TDMS Study 93026-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 04/11/02
EXPERIMENT: 93026 TEST: 06 TIME: 09:23:58
TEST TYPE: CHRONIC PAGE: 1
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: grumbein, sondra CAS: 91-17-8
------------------------------------------------------------------------------------------------------------------------------------
Final#1, Revision#2
REASONS FOR REMOVAL: 25022 Accidently Killed
25019 Moribund Sacrifice
25020 Natural Death
25021 Terminal Sacrifice
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 04/11/02
EXPERIMENT: 93026 TEST: 06 TIME: 09:23:58
TEST TYPE: CHRONIC
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: grumbein, sondra CAS: 91-17-8
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
Clitoral/Preputial Gland
Heart
Islets, Pancreatic
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thymus
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest DECALIN DATE: 04/11/02
EXPERIMENT: 93026 TEST: 06 TIME: 09:23:58
TEST TYPE: CHRONIC
CONT: N01-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: C93026
PATHOLOGIST: grumbein, sondra CAS: 91-17-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF DECALIN
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Adenoma
Testes Adenoma
All Organs Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma
Hepatocellular Carcinoma or Hepatoblastoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
Lung Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar Adenoma
Uterus Polyp Stromal
Sarcoma Stromal or Polyp Stromal
All Organs Benign Tumors
===============================================================
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 0/50 (0%) 4/50 (8%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 RATE (b) | 2/44.56 1/45.02 0/45.00 4/44.52 |1/44.80 0/42.57 0/45.02 0/45.26 |
|POLY-3 PERCENT (g) | 4.5% 2.2% 0.0% 9.0% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/41 (2%) 0/36 (0%) 3/34 (9%) |1/37 (3%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) --- 634 |735 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.062 P=0.491N P=0.262N P=0.271 |P=0.532N P=0.556N P=0.511N P=0.505N |
|POLY 3 | P=0.088 P=0.496N P=0.235N P=0.337 |P=0.538N P=0.510N P=0.499N P=0.498N |
|POLY 1.5 | P=0.090 P=0.496N P=0.233N P=0.342 |P=0.542N P=0.504N P=0.500N P=0.500N |
|POLY 6 | P=0.085 P=0.496N P=0.238N P=0.327 |P=0.533N P=0.518N P=0.498N P=0.495N |
|LOGISTIC REGRESSION| P=0.085 P=0.491N (e) P=0.332 |P=0.532N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.092 P=0.492N P=0.242N P=0.349 |P=0.549N P=0.495N P=0.495N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/48 (4%) 0/50 (0%) 2/50 (4%) 1/49 (2%) |
|POLY-3 RATE (b) | 0/44.56 0/45.02 0/45.00 0/44.16 |2/43.80 0/42.57 2/45.02 1/45.58 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 4.4% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |2/36 (6%) 0/28 (0%) 2/35 (6%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) --- 735 (T) 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.570N P=0.295N P=0.685 P=0.495N |
|POLY 3 | (e) (e) (e) (e) |P=0.578N P=0.243N P=0.684N P=0.486N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.591N P=0.237N P=0.685N P=0.491N |
|POLY 6 | (e) (e) (e) (e) |P=0.560N P=0.252N P=0.682N P=0.479N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.592N (e) P=0.685 P=0.493N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.605N P=0.237N P=0.676N P=0.492N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral/Preputial Gland |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 2/50 (4%) 0/50 (0%) |0/40 (0%) 0/42 (0%) 0/44 (0%) 0/44 (0%) |
|POLY-3 RATE (b) | 0/44.58 0/44.53 2/45.00 0/44.16 |0/37.16 0/35.32 0/40.55 0/40.61 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 2/36 (6%) 0/34 (0%) |0/31 (0%) 0/23 (0%) 0/33 (0%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- 733 (T) --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.690N (e) P=0.215 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.658N (e) P=0.239 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.652N (e) P=0.241 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.668N (e) P=0.236 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| (e) (e) P=0.215 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.647N (e) P=0.253 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 4/50 (8%) 4/50 (8%) 3/50 (6%) |3/49 (6%) 4/50 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 6/45.71 4/45.08 4/45.00 3/44.90 |3/45.15 4/43.34 2/45.21 2/45.81 |
|POLY-3 PERCENT (g) | 13.1% 8.9% 8.9% 6.7% |6.7% 9.2% 4.4% 4.4% |
|TERMINAL (d) | 5/40 (13%) 3/41 (7%) 4/36 (11%) 2/34 (6%) |2/37 (5%) 2/28 (7%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | 588 718 733 (T) 467 |638 588 686 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.354N P=0.362N P=0.430N P=0.309N |P=0.320N P=0.398 P=0.509N P=0.501N |
|POLY 3 | P=0.277N P=0.378N P=0.379N P=0.251N |P=0.342N P=0.478 P=0.499N P=0.493N |
|POLY 1.5 | P=0.272N P=0.377N P=0.373N P=0.245N |P=0.346N P=0.491 P=0.500N P=0.495N |
|POLY 6 | P=0.288N P=0.377N P=0.390N P=0.261N |P=0.333N P=0.461 P=0.498N P=0.488N |
|LOGISTIC REGRESSION| P=0.276N P=0.372N P=0.374N P=0.239N |P=0.349N P=0.527 P=0.493N P=0.486N |
|COCH-ARM / FISHERS | P=0.272N P=0.370N P=0.370N P=0.243N |P=0.348N P=0.511 P=0.490N P=0.490N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 1/50 (2%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 RATE (b) | 3/45.45 1/45.02 1/45.00 1/44.16 |1/44.80 0/42.57 3/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 6.6% 2.2% 2.2% 2.3% |2.2% 0.0% 6.7% 0.0% |
|TERMINAL (d) | 2/40 (5%) 1/41 (2%) 1/36 (3%) 1/34 (3%) |1/37 (3%) 0/28 (0%) 3/35 (9%) 0/36 (0%) |
|FIRST INCIDENCE | 674 733 (T) 733 (T) 733 (T) |735 (T) --- 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441N P=0.298N P=0.335N P=0.355N |P=0.381N P=0.556N P=0.285 P=0.505N |
|POLY 3 | P=0.392N P=0.309N P=0.309N P=0.316N |P=0.386N P=0.510N P=0.307 P=0.497N |
|POLY 1.5 | P=0.387N P=0.309N P=0.306N P=0.310N |P=0.395N P=0.504N P=0.306 P=0.498N |
|POLY 6 | P=0.399N P=0.308N P=0.314N P=0.325N |P=0.371N P=0.518N P=0.308 P=0.495N |
|LOGISTIC REGRESSION| P=0.400N P=0.306N P=0.307N P=0.315N |P=0.381N (e) P=0.285 (e) |
|COCH-ARM / FISHERS | P=0.385N P=0.309N P=0.309N P=0.309N |P=0.403N P=0.495N P=0.316 P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 5/50 (10%) 5/50 (10%) 4/50 (8%) |4/49 (8%) 4/50 (8%) 5/50 (10%) 2/50 (4%) |
|POLY-3 RATE (b) | 9/45.94 5/45.08 5/45.00 4/44.90 |4/45.15 4/43.34 5/45.21 2/45.81 |
|POLY-3 PERCENT (g) | 19.6% 11.1% 11.1% 8.9% |8.9% 9.2% 11.1% 4.4% |
|TERMINAL (d) | 7/40 (18%) 4/41 (10%) 5/36 (14%) 3/34 (9%) |3/37 (8%) 2/28 (7%) 4/35 (11%) 1/36 (3%) |
|FIRST INCIDENCE | 588 718 733 (T) 467 |638 588 686 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.268N P=0.189N P=0.249N P=0.177N |P=0.209N P=0.527 P=0.478 P=0.343N |
|POLY 3 | P=0.189N P=0.202N P=0.203N P=0.123N |P=0.225N P=0.621 P=0.501 P=0.330N |
|POLY 1.5 | P=0.184N P=0.201N P=0.197N P=0.118N |P=0.232N P=0.634 P=0.500 P=0.332N |
|POLY 6 | P=0.200N P=0.203N P=0.215N P=0.133N |P=0.213N P=0.604 P=0.502 P=0.325N |
|LOGISTIC REGRESSION| P=0.191N P=0.195N P=0.196N P=0.116N |P=0.234N P=0.629N P=0.503 P=0.326N |
|COCH-ARM / FISHERS | P=0.185N P=0.194N P=0.194N P=0.117N |P=0.235N P=0.631N P=0.513 P=0.329N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.23 1/45.02 2/45.13 0/44.16 |0/44.80 0/42.57 0/45.02 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 2.2% 4.4% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/40 (0%) 1/41 (2%) 1/36 (3%) 0/34 (0%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- 733 (T) 699 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.505 P=0.231 (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.481N P=0.499 P=0.237 (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.476N P=0.499 P=0.238 (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.489N P=0.500 P=0.235 (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.483N P=0.505 P=0.236 (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.473N P=0.500 P=0.247 (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/50 (0%) 2/50 (4%) 2/49 (4%) |1/49 (2%) 0/47 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 RATE (b) | 1/44.56 0/45.02 2/45.71 2/43.64 |1/45.08 0/40.98 1/45.11 0/45.26 |
|POLY-3 PERCENT (g) | 2.2% 0.0% 4.4% 4.6% |2.2% 0.0% 2.2% 0.0% |
|TERMINAL (d) | 1/40 (3%) 0/41 (0%) 0/36 (0%) 1/34 (3%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | 733 (T) --- 612 731 |659 --- 714 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.254 P=0.495N P=0.485 P=0.447 |P=0.454N P=0.530N P=0.760 P=0.495N |
|POLY 3 | P=0.282 P=0.498N P=0.509 P=0.493 |P=0.463N P=0.519N P=0.760N P=0.499N |
|POLY 1.5 | P=0.286 P=0.498N P=0.509 P=0.497 |P=0.469N P=0.515N P=0.760 P=0.500N |
|POLY 6 | P=0.273 P=0.497N P=0.507 P=0.486 |P=0.456N P=0.525N P=0.760N P=0.497N |
|LOGISTIC REGRESSION| P=0.287 (e) P=0.499 P=0.471 |P=0.476N P=0.489N P=0.754N P=0.489N |
|COCH-ARM / FISHERS | P=0.287 P=0.495N P=0.508 P=0.500 |P=0.474N P=0.510N P=0.747N P=0.500N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 3/50 (6%) 0/50 (0%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 RATE (b) | 1/45.23 3/45.02 0/45.00 2/44.16 |0/44.80 0/42.57 0/45.02 1/45.46 |
|POLY-3 PERCENT (g) | 2.2% 6.7% 0.0% 4.5% |0.0% 0.0% 0.0% 2.2% |
|TERMINAL (d) | 1/40 (3%) 3/41 (7%) 0/36 (0%) 2/34 (6%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 733 (T) 733 (T) --- 733 (T) |--- --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.499 P=0.314 P=0.521N P=0.443 |P=0.243 (e) (e) P=0.495 |
|POLY 3 | P=0.556 P=0.304 P=0.501N P=0.492 |P=0.234 (e) (e) P=0.503 |
|POLY 1.5 | P=0.561 P=0.303 P=0.500N P=0.496 |P=0.231 (e) (e) P=0.502 |
|POLY 6 | P=0.550 P=0.306 P=0.503N P=0.484 |P=0.239 (e) (e) P=0.505 |
|LOGISTIC REGRESSION| P=0.499 P=0.314 (e) P=0.443 |(e) (e) (e) P=0.495 |
|COCH-ARM / FISHERS | P=0.565 P=0.309 P=0.500N P=0.500 |P=0.229 (e) (e) P=0.505 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 22/50 (44%) 22/50 (44%) 14/50 (28%) 27/50 (54%) |7/49 (14%) 13/50 (26%) 8/50 (16%) 17/50 (34%) |
|POLY-3 RATE (b) | 22/47.09 22/46.93 14/47.39 27/45.45 |7/44.80 13/43.76 8/45.41 17/45.68 |
|POLY-3 PERCENT (g) | 46.7% 46.9% 29.5% 59.4% |15.6% 29.7% 17.6% 37.2% |
|TERMINAL (d) | 18/40 (45%) 19/41 (46%) 8/36 (22%) 21/34 (62%) |7/37 (19%) 9/28 (32%) 6/35 (17%) 14/36 (39%) |
|FIRST INCIDENCE | 476 495 448 605 |735 (T) 532 652 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.545N P=0.143N P=0.079 |P=0.047 * P=0.032 * P=0.462 P=0.015 * |
|POLY 3 | P=0.062 P=0.576 P=0.063N P=0.151 |P=0.024 * P=0.089 P=0.511 P=0.016 * |
|POLY 1.5 | P=0.076 P=0.572 P=0.064N P=0.177 |P=0.023 * P=0.099 P=0.506 P=0.016 * |
|POLY 6 | P=0.048 * P=0.581 P=0.066N P=0.122 |P=0.026 * P=0.079 P=0.521 P=0.017 * |
|LOGISTIC REGRESSION| P=0.094 P=0.574 P=0.072N P=0.183 |P=0.033 * P=0.078 P=0.509 P=0.019 * |
|COCH-ARM / FISHERS | P=0.098 P=0.580N P=0.072N P=0.212 |P=0.025 * P=0.115 P=0.517 P=0.019 * |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 7/50 (14%) 10/50 (20%) 11/50 (22%) |4/49 (8%) 16/50 (32%) 6/50 (12%) 5/50 (10%) |
|POLY-3 RATE (b) | 10/47.33 7/47.13 10/46.98 11/46.68 |4/44.92 16/45.09 6/45.89 5/45.87 |
|POLY-3 PERCENT (g) | 21.1% 14.9% 21.3% 23.6% |8.9% 35.5% 13.1% 10.9% |
|TERMINAL (d) | 6/40 (15%) 3/41 (7%) 5/36 (14%) 4/34 (12%) |3/37 (8%) 7/28 (25%) 3/35 (9%) 3/36 (8%) |
|FIRST INCIDENCE | 384 497 561 552 |703 488 594 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.242 P=0.309N P=0.534 P=0.408 |P=0.108N P<0.001 ** P=0.357 P=0.499 |
|POLY 3 | P=0.298 P=0.300N P=0.592 P=0.486 |P=0.115N P=0.002 ** P=0.383 P=0.513 |
|POLY 1.5 | P=0.306 P=0.303N P=0.595 P=0.492 |P=0.119N P=0.002 ** P=0.377 P=0.509 |
|POLY 6 | P=0.288 P=0.294N P=0.587 P=0.479 |P=0.107N P=0.002 ** P=0.392 P=0.523 |
|LOGISTIC REGRESSION| P=0.312 P=0.265N P=0.589 P=0.521 |P=0.125N P=0.003 ** P=0.377 P=0.509 |
|COCH-ARM / FISHERS | P=0.310 P=0.298N P=0.598N P=0.500 |P=0.125N P=0.003 ** P=0.383 P=0.513 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatoblastoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/50 (20%) 8/50 (16%) 10/50 (20%) 12/50 (24%) |4/49 (8%) 16/50 (32%) 6/50 (12%) 6/50 (12%) |
|POLY-3 RATE (b) | 10/47.33 8/47.13 10/46.98 12/46.74 |4/44.92 16/45.09 6/45.89 6/45.90 |
|POLY-3 PERCENT (g) | 21.1% 17.0% 21.3% 25.7% |8.9% 35.5% 13.1% 13.1% |
|TERMINAL (d) | 6/40 (15%) 4/41 (10%) 5/36 (14%) 4/34 (12%) |3/37 (8%) 7/28 (25%) 3/35 (9%) 3/36 (8%) |
|FIRST INCIDENCE | 384 497 561 552 |703 488 594 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.193 P=0.403N P=0.534 P=0.325 |P=0.178N P<0.001 ** P=0.357 P=0.372 |
|POLY 3 | P=0.243 P=0.401N P=0.592 P=0.391 |P=0.198N P=0.002 ** P=0.383 P=0.383 |
|POLY 1.5 | P=0.249 P=0.404N P=0.595 P=0.397 |P=0.203N P=0.002 ** P=0.377 P=0.379 |
|POLY 6 | P=0.234 P=0.394N P=0.587 P=0.386 |P=0.187N P=0.002 ** P=0.392 P=0.393 |
|LOGISTIC REGRESSION| P=0.254 P=0.366N P=0.589 P=0.422 |P=0.208N P=0.003 ** P=0.377 P=0.379 |
|COCH-ARM / FISHERS | P=0.253 P=0.398N P=0.598N P=0.405 |P=0.209N P=0.003 ** P=0.383 P=0.383 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 26/50 (52%) 22/50 (44%) 34/50 (68%) |11/49 (22%) 27/50 (54%) 14/50 (28%) 20/50 (40%) |
|POLY-3 RATE (b) | 28/48.71 26/48.44 22/48.98 34/47.10 |11/44.92 27/46.25 14/46.28 20/46.03 |
|POLY-3 PERCENT (g) | 57.5% 53.7% 44.9% 72.2% |24.5% 58.4% 30.3% 43.5% |
|TERMINAL (d) | 21/40 (53%) 20/41 (49%) 12/36 (33%) 24/34 (71%) |10/37 (27%) 15/28 (54%) 9/35 (26%) 16/36 (44%) |
|FIRST INCIDENCE | 384 495 448 552 |703 488 594 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.018 * P=0.404N P=0.298N P=0.061 |P=0.473 P<0.001 ** P=0.291 P=0.040 * |
|POLY 3 | P=0.026 * P=0.431N P=0.148N P=0.094 |P=0.339 P<0.001 ** P=0.351 P=0.043 * |
|POLY 1.5 | P=0.034 * P=0.436N P=0.150N P=0.114 |P=0.333 P<0.001 ** P=0.337 P=0.042 * |
|POLY 6 | P=0.020 * P=0.423N P=0.149N P=0.076 |P=0.360 P<0.001 ** P=0.374 P=0.048 * |
|LOGISTIC REGRESSION| P=0.050 P=0.412N P=0.146N P=0.149 |P=0.363 P<0.001 ** P=0.326 P=0.048 * |
|COCH-ARM / FISHERS | P=0.048 * P=0.421N P=0.159N P=0.151 |P=0.346 P<0.001 ** P=0.343 P=0.047 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 27/50 (54%) 22/50 (44%) 34/50 (68%) |11/49 (22%) 27/50 (54%) 14/50 (28%) 21/50 (42%) |
|POLY-3 RATE (b) | 28/48.71 27/48.44 22/48.98 34/47.10 |11/44.92 27/46.25 14/46.28 21/46.07 |
|POLY-3 PERCENT (g) | 57.5% 55.7% 44.9% 72.2% |24.5% 58.4% 30.3% 45.6% |
|TERMINAL (d) | 21/40 (53%) 21/41 (51%) 12/36 (33%) 24/34 (71%) |10/37 (27%) 15/28 (54%) 9/35 (26%) 16/36 (44%) |
|FIRST INCIDENCE | 384 495 448 552 |703 488 594 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.022 * P=0.471N P=0.298N P=0.061 |P=0.387 P<0.001 ** P=0.291 P=0.027 * |
|POLY 3 | P=0.033 * P=0.512N P=0.148N P=0.094 |P=0.250 P<0.001 ** P=0.351 P=0.027 * |
|POLY 1.5 | P=0.042 * P=0.517N P=0.150N P=0.114 |P=0.245 P<0.001 ** P=0.337 P=0.026 * |
|POLY 6 | P=0.025 * P=0.504N P=0.149N P=0.076 |P=0.269 P<0.001 ** P=0.374 P=0.030 * |
|LOGISTIC REGRESSION| P=0.060 P=0.492N P=0.146N P=0.149 |P=0.276 P<0.001 ** P=0.326 P=0.031 * |
|COCH-ARM / FISHERS | P=0.059 P=0.500N P=0.159N P=0.151 |P=0.261 P<0.001 ** P=0.343 P=0.031 * |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 5/50 (10%) 4/50 (8%) 2/50 (4%) |1/49 (2%) 4/50 (8%) 0/50 (0%) 4/50 (8%) |
|POLY-3 RATE (b) | 8/45.54 5/45.02 4/45.13 2/44.55 |1/44.80 4/42.98 0/45.02 4/45.58 |
|POLY-3 PERCENT (g) | 17.6% 11.1% 8.9% 4.5% |2.2% 9.3% 0.0% 8.8% |
|TERMINAL (d) | 7/40 (18%) 5/41 (12%) 3/36 (8%) 1/34 (3%) |1/37 (3%) 3/28 (11%) 0/35 (0%) 2/36 (6%) |
|FIRST INCIDENCE | 649 733 (T) 699 622 |735 (T) 616 --- 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.099N P=0.262N P=0.225N P=0.079N |P=0.255 P=0.117 P=0.511N P=0.183 |
|POLY 3 | P=0.063N P=0.283N P=0.180N P=0.048N* |P=0.217 P=0.166 P=0.499N P=0.184 |
|POLY 1.5 | P=0.061N P=0.282N P=0.178N P=0.047N* |P=0.216 P=0.174 P=0.500N P=0.183 |
|POLY 6 | P=0.067N P=0.281N P=0.186N P=0.051N |P=0.221 P=0.157 P=0.498N P=0.188 |
|LOGISTIC REGRESSION| P=0.067N P=0.272N P=0.183N P=0.050N |P=0.230 P=0.168 (e) P=0.188 |
|COCH-ARM / FISHERS | P=0.062N P=0.277N P=0.178N P=0.046N* |P=0.219 P=0.187 P=0.495N P=0.187 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 8/50 (16%) 6/50 (12%) 12/50 (24%) |6/49 (12%) 3/50 (6%) 1/50 (2%) 1/50 (2%) |
|POLY-3 RATE (b) | 8/45.54 8/45.70 6/45.39 12/46.70 |6/45.36 3/42.57 1/45.26 1/45.46 |
|POLY-3 PERCENT (g) | 17.6% 17.5% 13.2% 25.7% |13.2% 7.1% 2.2% 2.2% |
|TERMINAL (d) | 7/40 (18%) 7/41 (17%) 5/36 (14%) 7/34 (21%) |4/37 (11%) 3/28 (11%) 0/35 (0%) 1/36 (3%) |
|FIRST INCIDENCE | 649 497 623 469 |610 735 (T) 672 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.066 P=0.587N P=0.462N P=0.153 |P=0.069N P=0.376N P=0.067N P=0.063N |
|POLY 3 | P=0.133 P=0.605N P=0.389N P=0.244 |P=0.071N P=0.274N P=0.056N P=0.055N |
|POLY 1.5 | P=0.130 P=0.607 P=0.386N P=0.240 |P=0.074N P=0.256N P=0.056N P=0.055N |
|POLY 6 | P=0.133 P=0.599N P=0.396N P=0.245 |P=0.066N P=0.298N P=0.056N P=0.055N |
|LOGISTIC REGRESSION| P=0.122 P=0.604 P=0.392N P=0.231 |P=0.076N P=0.271N P=0.055N P=0.056N |
|COCH-ARM / FISHERS | P=0.122 P=0.607N P=0.387N P=0.227 |P=0.079N P=0.233N P=0.053N P=0.053N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 13/50 (26%) 10/50 (20%) 13/50 (26%) |7/49 (14%) 7/50 (14%) 1/50 (2%) 5/50 (10%) |
|POLY-3 RATE (b) | 15/45.54 13/45.70 10/45.52 13/46.70 |7/45.36 7/42.98 1/45.26 5/45.58 |
|POLY-3 PERCENT (g) | 32.9% 28.4% 22.0% 27.8% |15.4% 16.3% 2.2% 11.0% |
|TERMINAL (d) | 14/40 (35%) 12/41 (29%) 8/36 (22%) 8/34 (24%) |5/37 (14%) 6/28 (21%) 0/35 (0%) 3/36 (8%) |
|FIRST INCIDENCE | 649 497 623 469 |610 616 672 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.441 P=0.383N P=0.258N P=0.578N |P=0.327N P=0.422 P=0.039N* P=0.387N |
|POLY 3 | P=0.460N P=0.406N P=0.173N P=0.380N |P=0.367N P=0.572 P=0.030N* P=0.376N |
|POLY 1.5 | P=0.468N P=0.412N P=0.173N P=0.389N |P=0.372N P=0.595 P=0.030N* P=0.375N |
|POLY 6 | P=0.458N P=0.396N P=0.177N P=0.375N |P=0.357N P=0.540 P=0.030N* P=0.372N |
|LOGISTIC REGRESSION| P=0.502N P=0.415N P=0.185N P=0.414N |P=0.361N P=0.575 P=0.031N* P=0.368N |
|COCH-ARM / FISHERS | P=0.492N P=0.412N P=0.178N P=0.412N |P=0.376N P=0.597N P=0.028N* P=0.365N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 2/50 (4%) 2/50 (4%) 0/50 (0%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |1/45.08 2/43.19 2/45.21 0/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 4.6% 4.4% 0.0% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |0/37 (0%) 1/28 (4%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |659 532 700 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.220N P=0.448 P=0.503 P=0.495N |
|POLY 3 | (e) (e) (e) (e) |P=0.230N P=0.485 P=0.501 P=0.498N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.232N P=0.494 P=0.500 P=0.498N |
|POLY 6 | (e) (e) (e) (e) |P=0.226N P=0.473 P=0.502 P=0.497N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.230N P=0.565 P=0.511 P=0.480N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.231N P=0.508 P=0.508 P=0.495N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 0/49 (0%) 3/49 (6%) 2/48 (4%) |
|POLY-3 RATE (b) | |1/44.80 0/41.57 3/44.32 2/44.36 |
|POLY-3 PERCENT (g) | |2.2% 0.0% 6.8% 4.5% |
|TERMINAL (d) | |1/37 (3%) 0/27 (0%) 3/35 (9%) 1/35 (3%) |
|FIRST INCIDENCE | |735 (T) --- 735 (T) 710 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.370 P=0.563N P=0.285 P=0.499 |
|POLY 3 | |P=0.353 P=0.515N P=0.301 P=0.497 |
|POLY 1.5 | |P=0.340 P=0.509N P=0.300 P=0.493 |
|POLY 6 | |P=0.373 P=0.523N P=0.304 P=0.502 |
|LOGISTIC REGRESSION| |P=0.366 (e) P=0.285 P=0.500 |
|COCH-ARM / FISHERS | |P=0.328 P=0.500N P=0.309 P=0.492 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Granulosa Cell Tumor: Benign, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 0/49 (0%) 1/49 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | |1/44.80 0/41.57 1/44.32 2/44.58 |
|POLY-3 PERCENT (g) | |2.2% 0.0% 2.3% 4.5% |
|TERMINAL (d) | |1/37 (3%) 0/27 (0%) 1/35 (3%) 1/35 (3%) |
|FIRST INCIDENCE | |735 (T) --- 735 (T) 644 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.259 P=0.563N P=0.749 P=0.492 |
|POLY 3 | |P=0.251 P=0.515N P=0.758 P=0.498 |
|POLY 1.5 | |P=0.242 P=0.509N P=0.757 P=0.494 |
|POLY 6 | |P=0.263 P=0.523N P=0.760 P=0.505 |
|LOGISTIC REGRESSION| |P=0.238 (e) P=0.749 P=0.493 |
|COCH-ARM / FISHERS | |P=0.232 P=0.500N P=0.753N P=0.492 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/50 (2%) 0/50 (0%) 0/49 (0%) |13/49 (27%) 8/49 (16%) 10/49 (20%) 17/50 (34%) |
|POLY-3 RATE (b) | 1/43.23 1/45.02 0/45.00 0/43.63 |13/45.36 8/43.79 10/44.82 17/45.66 |
|POLY-3 PERCENT (g) | 2.3% 2.2% 0.0% 0.0% |28.7% 18.3% 22.3% 37.2% |
|TERMINAL (d) | 1/38 (3%) 1/41 (2%) 0/36 (0%) 0/34 (0%) |11/37 (30%) 4/28 (14%) 8/34 (24%) 14/36 (39%) |
|FIRST INCIDENCE | 733 (T) 733 (T) --- --- |659 532 511 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.375N P=0.745N P=0.511N P=0.522N |P=0.100 P=0.351N P=0.388N P=0.243 |
|POLY 3 | P=0.350N P=0.752N P=0.492N P=0.498N |P=0.059 P=0.181N P=0.326N P=0.258 |
|POLY 1.5 | P=0.349N P=0.752N P=0.491N P=0.497N |P=0.058 P=0.173N P=0.331N P=0.260 |
|POLY 6 | P=0.351N P=0.750N P=0.494N P=0.501N |P=0.064 P=0.195N P=0.323N P=0.262 |
|LOGISTIC REGRESSION| P=0.375N P=0.745N (e) (e) |P=0.067 P=0.173N P=0.333N P=0.286 |
|COCH-ARM / FISHERS | P=0.348N P=0.742N P=0.490N P=0.495N |P=0.062 P=0.162N P=0.317N P=0.278 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Intermedia |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |1/49 (2%) 1/49 (2%) 2/49 (4%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/43.23 0/45.02 0/45.00 0/43.63 |1/44.80 1/42.30 2/44.37 2/45.46 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |2.2% 2.4% 4.5% 4.4% |
|TERMINAL (d) | 0/38 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 0/34 (0%) 2/36 (6%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) 731 652 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.441 P=0.705 P=0.496 P=0.490 |
|POLY 3 | (e) (e) (e) (e) |P=0.428 P=0.748 P=0.497 P=0.505 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.422 P=0.753 P=0.495 P=0.504 |
|POLY 6 | (e) (e) (e) (e) |P=0.439 P=0.740 P=0.500 P=0.509 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.427 P=0.728 P=0.499 P=0.490 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.419 P=0.753N P=0.500 P=0.508 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |2/44.88 3/43.42 3/45.91 2/45.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 6.9% 6.5% 4.4% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |714 588 356 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.473N P=0.437 P=0.488 P=0.684N |
|POLY 3 | (e) (e) (e) (e) |P=0.499N P=0.485 P=0.510 P=0.689N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.504N P=0.494 P=0.507 P=0.690N |
|POLY 6 | (e) (e) (e) (e) |P=0.490N P=0.473 P=0.513 P=0.685N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.507N P=0.533 P=0.550 P=0.688N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.505N P=0.510 P=0.510 P=0.684N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 3/50 (6%) 3/50 (6%) 2/50 (4%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |2/44.88 3/43.42 3/45.91 2/45.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 6.9% 6.5% 4.4% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 1/35 (3%) 1/36 (3%) |
|FIRST INCIDENCE | --- --- --- --- |714 588 356 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.473N P=0.437 P=0.488 P=0.684N |
|POLY 3 | (e) (e) (e) (e) |P=0.499N P=0.485 P=0.510 P=0.689N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.504N P=0.494 P=0.507 P=0.690N |
|POLY 6 | (e) (e) (e) (e) |P=0.490N P=0.473 P=0.513 P=0.685N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.507N P=0.533 P=0.550 P=0.688N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.505N P=0.510 P=0.510 P=0.684N |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/49 (4%) 2/50 (4%) 2/50 (4%) 1/50 (2%) |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 0/44.16 |2/44.88 2/43.09 2/45.91 1/45.54 |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 0.0% |4.5% 4.6% 4.4% 2.2% |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 0/34 (0%) |1/37 (3%) 0/28 (0%) 0/35 (0%) 0/36 (0%) |
|FIRST INCIDENCE | --- --- --- --- |714 588 356 714 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.363N P=0.634 P=0.684 P=0.486N |
|POLY 3 | (e) (e) (e) (e) |P=0.377N P=0.679 P=0.686N P=0.495N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.382N P=0.688 P=0.688N P=0.496N |
|POLY 6 | (e) (e) (e) (e) |P=0.368N P=0.668 P=0.684N P=0.491N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.383N P=0.682N P=0.643N P=0.494N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.383N P=0.684N P=0.684N P=0.492N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/50 (6%) 0/50 (0%) 2/49 (4%) |1/49 (2%) 1/47 (2%) 1/50 (2%) 2/48 (4%) |
|POLY-3 RATE (b) | 0/44.56 3/45.08 0/45.00 2/43.69 |1/44.88 1/41.11 1/45.16 2/44.36 |
|POLY-3 PERCENT (g) | 0.0% 6.7% 0.0% 4.6% |2.2% 2.4% 2.2% 4.5% |
|TERMINAL (d) | 0/40 (0%) 2/41 (5%) 0/36 (0%) 1/34 (3%) |0/37 (0%) 0/28 (0%) 0/35 (0%) 2/36 (6%) |
|FIRST INCIDENCE | --- 718 --- 718 |714 700 700 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.377 P=0.129 (e) P=0.217 |P=0.408 P=0.726 P=0.758N P=0.502 |
|POLY 3 | P=0.411 P=0.121 (e) P=0.233 |P=0.376 P=0.741 P=0.759N P=0.496 |
|POLY 1.5 | P=0.415 P=0.121 (e) P=0.235 |P=0.371 P=0.745 P=0.760N P=0.493 |
|POLY 6 | P=0.406 P=0.121 (e) P=0.229 |P=0.385 P=0.736 P=0.758N P=0.501 |
|LOGISTIC REGRESSION| P=0.401 P=0.123 (e) P=0.227 |P=0.374 P=0.751 P=0.760N P=0.503 |
|COCH-ARM / FISHERS | P=0.418 P=0.125 (e) P=0.247 |P=0.365 P=0.742 P=0.747N P=0.492 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 3/50 (6%) | |
|POLY-3 RATE (b) | 0/45.23 0/45.02 0/45.00 3/44.61 | |
|POLY-3 PERCENT (g) | 0.0% 0.0% 0.0% 6.7% | |
|TERMINAL (d) | 0/40 (0%) 0/41 (0%) 0/36 (0%) 2/34 (6%) | |
|FIRST INCIDENCE | --- --- --- 602 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006 ** (e) (e) P=0.103 | |
|POLY 3 | P=0.007 ** (e) (e) P=0.116 | |
|POLY 1.5 | P=0.008 ** (e) (e) P=0.118 | |
|POLY 6 | P=0.007 ** (e) (e) P=0.113 | |
|LOGISTIC REGRESSION| P=0.008 ** (e) (e) P=0.121 | |
|COCH-ARM / FISHERS | P=0.008 ** (e) (e) P=0.121 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/49 (0%) 0/50 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 RATE (b) | |0/44.80 0/42.57 2/45.11 3/45.46 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.4% 6.6% |
|TERMINAL (d) | |0/37 (0%) 0/28 (0%) 1/35 (3%) 3/36 (8%) |
|FIRST INCIDENCE | |--- --- 714 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.059 (e) P=0.234 P=0.116 |
|POLY 3 | |P=0.049 * (e) P=0.239 P=0.121 |
|POLY 1.5 | |P=0.047 * (e) P=0.238 P=0.121 |
|POLY 6 | |P=0.053 (e) P=0.240 P=0.123 |
|LOGISTIC REGRESSION| |P=0.057 (e) P=0.239 P=0.116 |
|COCH-ARM / FISHERS | |P=0.047 * (e) P=0.253 P=0.125 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Sarcoma Stromal or Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/49 (0%) 0/50 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 RATE (b) | |0/44.80 0/42.57 2/45.11 4/45.46 |
|POLY-3 PERCENT (g) | |0.0% 0.0% 4.4% 8.8% |
|TERMINAL (d) | |0/37 (0%) 0/28 (0%) 1/35 (3%) 4/36 (11%) |
|FIRST INCIDENCE | |--- --- 714 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.018 * (e) P=0.234 P=0.059 |
|POLY 3 | |P=0.013 * (e) P=0.239 P=0.062 |
|POLY 1.5 | |P=0.013 * (e) P=0.238 P=0.062 |
|POLY 6 | |P=0.014 * (e) P=0.240 P=0.063 |
|LOGISTIC REGRESSION| |P=0.017 * (e) P=0.239 P=0.059 |
|COCH-ARM / FISHERS | |P=0.013 * (e) P=0.253 P=0.061 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 2/50 (4%) 3/50 (6%) |1/49 (2%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/45.23 6/45.08 2/45.00 3/44.22 |1/44.88 2/42.71 3/45.16 4/45.46 |
|POLY-3 PERCENT (g) | 2.2% 13.3% 4.4% 6.8% |2.2% 4.7% 6.6% 8.8% |
|TERMINAL (d) | 1/40 (3%) 5/41 (12%) 2/36 (6%) 2/34 (6%) |0/37 (0%) 1/28 (4%) 2/35 (6%) 4/36 (11%) |
|FIRST INCIDENCE | 733 (T) 718 733 (T) 718 |714 700 700 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.546 P=0.065 P=0.463 P=0.260 |P=0.200 P=0.433 P=0.300 P=0.179 |
|POLY 3 | P=0.605N P=0.055 P=0.498 P=0.297 |P=0.171 P=0.483 P=0.307 P=0.182 |
|POLY 1.5 | P=0.598N P=0.055 P=0.500 P=0.302 |P=0.167 P=0.493 P=0.306 P=0.182 |
|POLY 6 | P=0.606 P=0.056 P=0.494 P=0.290 |P=0.178 P=0.470 P=0.309 P=0.185 |
|LOGISTIC REGRESSION| P=0.588 P=0.060 P=0.463 P=0.282 |P=0.184 P=0.480 P=0.307 P=0.189 |
|COCH-ARM / FISHERS | P=0.592N P=0.056 P=0.500 P=0.309 |P=0.164 P=0.508 P=0.316 P=0.187 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 6/50 (12%) 3/50 (6%) 3/50 (6%) |2/49 (4%) 2/50 (4%) 3/50 (6%) 4/50 (8%) |
|POLY-3 RATE (b) | 1/45.23 6/45.08 3/45.46 3/44.22 |2/44.88 2/42.71 3/45.16 4/45.46 |
|POLY-3 PERCENT (g) | 2.2% 13.3% 6.6% 6.8% |4.5% 4.7% 6.6% 8.8% |
|TERMINAL (d) | 1/40 (3%) 5/41 (12%) 2/36 (6%) 2/34 (6%) |1/37 (3%) 1/28 (4%) 2/35 (6%) 4/36 (11%) |
|FIRST INCIDENCE | 733 (T) 718 596 718 |714 700 700 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.567 P=0.065 P=0.281 P=0.260 |P=0.292 P=0.614 P=0.487 P=0.333 |
|POLY 3 | P=0.582N P=0.055 P=0.307 P=0.297 |P=0.260 P=0.676 P=0.503 P=0.343 |
|POLY 1.5 | P=0.574N P=0.055 P=0.307 P=0.302 |P=0.254 P=0.686 P=0.501 P=0.342 |
|POLY 6 | P=0.593N P=0.056 P=0.305 P=0.290 |P=0.271 P=0.663 P=0.505 P=0.347 |
|LOGISTIC REGRESSION| P=0.586N P=0.060 P=0.305 P=0.282 |P=0.277 P=0.667 P=0.503 P=0.353 |
|COCH-ARM / FISHERS | P=0.567N P=0.056 P=0.309 P=0.309 |P=0.249 P=0.684N P=0.510 P=0.349 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 4/50 (8%) 4/50 (8%) |11/49 (22%) 8/50 (16%) 13/50 (26%) 14/50 (28%) |
|POLY-3 RATE (b) | 3/45.58 3/45.02 4/45.91 4/45.17 |11/46.93 8/43.98 13/45.73 14/46.77 |
|POLY-3 PERCENT (g) | 6.6% 6.7% 8.7% 8.9% |23.4% 18.2% 28.4% 29.9% |
|TERMINAL (d) | 2/40 (5%) 3/41 (7%) 2/36 (6%) 1/34 (3%) |6/37 (16%) 4/28 (14%) 10/35 (29%) 9/36 (25%) |
|FIRST INCIDENCE | 635 733 (T) 596 552 |363 588 612 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373 P=0.656N P=0.463 P=0.441 |P=0.255 P=0.479N P=0.378 P=0.332 |
|POLY 3 | P=0.437 P=0.657 P=0.504 P=0.495 |P=0.190 P=0.361N P=0.378 P=0.317 |
|POLY 1.5 | P=0.441 P=0.657 P=0.504 P=0.499 |P=0.179 P=0.333N P=0.387 P=0.319 |
|POLY 6 | P=0.428 P=0.657 P=0.502 P=0.488 |P=0.215 P=0.395N P=0.372 P=0.328 |
|LOGISTIC REGRESSION| P=0.440 P=0.661 P=0.494 P=0.504 |P=0.176 P=0.223N P=0.438 P=0.359 |
|COCH-ARM / FISHERS | P=0.440 P=0.661N P=0.500 P=0.500 |P=0.176 P=0.288N P=0.430 P=0.343 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 32/50 (64%) 27/50 (54%) 22/50 (44%) 32/50 (64%) |28/49 (57%) 25/50 (50%) 27/50 (54%) 34/50 (68%) |
|POLY-3 RATE (b) | 32/47.09 27/46.99 22/48.40 32/46.64 |28/46.33 25/45.83 27/46.74 34/46.58 |
|POLY-3 PERCENT (g) | 68.0% 57.5% 45.5% 68.6% |60.4% 54.6% 57.8% 73.0% |
|TERMINAL (d) | 28/40 (70%) 23/41 (56%) 13/36 (36%) 24/34 (71%) |23/37 (62%) 15/28 (54%) 20/35 (57%) 26/36 (72%) |
|FIRST INCIDENCE | 476 495 448 467 |568 532 511 636 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.085 P=0.188N P=0.115N P=0.248 |P=0.174 P=0.357 P=0.565 P=0.159 |
|POLY 3 | P=0.227 P=0.198N P=0.019N* P=0.562 |P=0.046 * P=0.357N P=0.479N P=0.138 |
|POLY 1.5 | P=0.249 P=0.206N P=0.023N* P=0.578 |P=0.047 * P=0.337N P=0.489N P=0.144 |
|POLY 6 | P=0.197 P=0.187N P=0.016N* P=0.533 |P=0.052 P=0.381N P=0.464N P=0.145 |
|LOGISTIC REGRESSION| P=0.259 P=0.215N P=0.035N* P=0.551 |P=0.065 P=0.380N P=0.492N P=0.161 |
|COCH-ARM / FISHERS | P=0.267 P=0.208N P=0.035N* P=0.582N |P=0.059 P=0.305N P=0.455N P=0.182 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 20/50 (40%) 23/50 (46%) 23/50 (46%) |22/49 (45%) 28/50 (56%) 29/50 (58%) 26/50 (52%) |
|POLY-3 RATE (b) | 23/48.21 20/47.19 23/47.56 23/48.45 |22/47.89 28/47.21 29/47.95 26/46.89 |
|POLY-3 PERCENT (g) | 47.7% 42.4% 48.4% 47.5% |45.9% 59.3% 60.5% 55.5% |
|TERMINAL (d) | 16/40 (40%) 15/41 (37%) 16/36 (44%) 12/34 (35%) |13/37 (35%) 12/28 (43%) 18/35 (51%) 19/36 (53%) |
|FIRST INCIDENCE | 384 497 561 469 |363 488 356 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.251 P=0.342N P=0.446 P=0.388 |P=0.451N P=0.062 P=0.136 P=0.295 |
|POLY 3 | P=0.473 P=0.376N P=0.556 P=0.571N |P=0.427 P=0.133 P=0.109 P=0.235 |
|POLY 1.5 | P=0.467 P=0.369N P=0.567 P=0.571N |P=0.443 P=0.148 P=0.110 P=0.251 |
|POLY 6 | P=0.471 P=0.382N P=0.537 P=0.578N |P=0.428 P=0.123 P=0.111 P=0.230 |
|LOGISTIC REGRESSION| P=0.448 P=0.339N P=0.579 P=0.551N |P=0.502 P=0.234 P=0.141 P=0.305 |
|COCH-ARM / FISHERS | P=0.440 P=0.343N P=0.579N P=0.579N |P=0.500 P=0.183 P=0.135 P=0.307 |
|=================================================================================================================================|
Date: 04/11/02 EXPERIMENT: 93026 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - DECALIN
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 25 PPM 100 PPM 400 PPM |CONTROL 25 PPM 100 PPM 400 PPM |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 43/50 (86%) 39/50 (78%) 37/50 (74%) 42/50 (84%) |39/49 (80%) 40/50 (80%) 43/50 (86%) 41/50 (82%) |
|POLY-3 RATE (b) | 43/48.94 39/48.50 37/49.98 42/49.20 |39/47.89 40/47.74 43/49.00 41/47.15 |
|POLY-3 PERCENT (g) | 87.9% 80.4% 74.0% 85.4% |81.4% 83.8% 87.8% 87.0% |
|TERMINAL (d) | 35/40 (88%) 32/41 (78%) 24/36 (67%) 29/34 (85%) |30/37 (81%) 22/28 (79%) 29/35 (83%) 31/36 (86%) |
|FIRST INCIDENCE | 384 495 448 467 |363 488 356 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.113 P=0.233N P=0.380N P=0.251 |P=0.380N P=0.079 P=0.219 P=0.396 |
|POLY 3 | P=0.440 P=0.230N P=0.065N P=0.472N |P=0.327 P=0.486 P=0.278 P=0.320 |
|POLY 1.5 | P=0.446 P=0.235N P=0.077N P=0.474N |P=0.358 P=0.508 P=0.244 P=0.350 |
|POLY 6 | P=0.416 P=0.221N P=0.055N P=0.489N |P=0.334 P=0.484 P=0.333 P=0.329 |
|LOGISTIC REGRESSION| P=0.414 P=0.229N P=0.104N P=0.504N |P=0.482 P=0.510 P=0.244 P=0.422 |
|COCH-ARM / FISHERS | P=0.414 P=0.218N P=0.105N P=0.500N |P=0.478 P=0.579 P=0.282 P=0.480 |
|=================================================================================================================================|
(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).