TDMS Study 05184-05 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:31:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
------------------------------------------------------------------------------------------------------------------------------------
2 YEAR CHRONIC
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:31:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF GLUTARALDEHYDE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Adrenal Medulla Hyperplasia
Blood Vessel Mineralization
Brain Hemorrhage
Heart: Atrium Thrombosis
Intestine Large, Rectum Parasite Metazoan
Kidney Mineralization
Nephropathy Chronic
Larynx: Glands Inflammation
Liver Vacuolization Cytoplasmic
Lung: Alveolar Epithelium Hyperplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Lung: Interstitium Fibrosis
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Atrophy
Degeneration Hyaline
Nose: Respiratory Epithelium Hyperplasia
Inflammation
Metaplasia
Nose: Squamous Epithelium Hyperplasia
Inflammation
Pancreas: Acinus Atrophy
Parathyroid Gland Hyperplasia
Pituitary Gland Hemorrhage
Pituitary Gland: Pars Distalis Hyperplasia
Prostate Inflammation
Seminal Vesicle Inflammation
Stomach, Forestomach Mineralization
Stomach, Forestomach: Epithelium Hyperplasia
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Vacuolization Cytoplasmic
Brain Hydrocephalus
Kidney Nephropathy Chronic
Larynx: Epiglottis Inflammation
Larynx: Glands Inflammation
Larynx: Squamous Epithelium Hyperplasia
Liver Necrosis
Vacuolization Cytoplasmic
Lung: Alveolus Emphysema
Infiltration Cellular Histiocyte
Lung: Interstitium Fibrosis
Nose Concretion
Foreign Body
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest GLUTARALDEHYDE DATE: 09/14/98
EXPERIMENT: 05184 TEST: 05 TIME: 08:31:56
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-25335 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 55425C
PATHOLOGIST: RENNE, ROGER CAS: 111-30-8
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Atrophy
Degeneration Hyaline
Nose: Respiratory Epithelium Hyperplasia
Inflammation
Metaplasia
Nose: Squamous Epithelium Hyperplasia
Inflammation
Pituitary Gland: Pars Distalis Hyperplasia
===============================================================
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 6/50 (12%) 8/50 (16%) 2/49 (4%) |7/50 (14%) 6/50 (12%) 11/50 (22%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 23.7% 15.3% 21.5% 7.2% |16.5% 14.2% 29.1% 26.9% |
|TERMINAL (d) | 2/12 (17%) 3/14 (21%) 2/9 (22%) 0/6 (0%) |5/26 (19%) 5/31 (16%) 3/15 (20%) 5/14 (36%) |
|FIRST INCIDENCE | 117 577 581 634 |589 675 614 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.169N P=0.194N P=0.553N P=0.096N |P=0.014 * P=0.390N P=0.052 P=0.082 |
|POLY 3 | P=0.135N P=0.255N P=0.521N P=0.077N |P=0.070 P=0.500N P=0.138 P=0.209 |
|POLY 1.5 | P=0.116N P=0.269N P=0.512N P=0.067N |P=0.091 P=0.507N P=0.168 P=0.238 |
|POLY 6 | P=0.155N P=0.242N P=0.539N P=0.087N |P=0.055 P=0.484N P=0.112 P=0.187 |
|LOGISTIC REGRESSION| P=0.073N P=0.304N P=0.503N P=0.038N* |P=0.063 P=0.475N P=0.125 P=0.205 |
|COCH-ARM / FISHERS | P=0.046N* P=0.288N P=0.500N P=0.028N* |P=0.185 P=0.500N P=0.218 P=0.376 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/50 (26%) 9/50 (18%) 6/50 (12%) 2/49 (4%) |2/50 (4%) 1/50 (2%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 34.4% 22.5% 16.0% 7.3% |4.8% 2.4% 5.5% 3.2% |
|TERMINAL (d) | 3/12 (25%) 4/14 (29%) 0/9 (0%) 1/6 (17%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 555 617 365 708 |638 724 533 716 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.012N* P=0.133N P=0.111N P=0.025N* |P=0.515 P=0.455N P=0.560 P=0.650N |
|POLY 3 | P=0.004N** P=0.175N P=0.051N P=0.010N* |P=0.545N P=0.500N P=0.641 P=0.596N |
|POLY 1.5 | P=0.003N** P=0.194N P=0.052N P=0.008N** |P=0.516N P=0.503N P=0.664 P=0.575N |
|POLY 6 | P=0.005N** P=0.158N P=0.054N P=0.014N* |P=0.576N P=0.492N P=0.609 P=0.617N |
|LOGISTIC REGRESSION| P=0.003N** P=0.158N P=0.060N P=0.009N** |P=0.500N P=0.499N P=0.697 P=0.594N |
|COCH-ARM / FISHERS | P<0.001N** P=0.235N P=0.062N P=0.002N** |P=0.433N P=0.500N P=0.691N P=0.508N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/45 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 3.0% 5.1% 0.0% 0.0% |2.4% 2.3% 0.0% 3.1% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 652 --- --- |698 561 --- 253 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.212N P=0.556 P=0.557N P=0.638N |P=0.572N P=0.748N P=0.578N P=0.710 |
|POLY 3 | P=0.178N P=0.562 P=0.484N P=0.535N |P=0.566N P=0.757N P=0.531N P=0.702 |
|POLY 1.5 | P=0.170N P=0.550 P=0.482N P=0.526N |P=0.545N P=0.760N P=0.518N P=0.715 |
|POLY 6 | P=0.187N P=0.579 P=0.488N P=0.542N |P=0.591N P=0.750N P=0.549N P=0.689 |
|LOGISTIC REGRESSION| P=0.169N P=0.564 (e) (e) |P=0.349N P=0.758N P=0.541N P=0.667N |
|COCH-ARM / FISHERS | P=0.133N P=0.540 P=0.474N P=0.474N |P=0.505N P=0.753N P=0.500N P=0.747 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Blood Vessel |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/45 (16%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 21.1% 7.6% 2.8% 13.8% |0.0% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 3/12 (25%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 689 579 632 492 |--- --- 680 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.252N P=0.105N P=0.060N P=0.496N |P=0.423 (e) P=0.407 (e) |
|POLY 3 | P=0.114N P=0.089N P=0.019N* P=0.335N |P=0.448 (e) P=0.470 (e) |
|POLY 1.5 | P=0.108N P=0.102N P=0.020N* P=0.323N |P=0.456 (e) P=0.483 (e) |
|POLY 6 | P=0.121N P=0.073N P=0.019N* P=0.337N |P=0.444 (e) P=0.455 (e) |
|LOGISTIC REGRESSION| P=0.147N P=0.087N P=0.026N* P=0.374N |P=0.467 (e) P=0.479 (e) |
|COCH-ARM / FISHERS | P=0.088N P=0.119N P=0.020N* P=0.204N |P=0.497 (e) P=0.500 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Bone Marrow |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 5/50 (10%) 2/50 (4%) 3/50 (6%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 19.4% 12.3% 5.6% 10.4% |0.0% 0.0% 5.5% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 555 356 632 492 |--- --- 558 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.154N P=0.291N P=0.135N P=0.338N |P=0.271 (e) P=0.167 (e) |
|POLY 3 | P=0.089N P=0.292N P=0.074N P=0.256N |P=0.289 (e) P=0.207 (e) |
|POLY 1.5 | P=0.084N P=0.324N P=0.075N P=0.246N |P=0.306 (e) P=0.220 (e) |
|POLY 6 | P=0.096N P=0.254N P=0.076N P=0.261N |P=0.277 (e) P=0.192 (e) |
|LOGISTIC REGRESSION| P=0.073N P=0.373N P=0.077N P=0.256N |P=0.366 (e) P=0.242 (e) |
|COCH-ARM / FISHERS | P=0.056N P=0.380N P=0.080N P=0.159N |P=0.375 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 4/50 (8%) 10/50 (20%) 1/50 (2%) |3/49 (6%) 1/50 (2%) 7/50 (14%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 8.1% 10.1% 25.9% 3.6% |7.2% 2.4% 17.4% 9.2% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 1/9 (11%) 0/6 (0%) |2/26 (8%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 452 607 524 608 |566 615 355 641 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.590 P=0.052 P=0.400N |P=0.133 P=0.279N P=0.101 P=0.460 |
|POLY 3 | P=0.264 P=0.541 P=0.037 * P=0.410N |P=0.150 P=0.296N P=0.142 P=0.549 |
|POLY 1.5 | P=0.309 P=0.526 P=0.037 * P=0.391N |P=0.176 P=0.300N P=0.155 P=0.578 |
|POLY 6 | P=0.223 P=0.564 P=0.039 * P=0.427N |P=0.129 P=0.287N P=0.125 P=0.526 |
|LOGISTIC REGRESSION| P=0.529 P=0.416 P=0.032 * P=0.250N |P=0.423 P=0.296N P=0.282 P=0.601 |
|COCH-ARM / FISHERS | P=0.544 P=0.500 P=0.036 * P=0.309N |P=0.276 P=0.301N P=0.167 P=0.651N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Brain |
| Hydrocephalus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 7/50 (14%) 10/50 (20%) 5/50 (10%) |10/49 (20%) 10/50 (20%) 7/50 (14%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 13.2% 17.5% 25.3% 16.9% |23.5% 22.9% 18.3% 6.3% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |3/26 (12%) 6/31 (19%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 392 615 393 586 |542 561 508 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.233 P=0.502 P=0.150 P=0.485 |P=0.123N P=0.487N P=0.588N P=0.107N |
|POLY 3 | P=0.228 P=0.417 P=0.143 P=0.471 |P=0.047N* P=0.575N P=0.384N P=0.046N* |
|POLY 1.5 | P=0.249 P=0.403 P=0.140 P=0.491 |P=0.030N* P=0.585N P=0.339N P=0.033N* |
|POLY 6 | P=0.218 P=0.439 P=0.148 P=0.466 |P=0.076N P=0.556N P=0.441N P=0.065N |
|LOGISTIC REGRESSION| P=0.432 P=0.334 P=0.098 P=0.634N |P=0.018N* P=0.581N P=0.287N P=0.037N* |
|COCH-ARM / FISHERS | P=0.427 P=0.380 P=0.131 P=0.630N |P=0.009N** P=0.579N P=0.282N P=0.013N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |4/49 (8%) 7/50 (14%) 0/50 (0%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| |9.6% 16.5% 0.0% 6.3% |
|TERMINAL (d) | |2/26 (8%) 5/31 (16%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | |550 674 --- 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.240N P=0.335 P=0.125N P=0.585N |
|POLY 3 | |P=0.126N P=0.269 P=0.082N P=0.466N |
|POLY 1.5 | |P=0.097N P=0.266 P=0.071N P=0.429N |
|POLY 6 | |P=0.169N P=0.280 P=0.100N P=0.504N |
|LOGISTIC REGRESSION| |P=0.125N P=0.273 P=0.061N P=0.438N |
|COCH-ARM / FISHERS | |P=0.058N P=0.274 P=0.056N P=0.329N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 3/3 (100%) 2/3 (67%) 0/0 (0%) |1/2 (50%) 1/2 (50%) 3/3 (100%) 0/0 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 100.0% 66.7% 0.0% |65.6% 50.0% 100.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 1/1 (100%) 0/1 (0%) 0/0 (0%) |1/1 (100%) 0/1 (0%) 1/1 (100%) 0/0 (0%) |
|FIRST INCIDENCE | 694 694 481 --- |730 (T) 720 357 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.407N (e) P=0.461 (e) |P=0.357 P=0.738N P=0.175 P=1.000 |
|POLY 3 | (e) (e) P=0.691N (e) |(e) P=0.721N P=0.719 (e) |
|POLY 1.5 | (e) (e) P=0.691N (e) |(e) P=0.741N P=0.546 (e) |
|POLY 6 | (e) (e) P=0.691N (e) |(e) P=0.683N P=0.981 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.222 P=0.703N P=0.381 (e) |
|COCH-ARM / FISHERS | P=0.370N (e) P=0.750N (e) |P=0.215 P=0.833N P=0.400 P=1.000 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 16.9% 5.1% 2.8% 13.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 689 579 632 492 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.385N P=0.096N P=0.097N P=0.590N |(e) (e) (e) (e) |
|POLY 3 | P=0.259N P=0.097N P=0.050N P=0.498N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.251N P=0.110N P=0.052N P=0.490N |(e) (e) (e) (e) |
|POLY 6 | P=0.270N P=0.081N P=0.049N* P=0.496N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.295N P=0.093N P=0.057N P=0.528N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.221N P=0.134N P=0.056N P=0.370N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.4% 5.0% 2.7% 0.0% |2.4% 2.4% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 612 495 365 --- |651 724 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.071N P=0.439N P=0.316N P=0.182N |P=0.245N P=0.737N P=0.559N P=0.566N |
|POLY 3 | P=0.077N P=0.450N P=0.297N P=0.171N |P=0.226N P=0.760N P=0.532N P=0.554N |
|POLY 1.5 | P=0.071N P=0.468N P=0.297N P=0.162N |P=0.208N P=0.759 P=0.518N P=0.541N |
|POLY 6 | P=0.084N P=0.428N P=0.303N P=0.181N |P=0.249N P=0.756N P=0.550N P=0.567N |
|LOGISTIC REGRESSION| P=0.027N* P=0.547N P=0.327N P=0.162N |P=0.199N P=0.762 P=0.497N P=0.520N |
|COCH-ARM / FISHERS | P=0.048N* P=0.500N P=0.309N P=0.121N |P=0.170N P=0.753N P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Heart: Myocardium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 10/50 (20%) 8/50 (16%) 7/50 (14%) |3/50 (6%) 1/50 (2%) 4/50 (8%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 31.7% 24.7% 21.1% 24.4% |7.2% 2.4% 11.1% 3.1% |
|TERMINAL (d) | 2/12 (17%) 4/14 (29%) 1/9 (11%) 2/6 (33%) |3/26 (12%) 1/31 (3%) 3/15 (20%) 1/14 (7%) |
|FIRST INCIDENCE | 555 613 524 561 |730 (T) 730 (T) 676 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.257N P=0.307N P=0.429N |P=0.421 P=0.243N P=0.229 P=0.543N |
|POLY 3 | P=0.216N P=0.328N P=0.210N P=0.351N |P=0.532N P=0.301N P=0.419 P=0.406N |
|POLY 1.5 | P=0.192N P=0.354N P=0.211N P=0.310N |P=0.494N P=0.306N P=0.454 P=0.381N |
|POLY 6 | P=0.246N P=0.300N P=0.216N P=0.399N |P=0.569N P=0.291N P=0.376 P=0.430N |
|LOGISTIC REGRESSION| P=0.203N P=0.323N P=0.217N P=0.323N |P=0.510 P=0.243N P=0.291 P=0.543N |
|COCH-ARM / FISHERS | P=0.096N P=0.405N P=0.227N P=0.154N |P=0.380N P=0.309N P=0.500 P=0.309N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Cecum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/47 (6%) 1/46 (2%) 9/48 (19%) 2/45 (4%) |5/48 (10%) 4/48 (8%) 3/49 (6%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 8.7% 2.7% 24.8% 7.7% |12.4% 9.7% 8.3% 9.4% |
|TERMINAL (d) | 0/11 (0%) 1/14 (7%) 4/9 (44%) 1/6 (17%) |5/26 (19%) 4/31 (13%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | 498 729 (T) 524 683 |730 (T) 730 (T) 558 569 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127 P=0.251N P=0.051 P=0.637N |P=0.511 P=0.388N P=0.619N P=0.633 |
|POLY 3 | P=0.134 P=0.278N P=0.065 P=0.626N |P=0.358N P=0.487N P=0.419N P=0.493N |
|POLY 1.5 | P=0.160 P=0.290N P=0.066 P=0.608N |P=0.318N P=0.497N P=0.386N P=0.458N |
|POLY 6 | P=0.112 P=0.262N P=0.063 P=0.642N |P=0.401N P=0.468N P=0.461N P=0.524N |
|LOGISTIC REGRESSION| P=0.225 P=0.356N P=0.067 P=0.577N |P=0.409N P=0.388N P=0.477N P=0.543N |
|COCH-ARM / FISHERS | P=0.301 P=0.317N P=0.065 P=0.521N |P=0.224N P=0.500N P=0.346N P=0.346N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Colon |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 3/48 (6%) 0/48 (0%) 0/45 (0%) |2/48 (4%) 4/49 (8%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 5.8% 7.8% 0.0% 0.0% |4.9% 9.3% 2.8% 3.2% |
|TERMINAL (d) | 1/12 (8%) 2/14 (14%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 2/31 (7%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 601 647 --- --- |730 (T) 589 558 630 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.100N P=0.574 P=0.268N P=0.351N |P=0.399N P=0.397 P=0.642N P=0.673N |
|POLY 3 | P=0.077N P=0.546 P=0.235N P=0.307N |P=0.317N P=0.363 P=0.540N P=0.585N |
|POLY 1.5 | P=0.074N P=0.526 P=0.236N P=0.300N |P=0.282N P=0.353 P=0.520N P=0.563N |
|POLY 6 | P=0.080N P=0.571 P=0.236N P=0.313N |P=0.357N P=0.381 P=0.567N P=0.603N |
|LOGISTIC REGRESSION| P=0.071N P=0.564 P=0.235N P=0.299N |P=0.229N P=0.346 P=0.513N P=0.595N |
|COCH-ARM / FISHERS | P=0.059N P=0.490 P=0.253N P=0.269N |P=0.204N P=0.349 P=0.492N P=0.492N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Intestine Large, Rectum |
| Parasite Metazoan |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/48 (8%) 2/49 (4%) 3/46 (7%) |3/48 (6%) 4/50 (8%) 4/49 (8%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.5% 5.7% 11.3% |7.4% 9.4% 10.9% 0.0% |
|TERMINAL (d) | 0/12 (0%) 3/14 (21%) 2/9 (22%) 3/6 (50%) |2/26 (8%) 2/31 (7%) 2/15 (13%) 0/14 (0%) |
|FIRST INCIDENCE | --- 708 729 (T) 729 (T) |638 593 357 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030 * P=0.088 P=0.173 P=0.025 * |P=0.336N P=0.560 P=0.296 P=0.230N |
|POLY 3 | P=0.120 P=0.070 P=0.237 P=0.074 |P=0.271N P=0.525 P=0.440 P=0.174N |
|POLY 1.5 | P=0.125 P=0.064 P=0.237 P=0.078 |P=0.227N P=0.519 P=0.473 P=0.157N |
|POLY 6 | P=0.113 P=0.077 P=0.235 P=0.070 |P=0.321N P=0.538 P=0.396 P=0.191N |
|LOGISTIC REGRESSION| P=0.046 * P=0.085 P=0.173 P=0.025 * |P=0.161N P=0.520 P=0.516 P=0.171N |
|COCH-ARM / FISHERS | P=0.159 P=0.054 P=0.242 P=0.106 |P=0.129N P=0.523 P=0.512 P=0.117N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 1/50 (2%) 2/50 (4%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.0% 2.8% 7.3% |0.0% 0.0% 0.0% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 2/6 (33%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 356 593 729 (T) |--- --- --- 654 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.110 P=0.275 P=0.511 P=0.099 |P=0.146 (e) (e) P=0.432 |
|POLY 3 | P=0.178 P=0.265 P=0.505 P=0.187 |P=0.199 (e) (e) P=0.453 |
|POLY 1.5 | P=0.181 P=0.255 P=0.504 P=0.194 |P=0.199 (e) (e) P=0.465 |
|POLY 6 | P=0.174 P=0.279 P=0.506 P=0.180 |P=0.198 (e) (e) P=0.442 |
|LOGISTIC REGRESSION| P=0.191 P=0.151 P=0.488 P=0.099 |P=0.171 (e) (e) P=0.481 |
|COCH-ARM / FISHERS | P=0.209 P=0.247 P=0.500 P=0.247 |P=0.186 (e) (e) P=0.505 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |1/49 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.5% 2.6% 0.0% 0.0% |2.4% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 689 579 --- --- |730 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.035N* P=0.246N P=0.163N P=0.202N |P=0.252N P=0.465N P=0.610N P=0.623N |
|POLY 3 | P=0.027N* P=0.267N P=0.115N P=0.167N |P=0.212N P=0.494N P=0.527N P=0.549N |
|POLY 1.5 | P=0.026N* P=0.281N P=0.116N P=0.160N |P=0.202N P=0.497N P=0.514N P=0.536N |
|POLY 6 | P=0.029N* P=0.249N P=0.117N P=0.174N |P=0.224N P=0.489N P=0.544N P=0.561N |
|LOGISTIC REGRESSION| P=0.026N* P=0.270N P=0.124N P=0.176N |P=0.252N (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.021N* P=0.309N P=0.121N P=0.121N |P=0.183N P=0.495N P=0.495N P=0.495N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 39/50 (78%) 48/50 (96%) 48/50 (96%) 38/50 (76%) |3/50 (6%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 86.4% 97.9% 98.7% 97.1% |8.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 11/12 (92%) 14/14 (100%) 9/9 (100%) 6/6 (100%) |0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |
|FIRST INCIDENCE | 392 356 393 393 |495 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.021 * P=0.463 P=0.083 P=0.067 |P=0.023N* P=0.093N P=0.128N P=0.169N |
|POLY 3 | P=0.004 ** P=0.019 * P=0.010 * P=0.055 |P=0.021N* P=0.106N P=0.120N P=0.174N |
|POLY 1.5 | P=0.007 ** P=0.014 * P=0.008 ** P=0.064 |P=0.020N* P=0.110N P=0.118N P=0.164N |
|POLY 6 | P=0.009 ** P=0.034 * P=0.022 * P=0.101 |P=0.022N* P=0.101N P=0.125N P=0.185N |
|LOGISTIC REGRESSION| P=0.008 ** P=0.019 * P=0.010 * P=0.039 * |P=0.015N* P=0.137N P=0.126N P=0.128N |
|COCH-ARM / FISHERS | P=0.427N P=0.007 ** P=0.007 ** P=0.500N |P=0.019N* P=0.121N P=0.121N P=0.121N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 3/50 (6%) 2/50 (4%) |4/49 (8%) 3/50 (6%) 2/50 (4%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 2.9% 5.1% 8.1% 6.9% |9.7% 7.0% 5.5% 16.8% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 1/31 (3%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 666 526 262 |666 589 614 32 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190 P=0.567 P=0.294 P=0.372 |P=0.141 P=0.448N P=0.536N P=0.199 |
|POLY 3 | P=0.243 P=0.537 P=0.324 P=0.432 |P=0.238 P=0.478N P=0.399N P=0.281 |
|POLY 1.5 | P=0.249 P=0.523 P=0.318 P=0.438 |P=0.264 P=0.487N P=0.368N P=0.299 |
|POLY 6 | P=0.240 P=0.556 P=0.333 P=0.431 |P=0.209 P=0.460N P=0.441N P=0.269 |
|LOGISTIC REGRESSION| P=0.354 P=0.566 P=0.292 P=0.543 |P=0.496 P=0.490N P=0.417N P=0.598 |
|COCH-ARM / FISHERS | P=0.314 P=0.500 P=0.309 P=0.500 |P=0.315 P=0.489N P=0.329N P=0.370 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Larynx: Epiglottis |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |1/49 (2%) 0/50 (0%) 2/50 (4%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 2.8% 0.0% 0.0% 3.5% |2.4% 0.0% 5.5% 15.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 0/31 (0%) 1/15 (7%) 2/14 (14%) |
|FIRST INCIDENCE | 702 --- --- 468 |730 (T) --- 543 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.577 P=0.460N P=0.523N P=0.708 |P=0.003 ** P=0.465N P=0.361 P=0.033 * |
|POLY 3 | P=0.641N P=0.481N P=0.498N P=0.711 |P=0.011 * P=0.494N P=0.458 P=0.059 |
|POLY 1.5 | P=0.636N P=0.488N P=0.497N P=0.716 |P=0.013 * P=0.497N P=0.479 P=0.067 |
|POLY 6 | P=0.639 P=0.472N P=0.501N P=0.708 |P=0.009 ** P=0.489N P=0.432 P=0.052 |
|LOGISTIC REGRESSION| P=0.600N P=0.465N P=0.505N P=0.767 |P=0.019 * (e) P=0.490 P=0.103 |
|COCH-ARM / FISHERS | P=0.625 P=0.500N P=0.500N P=0.753N |P=0.018 * P=0.495N P=0.508 P=0.102 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Larynx: Glands |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 28/50 (56%) 18/50 (36%) 18/50 (36%) 26/50 (52%) |20/49 (41%) 16/50 (32%) 18/50 (36%) 19/49 (39%) |
|POLY-3 ADJUSTED (b)| 65.5% 42.5% 45.2% 70.5% |47.1% 36.4% 44.7% 50.1% |
|TERMINAL (d) | 7/12 (58%) 6/14 (43%) 4/9 (44%) 2/6 (33%) |12/26 (46%) 10/31 (32%) 5/15 (33%) 5/14 (36%) |
|FIRST INCIDENCE | 452 495 526 100 |598 542 455 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.150 P=0.021N* P=0.122N P=0.205 |P=0.034 * P=0.149N P=0.200 P=0.108 |
|POLY 3 | P=0.432 P=0.020N* P=0.040N* P=0.399 |P=0.355 P=0.210N P=0.500N P=0.484 |
|POLY 1.5 | P=0.484 P=0.023N* P=0.033N* P=0.448 |P=0.388 P=0.231N P=0.451N P=0.492 |
|POLY 6 | P=0.379 P=0.020N* P=0.057N P=0.372 |P=0.337 P=0.179N P=0.557N P=0.508 |
|LOGISTIC REGRESSION| P=0.505 P=0.025N* P=0.030N* P=0.505 |P=0.339 P=0.228N P=0.567N P=0.453 |
|COCH-ARM / FISHERS | P=0.375N P=0.035N* P=0.035N* P=0.421N |P=0.500N P=0.241N P=0.387N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Larynx: Squamous Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 1/50 (2%) 1/50 (2%) |5/49 (10%) 1/50 (2%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 0.0% 2.8% 3.6% |12.0% 2.4% 2.8% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |3/26 (12%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 702 --- 721 589 |598 730 (T) 634 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.410 P=0.460N P=0.737 P=0.712 |P=0.028N* P=0.081N P=0.215N P=0.099N |
|POLY 3 | P=0.467 P=0.481N P=0.759N P=0.708 |P=0.013N* P=0.098N P=0.136N P=0.061N |
|POLY 1.5 | P=0.472 P=0.488N P=0.758N P=0.714 |P=0.011N* P=0.099N P=0.118N P=0.052N |
|POLY 6 | P=0.460 P=0.472N P=0.763 P=0.706 |P=0.016N* P=0.094N P=0.163N P=0.072N |
|LOGISTIC REGRESSION| P=0.442 P=0.465N P=0.754 P=0.722 |P=0.012N* P=0.098N P=0.118N P=0.054N |
|COCH-ARM / FISHERS | P=0.500 P=0.500N P=0.753N P=0.753N |P=0.008N** P=0.098N P=0.098N P=0.028N* |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.6% 5.1% 2.8% 10.7% |2.4% 0.0% 5.5% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 602 647 726 638 |589 --- 617 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.256 P=0.630N P=0.548N P=0.349 |P=0.595 P=0.500N P=0.410 P=0.570N |
|POLY 3 | P=0.393 P=0.661N P=0.499N P=0.392 |P=0.616N P=0.500N P=0.446 P=0.555N |
|POLY 1.5 | P=0.401 P=0.673N P=0.497N P=0.407 |P=0.589N P=0.502N P=0.469 P=0.541N |
|POLY 6 | P=0.379 P=0.645N P=0.507N P=0.383 |P=0.605 P=0.496N P=0.418 P=0.568N |
|LOGISTIC REGRESSION| P=0.321 P=0.661N P=0.499N P=0.383 |P=0.506N P=0.488N P=0.513 P=0.474N |
|COCH-ARM / FISHERS | P=0.436 P=0.691N P=0.500N P=0.500 |P=0.500N P=0.500N P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.8% 2.6% 0.0% 0.0% |4.8% 4.8% 8.3% 9.3% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 2/31 (7%) 1/15 (7%) 1/14 (7%) |
|FIRST INCIDENCE | 556 729 (T) --- --- |660 730 (T) 617 698 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.221N P=0.730N P=0.495N P=0.538N |P=0.115 P=0.646N P=0.326 P=0.280 |
|POLY 3 | P=0.209N P=0.743N P=0.500N P=0.551N |P=0.228 P=0.693N P=0.434 P=0.380 |
|POLY 1.5 | P=0.202N P=0.749N P=0.499N P=0.543N |P=0.255 P=0.692 P=0.462 P=0.409 |
|POLY 6 | P=0.216N P=0.735N P=0.505N P=0.558N |P=0.202 P=0.686N P=0.400 P=0.354 |
|LOGISTIC REGRESSION| P=0.179N P=0.763 P=0.529N P=0.485N |P=0.191 P=0.684N P=0.444 P=0.350 |
|COCH-ARM / FISHERS | P=0.170N P=0.753N P=0.500N P=0.500N |P=0.332 P=0.691N P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 4/50 (8%) 3/50 (6%) 1/50 (2%) |6/50 (12%) 7/50 (14%) 6/50 (12%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 0.0% 10.3% 8.3% 3.6% |14.2% 16.3% 15.9% 12.0% |
|TERMINAL (d) | 0/12 (0%) 3/14 (21%) 1/9 (11%) 0/6 (0%) |3/26 (12%) 5/31 (16%) 1/15 (7%) 2/14 (14%) |
|FIRST INCIDENCE | --- 666 617 638 |666 589 508 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.239 P=0.086 P=0.106 P=0.452 |P=0.403 P=0.587 P=0.350 P=0.590 |
|POLY 3 | P=0.314 P=0.073 P=0.122 P=0.455 |P=0.468N P=0.513 P=0.539 P=0.525N |
|POLY 1.5 | P=0.327 P=0.068 P=0.122 P=0.460 |P=0.416N P=0.501 P=0.574 P=0.489N |
|POLY 6 | P=0.307 P=0.080 P=0.121 P=0.452 |P=0.527N P=0.535 P=0.494 P=0.560N |
|LOGISTIC REGRESSION| P=0.315 P=0.087 P=0.120 P=0.466 |P=0.360N P=0.504 P=0.591 P=0.474N |
|COCH-ARM / FISHERS | P=0.436 P=0.059 P=0.121 P=0.500 |P=0.276N P=0.500 P=0.620N P=0.370N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |3/50 (6%) 6/50 (12%) 3/50 (6%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.1% 0.0% 0.0% |7.0% 14.3% 8.2% 9.0% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 6/31 (19%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 580 671 --- --- |119 730 (T) 508 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.206N P=0.549 P=0.495N P=0.546N |P=0.365 P=0.315 P=0.527 P=0.490 |
|POLY 3 | P=0.192N P=0.532 P=0.500N P=0.550N |P=0.520 P=0.231 P=0.589 P=0.539 |
|POLY 1.5 | P=0.185N P=0.520 P=0.498N P=0.542N |P=0.540N P=0.228 P=0.618 P=0.569 |
|POLY 6 | P=0.201N P=0.547 P=0.504N P=0.558N |P=0.470 P=0.239 P=0.554 P=0.511 |
|LOGISTIC REGRESSION| P=0.169N P=0.516 P=0.518N P=0.501N |P=0.348N P=0.246 P=0.579N P=0.466N |
|COCH-ARM / FISHERS | P=0.149N P=0.500 P=0.500N P=0.500N |P=0.405N P=0.243 P=0.661N P=0.661N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.1% 2.8% 0.0% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 657 550 716 --- |550 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.327N P=0.564 P=0.748 P=0.557N |P=0.086N P=0.218N P=0.317N P=0.349N |
|POLY 3 | P=0.340N P=0.538 P=0.760N P=0.549N |P=0.068N P=0.238N P=0.276N P=0.305N |
|POLY 1.5 | P=0.325N P=0.524 P=0.758N P=0.542N |P=0.063N P=0.240N P=0.259N P=0.287N |
|POLY 6 | P=0.356N P=0.557 P=0.761 P=0.556N |P=0.075N P=0.233N P=0.300N P=0.323N |
|LOGISTIC REGRESSION| P=0.283N P=0.487 P=0.763N P=0.543N |P=0.049N* P=0.232N P=0.223N P=0.238N |
|COCH-ARM / FISHERS | P=0.249N P=0.500 P=0.753N P=0.500N |P=0.056N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/50 (14%) 1/50 (2%) 2/50 (4%) 1/50 (2%) |5/50 (10%) 1/50 (2%) 0/50 (0%) 3/50 (6%) |
|POLY-3 ADJUSTED (b)| 19.1% 2.6% 5.4% 3.6% |11.8% 2.4% 0.0% 9.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 495 694 525 561 |651 730 (T) --- 516 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.030N* P=0.019N* P=0.104N P=0.080N |P=0.366N P=0.087N P=0.092N P=0.591N |
|POLY 3 | P=0.020N* P=0.022N* P=0.073N P=0.066N |P=0.223N P=0.102N P=0.047N* P=0.492N |
|POLY 1.5 | P=0.019N* P=0.025N* P=0.074N P=0.060N |P=0.204N P=0.104N P=0.039N* P=0.462N |
|POLY 6 | P=0.021N* P=0.020N* P=0.075N P=0.073N |P=0.250N P=0.097N P=0.060N P=0.519N |
|LOGISTIC REGRESSION| P=0.014N* P=0.026N* P=0.082N P=0.055N |P=0.211N P=0.100N P=0.049N* P=0.417N |
|COCH-ARM / FISHERS | P=0.013N* P=0.030N* P=0.080N P=0.030N* |P=0.180N P=0.102N P=0.028N* P=0.357N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 2/50 (4%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.4% 0.0% 0.0% 7.1% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 --- --- 502 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.448N P=0.095N P=0.130N P=0.645N |(e) (e) (e) (e) |
|POLY 3 | P=0.354N P=0.103N P=0.117N P=0.605N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.349N P=0.109N P=0.117N P=0.591N |(e) (e) (e) (e) |
|POLY 6 | P=0.362N P=0.097N P=0.121N P=0.617N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.381N P=0.104N P=0.118N P=0.587N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.343N P=0.121N P=0.121N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Liver: Hepatocyte |
| Degeneration Focal |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 8.4% 0.0% 0.0% 3.6% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 638 --- --- 708 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.191N P=0.095N P=0.147N P=0.441N |(e) (e) (e) (e) |
|POLY 3 | P=0.138N P=0.103N P=0.117N P=0.399N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.136N P=0.108N P=0.116N P=0.384N |(e) (e) (e) (e) |
|POLY 6 | P=0.141N P=0.096N P=0.119N P=0.413N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.164N P=0.098N P=0.119N P=0.406N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.129N P=0.121N P=0.121N P=0.309N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/50 (6%) 5/50 (10%) 4/50 (8%) |7/50 (14%) 4/50 (8%) 2/50 (4%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 24.1% 7.6% 13.2% 13.3% |16.8% 9.5% 5.5% 12.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |7/26 (27%) 4/31 (13%) 1/15 (7%) 0/14 (0%) |
|FIRST INCIDENCE | 555 617 481 100 |730 (T) 730 (T) 617 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.235N P=0.039N* P=0.232N P=0.266N |P=0.436N P=0.161N P=0.252N P=0.591N |
|POLY 3 | P=0.166N P=0.044N* P=0.177N P=0.209N |P=0.208N P=0.253N P=0.115N P=0.403N |
|POLY 1.5 | P=0.158N P=0.049N* P=0.179N P=0.195N |P=0.184N P=0.262N P=0.099N P=0.379N |
|POLY 6 | P=0.176N P=0.039N* P=0.182N P=0.224N |P=0.234N P=0.236N P=0.139N P=0.418N |
|LOGISTIC REGRESSION| P=0.080N P=0.052N P=0.196N P=0.124N |P=0.248N P=0.161N P=0.180N P=0.413N |
|COCH-ARM / FISHERS | P=0.108N P=0.061N P=0.194N P=0.117N |P=0.134N P=0.262N P=0.080N P=0.274N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Emphysema |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.9% 0.0% 0.0% 0.0% |0.0% 0.0% 0.0% 6.2% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) --- --- --- |--- --- --- 474 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.241N P=0.469N P=0.557N P=0.638N |P=0.032 * (e) (e) P=0.170 |
|POLY 3 | P=0.212N P=0.480N P=0.497N P=0.548N |P=0.054 (e) (e) P=0.186 |
|POLY 1.5 | P=0.207N P=0.488N P=0.497N P=0.541N |P=0.056 (e) (e) P=0.195 |
|POLY 6 | P=0.219N P=0.470N P=0.499N P=0.553N |P=0.051 (e) (e) P=0.177 |
|LOGISTIC REGRESSION| P=0.241N (e) (e) (e) |P=0.060 (e) (e) P=0.243 |
|COCH-ARM / FISHERS | P=0.185N P=0.500N P=0.500N P=0.500N |P=0.055 (e) (e) P=0.242 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 2/50 (4%) 1/50 (2%) 1/50 (2%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 8.5% 5.1% 2.8% 3.6% |2.4% 0.0% 2.8% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 1/6 (17%) |1/26 (4%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 637 569 561 729 (T) |730 (T) --- 533 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245N P=0.417N P=0.337N P=0.489N |P=0.483N P=0.465N P=0.687 P=0.623N |
|POLY 3 | P=0.203N P=0.453N P=0.297N P=0.400N |P=0.457N P=0.498N P=0.729 P=0.554N |
|POLY 1.5 | P=0.194N P=0.471N P=0.298N P=0.385N |P=0.438N P=0.501N P=0.743 P=0.543N |
|POLY 6 | P=0.214N P=0.431N P=0.299N P=0.415N |P=0.474N P=0.493N P=0.712 P=0.565N |
|LOGISTIC REGRESSION| P=0.191N P=0.466N P=0.301N P=0.411N |P=0.367N (e) P=0.750N (e) |
|COCH-ARM / FISHERS | P=0.151N P=0.500N P=0.309N P=0.309N |P=0.379N P=0.500N P=0.753N P=0.505N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/50 (46%) 15/50 (30%) 14/50 (28%) 11/50 (22%) |29/50 (58%) 24/50 (48%) 22/50 (44%) 35/49 (71%) |
|POLY-3 ADJUSTED (b)| 56.3% 36.7% 35.6% 35.5% |64.0% 53.5% 54.0% 90.7% |
|TERMINAL (d) | 7/12 (58%) 4/14 (29%) 1/9 (11%) 2/6 (33%) |17/26 (65%) 17/31 (55%) 7/15 (47%) 13/14 (93%) |
|FIRST INCIDENCE | 392 613 481 468 |542 178 355 117 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.153N P=0.036N* P=0.132N P=0.181N |P<0.001 ** P=0.099N P=0.359 P<0.001 ** |
|POLY 3 | P=0.030N* P=0.050N P=0.041N* P=0.057N |P=0.011 * P=0.205N P=0.224N P=0.002 ** |
|POLY 1.5 | P=0.026N* P=0.056N P=0.041N* P=0.046N* |P=0.025 * P=0.208N P=0.166N P=0.006 ** |
|POLY 6 | P=0.034N* P=0.044N* P=0.043N* P=0.067N |P=0.006 ** P=0.199N P=0.308N P<0.001 ** |
|LOGISTIC REGRESSION| P=0.027N* P=0.042N* P=0.044N* P=0.042N* |P=0.015 * P=0.215N P=0.220N P=0.003 ** |
|COCH-ARM / FISHERS | P=0.007N** P=0.074N P=0.048N* P=0.010N* |P=0.144 P=0.212N P=0.115N P=0.117 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 2/50 (4%) 0/50 (0%) 2/50 (4%) |2/50 (4%) 1/50 (2%) 0/50 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.2% 0.0% 7.0% |4.8% 2.4% 0.0% 3.2% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |2/26 (8%) 1/31 (3%) 0/15 (0%) 1/14 (7%) |
|FIRST INCIDENCE | --- 712 --- 23 |730 (T) 730 (T) --- 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.162 P=0.291 (e) P=0.196 |P=0.444N P=0.438N P=0.365N P=0.712N |
|POLY 3 | P=0.243 P=0.260 (e) P=0.193 |P=0.307N P=0.497N P=0.273N P=0.594N |
|POLY 1.5 | P=0.243 P=0.251 (e) P=0.199 |P=0.288N P=0.501N P=0.257N P=0.574N |
|POLY 6 | P=0.240 P=0.271 (e) P=0.189 |P=0.331N P=0.487N P=0.294N P=0.613N |
|LOGISTIC REGRESSION| P=0.328 P=0.282 (e) P=0.391 |P=0.444N P=0.438N (e) P=0.712N |
|COCH-ARM / FISHERS | P=0.249 P=0.247 (e) P=0.247 |P=0.253N P=0.500N P=0.247N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 3/50 (6%) 1/50 (2%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 11.3% 7.5% 2.8% 13.8% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 689 579 632 492 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.490 P=0.421N P=0.235N P=0.457 |(e) (e) (e) (e) |
|POLY 3 | P=0.507N P=0.435N P=0.171N P=0.533 |(e) (e) (e) (e) |
|POLY 1.5 | P=0.496N P=0.460N P=0.172N P=0.539 |(e) (e) (e) (e) |
|POLY 6 | P=0.522N P=0.400N P=0.171N P=0.538 |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.522N P=0.454N P=0.178N P=0.519 |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.447N P=0.500N P=0.181N P=0.643N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Lung: Interstitium |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/50 (16%) 14/50 (28%) 17/50 (34%) 7/50 (14%) |9/50 (18%) 13/50 (26%) 17/50 (34%) 24/49 (49%) |
|POLY-3 ADJUSTED (b)| 22.0% 34.3% 41.8% 23.2% |21.3% 30.3% 42.5% 70.4% |
|TERMINAL (d) | 4/12 (33%) 4/14 (29%) 0/9 (0%) 0/6 (0%) |7/26 (27%) 9/31 (29%) 5/15 (33%) 11/14 (79%) |
|FIRST INCIDENCE | 583 579 481 468 |566 593 355 567 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.185 P=0.257 P=0.039 * P=0.444 |P<0.001 ** P=0.374 P=0.005 ** P<0.001 ** |
|POLY 3 | P=0.285 P=0.168 P=0.047 * P=0.573 |P<0.001 ** P=0.239 P=0.029 * P<0.001 ** |
|POLY 1.5 | P=0.295 P=0.145 P=0.040 * P=0.577 |P<0.001 ** P=0.229 P=0.037 * P<0.001 ** |
|POLY 6 | P=0.298 P=0.208 P=0.064 P=0.585 |P<0.001 ** P=0.266 P=0.023 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.329 P=0.183 P=0.034 * P=0.563 |P<0.001 ** P=0.251 P=0.034 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.530 P=0.114 P=0.032 * P=0.500N |P<0.001 ** P=0.235 P=0.055 P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 1/50 (2%) 5/50 (10%) 0/50 (0%) |2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.7% 2.6% 13.6% 0.0% |4.8% 4.7% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 1/9 (11%) 0/6 (0%) |1/26 (4%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 583 729 (T) 608 --- |708 724 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.513 P=0.452N P=0.197 P=0.340N |P=0.126N P=0.624N P=0.345N P=0.353N |
|POLY 3 | P=0.518 P=0.464N P=0.233 P=0.293N |P=0.090N P=0.692N P=0.273N P=0.301N |
|POLY 1.5 | P=0.549 P=0.474N P=0.232 P=0.283N |P=0.078N P=0.692 P=0.257N P=0.285N |
|POLY 6 | P=0.486 P=0.453N P=0.234 P=0.303N |P=0.106N P=0.683N P=0.295N P=0.318N |
|LOGISTIC REGRESSION| P=0.518N P=0.457N P=0.228 P=0.280N |P=0.104N P=0.665N P=0.317N P=0.326N |
|COCH-ARM / FISHERS | P=0.428N P=0.492N P=0.226 P=0.242N |P=0.057N P=0.691N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 0.0% 5.5% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- --- 589 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.305 (e) P=0.194 (e) |
|POLY 3 | (e) (e) (e) (e) |P=0.288 (e) P=0.208 (e) |
|POLY 1.5 | (e) (e) (e) (e) |P=0.305 (e) P=0.220 (e) |
|POLY 6 | (e) (e) (e) (e) |P=0.275 (e) P=0.195 (e) |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.395 (e) P=0.258 (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.375 (e) P=0.247 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/10 (80%) 6/7 (86%) 5/6 (83%) 6/7 (86%) |9/10 (90%) 9/9 (100%) 7/7 (100%) 3/3 (100%) |
|POLY-3 ADJUSTED (b)| 82.8% 86.6% 83.3% 88.7% |96.2% 100.0% 100.0% 100.0% |
|TERMINAL (d) | 3/3 (100%) 2/2 (100%) 0/1 (0%) 0/0 (0%) |5/5 (100%) 6/6 (100%) 3/3 (100%) 2/2 (100%) |
|FIRST INCIDENCE | 583 550 533 449 |651 437 634 721 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.295 P=0.373N P=0.453N P=0.350 |P=0.412N P=0.448N P=0.414 P=0.379N |
|POLY 3 | P=0.486 P=0.684 P=0.744 P=0.650 |P=0.625 P=0.960 P=0.970 P=0.994 |
|POLY 1.5 | P=0.479 P=0.655 P=0.712 P=0.637 |P=0.402 P=0.755 P=0.792 P=0.909 |
|POLY 6 | P=0.504 P=0.740 P=0.737N P=0.683 |P=0.998 P=1.000 P=1.000 P=1.000 |
|LOGISTIC REGRESSION| P=0.355N P=0.636 P=0.739N P=0.640N |P=0.285 P=0.349 (e) (e) |
|COCH-ARM / FISHERS | P=0.472 P=0.640 P=0.786N P=0.640 |P=0.268 P=0.526 P=0.588 P=0.769 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Concretion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- --- |518 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.075N P=0.244N P=0.274N P=0.318N |
|POLY 3 | (e) (e) (e) (e) |P=0.069N P=0.241N P=0.279N P=0.310N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.064N P=0.241N P=0.261N P=0.292N |
|POLY 6 | (e) (e) (e) (e) |P=0.076N P=0.238N P=0.305N P=0.328N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.031N* P=0.213N P=0.202N P=0.173N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.057N P=0.247N P=0.247N P=0.253N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Foreign Body |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 1/50 (2%) 0/50 (0%) |5/50 (10%) 3/50 (6%) 2/50 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 5.7% 5.1% 2.8% 0.0% |11.9% 7.1% 5.6% 0.0% |
|TERMINAL (d) | 2/12 (17%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |3/26 (12%) 3/31 (10%) 2/15 (13%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) 533 664 --- |651 730 (T) 730 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.190N P=0.637N P=0.562N P=0.398N |P=0.072N P=0.286N P=0.453N P=0.099N |
|POLY 3 | P=0.165N P=0.652N P=0.493N P=0.293N |P=0.035N* P=0.357N P=0.287N P=0.063N |
|POLY 1.5 | P=0.157N P=0.668N P=0.494N P=0.286N |P=0.028N* P=0.361N P=0.255N P=0.054N |
|POLY 6 | P=0.174N P=0.628N P=0.493N P=0.299N |P=0.045N* P=0.346N P=0.333N P=0.073N |
|LOGISTIC REGRESSION| P=0.140N P=0.667N P=0.513N (e) |P=0.043N* P=0.333N P=0.346N P=0.065N |
|COCH-ARM / FISHERS | P=0.112N P=0.691N P=0.500N P=0.247N |P=0.015N* P=0.357N P=0.218N P=0.030N* |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Goblet Cell, Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/50 (0%) 6/50 (12%) 6/50 (12%) |1/50 (2%) 3/50 (6%) 5/50 (10%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| 2.8% 0.0% 16.2% 20.0% |2.4% 7.1% 13.4% 23.5% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 2/9 (22%) 1/6 (17%) |0/26 (0%) 2/31 (7%) 1/15 (7%) 3/14 (21%) |
|FIRST INCIDENCE | 495 --- 593 393 |682 674 469 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.496N P=0.057 P=0.027 * |P<0.001 ** P=0.347 P=0.047 * P=0.004 ** |
|POLY 3 | P=0.002 ** P=0.484N P=0.058 P=0.029 * |P=0.002 ** P=0.308 P=0.075 P=0.005 ** |
|POLY 1.5 | P=0.002 ** P=0.490N P=0.058 P=0.031 * |P=0.002 ** P=0.304 P=0.086 P=0.007 ** |
|POLY 6 | P<0.001 ** P=0.477N P=0.059 P=0.029 * |P<0.001 ** P=0.318 P=0.063 P=0.005 ** |
|LOGISTIC REGRESSION| P=0.004 ** P=0.605N P=0.058 P=0.052 |P=0.003 ** P=0.309 P=0.108 P=0.011 * |
|COCH-ARM / FISHERS | P=0.005 ** P=0.500N P=0.056 P=0.056 |P=0.006 ** P=0.309 P=0.102 P=0.014 * |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Nasolacrimal Duct |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |4/50 (8%) 2/50 (4%) 2/50 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.6% 0.0% 0.0% |9.3% 4.7% 5.6% 3.2% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 1/31 (3%) 1/15 (7%) 1/14 (7%) |
|FIRST INCIDENCE | --- 617 --- --- |542 612 676 730 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.162 (e) (e) |P=0.256N P=0.311N P=0.490N P=0.334N |
|POLY 3 | P=0.370N P=0.141 (e) (e) |P=0.197N P=0.344N P=0.425N P=0.287N |
|POLY 1.5 | P=0.362N P=0.132 (e) (e) |P=0.170N P=0.346N P=0.386N P=0.258N |
|POLY 6 | P=0.378N P=0.154 (e) (e) |P=0.230N P=0.338N P=0.475N P=0.318N |
|LOGISTIC REGRESSION| P=0.331N P=0.121 (e) (e) |P=0.130N P=0.326N P=0.319N P=0.190N |
|COCH-ARM / FISHERS | P=0.301N P=0.121 (e) (e) |P=0.115N P=0.339N P=0.339N P=0.187N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 4/50 (8%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 12.7% |0.0% 0.0% 0.0% 6.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 100 |--- --- --- 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.005 ** (e) (e) P=0.055 |P=0.043 * (e) (e) P=0.196 |
|POLY 3 | P=0.006 ** (e) (e) P=0.046 * |P=0.054 (e) (e) P=0.188 |
|POLY 1.5 | P=0.006 ** (e) (e) P=0.047 * |P=0.055 (e) (e) P=0.198 |
|POLY 6 | P=0.005 ** (e) (e) P=0.045 * |P=0.050 (e) (e) P=0.180 |
|LOGISTIC REGRESSION| P=0.326 (e) (e) P=0.609 |P=0.132 (e) (e) P=0.414 |
|COCH-ARM / FISHERS | P=0.006 ** (e) (e) P=0.059 |P=0.055 (e) (e) P=0.242 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 8/50 (16%) 9/50 (18%) 14/50 (28%) |4/50 (8%) 5/50 (10%) 12/50 (24%) 15/49 (31%) |
|POLY-3 ADJUSTED (b)| 11.0% 19.3% 23.7% 44.0% |9.6% 11.8% 30.6% 42.9% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 3/9 (33%) 2/6 (33%) |3/26 (12%) 4/31 (13%) 2/15 (13%) 5/14 (36%) |
|FIRST INCIDENCE | 556 533 393 474 |708 675 533 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.283 P=0.110 P=0.002 ** |P<0.001 ** P=0.598 P=0.005 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.240 P=0.123 P<0.001 ** |P<0.001 ** P=0.508 P=0.015 * P<0.001 ** |
|POLY 1.5 | P=0.002 ** P=0.214 P=0.123 P=0.002 ** |P<0.001 ** P=0.499 P=0.019 * P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.276 P=0.119 P=0.002 ** |P<0.001 ** P=0.527 P=0.013 * P<0.001 ** |
|LOGISTIC REGRESSION| P=0.002 ** P=0.150 P=0.117 P=0.003 ** |P<0.001 ** P=0.548 P=0.022 * P<0.001 ** |
|COCH-ARM / FISHERS | P=0.006 ** P=0.178 P=0.117 P=0.009 ** |P<0.001 ** P=0.500 P=0.027 * P=0.004 ** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/50 (10%) 17/50 (34%) 35/50 (70%) |1/50 (2%) 6/50 (12%) 15/50 (30%) 29/49 (59%) |
|POLY-3 ADJUSTED (b)| 16.6% 12.6% 44.1% 86.1% |2.4% 14.2% 37.3% 71.8% |
|TERMINAL (d) | 2/12 (17%) 1/14 (7%) 4/9 (44%) 6/6 (100%) |1/26 (4%) 5/31 (16%) 2/15 (13%) 7/14 (50%) |
|FIRST INCIDENCE | 543 550 526 23 |730 (T) 675 355 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.379N P=0.008 ** P<0.001 ** |P<0.001 ** P=0.086 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.434N P=0.007 ** P<0.001 ** |P<0.001 ** P=0.057 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.458N P=0.007 ** P<0.001 ** |P<0.001 ** P=0.055 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.404N P=0.006 ** P<0.001 ** |P<0.001 ** P=0.062 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.449N P=0.008 ** P<0.001 ** |P<0.001 ** P=0.069 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500N P=0.008 ** P<0.001 ** |P<0.001 ** P=0.056 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 17/50 (34%) 10/50 (20%) 25/50 (50%) 43/50 (86%) |5/50 (10%) 9/50 (18%) 26/50 (52%) 42/49 (86%) |
|POLY-3 ADJUSTED (b)| 44.9% 23.9% 61.4% 93.6% |11.6% 21.3% 61.2% 92.2% |
|TERMINAL (d) | 8/12 (67%) 1/14 (7%) 6/9 (67%) 5/6 (83%) |2/26 (8%) 8/31 (26%) 6/15 (40%) 11/14 (79%) |
|FIRST INCIDENCE | 543 449 481 23 |550 675 355 32 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.046N* P=0.052 P<0.001 ** |P<0.001 ** P=0.272 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.034N* P=0.091 P<0.001 ** |P<0.001 ** P=0.179 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.051N P=0.086 P<0.001 ** |P<0.001 ** P=0.180 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.020N* P=0.106 P<0.001 ** |P<0.001 ** P=0.183 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.062N P=0.075 P<0.001 ** |P<0.001 ** P=0.194 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.088N P=0.078 P<0.001 ** |P<0.001 ** P=0.194 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 2/50 (4%) 11/50 (22%) 24/50 (48%) |1/50 (2%) 1/50 (2%) 11/50 (22%) 16/49 (33%) |
|POLY-3 ADJUSTED (b)| 2.8% 5.1% 29.1% 65.1% |2.4% 2.4% 28.4% 43.2% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 2/9 (22%) 5/6 (83%) |0/26 (0%) 1/31 (3%) 1/15 (7%) 2/14 (14%) |
|FIRST INCIDENCE | 708 708 526 23 |550 730 (T) 533 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.589 P=0.003 ** P<0.001 ** |P<0.001 ** P=0.741N P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.535 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.760 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.522 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.758 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.553 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.758N P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.568 P=0.003 ** P<0.001 ** |P<0.001 ** P=0.759N P=0.003 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.500 P=0.002 ** P<0.001 ** |P<0.001 ** P=0.753N P=0.002 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Squamous Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 11/50 (22%) 39/50 (78%) 48/50 (96%) |3/50 (6%) 15/50 (30%) 29/50 (58%) 45/49 (92%) |
|POLY-3 ADJUSTED (b)| 8.5% 26.7% 86.4% 98.6% |7.0% 33.8% 66.6% 94.6% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 8/9 (89%) 6/6 (100%) |1/26 (4%) 7/31 (23%) 7/15 (47%) 12/14 (86%) |
|FIRST INCIDENCE | 702 533 365 23 |550 561 276 32 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.067 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.037 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.029 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.053 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.032 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.020 * P<0.001 ** P<0.001 ** |P<0.001 ** P=0.002 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Nose: Squamous Epithelium |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 17/50 (34%) 41/50 (82%) 49/50 (98%) |6/50 (12%) 26/50 (52%) 42/50 (84%) 48/49 (98%) |
|POLY-3 ADJUSTED (b)| 16.7% 39.3% 89.1% 99.7% |13.8% 56.0% 85.4% 99.3% |
|TERMINAL (d) | 2/12 (17%) 1/14 (7%) 7/9 (78%) 6/6 (100%) |1/26 (4%) 14/31 (45%) 9/15 (60%) 14/14 (100%) |
|FIRST INCIDENCE | 556 449 365 23 |550 542 276 32 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.047 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.021 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.014 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.040 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.011 * P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.008 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |3/50 (6%) 3/50 (6%) 7/50 (14%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| |7.0% 7.0% 18.8% 12.3% |
|TERMINAL (d) | |0/26 (0%) 1/31 (3%) 3/15 (20%) 2/14 (14%) |
|FIRST INCIDENCE | |550 593 357 432 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.070 P=0.642N P=0.061 P=0.297 |
|POLY 3 | |P=0.116 P=0.663N P=0.104 P=0.354 |
|POLY 1.5 | |P=0.143 P=0.658 P=0.126 P=0.385 |
|POLY 6 | |P=0.092 P=0.653N P=0.080 P=0.323 |
|LOGISTIC REGRESSION| |P=0.207 P=0.657N P=0.168 P=0.457 |
|COCH-ARM / FISHERS | |P=0.239 P=0.661N P=0.159 P=0.489 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Pancreas: Acinus |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 3/49 (6%) 2/50 (4%) 5/48 (10%) |3/50 (6%) 3/50 (6%) 3/50 (6%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 24.1% 7.8% 5.5% 17.6% |7.2% 7.1% 8.2% 12.2% |
|TERMINAL (d) | 2/12 (17%) 3/14 (21%) 0/9 (0%) 2/6 (33%) |2/26 (8%) 3/31 (10%) 0/15 (0%) 2/14 (14%) |
|FIRST INCIDENCE | 543 729 (T) 481 561 |708 730 (T) 619 583 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.273N P=0.038N* P=0.042N* P=0.448N |P=0.133 P=0.581N P=0.469 P=0.247 |
|POLY 3 | P=0.138N P=0.047N* P=0.024N* P=0.371N |P=0.284 P=0.660N P=0.598 P=0.368 |
|POLY 1.5 | P=0.131N P=0.052N P=0.024N* P=0.345N |P=0.315 P=0.660 P=0.626 P=0.397 |
|POLY 6 | P=0.149N P=0.044N* P=0.028N* P=0.401N |P=0.254 P=0.648N P=0.564 P=0.345 |
|LOGISTIC REGRESSION| P=0.161N P=0.043N* P=0.027N* P=0.340N |P=0.243 P=0.607N P=0.580 P=0.350 |
|COCH-ARM / FISHERS | P=0.106N P=0.065N P=0.026N* P=0.217N |P=0.399 P=0.661N P=0.661N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Parathyroid Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/42 (17%) 7/38 (18%) 1/45 (2%) 3/41 (7%) |0/42 (0%) 0/39 (0%) 2/44 (5%) 0/36 (0%) |
|POLY-3 ADJUSTED (b)| 22.6% 22.7% 3.1% 11.9% |0.0% 0.0% 6.2% 0.0% |
|TERMINAL (d) | 1/10 (10%) 1/11 (9%) 0/6 (0%) 0/5 (0%) |0/23 (0%) 0/25 (0%) 1/13 (8%) 0/10 (0%) |
|FIRST INCIDENCE | 657 356 661 561 |--- --- 543 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.101N P=0.490N P=0.058N P=0.336N |P=0.256 (e) P=0.168 (e) |
|POLY 3 | P=0.036N* P=0.619 P=0.022N* P=0.240N |P=0.277 (e) P=0.214 (e) |
|POLY 1.5 | P=0.033N* P=0.588 P=0.021N* P=0.225N |P=0.292 (e) P=0.228 (e) |
|POLY 6 | P=0.043N* P=0.581N P=0.024N* P=0.258N |P=0.264 (e) P=0.197 (e) |
|LOGISTIC REGRESSION| P=0.039N* P=0.566 P=0.028N* P=0.268N |P=0.357 (e) P=0.258 (e) |
|COCH-ARM / FISHERS | P=0.026N* P=0.534 P=0.023N* P=0.166N |P=0.354 (e) P=0.259 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/49 (4%) 1/50 (2%) 1/50 (2%) |3/50 (6%) 1/50 (2%) 3/50 (6%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 5.6% 5.2% 2.8% 3.6% |7.1% 2.4% 8.1% 6.2% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 495 671 652 708 |550 730 (T) 558 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.413N P=0.643N P=0.515N P=0.593N |P=0.415 P=0.277N P=0.509 P=0.668N |
|POLY 3 | P=0.367N P=0.670N P=0.501N P=0.590N |P=0.510 P=0.308N P=0.595 P=0.624N |
|POLY 1.5 | P=0.353N P=0.682N P=0.498N P=0.576N |P=0.536 P=0.310N P=0.624 P=0.598N |
|POLY 6 | P=0.383N P=0.655N P=0.507N P=0.604N |P=0.484 P=0.302N P=0.561 P=0.647N |
|LOGISTIC REGRESSION| P=0.340N P=0.690 P=0.509N P=0.553N |P=0.540N P=0.305N P=0.641N P=0.562N |
|COCH-ARM / FISHERS | P=0.288N P=0.684 P=0.500N P=0.500N |P=0.508N P=0.309N P=0.661N P=0.510N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/50 (2%) 0/49 (0%) 3/50 (6%) 3/50 (6%) |1/50 (2%) 0/50 (0%) 1/50 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.9% 0.0% 8.3% 10.6% |2.4% 0.0% 2.7% 3.1% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 1/9 (11%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 729 (T) --- 587 492 |566 --- 513 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.031 * P=0.469N P=0.246 P=0.185 |P=0.428 P=0.504N P=0.729 P=0.697 |
|POLY 3 | P=0.058 P=0.483N P=0.315 P=0.231 |P=0.458 P=0.501N P=0.727 P=0.698 |
|POLY 1.5 | P=0.062 P=0.491N P=0.313 P=0.239 |P=0.468 P=0.502N P=0.742 P=0.711 |
|POLY 6 | P=0.054 P=0.472N P=0.316 P=0.228 |P=0.447 P=0.497N P=0.707 P=0.685 |
|LOGISTIC REGRESSION| P=0.051 (e) P=0.305 P=0.226 |P=0.595N P=0.484N P=0.731N P=0.718N |
|COCH-ARM / FISHERS | P=0.086 P=0.505N P=0.309 P=0.309 |P=0.495 P=0.500N P=0.753N P=0.747 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 5/49 (10%) 4/50 (8%) 1/50 (2%) |3/50 (6%) 4/50 (8%) 4/50 (8%) 7/49 (14%) |
|POLY-3 ADJUSTED (b)| 16.6% 12.8% 11.0% 3.6% |7.1% 9.5% 11.0% 21.5% |
|TERMINAL (d) | 3/12 (25%) 1/14 (7%) 1/9 (11%) 0/6 (0%) |1/26 (4%) 3/31 (10%) 2/15 (13%) 2/14 (14%) |
|FIRST INCIDENCE | 555 634 533 718 |598 720 617 628 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.127N P=0.387N P=0.441N P=0.167N |P=0.014 * P=0.573 P=0.299 P=0.044 * |
|POLY 3 | P=0.091N P=0.446N P=0.362N P=0.109N |P=0.051 P=0.497 P=0.417 P=0.071 |
|POLY 1.5 | P=0.079N P=0.472N P=0.360N P=0.099N |P=0.064 P=0.494 P=0.452 P=0.085 |
|POLY 6 | P=0.104N P=0.412N P=0.369N P=0.120N |P=0.039 * P=0.506 P=0.373 P=0.060 |
|LOGISTIC REGRESSION| P=0.071N P=0.440N P=0.361N P=0.105N |P=0.037 * P=0.506 P=0.443 P=0.073 |
|COCH-ARM / FISHERS | P=0.040N* P=0.514N P=0.370N P=0.056N |P=0.106 P=0.500 P=0.500 P=0.151 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.5% 0.0% | |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) | |
|FIRST INCIDENCE | --- 634 593 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.431 P=0.531 P=0.246 (e) | |
|POLY 3 | P=0.391 P=0.522 P=0.243 (e) | |
|POLY 1.5 | P=0.406 P=0.513 P=0.242 (e) | |
|POLY 6 | P=0.378 P=0.533 P=0.245 (e) | |
|LOGISTIC REGRESSION| P=0.480 P=0.493 P=0.236 (e) | |
|COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.247 (e) | |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/50 (10%) 2/50 (4%) 3/50 (6%) 1/50 (2%) | |
|POLY-3 ADJUSTED (b)| 13.8% 5.2% 8.2% 3.6% | |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) | |
|FIRST INCIDENCE | 543 724 593 708 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.183N P=0.168N P=0.407N P=0.203N | |
|POLY 3 | P=0.142N P=0.186N P=0.351N P=0.173N | |
|POLY 1.5 | P=0.131N P=0.196N P=0.350N P=0.160N | |
|POLY 6 | P=0.154N P=0.175N P=0.356N P=0.188N | |
|LOGISTIC REGRESSION| P=0.124N P=0.175N P=0.350N P=0.162N | |
|COCH-ARM / FISHERS | P=0.083N P=0.218N P=0.357N P=0.102N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 2/50 (4%) 0/50 (0%) | |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.6% 0.0% | |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 1/9 (11%) 0/6 (0%) | |
|FIRST INCIDENCE | --- 729 (T) 711 --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348 P=0.531 P=0.201 (e) | |
|POLY 3 | P=0.390 P=0.520 P=0.239 (e) | |
|POLY 1.5 | P=0.405 P=0.512 P=0.240 (e) | |
|POLY 6 | P=0.377 P=0.530 P=0.237 (e) | |
|LOGISTIC REGRESSION| P=0.386 P=0.531 P=0.211 (e) | |
|COCH-ARM / FISHERS | P=0.500 P=0.500 P=0.247 (e) | |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/50 (18%) 4/50 (8%) 5/50 (10%) 3/50 (6%) | |
|POLY-3 ADJUSTED (b)| 24.7% 10.0% 13.7% 10.4% | |
|TERMINAL (d) | 5/12 (42%) 0/14 (0%) 1/9 (11%) 0/6 (0%) | |
|FIRST INCIDENCE | 543 495 561 107 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.178N P=0.076N P=0.301N P=0.236N | |
|POLY 3 | P=0.094N P=0.075N P=0.178N P=0.120N | |
|POLY 1.5 | P=0.086N P=0.090N P=0.181N P=0.111N | |
|POLY 6 | P=0.102N P=0.058N P=0.175N P=0.125N | |
|LOGISTIC REGRESSION| P=0.066N P=0.094N P=0.184N P=0.103N | |
|COCH-ARM / FISHERS | P=0.049N* P=0.117N P=0.194N P=0.061N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Seminal Vesicle |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/50 (6%) 1/50 (2%) 0/50 (0%) 0/49 (0%) | |
|POLY-3 ADJUSTED (b)| 8.5% 2.6% 0.0% 0.0% | |
|TERMINAL (d) | 2/12 (17%) 0/14 (0%) 0/9 (0%) 0/6 (0%) | |
|FIRST INCIDENCE | 694 716 --- --- | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.041N* P=0.250N P=0.171N P=0.238N | |
|POLY 3 | P=0.027N* P=0.270N P=0.115N P=0.171N | |
|POLY 1.5 | P=0.026N* P=0.283N P=0.115N P=0.165N | |
|POLY 6 | P=0.028N* P=0.253N P=0.115N P=0.175N | |
|LOGISTIC REGRESSION| P=0.029N* P=0.231N P=0.130N P=0.180N | |
|COCH-ARM / FISHERS | P=0.022N* P=0.309N P=0.121N P=0.125N | |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Cyst Epithelial Inclusion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 2/50 (4%) 0/50 (0%) 0/50 (0%) |1/50 (2%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.6% 5.1% 0.0% 0.0% |2.4% 7.0% 0.0% 0.0% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 617 634 --- --- |682 615 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.092N P=0.630N P=0.260N P=0.342N |P=0.219N P=0.337 P=0.590N P=0.581N |
|POLY 3 | P=0.077N P=0.660N P=0.235N P=0.296N |P=0.205N P=0.311 P=0.532N P=0.553N |
|POLY 1.5 | P=0.073N P=0.672N P=0.234N P=0.287N |P=0.179N P=0.305 P=0.518N P=0.540N |
|POLY 6 | P=0.082N P=0.643N P=0.239N P=0.305N |P=0.238N P=0.323 P=0.549N P=0.566N |
|LOGISTIC REGRESSION| P=0.071N P=0.660N P=0.235N P=0.292N |P=0.158N P=0.304 P=0.523N P=0.545N |
|COCH-ARM / FISHERS | P=0.057N P=0.691N P=0.247N P=0.247N |P=0.129N P=0.309 P=0.500N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 0/50 (0%) 0/50 (0%) 1/50 (2%) |2/50 (4%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 3.6% |4.8% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- --- --- 683 |674 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142 (e) (e) P=0.436 |P=0.092N P=0.218N P=0.340N P=0.357N |
|POLY 3 | P=0.215 (e) (e) P=0.454 |P=0.068N P=0.236N P=0.274N P=0.302N |
|POLY 1.5 | P=0.210 (e) (e) P=0.459 |P=0.063N P=0.238N P=0.258N P=0.285N |
|POLY 6 | P=0.216 (e) (e) P=0.450 |P=0.074N P=0.231N P=0.296N P=0.319N |
|LOGISTIC REGRESSION| P=0.150 (e) (e) P=0.447 |P=0.073N P=0.235N P=0.286N P=0.306N |
|COCH-ARM / FISHERS | P=0.185 (e) (e) P=0.500 |P=0.056N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Spinal Cord |
| Demyelination |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/1 (0%) 2/2 (100%) 0/0 (0%) 2/4 (50%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |0.0% 100.0% 0.0% 99.7% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- --- --- --- |--- 117 --- 108 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.139 P=0.500 (e) P=0.229 |
|POLY 3 | (e) (e) (e) (e) |(e) P=1.000N (e) P=1.000 |
|POLY 1.5 | (e) (e) (e) (e) |(e) P=1.000N (e) P=1.000 |
|POLY 6 | (e) (e) (e) (e) |(e) P=1.000N (e) P=1.000 |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.476 P=0.496 (e) P=0.863 |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.625N P=0.333 (e) P=0.600 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 15/50 (30%) 15/50 (30%) 16/50 (32%) 9/50 (18%) |5/50 (10%) 7/50 (14%) 8/50 (16%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 39.4% 36.1% 41.2% 31.5% |11.9% 16.5% 20.8% 12.0% |
|TERMINAL (d) | 6/12 (50%) 6/14 (43%) 3/9 (33%) 3/6 (50%) |3/26 (12%) 4/31 (13%) 1/15 (7%) 2/14 (14%) |
|FIRST INCIDENCE | 543 449 561 561 |708 617 513 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.475 P=0.378N P=0.399 P=0.494N |P=0.229 P=0.501 P=0.115 P=0.495 |
|POLY 3 | P=0.403N P=0.469N P=0.530 P=0.340N |P=0.407 P=0.389 P=0.218 P=0.634 |
|POLY 1.5 | P=0.341N P=0.510N P=0.525 P=0.288N |P=0.462 P=0.379 P=0.241 P=0.607N |
|POLY 6 | P=0.474N P=0.429N P=0.538 P=0.408N |P=0.354 P=0.412 P=0.194 P=0.604 |
|LOGISTIC REGRESSION| P=0.336N P=0.484N P=0.519 P=0.313N |P=0.535N P=0.410 P=0.256 P=0.551N |
|COCH-ARM / FISHERS | P=0.129N P=0.586N P=0.500 P=0.121N |P=0.461N P=0.380 P=0.277 P=0.500N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 0/50 (0%) 0/50 (0%) |2/50 (4%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |4.7% 2.4% 2.7% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |1/26 (4%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 617 --- --- |518 730 (T) 276 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.534N P=0.546 (e) (e) |P=0.210N P=0.464N P=0.575N P=0.349N |
|POLY 3 | P=0.563N P=0.522 (e) (e) |P=0.193N P=0.502N P=0.550N P=0.305N |
|POLY 1.5 | P=0.555N P=0.513 (e) (e) |P=0.174N P=0.504N P=0.527N P=0.287N |
|POLY 6 | P=0.571N P=0.533 (e) (e) |P=0.216N P=0.495N P=0.579N P=0.323N |
|LOGISTIC REGRESSION| P=0.502N P=0.482 (e) (e) |P=0.074N P=0.498N P=0.434N P=0.227N |
|COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.129N P=0.500N P=0.500N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 1/50 (2%) 1/50 (2%) 0/50 (0%) |1/50 (2%) 0/50 (0%) 2/50 (4%) 1/50 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.5% 2.8% 0.0% |2.4% 0.0% 5.5% 3.1% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 569 654 --- |660 --- 355 514 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.579 P=0.529 P=0.523 (e) |P=0.313 P=0.500N P=0.419 P=0.676 |
|POLY 3 | P=0.557 P=0.522 P=0.504 (e) |P=0.343 P=0.499N P=0.453 P=0.701 |
|POLY 1.5 | P=0.565 P=0.514 P=0.504 (e) |P=0.359 P=0.501N P=0.474 P=0.716 |
|POLY 6 | P=0.550 P=0.534 P=0.504 (e) |P=0.329 P=0.495N P=0.425 P=0.687 |
|LOGISTIC REGRESSION| P=0.626N P=0.450 P=0.502 (e) |P=0.514 P=0.499N P=0.552 P=0.747N |
|COCH-ARM / FISHERS | P=0.625 P=0.500 P=0.500 (e) |P=0.411 P=0.500N P=0.500 P=0.753N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/50 (0%) 3/50 (6%) 0/50 (0%) 0/50 (0%) |0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.6% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 634 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.364N P=0.164 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.371N P=0.139 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.362N P=0.131 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.378N P=0.152 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.347N P=0.134 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.301N P=0.121 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 8/49 (16%) 3/49 (6%) 3/50 (6%) 5/48 (10%) |3/49 (6%) 4/50 (8%) 2/50 (4%) 4/50 (8%) |
|POLY-3 ADJUSTED (b)| 21.5% 7.6% 8.2% 16.5% |7.2% 9.1% 5.5% 11.7% |
|TERMINAL (d) | 2/12 (17%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 580 550 593 106 |651 542 543 375 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.360N P=0.067N P=0.121N P=0.493N |P=0.315 P=0.516 P=0.642N P=0.349 |
|POLY 3 | P=0.262N P=0.075N P=0.097N P=0.417N |P=0.391 P=0.529 P=0.560N P=0.394 |
|POLY 1.5 | P=0.245N P=0.082N P=0.093N P=0.388N |P=0.427 P=0.517 P=0.530N P=0.418 |
|POLY 6 | P=0.284N P=0.069N P=0.108N P=0.452N |P=0.349 P=0.549 P=0.599N P=0.369 |
|LOGISTIC REGRESSION| P=0.121N P=0.107N P=0.094N P=0.229N |P=0.513N P=0.521 P=0.499N P=0.560 |
|COCH-ARM / FISHERS | P=0.199N P=0.100N P=0.094N P=0.290N |P=0.510 P=0.511 P=0.490N P=0.511 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 1/49 (2%) 1/50 (2%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 11.4% 2.6% 2.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 689 579 632 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.036N* P=0.138N P=0.225N P=0.112N |(e) (e) (e) (e) |
|POLY 3 | P=0.031N* P=0.146N P=0.169N P=0.095N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.029N* P=0.158N P=0.169N P=0.090N |(e) (e) (e) (e) |
|POLY 6 | P=0.034N* P=0.133N P=0.172N P=0.102N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.027N* P=0.148N P=0.176N P=0.102N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.021N* P=0.181N P=0.175N P=0.061N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 7/49 (14%) 4/50 (8%) 2/48 (4%) |3/49 (6%) 2/50 (4%) 2/50 (4%) 2/50 (4%) |
|POLY-3 ADJUSTED (b)| 13.9% 17.5% 11.0% 7.0% |7.2% 4.7% 5.6% 5.9% |
|TERMINAL (d) | 1/12 (8%) 1/14 (7%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 1/31 (3%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 602 550 581 106 |598 720 703 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.248N P=0.524 P=0.520N P=0.359N |P=0.544 P=0.449N P=0.654N P=0.617N |
|POLY 3 | P=0.197N P=0.453 P=0.492N P=0.314N |P=0.485N P=0.495N P=0.568N P=0.596N |
|POLY 1.5 | P=0.178N P=0.427 P=0.486N P=0.295N |P=0.450N P=0.497N P=0.534N P=0.569N |
|POLY 6 | P=0.222N P=0.486 P=0.505N P=0.334N |P=0.526N P=0.490N P=0.611N P=0.624N |
|LOGISTIC REGRESSION| P=0.129N P=0.422 P=0.486N P=0.208N |P=0.298N P=0.492N P=0.535N P=0.310N |
|COCH-ARM / FISHERS | P=0.115N P=0.380 P=0.487N P=0.226N |P=0.372N P=0.490N P=0.490N P=0.490N |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach: Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 2/49 (4%) 2/50 (4%) 4/48 (8%) |3/49 (6%) 4/50 (8%) 3/50 (6%) 5/50 (10%) |
|POLY-3 ADJUSTED (b)| 29.0% 5.1% 5.5% 13.1% |7.2% 9.4% 8.2% 14.8% |
|TERMINAL (d) | 1/12 (8%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 2/31 (7%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 580 666 525 106 |651 612 543 375 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.047N* P=0.005N** P=0.015N* P=0.149N |P=0.131 P=0.540 P=0.497 P=0.206 |
|POLY 3 | P=0.019N* P=0.005N** P=0.007N** P=0.095N |P=0.215 P=0.515 P=0.603 P=0.248 |
|POLY 1.5 | P=0.018N* P=0.005N** P=0.006N** P=0.083N |P=0.246 P=0.509 P=0.633 P=0.273 |
|POLY 6 | P=0.022N* P=0.004N** P=0.009N** P=0.113N |P=0.184 P=0.528 P=0.563 P=0.226 |
|LOGISTIC REGRESSION| P=0.005N** P=0.007N** P=0.008N** P=0.031N* |P=0.291 P=0.510 P=0.665N P=0.344 |
|COCH-ARM / FISHERS | P=0.016N* P=0.007N** P=0.007N** P=0.049N* |P=0.325 P=0.511 P=0.651N P=0.369 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Erosion |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 1/50 (2%) 2/48 (4%) |0/49 (0%) 1/49 (2%) 1/50 (2%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 2.9% 0.0% 2.8% 7.0% |0.0% 2.4% 2.7% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 717 --- 705 449 |--- 720 355 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.181 P=0.486N P=0.726 P=0.401 |P=0.542 P=0.546 P=0.500 (e) |
|POLY 3 | P=0.227 P=0.480N P=0.757N P=0.432 |P=0.547 P=0.505 P=0.478 (e) |
|POLY 1.5 | P=0.232 P=0.487N P=0.755N P=0.438 |P=0.567 P=0.501 P=0.490 (e) |
|POLY 6 | P=0.220 P=0.471N P=0.761N P=0.431 |P=0.526 P=0.511 P=0.462 (e) |
|LOGISTIC REGRESSION| P=0.241 P=0.459N P=0.754 P=0.491 |P=0.528N P=0.516 P=0.470 (e) |
|COCH-ARM / FISHERS | P=0.245 P=0.500N P=0.747N P=0.492 |P=0.620N P=0.500 P=0.505 (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 1/50 (2%) 0/48 (0%) |0/49 (0%) 1/49 (2%) 2/50 (4%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 2.8% 0.0% |0.0% 2.4% 5.5% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 689 593 --- |--- 612 355 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.559 P=0.533 P=0.511 (e) |P=0.425 P=0.505 P=0.196 (e) |
|POLY 3 | P=0.563 P=0.521 P=0.507 (e) |P=0.390 P=0.507 P=0.213 (e) |
|POLY 1.5 | P=0.572 P=0.514 P=0.507 (e) |P=0.417 P=0.502 P=0.226 (e) |
|POLY 6 | P=0.555 P=0.532 P=0.506 (e) |P=0.367 P=0.514 P=0.197 (e) |
|LOGISTIC REGRESSION| P=0.609 P=0.527 P=0.494 (e) |P=0.601 P=0.505 P=0.272 (e) |
|COCH-ARM / FISHERS | P=0.623 P=0.500 P=0.505 (e) |P=0.506 P=0.500 P=0.253 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 0/50 (0%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 0.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | --- 550 --- --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.421N P=0.281 (e) (e) |(e) (e) (e) (e) |
|POLY 3 | P=0.437N P=0.265 (e) (e) |(e) (e) (e) (e) |
|POLY 1.5 | P=0.427N P=0.255 (e) (e) |(e) (e) (e) (e) |
|POLY 6 | P=0.447N P=0.280 (e) (e) |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.355N P=0.188 (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.377N P=0.247 (e) (e) |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular: Epithelium |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 9/49 (18%) 5/49 (10%) 3/50 (6%) 4/48 (8%) |0/49 (0%) 0/49 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 25.2% 12.5% 8.4% 13.9% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/12 (25%) 0/14 (0%) 1/9 (11%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 612 579 632 492 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.168N P=0.126N P=0.118N P=0.325N |(e) (e) (e) (e) |
|POLY 3 | P=0.081N P=0.127N P=0.051N P=0.209N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.075N P=0.151N P=0.051N P=0.198N |(e) (e) (e) (e) |
|POLY 6 | P=0.089N P=0.100N P=0.052N P=0.215N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.093N P=0.133N P=0.056N P=0.233N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.051N P=0.194N P=0.056N P=0.124N |(e) (e) (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Testes: Germinal Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/50 (24%) 9/50 (18%) 13/50 (26%) 6/50 (12%) | |
|POLY-3 ADJUSTED (b)| 32.5% 21.9% 34.5% 20.2% | |
|TERMINAL (d) | 4/12 (33%) 1/14 (7%) 3/9 (33%) 0/6 (0%) | |
|FIRST INCIDENCE | 555 356 526 474 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.477N P=0.184N P=0.375 P=0.311N | |
|POLY 3 | P=0.343N P=0.209N P=0.524 P=0.197N | |
|POLY 1.5 | P=0.314N P=0.245N P=0.521 P=0.188N | |
|POLY 6 | P=0.373N P=0.169N P=0.522 P=0.201N | |
|LOGISTIC REGRESSION| P=0.296N P=0.254N P=0.512 P=0.210N | |
|COCH-ARM / FISHERS | P=0.152N P=0.312N P=0.500 P=0.096N | |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/50 (8%) 0/50 (0%) 1/50 (2%) 4/50 (8%) | |
|POLY-3 ADJUSTED (b)| 10.9% 0.0% 2.8% 13.3% | |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) | |
|FIRST INCIDENCE | 495 --- 661 393 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.387 P=0.050N P=0.188N P=0.503 | |
|POLY 3 | P=0.477 P=0.052N P=0.184N P=0.530 | |
|POLY 1.5 | P=0.486 P=0.055N P=0.179N P=0.540 | |
|POLY 6 | P=0.462 P=0.050N P=0.193N P=0.522 | |
|LOGISTIC REGRESSION| P=0.503N P=0.078N P=0.187N P=0.595N | |
|COCH-ARM / FISHERS | P=0.500 P=0.059N P=0.181N P=0.643N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/50 (12%) 2/50 (4%) 8/50 (16%) 5/50 (10%) |3/50 (6%) 4/50 (8%) 4/49 (8%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 16.4% 5.2% 21.8% 17.3% |7.1% 9.5% 11.3% 12.2% |
|TERMINAL (d) | 0/12 (0%) 1/14 (7%) 3/9 (33%) 1/6 (17%) |1/26 (4%) 4/31 (13%) 2/15 (13%) 2/14 (14%) |
|FIRST INCIDENCE | 543 724 481 449 |542 730 (T) 674 106 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.167 P=0.095N P=0.319 P=0.550 |P=0.118 P=0.572 P=0.285 P=0.278 |
|POLY 3 | P=0.261 P=0.111N P=0.385 P=0.593 |P=0.253 P=0.495 P=0.399 P=0.361 |
|POLY 1.5 | P=0.284 P=0.118N P=0.393 P=0.613 |P=0.292 P=0.492 P=0.437 P=0.393 |
|POLY 6 | P=0.236 P=0.105N P=0.365 P=0.575 |P=0.214 P=0.504 P=0.354 P=0.329 |
|LOGISTIC REGRESSION| P=0.272 P=0.107N P=0.395 P=0.622 |P=0.314 P=0.502 P=0.419 P=0.528 |
|COCH-ARM / FISHERS | P=0.418 P=0.134N P=0.387 P=0.500N |P=0.391 P=0.500 P=0.489 P=0.489 |
|=================================================================================================================================|
Date: 09/14/98 EXPERIMENT: 05184 TEST: 05 Page 41
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - GLUTARALDEHYDE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Degeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 0/0 (0%) 0/0 (0%) 8/8 (100%) |1/1 (100%) 2/2 (100%) 0/0 (0%) 2/3 (67%) |
|POLY-3 ADJUSTED (b)| 100.0% 0.0% 0.0% 100.0% |100.0% 100.0% 0.0% 99.8% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 117 --- --- 99 |119 117 --- 113 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.384 (e) (e) P=0.464 |
|POLY 3 | (e) (e) (e) (e) |(e) (e) (e) P=1.000N |
|POLY 1.5 | (e) (e) (e) (e) |(e) (e) (e) P=1.000N |
|POLY 6 | (e) (e) (e) (e) |(e) (e) (e) P=1.000N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.274N (e) (e) P=0.750N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 250 PPB 500 PPB 750 PPB |CONTROL 250 PPB 500 PPB 750 PPB |
| | | |
|=================================================================================================================================|
| |
|Urinary Bladder: Transitional Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/50 (4%) 0/49 (0%) 1/50 (2%) 0/48 (0%) |0/49 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) |
|POLY-3 ADJUSTED (b)| 5.5% 0.0% 2.8% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/14 (0%) 0/9 (0%) 0/6 (0%) |0/26 (0%) 0/31 (0%) 0/15 (0%) 0/14 (0%) |
|FIRST INCIDENCE | 543 --- 705 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.180N P=0.213N P=0.507N P=0.299N |(e) (e) (e) (e) |
|POLY 3 | P=0.203N P=0.222N P=0.504N P=0.303N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.194N P=0.228N P=0.500N P=0.294N |(e) (e) (e) (e) |
|POLY 6 | P=0.211N P=0.215N P=0.515N P=0.314N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.145N P=0.301N P=0.507N P=0.230N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.153N P=0.253N P=0.500N P=0.258N |(e) (e) (e) (e) |
|=================================================================================================================================|
(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).