TDMS Study 50215-03 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:42:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
------------------------------------------------------------------------------------------------------------------------------------
MICE FINAL#1
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:42:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
Mice(B6C3F1)
-----------------------------
FOR ALL DOSES THE TUMOR RATES IN THE FOLLOWING TISSUES/ORGANS ARE
BASED ON NUMBER OF TISSUES EXAMINED. IN OTHER TISSUES/ORGANS RATES
ARE BASED ON THE NUMBER OF ANIMALS NECROPSIED.
---------------
Adrenal Cortex
Adrenal Medulla
Bone Marrow
Brain
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Columbus ACRYLONITRILE DATE: 10/31/00
EXPERIMENT: 50215 TEST: 03 TIME: 12:42:30
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: N01-ES-55388 ROUTE: GAVAGE NTP C#: 50215B
PATHOLOGIST: MISSING CAS: 107-13-1
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF ACRYLONITRILE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Carcinoma
Carcinoma or Adenoma
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Stomach, Forestomach Squamous Cell Carcinoma
Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
All Organs Hemangiosarcoma or Hemangioma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Harderian Gland Adenoma
Carcinoma or Adenoma
Liver Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Ovary Cystadenoma
Hemangioma
Stomach, Forestomach Squamous Cell Carcinoma
Squamous Cell Carcinoma or Papilloma Squamous
Squamous Cell Papilloma
All Organs Hemangioma
Hemangiosarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 4/50 (8%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 3/46.19 0/46.03 4/45.96 0/30.48 |0/46.90 0/44.06 0/47.00 1/35.19 |
|POLY-3 PERCENT (g) | 6.5% 0.0% 8.7% 0.0% |0.0% 0.0% 0.0% 2.8% |
|TERMINAL (d) | 3/38 (8%) 0/42 (0%) 3/39 (8%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) --- 497 --- |--- --- --- 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.561N P=0.104N P=0.512 P=0.341N |P=0.131 (e) (e) P=0.395 |
|POLY 3 | P=0.512N P=0.119N P=0.497 P=0.212N |P=0.168 (e) (e) P=0.444 |
|POLY 1.5 | P=0.418N P=0.122N P=0.495 P=0.178N |P=0.165 (e) (e) P=0.460 |
|POLY 6 | P=0.597 P=0.115N P=0.502 P=0.251N |P=0.179 (e) (e) P=0.429 |
|LOGISTIC REGRESSION| P=0.351N (e) P=0.505 (e) |(e) (e) (e) P=0.395 |
|COCH-ARM / FISHERS | P=0.279N P=0.121N P=0.500 P=0.121N |P=0.188 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.74 0/45.28 1/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 3.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 518 --- 730 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.243 (e) P=0.301 |(e) (e) (e) (e) |
|POLY 3 | P=0.570 P=0.240 (e) P=0.420 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.568 P=0.235 (e) P=0.445 |(e) (e) (e) (e) |
|POLY 6 | P=0.582 P=0.246 (e) P=0.395 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.653N P=0.269 (e) P=0.301 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.628 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.69 0/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 582 --- --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.214N P=0.233N P=0.244N P=0.422N |(e) (e) (e) (e) |
|POLY 3 | P=0.157N P=0.240N P=0.244N P=0.342N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.145N P=0.243N P=0.243N P=0.306N |(e) (e) (e) (e) |
|POLY 6 | P=0.169N P=0.237N P=0.245N P=0.382N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.131N P=0.213N P=0.205N P=0.240N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.152N P=0.247N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 16/50 (32%) 24/50 (48%) 27/50 (54%) |10/50 (20%) 10/50 (20%) 25/50 (50%) 23/50 (46%) |
|POLY-3 RATE (b) | 5/46.19 16/46.99 24/48.52 27/36.28 |10/47.80 10/44.76 25/47.71 23/37.23 |
|POLY-3 PERCENT (g) | 10.8% 34.1% 49.5% 74.4% |20.9% 22.3% 52.4% 61.8% |
|TERMINAL (d) | 5/38 (13%) 13/42 (31%) 16/39 (41%) 12/14 (86%) |9/39 (23%) 8/32 (25%) 22/39 (56%) 15/23 (65%) |
|FIRST INCIDENCE | 730 (T) 518 497 477 |338 563 639 547 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.424 P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.535 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.005 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.558 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.509 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.597N P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.006 ** P<0.001 ** P<0.001 ** |P<0.001 ** P=0.598N P=0.002 ** P=0.005 ** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 1/46.19 1/46.03 4/45.96 3/31.12 |1/46.90 0/44.06 3/47.08 2/35.27 |
|POLY-3 PERCENT (g) | 2.2% 2.2% 8.7% 9.6% |2.1% 0.0% 6.4% 5.7% |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 3/39 (8%) 0/14 (0%) |1/39 (3%) 0/32 (0%) 2/39 (5%) 1/23 (4%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 497 554 |729 (T) --- 711 711 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.017 * P=0.739N P=0.188 P=0.094 |P=0.096 P=0.539N P=0.315 P=0.330 |
|POLY 3 | P=0.053 P=0.760 P=0.177 P=0.184 |P=0.115 P=0.512N P=0.307 P=0.403 |
|POLY 1.5 | P=0.071 P=0.756 P=0.176 P=0.217 |P=0.131 P=0.507N P=0.305 P=0.430 |
|POLY 6 | P=0.041 * P=0.757N P=0.180 P=0.155 |P=0.105 P=0.519N P=0.310 P=0.378 |
|LOGISTIC REGRESSION| P=0.096 P=0.739N P=0.189 P=0.196 |P=0.104 (e) P=0.310 P=0.351 |
|COCH-ARM / FISHERS | P=0.143 P=0.753N P=0.181 P=0.309 |P=0.193 P=0.500N P=0.309 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 16/50 (32%) 27/50 (54%) 30/50 (60%) |11/50 (22%) 10/50 (20%) 26/50 (52%) 25/50 (50%) |
|POLY-3 RATE (b) | 6/46.19 16/46.99 27/48.52 30/36.92 |11/47.80 10/44.76 26/47.71 25/37.30 |
|POLY-3 PERCENT (g) | 13.0% 34.1% 55.6% 81.3% |23.0% 22.3% 54.5% 67.0% |
|TERMINAL (d) | 6/38 (16%) 13/42 (31%) 19/39 (49%) 12/14 (86%) |10/39 (26%) 8/32 (25%) 23/39 (59%) 16/23 (70%) |
|FIRST INCIDENCE | 730 (T) 518 497 477 |338 563 639 547 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.028 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.514 P=0.002 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.568N P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.012 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.543N P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.017 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.594N P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.013 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.502N P=0.002 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.500N P=0.002 ** P=0.003 ** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Duodenum |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.44 3/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 2.2% 6.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 3/42 (7%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 664 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.338 P=0.500N P=0.625N |(e) (e) (e) (e) |
|POLY 3 | P=0.135N P=0.302 P=0.505N P=0.581N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.118N P=0.298 P=0.504N P=0.555N |(e) (e) (e) (e) |
|POLY 6 | P=0.153N P=0.308 P=0.505N P=0.606N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.134N P=0.301 P=0.480N P=0.534N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097N P=0.309 P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Jejunum |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 1/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178N P=0.465N P=0.233N P=0.475N |(e) (e) (e) (e) |
|POLY 3 | P=0.122N P=0.501N P=0.242N P=0.340N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.110N P=0.507N P=0.241N P=0.305N |(e) (e) (e) (e) |
|POLY 6 | P=0.134N P=0.494N P=0.241N P=0.377N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.178N P=0.465N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 1/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178N P=0.465N P=0.233N P=0.475N |(e) (e) (e) (e) |
|POLY 3 | P=0.122N P=0.501N P=0.242N P=0.340N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.110N P=0.507N P=0.241N P=0.305N |(e) (e) (e) (e) |
|POLY 6 | P=0.134N P=0.494N P=0.241N P=0.377N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.178N P=0.465N (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 1/46.44 3/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 2.2% 6.5% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 3/42 (7%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 664 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185N P=0.338 P=0.500N P=0.625N |(e) (e) (e) (e) |
|POLY 3 | P=0.135N P=0.302 P=0.505N P=0.581N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.118N P=0.298 P=0.504N P=0.555N |(e) (e) (e) (e) |
|POLY 6 | P=0.153N P=0.308 P=0.505N P=0.606N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.134N P=0.301 P=0.480N P=0.534N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.097N P=0.309 P=0.500N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 0/46.03 2/45.82 0/30.48 |0/46.90 1/44.60 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 0.0% 4.4% 0.0% |0.0% 2.2% 2.1% 0.0% |
|TERMINAL (d) | 2/38 (5%) 0/42 (0%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) --- 626 --- |--- 563 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.217N P=0.687N P=0.475N |P=0.620N P=0.496 P=0.500 (e) |
|POLY 3 | P=0.467N P=0.238N P=0.691 P=0.340N |P=0.618N P=0.490 P=0.500 (e) |
|POLY 1.5 | P=0.401N P=0.242N P=0.689 P=0.305N |P=0.590N P=0.494 P=0.500 (e) |
|POLY 6 | P=0.537N P=0.233N P=0.692N P=0.377N |P=0.649N P=0.485 P=0.502 (e) |
|LOGISTIC REGRESSION| P=0.358N (e) P=0.690N (e) |P=0.499N P=0.551 P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.313N P=0.247N P=0.691N P=0.247N |P=0.545N P=0.500 P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.19 1/46.03 2/45.28 2/30.48 |2/46.90 1/44.06 1/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 4.4% 6.6% |4.3% 2.3% 2.1% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 2/39 (5%) 2/14 (14%) |2/39 (5%) 1/32 (3%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | 730 (T) 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.152 P=0.465N P=0.686N P=0.312 |P=0.229N P=0.569N P=0.500N P=0.361N |
|POLY 3 | P=0.347 P=0.501N P=0.687 P=0.536 |P=0.201N P=0.522N P=0.499N P=0.306N |
|POLY 1.5 | P=0.379 P=0.507N P=0.687 P=0.588 |P=0.189N P=0.513N P=0.501N P=0.285N |
|POLY 6 | P=0.323 P=0.494N P=0.688 P=0.482 |P=0.214N P=0.533N P=0.497N P=0.327N |
|LOGISTIC REGRESSION| P=0.152 P=0.465N P=0.686N P=0.312 |P=0.229N P=0.569N P=0.500N (e) |
|COCH-ARM / FISHERS | P=0.488 P=0.500N P=0.691N P=0.691N |P=0.165N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 32/50 (64%) 29/50 (58%) 14/50 (28%) |14/50 (28%) 14/50 (28%) 15/50 (30%) 10/50 (20%) |
|POLY-3 RATE (b) | 23/47.35 32/46.03 29/46.30 14/33.16 |14/46.90 14/44.74 15/47.06 10/36.44 |
|POLY-3 PERCENT (g) | 48.6% 69.5% 62.6% 42.2% |29.9% 31.3% 31.9% 27.5% |
|TERMINAL (d) | 20/38 (53%) 32/42 (76%) 26/39 (67%) 6/14 (43%) |14/39 (36%) 10/32 (31%) 14/39 (36%) 7/23 (30%) |
|FIRST INCIDENCE | 607 730 (T) 563 505 |729 (T) 640 716 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.075 P=0.122 P=0.183 P=0.131 |P=0.430 P=0.359 P=0.502 P=0.409 |
|POLY 3 | P=0.222N P=0.029 * P=0.119 P=0.370N |P=0.451N P=0.531 P=0.504 P=0.501N |
|POLY 1.5 | P=0.089N P=0.029 * P=0.127 P=0.226N |P=0.383N P=0.553 P=0.498 P=0.424N |
|POLY 6 | P=0.415N P=0.028 * P=0.115 P=0.538N |P=0.505N P=0.507 P=0.516 P=0.570N |
|LOGISTIC REGRESSION| P=0.329N P=0.053 P=0.127 P=0.425N |P=0.528N P=0.438 P=0.537 P=0.573N |
|COCH-ARM / FISHERS | P=0.005N** P=0.054 P=0.158 P=0.048N* |P=0.201N P=0.588N P=0.500 P=0.241N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 17/50 (34%) 6/50 (12%) |7/50 (14%) 3/50 (6%) 6/50 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/48.23 10/47.29 17/47.14 6/30.62 |7/47.11 3/44.06 6/47.06 2/35.38 |
|POLY-3 PERCENT (g) | 29.0% 21.1% 36.1% 19.6% |14.9% 6.8% 12.8% 5.7% |
|TERMINAL (d) | 9/38 (24%) 6/42 (14%) 11/39 (28%) 3/14 (21%) |6/39 (15%) 3/32 (9%) 5/39 (13%) 1/23 (4%) |
|FIRST INCIDENCE | 464 535 515 715 |673 729 (T) 715 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 P=0.202N P=0.355 P=0.597N |P=0.318N P=0.247N P=0.496N P=0.265N |
|POLY 3 | P=0.541 P=0.258N P=0.304 P=0.259N |P=0.253N P=0.186N P=0.501N P=0.170N |
|POLY 1.5 | P=0.358N P=0.268N P=0.307 P=0.155N |P=0.220N P=0.174N P=0.503N P=0.139N |
|POLY 6 | P=0.374 P=0.242N P=0.309 P=0.396N |P=0.282N P=0.202N P=0.497N P=0.203N |
|LOGISTIC REGRESSION| P=0.230N P=0.225N P=0.358 P=0.186N |P=0.280N P=0.212N P=0.490N P=0.194N |
|COCH-ARM / FISHERS | P=0.092N P=0.241N P=0.333 P=0.039N* |P=0.142N P=0.159N P=0.500N P=0.080N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 10/50 (20%) 17/50 (34%) 6/50 (12%) |7/50 (14%) 3/50 (6%) 6/50 (12%) 2/50 (4%) |
|POLY-3 RATE (b) | 14/48.23 10/47.29 17/47.14 6/30.62 |7/47.11 3/44.06 6/47.06 2/35.38 |
|POLY-3 PERCENT (g) | 29.0% 21.1% 36.1% 19.6% |14.9% 6.8% 12.8% 5.7% |
|TERMINAL (d) | 9/38 (24%) 6/42 (14%) 11/39 (28%) 3/14 (21%) |6/39 (15%) 3/32 (9%) 5/39 (13%) 1/23 (4%) |
|FIRST INCIDENCE | 464 535 515 715 |673 729 (T) 715 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 P=0.202N P=0.355 P=0.597N |P=0.318N P=0.247N P=0.496N P=0.265N |
|POLY 3 | P=0.541 P=0.258N P=0.304 P=0.259N |P=0.253N P=0.186N P=0.501N P=0.170N |
|POLY 1.5 | P=0.358N P=0.268N P=0.307 P=0.155N |P=0.220N P=0.174N P=0.503N P=0.139N |
|POLY 6 | P=0.374 P=0.242N P=0.309 P=0.396N |P=0.282N P=0.202N P=0.497N P=0.203N |
|LOGISTIC REGRESSION| P=0.230N P=0.225N P=0.358 P=0.186N |P=0.280N P=0.212N P=0.490N P=0.194N |
|COCH-ARM / FISHERS | P=0.092N P=0.241N P=0.333 P=0.039N* |P=0.142N P=0.159N P=0.500N P=0.080N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 36/50 (72%) 37/50 (74%) 17/50 (34%) |20/50 (40%) 15/50 (30%) 19/50 (38%) 10/50 (20%) |
|POLY-3 RATE (b) | 32/48.99 36/47.29 37/47.14 17/33.21 |20/47.11 15/44.74 19/47.11 10/36.44 |
|POLY-3 PERCENT (g) | 65.3% 76.1% 78.5% 51.2% |42.5% 33.5% 40.3% 27.5% |
|TERMINAL (d) | 25/38 (66%) 32/42 (76%) 31/39 (80%) 8/14 (57%) |19/39 (49%) 11/32 (34%) 17/39 (44%) 7/23 (30%) |
|FIRST INCIDENCE | 464 535 515 505 |673 640 715 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.497 P=0.258 P=0.228 |P=0.359N P=0.439N P=0.495N P=0.357N |
|POLY 3 | P=0.157N P=0.172 P=0.109 P=0.145N |P=0.183N P=0.251N P=0.500N P=0.117N |
|POLY 1.5 | P=0.031N* P=0.168 P=0.128 P=0.048N* |P=0.135N P=0.230N P=0.506N P=0.078N |
|POLY 6 | P=0.427N P=0.182 P=0.097 P=0.333N |P=0.228N P=0.277N P=0.490N P=0.163N |
|LOGISTIC REGRESSION| P=0.073N P=0.213 P=0.163 P=0.110N |P=0.238N P=0.335N P=0.452N P=0.165N |
|COCH-ARM / FISHERS | P<0.001N** P=0.260 P=0.194 P=0.002N** |P=0.044N* P=0.201N P=0.500N P=0.024N* |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 36/50 (72%) 37/50 (74%) 17/50 (34%) |20/50 (40%) 15/50 (30%) 19/50 (38%) 10/50 (20%) |
|POLY-3 RATE (b) | 32/48.99 36/47.29 37/47.14 17/33.21 |20/47.11 15/44.74 19/47.11 10/36.44 |
|POLY-3 PERCENT (g) | 65.3% 76.1% 78.5% 51.2% |42.5% 33.5% 40.3% 27.5% |
|TERMINAL (d) | 25/38 (66%) 32/42 (76%) 31/39 (80%) 8/14 (57%) |19/39 (49%) 11/32 (34%) 17/39 (44%) 7/23 (30%) |
|FIRST INCIDENCE | 464 535 515 505 |673 640 715 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.095 P=0.497 P=0.258 P=0.228 |P=0.359N P=0.439N P=0.495N P=0.357N |
|POLY 3 | P=0.157N P=0.172 P=0.109 P=0.145N |P=0.183N P=0.251N P=0.500N P=0.117N |
|POLY 1.5 | P=0.031N* P=0.168 P=0.128 P=0.048N* |P=0.135N P=0.230N P=0.506N P=0.078N |
|POLY 6 | P=0.427N P=0.182 P=0.097 P=0.333N |P=0.228N P=0.277N P=0.490N P=0.163N |
|LOGISTIC REGRESSION| P=0.073N P=0.213 P=0.163 P=0.110N |P=0.238N P=0.335N P=0.452N P=0.165N |
|COCH-ARM / FISHERS | P<0.001N** P=0.260 P=0.194 P=0.002N** |P=0.044N* P=0.201N P=0.500N P=0.024N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 9/50 (18%) 4/50 (8%) 8/50 (16%) |4/50 (8%) 1/50 (2%) 8/50 (16%) 5/50 (10%) |
|POLY-3 RATE (b) | 10/46.26 9/46.03 4/45.28 8/31.04 |4/47.01 1/44.41 8/47.47 5/35.43 |
|POLY-3 PERCENT (g) | 21.6% 19.6% 8.8% 25.8% |8.5% 2.3% 16.9% 14.1% |
|TERMINAL (d) | 9/38 (24%) 9/42 (21%) 4/39 (10%) 4/14 (29%) |3/39 (8%) 0/32 (0%) 5/39 (13%) 4/23 (17%) |
|FIRST INCIDENCE | 714 730 (T) 730 (T) 642 |701 633 639 667 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.145 P=0.406N P=0.068N P=0.088 |P=0.044 * P=0.239N P=0.192 P=0.210 |
|POLY 3 | P=0.469N P=0.505N P=0.078N P=0.443 |P=0.062 P=0.196N P=0.182 P=0.330 |
|POLY 1.5 | P=0.409N P=0.519N P=0.078N P=0.559 |P=0.080 P=0.189N P=0.178 P=0.377 |
|POLY 6 | P=0.512N P=0.485N P=0.076N P=0.333 |P=0.052 P=0.206N P=0.188 P=0.289 |
|LOGISTIC REGRESSION| P=0.310 P=0.448N P=0.073N P=0.231 |P=0.069 P=0.182N P=0.177 P=0.268 |
|COCH-ARM / FISHERS | P=0.270N P=0.500N P=0.074N P=0.398N |P=0.161 P=0.181N P=0.178 P=0.500 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 2/50 (4%) 5/50 (10%) 2/50 (4%) |2/50 (4%) 5/50 (10%) 6/50 (12%) 4/50 (8%) |
|POLY-3 RATE (b) | 4/47.35 2/46.80 5/45.82 2/30.80 |2/47.18 5/44.83 6/47.31 4/35.38 |
|POLY-3 PERCENT (g) | 8.5% 4.3% 10.9% 6.5% |4.2% 11.2% 12.7% 11.3% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 4/39 (10%) 1/14 (7%) |0/39 (0%) 1/32 (3%) 5/39 (13%) 3/23 (13%) |
|FIRST INCIDENCE | 617 535 563 642 |677 647 645 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.370 P=0.331N P=0.493 P=0.661N |P=0.174 P=0.167 P=0.144 P=0.149 |
|POLY 3 | P=0.461 P=0.343N P=0.479 P=0.544N |P=0.203 P=0.196 P=0.134 P=0.218 |
|POLY 1.5 | P=0.540 P=0.348N P=0.485 P=0.477N |P=0.242 P=0.204 P=0.133 P=0.250 |
|POLY 6 | P=0.387 P=0.337N P=0.474 P=0.612N |P=0.173 P=0.187 P=0.136 P=0.191 |
|LOGISTIC REGRESSION| P=0.419N P=0.274N P=0.538 P=0.393N |P=0.259 P=0.228 P=0.134 P=0.206 |
|COCH-ARM / FISHERS | P=0.418N P=0.339N P=0.500 P=0.339N |P=0.380 P=0.218 P=0.134 P=0.339 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 14/50 (28%) 11/50 (22%) 8/50 (16%) 9/50 (18%) |6/50 (12%) 6/50 (12%) 14/50 (28%) 9/50 (18%) |
|POLY-3 RATE (b) | 14/47.41 11/46.80 8/45.82 9/31.04 |6/47.29 6/45.18 14/47.77 9/35.62 |
|POLY-3 PERCENT (g) | 29.5% 23.5% 17.5% 29.0% |12.7% 13.3% 29.3% 25.3% |
|TERMINAL (d) | 9/38 (24%) 9/42 (21%) 7/39 (18%) 5/14 (36%) |3/39 (8%) 1/32 (3%) 10/39 (26%) 7/23 (30%) |
|FIRST INCIDENCE | 617 535 563 642 |677 633 639 667 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.219 P=0.257N P=0.120N P=0.198 |P=0.020 * P=0.502 P=0.052 P=0.055 |
|POLY 3 | P=0.399N P=0.335N P=0.129N P=0.578N |P=0.029 * P=0.588 P=0.039 * P=0.121 |
|POLY 1.5 | P=0.305N P=0.347N P=0.125N P=0.430N |P=0.045 * P=0.600 P=0.038 * P=0.160 |
|POLY 6 | P=0.484N P=0.323N P=0.133N P=0.465 |P=0.019 * P=0.575 P=0.042 * P=0.091 |
|LOGISTIC REGRESSION| P=0.450N P=0.333N P=0.118N P=0.539 |P=0.043 * P=0.612N P=0.040 * P=0.090 |
|COCH-ARM / FISHERS | P=0.138N P=0.322N P=0.114N P=0.171N |P=0.138 P=0.620N P=0.039 * P=0.288 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Lymph Node, Mesenteric |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 2/46.22 1/46.03 0/45.28 0/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 4.3% 2.2% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/38 (3%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | 723 730 (T) --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.177N P=0.471N P=0.240N P=0.458N |(e) (e) (e) (e) |
|POLY 3 | P=0.122N P=0.501N P=0.242N P=0.340N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.110N P=0.507N P=0.241N P=0.305N |(e) (e) (e) (e) |
|POLY 6 | P=0.134N P=0.494N P=0.241N P=0.378N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.159N P=0.486N P=0.239N P=0.407N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.104N P=0.500N P=0.247N P=0.247N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |8/50 (16%) 4/50 (8%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | |8/47.16 4/44.06 2/47.00 3/35.29 |
|POLY-3 PERCENT (g) | |17.0% 9.1% 4.3% 8.5% |
|TERMINAL (d) | |7/39 (18%) 4/32 (13%) 2/39 (5%) 2/23 (9%) |
|FIRST INCIDENCE | |659 729 (T) 729 (T) 704 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.194N P=0.283N P=0.049N* P=0.340N |
|POLY 3 | |P=0.112N P=0.211N P=0.046N* P=0.219N |
|POLY 1.5 | |P=0.104N P=0.197N P=0.046N* P=0.177N |
|POLY 6 | |P=0.116N P=0.231N P=0.045N* P=0.263N |
|LOGISTIC REGRESSION| |P=0.171N P=0.241N P=0.046N* P=0.268N |
|COCH-ARM / FISHERS | |P=0.080N P=0.178N P=0.046N* P=0.100N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 3/50 (6%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/46.90 0/44.06 3/47.00 1/35.19 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 6.4% 2.8% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 3/39 (8%) 1/23 (4%) |
|FIRST INCIDENCE | |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.114 (e) P=0.121 P=0.395 |
|POLY 3 | |P=0.109 (e) P=0.119 P=0.444 |
|POLY 1.5 | |P=0.129 (e) P=0.119 P=0.460 |
|POLY 6 | |P=0.094 (e) P=0.120 P=0.429 |
|LOGISTIC REGRESSION| |(e) (e) P=0.121 P=0.395 |
|COCH-ARM / FISHERS | |P=0.209 (e) P=0.121 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 4/50 (8%) 1/50 (2%) |
|POLY-3 RATE (b) | |0/46.90 0/44.06 4/47.00 1/35.19 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 8.5% 2.8% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 4/39 (10%) 1/23 (4%) |
|FIRST INCIDENCE | |--- --- 729 (T) 729 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.102 (e) P=0.063 P=0.395 |
|POLY 3 | |P=0.090 (e) P=0.061 P=0.444 |
|POLY 1.5 | |P=0.113 (e) P=0.060 P=0.460 |
|POLY 6 | |P=0.074 (e) P=0.061 P=0.429 |
|LOGISTIC REGRESSION| |(e) (e) P=0.063 P=0.395 |
|COCH-ARM / FISHERS | |P=0.201 (e) P=0.059 P=0.500 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Ovary |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 1/50 (2%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.90 0/44.06 1/47.00 2/35.55 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 2.1% 5.6% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | |--- --- 729 (T) 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.030 * (e) P=0.500 P=0.153 |
|POLY 3 | |P=0.042 * (e) P=0.500 P=0.182 |
|POLY 1.5 | |P=0.045 * (e) P=0.500 P=0.196 |
|POLY 6 | |P=0.042 * (e) P=0.502 P=0.170 |
|LOGISTIC REGRESSION| |P=0.043 * (e) P=0.500 P=0.198 |
|COCH-ARM / FISHERS | |P=0.062 (e) P=0.500 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/46 (0%) 0/47 (0%) 0/47 (0%) |2/48 (4%) 4/49 (8%) 4/48 (8%) 2/49 (4%) |
|POLY-3 RATE (b) | 0/45.19 0/42.03 0/42.45 0/28.82 |2/44.90 4/44.18 4/45.36 2/35.08 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 9.1% 8.8% 5.7% |
|TERMINAL (d) | 0/37 (0%) 0/38 (0%) 0/37 (0%) 0/14 (0%) |2/37 (5%) 2/32 (6%) 3/38 (8%) 1/23 (4%) |
|FIRST INCIDENCE | --- --- --- --- |729 (T) 653 646 640 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.503 P=0.277 P=0.347 P=0.529 |
|POLY 3 | (e) (e) (e) (e) |P=0.529 P=0.330 P=0.342 P=0.601 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.564N P=0.337 P=0.338 P=0.630 |
|POLY 6 | (e) (e) (e) (e) |P=0.502 P=0.319 P=0.348 P=0.577 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.569N P=0.324 P=0.337 P=0.606 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.456N P=0.349 P=0.339 P=0.684N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 0/45.28 0/30.48 |3/47.44 5/44.65 4/47.45 3/36.24 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |6.3% 11.2% 8.4% 8.3% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |1/39 (3%) 2/32 (6%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |653 640 646 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605N P=0.520 (e) (e) |P=0.493 P=0.278 P=0.504 P=0.462 |
|POLY 3 | P=0.505N P=0.499 (e) (e) |P=0.539 P=0.324 P=0.500 P=0.533 |
|POLY 1.5 | P=0.473N P=0.496 (e) (e) |P=0.544N P=0.337 P=0.498 P=0.570 |
|POLY 6 | P=0.539N P=0.504 (e) (e) |P=0.513 P=0.308 P=0.503 P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.520 (e) (e) |P=0.448N P=0.371 P=0.507 P=0.667N |
|COCH-ARM / FISHERS | P=0.468N P=0.500 (e) (e) |P=0.440N P=0.357 P=0.500 P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 0/45.28 0/30.48 |2/47.18 3/44.33 3/47.45 2/36.05 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |4.2% 6.8% 6.3% 5.6% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |1/39 (3%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |653 694 646 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605N P=0.520 (e) (e) |P=0.480 P=0.419 P=0.507 P=0.539 |
|POLY 3 | P=0.505N P=0.499 (e) (e) |P=0.509 P=0.472 P=0.503 P=0.593 |
|POLY 1.5 | P=0.473N P=0.496 (e) (e) |P=0.540 P=0.483 P=0.500 P=0.622 |
|POLY 6 | P=0.539N P=0.504 (e) (e) |P=0.488 P=0.457 P=0.507 P=0.566 |
|LOGISTIC REGRESSION| (e) P=0.520 (e) (e) |P=0.519N P=0.500 P=0.507 P=0.689N |
|COCH-ARM / FISHERS | P=0.468N P=0.500 (e) (e) |P=0.521N P=0.500 P=0.500 P=0.691N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 5/50 (10%) 4/50 (8%) 3/50 (6%) |
|POLY-3 RATE (b) | 0/46.19 1/46.03 0/45.28 0/30.48 |3/47.44 5/44.65 4/47.45 3/36.24 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 0.0% 0.0% |6.3% 11.2% 8.4% 8.3% |
|TERMINAL (d) | 0/38 (0%) 1/42 (2%) 0/39 (0%) 0/14 (0%) |1/39 (3%) 2/32 (6%) 1/39 (3%) 0/23 (0%) |
|FIRST INCIDENCE | --- 730 (T) --- --- |653 640 646 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.605N P=0.520 (e) (e) |P=0.493 P=0.278 P=0.504 P=0.462 |
|POLY 3 | P=0.505N P=0.499 (e) (e) |P=0.539 P=0.324 P=0.500 P=0.533 |
|POLY 1.5 | P=0.473N P=0.496 (e) (e) |P=0.544N P=0.337 P=0.498 P=0.570 |
|POLY 6 | P=0.539N P=0.504 (e) (e) |P=0.513 P=0.308 P=0.503 P=0.500 |
|LOGISTIC REGRESSION| (e) P=0.520 (e) (e) |P=0.448N P=0.371 P=0.507 P=0.667N |
|COCH-ARM / FISHERS | P=0.468N P=0.500 (e) (e) |P=0.440N P=0.357 P=0.500 P=0.661N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 8/50 (16%) 9/50 (18%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 11/50 (22%) |
|POLY-3 RATE (b) | 0/46.19 0/46.03 8/46.58 9/33.02 |0/46.90 1/44.30 1/47.33 11/37.19 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 17.2% 27.3% |0.0% 2.3% 2.1% 29.6% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 4/39 (10%) 0/14 (0%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 3/23 (13%) |
|FIRST INCIDENCE | --- --- 515 525 |--- 665 639 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** (e) P=0.006 ** P<0.001 ** |P<0.001 ** P=0.477 P=0.504 P<0.001 ** |
|POLY 3 | P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** P=0.489 P=0.502 P<0.001 ** |
|POLY 1.5 | P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** P=0.493 P=0.500 P<0.001 ** |
|POLY 6 | P<0.001 ** (e) P=0.004 ** P<0.001 ** |P<0.001 ** P=0.483 P=0.504 P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** (e) P=0.006 ** P<0.001 ** |P<0.001 ** P=0.519 P=0.520 P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** (e) P=0.003 ** P<0.001 ** |P<0.001 ** P=0.500 P=0.500 P<0.001 ** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 26/50 (52%) 32/50 (64%) |3/50 (6%) 7/50 (14%) 25/50 (50%) 29/50 (58%) |
|POLY-3 RATE (b) | 3/46.94 4/46.03 26/46.66 32/38.42 |3/46.90 7/44.46 25/47.42 29/38.47 |
|POLY-3 PERCENT (g) | 6.4% 8.7% 55.7% 83.3% |6.4% 15.7% 52.7% 75.4% |
|TERMINAL (d) | 2/38 (5%) 4/42 (10%) 21/39 (54%) 12/14 (86%) |3/39 (8%) 5/32 (16%) 22/39 (56%) 17/23 (74%) |
|FIRST INCIDENCE | 464 730 (T) 515 410 |729 (T) 665 639 513 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.543 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.097 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.136 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.484 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.145 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.498 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.126 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.505 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.123 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.159 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Papilloma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 19/50 (38%) 25/50 (50%) |3/50 (6%) 6/50 (12%) 24/50 (48%) 19/50 (38%) |
|POLY-3 RATE (b) | 3/46.94 4/46.03 19/45.36 25/35.98 |3/46.90 6/44.22 24/47.09 19/36.73 |
|POLY-3 PERCENT (g) | 6.4% 8.7% 41.9% 69.5% |6.4% 13.6% 51.0% 51.7% |
|TERMINAL (d) | 2/38 (5%) 4/42 (10%) 18/39 (46%) 12/14 (86%) |3/39 (8%) 5/32 (16%) 22/39 (56%) 14/23 (61%) |
|FIRST INCIDENCE | 464 730 (T) 709 410 |729 (T) 688 716 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.543 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.158 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.489 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.214 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.484 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.225 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.498 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.200 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.505 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.177 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.243 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 1/46.10 1/45.28 0/30.48 |2/46.90 1/44.06 0/46.06 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 2.2% 0.0% |4.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 1/39 (3%) 0/14 (0%) |2/39 (5%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 714 730 (T) --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.690 P=0.510 P=0.505 (e) |P=0.136N P=0.569N P=0.238N P=0.361N |
|POLY 3 | P=0.659 P=0.500 P=0.496 (e) |P=0.107N P=0.522N P=0.241N P=0.306N |
|POLY 1.5 | P=0.618N P=0.496 P=0.496 (e) |P=0.105N P=0.513N P=0.242N P=0.285N |
|POLY 6 | P=0.630 P=0.504 P=0.497 (e) |P=0.109N P=0.533N P=0.239N P=0.327N |
|LOGISTIC REGRESSION| P=0.674N P=0.498 P=0.505 (e) |P=0.136N P=0.569N (e) (e) |
|COCH-ARM / FISHERS | P=0.545N P=0.500 P=0.500 (e) |P=0.104N P=0.500N P=0.253N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.74 1/45.28 0/30.48 |2/46.90 1/44.06 0/46.06 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 2.2% 0.0% |4.3% 2.3% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 1/39 (3%) 0/14 (0%) |2/39 (5%) 1/32 (3%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 518 730 (T) --- |729 (T) 729 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.524N P=0.243 P=0.505 (e) |P=0.136N P=0.569N P=0.238N P=0.361N |
|POLY 3 | P=0.510N P=0.240 P=0.496 (e) |P=0.107N P=0.522N P=0.241N P=0.306N |
|POLY 1.5 | P=0.453N P=0.235 P=0.496 (e) |P=0.105N P=0.513N P=0.242N P=0.285N |
|POLY 6 | P=0.568N P=0.246 P=0.497 (e) |P=0.109N P=0.533N P=0.239N P=0.327N |
|LOGISTIC REGRESSION| P=0.345N P=0.269 P=0.505 (e) |P=0.136N P=0.569N (e) (e) |
|COCH-ARM / FISHERS | P=0.372N P=0.247 P=0.500 (e) |P=0.104N P=0.500N P=0.253N P=0.247N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 0/50 (0%) 2/50 (4%) |
|POLY-3 RATE (b) | |0/46.90 1/44.60 0/47.00 2/35.49 |
|POLY-3 PERCENT (g) | |0.0% 2.2% 0.0% 5.6% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 0/39 (0%) 1/23 (4%) |
|FIRST INCIDENCE | |--- 563 --- 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.104 P=0.496 (e) P=0.147 |
|POLY 3 | |P=0.140 P=0.490 (e) P=0.182 |
|POLY 1.5 | |P=0.141 P=0.494 (e) P=0.196 |
|POLY 6 | |P=0.144 P=0.485 (e) P=0.170 |
|LOGISTIC REGRESSION| |P=0.187 P=0.551 (e) P=0.191 |
|COCH-ARM / FISHERS | |P=0.163 P=0.500 (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | |0/46.90 1/44.08 3/47.00 0/35.19 |
|POLY-3 PERCENT (g) | |0.0% 2.3% 6.4% 0.0% |
|TERMINAL (d) | |0/39 (0%) 0/32 (0%) 3/39 (8%) 0/23 (0%) |
|FIRST INCIDENCE | |--- 724 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.512 P=0.467 P=0.121 (e) |
|POLY 3 | |P=0.441 P=0.488 P=0.119 (e) |
|POLY 1.5 | |P=0.491 P=0.493 P=0.119 (e) |
|POLY 6 | |P=0.400 P=0.481 P=0.120 (e) |
|LOGISTIC REGRESSION| |P=0.524 P=0.473 P=0.121 (e) |
|COCH-ARM / FISHERS | |P=0.627 P=0.500 P=0.121 (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/50 (0%) 1/50 (2%) 1/50 (2%) 4/50 (8%) |
|POLY-3 RATE (b) | 2/46.22 2/46.03 1/45.28 2/30.51 |0/46.90 1/44.60 1/47.00 4/35.85 |
|POLY-3 PERCENT (g) | 4.3% 4.3% 2.2% 6.6% |0.0% 2.2% 2.1% 11.2% |
|TERMINAL (d) | 1/38 (3%) 2/42 (5%) 1/39 (3%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 1/39 (3%) 1/23 (4%) |
|FIRST INCIDENCE | 723 730 (T) 730 (T) 724 |--- 563 729 (T) 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.301 P=0.662N P=0.497N P=0.347 |P=0.006 ** P=0.496 P=0.500 P=0.024 * |
|POLY 3 | P=0.529 P=0.692 P=0.507N P=0.536 |P=0.012 * P=0.490 P=0.500 P=0.034 * |
|POLY 1.5 | P=0.547 P=0.687 P=0.506N P=0.588 |P=0.013 * P=0.494 P=0.500 P=0.040 * |
|POLY 6 | P=0.520 P=0.688N P=0.506N P=0.482 |P=0.012 * P=0.485 P=0.502 P=0.029 * |
|LOGISTIC REGRESSION| P=0.362 P=0.679N P=0.503N P=0.412 |P=0.017 * P=0.551 P=0.500 P=0.039 * |
|COCH-ARM / FISHERS | P=0.561N P=0.691N P=0.500N P=0.691N |P=0.019 * P=0.500 P=0.500 P=0.059 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 4/50 (8%) 3/50 (6%) |4/50 (8%) 3/50 (6%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/46.69 1/46.03 4/45.28 3/30.48 |4/46.90 3/44.06 2/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 6.4% 2.2% 8.8% 9.8% |8.5% 6.8% 4.3% 0.0% |
|TERMINAL (d) | 2/38 (5%) 1/42 (2%) 4/39 (10%) 3/14 (21%) |4/39 (10%) 3/32 (9%) 2/39 (5%) 0/23 (0%) |
|FIRST INCIDENCE | 582 730 (T) 730 (T) 730 (T) |729 (T) 729 (T) 729 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.055 P=0.284N P=0.507 P=0.228 |P=0.072N P=0.608N P=0.336N P=0.148N |
|POLY 3 | P=0.193 P=0.310N P=0.483 P=0.457 |P=0.062N P=0.534N P=0.336N P=0.107N |
|POLY 1.5 | P=0.237 P=0.315N P=0.487 P=0.524 |P=0.054N P=0.520N P=0.339N P=0.091N |
|POLY 6 | P=0.159 P=0.305N P=0.482 P=0.389 |P=0.070N P=0.552N P=0.333N P=0.124N |
|LOGISTIC REGRESSION| P=0.153 P=0.301N P=0.494 P=0.431 |P=0.072N P=0.608N P=0.336N (e) |
|COCH-ARM / FISHERS | P=0.373 P=0.309N P=0.500 P=0.661N |P=0.037N* P=0.500N P=0.339N P=0.059N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 3/50 (6%) 5/50 (10%) 5/50 (10%) |4/50 (8%) 4/50 (8%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 5/46.72 3/46.03 5/45.28 5/30.51 |4/46.90 4/44.60 3/47.00 4/35.85 |
|POLY-3 PERCENT (g) | 10.7% 6.5% 11.0% 16.4% |8.5% 9.0% 6.4% 11.2% |
|TERMINAL (d) | 3/38 (8%) 3/42 (7%) 5/39 (13%) 4/14 (29%) |4/39 (10%) 3/32 (9%) 3/39 (8%) 1/23 (4%) |
|FIRST INCIDENCE | 582 730 (T) 730 (T) 724 |729 (T) 563 729 (T) 649 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036 * P=0.318N P=0.621N P=0.114 |P=0.369 P=0.544 P=0.500N P=0.369 |
|POLY 3 | P=0.211 P=0.365N P=0.610 P=0.358 |P=0.470 P=0.615 P=0.499N P=0.490 |
|POLY 1.5 | P=0.262 P=0.371N P=0.615 P=0.444 |P=0.496 P=0.627 P=0.501N P=0.533 |
|POLY 6 | P=0.174 P=0.356N P=0.608 P=0.276 |P=0.457 P=0.601 P=0.495N P=0.454 |
|LOGISTIC REGRESSION| P=0.113 P=0.363N P=0.620 P=0.268 |P=0.474 P=0.627 P=0.500N P=0.481 |
|COCH-ARM / FISHERS | P=0.421 P=0.357N P=0.630N P=0.630N |P=0.543N P=0.643N P=0.500N P=0.643N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|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%) 3/50 (6%) |4/50 (8%) 5/50 (10%) 7/50 (14%) 6/50 (12%) |
|POLY-3 RATE (b) | 3/46.22 3/46.03 1/45.28 3/31.35 |4/46.90 5/45.49 7/47.99 6/36.54 |
|POLY-3 PERCENT (g) | 6.5% 6.5% 2.2% 9.6% |8.5% 11.0% 14.6% 16.4% |
|TERMINAL (d) | 2/38 (5%) 3/42 (7%) 1/39 (3%) 1/14 (7%) |4/39 (10%) 3/32 (9%) 6/39 (15%) 3/23 (13%) |
|FIRST INCIDENCE | 723 730 (T) 730 (T) 502 |729 (T) 354 190 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.280 P=0.619N P=0.302N P=0.291 |P=0.106 P=0.405 P=0.262 P=0.134 |
|POLY 3 | P=0.539 P=0.660 P=0.313N P=0.475 |P=0.156 P=0.481 P=0.275 P=0.227 |
|POLY 1.5 | P=0.558 P=0.653 P=0.312N P=0.534 |P=0.183 P=0.490 P=0.271 P=0.262 |
|POLY 6 | P=0.531 P=0.655N P=0.312N P=0.417 |P=0.139 P=0.467 P=0.279 P=0.199 |
|LOGISTIC REGRESSION| P=0.509 P=0.640N P=0.306N P=0.530 |P=0.373 P=0.559 P=0.273 P=0.276 |
|COCH-ARM / FISHERS | P=0.521N P=0.661N P=0.309N P=0.661N |P=0.293 P=0.500 P=0.262 P=0.370 |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 21
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.74 0/45.28 1/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 3.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 518 --- 730 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.243 (e) P=0.301 |(e) (e) (e) (e) |
|POLY 3 | P=0.570 P=0.240 (e) P=0.420 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.568 P=0.235 (e) P=0.445 |(e) (e) (e) (e) |
|POLY 6 | P=0.582 P=0.246 (e) P=0.395 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.653N P=0.269 (e) P=0.301 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.628 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Osteosarcoma or Osteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/46.19 2/46.74 0/45.28 1/30.48 |0/46.90 0/44.06 0/47.00 0/35.19 |
|POLY-3 PERCENT (g) | 0.0% 4.3% 0.0% 3.3% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/38 (0%) 0/42 (0%) 0/39 (0%) 1/14 (7%) |0/39 (0%) 0/32 (0%) 0/39 (0%) 0/23 (0%) |
|FIRST INCIDENCE | --- 518 --- 730 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.476 P=0.243 (e) P=0.301 |(e) (e) (e) (e) |
|POLY 3 | P=0.570 P=0.240 (e) P=0.420 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.568 P=0.235 (e) P=0.445 |(e) (e) (e) (e) |
|POLY 6 | P=0.582 P=0.246 (e) P=0.395 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.653N P=0.269 (e) P=0.301 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.628 P=0.247 (e) P=0.500 |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 22
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 34/50 (68%) 39/50 (78%) 45/50 (90%) 39/50 (78%) |29/50 (58%) 33/50 (66%) 45/50 (90%) 33/50 (66%) |
|POLY-3 RATE (b) | 34/48.44 39/47.06 45/49.02 39/40.86 |29/48.17 33/45.94 45/47.93 33/39.44 |
|POLY-3 PERCENT (g) | 70.2% 82.9% 91.8% 95.4% |60.2% 71.8% 93.9% 83.7% |
|TERMINAL (d) | 27/38 (71%) 35/42 (83%) 35/39 (90%) 14/14 (100%)|26/39 (67%) 25/32 (78%) 38/39 (97%) 20/23 (87%) |
|FIRST INCIDENCE | 464 518 497 410 |338 563 639 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.440 P=0.041 * P<0.001 ** |P<0.001 ** P=0.043 * P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.106 P=0.005 ** P<0.001 ** |P<0.001 ** P=0.159 P<0.001 ** P=0.011 * |
|POLY 1.5 | P=0.002 ** P=0.103 P=0.004 ** P=0.005 ** |P=0.003 ** P=0.193 P<0.001 ** P=0.030 * |
|POLY 6 | P<0.001 ** P=0.113 P=0.007 ** P<0.001 ** |P<0.001 ** P=0.131 P<0.001 ** P=0.006 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.134 P=0.005 ** P<0.001 ** |P<0.001 ** P=0.168 P<0.001 ** P=0.010 * |
|COCH-ARM / FISHERS | P=0.150 P=0.184 P=0.006 ** P=0.184 |P=0.161 P=0.268 P<0.001 ** P=0.268 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 29/50 (58%) 18/50 (36%) 30/50 (60%) 24/50 (48%) |24/50 (48%) 22/50 (44%) 30/50 (60%) 24/50 (48%) |
|POLY-3 RATE (b) | 29/49.58 18/48.00 30/48.37 24/36.08 |24/48.92 22/46.98 30/49.92 24/39.58 |
|POLY-3 PERCENT (g) | 58.5% 37.5% 62.0% 66.5% |49.1% 46.8% 60.1% 60.6% |
|TERMINAL (d) | 18/38 (47%) 12/42 (29%) 21/39 (54%) 6/14 (43%) |16/39 (41%) 12/32 (38%) 21/39 (54%) 10/23 (44%) |
|FIRST INCIDENCE | 464 518 497 494 |562 354 190 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.026N* P=0.515 P=0.014 * |P=0.026 * P=0.443 P=0.212 P=0.047 * |
|POLY 3 | P=0.048 * P=0.029N* P=0.441 P=0.299 |P=0.080 P=0.494N P=0.185 P=0.192 |
|POLY 1.5 | P=0.112 P=0.030N* P=0.451 P=0.487 |P=0.118 P=0.460N P=0.177 P=0.272 |
|POLY 6 | P=0.023 * P=0.027N* P=0.440 P=0.177 |P=0.065 P=0.542N P=0.189 P=0.147 |
|LOGISTIC REGRESSION| P=0.193 P=0.021N* P=0.521 P=0.475 |P=0.218 P=0.397N P=0.155 P=0.262 |
|COCH-ARM / FISHERS | P=0.505 P=0.022N* P=0.500 P=0.212N |P=0.375 P=0.421N P=0.158 P=0.579N |
|=================================================================================================================================|
Date: 10/31/00 EXPERIMENT: 50215 TEST: 03 Page 23
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - ACRYLONITRILE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | 0 MG/KG 2.5 10 MG/KG 20 MG/KG |0 MG/KG 2.5 10 MG/KG 20 MG/KG |
| | MG/KG | MG/KG |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 45/50 (90%) 43/50 (86%) 49/50 (98%) 41/50 (82%) |39/50 (78%) 41/50 (82%) 50/50 (100%) 40/50 (80%) |
|POLY-3 RATE (b) | 45/50.00 43/48.00 49/49.02 41/41.72 |39/49.82 41/47.64 50/50.00 40/40.97 |
|POLY-3 PERCENT (g) | 90.0% 89.6% 100.0% 98.3% |78.3% 86.1% 100.0% 97.6% |
|TERMINAL (d) | 33/38 (87%) 37/42 (88%) 39/39 (100%) 14/14 (100%)|30/39 (77%) 28/32 (88%) 39/39 (100%) 23/23 (100%) |
|FIRST INCIDENCE | 464 518 497 410 |338 354 190 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.183N P=0.323 P<0.001 ** |P<0.001 ** P=0.082 P=0.032 * P<0.001 ** |
|POLY 3 | P=0.014 * P=0.604N P=0.034 * P=0.106 |P<0.001 ** P=0.226 P<0.001 ** P=0.005 ** |
|POLY 1.5 | P=0.063 P=0.604N P=0.039 * P=0.260 |P=0.002 ** P=0.288 P<0.001 ** P=0.026 * |
|POLY 6 | P=0.007 ** P=0.604N P=0.033 * P=0.065 |P<0.001 ** P=0.168 P<0.001 ** P=0.002 ** |
|LOGISTIC REGRESSION| P=0.024 * P=0.504N P=0.066 P=0.083 |P=0.005 ** P=0.359 P<0.001 ** P=0.013 * |
|COCH-ARM / FISHERS | P=0.245N P=0.380N P=0.102 P=0.194N |P=0.340 P=0.402 P<0.001 ** P=0.500 |
|=================================================================================================================================|
(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).