TDMS Study 05203-09 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:02:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
------------------------------------------------------------------------------------------------------------------------------------
MICE, FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:02:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
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
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pancreas
Pituitary Gland
Prostate
Spleen
Testes
Thymus
Thyroid Gland
Urinary Bladder
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:02:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF O-NITROTOLUENE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Carcinoma or Adenoma
Heart Hemangiosarcoma
Intestine Large: Cecum Carcinoma
Liver Hemangiosarcoma
Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Hemangiosarcoma
Mesentery Hemangiosarcoma
Prostate Hemangiosarcoma
Skeletal Muscle Hemangiosarcoma
Skin Hemangiosarcoma
Stomach, Forestomach Squamous Cell Papilloma
Tissue NOS Hemangiosarcoma
All Organs Hemangioma
Hemangiosarcoma
Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Harderian Gland Carcinoma
Carcinoma or Adenoma
Intestine Large: Cecum Carcinoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Mesentery Hemangiosarcoma
Pituitary Gland: Pars Distalis or Unspecified Site
Adenoma
Skeletal Muscle Hemangiosarcoma
Sarcoma
Skin Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, or Fibrous Histiocytoma
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Southern Research Inst O-NITROTOLUENE DATE: 11/16/00
EXPERIMENT: 05203 TEST: 09 TIME: 10:02:33
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55393 ROUTE: DOSED FEED NTP C#: 62340D
PATHOLOGIST: FARNELL, D. CAS: 88-72-2
Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma
Hemangiosarcoma
Sarcoma
Tissue NOS Hemangiosarcoma
Uterus Hemangiosarcoma
All Organs Hemangioma
Hemangiosarcoma
Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/58 (0%) 0/60 (0%) |1/59 (2%) 0/59 (0%) 0/58 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 2/56.99 0/49.65 0/22.81 0/9.13 |1/55.32 0/53.27 0/55.51 0/39.77 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |1.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/52 (4%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |729 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620N P=0.336N P=1.000 P=1.000N |P=0.473N P=0.524N P=0.520N P=0.927N |
|POLY 3 | P=0.156N P=0.270N P=0.462N P=0.602N |P=0.248N P=0.508N P=0.499N P=0.564N |
|POLY 1.5 | P=0.119N P=0.255N P=0.358N P=0.463N |P=0.278N P=0.505N P=0.500N P=0.532N |
|POLY 6 | P=0.201N P=0.288N P=0.589N P=0.679N |P=0.232N P=0.511N P=0.502N P=0.612N |
|LOGISTIC REGRESSION| P=0.620N (e) (e) (e) |P=0.473N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.116N P=0.248N P=0.256N P=0.248N |P=0.305N P=0.500N P=0.504N P=0.496N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |4/60 (7%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |
|POLY-3 RATE (b) | 4/56.99 1/49.65 1/23.78 0/9.13 |4/56.31 0/54.01 1/57.18 2/40.12 |
|POLY-3 PERCENT (g) | 7.0% 2.0% 4.2% 0.0% |7.1% 0.0% 1.8% 5.0% |
|TERMINAL (d) | 4/52 (8%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |4/52 (8%) 0/46 (0%) 1/47 (2%) 1/5 (20%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 645 --- |729 (T) --- 729 (T) 630 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.646 P=0.328N P=0.006 ** P=1.000N |P=0.342 P=0.080N P=0.212N P=0.186 |
|POLY 3 | P=0.196N P=0.225N P=0.509N P=0.483N |P=0.378N P=0.067N P=0.175N P=0.501N |
|POLY 1.5 | P=0.099N P=0.205N P=0.345N P=0.273N |P=0.381N P=0.065N P=0.175N P=0.422N |
|POLY 6 | P=0.269N P=0.252N P=0.598 P=0.616N |P=0.366N P=0.070N P=0.180N P=0.624N |
|LOGISTIC REGRESSION| P=0.747N P=0.328N P=0.479 (e) |P=0.599N (e) P=0.212N P=0.646 |
|COCH-ARM / FISHERS | P=0.035N* P=0.182N P=0.182N P=0.059N |P=0.373N P=0.059N P=0.182N P=0.340N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |1/60 (2%) 1/60 (2%) 3/60 (5%) 2/60 (3%) |
|POLY-3 RATE (b) | 1/56.99 1/49.97 1/24.02 0/9.13 |1/56.31 1/54.32 3/57.40 2/40.34 |
|POLY-3 PERCENT (g) | 1.8% 2.0% 4.2% 0.0% |1.8% 1.8% 5.2% 5.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 0/46 (0%) 2/47 (4%) 1/5 (20%) |
|FIRST INCIDENCE | 729 (T) 641 560 --- |729 (T) 644 672 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.343 P=0.690 P=0.295 P=1.000N |P=0.042 * P=0.743 P=0.281 P=0.092 |
|POLY 3 | P=0.581 P=0.730 P=0.549 P=0.721N |P=0.190 P=0.752 P=0.313 P=0.388 |
|POLY 1.5 | P=0.570N P=0.744 P=0.651 P=0.654N |P=0.248 P=0.755 P=0.313 P=0.440 |
|POLY 6 | P=0.575 P=0.713 P=0.422 P=0.754N |P=0.131 P=0.749 P=0.308 P=0.310 |
|LOGISTIC REGRESSION| P=0.708N P=0.758N P=0.796 (e) |P=0.324 P=0.759N P=0.308 P=0.489 |
|COCH-ARM / FISHERS | P=0.312N P=0.752N P=0.752N P=0.500N |P=0.325 P=0.752N P=0.309 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 2/60 (3%) 2/60 (3%) 0/60 (0%) |5/60 (8%) 1/60 (2%) 4/60 (7%) 4/60 (7%) |
|POLY-3 RATE (b) | 5/56.99 2/49.97 2/24.33 0/9.13 |5/56.31 1/54.32 4/57.40 4/40.70 |
|POLY-3 PERCENT (g) | 8.8% 4.0% 8.2% 0.0% |8.9% 1.8% 7.0% 9.8% |
|TERMINAL (d) | 5/52 (10%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |5/52 (10%) 0/46 (0%) 3/47 (6%) 2/5 (40%) |
|FIRST INCIDENCE | 729 (T) 641 560 --- |729 (T) 644 672 548 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268 P=0.399N P=0.006 ** P=1.000N |P=0.034 * P=0.133N P=0.555N P=0.020 * |
|POLY 3 | P=0.298N P=0.274N P=0.617N P=0.443N |P=0.397 P=0.112N P=0.488N P=0.575 |
|POLY 1.5 | P=0.123N P=0.249N P=0.428N P=0.215N |P=0.459 P=0.109N P=0.488N P=0.603N |
|POLY 6 | P=0.423N P=0.307N P=0.426 P=0.599N |P=0.335 P=0.115N P=0.496N P=0.424 |
|LOGISTIC REGRESSION| P=0.611N P=0.293N P=0.371 (e) |P=0.427 P=0.111N P=0.496N P=0.506 |
|COCH-ARM / FISHERS | P=0.022N* P=0.219N P=0.219N P=0.029N* |P=0.537 P=0.103N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 2/60 (3%) 0/60 (0%) 2/60 (3%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 0/58 (0%) |
|POLY-3 RATE (b) | 0/56.99 2/49.97 0/23.48 2/10.80 |0/56.31 0/54.01 0/56.26 0/38.16 |
|POLY-3 PERCENT (g) | 0.0% 4.0% 0.0% 18.5% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 641 --- 386 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** P=0.174 (e) P=0.060 |(e) (e) (e) (e) |
|POLY 3 | P=0.092 P=0.210 (e) P=0.077 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.109 P=0.222 (e) P=0.112 |(e) (e) (e) (e) |
|POLY 6 | P=0.103 P=0.196 (e) P=0.063 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.281 P=0.242 (e) P=0.783 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.248 P=0.248 (e) P=0.248 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Large: Cecum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 12/60 (20%) 9/60 (15%) 0/60 (0%) |0/60 (0%) 1/60 (2%) 4/60 (7%) 3/60 (5%) |
|POLY-3 RATE (b) | 0/56.99 12/52.82 9/28.51 0/9.13 |0/56.31 1/54.01 4/57.24 3/40.36 |
|POLY-3 PERCENT (g) | 0.0% 22.7% 31.6% 0.0% |0.0% 1.9% 7.0% 7.4% |
|TERMINAL (d) | 0/52 (0%) 4/34 (12%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 3/47 (6%) 1/5 (20%) |
|FIRST INCIDENCE | --- 485 270 --- |--- 729 (T) 715 619 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** (e) |P<0.001 ** P=0.476 P=0.053 P=0.008 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** (e) |P=0.024 * P=0.492 P=0.064 P=0.072 |
|POLY 1.5 | P=0.042 * P<0.001 ** P<0.001 ** (e) |P=0.041 * P=0.495 P=0.064 P=0.092 |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** (e) |P=0.012 * P=0.488 P=0.062 P=0.050 |
|LOGISTIC REGRESSION| P=0.352N P<0.001 ** P=0.028 * (e) |P=0.016 * P=0.476 P=0.060 P=0.077 |
|COCH-ARM / FISHERS | P=0.187N P<0.001 ** P<0.001 ** (e) |P=0.072 P=0.500 P=0.059 P=0.122 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 2/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 1/39.91 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/52 (4%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.620N P=0.336N P=1.000N P=1.000N |P=0.053 (e) (e) P=0.201 |
|POLY 3 | P=0.154N P=0.270N P=0.456N P=0.602N |P=0.163 (e) (e) P=0.433 |
|POLY 1.5 | P=0.117N P=0.255N P=0.351N P=0.463N |P=0.178 (e) (e) P=0.465 |
|POLY 6 | P=0.200N P=0.288N P=0.586N P=0.679N |P=0.179 (e) (e) P=0.386 |
|LOGISTIC REGRESSION| P=0.620N (e) (e) (e) |P=0.167 (e) (e) P=0.415 |
|COCH-ARM / FISHERS | P=0.115N P=0.248N P=0.248N P=0.248N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 2/56.99 1/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 1/39.91 |
|POLY-3 PERCENT (g) | 3.5% 2.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 2/52 (4%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) --- --- |--- --- --- 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.835N P=0.646N P=1.000N P=1.000N |P=0.053 (e) (e) P=0.201 |
|POLY 3 | P=0.322N P=0.548N P=0.456N P=0.602N |P=0.163 (e) (e) P=0.433 |
|POLY 1.5 | P=0.174N P=0.527N P=0.351N P=0.463N |P=0.178 (e) (e) P=0.465 |
|POLY 6 | P=0.530N P=0.573N P=0.586N P=0.679N |P=0.179 (e) (e) P=0.386 |
|LOGISTIC REGRESSION| P=0.835N P=0.646N (e) (e) |P=0.167 (e) (e) P=0.415 |
|COCH-ARM / FISHERS | P=0.101N P=0.500N P=0.248N P=0.248N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 4/59 (7%) 1/57 (2%) 0/60 (0%) |0/60 (0%) 0/59 (0%) 1/59 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/56.99 4/49.88 1/23.28 0/9.13 |0/56.31 0/53.32 1/56.29 0/39.77 |
|POLY-3 PERCENT (g) | 1.8% 8.0% 4.3% 0.0% |0.0% 0.0% 1.8% 0.0% |
|TERMINAL (d) | 1/52 (2%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 641 588 --- |--- --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037 * P=0.098 P=0.139 P=1.000N |P=0.527 (e) P=0.480 (e) |
|POLY 3 | P=0.257 P=0.142 P=0.542 P=0.721N |P=0.517 (e) P=0.500 (e) |
|POLY 1.5 | P=0.582N P=0.156 P=0.642 P=0.654N |P=0.609 (e) P=0.500 (e) |
|POLY 6 | P=0.070 P=0.127 P=0.419 P=0.754N |P=0.413 (e) P=0.497 (e) |
|LOGISTIC REGRESSION| P=0.434 P=0.155 P=0.719 (e) |(e) (e) P=0.480 (e) |
|COCH-ARM / FISHERS | P=0.166N P=0.177 P=0.739 P=0.500N |P=0.694 (e) P=0.496 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/60 (30%) 18/59 (31%) 3/57 (5%) 0/60 (0%) |7/60 (12%) 5/59 (8%) 19/59 (32%) 29/60 (48%) |
|POLY-3 RATE (b) | 18/57.33 18/51.36 3/24.45 0/9.13 |7/56.31 5/53.32 19/56.66 29/46.76 |
|POLY-3 PERCENT (g) | 31.4% 35.0% 12.3% 0.0% |12.4% 9.4% 33.5% 62.0% |
|TERMINAL (d) | 17/52 (33%) 14/34 (41%) 0/0 (0%) 0/0 (0%) |7/52 (14%) 5/46 (11%) 17/47 (36%) 5/5 (100%) |
|FIRST INCIDENCE | 637 451 470 --- |729 (T) 729 (T) 673 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028 * P=0.117 P=0.008 ** P=1.000N |P<0.001 ** P=0.468N P=0.003 ** P<0.001 ** |
|POLY 3 | P=0.118N P=0.421 P=0.087N P=0.183N |P<0.001 ** P=0.419N P=0.006 ** P<0.001 ** |
|POLY 1.5 | P<0.001N** P=0.482 P=0.010N* P=0.008N** |P<0.001 ** P=0.410N P=0.006 ** P<0.001 ** |
|POLY 6 | P=0.424 P=0.345 P=0.439N P=0.506N |P<0.001 ** P=0.430N P=0.005 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.299N P=0.417 P=0.551N P=0.982N |P<0.001 ** P=0.468N P=0.005 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.555 P<0.001N** P<0.001N** |P<0.001 ** P=0.393N P=0.006 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 12/60 (20%) 16/59 (27%) 5/57 (9%) 2/60 (3%) |2/60 (3%) 4/59 (7%) 6/59 (10%) 16/60 (27%) |
|POLY-3 RATE (b) | 12/58.54 16/50.92 5/24.91 2/10.84 |2/57.19 4/53.32 6/56.62 16/44.16 |
|POLY-3 PERCENT (g) | 20.5% 31.4% 20.1% 18.5% |3.5% 7.5% 10.6% 36.2% |
|TERMINAL (d) | 7/52 (14%) 10/34 (29%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 4/46 (9%) 4/47 (9%) 1/5 (20%) |
|FIRST INCIDENCE | 596 451 556 350 |362 729 (T) 661 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.054 P<0.001 ** P=0.083 |P<0.001 ** P=0.291 P=0.120 P<0.001 ** |
|POLY 3 | P=0.354 P=0.138 P=0.587N P=0.562N |P<0.001 ** P=0.307 P=0.132 P<0.001 ** |
|POLY 1.5 | P=0.143N P=0.180 P=0.295N P=0.189N |P<0.001 ** P=0.314 P=0.133 P<0.001 ** |
|POLY 6 | P=0.034 * P=0.095 P=0.263 P=0.372 |P<0.001 ** P=0.298 P=0.128 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.568 P=0.229 P=0.560N P=0.062N |P<0.001 ** P=0.350 P=0.081 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.242 P=0.071N P=0.004N** |P<0.001 ** P=0.332 P=0.131 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 13/60 (22%) 17/59 (29%) 5/57 (9%) 2/60 (3%) |2/60 (3%) 4/59 (7%) 6/59 (10%) 16/60 (27%) |
|POLY-3 RATE (b) | 13/58.58 17/50.92 5/24.91 2/10.84 |2/57.19 4/53.32 6/56.62 16/44.16 |
|POLY-3 PERCENT (g) | 22.2% 33.4% 20.1% 18.5% |3.5% 7.5% 10.6% 36.2% |
|TERMINAL (d) | 7/52 (14%) 10/34 (29%) 0/0 (0%) 0/0 (0%) |1/52 (2%) 4/46 (9%) 4/47 (9%) 1/5 (20%) |
|FIRST INCIDENCE | 596 451 556 350 |362 729 (T) 661 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.052 P<0.001 ** P=0.083 |P<0.001 ** P=0.291 P=0.120 P<0.001 ** |
|POLY 3 | P=0.399 P=0.136 P=0.526N P=0.531N |P<0.001 ** P=0.307 P=0.132 P<0.001 ** |
|POLY 1.5 | P=0.105N P=0.181 P=0.234N P=0.155N |P<0.001 ** P=0.314 P=0.133 P<0.001 ** |
|POLY 6 | P=0.036 * P=0.091 P=0.296 P=0.385 |P<0.001 ** P=0.298 P=0.128 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.553 P=0.222 P=0.521N P=0.057N |P<0.001 ** P=0.350 P=0.081 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.246 P=0.046N* P=0.002N** |P<0.001 ** P=0.332 P=0.131 P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 27/60 (45%) 28/59 (47%) 7/57 (12%) 2/60 (3%) |9/60 (15%) 9/59 (15%) 24/59 (41%) 39/60 (65%) |
|POLY-3 RATE (b) | 27/58.54 28/52.13 7/26.18 2/10.84 |9/57.19 9/53.32 24/56.99 39/49.33 |
|POLY-3 PERCENT (g) | 46.1% 53.7% 26.7% 18.5% |15.7% 16.9% 42.1% 79.1% |
|TERMINAL (d) | 22/52 (42%) 19/34 (56%) 0/0 (0%) 0/0 (0%) |8/52 (15%) 9/46 (20%) 20/47 (43%) 5/5 (100%) |
|FIRST INCIDENCE | 596 451 470 350 |362 729 (T) 661 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.042 * P<0.001 ** P=0.083 |P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.149N P=0.271 P=0.093N P=0.198N |P<0.001 ** P=0.538 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001N** P=0.354 P=0.006N** P=0.003N** |P<0.001 ** P=0.553 P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.189 P=0.181 P=0.581N P=0.518 |P<0.001 ** P=0.521 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.421N P=0.324 P=0.343N P=0.146N |P<0.001 ** P=0.573 P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.466 P<0.001N** P<0.001N** |P<0.001 ** P=0.585 P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/60 (47%) 29/59 (49%) 7/57 (12%) 2/60 (3%) |9/60 (15%) 9/59 (15%) 24/59 (41%) 39/60 (65%) |
|POLY-3 RATE (b) | 28/58.58 29/52.13 7/26.18 2/10.84 |9/57.19 9/53.32 24/56.99 39/49.33 |
|POLY-3 PERCENT (g) | 47.8% 55.6% 26.7% 18.5% |15.7% 16.9% 42.1% 79.1% |
|TERMINAL (d) | 22/52 (42%) 19/34 (56%) 0/0 (0%) 0/0 (0%) |8/52 (15%) 9/46 (20%) 20/47 (43%) 5/5 (100%) |
|FIRST INCIDENCE | 596 451 470 350 |362 729 (T) 661 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.040 * P<0.001 ** P=0.083 |P<0.001 ** P=0.494 P<0.001 ** P<0.001 ** |
|POLY 3 | P=0.125N P=0.262 P=0.073N P=0.181N |P<0.001 ** P=0.538 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001N** P=0.348 P=0.003N** P=0.002N** |P<0.001 ** P=0.553 P<0.001 ** P<0.001 ** |
|POLY 6 | P=0.192 P=0.170 P=0.548N P=0.526 |P<0.001 ** P=0.521 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P=0.435N P=0.310 P=0.314N P=0.139N |P<0.001 ** P=0.573 P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.465 P<0.001N** P<0.001N** |P<0.001 ** P=0.585 P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 9/60 (15%) 6/60 (10%) 4/60 (7%) 0/60 (0%) |2/60 (3%) 3/60 (5%) 4/59 (7%) 4/57 (7%) |
|POLY-3 RATE (b) | 9/56.99 6/51.06 4/26.03 0/9.13 |2/56.31 3/54.01 4/56.37 4/38.86 |
|POLY-3 PERCENT (g) | 15.8% 11.8% 15.4% 0.0% |3.6% 5.6% 7.1% 10.3% |
|TERMINAL (d) | 9/52 (17%) 3/34 (9%) 0/0 (0%) 0/0 (0%) |2/52 (4%) 3/46 (7%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 469 434 --- |729 (T) 729 (T) 701 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123 P=0.583N P=0.010 * P=1.000N |P=0.004 ** P=0.444 P=0.297 P=0.022 * |
|POLY 3 | P=0.323N P=0.372N P=0.595N P=0.332N |P=0.126 P=0.481 P=0.339 P=0.190 |
|POLY 1.5 | P=0.064N P=0.336N P=0.345N P=0.086N |P=0.172 P=0.488 P=0.339 P=0.244 |
|POLY 6 | P=0.604N P=0.420N P=0.314 P=0.555N |P=0.083 P=0.472 P=0.332 P=0.124 |
|LOGISTIC REGRESSION| P=0.049N* P=0.311N P=0.585N (e) |P=0.170 P=0.444 P=0.328 P=0.325 |
|COCH-ARM / FISHERS | P=0.002N** P=0.291N P=0.120N P<0.001N** |P=0.240 P=0.500 P=0.332 P=0.315 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 1/60 (2%) 2/60 (3%) 0/60 (0%) |3/60 (5%) 3/60 (5%) 0/59 (0%) 2/57 (4%) |
|POLY-3 RATE (b) | 5/57.29 1/49.65 2/24.63 0/9.13 |3/56.31 3/54.57 0/56.26 2/38.33 |
|POLY-3 PERCENT (g) | 8.7% 2.0% 8.1% 0.0% |5.3% 5.5% 0.0% 5.2% |
|TERMINAL (d) | 4/52 (8%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |3/52 (6%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 649 729 (T) 544 --- |729 (T) 553 --- 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.494 P=0.218N P=0.104 P=1.000N |P=0.509 P=0.612 P=0.140N P=0.272 |
|POLY 3 | P=0.219N P=0.140N P=0.614N P=0.444N |P=0.358N P=0.647 P=0.120N P=0.666N |
|POLY 1.5 | P=0.106N P=0.123N P=0.427N P=0.216N |P=0.352N P=0.652 P=0.120N P=0.600N |
|POLY 6 | P=0.265N P=0.164N P=0.431 P=0.599N |P=0.359N P=0.640 P=0.123N P=0.574 |
|LOGISTIC REGRESSION| P=0.265N P=0.143N P=0.700N P=0.991N |P=0.283N P=0.662 (e) P=0.560N |
|COCH-ARM / FISHERS | P=0.026N* P=0.103N P=0.219N P=0.029N* |P=0.333N P=0.660N P=0.125N P=0.524N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/60 (23%) 7/60 (12%) 6/60 (10%) 0/60 (0%) |5/60 (8%) 6/60 (10%) 4/59 (7%) 6/57 (11%) |
|POLY-3 RATE (b) | 14/57.29 7/51.06 6/27.18 0/9.13 |5/56.31 6/54.57 4/56.37 6/39.73 |
|POLY-3 PERCENT (g) | 24.4% 13.7% 22.1% 0.0% |8.9% 11.0% 7.1% 15.1% |
|TERMINAL (d) | 13/52 (25%) 4/34 (12%) 0/0 (0%) 0/0 (0%) |5/52 (10%) 5/46 (11%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | 649 469 434 --- |729 (T) 553 701 488 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.089 P=0.308N P<0.001 ** P=1.000N |P=0.011 * P=0.422 P=0.559N P=0.010 * |
|POLY 3 | P=0.136N P=0.121N P=0.513N P=0.241N |P=0.293 P=0.478 P=0.499N P=0.273 |
|POLY 1.5 | P=0.014N* P=0.098N P=0.221N P=0.026N* |P=0.358 P=0.486 P=0.499N P=0.360 |
|POLY 6 | P=0.340N P=0.157N P=0.291 P=0.525N |P=0.224 P=0.468 P=0.508N P=0.164 |
|LOGISTIC REGRESSION| P=0.017N* P=0.096N P=0.484N P=0.989N |P=0.436 P=0.482 P=0.522N P=0.464 |
|COCH-ARM / FISHERS | P<0.001N** P=0.074N P=0.042N* P<0.001N** |P=0.446 P=0.500 P=0.511N P=0.464 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 4/60 (7%) |0/60 (0%) 0/60 (0%) 0/59 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 4/12.46 |0/56.31 0/54.01 0/56.26 0/37.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 32.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- 358 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) (e) P=0.003 ** |(e) (e) (e) (e) |
|POLY 3 | P=0.014 * (e) (e) P=0.006 ** |(e) (e) (e) (e) |
|POLY 1.5 | P=0.002 ** (e) (e) P=0.012 * |(e) (e) (e) (e) |
|POLY 6 | P=0.103 (e) (e) P=0.004 ** |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.145 (e) (e) P=0.539 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.003 ** (e) (e) P=0.059 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 8/60 (13%) 38/60 (63%) 38/60 (63%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 32/60 (53%) |
|POLY-3 RATE (b) | 0/56.99 8/50.49 38/45.78 38/40.95 |0/56.31 0/54.01 0/57.18 32/48.83 |
|POLY-3 PERCENT (g) | 0.0% 15.8% 83.0% 92.8% |0.0% 0.0% 0.0% 65.5% |
|TERMINAL (d) | 0/52 (0%) 5/34 (15%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 4/5 (80%) |
|FIRST INCIDENCE | --- 572 410 297 |--- --- --- 507 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.004 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/59 (2%) 0/56 (0%) 2/56 (4%) 0/56 (0%) |
|POLY-3 RATE (b) | |1/55.31 0/51.25 2/53.29 0/36.99 |
|POLY-3 PERCENT (g) | |1.8% 0.0% 3.8% 0.0% |
|TERMINAL (d) | |1/51 (2%) 0/45 (0%) 2/44 (5%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.539 P=0.525N P=0.449 P=0.925N |
|POLY 3 | |P=0.574N P=0.515N P=0.487 P=0.578N |
|POLY 1.5 | |P=0.527N P=0.513N P=0.488 P=0.546N |
|POLY 6 | |P=0.552 P=0.518N P=0.481 P=0.624N |
|LOGISTIC REGRESSION| |P=0.539 (e) P=0.449 (e) |
|COCH-ARM / FISHERS | |P=0.472N P=0.513N P=0.480 P=0.513N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Luteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/59 (3%) 0/56 (0%) 1/56 (2%) 1/56 (2%) |
|POLY-3 RATE (b) | |2/55.31 0/51.25 1/53.29 1/36.99 |
|POLY-3 PERCENT (g) | |3.6% 0.0% 1.9% 2.7% |
|TERMINAL (d) | |2/51 (4%) 0/45 (0%) 1/44 (2%) 1/5 (20%) |
|FIRST INCIDENCE | |729 (T) --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.344 P=0.267N P=0.551N P=0.316 |
|POLY 3 | |P=0.533N P=0.255N P=0.513N P=0.634N |
|POLY 1.5 | |P=0.529N P=0.252N P=0.512N P=0.580N |
|POLY 6 | |P=0.546N P=0.259N P=0.519N P=0.710N |
|LOGISTIC REGRESSION| |P=0.344 (e) P=0.551N P=0.316 |
|COCH-ARM / FISHERS | |P=0.513N P=0.261N P=0.520N P=0.520N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/53 (2%) 0/50 (0%) 0/50 (0%) 0/46 (0%) |3/58 (5%) 4/58 (7%) 3/53 (6%) 0/53 (0%) |
|POLY-3 RATE (b) | 1/51.28 0/41.29 0/19.25 0/6.89 |3/56.12 4/53.48 3/50.37 0/35.53 |
|POLY-3 PERCENT (g) | 2.0% 0.0% 0.0% 0.0% |5.4% 7.5% 6.0% 0.0% |
|TERMINAL (d) | 1/47 (2%) 0/29 (0%) 0/0 (0%) 0/0 (0%) |2/51 (4%) 3/46 (7%) 3/42 (7%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |299 644 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.899N P=0.596N P=1.000N P=1.000N |P=0.435N P=0.456 P=0.585 P=0.390N |
|POLY 3 | P=0.418N P=0.543N P=0.662N P=0.735N |P=0.201N P=0.474 P=0.611 P=0.221N |
|POLY 1.5 | P=0.313N P=0.530N P=0.600N P=0.676N |P=0.148N P=0.482 P=0.616 P=0.179N |
|POLY 6 | P=0.543N P=0.557N P=0.724N P=0.763N |P=0.309N P=0.467 P=0.601 P=0.296N |
|LOGISTIC REGRESSION| P=0.899N (e) (e) (e) |P=0.066N P=0.549 P=0.534 P=0.047N* |
|COCH-ARM / FISHERS | P=0.321N P=0.515N P=0.515N P=0.535N |P=0.096N P=0.500 P=0.617 P=0.139N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/59 (0%) 4/57 (7%) 0/58 (0%) | |
|POLY-3 RATE (b) | 0/56.99 0/48.73 4/23.82 0/8.87 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 16.8% 0.0% | |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) | |
|FIRST INCIDENCE | --- --- 476 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.002 ** (e) P<0.001 ** (e) | |
|POLY 3 | P=0.029 * (e) P=0.011 * (e) | |
|POLY 1.5 | P=0.084 (e) P=0.022 * (e) | |
|POLY 6 | P=0.074 (e) P=0.005 ** (e) | |
|LOGISTIC REGRESSION| P=0.703 (e) P=0.137 (e) | |
|COCH-ARM / FISHERS | P=0.490 (e) P=0.053 (e) | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 6/60 (10%) 33/60 (55%) 45/60 (75%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 16/60 (27%) |
|POLY-3 RATE (b) | 0/56.99 6/51.27 33/41.72 45/47.22 |0/56.31 0/54.01 0/57.18 16/44.94 |
|POLY-3 PERCENT (g) | 0.0% 11.7% 79.1% 95.3% |0.0% 0.0% 0.0% 35.6% |
|TERMINAL (d) | 0/52 (0%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- 542 365 277 |--- --- --- 444 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.009 ** P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) (e) P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skeletal Muscle |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 1/60 (2%) 3/60 (5%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 1/54.01 3/58.04 2/40.33 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 1.9% 5.2% 5.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 729 (T) 553 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.022 * P=0.476 P=0.120 P=0.066 |
|POLY 3 | (e) (e) (e) (e) |P=0.074 P=0.492 P=0.125 P=0.173 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.110 P=0.495 P=0.124 P=0.202 |
|POLY 6 | (e) (e) (e) (e) |P=0.044 * P=0.488 P=0.124 P=0.136 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.214 P=0.476 P=0.062 P=0.259 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.164 P=0.500 P=0.122 P=0.248 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Basal or Sq. Cell Carcinoma, Carcinoma, Basosq. Tumor |
| (M or B), Basal Cell Adenoma, Adenoma, Papilloma, Sq Papilloma, Keratoacanthoma, Trichoepitheliom |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 2/54.76 0/57.18 1/39.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.7% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 553 --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.366 P=0.227 (e) P=0.230 |
|POLY 3 | (e) (e) (e) (e) |P=0.437 P=0.232 (e) P=0.433 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.483 P=0.234 (e) P=0.465 |
|POLY 6 | (e) (e) (e) (e) |P=0.402 P=0.229 (e) P=0.386 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.607 P=0.262 (e) P=0.427 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 P=0.248 (e) P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |1/60 (2%) 1/60 (2%) 6/60 (10%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 1/24.15 0/9.13 |1/56.38 1/54.01 6/57.89 2/39.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.1% 0.0% |1.8% 1.9% 10.4% 5.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 504 --- |710 729 (T) 661 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442 (e) P=0.427 (e) |P=0.009 ** P=0.734 P=0.056 P=0.043 * |
|POLY 3 | P=0.419 (e) P=0.353 (e) |P=0.112 P=0.751 P=0.062 P=0.384 |
|POLY 1.5 | P=0.419 (e) P=0.415 (e) |P=0.184 P=0.754 P=0.062 P=0.438 |
|POLY 6 | P=0.640 (e) P=0.288 (e) |P=0.050 P=0.746 P=0.061 P=0.306 |
|LOGISTIC REGRESSION| P=0.772N (e) P=0.748 (e) |P=0.161 P=0.753 P=0.052 P=0.249 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.293 P=0.752N P=0.057 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |1/60 (2%) 1/60 (2%) 6/60 (10%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 1/24.15 0/9.13 |1/56.38 1/54.01 6/57.89 2/39.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.1% 0.0% |1.8% 1.9% 10.4% 5.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 504 --- |710 729 (T) 661 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.442 (e) P=0.427 (e) |P=0.009 ** P=0.734 P=0.056 P=0.043 * |
|POLY 3 | P=0.419 (e) P=0.353 (e) |P=0.112 P=0.751 P=0.062 P=0.384 |
|POLY 1.5 | P=0.419 (e) P=0.415 (e) |P=0.184 P=0.754 P=0.062 P=0.438 |
|POLY 6 | P=0.640 (e) P=0.288 (e) |P=0.050 P=0.746 P=0.061 P=0.306 |
|LOGISTIC REGRESSION| P=0.772N (e) P=0.748 (e) |P=0.161 P=0.753 P=0.052 P=0.249 |
|COCH-ARM / FISHERS | P=0.694 (e) P=0.500 (e) |P=0.293 P=0.752N P=0.057 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 4/60 (7%) 8/60 (13%) 20/60 (33%) |0/60 (0%) 0/60 (0%) 2/60 (3%) 19/60 (32%) |
|POLY-3 RATE (b) | 0/56.99 4/50.29 8/27.25 20/25.99 |0/56.31 0/54.01 2/57.56 19/43.97 |
|POLY-3 PERCENT (g) | 0.0% 8.0% 29.4% 77.0% |0.0% 0.0% 3.5% 43.2% |
|TERMINAL (d) | 0/52 (0%) 2/34 (6%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 1/47 (2%) 2/5 (40%) |
|FIRST INCIDENCE | --- 542 544 326 |--- --- 624 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.234 P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.047 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.243 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.053 P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.242 P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.041 * P<0.001 ** P<0.001 ** |P<0.001 ** (e) P=0.240 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.068 P<0.001 ** P=0.053 |P<0.001 ** (e) P=0.200 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.059 P=0.003 ** P<0.001 ** |P<0.001 ** (e) P=0.248 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |1/60 (2%) 1/60 (2%) 6/60 (10%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |1/56.38 1/54.01 6/57.89 2/39.97 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |1.8% 1.9% 10.4% 5.0% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |710 729 (T) 661 696 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.009 ** P=0.734 P=0.056 P=0.043 * |
|POLY 3 | (e) (e) (e) (e) |P=0.112 P=0.751 P=0.062 P=0.384 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.184 P=0.754 P=0.062 P=0.438 |
|POLY 6 | (e) (e) (e) (e) |P=0.050 P=0.746 P=0.061 P=0.306 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.161 P=0.753 P=0.052 P=0.249 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.293 P=0.752N P=0.057 P=0.500 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Squamous Cell Carcinoma, Basal Cell Carcinoma, Basosquamous |
| Tumor (malignant or NOS), or Carcinoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/60 (3%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 0/9.13 |0/56.31 2/54.76 0/57.18 1/39.92 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |0.0% 3.7% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 553 --- 690 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.366 P=0.227 (e) P=0.230 |
|POLY 3 | (e) (e) (e) (e) |P=0.437 P=0.232 (e) P=0.433 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.483 P=0.234 (e) P=0.465 |
|POLY 6 | (e) (e) (e) (e) |P=0.402 P=0.229 (e) P=0.386 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.607 P=0.262 (e) P=0.427 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.539 P=0.248 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 3/60 (5%) 0/58 (0%) 0/60 (0%) |0/59 (0%) 0/57 (0%) 0/58 (0%) 0/57 (0%) |
|POLY-3 RATE (b) | 2/57.07 3/50.02 0/22.92 0/9.13 |0/55.32 0/53.12 0/55.37 0/37.66 |
|POLY-3 PERCENT (g) | 3.5% 6.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/52 (2%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 710 641 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534 P=0.346 P=1.000N P=1.000N |(e) (e) (e) (e) |
|POLY 3 | P=0.589N P=0.441 P=0.462N P=0.602N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.252N P=0.466 P=0.358N P=0.463N |(e) (e) (e) (e) |
|POLY 6 | P=0.466 P=0.410 P=0.588N P=0.679N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.792N P=0.461 P=0.981N (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.075N P=0.500 P=0.256N P=0.248N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |1/60 (2%) 2/60 (3%) 2/60 (3%) 1/60 (2%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 0/23.48 2/10.78 |1/56.77 2/54.01 2/57.18 1/39.93 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 18.6% |1.8% 3.7% 3.5% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 2/46 (4%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- --- 391 |592 729 (T) 729 (T) 688 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** (e) (e) P=0.037 * |P=0.238 P=0.470 P=0.483 P=0.584 |
|POLY 3 | P=0.149 (e) (e) P=0.077 |P=0.495 P=0.483 P=0.503 P=0.676 |
|POLY 1.5 | P=0.045 * (e) (e) P=0.112 |P=0.575 P=0.489 P=0.504 P=0.718 |
|POLY 6 | P=0.506 (e) (e) P=0.063 |P=0.398 P=0.474 P=0.495 P=0.603 |
|LOGISTIC REGRESSION| P=0.313 (e) (e) P=0.762 |P=0.610 P=0.509 P=0.463 P=0.728N |
|COCH-ARM / FISHERS | P=0.046 * (e) (e) P=0.248 |P=0.556N P=0.500 P=0.500 P=0.752N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tissue NOS |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/60 (0%) 0/60 (0%) 1/60 (2%) 2/60 (3%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 2/60 (3%) |
|POLY-3 RATE (b) | 0/56.99 0/49.65 1/24.22 2/10.87 |0/56.31 0/54.01 0/57.18 2/40.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.1% 18.4% |0.0% 0.0% 0.0% 4.9% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | --- --- 466 339 |--- --- --- 608 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.011 * (e) P=0.471 P=0.166 |P=0.020 * (e) (e) P=0.149 |
|POLY 3 | P=0.073 (e) P=0.353 P=0.077 |P=0.038 * (e) (e) P=0.174 |
|POLY 1.5 | P=0.034 * (e) P=0.415 P=0.112 |P=0.041 * (e) (e) P=0.202 |
|POLY 6 | P=0.308 (e) P=0.289 P=0.063 |P=0.046 * (e) (e) P=0.138 |
|LOGISTIC REGRESSION| P=0.607 (e) P=0.773 P=0.844 |P=0.077 (e) (e) P=0.302 |
|COCH-ARM / FISHERS | P=0.070 (e) P=0.500 P=0.248 |P=0.046 * (e) (e) P=0.248 |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Tissue NOS |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/60 (3%) 0/60 (0%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 0/60 (0%) 0/60 (0%) 1/60 (2%) |
|POLY-3 RATE (b) | 2/57.37 0/49.65 0/23.48 0/9.13 |0/56.31 0/54.01 0/57.18 1/39.91 |
|POLY-3 PERCENT (g) | 3.5% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 2.5% |
|TERMINAL (d) | 0/52 (0%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 649 --- --- --- |--- --- --- 693 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.574N P=0.307N P=1.000N P=1.000N |P=0.053 (e) (e) P=0.201 |
|POLY 3 | P=0.155N P=0.271N P=0.458N P=0.603N |P=0.163 (e) (e) P=0.433 |
|POLY 1.5 | P=0.118N P=0.256N P=0.351N P=0.464N |P=0.178 (e) (e) P=0.465 |
|POLY 6 | P=0.203N P=0.291N P=0.587N P=0.679N |P=0.179 (e) (e) P=0.386 |
|LOGISTIC REGRESSION| P=0.206N P=0.217N P=0.491N P=0.975N |P=0.167 (e) (e) P=0.415 |
|COCH-ARM / FISHERS | P=0.115N P=0.248N P=0.248N P=0.248N |P=0.199 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |1/60 (2%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | |1/56.31 2/54.01 0/57.18 0/39.77 |
|POLY-3 PERCENT (g) | |1.8% 3.7% 0.0% 0.0% |
|TERMINAL (d) | |1/52 (2%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.453N P=0.457 P=0.520N P=0.927N |
|POLY 3 | |P=0.211N P=0.485 P=0.497N P=0.567N |
|POLY 1.5 | |P=0.203N P=0.491 P=0.497N P=0.536N |
|POLY 6 | |P=0.240N P=0.479 P=0.500N P=0.615N |
|LOGISTIC REGRESSION| |P=0.453N P=0.457 (e) (e) |
|COCH-ARM / FISHERS | |P=0.188N P=0.500 P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/60 (0%) 1/60 (2%) 0/60 (0%) 3/60 (5%) |
|POLY-3 RATE (b) | |0/56.31 1/54.01 0/57.18 3/40.93 |
|POLY-3 PERCENT (g) | |0.0% 1.9% 0.0% 7.3% |
|TERMINAL (d) | |0/52 (0%) 1/46 (2%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | |--- 729 (T) --- 522 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.005 ** P=0.476 (e) P=0.043 * |
|POLY 3 | |P=0.033 * P=0.492 (e) P=0.074 |
|POLY 1.5 | |P=0.037 * P=0.495 (e) P=0.093 |
|POLY 6 | |P=0.036 * P=0.488 (e) P=0.051 |
|LOGISTIC REGRESSION| |P=0.073 P=0.476 (e) P=0.180 |
|COCH-ARM / FISHERS | |P=0.044 * P=0.500 (e) P=0.122 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |2/60 (3%) 2/60 (3%) 2/60 (3%) 0/60 (0%) |
|POLY-3 RATE (b) | |2/56.38 2/54.01 2/57.18 0/39.77 |
|POLY-3 PERCENT (g) | |3.6% 3.7% 3.5% 0.0% |
|TERMINAL (d) | |1/52 (2%) 2/46 (4%) 2/47 (4%) 0/5 (0%) |
|FIRST INCIDENCE | |710 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.588N P=0.649 P=0.655 P=0.728N |
|POLY 3 | |P=0.250N P=0.678 P=0.688N P=0.323N |
|POLY 1.5 | |P=0.208N P=0.683 P=0.687N P=0.280N |
|POLY 6 | |P=0.338N P=0.670 P=0.692 P=0.396N |
|LOGISTIC REGRESSION| |P=0.453N P=0.673 P=0.694 P=0.509N |
|COCH-ARM / FISHERS | |P=0.164N P=0.691N P=0.691N P=0.248N |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 1/60 (2%) 0/60 (0%) |3/60 (5%) 2/60 (3%) 0/60 (0%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/56.99 1/49.65 1/23.78 0/9.13 |3/56.31 2/54.01 0/57.18 0/39.77 |
|POLY-3 PERCENT (g) | 1.8% 2.0% 4.2% 0.0% |5.3% 3.7% 0.0% 0.0% |
|TERMINAL (d) | 1/52 (2%) 1/34 (3%) 0/0 (0%) 0/0 (0%) |3/52 (6%) 2/46 (4%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 729 (T) 645 --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.198 P=0.664 P=0.006 ** P=1.000N |P=0.140N P=0.556N P=0.140N P=0.689N |
|POLY 3 | P=0.580 P=0.729 P=0.547 P=0.721N |P=0.043N* P=0.519N P=0.117N P=0.195N |
|POLY 1.5 | P=0.571N P=0.743 P=0.650 P=0.654N |P=0.042N* P=0.512N P=0.117N P=0.155N |
|POLY 6 | P=0.573 P=0.711 P=0.420 P=0.754N |P=0.048N* P=0.528N P=0.120N P=0.272N |
|LOGISTIC REGRESSION| P=0.472 P=0.664 P=0.410 (e) |P=0.140N P=0.556N (e) (e) |
|COCH-ARM / FISHERS | P=0.312N P=0.752N P=0.752N P=0.500N |P=0.039N* P=0.500N P=0.122N P=0.122N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/60 (7%) 17/60 (28%) 55/60 (92%) 60/60 (100%)|0/60 (0%) 2/60 (3%) 3/60 (5%) 50/60 (83%) |
|POLY-3 RATE (b) | 4/57.07 17/51.92 55/56.21 60/60.00 |0/56.31 2/54.90 3/57.56 50/55.42 |
|POLY-3 PERCENT (g) | 7.0% 32.7% 97.9% 100.0% |0.0% 3.6% 5.2% 90.2% |
|TERMINAL (d) | 3/52 (6%) 9/34 (27%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 1/46 (2%) 2/47 (4%) 4/5 (80%) |
|FIRST INCIDENCE | 710 542 365 277 |--- 343 624 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.224 P=0.114 P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.232 P=0.124 P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.234 P=0.124 P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.228 P=0.122 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.284 P=0.107 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.248 P=0.122 P<0.001 ** |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/60 (8%) 18/60 (30%) 55/60 (92%) 60/60 (100%)|3/60 (5%) 4/60 (7%) 3/60 (5%) 50/60 (83%) |
|POLY-3 RATE (b) | 5/57.07 18/51.92 55/56.21 60/60.00 |3/56.31 4/54.90 3/57.56 50/55.42 |
|POLY-3 PERCENT (g) | 8.8% 34.7% 97.9% 100.0% |5.3% 7.3% 5.2% 90.2% |
|TERMINAL (d) | 4/52 (8%) 10/34 (29%) 0/0 (0%) 0/0 (0%) |3/52 (6%) 3/46 (7%) 2/47 (4%) 4/5 (80%) |
|FIRST INCIDENCE | 710 542 365 277 |729 (T) 343 624 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.442 P=0.626 P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.486 P=0.651N P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.492 P=0.652N P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.477 P=0.657N P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.521 P=0.662N P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.660N P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/60 (2%) 1/60 (2%) 0/60 (0%) 0/60 (0%) |0/60 (0%) 2/60 (3%) 1/60 (2%) 0/60 (0%) |
|POLY-3 RATE (b) | 1/56.99 1/49.66 0/23.48 0/9.13 |0/56.31 2/54.53 1/57.29 0/39.77 |
|POLY-3 PERCENT (g) | 1.8% 2.0% 0.0% 0.0% |0.0% 3.7% 1.8% 0.0% |
|TERMINAL (d) | 1/52 (2%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |0/52 (0%) 0/46 (0%) 0/47 (0%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) 726 --- --- |--- 658 701 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.877 P=0.670 P=1.000N P=1.000N |P=0.675N P=0.225 P=0.489 (e) |
|POLY 3 | P=0.604N P=0.729 P=0.650N P=0.721N |P=0.564N P=0.231 P=0.503 (e) |
|POLY 1.5 | P=0.367N P=0.743 P=0.587N P=0.654N |P=0.517N P=0.233 P=0.504 (e) |
|POLY 6 | P=0.799 P=0.711 P=0.714N P=0.754N |P=0.562 P=0.228 P=0.501 (e) |
|LOGISTIC REGRESSION| P=0.890 P=0.689 (e) (e) |P=0.432N P=0.250 P=0.493 (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.752N P=0.500N P=0.500N |P=0.461N P=0.248 P=0.500 (e) |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 22
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/60 (5%) 0/60 (0%) 1/60 (2%) 0/60 (0%) |8/60 (13%) 7/60 (12%) 5/60 (8%) 3/60 (5%) |
|POLY-3 RATE (b) | 3/56.99 0/49.65 1/24.27 0/9.13 |8/56.32 7/55.37 5/57.46 3/40.41 |
|POLY-3 PERCENT (g) | 5.3% 0.0% 4.1% 0.0% |14.2% 12.6% 8.7% 7.4% |
|TERMINAL (d) | 3/52 (6%) 0/34 (0%) 0/0 (0%) 0/0 (0%) |7/52 (14%) 5/46 (11%) 3/47 (6%) 0/5 (0%) |
|FIRST INCIDENCE | 729 (T) --- 434 --- |725 266 671 661 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.734N P=0.206N P=0.482 P=1.000N |P=0.412 P=0.587N P=0.344N P=0.190 |
|POLY 3 | P=0.220N P=0.146N P=0.614N P=0.533N |P=0.148N P=0.514N P=0.266N P=0.244N |
|POLY 1.5 | P=0.154N P=0.134N P=0.474N P=0.350N |P=0.105N P=0.507N P=0.267N P=0.166N |
|POLY 6 | P=0.219N P=0.163N P=0.561 P=0.641N |P=0.225N P=0.526N P=0.273N P=0.399N |
|LOGISTIC REGRESSION| P=0.168N (e) P=0.556N (e) |P=0.072N P=0.488N P=0.275N P=0.572N |
|COCH-ARM / FISHERS | P=0.086N P=0.122N P=0.309N P=0.122N |P=0.064N P=0.500N P=0.279N P=0.102N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 30/60 (50%) 24/60 (40%) 8/60 (13%) 2/60 (3%) |21/60 (35%) 20/60 (33%) 26/60 (43%) 33/60 (55%) |
|POLY-3 RATE (b) | 30/57.33 24/53.03 8/27.98 2/10.78 |21/57.78 20/54.32 26/57.66 33/48.17 |
|POLY-3 PERCENT (g) | 52.3% 45.3% 28.6% 18.6% |36.4% 36.8% 45.1% 68.5% |
|TERMINAL (d) | 29/52 (56%) 17/34 (50%) 0/0 (0%) 0/0 (0%) |18/52 (35%) 19/46 (41%) 23/47 (49%) 5/5 (100%) |
|FIRST INCIDENCE | 637 451 434 391 |299 644 673 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.273 P<0.001 ** P=0.037 * |P<0.001 ** P=0.473 P=0.131 P<0.001 ** |
|POLY 3 | P=0.016N* P=0.288N P=0.040N* P=0.137N |P<0.001 ** P=0.557 P=0.221 P<0.001 ** |
|POLY 1.5 | P<0.001N** P=0.234N P<0.001N** P<0.001N** |P<0.001 ** P=0.566N P=0.230 P=0.003 ** |
|POLY 6 | P=0.331N P=0.367N P=0.467N P=0.553 |P<0.001 ** P=0.521 P=0.199 P<0.001 ** |
|LOGISTIC REGRESSION| P=0.088N P=0.320N P=0.534N P=0.763 |P<0.001 ** P=0.539N P=0.237 P=0.003 ** |
|COCH-ARM / FISHERS | P<0.001N** P=0.179N P<0.001N** P<0.001N** |P=0.007 ** P=0.500N P=0.227 P=0.022 * |
|=================================================================================================================================|
Date: 11/16/00 EXPERIMENT: 05203 TEST: 09 Page 23
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - O-NITROTOLUENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 26/60 (43%) 41/60 (68%) 59/60 (98%) 60/60 (100%)|16/60 (27%) 23/60 (38%) 27/60 (45%) 55/60 (92%) |
|POLY-3 RATE (b) | 26/58.58 41/57.74 59/59.07 60/60.00 |16/57.28 23/58.53 27/59.79 55/57.22 |
|POLY-3 PERCENT (g) | 44.4% 71.0% 99.9% 100.0% |27.9% 39.3% 45.2% 96.1% |
|TERMINAL (d) | 20/52 (39%) 19/34 (56%) 0/0 (0%) 0/0 (0%) |13/52 (25%) 14/46 (30%) 15/47 (32%) 5/5 (100%) |
|FIRST INCIDENCE | 596 451 270 277 |362 266 553 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.079 P=0.025 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.136 P=0.039 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.003 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.130 P=0.035 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.142 P=0.044 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.009 ** P<0.001 ** P=0.006 ** |P<0.001 ** P=0.147 P=0.022 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.121 P=0.028 * P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 PPM 1250 PPM 2500 PPM 5000 PPM |0 PPM 1250 PPM 2500 PPM 5000 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/60 (75%) 50/60 (83%) 59/60 (98%) 60/60 (100%)|33/60 (55%) 37/60 (62%) 44/60 (73%) 56/60 (93%) |
|POLY-3 RATE (b) | 45/58.58 50/58.48 59/59.07 60/60.00 |33/58.67 37/58.53 44/60.00 56/57.38 |
|POLY-3 PERCENT (g) | 76.8% 85.5% 99.9% 100.0% |56.2% 63.2% 73.3% 97.6% |
|TERMINAL (d) | 39/52 (75%) 27/34 (79%) 0/0 (0%) 0/0 (0%) |28/52 (54%) 28/46 (61%) 31/47 (66%) 5/5 (100%) |
|FIRST INCIDENCE | 596 451 270 277 |299 266 553 409 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.137 P=0.021 * P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.164 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.281 P=0.038 * P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.177 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.280 P=0.033 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.149 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.283 P=0.043 * P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.143 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.316 P=0.024 * P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.184 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.289 P=0.028 * P<0.001 ** |
|=================================================================================================================================|
(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).