TDMS Study 97006-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 04/29/04
EXPERIMENT: 97006 TEST: 02 TIME: 07:49:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 108-10-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1 MICE
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 04/29/04
EXPERIMENT: 97006 TEST: 02 TIME: 07:49:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 108-10-1
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
Brain
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Parathyroid Gland
Pituitary Gland
Salivary Glands
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 04/29/04
EXPERIMENT: 97006 TEST: 02 TIME: 07:49:21
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 108-10-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYL ISOBUTYL KETONE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Hepatocholangiocarcinoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Stomach, Forestomach Squamous Cell Carcinoma or Papilloma Squamous
All Organs Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Uterus Sarcoma Stromal or Polyp Stromal
All Organs Histiocytic Sarcoma
Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, NOS, or Undifferentiated Cell Type
===============================================================
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 1/49 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.53 0/47.50 1/41.96 1/45.34 |0/44.99 0/45.87 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 2.4% 2.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 0/42 (0%) 0/35 (0%) 1/37 (3%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) --- 698 729 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529N P=0.228N P=0.540N P=0.527N |(e) (e) (e) (e) |
|POLY 3 | P=0.513N P=0.233N P=0.536N P=0.509N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.509N P=0.235N P=0.529N P=0.506N |(e) (e) (e) (e) |
|POLY 6 | P=0.518N P=0.229N P=0.540N P=0.512N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.518N (e) P=0.540N P=0.527N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.501N P=0.247N P=0.508N P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.283N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/41.84 0/45.34 |2/44.99 0/45.87 0/44.87 1/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |2/35 (6%) 0/37 (0%) 0/38 (0%) 1/37 (3%) |
|FIRST INCIDENCE | --- --- --- --- |731 (T) --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.449N P=0.226N P=0.220N P=0.481N |
|POLY 3 | (e) (e) (e) (e) |P=0.469N P=0.233N P=0.238N P=0.496N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.468N P=0.235N P=0.239N P=0.500N |
|POLY 6 | (e) (e) (e) (e) |P=0.470N P=0.232N P=0.236N P=0.491N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.449N (e) (e) P=0.481N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.467N P=0.247N P=0.253N P=0.508N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.129N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 1/46.53 0/47.50 0/41.84 0/45.34 |2/44.99 0/45.87 0/44.87 1/45.46 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |4.5% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |2/35 (6%) 0/37 (0%) 0/38 (0%) 1/37 (3%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) --- --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320N P=0.490N P=0.527N P=0.516N |P=0.449N P=0.226N P=0.220N P=0.481N |
|POLY 3 | P=0.312N P=0.496N P=0.521N P=0.505N |P=0.469N P=0.233N P=0.238N P=0.496N |
|POLY 1.5 | P=0.310N P=0.498N P=0.517N P=0.503N |P=0.468N P=0.235N P=0.239N P=0.500N |
|POLY 6 | P=0.313N P=0.493N P=0.524N P=0.507N |P=0.470N P=0.232N P=0.236N P=0.491N |
|LOGISTIC REGRESSION| P=0.320N (e) (e) (e) |P=0.449N (e) (e) P=0.481N |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.505N P=0.500N |P=0.467N P=0.247N P=0.253N P=0.508N |
|ORDER RESTRICTED | P=0.125N (e) (e) (e) |P=0.129N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 4/50 (8%) 5/50 (10%) 7/50 (14%) |6/50 (12%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 5/46.97 4/47.50 5/42.99 7/46.37 |6/45.54 4/45.87 2/46.02 3/47.37 |
|POLY-3 PERCENT (g) | 10.6% 8.4% 11.6% 15.1% |13.2% 8.7% 4.4% 6.3% |
|TERMINAL (d) | 4/40 (10%) 4/42 (10%) 4/35 (11%) 5/37 (14%) |4/35 (11%) 4/37 (11%) 1/39 (3%) 2/38 (5%) |
|FIRST INCIDENCE | 598 729 (T) 480 551 |586 731 (T) 695 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.203 P=0.476N P=0.546 P=0.335 |P=0.148N P=0.339N P=0.117N P=0.214N |
|POLY 3 | P=0.238 P=0.493N P=0.574 P=0.370 |P=0.160N P=0.365N P=0.129N P=0.223N |
|POLY 1.5 | P=0.244 P=0.496N P=0.589 P=0.373 |P=0.163N P=0.367N P=0.131N P=0.228N |
|POLY 6 | P=0.233 P=0.487N P=0.561 P=0.368 |P=0.155N P=0.367N P=0.128N P=0.217N |
|LOGISTIC REGRESSION| P=0.256 P=0.495N P=0.629 P=0.403 |P=0.174N P=0.360N P=0.132N P=0.265N |
|COCH-ARM / FISHERS | P=0.254 P=0.500N P=0.630N P=0.380 |P=0.170N P=0.370N P=0.134N P=0.243N |
|ORDER RESTRICTED | P=0.314 (e) (e) (e) |P=0.130N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 3/50 (6%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | 2/46.53 1/47.50 1/42.28 2/45.34 |1/45.05 3/45.87 2/46.18 3/46.46 |
|POLY-3 PERCENT (g) | 4.3% 2.1% 2.4% 4.4% |2.2% 6.5% 4.3% 6.5% |
|TERMINAL (d) | 2/40 (5%) 1/42 (2%) 1/35 (3%) 2/37 (5%) |0/35 (0%) 3/37 (8%) 1/39 (3%) 3/38 (8%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 729 (T) |715 731 (T) 648 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.483N P=0.547N P=0.667 |P=0.332 P=0.324 P=0.521 P=0.338 |
|POLY 3 | P=0.539 P=0.493N P=0.533N P=0.685 |P=0.317 P=0.312 P=0.509 P=0.316 |
|POLY 1.5 | P=0.545 P=0.496N P=0.524N P=0.688 |P=0.312 P=0.309 P=0.505 P=0.313 |
|POLY 6 | P=0.533 P=0.487N P=0.540N P=0.682 |P=0.324 P=0.312 P=0.512 P=0.322 |
|LOGISTIC REGRESSION| P=0.515 P=0.483N P=0.547N P=0.667 |P=0.315 P=0.314 P=0.500 P=0.329 |
|COCH-ARM / FISHERS | P=0.556 P=0.500N P=0.500N P=0.691N |P=0.302 P=0.309 P=0.500 P=0.309 |
|ORDER RESTRICTED | P=0.543 (e) (e) (e) |P=0.279 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 6/50 (12%) 8/50 (16%) |7/50 (14%) 7/50 (14%) 4/50 (8%) 6/50 (12%) |
|POLY-3 RATE (b) | 7/46.97 5/47.50 6/42.99 8/46.37 |7/45.60 7/45.87 4/46.32 6/47.37 |
|POLY-3 PERCENT (g) | 14.9% 10.5% 14.0% 17.3% |15.4% 15.3% 8.6% 12.7% |
|TERMINAL (d) | 6/40 (15%) 5/42 (12%) 5/35 (14%) 6/37 (16%) |4/35 (11%) 7/37 (19%) 2/39 (5%) 5/38 (13%) |
|FIRST INCIDENCE | 598 729 (T) 480 551 |586 731 (T) 648 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.288 P=0.351N P=0.599N P=0.442 |P=0.335N P=0.573N P=0.230N P=0.444N |
|POLY 3 | P=0.341 P=0.372N P=0.568N P=0.489 |P=0.360N P=0.609N P=0.252N P=0.471N |
|POLY 1.5 | P=0.348 P=0.376N P=0.549N P=0.493 |P=0.366N P=0.610N P=0.256N P=0.478N |
|POLY 6 | P=0.334 P=0.365N P=0.583N P=0.487 |P=0.351N P=0.614N P=0.248N P=0.463N |
|LOGISTIC REGRESSION| P=0.354 P=0.365N P=0.532N P=0.511 |P=0.382N P=0.599N P=0.259N P=0.517N |
|COCH-ARM / FISHERS | P=0.361 P=0.380N P=0.500N P=0.500 |P=0.384N P=0.613N P=0.262N P=0.500N |
|ORDER RESTRICTED | P=0.417 (e) (e) (e) |P=0.399N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.53 2/47.50 1/42.28 2/45.36 |1/44.99 0/45.87 1/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 2.2% 4.2% 2.4% 4.4% |2.2% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/40 (3%) 2/42 (5%) 1/35 (3%) 1/37 (3%) |1/35 (3%) 0/37 (0%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 725 |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.405 P=0.517 P=0.732 P=0.476 |P=0.389N P=0.489N P=0.738N P=0.484N |
|POLY 3 | P=0.429 P=0.507 P=0.739 P=0.491 |P=0.403N P=0.496N P=0.756N P=0.494N |
|POLY 1.5 | P=0.434 P=0.504 P=0.745 P=0.494 |P=0.404N P=0.498N P=0.758N P=0.496N |
|POLY 6 | P=0.423 P=0.513 P=0.734 P=0.488 |P=0.401N P=0.495N P=0.755N P=0.490N |
|LOGISTIC REGRESSION| P=0.416 P=0.517 P=0.732 P=0.486 |P=0.389N (e) P=0.738N (e) |
|COCH-ARM / FISHERS | P=0.444 P=0.500 P=0.753N P=0.500 |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.431 (e) (e) (e) |P=0.245N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.24 1/47.50 0/41.84 3/45.54 |0/44.99 0/45.87 0/45.09 0/46.46 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 6.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/40 (3%) 1/42 (2%) 0/35 (0%) 2/37 (5%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 678 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141 P=0.751N P=0.527N P=0.284 |(e) (e) (e) (e) |
|POLY 3 | P=0.153 P=0.755N P=0.520N P=0.300 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.157 P=0.755N P=0.514N P=0.304 |(e) (e) (e) (e) |
|POLY 6 | P=0.150 P=0.752N P=0.524N P=0.296 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.151 P=0.751N (e) P=0.298 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.163 P=0.747N P=0.500N P=0.316 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/50 (2%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/49 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.24 1/47.50 0/41.84 3/45.54 |0/44.99 0/45.87 0/45.09 1/46.51 |
|POLY-3 PERCENT (g) | 2.2% 2.1% 0.0% 6.6% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/40 (3%) 1/42 (2%) 0/35 (0%) 2/37 (5%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- 678 |--- --- --- 719 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.141 P=0.751N P=0.527N P=0.284 |P=0.215 (e) (e) P=0.526 |
|POLY 3 | P=0.153 P=0.755N P=0.520N P=0.300 |P=0.203 (e) (e) P=0.507 |
|POLY 1.5 | P=0.157 P=0.755N P=0.514N P=0.304 |P=0.202 (e) (e) P=0.504 |
|POLY 6 | P=0.150 P=0.752N P=0.524N P=0.296 |P=0.205 (e) (e) P=0.510 |
|LOGISTIC REGRESSION| P=0.151 P=0.751N (e) P=0.298 |P=0.202 (e) (e) P=0.507 |
|COCH-ARM / FISHERS | P=0.163 P=0.747N P=0.500N P=0.316 |P=0.199 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.127 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/47.24 1/48.03 2/42.61 0/45.34 |1/45.17 2/45.87 1/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 4.2% 2.1% 4.7% 0.0% |2.2% 4.4% 2.2% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 1/35 (3%) 0/37 (0%) |0/35 (0%) 2/37 (5%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | 482 565 639 --- |684 731 (T) 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222N P=0.494N P=0.652 P=0.251N |P=0.230N P=0.513 P=0.746N P=0.486N |
|POLY 3 | P=0.215N P=0.494N P=0.656 P=0.246N |P=0.241N P=0.505 P=0.757N P=0.494N |
|POLY 1.5 | P=0.209N P=0.497N P=0.667 P=0.243N |P=0.243N P=0.503 P=0.758N P=0.496N |
|POLY 6 | P=0.221N P=0.489N P=0.649 P=0.250N |P=0.238N P=0.505 P=0.757N P=0.492N |
|LOGISTIC REGRESSION| P=0.163N P=0.530N P=0.638N P=0.154N |P=0.240N P=0.505 P=0.761N P=0.505N |
|COCH-ARM / FISHERS | P=0.200N P=0.500N P=0.691N P=0.247N |P=0.247N P=0.500 P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.163N (e) (e) (e) |P=0.223N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 25/50 (50%) 23/50 (46%) 34/50 (68%) |13/50 (26%) 15/50 (30%) 20/50 (40%) 23/50 (46%) |
|POLY-3 RATE (b) | 17/46.72 25/48.11 23/44.32 34/47.29 |13/45.12 15/46.28 20/46.39 23/46.66 |
|POLY-3 PERCENT (g) | 36.4% 52.0% 51.9% 71.9% |28.8% 32.4% 43.1% 49.3% |
|TERMINAL (d) | 16/40 (40%) 22/42 (52%) 17/35 (49%) 28/37 (76%) |11/35 (31%) 11/37 (30%) 17/39 (44%) 20/38 (53%) |
|FIRST INCIDENCE | 678 582 471 551 |715 687 673 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.114 P=0.068 P<0.001 ** |P=0.034 * P=0.474 P=0.176 P=0.060 |
|POLY 3 | P<0.001 ** P=0.090 P=0.097 P<0.001 ** |P=0.016 * P=0.442 P=0.111 P=0.033 * |
|POLY 1.5 | P<0.001 ** P=0.084 P=0.107 P<0.001 ** |P=0.016 * P=0.429 P=0.106 P=0.032 * |
|POLY 6 | P<0.001 ** P=0.103 P=0.096 P<0.001 ** |P=0.018 * P=0.454 P=0.119 P=0.037 * |
|LOGISTIC REGRESSION| P<0.001 ** P=0.100 P=0.076 P<0.001 ** |P=0.023 * P=0.440 P=0.114 P=0.051 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.078 P=0.154 P<0.001 ** |P=0.015 * P=0.412 P=0.101 P=0.030 * |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.028 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 12/50 (24%) 10/50 (20%) 9/50 (18%) |6/50 (12%) 5/50 (10%) 6/50 (12%) 11/50 (22%) |
|POLY-3 RATE (b) | 12/47.98 12/49.17 10/43.87 9/46.83 |6/45.72 5/46.39 6/46.41 11/46.76 |
|POLY-3 PERCENT (g) | 25.0% 24.4% 22.8% 19.2% |13.1% 10.8% 12.9% 23.5% |
|TERMINAL (d) | 8/40 (20%) 8/42 (19%) 6/35 (17%) 4/37 (11%) |2/35 (6%) 3/37 (8%) 5/39 (13%) 7/38 (18%) |
|FIRST INCIDENCE | 482 493 480 551 |586 598 567 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.329N P=0.540N P=0.536N P=0.376N |P=0.096 P=0.472N P=0.565N P=0.205 |
|POLY 3 | P=0.271N P=0.566N P=0.498N P=0.333N |P=0.068 P=0.490N P=0.610N P=0.153 |
|POLY 1.5 | P=0.258N P=0.577N P=0.473N P=0.327N |P=0.067 P=0.494N P=0.614N P=0.150 |
|POLY 6 | P=0.282N P=0.548N P=0.516N P=0.338N |P=0.070 P=0.490N P=0.609N P=0.158 |
|LOGISTIC REGRESSION| P=0.207N P=0.538 P=0.388N P=0.266N |P=0.068 P=0.499N P=0.620N P=0.154 |
|COCH-ARM / FISHERS | P=0.234N P=0.592N P=0.405N P=0.312N |P=0.065 P=0.500N P=0.620N P=0.143 |
|ORDER RESTRICTED | P=0.398N (e) (e) (e) |P=0.091 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 13/50 (26%) 10/50 (20%) 9/50 (18%) |6/50 (12%) 5/50 (10%) 6/50 (12%) 11/50 (22%) |
|POLY-3 RATE (b) | 12/47.98 13/49.17 10/43.87 9/46.83 |6/45.72 5/46.39 6/46.41 11/46.76 |
|POLY-3 PERCENT (g) | 25.0% 26.4% 22.8% 19.2% |13.1% 10.8% 12.9% 23.5% |
|TERMINAL (d) | 8/40 (20%) 9/42 (21%) 6/35 (17%) 4/37 (11%) |2/35 (6%) 3/37 (8%) 5/39 (13%) 7/38 (18%) |
|FIRST INCIDENCE | 482 493 480 551 |586 598 567 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.304N P=0.548 P=0.536N P=0.376N |P=0.096 P=0.472N P=0.565N P=0.205 |
|POLY 3 | P=0.245N P=0.528 P=0.498N P=0.333N |P=0.068 P=0.490N P=0.610N P=0.153 |
|POLY 1.5 | P=0.233N P=0.515 P=0.473N P=0.327N |P=0.067 P=0.494N P=0.614N P=0.150 |
|POLY 6 | P=0.256N P=0.547 P=0.516N P=0.338N |P=0.070 P=0.490N P=0.609N P=0.158 |
|LOGISTIC REGRESSION| P=0.186N P=0.443 P=0.388N P=0.266N |P=0.068 P=0.499N P=0.620N P=0.154 |
|COCH-ARM / FISHERS | P=0.210N P=0.500 P=0.405N P=0.312N |P=0.065 P=0.500N P=0.620N P=0.143 |
|ORDER RESTRICTED | P=0.360N (e) (e) (e) |P=0.091 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 34/50 (68%) 28/50 (56%) 37/50 (74%) |17/50 (34%) 17/50 (34%) 22/50 (44%) 27/50 (54%) |
|POLY-3 RATE (b) | 27/48.17 34/49.78 28/45.47 37/47.88 |17/45.79 17/46.73 22/46.93 27/46.86 |
|POLY-3 PERCENT (g) | 56.1% 68.3% 61.6% 77.3% |37.1% 36.4% 46.9% 57.6% |
|TERMINAL (d) | 22/40 (55%) 27/42 (64%) 20/35 (57%) 28/37 (76%) |12/35 (34%) 12/37 (32%) 18/39 (46%) 22/38 (58%) |
|FIRST INCIDENCE | 482 493 471 551 |586 598 567 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.025 * P=0.210 P=0.265 P=0.023 * |P=0.041 * P=0.514N P=0.331 P=0.089 |
|POLY 3 | P=0.028 * P=0.146 P=0.368 P=0.019 * |P=0.013 * P=0.556N P=0.228 P=0.035 * |
|POLY 1.5 | P=0.033 * P=0.129 P=0.395 P=0.022 * |P=0.013 * P=0.567N P=0.218 P=0.035 * |
|POLY 6 | P=0.026 * P=0.175 P=0.361 P=0.019 * |P=0.014 * P=0.548N P=0.238 P=0.038 * |
|LOGISTIC REGRESSION| P=0.039 * P=0.103 P=0.392 P=0.023 * |P=0.017 * P=0.559N P=0.223 P=0.047 * |
|COCH-ARM / FISHERS | P=0.051 P=0.109 P=0.500 P=0.030 * |P=0.014 * P=0.583N P=0.206 P=0.035 * |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.028 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 35/50 (70%) 28/50 (56%) 37/50 (74%) |17/50 (34%) 17/50 (34%) 22/50 (44%) 27/50 (54%) |
|POLY-3 RATE (b) | 27/48.17 35/49.78 28/45.47 37/47.88 |17/45.79 17/46.73 22/46.93 27/46.86 |
|POLY-3 PERCENT (g) | 56.1% 70.3% 61.6% 77.3% |37.1% 36.4% 46.9% 57.6% |
|TERMINAL (d) | 22/40 (55%) 28/42 (67%) 20/35 (57%) 28/37 (76%) |12/35 (34%) 12/37 (32%) 18/39 (46%) 22/38 (58%) |
|FIRST INCIDENCE | 482 493 471 551 |586 598 567 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.163 P=0.265 P=0.023 * |P=0.041 * P=0.514N P=0.331 P=0.089 |
|POLY 3 | P=0.033 * P=0.102 P=0.368 P=0.019 * |P=0.013 * P=0.556N P=0.228 P=0.035 * |
|POLY 1.5 | P=0.039 * P=0.088 P=0.395 P=0.022 * |P=0.013 * P=0.567N P=0.218 P=0.035 * |
|POLY 6 | P=0.031 * P=0.125 P=0.361 P=0.019 * |P=0.014 * P=0.548N P=0.238 P=0.038 * |
|LOGISTIC REGRESSION| P=0.044 * P=0.071 P=0.392 P=0.023 * |P=0.017 * P=0.559N P=0.223 P=0.047 * |
|COCH-ARM / FISHERS | P=0.059 P=0.074 P=0.500 P=0.030 * |P=0.014 * P=0.583N P=0.206 P=0.035 * |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.028 * (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocholangiocarcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/47.70 2/48.21 0/42.28 0/45.34 |1/45.50 1/46.52 0/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 10.5% 4.2% 0.0% 0.0% |2.2% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | 612 582 --- --- |578 515 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012N* P=0.214N P=0.051N P=0.043N* |P=0.237N P=0.756N P=0.504N P=0.500N |
|POLY 3 | P=0.008N** P=0.212N P=0.042N* P=0.035N* |P=0.236N P=0.756N P=0.498N P=0.496N |
|POLY 1.5 | P=0.008N** P=0.215N P=0.038N* P=0.033N* |P=0.236N P=0.757N P=0.499N P=0.497N |
|POLY 6 | P=0.009N** P=0.209N P=0.046N* P=0.037N* |P=0.235N P=0.755N P=0.498N P=0.494N |
|LOGISTIC REGRESSION| P=0.005N** P=0.234N P=0.021N* P=0.021N* |P=0.255N P=0.754N P=0.495N P=0.548N |
|COCH-ARM / FISHERS | P=0.008N** P=0.218N P=0.028N* P=0.028N* |P=0.236N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.004N** (e) (e) (e) |P=0.247N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 1/50 (2%) 5/50 (10%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 9/46.76 5/47.75 1/42.28 5/45.74 |4/45.41 2/45.87 1/46.41 1/46.46 |
|POLY-3 PERCENT (g) | 19.3% 10.5% 2.4% 10.9% |8.8% 4.4% 2.2% 2.2% |
|TERMINAL (d) | 8/40 (20%) 4/42 (10%) 1/35 (3%) 4/37 (11%) |2/35 (6%) 2/37 (5%) 0/39 (0%) 1/38 (3%) |
|FIRST INCIDENCE | 666 661 729 (T) 617 |653 731 (T) 567 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.171N P=0.017N* P=0.240N |P=0.102N P=0.321N P=0.172N P=0.162N |
|POLY 3 | P=0.146N P=0.181N P=0.013N* P=0.205N |P=0.108N P=0.333N P=0.172N P=0.172N |
|POLY 1.5 | P=0.140N P=0.187N P=0.011N* P=0.201N |P=0.109N P=0.334N P=0.175N P=0.174N |
|POLY 6 | P=0.152N P=0.172N P=0.014N* P=0.208N |P=0.106N P=0.334N P=0.170N P=0.169N |
|LOGISTIC REGRESSION| P=0.151N P=0.179N P=0.015N* P=0.208N |P=0.112N P=0.331N P=0.181N P=0.175N |
|COCH-ARM / FISHERS | P=0.132N P=0.194N P=0.008N** P=0.194N |P=0.111N P=0.339N P=0.181N P=0.181N |
|ORDER RESTRICTED | P=0.035N* (e) (e) (e) |P=0.090N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 1/50 (2%) 3/50 (6%) 5/50 (10%) |0/50 (0%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 5/46.53 1/47.50 3/42.54 5/45.77 |0/44.99 2/46.13 1/45.87 1/46.63 |
|POLY-3 PERCENT (g) | 10.8% 2.1% 7.1% 10.9% |0.0% 4.3% 2.2% 2.1% |
|TERMINAL (d) | 5/40 (13%) 1/42 (2%) 2/35 (6%) 4/37 (11%) |0/35 (0%) 1/37 (3%) 1/39 (3%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 659 607 |--- 662 731 (T) 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.331 P=0.092N P=0.431N P=0.581 |P=0.521 P=0.248 P=0.522 P=0.519 |
|POLY 3 | P=0.369 P=0.097N P=0.407N P=0.620 |P=0.517 P=0.243 P=0.504 P=0.507 |
|POLY 1.5 | P=0.376 P=0.099N P=0.393N P=0.623 |P=0.511 P=0.240 P=0.502 P=0.505 |
|POLY 6 | P=0.362 P=0.093N P=0.415N P=0.618 |P=0.526 P=0.245 P=0.505 P=0.511 |
|LOGISTIC REGRESSION| P=0.365 P=0.092N P=0.419N P=0.613 |P=0.501 P=0.237 P=0.522 P=0.496 |
|COCH-ARM / FISHERS | P=0.389 P=0.102N P=0.357N P=0.630N |P=0.500 P=0.247 P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.324 (e) (e) (e) |P=0.275 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 5/50 (10%) 3/50 (6%) 10/50 (20%) |4/50 (8%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/46.76 5/47.75 3/42.54 10/46.16 |4/45.41 4/46.13 2/46.41 2/46.63 |
|POLY-3 PERCENT (g) | 29.9% 10.5% 7.1% 21.7% |8.8% 8.7% 4.3% 4.3% |
|TERMINAL (d) | 13/40 (33%) 4/42 (10%) 2/35 (6%) 8/37 (22%) |2/35 (6%) 3/37 (8%) 1/39 (3%) 1/38 (3%) |
|FIRST INCIDENCE | 666 661 659 607 |653 662 567 687 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.394N P=0.016N* P=0.009N** P=0.313N |P=0.191N P=0.618N P=0.316N P=0.307N |
|POLY 3 | P=0.326N P=0.016N* P=0.005N** P=0.250N |P=0.203N P=0.635N P=0.327N P=0.325N |
|POLY 1.5 | P=0.316N P=0.017N* P=0.004N** P=0.248N |P=0.205N P=0.638N P=0.331N P=0.329N |
|POLY 6 | P=0.335N P=0.014N* P=0.006N** P=0.249N |P=0.198N P=0.634N P=0.325N P=0.319N |
|LOGISTIC REGRESSION| P=0.337N P=0.016N* P=0.007N** P=0.265N |P=0.211N P=0.640N P=0.339N P=0.333N |
|COCH-ARM / FISHERS | P=0.301N P=0.020N* P=0.003N** P=0.241N |P=0.210N P=0.643N P=0.339N P=0.339N |
|ORDER RESTRICTED | P=0.019N* (e) (e) (e) |P=0.302N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/49 (0%) 2/50 (4%) 1/48 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | |0/44.98 2/45.98 1/44.09 3/46.46 |
|POLY-3 PERCENT (g) | |0.0% 4.4% 2.3% 6.5% |
|TERMINAL (d) | |0/35 (0%) 1/37 (3%) 1/38 (3%) 3/38 (8%) |
|FIRST INCIDENCE | |--- 702 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.119 P=0.251 P=0.516 P=0.136 |
|POLY 3 | |P=0.109 P=0.242 P=0.496 P=0.125 |
|POLY 1.5 | |P=0.107 P=0.241 P=0.495 P=0.123 |
|POLY 6 | |P=0.112 P=0.243 P=0.498 P=0.127 |
|LOGISTIC REGRESSION| |P=0.115 P=0.241 P=0.516 P=0.136 |
|COCH-ARM / FISHERS | |P=0.106 P=0.253 P=0.495 P=0.125 |
|ORDER RESTRICTED | |P=0.061 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/48 (0%) 1/49 (2%) |7/50 (14%) 9/49 (18%) 4/48 (8%) 6/49 (12%) |
|POLY-3 RATE (b) | 0/46.53 0/45.01 0/40.84 1/44.34 |7/44.99 9/45.05 4/44.41 6/45.49 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.3% |15.6% 20.0% 9.0% 13.2% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/34 (0%) 1/36 (3%) |7/35 (20%) 8/36 (22%) 3/39 (8%) 6/38 (16%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |731 (T) 683 696 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183 (e) (e) P=0.479 |P=0.249N P=0.415 P=0.207N P=0.435N |
|POLY 3 | P=0.195 (e) (e) P=0.490 |P=0.302N P=0.393 P=0.268N P=0.491N |
|POLY 1.5 | P=0.197 (e) (e) P=0.493 |P=0.309N P=0.386 P=0.276N P=0.499N |
|POLY 6 | P=0.192 (e) (e) P=0.488 |P=0.290N P=0.398 P=0.258N P=0.478N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.479 |P=0.267N P=0.392 P=0.246N P=0.435N |
|COCH-ARM / FISHERS | P=0.200 (e) (e) P=0.495 |P=0.323N P=0.376 P=0.286N P=0.516N |
|ORDER RESTRICTED | P=0.112 (e) (e) (e) |P=0.292N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/47 (0%) 0/48 (0%) 0/49 (0%) |0/50 (0%) 0/49 (0%) 2/48 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/46.53 0/45.01 0/40.84 0/44.34 |0/44.99 0/44.87 2/44.28 0/45.49 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 4.5% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/34 (0%) 0/36 (0%) |0/35 (0%) 0/36 (0%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.613 (e) P=0.262 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.605 (e) P=0.234 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.601 (e) P=0.231 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.614 (e) P=0.236 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) P=0.262 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.591 (e) P=0.237 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.244 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/46.73 0/47.50 0/42.28 2/46.39 |4/45.61 2/45.87 1/46.45 5/46.61 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 4.3% |8.8% 4.4% 2.2% 10.7% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |2/35 (6%) 2/37 (5%) 0/39 (0%) 3/38 (8%) |
|FIRST INCIDENCE | 676 --- --- 513 |586 731 (T) 551 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238 P=0.491N P=0.525N P=0.489 |P=0.382 P=0.318N P=0.171N P=0.552 |
|POLY 3 | P=0.240 P=0.497N P=0.520N P=0.497 |P=0.351 P=0.335N P=0.173N P=0.514 |
|POLY 1.5 | P=0.242 P=0.498N P=0.514N P=0.498 |P=0.349 P=0.336N P=0.176N P=0.510 |
|POLY 6 | P=0.237 P=0.494N P=0.525N P=0.497 |P=0.356 P=0.337N P=0.172N P=0.520 |
|LOGISTIC REGRESSION| P=0.261 P=0.511N P=0.489N P=0.627 |P=0.342 P=0.336N P=0.181N P=0.506 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.344 P=0.339N P=0.181N P=0.500 |
|ORDER RESTRICTED | P=0.131 (e) (e) (e) |P=0.212 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |4/50 (8%) 2/50 (4%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 1/46.73 0/47.50 0/42.28 2/46.39 |4/45.61 2/45.87 1/46.45 5/46.61 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 4.3% |8.8% 4.4% 2.2% 10.7% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |2/35 (6%) 2/37 (5%) 0/39 (0%) 3/38 (8%) |
|FIRST INCIDENCE | 676 --- --- 513 |586 731 (T) 551 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.238 P=0.491N P=0.525N P=0.489 |P=0.382 P=0.318N P=0.171N P=0.552 |
|POLY 3 | P=0.240 P=0.497N P=0.520N P=0.497 |P=0.351 P=0.335N P=0.173N P=0.514 |
|POLY 1.5 | P=0.242 P=0.498N P=0.514N P=0.498 |P=0.349 P=0.336N P=0.176N P=0.510 |
|POLY 6 | P=0.237 P=0.494N P=0.525N P=0.497 |P=0.356 P=0.337N P=0.172N P=0.520 |
|LOGISTIC REGRESSION| P=0.261 P=0.511N P=0.489N P=0.627 |P=0.342 P=0.336N P=0.181N P=0.506 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.344 P=0.339N P=0.181N P=0.500 |
|ORDER RESTRICTED | P=0.131 (e) (e) (e) |P=0.212 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.73 0/47.50 0/42.28 1/45.99 |2/45.48 1/45.87 0/45.87 1/46.46 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 2.2% |4.4% 2.2% 0.0% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 1/37 (3%) 0/39 (0%) 1/38 (3%) |
|FIRST INCIDENCE | 676 --- --- 513 |586 731 (T) --- 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.585 P=0.491N P=0.525N P=0.755 |P=0.350N P=0.482N P=0.228N P=0.478N |
|POLY 3 | P=0.588 P=0.497N P=0.520N P=0.757 |P=0.366N P=0.497N P=0.235N P=0.493N |
|POLY 1.5 | P=0.590 P=0.498N P=0.514N P=0.758 |P=0.366N P=0.498N P=0.236N P=0.495N |
|POLY 6 | P=0.584 P=0.494N P=0.525N P=0.756 |P=0.364N P=0.498N P=0.235N P=0.489N |
|LOGISTIC REGRESSION| P=0.634 P=0.511N P=0.489N P=0.688N |P=0.368N P=0.501N P=0.238N P=0.510N |
|COCH-ARM / FISHERS | P=0.595 P=0.500N P=0.500N P=0.753N |P=0.366N P=0.500N P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.399 (e) (e) (e) |P=0.218N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 0/45.34 |2/45.12 1/45.87 0/45.87 4/46.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.4% 2.2% 0.0% 8.6% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 1/37 (3%) 0/39 (0%) 2/38 (5%) |
|FIRST INCIDENCE | --- --- --- --- |697 731 (T) --- 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.192 P=0.484N P=0.228N P=0.386 |
|POLY 3 | (e) (e) (e) (e) |P=0.167 P=0.494N P=0.233N P=0.352 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.166 P=0.497N P=0.235N P=0.348 |
|POLY 6 | (e) (e) (e) (e) |P=0.169 P=0.494N P=0.232N P=0.360 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.173 P=0.493N P=0.234N P=0.352 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.165 P=0.500N P=0.247N P=0.339 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.082 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/49 (0%) 0/49 (0%) |1/50 (2%) 2/50 (4%) 2/49 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.53 0/47.50 0/41.84 0/44.91 |1/44.99 2/45.98 2/45.09 1/46.56 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 0.0% |2.2% 4.4% 4.4% 2.2% |
|TERMINAL (d) | 1/40 (3%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 1/37 (3%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |731 (T) 702 731 (T) 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.320N P=0.490N P=0.527N P=0.516N |P=0.523N P=0.519 P=0.538 P=0.738N |
|POLY 3 | P=0.315N P=0.496N P=0.521N P=0.507N |P=0.543N P=0.508 P=0.501 P=0.753N |
|POLY 1.5 | P=0.313N P=0.498N P=0.517N P=0.506N |P=0.547N P=0.504 P=0.497 P=0.755N |
|POLY 6 | P=0.317N P=0.493N P=0.524N P=0.508N |P=0.535N P=0.510 P=0.504 P=0.749N |
|LOGISTIC REGRESSION| P=0.320N (e) (e) (e) |P=0.542N P=0.508 P=0.538 P=0.756N |
|COCH-ARM / FISHERS | P=0.308N P=0.500N P=0.505N P=0.505N |P=0.556N P=0.500 P=0.492 P=0.753N |
|ORDER RESTRICTED | P=0.127N (e) (e) (e) |P=0.536N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 2/45.34 |1/44.99 0/45.87 3/45.87 1/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% |2.2% 0.0% 6.5% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 2/37 (5%) |1/35 (3%) 0/37 (0%) 3/39 (8%) 1/38 (3%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |731 (T) --- 731 (T) 731 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041 * (e) (e) P=0.221 |P=0.495 P=0.489N P=0.344 P=0.743N |
|POLY 3 | P=0.043 * (e) (e) P=0.231 |P=0.483 P=0.496N P=0.312 P=0.753N |
|POLY 1.5 | P=0.044 * (e) (e) P=0.234 |P=0.479 P=0.498N P=0.310 P=0.756N |
|POLY 6 | P=0.042 * (e) (e) P=0.229 |P=0.491 P=0.495N P=0.315 P=0.750N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.221 |P=0.495 (e) P=0.344 P=0.743N |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.247 |P=0.469 P=0.500N P=0.309 P=0.753N |
|ORDER RESTRICTED | P=0.027 * (e) (e) (e) |P=0.273 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.53 0/47.50 0/42.28 1/45.34 |1/44.99 0/45.87 3/45.87 0/46.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 2.2% |2.2% 0.0% 6.5% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 1/37 (3%) |1/35 (3%) 0/37 (0%) 3/39 (8%) 0/38 (0%) |
|FIRST INCIDENCE | --- --- --- 729 (T) |731 (T) --- 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.187 (e) (e) P=0.484 |P=0.477N P=0.489N P=0.344 P=0.484N |
|POLY 3 | P=0.194 (e) (e) P=0.495 |P=0.490N P=0.496N P=0.312 P=0.494N |
|POLY 1.5 | P=0.196 (e) (e) P=0.497 |P=0.493N P=0.498N P=0.310 P=0.496N |
|POLY 6 | P=0.192 (e) (e) P=0.493 |P=0.483N P=0.495N P=0.315 P=0.490N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.484 |P=0.477N (e) P=0.344 (e) |
|COCH-ARM / FISHERS | P=0.198 (e) (e) P=0.500 |P=0.500N P=0.500N P=0.309 P=0.500N |
|ORDER RESTRICTED | P=0.115 (e) (e) (e) |P=0.267N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) | |
|POLY-3 RATE (b) | 0/46.53 2/47.50 0/42.28 0/45.34 | |
|POLY-3 PERCENT (g) | 0.0% 4.2% 0.0% 0.0% | |
|TERMINAL (d) | 0/40 (0%) 2/42 (5%) 0/35 (0%) 0/37 (0%) | |
|FIRST INCIDENCE | --- 729 (T) --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.249 (e) (e) | |
|POLY 3 | P=0.413N P=0.242 (e) (e) | |
|POLY 1.5 | P=0.411N P=0.240 (e) (e) | |
|POLY 6 | P=0.415N P=0.245 (e) (e) | |
|LOGISTIC REGRESSION| (e) P=0.249 (e) (e) | |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) | |
|ORDER RESTRICTED | P=0.256N (e) (e) (e) | |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 0/49 (0%) 0/48 (0%) |
|POLY-3 RATE (b) | 0/46.53 2/46.69 0/42.28 0/45.34 |1/44.99 0/45.87 0/44.87 0/44.56 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 0.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 2/42 (5%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 0/37 (0%) 0/38 (0%) 0/37 (0%) |
|FIRST INCIDENCE | --- 729 (T) --- --- |731 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.428N P=0.249 (e) (e) |P=0.299N P=0.489N P=0.484N P=0.489N |
|POLY 3 | P=0.412N P=0.238 (e) (e) |P=0.315N P=0.496N P=0.501N P=0.502N |
|POLY 1.5 | P=0.409N P=0.236 (e) (e) |P=0.314N P=0.498N P=0.502N P=0.504N |
|POLY 6 | P=0.413N P=0.242 (e) (e) |P=0.317N P=0.495N P=0.499N P=0.498N |
|LOGISTIC REGRESSION| (e) P=0.249 (e) (e) |P=0.299N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.242 (e) (e) |P=0.311N P=0.500N P=0.505N P=0.510N |
|ORDER RESTRICTED | P=0.253N (e) (e) (e) |P=0.122N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |1/44.99 0/45.87 2/46.17 0/46.46 |
|POLY-3 PERCENT (g) | |2.2% 0.0% 4.3% 0.0% |
|TERMINAL (d) | |1/35 (3%) 0/37 (0%) 0/39 (0%) 0/38 (0%) |
|FIRST INCIDENCE | |731 (T) --- 684 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.439N P=0.489N P=0.518 P=0.484N |
|POLY 3 | |P=0.454N P=0.496N P=0.509 P=0.494N |
|POLY 1.5 | |P=0.456N P=0.498N P=0.505 P=0.496N |
|POLY 6 | |P=0.449N P=0.495N P=0.514 P=0.490N |
|LOGISTIC REGRESSION| |P=0.459N (e) P=0.502 (e) |
|COCH-ARM / FISHERS | |P=0.461N P=0.500N P=0.500 P=0.500N |
|ORDER RESTRICTED | |P=0.319N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |3/45.48 3/46.23 2/45.87 0/46.46 |
|POLY-3 PERCENT (g) | |6.6% 6.5% 4.4% 0.0% |
|TERMINAL (d) | |2/35 (6%) 2/37 (5%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | |586 628 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.064N P=0.639N P=0.461N P=0.112N |
|POLY 3 | |P=0.069N P=0.655N P=0.496N P=0.115N |
|POLY 1.5 | |P=0.070N P=0.658N P=0.497N P=0.116N |
|POLY 6 | |P=0.067N P=0.653N P=0.496N P=0.113N |
|LOGISTIC REGRESSION| |P=0.071N P=0.662 P=0.499N P=0.124N |
|COCH-ARM / FISHERS | |P=0.072N P=0.661N P=0.500N P=0.121N |
|ORDER RESTRICTED | |P=0.092N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |4/50 (8%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | |4/45.48 3/46.23 2/45.87 0/46.46 |
|POLY-3 PERCENT (g) | |8.8% 6.5% 4.4% 0.0% |
|TERMINAL (d) | |3/35 (9%) 2/37 (5%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | |586 628 731 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.032N* P=0.474N P=0.298N P=0.057N |
|POLY 3 | |P=0.035N* P=0.491N P=0.333N P=0.058N |
|POLY 1.5 | |P=0.036N* P=0.495N P=0.335N P=0.058N |
|POLY 6 | |P=0.034N* P=0.489N P=0.332N P=0.056N |
|LOGISTIC REGRESSION| |P=0.036N* P=0.500N P=0.334N P=0.063N |
|COCH-ARM / FISHERS | |P=0.037N* P=0.500N P=0.339N P=0.059N |
|ORDER RESTRICTED | |P=0.035N* (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/46.90 0/47.50 0/42.28 0/45.34 |0/44.99 0/45.87 2/45.87 1/46.86 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 0.0% 0.0% |0.0% 0.0% 4.4% 2.1% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |0/35 (0%) 0/37 (0%) 2/39 (5%) 0/38 (0%) |
|FIRST INCIDENCE | 622 --- --- --- |--- --- 731 (T) 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316N P=0.491N P=0.523N P=0.509N |P=0.259 (e) P=0.262 P=0.509 |
|POLY 3 | P=0.310N P=0.497N P=0.521N P=0.507N |P=0.259 (e) P=0.242 P=0.508 |
|POLY 1.5 | P=0.309N P=0.499N P=0.515N P=0.504N |P=0.255 (e) P=0.240 P=0.505 |
|POLY 6 | P=0.312N P=0.496N P=0.526N P=0.510N |P=0.268 (e) P=0.243 P=0.513 |
|LOGISTIC REGRESSION| P=0.280N P=0.518N P=0.447N P=0.443N |P=0.243 (e) P=0.262 P=0.470 |
|COCH-ARM / FISHERS | P=0.306N P=0.500N P=0.500N P=0.500N |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.127N (e) (e) (e) |P=0.171 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |3/50 (6%) 4/50 (8%) 7/50 (14%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/47.24 1/48.03 3/42.72 1/45.34 |3/45.17 4/45.98 7/46.17 1/46.56 |
|POLY-3 PERCENT (g) | 6.4% 2.1% 7.0% 2.2% |6.6% 8.7% 15.2% 2.2% |
|TERMINAL (d) | 2/40 (5%) 0/42 (0%) 1/35 (3%) 1/37 (3%) |2/35 (6%) 3/37 (8%) 5/39 (13%) 0/38 (0%) |
|FIRST INCIDENCE | 482 565 639 729 (T) |684 702 684 705 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N P=0.299N P=0.607 P=0.330N |P=0.242N P=0.525 P=0.199 P=0.277N |
|POLY 3 | P=0.336N P=0.300N P=0.615 P=0.320N |P=0.257N P=0.510 P=0.166 P=0.295N |
|POLY 1.5 | P=0.327N P=0.303N P=0.628 P=0.315N |P=0.263N P=0.506 P=0.163 P=0.298N |
|POLY 6 | P=0.345N P=0.294N P=0.607 P=0.325N |P=0.247N P=0.511 P=0.170 P=0.289N |
|LOGISTIC REGRESSION| P=0.284N P=0.321N P=0.628N P=0.262N |P=0.263N P=0.511 P=0.166 P=0.298N |
|COCH-ARM / FISHERS | P=0.313N P=0.309N P=0.661N P=0.309N |P=0.278N P=0.500 P=0.159 P=0.309N |
|ORDER RESTRICTED | P=0.260N (e) (e) (e) |P=0.121N (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 3/50 (6%) 1/50 (2%) |3/50 (6%) 4/50 (8%) 9/50 (18%) 2/50 (4%) |
|POLY-3 RATE (b) | 4/47.62 1/48.03 3/42.72 1/45.34 |3/45.17 4/45.98 9/46.17 2/46.96 |
|POLY-3 PERCENT (g) | 8.4% 2.1% 7.0% 2.2% |6.6% 8.7% 19.5% 4.3% |
|TERMINAL (d) | 2/40 (5%) 0/42 (0%) 1/35 (3%) 1/37 (3%) |2/35 (6%) 3/37 (8%) 7/39 (18%) 0/38 (0%) |
|FIRST INCIDENCE | 482 565 639 729 (T) |684 702 684 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.226N P=0.177N P=0.560N P=0.202N |P=0.417N P=0.525 P=0.088 P=0.464N |
|POLY 3 | P=0.213N P=0.176N P=0.559N P=0.194N |P=0.433N P=0.510 P=0.064 P=0.482N |
|POLY 1.5 | P=0.206N P=0.178N P=0.542N P=0.188N |P=0.444N P=0.506 P=0.062 P=0.488N |
|POLY 6 | P=0.221N P=0.173N P=0.571N P=0.200N |P=0.414N P=0.511 P=0.066 P=0.473N |
|LOGISTIC REGRESSION| P=0.165N P=0.179N P=0.438N P=0.133N |P=0.453N P=0.511 P=0.066 P=0.505N |
|COCH-ARM / FISHERS | P=0.194N P=0.181N P=0.500N P=0.181N |P=0.467N P=0.500 P=0.061 P=0.500N |
|ORDER RESTRICTED | P=0.127N (e) (e) (e) |P=0.176N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 0/50 (0%) 1/50 (2%) 6/50 (12%) |
|POLY-3 RATE (b) | 1/46.97 0/47.50 1/42.92 1/45.77 |3/45.24 0/45.87 1/46.02 6/47.30 |
|POLY-3 PERCENT (g) | 2.1% 0.0% 2.3% 2.2% |6.6% 0.0% 2.2% 12.7% |
|TERMINAL (d) | 0/40 (0%) 0/42 (0%) 0/35 (0%) 0/37 (0%) |1/35 (3%) 0/37 (0%) 0/39 (0%) 2/38 (5%) |
|FIRST INCIDENCE | 598 --- 520 607 |691 --- 695 535 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.508N P=0.728 P=0.746 |P=0.065 P=0.119N P=0.293N P=0.290 |
|POLY 3 | P=0.529 P=0.498N P=0.740 P=0.755 |P=0.050 P=0.116N P=0.299N P=0.265 |
|POLY 1.5 | P=0.533 P=0.499N P=0.746 P=0.757 |P=0.049 * P=0.117N P=0.302N P=0.257 |
|POLY 6 | P=0.524 P=0.496N P=0.736 P=0.753 |P=0.052 P=0.116N P=0.297N P=0.275 |
|LOGISTIC REGRESSION| P=0.591 P=0.520N P=0.667N P=0.694N |P=0.049 * P=0.119N P=0.303N P=0.238 |
|COCH-ARM / FISHERS | P=0.539 P=0.500N P=0.753N P=0.753N |P=0.050 P=0.121N P=0.309N P=0.243 |
|ORDER RESTRICTED | P=0.511 (e) (e) (e) |P=0.024 * (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |13/50 (26%) 5/50 (10%) 11/50 (22%) 13/50 (26%) |
|POLY-3 RATE (b) | 1/46.53 3/47.50 1/42.28 2/45.42 |13/45.34 5/46.26 11/47.67 13/48.27 |
|POLY-3 PERCENT (g) | 2.2% 6.3% 2.4% 4.4% |28.7% 10.8% 23.1% 26.9% |
|TERMINAL (d) | 1/40 (3%) 3/42 (7%) 1/35 (3%) 1/37 (3%) |11/35 (31%) 4/37 (11%) 8/39 (21%) 9/38 (24%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 729 (T) 710 |653 620 75 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.485 P=0.323 P=0.732 P=0.482 |P=0.371 P=0.027N* P=0.319N P=0.498N |
|POLY 3 | P=0.509 P=0.313 P=0.739 P=0.492 |P=0.349 P=0.027N* P=0.352N P=0.517N |
|POLY 1.5 | P=0.515 P=0.310 P=0.745 P=0.495 |P=0.335 P=0.029N* P=0.367N P=0.538N |
|POLY 6 | P=0.504 P=0.318 P=0.734 P=0.489 |P=0.366 P=0.026N* P=0.340N P=0.495N |
|LOGISTIC REGRESSION| P=0.497 P=0.323 P=0.732 P=0.487 |P=0.284 P=0.030N* P=0.411N P=0.588 |
|COCH-ARM / FISHERS | P=0.526 P=0.309 P=0.753N P=0.500 |P=0.299 P=0.033N* P=0.408N P=0.590N |
|ORDER RESTRICTED | P=0.449 (e) (e) (e) |P=0.265N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 32/50 (64%) 29/50 (58%) 37/50 (74%) |29/50 (58%) 29/50 (58%) 30/50 (60%) 33/50 (66%) |
|POLY-3 RATE (b) | 27/47.79 32/48.36 29/45.16 37/47.75 |29/46.02 29/46.92 30/47.20 33/47.96 |
|POLY-3 PERCENT (g) | 56.5% 66.2% 64.2% 77.5% |63.0% 61.8% 63.6% 68.8% |
|TERMINAL (d) | 23/40 (58%) 28/42 (67%) 21/35 (60%) 30/37 (81%) |24/35 (69%) 22/37 (60%) 24/39 (62%) 28/38 (74%) |
|FIRST INCIDENCE | 598 582 471 551 |586 628 567 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012 * P=0.310 P=0.203 P=0.016 * |P=0.387 P=0.467N P=0.448N P=0.460 |
|POLY 3 | P=0.021 * P=0.220 P=0.289 P=0.021 * |P=0.276 P=0.538N P=0.564 P=0.352 |
|POLY 1.5 | P=0.025 * P=0.214 P=0.317 P=0.023 * |P=0.260 P=0.557N P=0.537 P=0.329 |
|POLY 6 | P=0.020 * P=0.232 P=0.277 P=0.020 * |P=0.297 P=0.523N P=0.581N P=0.379 |
|LOGISTIC REGRESSION| P=0.019 * P=0.239 P=0.270 P=0.020 * |P=0.249 P=0.530N P=0.551 P=0.316 |
|COCH-ARM / FISHERS | P=0.036 * P=0.208 P=0.420 P=0.030 * |P=0.210 P=0.580N P=0.500 P=0.268 |
|ORDER RESTRICTED | P=0.016 * (e) (e) (e) |P=0.405 (e) (e) (e) |
|=================================================================================================================================|
Date: 04/29/04 EXPERIMENT: 97006 TEST: 02 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 21/50 (42%) 16/50 (32%) 20/50 (40%) |30/50 (60%) 22/50 (44%) 28/50 (56%) 31/50 (62%) |
|POLY-3 RATE (b) | 29/49.80 21/49.88 16/45.59 20/48.30 |30/47.18 22/47.80 28/49.34 31/49.28 |
|POLY-3 PERCENT (g) | 58.2% 42.1% 35.1% 41.4% |63.6% 46.0% 56.8% 62.9% |
|TERMINAL (d) | 20/40 (50%) 15/42 (36%) 9/35 (26%) 12/37 (32%) |19/35 (54%) 16/37 (43%) 20/39 (51%) 21/38 (55%) |
|FIRST INCIDENCE | 482 493 412 513 |578 515 75 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.159N P=0.088N P=0.059N P=0.143N |P=0.423 P=0.084N P=0.296N P=0.475N |
|POLY 3 | P=0.075N P=0.078N P=0.018N* P=0.070N |P=0.340 P=0.062N P=0.317N P=0.557N |
|POLY 1.5 | P=0.067N P=0.079N P=0.013N* P=0.063N |P=0.324 P=0.067N P=0.338N P=0.578N |
|POLY 6 | P=0.086N P=0.077N P=0.024N* P=0.078N |P=0.352 P=0.065N P=0.310N P=0.548N |
|LOGISTIC REGRESSION| P=0.041N* P=0.121N P=0.005N** P=0.035N* |P=0.255 P=0.074N P=0.420N P=0.514 |
|COCH-ARM / FISHERS | P=0.056N P=0.081N P=0.008N** P=0.055N |P=0.258 P=0.080N P=0.420N P=0.500 |
|ORDER RESTRICTED | P=0.030N* (e) (e) (e) |P=0.324N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 41/50 (82%) 36/50 (72%) 45/50 (90%) |42/50 (84%) 40/50 (80%) 40/50 (80%) 42/50 (84%) |
|POLY-3 RATE (b) | 45/50.00 41/50.00 36/47.05 45/48.95 |42/47.18 40/48.67 40/49.70 42/49.68 |
|POLY-3 PERCENT (g) | 90.0% 82.0% 76.5% 91.9% |89.0% 82.2% 80.5% 84.5% |
|TERMINAL (d) | 35/40 (88%) 33/42 (79%) 25/35 (71%) 34/37 (92%) |31/35 (89%) 29/37 (78%) 30/39 (77%) 31/38 (82%) |
|FIRST INCIDENCE | 482 493 412 513 |578 515 75 329 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.222 P=0.181N P=0.313N P=0.345 |P=0.354N P=0.301N P=0.213N P=0.339N |
|POLY 3 | P=0.372 P=0.194N P=0.061N P=0.506 |P=0.387N P=0.251N P=0.184N P=0.361N |
|POLY 1.5 | P=0.419 P=0.194N P=0.045N* P=0.553 |P=0.431N P=0.305N P=0.232N P=0.424N |
|POLY 6 | P=0.327 P=0.194N P=0.082N P=0.458 |P=0.357N P=0.215N P=0.154N P=0.318N |
|LOGISTIC REGRESSION| P=0.470 (e) P=0.035N* P=0.611 |P=0.534 P=0.331N P=0.381N P=0.549N |
|COCH-ARM / FISHERS | P=0.513 P=0.194N P=0.020N* P=0.630N |P=0.500 P=0.398N P=0.398N P=0.607N |
|ORDER RESTRICTED | P=0.152 (e) (e) (e) |P=0.295N (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).