TDMS Study 05184-06 Pathology Tables
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 07/13/98
EXPERIMENT: 05184 TEST: 06 TIME: 08:38:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: GRUMBEIN, S. CAS: 111-30-8
------------------------------------------------------------------------------------------------------------------------------------
CORE STUDY
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 07/13/98
EXPERIMENT: 05184 TEST: 06 TIME: 08:38:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: GRUMBEIN, S. CAS: 111-30-8
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
Gallbladder
Heart
Islets, Pancreatic
Kidney
Liver
Lung
Ovary
Pituitary Gland
Spleen
Testes
Thyroid Gland
NTP STATISTICAL ANALYSIS OF PRIMARY TUMORS REPORT: PEIRPT08
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 07/13/98
EXPERIMENT: 05184 TEST: 06 TIME: 08:38:05
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: GRUMBEIN, S. CAS: 111-30-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF GLUTARALDEHYDE
===============================================================
Male Mice
------------
Organ Morphology
----- ----------
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
All Organs Histiocytic Sarcoma
Benign Tumors
Malignant Tumors
Malignant and Benign Tumors
===============================================================
Female Mice
------------
Organ Morphology
----- ----------
Intestine Small: Site Unspecified Polyp Adenomatous
Liver Hepatocellular Adenoma
Hepatocellular Carcinoma or Hepatocellular Adenoma
Hepatocellular Carcinoma, Hepatocellular Adenoma, or Hepatoblastoma
===============================================================
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 1
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/47 (4%) 0/49 (0%) 3/50 (6%) 1/49 (2%) |0/50 (0%) 1/49 (2%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 4.9% 0.0% 6.7% 2.2% |0.0% 2.2% 0.0% 0.0% |
|TERMINAL (d) | 2/31 (7%) 0/27 (0%) 3/40 (8%) 1/38 (3%) |0/34 (0%) 1/37 (3%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 733 (T) --- 733 (T) 733 (T) |--- 735 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.269N P=0.616 P=0.429N |P=0.581N P=0.517 (e) (e) |
|POLY 3 | P=0.500N P=0.246N P=0.544 P=0.467N |P=0.561N P=0.502 (e) (e) |
|POLY 1.5 | P=0.518N P=0.238N P=0.535 P=0.475N |P=0.563N P=0.500 (e) (e) |
|POLY 6 | P=0.480N P=0.254N P=0.558 P=0.458N |P=0.559N P=0.506 (e) (e) |
|LOGISTIC REGRESSION| P=0.453N (e) P=0.616 P=0.429N |(e) P=0.517 (e) (e) |
|COCH-ARM / FISHERS | P=0.543N P=0.237N P=0.530 P=0.484N |P=0.566N P=0.495 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma Benign |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |4/50 (8%) 1/49 (2%) 1/48 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |9.0% 2.2% 2.2% 4.7% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |4/34 (12%) 1/37 (3%) 0/35 (0%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) 735 (T) 635 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.352N P=0.154N P=0.170N P=0.379N |
|POLY 3 | (e) (e) (e) (e) |P=0.328N P=0.175N P=0.179N P=0.358N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.325N P=0.179N P=0.183N P=0.352N |
|POLY 6 | (e) (e) (e) (e) |P=0.332N P=0.169N P=0.174N P=0.364N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.334N P=0.154N P=0.184N P=0.379N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.320N P=0.187N P=0.194N P=0.349N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 2
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Pheochromocytoma: Benign, Complex, Malignant, NOS |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/47 (0%) 0/49 (0%) 0/50 (0%) 0/49 (0%) |4/50 (8%) 2/49 (4%) 1/48 (2%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |9.0% 4.4% 2.2% 4.7% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |4/34 (12%) 2/37 (5%) 0/35 (0%) 2/31 (7%) |
|FIRST INCIDENCE | --- --- --- --- |735 (T) 735 (T) 635 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.301N P=0.298N P=0.170N P=0.379N |
|POLY 3 | (e) (e) (e) (e) |P=0.278N P=0.332N P=0.179N P=0.358N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.275N P=0.337N P=0.183N P=0.352N |
|POLY 6 | (e) (e) (e) (e) |P=0.281N P=0.323N P=0.174N P=0.364N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.285N P=0.298N P=0.184N P=0.379N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.271N P=0.349N P=0.194N P=0.349N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/47 (2%) 0/50 (0%) 1/49 (2%) |1/50 (2%) 3/48 (6%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 0.0% 2.2% |2.2% 6.6% 2.2% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 2/37 (5%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 516 685 --- 663 |735 (T) 672 715 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588N P=0.748 P=0.504N P=0.750N |P=0.212N P=0.336 P=0.748N P=0.512N |
|POLY 3 | P=0.599N P=0.736 P=0.488N P=0.746N |P=0.203N P=0.309 P=0.754N P=0.507N |
|POLY 1.5 | P=0.603N P=0.744 P=0.490N P=0.750N |P=0.202N P=0.302 P=0.756N P=0.506N |
|POLY 6 | P=0.595N P=0.729 P=0.482N P=0.740N |P=0.204N P=0.319 P=0.752N P=0.509N |
|LOGISTIC REGRESSION| P=0.650N P=0.728N P=0.456N P=0.741 |P=0.205N P=0.304 P=0.755N (e) |
|COCH-ARM / FISHERS | P=0.608N P=0.747 P=0.490N P=0.747N |P=0.202N P=0.293 P=0.753N P=0.505N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 3
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 3/50 (6%) 2/50 (4%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 7.0% 7.5% 4.4% 2.2% |2.2% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/31 (3%) 3/27 (11%) 2/40 (5%) 1/38 (3%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | 684 733 (T) 733 (T) 733 (T) |735 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.595 P=0.402N P=0.257N |P=0.314N P=0.483N P=0.494N P=0.512N |
|POLY 3 | P=0.171N P=0.628 P=0.480N P=0.285N |P=0.304N P=0.495N P=0.494N P=0.504N |
|POLY 1.5 | P=0.180N P=0.642 P=0.490N P=0.293N |P=0.305N P=0.497N P=0.496N P=0.502N |
|POLY 6 | P=0.160N P=0.611 P=0.463N P=0.276N |P=0.304N P=0.493N P=0.493N P=0.507N |
|LOGISTIC REGRESSION| P=0.148N P=0.613 P=0.467N P=0.280N |P=0.314N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.194N P=0.661N P=0.500N P=0.309N |P=0.306N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 2.3% 5.0% 0.0% 2.2% |4.5% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 1/31 (3%) 1/27 (4%) 0/40 (0%) 1/38 (3%) |1/34 (3%) 0/37 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 733 (T) 706 --- 733 (T) |708 --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.424N P=0.457 P=0.449N P=0.716N |P=0.479N P=0.216N P=0.231N P=0.514N |
|POLY 3 | P=0.487N P=0.477 P=0.490N P=0.747N |P=0.461N P=0.233N P=0.231N P=0.509N |
|POLY 1.5 | P=0.493N P=0.486 P=0.495N P=0.752N |P=0.461N P=0.234N P=0.233N P=0.504N |
|POLY 6 | P=0.482N P=0.468 P=0.481N P=0.739N |P=0.462N P=0.230N P=0.230N P=0.513N |
|LOGISTIC REGRESSION| P=0.450N P=0.459 (e) P=0.716N |P=0.472N P=0.231N P=0.231N P=0.512N |
|COCH-ARM / FISHERS | P=0.500N P=0.500 P=0.500N P=0.753N |P=0.461N P=0.247N P=0.247N P=0.500N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 4
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Harderian Gland |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 2/50 (4%) 2/50 (4%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 9.3% 12.5% 4.4% 4.4% |6.7% 0.0% 0.0% 2.3% |
|TERMINAL (d) | 2/31 (7%) 4/27 (15%) 2/40 (5%) 2/38 (5%) |2/34 (6%) 0/37 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 684 706 733 (T) 733 (T) |708 --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.104N P=0.417 P=0.243N P=0.266N |P=0.262N P=0.106N P=0.116N P=0.323N |
|POLY 3 | P=0.154N P=0.455 P=0.316N P=0.311N |P=0.247N P=0.115N P=0.114N P=0.314N |
|POLY 1.5 | P=0.164N P=0.473 P=0.327N P=0.322N |P=0.247N P=0.116N P=0.115N P=0.310N |
|POLY 6 | P=0.143N P=0.434 P=0.300N P=0.300N |P=0.248N P=0.113N P=0.113N P=0.318N |
|LOGISTIC REGRESSION| P=0.126N P=0.430 P=0.298N P=0.295N |P=0.255N P=0.113N P=0.114N P=0.317N |
|COCH-ARM / FISHERS | P=0.178N P=0.500 P=0.339N P=0.339N |P=0.247N P=0.121N P=0.121N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Intestine Small: Site Unspecified |
| Polyp Adenomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 4.6% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- --- 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.039 * (e) (e) P=0.225 |
|POLY 3 | (e) (e) (e) (e) |P=0.044 * (e) (e) P=0.232 |
|POLY 1.5 | (e) (e) (e) (e) |P=0.045 * (e) (e) P=0.235 |
|POLY 6 | (e) (e) (e) (e) |P=0.043 * (e) (e) P=0.230 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) P=0.225 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.046 * (e) (e) P=0.247 |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 5
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 0/50 (0%) 3/50 (6%) 2/49 (4%) |0/50 (0%) 2/48 (4%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 0.0% 6.7% 4.4% |0.0% 4.5% 2.2% 2.3% |
|TERMINAL (d) | 1/31 (3%) 0/27 (0%) 3/40 (8%) 1/38 (3%) |0/34 (0%) 2/37 (5%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 716 --- 733 (T) 663 |--- 735 (T) 687 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.523 P=0.270N P=0.611 P=0.634N |P=0.476 P=0.257 P=0.510 P=0.488 |
|POLY 3 | P=0.477 P=0.248N P=0.531 P=0.668N |P=0.495 P=0.238 P=0.506 P=0.496 |
|POLY 1.5 | P=0.453 P=0.242N P=0.520 P=0.679N |P=0.500 P=0.235 P=0.505 P=0.498 |
|POLY 6 | P=0.505 P=0.257N P=0.548 P=0.655N |P=0.490 P=0.243 P=0.508 P=0.493 |
|LOGISTIC REGRESSION| P=0.475 P=0.260N P=0.575 P=0.678N |P=0.490 P=0.257 P=0.490 P=0.488 |
|COCH-ARM / FISHERS | P=0.421 P=0.242N P=0.510 P=0.691N |P=0.504 P=0.237 P=0.500 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 19/49 (39%) 10/50 (20%) 20/50 (40%) 11/49 (22%) |11/50 (22%) 11/48 (23%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 44.0% 24.3% 43.7% 24.4% |24.6% 24.5% 15.0% 6.8% |
|TERMINAL (d) | 16/31 (52%) 7/27 (26%) 17/40 (43%) 10/38 (26%) |9/34 (27%) 10/37 (27%) 6/35 (17%) 2/32 (6%) |
|FIRST INCIDENCE | 516 573 492 673 |701 708 524 616 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.028N* P=0.085N P=0.302N P=0.015N* |P=0.014N* P=0.505N P=0.201N P=0.030N* |
|POLY 3 | P=0.083N P=0.042N* P=0.573N P=0.039N* |P=0.009N** P=0.592N P=0.188N P=0.020N* |
|POLY 1.5 | P=0.106N P=0.038N* P=0.564 P=0.047N* |P=0.009N** P=0.584 P=0.197N P=0.020N* |
|POLY 6 | P=0.062N P=0.049N* P=0.523N P=0.032N* |P=0.009N** P=0.569N P=0.181N P=0.020N* |
|LOGISTIC REGRESSION| P=0.078N P=0.050N P=0.555N P=0.033N* |P=0.010N* P=0.520N P=0.195N P=0.024N* |
|COCH-ARM / FISHERS | P=0.151N P=0.033N* P=0.532 P=0.062N |P=0.009N** P=0.553 P=0.218N P=0.020N* |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 6
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 15/49 (31%) 15/50 (30%) 12/50 (24%) 12/49 (24%) |4/50 (8%) 7/48 (15%) 5/50 (10%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 32.6% 33.8% 25.5% 25.6% |8.9% 15.3% 10.8% 9.0% |
|TERMINAL (d) | 3/31 (10%) 4/27 (15%) 8/40 (20%) 6/38 (16%) |2/34 (6%) 3/37 (8%) 4/35 (11%) 1/32 (3%) |
|FIRST INCIDENCE | 498 517 492 558 |657 551 672 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.129N P=0.463 P=0.213N P=0.232N |P=0.480N P=0.318 P=0.523 P=0.623 |
|POLY 3 | P=0.209N P=0.543 P=0.300N P=0.305N |P=0.441N P=0.268 P=0.514 P=0.637 |
|POLY 1.5 | P=0.223N P=0.570 P=0.303N P=0.313N |P=0.433N P=0.258 P=0.511 P=0.642 |
|POLY 6 | P=0.196N P=0.510 P=0.297N P=0.299N |P=0.454N P=0.283 P=0.515 P=0.630 |
|LOGISTIC REGRESSION| P=0.340N P=0.472N P=0.338N P=0.421N |P=0.418N P=0.227 P=0.512 P=0.640N |
|COCH-ARM / FISHERS | P=0.245N P=0.560N P=0.304N P=0.326N |P=0.427N P=0.239 P=0.500 P=0.643N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma or Hepatocellular Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/49 (65%) 24/50 (48%) 26/50 (52%) 21/49 (43%) |14/50 (28%) 17/48 (35%) 11/50 (22%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 68.6% 53.1% 55.2% 44.6% |30.9% 37.2% 23.5% 15.6% |
|TERMINAL (d) | 19/31 (61%) 11/27 (41%) 21/40 (53%) 14/38 (37%) |10/34 (29%) 13/37 (35%) 9/35 (26%) 3/32 (9%) |
|FIRST INCIDENCE | 498 517 492 558 |657 551 524 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.275N P=0.035N* P=0.010N* |P=0.043N* P=0.442 P=0.297N P=0.101N |
|POLY 3 | P=0.018N* P=0.091N P=0.128N P=0.014N* |P=0.021N* P=0.342 P=0.285N P=0.067N |
|POLY 1.5 | P=0.023N* P=0.077N P=0.128N P=0.016N* |P=0.021N* P=0.321 P=0.295N P=0.066N |
|POLY 6 | P=0.015N* P=0.108N P=0.127N P=0.013N* |P=0.023N* P=0.369 P=0.279N P=0.068N |
|LOGISTIC REGRESSION| P=0.030N* P=0.065N P=0.120N P=0.022N* |P=0.024N* P=0.339 P=0.295N P=0.072N |
|COCH-ARM / FISHERS | P=0.033N* P=0.062N P=0.127N P=0.021N* |P=0.022N* P=0.284 P=0.322N P=0.070N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 7
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatocellular Carcinoma, Hepatocellular Adenoma, |
| or Hepatoblastoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 32/49 (65%) 24/50 (48%) 26/50 (52%) 21/49 (43%) |14/50 (28%) 17/48 (35%) 11/50 (22%) 7/50 (14%) |
|POLY-3 ADJUSTED (b)| 68.6% 53.1% 55.2% 44.6% |30.9% 37.2% 23.5% 15.6% |
|TERMINAL (d) | 19/31 (61%) 11/27 (41%) 21/40 (53%) 14/38 (37%) |10/34 (29%) 13/37 (35%) 9/35 (26%) 3/32 (9%) |
|FIRST INCIDENCE | 498 517 492 558 |657 551 524 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.275N P=0.035N* P=0.010N* |P=0.043N* P=0.442 P=0.297N P=0.101N |
|POLY 3 | P=0.018N* P=0.091N P=0.128N P=0.014N* |P=0.021N* P=0.342 P=0.285N P=0.067N |
|POLY 1.5 | P=0.023N* P=0.077N P=0.128N P=0.016N* |P=0.021N* P=0.321 P=0.295N P=0.066N |
|POLY 6 | P=0.015N* P=0.108N P=0.127N P=0.013N* |P=0.023N* P=0.369 P=0.279N P=0.068N |
|LOGISTIC REGRESSION| P=0.030N* P=0.065N P=0.120N P=0.022N* |P=0.024N* P=0.339 P=0.295N P=0.072N |
|COCH-ARM / FISHERS | P=0.033N* P=0.062N P=0.127N P=0.021N* |P=0.022N* P=0.284 P=0.322N P=0.070N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 8/48 (17%) 10/50 (20%) 9/50 (18%) 7/50 (14%) |2/50 (4%) 4/49 (8%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 19.0% 24.3% 19.7% 15.2% |4.5% 8.7% 4.3% 4.6% |
|TERMINAL (d) | 7/31 (23%) 7/27 (26%) 6/40 (15%) 5/38 (13%) |2/34 (6%) 3/37 (8%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | 573 517 516 628 |735 (T) 463 702 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.189N P=0.291 P=0.512N P=0.348N |P=0.491N P=0.372 P=0.678N P=0.674 |
|POLY 3 | P=0.283N P=0.371 P=0.574 P=0.427N |P=0.464N P=0.350 P=0.682N P=0.686 |
|POLY 1.5 | P=0.309N P=0.396 P=0.554 P=0.443N |P=0.459N P=0.342 P=0.685N P=0.690 |
|POLY 6 | P=0.253N P=0.345 P=0.606 P=0.407N |P=0.469N P=0.361 P=0.678N P=0.683 |
|LOGISTIC REGRESSION| P=0.298N P=0.364 P=0.555 P=0.431N |P=0.452N P=0.313 P=0.686N P=0.674 |
|COCH-ARM / FISHERS | P=0.346N P=0.435 P=0.537 P=0.465N |P=0.453N P=0.329 P=0.691N P=0.691N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 8
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 10/48 (21%) 6/50 (12%) 7/50 (14%) 7/50 (14%) |1/50 (2%) 4/49 (8%) 5/50 (10%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 23.3% 14.3% 15.1% 15.3% |2.2% 8.9% 10.8% 4.6% |
|TERMINAL (d) | 7/31 (23%) 3/27 (11%) 5/40 (13%) 5/38 (13%) |1/34 (3%) 3/37 (8%) 4/35 (11%) 2/32 (6%) |
|FIRST INCIDENCE | 454 364 470 673 |735 (T) 728 635 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.179N P=0.288N P=0.172N P=0.184N |P=0.453 P=0.207 P=0.113 P=0.479 |
|POLY 3 | P=0.253N P=0.216N P=0.236N P=0.245N |P=0.482 P=0.182 P=0.110 P=0.492 |
|POLY 1.5 | P=0.271N P=0.201N P=0.252N P=0.255N |P=0.493 P=0.179 P=0.107 P=0.496 |
|POLY 6 | P=0.232N P=0.236N P=0.214N P=0.234N |P=0.471 P=0.188 P=0.112 P=0.489 |
|LOGISTIC REGRESSION| P=0.320N P=0.155N P=0.272N P=0.252N |P=0.478 P=0.203 P=0.109 P=0.479 |
|COCH-ARM / FISHERS | P=0.294N P=0.182N P=0.266N P=0.266N |P=0.504 P=0.175 P=0.102 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Alveolar/Bronchiolar Carcinoma or Alveolar/Bronchiolar |
| Adenoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 18/48 (38%) 15/50 (30%) 15/50 (30%) 14/50 (28%) |3/50 (6%) 8/49 (16%) 7/50 (14%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 41.5% 34.8% 31.8% 30.3% |6.7% 17.4% 15.0% 9.2% |
|TERMINAL (d) | 14/31 (45%) 9/27 (33%) 10/40 (25%) 10/38 (26%) |3/34 (9%) 6/37 (16%) 4/35 (11%) 4/32 (13%) |
|FIRST INCIDENCE | 454 364 470 628 |735 (T) 463 635 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.082N P=0.494N P=0.139N P=0.114N |P=0.533 P=0.129 P=0.179 P=0.466 |
|POLY 3 | P=0.165N P=0.338N P=0.230N P=0.186N |P=0.549N P=0.107 P=0.174 P=0.488 |
|POLY 1.5 | P=0.186N P=0.315N P=0.256N P=0.199N |P=0.538N P=0.102 P=0.169 P=0.494 |
|POLY 6 | P=0.140N P=0.365N P=0.194N P=0.168N |P=0.558 P=0.114 P=0.181 P=0.482 |
|LOGISTIC REGRESSION| P=0.209N P=0.298N P=0.284N P=0.187N |P=0.541N P=0.097 P=0.169 P=0.466 |
|COCH-ARM / FISHERS | P=0.215N P=0.284N P=0.284N P=0.216N |P=0.525N P=0.094 P=0.159 P=0.500 |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 9
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 0/50 (0%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |6.7% 0.0% 6.5% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |2/34 (6%) 0/37 (0%) 1/35 (3%) 0/32 (0%) |
|FIRST INCIDENCE | --- --- --- --- |664 --- 704 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.176N P=0.111N P=0.642N P=0.133N |
|POLY 3 | (e) (e) (e) (e) |P=0.171N P=0.116N P=0.650N P=0.124N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.167N P=0.117N P=0.653N P=0.121N |
|POLY 6 | (e) (e) (e) (e) |P=0.176N P=0.114N P=0.648N P=0.126N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.166N P=0.118N P=0.653N P=0.123N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.163N P=0.121N P=0.661N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cystadenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 1/47 (2%) 1/49 (2%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |2.3% 2.3% 2.2% 4.6% |
|TERMINAL (d) | |1/34 (3%) 1/36 (3%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | |735 (T) 735 (T) 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.324 P=0.749N P=0.755N P=0.479 |
|POLY 3 | |P=0.352 P=0.760N P=0.753N P=0.499 |
|POLY 1.5 | |P=0.357 P=0.758 P=0.755N P=0.503 |
|POLY 6 | |P=0.346 P=0.755N P=0.752N P=0.495 |
|LOGISTIC REGRESSION| |P=0.324 P=0.749N P=0.755N P=0.479 |
|COCH-ARM / FISHERS | |P=0.363 P=0.742 P=0.753N P=0.508 |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 10
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Luteoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 0/47 (0%) 0/49 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | |1/34 (3%) 0/36 (0%) 0/35 (0%) 0/32 (0%) |
|FIRST INCIDENCE | |702 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.118N P=0.220N P=0.231N P=0.249N |
|POLY 3 | |P=0.113N P=0.237N P=0.231N P=0.238N |
|POLY 1.5 | |P=0.113N P=0.240N P=0.232N P=0.235N |
|POLY 6 | |P=0.114N P=0.233N P=0.229N P=0.241N |
|LOGISTIC REGRESSION| |P=0.113N P=0.238N P=0.231N P=0.238N |
|COCH-ARM / FISHERS | |P=0.113N P=0.258N P=0.247N P=0.242N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 0/47 (0%) 0/48 (0%) 0/47 (0%) |20/49 (41%) 16/49 (33%) 20/49 (41%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |44.9% 35.4% 43.0% 35.2% |
|TERMINAL (d) | 1/30 (3%) 0/27 (0%) 0/38 (0%) 0/37 (0%) |17/34 (50%) 15/37 (41%) 16/35 (46%) 11/32 (34%) |
|FIRST INCIDENCE | 733 (T) --- --- --- |616 714 502 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.521N P=0.453N P=0.458N |P=0.423N P=0.168N P=0.529N P=0.343N |
|POLY 3 | P=0.302N P=0.509N P=0.484N P=0.481N |P=0.277N P=0.240N P=0.511N P=0.233N |
|POLY 1.5 | P=0.303N P=0.504N P=0.488N P=0.486N |P=0.277N P=0.247N P=0.533N P=0.234N |
|POLY 6 | P=0.301N P=0.514N P=0.477N P=0.474N |P=0.274N P=0.229N P=0.489N P=0.228N |
|LOGISTIC REGRESSION| P=0.273N (e) (e) (e) |P=0.326N P=0.189N P=0.537N P=0.270N |
|COCH-ARM / FISHERS | P=0.302N P=0.495N P=0.489N P=0.495N |P=0.281N P=0.265N P=0.581N P=0.241N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 11
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis or Unspecified Site |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/46 (2%) 0/47 (0%) 0/48 (0%) 0/47 (0%) |21/49 (43%) 16/49 (33%) 20/49 (41%) 16/50 (32%) |
|POLY-3 ADJUSTED (b)| 2.5% 0.0% 0.0% 0.0% |46.8% 35.4% 43.0% 35.2% |
|TERMINAL (d) | 1/30 (3%) 0/27 (0%) 0/38 (0%) 0/37 (0%) |17/34 (50%) 15/37 (41%) 16/35 (46%) 11/32 (34%) |
|FIRST INCIDENCE | 733 (T) --- --- --- |616 714 502 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.521N P=0.453N P=0.458N |P=0.358N P=0.124N P=0.447N P=0.277N |
|POLY 3 | P=0.302N P=0.509N P=0.484N P=0.481N |P=0.225N P=0.185N P=0.436N P=0.179N |
|POLY 1.5 | P=0.303N P=0.504N P=0.488N P=0.486N |P=0.224N P=0.189N P=0.454N P=0.177N |
|POLY 6 | P=0.301N P=0.514N P=0.477N P=0.474N |P=0.226N P=0.179N P=0.420N P=0.179N |
|LOGISTIC REGRESSION| P=0.273N (e) (e) (e) |P=0.262N P=0.148N P=0.456N P=0.203N |
|COCH-ARM / FISHERS | P=0.302N P=0.495N P=0.489N P=0.495N |P=0.225N P=0.202N P=0.500N P=0.182N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibroma, Fibrosarcoma, Sarcoma, Myxoma, Myxosarcoma, |
| or Fibrous Histiocytoma |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.9% 0.0% 0.0% |6.7% 2.2% 6.5% 6.8% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 1/37 (3%) 2/35 (6%) 2/32 (6%) |
|FIRST INCIDENCE | 712 476 --- --- |681 735 (T) 715 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.464 P=0.458N P=0.473N |P=0.424 P=0.278N P=0.641N P=0.640 |
|POLY 3 | P=0.181N P=0.485 P=0.490N P=0.488N |P=0.442 P=0.300N P=0.652N P=0.652 |
|POLY 1.5 | P=0.184N P=0.491 P=0.495N P=0.493N |P=0.448 P=0.301N P=0.654N P=0.657 |
|POLY 6 | P=0.178N P=0.478 P=0.482N P=0.482N |P=0.434 P=0.297N P=0.652N P=0.646 |
|LOGISTIC REGRESSION| P=0.209N P=0.547 P=0.491N P=0.489N |P=0.445 P=0.300N P=0.652N P=0.658 |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.456 P=0.309N P=0.661N P=0.661N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 12
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.3% 2.5% 0.0% 0.0% |2.2% 2.2% 6.5% 0.0% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 1/37 (3%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE | 712 476 --- --- |735 (T) 735 (T) 715 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.219N P=0.740 P=0.458N P=0.473N |P=0.432N P=0.743N P=0.322 P=0.512N |
|POLY 3 | P=0.231N P=0.749 P=0.490N P=0.488N |P=0.423N P=0.756N P=0.316 P=0.504N |
|POLY 1.5 | P=0.234N P=0.754 P=0.495N P=0.493N |P=0.417N P=0.757N P=0.313 P=0.502N |
|POLY 6 | P=0.229N P=0.744 P=0.482N P=0.482N |P=0.430N P=0.753N P=0.319 P=0.507N |
|LOGISTIC REGRESSION| P=0.257N P=0.729N P=0.491N P=0.489N |P=0.425N P=0.743N P=0.317 (e) |
|COCH-ARM / FISHERS | P=0.236N P=0.753N P=0.500N P=0.500N |P=0.409N P=0.753N P=0.309 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Fibrosarcoma, Sarcoma, Myxosarcoma, or Fibrous Histiocytoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.3% 4.9% 0.0% 0.0% |6.7% 2.2% 6.5% 6.8% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 1/37 (3%) 2/35 (6%) 2/32 (6%) |
|FIRST INCIDENCE | 712 476 --- --- |681 735 (T) 715 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.170N P=0.464 P=0.458N P=0.473N |P=0.424 P=0.278N P=0.641N P=0.640 |
|POLY 3 | P=0.181N P=0.485 P=0.490N P=0.488N |P=0.442 P=0.300N P=0.652N P=0.652 |
|POLY 1.5 | P=0.184N P=0.491 P=0.495N P=0.493N |P=0.448 P=0.301N P=0.654N P=0.657 |
|POLY 6 | P=0.178N P=0.478 P=0.482N P=0.482N |P=0.434 P=0.297N P=0.652N P=0.646 |
|LOGISTIC REGRESSION| P=0.209N P=0.547 P=0.491N P=0.489N |P=0.445 P=0.300N P=0.652N P=0.658 |
|COCH-ARM / FISHERS | P=0.188N P=0.500 P=0.500N P=0.500N |P=0.456 P=0.309N P=0.661N P=0.661N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 13
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 0.0% 0.0% |4.4% 0.0% 0.0% 6.8% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 2/32 (6%) |
|FIRST INCIDENCE | --- 647 --- --- |681 --- --- 660 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.544N P=0.473 (e) (e) |P=0.228 P=0.221N P=0.232N P=0.482 |
|POLY 3 | P=0.569N P=0.488 (e) (e) |P=0.240 P=0.234N P=0.232N P=0.489 |
|POLY 1.5 | P=0.568N P=0.493 (e) (e) |P=0.242 P=0.235N P=0.233N P=0.495 |
|POLY 6 | P=0.570N P=0.483 (e) (e) |P=0.237 P=0.232N P=0.233N P=0.484 |
|LOGISTIC REGRESSION| P=0.585N P=0.512 (e) (e) |P=0.245 P=0.241N P=0.243N P=0.498 |
|COCH-ARM / FISHERS | P=0.567N P=0.500 (e) (e) |P=0.245 P=0.247N P=0.247N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 1/48 (2%) 1/50 (2%) 1/48 (2%) |1/50 (2%) 3/48 (6%) 1/48 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 2.2% 2.2% |2.2% 6.6% 2.2% 2.3% |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 1/40 (3%) 0/38 (0%) |1/34 (3%) 2/37 (5%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 516 685 733 (T) 663 |735 (T) 672 715 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.589N P=0.748 P=0.735N P=0.750N |P=0.468N P=0.336 P=0.748N P=0.748 |
|POLY 3 | P=0.610N P=0.743 P=0.747N P=0.746N |P=0.452N P=0.309 P=0.760 P=0.753 |
|POLY 1.5 | P=0.619N P=0.750 P=0.750N P=0.752N |P=0.450N P=0.302 P=0.757 P=0.754 |
|POLY 6 | P=0.601N P=0.736 P=0.740N P=0.740N |P=0.453N P=0.319 P=0.757N P=0.751 |
|LOGISTIC REGRESSION| P=0.591 P=0.727N P=0.753N P=0.633 |P=0.459N P=0.304 P=0.761N P=0.748 |
|COCH-ARM / FISHERS | P=0.633N P=0.753N P=0.742N P=0.753N |P=0.449N P=0.293 P=0.742 P=0.747 |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 14
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Squamous Cell Carcinoma or Papilloma Squamous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.0% 0.0% 0.0% |2.2% 2.2% 4.4% 0.0% |
|TERMINAL (d) | 0/31 (0%) 1/27 (4%) 0/40 (0%) 0/38 (0%) |1/34 (3%) 1/37 (3%) 2/35 (6%) 0/32 (0%) |
|FIRST INCIDENCE | --- 718 --- --- |735 (T) 735 (T) 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.352N P=0.214 (e) (e) |P=0.388N P=0.743N P=0.510 P=0.512N |
|POLY 3 | P=0.402N P=0.222 (e) (e) |P=0.377N P=0.756N P=0.510 P=0.504N |
|POLY 1.5 | P=0.403N P=0.228 (e) (e) |P=0.372N P=0.757N P=0.507 P=0.502N |
|POLY 6 | P=0.401N P=0.216 (e) (e) |P=0.382N P=0.753N P=0.512 P=0.507N |
|LOGISTIC REGRESSION| P=0.373N P=0.211 (e) (e) |P=0.388N P=0.743N P=0.510 (e) |
|COCH-ARM / FISHERS | P=0.405N P=0.247 (e) (e) |P=0.366N P=0.753N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 4.4% 4.4% | |
|TERMINAL (d) | 0/31 (0%) 0/27 (0%) 2/40 (5%) 1/38 (3%) | |
|FIRST INCIDENCE | --- 640 733 (T) 651 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.216 P=0.484 P=0.296 P=0.273 | |
|POLY 3 | P=0.190 P=0.493 P=0.254 P=0.259 | |
|POLY 1.5 | P=0.180 P=0.499 P=0.250 P=0.254 | |
|POLY 6 | P=0.202 P=0.487 P=0.263 P=0.265 | |
|LOGISTIC REGRESSION| P=0.171 P=0.528 P=0.296 P=0.243 | |
|COCH-ARM / FISHERS | P=0.166 P=0.510 P=0.258 P=0.258 | |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 15
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 1/48 (2%) 3/49 (6%) 2/49 (4%) 1/49 (2%) |4/50 (8%) 0/48 (0%) 2/50 (4%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.6% 4.5% 2.2% |9.0% 0.0% 4.4% 6.9% |
|TERMINAL (d) | 1/31 (3%) 3/27 (11%) 2/39 (5%) 1/38 (3%) |4/34 (12%) 0/37 (0%) 2/35 (6%) 3/32 (9%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 733 (T) |735 (T) --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.366N P=0.256 P=0.580 P=0.716N |P=0.531 P=0.053N P=0.322N P=0.534N |
|POLY 3 | P=0.439N P=0.284 P=0.519 P=0.744N |P=0.554 P=0.059N P=0.324N P=0.512N |
|POLY 1.5 | P=0.451N P=0.295 P=0.512 P=0.749N |P=0.563 P=0.062N P=0.328N P=0.506N |
|POLY 6 | P=0.426N P=0.272 P=0.531 P=0.738N |P=0.544 P=0.056N P=0.321N P=0.518N |
|LOGISTIC REGRESSION| P=0.366N P=0.256 P=0.580 P=0.716N |P=0.531 (e) P=0.322N P=0.534N |
|COCH-ARM / FISHERS | P=0.468N P=0.316 P=0.508 P=0.747N |P=0.575 P=0.064N P=0.339N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Carcinoma or Adenoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 3/49 (6%) 2/49 (4%) 1/49 (2%) |4/50 (8%) 0/48 (0%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 4.8% 7.6% 4.5% 2.2% |9.0% 0.0% 4.4% 9.2% |
|TERMINAL (d) | 1/31 (3%) 3/27 (11%) 2/39 (5%) 1/38 (3%) |4/34 (12%) 0/37 (0%) 2/35 (6%) 4/32 (13%) |
|FIRST INCIDENCE | 716 733 (T) 733 (T) 733 (T) |735 (T) --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.219N P=0.438 P=0.610N P=0.434N |P=0.328 P=0.053N P=0.322N P=0.612 |
|POLY 3 | P=0.280N P=0.472 P=0.675N P=0.475N |P=0.357 P=0.059N P=0.324N P=0.631 |
|POLY 1.5 | P=0.291N P=0.487 P=0.681N P=0.482N |P=0.366 P=0.062N P=0.328N P=0.637 |
|POLY 6 | P=0.268N P=0.456 P=0.663N P=0.465N |P=0.347 P=0.056N P=0.321N P=0.626 |
|LOGISTIC REGRESSION| P=0.238N P=0.442 P=0.650N P=0.457N |P=0.328 (e) P=0.322N P=0.612 |
|COCH-ARM / FISHERS | P=0.306N P=0.510 P=0.684N P=0.492N |P=0.378 P=0.064N P=0.339N P=0.643N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 16
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Carcinoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 1/50 (2%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |0.0% 2.2% 4.3% 4.6% |
|TERMINAL (d) | |0/34 (0%) 0/37 (0%) 1/35 (3%) 2/32 (6%) |
|FIRST INCIDENCE | |--- 714 570 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.144 P=0.522 P=0.248 P=0.225 |
|POLY 3 | |P=0.152 P=0.505 P=0.246 P=0.232 |
|POLY 1.5 | |P=0.156 P=0.503 P=0.244 P=0.235 |
|POLY 6 | |P=0.148 P=0.508 P=0.249 P=0.230 |
|LOGISTIC REGRESSION| |P=0.162 P=0.503 P=0.194 P=0.225 |
|COCH-ARM / FISHERS | |P=0.160 P=0.500 P=0.247 P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Leiomyoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |0/50 (0%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| |0.0% 0.0% 4.4% 2.3% |
|TERMINAL (d) | |0/34 (0%) 0/37 (0%) 2/35 (6%) 1/32 (3%) |
|FIRST INCIDENCE | |--- --- 735 (T) 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.224 (e) P=0.245 P=0.488 |
|POLY 3 | |P=0.233 (e) P=0.243 P=0.496 |
|POLY 1.5 | |P=0.239 (e) P=0.242 P=0.498 |
|POLY 6 | |P=0.227 (e) P=0.245 P=0.493 |
|LOGISTIC REGRESSION| |(e) (e) P=0.245 P=0.488 |
|COCH-ARM / FISHERS | |P=0.246 (e) P=0.247 P=0.500 |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 17
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|Uterus |
| Polyp Stromal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 4/50 (8%) 3/50 (6%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| |6.7% 8.6% 6.5% 0.0% |
|TERMINAL (d) | |3/34 (9%) 3/37 (8%) 3/35 (9%) 0/32 (0%) |
|FIRST INCIDENCE | |735 (T) 527 735 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.087N P=0.539 P=0.651N P=0.131N |
|POLY 3 | |P=0.082N P=0.520 P=0.649N P=0.122N |
|POLY 1.5 | |P=0.079N P=0.513 P=0.652N P=0.121N |
|POLY 6 | |P=0.084N P=0.531 P=0.647N P=0.124N |
|LOGISTIC REGRESSION| |P=0.079N P=0.502 P=0.651N (e) |
|COCH-ARM / FISHERS | |P=0.077N P=0.500 P=0.661N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |3/50 (6%) 6/50 (12%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.5% 8.9% 4.4% |6.7% 13.1% 4.3% 2.3% |
|TERMINAL (d) | 1/31 (3%) 0/27 (0%) 4/40 (10%) 1/38 (3%) |2/34 (6%) 5/37 (14%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 516 685 733 (T) 663 |701 672 687 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.438N P=0.342N P=0.612 P=0.440N |P=0.131N P=0.288 P=0.481N P=0.325N |
|POLY 3 | P=0.495N P=0.334N P=0.519 P=0.476N |P=0.117N P=0.254 P=0.486N P=0.314N |
|POLY 1.5 | P=0.515N P=0.323N P=0.508 P=0.486N |P=0.115N P=0.251 P=0.490N P=0.310N |
|POLY 6 | P=0.471N P=0.347N P=0.538 P=0.464N |P=0.120N P=0.261 P=0.482N P=0.319N |
|LOGISTIC REGRESSION| P=0.528N P=0.293N P=0.507 P=0.525N |P=0.119N P=0.258 P=0.491N P=0.317N |
|COCH-ARM / FISHERS | P=0.544N P=0.309N P=0.500 P=0.500N |P=0.114N P=0.243 P=0.500N P=0.309N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 18
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Hemangiosarcoma or Hemangioma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 4/50 (8%) 2/50 (4%) |3/50 (6%) 7/50 (14%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.5% 8.9% 4.4% |6.7% 15.2% 4.3% 2.3% |
|TERMINAL (d) | 1/31 (3%) 0/27 (0%) 4/40 (10%) 1/38 (3%) |2/34 (6%) 6/37 (16%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 516 685 733 (T) 663 |701 672 687 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.438N P=0.342N P=0.612 P=0.440N |P=0.112N P=0.197 P=0.481N P=0.325N |
|POLY 3 | P=0.495N P=0.334N P=0.519 P=0.476N |P=0.097N P=0.167 P=0.486N P=0.314N |
|POLY 1.5 | P=0.515N P=0.323N P=0.508 P=0.486N |P=0.095N P=0.164 P=0.490N P=0.310N |
|POLY 6 | P=0.471N P=0.347N P=0.538 P=0.464N |P=0.100N P=0.173 P=0.482N P=0.319N |
|LOGISTIC REGRESSION| P=0.528N P=0.293N P=0.507 P=0.525N |P=0.101N P=0.172 P=0.491N P=0.317N |
|COCH-ARM / FISHERS | P=0.544N P=0.309N P=0.500 P=0.500N |P=0.095N P=0.159 P=0.500N P=0.309N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Histiocytic Sarcoma |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 6.9% 2.5% 0.0% 0.0% |2.2% 0.0% 2.2% 2.3% |
|TERMINAL (d) | 1/31 (3%) 0/27 (0%) 0/40 (0%) 0/38 (0%) |0/34 (0%) 0/37 (0%) 0/35 (0%) 1/32 (3%) |
|FIRST INCIDENCE | 573 616 --- --- |558 --- 704 735 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.037N* P=0.349N P=0.102N P=0.106N |P=0.525 P=0.504N P=0.752N P=0.749 |
|POLY 3 | P=0.039N* P=0.332N P=0.112N P=0.110N |P=0.526 P=0.498N P=0.757N P=0.753 |
|POLY 1.5 | P=0.041N* P=0.321N P=0.116N P=0.114N |P=0.532 P=0.498N P=0.757N P=0.756 |
|POLY 6 | P=0.037N* P=0.344N P=0.107N P=0.107N |P=0.519 P=0.496N P=0.756N P=0.749 |
|LOGISTIC REGRESSION| P=0.047N* P=0.285N P=0.124N P=0.132N |P=0.539 P=0.584N P=0.717 P=0.761 |
|COCH-ARM / FISHERS | P=0.044N* P=0.309N P=0.121N P=0.121N |P=0.539 P=0.500N P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 19
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Lymphoma: Histiocytic, Lymphocytic, Mixed, |
| NOS, or Undifferentiated Cell Type |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 5/50 (10%) 1/50 (2%) 5/50 (10%) |12/50 (24%) 12/50 (24%) 8/50 (16%) 12/50 (24%) |
|POLY-3 ADJUSTED (b)| 9.3% 12.4% 2.2% 11.0% |26.7% 26.2% 17.2% 26.5% |
|TERMINAL (d) | 3/31 (10%) 2/27 (7%) 1/40 (3%) 5/38 (13%) |9/34 (27%) 10/37 (27%) 5/35 (14%) 8/32 (25%) |
|FIRST INCIDENCE | 670 640 733 (T) 733 (T) |686 707 672 542 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475N P=0.423 P=0.122N P=0.616 |P=0.511 P=0.493N P=0.211N P=0.535 |
|POLY 3 | P=0.558 P=0.462 P=0.165N P=0.536 |P=0.495N P=0.570N P=0.200N P=0.586N |
|POLY 1.5 | P=0.542 P=0.477 P=0.172N P=0.521 |P=0.495N P=0.577N P=0.208N P=0.587N |
|POLY 6 | P=0.576 P=0.447 P=0.154N P=0.552 |P=0.493N P=0.557N P=0.191N P=0.581N |
|LOGISTIC REGRESSION| P=0.551N P=0.450 P=0.155N P=0.571 |P=0.529N P=0.534N P=0.199N P=0.576 |
|COCH-ARM / FISHERS | P=0.518 P=0.500 P=0.181N P=0.500 |P=0.500N P=0.592N P=0.227N P=0.592N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 27/50 (54%) 24/50 (48%) 29/50 (58%) 19/50 (38%) |32/50 (64%) 32/50 (64%) 30/50 (60%) 26/50 (52%) |
|POLY-3 ADJUSTED (b)| 60.3% 56.2% 62.4% 40.8% |70.5% 67.7% 62.1% 56.7% |
|TERMINAL (d) | 21/31 (68%) 17/27 (63%) 25/40 (63%) 15/38 (40%) |27/34 (79%) 28/37 (76%) 23/35 (66%) 20/32 (63%) |
|FIRST INCIDENCE | 516 517 492 628 |616 463 502 552 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.560 P=0.258N P=0.017N* |P=0.222N P=0.361N P=0.347N P=0.248N |
|POLY 3 | P=0.033N* P=0.430N P=0.504 P=0.045N* |P=0.079N P=0.476N P=0.256N P=0.116N |
|POLY 1.5 | P=0.049N* P=0.396N P=0.460 P=0.057N |P=0.087N P=0.512N P=0.311N P=0.129N |
|POLY 6 | P=0.020N* P=0.463N P=0.571 P=0.033N* |P=0.067N P=0.431N P=0.200N P=0.097N |
|LOGISTIC REGRESSION| P=0.032N* P=0.472N P=0.507 P=0.042N* |P=0.124N P=0.523N P=0.342N P=0.186N |
|COCH-ARM / FISHERS | P=0.086N P=0.345N P=0.420 P=0.080N |P=0.102N P=0.582N P=0.418N P=0.156N |
|=================================================================================================================================|
Date: 07/13/98 EXPERIMENT: 05184 TEST: 06 Page 20
Statistical Analysis of Primary Tumors in Mice(B6C3F1) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 33/50 (66%) 28/50 (56%) 23/50 (46%) 22/50 (44%) |24/50 (48%) 27/50 (54%) 24/50 (48%) 25/50 (50%) |
|POLY-3 ADJUSTED (b)| 67.2% 58.2% 47.5% 46.1% |51.6% 56.6% 50.3% 53.8% |
|TERMINAL (d) | 15/31 (48%) 8/27 (30%) 17/40 (43%) 14/38 (37%) |15/34 (44%) 18/37 (49%) 15/35 (43%) 17/32 (53%) |
|FIRST INCIDENCE | 454 364 470 558 |558 492 570 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.006N** P=0.457N P=0.016N* P=0.016N* |P=0.409 P=0.507 P=0.510N P=0.420 |
|POLY 3 | P=0.018N* P=0.240N P=0.037N* P=0.027N* |P=0.526 P=0.391 P=0.531N P=0.498 |
|POLY 1.5 | P=0.017N* P=0.226N P=0.035N* P=0.024N* |P=0.538N P=0.378 P=0.543N P=0.508 |
|POLY 6 | P=0.021N* P=0.256N P=0.040N* P=0.032N* |P=0.501 P=0.408 P=0.524N P=0.479 |
|LOGISTIC REGRESSION| P=0.030N* P=0.130N P=0.044N* P=0.030N* |P=0.521 P=0.367 P=0.544N P=0.486 |
|COCH-ARM / FISHERS | P=0.016N* P=0.206N P=0.035N* P=0.022N* |P=0.538 P=0.345 P=0.579N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 62.5 PPB 125 PPB 250 PPB |CONTROL 62.5 PPB 125 PPB 250 PPB |
| | | |
|=================================================================================================================================|
| |
|All Organs |
| Malignant and Benign Tumors |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|TUMOR RATES | # # # # |# # # # |
|----------- | | |
|OVERALL (a) | 44/50 (88%) 42/50 (84%) 39/50 (78%) 33/50 (66%) |41/50 (82%) 45/50 (90%) 41/50 (82%) 40/50 (80%) |
|POLY-3 ADJUSTED (b)| 89.6% 86.9% 80.4% 68.6% |87.4% 91.6% 82.6% 82.8% |
|TERMINAL (d) | 26/31 (84%) 21/27 (78%) 32/40 (80%) 24/38 (63%) |31/34 (91%) 34/37 (92%) 27/35 (77%) 27/32 (84%) |
|FIRST INCIDENCE | 454 364 470 558 |558 463 502 401 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001N** P=0.388 P=0.019N* P=0.005N** |P=0.489 P=0.536 P=0.472N P=0.496 |
|POLY 3 | P=0.002N** P=0.459N P=0.159N P=0.009N** |P=0.185N P=0.356 P=0.348N P=0.362N |
|POLY 1.5 | P=0.002N** P=0.431N P=0.151N P=0.008N** |P=0.215N P=0.296 P=0.435N P=0.405N |
|POLY 6 | P=0.003N** P=0.480N P=0.175N P=0.011N* |P=0.156N P=0.424 P=0.264N P=0.318N |
|LOGISTIC REGRESSION| P=0.002N** P=0.412N P=0.133N P=0.007N** |P=0.316N P=0.219 P=0.516N P=0.544N |
|COCH-ARM / FISHERS | P=0.003N** P=0.387N P=0.143N P=0.008N** |P=0.292N P=0.194 P=0.602N P=0.500N |
|=================================================================================================================================|
(a) Number of tumor-bearing animals / number of animals examined at site.
(b) Poly-3 adjusted lifetime tumor incidence.
(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.
(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).