TDMS Study 05110-02 Pathology Tables
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest NAPHTHALENE DATE: 03/06/00
EXPERIMENT: 05110 TEST: 02 TIME: 11:09:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE PAGE: 1
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 52904C
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 91-20-3
------------------------------------------------------------------------------------------------------------------------------------
FINAL#2, CORE STUDY RATS
REASONS FOR REMOVAL: ALL
REMOVAL DATE RANGE: ALL
TREATMENT GROUPS: INCLUDE ALL
NTP STATISTICAL ANALYSIS OF NON-NEOPLASTIC LESIONS REPORT: PEIRPT10
LAB: Battelle Northwest NAPHTHALENE DATE: 03/06/00
EXPERIMENT: 05110 TEST: 02 TIME: 11:09:10
TEST TYPE: CHRONIC CAGES FROM 0000 TO LAST CAGE
CONT: NO1-ES-55392 ROUTE: RESPIRATORY EXPOSURE WHOLE BODY NTP C#: 52904C
PATHOLOGIST: GRUMBEIN, SONDRA CAS: 91-20-3
SUMMARY OF STATISTICALLY SIGNIFICANT (P<=.05) RESULTS
IN THE ANALYSIS OF NAPHTHALENE
===============================================================
Male Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Adrenal Medulla Hyperplasia
Liver: Bile Duct Hyperplasia
Liver: Centrilobular Necrosis
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Nose: Glands Hyperplasia
Metaplasia
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Atrophy
Degeneration Hyaline
Hyperplasia Atypical
Inflammation Chronic
Nose: Respiratory Epithelium Degeneration Hyaline
Hyperplasia
Metaplasia
Skin Inflammation Chronic
===============================================================
Female Rats
------------
Organ Morphology
----- ----------
Adrenal Cortex Hyperplasia
Adrenal Medulla Hyperplasia
Kidney Nephropathy
Liver Clear Cell Focus
Eosinophilic Focus
Fatty Change
Lung Inflammation Chronic
Lung: Alveolar Epithelium Hyperplasia
Lung: Alveolus Infiltration Cellular Histiocyte
Nose: Glands Hyperplasia
Metaplasia
Nose: Goblet Cell, Respiratory Epithelium
Hyperplasia
Nose: Olfactory Epithelium Atrophy
Degeneration Hyaline
Hyperplasia Atypical
Inflammation Chronic
Nose: Respiratory Epithelium Degeneration Hyaline
Hyperplasia
Metaplasia
Pancreas Atrophy
Pituitary Gland: Pars Distalis Hyperplasia
Skin Inflammation Acute
===============================================================
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 1
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- --- |657 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.159N P=0.298N P=0.266N P=0.300N |
|POLY 3 | (e) (e) (e) (e) |P=0.124N P=0.265N P=0.252N P=0.269N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.129N P=0.253N P=0.247N P=0.258N |
|POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.281N P=0.258N P=0.283N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.139N P=0.228N P=0.227N P=0.236N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.139N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 1/48 (2%) 1/49 (2%) |4/49 (8%) 4/49 (8%) 3/49 (6%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 2.6% 2.7% |9.2% 10.2% 7.3% 7.9% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 1/23 (4%) 1/21 (5%) |3/28 (11%) 3/21 (14%) 1/28 (4%) 2/24 (8%) |
|FIRST INCIDENCE | --- 695 733 (T) 733 (T) |713 581 586 680 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.508 P=0.211 P=0.492 P=0.473 |P=0.415N P=0.499 P=0.506N P=0.587N |
|POLY 3 | P=0.497 P=0.228 P=0.490 P=0.479 |P=0.429N P=0.588 P=0.526N P=0.569N |
|POLY 1.5 | P=0.514 P=0.232 P=0.493 P=0.487 |P=0.414N P=0.611 P=0.517N P=0.546N |
|POLY 6 | P=0.477 P=0.223 P=0.485 P=0.470 |P=0.442N P=0.558 P=0.532N P=0.593N |
|LOGISTIC REGRESSION| P=0.498 P=0.220 P=0.492 P=0.473 |P=0.438N P=0.551 P=0.530N P=0.612N |
|COCH-ARM / FISHERS | P=0.543 P=0.247 P=0.495 P=0.500 |P=0.381N P=0.643N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 2
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 30/49 (61%) 28/49 (57%) 23/48 (48%) 36/49 (73%) |23/49 (47%) 12/49 (24%) 18/49 (37%) 24/49 (49%) |
|POLY-3 ADJUSTED (b)| 66.5% 68.5% 56.5% 80.2% |51.3% 29.5% 42.6% 57.7% |
|TERMINAL (d) | 17/24 (71%) 20/22 (91%) 16/23 (70%) 18/21 (86%) |17/28 (61%) 9/21 (43%) 13/28 (46%) 16/24 (67%) |
|FIRST INCIDENCE | 460 593 574 399 |602 440 586 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.042 * P=0.536 P=0.213N P=0.063 |P=0.098 P=0.116N P=0.248N P=0.230 |
|POLY 3 | P=0.093 P=0.515 P=0.221N P=0.094 |P=0.105 P=0.029N* P=0.270N P=0.347 |
|POLY 1.5 | P=0.094 P=0.566N P=0.177N P=0.104 |P=0.121 P=0.022N* P=0.245N P=0.410 |
|POLY 6 | P=0.097 P=0.381 P=0.295N P=0.087 |P=0.091 P=0.044N* P=0.292N P=0.272 |
|LOGISTIC REGRESSION| P=0.039 * P=0.522N P=0.153N P=0.105 |P=0.088 P=0.038N* P=0.296N P=0.359 |
|COCH-ARM / FISHERS | P=0.110 P=0.419N P=0.133N P=0.141 |P=0.154 P=0.017N* P=0.206N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Hypertrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 6/49 (12%) 9/48 (19%) 4/49 (8%) |7/49 (14%) 4/49 (8%) 12/49 (24%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 16.9% 15.0% 22.9% 10.8% |16.1% 10.2% 28.5% 15.3% |
|TERMINAL (d) | 4/24 (17%) 3/22 (14%) 7/23 (30%) 1/21 (5%) |5/28 (18%) 2/21 (10%) 10/28 (36%) 4/24 (17%) |
|FIRST INCIDENCE | 657 593 615 685 |705 622 440 445 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.371N P=0.551N P=0.335 P=0.365N |P=0.383 P=0.439N P=0.147 P=0.615N |
|POLY 3 | P=0.361N P=0.529N P=0.344 P=0.328N |P=0.364 P=0.321N P=0.129 P=0.578N |
|POLY 1.5 | P=0.328N P=0.517N P=0.360 P=0.302N |P=0.382 P=0.296N P=0.138 P=0.552N |
|POLY 6 | P=0.401N P=0.546N P=0.318 P=0.360N |P=0.347 P=0.355N P=0.121 P=0.605N |
|LOGISTIC REGRESSION| P=0.358N P=0.529N P=0.329 P=0.343N |P=0.361 P=0.387N P=0.119 P=0.574N |
|COCH-ARM / FISHERS | P=0.278N P=0.500N P=0.375 P=0.262N |P=0.430 P=0.262N P=0.153 P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 3
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/48 (4%) 1/49 (2%) |4/49 (8%) 2/49 (4%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.1% 2.7% |9.1% 5.1% 0.0% 2.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 695 613 632 |671 577 --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.316 P=0.465 P=0.223 P=0.462 |P=0.117N P=0.436N P=0.083N P=0.258N |
|POLY 3 | P=0.327 P=0.492 P=0.229 P=0.481 |P=0.092N P=0.388N P=0.070N P=0.223N |
|POLY 1.5 | P=0.342 P=0.495 P=0.231 P=0.488 |P=0.091N P=0.366N P=0.066N P=0.207N |
|POLY 6 | P=0.311 P=0.488 P=0.227 P=0.474 |P=0.093N P=0.417N P=0.074N P=0.241N |
|LOGISTIC REGRESSION| P=0.388 P=0.493 P=0.238 P=0.524 |P=0.075N P=0.284N P=0.060N P=0.168N |
|COCH-ARM / FISHERS | P=0.370 P=0.500 P=0.242 P=0.500 |P=0.089N P=0.339N P=0.059N P=0.181N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Cortex |
| Vacuolization Cytoplasmic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 3/48 (6%) 0/49 (0%) |0/49 (0%) 2/49 (4%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.5% 7.7% 0.0% |0.0% 5.1% 0.0% 2.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 2/23 (9%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 639 615 643 --- |--- 679 --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.478N P=0.747 P=0.284 P=0.539N |P=0.578 P=0.190 (e) P=0.469 |
|POLY 3 | P=0.472N P=0.752 P=0.286 P=0.523N |P=0.553 P=0.215 (e) P=0.474 |
|POLY 1.5 | P=0.453N P=0.755 P=0.292 P=0.514N |P=0.570 P=0.224 (e) P=0.483 |
|POLY 6 | P=0.494N P=0.747 P=0.277 P=0.533N |P=0.535 P=0.204 (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.427N P=0.746N P=0.293 P=0.482N |P=0.573 P=0.218 (e) P=0.469 |
|COCH-ARM / FISHERS | P=0.423N P=0.753N P=0.301 P=0.500N |P=0.600 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 4
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 26/49 (53%) 13/49 (27%) 23/47 (49%) 12/49 (24%) |10/48 (21%) 3/49 (6%) 9/49 (18%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 59.2% 32.0% 57.0% 31.3% |22.9% 7.6% 21.3% 12.8% |
|TERMINAL (d) | 15/24 (63%) 6/22 (27%) 12/23 (52%) 7/21 (33%) |4/28 (14%) 0/21 (0%) 5/28 (18%) 2/24 (8%) |
|FIRST INCIDENCE | 460 593 600 469 |657 625 586 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.105N P=0.028N* P=0.472N P=0.026N* |P=0.386N P=0.108N P=0.562N P=0.258N |
|POLY 3 | P=0.053N P=0.008N** P=0.508N P=0.007N** |P=0.324N P=0.051N P=0.534N P=0.182N |
|POLY 1.5 | P=0.041N* P=0.006N** P=0.469N P=0.005N** |P=0.312N P=0.042N* P=0.514N P=0.159N |
|POLY 6 | P=0.074N P=0.010N* P=0.552N P=0.012N* |P=0.336N P=0.067N P=0.554N P=0.213N |
|LOGISTIC REGRESSION| P=0.060N P=0.009N** P=0.474N P=0.008N** |P=0.314N P=0.041N* P=0.497N P=0.143N |
|COCH-ARM / FISHERS | P=0.031N* P=0.006N** P=0.421N P=0.003N** |P=0.283N P=0.032N* P=0.480N P=0.121N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Adrenal Medulla |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/47 (0%) 0/49 (0%) |2/48 (4%) 1/49 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |4.7% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 700 --- --- |677 663 --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.520N P=0.464 (e) (e) |P=0.121N P=0.574N P=0.256N P=0.287N |
|POLY 3 | P=0.508N P=0.492 (e) (e) |P=0.100N P=0.532N P=0.248N P=0.265N |
|POLY 1.5 | P=0.505N P=0.495 (e) (e) |P=0.101N P=0.516N P=0.242N P=0.253N |
|POLY 6 | P=0.512N P=0.488 (e) (e) |P=0.100N P=0.554N P=0.254N P=0.279N |
|LOGISTIC REGRESSION| P=0.516N P=0.491 (e) (e) |P=0.101N P=0.488N P=0.232N P=0.244N |
|COCH-ARM / FISHERS | P=0.501N P=0.500 (e) (e) |P=0.100N P=0.492N P=0.242N P=0.242N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 5
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Bone |
| Osteopetrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 1/48 (2%) 0/49 (0%) |10/49 (20%) 4/49 (8%) 7/49 (14%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 2.6% 0.0% |22.4% 10.1% 16.9% 12.8% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |3/28 (11%) 1/21 (5%) 5/28 (18%) 2/24 (8%) |
|FIRST INCIDENCE | --- --- 707 --- |657 574 587 482 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.652 (e) P=0.478 (e) |P=0.294N P=0.189N P=0.360N P=0.261N |
|POLY 3 | P=0.625 (e) P=0.490 (e) |P=0.256N P=0.109N P=0.352N P=0.195N |
|POLY 1.5 | P=0.641 (e) P=0.493 (e) |P=0.243N P=0.092N P=0.330N P=0.170N |
|POLY 6 | P=0.608 (e) P=0.486 (e) |P=0.270N P=0.136N P=0.379N P=0.229N |
|LOGISTIC REGRESSION| P=0.654 (e) P=0.487 (e) |P=0.244N P=0.079N P=0.323N P=0.146N |
|COCH-ARM / FISHERS | P=0.668 (e) P=0.495 (e) |P=0.217N P=0.074N P=0.297N P=0.131N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 2/47 (4%) 2/49 (4%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| |2.3% 5.3% 4.9% 8.0% |
|TERMINAL (d) | |1/28 (4%) 1/21 (5%) 1/28 (4%) 3/24 (13%) |
|FIRST INCIDENCE | |734 (T) 663 715 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.217 P=0.409 P=0.500 P=0.250 |
|POLY 3 | |P=0.203 P=0.454 P=0.480 P=0.258 |
|POLY 1.5 | |P=0.215 P=0.467 P=0.487 P=0.271 |
|POLY 6 | |P=0.191 P=0.439 P=0.474 P=0.243 |
|LOGISTIC REGRESSION| |P=0.196 P=0.441 P=0.476 P=0.250 |
|COCH-ARM / FISHERS | |P=0.238 P=0.484 P=0.500 P=0.301 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 6
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Clitoral Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |2/49 (4%) 0/47 (0%) 1/49 (2%) 1/48 (2%) |
|POLY-3 ADJUSTED (b)| |4.6% 0.0% 2.5% 2.6% |
|TERMINAL (d) | |2/28 (7%) 0/21 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE | |734 (T) --- 734 (T) 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.570N P=0.303N P=0.500N P=0.570N |
|POLY 3 | |P=0.545N P=0.269N P=0.521N P=0.545N |
|POLY 1.5 | |P=0.546N P=0.259N P=0.513N P=0.532N |
|POLY 6 | |P=0.542N P=0.281N P=0.527N P=0.557N |
|LOGISTIC REGRESSION| |P=0.579N (e) P=0.500N P=0.552N |
|COCH-ARM / FISHERS | |P=0.545N P=0.258N P=0.500N P=0.508N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye |
| Cataract |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 2/48 (4%) 1/48 (2%) 3/48 (6%) |5/48 (10%) 2/47 (4%) 6/46 (13%) 3/48 (6%) |
|POLY-3 ADJUSTED (b)| 9.8% 5.3% 2.6% 8.4% |11.7% 5.4% 15.5% 7.8% |
|TERMINAL (d) | 2/24 (8%) 2/22 (9%) 0/23 (0%) 2/20 (10%) |4/28 (14%) 1/19 (5%) 4/26 (15%) 2/24 (8%) |
|FIRST INCIDENCE | 516 733 (T) 677 660 |671 609 587 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.548N P=0.372N P=0.203N P=0.590N |P=0.512N P=0.371N P=0.437 P=0.445N |
|POLY 3 | P=0.494N P=0.368N P=0.191N P=0.568N |P=0.509N P=0.275N P=0.431 P=0.414N |
|POLY 1.5 | P=0.486N P=0.355N P=0.185N P=0.542N |P=0.500N P=0.253N P=0.445 P=0.394N |
|POLY 6 | P=0.503N P=0.387N P=0.200N P=0.597N |P=0.519N P=0.305N P=0.419 P=0.438N |
|LOGISTIC REGRESSION| P=0.510N P=0.345N P=0.176N P=0.533N |P=0.503N P=0.289N P=0.421 P=0.374N |
|COCH-ARM / FISHERS | P=0.472N P=0.339N P=0.181N P=0.500N |P=0.476N P=0.226N P=0.470 P=0.357N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 7
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Cornea |
| Infiltration Cellular Polymorphonuclear |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 0/48 (0%) 0/48 (0%) 0/48 (0%) |2/48 (4%) 0/47 (0%) 0/46 (0%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.7% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/20 (0%) |1/28 (4%) 0/19 (0%) 0/26 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- --- |657 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.156N P=0.314N P=0.271N P=0.294N |
|POLY 3 | (e) (e) (e) (e) |P=0.125N P=0.272N P=0.264N P=0.266N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.131N P=0.259N P=0.257N P=0.256N |
|POLY 6 | (e) (e) (e) (e) |P=0.119N P=0.291N P=0.272N P=0.278N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.146N P=0.255N P=0.250N P=0.251N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.140N P=0.253N P=0.258N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Eye: Retina |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 1/48 (2%) 1/48 (2%) 2/48 (4%) |5/48 (10%) 2/47 (4%) 4/46 (9%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 5.0% 2.6% 2.6% 5.6% |11.7% 5.4% 10.4% 5.3% |
|TERMINAL (d) | 1/24 (4%) 1/22 (5%) 0/23 (0%) 1/20 (5%) |4/28 (14%) 1/19 (5%) 3/26 (12%) 2/24 (8%) |
|FIRST INCIDENCE | 516 733 (T) 677 657 |671 609 587 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.481 P=0.520N P=0.513N P=0.639 |P=0.289N P=0.371N P=0.554N P=0.292N |
|POLY 3 | P=0.506 P=0.521N P=0.513N P=0.652 |P=0.295N P=0.275N P=0.566N P=0.268N |
|POLY 1.5 | P=0.517 P=0.512N P=0.507N P=0.668 |P=0.286N P=0.253N P=0.551N P=0.250N |
|POLY 6 | P=0.495 P=0.533N P=0.522N P=0.634 |P=0.303N P=0.305N P=0.581N P=0.291N |
|LOGISTIC REGRESSION| P=0.526 P=0.492N P=0.494N P=0.693N |P=0.307N P=0.289N P=0.576N P=0.298N |
|COCH-ARM / FISHERS | P=0.536 P=0.500N P=0.500N P=0.692N |P=0.265N P=0.226N P=0.527N P=0.218N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 8
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart |
| Cardiomyopathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 42/49 (86%) 44/49 (90%) 37/48 (77%) 42/49 (86%) |32/49 (65%) 31/49 (63%) 31/49 (63%) 34/49 (69%) |
|POLY-3 ADJUSTED (b)| 91.3% 92.3% 84.6% 91.7% |70.4% 68.6% 70.2% 79.2% |
|TERMINAL (d) | 23/24 (96%) 21/22 (96%) 22/23 (96%) 21/21 (100%)|22/28 (79%) 15/21 (71%) 22/28 (79%) 21/24 (88%) |
|FIRST INCIDENCE | 460 390 433 399 |519 440 440 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.313 P=0.253 P=0.405N P=0.216 |P=0.211 P=0.168 P=0.563N P=0.116 |
|POLY 3 | P=0.491N P=0.590 P=0.223N P=0.643 |P=0.159 P=0.517N P=0.585N P=0.225 |
|POLY 1.5 | P=0.444N P=0.501 P=0.199N P=0.622 |P=0.202 P=0.513N P=0.554N P=0.273 |
|POLY 6 | P=0.579 P=0.675 P=0.326N P=0.634 |P=0.131 P=0.510N P=0.598 P=0.198 |
|LOGISTIC REGRESSION| P=0.522 P=0.306 P=0.217N P=0.372 |P=0.165 P=0.548 P=0.506 P=0.118 |
|COCH-ARM / FISHERS | P=0.379N P=0.380 P=0.203N P=0.613N |P=0.335 P=0.500N P=0.500N P=0.415 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Heart: Atrium |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 2/49 (4%) 3/48 (6%) 2/49 (4%) |2/49 (4%) 2/49 (4%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 12.1% 5.1% 7.6% 5.4% |4.6% 5.1% 2.4% 2.6% |
|TERMINAL (d) | 1/24 (4%) 0/22 (0%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 639 643 630 600 |671 663 586 579 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.311N P=0.261N P=0.408N P=0.301N |P=0.378N P=0.600 P=0.531N P=0.574N |
|POLY 3 | P=0.267N P=0.234N P=0.383N P=0.261N |P=0.350N P=0.656 P=0.519N P=0.543N |
|POLY 1.5 | P=0.257N P=0.227N P=0.376N P=0.243N |P=0.343N P=0.672 P=0.512N P=0.528N |
|POLY 6 | P=0.279N P=0.246N P=0.397N P=0.282N |P=0.357N P=0.636 P=0.524N P=0.558N |
|LOGISTIC REGRESSION| P=0.249N P=0.224N P=0.372N P=0.240N |P=0.280N P=0.699N P=0.455N P=0.467N |
|COCH-ARM / FISHERS | P=0.239N P=0.218N P=0.369N P=0.218N |P=0.325N P=0.691N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 9
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Islets, Pancreatic |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/48 (4%) 1/49 (2%) |0/49 (0%) 0/49 (0%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.2% 2.7% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 1/23 (4%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE | --- 733 (T) 710 733 (T) |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338 P=0.483 P=0.227 P=0.473 |P=0.664 (e) P=0.500 (e) |
|POLY 3 | P=0.322 P=0.491 P=0.226 P=0.479 |P=0.625 (e) P=0.488 (e) |
|POLY 1.5 | P=0.340 P=0.495 P=0.229 P=0.487 |P=0.640 (e) P=0.493 (e) |
|POLY 6 | P=0.304 P=0.486 P=0.221 P=0.470 |P=0.610 (e) P=0.485 (e) |
|LOGISTIC REGRESSION| P=0.326 P=0.483 P=0.216 P=0.473 |(e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.370 P=0.500 P=0.242 P=0.500 |P=0.669 (e) P=0.500 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Infarct |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 0/49 (0%) 1/48 (2%) 3/49 (6%) |0/48 (0%) 0/49 (0%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 7.1% 0.0% 2.6% 8.0% |0.0% 0.0% 2.4% 2.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 502 --- 600 639 |--- --- 653 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.315 P=0.139N P=0.338N P=0.581 |P=0.194 (e) P=0.470 P=0.465 |
|POLY 3 | P=0.353 P=0.132N P=0.331N P=0.608 |P=0.200 (e) P=0.494 P=0.480 |
|POLY 1.5 | P=0.357 P=0.126N P=0.322N P=0.628 |P=0.207 (e) P=0.498 P=0.488 |
|POLY 6 | P=0.350 P=0.141N P=0.344N P=0.588 |P=0.195 (e) P=0.492 P=0.473 |
|LOGISTIC REGRESSION| P=0.441 P=0.091N P=0.301N P=0.599N |P=0.248 (e) P=0.537 P=0.555 |
|COCH-ARM / FISHERS | P=0.368 P=0.121N P=0.316N P=0.661N |P=0.221 (e) P=0.505 P=0.505 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 10
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Kidney |
| Nephropathy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 43/49 (88%) 44/49 (90%) 45/48 (94%) 43/49 (88%) |41/48 (85%) 38/49 (78%) 34/49 (69%) 31/49 (63%) |
|POLY-3 ADJUSTED (b)| 93.6% 96.8% 96.5% 92.8% |88.9% 84.4% 78.2% 74.6% |
|TERMINAL (d) | 24/24 (100%) 22/22 (100%) 23/23 (100%) 20/21 (95%) |27/28 (96%) 20/21 (95%) 24/28 (86%) 19/24 (79%) |
|FIRST INCIDENCE | 460 520 433 399 |509 503 581 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.217 P=0.288 P=0.279 P=0.208 |P=0.098N P=0.164 P=0.171N P=0.305N |
|POLY 3 | P=0.410N P=0.377 P=0.409 P=0.624N |P=0.028N* P=0.359N P=0.111N P=0.049N* |
|POLY 1.5 | P=0.513N P=0.420 P=0.331 P=0.653N |P=0.018N* P=0.306N P=0.080N P=0.030N* |
|POLY 6 | P=0.252N P=0.397 P=0.538 P=0.548N |P=0.041N* P=0.416N P=0.152N P=0.076N |
|LOGISTIC REGRESSION| P=0.254 P=0.328 P=0.218 P=0.358 |P=0.035N* P=0.489N P=0.122N P=0.090N |
|COCH-ARM / FISHERS | P=0.559N P=0.500 P=0.254 P=0.620N |P=0.007N** P=0.232N P=0.050N P=0.011N* |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Larynx |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 2/48 (4%) 0/49 (0%) |2/49 (4%) 0/49 (0%) 4/49 (8%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 5.2% 0.0% |4.6% 0.0% 9.6% 2.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 2/23 (9%) 0/21 (0%) |2/28 (7%) 0/21 (0%) 2/28 (7%) 0/24 (0%) |
|FIRST INCIDENCE | --- 726 733 (T) --- |734 (T) --- 586 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.631N P=0.483 P=0.228 (e) |P=0.540 P=0.303N P=0.328 P=0.553N |
|POLY 3 | P=0.640N P=0.491 P=0.225 (e) |P=0.525 P=0.262N P=0.320 P=0.542N |
|POLY 1.5 | P=0.626N P=0.495 P=0.229 (e) |P=0.536 P=0.252N P=0.325 P=0.528N |
|POLY 6 | P=0.619 P=0.486 P=0.220 (e) |P=0.517 P=0.277N P=0.317 P=0.555N |
|LOGISTIC REGRESSION| P=0.636N P=0.478 P=0.228 (e) |P=0.563 (e) P=0.337 P=0.530N |
|COCH-ARM / FISHERS | P=0.601N P=0.500 P=0.242 (e) |P=0.567 P=0.247N P=0.339 P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 11
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 1/49 (2%) 1/48 (2%) 0/49 (0%) |2/49 (4%) 4/49 (8%) 2/49 (4%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 2.4% 2.6% 2.6% 0.0% |4.6% 10.3% 4.9% 2.6% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 3/21 (14%) 1/28 (4%) 1/24 (4%) |
|FIRST INCIDENCE | 634 733 (T) 733 (T) --- |509 721 624 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.338N P=0.745 P=0.741 P=0.545N |P=0.251N P=0.236 P=0.676 P=0.551N |
|POLY 3 | P=0.329N P=0.749 P=0.748 P=0.523N |P=0.278N P=0.281 P=0.671 P=0.551N |
|POLY 1.5 | P=0.321N P=0.754 P=0.752 P=0.514N |P=0.261N P=0.304 P=0.679 P=0.533N |
|POLY 6 | P=0.339N P=0.742 P=0.741 P=0.533N |P=0.297N P=0.253 P=0.664 P=0.569N |
|LOGISTIC REGRESSION| P=0.328N P=0.760 P=0.757 P=0.478N |P=0.252N P=0.307 P=0.634N P=0.467N |
|COCH-ARM / FISHERS | P=0.307N P=0.753N P=0.747 P=0.500N |P=0.228N P=0.339 P=0.691N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Basophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 34/49 (69%) 31/49 (63%) 28/48 (58%) 32/49 (65%) |46/49 (94%) 44/49 (90%) 46/49 (94%) 44/49 (90%) |
|POLY-3 ADJUSTED (b)| 77.1% 74.7% 67.8% 78.0% |95.7% 93.9% 95.4% 96.8% |
|TERMINAL (d) | 22/24 (92%) 22/22 (100%) 20/23 (87%) 20/21 (95%) |28/28 (100%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | 469 551 489 245 |509 440 440 482 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.367 P=0.567N P=0.256N P=0.378 |P=0.365 P=0.106 P=0.461 P=0.216 |
|POLY 3 | P=0.536 P=0.500N P=0.216N P=0.570 |P=0.400 P=0.524N P=0.680N P=0.631 |
|POLY 1.5 | P=0.486N P=0.422N P=0.192N P=0.545N |P=0.485 P=0.437N P=0.665N P=0.696N |
|POLY 6 | P=0.424 P=0.619N P=0.277N P=0.433 |P=0.353 P=0.680N P=0.730N P=0.570 |
|LOGISTIC REGRESSION| P=0.349 P=0.480N P=0.224N P=0.475 |P=0.382 P=0.619N P=0.576 P=0.376 |
|COCH-ARM / FISHERS | P=0.405N P=0.335N P=0.178N P=0.415N |P=0.388N P=0.357N P=0.661N P=0.357N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 12
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Clear Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 14/49 (29%) 14/49 (29%) 14/48 (29%) 11/49 (22%) |7/49 (14%) 16/49 (33%) 8/49 (16%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 34.4% 35.9% 35.7% 30.0% |16.2% 40.9% 19.6% 15.8% |
|TERMINAL (d) | 14/24 (58%) 14/22 (64%) 13/23 (57%) 11/21 (52%) |7/28 (25%) 15/21 (71%) 8/28 (29%) 6/24 (25%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 574 733 (T) |734 (T) 609 734 (T) 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.348N P=0.474 P=0.546 P=0.461N |P=0.112N P<0.001 ** P=0.500 P=0.625 |
|POLY 3 | P=0.362N P=0.537 P=0.545 P=0.433N |P=0.181N P=0.010 * P=0.450 P=0.601N |
|POLY 1.5 | P=0.325N P=0.560 P=0.555 P=0.388N |P=0.155N P=0.015 * P=0.469 P=0.566N |
|POLY 6 | P=0.406N P=0.503 P=0.526 P=0.487N |P=0.210N P=0.005 ** P=0.433 P=0.601 |
|LOGISTIC REGRESSION| P=0.415N P=0.474 P=0.454 P=0.461N |P=0.158N P=0.002 ** P=0.500 P=0.625 |
|COCH-ARM / FISHERS | P=0.267N P=0.588N P=0.563 P=0.322N |P=0.116N P=0.028 * P=0.500 P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Degeneration Cystic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 3/49 (6%) 2/48 (4%) 2/49 (4%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 7.4% 7.7% 5.2% 5.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 3/24 (13%) 3/22 (14%) 2/23 (9%) 1/21 (5%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 733 (T) 733 (T) 733 (T) 707 |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.409N P=0.626 P=0.520N P=0.566N |(e) (e) (e) (e) |
|POLY 3 | P=0.398N P=0.643 P=0.523N P=0.547N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.386N P=0.651 P=0.516N P=0.529N |(e) (e) (e) (e) |
|POLY 6 | P=0.412N P=0.632 P=0.535N P=0.566N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.423N P=0.626 P=0.520N P=0.583N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.363N P=0.661N P=0.510N P=0.500N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 13
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Eosinophilic Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 1/48 (2%) 2/49 (4%) |1/49 (2%) 0/49 (0%) 6/49 (12%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 7.4% 5.1% 2.6% 5.5% |2.3% 0.0% 14.5% 5.3% |
|TERMINAL (d) | 3/24 (13%) 1/22 (5%) 1/23 (4%) 2/21 (10%) |1/28 (4%) 0/21 (0%) 5/28 (18%) 1/24 (4%) |
|FIRST INCIDENCE | 733 (T) 713 733 (T) 733 (T) |734 (T) --- 587 722 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.453N P=0.543N P=0.318N P=0.562N |P=0.168 P=0.557N P=0.056 P=0.443 |
|POLY 3 | P=0.431N P=0.519N P=0.323N P=0.548N |P=0.138 P=0.522N P=0.048 * P=0.455 |
|POLY 1.5 | P=0.423N P=0.511N P=0.318N P=0.530N |P=0.151 P=0.513N P=0.051 P=0.470 |
|POLY 6 | P=0.441N P=0.530N P=0.331N P=0.568N |P=0.126 P=0.534N P=0.045 * P=0.439 |
|LOGISTIC REGRESSION| P=0.464N P=0.554N P=0.318N P=0.562N |P=0.147 (e) P=0.047 * P=0.429 |
|COCH-ARM / FISHERS | P=0.408N P=0.500N P=0.316N P=0.500N |P=0.186 P=0.500N P=0.056 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Fatty Change |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/49 (4%) 4/48 (8%) 5/49 (10%) |10/49 (20%) 3/49 (6%) 2/49 (4%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 4.9% 5.0% 10.1% 12.8% |21.9% 7.6% 4.8% 10.0% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 2/23 (9%) 0/21 (0%) |1/28 (4%) 1/21 (5%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 657 502 560 469 |519 647 624 445 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.084 P=0.665 P=0.303 P=0.175 |P=0.135N P=0.103N P=0.030N* P=0.164N |
|POLY 3 | P=0.093 P=0.682 P=0.319 P=0.195 |P=0.084N P=0.063N P=0.021N* P=0.116N |
|POLY 1.5 | P=0.097 P=0.687 P=0.324 P=0.202 |P=0.084N P=0.049N* P=0.018N* P=0.099N |
|POLY 6 | P=0.092 P=0.673 P=0.310 P=0.190 |P=0.084N P=0.086N P=0.026N* P=0.138N |
|LOGISTIC REGRESSION| P=0.151 P=0.682N P=0.329 P=0.304 |P=0.049N* P=0.021N* P=0.008N** P=0.025N* |
|COCH-ARM / FISHERS | P=0.105 P=0.691N P=0.329 P=0.218 |P=0.085N P=0.035N* P=0.014N* P=0.074N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 14
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Hepatodiaphragmatic Nodule |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 3/49 (6%) 2/48 (4%) 2/49 (4%) |4/49 (8%) 1/49 (2%) 6/49 (12%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 2.4% 7.5% 5.1% 5.3% |9.1% 2.5% 14.4% 12.8% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 1/23 (4%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 4/28 (14%) 1/24 (4%) |
|FIRST INCIDENCE | 692 505 643 600 |602 503 581 503 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.469 P=0.270 P=0.462 P=0.430 |P=0.165 P=0.246N P=0.341 P=0.399 |
|POLY 3 | P=0.485 P=0.295 P=0.484 P=0.470 |P=0.163 P=0.214N P=0.332 P=0.425 |
|POLY 1.5 | P=0.501 P=0.299 P=0.488 P=0.480 |P=0.172 P=0.199N P=0.346 P=0.450 |
|POLY 6 | P=0.470 P=0.288 P=0.476 P=0.459 |P=0.156 P=0.237N P=0.318 P=0.398 |
|LOGISTIC REGRESSION| P=0.554 P=0.315 P=0.487 P=0.533 |P=0.215 P=0.094N P=0.379 P=0.540 |
|COCH-ARM / FISHERS | P=0.530 P=0.309 P=0.492 P=0.500 |P=0.197 P=0.181N P=0.370 P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 0/49 (0%) 0/48 (0%) 0/49 (0%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- --- |713 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.146N P=0.296N P=0.243N P=0.277N |
|POLY 3 | (e) (e) (e) (e) |P=0.124N P=0.263N P=0.251N P=0.268N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.130N P=0.252N P=0.246N P=0.257N |
|POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.278N P=0.255N P=0.280N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.151N P=0.287N P=0.254N P=0.283N |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.139N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 15
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Mixed Cell Focus |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 2/48 (4%) 2/49 (4%) |6/49 (12%) 6/49 (12%) 7/49 (14%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 7.3% 5.1% 5.1% 5.4% |13.5% 15.2% 16.3% 15.1% |
|TERMINAL (d) | 1/24 (4%) 2/22 (9%) 1/23 (4%) 1/21 (5%) |2/28 (7%) 3/21 (14%) 1/28 (4%) 1/24 (4%) |
|FIRST INCIDENCE | 660 733 (T) 563 624 |572 647 512 555 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.502N P=0.546N P=0.533N P=0.580N |P=0.453 P=0.445 P=0.464 P=0.486 |
|POLY 3 | P=0.472N P=0.524N P=0.521N P=0.547N |P=0.475 P=0.535 P=0.474 P=0.541 |
|POLY 1.5 | P=0.461N P=0.514N P=0.515N P=0.530N |P=0.492 P=0.572 P=0.482 P=0.567 |
|POLY 6 | P=0.483N P=0.540N P=0.532N P=0.568N |P=0.464 P=0.490 P=0.471 P=0.518 |
|LOGISTIC REGRESSION| P=0.476N P=0.535N P=0.510N P=0.541N |P=0.531N P=0.604 P=0.612 P=0.566N |
|COCH-ARM / FISHERS | P=0.442N P=0.500N P=0.510N P=0.500N |P=0.537 P=0.620N P=0.500 P=0.620N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver |
| Regeneration |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 2/49 (4%) 1/48 (2%) 1/49 (2%) |1/49 (2%) 2/49 (4%) 2/49 (4%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 2.5% 5.1% 2.6% 2.7% |2.3% 5.0% 4.8% 5.2% |
|TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 733 (T) 615 707 657 |707 471 587 579 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.554N P=0.475 P=0.743 P=0.723 |P=0.375 P=0.442 P=0.471 P=0.426 |
|POLY 3 | P=0.528N P=0.490 P=0.750 P=0.739 |P=0.388 P=0.470 P=0.485 P=0.461 |
|POLY 1.5 | P=0.518N P=0.494 P=0.753 P=0.747 |P=0.402 P=0.483 P=0.490 P=0.473 |
|POLY 6 | P=0.539N P=0.486 P=0.746 P=0.731 |P=0.376 P=0.453 P=0.483 P=0.449 |
|LOGISTIC REGRESSION| P=0.513N P=0.499 P=0.743 P=0.742 |P=0.569 P=0.676 P=0.566 P=0.553 |
|COCH-ARM / FISHERS | P=0.501N P=0.500 P=0.747 P=0.753N |P=0.433 P=0.500 P=0.500 P=0.500 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 16
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Bile Duct |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 35/49 (71%) 32/49 (65%) 28/48 (58%) 21/49 (43%) |5/49 (10%) 5/49 (10%) 5/49 (10%) 6/49 (12%) |
|POLY-3 ADJUSTED (b)| 76.6% 71.1% 64.3% 51.0% |11.3% 12.7% 12.1% 15.0% |
|TERMINAL (d) | 19/24 (79%) 14/22 (64%) 14/23 (61%) 8/21 (38%) |0/28 (0%) 1/21 (5%) 3/28 (11%) 1/24 (4%) |
|FIRST INCIDENCE | 460 505 523 469 |602 625 587 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.050N P=0.537N P=0.264N P=0.082N |P=0.352 P=0.475 P=0.589 P=0.371 |
|POLY 3 | P=0.004N** P=0.355N P=0.136N P=0.007N** |P=0.371 P=0.558 P=0.590 P=0.429 |
|POLY 1.5 | P=0.003N** P=0.349N P=0.129N P=0.005N** |P=0.385 P=0.589 P=0.605 P=0.451 |
|POLY 6 | P=0.007N** P=0.358N P=0.151N P=0.012N* |P=0.359 P=0.519 P=0.575 P=0.407 |
|LOGISTIC REGRESSION| P=0.003N** P=0.374N P=0.138N P=0.008N** |P=0.425 P=0.617 P=0.632N P=0.577 |
|COCH-ARM / FISHERS | P=0.002N** P=0.332N P=0.127N P=0.004N** |P=0.420 P=0.630N P=0.630N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Liver: Centrilobular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 13/49 (27%) 11/49 (22%) 7/48 (15%) 4/49 (8%) |11/49 (22%) 11/49 (22%) 7/49 (14%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 29.1% 26.6% 17.4% 10.5% |23.9% 26.3% 16.4% 21.9% |
|TERMINAL (d) | 2/24 (8%) 1/22 (5%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 469 567 613 526 |572 471 586 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.029N* P=0.489N P=0.177N P=0.052N |P=0.418N P=0.394 P=0.320N P=0.578 |
|POLY 3 | P=0.015N* P=0.492N P=0.153N P=0.032N* |P=0.349N P=0.494 P=0.268N P=0.516N |
|POLY 1.5 | P=0.011N* P=0.457N P=0.134N P=0.024N* |P=0.325N P=0.539 P=0.248N P=0.476N |
|POLY 6 | P=0.021N* P=0.532N P=0.182N P=0.046N* |P=0.375N P=0.434 P=0.291N P=0.560N |
|LOGISTIC REGRESSION| P=0.005N** P=0.367N P=0.099N P=0.007N** |P=0.170N P=0.401N P=0.129N P=0.258N |
|COCH-ARM / FISHERS | P=0.008N** P=0.407N P=0.114N P=0.015N* |P=0.277N P=0.595N P=0.217N P=0.401N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 17
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 13/49 (27%) 6/48 (13%) 15/49 (31%) |16/49 (33%) 15/49 (31%) 19/49 (39%) 22/49 (45%) |
|POLY-3 ADJUSTED (b)| 4.9% 32.5% 15.4% 39.1% |36.2% 36.5% 44.6% 54.4% |
|TERMINAL (d) | 1/24 (4%) 8/22 (36%) 4/23 (17%) 9/21 (43%) |12/28 (43%) 7/21 (33%) 14/28 (50%) 13/24 (54%) |
|FIRST INCIDENCE | 624 643 685 552 |604 574 440 547 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.004 ** P=0.002 ** P=0.117 P<0.001 ** |P=0.050 P=0.343 P=0.318 P=0.053 |
|POLY 3 | P=0.003 ** P<0.001 ** P=0.114 P<0.001 ** |P=0.032 * P=0.580 P=0.278 P=0.065 |
|POLY 1.5 | P=0.004 ** P<0.001 ** P=0.120 P<0.001 ** |P=0.042 * P=0.560N P=0.301 P=0.087 |
|POLY 6 | P=0.002 ** P<0.001 ** P=0.105 P<0.001 ** |P=0.026 * P=0.541 P=0.253 P=0.051 |
|LOGISTIC REGRESSION| P=0.003 ** P<0.001 ** P=0.109 P<0.001 ** |P=0.028 * P=0.522 P=0.252 P=0.043 * |
|COCH-ARM / FISHERS | P=0.009 ** P=0.002 ** P=0.127 P<0.001 ** |P=0.073 P=0.500N P=0.337 P=0.150 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolar Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 23/49 (47%) 12/49 (24%) 9/48 (19%) 16/49 (33%) |4/49 (8%) 11/49 (22%) 11/49 (22%) 9/49 (18%) |
|POLY-3 ADJUSTED (b)| 54.5% 29.7% 22.6% 40.1% |9.2% 27.5% 26.3% 23.6% |
|TERMINAL (d) | 18/24 (75%) 8/22 (36%) 6/23 (26%) 8/21 (38%) |3/28 (11%) 5/21 (24%) 9/28 (32%) 8/24 (33%) |
|FIRST INCIDENCE | 516 525 489 419 |671 609 581 677 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.298N P=0.031N* P=0.003N** P=0.248N |P=0.183 P=0.015 * P=0.042 * P=0.060 |
|POLY 3 | P=0.188N P=0.015N* P=0.002N** P=0.129N |P=0.132 P=0.026 * P=0.034 * P=0.069 |
|POLY 1.5 | P=0.187N P=0.015N* P=0.002N** P=0.123N |P=0.163 P=0.033 * P=0.037 * P=0.083 |
|POLY 6 | P=0.187N P=0.015N* P=0.002N** P=0.132N |P=0.104 P=0.020 * P=0.031 * P=0.055 |
|LOGISTIC REGRESSION| P=0.269N P=0.024N* P=0.004N** P=0.192N |P=0.146 P=0.022 * P=0.034 * P=0.050 |
|COCH-ARM / FISHERS | P=0.184N P=0.017N* P=0.003N** P=0.108N |P=0.232 P=0.045 * P=0.045 * P=0.116 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 18
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Lung: Alveolus |
| Infiltration Cellular Histiocyte |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 9/49 (18%) 6/48 (13%) 15/49 (31%) |19/49 (39%) 7/49 (14%) 11/49 (22%) 14/49 (29%) |
|POLY-3 ADJUSTED (b)| 25.6% 22.4% 15.1% 38.0% |41.4% 17.2% 25.6% 34.2% |
|TERMINAL (d) | 7/24 (29%) 4/22 (18%) 2/23 (9%) 9/21 (43%) |12/28 (43%) 3/21 (14%) 7/28 (25%) 7/24 (29%) |
|FIRST INCIDENCE | 460 643 523 245 |519 440 440 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.107 P=0.473N P=0.186N P=0.152 |P=0.533N P=0.041N* P=0.091N P=0.401N |
|POLY 3 | P=0.115 P=0.463N P=0.180N P=0.162 |P=0.492N P=0.011N* P=0.086N P=0.318N |
|POLY 1.5 | P=0.132 P=0.440N P=0.168N P=0.194 |P=0.481N P=0.008N** P=0.075N P=0.273N |
|POLY 6 | P=0.095 P=0.484N P=0.198N P=0.130 |P=0.498N P=0.017N* P=0.098N P=0.370N |
|LOGISTIC REGRESSION| P=0.146 P=0.407N P=0.150N P=0.250 |P=0.414N P=0.003N** P=0.050N P=0.198N |
|COCH-ARM / FISHERS | P=0.158 P=0.401N P=0.154N P=0.246 |P=0.443N P=0.006N** P=0.062N P=0.196N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Galactocele |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/21 (0%) 0/20 (0%) 1/30 (3%) 0/28 (0%) |1/49 (2%) 2/49 (4%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 4.1% 0.0% |2.3% 5.2% 2.4% 2.6% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/14 (0%) 0/10 (0%) |1/28 (4%) 2/21 (10%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- --- 728 --- |734 (T) 734 (T) 587 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.658 (e) P=0.500 (e) |P=0.519N P=0.399 P=0.753 P=0.728 |
|POLY 3 | P=0.664 (e) P=0.566 (e) |P=0.533N P=0.461 P=0.750 P=0.731 |
|POLY 1.5 | P=0.682 (e) P=0.569 (e) |P=0.522N P=0.478 P=0.754 P=0.741 |
|POLY 6 | P=0.642 (e) P=0.561 (e) |P=0.544N P=0.440 P=0.748 P=0.720 |
|LOGISTIC REGRESSION| P=0.680 (e) P=0.545 (e) |P=0.534N P=0.399 P=0.739N P=0.728 |
|COCH-ARM / FISHERS | P=0.717 (e) P=0.588 (e) |P=0.500N P=0.500 P=0.753N P=0.753N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 19
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Mammary Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/21 (0%) 0/20 (0%) 0/30 (0%) 0/28 (0%) |2/49 (4%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 0.0% 0.0% 0.0% |4.6% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/12 (0%) 0/11 (0%) 0/14 (0%) 0/10 (0%) |2/28 (7%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- --- --- --- |734 (T) --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | (e) (e) (e) (e) |P=0.142N P=0.303N P=0.238N P=0.272N |
|POLY 3 | (e) (e) (e) (e) |P=0.125N P=0.262N P=0.250N P=0.267N |
|POLY 1.5 | (e) (e) (e) (e) |P=0.130N P=0.252N P=0.245N P=0.257N |
|POLY 6 | (e) (e) (e) (e) |P=0.118N P=0.277N P=0.254N P=0.279N |
|LOGISTIC REGRESSION| (e) (e) (e) (e) |P=0.142N (e) (e) (e) |
|COCH-ARM / FISHERS | (e) (e) (e) (e) |P=0.139N P=0.247N P=0.247N P=0.247N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/13 (23%) 0/6 (0%) 0/9 (0%) 1/8 (13%) |0/13 (0%) 0/8 (0%) 0/7 (0%) 0/5 (0%) |
|POLY-3 ADJUSTED (b)| 27.2% 0.0% 0.0% 13.4% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/7 (14%) 0/4 (0%) 0/5 (0%) 1/6 (17%) |0/7 (0%) 0/6 (0%) 0/3 (0%) 0/3 (0%) |
|FIRST INCIDENCE | 657 --- --- 733 (T) |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.317N P=0.173N P=0.161N P=0.371N |(e) (e) (e) (e) |
|POLY 3 | P=0.375N P=0.242N P=0.168N P=0.450N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.371N P=0.254N P=0.170N P=0.465N |(e) (e) (e) (e) |
|POLY 6 | P=0.379N P=0.234N P=0.173N P=0.438N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.344N P=0.255N P=0.171N P=0.443N |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.366N P=0.295N P=0.186N P=0.502N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 20
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Mesentery: Fat |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 10/13 (77%) 4/6 (67%) 8/9 (89%) 6/8 (75%) |13/13 (100%) 7/8 (88%) 6/7 (86%) 5/5 (100%) |
|POLY-3 ADJUSTED (b)| 77.9% 69.0% 88.9% 75.0% |100.0% 87.5% 91.1% 100.0% |
|TERMINAL (d) | 5/7 (71%) 3/4 (75%) 4/5 (80%) 4/6 (67%) |7/7 (100%) 5/6 (83%) 3/3 (100%) 3/3 (100%) |
|FIRST INCIDENCE | 502 677 600 659 |509 587 587 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.386N P=0.175N P=0.604N P=0.297N |P=0.251N P=0.146N P=0.304N (e) |
|POLY 3 | P=0.569 P=0.565N P=0.463 P=0.644N |P=0.726 P=0.402N P=0.652N (e) |
|POLY 1.5 | P=0.551 P=0.550N P=0.452 P=0.651N |P=0.699N P=0.402N P=0.495N (e) |
|POLY 6 | P=0.599 P=0.591N P=0.483 P=0.631N |P=0.708 P=0.402N P=0.946N (e) |
|LOGISTIC REGRESSION| P=0.446 P=0.627N P=0.411 P=0.625 |P=0.672N (e) P=0.379N (e) |
|COCH-ARM / FISHERS | P=0.535 P=0.520N P=0.450 P=0.656N |P=0.646N P=0.381N P=0.350N (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Inflammation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 12/49 (24%) 18/49 (37%) 16/48 (33%) 9/48 (19%) |2/49 (4%) 5/49 (10%) 5/49 (10%) 5/49 (10%) |
|POLY-3 ADJUSTED (b)| 28.0% 43.4% 38.1% 23.8% |4.6% 12.7% 11.8% 12.5% |
|TERMINAL (d) | 4/24 (17%) 8/22 (36%) 8/23 (35%) 4/21 (19%) |2/28 (7%) 2/21 (10%) 1/28 (4%) 1/24 (4%) |
|FIRST INCIDENCE | 460 525 489 469 |734 (T) 625 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.265N P=0.111 P=0.213 P=0.467N |P=0.221 P=0.133 P=0.220 P=0.171 |
|POLY 3 | P=0.233N P=0.101 P=0.220 P=0.432N |P=0.217 P=0.178 P=0.206 P=0.184 |
|POLY 1.5 | P=0.193N P=0.113 P=0.226 P=0.387N |P=0.231 P=0.194 P=0.209 P=0.197 |
|POLY 6 | P=0.297N P=0.089 P=0.209 P=0.494N |P=0.204 P=0.161 P=0.205 P=0.172 |
|LOGISTIC REGRESSION| P=0.176N P=0.120 P=0.234 P=0.371N |P=0.365 P=0.160 P=0.261 P=0.394 |
|COCH-ARM / FISHERS | P=0.150N P=0.137 P=0.231 P=0.331N |P=0.253 P=0.218 P=0.218 P=0.218 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 21
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose |
| Thrombosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 6/49 (12%) 7/49 (14%) 6/48 (13%) 3/48 (6%) |7/49 (14%) 4/49 (8%) 3/49 (6%) 3/49 (6%) |
|POLY-3 ADJUSTED (b)| 13.9% 16.8% 14.8% 8.0% |15.6% 10.1% 7.2% 7.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 1/23 (4%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 469 502 560 600 |572 663 586 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.228N P=0.472 P=0.574 P=0.329N |P=0.203N P=0.408N P=0.219N P=0.271N |
|POLY 3 | P=0.217N P=0.470 P=0.577 P=0.315N |P=0.151N P=0.339N P=0.186N P=0.213N |
|POLY 1.5 | P=0.193N P=0.481 P=0.589 P=0.289N |P=0.146N P=0.305N P=0.175N P=0.192N |
|POLY 6 | P=0.247N P=0.458 P=0.562 P=0.346N |P=0.158N P=0.385N P=0.198N P=0.240N |
|LOGISTIC REGRESSION| P=0.104N P=0.588 P=0.616N P=0.164N |P=0.081N P=0.217N P=0.096N P=0.075N |
|COCH-ARM / FISHERS | P=0.160N P=0.500 P=0.606 P=0.254N |P=0.134N P=0.262N P=0.159N P=0.159N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Glands |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 49/49 (100%) 48/48 (100%) 48/48 (100%)|0/49 (0%) 48/49 (98%) 48/49 (98%) 42/49 (86%) |
|POLY-3 ADJUSTED (b)| 2.5% 100.0% 100.0% 100.0% |0.0% 98.0% 99.4% 93.2% |
|TERMINAL (d) | 1/24 (4%) 22/22 (100%) 23/23 (100%) 21/21 (100%)|0/28 (0%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | 733 (T) 390 433 399 |--- 440 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 22
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Glands |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/49 (6%) 14/48 (29%) 26/48 (54%) |0/49 (0%) 2/49 (4%) 20/49 (41%) 20/49 (41%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.7% 35.1% 62.3% |0.0% 5.2% 46.8% 51.2% |
|TERMINAL (d) | 0/24 (0%) 3/22 (14%) 8/23 (35%) 9/21 (43%) |0/28 (0%) 1/21 (5%) 12/28 (43%) 16/24 (67%) |
|FIRST INCIDENCE | --- 733 (T) 643 526 |--- 713 587 579 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P=0.104 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.186 P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P=0.110 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.213 P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P=0.114 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.223 P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P=0.105 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.201 P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P=0.104 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.188 P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P=0.121 P<0.001 ** P<0.001 ** |P<0.001 ** P=0.247 P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Goblet Cell, Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 25/49 (51%) 29/48 (60%) 26/48 (54%) |0/49 (0%) 16/49 (33%) 29/49 (59%) 20/49 (41%) |
|POLY-3 ADJUSTED (b)| 0.0% 59.8% 70.0% 65.1% |0.0% 40.8% 67.5% 51.9% |
|TERMINAL (d) | 0/24 (0%) 17/22 (77%) 22/23 (96%) 19/21 (91%) |0/28 (0%) 14/21 (67%) 23/28 (82%) 18/24 (75%) |
|FIRST INCIDENCE | --- 520 433 469 |--- 581 440 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 23
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 49/49 (100%) 48/48 (100%) 47/48 (98%) |0/49 (0%) 49/49 (100%) 49/49 (100%) 47/49 (96%) |
|POLY-3 ADJUSTED (b)| 7.2% 100.0% 100.0% 99.4% |0.0% 100.0% 100.0% 98.7% |
|TERMINAL (d) | 1/24 (4%) 22/22 (100%) 23/23 (100%) 21/21 (100%)|0/28 (0%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | 460 390 433 399 |--- 440 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 45/49 (92%) 40/48 (83%) 38/48 (79%) |13/49 (27%) 46/49 (94%) 49/49 (100%) 45/49 (92%) |
|POLY-3 ADJUSTED (b)| 7.3% 95.0% 90.7% 87.8% |29.0% 96.3% 100.0% 97.7% |
|TERMINAL (d) | 2/24 (8%) 21/22 (96%) 22/23 (96%) 19/21 (91%) |8/28 (29%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | 703 390 523 469 |509 440 440 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 24
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Hyperplasia Atypical |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 48/49 (98%) 45/48 (94%) 46/48 (96%) |0/49 (0%) 48/49 (98%) 48/49 (98%) 43/49 (88%) |
|POLY-3 ADJUSTED (b)| 0.0% 98.6% 95.8% 99.1% |0.0% 98.0% 99.4% 94.6% |
|TERMINAL (d) | 0/24 (0%) 22/22 (100%) 22/23 (96%) 21/21 (100%)|0/28 (0%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | --- 390 489 419 |--- 440 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Olfactory Epithelium |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 49/49 (100%) 48/48 (100%) 48/48 (100%)|0/49 (0%) 47/49 (96%) 47/49 (96%) 45/49 (92%) |
|POLY-3 ADJUSTED (b)| 0.0% 100.0% 100.0% 100.0% |0.0% 96.3% 99.0% 96.9% |
|TERMINAL (d) | 0/24 (0%) 22/22 (100%) 23/23 (100%) 21/21 (100%)|0/28 (0%) 21/21 (100%) 28/28 (100%) 24/24 (100%) |
|FIRST INCIDENCE | --- 390 433 399 |--- 440 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 25
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Degeneration Hyaline |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 20/49 (41%) 19/48 (40%) 19/48 (40%) |8/49 (16%) 33/49 (67%) 34/49 (69%) 28/49 (57%) |
|POLY-3 ADJUSTED (b)| 0.0% 48.2% 45.9% 48.4% |18.1% 76.1% 74.0% 63.7% |
|TERMINAL (d) | 0/24 (0%) 11/22 (50%) 10/23 (44%) 11/21 (52%) |3/28 (11%) 16/21 (76%) 20/28 (71%) 14/24 (58%) |
|FIRST INCIDENCE | --- 567 523 399 |657 581 440 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.004 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P=0.003 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 21/49 (43%) 29/48 (60%) 29/48 (60%) |0/49 (0%) 18/49 (37%) 22/49 (45%) 23/49 (47%) |
|POLY-3 ADJUSTED (b)| 7.4% 49.8% 64.5% 68.3% |0.0% 43.9% 49.3% 53.5% |
|TERMINAL (d) | 2/24 (8%) 10/22 (46%) 12/23 (52%) 15/21 (71%) |0/28 (0%) 9/21 (43%) 10/28 (36%) 10/24 (42%) |
|FIRST INCIDENCE | 713 525 489 399 |--- 503 480 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** 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<0.001 ** P<0.001 ** P<0.001 ** |P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 26
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Nose: Respiratory Epithelium |
| Metaplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 15/49 (31%) 23/48 (48%) 18/48 (38%) |0/49 (0%) 21/49 (43%) 17/49 (35%) 15/49 (31%) |
|POLY-3 ADJUSTED (b)| 0.0% 35.3% 51.9% 41.7% |0.0% 46.9% 36.4% 34.5% |
|TERMINAL (d) | 0/24 (0%) 3/22 (14%) 7/23 (30%) 2/21 (10%) |0/28 (0%) 2/21 (10%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 505 433 469 |--- 471 440 429 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.021 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 3 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.017 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 1.5 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.015 * P<0.001 ** P<0.001 ** P<0.001 ** |
|POLY 6 | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|LOGISTIC REGRESSION| P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.074 P<0.001 ** P<0.001 ** P<0.001 ** |
|COCH-ARM / FISHERS | P<0.001 ** P<0.001 ** P<0.001 ** P<0.001 ** |P=0.025 * P<0.001 ** P<0.001 ** P<0.001 ** |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Cyst |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |7/49 (14%) 9/49 (18%) 11/49 (22%) 8/49 (16%) |
|POLY-3 ADJUSTED (b)| |15.9% 22.8% 26.6% 19.7% |
|TERMINAL (d) | |5/28 (18%) 6/21 (29%) 9/28 (32%) 3/24 (13%) |
|FIRST INCIDENCE | |572 574 587 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.406 P=0.211 P=0.204 P=0.379 |
|POLY 3 | |P=0.407 P=0.301 P=0.169 P=0.432 |
|POLY 1.5 | |P=0.430 P=0.339 P=0.187 P=0.458 |
|POLY 6 | |P=0.386 P=0.257 P=0.153 P=0.407 |
|LOGISTIC REGRESSION| |P=0.444 P=0.294 P=0.170 P=0.574N |
|COCH-ARM / FISHERS | |P=0.468 P=0.393 P=0.217 P=0.500 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 27
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Ovary |
| Inflammation Granulomatous |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | |1/49 (2%) 1/49 (2%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| |2.3% 2.6% 0.0% 5.3% |
|TERMINAL (d) | |1/28 (4%) 0/21 (0%) 0/28 (0%) 2/24 (8%) |
|FIRST INCIDENCE | |734 (T) 679 --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | |P=0.352 P=0.699 P=0.500N P=0.446 |
|POLY 3 | |P=0.350 P=0.737 P=0.512N P=0.454 |
|POLY 1.5 | |P=0.357 P=0.747 P=0.507N P=0.470 |
|POLY 6 | |P=0.343 P=0.724 P=0.515N P=0.438 |
|LOGISTIC REGRESSION| |P=0.333 P=0.736 (e) P=0.446 |
|COCH-ARM / FISHERS | |P=0.370 P=0.753N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 19/49 (39%) 17/49 (35%) 17/48 (35%) 14/49 (29%) |18/49 (37%) 9/49 (18%) 11/49 (22%) 10/49 (20%) |
|POLY-3 ADJUSTED (b)| 43.7% 40.6% 41.3% 34.5% |40.1% 22.1% 25.6% 25.2% |
|TERMINAL (d) | 10/24 (42%) 8/22 (36%) 9/23 (39%) 4/21 (19%) |14/28 (50%) 4/21 (19%) 6/28 (21%) 5/24 (21%) |
|FIRST INCIDENCE | 460 525 523 469 |509 471 586 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.344N P=0.532N P=0.503N P=0.389N |P=0.174N P=0.145N P=0.116N P=0.151N |
|POLY 3 | P=0.231N P=0.473N P=0.498N P=0.258N |P=0.147N P=0.056N P=0.108N P=0.108N |
|POLY 1.5 | P=0.216N P=0.452N P=0.473N P=0.237N |P=0.139N P=0.045N* P=0.104N P=0.089N |
|POLY 6 | P=0.244N P=0.498N P=0.537N P=0.274N |P=0.149N P=0.071N P=0.106N P=0.126N |
|LOGISTIC REGRESSION| P=0.218N P=0.446N P=0.468N P=0.213N |P=0.135N P=0.042N* P=0.096N P=0.093N |
|COCH-ARM / FISHERS | P=0.182N P=0.417N P=0.448N P=0.196N |P=0.116N P=0.035N* P=0.092N P=0.058N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 28
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Pancreas |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 3/49 (6%) 2/48 (4%) 1/49 (2%) |0/49 (0%) 1/49 (2%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 0.0% 7.6% 5.2% 2.7% |0.0% 2.6% 0.0% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/22 (9%) 2/23 (9%) 1/21 (5%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | --- 648 733 (T) 733 (T) |--- 734 (T) --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.565 P=0.108 P=0.228 P=0.473 |P=0.506N P=0.443 (e) (e) |
|POLY 3 | P=0.547 P=0.111 P=0.225 P=0.479 |P=0.519N P=0.478 (e) (e) |
|POLY 1.5 | P=0.569 P=0.114 P=0.229 P=0.487 |P=0.511N P=0.487 (e) (e) |
|POLY 6 | P=0.521 P=0.108 P=0.220 P=0.470 |P=0.527N P=0.466 (e) (e) |
|LOGISTIC REGRESSION| P=0.554 P=0.110 P=0.228 P=0.473 |(e) P=0.443 (e) (e) |
|COCH-ARM / FISHERS | P=0.606 P=0.121 P=0.242 P=0.500 |P=0.500N P=0.500 (e) (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland |
| Angiectasis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 0/49 (0%) 0/47 (0%) 1/49 (2%) |2/49 (4%) 2/49 (4%) 3/49 (6%) 2/48 (4%) |
|POLY-3 ADJUSTED (b)| 2.4% 0.0% 0.0% 2.7% |4.6% 5.1% 7.3% 5.2% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 1/21 (5%) |2/28 (7%) 0/21 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE | 660 --- --- 733 (T) |734 (T) 663 587 643 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.529 P=0.511N P=0.523N P=0.721 |P=0.508 P=0.595 P=0.491 P=0.620 |
|POLY 3 | P=0.548 P=0.510N P=0.514N P=0.736 |P=0.510 P=0.657 P=0.480 P=0.649 |
|POLY 1.5 | P=0.552 P=0.506N P=0.511N P=0.745 |P=0.522 P=0.672 P=0.487 P=0.661 |
|POLY 6 | P=0.544 P=0.516N P=0.519N P=0.724 |P=0.502 P=0.637 P=0.476 P=0.638 |
|LOGISTIC REGRESSION| P=0.542 P=0.495N P=0.507N P=0.740 |P=0.531 P=0.633 P=0.486 P=0.658 |
|COCH-ARM / FISHERS | P=0.560 P=0.500N P=0.510N P=0.753N |P=0.550 P=0.691N P=0.500 P=0.684 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 29
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Pituitary Gland: Pars Distalis |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 12/49 (24%) 10/47 (21%) 15/49 (31%) |24/49 (49%) 13/49 (27%) 18/49 (37%) 15/48 (31%) |
|POLY-3 ADJUSTED (b)| 26.3% 29.2% 25.2% 37.4% |52.9% 32.0% 42.1% 36.8% |
|TERMINAL (d) | 7/24 (29%) 3/22 (14%) 6/23 (26%) 9/21 (43%) |15/28 (54%) 6/21 (29%) 14/28 (50%) 7/24 (29%) |
|FIRST INCIDENCE | 469 593 600 399 |572 503 440 478 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.142 P=0.411 P=0.566N P=0.149 |P=0.237N P=0.158N P=0.200N P=0.201N |
|POLY 3 | P=0.178 P=0.482 P=0.553N P=0.196 |P=0.176N P=0.036N* P=0.205N P=0.094N |
|POLY 1.5 | P=0.193 P=0.486 P=0.549N P=0.214 |P=0.175N P=0.026N* P=0.181N P=0.081N |
|POLY 6 | P=0.160 P=0.490 P=0.559N P=0.179 |P=0.175N P=0.054N P=0.240N P=0.109N |
|LOGISTIC REGRESSION| P=0.183 P=0.465 P=0.561N P=0.215 |P=0.215N P=0.042N* P=0.201N P=0.090N |
|COCH-ARM / FISHERS | P=0.219 P=0.500 P=0.543N P=0.246 |P=0.159N P=0.018N* P=0.154N P=0.058N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Preputial Gland |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/48 (4%) 0/49 (0%) 2/47 (4%) 2/49 (4%) | |
|POLY-3 ADJUSTED (b)| 5.0% 0.0% 5.2% 5.3% | |
|TERMINAL (d) | 2/23 (9%) 0/22 (0%) 1/23 (4%) 0/21 (0%) | |
|FIRST INCIDENCE | 733 (T) --- 523 552 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.373 P=0.247N P=0.691N P=0.661 | |
|POLY 3 | P=0.378 P=0.241N P=0.686 P=0.677 | |
|POLY 1.5 | P=0.384 P=0.237N P=0.687 P=0.685 | |
|POLY 6 | P=0.375 P=0.245N P=0.684 P=0.669 | |
|LOGISTIC REGRESSION| P=0.436 (e) P=0.687 P=0.667N | |
|COCH-ARM / FISHERS | P=0.397 P=0.242N P=0.684 P=0.684N | |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 30
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 11/49 (22%) 8/49 (16%) 16/48 (33%) 8/49 (16%) | |
|POLY-3 ADJUSTED (b)| 26.6% 20.2% 40.6% 21.0% | |
|TERMINAL (d) | 7/24 (29%) 6/22 (27%) 13/23 (57%) 4/21 (19%) | |
|FIRST INCIDENCE | 615 600 630 562 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.517 P=0.395N P=0.134 P=0.449N | |
|POLY 3 | P=0.531N P=0.338N P=0.130 P=0.373N | |
|POLY 1.5 | P=0.501N P=0.324N P=0.146 P=0.349N | |
|POLY 6 | P=0.534 P=0.359N P=0.107 P=0.398N | |
|LOGISTIC REGRESSION| P=0.499 P=0.370N P=0.097 P=0.412N | |
|COCH-ARM / FISHERS | P=0.443N P=0.305N P=0.166 P=0.305N | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Prostate |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 3/48 (6%) 2/49 (4%) | |
|POLY-3 ADJUSTED (b)| 7.3% 5.0% 7.6% 5.4% | |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 1/23 (4%) 0/21 (0%) | |
|FIRST INCIDENCE | 634 502 643 639 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.545N P=0.541N P=0.613 P=0.588N | |
|POLY 3 | P=0.515N P=0.518N P=0.641 P=0.549N | |
|POLY 1.5 | P=0.500N P=0.510N P=0.647 P=0.530N | |
|POLY 6 | P=0.531N P=0.532N P=0.631 P=0.569N | |
|LOGISTIC REGRESSION| P=0.467N P=0.486N P=0.653 P=0.521N | |
|COCH-ARM / FISHERS | P=0.473N P=0.500N P=0.651 P=0.500N | |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 31
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Salivary Glands |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 1/49 (2%) 0/47 (0%) 0/49 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |2.3% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/24 (0%) 1/22 (5%) 0/23 (0%) 0/21 (0%) |1/28 (4%) 0/21 (0%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |734 (T) --- --- 624 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.516N P=0.483 (e) (e) |P=0.211 P=0.557N P=0.500N P=0.444 |
|POLY 3 | P=0.508N P=0.491 (e) (e) |P=0.220 P=0.522N P=0.512N P=0.458 |
|POLY 1.5 | P=0.505N P=0.495 (e) (e) |P=0.220 P=0.513N P=0.507N P=0.472 |
|POLY 6 | P=0.512N P=0.486 (e) (e) |P=0.221 P=0.534N P=0.515N P=0.444 |
|LOGISTIC REGRESSION| (e) P=0.483 (e) (e) |P=0.206 (e) (e) P=0.466 |
|COCH-ARM / FISHERS | P=0.501N P=0.500 (e) (e) |P=0.223 P=0.500N P=0.500N P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Hyperkeratosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 2/48 (4%) 0/48 (0%) 1/48 (2%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 9.9% 5.2% 0.0% 2.8% |0.0% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 1/23 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 660 695 --- 639 |--- --- --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.123N P=0.378N P=0.077N P=0.246N |P=0.186 (e) (e) P=0.469 |
|POLY 3 | P=0.092N P=0.361N P=0.065N P=0.212N |P=0.180 (e) (e) P=0.474 |
|POLY 1.5 | P=0.091N P=0.351N P=0.063N P=0.199N |P=0.183 (e) (e) P=0.483 |
|POLY 6 | P=0.094N P=0.375N P=0.070N P=0.228N |P=0.177 (e) (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.095N P=0.348N P=0.063N P=0.186N |(e) (e) (e) P=0.469 |
|COCH-ARM / FISHERS | P=0.089N P=0.339N P=0.059N P=0.181N |P=0.191 (e) (e) P=0.500 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 32
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Acute |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/48 (0%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 2.6% 0.0% 0.0% |0.0% 0.0% 0.0% 5.2% |
|TERMINAL (d) | 0/23 (0%) 1/22 (5%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | --- 733 (T) --- --- |--- --- --- 536 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.511N P=0.491 (e) (e) |P=0.041 * (e) (e) P=0.213 |
|POLY 3 | P=0.506N P=0.492 (e) (e) |P=0.040 * (e) (e) P=0.212 |
|POLY 1.5 | P=0.504N P=0.495 (e) (e) |P=0.041 * (e) (e) P=0.220 |
|POLY 6 | P=0.511N P=0.488 (e) (e) |P=0.040 * (e) (e) P=0.204 |
|LOGISTIC REGRESSION| (e) P=0.491 (e) (e) |P=0.051 (e) (e) P=0.271 |
|COCH-ARM / FISHERS | P=0.500N P=0.500 (e) (e) |P=0.044 * (e) (e) P=0.247 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Skin |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/48 (8%) 1/48 (2%) 0/48 (0%) 0/48 (0%) |1/49 (2%) 0/49 (0%) 0/49 (0%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 10.0% 2.6% 0.0% 0.0% |2.3% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 1/23 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 660 695 --- --- |572 --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.033N* P=0.221N P=0.079N P=0.093N |P=0.348N P=0.513N P=0.509N P=0.532N |
|POLY 3 | P=0.022N* P=0.192N P=0.064N P=0.075N |P=0.308N P=0.524N P=0.514N P=0.528N |
|POLY 1.5 | P=0.022N* P=0.186N P=0.062N P=0.069N |P=0.317N P=0.514N P=0.509N P=0.518N |
|POLY 6 | P=0.022N* P=0.200N P=0.068N P=0.082N |P=0.298N P=0.538N P=0.519N P=0.539N |
|LOGISTIC REGRESSION| P=0.027N* P=0.192N P=0.066N P=0.077N |P=0.237N P=0.341N P=0.361N P=0.397N |
|COCH-ARM / FISHERS | P=0.024N* P=0.181N P=0.059N P=0.059N |P=0.331N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 33
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Fibrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 12/49 (24%) 6/48 (13%) 6/49 (12%) |3/49 (6%) 3/49 (6%) 3/49 (6%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 16.7% 28.8% 15.4% 16.1% |6.9% 7.6% 7.3% 5.2% |
|TERMINAL (d) | 3/24 (13%) 4/22 (18%) 4/23 (17%) 3/21 (14%) |1/28 (4%) 0/21 (0%) 2/28 (7%) 0/24 (0%) |
|FIRST INCIDENCE | 502 502 681 657 |707 663 660 617 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.299N P=0.133 P=0.549N P=0.611 |P=0.456N P=0.543 P=0.640 P=0.580N |
|POLY 3 | P=0.276N P=0.143 P=0.555N P=0.590N |P=0.435N P=0.618 P=0.637 P=0.552N |
|POLY 1.5 | P=0.245N P=0.146 P=0.536N P=0.556N |P=0.423N P=0.636 P=0.646 P=0.535N |
|POLY 6 | P=0.316N P=0.142 P=0.583N P=0.615 |P=0.445N P=0.597 P=0.630 P=0.567N |
|LOGISTIC REGRESSION| P=0.241N P=0.154 P=0.542N P=0.573N |P=0.410N P=0.636 P=0.630 P=0.508N |
|COCH-ARM / FISHERS | P=0.199N P=0.153 P=0.516N P=0.500N |P=0.393N P=0.661N P=0.661N P=0.500N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hematopoietic Cell Proliferation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 4/49 (8%) 3/49 (6%) 1/48 (2%) 4/49 (8%) |2/49 (4%) 4/49 (8%) 1/49 (2%) 4/49 (8%) |
|POLY-3 ADJUSTED (b)| 9.6% 7.6% 2.6% 10.5% |4.6% 10.2% 2.4% 10.1% |
|TERMINAL (d) | 2/24 (8%) 1/22 (5%) 1/23 (4%) 1/21 (5%) |1/28 (4%) 1/21 (5%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 460 684 733 (T) 526 |677 602 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.515 P=0.551N P=0.200N P=0.568 |P=0.356 P=0.243 P=0.513N P=0.279 |
|POLY 3 | P=0.545 P=0.533N P=0.201N P=0.592 |P=0.359 P=0.292 P=0.516N P=0.296 |
|POLY 1.5 | P=0.556 P=0.520N P=0.194N P=0.610 |P=0.372 P=0.311 P=0.510N P=0.312 |
|POLY 6 | P=0.534 P=0.549N P=0.213N P=0.574 |P=0.346 P=0.270 P=0.522N P=0.280 |
|LOGISTIC REGRESSION| P=0.568N P=0.497N P=0.181N P=0.594N |P=0.583N P=0.314 P=0.371N P=0.561 |
|COCH-ARM / FISHERS | P=0.576 P=0.500N P=0.187N P=0.643N |P=0.393 P=0.339 P=0.500N P=0.339 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 34
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Hemorrhage |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 1/49 (2%) 2/48 (4%) 2/49 (4%) |0/49 (0%) 2/49 (4%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 7.2% 2.5% 5.0% 5.3% |0.0% 5.1% 0.0% 2.6% |
|TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 1/21 (5%) 0/28 (0%) 1/24 (4%) |
|FIRST INCIDENCE | 634 502 560 527 |--- 581 --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.588N P=0.321N P=0.539N P=0.569N |P=0.583 P=0.199 (e) P=0.469 |
|POLY 3 | P=0.556N P=0.320N P=0.520N P=0.545N |P=0.553 P=0.216 (e) P=0.474 |
|POLY 1.5 | P=0.548N P=0.314N P=0.514N P=0.528N |P=0.570 P=0.225 (e) P=0.483 |
|POLY 6 | P=0.564N P=0.331N P=0.529N P=0.564N |P=0.535 P=0.205 (e) P=0.465 |
|LOGISTIC REGRESSION| P=0.431N P=0.274N P=0.498N P=0.461N |P=0.594 P=0.267 (e) P=0.469 |
|COCH-ARM / FISHERS | P=0.533N P=0.309N P=0.510N P=0.500N |P=0.600 P=0.247 (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Spleen |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 3/49 (6%) 2/49 (4%) 1/48 (2%) 2/49 (4%) |2/49 (4%) 1/49 (2%) 1/49 (2%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 7.1% 5.0% 2.6% 5.4% |4.6% 2.6% 2.4% 2.6% |
|TERMINAL (d) | 0/24 (0%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 469 643 600 657 |676 581 615 656 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.474N P=0.517N P=0.335N P=0.570N |P=0.471N P=0.569N P=0.535N P=0.586N |
|POLY 3 | P=0.435N P=0.527N P=0.331N P=0.557N |P=0.437N P=0.536N P=0.519N P=0.545N |
|POLY 1.5 | P=0.425N P=0.516N P=0.322N P=0.536N |P=0.433N P=0.521N P=0.512N P=0.530N |
|POLY 6 | P=0.447N P=0.541N P=0.343N P=0.580N |P=0.440N P=0.556N P=0.525N P=0.561N |
|LOGISTIC REGRESSION| P=0.339N P=0.451N P=0.301N P=0.430N |P=0.378N P=0.447N P=0.473N P=0.513N |
|COCH-ARM / FISHERS | P=0.408N P=0.500N P=0.316N P=0.500N |P=0.422N P=0.500N P=0.500N P=0.500N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 35
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 2/49 (4%) 2/48 (4%) 1/49 (2%) |0/49 (0%) 0/49 (0%) 0/49 (0%) 1/49 (2%) |
|POLY-3 ADJUSTED (b)| 4.8% 5.0% 5.0% 2.7% |0.0% 0.0% 0.0% 2.6% |
|TERMINAL (d) | 1/24 (4%) 1/22 (5%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 460 502 547 419 |--- --- --- 667 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.396N P=0.675 P=0.686 P=0.527N |P=0.170 (e) (e) P=0.444 |
|POLY 3 | P=0.402N P=0.678 P=0.680 P=0.535N |P=0.181 (e) (e) P=0.475 |
|POLY 1.5 | P=0.390N P=0.685 P=0.683 P=0.522N |P=0.184 (e) (e) P=0.484 |
|POLY 6 | P=0.415N P=0.670 P=0.676 P=0.551N |P=0.178 (e) (e) P=0.467 |
|LOGISTIC REGRESSION| P=0.211N P=0.656N P=0.697 P=0.322N |P=0.192 (e) (e) P=0.511 |
|COCH-ARM / FISHERS | P=0.370N P=0.691N P=0.684 P=0.500N |P=0.191 (e) (e) P=0.500 |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Forestomach |
| Ulcer |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/49 (2%) 6/49 (12%) 3/48 (6%) 2/49 (4%) |3/49 (6%) 2/49 (4%) 2/49 (4%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 2.4% 14.9% 7.5% 5.4% |6.8% 5.1% 4.8% 0.0% |
|TERMINAL (d) | 0/24 (0%) 2/22 (9%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 460 525 560 639 |519 677 615 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.491N P=0.058 P=0.287 P=0.455 |P=0.115N P=0.593N P=0.545N P=0.158N |
|POLY 3 | P=0.491N P=0.050 P=0.289 P=0.460 |P=0.106N P=0.556N P=0.529N P=0.148N |
|POLY 1.5 | P=0.467N P=0.052 P=0.293 P=0.475 |P=0.101N P=0.533N P=0.518N P=0.137N |
|POLY 6 | P=0.516N P=0.048 * P=0.285 P=0.446 |P=0.113N P=0.586N P=0.537N P=0.161N |
|LOGISTIC REGRESSION| P=0.373N P=0.067 P=0.296 P=0.575 |P=0.073N P=0.441N P=0.397N P=0.081N |
|COCH-ARM / FISHERS | P=0.424N P=0.056 P=0.301 P=0.500 |P=0.089N P=0.500N P=0.500N P=0.121N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 36
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Mineralization |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 1/48 (2%) 0/49 (0%) |2/49 (4%) 2/48 (4%) 0/49 (0%) 2/49 (4%) |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 2.6% 0.0% |4.6% 5.2% 0.0% 5.3% |
|TERMINAL (d) | 0/24 (0%) 2/22 (9%) 1/23 (4%) 0/21 (0%) |2/28 (7%) 2/21 (10%) 0/28 (0%) 2/24 (8%) |
|FIRST INCIDENCE | --- 733 (T) 733 (T) --- |734 (T) 734 (T) --- 734 (T) |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.425N P=0.218 P=0.492 (e) |P=0.552N P=0.588 P=0.238N P=0.640 |
|POLY 3 | P=0.435N P=0.227 P=0.490 (e) |P=0.549N P=0.649 P=0.250N P=0.646 |
|POLY 1.5 | P=0.422N P=0.231 P=0.493 (e) |P=0.544N P=0.665 P=0.245N P=0.663 |
|POLY 6 | P=0.451N P=0.221 P=0.485 (e) |P=0.554N P=0.628 P=0.254N P=0.628 |
|LOGISTIC REGRESSION| (e) P=0.218 P=0.492 (e) |P=0.552N P=0.588 (e) P=0.640 |
|COCH-ARM / FISHERS | P=0.401N P=0.247 P=0.495 (e) |P=0.533N P=0.684 P=0.247N P=0.691N |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Stomach, Glandular |
| Necrosis |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 7/49 (14%) 2/49 (4%) 2/48 (4%) 3/49 (6%) |3/49 (6%) 2/48 (4%) 1/49 (2%) 0/49 (0%) |
|POLY-3 ADJUSTED (b)| 16.2% 5.1% 5.1% 7.9% |6.8% 5.2% 2.4% 0.0% |
|TERMINAL (d) | 1/24 (4%) 0/22 (0%) 0/23 (0%) 0/21 (0%) |0/28 (0%) 0/21 (0%) 0/28 (0%) 0/24 (0%) |
|FIRST INCIDENCE | 469 643 643 527 |657 663 707 --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.245N P=0.104N P=0.108N P=0.229N |P=0.087N P=0.604N P=0.356N P=0.179N |
|POLY 3 | P=0.198N P=0.100N P=0.102N P=0.214N |P=0.071N P=0.559N P=0.332N P=0.147N |
|POLY 1.5 | P=0.192N P=0.091N P=0.094N P=0.192N |P=0.067N P=0.538N P=0.321N P=0.137N |
|POLY 6 | P=0.205N P=0.113N P=0.114N P=0.241N |P=0.075N P=0.585N P=0.343N P=0.161N |
|LOGISTIC REGRESSION| P=0.123N P=0.059N P=0.073N P=0.087N |P=0.057N P=0.458N P=0.279N P=0.101N |
|COCH-ARM / FISHERS | P=0.184N P=0.080N P=0.084N P=0.159N |P=0.061N P=0.510N P=0.309N P=0.121N |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 37
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes |
| Atrophy |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/49 (4%) 4/49 (8%) 2/48 (4%) 4/49 (8%) | |
|POLY-3 ADJUSTED (b)| 4.9% 10.1% 5.2% 10.7% | |
|TERMINAL (d) | 1/24 (4%) 3/22 (14%) 2/23 (9%) 2/21 (10%) | |
|FIRST INCIDENCE | 624 551 733 (T) 572 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.314 P=0.305 P=0.671 P=0.272 | |
|POLY 3 | P=0.327 P=0.318 P=0.673 P=0.295 | |
|POLY 1.5 | P=0.343 P=0.327 P=0.680 P=0.310 | |
|POLY 6 | P=0.310 P=0.307 P=0.662 P=0.279 | |
|LOGISTIC REGRESSION| P=0.337 P=0.328 P=0.673 P=0.323 | |
|COCH-ARM / FISHERS | P=0.371 P=0.339 P=0.684 P=0.339 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Artery |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/49 (0%) 2/49 (4%) 0/48 (0%) 2/49 (4%) | |
|POLY-3 ADJUSTED (b)| 0.0% 5.1% 0.0% 5.5% | |
|TERMINAL (d) | 0/24 (0%) 2/22 (9%) 0/23 (0%) 2/21 (10%) | |
|FIRST INCIDENCE | --- 733 (T) --- 733 (T) | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.261 P=0.218 (e) P=0.208 | |
|POLY 3 | P=0.262 P=0.227 (e) P=0.214 | |
|POLY 1.5 | P=0.273 P=0.231 (e) P=0.223 | |
|POLY 6 | P=0.250 P=0.221 (e) P=0.204 | |
|LOGISTIC REGRESSION| (e) P=0.218 (e) P=0.208 | |
|COCH-ARM / FISHERS | P=0.290 P=0.247 (e) P=0.247 | |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 38
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Testes: Interstitial Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 5/49 (10%) 9/49 (18%) 2/48 (4%) 11/49 (22%) | |
|POLY-3 ADJUSTED (b)| 11.5% 21.9% 5.0% 26.4% | |
|TERMINAL (d) | 0/24 (0%) 3/22 (14%) 0/23 (0%) 2/21 (10%) | |
|FIRST INCIDENCE | 460 525 433 419 | |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.106 P=0.182 P=0.248N P=0.067 | |
|POLY 3 | P=0.115 P=0.159 P=0.249N P=0.067 | |
|POLY 1.5 | P=0.122 P=0.172 P=0.238N P=0.072 | |
|POLY 6 | P=0.109 P=0.147 P=0.266N P=0.064 | |
|LOGISTIC REGRESSION| P=0.277 P=0.233 P=0.198N P=0.214 | |
|COCH-ARM / FISHERS | P=0.138 P=0.194 P=0.226N P=0.085 | |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: C-Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 32/46 (70%) 36/47 (77%) 31/45 (69%) 33/47 (70%) |39/47 (83%) 37/46 (80%) 37/48 (77%) 42/48 (88%) |
|POLY-3 ADJUSTED (b)| 73.7% 81.9% 76.0% 75.7% |85.2% 83.3% 81.4% 92.5% |
|TERMINAL (d) | 16/24 (67%) 17/22 (77%) 20/22 (91%) 14/20 (70%) |24/28 (86%) 16/21 (76%) 22/28 (79%) 22/24 (92%) |
|FIRST INCIDENCE | 460 435 523 419 |509 440 440 445 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.276 P=0.195 P=0.449 P=0.212 |P=0.148 P=0.175 P=0.527N P=0.079 |
|POLY 3 | P=0.491N P=0.244 P=0.502 P=0.513 |P=0.155 P=0.518N P=0.417N P=0.205 |
|POLY 1.5 | P=0.461N P=0.262 P=0.558 P=0.534 |P=0.177 P=0.505N P=0.383N P=0.230 |
|POLY 6 | P=0.543N P=0.230 P=0.403 P=0.481 |P=0.152 P=0.524N P=0.435N P=0.203 |
|LOGISTIC REGRESSION| P=0.510N P=0.277 P=0.584N P=0.546 |P=0.189 P=0.490N P=0.396N P=0.181 |
|COCH-ARM / FISHERS | P=0.428N P=0.298 P=0.562N P=0.563 |P=0.296 P=0.480N P=0.323N P=0.370 |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 39
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Thyroid Gland: Follicular Cell |
| Hyperplasia |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 2/46 (4%) 0/47 (0%) 3/45 (7%) 0/47 (0%) |0/47 (0%) 0/46 (0%) 1/48 (2%) 0/48 (0%) |
|POLY-3 ADJUSTED (b)| 5.2% 0.0% 8.1% 0.0% |0.0% 0.0% 2.5% 0.0% |
|TERMINAL (d) | 2/24 (8%) 0/22 (0%) 2/22 (9%) 0/20 (0%) |0/28 (0%) 0/21 (0%) 1/28 (4%) 0/24 (0%) |
|FIRST INCIDENCE | 733 (T) --- 677 --- |--- --- 734 (T) --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.400N P=0.257N P=0.460 P=0.278N |P=0.664 (e) P=0.500 (e) |
|POLY 3 | P=0.377N P=0.238N P=0.481 P=0.254N |P=0.624 (e) P=0.491 (e) |
|POLY 1.5 | P=0.362N P=0.235N P=0.486 P=0.244N |P=0.641 (e) P=0.496 (e) |
|POLY 6 | P=0.395N P=0.242N P=0.473 P=0.267N |P=0.605 (e) P=0.486 (e) |
|LOGISTIC REGRESSION| P=0.397N (e) P=0.456 (e) |(e) (e) P=0.500 (e) |
|COCH-ARM / FISHERS | P=0.344N P=0.242N P=0.489 P=0.242N |P=0.673 (e) P=0.505 (e) |
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Inflammation Chronic |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 1/1 (100%) 1/2 (50%) 4/4 (100%) 0/2 (0%) |0/0 (0%) 0/0 (0%) 0/1 (0%) 0/1 (0%) |
|POLY-3 ADJUSTED (b)| 100.0% 59.7% 100.0% 0.0% |0.0% 0.0% 0.0% 0.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 2/2 (100%) 0/1 (0%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | 460 525 650 --- |--- --- --- --- |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.253N P=0.755 (e) P=0.504N |(e) (e) (e) (e) |
|POLY 3 | P=0.119N P=0.714N (e) P=0.246N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.090N P=0.660N (e) P=0.041N* |(e) (e) (e) (e) |
|POLY 6 | P=0.162N P=0.833N (e) P=0.418N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.148N (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.154N P=0.667N (e) P=0.333N |(e) (e) (e) (e) |
|=================================================================================================================================|
Date: 03/06/00 EXPERIMENT: 05110 TEST: 02 Page 40
Statistical Analysis of Non-neoplastic Lesions in Rats(FISCHER 344) - NAPHTHALENE
Terminal Sacrifice at 105 weeks
|=================================================================================================================================|
| | | |
| | Males | Females |
|Dose | CONTROL 10 PPM 30 PPM 60 PPM |CONTROL 10 PPM 30 PPM 60 PPM |
| | | |
|=================================================================================================================================|
| |
|Tooth |
| Malformation |
| |
| |
|---------------------------------------------------------------------------------------------------------------------------------|
|LESION RATES | | |
|----------- | | |
|OVERALL (a) | 0/1 (0%) 1/2 (50%) 0/4 (0%) 2/2 (100%) |0/0 (0%) 0/0 (0%) 1/1 (100%) 1/1 (100%) |
|POLY-3 ADJUSTED (b)| 0.0% 73.1% 0.0% 100.0% |0.0% 0.0% 100.0% 100.0% |
|TERMINAL (d) | 0/0 (0%) 0/0 (0%) 0/2 (0%) 1/1 (100%) |0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) |
|FIRST INCIDENCE | --- 643 --- 560 |--- --- 440 111 |
|-------------------| | |
|STATISTICAL TESTS | | |
|-------------------| | |
|LIFE TABLE | P=0.209 P=0.484 (e) P=0.466 |(e) (e) (e) (e) |
|POLY 3 | P=0.089 P=0.822 (e) P=1.000N |(e) (e) (e) (e) |
|POLY 1.5 | P=0.084 P=0.709 (e) P=1.000N |(e) (e) (e) (e) |
|POLY 6 | P=0.100 P=0.992 (e) P=1.000N |(e) (e) (e) (e) |
|LOGISTIC REGRESSION| P=0.148 (e) (e) (e) |(e) (e) (e) (e) |
|COCH-ARM / FISHERS | P=0.154 P=0.667 (e) P=0.333 |(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).