TDMS Study 05094-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 03 TIME: 18:14:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-85222 ROUTE: DOSED FEED NTP C#: 54375C
PATHOLOGIST: DR J. E. HEATH CAS: 85-68-7
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 03 TIME: 18:14:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85222 ROUTE: DOSED FEED NTP C#: 54375C
PATHOLOGIST: DR J. E. HEATH CAS: 85-68-7
RATS(FISCHER344)
----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE BASED ON NUMBER OF TISSUES EXAMINED.
IN OTHER TISSUES/ORGANS, RATES ARE BASED ON NUMBER OF ANIMALS NECROPSIED.
----------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral Gland
Clitoral/Preputial Gland
Epididymis
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Preputial Gland
Prostate
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 03 TIME: 18:14:41
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-85222 ROUTE: DOSED FEED NTP C#: 54375C
PATHOLOGIST: DR J. E. HEATH CAS: 85-68-7
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF BUTYL BENZYL PHTHALATE
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Carcinoma
Carcinoma or Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Urinary Bladder Carcinoma or Papilloma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/110 (11%) 10/110 (9%) | 3/108 (3%) 5/110 (5%) |
|ADJUSTED (b) | 49.6% 42.5% | 16.8% 16.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 4/31 (13%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 3/10 (30%) 4/13 (31%) | 1/10 (10%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 467 729 (I) | 730 (I) 716 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.289N | P=0.444 |
|INCIDENTAL TUMOR | P=0.426N | P=0.396 |
|LOGISTIC REGRESSION | P=0.396N | P=0.416 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.411N | P=0.371 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/110 (1%) 2/110 (2%) | 1/108 (1%) 0/110 (0%) |
|ADJUSTED (b) | 1.4% 9.2% | 1.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 1/31 (3%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 723 729 (I) | 624 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.511 | P=0.487N |
|INCIDENTAL TUMOR | P=0.490 | P=0.581N |
|LOGISTIC REGRESSION | P=0.502 | P=0.528N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.495N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/110 (12%) 11/110 (10%) | 5/108 (5%) 5/110 (5%) |
|ADJUSTED (b) | 50.3% 43.5% | 19.0% 16.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 5/31 (16%) | 2/35 (6%) 0/39 (0%) |
|TERMINAL (d) | 3/10 (30%) 4/13 (31%) | 1/10 (10%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 467 729 (I) | 624 716 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.304N | P=0.539N |
|INCIDENTAL TUMOR | P=0.444N | P=0.612N |
|LOGISTIC REGRESSION | P=0.406N | P=0.575N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.415N | P=0.614N |
|=================================================================================================================================|
| |
|Brain |
| Astrocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 1/109 (1%) | 1/110 (1%) 1/109 (1%) |
|ADJUSTED (b) | 12.2% 1.5% | 1.1% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 746 716 | 564 872 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499N | P=0.740N |
|INCIDENTAL TUMOR | P=0.600N | P=0.700 |
|LOGISTIC REGRESSION | P=0.500N | P=0.756 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.503N | P=0.749 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 1/109 (1%) | 3/110 (3%) 2/109 (2%) |
|ADJUSTED (b) | 12.2% 1.5% | 6.7% 5.3% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 746 716 | 564 498 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.499N | P=0.457N |
|INCIDENTAL TUMOR | P=0.600N | P=0.539N |
|LOGISTIC REGRESSION | P=0.500N | P=0.522N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.503N | P=0.504N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/110 (1%) 3/110 (3%) | 9/110 (8%) 5/109 (5%) |
|ADJUSTED (b) | 1.5% 8.6% | 18.3% 15.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 1/31 (3%) | 2/35 (6%) 3/39 (8%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 723 | 457 (I) 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.319 | P=0.155N |
|INCIDENTAL TUMOR | P=0.247 | P=0.181N |
|LOGISTIC REGRESSION | P=0.301 | P=0.205N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.311 | P=0.209N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/110 (1%) 0/110 (0%) | 5/110 (5%) 0/109 (0%) |
|ADJUSTED (b) | 10.0% 0.0% | 38.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 3/10 (30%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 897 (T) --- | 829 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.448N | P=0.023N* |
|INCIDENTAL TUMOR | P=0.448N | P=0.028N* |
|LOGISTIC REGRESSION | P=0.448N | P=0.021N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.031N* |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 3/110 (3%) | 14/110 (13%) 5/109 (5%) |
|ADJUSTED (b) | 11.4% 8.6% | 49.8% 15.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 1/31 (3%) | 2/35 (6%) 3/39 (8%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 3/10 (30%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 723 | 457 (I) 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.536 | P=0.016N* |
|INCIDENTAL TUMOR | P=0.461 | P=0.021N* |
|LOGISTIC REGRESSION | P=0.503 | P=0.020N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.027N* |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 0/110 (0%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 2.3% 0.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 516 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255N | (e) (e) |
|INCIDENTAL TUMOR | P=0.204N | (e) (e) |
|LOGISTIC REGRESSION | P=0.203N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249N | (e) |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 0/110 (0%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 2.3% 0.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 516 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.255N | (e) (e) |
|INCIDENTAL TUMOR | P=0.204N | (e) (e) |
|LOGISTIC REGRESSION | P=0.203N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249N | (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/110 (6%) 6/109 (6%) | 1/107 (1%) 1/110 (1%) |
|ADJUSTED (b) | 20.0% 33.0% | 10.0% 5.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 1/31 (3%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 4/13 (31%) | 1/10 (10%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 719 723 | 977 (T) 928 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445N | P=0.736N |
|INCIDENTAL TUMOR | P=0.545N | P=0.747N |
|LOGISTIC REGRESSION | P=0.489N | P=0.741N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.507N | P=0.744N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/110 (3%) 3/109 (3%) | 1/107 (1%) 0/110 (0%) |
|ADJUSTED (b) | 16.3% 9.8% | 1.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 1/31 (3%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 729 (I) | 730 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.614N | P=0.478N |
|INCIDENTAL TUMOR | P=0.607 | P=0.478N |
|LOGISTIC REGRESSION | P=0.660N | P=0.496N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.654 | P=0.493N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/110 (9%) 9/109 (8%) | 2/107 (2%) 1/110 (1%) |
|ADJUSTED (b) | 33.3% 39.5% | 11.3% 5.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/34 (9%) 2/31 (6%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 4/13 (31%) | 1/10 (10%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 719 723 | 730 (I) 928 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.426N | P=0.462N |
|INCIDENTAL TUMOR | P=0.571N | P=0.474N |
|LOGISTIC REGRESSION | P=0.491N | P=0.459N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.508N | P=0.490N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 1/109 (1%) | 2/110 (2%) 4/110 (4%) |
|ADJUSTED (b) | 2.5% 1.4% | 11.3% 20.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 1/39 (3%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 1/10 (10%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | 645 698 | 730 (I) 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.536N | P=0.387 |
|INCIDENTAL TUMOR | P=0.590N | P=0.378 |
|LOGISTIC REGRESSION | P=0.499N | P=0.384 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.503N | P=0.342 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 0/109 (0%) | 0/110 (0%) 3/110 (3%) |
|ADJUSTED (b) | 11.3% 0.0% | 0.0% 13.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 1/39 (3%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 719 --- | --- 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.222N | P=0.150 |
|INCIDENTAL TUMOR | P=0.237N | P=0.132 |
|LOGISTIC REGRESSION | P=0.229N | P=0.140 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.251N | P=0.123 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 1/109 (1%) | 2/110 (2%) 7/110 (6%) |
|ADJUSTED (b) | 13.5% 1.4% | 11.3% 30.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 2/39 (5%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 1/10 (10%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | 645 698 | 730 (I) 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.194N | P=0.118 |
|INCIDENTAL TUMOR | P=0.229N | P=0.105 |
|LOGISTIC REGRESSION | P=0.190N | P=0.110 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.187N | P=0.085 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 1/109 (1%) | 2/110 (2%) 7/110 (6%) |
|ADJUSTED (b) | 13.5% 1.4% | 11.3% 30.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 2/39 (5%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 1/10 (10%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | 645 698 | 730 (I) 696 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.194N | P=0.118 |
|INCIDENTAL TUMOR | P=0.229N | P=0.105 |
|LOGISTIC REGRESSION | P=0.190N | P=0.110 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.187N | P=0.085 |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/110 (1%) 2/110 (2%) | 1/110 (1%) 1/110 (1%) |
|ADJUSTED (b) | 0.9% 10.5% | 1.4% 2.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 827 | 730 (I) 796 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.590 | P=0.722N |
|INCIDENTAL TUMOR | P=0.441 | P=0.746N |
|LOGISTIC REGRESSION | P=0.497 | P=0.755N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.751N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 3/110 (3%) | 2/110 (2%) 1/110 (1%) |
|ADJUSTED (b) | 10.8% 17.4% | 2.7% 2.9% |
|INTERIM SACRIFICE 1 (c)| 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 1/13 (8%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 827 | 687 796 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.616 | P=0.453N |
|INCIDENTAL TUMOR | P=0.501 | P=0.482N |
|LOGISTIC REGRESSION | P=0.503 | P=0.499N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.500N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 1/110 (1%) | 5/110 (5%) 1/110 (1%) |
|ADJUSTED (b) | 0.0% 5.3% | 15.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | --- 827 | 694 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.576 | P=0.083N |
|INCIDENTAL TUMOR | P=0.449 | P=0.098N |
|LOGISTIC REGRESSION | P=0.515 | P=0.090N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.106N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/110 (5%) 3/110 (3%) | 33/110 (30%) 7/110 (6%) |
|ADJUSTED (b) | 17.2% 12.0% | 82.1% 27.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 0/31 (0%) | 12/35 (34%) 1/39 (3%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 5/10 (50%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 687 | 687 600 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.337N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.443N | P<0.001N** |
|LOGISTIC REGRESSION | P=0.362N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.361N | P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/110 (5%) 4/110 (4%) | 37/110 (34%) 8/110 (7%) |
|ADJUSTED (b) | 17.2% 16.7% | 84.3% 35.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 0/31 (0%) | 12/35 (34%) 1/39 (3%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 5/10 (50%) 3/11 (27%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 687 | 687 600 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.450N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.599N | P<0.001N** |
|LOGISTIC REGRESSION | P=0.502N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P<0.001N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/110 (1%) 2/110 (2%) | 1/110 (1%) 0/110 (0%) |
|ADJUSTED (b) | 4.0% 9.2% | 1.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 1/31 (3%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 761 729 (I) | 685 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.524 | P=0.488N |
|INCIDENTAL TUMOR | P=0.490 | P=0.495N |
|LOGISTIC REGRESSION | P=0.507 | P=0.512N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.500N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 3/110 (3%) 0/110 (0%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 6.5% 0.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 549 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129N | (e) (e) |
|INCIDENTAL TUMOR | P=0.127N | (e) (e) |
|LOGISTIC REGRESSION | P=0.118N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.123N | (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 2/110 (2%) | 1/110 (1%) 0/110 (0%) |
|ADJUSTED (b) | 10.2% 9.2% | 1.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 1/31 (3%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 549 729 (I) | 685 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.332N | P=0.488N |
|INCIDENTAL TUMOR | P=0.355N | P=0.495N |
|LOGISTIC REGRESSION | P=0.348N | P=0.512N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.342N | P=0.500N |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 0/110 (0%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 5.5% 0.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 719 --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.242N | (e) (e) |
|INCIDENTAL TUMOR | P=0.297N | (e) (e) |
|LOGISTIC REGRESSION | P=0.243N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249N | (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 3/109 (3%) | 0/107 (0%) 1/110 (1%) |
|ADJUSTED (b) | 0.0% 23.1% | 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 3/13 (23%) | 0/10 (0%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | --- 897 (T) | --- 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.163 | P=0.519 |
|INCIDENTAL TUMOR | P=0.163 | P=0.519 |
|LOGISTIC REGRESSION | P=0.163 | P=0.519 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.122 | P=0.507 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/106 (10%) 13/105 (12%) | 41/110 (37%) 22/109 (20%) |
|ADJUSTED (b) | 35.5% 42.8% | 87.6% 82.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/33 (9%) 5/31 (16%) | 12/35 (34%) 4/39 (10%) |
|TERMINAL (d) | 2/10 (20%) 4/13 (31%) | 7/10 (70%) 8/11 (73%) |
|FIRST INCIDENCE (DAYS) | 597 350 | 457 (I) 600 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464 | P<0.001N** |
|INCIDENTAL TUMOR | P=0.476 | P=0.001N** |
|LOGISTIC REGRESSION | P=0.383 | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.405 | P=0.004N** |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/106 (10%) 13/105 (12%) | 42/110 (38%) 22/109 (20%) |
|ADJUSTED (b) | 35.5% 42.8% | 88.1% 82.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 1/10 (10%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/33 (9%) 5/31 (16%) | 12/35 (34%) 4/39 (10%) |
|TERMINAL (d) | 2/10 (20%) 4/13 (31%) | 7/10 (70%) 8/11 (73%) |
|FIRST INCIDENCE (DAYS) | 597 350 | 457 (I) 600 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.464 | P<0.001N** |
|INCIDENTAL TUMOR | P=0.476 | P<0.001N** |
|LOGISTIC REGRESSION | P=0.383 | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.405 | P=0.003N** |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal |
| Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/110 (5%) 4/110 (4%) | 5/110 (5%) 1/110 (1%) |
|ADJUSTED (b) | 25.7% 5.8% | 25.3% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 2/31 (6%) | 2/35 (6%) 0/39 (0%) |
|TERMINAL (d) | 2/10 (20%) 0/13 (0%) | 2/10 (20%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 521 | 730 (I) 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.491N | P=0.080N |
|INCIDENTAL TUMOR | P=0.487N | P=0.085N |
|LOGISTIC REGRESSION | P=0.511N | P=0.081N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.106N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/110 (5%) 3/110 (3%) | 5/110 (5%) 0/110 (0%) |
|ADJUSTED (b) | 25.3% 8.3% | 28.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 1/31 (3%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 2/10 (20%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 703 674 | 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N | P=0.028N* |
|INCIDENTAL TUMOR | P=0.492N | P=0.029N* |
|LOGISTIC REGRESSION | P=0.355N | P=0.025N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.361N | P=0.030N* |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 6/110 (5%) 4/110 (4%) | 5/110 (5%) 0/110 (0%) |
|ADJUSTED (b) | 30.3% 9.9% | 28.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 2/31 (6%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 2/10 (20%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 703 674 | 687 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.322N | P=0.028N* |
|INCIDENTAL TUMOR | P=0.516N | P=0.029N* |
|LOGISTIC REGRESSION | P=0.370N | P=0.025N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.374N | P=0.030N* |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 4/110 (4%) | 3/110 (3%) 1/110 (1%) |
|ADJUSTED (b) | 16.4% 5.8% | 14.7% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 2/31 (6%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 1/10 (10%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 521 | 730 (I) 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.632 | P=0.265N |
|INCIDENTAL TUMOR | P=0.636 | P=0.278N |
|LOGISTIC REGRESSION | P=0.632 | P=0.266N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.639N | P=0.311N |
|=================================================================================================================================|
| |
|Skin |
| Melanoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 2/110 (2%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 0.0% 4.4% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | --- 508 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.234 | (e) (e) |
|INCIDENTAL TUMOR | P=0.268 | (e) (e) |
|LOGISTIC REGRESSION | P=0.260 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249 | (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 0/110 (0%) | 2/110 (2%) 0/110 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 11.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 1/10 (10%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- | 730 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.218N |
|INCIDENTAL TUMOR | (e) (e) | P=0.218N |
|LOGISTIC REGRESSION | (e) (e) | P=0.216N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.249N |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 4/110 (4%) | 5/110 (5%) 1/110 (1%) |
|ADJUSTED (b) | 16.4% 5.8% | 25.3% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 2/31 (6%) | 2/35 (6%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 2/10 (20%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 521 | 730 (I) 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.632 | P=0.080N |
|INCIDENTAL TUMOR | P=0.636 | P=0.085N |
|LOGISTIC REGRESSION | P=0.632 | P=0.081N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.639N | P=0.106N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 4/110 (4%) | 5/110 (5%) 1/110 (1%) |
|ADJUSTED (b) | 16.4% 5.8% | 25.3% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 2/34 (6%) 2/31 (6%) | 2/35 (6%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 2/10 (20%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 729 (I) 521 | 730 (I) 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.632 | P=0.080N |
|INCIDENTAL TUMOR | P=0.636 | P=0.085N |
|LOGISTIC REGRESSION | P=0.632 | P=0.081N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.639N | P=0.106N |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/110 (5%) 1/110 (1%) | 0/110 (0%) 0/110 (0%) |
|ADJUSTED (b) | 19.0% 1.6% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 1/31 (3%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 1/10 (10%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 719 729 (I) | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.111N | (e) (e) |
|INCIDENTAL TUMOR | P=0.142N | (e) (e) |
|LOGISTIC REGRESSION | P=0.109N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.106N | (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 100/110 (91%) 99/110 (90%) | |
|ADJUSTED (b) | 100.0% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 7/10 (70%) 6/10 (60%) | |
|INTERIM SACRIFICE 2 (c)| 34/34 (100%) 31/31 (100%) | |
|TERMINAL (d) | 10/10 (100%) 13/13 (100%) | |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.471N | |
|INCIDENTAL TUMOR | P=0.278 | |
|LOGISTIC REGRESSION | P=0.411 | |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | |
|=================================================================================================================================|
| |
|Thymus |
| Thymoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/102 (0%) 2/103 (2%) | 1/109 (1%) 0/106 (0%) |
|ADJUSTED (b) | 0.0% 5.3% | 1.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/31 (0%) 1/30 (3%) | 1/35 (3%) 0/39 (0%) |
|TERMINAL (d) | 0/9 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (I) | 730 (I) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.236 | P=0.478N |
|INCIDENTAL TUMOR | P=0.210 | P=0.478N |
|LOGISTIC REGRESSION | P=0.232 | P=0.506N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.251 | P=0.507N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/110 (7%) 8/110 (7%) | 6/109 (6%) 7/110 (6%) |
|ADJUSTED (b) | 16.4% 20.8% | 19.4% 20.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 3/31 (10%) | 0/35 (0%) 2/39 (5%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 1/10 (10%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 549 498 | 687 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.595 | P=0.605N |
|INCIDENTAL TUMOR | P=0.553 | P=0.499 |
|LOGISTIC REGRESSION | P=0.593 | P=0.542 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.602N | P=0.507 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/110 (7%) 8/110 (7%) | 7/109 (6%) 7/110 (6%) |
|ADJUSTED (b) | 16.4% 20.8% | 25.6% 20.7% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 3/31 (10%) | 0/35 (0%) 2/39 (5%) |
|TERMINAL (d) | 0/10 (0%) 1/13 (8%) | 1/10 (10%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 549 498 | 687 634 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.595 | P=0.492N |
|INCIDENTAL TUMOR | P=0.553 | P=0.610N |
|LOGISTIC REGRESSION | P=0.593 | P=0.559N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.602N | P=0.601N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 1/110 (1%) | 0/109 (0%) 4/110 (4%) |
|ADJUSTED (b) | 0.0% 5.6% | 0.0% 28.2% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 3/11 (27%) |
|FIRST INCIDENCE (DAYS) | --- 844 | --- 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.581 | P=0.074 |
|INCIDENTAL TUMOR | P=0.449 | P=0.070 |
|LOGISTIC REGRESSION | P=0.522 | P=0.077 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.062 |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Carcinoma or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 2/110 (2%) | 1/109 (1%) 8/110 (7%) |
|ADJUSTED (b) | 0.0% 6.9% | 1.3% 41.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 2/39 (5%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 4/11 (36%) |
|FIRST INCIDENCE (DAYS) | --- 677 | 694 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.270 | P=0.028 * |
|INCIDENTAL TUMOR | P=0.184 | P=0.025 * |
|LOGISTIC REGRESSION | P=0.236 | P=0.028 * |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249 | P=0.018 * |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/110 (0%) 2/110 (2%) | 1/109 (1%) 4/110 (4%) |
|ADJUSTED (b) | 0.0% 6.9% | 1.3% 15.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 2/39 (5%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | --- 677 | 694 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.270 | P=0.219 |
|INCIDENTAL TUMOR | P=0.184 | P=0.209 |
|LOGISTIC REGRESSION | P=0.236 | P=0.206 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249 | P=0.187 |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 4/110 (4%) 9/110 (8%) |
|ADJUSTED (b) | | 22.0% 32.7% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/35 (0%) 1/39 (3%) |
|TERMINAL (d) | | 2/10 (20%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | | 649 683 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.179 |
|INCIDENTAL TUMOR | | P=0.142 |
|LOGISTIC REGRESSION | | P=0.159 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.126 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 4/110 (4%) 9/110 (8%) |
|ADJUSTED (b) | | 22.0% 32.7% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/35 (0%) 1/39 (3%) |
|TERMINAL (d) | | 2/10 (20%) 2/11 (18%) |
|FIRST INCIDENCE (DAYS) | | 649 683 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.179 |
|INCIDENTAL TUMOR | | P=0.142 |
|LOGISTIC REGRESSION | | P=0.159 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.126 |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/110 (2%) 1/110 (1%) | 2/110 (2%) 2/110 (2%) |
|ADJUSTED (b) | 2.3% 1.6% | 5.4% 5.8% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/34 (0%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 0/11 (0%) |
|FIRST INCIDENCE (DAYS) | 432 723 | 597 683 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.521N | P=0.657N |
|INCIDENTAL TUMOR | P=0.496N | P=0.651 |
|LOGISTIC REGRESSION | P=0.464N | P=0.686N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.689N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 60/110 (55%) 64/110 (58%) | 45/110 (41%) 58/110 (53%) |
|ADJUSTED (b) | 92.1% 91.1% | 86.5% 92.9% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) |
|INTERIM SACRIFICE 2 (c)| 12/34 (35%) 12/31 (39%) | 7/35 (20%) 11/39 (28%) |
|TERMINAL (d) | 7/10 (70%) 9/13 (69%) | 6/10 (60%) 8/11 (73%) |
|FIRST INCIDENCE (DAYS) | 569 457 (I) | 358 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.433 | P=0.269 |
|INCIDENTAL TUMOR | P=0.196 | P=0.019 * |
|LOGISTIC REGRESSION | P=0.208 | P=0.090 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.342 | P=0.052 |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/110 (4%) 3/110 (3%) | 0/110 (0%) 1/110 (1%) |
|ADJUSTED (b) | 14.3% 7.4% | 0.0% 9.1% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/34 (3%) 0/31 (0%) | 0/35 (0%) 0/39 (0%) |
|TERMINAL (d) | 0/10 (0%) 0/13 (0%) | 0/10 (0%) 1/11 (9%) |
|FIRST INCIDENCE (DAYS) | 600 669 | --- 977 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.482N | P=0.519 |
|INCIDENTAL TUMOR | P=0.575N | P=0.519 |
|LOGISTIC REGRESSION | P=0.510N | P=0.519 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.500 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 103/110 (94%) 102/110 (93%) | 74/110 (67%) 49/110 (45%) |
|ADJUSTED (b) | 100.0% 100.0% | 100.0% 97.1% |
|INTERIM SACRIFICE 1 (c)| 8/10 (80%) 6/10 (60%) | 2/10 (20%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 34/34 (100%) 31/31 (100%) | 24/35 (69%) 12/39 (31%) |
|TERMINAL (d) | 10/10 (100%) 13/13 (100%) | 10/10 (100%) 10/11 (91%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 350 | 457 (I) 600 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.470N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.343 | P<0.001N** |
|LOGISTIC REGRESSION | P=0.411 | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P<0.001N** |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 75/110 (68%) 75/110 (68%) | 63/110 (57%) 62/110 (56%) |
|ADJUSTED (b) | 96.6% 94.8% | 97.5% 95.6% |
|INTERIM SACRIFICE 1 (c)| 0/10 (0%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) |
|INTERIM SACRIFICE 2 (c)| 15/34 (44%) 15/31 (48%) | 11/35 (31%) 12/39 (31%) |
|TERMINAL (d) | 8/10 (80%) 10/13 (77%) | 9/10 (90%) 9/11 (82%) |
|FIRST INCIDENCE (DAYS) | 432 457 (I) | 358 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.481N | P=0.234N |
|INCIDENTAL TUMOR | P=0.386 | P=0.529 |
|LOGISTIC REGRESSION | P=0.391 | P=0.342N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.558N | P=0.500N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 03 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 129 WEEKS
FEMALE TERMINAL SACRIFICE AT 140 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | UNTREATD 1.2% | UNTREATD 2.4% |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 107/110 (97%) 104/110 (95%) | 94/110 (85%) 78/110 (71%) |
|ADJUSTED (b) | 100.0% 100.0% | 100.0% 100.0% |
|INTERIM SACRIFICE 1 (c)| 8/10 (80%) 6/10 (60%) | 2/10 (20%) 1/10 (10%) |
|INTERIM SACRIFICE 2 (c)| 34/34 (100%) 31/31 (100%) | 28/35 (80%) 18/39 (46%) |
|TERMINAL (d) | 10/10 (100%) 13/13 (100%) | 10/10 (100%) 11/11 (100%) |
|FIRST INCIDENCE (DAYS) | 432 350 | 358 457 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.403N | P=0.012N* |
|INCIDENTAL TUMOR | P=0.547N | P=0.001N** |
|LOGISTIC REGRESSION | P=0.594N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.249N | P=0.007N** |
|=================================================================================================================================|
(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): 457 729
Female interim sacrifices(days): 457 730
(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).