TR 393 Rat Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94
EXPERIMENT: 05131 TEST: 01 TIME: 04:23:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 7681-49-4
------------------------------------------------------------------------------------------------------------------------------------
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94
EXPERIMENT: 05131 TEST: 01 TIME: 04:23:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 7681-49-4
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
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: Battelle Columbus SODIUM FLUORIDE DATE: 09/17/94
EXPERIMENT: 05131 TEST: 01 TIME: 04:23:52
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55102 ROUTE: DOSED WATER NTP C#: 55221B
PATHOLOGIST: R. PERSING S. EUSTIS CAS: 7681-49-4
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF THE STUDY OF SODIUM FLUORIDE
====================================================================================================
MALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Bone Osteosarcoma
Skin: Subcutaneous Tissue Fibroma
Neurofibroma or Fibroma
Neurofibrosarcoma, Fibrosarcoma, Sarcoma,
Neurofibroma, or Fibroma
Testes Adenoma
Thyroid Gland: Follicular Cell
Adenoma
Carcinoma or Adenoma
All Organs Histiocytic Sarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear,
or Undifferentiated
Malignant Lymphoma And Histiocytic Sarcoma
Osteosarcoma
Osteosarcoma or Osteoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
====================================================================================================
FEMALE RATS
-------------
ORGAN MORPHOLOGY
------- ------------
Clitoral/Preputial Gland Adenoma
Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip)
Squamous Cell Carcinoma
Skin Keratoacanthoma
Thyroid Gland: C-Cell Adenoma
Carcinoma or Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Malignant and Benign Tumors
====================================================================================================
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 1
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/143 (22%) 21/70 (30%) 15/70 (21%) 30/100 (30%)| 6/132 (5%) 2/69 (3%) 1/70 (1%) 5/100 (5%) |
|ADJUSTED (b) | 52.7% 56.3% 46.2% 56.7% | 9.5% 5.5% 2.9% 8.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/9 (11%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 16/41 (39%) 10/25 (40%) 7/23 (30%) 20/42 (48%) | 3/59 (5%) 1/31 (3%) 1/34 (3%) 3/54 (6%) |
|FIRST INCIDENCE (DAYS) | 537 459 (I) 460 (I) 645 | 683 677 729 (T) 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.395N P=0.387 P=0.350N P=0.533N | P=0.491N P=0.407N P=0.208N P=0.553N |
|INCIDENTAL TUMOR | P=0.356 P=0.208 P=0.495N P=0.286 | P=0.555N P=0.423N P=0.211N P=0.612 |
|LOGISTIC REGRESSION | P=0.354 P=0.213 P=0.478N P=0.289 | P=0.451 P=0.421N P=0.217N P=0.601N |
|COCHRAN-ARMITAGE | P=0.200 | P=0.503 |
|FISHER EXACT | P=0.149 P=0.512N P=0.117 | P=0.441N P=0.235N P=0.554 |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/143 (1%) 0/70 (0%) 1/70 (1%) 0/100 (0%) | 0/132 (0%) 0/69 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 4.9% 0.0% 4.3% 0.0% | 0.0% 0.0% 2.8% 1.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/41 (5%) 0/25 (0%) 1/23 (4%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | --- --- 716 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.222N P=0.353N P=0.697N P=0.233N | P=0.214 (e) P=0.388 P=0.487 |
|INCIDENTAL TUMOR | P=0.222N P=0.353N P=0.697N P=0.233N | P=0.162 (e) P=0.371 P=0.433 |
|LOGISTIC REGRESSION | P=0.222N P=0.353N P=0.697N P=0.233N | P=0.197 (e) P=0.375 P=0.473 |
|COCHRAN-ARMITAGE | P=0.293N | P=0.174 |
|FISHER EXACT | P=0.450N P=0.699 P=0.345N | (e) P=0.347 P=0.431 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 2
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 33/143 (23%) 21/70 (30%) 16/70 (23%) 30/100 (30%)| 6/132 (5%) 2/69 (3%) 2/70 (3%) 6/100 (6%) |
|ADJUSTED (b) | 53.5% 56.3% 49.5% 56.7% | 9.5% 5.5% 5.6% 10.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/9 (11%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 16/41 (39%) 10/25 (40%) 8/23 (35%) 20/42 (48%) | 3/59 (5%) 1/31 (3%) 1/34 (3%) 3/54 (6%) |
|FIRST INCIDENCE (DAYS) | 537 459 (I) 460 (I) 645 | 683 677 716 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.365N P=0.434 P=0.387N P=0.478N | P=0.446 P=0.407N P=0.387N P=0.562 |
|INCIDENTAL TUMOR | P=0.385 P=0.247 P=0.545N P=0.332 | P=0.362 P=0.423N P=0.398N P=0.468 |
|LOGISTIC REGRESSION | P=0.384 P=0.252 P=0.527N P=0.342 | P=0.263 P=0.421N P=0.407N P=0.436 |
|COCHRAN-ARMITAGE | P=0.218 | P=0.322 |
|FISHER EXACT | P=0.178 P=0.559N P=0.144 | P=0.441N P=0.434N P=0.418 |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 1/70 (1%) 3/100 (3%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 5.2% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 1/23 (4%) 1/42 (2%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 388 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.025 * (e) P=0.380 P=0.095 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.014 * (e) P=0.380 P=0.049 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.016 * (e) P=0.380 P=0.067 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.015 * | (e) |
|FISHER EXACT | (e) P=0.327 P=0.068 | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 3
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Brain |
| Oligodendroglioma, Glioma, or Astrocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) | 1/132 (1%) 0/70 (0%) 2/70 (3%) 2/100 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.8% 0.0% 4.6% 3.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | 376 --- 568 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.189 P=0.636N P=0.291 P=0.428 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.076 P=0.923N P=0.065 P=0.246 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.159 P=0.583N P=0.298 P=0.399 |
|COCHRAN-ARMITAGE | (e) | P=0.161 |
|FISHER EXACT | (e) (e) (e) | P=0.653N P=0.276 P=0.397 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/144 (6%) 5/70 (7%) 3/67 (4%) 5/100 (5%) | 10/130 (8%) 1/68 (1%) 6/69 (9%) 12/98 (12%) |
|ADJUSTED (b) | 16.2% 16.1% 9.0% 9.4% | 16.9% 2.1% 15.9% 21.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/9 (11%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/42 (10%) 3/25 (12%) 1/23 (4%) 2/42 (5%) | 9/58 (16%) 0/31 (0%) 4/33 (12%) 10/53 (19%) |
|FIRST INCIDENCE (DAYS) | 614 460 (I) 603 460 (I) | 719 618 575 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.166N P=0.556N P=0.352N P=0.247N | P=0.096 P=0.063N P=0.557 P=0.316 |
|INCIDENTAL TUMOR | P=0.258N P=0.586 P=0.439N P=0.384N | P=0.069 P=0.071N P=0.529 P=0.276 |
|LOGISTIC REGRESSION | P=0.272N P=0.556 P=0.412N P=0.383N | P=0.068 P=0.060N P=0.511 P=0.276 |
|COCHRAN-ARMITAGE | P=0.313N | P=0.043 * |
|FISHER EXACT | P=0.506 P=0.436N P=0.453N | P=0.061N P=0.501 P=0.177 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 4
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/144 (1%) 3/70 (4%) 1/67 (1%) 4/100 (4%) | 1/130 (1%) 2/68 (3%) 0/69 (0%) 1/98 (1%) |
|ADJUSTED (b) | 2.3% 8.4% 4.0% 7.7% | 1.7% 5.7% 0.0% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 2/42 (5%) | 1/58 (2%) 1/31 (3%) 0/33 (0%) 1/53 (2%) |
|FIRST INCIDENCE (DAYS) | 537 638 718 607 | 729 (T) 702 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.336 P=0.251 P=0.727 P=0.274 | P=0.384N P=0.301 P=0.612N P=0.741 |
|INCIDENTAL TUMOR | P=0.196 P=0.123 P=0.576 P=0.151 | P=0.406N P=0.293 P=0.612N P=0.741 |
|LOGISTIC REGRESSION | P=0.267 P=0.206 P=0.711 P=0.206 | P=0.397N P=0.292 P=0.612N P=0.741 |
|COCHRAN-ARMITAGE | P=0.245 | P=0.446N |
|FISHER EXACT | P=0.198 P=0.684 P=0.190 | P=0.272 P=0.653N P=0.676 |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/144 (8%) 8/70 (11%) 4/67 (6%) 9/100 (9%) | 11/130 (8%) 3/68 (4%) 6/69 (9%) 13/98 (13%) |
|ADJUSTED (b) | 18.1% 23.5% 12.7% 16.6% | 18.6% 7.7% 15.9% 23.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 1/9 (11%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/42 (10%) 4/25 (16%) 1/23 (4%) 4/42 (10%) | 10/58 (17%) 1/31 (3%) 4/33 (12%) 11/53 (21%) |
|FIRST INCIDENCE (DAYS) | 537 460 (I) 603 460 (I) | 719 618 575 578 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.318N P=0.410 P=0.369N P=0.494N | P=0.152 P=0.206N P=0.581N P=0.314 |
|INCIDENTAL TUMOR | P=0.518N P=0.256 P=0.532N P=0.467 | P=0.111 P=0.228N P=0.606 P=0.276 |
|LOGISTIC REGRESSION | P=0.478N P=0.278 P=0.437N P=0.508 | P=0.110 P=0.202N P=0.587 P=0.277 |
|COCHRAN-ARMITAGE | P=0.533N | P=0.071 |
|FISHER EXACT | P=0.251 P=0.452N P=0.438 | P=0.227N P=0.574 P=0.170 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 5
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Ear |
| Fibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 1/70 (1%) 0/100 (0%) | 2/132 (2%) 0/70 (0%) 0/70 (0%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 2.4% 0.0% | 3.0% 0.0% 0.0% 1.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 1/59 (2%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 607 --- | 647 --- --- 647 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.547 (e) P=0.357 (e) | P=0.459N P=0.384N P=0.370N P=0.542N |
|INCIDENTAL TUMOR | P=0.457 (e) P=0.322 (e) | P=0.498N P=0.379N P=0.378N P=0.588N |
|LOGISTIC REGRESSION | P=0.534 (e) P=0.354 (e) | P=0.490N P=0.391N P=0.391N P=0.582N |
|COCHRAN-ARMITAGE | P=0.532 | P=0.503N |
|FISHER EXACT | (e) P=0.327 (e) | P=0.426N P=0.426N P=0.603N |
|=================================================================================================================================|
| |
|Ear |
| Neurofibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 2/144 (1%) 0/70 (0%) 0/70 (0%) 0/100 (0%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 4.2% 0.0% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 710 --- --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.135N P=0.365N P=0.379N P=0.251N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.154N P=0.373N P=0.405N P=0.287N | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.144N P=0.371N P=0.388N P=0.270N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.166N | (e) |
|FISHER EXACT | P=0.452N P=0.452N P=0.347N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 6
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/143 (2%) 0/68 (0%) 3/70 (4%) 4/100 (4%) | 3/132 (2%) 1/70 (1%) 1/70 (1%) 0/99 (0%) |
|ADJUSTED (b) | 4.9% 0.0% 13.0% 8.5% | 5.1% 3.2% 2.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/25 (0%) 3/23 (13%) 3/42 (7%) | 3/59 (5%) 1/31 (3%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 627 --- 729 (T) 614 | 729 (T) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.191 P=0.239N P=0.355 P=0.454 | P=0.089N P=0.552N P=0.516N P=0.138N |
|INCIDENTAL TUMOR | P=0.145 P=0.319N P=0.334 P=0.324 | P=0.089N P=0.552N P=0.516N P=0.138N |
|LOGISTIC REGRESSION | P=0.140 P=0.274N P=0.326 P=0.361 | P=0.089N P=0.552N P=0.516N P=0.138N |
|COCHRAN-ARMITAGE | P=0.112 | P=0.120N |
|FISHER EXACT | P=0.309N P=0.309 P=0.310 | P=0.569N P=0.569N P=0.185N |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/143 (3%) 1/68 (1%) 4/70 (6%) 5/100 (5%) | 3/132 (2%) 1/70 (1%) 2/70 (3%) 0/99 (0%) |
|ADJUSTED (b) | 7.2% 4.0% 15.9% 10.4% | 5.1% 3.2% 5.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 2/42 (5%) 1/25 (4%) 3/23 (13%) 3/42 (7%) | 3/59 (5%) 1/31 (3%) 2/34 (6%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 627 729 (T) 702 614 | 729 (T) 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.233 P=0.376N P=0.294 P=0.450 | P=0.135N P=0.552N P=0.622 P=0.138N |
|INCIDENTAL TUMOR | P=0.171 P=0.458N P=0.262 P=0.317 | P=0.135N P=0.552N P=0.622 P=0.138N |
|LOGISTIC REGRESSION | P=0.170 P=0.429N P=0.260 P=0.349 | P=0.135N P=0.552N P=0.622 P=0.138N |
|COCHRAN-ARMITAGE | P=0.130 | P=0.183N |
|FISHER EXACT | P=0.482N P=0.246 P=0.288 | P=0.569N P=0.567 P=0.185N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 7
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 1/70 (1%) 1/70 (1%) 1/100 (1%) | 2/132 (2%) 0/70 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 2.4% 2.3% 4.3% 2.4% | 3.4% 0.0% 2.9% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/25 (0%) 1/23 (4%) 1/42 (2%) | 2/59 (3%) 0/31 (0%) 1/34 (3%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 647 729 (T) 729 (T) | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.585N P=0.639 P=0.622 P=0.762 | P=0.517N P=0.389N P=0.687N P=0.531N |
|INCIDENTAL TUMOR | P=0.597 P=0.627 P=0.622 P=0.762 | P=0.517N P=0.389N P=0.687N P=0.531N |
|LOGISTIC REGRESSION | P=0.573 P=0.608 P=0.622 P=0.762 | P=0.517N P=0.389N P=0.687N P=0.531N |
|COCHRAN-ARMITAGE | P=0.530 | P=0.583N |
|FISHER EXACT | P=0.548 P=0.548 P=0.653 | P=0.426N P=0.724N P=0.603N |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 1/70 (1%) 1/70 (1%) 1/100 (1%) | 2/132 (2%) 1/70 (1%) 0/70 (0%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 4.0% 1.8% 1.2% | 3.4% 3.2% 0.0% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 0/42 (0%) | 2/59 (3%) 1/31 (3%) 0/34 (0%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 460 (I) 460 (I) | 729 (T) 729 (T) --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.408 P=0.397 P=0.521 P=0.521 | P=0.319N P=0.717N P=0.366N P=0.531N |
|INCIDENTAL TUMOR | P=0.408 P=0.397 P=0.521 P=0.521 | P=0.319N P=0.717N P=0.366N P=0.531N |
|LOGISTIC REGRESSION | P=0.318 P=0.397 P=0.372 P=0.417 | P=0.319N P=0.717N P=0.366N P=0.531N |
|COCHRAN-ARMITAGE | P=0.323 | P=0.378N |
|FISHER EXACT | P=0.327 P=0.327 P=0.410 | P=0.724N P=0.426N P=0.603N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 8
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 1/70 (1%) 1/70 (1%) 1/100 (1%) | 2/132 (2%) 1/70 (1%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 4.0% 1.8% 1.2% | 3.4% 3.2% 1.7% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 0/42 (0%) | 2/59 (3%) 1/31 (3%) 0/34 (0%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 460 (I) 460 (I) | 729 (T) 729 (T) 460 (I) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.408 P=0.397 P=0.521 P=0.521 | P=0.399N P=0.717N P=0.625N P=0.531N |
|INCIDENTAL TUMOR | P=0.408 P=0.397 P=0.521 P=0.521 | P=0.399N P=0.717N P=0.625N P=0.531N |
|LOGISTIC REGRESSION | P=0.318 P=0.397 P=0.372 P=0.417 | P=0.446N P=0.717N P=0.718N P=0.531N |
|COCHRAN-ARMITAGE | P=0.323 | P=0.462N |
|FISHER EXACT | P=0.327 P=0.327 P=0.410 | P=0.724N P=0.724N P=0.603N |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) | 0/132 (0%) 2/70 (3%) 1/70 (1%) 2/100 (2%) |
|ADJUSTED (b) | 0.0% 0.0% 0.0% 0.0% | 0.0% 6.5% 2.9% 3.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 2/31 (6%) 1/34 (3%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | --- --- --- --- | --- 729 (T) 729 (T) 716 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | (e) (e) (e) (e) | P=0.316 P=0.112 P=0.390 P=0.227 |
|INCIDENTAL TUMOR | (e) (e) (e) (e) | P=0.294 P=0.112 P=0.390 P=0.194 |
|LOGISTIC REGRESSION | (e) (e) (e) (e) | P=0.308 P=0.112 P=0.390 P=0.213 |
|COCHRAN-ARMITAGE | (e) | P=0.248 |
|FISHER EXACT | (e) (e) (e) | P=0.119 P=0.347 P=0.185 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 9
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/144 (4%) 1/70 (1%) 0/70 (0%) 2/100 (2%) | 30/132 (23%) 13/70 (19%) 15/70 (21%) 24/100 (24%)|
|ADJUSTED (b) | 13.1% 4.0% 0.0% 4.5% | 42.8% 34.7% 39.9% 38.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/42 (10%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 21/59 (36%) 8/31 (26%) 12/34 (35%) 16/54 (30%) |
|FIRST INCIDENCE (DAYS) | 712 729 (T) --- 718 | 557 618 646 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.100N P=0.195N P=0.081N P=0.151N | P=0.382N P=0.309N P=0.383N P=0.358N |
|INCIDENTAL TUMOR | P=0.125N P=0.197N P=0.089N P=0.195N | P=0.502 P=0.356N P=0.457N P=0.528N |
|LOGISTIC REGRESSION | P=0.112N P=0.195N P=0.079N P=0.173N | P=0.524N P=0.304N P=0.494N P=0.482N |
|COCHRAN-ARMITAGE | P=0.172N | P=0.364 |
|FISHER EXACT | P=0.271N P=0.090N P=0.292N | P=0.309N P=0.491N P=0.470 |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/144 (4%) 1/70 (1%) 0/70 (0%) 2/100 (2%) | 30/132 (23%) 14/70 (20%) 16/70 (23%) 25/100 (25%)|
|ADJUSTED (b) | 13.1% 4.0% 0.0% 4.5% | 42.8% 37.6% 42.6% 39.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/42 (10%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 21/59 (36%) 9/31 (29%) 13/34 (38%) 17/54 (31%) |
|FIRST INCIDENCE (DAYS) | 712 729 (T) --- 718 | 557 618 646 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.100N P=0.195N P=0.081N P=0.151N | P=0.428N P=0.397N P=0.472N P=0.420N |
|INCIDENTAL TUMOR | P=0.125N P=0.197N P=0.089N P=0.195N | P=0.452 P=0.454N P=0.553N P=0.535 |
|LOGISTIC REGRESSION | P=0.112N P=0.195N P=0.079N P=0.173N | P=0.476 P=0.397N P=0.559 P=0.552N |
|COCHRAN-ARMITAGE | P=0.172N | P=0.311 |
|FISHER EXACT | P=0.271N P=0.090N P=0.292N | P=0.398N P=0.558 P=0.401 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 10
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 6/144 (4%) 1/70 (1%) 0/70 (0%) 2/100 (2%) | 30/132 (23%) 15/70 (21%) 16/70 (23%) 25/100 (25%)|
|ADJUSTED (b) | 13.1% 4.0% 0.0% 4.5% | 42.8% 40.4% 42.6% 39.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 4/42 (10%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 21/59 (36%) 10/31 (32%) 13/34 (38%) 17/54 (31%) |
|FIRST INCIDENCE (DAYS) | 712 729 (T) --- 718 | 557 618 646 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.100N P=0.195N P=0.081N P=0.151N | P=0.395N P=0.490N P=0.472N P=0.420N |
|INCIDENTAL TUMOR | P=0.125N P=0.197N P=0.089N P=0.195N | P=0.489 P=0.553N P=0.553N P=0.535 |
|LOGISTIC REGRESSION | P=0.112N P=0.195N P=0.079N P=0.173N | P=0.511 P=0.494N P=0.559 P=0.552N |
|COCHRAN-ARMITAGE | P=0.172N | P=0.339 |
|FISHER EXACT | P=0.271N P=0.090N P=0.292N | P=0.491N P=0.558 P=0.401 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Papilloma Squamous or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 1/70 (1%) 1/70 (1%) 2/100 (2%) | 0/132 (0%) 1/70 (1%) 1/70 (1%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 4.0% 3.2% 4.5% | 0.0% 3.2% 2.9% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 0/59 (0%) 1/31 (3%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 729 (T) 698 711 | --- 729 (T) 729 (T) --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.186 P=0.397 P=0.389 P=0.229 | P=0.536N P=0.372 P=0.390 (e) |
|INCIDENTAL TUMOR | P=0.149 P=0.397 P=0.337 P=0.193 | P=0.536N P=0.372 P=0.390 (e) |
|LOGISTIC REGRESSION | P=0.161 P=0.397 P=0.360 P=0.207 | P=0.536N P=0.372 P=0.390 (e) |
|COCHRAN-ARMITAGE | P=0.127 | P=0.583N |
|FISHER EXACT | P=0.327 P=0.327 P=0.167 | P=0.347 P=0.347 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 11
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 0/70 (0%) 1/70 (1%) 1/100 (1%) | 1/132 (1%) 0/70 (0%) 0/70 (0%) 3/100 (3%) |
|ADJUSTED (b) | 1.2% 0.0% 2.9% 1.5% | 1.4% 0.0% 0.0% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 634 --- 681 620 | 674 --- --- 628 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436 P=0.615N P=0.611 P=0.711 | P=0.099 P=0.613N P=0.633N P=0.259 |
|INCIDENTAL TUMOR | P=0.301 P=0.791N P=0.559 P=0.522 | P=0.048 * P=0.612N P=0.629N P=0.139 |
|LOGISTIC REGRESSION | P=0.407 P=0.642N P=0.589 P=0.684 | P=0.083 P=0.631N P=0.631N P=0.224 |
|COCHRAN-ARMITAGE | P=0.398 | P=0.077 |
|FISHER EXACT | P=0.673N P=0.548 P=0.653 | P=0.653N P=0.653N P=0.215 |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Lip) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 1/70 (1%) 2/70 (3%) 3/100 (3%) | 1/132 (1%) 1/70 (1%) 1/70 (1%) 3/100 (3%) |
|ADJUSTED (b) | 1.2% 4.0% 6.0% 5.9% | 1.4% 3.2% 2.9% 4.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 0/59 (0%) 1/31 (3%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 634 729 (T) 681 620 | 674 729 (T) 729 (T) 628 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.165 P=0.634 P=0.294 P=0.262 | P=0.185 P=0.620 P=0.619 P=0.259 |
|INCIDENTAL TUMOR | P=0.090 P=0.537 P=0.224 P=0.124 | P=0.118 P=0.621 P=0.622 P=0.139 |
|LOGISTIC REGRESSION | P=0.128 P=0.605 P=0.257 P=0.211 | P=0.157 P=0.611 P=0.611 P=0.224 |
|COCHRAN-ARMITAGE | P=0.109 | P=0.141 |
|FISHER EXACT | P=0.548 P=0.250 P=0.189 | P=0.574 P=0.574 P=0.215 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 12
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Oral Mucosa |
| Squamous Cell Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 0/70 (0%) 1/70 (1%) 1/100 (1%) | 1/132 (1%) 0/70 (0%) 0/70 (0%) 2/100 (2%) |
|ADJUSTED (b) | 1.2% 0.0% 2.9% 1.5% | 1.4% 0.0% 0.0% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 634 --- 681 620 | 674 --- --- 628 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.436 P=0.615N P=0.611 P=0.711 | P=0.244 P=0.613N P=0.633N P=0.455 |
|INCIDENTAL TUMOR | P=0.301 P=0.791N P=0.559 P=0.522 | P=0.168 P=0.612N P=0.629N P=0.339 |
|LOGISTIC REGRESSION | P=0.407 P=0.642N P=0.589 P=0.684 | P=0.221 P=0.631N P=0.631N P=0.418 |
|COCHRAN-ARMITAGE | P=0.398 | P=0.210 |
|FISHER EXACT | P=0.673N P=0.548 P=0.653 | P=0.653N P=0.653N P=0.397 |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/139 (3%) 1/70 (1%) 1/69 (1%) 1/97 (1%) | 0/131 (0%) 0/66 (0%) 1/66 (2%) 1/99 (1%) |
|ADJUSTED (b) | 9.3% 4.0% 4.3% 2.3% | 0.0% 0.0% 2.4% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 3/41 (7%) 1/25 (4%) 1/23 (4%) 0/39 (0%) | 0/58 (0%) 0/29 (0%) 0/32 (0%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | 719 729 (T) 729 (T) 726 | --- --- 662 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.154N P=0.362N P=0.398N P=0.196N | P=0.204 (e) P=0.377 P=0.486 |
|INCIDENTAL TUMOR | P=0.180N P=0.364N P=0.405N P=0.243N | P=0.192 (e) P=0.371 P=0.486 |
|LOGISTIC REGRESSION | P=0.176N P=0.368N P=0.396N P=0.219N | P=0.191 (e) P=0.358 P=0.486 |
|COCHRAN-ARMITAGE | P=0.228N | P=0.175 |
|FISHER EXACT | P=0.456N P=0.462N P=0.316N | (e) P=0.335 P=0.430 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 13
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/143 (13%) 9/69 (13%) 9/69 (13%) 15/100 (15%)| 39/132 (30%) 24/70 (34%) 22/70 (31%) 32/100 (32%)|
|ADJUSTED (b) | 32.5% 26.7% 29.8% 25.2% | 54.3% 55.0% 54.9% 48.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 0/9 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 3/10 (30%) 2/10 (20%) 1/9 (11%) |
|TERMINAL (d) | 10/42 (24%) 3/25 (12%) 4/22 (18%) 5/42 (12%) | 28/59 (47%) 13/31 (42%) 17/34 (50%) 21/54 (39%) |
|FIRST INCIDENCE (DAYS) | 417 623 404 460 (I) | 402 459 (I) 460 (I) 459 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.402N P=0.373N P=0.467N P=0.389N | P=0.254N P=0.355 P=0.523N P=0.361N |
|INCIDENTAL TUMOR | P=0.391 P=0.536N P=0.558 P=0.495 | P=0.451N P=0.236 P=0.426 P=0.539 |
|LOGISTIC REGRESSION | P=0.437 P=0.522N P=0.582 P=0.483 | P=0.471N P=0.247 P=0.409 P=0.554N |
|COCHRAN-ARMITAGE | P=0.381 | P=0.435 |
|FISHER EXACT | P=0.574N P=0.574N P=0.421 | P=0.296 P=0.451 P=0.397 |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/143 (0%) 0/69 (0%) 1/69 (1%) 0/100 (0%) | 0/132 (0%) 0/70 (0%) 2/70 (3%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.5% 0.0% | 0.0% 0.0% 5.1% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 1/22 (5%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) --- | --- --- 647 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.580 (e) P=0.371 (e) | P=0.456 (e) P=0.128 (e) |
|INCIDENTAL TUMOR | P=0.580 (e) P=0.371 (e) | P=0.432 (e) P=0.121 (e) |
|LOGISTIC REGRESSION | P=0.580 (e) P=0.371 (e) | P=0.432 (e) P=0.110 (e) |
|COCHRAN-ARMITAGE | P=0.533 | P=0.417 |
|FISHER EXACT | (e) P=0.325 (e) | (e) P=0.119 (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 14
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/143 (13%) 9/69 (13%) 9/69 (13%) 15/100 (15%)| 39/132 (30%) 24/70 (34%) 24/70 (34%) 32/100 (32%)|
|ADJUSTED (b) | 32.5% 26.7% 29.8% 25.2% | 54.3% 55.0% 58.5% 48.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 1/9 (11%) 0/9 (0%) 0/10 (0%) 2/10 (20%) | 0/10 (0%) 3/10 (30%) 2/10 (20%) 1/9 (11%) |
|TERMINAL (d) | 10/42 (24%) 3/25 (12%) 4/22 (18%) 5/42 (12%) | 28/59 (47%) 13/31 (42%) 18/34 (53%) 21/54 (39%) |
|FIRST INCIDENCE (DAYS) | 417 623 404 460 (I) | 402 459 (I) 460 (I) 459 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.402N P=0.373N P=0.467N P=0.389N | P=0.280N P=0.355 P=0.442 P=0.361N |
|INCIDENTAL TUMOR | P=0.391 P=0.536N P=0.558 P=0.495 | P=0.486N P=0.236 P=0.261 P=0.539 |
|LOGISTIC REGRESSION | P=0.437 P=0.522N P=0.582 P=0.483 | P=0.508N P=0.247 P=0.247 P=0.554N |
|COCHRAN-ARMITAGE | P=0.381 | P=0.400 |
|FISHER EXACT | P=0.574N P=0.574N P=0.421 | P=0.296 P=0.296 P=0.397 |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 11/144 (8%) 2/70 (3%) 2/70 (3%) 8/100 (8%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 3/100 (3%) |
|ADJUSTED (b) | 19.9% 8.0% 6.1% 16.8% | 0.0% 0.0% 0.0% 5.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 6/42 (14%) 2/25 (8%) 1/23 (4%) 5/42 (12%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 2/54 (4%) |
|FIRST INCIDENCE (DAYS) | 549 729 (T) 460 (I) 661 | --- --- --- 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.430N P=0.091N P=0.095N P=0.385N | P=0.022 * (e) (e) P=0.109 |
|INCIDENTAL TUMOR | P=0.522N P=0.121N P=0.112N P=0.522N | P=0.018 * (e) (e) P=0.095 |
|LOGISTIC REGRESSION | P=0.521 P=0.115N P=0.143N P=0.529N | P=0.020 * (e) (e) P=0.106 |
|COCHRAN-ARMITAGE | P=0.452 | P=0.014 * |
|FISHER EXACT | P=0.141N P=0.141N P=0.550 | (e) (e) P=0.079 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 15
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 1/70 (1%) 0/70 (0%) 2/100 (2%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 2.9% 0.0% 4.4% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 1/42 (2%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 691 --- 710 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.191 P=0.390 (e) P=0.229 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.151 P=0.373 (e) P=0.193 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.171 P=0.369 (e) P=0.206 | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.144 | (e) |
|FISHER EXACT | P=0.327 (e) P=0.167 | (e) (e) (e) |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 3/70 (4%) 1/70 (1%) 4/100 (4%) | 1/132 (1%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 2.4% 10.7% 4.3% 9.1% | 1.2% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 2/25 (8%) 1/23 (4%) 3/42 (7%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 691 729 (T) 710 | 643 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.254 P=0.144 P=0.622 P=0.176 | P=0.311N P=0.631N P=0.618N P=0.537N |
|INCIDENTAL TUMOR | P=0.228 P=0.139 P=0.622 P=0.156 | P=0.393N P=0.729N P=0.764N P=0.649N |
|LOGISTIC REGRESSION | P=0.218 P=0.131 P=0.622 P=0.151 | P=0.322N P=0.630N P=0.630N P=0.553N |
|COCHRAN-ARMITAGE | P=0.150 | P=0.324N |
|FISHER EXACT | P=0.104 P=0.548 P=0.093 | P=0.653N P=0.653N P=0.569N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 16
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 2/70 (3%) 1/70 (1%) 2/100 (2%) | 1/132 (1%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 2.4% 8.0% 4.3% 4.8% | 1.2% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 2/25 (8%) 1/23 (4%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) 729 (T) 729 (T) 729 (T) | 643 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.510 P=0.322 P=0.622 P=0.500 | P=0.311N P=0.631N P=0.618N P=0.537N |
|INCIDENTAL TUMOR | P=0.510 P=0.322 P=0.622 P=0.500 | P=0.393N P=0.729N P=0.764N P=0.649N |
|LOGISTIC REGRESSION | P=0.510 P=0.322 P=0.622 P=0.500 | P=0.322N P=0.630N P=0.630N P=0.553N |
|COCHRAN-ARMITAGE | P=0.383 | P=0.324N |
|FISHER EXACT | P=0.250 P=0.548 P=0.366 | P=0.653N P=0.653N P=0.569N |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Basal Cell Carcinoma, or Basal Cell Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 0/70 (0%) 2/70 (3%) 0/100 (0%) | 1/132 (1%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 2.4% 0.0% 8.7% 0.0% | 1.3% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/25 (0%) 2/23 (9%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 729 (T) --- 729 (T) --- | 647 --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.512N P=0.603N P=0.295 P=0.500N | P=0.307N P=0.619N P=0.614N P=0.527N |
|INCIDENTAL TUMOR | P=0.512N P=0.603N P=0.295 P=0.500N | P=0.334N P=0.612N P=0.629N P=0.567N |
|LOGISTIC REGRESSION | P=0.512N P=0.603N P=0.295 P=0.500N | P=0.322N P=0.631N P=0.631N P=0.552N |
|COCHRAN-ARMITAGE | P=0.602N | P=0.324N |
|FISHER EXACT | P=0.673N P=0.250 P=0.590N | P=0.653N P=0.653N P=0.569N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 17
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin |
| Trichoepithelioma, Kertatocanthoma, Squamous Cell Carcinoma, |
| Basal Cell Carcinoma or Adenoma, Papilloma Squamous, or Papilloma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 13/144 (9%) 5/70 (7%) 5/70 (7%) 12/100 (12%)| 2/132 (2%) 0/70 (0%) 0/70 (0%) 3/100 (3%) |
|ADJUSTED (b) | 24.4% 18.5% 18.9% 25.1% | 2.5% 0.0% 0.0% 5.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 8/42 (19%) 4/25 (16%) 4/23 (17%) 8/42 (19%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 2/54 (4%) |
|FIRST INCIDENCE (DAYS) | 549 691 460 (I) 661 | 643 --- --- 719 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.487 P=0.285N P=0.306N P=0.569N | P=0.253 P=0.385N P=0.374N P=0.450 |
|INCIDENTAL TUMOR | P=0.393 P=0.347N P=0.341N P=0.462 | P=0.192 P=0.436N P=0.467N P=0.360 |
|LOGISTIC REGRESSION | P=0.327 P=0.346N P=0.414N P=0.434 | P=0.222 P=0.391N P=0.391N P=0.405 |
|COCHRAN-ARMITAGE | P=0.235 | P=0.201 |
|FISHER EXACT | P=0.429N P=0.429N P=0.293 | P=0.426N P=0.426N P=0.371 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 2/70 (3%) 3/70 (4%) 4/100 (4%) | 0/132 (0%) 1/70 (1%) 0/70 (0%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 6.0% 10.0% 7.8% | 0.0% 2.7% 0.0% 1.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 584 668 587 | --- 709 --- 460 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.063 P=0.126 P=0.038 * P=0.055 | P=0.450 P=0.388 (e) P=0.479 |
|INCIDENTAL TUMOR | P=0.028 * P=0.065 P=0.021 * P=0.028 * | P=0.412 P=0.388 (e) P=0.479 |
|LOGISTIC REGRESSION | P=0.040 * P=0.103 P=0.031 * P=0.035 * | P=0.415 P=0.373 (e) P=0.443 |
|COCHRAN-ARMITAGE | P=0.032 * | P=0.417 |
|FISHER EXACT | P=0.106 P=0.034 * P=0.027 * | P=0.347 (e) P=0.431 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 18
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibroma or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 3/70 (4%) 4/70 (6%) 4/100 (4%) | 0/132 (0%) 1/70 (1%) 0/70 (0%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 9.9% 13.6% 7.8% | 0.0% 2.7% 0.0% 1.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) |
|TERMINAL (d) | 0/42 (0%) 2/25 (8%) 0/23 (0%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 584 668 587 | --- 709 --- 460 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.103 P=0.045 * P=0.013 * P=0.055 | P=0.450 P=0.388 (e) P=0.479 |
|INCIDENTAL TUMOR | P=0.049 * P=0.022 * P=0.005 ** P=0.028 * | P=0.412 P=0.388 (e) P=0.479 |
|LOGISTIC REGRESSION | P=0.066 P=0.033 * P=0.010 ** P=0.035 * | P=0.415 P=0.373 (e) P=0.443 |
|COCHRAN-ARMITAGE | P=0.052 | P=0.417 |
|FISHER EXACT | P=0.034 * P=0.011 * P=0.027 * | P=0.347 (e) P=0.431 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 2/70 (3%) 0/70 (0%) 0/100 (0%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 6.4% 0.0% 0.0% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 699 --- --- | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.275N P=0.130 (e) (e) | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.335N P=0.113 (e) (e) | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.292N P=0.116 (e) (e) | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.315N | (e) |
|FISHER EXACT | P=0.106 (e) (e) | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 19
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, Sarcoma, |
| Neurofibroma, or Fibroma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 5/70 (7%) 5/70 (7%) 4/100 (4%) | 0/132 (0%) 1/70 (1%) 1/70 (1%) 2/100 (2%) |
|ADJUSTED (b) | 1.4% 15.6% 15.9% 7.8% | 0.0% 2.7% 2.4% 2.8% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 1/9 (11%) |
|TERMINAL (d) | 0/42 (0%) 2/25 (8%) 0/23 (0%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 646 584 648 587 | --- 709 662 460 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.282 P=0.025 * P=0.018 * P=0.154 | P=0.173 P=0.388 P=0.377 P=0.225 |
|INCIDENTAL TUMOR | P=0.150 P=0.012 * P=0.006 ** P=0.089 | P=0.125 P=0.388 P=0.371 P=0.192 |
|LOGISTIC REGRESSION | P=0.205 P=0.015 * P=0.006 ** P=0.107 | P=0.144 P=0.373 P=0.369 P=0.178 |
|COCHRAN-ARMITAGE | P=0.170 | P=0.141 |
|FISHER EXACT | P=0.015 * P=0.015 * P=0.093 | P=0.347 P=0.347 P=0.185 |
|=================================================================================================================================|
| |
|Skin: Subcutaneous Tissue |
| Neurofibrosarcoma, Fibrosarcoma, or Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 2/70 (3%) 1/70 (1%) 0/100 (0%) | 0/132 (0%) 0/70 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 1.4% 6.4% 2.6% 0.0% | 0.0% 0.0% 2.4% 1.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 646 699 648 --- | --- --- 662 716 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.232N P=0.316 P=0.607 P=0.532N | P=0.205 (e) P=0.377 P=0.494 |
|INCIDENTAL TUMOR | P=0.302N P=0.284 P=0.569 P=0.587N | P=0.157 (e) P=0.371 P=0.433 |
|LOGISTIC REGRESSION | P=0.259N P=0.277 P=0.589 P=0.565N | P=0.185 (e) P=0.369 P=0.470 |
|COCHRAN-ARMITAGE | P=0.275N | P=0.173 |
|FISHER EXACT | P=0.250 P=0.548 P=0.590N | (e) P=0.347 P=0.431 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 20
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) |107/144 (74%) 52/70 (74%) 52/70 (74%) 77/100 (77%)| |
|ADJUSTED (b) | 100.0% 100.0% 98.1% 98.7% | |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | |
|INTERIM SACRIFICE 2 (c)| 2/9 (22%) 6/9 (67%) 6/10 (60%) 4/10 (40%) | |
|TERMINAL (d) | 42/42 (100%) 25/25 (100%) 22/23 (96%) 41/42 (98%) | |
|FIRST INCIDENCE (DAYS) | 414 459 (I) 459 (I) 459 (I) | |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.030N* P=0.088N P=0.211N P=0.022N* | |
|INCIDENTAL TUMOR | P=0.507 P=0.513 P=0.297 P=0.489 | |
|LOGISTIC REGRESSION | P=0.405 P=0.503 P=0.197 P=0.586 | |
|COCHRAN-ARMITAGE | P=0.342 | |
|FISHER EXACT | P=0.561N P=0.561N P=0.373 | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/144 (15%) 10/70 (14%) 10/70 (14%) 13/100 (13%)| 20/132 (15%) 4/70 (6%) 7/70 (10%) 13/100 (13%)|
|ADJUSTED (b) | 35.0% 33.1% 28.9% 23.7% | 28.0% 9.9% 17.4% 22.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 9/42 (21%) 6/25 (24%) 3/23 (13%) 6/42 (14%) | 11/59 (19%) 2/31 (6%) 3/34 (9%) 11/54 (20%) |
|FIRST INCIDENCE (DAYS) | 571 669 459 (I) 459 (I) | 515 459 (I) 646 714 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.159N P=0.366N P=0.438N P=0.159N | P=0.314N P=0.040N* P=0.181N P=0.207N |
|INCIDENTAL TUMOR | P=0.318N P=0.474N P=0.548N P=0.354N | P=0.470N P=0.058N P=0.270N P=0.340N |
|LOGISTIC REGRESSION | P=0.300N P=0.457N P=0.562N P=0.321N | P=0.421N P=0.043N* P=0.218N P=0.276N |
|COCHRAN-ARMITAGE | P=0.397N | P=0.507N |
|FISHER EXACT | P=0.566N P=0.566N P=0.438N | P=0.036N* P=0.212N P=0.394N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 21
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 1/70 (1%) 0/70 (0%) 4/100 (4%) | 1/132 (1%) 0/70 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 2.2% 1.7% 0.0% 9.1% | 1.7% 0.0% 2.9% 1.9% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 3/42 (7%) | 1/59 (2%) 0/31 (0%) 1/34 (3%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | 719 424 --- 710 | 729 (T) --- 729 (T) 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.099 P=0.611 P=0.638N P=0.175 | P=0.475 P=0.628N P=0.634 P=0.742 |
|INCIDENTAL TUMOR | P=0.059 P=0.480 P=0.663N P=0.134 | P=0.475 P=0.628N P=0.634 P=0.742 |
|LOGISTIC REGRESSION | P=0.066 P=0.593 P=0.629N P=0.146 | P=0.475 P=0.628N P=0.634 P=0.742 |
|COCHRAN-ARMITAGE | P=0.057 | P=0.418 |
|FISHER EXACT | P=0.548 P=0.673N P=0.093 | P=0.653N P=0.574 P=0.677 |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/144 (15%) 11/70 (16%) 10/70 (14%) 17/100 (17%)| 21/132 (16%) 4/70 (6%) 8/70 (11%) 14/100 (14%)|
|ADJUSTED (b) | 36.4% 34.2% 28.9% 31.5% | 29.5% 9.9% 20.1% 24.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 9/42 (21%) 6/25 (24%) 3/23 (13%) 9/42 (21%) | 12/59 (20%) 2/31 (6%) 4/34 (12%) 12/54 (22%) |
|FIRST INCIDENCE (DAYS) | 571 424 459 (I) 459 (I) | 515 459 (I) 646 714 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.324N P=0.416N P=0.389N P=0.336N | P=0.353N P=0.030N* P=0.219N P=0.217N |
|INCIDENTAL TUMOR | P=0.489 P=0.563N P=0.496N P=0.537 | P=0.510N P=0.044N* P=0.318N P=0.350N |
|LOGISTIC REGRESSION | P=0.518 P=0.533N P=0.505N P=0.569 | P=0.468N P=0.032N* P=0.266N P=0.288N |
|COCHRAN-ARMITAGE | P=0.415 | P=0.503 |
|FISHER EXACT | P=0.541 P=0.512N P=0.425 | P=0.027N* P=0.260N P=0.416N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 22
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 1/70 (1%) 3/100 (3%) | 0/132 (0%) 0/70 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 7.1% | 0.0% 0.0% 2.9% 1.6% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 1/23 (4%) 3/42 (7%) | 0/59 (0%) 0/31 (0%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 729 (T) | --- --- 729 (T) 716 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.030 * (e) P=0.380 P=0.121 | P=0.213 (e) P=0.390 P=0.494 |
|INCIDENTAL TUMOR | P=0.030 * (e) P=0.380 P=0.121 | P=0.184 (e) P=0.390 P=0.433 |
|LOGISTIC REGRESSION | P=0.030 * (e) P=0.380 P=0.121 | P=0.200 (e) P=0.390 P=0.470 |
|COCHRAN-ARMITAGE | P=0.015 * | P=0.173 |
|FISHER EXACT | (e) P=0.327 P=0.068 | (e) P=0.347 P=0.431 |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 1/70 (1%) 0/70 (0%) 2/100 (2%) | 2/132 (2%) 0/70 (0%) 2/70 (3%) 1/100 (1%) |
|ADJUSTED (b) | 1.9% 4.0% 0.0% 3.5% | 3.4% 0.0% 5.9% 1.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 1/42 (2%) | 2/59 (3%) 0/31 (0%) 2/34 (6%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 712 729 (T) --- 459 (I) | 729 (T) --- 729 (T) 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.423 P=0.629 P=0.616N P=0.498 | P=0.577N P=0.389N P=0.484 P=0.538N |
|INCIDENTAL TUMOR | P=0.395 P=0.627 P=0.663N P=0.463 | P=0.590 P=0.389N P=0.484 P=0.559N |
|LOGISTIC REGRESSION | P=0.342 P=0.630 P=0.634N P=0.384 | P=0.577 P=0.389N P=0.484 P=0.568N |
|COCHRAN-ARMITAGE | P=0.328 | P=0.538 |
|FISHER EXACT | P=0.548 P=0.673N P=0.366 | P=0.426N P=0.431 P=0.603N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 23
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 1/70 (1%) 1/70 (1%) 5/100 (5%) | 2/132 (2%) 0/70 (0%) 3/70 (4%) 2/100 (2%) |
|ADJUSTED (b) | 1.9% 4.0% 4.3% 10.6% | 3.4% 0.0% 8.8% 3.1% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/10 (10%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 1/23 (4%) 4/42 (10%) | 2/59 (3%) 0/31 (0%) 3/34 (9%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 712 729 (T) 729 (T) 459 (I) | 729 (T) --- 729 (T) 646 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.048 * P=0.629 P=0.623 P=0.107 | P=0.344 P=0.389N P=0.262 P=0.660 |
|INCIDENTAL TUMOR | P=0.043 * P=0.627 P=0.595 P=0.095 | P=0.313 P=0.389N P=0.262 P=0.616 |
|LOGISTIC REGRESSION | P=0.027 * P=0.630 P=0.613 P=0.055 | P=0.312 P=0.389N P=0.262 P=0.626 |
|COCHRAN-ARMITAGE | P=0.020 * | P=0.266 |
|FISHER EXACT | P=0.548 P=0.548 P=0.044 * | P=0.426N P=0.227 P=0.579 |
|=================================================================================================================================|
| |
|Uterus |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 0/132 (0%) 1/70 (1%) 0/70 (0%) 2/100 (2%) |
|ADJUSTED (b) | | 0.0% 2.3% 0.0% 3.7% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | | 0/59 (0%) 0/31 (0%) 0/34 (0%) 2/54 (4%) |
|FIRST INCIDENCE (DAYS) | | --- 659 --- 729 (T) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.191 P=0.384 (e) P=0.219 |
|INCIDENTAL TUMOR | | P=0.179 P=0.388 (e) P=0.219 |
|LOGISTIC REGRESSION | | P=0.176 P=0.369 (e) P=0.219 |
|COCHRAN-ARMITAGE | | P=0.157 |
|FISHER EXACT | | P=0.347 (e) P=0.185 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 24
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 13/132 (10%) 4/70 (6%) 7/70 (10%) 2/100 (2%) |
|ADJUSTED (b) | | 18.4% 11.6% 16.3% 3.2% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | | 8/59 (14%) 3/31 (10%) 3/34 (9%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | | 376 620 460 (I) 631 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.018N* P=0.236N P=0.541N P=0.008N** |
|INCIDENTAL TUMOR | | P=0.044N* P=0.327N P=0.489 P=0.020N* |
|LOGISTIC REGRESSION | | P=0.029N* P=0.241N P=0.565 P=0.013N* |
|COCHRAN-ARMITAGE | | P=0.035N* |
|FISHER EXACT | | P=0.233N P=0.576 P=0.013N* |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | # # # # |
|----------- | | |
|OVERALL (a) | | 13/132 (10%) 4/70 (6%) 7/70 (10%) 3/100 (3%) |
|ADJUSTED (b) | | 18.4% 11.6% 16.3% 4.3% |
|INTERIM SACRIFICE 1 (c)| | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| | 0/10 (0%) 0/10 (0%) 1/10 (10%) 0/9 (0%) |
|TERMINAL (d) | | 8/59 (14%) 3/31 (10%) 3/34 (9%) 1/54 (2%) |
|FIRST INCIDENCE (DAYS) | | 376 620 460 (I) 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | | P=0.039N* P=0.236N P=0.541N P=0.022N* |
|INCIDENTAL TUMOR | | P=0.097N P=0.327N P=0.489 P=0.055N |
|LOGISTIC REGRESSION | | P=0.060N P=0.241N P=0.565 P=0.035N* |
|COCHRAN-ARMITAGE | | P=0.067N |
|FISHER EXACT | | P=0.233N P=0.576 P=0.034N* |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 25
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/144 (3%) 1/70 (1%) 1/70 (1%) 3/100 (3%) | 1/132 (1%) 0/70 (0%) 1/70 (1%) 1/100 (1%) |
|ADJUSTED (b) | 5.6% 3.2% 2.6% 4.6% | 1.1% 0.0% 2.9% 1.4% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 1/34 (3%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 533 706 648 570 | 620 --- 729 (T) 613 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.564N P=0.404N P=0.442N P=0.612N | P=0.449 P=0.636N P=0.617 P=0.711 |
|INCIDENTAL TUMOR | P=0.357 P=0.563N P=0.585N P=0.410 | P=0.354 P=0.729N P=0.547 P=0.587 |
|LOGISTIC REGRESSION | P=0.409 P=0.439N P=0.455N P=0.483 | P=0.426 P=0.629N P=0.608 P=0.698 |
|COCHRAN-ARMITAGE | P=0.505 | P=0.418 |
|FISHER EXACT | P=0.472N P=0.472N P=0.603 | P=0.653N P=0.574 P=0.677 |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 1/144 (1%) 0/70 (0%) 0/70 (0%) 2/100 (2%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 1/100 (1%) |
|ADJUSTED (b) | 2.0% 0.0% 0.0% 2.7% | 0.0% 0.0% 0.0% 1.5% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 716 --- --- 282 | --- --- --- 678 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.225 P=0.620N P=0.627N P=0.426 | P=0.201 (e) (e) P=0.482 |
|INCIDENTAL TUMOR | P=0.106 P=0.627N P=0.663N P=0.229 | P=0.167 (e) (e) P=0.433 |
|LOGISTIC REGRESSION | P=0.191 P=0.617N P=0.631N P=0.367 | P=0.185 (e) (e) P=0.453 |
|COCHRAN-ARMITAGE | P=0.195 | P=0.178 |
|FISHER EXACT | P=0.673N P=0.673N P=0.366 | (e) (e) P=0.431 |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 26
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 3/70 (4%) 1/70 (1%) 1/100 (1%) | 0/132 (0%) 0/70 (0%) 1/70 (1%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 10.5% 3.4% 1.5% | 0.0% 0.0% 2.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 706 715 614 | --- --- 663 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.527N P=0.046 * P=0.387 P=0.457 | P=0.560 (e) P=0.372 (e) |
|INCIDENTAL TUMOR | P=0.540 P=0.041 * P=0.337 P=0.299 | P=0.532 (e) P=0.371 (e) |
|LOGISTIC REGRESSION | P=0.576N P=0.041 * P=0.368 P=0.430 | P=0.550 (e) P=0.369 (e) |
|COCHRAN-ARMITAGE | P=0.572 | P=0.544 |
|FISHER EXACT | P=0.034 * P=0.327 P=0.410 | (e) P=0.347 (e) |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, |
| or Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 71/144 (49%) 23/70 (33%) 21/70 (30%) 47/100 (47%)| 33/132 (25%) 16/70 (23%) 14/70 (20%) 20/100 (20%)|
|ADJUSTED (b) | 80.7% 55.6% 49.8% 69.1% | 40.9% 36.7% 35.9% 29.7% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/9 (33%) 0/9 (0%) 3/10 (30%) 0/10 (0%) | 0/10 (0%) 1/10 (10%) 0/10 (0%) 2/9 (22%) |
|TERMINAL (d) | 27/42 (64%) 9/25 (36%) 6/23 (26%) 22/42 (52%) | 15/59 (25%) 6/31 (19%) 10/34 (29%) 11/54 (20%) |
|FIRST INCIDENCE (DAYS) | 325 422 459 (I) 389 | 379 451 571 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.081N P=0.005N** P=0.003N** P=0.038N* | P=0.071N P=0.410N P=0.226N P=0.097N |
|INCIDENTAL TUMOR | P=0.522 P=0.026N* P=0.007N** P=0.423N | P=0.234N P=0.536 P=0.435N P=0.272N |
|LOGISTIC REGRESSION | P=0.410N P=0.007N** P=0.005N** P=0.238N | P=0.136N P=0.472N P=0.289N P=0.184N |
|COCHRAN-ARMITAGE | P=0.423N | P=0.186N |
|FISHER EXACT | P=0.016N* P=0.005N** P=0.411N | P=0.438N P=0.268N P=0.230N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 27
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma And Histiocytic Sarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 3/70 (4%) 1/70 (1%) 1/100 (1%) | 0/132 (0%) 0/70 (0%) 1/70 (1%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 10.5% 3.4% 1.5% | 0.0% 0.0% 2.5% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 1/25 (4%) 0/23 (0%) 0/42 (0%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- 706 715 614 | --- --- 663 --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.527N P=0.046 * P=0.387 P=0.457 | P=0.560 (e) P=0.372 (e) |
|INCIDENTAL TUMOR | P=0.540 P=0.041 * P=0.337 P=0.299 | P=0.532 (e) P=0.371 (e) |
|LOGISTIC REGRESSION | P=0.576N P=0.041 * P=0.368 P=0.430 | P=0.550 (e) P=0.369 (e) |
|COCHRAN-ARMITAGE | P=0.572 | P=0.544 |
|FISHER EXACT | P=0.034 * P=0.327 P=0.410 | (e) P=0.347 (e) |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma Benign, Malignant, NOS |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 4/144 (3%) 1/70 (1%) 1/70 (1%) 2/100 (2%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 5.4% 3.7% 2.1% 3.8% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 1/42 (2%) 0/25 (0%) 0/23 (0%) 1/42 (2%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | 317 718 570 587 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.366N P=0.409N P=0.440N P=0.426N | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.576N P=0.682N P=0.555N P=0.659 | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.429N P=0.448N P=0.443N P=0.514N | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.433N | (e) |
|FISHER EXACT | P=0.472N P=0.472N P=0.524N | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 28
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 1/70 (1%) 4/100 (4%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 7.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 1/23 (4%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 388 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.009 ** (e) P=0.380 P=0.050 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.005 ** (e) P=0.380 P=0.026 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.005 ** (e) P=0.380 P=0.030 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.004 ** | (e) |
|FISHER EXACT | (e) P=0.327 P=0.027 * | (e) (e) (e) |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 0/144 (0%) 0/70 (0%) 1/70 (1%) 4/100 (4%) | 0/132 (0%) 0/70 (0%) 0/70 (0%) 0/100 (0%) |
|ADJUSTED (b) | 0.0% 0.0% 4.3% 7.5% | 0.0% 0.0% 0.0% 0.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/10 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/9 (0%) |
|TERMINAL (d) | 0/42 (0%) 0/25 (0%) 1/23 (4%) 2/42 (5%) | 0/59 (0%) 0/31 (0%) 0/34 (0%) 0/54 (0%) |
|FIRST INCIDENCE (DAYS) | --- --- 729 (T) 388 | --- --- --- --- |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.009 ** (e) P=0.380 P=0.050 | (e) (e) (e) (e) |
|INCIDENTAL TUMOR | P=0.005 ** (e) P=0.380 P=0.026 * | (e) (e) (e) (e) |
|LOGISTIC REGRESSION | P=0.005 ** (e) P=0.380 P=0.030 * | (e) (e) (e) (e) |
|COCHRAN-ARMITAGE | P=0.004 ** | (e) |
|FISHER EXACT | (e) P=0.327 P=0.027 * | (e) (e) (e) |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 29
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |112/144 (78%) 56/70 (80%) 54/70 (77%) 83/100 (83%)| 80/132 (61%) 39/70 (56%) 40/70 (57%) 61/100 (61%)|
|ADJUSTED (b) | 100.0% 100.0% 98.2% 100.0% | 90.7% 80.6% 86.4% 80.2% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/9 (33%) 7/9 (78%) 7/10 (70%) 7/10 (70%) | 0/10 (0%) 3/10 (30%) 3/10 (30%) 2/9 (22%) |
|TERMINAL (d) | 42/42 (100%) 25/25 (100%) 22/23 (96%) 42/42 (100%)| 51/59 (86%) 22/31 (71%) 28/34 (82%) 39/54 (72%) |
|FIRST INCIDENCE (DAYS) | 414 459 (I) 404 459 (I) | 376 459 (I) 460 (I) 459 (I) |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.041N* P=0.118N P=0.176N P=0.035N* | P=0.100N P=0.277N P=0.182N P=0.101N |
|INCIDENTAL TUMOR | P=0.226 P=0.199 P=0.301 P=0.166 | P=0.417N P=0.506N P=0.509N P=0.425N |
|LOGISTIC REGRESSION | P=0.154 P=0.141 P=0.210 P=0.163 | P=0.379N P=0.380N P=0.474N P=0.344N |
|COCHRAN-ARMITAGE | P=0.223 | P=0.449 |
|FISHER EXACT | P=0.428 P=0.523N P=0.201 | P=0.300N P=0.371N P=0.530 |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) | 83/144 (58%) 31/70 (44%) 29/70 (41%) 63/100 (63%)| 46/132 (35%) 21/70 (30%) 25/70 (36%) 32/100 (32%)|
|ADJUSTED (b) | 85.3% 66.0% 64.8% 81.4% | 53.5% 46.9% 54.7% 43.0% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 3/9 (33%) 0/9 (0%) 3/10 (30%) 1/10 (10%) | 0/10 (0%) 1/10 (10%) 1/10 (10%) 2/9 (22%) |
|TERMINAL (d) | 29/42 (69%) 10/25 (40%) 9/23 (39%) 28/42 (67%) | 22/59 (37%) 9/31 (29%) 14/34 (41%) 14/54 (26%) |
|FIRST INCIDENCE (DAYS) | 180 422 459 (I) 282 | 320 451 460 (I) 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.250N P=0.015N* P=0.012N* P=0.155N | P=0.184N P=0.294N P=0.501N P=0.156N |
|INCIDENTAL TUMOR | P=0.059 P=0.132N P=0.041N* P=0.098 | P=0.468 P=0.557N P=0.241 P=0.512N |
|LOGISTIC REGRESSION | P=0.213 P=0.027N* P=0.019N* P=0.348 | P=0.432N P=0.334N P=0.456 P=0.312N |
|COCHRAN-ARMITAGE | P=0.206 | P=0.447N |
|FISHER EXACT | P=0.045N* P=0.019N* P=0.240 | P=0.296N P=0.511 P=0.377N |
|=================================================================================================================================|
DATE: 09/17/94 EXPERIMENT: 05131 TEST: 01 PAGE 30
STATISTICAL ANALYSIS OF PRIMARY TUMORS IN RATS(FISCHER344) -- SODIUM FLUORIDE
TERMINAL SACRIFICE AT 105 WEEKS
|=================================================================================================================================|
| | | |
| | MALES | FEMALES |
| | | |
|DOSE | SPECIAL 25 PPM 100 PPM 175 PPM | SPECIAL 25 PPM 100 PPM 175 PPM |
| | CONTROL | CONTROL |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # | # # # # |
|----------- | | |
|OVERALL (a) |118/144 (82%) 58/70 (83%) 56/70 (80%) 88/100 (88%)| 95/132 (72%) 45/70 (64%) 51/70 (73%) 74/100 (74%)|
|ADJUSTED (b) | 100.0% 100.0% 100.0% 100.0% | 94.9% 86.1% 96.2% 91.3% |
|INTERIM SACRIFICE 1 (c)| 0/0 0/0 0/0 0/1 (0%) | 0/10 (0%) 0/10 (0%) 0/10 (0%) 0/10 (0%) |
|INTERIM SACRIFICE 2 (c)| 4/9 (44%) 7/9 (78%) 8/10 (80%) 8/10 (80%) | 0/10 (0%) 4/10 (40%) 3/10 (30%) 3/9 (33%) |
|TERMINAL (d) | 42/42 (100%) 25/25 (100%) 23/23 (100%) 42/42 (100%)| 54/59 (92%) 24/31 (77%) 32/34 (94%) 47/54 (87%) |
|FIRST INCIDENCE (DAYS) | 180 422 404 282 | 320 451 460 (I) 338 |
|-----------------------| | |
|STATISTICAL TESTS (f) | | |
|-----------------------| | |
|LIFE TABLE | P=0.052N P=0.096N P=0.131N P=0.046N* | P=0.160N P=0.188N P=0.366N P=0.118N |
|INCIDENTAL TUMOR | P=0.021 * P=0.055 P=0.299 P=0.011 * | P=0.177 P=0.574N P=0.043 * P=0.374 |
|LOGISTIC REGRESSION | P=0.048 * P=0.254 P=0.332 P=0.064 | P=0.363 P=0.235N P=0.278 P=0.554N |
|COCHRAN-ARMITAGE | P=0.155 | P=0.244 |
|FISHER EXACT | P=0.516 P=0.433N P=0.134 | P=0.167N P=0.515 P=0.424 |
|=================================================================================================================================|
(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): 190 459
Female interim sacrifices(days): 184 459
(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).
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