TDMS Study 05094-99 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: SOUTHERN RESEARCH INST BUTYL BENZYL PHTHALATE DATE: 05/10/95
EXPERIMENT: 05094 TEST: 99 TIME: 17:39:41
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
05094/02 -VS- 05094/03 COMPARISON
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
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: 05/10/95
EXPERIMENT: 05094 TEST: 99 TIME: 17:39:41
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
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Skin Fibroma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Uterus Polyp Stromal
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/50 (6%) | 1/49 (2%) 1/51 (2%) |
|ADJUSTED (b) | 28.2% 7.3% | 2.1% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 1/34 (3%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 6/28 (21%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 467 | 512 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.361N | P=0.492N |
|INCIDENTAL TUMOR | P=0.563N | (e) (e) |
|LOGISTIC REGRESSION | P=0.051N | P=0.757 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.061N | P=0.742N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/49 (0%) 1/51 (2%) |
|ADJUSTED (b) | 6.2% 2.8% | 0.0% 2.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 1/28 (4%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 614 723 | --- 624 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.690N | P=0.509 |
|INCIDENTAL TUMOR | P=0.731 | P=0.682 |
|LOGISTIC REGRESSION | P=0.484N | P=0.491 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.510 |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/50 (8%) | 1/49 (2%) 3/51 (6%) |
|ADJUSTED (b) | 30.1% 9.9% | 2.1% 7.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 1/34 (3%) | 0/0 2/35 (6%) |
|TERMINAL (d) | 6/28 (21%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 607 467 | 512 624 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.351N | P=0.751N |
|INCIDENTAL TUMOR | P=0.598N | P=0.682 |
|LOGISTIC REGRESSION | P=0.064N | P=0.303 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.074N | P=0.324 |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 0/50 (0%) 2/52 (4%) |
|ADJUSTED (b) | 2.0% 0.0% | 0.0% 4.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 261 --- | --- 564 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.496N | P=0.508 |
|INCIDENTAL TUMOR | (e) (e) | P=0.638 |
|LOGISTIC REGRESSION | (e) (e) | P=0.235 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.257 |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) | 3/50 (6%) 3/52 (6%) |
|ADJUSTED (b) | 12.8% 2.9% | 11.2% 16.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 1/34 (3%) | 0/0 2/35 (6%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | 644 729 (T) | 725 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.182N | P=0.737N |
|INCIDENTAL TUMOR | P=0.260N | P=0.587 |
|LOGISTIC REGRESSION | P=0.138N | P=0.662N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.181N | P=0.642N |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) | 4/50 (8%) 0/52 (0%) |
|ADJUSTED (b) | 2.7% 0.0% | 14.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 3/25 (12%) 0/0 |
|FIRST INCIDENCE (DAYS) | 614 --- | 702 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.465N | P=0.505N |
|INCIDENTAL TUMOR | P=0.739N | P=0.649N |
|LOGISTIC REGRESSION | P=0.554N | P=0.066N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.054N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) | 7/50 (14%) 3/52 (6%) |
|ADJUSTED (b) | 15.1% 2.9% | 24.7% 16.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 1/34 (3%) | 0/0 2/35 (6%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 5/25 (20%) 0/0 |
|FIRST INCIDENCE (DAYS) | 614 729 (T) | 702 677 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.087N | P=0.479N |
|INCIDENTAL TUMOR | P=0.196N | P=0.725 |
|LOGISTIC REGRESSION | P=0.086N | P=0.159N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.102N | P=0.144N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) | 1/50 (2%) 0/49 (0%) |
|ADJUSTED (b) | 17.9% 11.0% | 4.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 5/28 (18%) 1/1 (100%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 719 | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129 | (e) (e) |
|INCIDENTAL TUMOR | P=0.150 | (e) (e) |
|LOGISTIC REGRESSION | P=0.362N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.505N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 5/50 (10%) | 1/50 (2%) 1/49 (2%) |
|ADJUSTED (b) | 17.9% 13.8% | 4.0% 7.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 3/34 (9%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 5/28 (18%) 1/1 (100%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 719 | 736 (T) 731 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.129 | (e) (e) |
|INCIDENTAL TUMOR | P=0.150 | (e) (e) |
|LOGISTIC REGRESSION | P=0.488N | P=0.698 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.630N | P=0.747 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) | 0/50 (0%) 1/52 (2%) |
|ADJUSTED (b) | 6.5% 2.3% | 0.0% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 1/28 (4%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 662 645 | --- 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.681N | (e) (e) |
|INCIDENTAL TUMOR | P=0.605N | (e) (e) |
|LOGISTIC REGRESSION | P=0.498N | P=0.480 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.510 |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/52 (2%) |
|ADJUSTED (b) | 0.0% 0.0% | 6.9% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 717 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.488N |
|INCIDENTAL TUMOR | (e) (e) | P=0.649N |
|LOGISTIC REGRESSION | (e) (e) | P=0.514N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.485N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 8.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.238N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 1/52 (2%) |
|ADJUSTED (b) | 0.0% 0.0% | 6.8% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 716 712 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.754N |
|INCIDENTAL TUMOR | (e) (e) | P=0.587 |
|LOGISTIC REGRESSION | (e) (e) | P=0.497N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.485N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 4/50 (8%) 1/52 (2%) |
|ADJUSTED (b) | 0.0% 0.0% | 14.6% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 3/25 (12%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 716 712 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.754N |
|INCIDENTAL TUMOR | (e) (e) | P=0.587 |
|LOGISTIC REGRESSION | (e) (e) | P=0.187N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.169N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 28/50 (56%) 12/52 (23%) |
|ADJUSTED (b) | 7.1% 5.7% | 71.0% 44.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 12/35 (34%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 14/25 (56%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 587 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.956N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.956N | P<0.001N** |
|LOGISTIC REGRESSION | P=0.956N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.691N | P<0.001N** |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 28/50 (56%) 12/52 (23%) |
|ADJUSTED (b) | 7.1% 5.7% | 71.0% 44.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 12/35 (34%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 14/25 (56%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 587 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.956N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.956N | P<0.001N** |
|LOGISTIC REGRESSION | P=0.956N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.691N | P<0.001N** |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 29/50 (58%) 13/52 (25%) |
|ADJUSTED (b) | 7.1% 5.7% | 71.8% 46.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 12/35 (34%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 14/25 (56%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 587 712 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.956N | P<0.001N** |
|INCIDENTAL TUMOR | P=0.956N | P=0.001N** |
|LOGISTIC REGRESSION | P=0.956N | P<0.001N** |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.691N | P<0.001N** |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 8.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.238N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 0/50 (0%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 4.8% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 549 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.281 | (e) (e) |
|INCIDENTAL TUMOR | P=0.163 | (e) (e) |
|LOGISTIC REGRESSION | P=0.191 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247 | (e) |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 4.8% | 8.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 549 | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.281 | (e) (e) |
|INCIDENTAL TUMOR | P=0.163 | (e) (e) |
|LOGISTIC REGRESSION | P=0.191 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.247 | P=0.238N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/50 (4%) 1/52 (2%) |
|ADJUSTED (b) | | 6.1% 2.8% |
|INTERIM SACRIFICE 1 (c)| | 0/0 0/35 (0%) |
|TERMINAL (d) | | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 598 712 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.752N |
|INCIDENTAL TUMOR | | P=0.769 |
|LOGISTIC REGRESSION | | P=0.488N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.485N |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) | 0/50 (0%) 0/49 (0%) |
|ADJUSTED (b) | 10.7% 0.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 3/28 (11%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) --- | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.904N | (e) (e) |
|INCIDENTAL TUMOR | P=0.904N | (e) (e) |
|LOGISTIC REGRESSION | P=0.904N | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.121N | (e) |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/46 (9%) | 20/49 (41%) 17/52 (33%) |
|ADJUSTED (b) | 30.6% 11.0% | 57.0% 48.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 3/33 (9%) | 0/0 12/35 (34%) |
|TERMINAL (d) | 7/28 (25%) 0/0 | 11/25 (44%) 0/0 |
|FIRST INCIDENCE (DAYS) | 438 681 | 598 564 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.259N | P=0.175N |
|INCIDENTAL TUMOR | P=0.468N | P=0.542N |
|LOGISTIC REGRESSION | P=0.084N | P=0.279N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.100N | P=0.261N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/46 (0%) | 2/49 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 6.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/33 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/0 | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 717 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | P=0.488N |
|INCIDENTAL TUMOR | (e) (e) | P=0.649N |
|LOGISTIC REGRESSION | (e) (e) | P=0.241N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.233N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 4/46 (9%) | 22/49 (45%) 17/52 (33%) |
|ADJUSTED (b) | 30.6% 11.0% | 61.3% 48.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 3/33 (9%) | 0/0 12/35 (34%) |
|TERMINAL (d) | 7/28 (25%) 0/0 | 12/25 (48%) 0/0 |
|FIRST INCIDENCE (DAYS) | 438 681 | 598 564 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.259N | P=0.121N |
|INCIDENTAL TUMOR | P=0.468N | P=0.448N |
|LOGISTIC REGRESSION | P=0.084N | P=0.158N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.100N | P=0.146N |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 0/50 (0%) | 1/50 (2%) 1/52 (2%) |
|ADJUSTED (b) | 16.0% 0.0% | 2.8% 2.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 3/28 (11%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 614 --- | 711 730 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.181N | P=0.500N |
|INCIDENTAL TUMOR | P=0.250N | P=0.649N |
|LOGISTIC REGRESSION | P=0.023N* | P=0.761N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.028N* | P=0.743N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) | 1/50 (2%) 1/52 (2%) |
|ADJUSTED (b) | 7.1% 5.7% | 4.0% 7.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 1/35 (3%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) | 736 (T) 731 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.956N | (e) (e) |
|INCIDENTAL TUMOR | P=0.956N | (e) (e) |
|LOGISTIC REGRESSION | P=0.956N | P=0.698 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.691N | P=0.743N |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) | 1/50 (2%) 2/52 (4%) |
|ADJUSTED (b) | 12.9% 5.7% | 4.0% 14.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 2/34 (6%) | 0/0 2/35 (6%) |
|TERMINAL (d) | 3/28 (11%) 0/1 (0%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | 593 729 (T) | 736 (T) 731 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.410N | (e) (e) |
|INCIDENTAL TUMOR | P=0.625N | (e) (e) |
|LOGISTIC REGRESSION | P=0.280N | P=0.410 |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.339N | P=0.515 |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 47/50 (94%) | |
|ADJUSTED (b) | 97.8% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 0/0 34/34 (100%) | |
|TERMINAL (d) | 27/28 (96%) 1/1 (100%) | |
|FIRST INCIDENCE (DAYS) | 477 549 | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.110N | |
|INCIDENTAL TUMOR | P=0.372N | |
|LOGISTIC REGRESSION | P=0.685N | |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.243 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) | 4/49 (8%) 2/51 (4%) |
|ADJUSTED (b) | 14.1% 9.9% | 11.4% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 1/25 (4%) 0/0 |
|FIRST INCIDENCE (DAYS) | 438 549 | 702 687 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.608 | P=0.498N |
|INCIDENTAL TUMOR | P=0.492 | P=0.544 |
|LOGISTIC REGRESSION | P=0.571N | P=0.431N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.320N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) | 5/49 (10%) 2/51 (4%) |
|ADJUSTED (b) | 14.1% 9.9% | 15.1% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 2/28 (7%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | 438 549 | 702 687 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.608 | P=0.498N |
|INCIDENTAL TUMOR | P=0.492 | P=0.544 |
|LOGISTIC REGRESSION | P=0.571N | P=0.199N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.202N |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 2.1% | 8.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- 549 | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.518 | (e) (e) |
|INCIDENTAL TUMOR | P=0.261 | (e) (e) |
|LOGISTIC REGRESSION | P=0.384 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | P=0.238N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) | 2/50 (4%) 0/52 (0%) |
|ADJUSTED (b) | 0.0% 0.0% | 8.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/34 (0%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 2/25 (8%) 0/0 |
|FIRST INCIDENCE (DAYS) | --- --- | 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) | (e) (e) |
|INCIDENTAL TUMOR | (e) (e) | (e) (e) |
|LOGISTIC REGRESSION | (e) (e) | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | (e) | P=0.238N |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # |
|----------- | | |
|OVERALL (a) | | 6/50 (12%) 0/52 (0%) |
|ADJUSTED (b) | | 19.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/0 0/35 (0%) |
|TERMINAL (d) | | 3/25 (12%) 0/0 |
|FIRST INCIDENCE (DAYS) | | 681 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.110N |
|INCIDENTAL TUMOR | | P=0.275N |
|LOGISTIC REGRESSION | | P=0.017N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | | P=0.012N* |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 21/50 (42%) | 21/50 (42%) 17/52 (33%) |
|ADJUSTED (b) | 71.8% 47.4% | 51.7% 44.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 12/34 (35%) | 0/0 7/35 (20%) |
|TERMINAL (d) | 16/28 (57%) 0/1 (0%) | 7/25 (28%) 0/0 |
|FIRST INCIDENCE (DAYS) | 479 583 | 368 359 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.047N* | P=0.230N |
|INCIDENTAL TUMOR | P=0.030N* | P=0.491 |
|LOGISTIC REGRESSION | P=0.031N* | P=0.225N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.036N* | P=0.222N |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) | 0/50 (0%) 0/52 (0%) |
|ADJUSTED (b) | 3.1% 5.0% | 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 1/34 (3%) | 0/0 0/35 (0%) |
|TERMINAL (d) | 0/28 (0%) 0/1 (0%) | 0/25 (0%) 0/0 |
|FIRST INCIDENCE (DAYS) | 677 600 | --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.716N | (e) (e) |
|INCIDENTAL TUMOR | P=0.721 | (e) (e) |
|LOGISTIC REGRESSION | P=0.488 | (e) (e) |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500 | (e) |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 46/50 (92%) 48/50 (96%) | 40/50 (80%) 31/52 (60%) |
|ADJUSTED (b) | 100.0% 100.0% | 88.7% 85.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 34/34 (100%) | 0/0 24/35 (69%) |
|TERMINAL (d) | 28/28 (100%) 1/1 (100%) | 20/25 (80%) 0/0 |
|FIRST INCIDENCE (DAYS) | 438 467 | 512 564 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114N | P=0.007N** |
|INCIDENTAL TUMOR | P=0.500N | P=0.057N |
|LOGISTIC REGRESSION | P=0.642N | P=0.017N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.339 | P=0.021N* |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 37/50 (74%) 29/50 (58%) | 30/50 (60%) 25/52 (48%) |
|ADJUSTED (b) | 78.5% 59.1% | 70.1% 58.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 15/34 (44%) | 0/0 11/35 (31%) |
|TERMINAL (d) | 18/28 (64%) 0/1 (0%) | 13/25 (52%) 0/0 |
|FIRST INCIDENCE (DAYS) | 255 432 | 39 359 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.088N | P=0.311N |
|INCIDENTAL TUMOR | P=0.597N | P=0.288 |
|LOGISTIC REGRESSION | P=0.141N | P=0.152N |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.069N | P=0.157N |
|=================================================================================================================================|
DATE: 05/11/95 EXPERIMENT: 05094 TEST: 99 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | AD LIB RTD | AD LIB RTD |
| | CONTROL CONTROL | CONTROL CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # | # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 49/50 (98%) | 49/50 (98%) 44/52 (85%) |
|ADJUSTED (b) | 100.0% 100.0% | 98.0% 92.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 34/34 (100%) | 0/0 28/35 (80%) |
|TERMINAL (d) | 28/28 (100%) 1/1 (100%) | 24/25 (96%) 0/0 |
|FIRST INCIDENCE (DAYS) | 255 432 | 39 359 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.051N | P=0.079N |
|INCIDENTAL TUMOR | P=0.398N | P=0.638N |
|LOGISTIC REGRESSION | P=0.339N | P=0.021N* |
|COCHRAN-ARMITAGE | | |
|FISHER EXACT | P=0.500N | P=0.018N* |
|=================================================================================================================================|
(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): 729
Female interim sacrifices(days): 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).