TDMS Study 05094-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 02 TIME: 07:12:48
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: 02 TIME: 07:12:48
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: 02 TIME: 07:12:48
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
------- ------------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Clitoral/Preputial Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva)
Papilloma Squamous or Papilloma
Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma
Pancreas Adenoma
Carcinoma or Adenoma
Testes Adenoma
Thymus Thymoma: Benign, Malignant, NOS
Thyroid Gland: Follicular Cell
Carcinoma
Carcinoma or Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst BUTYL BENZYL PHTHALATE DATE: 04/03/96
EXPERIMENT: 05094 TEST: 02 TIME: 07:12:48
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
------- ------------
Adrenal Cortex Adenoma
Clitoral/Preputial Gland Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Pancreas Adenoma
Carcinoma or Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Carcinoma or Adenoma
Uterus Sarcoma Stromal or Polyp Stromal
All Organs Benign Tumors
Malignant and Benign Tumors
====================================================================================================
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/120 (1%) 5/60 (8%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 1.1% 15.6% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 3/29 (10%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 681 725 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.375N P=0.010 ** P=0.562 P=0.662N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.370N P=0.010 * P=0.593 P=0.674N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.372N P=0.010 ** P=0.586 P=0.646N |
|COCHRAN-ARMITAGE | (e) | P=0.323N |
|FISHER EXACT | (e) (e) (e) | P=0.016 * P=0.557 P=0.667N |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/120 (11%) 10/60 (17%) 10/60 (17%) 8/60 (13%) | 1/119 (1%) 2/59 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 18.5% 38.8% 35.6% 25.4% | 1.0% 5.5% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/61 (13%) 6/20 (30%) 6/22 (27%) 3/22 (14%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 544 458 (I) 639 | 512 703 --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.183 P=0.044 * P=0.078 P=0.252 | P=0.541 P=0.251 P=0.642N P=0.573 |
|INCIDENTAL TUMOR | P=0.388 P=0.140 P=0.207 P=0.497 | P=0.613N P=0.343 P=0.443N P=0.763 |
|LOGISTIC REGRESSION | P=0.338 P=0.111 P=0.192 P=0.384 | P=0.578 P=0.266 P=0.653N P=0.607 |
|COCHRAN-ARMITAGE | P=0.343 | P=0.583 |
|FISHER EXACT | P=0.191 P=0.191 P=0.395 | P=0.255 P=0.665N P=0.559 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 0/60 (0%) 2/60 (3%) 2/60 (3%) | 0/119 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 4.3% 0.0% 6.1% 9.1% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 0/20 (0%) 0/22 (0%) 2/22 (9%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 614 --- 681 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.325 P=0.342N P=0.537 P=0.485 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.478 P=0.218N P=0.587N P=0.562 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.377 P=0.287N P=0.567 P=0.553 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.380 | (e) |
|FISHER EXACT | P=0.294N P=0.541 P=0.541 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/120 (12%) 10/60 (17%) 12/60 (20%) 10/60 (17%) | 2/119 (2%) 2/59 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 19.5% 38.8% 39.7% 33.3% | 2.5% 5.5% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 1/10 (10%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 8/61 (13%) 6/20 (30%) 6/22 (27%) 5/22 (23%) | 1/66 (2%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 544 458 (I) 639 | 512 703 --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.078 P=0.063 P=0.038 * P=0.124 | P=0.545N P=0.400 P=0.419N P=0.703 |
|INCIDENTAL TUMOR | P=0.225 P=0.207 P=0.151 P=0.288 | P=0.441N P=0.488 P=0.289N P=0.610N |
|LOGISTIC REGRESSION | P=0.172 P=0.154 P=0.101 P=0.224 | P=0.510N P=0.425 P=0.396N P=0.732N |
|COCHRAN-ARMITAGE | P=0.179 | P=0.496N |
|FISHER EXACT | P=0.240 P=0.103 P=0.240 | P=0.404 P=0.441N P=0.740N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.8% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 261 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.120N P=0.325N P=0.288N P=0.292N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.094N P=0.310N P=0.311N P=0.194N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.107N P=0.257N P=0.294N P=0.257N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.107N | (e) |
|FISHER EXACT | P=0.294N P=0.294N P=0.294N | (e) (e) (e) |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 1/60 (2%) 1/60 (2%) 0/60 (0%) | 0/120 (0%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 3.8% 5.0% 4.2% 0.0% | 0.0% 0.0% 1.7% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 261 729 (T) 722 --- | --- --- 459 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.228N P=0.674N P=0.618N P=0.292N | P=0.151 (e) P=0.362 P=0.367 |
|INCIDENTAL TUMOR | P=0.136N P=0.659N P=0.553N P=0.194N | P=0.256 (e) P=0.362 P=0.638 |
|LOGISTIC REGRESSION | P=0.183N P=0.557N P=0.588N P=0.257N | P=0.096 (e) P=0.325 P=0.294 |
|COCHRAN-ARMITAGE | P=0.183N | P=0.149 |
|FISHER EXACT | P=0.593N P=0.593N P=0.294N | (e) P=0.333 P=0.333 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 7/120 (6%) 3/60 (5%) 1/60 (2%) 0/60 (0%) | 5/120 (4%) 4/60 (7%) 4/60 (7%) 4/60 (7%) |
|ADJUSTED (b) | 10.5% 15.0% 4.5% 0.0% | 7.4% 13.0% 12.5% 13.8% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/61 (7%) 3/20 (15%) 1/22 (5%) 0/22 (0%) | 4/66 (6%) 3/29 (10%) 3/29 (10%) 4/29 (14%) |
|FIRST INCIDENCE (DAYS) | 644 729 (T) 729 (T) --- | 725 725 646 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.054N P=0.512 P=0.266N P=0.105N | P=0.223 P=0.296 P=0.296 P=0.283 |
|INCIDENTAL TUMOR | P=0.031N* P=0.638N P=0.160N P=0.050N | P=0.223 P=0.303 P=0.313 P=0.283 |
|LOGISTIC REGRESSION | P=0.031N* P=0.599 P=0.192N P=0.071N | P=0.211 P=0.295 P=0.307 P=0.261 |
|COCHRAN-ARMITAGE | P=0.027N* | P=0.297 |
|FISHER EXACT | P=0.559N P=0.189N P=0.055N | P=0.347 P=0.347 P=0.347 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 6/60 (10%) 1/60 (2%) 0/60 (0%) | 5/120 (4%) 6/60 (10%) 5/60 (8%) 0/60 (0%) |
|ADJUSTED (b) | 5.6% 25.1% 4.5% 0.0% | 7.2% 19.2% 14.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 3/20 (15%) 1/22 (5%) 0/22 (0%) | 4/66 (6%) 5/29 (17%) 3/29 (10%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 607 626 729 (T) --- | 702 618 572 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.150N P=0.019 * P=0.508N P=0.215N | P=0.233N P=0.074 P=0.161 P=0.159N |
|INCIDENTAL TUMOR | P=0.100N P=0.082 P=0.530N P=0.229N | P=0.193N P=0.099 P=0.186 P=0.158N |
|LOGISTIC REGRESSION | P=0.097N P=0.038 * P=0.434N P=0.188N | P=0.220N P=0.088 P=0.177 P=0.160N |
|COCHRAN-ARMITAGE | P=0.094N | P=0.177N |
|FISHER EXACT | P=0.071 P=0.459N P=0.194N | P=0.115 P=0.207 P=0.128N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/120 (9%) 8/60 (13%) 2/60 (3%) 0/60 (0%) | 10/120 (8%) 10/60 (17%) 9/60 (15%) 4/60 (7%) |
|ADJUSTED (b) | 15.7% 33.9% 9.1% 0.0% | 14.4% 31.4% 26.5% 13.8% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/61 (10%) 5/20 (25%) 2/22 (9%) 0/22 (0%) | 8/66 (12%) 8/29 (28%) 6/29 (21%) 4/29 (14%) |
|FIRST INCIDENCE (DAYS) | 607 626 729 (T) --- | 702 618 572 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.020N* P=0.082 P=0.213N P=0.034N* | P=0.536 P=0.041 * P=0.084 P=0.561N |
|INCIDENTAL TUMOR | P=0.007N** P=0.257 P=0.141N P=0.016N* | P=0.523N P=0.053 P=0.100 P=0.561N |
|LOGISTIC REGRESSION | P=0.007N** P=0.152 P=0.131N P=0.019N* | P=0.541 P=0.047 * P=0.093 P=0.590N |
|COCHRAN-ARMITAGE | P=0.007N** | P=0.441N |
|FISHER EXACT | P=0.270 P=0.129N P=0.010N** | P=0.079 P=0.133 P=0.472N |
|=================================================================================================================================|
| |
|Heart |
| Schwannoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.0% 0.0% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 2/66 (3%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) --- --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.649 P=0.432N P=0.432N P=0.701 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.649 P=0.432N P=0.432N P=0.701 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.649 P=0.432N P=0.432N P=0.701 |
|COCHRAN-ARMITAGE | (e) | P=0.622N |
|FISHER EXACT | (e) (e) (e) | P=0.443N P=0.443N P=0.742N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/120 (5%) 2/59 (3%) 4/60 (7%) 1/60 (2%) | 1/119 (1%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 9.8% 6.8% 15.2% 4.5% | 1.5% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/61 (10%) 0/20 (0%) 2/22 (9%) 1/22 (5%) | 1/66 (2%) 1/29 (3%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 607 701 729 (T) | 736 (T) 736 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.401N P=0.646N P=0.284 P=0.376N | P=0.378N P=0.568 P=0.664N P=0.664N |
|INCIDENTAL TUMOR | P=0.277N P=0.541N P=0.427 P=0.376N | P=0.378N P=0.568 P=0.664N P=0.664N |
|LOGISTIC REGRESSION | P=0.291N P=0.566N P=0.384 P=0.376N | P=0.378N P=0.568 P=0.664N P=0.664N |
|COCHRAN-ARMITAGE | P=0.271N | P=0.351N |
|FISHER EXACT | P=0.475N P=0.441 P=0.258N | P=0.559 P=0.665N P=0.665N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/59 (0%) 0/60 (0%) 0/60 (0%) | 0/119 (0%) 0/60 (0%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 0.0% 5.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- --- 666 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.433 (e) P=0.085 (e) |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.433 (e) P=0.102 (e) |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.447 (e) P=0.098 (e) |
|COCHRAN-ARMITAGE | (e) | P=0.464 |
|FISHER EXACT | (e) (e) (e) | (e) P=0.111 (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/120 (5%) 2/59 (3%) 4/60 (7%) 1/60 (2%) | 1/119 (1%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 9.8% 6.8% 15.2% 4.5% | 1.5% 3.4% 5.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 6/61 (10%) 0/20 (0%) 2/22 (9%) 1/22 (5%) | 1/66 (2%) 1/29 (3%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 607 701 729 (T) | 736 (T) 736 (T) 666 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.401N P=0.646N P=0.284 P=0.376N | P=0.594N P=0.568 P=0.230 P=0.664N |
|INCIDENTAL TUMOR | P=0.277N P=0.541N P=0.427 P=0.376N | P=0.594N P=0.568 P=0.252 P=0.664N |
|LOGISTIC REGRESSION | P=0.291N P=0.566N P=0.384 P=0.376N | P=0.589N P=0.568 P=0.249 P=0.664N |
|COCHRAN-ARMITAGE | P=0.271N | P=0.551N |
|FISHER EXACT | P=0.475N P=0.441 P=0.258N | P=0.559 P=0.260 P=0.665N |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 1/120 (1%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 7.6% 0.0% 0.0% | 1.4% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 654 607 --- --- | 722 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.220N P=0.310 P=0.433N P=0.433N | P=0.415N P=0.649N P=0.644N P=0.673N |
|INCIDENTAL TUMOR | P=0.180N P=0.451 P=0.311N P=0.319N | P=0.411N P=0.638N P=0.622N P=0.674N |
|LOGISTIC REGRESSION | P=0.192N P=0.390 P=0.401N P=0.406N | P=0.412N P=0.653N P=0.656N P=0.664N |
|COCHRAN-ARMITAGE | P=0.191N | P=0.394N |
|FISHER EXACT | P=0.407 P=0.443N P=0.443N | P=0.667N P=0.667N P=0.667N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 2/120 (2%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 7.6% 0.0% 3.8% | 2.5% 0.0% 2.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 654 607 --- 716 | 670 --- 724 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.550N P=0.310 P=0.433N P=0.689 | P=0.355N P=0.421N P=0.713 P=0.439N |
|INCIDENTAL TUMOR | P=0.425N P=0.451 P=0.311N P=0.567N | P=0.346N P=0.400N P=0.711N P=0.445N |
|LOGISTIC REGRESSION | P=0.501N P=0.390 P=0.401N P=0.725 | P=0.339N P=0.409N P=0.720 P=0.416N |
|COCHRAN-ARMITAGE | P=0.500N | P=0.321N |
|FISHER EXACT | P=0.407 P=0.443N P=0.742N | P=0.443N P=0.742N P=0.443N |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 2/60 (3%) 0/60 (0%) 4/60 (7%) | 0/120 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 4.6% 8.5% 0.0% 14.2% | 0.0% 0.0% 5.1% 6.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 1/20 (5%) 0/22 (0%) 2/22 (9%) | 0/66 (0%) 0/29 (0%) 1/29 (3%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | 662 678 --- 464 | --- --- 459 (I) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.114 P=0.416 P=0.315N P=0.109 | P=0.029 * (e) P=0.096 P=0.085 |
|INCIDENTAL TUMOR | P=0.185 P=0.509 P=0.228N P=0.179 | P=0.029 * (e) P=0.096 P=0.085 |
|LOGISTIC REGRESSION | P=0.160 P=0.486 P=0.272N P=0.164 | P=0.033 * (e) P=0.105 P=0.085 |
|COCHRAN-ARMITAGE | P=0.160 | P=0.035 * |
|FISHER EXACT | P=0.541 P=0.294N P=0.169 | (e) P=0.110 P=0.110 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 2/60 (3%) 1/60 (2%) 4/60 (7%) | 0/120 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 6.2% 8.5% 4.2% 14.2% | 0.0% 0.0% 5.1% 6.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 3/61 (5%) 1/20 (5%) 0/22 (0%) 2/22 (9%) | 0/66 (0%) 0/29 (0%) 1/29 (3%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | 662 678 722 464 | --- --- 459 (I) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156 P=0.516 P=0.533N P=0.171 | P=0.029 * (e) P=0.096 P=0.085 |
|INCIDENTAL TUMOR | P=0.284 P=0.599 P=0.341N P=0.256 | P=0.029 * (e) P=0.096 P=0.085 |
|LOGISTIC REGRESSION | P=0.228 P=0.586 P=0.453N P=0.252 | P=0.033 * (e) P=0.105 P=0.085 |
|COCHRAN-ARMITAGE | P=0.230 | P=0.035 * |
|FISHER EXACT | P=0.682N P=0.459N P=0.255 | (e) P=0.110 P=0.110 |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 2/60 (3%) 1/60 (2%) 4/60 (7%) | 0/120 (0%) 0/60 (0%) 2/60 (3%) 2/60 (3%) |
|ADJUSTED (b) | 6.2% 8.5% 4.2% 14.2% | 0.0% 0.0% 5.1% 6.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 3/61 (5%) 1/20 (5%) 0/22 (0%) 2/22 (9%) | 0/66 (0%) 0/29 (0%) 1/29 (3%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | 662 678 722 464 | --- --- 459 (I) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156 P=0.516 P=0.533N P=0.171 | P=0.029 * (e) P=0.096 P=0.085 |
|INCIDENTAL TUMOR | P=0.284 P=0.599 P=0.341N P=0.256 | P=0.029 * (e) P=0.096 P=0.085 |
|LOGISTIC REGRESSION | P=0.228 P=0.586 P=0.453N P=0.252 | P=0.033 * (e) P=0.105 P=0.085 |
|COCHRAN-ARMITAGE | P=0.230 | P=0.035 * |
|FISHER EXACT | P=0.682N P=0.459N P=0.255 | (e) P=0.110 P=0.110 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 2/60 (3%) 0/60 (0%) 0/60 (0%) | 2/120 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 10.0% 0.0% 0.0% | 2.8% 2.6% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 2/20 (10%) 0/22 (0%) 0/22 (0%) | 1/66 (2%) 0/29 (0%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 717 689 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.607N P=0.048 * (e) (e) | P=0.338N P=0.704 P=0.703 P=0.442N |
|INCIDENTAL TUMOR | P=0.607N P=0.048 * (e) (e) | P=0.328N P=0.722 P=0.717 P=0.439N |
|LOGISTIC REGRESSION | P=0.607N P=0.048 * (e) (e) | P=0.325N P=0.719 P=0.707 P=0.436N |
|COCHRAN-ARMITAGE | P=0.538N | P=0.295N |
|FISHER EXACT | P=0.110 (e) (e) | P=0.742N P=0.742N P=0.443N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 1/60 (2%) 0/60 (0%) 1/60 (2%) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.3% 5.0% 0.0% 4.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 1/20 (5%) 0/22 (0%) 1/22 (5%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 729 (T) | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.616 P=0.628 P=0.481N P=0.652 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.616 P=0.628 P=0.481N P=0.652 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.616 P=0.628 P=0.481N P=0.652 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.554N | (e) |
|FISHER EXACT | P=0.742N P=0.443N P=0.742N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 3/60 (5%) 0/60 (0%) 1/60 (2%) | 2/120 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 3.3% 15.0% 0.0% 4.5% | 2.8% 2.6% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 3/20 (15%) 0/22 (0%) 1/22 (5%) | 1/66 (2%) 0/29 (0%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) --- 729 (T) | 717 689 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.578N P=0.089 P=0.481N P=0.652 | P=0.338N P=0.704 P=0.703 P=0.442N |
|INCIDENTAL TUMOR | P=0.578N P=0.089 P=0.481N P=0.652 | P=0.328N P=0.722 P=0.717 P=0.439N |
|LOGISTIC REGRESSION | P=0.578N P=0.089 P=0.481N P=0.652 | P=0.325N P=0.719 P=0.707 P=0.436N |
|COCHRAN-ARMITAGE | P=0.456N | P=0.295N |
|FISHER EXACT | P=0.207 P=0.443N P=0.742N | P=0.742N P=0.742N P=0.443N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 3.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 2/66 (3%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.216N P=0.432N P=0.432N P=0.432N |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.216N P=0.432N P=0.432N P=0.432N |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.216N P=0.432N P=0.432N P=0.432N |
|COCHRAN-ARMITAGE | (e) | P=0.197N |
|FISHER EXACT | (e) (e) (e) | P=0.443N P=0.443N P=0.443N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 2/120 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% | 2.7% 1.7% 6.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 1/66 (2%) 0/29 (0%) 2/29 (7%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 716 424 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.701N P=0.279 (e) (e) | P=0.420N P=0.711 P=0.382 P=0.444N |
|INCIDENTAL TUMOR | P=0.701N P=0.279 (e) (e) | P=0.327N P=0.669N P=0.400 P=0.439N |
|LOGISTIC REGRESSION | P=0.701N P=0.279 (e) (e) | P=0.388N P=0.728N P=0.387 P=0.435N |
|COCHRAN-ARMITAGE | P=0.656N | P=0.382N |
|FISHER EXACT | P=0.333 (e) (e) | P=0.742N P=0.407 P=0.443N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 0/60 (0%) 0/60 (0%) | 4/120 (3%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 0.0% 0.0% | 5.7% 1.7% 6.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 3/66 (5%) 0/29 (0%) 2/29 (7%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- --- | 716 424 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.701N P=0.279 (e) (e) | P=0.197N P=0.478N P=0.619 P=0.220N |
|INCIDENTAL TUMOR | P=0.701N P=0.279 (e) (e) | P=0.144N P=0.406N P=0.633 P=0.218N |
|LOGISTIC REGRESSION | P=0.701N P=0.279 (e) (e) | P=0.177N P=0.440N P=0.625 P=0.221N |
|COCHRAN-ARMITAGE | P=0.656N | P=0.166N |
|FISHER EXACT | P=0.333 (e) (e) | P=0.459N P=0.682N P=0.194N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 5/60 (8%) 2/60 (3%) 0/60 (0%) | 35/120 (29%) 31/60 (52%) 32/60 (53%) 11/60 (18%) |
|ADJUSTED (b) | 8.2% 19.8% 9.1% 0.0% | 42.4% 73.3% 72.2% 28.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 2/20 (10%) 2/22 (9%) 0/22 (0%) | 20/66 (30%) 18/29 (62%) 17/29 (59%) 5/29 (17%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 645 729 (T) --- | 587 459 (I) 459 (I) 487 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.157N P=0.073 P=0.624 P=0.196N | P=0.375N P=0.001 ** P<0.001 ** P=0.200N |
|INCIDENTAL TUMOR | P=0.088N P=0.120 P=0.624 P=0.196N | P=0.173N P<0.001 ** P<0.001 ** P=0.089N |
|LOGISTIC REGRESSION | P=0.101N P=0.112 P=0.624 P=0.196N | P=0.188N P=0.001 ** P<0.001 ** P=0.084N |
|COCHRAN-ARMITAGE | P=0.090N | P=0.156N |
|FISHER EXACT | P=0.207 P=0.571N P=0.128N | P=0.003 ** P=0.001 ** P=0.081N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 5/60 (8%) 2/60 (3%) 0/60 (0%) | 35/120 (29%) 31/60 (52%) 32/60 (53%) 11/60 (18%) |
|ADJUSTED (b) | 8.2% 19.8% 9.1% 0.0% | 42.4% 73.3% 72.2% 28.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 2/20 (10%) 2/22 (9%) 0/22 (0%) | 20/66 (30%) 18/29 (62%) 17/29 (59%) 5/29 (17%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 645 729 (T) --- | 587 459 (I) 459 (I) 487 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.157N P=0.073 P=0.624 P=0.196N | P=0.375N P=0.001 ** P<0.001 ** P=0.200N |
|INCIDENTAL TUMOR | P=0.088N P=0.120 P=0.624 P=0.196N | P=0.173N P<0.001 ** P<0.001 ** P=0.089N |
|LOGISTIC REGRESSION | P=0.101N P=0.112 P=0.624 P=0.196N | P=0.188N P=0.001 ** P<0.001 ** P=0.084N |
|COCHRAN-ARMITAGE | P=0.090N | P=0.156N |
|FISHER EXACT | P=0.207 P=0.571N P=0.128N | P=0.003 ** P=0.001 ** P=0.081N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 6/60 (10%) 2/60 (3%) 0/60 (0%) | 36/120 (30%) 32/60 (53%) 33/60 (55%) 11/60 (18%) |
|ADJUSTED (b) | 8.2% 24.3% 9.1% 0.0% | 43.1% 73.7% 74.5% 28.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 3/20 (15%) 2/22 (9%) 0/22 (0%) | 20/66 (30%) 18/29 (62%) 18/29 (62%) 5/29 (17%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 645 729 (T) --- | 587 424 459 (I) 487 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.156N P=0.027 * P=0.624 P=0.196N | P=0.349N P<0.001 ** P<0.001 ** P=0.177N |
|INCIDENTAL TUMOR | P=0.089N P=0.049 * P=0.624 P=0.196N | P=0.136N P<0.001 ** P<0.001 ** P=0.072N |
|LOGISTIC REGRESSION | P=0.098N P=0.046 * P=0.624 P=0.196N | P=0.166N P<0.001 ** P<0.001 ** P=0.066N |
|COCHRAN-ARMITAGE | P=0.086N | P=0.136N |
|FISHER EXACT | P=0.115 P=0.571N P=0.128N | P=0.002 ** P=0.001 ** P=0.065N |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 3/60 (5%) 0/60 (0%) | 4/120 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 11.9% 0.0% | 6.1% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/20 (5%) 2/22 (9%) 0/22 (0%) | 4/66 (6%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 697 --- | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370 P=0.279 P=0.017 * (e) | P=0.072N P=0.213N P=0.213N P=0.213N |
|INCIDENTAL TUMOR | P=0.446 P=0.279 P=0.038 * (e) | P=0.072N P=0.213N P=0.213N P=0.213N |
|LOGISTIC REGRESSION | P=0.420 P=0.279 P=0.026 * (e) | P=0.072N P=0.213N P=0.213N P=0.213N |
|COCHRAN-ARMITAGE | P=0.446 | P=0.061N |
|FISHER EXACT | P=0.333 P=0.036 * (e) | P=0.194N P=0.194N P=0.194N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 3/60 (5%) 0/60 (0%) | 4/120 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 11.9% 0.0% | 6.1% 2.8% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/20 (5%) 2/22 (9%) 0/22 (0%) | 4/66 (6%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 697 --- | 736 (T) 718 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.370 P=0.279 P=0.017 * (e) | P=0.081N P=0.483N P=0.213N P=0.213N |
|INCIDENTAL TUMOR | P=0.446 P=0.279 P=0.038 * (e) | P=0.079N P=0.479N P=0.213N P=0.213N |
|LOGISTIC REGRESSION | P=0.420 P=0.279 P=0.026 * (e) | P=0.082N P=0.480N P=0.213N P=0.213N |
|COCHRAN-ARMITAGE | P=0.446 | P=0.066N |
|FISHER EXACT | P=0.333 P=0.036 * (e) | P=0.459N P=0.194N P=0.194N |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 2/60 (3%) 0/60 (0%) | 1/120 (1%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 5.0% 9.1% 0.0% | 1.5% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/20 (5%) 2/22 (9%) 0/22 (0%) | 1/66 (2%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 729 (T) --- | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.445 P=0.279 P=0.059 (e) | P=0.413N P=0.664N P=0.664N P=0.664N |
|INCIDENTAL TUMOR | P=0.445 P=0.279 P=0.059 (e) | P=0.413N P=0.664N P=0.664N P=0.664N |
|LOGISTIC REGRESSION | P=0.445 P=0.279 P=0.059 (e) | P=0.413N P=0.664N P=0.664N P=0.664N |
|COCHRAN-ARMITAGE | P=0.531 | P=0.394N |
|FISHER EXACT | P=0.333 P=0.110 (e) | P=0.667N P=0.667N P=0.667N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | | 2/120 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | | 2.6% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 1/66 (2%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | | 598 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.212N P=0.418N P=0.424N P=0.427N |
|INCIDENTAL TUMOR | | P=0.171N P=0.327N P=0.394N P=0.327N |
|LOGISTIC REGRESSION | | P=0.198N P=0.402N P=0.402N P=0.404N |
|COCHRAN-ARMITAGE | | P=0.197N |
|FISHER EXACT | | P=0.443N P=0.443N P=0.443N |
|=================================================================================================================================|
| |
|Pancreas |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 2/59 (3%) 3/60 (5%) 10/60 (17%) | 0/119 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 4.9% 7.4% 13.6% 41.0% | 0.0% 0.0% 0.0% 6.2% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/61 (5%) 1/20 (5%) 3/22 (14%) 8/22 (36%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 569 729 (T) 709 | --- --- --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.420 P=0.193 P<0.001 ** | P=0.019 * (e) (e) P=0.083 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.495 P=0.193 P<0.001 ** | P=0.018 * (e) (e) P=0.082 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.498 P=0.193 P<0.001 ** | P=0.019 * (e) (e) P=0.086 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.024 * |
|FISHER EXACT | P=0.534 P=0.318 P=0.001 ** | (e) (e) P=0.111 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Pancreas |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 2/59 (3%) 3/60 (5%) 11/60 (18%) | 0/119 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 6.6% 7.4% 13.6% 42.7% | 0.0% 0.0% 0.0% 6.2% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/61 (7%) 1/20 (5%) 3/22 (14%) 8/22 (36%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 569 729 (T) 674 | --- --- --- 703 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P<0.001 ** P=0.520 P=0.283 P<0.001 ** | P=0.019 * (e) (e) P=0.083 |
|INCIDENTAL TUMOR | P<0.001 ** P=0.587 P=0.283 P<0.001 ** | P=0.018 * (e) (e) P=0.082 |
|LOGISTIC REGRESSION | P<0.001 ** P=0.598 P=0.283 P<0.001 ** | P=0.019 * (e) (e) P=0.086 |
|COCHRAN-ARMITAGE | P<0.001 ** | P=0.024 * |
|FISHER EXACT | P=0.645 P=0.429 P=0.001 ** | (e) (e) P=0.111 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/119 (19%) 13/60 (22%) 11/60 (18%) 11/59 (19%) | 28/116 (24%) 27/60 (45%) 26/58 (45%) 13/60 (22%) |
|ADJUSTED (b) | 29.2% 44.2% 37.9% 36.3% | 35.8% 64.0% 71.7% 36.1% |
|INTERIM SACRIFICE 1 (c)| 3/19 (16%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 1/20 (5%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 12/61 (20%) 7/20 (35%) 6/22 (27%) 5/22 (23%) | 16/63 (25%) 15/29 (52%) 19/29 (66%) 7/29 (24%) |
|FIRST INCIDENCE (DAYS) | 438 458 (I) 569 458 (I) | 459 (I) 459 (I) 459 (I) 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.394 P=0.160 P=0.422 P=0.411 | P=0.380 P=0.002 ** P=0.002 ** P=0.526 |
|INCIDENTAL TUMOR | P=0.440N P=0.379 P=0.481N P=0.475N | P=0.502 P=0.004 ** P=0.001 ** P=0.563N |
|LOGISTIC REGRESSION | P=0.450N P=0.401 P=0.509N P=0.536N | P=0.516 P=0.004 ** P=0.001 ** P=0.475N |
|COCHRAN-ARMITAGE | P=0.462N | P=0.467N |
|FISHER EXACT | P=0.427 P=0.522N P=0.543N | P=0.004 ** P=0.005 ** P=0.433N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/119 (0%) 1/60 (2%) 0/60 (0%) 0/59 (0%) | 2/116 (2%) 0/60 (0%) 0/58 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 1.7% 0.0% 0.0% | 2.8% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/19 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 1/63 (2%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 303 --- --- | 717 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.659N P=0.365 (e) (e) | P=0.215N P=0.423N P=0.423N P=0.437N |
|INCIDENTAL TUMOR | P=0.741N P=0.282 (e) (e) | P=0.214N P=0.411N P=0.422N P=0.433N |
|LOGISTIC REGRESSION | P=0.739 P=0.192 (e) (e) | P=0.211N P=0.411N P=0.422N P=0.426N |
|COCHRAN-ARMITAGE | P=0.657N | P=0.194N |
|FISHER EXACT | P=0.335 (e) (e) | P=0.433N P=0.443N P=0.433N |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/119 (19%) 14/60 (23%) 11/60 (18%) 11/59 (19%) | 30/116 (26%) 27/60 (45%) 26/58 (45%) 13/60 (22%) |
|ADJUSTED (b) | 29.2% 45.1% 37.9% 36.3% | 38.0% 64.0% 71.7% 36.1% |
|INTERIM SACRIFICE 1 (c)| 3/19 (16%) 2/10 (20%) 0/10 (0%) 1/10 (10%) | 1/20 (5%) 1/10 (10%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 12/61 (20%) 7/20 (35%) 6/22 (27%) 5/22 (23%) | 17/63 (27%) 15/29 (52%) 19/29 (66%) 7/29 (24%) |
|FIRST INCIDENCE (DAYS) | 438 303 569 458 (I) | 459 (I) 459 (I) 459 (I) 592 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.409 P=0.108 P=0.422 P=0.411 | P=0.462 P=0.004 ** P=0.004 ** P=0.531N |
|INCIDENTAL TUMOR | P=0.440N P=0.274 P=0.481N P=0.475N | P=0.476N P=0.008 ** P=0.003 ** P=0.466N |
|LOGISTIC REGRESSION | P=0.437N P=0.322 P=0.509N P=0.536N | P=0.460N P=0.008 ** P=0.003 ** P=0.377N |
|COCHRAN-ARMITAGE | P=0.447N | P=0.375N |
|FISHER EXACT | P=0.330 P=0.522N P=0.543N | P=0.009 ** P=0.010 ** P=0.337N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 1/120 (1%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 3.3% 0.0% 0.0% 6.9% | 1.5% 0.0% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 0/20 (0%) 0/22 (0%) 1/22 (5%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 639 | 733 --- --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 P=0.504N P=0.481N P=0.344 | P=0.434 P=0.667N P=0.660N P=0.566 |
|INCIDENTAL TUMOR | P=0.237 P=0.504N P=0.481N P=0.330 | P=0.433 P=0.638N P=0.622N P=0.561 |
|LOGISTIC REGRESSION | P=0.314 P=0.504N P=0.481N P=0.413 | P=0.425 P=0.661N P=0.661N P=0.556 |
|COCHRAN-ARMITAGE | P=0.319 | P=0.462 |
|FISHER EXACT | P=0.443N P=0.443N P=0.407 | P=0.667N P=0.667N P=0.557 |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 3.3% 0.0% 0.0% 6.9% | 3.0% 0.0% 0.0% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 0/20 (0%) 0/22 (0%) 1/22 (5%) | 1/66 (2%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- --- 639 | 733 --- --- 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.262 P=0.504N P=0.481N P=0.344 | P=0.648 P=0.434N P=0.430N P=0.698 |
|INCIDENTAL TUMOR | P=0.237 P=0.504N P=0.481N P=0.330 | P=0.649 P=0.417N P=0.407N P=0.695 |
|LOGISTIC REGRESSION | P=0.314 P=0.504N P=0.481N P=0.413 | P=0.643 P=0.429N P=0.427N P=0.691 |
|COCHRAN-ARMITAGE | P=0.319 | P=0.622N |
|FISHER EXACT | P=0.443N P=0.443N P=0.407 | P=0.443N P=0.443N P=0.742N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous Tumor (benign, |
| malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 3/120 (3%) 0/60 (0%) 1/60 (2%) 3/60 (5%) | 2/120 (2%) 0/60 (0%) 1/60 (2%) 1/60 (2%) |
|ADJUSTED (b) | 4.4% 0.0% 4.5% 11.3% | 3.0% 0.0% 3.4% 3.4% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 0/20 (0%) 1/22 (5%) 2/22 (9%) | 1/66 (2%) 0/29 (0%) 1/29 (3%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 593 --- 729 (T) 639 | 733 --- 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.152 P=0.347N P=0.659N P=0.247 | P=0.541 P=0.434N P=0.701 P=0.698 |
|INCIDENTAL TUMOR | P=0.125 P=0.265N P=0.670N P=0.226 | P=0.541 P=0.417N P=0.717 P=0.695 |
|LOGISTIC REGRESSION | P=0.205 P=0.293N P=0.572N P=0.319 | P=0.533 P=0.429N P=0.707 P=0.691 |
|COCHRAN-ARMITAGE | P=0.207 | P=0.580 |
|FISHER EXACT | P=0.294N P=0.593N P=0.318 | P=0.443N P=0.742N P=0.742N |
|=================================================================================================================================|
| |
|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) | 8/120 (7%) 2/60 (3%) 4/60 (7%) 5/60 (8%) | 3/120 (3%) 1/60 (2%) 2/60 (3%) 1/60 (2%) |
|ADJUSTED (b) | 11.5% 10.0% 13.8% 20.2% | 4.5% 3.4% 6.9% 3.4% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 2/20 (10%) 2/22 (9%) 4/22 (18%) | 2/66 (3%) 1/29 (3%) 2/29 (7%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 655 639 | 733 736 (T) 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.222 P=0.464N P=0.500 P=0.297 | P=0.573N P=0.621N P=0.512 P=0.621N |
|INCIDENTAL TUMOR | P=0.293 P=0.372N P=0.579N P=0.351 | P=0.574N P=0.608N P=0.528 P=0.625N |
|LOGISTIC REGRESSION | P=0.347 P=0.341N P=0.621N P=0.445 | P=0.582N P=0.619N P=0.520 P=0.636N |
|COCHRAN-ARMITAGE | P=0.352 | P=0.520N |
|FISHER EXACT | P=0.292N P=0.634N P=0.448 | P=0.593N P=0.541 P=0.593N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 21
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/120 (5%) 2/60 (3%) 5/60 (8%) 5/60 (8%) | 2/120 (2%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |
|ADJUSTED (b) | 9.1% 8.3% 15.9% 17.3% | 2.7% 2.6% 6.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 4/61 (7%) 1/20 (5%) 1/22 (5%) 2/22 (9%) | 1/66 (2%) 0/29 (0%) 2/29 (7%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 614 645 628 668 | 711 701 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.116 P=0.645N P=0.191 P=0.181 | P=0.435N P=0.700 P=0.380 P=0.447N |
|INCIDENTAL TUMOR | P=0.303 P=0.495N P=0.422 P=0.394 | P=0.424N P=0.722 P=0.400 P=0.439N |
|LOGISTIC REGRESSION | P=0.168 P=0.544N P=0.286 P=0.267 | P=0.424N P=0.718 P=0.388 P=0.433N |
|COCHRAN-ARMITAGE | P=0.173 | P=0.382N |
|FISHER EXACT | P=0.466N P=0.284 P=0.284 | P=0.742N P=0.407 P=0.443N |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/120 (3%) 2/60 (3%) 2/60 (3%) 1/60 (2%) | 2/120 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 5.6% 10.0% 7.1% 4.5% | 3.0% 3.4% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 2/61 (3%) 2/20 (10%) 1/22 (5%) 1/22 (5%) | 2/66 (3%) 1/29 (3%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 670 729 (T) | 736 (T) 736 (T) --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.471N P=0.529 P=0.591 P=0.546N | P=0.220N P=0.701 P=0.432N P=0.432N |
|INCIDENTAL TUMOR | P=0.359N P=0.578 P=0.587N P=0.431N | P=0.220N P=0.701 P=0.432N P=0.432N |
|LOGISTIC REGRESSION | P=0.362N P=0.629 P=0.667N P=0.441N | P=0.220N P=0.701 P=0.432N P=0.432N |
|COCHRAN-ARMITAGE | P=0.359N | P=0.197N |
|FISHER EXACT | P=0.682N P=0.682N P=0.459N | P=0.742N P=0.443N P=0.443N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 22
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Skin |
| Neurofibrosarcoma, Neurofibroma, or Schwannoma (benign, malignant or NOS) |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/120 (1%) 2/60 (3%) 0/60 (0%) 1/60 (2%) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 1.2% 5.7% 0.0% 4.3% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 584 544 --- 718 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.565 P=0.233 P=0.631N P=0.561 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.589N P=0.421 P=0.654N P=0.704 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.589 P=0.279 P=0.650N P=0.598 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.580 | (e) |
|FISHER EXACT | P=0.258 P=0.667N P=0.557 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 2/60 (3%) 3/60 (5%) 2/60 (3%) | 2/120 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 7.2% 10.0% 9.4% 9.1% | 3.0% 3.4% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/61 (5%) 2/20 (10%) 1/22 (5%) 2/22 (9%) | 2/66 (3%) 1/29 (3%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 655 729 (T) | 736 (T) 736 (T) 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.516 P=0.612 P=0.458 P=0.640 | P=0.329N P=0.701 P=0.701 P=0.432N |
|INCIDENTAL TUMOR | P=0.502N P=0.654 P=0.627N P=0.598N | P=0.329N P=0.701 P=0.701 P=0.432N |
|LOGISTIC REGRESSION | P=0.520N P=0.619N P=0.555 P=0.565N | P=0.329N P=0.701 P=0.701 P=0.432N |
|COCHRAN-ARMITAGE | P=0.516N | P=0.295N |
|FISHER EXACT | P=0.571N P=0.534 P=0.571N | P=0.742N P=0.742N P=0.443N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 23
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 5/120 (4%) 2/60 (3%) 3/60 (5%) 2/60 (3%) | 2/120 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |
|ADJUSTED (b) | 7.2% 10.0% 9.4% 9.1% | 3.0% 3.4% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 3/61 (5%) 2/20 (10%) 1/22 (5%) 2/22 (9%) | 2/66 (3%) 1/29 (3%) 1/29 (3%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 458 (I) 729 (T) 655 729 (T) | 736 (T) 736 (T) 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.516 P=0.612 P=0.458 P=0.640 | P=0.329N P=0.701 P=0.701 P=0.432N |
|INCIDENTAL TUMOR | P=0.502N P=0.654 P=0.627N P=0.598N | P=0.329N P=0.701 P=0.701 P=0.432N |
|LOGISTIC REGRESSION | P=0.520N P=0.619N P=0.555 P=0.565N | P=0.329N P=0.701 P=0.701 P=0.432N |
|COCHRAN-ARMITAGE | P=0.516N | P=0.295N |
|FISHER EXACT | P=0.571N P=0.534 P=0.571N | P=0.742N P=0.742N P=0.443N |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) |105/120 (88%) 51/60 (85%) 57/60 (95%) 54/60 (90%) | |
|ADJUSTED (b) | 99.0% 98.0% 98.3% 100.0% | |
|INTERIM SACRIFICE 1 (c)| 16/20 (80%) 5/10 (50%) 9/10 (90%) 9/10 (90%) | |
|TERMINAL (d) | 60/61 (98%) 19/20 (95%) 21/22 (95%) 22/22 (100%)| |
|FIRST INCIDENCE (DAYS) | 422 450 458 (I) 458 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.032 * P=0.018 * P=0.011 * P=0.029 * | |
|INCIDENTAL TUMOR | P=0.194 P=0.489N P=0.221 P=0.352 | |
|LOGISTIC REGRESSION | P=0.196 P=0.455N P=0.154 P=0.351 | |
|COCHRAN-ARMITAGE | P=0.222 | |
|FISHER EXACT | P=0.401N P=0.090 P=0.411 | |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 24
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Thymus |
| Thymoma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/117 (0%) 1/58 (2%) 0/60 (0%) 2/57 (4%) | 0/117 (0%) 0/59 (0%) 1/60 (2%) 0/58 (0%) |
|ADJUSTED (b) | 0.0% 5.3% 0.0% 6.4% | 0.0% 0.0% 3.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) | 0/19 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 1/19 (5%) 0/22 (0%) 1/21 (5%) | 0/65 (0%) 0/29 (0%) 1/29 (3%) 0/28 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) --- 297 | --- --- 736 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.050 * P=0.269 (e) P=0.078 | P=0.585 (e) P=0.339 (e) |
|INCIDENTAL TUMOR | P=0.068 P=0.269 (e) P=0.099 | P=0.585 (e) P=0.339 (e) |
|LOGISTIC REGRESSION | P=0.068 P=0.269 (e) P=0.110 | P=0.585 (e) P=0.339 (e) |
|COCHRAN-ARMITAGE | P=0.068 | P=0.605 |
|FISHER EXACT | P=0.331 (e) P=0.106 | (e) P=0.339 (e) |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/120 (7%) 3/60 (5%) 3/60 (5%) 2/60 (3%) | 6/119 (5%) 5/60 (8%) 3/60 (5%) 2/60 (3%) |
|ADJUSTED (b) | 11.3% 12.8% 9.7% 5.2% | 7.3% 14.5% 10.3% 6.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 1/20 (5%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 2/20 (10%) 1/22 (5%) 0/22 (0%) | 2/66 (3%) 3/29 (10%) 3/29 (10%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | 438 626 674 458 (I) | 459 (I) 459 (I) 736 (T) 736 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N P=0.622 P=0.554N P=0.379N | P=0.414N P=0.240 P=0.580 P=0.520N |
|INCIDENTAL TUMOR | P=0.207N P=0.485N P=0.394N P=0.282N | P=0.407N P=0.258 P=0.618 P=0.520N |
|LOGISTIC REGRESSION | P=0.225N P=0.510N P=0.451N P=0.285N | P=0.370N P=0.288 P=0.628 P=0.471N |
|COCHRAN-ARMITAGE | P=0.225N | P=0.335N |
|FISHER EXACT | P=0.470N P=0.470N P=0.292N | P=0.289 P=0.648N P=0.461N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 25
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/119 (1%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 1.5% 5.9% 0.0% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 1/66 (2%) 1/29 (3%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 736 (T) 689 --- 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.546 P=0.234 P=0.664N P=0.584 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.611N P=0.244 P=0.664N P=0.763 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.583 P=0.248 P=0.664N P=0.608 |
|COCHRAN-ARMITAGE | (e) | P=0.582 |
|FISHER EXACT | (e) (e) (e) | P=0.260 P=0.665N P=0.559 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/120 (7%) 3/60 (5%) 3/60 (5%) 2/60 (3%) | 7/119 (6%) 7/60 (12%) 3/60 (5%) 3/60 (5%) |
|ADJUSTED (b) | 11.3% 12.8% 9.7% 5.2% | 8.7% 19.9% 10.3% 8.5% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 1/10 (10%) | 1/20 (5%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 5/61 (8%) 2/20 (10%) 1/22 (5%) 0/22 (0%) | 3/66 (5%) 4/29 (14%) 3/29 (10%) 2/29 (7%) |
|FIRST INCIDENCE (DAYS) | 438 626 674 458 (I) | 459 (I) 459 (I) 736 (T) 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.312N P=0.622 P=0.554N P=0.379N | P=0.462N P=0.103 P=0.615N P=0.616N |
|INCIDENTAL TUMOR | P=0.207N P=0.485N P=0.394N P=0.282N | P=0.406N P=0.113 P=0.577N P=0.525N |
|LOGISTIC REGRESSION | P=0.225N P=0.510N P=0.451N P=0.285N | P=0.404N P=0.133 P=0.567N P=0.552N |
|COCHRAN-ARMITAGE | P=0.225N | P=0.373N |
|FISHER EXACT | P=0.470N P=0.470N P=0.292N | P=0.144 P=0.554N P=0.554N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 26
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) | 1/119 (1%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 7.6% | 1.5% 6.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 1/22 (5%) | 1/66 (2%) 1/29 (3%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- --- 698 | 736 (T) 701 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.019 * (e) (e) P=0.075 | P=0.356N P=0.233 P=0.664N P=0.664N |
|INCIDENTAL TUMOR | P=0.035 * (e) (e) P=0.151 | P=0.351N P=0.244 P=0.664N P=0.664N |
|LOGISTIC REGRESSION | P=0.023 * (e) (e) P=0.094 | P=0.350N P=0.245 P=0.664N P=0.664N |
|COCHRAN-ARMITAGE | P=0.023 * | P=0.319N |
|FISHER EXACT | (e) (e) P=0.110 | P=0.260 P=0.665N P=0.665N |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 1/60 (2%) 0/60 (0%) 3/60 (5%) | 2/119 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 4.2% 0.0% 11.6% | 2.4% 6.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 1/22 (5%) | 1/66 (2%) 1/29 (3%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- 708 --- 698 | 459 (I) 701 --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.010 * P=0.296 (e) P=0.016 * | P=0.215N P=0.395 P=0.417N P=0.417N |
|INCIDENTAL TUMOR | P=0.048 * P=0.412 (e) P=0.083 | P=0.210N P=0.405 P=0.417N P=0.417N |
|LOGISTIC REGRESSION | P=0.015 * P=0.320 (e) P=0.026 * | P=0.190N P=0.432 P=0.397N P=0.392N |
|COCHRAN-ARMITAGE | P=0.016 * | P=0.189N |
|FISHER EXACT | P=0.333 (e) P=0.036 * | P=0.411 P=0.441N P=0.441N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 27
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Tongue |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) | 3/120 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 3.1% 0.0% | 4.5% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 3/66 (5%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 697 --- | 736 (T) --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.595 (e) P=0.350 (e) | P=0.122N P=0.299N P=0.299N P=0.299N |
|INCIDENTAL TUMOR | P=0.735 (e) P=0.550 (e) | P=0.123N P=0.299N P=0.299N P=0.299N |
|LOGISTIC REGRESSION | P=0.603 (e) P=0.360 (e) | P=0.123N P=0.299N P=0.299N P=0.299N |
|COCHRAN-ARMITAGE | P=0.606 | P=0.107N |
|FISHER EXACT | (e) P=0.333 (e) | P=0.294N P=0.294N P=0.294N |
|=================================================================================================================================|
| |
|Urinary Bladder |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 1/120 (1%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 1.0% 0.0% 0.0% 5.1% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 0/61 (0%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 1/29 (3%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 512 --- --- 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.130 P=0.642N P=0.642N P=0.250 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.308 P=0.500N P=0.443N P=0.571 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.139 P=0.647N P=0.655N P=0.272 |
|COCHRAN-ARMITAGE | (e) | P=0.139 |
|FISHER EXACT | (e) (e) (e) | P=0.667N P=0.667N P=0.258 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 28
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/120 (9%) 10/60 (17%) 6/60 (10%) 7/60 (12%) |
|ADJUSTED (b) | | 14.7% 27.1% 18.0% 22.4% |
|INTERIM SACRIFICE 1 (c)| | 1/20 (5%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 7/66 (11%) 5/29 (17%) 3/29 (10%) 6/29 (21%) |
|FIRST INCIDENCE (DAYS) | | 459 (I) 247 722 487 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.324 P=0.076 P=0.454 P=0.298 |
|INCIDENTAL TUMOR | | P=0.331 P=0.079 P=0.499 P=0.363 |
|LOGISTIC REGRESSION | | P=0.377 P=0.101 P=0.484 P=0.334 |
|COCHRAN-ARMITAGE | | P=0.432 |
|FISHER EXACT | | P=0.111 P=0.526 P=0.388 |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 11/120 (9%) 11/60 (18%) 6/60 (10%) 7/60 (12%) |
|ADJUSTED (b) | | 14.7% 29.2% 18.0% 22.4% |
|INTERIM SACRIFICE 1 (c)| | 1/20 (5%) 1/10 (10%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | | 7/66 (11%) 5/29 (17%) 3/29 (10%) 6/29 (21%) |
|FIRST INCIDENCE (DAYS) | | 459 (I) 247 722 487 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.340 P=0.043 * P=0.454 P=0.298 |
|INCIDENTAL TUMOR | | P=0.347 P=0.043 * P=0.499 P=0.363 |
|LOGISTIC REGRESSION | | P=0.395 P=0.057 P=0.484 P=0.334 |
|COCHRAN-ARMITAGE | | P=0.452 |
|FISHER EXACT | | P=0.066 P=0.526 P=0.388 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 29
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 0/60 (0%) 0/60 (0%) 0/60 (0%) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 2.5% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 0/20 (0%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 339 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.222N P=0.450N P=0.437N P=0.442N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.231N P=0.502N P=0.703N P=0.401N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.195N P=0.390N P=0.434N P=0.387N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.197N | (e) |
|FISHER EXACT | P=0.443N P=0.443N P=0.443N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 46/120 (38%) 29/60 (48%) 35/60 (58%) 30/60 (50%) | 35/120 (29%) 20/60 (33%) 21/60 (35%) 19/60 (32%) |
|ADJUSTED (b) | 53.3% 72.5% 74.4% 65.5% | 39.9% 46.4% 52.0% 45.9% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 1/10 (10%) 1/10 (10%) 0/10 (0%) | 1/20 (5%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 22/61 (36%) 10/20 (50%) 11/22 (50%) 7/22 (32%) | 16/66 (24%) 8/29 (28%) 10/29 (34%) 8/29 (28%) |
|FIRST INCIDENCE (DAYS) | 422 458 (I) 400 180 | 368 405 509 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.022 * P=0.012 * P=0.004 ** P=0.034 * | P=0.206 P=0.236 P=0.171 P=0.254 |
|INCIDENTAL TUMOR | P=0.128 P=0.299 P=0.038 * P=0.289 | P=0.413 P=0.449 P=0.284 P=0.450 |
|LOGISTIC REGRESSION | P=0.057 P=0.236 P=0.030 * P=0.079 | P=0.365 P=0.380 P=0.205 P=0.437 |
|COCHRAN-ARMITAGE | P=0.044 * | P=0.370 |
|FISHER EXACT | P=0.131 P=0.009 ** P=0.091 | P=0.342 P=0.264 P=0.429 |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 30
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/120 (2%) 3/60 (5%) 3/60 (5%) 1/60 (2%) | 0/120 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |
|ADJUSTED (b) | 3.0% 10.9% 5.1% 2.4% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/20 (0%) 0/10 (0%) 3/10 (30%) 0/10 (0%) | 0/20 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|TERMINAL (d) | 1/61 (2%) 1/20 (5%) 0/22 (0%) 0/22 (0%) | 0/66 (0%) 0/29 (0%) 0/29 (0%) 0/29 (0%) |
|FIRST INCIDENCE (DAYS) | 677 607 458 (I) 634 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.532 P=0.122 P=0.190 P=0.706 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.581N P=0.242 P=0.257 P=0.676N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.555 P=0.178 P=0.177 P=0.728 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.554 | (e) |
|FISHER EXACT | P=0.207 P=0.207 P=0.742N | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |111/120 (93%) 56/60 (93%) 58/60 (97%) 56/60 (93%) | 63/120 (53%) 47/60 (78%) 43/60 (72%) 31/60 (52%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 67.1% 92.0% 93.3% 74.9% |
|INTERIM SACRIFICE 1 (c)| 18/20 (90%) 7/10 (70%) 9/10 (90%) 9/10 (90%) | 4/20 (20%) 4/10 (40%) 2/10 (20%) 0/10 (0%) |
|TERMINAL (d) | 61/61 (100%) 20/20 (100%) 22/22 (100%) 22/22 (100%)| 36/66 (55%) 25/29 (86%) 26/29 (90%) 19/29 (66%) |
|FIRST INCIDENCE (DAYS) | 422 450 458 (I) 458 (I) | 459 (I) 247 459 (I) 452 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.055 P=0.006 ** P=0.025 * P=0.043 * | P=0.228 P<0.001 ** P=0.005 ** P=0.306 |
|INCIDENTAL TUMOR | P=0.428 P=0.525 P=0.487 P=0.590 | P=0.461 P<0.001 ** P=0.005 ** P=0.532 |
|LOGISTIC REGRESSION | P=0.362 P=0.629 P=0.423 P=0.484 | P=0.372 P<0.001 ** P=0.002 ** P=0.506 |
|COCHRAN-ARMITAGE | P=0.400 | P=0.513N |
|FISHER EXACT | P=0.552 P=0.226 P=0.552 | P<0.001 ** P=0.010 * P=0.521N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 31
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 | CONTROL 0.3% 0.6% 1.2% | CONTROL 0.6% 1.2% 2.4% |
| | FEED RTD | FEED RTD |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 66/120 (55%) 36/60 (60%) 41/60 (68%) 38/60 (63%) | 51/120 (43%) 31/60 (52%) 28/60 (47%) 22/60 (37%) |
|ADJUSTED (b) | 68.7% 81.1% 79.2% 77.4% | 55.5% 66.0% 64.4% 50.2% |
|INTERIM SACRIFICE 1 (c)| 1/20 (5%) 1/10 (10%) 4/10 (40%) 0/10 (0%) | 1/20 (5%) 0/10 (0%) 1/10 (10%) 0/10 (0%) |
|TERMINAL (d) | 32/61 (52%) 12/20 (60%) 12/22 (55%) 11/22 (50%) | 27/66 (41%) 14/29 (48%) 14/29 (48%) 9/29 (31%) |
|FIRST INCIDENCE (DAYS) | 255 303 400 180 | 39 247 459 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.050 * P=0.032 * P=0.027 * P=0.060 | P=0.514N P=0.094 P=0.209 P=0.521N |
|INCIDENTAL TUMOR | P=0.279 P=0.546 P=0.109 P=0.469 | P=0.208N P=0.188 P=0.345 P=0.264N |
|LOGISTIC REGRESSION | P=0.107 P=0.248 P=0.065 P=0.170 | P=0.298N P=0.139 P=0.234 P=0.317N |
|COCHRAN-ARMITAGE | P=0.109 | P=0.247N |
|FISHER EXACT | P=0.317 P=0.059 P=0.182 | P=0.157 P=0.354 P=0.278N |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |118/120 (98%) 57/60 (95%) 59/60 (98%) 59/60 (98%) | 86/120 (72%) 52/60 (87%) 48/60 (80%) 42/60 (70%) |
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 82.5% 96.2% 94.1% 83.8% |
|INTERIM SACRIFICE 1 (c)| 18/20 (90%) 7/10 (70%) 9/10 (90%) 9/10 (90%) | 5/20 (25%) 4/10 (40%) 3/10 (30%) 0/10 (0%) |
|TERMINAL (d) | 61/61 (100%) 20/20 (100%) 22/22 (100%) 22/22 (100%)| 48/66 (73%) 27/29 (93%) 26/29 (90%) 21/29 (72%) |
|FIRST INCIDENCE (DAYS) | 255 303 400 180 | 39 247 459 (I) 404 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.077 P=0.027 * P=0.080 P=0.066 | P=0.250 P=0.019 * P=0.073 P=0.288 |
|INCIDENTAL TUMOR | P=0.522 P=0.197N P=0.737 P=0.737 | P=0.347N P=0.012 * P=0.123 P=0.403N |
|LOGISTIC REGRESSION | P=0.472 P=0.190N P=0.649N P=0.692 | P=0.454 P=0.007 ** P=0.069 P=0.567 |
|COCHRAN-ARMITAGE | P=0.520 | P=0.421N |
|FISHER EXACT | P=0.207N P=0.706N P=0.706N | P=0.018 * P=0.152 P=0.474N |
|=================================================================================================================================|
DATE: 04/03/96 EXPERIMENT: 05094 TEST: 02 PAGE 32
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- BUTYL BENZYL PHTHALATE
MALE TERMINAL SACRIFICE AT 105 WEEKS
FEMALE TERMINAL SACRIFICE AT 106 WEEKS
(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): 458
Female interim sacrifices(days): 459
(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).