TDMS Study 97006-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 11/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 10:08:51
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(F 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.
---------------
Kidney
Kidney, Renal Tubule (Step Section)
Kidney, Renal Tubule (Step and Original Sections)
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest METHYL ISOBUTYL KETONE DATE: 11/11/04
EXPERIMENT: 97006 TEST: 01 TIME: 10:08:51
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
----- ----------
Kidney, Renal Tubule (Step Section) Adenoma
Carcinoma and Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Kidney, Renal Tubule (Step and Original Sections)
Adenoma
Carcinoma and Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma or Adenoma
Hyperplasia
Hyperplasia and Adenoma
Hyperplasia, Carcinoma or 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
===============================================================
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 1
Statistical Analysis of Primary Tumors in Rats(F 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 (Step Section) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 3/41.93 1/42.20 7/41.57 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 7.2% 2.4% 16.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 0/25 (0%) 5/19 (26%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 677 695 677 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.433 P=0.564N P=0.014 * |(e) (e) (e) (e) |
|POLY 3 | P=0.029 * P=0.473 P=0.519N P=0.062 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.032 * P=0.483 P=0.514N P=0.071 |(e) (e) (e) (e) |
|POLY 6 | P=0.024 * P=0.461 P=0.527N P=0.048 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.015 * P=0.454 P=0.529N P=0.023 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.036 * P=0.500 P=0.500N P=0.080 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.019 * (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 (Step Section) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 1/50 (2%) 7/50 (14%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 3/41.93 1/42.20 7/41.57 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 7.2% 2.4% 16.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 0/25 (0%) 5/19 (26%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 677 695 677 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** P=0.433 P=0.564N P=0.014 * |(e) (e) (e) (e) |
|POLY 3 | P=0.029 * P=0.473 P=0.519N P=0.062 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.032 * P=0.483 P=0.514N P=0.071 |(e) (e) (e) (e) |
|POLY 6 | P=0.024 * P=0.461 P=0.527N P=0.048 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.015 * P=0.454 P=0.529N P=0.023 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.036 * P=0.500 P=0.500N P=0.080 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.019 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 2
Statistical Analysis of Primary Tumors in Rats(F 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 (Step Section) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 4/50 (8%) 6/50 (12%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/44.48 3/42.57 4/42.35 6/42.38 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 0.0% 7.1% 9.5% 14.2% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/32 (0%) 2/28 (7%) 2/25 (8%) 1/19 (5%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- 405 667 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.106 P=0.042 * P=0.007 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.011 * P=0.111 P=0.054 P=0.013 * |(e) (e) (e) (e) |
|POLY 1.5 | P=0.013 * P=0.114 P=0.055 P=0.014 * |(e) (e) (e) (e) |
|POLY 6 | P=0.009 ** P=0.106 P=0.051 P=0.010 * |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.015 * P=0.153 P=0.054 P=0.018 * |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.015 * P=0.121 P=0.059 P=0.013 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.007 ** (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 (Step Section) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 5/50 (10%) 13/50 (26%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 6/42.76 5/42.47 13/42.63 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 14.0% 11.8% 30.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 4/28 (14%) 2/25 (8%) 6/19 (32%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 405 667 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.102 P=0.151 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.119 P=0.196 P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.125 P=0.201 P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.112 P=0.189 P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.137 P=0.186 P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.134 P=0.218 P=0.002 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 3
Statistical Analysis of Primary Tumors in Rats(F 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 (Step Section) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 6/50 (12%) 5/50 (10%) 13/50 (26%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 6/42.76 5/42.47 13/42.63 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 14.0% 11.8% 30.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 4/28 (14%) 2/25 (8%) 6/19 (32%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 405 667 645 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.102 P=0.151 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.119 P=0.196 P<0.001 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.125 P=0.201 P<0.001 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.112 P=0.189 P<0.001 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.137 P=0.186 P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P<0.001 ** P=0.134 P=0.218 P=0.002 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (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 (Step and Original Sections) |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 3/41.93 3/42.32 10/41.60 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 7.2% 7.1% 24.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 1/25 (4%) 7/19 (37%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 677 695 677 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.433 P=0.420 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.473 P=0.477 P=0.009 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.483 P=0.482 P=0.011 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.461 P=0.468 P=0.005 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.454 P=0.463 P=0.002 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500 P=0.500 P=0.014 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 4
Statistical Analysis of Primary Tumors in Rats(F 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 (Step and Original Sections) |
| 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 (Step and Original Sections) |
| Carcinoma and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 4/50 (8%) 3/50 (6%) 11/50 (22%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 4/41.93 3/42.32 11/41.60 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 9.5% 7.1% 26.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 3/28 (11%) 1/25 (4%) 8/19 (42%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 677 695 677 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.275 P=0.420 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P<0.001 ** P=0.309 P=0.477 P=0.004 ** |(e) (e) (e) (e) |
|POLY 1.5 | P<0.001 ** P=0.320 P=0.482 P=0.005 ** |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.297 P=0.468 P=0.002 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.286 P=0.463 P<0.001 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** P=0.339 P=0.500 P=0.007 ** |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 5
Statistical Analysis of Primary Tumors in Rats(F 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 (Step and Original Sections) |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 14/50 (28%) 7/50 (14%) 21/50 (42%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 14/43.08 7/42.45 21/43.68 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 32.5% 16.5% 48.1% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 11/28 (39%) 4/25 (16%) 9/19 (47%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 405 667 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.017 * P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.025 * P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.026 * P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.023 * P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.022 * P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P=0.030 * P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney, Renal Tubule (Step and Original Sections) |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 17/50 (34%) 10/50 (20%) 25/50 (50%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.54 17/43.27 10/42.69 25/43.87 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 6.7% 39.3% 23.4% 57.0% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 2/32 (6%) 13/28 (46%) 5/25 (20%) 12/19 (63%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 713 405 667 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.018 * P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.027 * P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.029 * P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.025 * P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.024 * P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P=0.036 * P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 6
Statistical Analysis of Primary Tumors in Rats(F 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 (Step and Original Sections) |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 17/50 (34%) 10/50 (20%) 26/50 (52%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/44.54 17/43.27 10/42.69 26/43.87 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 6.7% 39.3% 23.4% 59.3% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 2/32 (6%) 13/28 (46%) 5/25 (20%) 13/19 (68%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 713 405 667 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.018 * P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.027 * P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.029 * P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.025 * P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.024 * P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P=0.036 * P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (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: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 7
Statistical Analysis of Primary Tumors in Rats(F 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: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 8
Statistical Analysis of Primary Tumors in Rats(F 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 |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 3/50 (6%) 18/50 (36%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 11/42.25 3/42.17 18/42.93 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 26.0% 7.1% 41.9% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 9/28 (32%) 2/25 (8%) 9/19 (47%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 702 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.231 P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.286 P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.291 P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.278 P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.255 P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P=0.309 P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 450 PPM 900 PPM 1800 PPM |CONTROL 450 PPM 900 PPM 1800 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Hyperplasia and Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 5/50 (10%) 19/50 (38%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 11/42.25 5/42.29 19/42.93 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 26.0% 11.8% 44.3% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 9/28 (32%) 3/25 (12%) 10/19 (53%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 695 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.066 P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.089 P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.092 P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.085 P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.078 P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P=0.102 P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 9
Statistical Analysis of Primary Tumors in Rats(F 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 |
| Hyperplasia, Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 11/50 (22%) 5/50 (10%) 20/50 (40%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/44.48 11/42.25 5/42.29 20/42.93 |1/44.90 1/44.54 0/41.95 1/43.18 |
|POLY-3 PERCENT (g) | 2.3% 26.0% 11.8% 46.6% |2.2% 2.3% 0.0% 2.3% |
|TERMINAL (d) | 1/32 (3%) 9/28 (32%) 3/25 (12%) 11/19 (58%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 726 (T) 658 695 609 |707 727 (T) --- 727 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P=0.066 P<0.001 ** |P=0.647N P=0.760 P=0.559N P=0.735 |
|POLY 3 | P<0.001 ** P<0.001 ** P=0.089 P<0.001 ** |P=0.623N P=0.759 P=0.514N P=0.752 |
|POLY 1.5 | P<0.001 ** P<0.001 ** P=0.092 P<0.001 ** |P=0.619N P=0.759 P=0.507N P=0.755 |
|POLY 6 | P<0.001 ** P<0.001 ** P=0.085 P<0.001 ** |P=0.629N P=0.759 P=0.525N P=0.750 |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P=0.078 P<0.001 ** |P=0.633N P=0.762 P=0.518N P=0.753 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P=0.102 P<0.001 ** |P=0.616N P=0.753N P=0.500N P=0.753N |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.550N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | 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) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 10
Statistical Analysis of Primary Tumors in Rats(F 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) | 6/50 (12%) 5/50 (10%) 11/50 (22%) 15/50 (30%) |3/50 (6%) 4/50 (8%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/46.29 5/42.63 11/45.20 15/44.60 |3/45.69 4/45.76 3/42.75 2/43.77 |
|POLY-3 PERCENT (g) | 13.0% 11.7% 24.3% 33.6% |6.6% 8.7% 7.0% 4.6% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 1/25 (4%) 2/19 (11%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 468 602 539 567 |583 537 637 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.577N P=0.124 P=0.010 * |P=0.386N P=0.497 P=0.576 P=0.529N |
|POLY 3 | P=0.003 ** P=0.558N P=0.128 P=0.016 * |P=0.370N P=0.501 P=0.631 P=0.520N |
|POLY 1.5 | P=0.004 ** P=0.536N P=0.128 P=0.019 * |P=0.360N P=0.500 P=0.647 P=0.513N |
|POLY 6 | P=0.002 ** P=0.583N P=0.127 P=0.012 * |P=0.383N P=0.502 P=0.606 P=0.527N |
|LOGISTIC REGRESSION| P=0.005 ** P=0.432N P=0.196 P=0.035 * |P=0.293N P=0.515 P=0.642N P=0.459N |
|COCH-ARM / FISHERS | P=0.004 ** P=0.500N P=0.143 P=0.024 * |P=0.344N P=0.500 P=0.661N P=0.500N |
|ORDER RESTRICTED | P=0.006 ** (e) (e) (e) |P=0.445N (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) | 2/50 (4%) 3/50 (6%) 3/50 (6%) 10/50 (20%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/44.54 3/41.93 3/42.32 10/41.60 |0/44.82 0/44.54 0/41.95 0/43.18 |
|POLY-3 PERCENT (g) | 4.5% 7.2% 7.1% 24.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/32 (3%) 2/28 (7%) 1/25 (4%) 7/19 (37%) |0/35 (0%) 0/34 (0%) 0/26 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 713 677 695 677 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.433 P=0.420 P<0.001 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** P=0.473 P=0.477 P=0.009 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** P=0.483 P=0.482 P=0.011 * |(e) (e) (e) (e) |
|POLY 6 | P<0.001 ** P=0.461 P=0.468 P=0.005 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P<0.001 ** P=0.454 P=0.463 P=0.002 ** |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** P=0.500 P=0.500 P=0.014 * |(e) (e) (e) (e) |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/11/04 EXPERIMENT: 97006 TEST: 01 Page 11
Statistical Analysis of Primary Tumors in Rats(F 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) | 9/50 (18%) 20/50 (40%) 19/50 (38%) 34/50 (68%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 9/46.35 20/44.16 19/45.64 34/46.49 |3/45.69 5/45.76 4/43.41 5/43.77 |
|POLY-3 PERCENT (g) | 19.4% 45.3% 41.6% 73.1% |6.6% 10.9% 9.2% 11.4% |
|TERMINAL (d) | 3/32 (9%) 13/28 (46%) 6/25 (24%) 13/19 (68%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 3/32 (9%) |
|FIRST INCIDENCE | 468 405 539 567 |583 537 509 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.009 ** P=0.017 * P<0.001 ** |P=0.308 P=0.357 P=0.421 P=0.322 |
|POLY 3 | P<0.001 ** P=0.006 ** P=0.016 * P<0.001 ** |P=0.319 P=0.357 P=0.472 P=0.333 |
|POLY 1.5 | P<0.001 ** P=0.008 ** P=0.016 * P<0.001 ** |P=0.331 P=0.357 P=0.487 P=0.341 |
|POLY 6 | P<0.001 ** P=0.005 ** P=0.016 * P<0.001 ** |P=0.305 P=0.358 P=0.447 P=0.324 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.014 * P=0.026 * P<0.001 ** |P=0.393 P=0.366 P=0.529 P=0.370 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P=0.022 * P<0.001 ** |P=0.350 P=0.357 P=0.500 P=0.357 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.346 (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) | 9/50 (18%) 20/50 (40%) 19/50 (38%) 34/50 (68%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 5/50 (10%) |
|POLY-3 RATE (b) | 9/46.35 20/44.16 19/45.64 34/46.49 |3/45.69 5/45.76 4/43.41 5/43.77 |
|POLY-3 PERCENT (g) | 19.4% 45.3% 41.6% 73.1% |6.6% 10.9% 9.2% 11.4% |
|TERMINAL (d) | 3/32 (9%) 13/28 (46%) 6/25 (24%) 13/19 (68%) |0/35 (0%) 1/34 (3%) 0/26 (0%) 3/32 (9%) |
|FIRST INCIDENCE | 468 405 539 567 |583 537 509 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.009 ** P=0.017 * P<0.001 ** |P=0.308 P=0.357 P=0.421 P=0.322 |
|POLY 3 | P<0.001 ** P=0.006 ** P=0.016 * P<0.001 ** |P=0.319 P=0.357 P=0.472 P=0.333 |
|POLY 1.5 | P<0.001 ** P=0.008 ** P=0.016 * P<0.001 ** |P=0.331 P=0.357 P=0.487 P=0.341 |
|POLY 6 | P<0.001 ** P=0.005 ** P=0.016 * P<0.001 ** |P=0.305 P=0.358 P=0.447 P=0.324 |
|LOGISTIC REGRESSION| P<0.001 ** P=0.014 * P=0.026 * P<0.001 ** |P=0.393 P=0.366 P=0.529 P=0.370 |
|COCH-ARM / FISHERS | P<0.001 ** P=0.013 * P=0.022 * P<0.001 ** |P=0.350 P=0.357 P=0.500 P=0.357 |
|ORDER RESTRICTED | P<0.001 ** (e) (e) (e) |P=0.346 (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).