TDMS Study 88036-04 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ANTHRAQUINONE DATE: 12/11/98
EXPERIMENT: 88036 TEST: 04 TIME: 09:00:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: RYAN, M. CAS: 84-65-1
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ANTHRAQUINONE DATE: 12/11/98
EXPERIMENT: 88036 TEST: 04 TIME: 09:00:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: RYAN, M. CAS: 84-65-1
Mice(B6C3F1)
-----------------------------
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
Bone Marrow
Epididymis
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Salivary Glands
Spleen
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ANTHRAQUINONE DATE: 12/11/98
EXPERIMENT: 88036 TEST: 04 TIME: 09:00:07
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25337 ROUTE: DOSED FEED NTP C#: C88036
PATHOLOGIST: RYAN, M. CAS: 84-65-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ANTHRAQUINONE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatoblastoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Thyroid Gland: Follicular Cell Adenoma
Carcinoma or Adenoma
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Thyroid Gland: Follicular Cell Carcinoma
All Organs Benign Tumors
Malignant and Benign Tumors
===============================================================
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |2/50 (4%) 3/50 (6%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.1% 8.5% 8.4% 9.9% |4.5% 6.4% 8.9% 2.2% |
|TERMINAL (d) | 1/45 (2%) 3/41 (7%) 3/43 (7%) 2/23 (9%) |2/35 (6%) 3/42 (7%) 3/35 (9%) 1/42 (2%) |
|FIRST INCIDENCE | 550 662 662 647 |730 (T) 730 (T) 675 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.460 P=0.480 P=0.264 |P=0.262N P=0.583 P=0.338 P=0.436N |
|POLY 3 | P=0.375 P=0.480 P=0.486 P=0.398 |P=0.299N P=0.518 P=0.339 P=0.491N |
|POLY 1.5 | P=0.429 P=0.492 P=0.495 P=0.447 |P=0.307N P=0.512 P=0.341 P=0.498N |
|POLY 6 | P=0.307 P=0.465 P=0.479 P=0.334 |P=0.286N P=0.527 P=0.335 P=0.481N |
|LOGISTIC REGRESSION| P=0.517 P=0.488 P=0.486 P=0.531 |P=0.286N P=0.583 P=0.328 P=0.436N |
|COCH-ARM / FISHERS | P=0.492 P=0.500 P=0.500 P=0.500 |P=0.305N P=0.500 P=0.339 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 4/50 (8%) 4/50 (8%) |2/50 (4%) 4/50 (8%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.1% 8.5% 8.4% 9.9% |4.5% 8.6% 8.9% 2.2% |
|TERMINAL (d) | 1/45 (2%) 3/41 (7%) 3/43 (7%) 2/23 (9%) |2/35 (6%) 4/42 (10%) 3/35 (9%) 1/42 (2%) |
|FIRST INCIDENCE | 550 662 662 647 |730 (T) 730 (T) 675 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.199 P=0.460 P=0.480 P=0.264 |P=0.207N P=0.424 P=0.338 P=0.436N |
|POLY 3 | P=0.375 P=0.480 P=0.486 P=0.398 |P=0.238N P=0.356 P=0.339 P=0.491N |
|POLY 1.5 | P=0.429 P=0.492 P=0.495 P=0.447 |P=0.247N P=0.350 P=0.341 P=0.498N |
|POLY 6 | P=0.307 P=0.465 P=0.479 P=0.334 |P=0.226N P=0.365 P=0.335 P=0.481N |
|LOGISTIC REGRESSION| P=0.517 P=0.488 P=0.486 P=0.531 |P=0.227N P=0.424 P=0.328 P=0.436N |
|COCH-ARM / FISHERS | P=0.492 P=0.500 P=0.500 P=0.500 |P=0.246N P=0.339 P=0.339 P=0.500N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 0/42 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 2.1% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/45 (4%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 729 (T) --- 727 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.390N P=0.259N P=0.513N P=0.395N |(e) (e) (e) (e) |
|POLY 3 | P=0.313N P=0.243N P=0.505N P=0.306N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.307N P=0.239N P=0.501N P=0.291N |(e) (e) (e) (e) |
|POLY 6 | P=0.322N P=0.248N P=0.508N P=0.330N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.379N (e) P=0.509N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.300N P=0.247N P=0.500N P=0.293N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/47 (0%) |0/49 (0%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 1/41 (2%) 2/43 (5%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- 729 (T) 729 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.691N P=0.481 P=0.229 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.600N P=0.495 P=0.234 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.568N P=0.498 P=0.237 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.643N P=0.490 P=0.232 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.481 P=0.229 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.535N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 11/50 (22%) 37/49 (76%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.1% 12.8% 22.9% 79.2% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/45 (2%) 5/41 (12%) 10/43 (23%) 15/23 (65%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | 729 (T) 658 481 490 |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.048 * P=0.002 ** P<0.001 ** |P=0.234 (e) (e) P=0.536 |
|POLY 3 | P<0.001 ** P=0.053 P=0.002 ** P<0.001 ** |P=0.214 (e) (e) P=0.504 |
|POLY 1.5 | P<0.001 ** P=0.056 P=0.002 ** P<0.001 ** |P=0.212 (e) (e) P=0.501 |
|POLY 6 | P<0.001 ** P=0.050 P=0.002 ** P<0.001 ** |P=0.217 (e) (e) P=0.510 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.056 P=0.003 ** P<0.001 ** |(e) (e) (e) P=0.536 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.056 P=0.002 ** P<0.001 ** |P=0.213 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 21/50 (42%) 32/50 (64%) 38/50 (76%) 41/49 (84%) |6/49 (12%) 28/50 (56%) 27/50 (54%) 40/49 (82%) |
|POLY-3 ADJUSTED (b)| 43.4% 68.0% 79.7% 89.4% |13.4% 59.5% 58.9% 87.2% |
|TERMINAL (d) | 19/45 (42%) 30/41 (73%) 36/43 (84%) 22/23 (96%) |4/35 (11%) 27/42 (64%) 23/35 (66%) 38/42 (91%) |
|FIRST INCIDENCE | 662 677 662 490 |519 611 626 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.016 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.007 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.022 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 13/50 (26%) 17/50 (34%) 21/49 (43%) |2/49 (4%) 3/50 (6%) 8/50 (16%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| 16.6% 27.1% 35.9% 49.8% |4.5% 6.4% 17.4% 17.7% |
|TERMINAL (d) | 7/45 (16%) 11/41 (27%) 17/43 (40%) 14/23 (61%) |1/35 (3%) 3/42 (7%) 4/35 (11%) 7/42 (17%) |
|FIRST INCIDENCE | 702 464 729 (T) 456 |715 730 (T) 568 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.120 P=0.024 * P<0.001 ** |P=0.057 P=0.572 P=0.052 P=0.084 |
|POLY 3 | P<0.001 ** P=0.160 P=0.026 * P<0.001 ** |P=0.031 * P=0.524 P=0.051 P=0.048 * |
|POLY 1.5 | P<0.001 ** P=0.167 P=0.029 * P<0.001 ** |P=0.029 * P=0.519 P=0.051 P=0.045 * |
|POLY 6 | P<0.001 ** P=0.150 P=0.024 * P<0.001 ** |P=0.035 * P=0.530 P=0.051 P=0.053 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.163 P=0.026 * P<0.001 ** |P=0.031 * P=0.541 P=0.051 P=0.058 |
|COCH-ARM / FISHERS | P=0.004 ** P=0.163 P=0.032 * P=0.003 ** |P=0.031 * P=0.510 P=0.049 * P=0.046 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 18/50 (36%) 27/50 (54%) 45/49 (92%) |2/49 (4%) 3/50 (6%) 8/50 (16%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| 18.7% 37.3% 56.2% 92.7% |4.5% 6.4% 17.4% 17.7% |
|TERMINAL (d) | 8/45 (18%) 15/41 (37%) 26/43 (61%) 20/23 (87%) |1/35 (3%) 3/42 (7%) 4/35 (11%) 7/42 (17%) |
|FIRST INCIDENCE | 702 464 481 456 |715 730 (T) 568 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.023 * P<0.001 ** P<0.001 ** |P=0.057 P=0.572 P=0.052 P=0.084 |
|POLY 3 | P<0.001 ** P=0.033 * P<0.001 ** P<0.001 ** |P=0.031 * P=0.524 P=0.051 P=0.048 * |
|POLY 1.5 | P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P=0.029 * P=0.519 P=0.051 P=0.045 * |
|POLY 6 | P<0.001 ** P=0.031 * P<0.001 ** P<0.001 ** |P=0.035 * P=0.530 P=0.051 P=0.053 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.036 * P<0.001 ** P<0.001 ** |P=0.031 * P=0.541 P=0.051 P=0.058 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.035 * P<0.001 ** P<0.001 ** |P=0.031 * P=0.510 P=0.049 * P=0.046 * |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 34/50 (68%) 41/50 (82%) 46/49 (94%) |6/49 (12%) 30/50 (60%) 30/50 (60%) 41/49 (84%) |
|POLY-3 ADJUSTED (b)| 51.7% 70.5% 86.0% 96.1% |13.4% 63.8% 64.2% 89.3% |
|TERMINAL (d) | 23/45 (51%) 30/41 (73%) 39/43 (91%) 23/23 (100%)|4/35 (11%) 29/42 (69%) 24/35 (69%) 38/42 (91%) |
|FIRST INCIDENCE | 662 464 662 456 |519 611 568 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.019 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.051 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.034 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.052 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 26/50 (52%) 35/50 (70%) 43/50 (86%) 48/49 (98%) |6/49 (12%) 30/50 (60%) 30/50 (60%) 41/49 (84%) |
|POLY-3 ADJUSTED (b)| 53.8% 72.2% 88.9% 98.9% |13.4% 63.8% 64.2% 89.3% |
|TERMINAL (d) | 24/45 (53%) 30/41 (73%) 40/43 (93%) 23/23 (100%)|4/35 (11%) 29/42 (69%) 24/35 (69%) 38/42 (91%) |
|FIRST INCIDENCE | 662 464 481 456 |519 611 568 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.045 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.051 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.038 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.044 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.050 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 11/50 (22%) 8/50 (16%) 6/50 (12%) 8/50 (16%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 22.7% 17.1% 12.7% 19.5% |2.2% 2.1% 4.5% 6.7% |
|TERMINAL (d) | 8/45 (18%) 8/41 (20%) 6/43 (14%) 5/23 (22%) |1/35 (3%) 1/42 (2%) 2/35 (6%) 3/42 (7%) |
|FIRST INCIDENCE | 662 729 (T) 729 (T) 490 |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241 P=0.390N P=0.173N P=0.362 |P=0.221 P=0.721N P=0.500 P=0.372 |
|POLY 3 | P=0.489N P=0.335N P=0.155N P=0.454N |P=0.179 P=0.752N P=0.500 P=0.308 |
|POLY 1.5 | P=0.431N P=0.316N P=0.146N P=0.377N |P=0.174 P=0.755N P=0.502 P=0.300 |
|POLY 6 | P=0.553 P=0.362N P=0.163N P=0.567N |P=0.187 P=0.747N P=0.496 P=0.320 |
|LOGISTIC REGRESSION| P=0.513N P=0.333N P=0.148N P=0.382N |P=0.221 P=0.721N P=0.500 P=0.372 |
|COCH-ARM / FISHERS | P=0.367N P=0.306N P=0.143N P=0.306N |P=0.175 P=0.753N P=0.500 P=0.301 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 12/50 (24%) 11/50 (22%) 4/50 (8%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 16.7% 25.4% 23.2% 10.1% |6.6% 0.0% 0.0% 6.7% |
|TERMINAL (d) | 8/45 (18%) 11/41 (27%) 9/43 (21%) 4/23 (17%) |2/35 (6%) 0/42 (0%) 0/35 (0%) 3/42 (7%) |
|FIRST INCIDENCE | 729 (T) 601 711 729 (T) |613 --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.417N P=0.165 P=0.274 P=0.616N |P=0.335 P=0.102N P=0.123N P=0.589N |
|POLY 3 | P=0.138N P=0.213 P=0.295 P=0.281N |P=0.284 P=0.113N P=0.120N P=0.661 |
|POLY 1.5 | P=0.092N P=0.224 P=0.304 P=0.227N |P=0.282 P=0.115N P=0.119N P=0.653 |
|POLY 6 | P=0.225N P=0.200 P=0.288 P=0.368N |P=0.287 P=0.111N P=0.123N P=0.651N |
|LOGISTIC REGRESSION| P=0.256N P=0.202 P=0.281 P=0.616N |P=0.289 P=0.124N P=0.121N P=0.659 |
|COCH-ARM / FISHERS | P=0.056N P=0.227 P=0.306 P=0.178N |P=0.289 P=0.121N P=0.121N P=0.651 |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 19/50 (38%) 17/50 (34%) 12/50 (24%) |4/50 (8%) 1/50 (2%) 2/50 (4%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 35.1% 40.2% 35.9% 29.2% |8.8% 2.1% 4.5% 13.3% |
|TERMINAL (d) | 14/45 (31%) 18/41 (44%) 15/43 (35%) 9/23 (39%) |3/35 (9%) 1/42 (2%) 2/35 (6%) 6/42 (14%) |
|FIRST INCIDENCE | 662 601 711 490 |613 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.285 P=0.297 P=0.523 P=0.277 |P=0.133 P=0.141N P=0.338N P=0.477 |
|POLY 3 | P=0.235N P=0.379 P=0.554 P=0.356N |P=0.089 P=0.169N P=0.341N P=0.368 |
|POLY 1.5 | P=0.157N P=0.407 P=0.575 P=0.264N |P=0.087 P=0.172N P=0.337N P=0.358 |
|POLY 6 | P=0.375N P=0.344 P=0.533 P=0.505N |P=0.094 P=0.165N P=0.350N P=0.385 |
|LOGISTIC REGRESSION| P=0.343N P=0.376 P=0.558 P=0.417N |P=0.100 P=0.175N P=0.337N P=0.375 |
|COCH-ARM / FISHERS | P=0.095N P=0.418 P=0.583N P=0.189N |P=0.092 P=0.181N P=0.339N P=0.357 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/45 (4%) 0/50 (0%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| |5.0% 0.0% 4.6% 0.0% |
|TERMINAL (d) | |2/33 (6%) 0/42 (0%) 2/34 (6%) 0/42 (0%) |
|FIRST INCIDENCE | |730 (T) --- 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.248N P=0.187N P=0.685N P=0.187N |
|POLY 3 | |P=0.273N P=0.205N P=0.664N P=0.212N |
|POLY 1.5 | |P=0.275N P=0.208N P=0.661N P=0.217N |
|POLY 6 | |P=0.268N P=0.202N P=0.671N P=0.206N |
|LOGISTIC REGRESSION| |P=0.248N (e) P=0.685N (e) |
|COCH-ARM / FISHERS | |P=0.271N P=0.222N P=0.659N P=0.226N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 1/47 (2%) 0/46 (0%) |4/47 (9%) 7/50 (14%) 4/48 (8%) 6/46 (13%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.2% 0.0% |9.4% 15.0% 9.2% 14.1% |
|TERMINAL (d) | 0/43 (0%) 0/39 (0%) 1/41 (2%) 0/22 (0%) |3/33 (9%) 6/42 (14%) 3/35 (9%) 5/39 (13%) |
|FIRST INCIDENCE | --- --- 729 (T) --- |717 703 626 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.797 (e) P=0.490 (e) |P=0.500 P=0.397 P=0.622N P=0.461 |
|POLY 3 | P=0.770 (e) P=0.493 (e) |P=0.428 P=0.318 P=0.632N P=0.372 |
|POLY 1.5 | P=0.796 (e) P=0.496 (e) |P=0.415 P=0.311 P=0.629N P=0.359 |
|POLY 6 | P=0.727 (e) P=0.492 (e) |P=0.451 P=0.328 P=0.637N P=0.393 |
|LOGISTIC REGRESSION| (e) (e) P=0.490 (e) |P=0.415 P=0.340 P=0.639N P=0.356 |
|COCH-ARM / FISHERS | P=0.792N (e) P=0.495 (e) |P=0.416 P=0.299 P=0.631N P=0.356 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 6.4% 4.4% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 2/42 (5%) 1/35 (3%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |617 648 627 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.110N P=0.550 P=0.686 P=0.224N |
|POLY 3 | (e) (e) (e) (e) |P=0.117N P=0.517 P=0.693 P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.120N P=0.511 P=0.692N P=0.237N |
|POLY 6 | (e) (e) (e) (e) |P=0.113N P=0.524 P=0.689 P=0.229N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.113N P=0.482 P=0.683 P=0.233N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.118N P=0.500 P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 4.3% 2.2% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 2/42 (5%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |617 730 (T) 627 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.135N P=0.648N P=0.507N P=0.224N |
|POLY 3 | (e) (e) (e) (e) |P=0.142N P=0.683N P=0.501N P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.144N P=0.686N P=0.499N P=0.237N |
|POLY 6 | (e) (e) (e) (e) |P=0.139N P=0.679N P=0.505N P=0.229N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.137N P=0.693 P=0.529N P=0.233N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.142N P=0.691N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.4% 6.4% 4.4% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 2/42 (5%) 1/35 (3%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- --- --- |617 648 627 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.110N P=0.550 P=0.686 P=0.224N |
|POLY 3 | (e) (e) (e) (e) |P=0.117N P=0.517 P=0.693 P=0.234N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.120N P=0.511 P=0.692N P=0.237N |
|POLY 6 | (e) (e) (e) (e) |P=0.113N P=0.524 P=0.689 P=0.229N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.113N P=0.482 P=0.683 P=0.233N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.118N P=0.500 P=0.691N P=0.247N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Schwannoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.2% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 1/43 (2%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | --- --- 453 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.725 (e) P=0.237 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.684 (e) P=0.238 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.724 (e) P=0.239 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.616 (e) P=0.237 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.688N (e) P=0.178 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.695N (e) P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/49 (0%) 0/42 (0%) |0/45 (0%) 1/49 (2%) 0/48 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 0.0% 0.0% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 710 --- --- --- |--- 611 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.322N P=0.260N P=0.247N P=0.399N |P=0.579N P=0.513 (e) (e) |
|POLY 3 | P=0.255N P=0.244N P=0.242N P=0.310N |P=0.577N P=0.522 (e) (e) |
|POLY 1.5 | P=0.259N P=0.239N P=0.241N P=0.293N |P=0.579N P=0.521 (e) (e) |
|POLY 6 | P=0.248N P=0.249N P=0.244N P=0.335N |P=0.574N P=0.524 (e) (e) |
|LOGISTIC REGRESSION| P=0.276N P=0.240N P=0.241N P=0.323N |P=0.529N P=0.459 (e) (e) |
|COCH-ARM / FISHERS | P=0.262N P=0.247N P=0.253N P=0.293N |P=0.581N P=0.521 (e) (e) |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.7% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |3/35 (9%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | --- --- --- --- |730 (T) --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.409N P=0.091N P=0.121N P=0.242N |
|POLY 3 | (e) (e) (e) (e) |P=0.450N P=0.112N P=0.119N P=0.297N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.449N P=0.114N P=0.118N P=0.304N |
|POLY 6 | (e) (e) (e) (e) |P=0.450N P=0.108N P=0.121N P=0.286N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.409N (e) (e) P=0.242N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.443N P=0.121N P=0.121N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 2/46 (4%) |1/45 (2%) 1/48 (2%) 2/48 (4%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 5.3% |2.4% 2.2% 4.6% 4.5% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 2/43 (5%) 2/23 (9%) |1/35 (3%) 1/42 (2%) 2/35 (6%) 2/42 (5%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * (e) P=0.229 P=0.107 |P=0.429 P=0.721N P=0.500 P=0.564 |
|POLY 3 | P=0.078 (e) P=0.230 P=0.188 |P=0.393 P=0.741N P=0.519 P=0.522 |
|POLY 1.5 | P=0.091 (e) P=0.233 P=0.203 |P=0.390 P=0.742N P=0.523 P=0.519 |
|POLY 6 | P=0.063 (e) P=0.229 P=0.168 |P=0.399 P=0.739N P=0.513 P=0.528 |
|LOGISTIC REGRESSION| (e) (e) P=0.229 P=0.107 |P=0.429 P=0.721N P=0.500 P=0.564 |
|COCH-ARM / FISHERS | P=0.107 (e) P=0.242 P=0.227 |P=0.397 P=0.736N P=0.524 P=0.524 |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/46 (0%) |0/45 (0%) 0/48 (0%) 0/48 (0%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.5% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 0/43 (0%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 2/42 (5%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.052 (e) (e) P=0.279 |
|POLY 3 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.252 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.042 * (e) (e) P=0.250 |
|POLY 6 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.255 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.279 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.264 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/49 (4%) 2/46 (4%) |1/45 (2%) 1/48 (2%) 2/48 (4%) 4/48 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.3% 5.3% |2.4% 2.2% 4.6% 9.1% |
|TERMINAL (d) | 0/45 (0%) 0/41 (0%) 2/43 (5%) 2/23 (9%) |1/35 (3%) 1/42 (2%) 2/35 (6%) 4/42 (10%) |
|FIRST INCIDENCE | --- --- 729 (T) 729 (T) |730 (T) 730 (T) 730 (T) 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * (e) P=0.229 P=0.107 |P=0.099 P=0.721N P=0.500 P=0.238 |
|POLY 3 | P=0.078 (e) P=0.230 P=0.188 |P=0.078 P=0.741N P=0.519 P=0.198 |
|POLY 1.5 | P=0.091 (e) P=0.233 P=0.203 |P=0.077 P=0.742N P=0.523 P=0.196 |
|POLY 6 | P=0.063 (e) P=0.229 P=0.168 |P=0.080 P=0.739N P=0.513 P=0.204 |
|LOGISTIC REGRESSION| (e) (e) P=0.229 P=0.107 |P=0.099 P=0.721N P=0.500 P=0.238 |
|COCH-ARM / FISHERS | P=0.107 (e) P=0.242 P=0.227 |P=0.080 P=0.736N P=0.524 P=0.201 |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 2.1% 7.5% |2.2% 2.1% 0.0% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 1/43 (2%) 2/23 (9%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 0/42 (0%) |
|FIRST INCIDENCE | 710 --- 729 (T) 647 |717 611 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 P=0.260N P=0.513N P=0.240 |P=0.301N P=0.747N P=0.516N P=0.480N |
|POLY 3 | P=0.151 P=0.244N P=0.505N P=0.418 |P=0.305N P=0.750N P=0.500N P=0.495N |
|POLY 1.5 | P=0.166 P=0.239N P=0.501N P=0.458 |P=0.307N P=0.754N P=0.499N P=0.499N |
|POLY 6 | P=0.133 P=0.249N P=0.509N P=0.364 |P=0.303N P=0.745N P=0.503N P=0.490N |
|LOGISTIC REGRESSION| P=0.134 P=0.240N P=0.504N P=0.407 |P=0.290N P=0.742 P=0.502N P=0.495N |
|COCH-ARM / FISHERS | P=0.187 P=0.247N P=0.500N P=0.500 |P=0.305N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.2% 0.0% 2.1% 7.5% |2.2% 4.3% 2.2% 0.0% |
|TERMINAL (d) | 1/45 (2%) 0/41 (0%) 1/43 (2%) 2/23 (9%) |0/35 (0%) 1/42 (2%) 1/35 (3%) 0/42 (0%) |
|FIRST INCIDENCE | 710 --- 729 (T) 647 |717 611 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.053 P=0.260N P=0.513N P=0.240 |P=0.222N P=0.535 P=0.751 P=0.480N |
|POLY 3 | P=0.151 P=0.244N P=0.505N P=0.418 |P=0.231N P=0.517 P=0.760 P=0.495N |
|POLY 1.5 | P=0.166 P=0.239N P=0.501N P=0.458 |P=0.235N P=0.511 P=0.760N P=0.499N |
|POLY 6 | P=0.133 P=0.249N P=0.509N P=0.364 |P=0.225N P=0.525 P=0.757 P=0.490N |
|LOGISTIC REGRESSION| P=0.134 P=0.240N P=0.504N P=0.407 |P=0.234N P=0.484 P=0.758 P=0.495N |
|COCH-ARM / FISHERS | P=0.187 P=0.247N P=0.500N P=0.500 |P=0.235N P=0.500 P=0.753N P=0.500N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.1% 4.2% 2.5% |4.4% 2.1% 4.4% 2.2% |
|TERMINAL (d) | 0/45 (0%) 1/41 (2%) 1/43 (2%) 0/23 (0%) |0/35 (0%) 0/42 (0%) 0/35 (0%) 1/42 (2%) |
|FIRST INCIDENCE | --- 729 (T) 685 623 |554 549 491 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.347 P=0.481 P=0.232 P=0.448 |P=0.470N P=0.497N P=0.686 P=0.479N |
|POLY 3 | P=0.416 P=0.495 P=0.235 P=0.465 |P=0.482N P=0.489N P=0.692 P=0.499N |
|POLY 1.5 | P=0.456 P=0.498 P=0.237 P=0.482 |P=0.484N P=0.492N P=0.692N P=0.502N |
|POLY 6 | P=0.359 P=0.490 P=0.234 P=0.441 |P=0.477N P=0.484N P=0.687 P=0.492N |
|LOGISTIC REGRESSION| P=0.514 P=0.481 P=0.237 P=0.510 |P=0.371N P=0.652N P=0.615 P=0.483N |
|COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.247 P=0.500 |P=0.476N P=0.500N P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |14/50 (28%) 8/50 (16%) 8/50 (16%) 10/50 (20%) |
|POLY-3 ADJUSTED (b)| 6.3% 6.4% 4.2% 0.0% |30.6% 16.7% 17.4% 21.6% |
|TERMINAL (d) | 3/45 (7%) 3/41 (7%) 2/43 (5%) 0/23 (0%) |11/35 (31%) 6/42 (14%) 5/35 (14%) 9/42 (21%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) --- |519 499 505 625 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.171N P=0.619 P=0.521N P=0.262N |P=0.313N P=0.060N P=0.128N P=0.130N |
|POLY 3 | P=0.104N P=0.650 P=0.506N P=0.156N |P=0.413N P=0.089N P=0.107N P=0.229N |
|POLY 1.5 | P=0.089N P=0.658 P=0.501N P=0.137N |P=0.419N P=0.097N P=0.107N P=0.242N |
|POLY 6 | P=0.127N P=0.640 P=0.510N P=0.187N |P=0.398N P=0.081N P=0.110N P=0.208N |
|LOGISTIC REGRESSION| P=0.171N P=0.619 P=0.521N (e) |P=0.402N P=0.117N P=0.113N P=0.229N |
|COCH-ARM / FISHERS | P=0.074N P=0.661N P=0.500N P=0.121N |P=0.400N P=0.114N P=0.114N P=0.241N |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 34/50 (68%) 41/50 (82%) 43/50 (86%) |13/50 (26%) 31/50 (62%) 32/50 (64%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 55.1% 71.9% 86.0% 91.7% |28.5% 65.7% 69.5% 85.7% |
|TERMINAL (d) | 23/45 (51%) 31/41 (76%) 38/43 (88%) 22/23 (96%) |10/35 (29%) 29/42 (69%) 27/35 (77%) 38/42 (91%) |
|FIRST INCIDENCE | 550 662 662 490 |519 611 626 549 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.046 * P=0.002 ** P<0.001 ** |P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.064 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.087 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.078 P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.109 P=0.002 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 18/50 (36%) 28/50 (56%) 33/50 (66%) 45/50 (90%) |21/50 (42%) 17/50 (34%) 18/50 (36%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 37.4% 57.8% 67.3% 91.9% |44.1% 34.6% 37.6% 52.2% |
|TERMINAL (d) | 16/45 (36%) 24/41 (59%) 28/43 (65%) 20/23 (87%) |13/35 (37%) 12/42 (29%) 9/35 (26%) 21/42 (50%) |
|FIRST INCIDENCE | 702 464 453 456 |519 499 491 186 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.018 * P=0.003 ** P<0.001 ** |P=0.232 P=0.158N P=0.374N P=0.521 |
|POLY 3 | P<0.001 ** P=0.033 * P=0.002 ** P<0.001 ** |P=0.099 P=0.227N P=0.327N P=0.281 |
|POLY 1.5 | P<0.001 ** P=0.036 * P=0.002 ** P<0.001 ** |P=0.100 P=0.238N P=0.325N P=0.274 |
|POLY 6 | P<0.001 ** P=0.029 * P=0.002 ** P<0.001 ** |P=0.100 P=0.215N P=0.339N P=0.291 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.033 * P=0.003 ** P<0.001 ** |P=0.116 P=0.315N P=0.351N P=0.274 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.035 * P=0.002 ** P<0.001 ** |P=0.110 P=0.268N P=0.341N P=0.274 |
|=================================================================================================================================|
Date: 12/11/98 EXPERIMENT: 88036 TEST: 04 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ANTHRAQUINONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 833 PPM 2500 PPM 7500 PPM |0 PPM 833 PPM 2500 PPM 7500 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 38/50 (76%) 47/50 (94%) 48/50 (96%) |28/50 (56%) 38/50 (76%) 41/50 (82%) 44/50 (88%) |
|POLY-3 ADJUSTED (b)| 71.4% 78.0% 95.3% 98.0% |58.8% 77.2% 83.9% 91.5% |
|TERMINAL (d) | 31/45 (69%) 32/41 (78%) 41/43 (95%) 23/23 (100%)|19/35 (54%) 32/42 (76%) 29/35 (83%) 39/42 (93%) |
|FIRST INCIDENCE | 550 464 453 456 |519 499 491 186 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.157 P=0.004 ** P<0.001 ** |P=0.056 P=0.238 P=0.021 * P=0.038 * |
|POLY 3 | P<0.001 ** P=0.305 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.039 * P=0.004 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.336 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.035 * P=0.004 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.269 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.043 * P=0.004 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.322 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.032 * P=0.005 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.326 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.028 * P=0.004 ** P<0.001 ** |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).