TDMS Study 05201-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04
EXPERIMENT: 05201 TEST: 06 TIME: 14:19:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C
PATHOLOGIST: MILLER, RODNEY CAS: 98-00-0
------------------------------------------------------------------------------------------------------------------------------------
FINAL #2 MICE
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04
EXPERIMENT: 05201 TEST: 06 TIME: 14:19:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C
PATHOLOGIST: MILLER, RODNEY CAS: 98-00-0
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Epididymis
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest FURFURYL ALCOHOL DATE: 11/15/04
EXPERIMENT: 05201 TEST: 06 TIME: 14:19:15
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-15315 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 56224C
PATHOLOGIST: MILLER, RODNEY CAS: 98-00-0
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF FURFURYL ALCOHOL
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Adrenal Cortex Adenoma
Kidney: Renal Tubule Adenoma
Carcinoma
Carcinoma or Adenoma
Liver Hemangiosarcoma
All Organs Hemangiosarcoma or Hemangioma
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
===============================================================
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/49 (4%) 0/49 (0%) 1/48 (2%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 6/43.80 2/42.82 0/38.96 1/44.13 |0/43.20 2/42.18 0/43.06 1/46.16 |
|POLY-3 PERCENT (g) | 13.7% 4.7% 0.0% 2.3% |0.0% 4.7% 0.0% 2.2% |
|TERMINAL (d) | 4/34 (12%) 2/36 (6%) 0/30 (0%) 0/37 (0%) |0/34 (0%) 2/33 (6%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 567 733 (T) --- 646 |--- 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.096N P=0.123N P=0.028N* P=0.049N* |P=0.678 P=0.232 (e) P=0.532 |
|POLY 3 | P=0.094N P=0.139N P=0.022N* P=0.054N |P=0.655 P=0.232 (e) P=0.513 |
|POLY 1.5 | P=0.100N P=0.140N P=0.020N* P=0.058N |P=0.645 P=0.231 (e) P=0.507 |
|POLY 6 | P=0.087N P=0.139N P=0.025N* P=0.050N |P=0.667 P=0.234 (e) P=0.520 |
|LOGISTIC REGRESSION| P=0.107N P=0.137N P=0.022N* P=0.066N |(e) P=0.232 (e) P=0.532 |
|COCH-ARM / FISHERS | P=0.113N P=0.141N P=0.014N* P=0.062N |P=0.631 P=0.242 (e) P=0.495 |
|ORDER RESTRICTED | P=0.004N** (e) (e) (e) |P=0.318 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 0/50 (0%) |2/50 (4%) 1/49 (2%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.10 0/42.82 0/38.96 0/45.78 |2/43.50 1/42.18 0/42.25 1/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 2.4% 0.0% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |1/34 (3%) 1/33 (3%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- --- --- |651 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.503N P=0.510N P=0.249N P=0.449N |
|POLY 3 | (e) (e) (e) (e) |P=0.546N P=0.511N P=0.243N P=0.479N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.553N P=0.511N P=0.242N P=0.490N |
|POLY 6 | (e) (e) (e) (e) |P=0.537N P=0.508N P=0.246N P=0.469N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.539N P=0.508N P=0.242N P=0.501N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.566N P=0.508N P=0.253N P=0.508N |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.211N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 2/49 (4%) 5/50 (10%) 5/50 (10%) |
|POLY-3 RATE (b) | 3/43.10 3/43.23 5/39.96 2/45.85 |2/43.29 2/42.18 5/43.22 5/47.11 |
|POLY-3 PERCENT (g) | 7.0% 6.9% 12.5% 4.4% |4.6% 4.7% 11.6% 10.6% |
|TERMINAL (d) | 3/34 (9%) 2/36 (6%) 4/30 (13%) 1/38 (3%) |1/34 (3%) 2/33 (6%) 4/32 (13%) 4/40 (10%) |
|FIRST INCIDENCE | 733 (T) 632 317 716 |712 734 (T) 693 600 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.319N P=0.642N P=0.296 P=0.448N |P=0.256 P=0.686 P=0.193 P=0.284 |
|POLY 3 | P=0.330N P=0.661N P=0.315 P=0.472N |P=0.211 P=0.685 P=0.215 P=0.252 |
|POLY 1.5 | P=0.346N P=0.660 P=0.330 P=0.484N |P=0.195 P=0.684 P=0.216 P=0.238 |
|POLY 6 | P=0.313N P=0.656N P=0.300 P=0.458N |P=0.228 P=0.689 P=0.210 P=0.267 |
|LOGISTIC REGRESSION| P=0.359N P=0.663 P=0.340 P=0.449N |P=0.214 P=0.696N P=0.204 P=0.234 |
|COCH-ARM / FISHERS | P=0.372N P=0.661N P=0.357 P=0.500N |P=0.168 P=0.684 P=0.218 P=0.218 |
|ORDER RESTRICTED | P=0.343N (e) (e) (e) |P=0.197 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 2/49 (4%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/43.85 0/42.87 0/39.04 1/45.88 |0/43.20 2/42.87 0/43.06 1/46.65 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 2.2% |0.0% 4.7% 0.0% 2.1% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | 465 --- --- 707 |--- 525 --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544 P=0.508N P=0.513N P=0.743N |P=0.666 P=0.236 (e) P=0.532 |
|POLY 3 | P=0.540 P=0.504N P=0.523N P=0.750N |P=0.658 P=0.235 (e) P=0.515 |
|POLY 1.5 | P=0.534 P=0.504N P=0.515N P=0.755N |P=0.649 P=0.233 (e) P=0.510 |
|POLY 6 | P=0.547 P=0.504N P=0.530N P=0.745N |P=0.669 P=0.240 (e) P=0.521 |
|LOGISTIC REGRESSION| P=0.472 P=0.375N P=0.329N P=0.728 |P=0.600 P=0.248 (e) P=0.532 |
|COCH-ARM / FISHERS | P=0.522 P=0.500N P=0.500N P=0.753N |P=0.636 P=0.242 (e) P=0.500 |
|ORDER RESTRICTED | P=0.397N (e) (e) (e) |P=0.319 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 5/50 (10%) 3/50 (6%) |2/50 (4%) 4/49 (8%) 5/50 (10%) 6/50 (12%) |
|POLY-3 RATE (b) | 4/43.85 3/43.23 5/39.96 3/45.95 |2/43.29 4/42.87 5/43.22 6/47.11 |
|POLY-3 PERCENT (g) | 9.1% 6.9% 12.5% 6.5% |4.6% 9.3% 11.6% 12.7% |
|TERMINAL (d) | 3/34 (9%) 2/36 (6%) 4/30 (13%) 1/38 (3%) |1/34 (3%) 2/33 (6%) 4/32 (13%) 5/40 (13%) |
|FIRST INCIDENCE | 465 632 317 707 |712 525 693 600 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.406N P=0.483N P=0.434 P=0.444N |P=0.262 P=0.331 P=0.193 P=0.192 |
|POLY 3 | P=0.427N P=0.508N P=0.442 P=0.474N |P=0.210 P=0.332 P=0.215 P=0.162 |
|POLY 1.5 | P=0.444N P=0.508N P=0.463 P=0.486N |P=0.194 P=0.328 P=0.216 P=0.151 |
|POLY 6 | P=0.408N P=0.504N P=0.422 P=0.460N |P=0.227 P=0.340 P=0.210 P=0.175 |
|LOGISTIC REGRESSION| P=0.478N P=0.498N P=0.527 P=0.511N |P=0.195 P=0.326 P=0.204 P=0.153 |
|COCH-ARM / FISHERS | P=0.471N P=0.500N P=0.500 P=0.500N |P=0.166 P=0.329 P=0.218 P=0.134 |
|ORDER RESTRICTED | P=0.488N (e) (e) (e) |P=0.145 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/49 (2%) 2/48 (4%) 0/48 (0%) |1/49 (2%) 0/48 (0%) 1/49 (2%) 1/49 (2%) |
|POLY-3 RATE (b) | 2/43.64 1/42.82 2/39.34 0/44.13 |1/42.20 0/41.96 1/42.25 1/46.16 |
|POLY-3 PERCENT (g) | 4.6% 2.3% 5.1% 0.0% |2.4% 0.0% 2.4% 2.2% |
|TERMINAL (d) | 1/34 (3%) 1/36 (3%) 0/30 (0%) 0/38 (0%) |1/33 (3%) 0/33 (0%) 1/32 (3%) 1/40 (3%) |
|FIRST INCIDENCE | 567 733 (T) 576 --- |734 (T) --- 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.194N P=0.482N P=0.648 P=0.218N |P=0.617 P=0.500N P=0.755 P=0.718N |
|POLY 3 | P=0.203N P=0.507N P=0.656 P=0.235N |P=0.592 P=0.501N P=0.761N P=0.740N |
|POLY 1.5 | P=0.210N P=0.507N P=0.664 P=0.240N |P=0.583 P=0.503N P=0.760N P=0.748N |
|POLY 6 | P=0.196N P=0.506N P=0.651 P=0.229N |P=0.601 P=0.497N P=0.760 P=0.731N |
|LOGISTIC REGRESSION| P=0.231N P=0.508N P=0.677N P=0.267N |P=0.617 (e) P=0.755 P=0.718N |
|COCH-ARM / FISHERS | P=0.219N P=0.508N P=0.676 P=0.258N |P=0.566 P=0.505N P=0.753N P=0.753N |
|ORDER RESTRICTED | P=0.153N (e) (e) (e) |P=0.548 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.82 0/38.96 2/45.78 |0/43.20 0/41.96 0/42.25 0/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) |
|POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.034 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 2/50 (4%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.82 0/38.96 2/45.78 |0/43.20 0/41.96 0/42.25 0/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 4.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.054 (e) (e) P=0.263 |(e) (e) (e) (e) |
|POLY 3 | P=0.046 * (e) (e) P=0.251 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.045 * (e) (e) P=0.245 |(e) (e) (e) (e) |
|POLY 6 | P=0.048 * (e) (e) P=0.257 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.263 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.043 * (e) (e) P=0.247 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.034 * (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney: Renal Tubule |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 0/49 (0%) 4/50 (8%) |0/50 (0%) 0/48 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.82 0/38.96 4/45.78 |0/43.20 0/41.96 0/42.25 0/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 8.7% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 4/38 (11%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- 733 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.003 ** (e) (e) P=0.078 |(e) (e) (e) (e) |
|POLY 3 | P=0.002 ** (e) (e) P=0.068 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** (e) (e) P=0.065 |(e) (e) (e) (e) |
|POLY 6 | P=0.002 ** (e) (e) P=0.072 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) (e) P=0.078 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.002 ** (e) (e) P=0.059 |(e) (e) (e) (e) |
|ORDER RESTRICTED | P=0.003 ** (e) (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 5/50 (10%) 0/49 (0%) 3/50 (6%) |0/50 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.10 5/43.39 0/38.96 3/46.12 |0/43.20 0/42.18 0/42.25 1/46.16 |
|POLY-3 PERCENT (g) | 0.0% 11.5% 0.0% 6.5% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 0/34 (0%) 3/36 (8%) 0/30 (0%) 2/38 (5%) |0/34 (0%) 0/33 (0%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- 632 --- 637 |--- --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448 P=0.039 * (e) P=0.142 |P=0.262 (e) (e) P=0.532 |
|POLY 3 | P=0.428 P=0.031 * (e) P=0.131 |P=0.241 (e) (e) P=0.513 |
|POLY 1.5 | P=0.411 P=0.030 * (e) P=0.126 |P=0.236 (e) (e) P=0.507 |
|POLY 6 | P=0.450 P=0.032 * (e) P=0.138 |P=0.246 (e) (e) P=0.520 |
|LOGISTIC REGRESSION| P=0.413 P=0.033 * (e) P=0.121 |(e) (e) (e) P=0.532 |
|COCH-ARM / FISHERS | P=0.390 P=0.028 * (e) P=0.121 |P=0.226 (e) (e) P=0.495 |
|ORDER RESTRICTED | P=0.100 (e) (e) (e) |P=0.132 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 13/50 (26%) 10/49 (20%) 13/50 (26%) |7/50 (14%) 7/49 (14%) 9/49 (18%) 5/49 (10%) |
|POLY-3 RATE (b) | 13/43.10 13/44.81 10/40.56 13/47.36 |7/43.75 7/42.54 9/43.30 5/46.16 |
|POLY-3 PERCENT (g) | 30.2% 29.0% 24.7% 27.5% |16.0% 16.5% 20.8% 10.8% |
|TERMINAL (d) | 13/34 (38%) 10/36 (28%) 7/30 (23%) 9/38 (24%) |5/34 (15%) 5/33 (15%) 5/32 (16%) 5/40 (13%) |
|FIRST INCIDENCE | 733 (T) 433 471 582 |595 649 621 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.461N P=0.531N P=0.439N P=0.456N |P=0.177N P=0.596 P=0.363 P=0.280N |
|POLY 3 | P=0.483N P=0.546N P=0.374N P=0.479N |P=0.226N P=0.592 P=0.382 P=0.342N |
|POLY 1.5 | P=0.529N P=0.570N P=0.364N P=0.527N |P=0.248N P=0.590 P=0.380 P=0.361N |
|POLY 6 | P=0.426N P=0.517N P=0.380N P=0.421N |P=0.207N P=0.601 P=0.385 P=0.323N |
|LOGISTIC REGRESSION| P=0.548N P=0.584 P=0.425N P=0.527N |P=0.226N P=0.599 P=0.374 P=0.322N |
|COCH-ARM / FISHERS | P=0.526 P=0.590N P=0.337N P=0.590N |P=0.290N P=0.597 P=0.376 P=0.394N |
|ORDER RESTRICTED | P=0.525N (e) (e) (e) |P=0.290N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 19/50 (38%) 14/49 (29%) 13/50 (26%) |9/50 (18%) 15/49 (31%) 5/49 (10%) 8/49 (16%) |
|POLY-3 RATE (b) | 15/48.08 19/47.68 14/45.44 13/48.28 |9/43.66 15/43.50 5/43.08 8/46.66 |
|POLY-3 PERCENT (g) | 31.2% 39.9% 30.8% 26.9% |20.6% 34.5% 11.6% 17.1% |
|TERMINAL (d) | 3/34 (9%) 9/36 (25%) 3/30 (10%) 5/38 (13%) |6/34 (18%) 11/33 (33%) 1/32 (3%) 7/40 (18%) |
|FIRST INCIDENCE | 465 270 400 382 |651 525 665 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.327 P=0.531 P=0.327N |P=0.133N P=0.118 P=0.237N P=0.369N |
|POLY 3 | P=0.208N P=0.251 P=0.572N P=0.407N |P=0.174N P=0.111 P=0.198N P=0.440N |
|POLY 1.5 | P=0.213N P=0.254 P=0.554N P=0.408N |P=0.198N P=0.106 P=0.200N P=0.469N |
|POLY 6 | P=0.203N P=0.249 P=0.581 P=0.406N |P=0.153N P=0.121 P=0.196N P=0.411N |
|LOGISTIC REGRESSION| P=0.402N P=0.265 P=0.276N P=0.596N |P=0.191N P=0.105 P=0.205N P=0.441N |
|COCH-ARM / FISHERS | P=0.223N P=0.263 P=0.526N P=0.412N |P=0.244N P=0.109 P=0.205N P=0.518N |
|ORDER RESTRICTED | P=0.288N (e) (e) (e) |P=0.089N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 19/50 (38%) 14/49 (29%) 13/50 (26%) |9/50 (18%) 15/49 (31%) 5/49 (10%) 8/49 (16%) |
|POLY-3 RATE (b) | 15/48.08 19/47.68 14/45.44 13/48.28 |9/43.66 15/43.50 5/43.08 8/46.66 |
|POLY-3 PERCENT (g) | 31.2% 39.9% 30.8% 26.9% |20.6% 34.5% 11.6% 17.1% |
|TERMINAL (d) | 3/34 (9%) 9/36 (25%) 3/30 (10%) 5/38 (13%) |6/34 (18%) 11/33 (33%) 1/32 (3%) 7/40 (18%) |
|FIRST INCIDENCE | 465 270 400 382 |651 525 665 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.327 P=0.531 P=0.327N |P=0.133N P=0.118 P=0.237N P=0.369N |
|POLY 3 | P=0.208N P=0.251 P=0.572N P=0.407N |P=0.174N P=0.111 P=0.198N P=0.440N |
|POLY 1.5 | P=0.213N P=0.254 P=0.554N P=0.408N |P=0.198N P=0.106 P=0.200N P=0.469N |
|POLY 6 | P=0.203N P=0.249 P=0.581 P=0.406N |P=0.153N P=0.121 P=0.196N P=0.411N |
|LOGISTIC REGRESSION| P=0.402N P=0.265 P=0.276N P=0.596N |P=0.191N P=0.105 P=0.205N P=0.441N |
|COCH-ARM / FISHERS | P=0.223N P=0.263 P=0.526N P=0.412N |P=0.244N P=0.109 P=0.205N P=0.518N |
|ORDER RESTRICTED | P=0.288N (e) (e) (e) |P=0.089N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 27/50 (54%) 23/49 (47%) 22/50 (44%) |14/50 (28%) 19/49 (39%) 12/49 (24%) 12/49 (24%) |
|POLY-3 RATE (b) | 28/48.08 27/47.68 23/46.31 22/48.86 |14/44.13 19/43.81 12/43.61 12/46.66 |
|POLY-3 PERCENT (g) | 58.2% 56.6% 49.7% 45.0% |31.7% 43.4% 27.5% 25.7% |
|TERMINAL (d) | 16/34 (47%) 17/36 (47%) 10/30 (33%) 12/38 (32%) |10/34 (29%) 14/33 (42%) 6/32 (19%) 11/40 (28%) |
|FIRST INCIDENCE | 465 270 400 382 |595 525 621 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.433N P=0.434N P=0.113N |P=0.087N P=0.188 P=0.469N P=0.254N |
|POLY 3 | P=0.108N P=0.519N P=0.264N P=0.135N |P=0.135N P=0.179 P=0.421N P=0.344N |
|POLY 1.5 | P=0.119N P=0.515N P=0.257N P=0.144N |P=0.158N P=0.173 P=0.426N P=0.376N |
|POLY 6 | P=0.096N P=0.523N P=0.274N P=0.125N |P=0.116N P=0.196 P=0.416N P=0.315N |
|LOGISTIC REGRESSION| P=0.208N P=0.488N P=0.154N P=0.210N |P=0.140N P=0.170 P=0.434N P=0.333N |
|COCH-ARM / FISHERS | P=0.140N P=0.500N P=0.242N P=0.159N |P=0.210N P=0.178 P=0.433N P=0.433N |
|ORDER RESTRICTED | P=0.145N (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 27/50 (54%) 23/49 (47%) 22/50 (44%) |14/50 (28%) 19/49 (39%) 12/49 (24%) 12/49 (24%) |
|POLY-3 RATE (b) | 28/48.08 27/47.68 23/46.31 22/48.86 |14/44.13 19/43.81 12/43.61 12/46.66 |
|POLY-3 PERCENT (g) | 58.2% 56.6% 49.7% 45.0% |31.7% 43.4% 27.5% 25.7% |
|TERMINAL (d) | 16/34 (47%) 17/36 (47%) 10/30 (33%) 12/38 (32%) |10/34 (29%) 14/33 (42%) 6/32 (19%) 11/40 (28%) |
|FIRST INCIDENCE | 465 270 400 382 |595 525 621 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.433N P=0.434N P=0.113N |P=0.087N P=0.188 P=0.469N P=0.254N |
|POLY 3 | P=0.108N P=0.519N P=0.264N P=0.135N |P=0.135N P=0.179 P=0.421N P=0.344N |
|POLY 1.5 | P=0.119N P=0.515N P=0.257N P=0.144N |P=0.158N P=0.173 P=0.426N P=0.376N |
|POLY 6 | P=0.096N P=0.523N P=0.274N P=0.125N |P=0.116N P=0.196 P=0.416N P=0.315N |
|LOGISTIC REGRESSION| P=0.208N P=0.488N P=0.154N P=0.210N |P=0.140N P=0.170 P=0.434N P=0.333N |
|COCH-ARM / FISHERS | P=0.140N P=0.500N P=0.242N P=0.159N |P=0.210N P=0.178 P=0.433N P=0.433N |
|ORDER RESTRICTED | P=0.145N (e) (e) (e) |P=0.169N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 16/50 (32%) 16/50 (32%) 10/49 (20%) 14/50 (28%) |2/50 (4%) 4/49 (8%) 8/49 (16%) 0/50 (0%) |
|POLY-3 RATE (b) | 16/43.24 16/44.33 10/39.05 14/46.38 |2/43.36 4/42.51 8/42.25 0/46.65 |
|POLY-3 PERCENT (g) | 37.0% 36.1% 25.6% 30.2% |4.6% 9.4% 18.9% 0.0% |
|TERMINAL (d) | 15/34 (44%) 13/36 (36%) 9/30 (30%) 12/38 (32%) |1/34 (3%) 2/33 (6%) 8/32 (25%) 0/40 (0%) |
|FIRST INCIDENCE | 697 287 712 582 |693 649 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276N P=0.518N P=0.210N P=0.271N |P=0.056N P=0.332 P=0.038 * P=0.209N |
|POLY 3 | P=0.312N P=0.554N P=0.189N P=0.322N |P=0.058N P=0.328 P=0.040 * P=0.221N |
|POLY 1.5 | P=0.354N P=0.570N P=0.169N P=0.360N |P=0.065N P=0.325 P=0.041 * P=0.227N |
|POLY 6 | P=0.267N P=0.532N P=0.211N P=0.281N |P=0.052N P=0.334 P=0.037 * P=0.215N |
|LOGISTIC REGRESSION| P=0.293N P=0.581 P=0.230N P=0.291N |P=0.062N P=0.326 P=0.036 * P=0.223N |
|COCH-ARM / FISHERS | P=0.418N P=0.585N P=0.140N P=0.414N |P=0.084N P=0.329 P=0.043 * P=0.247N |
|ORDER RESTRICTED | P=0.282N (e) (e) (e) |P=0.033N* (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 7/50 (14%) 8/49 (16%) 8/50 (16%) |4/50 (8%) 4/49 (8%) 4/49 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | 4/43.28 7/42.87 8/40.22 8/45.85 |4/44.37 4/42.96 4/43.13 1/46.65 |
|POLY-3 PERCENT (g) | 9.2% 16.3% 19.9% 17.5% |9.0% 9.3% 9.3% 2.1% |
|TERMINAL (d) | 3/34 (9%) 7/36 (19%) 6/30 (20%) 7/38 (18%) |2/34 (6%) 3/33 (9%) 2/32 (6%) 1/40 (3%) |
|FIRST INCIDENCE | 687 733 (T) 502 716 |547 448 469 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.359 P=0.289 P=0.126 P=0.238 |P=0.089N P=0.613 P=0.615 P=0.151N |
|POLY 3 | P=0.324 P=0.254 P=0.140 P=0.205 |P=0.099N P=0.626 P=0.628 P=0.164N |
|POLY 1.5 | P=0.302 P=0.254 P=0.150 P=0.194 |P=0.105N P=0.626 P=0.631 P=0.169N |
|POLY 6 | P=0.349 P=0.255 P=0.132 P=0.219 |P=0.094N P=0.629 P=0.622 P=0.158N |
|LOGISTIC REGRESSION| P=0.337 P=0.263 P=0.145 P=0.229 |P=0.154N P=0.637N P=0.630 P=0.248N |
|COCH-ARM / FISHERS | P=0.268 P=0.262 P=0.168 P=0.178 |P=0.117N P=0.631 P=0.631 P=0.181N |
|ORDER RESTRICTED | P=0.168 (e) (e) (e) |P=0.148N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 20/50 (40%) 23/50 (46%) 17/49 (35%) 20/50 (40%) |6/50 (12%) 8/49 (16%) 11/49 (22%) 1/50 (2%) |
|POLY-3 RATE (b) | 20/43.42 23/44.33 17/40.31 20/46.45 |6/44.53 8/43.28 11/43.13 1/46.65 |
|POLY-3 PERCENT (g) | 46.1% 51.9% 42.2% 43.1% |13.5% 18.5% 25.5% 2.1% |
|TERMINAL (d) | 18/34 (53%) 20/36 (56%) 14/30 (47%) 17/38 (45%) |3/34 (9%) 5/33 (15%) 9/32 (28%) 1/40 (3%) |
|FIRST INCIDENCE | 687 287 502 582 |547 448 469 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.277N P=0.422 P=0.532N P=0.394N |P=0.011N* P=0.364 P=0.124 P=0.045N* |
|POLY 3 | P=0.332N P=0.368 P=0.444N P=0.470N |P=0.011N* P=0.364 P=0.122 P=0.049N* |
|POLY 1.5 | P=0.387N P=0.353 P=0.417N P=0.517N |P=0.013N* P=0.364 P=0.128 P=0.051N |
|POLY 6 | P=0.272N P=0.386 P=0.473N P=0.416N |P=0.010N* P=0.369 P=0.113 P=0.046N* |
|LOGISTIC REGRESSION| P=0.306N P=0.332 P=0.530N P=0.421N |P=0.019N* P=0.376 P=0.133 P=0.078N |
|COCH-ARM / FISHERS | P=0.468N P=0.343 P=0.368N P=0.581N |P=0.019N* P=0.371 P=0.133 P=0.056N |
|ORDER RESTRICTED | P=0.422N (e) (e) (e) |P=0.011N* (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 2/49 (4%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.87 0/39.04 0/45.78 |0/43.20 2/42.63 1/43.41 0/46.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 4.7% 2.3% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 1/33 (3%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 601 637 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.337N P=0.236 P=0.510 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.342N P=0.234 P=0.501 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.351N P=0.232 P=0.501 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.332N P=0.238 P=0.500 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.403N P=0.236 P=0.497 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.364N P=0.242 P=0.500 (e) |
|ORDER RESTRICTED | (e) (e) (e) (e) |P=0.308N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 1/49 (2%) 3/48 (6%) 2/49 (4%) |
|POLY-3 RATE (b) | |2/43.20 1/42.37 3/41.85 2/46.59 |
|POLY-3 PERCENT (g) | |4.6% 2.4% 7.2% 4.3% |
|TERMINAL (d) | |2/34 (6%) 0/33 (0%) 1/31 (3%) 1/40 (3%) |
|FIRST INCIDENCE | |734 (T) 684 637 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.619N P=0.507N P=0.477 P=0.638N |
|POLY 3 | |P=0.616 P=0.507N P=0.486 P=0.666N |
|POLY 1.5 | |P=0.597 P=0.509N P=0.484 P=0.680N |
|POLY 6 | |P=0.634 P=0.501N P=0.487 P=0.651N |
|LOGISTIC REGRESSION| |P=0.556 P=0.506N P=0.480 P=0.690 |
|COCH-ARM / FISHERS | |P=0.564 P=0.508N P=0.480 P=0.684 |
|ORDER RESTRICTED | |P=0.492 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/49 (0%) 2/48 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | |0/43.20 0/42.18 2/41.25 0/46.16 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.9% 0.0% |
|TERMINAL (d) | |0/34 (0%) 0/33 (0%) 2/31 (7%) 0/40 (0%) |
|FIRST INCIDENCE | |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.603N (e) P=0.218 (e) |
|POLY 3 | |P=0.625N (e) P=0.227 (e) |
|POLY 1.5 | |P=0.635N (e) P=0.228 (e) |
|POLY 6 | |P=0.616N (e) P=0.224 (e) |
|LOGISTIC REGRESSION| |(e) (e) P=0.218 (e) |
|COCH-ARM / FISHERS | |P=0.653N (e) P=0.237 (e) |
|ORDER RESTRICTED | |P=0.239 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/48 (0%) 1/48 (2%) 0/49 (0%) |7/48 (15%) 7/48 (15%) 4/48 (8%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/43.10 0/41.82 1/37.96 0/44.78 |7/41.74 7/41.36 4/42.32 1/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 0.0% |16.8% 16.9% 9.5% 2.2% |
|TERMINAL (d) | 0/34 (0%) 0/35 (0%) 1/29 (3%) 0/37 (0%) |7/33 (21%) 7/33 (21%) 2/32 (6%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |734 (T) 734 (T) 617 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.752N (e) P=0.468 (e) |P=0.009N** P=0.617 P=0.273N P=0.016N* |
|POLY 3 | P=0.763N (e) P=0.475 (e) |P=0.011N* P=0.608 P=0.251N P=0.020N* |
|POLY 1.5 | P=0.766N (e) P=0.481 (e) |P=0.013N* P=0.605 P=0.255N P=0.023N* |
|POLY 6 | P=0.759N (e) P=0.468 (e) |P=0.009N** P=0.614N P=0.247N P=0.018N* |
|LOGISTIC REGRESSION| (e) (e) P=0.468 (e) |P=0.011N* P=0.617 P=0.262N P=0.016N* |
|COCH-ARM / FISHERS | P=0.772N (e) P=0.490 (e) |P=0.018N* P=0.613N P=0.262N P=0.028N* |
|ORDER RESTRICTED | P=0.359 (e) (e) (e) |P=0.016N* (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.10 2/42.87 0/39.04 0/45.78 |0/43.20 0/42.18 1/43.06 1/46.65 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 0.0% 0.0% |0.0% 0.0% 2.3% 2.1% |
|TERMINAL (d) | 0/34 (0%) 2/36 (6%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 1/32 (3%) 1/40 (3%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |--- --- 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.251 (e) (e) |P=0.396 (e) P=0.488 P=0.532 |
|POLY 3 | P=0.371N P=0.236 (e) (e) |P=0.377 (e) P=0.499 P=0.515 |
|POLY 1.5 | P=0.380N P=0.235 (e) (e) |P=0.368 (e) P=0.500 P=0.510 |
|POLY 6 | P=0.362N P=0.237 (e) (e) |P=0.384 (e) P=0.497 P=0.521 |
|LOGISTIC REGRESSION| (e) P=0.251 (e) (e) |(e) (e) P=0.488 P=0.532 |
|COCH-ARM / FISHERS | P=0.390N P=0.247 (e) (e) |P=0.350 (e) P=0.500 P=0.500 |
|ORDER RESTRICTED | P=0.235N (e) (e) (e) |P=0.252 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/49 (2%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/43.10 0/42.87 1/39.41 0/45.78 |1/43.20 1/42.18 2/43.71 1/46.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.5% 0.0% |2.3% 2.4% 4.6% 2.1% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |1/34 (3%) 1/33 (3%) 0/32 (0%) 1/40 (3%) |
|FIRST INCIDENCE | --- --- 630 --- |734 (T) 734 (T) 621 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.749N (e) P=0.480 (e) |P=0.570N P=0.755 P=0.507 P=0.725N |
|POLY 3 | P=0.762N (e) P=0.482 (e) |P=0.598N P=0.756 P=0.504 P=0.743N |
|POLY 1.5 | P=0.766N (e) P=0.488 (e) |P=0.609N P=0.754 P=0.503 P=0.750N |
|POLY 6 | P=0.758N (e) P=0.477 (e) |P=0.588N P=0.759 P=0.505 P=0.736N |
|LOGISTIC REGRESSION| P=0.798N (e) P=0.526 (e) |P=0.626N P=0.755 P=0.499 P=0.725N |
|COCH-ARM / FISHERS | P=0.772N (e) P=0.500 (e) |P=0.629N P=0.747 P=0.500 P=0.753N |
|ORDER RESTRICTED | P=0.365 (e) (e) (e) |P=0.602 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/49 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.28 0/42.87 0/39.04 0/45.78 |1/43.20 0/42.18 1/43.06 2/47.16 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 0.0% 0.0% |2.3% 0.0% 2.3% 4.2% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 0/30 (0%) 0/38 (0%) |1/34 (3%) 0/33 (0%) 1/32 (3%) 0/40 (0%) |
|FIRST INCIDENCE | 687 --- --- --- |734 (T) --- 734 (T) 609 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.522N P=0.505N P=0.546N P=0.481N |P=0.291 P=0.506N P=0.748 P=0.550 |
|POLY 3 | P=0.534N P=0.502N P=0.521N P=0.489N |P=0.269 P=0.505N P=0.760 P=0.531 |
|POLY 1.5 | P=0.538N P=0.502N P=0.513N P=0.493N |P=0.259 P=0.506N P=0.761 P=0.519 |
|POLY 6 | P=0.529N P=0.501N P=0.527N P=0.484N |P=0.279 P=0.502N P=0.758 P=0.544 |
|LOGISTIC REGRESSION| P=0.545N P=0.500N P=0.509N P=0.505N |P=0.242 (e) P=0.748 P=0.466 |
|COCH-ARM / FISHERS | P=0.547N P=0.500N P=0.500N P=0.500N |P=0.240 P=0.505N P=0.753N P=0.500 |
|ORDER RESTRICTED | P=0.111N (e) (e) (e) |P=0.257 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/49 (0%) 1/49 (2%) 0/50 (0%) |0/50 (0%) 1/48 (2%) 2/49 (4%) 0/49 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.82 1/38.96 0/45.78 |0/43.20 1/41.96 2/42.67 0/46.16 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 2.6% 0.0% |0.0% 2.4% 4.7% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/38 (0%) |0/34 (0%) 1/33 (3%) 0/32 (0%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |--- 734 (T) 665 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.751N (e) P=0.475 (e) |P=0.429N P=0.494 P=0.236 (e) |
|POLY 3 | P=0.761N (e) P=0.480 (e) |P=0.442N P=0.494 P=0.234 (e) |
|POLY 1.5 | P=0.765N (e) P=0.486 (e) |P=0.454N P=0.492 P=0.234 (e) |
|POLY 6 | P=0.758N (e) P=0.474 (e) |P=0.430N P=0.498 P=0.234 (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.475 (e) |P=0.473N P=0.494 P=0.233 (e) |
|COCH-ARM / FISHERS | P=0.770N (e) P=0.495 (e) |P=0.473N P=0.490 P=0.242 (e) |
|ORDER RESTRICTED | P=0.364 (e) (e) (e) |P=0.307N (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/49 (0%) 4/50 (8%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.10 1/42.87 0/39.04 1/45.78 |0/43.20 0/42.18 4/43.06 0/46.65 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 2.2% |0.0% 0.0% 9.3% 0.0% |
|TERMINAL (d) | 0/34 (0%) 1/36 (3%) 0/30 (0%) 1/38 (3%) |0/34 (0%) 0/33 (0%) 4/32 (13%) 0/40 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- 733 (T) |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.503 P=0.511 (e) P=0.522 |P=0.468N (e) P=0.055 (e) |
|POLY 3 | P=0.496 P=0.499 (e) P=0.512 |P=0.487N (e) P=0.059 (e) |
|POLY 1.5 | P=0.489 P=0.498 (e) P=0.507 |P=0.501N (e) P=0.060 (e) |
|POLY 6 | P=0.505 P=0.500 (e) P=0.518 |P=0.475N (e) P=0.058 (e) |
|LOGISTIC REGRESSION| (e) P=0.511 (e) P=0.522 |(e) (e) P=0.055 (e) |
|COCH-ARM / FISHERS | P=0.478 P=0.500 (e) P=0.500 |P=0.529N (e) P=0.059 (e) |
|ORDER RESTRICTED | P=0.263 (e) (e) (e) |P=0.108 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/49 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.10 1/42.87 0/39.04 0/45.78 |0/43.20 0/42.18 3/43.06 0/46.65 |
|POLY-3 PERCENT (g) | 0.0% 2.3% 0.0% 0.0% |0.0% 0.0% 7.0% 0.0% |
|TERMINAL (d) | 0/34 (0%) 1/36 (3%) 0/30 (0%) 0/38 (0%) |0/34 (0%) 0/33 (0%) 3/32 (9%) 0/40 (0%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588N P=0.511 (e) (e) |P=0.525N (e) P=0.110 (e) |
|POLY 3 | P=0.595N P=0.499 (e) (e) |P=0.545N (e) P=0.118 (e) |
|POLY 1.5 | P=0.601N P=0.498 (e) (e) |P=0.557N (e) P=0.119 (e) |
|POLY 6 | P=0.588N P=0.500 (e) (e) |P=0.535N (e) P=0.116 (e) |
|LOGISTIC REGRESSION| (e) P=0.511 (e) (e) |(e) (e) P=0.110 (e) |
|COCH-ARM / FISHERS | P=0.608N P=0.500 (e) (e) |P=0.579N (e) P=0.121 (e) |
|ORDER RESTRICTED | P=0.369N (e) (e) (e) |P=0.162 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 0/48 (0%) |3/50 (6%) 1/49 (2%) 3/49 (6%) 5/49 (10%) |
|POLY-3 RATE (b) | 1/43.64 0/42.82 1/38.96 0/43.82 |3/43.20 1/42.18 3/42.66 5/46.16 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.6% 0.0% |6.9% 2.4% 7.0% 10.8% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/37 (0%) |3/34 (9%) 1/33 (3%) 2/32 (6%) 5/40 (13%) |
|FIRST INCIDENCE | 567 --- 733 (T) --- |734 (T) 734 (T) 617 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460N P=0.491N P=0.733 P=0.483N |P=0.208 P=0.315N P=0.648 P=0.448 |
|POLY 3 | P=0.473N P=0.504N P=0.735 P=0.499N |P=0.159 P=0.313N P=0.657 P=0.393 |
|POLY 1.5 | P=0.477N P=0.504N P=0.743 P=0.503N |P=0.148 P=0.315N P=0.656 P=0.375 |
|POLY 6 | P=0.467N P=0.504N P=0.727 P=0.495N |P=0.170 P=0.309N P=0.657 P=0.414 |
|LOGISTIC REGRESSION| P=0.501N P=0.485N P=0.755N P=0.540N |P=0.178 P=0.315N P=0.652 P=0.448 |
|COCH-ARM / FISHERS | P=0.485N P=0.505N P=0.747 P=0.510N |P=0.128 P=0.316N P=0.651 P=0.346 |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.192 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 1/49 (2%) 0/48 (0%) |3/50 (6%) 2/49 (4%) 3/49 (6%) 5/49 (10%) |
|POLY-3 RATE (b) | 1/43.64 0/42.82 1/38.96 0/43.82 |3/43.20 2/42.18 3/42.66 5/46.16 |
|POLY-3 PERCENT (g) | 2.3% 0.0% 2.6% 0.0% |6.9% 4.7% 7.0% 10.8% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 1/30 (3%) 0/37 (0%) |3/34 (9%) 2/33 (6%) 2/32 (6%) 5/40 (13%) |
|FIRST INCIDENCE | 567 --- 733 (T) --- |734 (T) 734 (T) 617 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.460N P=0.491N P=0.733 P=0.483N |P=0.281 P=0.514N P=0.648 P=0.448 |
|POLY 3 | P=0.473N P=0.504N P=0.735 P=0.499N |P=0.223 P=0.511N P=0.657 P=0.393 |
|POLY 1.5 | P=0.477N P=0.504N P=0.743 P=0.503N |P=0.209 P=0.513N P=0.656 P=0.375 |
|POLY 6 | P=0.467N P=0.504N P=0.727 P=0.495N |P=0.238 P=0.505N P=0.657 P=0.414 |
|LOGISTIC REGRESSION| P=0.501N P=0.485N P=0.755N P=0.540N |P=0.247 P=0.514N P=0.652 P=0.448 |
|COCH-ARM / FISHERS | P=0.485N P=0.505N P=0.747 P=0.510N |P=0.183 P=0.510N P=0.651 P=0.346 |
|ORDER RESTRICTED | P=0.250N (e) (e) (e) |P=0.292 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/50 (4%) 3/49 (6%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | |2/43.20 3/42.18 4/44.18 2/46.65 |
|POLY-3 PERCENT (g) | |4.6% 7.1% 9.1% 4.3% |
|TERMINAL (d) | |2/34 (6%) 3/33 (9%) 1/32 (3%) 2/40 (5%) |
|FIRST INCIDENCE | |734 (T) 734 (T) 582 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.395N P=0.486 P=0.339 P=0.635N |
|POLY 3 | |P=0.434N P=0.489 P=0.347 P=0.666N |
|POLY 1.5 | |P=0.451N P=0.487 P=0.343 P=0.676N |
|POLY 6 | |P=0.418N P=0.495 P=0.351 P=0.655N |
|LOGISTIC REGRESSION| |P=0.459N P=0.486 P=0.336 P=0.635N |
|COCH-ARM / FISHERS | |P=0.481N P=0.490 P=0.339 P=0.691N |
|ORDER RESTRICTED | |P=0.474N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |0/50 (0%) 1/49 (2%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.10 2/42.87 1/39.04 0/45.78 |0/43.20 1/42.18 1/43.06 2/46.65 |
|POLY-3 PERCENT (g) | 0.0% 4.7% 2.6% 0.0% |0.0% 2.4% 2.3% 4.3% |
|TERMINAL (d) | 0/34 (0%) 2/36 (6%) 1/30 (3%) 0/38 (0%) |0/34 (0%) 1/33 (3%) 1/32 (3%) 2/40 (5%) |
|FIRST INCIDENCE | --- 733 (T) 733 (T) --- |--- 734 (T) 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.342N P=0.251 P=0.475 (e) |P=0.273 P=0.494 P=0.488 P=0.275 |
|POLY 3 | P=0.345N P=0.236 P=0.480 (e) |P=0.241 P=0.495 P=0.499 P=0.255 |
|POLY 1.5 | P=0.354N P=0.235 P=0.487 (e) |P=0.232 P=0.494 P=0.500 P=0.248 |
|POLY 6 | P=0.334N P=0.237 P=0.474 (e) |P=0.250 P=0.498 P=0.497 P=0.262 |
|LOGISTIC REGRESSION| (e) P=0.251 P=0.475 (e) |(e) P=0.494 P=0.488 P=0.275 |
|COCH-ARM / FISHERS | P=0.366N P=0.247 P=0.500 (e) |P=0.217 P=0.495 P=0.500 P=0.247 |
|ORDER RESTRICTED | P=0.301N (e) (e) (e) |P=0.132 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 5/50 (10%) 3/50 (6%) 4/50 (8%) |2/50 (4%) 2/49 (4%) 4/50 (8%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/43.10 5/43.39 3/39.41 4/46.19 |2/43.50 2/42.18 4/43.87 2/46.65 |
|POLY-3 PERCENT (g) | 2.3% 11.5% 7.6% 8.7% |4.6% 4.7% 9.1% 4.3% |
|TERMINAL (d) | 1/34 (3%) 3/36 (8%) 2/30 (7%) 2/38 (5%) |1/34 (3%) 2/33 (6%) 1/32 (3%) 2/40 (5%) |
|FIRST INCIDENCE | 733 (T) 632 630 637 |651 734 (T) 621 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.456 P=0.116 P=0.265 P=0.219 |P=0.481N P=0.683 P=0.335 P=0.638N |
|POLY 3 | P=0.431 P=0.102 P=0.273 P=0.200 |P=0.522N P=0.683 P=0.341 P=0.669N |
|POLY 1.5 | P=0.411 P=0.101 P=0.284 P=0.191 |P=0.537N P=0.683 P=0.340 P=0.678N |
|POLY 6 | P=0.456 P=0.106 P=0.265 P=0.212 |P=0.508N P=0.686 P=0.340 P=0.659N |
|LOGISTIC REGRESSION| P=0.416 P=0.102 P=0.270 P=0.190 |P=0.548N P=0.688 P=0.337 P=0.676N |
|COCH-ARM / FISHERS | P=0.381 P=0.102 P=0.309 P=0.181 |P=0.566N P=0.684 P=0.339 P=0.691N |
|ORDER RESTRICTED | P=0.158 (e) (e) (e) |P=0.531 (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 7/50 (14%) 4/50 (8%) 4/50 (8%) |2/50 (4%) 3/49 (6%) 5/50 (10%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/43.10 7/43.39 4/39.41 4/46.19 |2/43.50 3/42.18 5/43.87 4/46.65 |
|POLY-3 PERCENT (g) | 2.3% 16.1% 10.2% 8.7% |4.6% 7.1% 11.4% 8.6% |
|TERMINAL (d) | 1/34 (3%) 5/36 (14%) 3/30 (10%) 2/38 (5%) |1/34 (3%) 3/33 (9%) 2/32 (6%) 4/40 (10%) |
|FIRST INCIDENCE | 733 (T) 632 630 637 |651 734 (T) 621 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.562N P=0.040 * P=0.147 P=0.219 |P=0.484 P=0.487 P=0.215 P=0.411 |
|POLY 3 | P=0.588N P=0.030 * P=0.152 P=0.200 |P=0.431 P=0.486 P=0.219 P=0.370 |
|POLY 1.5 | P=0.584 P=0.030 * P=0.161 P=0.191 |P=0.412 P=0.486 P=0.218 P=0.358 |
|POLY 6 | P=0.560N P=0.031 * P=0.145 P=0.212 |P=0.448 P=0.489 P=0.218 P=0.382 |
|LOGISTIC REGRESSION| P=0.594N P=0.032 * P=0.146 P=0.190 |P=0.421 P=0.492 P=0.217 P=0.378 |
|COCH-ARM / FISHERS | P=0.549 P=0.030 * P=0.181 P=0.181 |P=0.377 P=0.490 P=0.218 P=0.339 |
|ORDER RESTRICTED | P=0.092 (e) (e) (e) |P=0.274 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |2/50 (4%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/43.10 0/42.87 2/39.04 0/45.78 |2/44.04 1/42.18 2/43.22 0/46.65 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 5.1% 0.0% |4.5% 2.4% 4.6% 0.0% |
|TERMINAL (d) | 0/34 (0%) 0/36 (0%) 2/30 (7%) 0/38 (0%) |0/34 (0%) 1/33 (3%) 1/32 (3%) 0/40 (0%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |566 734 (T) 693 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.624N (e) P=0.211 (e) |P=0.183N P=0.514N P=0.681 P=0.218N |
|POLY 3 | P=0.636N (e) P=0.215 (e) |P=0.191N P=0.515N P=0.687 P=0.225N |
|POLY 1.5 | P=0.642N (e) P=0.223 (e) |P=0.198N P=0.513N P=0.691 P=0.229N |
|POLY 6 | P=0.629N (e) P=0.209 (e) |P=0.185N P=0.515N P=0.681 P=0.221N |
|LOGISTIC REGRESSION| (e) (e) P=0.211 (e) |P=0.225N P=0.494N P=0.694 P=0.354N |
|COCH-ARM / FISHERS | P=0.652N (e) P=0.247 (e) |P=0.210N P=0.508N P=0.691N P=0.247N |
|ORDER RESTRICTED | P=0.228 (e) (e) (e) |P=0.146N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 1/50 (2%) 2/50 (4%) |6/50 (12%) 3/49 (6%) 5/50 (10%) 8/50 (16%) |
|POLY-3 RATE (b) | 3/43.23 3/43.03 1/39.66 2/45.82 |6/44.72 3/42.20 5/43.41 8/47.25 |
|POLY-3 PERCENT (g) | 6.9% 7.0% 2.5% 4.4% |13.4% 7.1% 11.5% 16.9% |
|TERMINAL (d) | 1/34 (3%) 2/36 (6%) 0/30 (0%) 1/38 (3%) |2/34 (6%) 2/33 (6%) 4/32 (13%) 5/40 (13%) |
|FIRST INCIDENCE | 712 693 532 724 |573 730 637 663 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.640N P=0.358N P=0.449N |P=0.258 P=0.261N P=0.514N P=0.498 |
|POLY 3 | P=0.416N P=0.661 P=0.336N P=0.474N |P=0.193 P=0.271N P=0.521N P=0.430 |
|POLY 1.5 | P=0.430N P=0.658 P=0.326N P=0.484N |P=0.178 P=0.265N P=0.510N P=0.415 |
|POLY 6 | P=0.402N P=0.662N P=0.346N P=0.462N |P=0.209 P=0.275N P=0.539N P=0.445 |
|LOGISTIC REGRESSION| P=0.429N P=0.664N P=0.306N P=0.458N |P=0.165 P=0.251N P=0.500N P=0.335 |
|COCH-ARM / FISHERS | P=0.452N P=0.661N P=0.309N P=0.500N |P=0.152 P=0.254N P=0.500N P=0.387 |
|ORDER RESTRICTED | P=0.365N (e) (e) (e) |P=0.262 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 31/50 (62%) 31/50 (62%) 25/50 (50%) 29/50 (58%) |23/50 (46%) 23/49 (47%) 29/50 (58%) 21/50 (42%) |
|POLY-3 RATE (b) | 31/45.06 31/46.27 25/42.41 29/47.85 |23/44.86 23/42.75 29/45.88 21/47.53 |
|POLY-3 PERCENT (g) | 68.8% 67.0% 59.0% 60.6% |51.3% 53.8% 63.2% 44.2% |
|TERMINAL (d) | 26/34 (77%) 25/36 (69%) 18/30 (60%) 22/38 (58%) |18/34 (53%) 19/33 (58%) 20/32 (63%) 19/40 (48%) |
|FIRST INCIDENCE | 547 287 317 582 |573 649 582 600 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.202N P=0.460N P=0.380N P=0.204N |P=0.081N P=0.534 P=0.137 P=0.193N |
|POLY 3 | P=0.260N P=0.517N P=0.222N P=0.268N |P=0.152N P=0.490 P=0.168 P=0.316N |
|POLY 1.5 | P=0.328N P=0.545N P=0.196N P=0.330N |P=0.193N P=0.504 P=0.162 P=0.352N |
|POLY 6 | P=0.184N P=0.491N P=0.246N P=0.201N |P=0.123N P=0.488 P=0.178 P=0.285N |
|LOGISTIC REGRESSION| P=0.305N P=0.562 P=0.283N P=0.304N |P=0.142N P=0.553 P=0.150 P=0.291N |
|COCH-ARM / FISHERS | P=0.429N P=0.582N P=0.157N P=0.419N |P=0.289N P=0.543 P=0.158 P=0.420N |
|ORDER RESTRICTED | P=0.279N (e) (e) (e) |P=0.180N (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 30/50 (60%) 26/50 (52%) 25/50 (50%) |20/50 (40%) 25/49 (51%) 24/50 (48%) 22/50 (44%) |
|POLY-3 RATE (b) | 23/49.12 30/48.54 26/46.83 25/49.21 |20/48.00 25/44.34 24/47.72 22/48.26 |
|POLY-3 PERCENT (g) | 46.8% 61.8% 55.5% 50.8% |41.7% 56.4% 50.3% 45.6% |
|TERMINAL (d) | 9/34 (27%) 18/36 (50%) 11/30 (37%) 15/38 (40%) |9/34 (27%) 18/33 (55%) 11/32 (34%) 16/40 (40%) |
|FIRST INCIDENCE | 385 270 400 382 |352 448 411 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.289N P=0.216 P=0.227 P=0.541N |P=0.247N P=0.214 P=0.281 P=0.508N |
|POLY 3 | P=0.418N P=0.099 P=0.259 P=0.424 |P=0.437N P=0.111 P=0.260 P=0.428 |
|POLY 1.5 | P=0.424N P=0.100 P=0.281 P=0.423 |P=0.453N P=0.132 P=0.265 P=0.426 |
|POLY 6 | P=0.418N P=0.101 P=0.243 P=0.423 |P=0.423N P=0.094 P=0.256 P=0.428 |
|LOGISTIC REGRESSION| P=0.515 P=0.108 P=0.519 P=0.244 |P=0.553 P=0.187 P=0.265 P=0.279 |
|COCH-ARM / FISHERS | P=0.447N P=0.115 P=0.345 P=0.421 |P=0.494N P=0.184 P=0.273 P=0.420 |
|ORDER RESTRICTED | P=0.282 (e) (e) (e) |P=0.295 (e) (e) (e) |
|=================================================================================================================================|
Date: 11/15/04 EXPERIMENT: 05201 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - FURFURYL ALCOHOL
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |CONTROL 2.0 PPM 8.0 PPM 32.0 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 44/50 (88%) 41/50 (82%) 39/50 (78%) |36/50 (72%) 37/49 (76%) 40/50 (80%) 36/50 (72%) |
|POLY-3 RATE (b) | 43/49.70 44/49.48 41/48.76 39/50.00 |36/49.05 37/44.84 40/48.99 36/48.71 |
|POLY-3 PERCENT (g) | 86.5% 88.9% 84.1% 78.0% |73.4% 82.5% 81.7% 73.9% |
|TERMINAL (d) | 28/34 (82%) 31/36 (86%) 23/30 (77%) 27/38 (71%) |22/34 (65%) 28/33 (85%) 24/32 (75%) 29/40 (73%) |
|FIRST INCIDENCE | 385 270 317 382 |352 448 411 582 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.078N P=0.514N P=0.382 P=0.128N |P=0.106N P=0.433 P=0.263 P=0.244N |
|POLY 3 | P=0.091N P=0.476 P=0.477N P=0.197N |P=0.351N P=0.202 P=0.229 P=0.569 |
|POLY 1.5 | P=0.102N P=0.485 P=0.460N P=0.207N |P=0.369N P=0.273 P=0.232 P=0.581 |
|POLY 6 | P=0.079N P=0.471 P=0.483N P=0.183N |P=0.351N P=0.145 P=0.228 P=0.544 |
|LOGISTIC REGRESSION| P=0.167N P=0.503 P=0.338N P=0.293N |P=0.356N P=0.410 P=0.241 P=0.549 |
|COCH-ARM / FISHERS | P=0.124N P=0.500 P=0.393N P=0.218N |P=0.435N P=0.433 P=0.241 P=0.588N |
|ORDER RESTRICTED | P=0.137N (e) (e) (e) |P=0.374 (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).