TDMS Study 88138-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZOPHENONE DATE: 08/23/04
EXPERIMENT: 88138 TEST: 03 TIME: 08:33:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
------------------------------------------------------------------------------------------------------------------------------------
FINAL #2/RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZOPHENONE DATE: 08/23/04
EXPERIMENT: 88138 TEST: 03 TIME: 08:33:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
Rats(FISCHER 344)
-----------------------------
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 THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Nose
Ovary
Pancreas
Parathyroid Gland
Pituitary Gland
Salivary Glands
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus BENZOPHENONE DATE: 08/23/04
EXPERIMENT: 88138 TEST: 03 TIME: 08:33:46
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: DOSED FEED NTP C#: 88138B
PATHOLOGIST: MISSING CAS: 119-61-9
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF BENZOPHENONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Skin
Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthom
a, Trichoepitheliom
Keratoacanthoma
Squamous Cell Papilloma, Papilloma, Squamous Cell Carcinoma or Keratoacanthoma
Squamous Cell Papilloma, Papilloma, or Keratoacanthoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mammary Gland Fibroadenoma
Fibroma, Fibroadenoma or Adenoma
Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Skin Fibroma
Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
Keratoacanthoma
All Organs Histiocytic Sarcoma
Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
===============================================================
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/49 (10%) 8/50 (16%) 3/50 (6%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/42.42 5/41.31 8/44.47 3/32.72 |0/44.12 2/47.51 2/47.33 0/45.76 |
|POLY-3 PERCENT (g) | 18.9% 12.1% 18.0% 9.2% |0.0% 4.2% 4.2% 0.0% |
|TERMINAL (d) | 4/22 (18%) 3/27 (11%) 6/31 (19%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 690 673 708 624 |--- 725 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.191N P=0.342N P=0.306 |P=0.499N P=0.281 P=0.264 (e) |
|POLY 3 | P=0.235N P=0.290N P=0.568N P=0.199N |P=0.482N P=0.254 P=0.253 (e) |
|POLY 1.5 | P=0.173N P=0.295N P=0.587N P=0.144N |P=0.486N P=0.249 P=0.248 (e) |
|POLY 6 | P=0.348N P=0.275N P=0.536N P=0.325N |P=0.484N P=0.258 P=0.257 (e) |
|LOGISTIC REGRESSION| P=0.477N P=0.261N P=0.460N P=0.548N |P=0.498N P=0.259 P=0.251 (e) |
|COCH-ARM / FISHERS | P=0.117N P=0.290N P=0.607N P=0.100N |P=0.500N P=0.247 P=0.247 (e) |
|ORDER RESTRICTED | P=0.207N (e) (e) (e) |P=0.282N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/40.97 2/44.30 1/32.67 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.5% 3.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 729 (T) 507 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.072 (e) P=0.316 P=0.504 |(e) (e) (e) (e) |
|POLY 3 | P=0.156 (e) P=0.249 P=0.450 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.199 (e) P=0.243 P=0.475 |(e) (e) (e) (e) |
|POLY 6 | P=0.103 (e) P=0.258 P=0.408 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.267 (e) P=0.316 P=0.527 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247 (e) P=0.247 P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/49 (10%) 10/50 (20%) 4/50 (8%) |0/50 (0%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 8/42.42 5/41.31 10/44.47 4/33.38 |0/44.12 2/47.51 2/47.33 0/45.76 |
|POLY-3 PERCENT (g) | 18.9% 12.1% 22.5% 12.0% |0.0% 4.2% 4.2% 0.0% |
|TERMINAL (d) | 4/22 (18%) 3/27 (11%) 8/31 (26%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 690 673 708 507 |--- 725 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.191N P=0.514N P=0.198 |P=0.499N P=0.281 P=0.264 (e) |
|POLY 3 | P=0.405N P=0.290N P=0.439 P=0.310N |P=0.482N P=0.254 P=0.253 (e) |
|POLY 1.5 | P=0.313N P=0.295N P=0.419 P=0.239N |P=0.486N P=0.249 P=0.248 (e) |
|POLY 6 | P=0.526 P=0.275N P=0.475 P=0.456N |P=0.484N P=0.258 P=0.257 (e) |
|LOGISTIC REGRESSION| P=0.524 P=0.261N P=0.569 P=0.480N |P=0.498N P=0.259 P=0.251 (e) |
|COCH-ARM / FISHERS | P=0.227N P=0.290N P=0.398 P=0.178N |P=0.500N P=0.247 P=0.247 (e) |
|ORDER RESTRICTED | P=0.353N (e) (e) (e) |P=0.282N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 1/49 (2%) |3/50 (6%) 1/50 (2%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 0/42.08 3/42.15 1/44.30 1/31.40 |3/44.25 1/47.49 5/47.22 6/46.49 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 2.3% 3.2% |6.8% 2.1% 10.6% 12.9% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |2/32 (6%) 1/38 (3%) 5/37 (14%) 3/34 (9%) |
|FIRST INCIDENCE | --- 543 729 (T) 726 |697 729 (T) 729 (T) 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.143 P=0.568 P=0.114 |P=0.081 P=0.256N P=0.433 P=0.271 |
|POLY 3 | P=0.461 P=0.118 P=0.510 P=0.442 |P=0.083 P=0.280N P=0.393 P=0.267 |
|POLY 1.5 | P=0.520 P=0.118 P=0.505 P=0.469 |P=0.082 P=0.288N P=0.383 P=0.261 |
|POLY 6 | P=0.388 P=0.122 P=0.519 P=0.399 |P=0.082 P=0.276N P=0.398 P=0.269 |
|LOGISTIC REGRESSION| P=0.501 P=0.122 P=0.568 P=0.142 |P=0.082 P=0.274N P=0.401 P=0.250 |
|COCH-ARM / FISHERS | P=0.585 P=0.121 P=0.500 P=0.495 |P=0.080 P=0.309N P=0.357 P=0.243 |
|ORDER RESTRICTED | P=0.262 (e) (e) (e) |P=0.105 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 3/50 (6%) 1/49 (2%) |1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.08 3/41.64 3/45.29 1/31.91 |1/44.14 2/47.49 2/47.30 1/45.76 |
|POLY-3 PERCENT (g) | 2.4% 7.2% 6.6% 3.1% |2.3% 4.2% 4.2% 2.2% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 2/38 (5%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 709 543 569 |724 729 (T) 709 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360 P=0.375 P=0.371 P=0.533 |P=0.559N P=0.549 P=0.529 P=0.760N |
|POLY 3 | P=0.529 P=0.301 P=0.332 P=0.696 |P=0.544N P=0.525 P=0.524 P=0.753N |
|POLY 1.5 | P=0.573N P=0.301 P=0.320 P=0.726 |P=0.546N P=0.518 P=0.517 P=0.754N |
|POLY 6 | P=0.420 P=0.307 P=0.353 P=0.638 |P=0.547N P=0.531 P=0.529 P=0.754N |
|LOGISTIC REGRESSION| P=0.512N P=0.335 P=0.278 P=0.779N |P=0.561N P=0.534 P=0.528 P=0.762 |
|COCH-ARM / FISHERS | P=0.509N P=0.309 P=0.309 P=0.747 |P=0.556N P=0.500 P=0.500 P=0.753N |
|ORDER RESTRICTED | P=0.410 (e) (e) (e) |P=0.558N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 4/50 (8%) 2/49 (4%) |4/50 (8%) 3/50 (6%) 6/50 (12%) 7/50 (14%) |
|POLY-3 RATE (b) | 1/42.08 6/42.23 4/45.29 2/31.92 |4/44.27 3/47.49 6/47.30 7/46.49 |
|POLY-3 PERCENT (g) | 2.4% 14.2% 8.8% 6.3% |9.0% 6.3% 12.7% 15.1% |
|TERMINAL (d) | 1/22 (5%) 4/27 (15%) 2/31 (7%) 0/2 (0%) |2/32 (6%) 3/38 (8%) 5/37 (14%) 4/34 (12%) |
|FIRST INCIDENCE | 729 (T) 543 543 569 |697 729 (T) 709 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.174 P=0.088 P=0.250 P=0.100 |P=0.134 P=0.423N P=0.447 P=0.290 |
|POLY 3 | P=0.440 P=0.055 P=0.201 P=0.405 |P=0.142 P=0.462N P=0.412 P=0.290 |
|POLY 1.5 | P=0.528 P=0.055 P=0.191 P=0.448 |P=0.140 P=0.473N P=0.400 P=0.283 |
|POLY 6 | P=0.322 P=0.058 P=0.220 P=0.335 |P=0.141 P=0.455N P=0.419 P=0.292 |
|LOGISTIC REGRESSION| P=0.579 P=0.057 P=0.165 P=0.381 |P=0.136 P=0.449N P=0.421 P=0.276 |
|COCH-ARM / FISHERS | P=0.530N P=0.056 P=0.181 P=0.492 |P=0.132 P=0.500N P=0.370 P=0.262 |
|ORDER RESTRICTED | P=0.200 (e) (e) (e) |P=0.204 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.26 0/41.56 1/44.30 1/32.24 |0/44.12 0/47.49 2/47.41 1/45.76 |
|POLY-3 PERCENT (g) | 2.4% 0.0% 2.3% 3.1% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 680 --- 729 (T) 669 |--- --- 701 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.281 P=0.500N P=0.704N P=0.519 |P=0.240 (e) P=0.257 P=0.512 |
|POLY 3 | P=0.459 P=0.503N P=0.750N P=0.697 |P=0.248 (e) P=0.254 P=0.507 |
|POLY 1.5 | P=0.498 P=0.503N P=0.755N P=0.729 |P=0.249 (e) P=0.249 P=0.506 |
|POLY 6 | P=0.418 P=0.501N P=0.742N P=0.635 |P=0.244 (e) P=0.257 P=0.506 |
|LOGISTIC REGRESSION| P=0.463 P=0.500N P=0.752N P=0.719 |P=0.247 (e) P=0.240 P=0.512 |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.451 (e) (e) (e) |P=0.182 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.16 1/41.56 2/44.46 4/33.18 |0/44.12 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 2.4% 4.5% 12.1% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 1/27 (4%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 709 729 (T) 687 537 |--- --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.722N P=0.591 P=0.015 * |P=0.242 (e) P=0.257 P=0.514 |
|POLY 3 | P=0.046 * P=0.758 P=0.519 P=0.114 |P=0.250 (e) P=0.254 P=0.508 |
|POLY 1.5 | P=0.056 P=0.758 P=0.510 P=0.143 |P=0.250 (e) P=0.249 P=0.506 |
|POLY 6 | P=0.036 * P=0.761 P=0.534 P=0.075 |P=0.247 (e) P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P=0.047 * P=0.754N P=0.526 P=0.142 |P=0.239 (e) P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P=0.072 P=0.753N P=0.500 P=0.181 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.047 * (e) (e) (e) |P=0.182 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.16 2/41.56 2/44.46 4/33.18 |0/44.12 0/47.49 2/47.41 1/45.95 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 4.5% 12.1% |0.0% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 709 729 (T) 687 537 |--- --- 701 679 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** P=0.563 P=0.591 P=0.015 * |P=0.242 (e) P=0.257 P=0.514 |
|POLY 3 | P=0.073 P=0.495 P=0.519 P=0.114 |P=0.250 (e) P=0.254 P=0.508 |
|POLY 1.5 | P=0.090 P=0.495 P=0.510 P=0.143 |P=0.250 (e) P=0.249 P=0.506 |
|POLY 6 | P=0.057 P=0.500 P=0.534 P=0.075 |P=0.247 (e) P=0.257 P=0.508 |
|LOGISTIC REGRESSION| P=0.065 P=0.525 P=0.526 P=0.142 |P=0.239 (e) P=0.240 P=0.489 |
|COCH-ARM / FISHERS | P=0.113 P=0.500 P=0.500 P=0.181 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.060 (e) (e) (e) |P=0.182 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.28 0/41.56 1/44.30 0/32.01 |0/44.12 0/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 2.3% 0.0% |0.0% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 676 --- 729 (T) --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347N P=0.223N P=0.409N P=0.632N |P=0.700 (e) P=0.529 (e) |
|POLY 3 | P=0.204N P=0.241N P=0.484N P=0.304N |P=0.698 (e) P=0.514 (e) |
|POLY 1.5 | P=0.198N P=0.241N P=0.491N P=0.270N |P=0.698 (e) P=0.510 (e) |
|POLY 6 | P=0.221N P=0.238N P=0.470N P=0.369N |P=0.693 (e) P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.264N P=0.239N P=0.469N P=0.420N |(e) (e) P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.247N P=0.500N P=0.247N |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.122N (e) (e) (e) |P=0.393 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.28 0/41.56 2/44.30 0/32.01 |0/44.12 1/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 4.5% 0.0% |0.0% 2.1% 2.1% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 676 --- 729 (T) --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.223N P=0.589N P=0.632N |P=0.594N P=0.534 P=0.529 (e) |
|POLY 3 | P=0.306N P=0.241N P=0.677N P=0.304N |P=0.583N P=0.515 P=0.514 (e) |
|POLY 1.5 | P=0.277N P=0.241N P=0.685N P=0.270N |P=0.585N P=0.510 P=0.510 (e) |
|POLY 6 | P=0.366N P=0.238N P=0.664N P=0.369N |P=0.584N P=0.518 P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.408N P=0.239N P=0.653N P=0.420N |(e) P=0.534 P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.247N P=0.691N P=0.247N |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.409N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.28 0/41.56 2/44.30 0/32.01 |0/44.12 1/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 0.0% 4.5% 0.0% |0.0% 2.1% 2.1% 0.0% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 676 --- 729 (T) --- |--- 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.223N P=0.589N P=0.632N |P=0.594N P=0.534 P=0.529 (e) |
|POLY 3 | P=0.306N P=0.241N P=0.677N P=0.304N |P=0.583N P=0.515 P=0.514 (e) |
|POLY 1.5 | P=0.277N P=0.241N P=0.685N P=0.270N |P=0.585N P=0.510 P=0.510 (e) |
|POLY 6 | P=0.366N P=0.238N P=0.664N P=0.369N |P=0.584N P=0.518 P=0.516 (e) |
|LOGISTIC REGRESSION| P=0.408N P=0.239N P=0.653N P=0.420N |(e) P=0.534 P=0.529 (e) |
|COCH-ARM / FISHERS | P=0.248N P=0.247N P=0.691N P=0.247N |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.171N (e) (e) (e) |P=0.409N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/42.46 1/41.07 0/44.30 0/32.01 |4/44.12 0/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 9.4% 2.4% 0.0% 0.0% |9.1% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |4/32 (13%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 666 704 --- --- |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033N* P=0.153N P=0.038N* P=0.405N |P=0.034N* P=0.043N* P=0.137N P=0.055N |
|POLY 3 | P=0.017N* P=0.188N P=0.055N P=0.105N |P=0.040N* P=0.051N P=0.159N P=0.056N |
|POLY 1.5 | P=0.018N* P=0.189N P=0.057N P=0.080N |P=0.039N* P=0.054N P=0.165N P=0.057N |
|POLY 6 | P=0.015N* P=0.182N P=0.050N P=0.163N |P=0.040N* P=0.050N P=0.155N P=0.056N |
|LOGISTIC REGRESSION| P=0.022N* P=0.184N P=0.056N P=0.185N |P=0.034N* (e) P=0.137N (e) |
|COCH-ARM / FISHERS | P=0.019N* P=0.187N P=0.059N P=0.059N |P=0.039N* P=0.059N P=0.181N P=0.059N |
|ORDER RESTRICTED | P=0.017N* (e) (e) (e) |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/40.97 1/44.46 2/32.43 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.3% 6.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- 687 637 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** (e) P=0.549 P=0.067 |(e) (e) (e) (e) |
|POLY 3 | P=0.048 * (e) P=0.511 P=0.184 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.058 (e) P=0.506 P=0.209 |(e) (e) (e) (e) |
|POLY 6 | P=0.040 * (e) P=0.520 P=0.148 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.052 (e) P=0.500 P=0.154 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.071 (e) P=0.500 P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.045 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/49 (2%) 1/50 (2%) 2/50 (4%) |4/50 (8%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/42.46 1/41.07 1/44.46 2/32.43 |4/44.12 0/47.49 1/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 9.4% 2.4% 2.3% 6.2% |9.1% 0.0% 2.1% 0.0% |
|TERMINAL (d) | 2/22 (9%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |4/32 (13%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 666 704 687 637 |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556 P=0.153N P=0.117N P=0.389 |P=0.034N* P=0.043N* P=0.137N P=0.055N |
|POLY 3 | P=0.332N P=0.188N P=0.164N P=0.467N |P=0.040N* P=0.051N P=0.159N P=0.056N |
|POLY 1.5 | P=0.326N P=0.189N P=0.171N P=0.402N |P=0.039N* P=0.054N P=0.165N P=0.057N |
|POLY 6 | P=0.325N P=0.182N P=0.153N P=0.582N |P=0.040N* P=0.050N P=0.155N P=0.056N |
|LOGISTIC REGRESSION| P=0.418N P=0.184N P=0.167N P=0.648N |P=0.034N* (e) P=0.137N (e) |
|COCH-ARM / FISHERS | P=0.311N P=0.187N P=0.181N P=0.339N |P=0.039N* P=0.059N P=0.181N P=0.059N |
|ORDER RESTRICTED | P=0.203N (e) (e) (e) |P=0.005N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |2/45.06 2/47.84 3/47.49 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 4.2% 6.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 1/38 (3%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |288 633 679 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.194N P=0.653N P=0.543 P=0.233N |
|POLY 3 | (e) (e) (e) (e) |P=0.199N P=0.672N P=0.524 P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.198N P=0.679N P=0.516 P=0.234N |
|POLY 6 | (e) (e) (e) (e) |P=0.203N P=0.666N P=0.531 P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.292N P=0.459 P=0.317 P=0.433N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.199N P=0.691N P=0.500 P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |2/45.06 3/47.84 3/47.49 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 6.3% 6.3% 0.0% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |1/32 (3%) 2/38 (5%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |288 633 679 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.160N P=0.554 P=0.543 P=0.233N |
|POLY 3 | (e) (e) (e) (e) |P=0.162N P=0.527 P=0.524 P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.162N P=0.518 P=0.516 P=0.234N |
|POLY 6 | (e) (e) (e) (e) |P=0.165N P=0.535 P=0.531 P=0.235N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.235N P=0.285 P=0.317 P=0.433N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.164N P=0.500 P=0.500 P=0.247N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.144N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |27/50 (54%) 24/50 (48%) 15/50 (30%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/42.26 2/41.83 0/44.30 1/32.63 |27/46.22 24/47.99 15/47.97 7/46.28 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 0.0% 3.1% |58.4% 50.0% 31.3% 15.1% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |19/32 (59%) 18/38 (47%) 12/37 (32%) 3/34 (9%) |
|FIRST INCIDENCE | 681 657 --- 529 |528 693 609 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.655N P=0.181N P=0.679 |P<0.001N** P=0.147N P=0.005N** P<0.001N** |
|POLY 3 | P=0.307N P=0.691 P=0.227N P=0.589N |P<0.001N** P=0.269N P=0.006N** P<0.001N** |
|POLY 1.5 | P=0.306N P=0.690 P=0.232N P=0.545N |P<0.001N** P=0.283N P=0.007N** P<0.001N** |
|POLY 6 | P=0.296N P=0.693N P=0.218N P=0.661N |P<0.001N** P=0.275N P=0.006N** P<0.001N** |
|LOGISTIC REGRESSION| P=0.283N P=0.692 P=0.224N P=0.479N |P<0.001N** P=0.224N P=0.007N** P<0.001N** |
|COCH-ARM / FISHERS | P=0.296N P=0.691N P=0.247N P=0.500N |P<0.001N** P=0.345N P=0.013N* P<0.001N** |
|ORDER RESTRICTED | P=0.331N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |28/50 (56%) 25/50 (50%) 17/50 (34%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/42.26 2/41.83 0/44.30 1/32.63 |28/47.16 25/48.34 17/48.16 7/46.28 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 0.0% 3.1% |59.4% 51.7% 35.3% 15.1% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |19/32 (59%) 18/38 (47%) 13/37 (35%) 3/34 (9%) |
|FIRST INCIDENCE | 681 657 --- 529 |288 633 609 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.655N P=0.181N P=0.679 |P<0.001N** P=0.153N P=0.010N* P<0.001N** |
|POLY 3 | P=0.307N P=0.691 P=0.227N P=0.589N |P<0.001N** P=0.291N P=0.013N* P<0.001N** |
|POLY 1.5 | P=0.306N P=0.690 P=0.232N P=0.545N |P<0.001N** P=0.304N P=0.015N* P<0.001N** |
|POLY 6 | P=0.296N P=0.693N P=0.218N P=0.661N |P<0.001N** P=0.292N P=0.013N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.283N P=0.692 P=0.224N P=0.479N |P<0.001N** P=0.306N P=0.021N* P<0.001N** |
|COCH-ARM / FISHERS | P=0.296N P=0.691N P=0.247N P=0.500N |P<0.001N** P=0.344N P=0.022N* P<0.001N** |
|ORDER RESTRICTED | P=0.331N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |28/50 (56%) 25/50 (50%) 17/50 (34%) 7/50 (14%) |
|POLY-3 RATE (b) | 2/42.26 2/41.83 0/44.30 1/32.63 |28/47.16 25/48.34 17/48.16 7/46.28 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 0.0% 3.1% |59.4% 51.7% 35.3% 15.1% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |19/32 (59%) 18/38 (47%) 13/37 (35%) 3/34 (9%) |
|FIRST INCIDENCE | 681 657 --- 529 |288 633 609 686 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.527N P=0.655N P=0.181N P=0.679 |P<0.001N** P=0.153N P=0.010N* P<0.001N** |
|POLY 3 | P=0.307N P=0.691 P=0.227N P=0.589N |P<0.001N** P=0.291N P=0.013N* P<0.001N** |
|POLY 1.5 | P=0.306N P=0.690 P=0.232N P=0.545N |P<0.001N** P=0.304N P=0.015N* P<0.001N** |
|POLY 6 | P=0.296N P=0.693N P=0.218N P=0.661N |P<0.001N** P=0.292N P=0.013N* P<0.001N** |
|LOGISTIC REGRESSION| P=0.283N P=0.692 P=0.224N P=0.479N |P<0.001N** P=0.306N P=0.021N* P<0.001N** |
|COCH-ARM / FISHERS | P=0.296N P=0.691N P=0.247N P=0.500N |P<0.001N** P=0.344N P=0.022N* P<0.001N** |
|ORDER RESTRICTED | P=0.331N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Papilloma Squamous or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 2/41.56 0/44.30 2/32.72 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 6.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 593 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161 P=0.572 P=0.432N P=0.173 |(e) (e) (e) (e) |
|POLY 3 | P=0.417 P=0.496 P=0.490N P=0.413 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.439 P=0.495 P=0.495N P=0.456 |(e) (e) (e) (e) |
|POLY 6 | P=0.407 P=0.501 P=0.481N P=0.344 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.386 P=0.572 (e) P=0.456 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.470 P=0.500 P=0.500N P=0.500 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.298 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Oral Cavity (Oral Mucosa, Tongue, Pharynx, Tooth, Gingiva) |
| Squamous Cell Carcinoma, Papilloma Squamous, or Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 2/41.56 0/44.30 2/32.72 |0/44.12 1/47.64 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 6.1% |0.0% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 593 |--- 690 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.161 P=0.572 P=0.432N P=0.173 |P=0.581N P=0.523 (e) (e) |
|POLY 3 | P=0.417 P=0.496 P=0.490N P=0.413 |P=0.553N P=0.515 (e) (e) |
|POLY 1.5 | P=0.439 P=0.495 P=0.495N P=0.456 |P=0.557N P=0.511 (e) (e) |
|POLY 6 | P=0.407 P=0.501 P=0.481N P=0.344 |P=0.550N P=0.519 (e) (e) |
|LOGISTIC REGRESSION| P=0.386 P=0.572 (e) P=0.456 |P=0.575N P=0.487 (e) (e) |
|COCH-ARM / FISHERS | P=0.470 P=0.500 P=0.500N P=0.500 |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.298 (e) (e) (e) |P=0.389N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 6/50 (12%) 12/50 (24%) 5/50 (10%) |17/50 (34%) 17/50 (34%) 11/50 (22%) 13/50 (26%) |
|POLY-3 RATE (b) | 10/43.58 6/42.41 12/45.83 5/33.77 |17/45.66 17/48.82 11/47.80 13/46.21 |
|POLY-3 PERCENT (g) | 23.0% 14.2% 26.2% 14.8% |37.2% 34.8% 23.0% 28.1% |
|TERMINAL (d) | 1/22 (5%) 3/27 (11%) 6/31 (19%) 0/2 (0%) |12/32 (38%) 11/38 (29%) 8/37 (22%) 10/34 (29%) |
|FIRST INCIDENCE | 584 535 499 569 |430 613 644 659 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.225 P=0.160N P=0.539N P=0.359 |P=0.158N P=0.382N P=0.075N P=0.219N |
|POLY 3 | P=0.384N P=0.219N P=0.456 P=0.272N |P=0.157N P=0.488N P=0.100N P=0.239N |
|POLY 1.5 | P=0.284N P=0.217N P=0.433 P=0.194N |P=0.154N P=0.520N P=0.109N P=0.239N |
|POLY 6 | P=0.529 P=0.219N P=0.492 P=0.439N |P=0.168N P=0.457N P=0.093N P=0.246N |
|LOGISTIC REGRESSION| P=0.263N P=0.212N P=0.410 P=0.214N |P=0.150N P=0.575N P=0.117N P=0.227N |
|COCH-ARM / FISHERS | P=0.192N P=0.207N P=0.405 P=0.131N |P=0.158N P=0.583N P=0.133N P=0.257N |
|ORDER RESTRICTED | P=0.311N (e) (e) (e) |P=0.177N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 3/41.98 1/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 609 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.660N P=0.146 P=0.568 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.454N P=0.118 P=0.510 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.413N P=0.117 P=0.505 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.531N P=0.121 P=0.519 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.469N P=0.119 P=0.568 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.121 P=0.500 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.281N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Adenoma, Basosquamous Tumor Benign, or |
| Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 3/41.98 2/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 609 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556 P=0.146 P=0.316 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.534N P=0.118 P=0.249 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.474N P=0.117 P=0.243 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.531 P=0.121 P=0.258 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.575N P=0.119 P=0.316 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.121 P=0.247 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.258 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal Cell Carcinoma, Basal Cell Adenoma, Basosquamous |
| Tumor (benign, malignant or NOS), or Trichoepithelioma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/42.08 3/41.98 2/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 0.0% 7.2% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- 609 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.556 P=0.146 P=0.316 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.534N P=0.118 P=0.249 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.474N P=0.117 P=0.243 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.531 P=0.121 P=0.258 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.575N P=0.119 P=0.316 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.409N P=0.121 P=0.247 (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.258 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 5/50 (10%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 11/43.14 8/42.85 5/44.53 3/33.02 |3/44.48 0/47.49 2/47.33 1/45.76 |
|POLY-3 PERCENT (g) | 25.5% 18.7% 11.2% 9.1% |6.7% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 4/22 (18%) 4/27 (15%) 4/31 (13%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 584 590 669 537 |634 --- 701 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.234N P=0.225N P=0.031N* P=0.592 |P=0.337N P=0.106N P=0.457N P=0.296N |
|POLY 3 | P=0.027N* P=0.307N P=0.070N P=0.061N |P=0.344N P=0.107N P=0.472N P=0.295N |
|POLY 1.5 | P=0.018N* P=0.312N P=0.077N P=0.036N* |P=0.341N P=0.111N P=0.480N P=0.296N |
|POLY 6 | P=0.043N* P=0.290N P=0.061N P=0.141N |P=0.349N P=0.106N P=0.468N P=0.299N |
|LOGISTIC REGRESSION| P=0.026N* P=0.314N P=0.064N P=0.103N |P=0.335N P=0.120N P=0.494N P=0.298N |
|COCH-ARM / FISHERS | P=0.011N* P=0.306N P=0.086N P=0.020N* |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.047N* (e) (e) (e) |P=0.172N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/42.40 3/41.77 3/44.46 2/32.95 |3/44.14 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 11.8% 7.2% 6.8% 6.1% |6.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/22 (14%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |2/32 (6%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 704 687 555 |724 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.584 P=0.286N P=0.213N P=0.542 |P=0.045N* P=0.099N P=0.105N P=0.119N |
|POLY 3 | P=0.245N P=0.364N P=0.330N P=0.329N |P=0.048N* P=0.106N P=0.107N P=0.112N |
|POLY 1.5 | P=0.214N P=0.364N P=0.343N P=0.270N |P=0.047N* P=0.110N P=0.111N P=0.114N |
|POLY 6 | P=0.288N P=0.355N P=0.309N P=0.443N |P=0.049N* P=0.104N P=0.105N P=0.113N |
|LOGISTIC REGRESSION| P=0.278N P=0.349N P=0.300N P=0.345N |P=0.046N* P=0.103N P=0.107N P=0.121N |
|COCH-ARM / FISHERS | P=0.179N P=0.357N P=0.357N P=0.218N |P=0.047N* P=0.121N P=0.121N P=0.121N |
|ORDER RESTRICTED | P=0.308N (e) (e) (e) |P=0.007N** (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |4/50 (8%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 6/42.42 3/41.77 3/44.46 2/32.95 |4/44.16 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 14.2% 7.2% 6.8% 6.1% |9.1% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/22 (14%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |2/32 (6%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 680 704 687 555 |724 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.498N P=0.187N P=0.127N P=0.581 |P=0.020N* P=0.051N P=0.055N P=0.065N |
|POLY 3 | P=0.158N P=0.248N P=0.218N P=0.228N |P=0.020N* P=0.052N P=0.052N P=0.056N |
|POLY 1.5 | P=0.136N P=0.249N P=0.230N P=0.177N |P=0.019N* P=0.054N P=0.055N P=0.057N |
|POLY 6 | P=0.188N P=0.240N P=0.199N P=0.337N |P=0.020N* P=0.050N P=0.051N P=0.056N |
|LOGISTIC REGRESSION| P=0.195N P=0.232N P=0.188N P=0.280N |P=0.019N* P=0.051N P=0.053N P=0.062N |
|COCH-ARM / FISHERS | P=0.112N P=0.243N P=0.243N P=0.134N |P=0.020N* P=0.059N P=0.059N P=0.059N |
|ORDER RESTRICTED | P=0.186N (e) (e) (e) |P<0.001N** (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 3/50 (6%) 3/50 (6%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 10/43.06 3/42.43 3/44.53 3/33.02 |3/44.48 0/47.49 2/47.33 0/45.76 |
|POLY-3 PERCENT (g) | 23.2% 7.1% 6.7% 9.1% |6.7% 0.0% 4.2% 0.0% |
|TERMINAL (d) | 4/22 (18%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 1/37 (3%) 0/34 (0%) |
|FIRST INCIDENCE | 584 590 669 537 |634 --- 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.259N P=0.030N* P=0.014N* P=0.565 |P=0.125N P=0.106N P=0.457N P=0.120N |
|POLY 3 | P=0.047N* P=0.035N* P=0.028N* P=0.093N |P=0.128N P=0.107N P=0.472N P=0.114N |
|POLY 1.5 | P=0.040N* P=0.036N* P=0.031N* P=0.059N |P=0.127N P=0.111N P=0.480N P=0.114N |
|POLY 6 | P=0.053N P=0.032N* P=0.024N* P=0.191N |P=0.131N P=0.106N P=0.468N P=0.115N |
|LOGISTIC REGRESSION| P=0.044N* P=0.038N* P=0.029N* P=0.137N |P=0.126N P=0.120N P=0.494N P=0.119N |
|COCH-ARM / FISHERS | P=0.033N* P=0.036N* P=0.036N* P=0.036N* |P=0.126N P=0.121N P=0.500N P=0.121N |
|ORDER RESTRICTED | P=0.027N* (e) (e) (e) |P=0.034N* (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 2/41.64 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 710 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.568 P=0.432N P=0.934N |(e) (e) (e) (e) |
|POLY 3 | P=0.202N P=0.496 P=0.490N P=0.554N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.198N P=0.496 P=0.495N P=0.527N |(e) (e) (e) (e) |
|POLY 6 | P=0.210N P=0.503 P=0.481N P=0.598N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.315N P=0.527 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.226N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.16 2/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 0.0% 0.0% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/22 (0%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 709 729 (T) --- --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.563 P=0.460N P=0.909N |P=0.195 (e) (e) P=0.512 |
|POLY 3 | P=0.202N P=0.495 P=0.490N P=0.554N |P=0.200 (e) (e) P=0.507 |
|POLY 1.5 | P=0.198N P=0.495 P=0.495N P=0.528N |P=0.200 (e) (e) P=0.506 |
|POLY 6 | P=0.211N P=0.500 P=0.482N P=0.599N |P=0.198 (e) (e) P=0.506 |
|LOGISTIC REGRESSION| P=0.313N P=0.525 P=0.485N P=0.717N |(e) (e) (e) P=0.512 |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.226N (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 11/43.14 5/42.43 3/44.53 3/33.02 |3/44.48 0/47.49 2/47.33 1/45.76 |
|POLY-3 PERCENT (g) | 25.5% 11.8% 6.7% 9.1% |6.7% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 4/22 (18%) 2/27 (7%) 2/31 (7%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 584 590 669 537 |634 --- 701 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.063N P=0.008N** P=0.592 |P=0.337N P=0.106N P=0.457N P=0.296N |
|POLY 3 | P=0.021N* P=0.086N P=0.015N* P=0.061N |P=0.344N P=0.107N P=0.472N P=0.295N |
|POLY 1.5 | P=0.017N* P=0.087N P=0.017N* P=0.036N* |P=0.341N P=0.111N P=0.480N P=0.296N |
|POLY 6 | P=0.025N* P=0.080N P=0.013N* P=0.141N |P=0.349N P=0.106N P=0.468N P=0.299N |
|LOGISTIC REGRESSION| P=0.023N* P=0.089N P=0.016N* P=0.103N |P=0.335N P=0.120N P=0.494N P=0.298N |
|COCH-ARM / FISHERS | P=0.013N* P=0.086N P=0.020N* P=0.020N* |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.019N* (e) (e) (e) |P=0.172N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 5/50 (10%) 3/50 (6%) 3/50 (6%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 11/43.14 5/42.43 3/44.53 3/33.02 |3/44.48 0/47.49 2/47.33 1/45.76 |
|POLY-3 PERCENT (g) | 25.5% 11.8% 6.7% 9.1% |6.7% 0.0% 4.2% 2.2% |
|TERMINAL (d) | 4/22 (18%) 2/27 (7%) 2/31 (7%) 0/2 (0%) |1/32 (3%) 0/38 (0%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 584 590 669 537 |634 --- 701 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.063N P=0.008N** P=0.592 |P=0.337N P=0.106N P=0.457N P=0.296N |
|POLY 3 | P=0.021N* P=0.086N P=0.015N* P=0.061N |P=0.344N P=0.107N P=0.472N P=0.295N |
|POLY 1.5 | P=0.017N* P=0.087N P=0.017N* P=0.036N* |P=0.341N P=0.111N P=0.480N P=0.296N |
|POLY 6 | P=0.025N* P=0.080N P=0.013N* P=0.141N |P=0.349N P=0.106N P=0.468N P=0.299N |
|LOGISTIC REGRESSION| P=0.023N* P=0.089N P=0.016N* P=0.103N |P=0.335N P=0.120N P=0.494N P=0.298N |
|COCH-ARM / FISHERS | P=0.013N* P=0.086N P=0.020N* P=0.020N* |P=0.337N P=0.121N P=0.500N P=0.309N |
|ORDER RESTRICTED | P=0.019N* (e) (e) (e) |P=0.172N (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 46/50 (92%) 46/50 (92%) 48/50 (96%) | |
|POLY-3 RATE (b) | 45/48.31 46/46.96 46/48.16 48/48.92 | |
|POLY-3 PERCENT (g) | 93.2% 98.0% 95.5% 98.1% | |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 31/31 (100%) 2/2 (100%) | |
|FIRST INCIDENCE | 495 484 486 487 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.292N P=0.055N P<0.001 ** | |
|POLY 3 | P=0.172 P=0.219 P=0.473 P=0.203 | |
|POLY 1.5 | P=0.177 P=0.311 P=0.486 P=0.211 | |
|POLY 6 | P=0.156 P=0.178 P=0.466 P=0.196 | |
|LOGISTIC REGRESSION| P=0.040 * P=0.294 P=0.590 P=0.079 | |
|COCH-ARM / FISHERS | P=0.170 P=0.500 P=0.500 P=0.218 | |
|ORDER RESTRICTED | P=0.084 (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 6/50 (12%) 9/50 (18%) 4/50 (8%) |4/50 (8%) 6/50 (12%) 3/50 (6%) 6/50 (12%) |
|POLY-3 RATE (b) | 10/42.92 6/41.62 9/44.62 4/33.08 |4/44.14 6/47.51 3/47.22 6/46.55 |
|POLY-3 PERCENT (g) | 23.3% 14.4% 20.2% 12.1% |9.1% 12.6% 6.4% 12.9% |
|TERMINAL (d) | 5/22 (23%) 5/27 (19%) 6/31 (19%) 0/2 (0%) |3/32 (9%) 5/38 (13%) 3/37 (8%) 3/34 (9%) |
|FIRST INCIDENCE | 638 715 691 621 |724 725 729 (T) 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314 P=0.128N P=0.248N P=0.318 |P=0.392 P=0.476 P=0.430N P=0.398 |
|POLY 3 | P=0.197N P=0.221N P=0.462N P=0.171N |P=0.415 P=0.417 P=0.463N P=0.403 |
|POLY 1.5 | P=0.141N P=0.218N P=0.480N P=0.115N |P=0.409 P=0.403 P=0.474N P=0.395 |
|POLY 6 | P=0.300N P=0.219N P=0.431N P=0.307N |P=0.414 P=0.426 P=0.457N P=0.405 |
|LOGISTIC REGRESSION| P=0.395N P=0.191N P=0.406N P=0.354N |P=0.398 P=0.433 P=0.459N P=0.378 |
|COCH-ARM / FISHERS | P=0.093N P=0.207N P=0.500N P=0.074N |P=0.388 P=0.370 P=0.500N P=0.370 |
|ORDER RESTRICTED | P=0.174N (e) (e) (e) |P=0.439 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/42.08 2/41.56 2/44.30 1/32.09 |0/44.12 1/47.49 1/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 4.5% 3.1% |0.0% 2.1% 2.1% 2.2% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 1/38 (3%) 1/37 (3%) 1/34 (3%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 708 |--- 729 (T) 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.220 P=0.572 P=0.620 P=0.354 |P=0.385 P=0.534 P=0.529 P=0.512 |
|POLY 3 | P=0.533 P=0.496 P=0.518 P=0.697 |P=0.396 P=0.515 P=0.514 P=0.507 |
|POLY 1.5 | P=0.597 P=0.495 P=0.509 P=0.729 |P=0.394 P=0.510 P=0.510 P=0.506 |
|POLY 6 | P=0.444 P=0.501 P=0.533 P=0.635 |P=0.393 P=0.518 P=0.516 P=0.506 |
|LOGISTIC REGRESSION| P=0.277 P=0.572 P=0.620 P=0.442 |(e) P=0.534 P=0.529 P=0.512 |
|COCH-ARM / FISHERS | P=0.556N P=0.500 P=0.500 P=0.753N |P=0.384 P=0.500 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.545 (e) (e) (e) |P=0.335 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 10/50 (20%) 5/50 (10%) |4/50 (8%) 7/50 (14%) 4/50 (8%) 7/50 (14%) |
|POLY-3 RATE (b) | 11/42.92 8/41.62 10/44.62 5/33.16 |4/44.14 7/47.51 4/47.22 7/46.55 |
|POLY-3 PERCENT (g) | 25.6% 19.2% 22.4% 15.1% |9.1% 14.7% 8.5% 15.0% |
|TERMINAL (d) | 6/22 (27%) 7/27 (26%) 7/31 (23%) 0/2 (0%) |3/32 (9%) 6/38 (16%) 4/37 (11%) 4/34 (12%) |
|FIRST INCIDENCE | 638 715 691 621 |724 725 729 (T) 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.210 P=0.183N P=0.230N P=0.181 |P=0.300 P=0.364 P=0.570N P=0.291 |
|POLY 3 | P=0.205N P=0.327N P=0.459N P=0.201N |P=0.325 P=0.305 P=0.606N P=0.292 |
|POLY 1.5 | P=0.143N P=0.322N P=0.479N P=0.135N |P=0.319 P=0.292 P=0.617N P=0.285 |
|POLY 6 | P=0.318N P=0.327N P=0.426N P=0.359N |P=0.324 P=0.314 P=0.599N P=0.293 |
|LOGISTIC REGRESSION| P=0.492N P=0.276N P=0.390N P=0.492N |P=0.305 P=0.319 P=0.603N P=0.272 |
|COCH-ARM / FISHERS | P=0.091N P=0.306N P=0.500N P=0.086N |P=0.297 P=0.262 P=0.643N P=0.262 |
|ORDER RESTRICTED | P=0.221N (e) (e) (e) |P=0.305 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 2/42.42 2/41.70 3/44.71 3/33.80 |0/44.12 0/47.49 0/47.22 1/45.76 |
|POLY-3 PERCENT (g) | 4.7% 4.8% 6.7% 8.9% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/22 (5%) 0/27 (0%) 2/31 (7%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 1/34 (3%) |
|FIRST INCIDENCE | 634 709 613 487 |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100 P=0.654N P=0.594 P=0.275 |P=0.195 (e) (e) P=0.512 |
|POLY 3 | P=0.272 P=0.688 P=0.524 P=0.398 |P=0.200 (e) (e) P=0.507 |
|POLY 1.5 | P=0.318 P=0.688 P=0.513 P=0.448 |P=0.200 (e) (e) P=0.506 |
|POLY 6 | P=0.211 P=0.693 P=0.543 P=0.314 |P=0.198 (e) (e) P=0.506 |
|LOGISTIC REGRESSION| P=0.446 P=0.692 P=0.499 P=0.675N |(e) (e) (e) P=0.512 |
|COCH-ARM / FISHERS | P=0.371 P=0.691N P=0.500 P=0.500 |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.377 (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |6/50 (12%) 9/50 (18%) 10/50 (20%) 10/50 (20%) |
|POLY-3 RATE (b) | |6/44.12 9/47.99 10/47.66 10/46.21 |
|POLY-3 PERCENT (g) | |13.6% 18.8% 21.0% 21.6% |
|TERMINAL (d) | |6/32 (19%) 7/38 (18%) 8/37 (22%) 8/34 (24%) |
|FIRST INCIDENCE | |729 (T) 633 633 653 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.203 P=0.413 P=0.300 P=0.243 |
|POLY 3 | |P=0.218 P=0.350 P=0.257 P=0.234 |
|POLY 1.5 | |P=0.215 P=0.330 P=0.240 P=0.228 |
|POLY 6 | |P=0.215 P=0.368 P=0.270 P=0.236 |
|LOGISTIC REGRESSION| |P=0.204 P=0.350 P=0.258 P=0.219 |
|COCH-ARM / FISHERS | |P=0.198 P=0.288 P=0.207 P=0.207 |
|ORDER RESTRICTED | |P=0.268 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/42.08 0/41.56 0/44.30 0/32.01 |0/44.12 0/47.49 1/47.84 2/46.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 2.1% 4.3% |
|TERMINAL (d) | 0/22 (0%) 0/27 (0%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.074 (e) P=0.512 P=0.254 |
|POLY 3 | (e) (e) (e) (e) |P=0.074 (e) P=0.516 P=0.251 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.073 (e) P=0.511 P=0.248 |
|POLY 6 | (e) (e) (e) (e) |P=0.074 (e) P=0.520 P=0.253 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.007 ** (e) P=0.275 P=0.068 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.070 (e) P=0.500 P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.083 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 41/50 (82%) 39/50 (78%) 24/50 (48%) |19/50 (38%) 25/50 (50%) 30/50 (60%) 29/50 (58%) |
|POLY-3 RATE (b) | 27/48.36 41/49.82 39/48.01 24/40.48 |19/44.91 25/48.56 30/48.94 29/48.68 |
|POLY-3 PERCENT (g) | 55.8% 82.3% 81.2% 59.3% |42.3% 51.5% 61.3% 59.6% |
|TERMINAL (d) | 6/22 (27%) 20/27 (74%) 25/31 (81%) 2/2 (100%) |13/32 (41%) 19/38 (50%) 21/37 (57%) 20/34 (59%) |
|FIRST INCIDENCE | 425 344 494 487 |637 613 609 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.086 P=0.317 P=0.003 ** |P=0.052 P=0.383 P=0.115 P=0.084 |
|POLY 3 | P=0.508 P=0.003 ** P=0.005 ** P=0.454 |P=0.058 P=0.247 P=0.048 * P=0.068 |
|POLY 1.5 | P=0.292N P=0.002 ** P=0.006 ** P=0.540N |P=0.047 * P=0.216 P=0.037 * P=0.056 |
|POLY 6 | P=0.135 P=0.004 ** P=0.004 ** P=0.196 |P=0.066 P=0.271 P=0.060 P=0.078 |
|LOGISTIC REGRESSION| P=0.062N P=0.002 ** P=0.008 ** P=0.139N |P=0.034 * P=0.250 P=0.042 * P=0.045 * |
|COCH-ARM / FISHERS | P=0.091N P=0.002 ** P=0.010 * P=0.345N |P=0.029 * P=0.157 P=0.022 * P=0.036 * |
|ORDER RESTRICTED | P=0.025 * (e) (e) (e) |P=0.057 (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.65 3/42.03 2/44.77 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 7.1% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 549 590 624 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.547 P=0.635N P=0.466N |(e) (e) (e) (e) |
|POLY 3 | P=0.203N P=0.493 P=0.677N P=0.306N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.169N P=0.493 P=0.685N P=0.271N |(e) (e) (e) (e) |
|POLY 6 | P=0.270N P=0.500 P=0.661N P=0.372N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.122N P=0.508 P=0.670 P=0.194N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.500 P=0.691N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.190N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Mesothelioma: Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/42.65 3/42.03 2/44.77 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 4.7% 7.1% 4.5% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 2/27 (7%) 0/31 (0%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 549 590 624 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.286N P=0.547 P=0.635N P=0.466N |(e) (e) (e) (e) |
|POLY 3 | P=0.203N P=0.493 P=0.677N P=0.306N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.169N P=0.493 P=0.685N P=0.271N |(e) (e) (e) (e) |
|POLY 6 | P=0.270N P=0.500 P=0.661N P=0.372N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.122N P=0.508 P=0.670 P=0.194N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.500 P=0.691N P=0.247N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.190N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 23
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 2/41.64 1/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 710 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.557N P=0.568 P=0.684N P=0.934N |(e) (e) (e) (e) |
|POLY 3 | P=0.304N P=0.496 P=0.749N P=0.554N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.278N P=0.496 P=0.755N P=0.527N |(e) (e) (e) (e) |
|POLY 6 | P=0.354N P=0.503 P=0.740N P=0.598N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.480N P=0.527 P=0.684N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.283N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/42.08 2/41.64 1/44.30 0/32.01 |0/44.12 0/47.49 0/47.22 0/45.76 |
|POLY-3 PERCENT (g) | 2.4% 4.8% 2.3% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/22 (5%) 1/27 (4%) 1/31 (3%) 0/2 (0%) |0/32 (0%) 0/38 (0%) 0/37 (0%) 0/34 (0%) |
|FIRST INCIDENCE | 729 (T) 710 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.557N P=0.568 P=0.684N P=0.934N |(e) (e) (e) (e) |
|POLY 3 | P=0.304N P=0.496 P=0.749N P=0.554N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.278N P=0.496 P=0.755N P=0.527N |(e) (e) (e) (e) |
|POLY 6 | P=0.354N P=0.503 P=0.740N P=0.598N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.480N P=0.527 P=0.684N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.247N P=0.500 P=0.753N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.283N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 24
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 49/50 (98%) 47/50 (94%) 49/50 (98%) 50/50 (100%)|42/50 (84%) 40/50 (80%) 37/50 (74%) 33/50 (66%) |
|POLY-3 RATE (b) | 49/49.20 47/47.56 49/49.31 50/50.00 |42/48.73 40/49.18 37/49.11 33/48.18 |
|POLY-3 PERCENT (g) | 99.6% 98.8% 99.4% 100.0% |86.2% 81.3% 75.4% 68.5% |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 31/31 (100%) 2/2 (100%) |27/32 (84%) 30/38 (79%) 28/37 (76%) 22/34 (65%) |
|FIRST INCIDENCE | 495 484 486 487 |288 613 609 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.165N P=0.046N* P<0.001 ** |P=0.052N P=0.119N P=0.068N P=0.059N |
|POLY 3 | P=0.655 P=0.932N P=0.991N P=1.000 |P=0.016N* P=0.351N P=0.130N P=0.028N* |
|POLY 1.5 | P=0.349 P=0.576N P=0.891N P=0.891 |P=0.015N* P=0.358N P=0.136N P=0.026N* |
|POLY 6 | P=1.000 P=1.000N P=1.000N P=1.000 |P=0.020N* P=0.358N P=0.131N P=0.034N* |
|LOGISTIC REGRESSION| P=0.406 P=0.633N P=0.712N (e) |P=0.014N* P=0.335N P=0.137N P=0.027N* |
|COCH-ARM / FISHERS | P=0.200 P=0.309N P=0.753N P=0.500 |P=0.017N* P=0.398N P=0.163N P=0.032N* |
|ORDER RESTRICTED | P=0.232 (e) (e) (e) |P=0.021N* (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 42/50 (84%) 40/50 (80%) 26/50 (52%) |20/50 (40%) 29/50 (58%) 32/50 (64%) 32/50 (64%) |
|POLY-3 RATE (b) | 33/49.44 42/49.82 40/48.38 26/41.59 |20/44.93 29/48.98 32/49.71 32/49.17 |
|POLY-3 PERCENT (g) | 66.7% 84.3% 82.7% 62.5% |44.5% 59.2% 64.4% 65.1% |
|TERMINAL (d) | 9/22 (41%) 21/27 (78%) 25/31 (81%) 2/2 (100%) |13/32 (41%) 22/38 (58%) 21/37 (57%) 22/34 (65%) |
|FIRST INCIDENCE | 425 344 494 487 |637 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.268 P=0.479N P=0.006 ** |P=0.038 * P=0.224 P=0.096 P=0.047 * |
|POLY 3 | P=0.275N P=0.033 * P=0.053 P=0.417N |P=0.041 * P=0.109 P=0.039 * P=0.033 * |
|POLY 1.5 | P=0.094N P=0.032 * P=0.063 P=0.243N |P=0.031 * P=0.087 P=0.026 * P=0.024 * |
|POLY 6 | P=0.393 P=0.035 * P=0.047 * P=0.456 |P=0.051 P=0.129 P=0.054 P=0.041 * |
|LOGISTIC REGRESSION| P=0.008N** P=0.015 * P=0.064 P=0.017N* |P=0.018 * P=0.101 P=0.023 * P=0.018 * |
|COCH-ARM / FISHERS | P=0.019N* P=0.032 * P=0.088 P=0.111N |P=0.016 * P=0.055 P=0.014 * P=0.014 * |
|ORDER RESTRICTED | P=0.059N (e) (e) (e) |P=0.029 * (e) (e) (e) |
|=================================================================================================================================|
Date: 08/23/04 EXPERIMENT: 88138 TEST: 03 Page 25
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - BENZOPHENONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 312 PPM 625 PPM 1250 PPM |0 PPM 312 PPM 625 PPM 1250 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 50/50 (100%) 50/50 (100%) 50/50 (100%) 50/50 (100%)|46/50 (92%) 46/50 (92%) 45/50 (90%) 44/50 (88%) |
|POLY-3 RATE (b) | 50/50.00 50/50.00 50/50.00 50/50.00 |46/48.75 46/50.00 45/50.00 44/50.00 |
|POLY-3 PERCENT (g) | 100.0% 100.0% 100.0% 100.0% |94.4% 92.0% 90.0% 88.0% |
|TERMINAL (d) | 22/22 (100%) 27/27 (100%) 31/31 (100%) 2/2 (100%) |30/32 (94%) 34/38 (90%) 32/37 (87%) 28/34 (82%) |
|FIRST INCIDENCE | 425 344 486 487 |288 609 528 480 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.349N P=0.159N P=0.173N P=0.309N |
|POLY 3 | (e) (e) (e) (e) |P=0.167N P=0.473N P=0.330N P=0.221N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.197N P=0.531N P=0.384N P=0.265N |
|POLY 6 | (e) (e) (e) (e) |P=0.144N P=0.420N P=0.285N P=0.185N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.268N P=0.549N P=0.422N P=0.340N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.270N P=0.643N P=0.500N P=0.370N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.210N (e) (e) (e) |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Number of tumor-bearing animals / Poly-3 number
(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.
Logistic regression is an alternative
method for analyzing the incidence of non-fatal tumors. The Cochran-Armitage
and Fishers 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.
(g) Poly-3 adjusted lifetime tumor incidence.
(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).