TDMS Study 97006-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 08:53:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
------------------------------------------------------------------------------------------------------------------------------------
FINAL#1/RATS
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: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 08:53:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
Rats(FISCHER 344)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 05/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 08:53:29
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-05452 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C97006
PATHOLOGIST: RENNE, ROGER CAS: 108-10-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF METHYL ISOBUTYL KETONE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Medulla Pheochromocytoma Benign
Pheochromocytoma: Benign, Complex, Malignant, NOS
Islets, Pancreatic Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Lung Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Testes Adenoma
All Organs Leukemia: Lymphocytic, Monocytic, Mononuclear, or Undifferentiated
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Kidney: Renal Tubule Mesenchymal Tumor Malignant
Mammary Gland Fibroma, Fibroadenoma, Carcinoma, or Adenoma
Uterus Sarcoma Stromal or Polyp Stromal
All Organs Malignant and Benign Tumors
===============================================================
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | 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) | 8/50 (16%) 7/48 (15%) 10/50 (20%) 12/50 (24%) |3/50 (6%) 0/50 (0%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 8/44.85 7/40.55 10/42.79 12/43.38 |3/45.28 0/44.54 2/42.01 2/43.18 |
|POLY-3 PERCENT (g) | 17.8% 17.3% 23.4% 27.7% |6.6% 0.0% 4.8% 4.6% |
|TERMINAL (d) | 6/32 (19%) 6/28 (21%) 5/25 (20%) 4/19 (21%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 2/32 (6%) |
|FIRST INCIDENCE | 671 654 637 609 |643 --- 714 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.019 * P=0.603 P=0.244 P=0.057 |P=0.579 P=0.124N P=0.613N P=0.540N |
|POLY 3 | P=0.120 P=0.585N P=0.353 P=0.197 |P=0.590N P=0.122N P=0.534N P=0.522N |
|POLY 1.5 | P=0.130 P=0.567N P=0.362 P=0.213 |P=0.585N P=0.121N P=0.517N P=0.514N |
|POLY 6 | P=0.099 P=0.605N P=0.338 P=0.165 |P=0.597N P=0.123N P=0.563N P=0.530N |
|LOGISTIC REGRESSION| P=0.093 P=0.609N P=0.328 P=0.193 |P=0.595N P=0.120N P=0.523N P=0.512N |
|COCH-ARM / FISHERS | P=0.135 P=0.535N P=0.398 P=0.227 |P=0.577N P=0.121N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.187 (e) (e) (e) |P=0.312N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/48 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 2/40.60 1/42.07 2/41.33 |0/44.82 1/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 4.9% 2.4% 4.8% |0.0% 2.3% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 1/25 (4%) 2/19 (11%) |0/35 (0%) 1/34 (3%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- 664 726 (T) 726 (T) |--- 727 (T) 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.139 P=0.210 P=0.451 P=0.132 |P=0.616N P=0.494 P=0.441 (e) |
|POLY 3 | P=0.225 P=0.217 P=0.489 P=0.221 |P=0.606N P=0.499 P=0.487 (e) |
|POLY 1.5 | P=0.238 P=0.221 P=0.492 P=0.229 |P=0.602N P=0.499 P=0.494 (e) |
|POLY 6 | P=0.200 P=0.214 P=0.484 P=0.205 |P=0.610N P=0.499 P=0.475 (e) |
|LOGISTIC REGRESSION| P=0.204 P=0.226 P=0.451 P=0.132 |(e) P=0.494 P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.250 P=0.237 P=0.500 P=0.247 |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.143 (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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) | 8/50 (16%) 9/48 (19%) 11/50 (22%) 14/50 (28%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 8/44.85 9/40.87 11/42.79 14/43.38 |3/45.28 1/44.54 3/42.01 2/43.18 |
|POLY-3 PERCENT (g) | 17.8% 22.0% 25.7% 32.3% |6.6% 2.3% 7.1% 4.6% |
|TERMINAL (d) | 6/32 (19%) 6/28 (21%) 6/25 (24%) 6/19 (32%) |0/35 (0%) 1/34 (3%) 2/26 (8%) 2/32 (6%) |
|FIRST INCIDENCE | 671 654 637 609 |643 727 (T) 714 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.007 ** P=0.376 P=0.169 P=0.017 * |P=0.575N P=0.311N P=0.535 P=0.540N |
|POLY 3 | P=0.062 P=0.415 P=0.262 P=0.090 |P=0.543N P=0.311N P=0.627 P=0.522N |
|POLY 1.5 | P=0.071 P=0.432 P=0.272 P=0.102 |P=0.535N P=0.309N P=0.645 P=0.514N |
|POLY 6 | P=0.047 * P=0.400 P=0.248 P=0.069 |P=0.552N P=0.314N P=0.597 P=0.530N |
|LOGISTIC REGRESSION| P=0.046 * P=0.392 P=0.238 P=0.082 |P=0.548N P=0.305N P=0.630 P=0.512N |
|COCH-ARM / FISHERS | P=0.077 P=0.463 P=0.306 P=0.114 |P=0.523N P=0.309N P=0.661N P=0.500N |
|ORDER RESTRICTED | P=0.080 (e) (e) (e) |P=0.527N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 1/50 (2%) 3/50 (6%) |
|POLY-3 RATE (b) | 1/44.48 0/41.12 1/42.07 0/41.33 |1/44.82 3/44.54 1/41.95 3/43.18 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.4% 0.0% |2.2% 6.7% 2.4% 7.0% |
|TERMINAL (d) | 1/32 (3%) 0/28 (0%) 1/25 (4%) 0/19 (0%) |1/35 (3%) 3/34 (9%) 1/26 (4%) 3/32 (9%) |
|FIRST INCIDENCE | 726 (T) --- 726 (T) --- |727 (T) 727 (T) 727 (T) 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508N P=0.527N P=0.706 P=0.604N |P=0.272 P=0.294 P=0.694 P=0.273 |
|POLY 3 | P=0.409N P=0.516N P=0.748 P=0.515N |P=0.295 P=0.303 P=0.746 P=0.292 |
|POLY 1.5 | P=0.405N P=0.512N P=0.751 P=0.507N |P=0.302 P=0.304 P=0.753 P=0.296 |
|POLY 6 | P=0.418N P=0.520N P=0.743 P=0.530N |P=0.288 P=0.303 P=0.733 P=0.288 |
|LOGISTIC REGRESSION| P=0.508N (e) P=0.706 (e) |P=0.272 P=0.294 P=0.694 P=0.273 |
|COCH-ARM / FISHERS | P=0.404N P=0.505N P=0.753N P=0.500N |P=0.313 P=0.309 P=0.753N P=0.309 |
|ORDER RESTRICTED | P=0.266N (e) (e) (e) |P=0.229 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/48 (8%) 1/50 (2%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/45.04 4/40.28 1/42.13 1/41.60 |0/44.82 0/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 6.7% 9.9% 2.4% 2.4% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 2/32 (6%) 4/28 (14%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 554 726 (T) 713 652 |--- --- --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253N P=0.434 P=0.378N P=0.420N |P=0.192 (e) (e) P=0.482 |
|POLY 3 | P=0.152N P=0.439 P=0.329N P=0.334N |P=0.194 (e) (e) P=0.493 |
|POLY 1.5 | P=0.143N P=0.453 P=0.323N P=0.319N |P=0.196 (e) (e) P=0.495 |
|POLY 6 | P=0.169N P=0.423 P=0.340N P=0.363N |P=0.193 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.147N P=0.450 P=0.303N P=0.286N |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.134N P=0.477 P=0.309N P=0.309N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.172N (e) (e) (e) |P=0.114 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/48 (4%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.58 2/40.28 2/42.56 1/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 9.0% 5.0% 4.7% 2.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/32 (9%) 2/28 (7%) 1/25 (4%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 701 726 (T) 580 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.260N P=0.404N P=0.434N P=0.358N |(e) (e) (e) (e) |
|POLY 3 | P=0.145N P=0.385N P=0.358N P=0.202N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.139N P=0.375N P=0.354N P=0.190N |(e) (e) (e) (e) |
|POLY 6 | P=0.160N P=0.396N P=0.367N P=0.228N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.164N P=0.407N P=0.355N P=0.307N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.134N P=0.359N P=0.339N P=0.181N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.135N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 4
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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) | 7/50 (14%) 6/48 (13%) 3/50 (6%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 7/45.14 6/40.28 3/42.62 2/41.60 |0/44.82 0/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 15.5% 14.9% 7.0% 4.8% |0.0% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 5/32 (16%) 6/28 (21%) 1/25 (4%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 554 726 (T) 580 652 |--- --- --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.131N P=0.600N P=0.255N P=0.222N |P=0.192 (e) (e) P=0.482 |
|POLY 3 | P=0.045N* P=0.588N P=0.181N P=0.099N |P=0.194 (e) (e) P=0.493 |
|POLY 1.5 | P=0.041N* P=0.567N P=0.176N P=0.088N |P=0.196 (e) (e) P=0.495 |
|POLY 6 | P=0.056N P=0.612N P=0.190N P=0.121N |P=0.193 (e) (e) P=0.491 |
|LOGISTIC REGRESSION| P=0.049N* P=0.591N P=0.167N P=0.092N |(e) (e) (e) P=0.482 |
|COCH-ARM / FISHERS | P=0.038N* P=0.532N P=0.159N P=0.080N |P=0.198 (e) (e) P=0.500 |
|ORDER RESTRICTED | P=0.075N (e) (e) (e) |P=0.114 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 2/42.20 3/41.36 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.7% 7.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 1/25 (4%) 2/19 (11%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 695 719 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.008 ** (e) P=0.204 P=0.049 * |(e) (e) (e) (e) |
|POLY 3 | P=0.024 * (e) P=0.225 P=0.106 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.026 * (e) P=0.228 P=0.113 |(e) (e) (e) (e) |
|POLY 6 | P=0.020 * (e) P=0.221 P=0.094 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.012 * (e) P=0.219 P=0.052 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.028 * (e) P=0.247 P=0.121 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.031 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 5
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 1/41.74 0/42.07 2/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 0/25 (0%) 2/19 (11%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) --- 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.069 P=0.473 (e) P=0.132 |(e) (e) (e) (e) |
|POLY 3 | P=0.129 P=0.487 (e) P=0.221 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.134 P=0.492 (e) P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.119 P=0.482 (e) P=0.205 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) P=0.473 (e) P=0.132 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.140 P=0.500 (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.064 (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 1/41.74 2/42.20 4/41.36 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 4.7% 9.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 1/25 (4%) 3/19 (16%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 726 (T) 695 719 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.473 P=0.204 P=0.018 * |(e) (e) (e) (e) |
|POLY 3 | P=0.018 * P=0.487 P=0.225 P=0.051 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.020 * P=0.492 P=0.228 P=0.056 |(e) (e) (e) (e) |
|POLY 6 | P=0.014 * P=0.482 P=0.221 P=0.043 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.007 ** P=0.473 P=0.219 P=0.018 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.022 * P=0.500 P=0.247 P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.015 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 6
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Mesenchymal Tumor Malignant |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 0/42.07 0/41.33 |0/44.82 0/44.54 0/41.95 2/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.219 |
|POLY 3 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.229 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.232 |
|POLY 6 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.227 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.219 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.027 * (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) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 2/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 2/19 (11%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * (e) (e) P=0.132 |(e) (e) (e) (e) |
|POLY 3 | P=0.044 * (e) (e) P=0.221 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.229 |(e) (e) (e) (e) |
|POLY 6 | P=0.041 * (e) (e) P=0.205 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.132 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 7
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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) | 0/50 (0%) 0/49 (0%) 0/50 (0%) 2/50 (4%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.12 0/42.07 2/41.33 |1/44.82 1/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.8% |2.2% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 2/19 (11%) |1/35 (3%) 1/34 (3%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- 726 (T) |727 (T) 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.020 * (e) (e) P=0.132 |P=0.260N P=0.755 P=0.559N P=0.518N |
|POLY 3 | P=0.044 * (e) (e) P=0.221 |P=0.242N P=0.759 P=0.513N P=0.507N |
|POLY 1.5 | P=0.045 * (e) (e) P=0.229 |P=0.239N P=0.759 P=0.506N P=0.505N |
|POLY 6 | P=0.041 * (e) (e) P=0.205 |P=0.246N P=0.760 P=0.525N P=0.509N |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.132 |P=0.260N P=0.755 (e) (e) |
|COCH-ARM / FISHERS | P=0.047 * (e) (e) P=0.247 |P=0.236N P=0.753N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.024 * (e) (e) (e) |P=0.257N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/49 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 2/42.58 0/42.07 0/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 338 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.404N P=0.237 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.422N P=0.227 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.414N P=0.229 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.438N P=0.224 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.363N P=0.525 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.404N P=0.242 (e) (e) |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.254N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 8
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |5/50 (10%) 8/50 (16%) 6/50 (12%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/44.48 1/41.74 0/42.07 1/41.33 |5/45.24 8/46.32 6/42.43 4/43.18 |
|POLY-3 PERCENT (g) | 4.5% 2.4% 0.0% 2.4% |11.1% 17.3% 14.1% 9.3% |
|TERMINAL (d) | 2/32 (6%) 1/28 (4%) 0/25 (0%) 1/19 (5%) |4/35 (11%) 3/34 (9%) 4/26 (15%) 4/32 (13%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 726 (T) |606 539 653 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.547N P=0.294N P=0.679N |P=0.390N P=0.270 P=0.329 P=0.553N |
|POLY 3 | P=0.370N P=0.522N P=0.250N P=0.526N |P=0.357N P=0.291 P=0.455 P=0.529N |
|POLY 1.5 | P=0.369N P=0.514N P=0.247N P=0.512N |P=0.340N P=0.284 P=0.478 P=0.519N |
|POLY 6 | P=0.374N P=0.532N P=0.255N P=0.552N |P=0.377N P=0.302 P=0.418 P=0.539N |
|LOGISTIC REGRESSION| P=0.511N P=0.547N (e) P=0.679N |P=0.323N P=0.280 P=0.449 P=0.526N |
|COCH-ARM / FISHERS | P=0.366N P=0.500N P=0.247N P=0.500N |P=0.313N P=0.277 P=0.500 P=0.500N |
|ORDER RESTRICTED | P=0.249N (e) (e) (e) |P=0.391N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |22/50 (44%) 19/50 (38%) 25/50 (50%) 18/50 (36%) |
|POLY-3 RATE (b) | 2/44.48 2/41.74 2/42.30 1/41.33 |22/45.39 19/46.07 25/45.07 18/44.04 |
|POLY-3 PERCENT (g) | 4.5% 4.8% 4.7% 2.4% |48.5% 41.2% 55.5% 40.9% |
|TERMINAL (d) | 2/32 (6%) 2/28 (7%) 1/25 (4%) 1/19 (5%) |18/35 (51%) 13/34 (38%) 16/26 (62%) 15/32 (47%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 667 726 (T) |650 539 546 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.557N P=0.647 P=0.617 P=0.679N |P=0.494N P=0.378N P=0.064 P=0.392N |
|POLY 3 | P=0.396N P=0.671 P=0.676 P=0.526N |P=0.371N P=0.312N P=0.321 P=0.303N |
|POLY 1.5 | P=0.384N P=0.679 P=0.680 P=0.512N |P=0.348N P=0.327N P=0.337 P=0.291N |
|POLY 6 | P=0.422N P=0.661 P=0.669 P=0.552N |P=0.400N P=0.291N P=0.290 P=0.315N |
|LOGISTIC REGRESSION| P=0.479N P=0.647 P=0.667 P=0.679N |P=0.380N P=0.349N P=0.224 P=0.327N |
|COCH-ARM / FISHERS | P=0.373N P=0.691N P=0.691N P=0.500N |P=0.314N P=0.342N P=0.344 P=0.270N |
|ORDER RESTRICTED | P=0.474N (e) (e) (e) |P=0.369N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 9
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Fibroma, Fibroadenoma, Carcinoma, or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 2/50 (4%) 2/50 (4%) |26/50 (52%) 24/50 (48%) 29/50 (58%) 21/50 (42%) |
|POLY-3 RATE (b) | 4/44.48 3/41.74 2/42.30 2/41.33 |26/45.81 24/47.04 29/45.34 21/44.04 |
|POLY-3 PERCENT (g) | 9.0% 7.2% 4.7% 4.8% |56.8% 51.0% 64.0% 47.7% |
|TERMINAL (d) | 4/32 (13%) 3/28 (11%) 1/25 (4%) 2/19 (11%) |21/35 (60%) 16/34 (47%) 19/26 (73%) 18/32 (56%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 667 726 (T) |606 539 546 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.464N P=0.574N P=0.443N P=0.593N |P=0.420N P=0.467N P=0.046 * P=0.340N |
|POLY 3 | P=0.267N P=0.535N P=0.360N P=0.371N |P=0.300N P=0.363N P=0.308 P=0.254N |
|POLY 1.5 | P=0.257N P=0.522N P=0.356N P=0.353N |P=0.266N P=0.390N P=0.330 P=0.237N |
|POLY 6 | P=0.289N P=0.551N P=0.369N P=0.408N |P=0.348N P=0.326N P=0.269 P=0.276N |
|LOGISTIC REGRESSION| P=0.393N P=0.574N P=0.386N P=0.593N |P=0.281N P=0.431N P=0.211 P=0.265N |
|COCH-ARM / FISHERS | P=0.248N P=0.500N P=0.339N P=0.339N |P=0.222N P=0.421N P=0.344 P=0.212N |
|ORDER RESTRICTED | P=0.340N (e) (e) (e) |P=0.285N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 35/50 (70%) 29/49 (59%) 30/50 (60%) 29/50 (58%) |24/49 (49%) 28/50 (56%) 26/50 (52%) 30/50 (60%) |
|POLY-3 RATE (b) | 35/48.31 29/43.65 30/44.72 29/45.88 |24/45.40 28/48.76 26/47.26 30/45.79 |
|POLY-3 PERCENT (g) | 72.5% 66.4% 67.1% 63.2% |52.9% 57.4% 55.0% 65.5% |
|TERMINAL (d) | 21/32 (66%) 20/28 (71%) 16/25 (64%) 12/19 (63%) |16/34 (47%) 17/34 (50%) 10/26 (39%) 20/32 (63%) |
|FIRST INCIDENCE | 492 595 580 498 |606 455 513 489 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.444N P=0.494 P=0.218 |P=0.128 P=0.307 P=0.160 P=0.133 |
|POLY 3 | P=0.207N P=0.341N P=0.365N P=0.222N |P=0.141 P=0.406 P=0.500 P=0.150 |
|POLY 1.5 | P=0.179N P=0.275N P=0.317N P=0.181N |P=0.157 P=0.366 P=0.491 P=0.158 |
|POLY 6 | P=0.281N P=0.416N P=0.428N P=0.311N |P=0.130 P=0.450 P=0.499 P=0.149 |
|LOGISTIC REGRESSION| P=0.218N P=0.251N P=0.276N P=0.168N |P=0.181 P=0.309 P=0.453 P=0.139 |
|COCH-ARM / FISHERS | P=0.169N P=0.180N P=0.201N P=0.149N |P=0.192 P=0.309 P=0.460 P=0.184 |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.172 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 10
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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 |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 35/50 (70%) 29/49 (59%) 30/50 (60%) 29/50 (58%) |24/49 (49%) 28/50 (56%) 27/50 (54%) 30/50 (60%) |
|POLY-3 RATE (b) | 35/48.31 29/43.65 30/44.72 29/45.88 |24/45.40 28/48.76 27/47.26 30/45.79 |
|POLY-3 PERCENT (g) | 72.5% 66.4% 67.1% 63.2% |52.9% 57.4% 57.1% 65.5% |
|TERMINAL (d) | 21/32 (66%) 20/28 (71%) 16/25 (64%) 12/19 (63%) |16/34 (47%) 17/34 (50%) 10/26 (39%) 20/32 (63%) |
|FIRST INCIDENCE | 492 595 580 498 |606 455 513 489 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.140 P=0.444N P=0.494 P=0.218 |P=0.125 P=0.307 P=0.123 P=0.133 |
|POLY 3 | P=0.207N P=0.341N P=0.365N P=0.222N |P=0.135 P=0.406 P=0.419 P=0.150 |
|POLY 1.5 | P=0.179N P=0.275N P=0.317N P=0.181N |P=0.150 P=0.366 P=0.410 P=0.158 |
|POLY 6 | P=0.281N P=0.416N P=0.428N P=0.311N |P=0.124 P=0.450 P=0.416 P=0.149 |
|LOGISTIC REGRESSION| P=0.218N P=0.251N P=0.276N P=0.168N |P=0.173 P=0.309 P=0.371 P=0.139 |
|COCH-ARM / FISHERS | P=0.169N P=0.180N P=0.201N P=0.149N |P=0.185 P=0.309 P=0.383 P=0.184 |
|ORDER RESTRICTED | P=0.250N (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 |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 1/42.00 2/42.07 1/41.33 |0/44.82 1/44.62 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 2.4% 4.8% 2.4% |0.0% 2.2% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 2/25 (8%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- 659 726 (T) 726 (T) |--- 707 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245 P=0.469 P=0.185 P=0.396 |P=0.624N P=0.505 P=0.441 (e) |
|POLY 3 | P=0.335 P=0.489 P=0.225 P=0.485 |P=0.606N P=0.499 P=0.487 (e) |
|POLY 1.5 | P=0.353 P=0.493 P=0.228 P=0.493 |P=0.602N P=0.499 P=0.494 (e) |
|POLY 6 | P=0.301 P=0.484 P=0.219 P=0.470 |P=0.610N P=0.500 P=0.475 (e) |
|LOGISTIC REGRESSION| P=0.320 P=0.516 P=0.185 P=0.396 |P=0.608N P=0.499 P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.366 P=0.500 P=0.247 P=0.500 |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.213 (e) (e) (e) |P=0.395 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 11
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 4/44.48 1/41.74 2/42.07 2/41.36 |0/44.82 0/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 9.0% 2.4% 4.8% 4.8% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 4/32 (13%) 1/28 (4%) 2/25 (8%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 726 (T) 726 (T) 719 |--- --- 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565N P=0.220N P=0.455N P=0.590N |P=0.675 (e) P=0.441 (e) |
|POLY 3 | P=0.354N P=0.198N P=0.363N P=0.371N |P=0.683 (e) P=0.487 (e) |
|POLY 1.5 | P=0.347N P=0.191N P=0.357N P=0.353N |P=0.686 (e) P=0.494 (e) |
|POLY 6 | P=0.372N P=0.207N P=0.374N P=0.407N |P=0.683 (e) P=0.475 (e) |
|LOGISTIC REGRESSION| P=0.552N P=0.220N P=0.455N P=0.573N |(e) (e) P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.343N P=0.181N P=0.339N P=0.339N |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.238N (e) (e) (e) |P=0.368 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 5/50 (10%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 5/44.48 4/42.63 2/42.07 4/41.44 |0/44.82 1/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 11.2% 9.4% 4.8% 9.7% |0.0% 2.3% 2.4% 0.0% |
|TERMINAL (d) | 5/32 (16%) 2/28 (7%) 2/25 (8%) 2/19 (11%) |0/35 (0%) 1/34 (3%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 471 726 (T) 705 |--- 727 (T) 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.581N P=0.323N P=0.468 |P=0.616N P=0.494 P=0.441 (e) |
|POLY 3 | P=0.439N P=0.527N P=0.239N P=0.544N |P=0.606N P=0.499 P=0.487 (e) |
|POLY 1.5 | P=0.424N P=0.517N P=0.234N P=0.521N |P=0.602N P=0.499 P=0.494 (e) |
|POLY 6 | P=0.469N P=0.538N P=0.248N P=0.590N |P=0.610N P=0.499 P=0.475 (e) |
|LOGISTIC REGRESSION| P=0.472N P=0.520N P=0.323N P=0.516 |(e) P=0.494 P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.410N P=0.500N P=0.218N P=0.500N |P=0.595N P=0.500 P=0.500 (e) |
|ORDER RESTRICTED | P=0.401N (e) (e) (e) |P=0.394 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 12
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 2/41.90 0/42.07 0/41.33 |0/44.82 1/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 4.8% 0.0% 0.0% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 685 --- --- |--- 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.264N P=0.446 P=0.549N P=0.604N |P=0.583N P=0.494 (e) (e) |
|POLY 3 | P=0.200N P=0.479 P=0.511N P=0.515N |P=0.574N P=0.499 (e) (e) |
|POLY 1.5 | P=0.195N P=0.487 P=0.508N P=0.507N |P=0.571N P=0.499 (e) (e) |
|POLY 6 | P=0.210N P=0.470 P=0.516N P=0.530N |P=0.579N P=0.499 (e) (e) |
|LOGISTIC REGRESSION| P=0.217N P=0.466 (e) (e) |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.170N (e) (e) (e) |P=0.386N (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%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 3/42.63 0/42.07 2/41.41 |0/44.82 1/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 7.0% 0.0% 4.8% |0.0% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 0/25 (0%) 1/19 (5%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 471 --- 705 |--- 727 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424 P=0.264 P=0.549N P=0.337 |P=0.583N P=0.494 (e) (e) |
|POLY 3 | P=0.527 P=0.290 P=0.511N P=0.475 |P=0.574N P=0.499 (e) (e) |
|POLY 1.5 | P=0.541 P=0.295 P=0.508N P=0.488 |P=0.571N P=0.499 (e) (e) |
|POLY 6 | P=0.500 P=0.283 P=0.516N P=0.449 |P=0.579N P=0.499 (e) (e) |
|LOGISTIC REGRESSION| P=0.558 P=0.339 (e) P=0.378 |(e) P=0.494 (e) (e) |
|COCH-ARM / FISHERS | P=0.556 P=0.309 P=0.500N P=0.500 |P=0.567N P=0.500 (e) (e) |
|ORDER RESTRICTED | P=0.407 (e) (e) (e) |P=0.386N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 13
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, Squamous Cell |
| Carcinoma or Keratoacanthoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 2/42.07 0/41.33 |0/44.82 0/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 2/25 (8%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |--- --- 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.492 (e) P=0.185 (e) |P=0.675 (e) P=0.441 (e) |
|POLY 3 | P=0.566 (e) P=0.225 (e) |P=0.683 (e) P=0.487 (e) |
|POLY 1.5 | P=0.584 (e) P=0.228 (e) |P=0.686 (e) P=0.494 (e) |
|POLY 6 | P=0.526 (e) P=0.219 (e) |P=0.683 (e) P=0.475 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.185 (e) |(e) (e) P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) |P=0.368 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Papilloma, Papilloma, or Keratoacanthoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 0/41.74 2/42.07 0/41.33 |0/44.82 0/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.8% 0.0% |0.0% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 2/25 (8%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 726 (T) --- |--- --- 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.492 (e) P=0.185 (e) |P=0.675 (e) P=0.441 (e) |
|POLY 3 | P=0.566 (e) P=0.225 (e) |P=0.683 (e) P=0.487 (e) |
|POLY 1.5 | P=0.584 (e) P=0.228 (e) |P=0.686 (e) P=0.494 (e) |
|POLY 6 | P=0.526 (e) P=0.219 (e) |P=0.683 (e) P=0.475 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.185 (e) |(e) (e) P=0.441 (e) |
|COCH-ARM / FISHERS | P=0.595 (e) P=0.247 (e) |P=0.694 (e) P=0.500 (e) |
|ORDER RESTRICTED | P=0.237 (e) (e) (e) |P=0.368 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 14
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 42/50 (84%) 42/50 (84%) 44/50 (88%) 48/50 (96%) | |
|POLY-3 RATE (b) | 42/48.54 42/46.51 44/46.60 48/49.20 | |
|POLY-3 PERCENT (g) | 86.5% 90.3% 94.4% 97.6% | |
|TERMINAL (d) | 29/32 (91%) 26/28 (93%) 25/25 (100%) 19/19 (100%)| |
|FIRST INCIDENCE | 468 471 539 498 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.227 P=0.060 P<0.001 ** | |
|POLY 3 | P=0.015 * P=0.393 P=0.149 P=0.036 * | |
|POLY 1.5 | P=0.017 * P=0.463 P=0.183 P=0.040 * | |
|POLY 6 | P=0.013 * P=0.344 P=0.124 P=0.032 * | |
|LOGISTIC REGRESSION| P=0.018 * P=0.435 P=0.212 P=0.036 * | |
|COCH-ARM / FISHERS | P=0.028 * P=0.607N P=0.387 P=0.046 * | |
|ORDER RESTRICTED | P=0.014 * (e) (e) (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 4/48 (8%) 0/50 (0%) 4/50 (8%) |3/50 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/44.48 4/40.28 0/42.07 4/41.53 |3/44.82 2/44.54 2/42.23 2/43.46 |
|POLY-3 PERCENT (g) | 2.3% 9.9% 0.0% 9.6% |6.7% 4.5% 4.7% 4.6% |
|TERMINAL (d) | 1/32 (3%) 4/28 (14%) 0/25 (0%) 3/19 (16%) |3/35 (9%) 2/34 (6%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 726 (T) --- 674 |727 (T) 727 (T) 653 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.087 P=0.139 P=0.549N P=0.067 |P=0.475N P=0.513N P=0.621N P=0.530N |
|POLY 3 | P=0.206 P=0.149 P=0.511N P=0.158 |P=0.446N P=0.503N P=0.527N P=0.514N |
|POLY 1.5 | P=0.218 P=0.155 P=0.508N P=0.169 |P=0.441N P=0.502N P=0.513N P=0.510N |
|POLY 6 | P=0.185 P=0.143 P=0.516N P=0.138 |P=0.451N P=0.502N P=0.550N P=0.516N |
|LOGISTIC REGRESSION| P=0.121 P=0.139 (e) P=0.099 |P=0.454N P=0.513N P=0.557N P=0.518N |
|COCH-ARM / FISHERS | P=0.232 P=0.168 P=0.500N P=0.181 |P=0.431N P=0.500N P=0.500N P=0.500N |
|ORDER RESTRICTED | P=0.092 (e) (e) (e) |P=0.517N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 15
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/48 (6%) 0/50 (0%) 1/50 (2%) |1/50 (2%) 1/50 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 2/44.48 3/40.53 0/42.07 1/41.65 |1/44.82 1/44.54 1/42.26 2/43.20 |
|POLY-3 PERCENT (g) | 4.5% 7.4% 0.0% 2.4% |2.2% 2.3% 2.4% 4.6% |
|TERMINAL (d) | 2/32 (6%) 2/28 (7%) 0/25 (0%) 0/19 (0%) |1/35 (3%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 --- 638 |727 (T) 727 (T) 642 723 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.356N P=0.440 P=0.294N P=0.625N |P=0.329 P=0.755 P=0.713 P=0.476 |
|POLY 3 | P=0.254N P=0.458 P=0.250N P=0.523N |P=0.338 P=0.759 P=0.748 P=0.487 |
|POLY 1.5 | P=0.247N P=0.466 P=0.247N P=0.511N |P=0.343 P=0.759 P=0.754 P=0.491 |
|POLY 6 | P=0.267N P=0.450 P=0.255N P=0.547N |P=0.334 P=0.760 P=0.736 P=0.484 |
|LOGISTIC REGRESSION| P=0.258N P=0.444 (e) P=0.524N |P=0.336 P=0.755 P=0.762N P=0.476 |
|COCH-ARM / FISHERS | P=0.239N P=0.480 P=0.247N P=0.500N |P=0.351 P=0.753N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.183N (e) (e) (e) |P=0.397 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 7/48 (15%) 0/50 (0%) 5/50 (10%) |4/50 (8%) 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 3/44.48 7/40.53 0/42.07 5/41.85 |4/44.82 3/44.54 3/42.54 4/43.48 |
|POLY-3 PERCENT (g) | 6.7% 17.3% 0.0% 12.0% |8.9% 6.7% 7.1% 9.2% |
|TERMINAL (d) | 3/32 (9%) 6/28 (21%) 0/25 (0%) 3/19 (16%) |4/35 (11%) 3/34 (9%) 1/26 (4%) 2/32 (6%) |
|FIRST INCIDENCE | 726 (T) 658 --- 638 |727 (T) 727 (T) 642 651 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.266 P=0.108 P=0.167N P=0.153 |P=0.485 P=0.516N P=0.634N P=0.605 |
|POLY 3 | P=0.490 P=0.120 P=0.129N P=0.322 |P=0.518 P=0.503N P=0.529N P=0.627 |
|POLY 1.5 | P=0.507 P=0.128 P=0.126N P=0.341 |P=0.525 P=0.503N P=0.514N P=0.631 |
|POLY 6 | P=0.455 P=0.113 P=0.133N P=0.288 |P=0.513 P=0.503N P=0.553N P=0.625 |
|LOGISTIC REGRESSION| P=0.410 P=0.103 (e) P=0.257 |P=0.509 P=0.516N P=0.540N P=0.619 |
|COCH-ARM / FISHERS | P=0.526 P=0.142 P=0.121N P=0.357 |P=0.537 P=0.500N P=0.500N P=0.643N |
|ORDER RESTRICTED | P=0.262N (e) (e) (e) |P=0.607 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 16
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/48 (4%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 2/40.47 2/42.17 0/41.33 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 4.9% 4.7% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 1/25 (4%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 677 702 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.427N P=0.444 P=0.426 P=0.604N |(e) (e) (e) (e) |
|POLY 3 | P=0.320N P=0.467 P=0.481 P=0.515N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.306N P=0.473 P=0.486 P=0.507N |(e) (e) (e) (e) |
|POLY 6 | P=0.349N P=0.461 P=0.474 P=0.530N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.343N P=0.460 P=0.457 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.485 P=0.500 P=0.500N |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.221N (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) | 1/50 (2%) 2/48 (4%) 2/50 (4%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/44.48 2/40.47 2/42.17 0/41.33 |1/44.82 0/44.54 1/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 2.3% 4.9% 4.7% 0.0% |2.2% 0.0% 2.4% 0.0% |
|TERMINAL (d) | 1/32 (3%) 1/28 (4%) 1/25 (4%) 0/19 (0%) |1/35 (3%) 0/34 (0%) 1/26 (4%) 0/32 (0%) |
|FIRST INCIDENCE | 726 (T) 677 702 --- |727 (T) --- 727 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.427N P=0.444 P=0.426 P=0.604N |P=0.431N P=0.506N P=0.694 P=0.518N |
|POLY 3 | P=0.320N P=0.467 P=0.481 P=0.515N |P=0.412N P=0.501N P=0.746 P=0.507N |
|POLY 1.5 | P=0.306N P=0.473 P=0.486 P=0.507N |P=0.409N P=0.501N P=0.753 P=0.505N |
|POLY 6 | P=0.349N P=0.461 P=0.474 P=0.530N |P=0.415N P=0.501N P=0.733 P=0.509N |
|LOGISTIC REGRESSION| P=0.343N P=0.460 P=0.457 (e) |P=0.431N (e) P=0.694 (e) |
|COCH-ARM / FISHERS | P=0.293N P=0.485 P=0.500 P=0.500N |P=0.405N P=0.500N P=0.753N P=0.500N |
|ORDER RESTRICTED | P=0.221N (e) (e) (e) |P=0.258N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 17
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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) | |12/50 (24%) 5/50 (10%) 8/50 (16%) 14/50 (28%) |
|POLY-3 RATE (b) | |12/47.11 5/45.07 8/42.96 14/44.20 |
|POLY-3 PERCENT (g) | |25.5% 11.1% 18.6% 31.7% |
|TERMINAL (d) | |8/35 (23%) 3/34 (9%) 5/26 (19%) 12/32 (38%) |
|FIRST INCIDENCE | |370 595 581 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.126 P=0.070N P=0.424N P=0.328 |
|POLY 3 | |P=0.139 P=0.063N P=0.299N P=0.336 |
|POLY 1.5 | |P=0.152 P=0.060N P=0.265N P=0.362 |
|POLY 6 | |P=0.124 P=0.066N P=0.351N P=0.310 |
|LOGISTIC REGRESSION| |P=0.175 P=0.051N P=0.201N P=0.421 |
|COCH-ARM / FISHERS | |P=0.175 P=0.054N P=0.227N P=0.410 |
|ORDER RESTRICTED | |P=0.089 (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) | |13/50 (26%) 5/50 (10%) 8/50 (16%) 15/50 (30%) |
|POLY-3 RATE (b) | |13/47.11 5/45.07 8/42.96 15/44.32 |
|POLY-3 PERCENT (g) | |27.6% 11.1% 18.6% 33.8% |
|TERMINAL (d) | |9/35 (26%) 3/34 (9%) 5/26 (19%) 12/32 (38%) |
|FIRST INCIDENCE | |370 595 581 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.116 P=0.046N* P=0.348N P=0.325 |
|POLY 3 | |P=0.130 P=0.039N* P=0.224N P=0.337 |
|POLY 1.5 | |P=0.142 P=0.037N* P=0.195N P=0.363 |
|POLY 6 | |P=0.117 P=0.041N* P=0.271N P=0.313 |
|LOGISTIC REGRESSION| |P=0.163 P=0.032N* P=0.145N P=0.419 |
|COCH-ARM / FISHERS | |P=0.164 P=0.033N* P=0.163N P=0.412 |
|ORDER RESTRICTED | |P=0.065 (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 18
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Zymbal's Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.95 0/41.74 0/42.07 2/41.78 |0/44.82 0/44.54 2/42.26 1/43.18 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 0.0% 4.8% |0.0% 0.0% 4.7% 2.3% |
|TERMINAL (d) | 0/32 (0%) 0/28 (0%) 0/25 (0%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 1/26 (4%) 1/32 (3%) |
|FIRST INCIDENCE | 588 --- --- 595 |--- --- 642 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.218 P=0.504N P=0.513N P=0.451 |P=0.233 (e) P=0.195 P=0.482 |
|POLY 3 | P=0.243 P=0.515N P=0.513N P=0.474 |P=0.233 (e) P=0.224 P=0.493 |
|POLY 1.5 | P=0.245 P=0.509N P=0.510N P=0.488 |P=0.237 (e) P=0.231 P=0.495 |
|POLY 6 | P=0.236 P=0.522N P=0.519N P=0.449 |P=0.231 (e) P=0.213 P=0.491 |
|LOGISTIC REGRESSION| P=0.247 P=0.425N P=0.443N P=0.515 |P=0.240 (e) P=0.238 P=0.482 |
|COCH-ARM / FISHERS | P=0.246 P=0.500N P=0.500N P=0.500 |P=0.246 (e) P=0.247 P=0.500 |
|ORDER RESTRICTED | P=0.116 (e) (e) (e) |P=0.157 (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) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/44.48 2/42.15 0/42.07 0/41.33 |2/45.97 0/44.54 0/41.95 1/43.94 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |4.4% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 0/32 (0%) 1/28 (4%) 0/25 (0%) 0/19 (0%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 609 --- --- |454 --- --- 454 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.452N P=0.223 (e) (e) |P=0.465N P=0.245N P=0.243N P=0.507N |
|POLY 3 | P=0.427N P=0.225 (e) (e) |P=0.462N P=0.244N P=0.258N P=0.516N |
|POLY 1.5 | P=0.418N P=0.229 (e) (e) |P=0.461N P=0.242N P=0.248N P=0.510N |
|POLY 6 | P=0.444N P=0.220 (e) (e) |P=0.466N P=0.246N P=0.274N P=0.521N |
|LOGISTIC REGRESSION| P=0.402N P=0.246 (e) (e) |P=0.357N P=0.206N P=0.276N P=0.359N |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.461N P=0.247N P=0.247N P=0.500N |
|ORDER RESTRICTED | P=0.252N (e) (e) (e) |P=0.144N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 19
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Leukemia: Lymphocytic, Monocytic, Mononuclear, or |
| Undifferentiated |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 25/50 (50%) 26/50 (52%) 32/50 (64%) 35/50 (70%) |14/50 (28%) 21/50 (42%) 12/50 (24%) 16/50 (32%) |
|POLY-3 RATE (b) | 25/48.08 26/43.97 32/47.77 35/48.24 |14/46.16 21/47.33 12/43.44 16/45.69 |
|POLY-3 PERCENT (g) | 52.0% 59.1% 67.0% 72.6% |30.3% 44.4% 27.6% 35.0% |
|TERMINAL (d) | 13/32 (41%) 16/28 (57%) 13/25 (52%) 9/19 (47%) |9/35 (26%) 12/34 (35%) 6/26 (23%) 8/32 (25%) |
|FIRST INCIDENCE | 468 595 205 544 |583 356 637 499 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.288 P=0.056 P=0.004 ** |P=0.454 P=0.119 P=0.486 P=0.336 |
|POLY 3 | P=0.016 * P=0.314 P=0.096 P=0.027 * |P=0.526N P=0.115 P=0.480N P=0.399 |
|POLY 1.5 | P=0.015 * P=0.381 P=0.094 P=0.029 * |P=0.513N P=0.111 P=0.445N P=0.402 |
|POLY 6 | P=0.017 * P=0.247 P=0.095 P=0.024 * |P=0.537N P=0.120 P=0.536N P=0.400 |
|LOGISTIC REGRESSION| P=0.014 * P=0.436 P=0.129 P=0.054 |P=0.492N P=0.105 P=0.450N P=0.412 |
|COCH-ARM / FISHERS | P=0.014 * P=0.500 P=0.113 P=0.033 * |P=0.490N P=0.104 P=0.410N P=0.414 |
|ORDER RESTRICTED | P=0.020 * (e) (e) (e) |P=0.426N (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) | 50/50 (100%) 47/50 (94%) 47/50 (94%) 49/50 (98%) |44/50 (88%) 39/50 (78%) 40/50 (80%) 40/50 (80%) |
|POLY-3 RATE (b) | 50/50.00 47/47.47 47/47.44 49/49.48 |44/48.74 39/49.07 40/47.96 40/47.30 |
|POLY-3 PERCENT (g) | 100.0% 99.0% 99.1% 99.0% |90.3% 79.5% 83.4% 84.6% |
|TERMINAL (d) | 32/32 (100%) 28/28 (100%) 25/25 (100%) 19/19 (100%)|31/35 (89%) 26/34 (77%) 22/26 (85%) 28/32 (88%) |
|FIRST INCIDENCE | 468 471 539 498 |370 455 513 398 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** P=0.365 P=0.215 P=0.010 * |P=0.447 P=0.300N P=0.212 P=0.519N |
|POLY 3 | P=0.563N P=0.968N P=0.901N P=0.862N |P=0.380N P=0.109N P=0.233N P=0.288N |
|POLY 1.5 | P=0.525N P=0.387N P=0.595N P=0.672N |P=0.330N P=0.124N P=0.215N P=0.255N |
|POLY 6 | P=0.876N P=1.000N P=1.000N P=1.000N |P=0.441N P=0.094N P=0.270N P=0.327N |
|LOGISTIC REGRESSION| P=0.153N (e) P=0.343N P=0.442N |P=0.303N P=0.146N P=0.238N P=0.259N |
|COCH-ARM / FISHERS | P=0.526N P=0.121N P=0.121N P=0.500N |P=0.259N P=0.143N P=0.207N P=0.207N |
|ORDER RESTRICTED | P=0.265N (e) (e) (e) |P=0.217N (e) (e) (e) |
|=================================================================================================================================|
Date: 05/11/04 EXPERIMENT: 97006 TEST: 01 Page 20
Statistical Analysis of Primary Tumors in Rats(FISCHER 344) - METHYL ISOBUTYL KETONE
Terminal Sacrifice at 104 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) | 31/50 (62%) 35/50 (70%) 34/50 (68%) 41/50 (82%) |22/50 (44%) 27/50 (54%) 22/50 (44%) 25/50 (50%) |
|POLY-3 RATE (b) | 31/48.63 35/47.02 34/48.26 41/48.61 |22/47.31 27/48.61 22/45.28 25/47.45 |
|POLY-3 PERCENT (g) | 63.7% 74.4% 70.5% 84.4% |46.5% 55.5% 48.6% 52.7% |
|TERMINAL (d) | 17/32 (53%) 19/28 (68%) 14/25 (56%) 14/19 (74%) |15/35 (43%) 15/34 (44%) 11/26 (42%) 14/32 (44%) |
|FIRST INCIDENCE | 468 338 205 544 |454 356 489 364 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.141 P=0.143 P=0.002 ** |P=0.288 P=0.228 P=0.238 P=0.260 |
|POLY 3 | P=0.018 * P=0.177 P=0.312 P=0.015 * |P=0.400 P=0.247 P=0.503 P=0.345 |
|POLY 1.5 | P=0.019 * P=0.207 P=0.306 P=0.017 * |P=0.411 P=0.233 P=0.543 P=0.345 |
|POLY 6 | P=0.016 * P=0.148 P=0.311 P=0.012 * |P=0.385 P=0.268 P=0.440 P=0.346 |
|LOGISTIC REGRESSION| P=0.022 * P=0.266 P=0.365 P=0.031 * |P=0.452 P=0.215 P=0.577 P=0.367 |
|COCH-ARM / FISHERS | P=0.022 * P=0.263 P=0.338 P=0.022 * |P=0.424 P=0.212 P=0.580N P=0.344 |
|ORDER RESTRICTED | P=0.011 * (e) (e) (e) |P=0.429 (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) | 50/50 (100%) 48/50 (96%) 49/50 (98%) 50/50 (100%)|46/50 (92%) 46/50 (92%) 49/50 (98%) 47/50 (94%) |
|POLY-3 RATE (b) | 50/50.00 48/48.37 49/49.00 50/50.00 |46/49.50 46/50.00 49/50.00 47/50.00 |
|POLY-3 PERCENT (g) | 100.0% 99.2% 100.0% 100.0% |92.9% 92.0% 98.0% 94.0% |
|TERMINAL (d) | 32/32 (100%) 28/28 (100%) 25/25 (100%) 19/19 (100%)|32/35 (91%) 30/34 (88%) 25/26 (96%) 29/32 (91%) |
|FIRST INCIDENCE | 468 338 205 498 |370 356 489 364 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.307 P=0.140 (e) |P=0.186 P=0.506 P=0.023 * P=0.282 |
|POLY 3 | P=0.972 P=0.992N P=1.000N (e) |P=0.405 P=0.581N P=0.226 P=0.576 |
|POLY 1.5 | P=0.663 P=0.587N P=1.000N (e) |P=0.379 P=0.608N P=0.204 P=0.544 |
|POLY 6 | P=1.000 P=1.000N P=1.000N (e) |P=0.438 P=0.547N P=0.259 P=0.615 |
|LOGISTIC REGRESSION| P=0.432 P=0.653N (e) (e) |P=0.373 P=0.641N P=0.188 P=0.517 |
|COCH-ARM / FISHERS | P=0.461 P=0.247N P=0.500N (e) |P=0.344 P=0.643N P=0.181 P=0.500 |
|ORDER RESTRICTED | P=0.245 (e) (e) (e) |P=0.356 (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).