TDMS Study 05135-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest ISOPRENE DATE: 10/15/04
EXPERIMENT: 05135 TEST: 04 TIME: 13:10:41
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
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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: 04 TIME: 13:10:41
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 Mice
------------
Organ Morphology
----- ----------
Liver Vacuolization Cytoplasmic
Nose: Turbinate, Olfactory Epithelium Degeneration
Stomach, Forestomach: Epithelium Hyperplasia
Testes Atrophy
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Stomach, Forestomach: Epithelium Hyperplasia
===============================================================
Date: 10/15/04 EXPERIMENT: 05135 TEST: 04 Page 1
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 3/9 (33%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/2.00 0/10.00 3/9.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 33.3% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/2 (0%) 0/10 (0%) 3/9 (33%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- --- 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P<0.001 ** (e) (e) (e) P=0.093 P<0.001 ** |
|POLY 3 | (e) (e) (e) (e) P=0.074 P<0.001 ** |
|POLY 1.5 | (e) (e) (e) (e) P=0.074 P<0.001 ** |
|POLY 6 | (e) (e) (e) (e) P=0.074 P<0.001 ** |
|LOGISTIC REGRESSION| (e) (e) (e) (e) P=0.093 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) (e) (e) P=0.087 P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|POLY-3 RATE (b) | 0/10.00 0/1.00 0/1.00 0/10.00 0/10.00 1/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 10.0% |
|TERMINAL (d) | 0/10 (0%) 0/1 (0%) 0/1 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) |
|FIRST INCIDENCE | --- --- --- --- --- 94 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.205 (e) (e) (e) (e) P=0.500 |
|POLY 3 | P=0.210 (e) (e) (e) (e) P=0.500 |
|POLY 1.5 | P=0.210 (e) (e) (e) (e) P=0.500 |
|POLY 6 | P=0.210 (e) (e) (e) (e) P=0.500 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.500 |
|COCH-ARM / FISHERS | P=0.202 (e) (e) (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 04 Page 2
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Turbinate, Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 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%) 0/0 (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) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Nose: Turbinate, Olfactory Epithelium |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|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) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 04 Page 3
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 9/9 (100%) 8/8 (100%) 9/10 (90%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 9/9.00 8/8.00 9/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 100.0% 90.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 9/9 (100%) 8/8 (100%) 9/10 (90%) |
|FIRST INCIDENCE | --- --- --- 93 (T) 93 (T) 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.007 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (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=0.006 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 9/10 (90%) 10/10 (100%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/0.00 10/10.00 9/10.00 10/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 100.0% 90.0% 100.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/0 (0%) 10/10 (100%) 9/10 (90%) 10/10 (100%) |
|FIRST INCIDENCE | --- --- --- 94 (T) 94 (T) 94 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.002 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | (e) (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | (e) (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=0.002 ** (e) (e) P<0.001 ** P<0.001 ** P<0.001 ** |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/15/04 EXPERIMENT: 05135 TEST: 04 Page 4
Statistical Analysis of Non-neoplastic Lesions in Mice(B6C3F1) - ISOPRENE
Terminal Sacrifice at 14 weeks
|=================================================================================================================================|
| | |
| | Males |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | |
|----------- | |
|OVERALL (a) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/10 (0%) 0/9 (0%) 2/10 (20%) |
|POLY-3 RATE (b) | 0/10.00 0/0.00 0/1.00 0/10.00 0/9.00 2/10.00 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% 0.0% 20.0% |
|TERMINAL (d) | 0/10 (0%) 0/0 (0%) 0/1 (0%) 0/10 (0%) 0/9 (0%) 2/10 (20%) |
|FIRST INCIDENCE | --- --- --- --- --- 93 (T) |
|-------------------| |
|STATISTICAL TESTS | |
|-------------------| |
|LIFE TABLE | P=0.040 * (e) (e) (e) (e) P=0.234 |
|POLY 3 | (e) (e) (e) (e) (e) P=0.227 |
|POLY 1.5 | (e) (e) (e) (e) (e) P=0.227 |
|POLY 6 | (e) (e) (e) (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) (e) P=0.234 |
|COCH-ARM / FISHERS | P=0.038 * (e) (e) (e) (e) P=0.237 |
|ORDER RESTRICTED | (e) (e) (e) (e) (e) (e) |
|=================================================================================================================================|
| | |
| | Females |
|Dose | CONTROL 70 PPM 220 PPM 700 PPM 2200 PPM 7000 PPM |
| | |
|=================================================================================================================================|
| |
|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 | |
|=================================================================================================================================|
(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).