POLY-3 PERCENT (g) | 80.0% 0.0% 0.0% 0.0% 0.0% 100.0% |
|TERMINAL (d) | 8/10 (80%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 9/9 (100%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.189 P=1.000 P=1.000N P=1.000N P=1.000 P=0.257 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.251 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.251 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.251 |
|LOGISTIC REGRESSION| P=0.189 (e) (e) (e) (e) P=0.257 |
|COCH-ARM / FISHERS | P=0.183 P=1.000 P=1.000 P=1.000 P=1.000 P=0.263 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Congestion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 8/9 (89%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) |
|POLY-3 RATE (b) | 8/9.00 0/0.00 0/0.00 0/0.00 0/0.00 8/10.00 |
|POLY-3 PERCENT (g) | 88.9% 0.0% 0.0% 0.0% 0.0% 80.0% |
|TERMINAL (d) | 8/9 (89%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 8/10 (80%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.462N P=1.000N P=1.000N P=1.000 P=1.000 P=0.539N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.538N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.538N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.538N |
|LOGISTIC REGRESSION| P=0.462N (e) (e) (e) (e) P=0.539N |
|COCH-ARM / FISHERS | P=0.461N P=1.000 P=1.000 P=1.000 P=1.000 P=0.542N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) |
|POLY-3 RATE (b) | 9/10.00 0/0.00 0/0.00 0/0.00 0/0.00 1/9.00 |
|POLY-3 PERCENT (g) | 90.0% 0.0% 0.0% 0.0% 0.0% 11.1% |
|TERMINAL (d) | 9/10 (90%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 1/9 (11%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001N** P=1.000N P=1.000N P=1.000N P=1.000N P=0.002N** |
|POLY 3 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 1.5 | (e) (e) (e) (e) (e) P<0.001N** |
|POLY 6 | (e) (e) (e) (e) (e) P<0.001N** |
|LOGISTIC REGRESSION| P<0.001N** (e) (e) (e) (e) P=0.002N** |
|COCH-ARM / FISHERS | P<0.001N** P=1.000 P=1.000 P=1.000 P=1.000 P<0.001N** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Lymph Node, Mediastinal |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 7/9 (78%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|POLY-3 RATE (b) | 7/9.00 0/0.00 0/0.00 0/0.00 0/0.00 4/10.00 |
|POLY-3 PERCENT (g) | 77.8% 0.0% 0.0% 0.0% 0.0% 40.0% |
|TERMINAL (d) | 7/9 (78%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 4/10 (40%) |
|FIRST INCIDENCE | 93 (T) --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.095N P=1.000 P=1.000 P=1.000 P=1.000 P=0.121N |
|POLY 3 | (e) (e) (e) (e) (e) P=0.110N |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.110N |
|POLY 6 | (e) (e) (e) (e) (e) P=0.110N |
|LOGISTIC REGRESSION| P=0.095N (e) (e) (e) (e) P=0.121N |
|COCH-ARM / FISHERS | P=0.089N P=1.000 P=1.000 P=1.000 P=1.000 P=0.115N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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 | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Ovary: Periovarian Tissue |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 2/10 (20%) 0/0 (0%) 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 2/10.00 0/0.00 2/3.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 20.0% 0.0% 66.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/10 (20%) 0/0 (0%) 2/3 (67%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | 93 (T) --- 93 (T) --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.070N P=1.000 P=0.215 P=1.000 P=1.000 P=0.234N |
|POLY 3 | (e) (e) P=0.201 (e) (e) P=0.227N |
|POLY 1.5 | (e) (e) P=0.201 (e) (e) P=0.227N |
|POLY 6 | (e) (e) P=0.201 (e) (e) P=0.227N |
|LOGISTIC REGRESSION| P=0.070N (e) P=0.215 (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.066N P=1.000 P=0.203 P=1.000 P=1.000 P=0.237N |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 03 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) 2/3 (67%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 1/1.00 2/3.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 66.7% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 1/1 (100%) 2/3 (67%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.345N (e) (e) P=0.077 P=0.034 * (e) |
|POLY 3 | (e) (e) (e) P=0.091N P=0.003 ** (e) |
|POLY 1.5 | (e) (e) (e) P=0.091N P=0.003 ** (e) |
|POLY 6 | (e) (e) (e) P=0.091N P=0.003 ** (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.077 P=0.034 * (e) |
|COCH-ARM / FISHERS | P=0.341N (e) (e) P=0.091 P=0.038 * (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Pancreas |
| Accessory Spleen |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 0/0.00 0/0.00 0/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/10 (0%) |
|FIRST INCIDENCE | --- --- --- --- --- --- |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | (e) (e) (e) (e) (e) (e) |
|POLY 3 | (e) (e) (e) (e) (e) (e) |
|POLY 1.5 | (e) (e) (e) (e) (e) (e) |
|POLY 6 | (e) (e) (e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) (e) (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
(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).