TDMS Study 05704-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC RESORCINOL DATE: 09/18/94
EXPERIMENT: 05704 TEST: 03 TIME: 18:56:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: 000000570004 ROUTE: GAVAGE NTP C#: 05970B
PATHOLOGIST: F. VOELKER S. EUSTIS CAS: 000108463
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC RESORCINOL DATE: 09/18/94
EXPERIMENT: 05704 TEST: 03 TIME: 18:56:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: 000000570004 ROUTE: GAVAGE NTP C#: 05970B
PATHOLOGIST: F. VOELKER S. EUSTIS CAS: 000108463
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 Gland
Bone Marrow
Brain
Clitoral Gland
Heart
Islets, Pancreatic
Kidney
Larynx
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Spleen
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: IRDC RESORCINOL DATE: 09/18/94
EXPERIMENT: 05704 TEST: 03 TIME: 18:56:17
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: 000000570004 ROUTE: GAVAGE NTP C#: 05970B
PATHOLOGIST: F. VOELKER S. EUSTIS CAS: 000108463
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF RESORCINOL
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Adrenal Medulla Pheochromocytoma Benign
All Organs Benign Tumors
Malignant and Benign Tumors
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
====================================================================================================
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 1/56 (2%) 1/52 (2%) 6/50 (12%) 1/55 (2%) |
|ADJUSTED (b) | 3.0% 2.2% 16.6% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/33 (3%) 0/33 (0%) 2/26 (8%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 646 627 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.166 P=0.750N P=0.045 * P=0.679 |
|INCIDENTAL TUMOR | P=0.265 P=0.702N P=0.061 P=0.679 |
|LOGISTIC REGRESSION | P=0.217 P=0.753 P=0.043 * P=0.679 |
|COCHRAN-ARMITAGE | P=0.264 |
|FISHER EXACT | P=0.733 P=0.041 * P=0.748 |
|==============================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/56 (4%) 1/52 (2%) 6/50 (12%) 1/55 (2%) |
|ADJUSTED (b) | 6.1% 2.2% 16.6% 4.3% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/33 (6%) 0/33 (0%) 2/26 (8%) 1/23 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 646 627 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.298 P=0.489N P=0.100 P=0.626N |
|INCIDENTAL TUMOR | P=0.419 P=0.439N P=0.131 P=0.626N |
|LOGISTIC REGRESSION | P=0.365 P=0.504N P=0.102 P=0.626N |
|COCHRAN-ARMITAGE | P=0.430 |
|FISHER EXACT | P=0.528N P=0.101 P=0.507N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/53 (17%) 8/44 (18%) 6/47 (13%) 4/55 (7%) |
|ADJUSTED (b) | 24.2% 23.7% 19.9% 15.3% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 6/33 (18%) 7/32 (22%) 4/26 (15%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 663 662 689 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.206N P=0.570N P=0.466N P=0.270N |
|INCIDENTAL TUMOR | P=0.151N P=0.545N P=0.400N P=0.204N |
|LOGISTIC REGRESSION | P=0.136N P=0.599N P=0.402N P=0.192N |
|COCHRAN-ARMITAGE | P=0.061N |
|FISHER EXACT | P=0.543 P=0.381N P=0.104N |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 0/53 (0%) 0/44 (0%) 3/47 (6%) 0/55 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 8.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/33 (0%) 0/32 (0%) 1/26 (4%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 623 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.240 (e) P=0.107 (e) |
|INCIDENTAL TUMOR | P=0.357 (e) P=0.131 (e) |
|LOGISTIC REGRESSION | P=0.299 (e) P=0.100 (e) |
|COCHRAN-ARMITAGE | P=0.319 |
|FISHER EXACT | (e) P=0.100 (e) |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 9/53 (17%) 8/44 (18%) 9/47 (19%) 4/55 (7%) |
|ADJUSTED (b) | 24.2% 23.7% 27.2% 15.3% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 6/33 (18%) 7/32 (22%) 5/26 (19%) 3/24 (13%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 663 623 689 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.324N P=0.570N P=0.417 P=0.270N |
|INCIDENTAL TUMOR | P=0.223N P=0.545N P=0.496 P=0.204N |
|LOGISTIC REGRESSION | P=0.219N P=0.599N P=0.468 P=0.192N |
|COCHRAN-ARMITAGE | P=0.109N |
|FISHER EXACT | P=0.543 P=0.490 P=0.104N |
|==============================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/58 (2%) 2/53 (4%) 1/55 (2%) 3/57 (5%) |
|ADJUSTED (b) | 2.9% 5.9% 3.6% 9.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/34 (3%) 1/33 (3%) 1/28 (4%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 716 729 (T) 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.158 P=0.486 P=0.718 P=0.217 |
|INCIDENTAL TUMOR | P=0.209 P=0.549 P=0.718 P=0.272 |
|LOGISTIC REGRESSION | P=0.183 P=0.494 P=0.718 P=0.242 |
|COCHRAN-ARMITAGE | P=0.247 |
|FISHER EXACT | P=0.466 P=0.739 P=0.303 |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/58 (3%) 2/53 (4%) 1/55 (2%) 3/57 (5%) |
|ADJUSTED (b) | 5.9% 5.9% 3.6% 9.7% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/34 (6%) 1/33 (3%) 1/28 (4%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 716 729 (T) 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.308 P=0.680 P=0.568N P=0.372 |
|INCIDENTAL TUMOR | P=0.376 P=0.659N P=0.568N P=0.433 |
|LOGISTIC REGRESSION | P=0.346 P=0.687 P=0.568N P=0.409 |
|COCHRAN-ARMITAGE | P=0.435 |
|FISHER EXACT | P=0.656 P=0.520N P=0.492 |
|==============================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 26/58 (45%) 14/53 (26%) 12/55 (22%) 9/57 (16%) |
|ADJUSTED (b) | 59.8% 40.8% 38.1% 33.1% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 17/34 (50%) 13/33 (39%) 9/28 (32%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 673 662 694 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.008N** P=0.026N* P=0.033N* P=0.020N* |
|INCIDENTAL TUMOR | P=0.002N** P=0.034N* P=0.007N** P=0.003N** |
|LOGISTIC REGRESSION | P=0.002N** P=0.015N* P=0.007N** P=0.004N** |
|COCHRAN-ARMITAGE | P<0.001N** |
|FISHER EXACT | P=0.034N* P=0.008N** P<0.001N** |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 26/58 (45%) 14/53 (26%) 12/55 (22%) 10/57 (18%) |
|ADJUSTED (b) | 59.8% 40.8% 38.1% 35.2% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 17/34 (50%) 13/33 (39%) 9/28 (32%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 673 662 689 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.015N* P=0.026N* P=0.033N* P=0.036N* |
|INCIDENTAL TUMOR | P=0.003N** P=0.034N* P=0.007N** P=0.006N** |
|LOGISTIC REGRESSION | P=0.003N** P=0.015N* P=0.007N** P=0.008N** |
|COCHRAN-ARMITAGE | P<0.001N** |
|FISHER EXACT | P=0.034N* P=0.008N** P=0.001N** |
|==============================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 27/58 (47%) 16/53 (30%) 13/55 (24%) 11/57 (19%) |
|ADJUSTED (b) | 62.1% 45.4% 41.3% 36.9% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 18/34 (53%) 14/33 (42%) 10/28 (36%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 673 662 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.019N* P=0.044N* P=0.037N* P=0.043N* |
|INCIDENTAL TUMOR | P=0.004N** P=0.051N P=0.008N** P=0.007N** |
|LOGISTIC REGRESSION | P=0.004N** P=0.024N* P=0.008N** P=0.009N** |
|COCHRAN-ARMITAGE | P<0.001N** |
|FISHER EXACT | P=0.058N P=0.009N** P=0.002N** |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 28/57 (49%) 27/53 (51%) 21/55 (38%) 24/57 (42%) |
|ADJUSTED (b) | 67.2% 62.3% 54.2% 70.9% |
|INTERIM SACRIFICE 1 (c)| 3/8 (38%) 1/3 (33%) 2/5 (40%) 1/7 (14%) |
|TERMINAL (d) | 20/33 (61%) 17/33 (52%) 12/28 (43%) 15/24 (63%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 323 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.402 P=0.509 P=0.382N P=0.333 |
|INCIDENTAL TUMOR | P=0.340N P=0.414N P=0.199N P=0.539N |
|LOGISTIC REGRESSION | P=0.306N P=0.567N P=0.163N P=0.543N |
|COCHRAN-ARMITAGE | P=0.143N |
|FISHER EXACT | P=0.500 P=0.164N P=0.286N |
|==============================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 29/57 (51%) 27/53 (51%) 22/55 (40%) 24/57 (42%) |
|ADJUSTED (b) | 67.9% 62.3% 55.4% 70.9% |
|INTERIM SACRIFICE 1 (c)| 3/8 (38%) 1/3 (33%) 2/5 (40%) 1/7 (14%) |
|TERMINAL (d) | 20/33 (61%) 17/33 (52%) 12/28 (43%) 15/24 (63%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 323 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.439 P=0.561N P=0.389N P=0.397 |
|INCIDENTAL TUMOR | P=0.282N P=0.354N P=0.181N P=0.438N |
|LOGISTIC REGRESSION | P=0.259N P=0.505N P=0.166N P=0.455N |
|COCHRAN-ARMITAGE | P=0.118N |
|FISHER EXACT | P=0.573 P=0.167N P=0.226N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 2/58 (3%) 1/53 (2%) 2/55 (4%) 0/57 (0%) |
|ADJUSTED (b) | 5.9% 2.3% 5.4% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 1/5 (20%) 0/7 (0%) |
|TERMINAL (d) | 2/34 (6%) 0/33 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 663 457 (I) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.283N P=0.496N P=0.597 P=0.318N |
|INCIDENTAL TUMOR | P=0.265N P=0.451N P=0.597 P=0.318N |
|LOGISTIC REGRESSION | P=0.219N P=0.508N P=0.676 P=0.318N |
|COCHRAN-ARMITAGE | P=0.213N |
|FISHER EXACT | P=0.534N P=0.671 P=0.252N |
|==============================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 1/58 (2%) 1/53 (2%) 2/55 (4%) 0/57 (0%) |
|ADJUSTED (b) | 2.9% 2.4% 6.3% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/34 (3%) 0/33 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 674 678 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.498N P=0.760 P=0.440 P=0.569N |
|INCIDENTAL TUMOR | P=0.452N P=0.711N P=0.502 P=0.569N |
|LOGISTIC REGRESSION | P=0.469N P=0.755 P=0.471 P=0.569N |
|COCHRAN-ARMITAGE | P=0.413N |
|FISHER EXACT | P=0.729 P=0.480 P=0.504N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 3/52 (6%) 4/55 (7%) 4/56 (7%) |
|ADJUSTED (b) | 5.6% 8.4% 14.3% 13.9% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 1/7 (14%) |
|TERMINAL (d) | 1/34 (3%) 2/33 (6%) 4/28 (14%) 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 717 674 729 (T) 457 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.113 P=0.486 P=0.249 P=0.211 |
|INCIDENTAL TUMOR | P=0.135 P=0.565 P=0.294 P=0.269 |
|LOGISTIC REGRESSION | P=0.144 P=0.491 P=0.263 P=0.261 |
|COCHRAN-ARMITAGE | P=0.218 |
|FISHER EXACT | P=0.448 P=0.314 P=0.323 |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 1/52 (2%) 0/55 (0%) 1/56 (2%) |
|ADJUSTED (b) | 5.6% 3.0% 0.0% 4.2% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/34 (3%) 1/33 (3%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE (DAYS) | 717 729 (T) --- 729 (T) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.342N P=0.517N P=0.290N P=0.626N |
|INCIDENTAL TUMOR | P=0.305N P=0.460N P=0.215N P=0.567N |
|LOGISTIC REGRESSION | P=0.324N P=0.508N P=0.264N P=0.605N |
|COCHRAN-ARMITAGE | P=0.256N |
|FISHER EXACT | P=0.541N P=0.261N P=0.513N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 3/58 (5%) 4/52 (8%) 4/55 (7%) 4/56 (7%) |
|ADJUSTED (b) | 8.5% 11.3% 14.3% 13.9% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 1/7 (14%) |
|TERMINAL (d) | 2/34 (6%) 3/33 (9%) 4/28 (14%) 2/24 (8%) |
|FIRST INCIDENCE (DAYS) | 717 674 729 (T) 457 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.234 P=0.484 P=0.390 P=0.335 |
|INCIDENTAL TUMOR | P=0.268 P=0.551 P=0.440 P=0.401 |
|LOGISTIC REGRESSION | P=0.285 P=0.492 P=0.409 P=0.397 |
|COCHRAN-ARMITAGE | P=0.397 |
|FISHER EXACT | P=0.439 P=0.470 P=0.480 |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 0/52 (0%) 1/55 (2%) 1/56 (2%) |
|ADJUSTED (b) | 5.6% 0.0% 3.6% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/34 (3%) 0/33 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 717 --- 729 (T) 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.514N P=0.253N P=0.574N P=0.616N |
|INCIDENTAL TUMOR | P=0.448N P=0.199N P=0.498N P=0.513N |
|LOGISTIC REGRESSION | P=0.485N P=0.241N P=0.549N P=0.588N |
|COCHRAN-ARMITAGE | P=0.417N |
|FISHER EXACT | P=0.276N P=0.520N P=0.513N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 2/58 (3%) 0/52 (0%) 1/55 (2%) 0/56 (0%) |
|ADJUSTED (b) | 5.1% 0.0% 3.6% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 1/34 (3%) 0/33 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 629 --- 729 (T) --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.199N P=0.236N P=0.553N P=0.308N |
|INCIDENTAL TUMOR | P=0.171N P=0.399N P=0.524N P=0.278N |
|LOGISTIC REGRESSION | P=0.175N P=0.259N P=0.522N P=0.275N |
|COCHRAN-ARMITAGE | P=0.155N |
|FISHER EXACT | P=0.276N P=0.520N P=0.257N |
|==============================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | |
|----------- | |
|OVERALL (a) | 4/58 (7%) 0/52 (0%) 2/55 (4%) 1/56 (2%) |
|ADJUSTED (b) | 10.6% 0.0% 7.1% 3.3% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 2/34 (6%) 0/33 (0%) 2/28 (7%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | 629 --- 729 (T) 690 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.242N P=0.069N P=0.425N P=0.293N |
|INCIDENTAL TUMOR | P=0.179N P=0.090N P=0.353N P=0.209N |
|LOGISTIC REGRESSION | P=0.204N P=0.069N P=0.373N P=0.251N |
|COCHRAN-ARMITAGE | P=0.158N |
|FISHER EXACT | P=0.073N P=0.365N P=0.193N |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 9/58 (16%) 11/53 (21%) 10/55 (18%) 8/57 (14%) |
|ADJUSTED (b) | 22.6% 28.7% 30.5% 29.5% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 2/3 (67%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 6/34 (18%) 8/33 (24%) 7/28 (25%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 601 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.360 P=0.264 P=0.345 P=0.441 |
|INCIDENTAL TUMOR | P=0.498 P=0.144 P=0.413 P=0.521 |
|LOGISTIC REGRESSION | P=0.524N P=0.313 P=0.447 P=0.549 |
|COCHRAN-ARMITAGE | P=0.412N |
|FISHER EXACT | P=0.319 P=0.449 P=0.516N |
|==============================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 9/58 (16%) 11/53 (21%) 10/55 (18%) 9/57 (16%) |
|ADJUSTED (b) | 22.6% 28.7% 30.5% 31.0% |
|INTERIM SACRIFICE 1 (c)| 1/8 (13%) 2/3 (67%) 0/5 (0%) 1/7 (14%) |
|TERMINAL (d) | 6/34 (18%) 8/33 (24%) 7/28 (25%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 457 (I) |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.276 P=0.264 P=0.345 P=0.338 |
|INCIDENTAL TUMOR | P=0.403 P=0.144 P=0.413 P=0.410 |
|LOGISTIC REGRESSION | P=0.464 P=0.313 P=0.447 P=0.466 |
|COCHRAN-ARMITAGE | P=0.505N |
|FISHER EXACT | P=0.319 P=0.449 P=0.585 |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 0/58 (0%) 0/53 (0%) 2/55 (4%) 0/57 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 5.2% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 0/34 (0%) 0/33 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 637 --- |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.327 (e) P=0.223 (e) |
|INCIDENTAL TUMOR | P=0.436 (e) P=0.306 (e) |
|LOGISTIC REGRESSION | P=0.369 (e) P=0.226 (e) |
|COCHRAN-ARMITAGE | P=0.376 |
|FISHER EXACT | (e) P=0.235 (e) |
|==============================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 14/58 (24%) 16/53 (30%) 11/55 (20%) 15/57 (26%) |
|ADJUSTED (b) | 34.9% 38.5% 28.8% 41.5% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 0/7 (0%) |
|TERMINAL (d) | 9/34 (26%) 9/33 (27%) 3/28 (11%) 5/24 (21%) |
|FIRST INCIDENCE (DAYS) | 509 472 579 303 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.248 P=0.400 P=0.490N P=0.202 |
|INCIDENTAL TUMOR | P=0.456N P=0.404 P=0.236N P=0.493 |
|LOGISTIC REGRESSION | P=0.442 P=0.348 P=0.285N P=0.339 |
|COCHRAN-ARMITAGE | P=0.480N |
|FISHER EXACT | P=0.307 P=0.382N P=0.478 |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 47/58 (81%) 44/53 (83%) 39/55 (71%) 36/57 (63%) |
|ADJUSTED (b) | 93.9% 91.5% 90.2% 91.9% |
|INTERIM SACRIFICE 1 (c)| 4/8 (50%) 3/3 (100%) 3/5 (60%) 3/7 (43%) |
|TERMINAL (d) | 31/34 (91%) 29/33 (88%) 24/28 (86%) 21/24 (88%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 323 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.451 P=0.495 P=0.566 P=0.468 |
|INCIDENTAL TUMOR | P=0.098N P=0.525 P=0.187N P=0.186N |
|LOGISTIC REGRESSION | P=0.076N P=0.590 P=0.136N P=0.205N |
|COCHRAN-ARMITAGE | P=0.007N** |
|FISHER EXACT | P=0.491 P=0.149N P=0.026N* |
|==============================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 20/58 (34%) 21/53 (40%) 21/55 (38%) 21/57 (37%) |
|ADJUSTED (b) | 46.7% 48.1% 48.4% 51.9% |
|INTERIM SACRIFICE 1 (c)| 0/8 (0%) 0/3 (0%) 0/5 (0%) 1/7 (14%) |
|TERMINAL (d) | 12/34 (35%) 11/33 (33%) 7/28 (25%) 6/24 (25%) |
|FIRST INCIDENCE (DAYS) | 509 472 463 303 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.121 P=0.470 P=0.313 P=0.164 |
|INCIDENTAL TUMOR | P=0.492 P=0.493 P=0.531N P=0.488 |
|LOGISTIC REGRESSION | P=0.234 P=0.456 P=0.531 P=0.318 |
|COCHRAN-ARMITAGE | P=0.442 |
|FISHER EXACT | P=0.358 P=0.416 P=0.472 |
|==============================================================================|
DATE: 09/18/94 EXPERIMENT: 05704 TEST: 03 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN FEMALE RATS(FISCHER344) -- RESORCINOL
TERMINAL SACRIFICE AT 105 WEEKS
|==============================================================================|
|DOSE | VEHICLE/ 50 MG/KG 100 MG/K 150 MG/K |
| | CONTROL G G |
|==============================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |
|----------- | |
|OVERALL (a) | 53/58 (91%) 49/53 (92%) 47/55 (85%) 46/57 (81%) |
|ADJUSTED (b) | 98.1% 94.2% 92.1% 95.8% |
|INTERIM SACRIFICE 1 (c)| 4/8 (50%) 3/3 (100%) 3/5 (60%) 4/7 (57%) |
|TERMINAL (d) | 33/34 (97%) 30/33 (91%) 24/28 (86%) 22/24 (92%) |
|FIRST INCIDENCE (DAYS) | 457 (I) 457 (I) 430 303 |
|-----------------------| |
|STATISTICAL TESTS (f) | |
|-----------------------| |
|LIFE TABLE | P=0.134 P=0.555 P=0.396 P=0.167 |
|INCIDENTAL TUMOR | P=0.150N P=0.640 P=0.131N P=0.304N |
|LOGISTIC REGRESSION | P=0.251N P=0.610 P=0.231N P=0.572N |
|COCHRAN-ARMITAGE | P=0.030N* |
|FISHER EXACT | P=0.557 P=0.245N P=0.082N |
|==============================================================================|
(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):
Female interim sacrifices(days): 457
(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).