Statistical Analysis of Non-Neoplastic Lesions
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/23/97
EXPERIMENT: 91014 TEST: 04 TIME: 09:38:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
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14 WEEK SSAC
REASONS FOR REMOVAL: 25017 Scheduled Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE 001 0 MG/KG
INCLUDE 002 0 MG/KG
INCLUDE 003 15 MG/KG
INCLUDE 004 15 MG/KG
INCLUDE 005 30 MG/KG
INCLUDE 006 30 MG/KG
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Columbus OLEIC ACID DIETHANOLAMINE CONDENSATE DATE: 09/23/97
EXPERIMENT: 91014 TEST: 04 TIME: 09:38:11
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15314 ROUTE: SKIN APPLICATION NTP C#: C91014
PATHOLOGIST: SELLS, D. CAS: 93-83-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF OLEIC ACID DIETHANOLAMINE CONDENSATE
====================================================================================================
MALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Skin Hyperkeratosis
Hyperplasia
Inflammation Chronic
Parakeratosis
====================================================================================================
FEMALE MICE
-------------
ORGAN MORPHOLOGY
------- ------------
Skin Hyperkeratosis
Hyperplasia
Inflammation Chronic
====================================================================================================
DATE: 09/23/97 EXPERIMENT: 91014 TEST: 04 PAGE 1
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE
TERMINAL SACRIFICE AT . WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Dermis Skin, Site of Application |
| Inflammation Chronic |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 4/5 (80%) 4/5 (80%) |
|ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 80.0% 80.0% |
|INTERIM SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 4/5 (80%) 4/5 (80%) |
|TERMINAL (d) | 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.016 * P=0.033 * P=0.033 * |
|INCIDENTAL TUMOR | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.016 * P=0.033 * P=0.033 * |
|LOGISTIC REGRESSION | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.016 * P=0.033 * P=0.033 * |
|COCHRAN-ARMITAGE | P=0.001 ** | P=0.013 * |
|FISHER EXACT | P=0.004 ** P=0.004 ** | P=0.024 * P=0.024 * |
|=================================================================================================================================|
| |
|Skin: Epidermis Skin, Site of Application |
| Hyperplasia |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 4/5 (80%) |
|ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 100.0% 80.0% |
|INTERIM SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 4/5 (80%) |
|TERMINAL (d) | 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.015 * P=0.008 ** P=0.033 * |
|INCIDENTAL TUMOR | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.015 * P=0.008 ** P=0.033 * |
|LOGISTIC REGRESSION | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.015 * P=0.008 ** P=0.033 * |
|COCHRAN-ARMITAGE | P=0.001 ** | P=0.012 * |
|FISHER EXACT | P=0.004 ** P=0.004 ** | P=0.004 ** P=0.024 * |
|=================================================================================================================================|
DATE: 09/23/97 EXPERIMENT: 91014 TEST: 04 PAGE 2
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE
TERMINAL SACRIFICE AT . WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Epidermis Skin, Site of Application |
| Parakeratosis |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 1/5 (20%) 4/5 (80%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|ADJUSTED (b) | 0.0% 20.0% 80.0% | 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/5 (0%) 1/5 (20%) 4/5 (80%) | 0/5 (0%) 0/5 (0%) 0/5 (0%) |
|TERMINAL (d) | 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 94 (I) 94 (I) | --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.012 * P=0.500 P=0.033 * | (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.012 * P=0.500 P=0.033 * | (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.012 * P=0.500 P=0.033 * | (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.009 ** | (e) |
|FISHER EXACT | P=0.500 P=0.024 * | (e) (e) |
|=================================================================================================================================|
| |
|Skin: Sebaceous Gland Skin, Site of Application |
| Hyperplasia |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 5/5 (100%) |
|ADJUSTED (b) | 0.0% 100.0% 100.0% | 0.0% 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 0/5 (0%) 5/5 (100%) 5/5 (100%) | 0/5 (0%) 5/5 (100%) 5/5 (100%) |
|TERMINAL (d) | 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.002 ** P=0.008 ** P=0.008 ** |
|INCIDENTAL TUMOR | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.002 ** P=0.008 ** P=0.008 ** |
|LOGISTIC REGRESSION | P=0.002 ** P=0.008 ** P=0.008 ** | P=0.002 ** P=0.008 ** P=0.008 ** |
|COCHRAN-ARMITAGE | P=0.001 ** | P=0.001 ** |
|FISHER EXACT | P=0.004 ** P=0.004 ** | P=0.004 ** P=0.004 ** |
|=================================================================================================================================|
DATE: 09/23/97 EXPERIMENT: 91014 TEST: 04 PAGE 3
STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS IN MICE(B6C3F1) -- OLEIC ACID DIETHANOLAMINE CONDENSATE
TERMINAL SACRIFICE AT . WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | 0 MG/KG 15 MG/KG 30 MG/KG | 0 MG/KG 15 MG/KG 30 MG/KG |
| | | |
|=================================================================================================================================|
| |
|Skin: Skin, Site of Application |
| Hyperkeratosis |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/5 (0%) 4/5 (80%) 4/5 (80%) | 0/5 (0%) 2/5 (40%) 3/5 (60%) |
|ADJUSTED (b) | 0.0% 80.0% 80.0% | 0.0% 40.0% 60.0% |
|INTERIM SACRIFICE 1 (c)| 0/5 (0%) 4/5 (80%) 4/5 (80%) | 0/5 (0%) 2/5 (40%) 3/5 (60%) |
|TERMINAL (d) | 0/0 0/0 0/0 | 0/0 0/0 0/0 |
|FIRST INCIDENCE (DAYS) | --- 94 (I) 94 (I) | --- 94 (I) 94 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.016 * P=0.033 * P=0.033 * | P=0.053 P=0.227 P=0.095 |
|INCIDENTAL TUMOR | P=0.016 * P=0.033 * P=0.033 * | P=0.053 P=0.227 P=0.095 |
|LOGISTIC REGRESSION | P=0.016 * P=0.033 * P=0.033 * | P=0.053 P=0.227 P=0.095 |
|COCHRAN-ARMITAGE | P=0.013 * | P=0.047 * |
|FISHER EXACT | P=0.024 * P=0.024 * | P=0.222 P=0.083 |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Kaplan-Meier estimated lifetime tumor incidence after adjustment for
intercurrent mortality.
(c) Observed incidence at interim kill.
Male interim sacrifices(days): 94
Female interim sacrifices(days): 94
(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. The incidental tumor
test regards these lesions as non-fatal. Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fisher's 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.
(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).