TDMS Study 99033-02 Pathology Tables
NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 FINAL #3/P53 MICE Facility: BIORELIANCE Chemical CAS #: 22839-47-0 Lock Date: 07/20/01 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include All Page 1 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 7| | | | 8| 8| 8| 5| 8| 8| 5| 5| 8| 5| 5| 8| 6| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | VEHICLE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Gallbladder | + + + M + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 | 4 1.0| Pigmentation, Focal, Hemosiderin | 3 | 1 3.0| Tension Lipidosis | X | 1 | |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 1 1 | 6 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 2 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 7| | | | 8| 8| 8| 5| 8| 8| 5| 5| 8| 5| 5| 8| 6| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | VEHICLE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Subcapsular, Hyperplasia, Focal | 3 1 1 1 1 1 1 1 1 2 1 1 | 12 1.3| |__________________________________________________________________________|____________| Adrenal Medulla | + + + M + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | M M M M + M M + M + + M M + + | 6 | |__________________________________________________________________________|____________| Pituitary Gland | M M + + I + + + I + + + I I + | 9 | |__________________________________________________________________________|____________| Thyroid Gland | + + + M + + + + + + + + + + + | 14 | Ectopic Thymus | 1 1 | 2 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | M + + + + + + + + + + + M + M | 12 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + | 15 | Cyst | 3 | 1 3.0| |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + | 15 | Endometrium, Hyperplasia, Cystic | 1 1 2 2 2 1 1 2 1 1 1 2 1 2 | 14 1.4| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 3 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 7| | | | 8| 8| 8| 5| 8| 8| 5| 5| 8| 5| 5| 8| 6| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | VEHICLE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Vagina | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Histiocytic | 2 | 1 2.0| Hyperplasia, Lymphoid | 2 3 | 2 2.5| Hyperplasia | 2 | 1 2.0| Hyperplasia, Plasma Cell | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Lymphoid | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mediastinal | M + + + + + M + + + + + + M + | 12 | Hyperplasia, Lymphoid | 4 | 1 4.0| |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 2 1 3 | 3 2.0| |__________________________________________________________________________|____________| Thymus | M + + + + + + + + + + + + + + | 14 | Atrophy, Focal | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + M M + + + + + + + | 13 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 4 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 7| | | | 8| 8| 8| 5| 8| 8| 5| 5| 8| 5| 5| 8| 6| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | VEHICLE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM - cont | | | Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | M M M + M M M + M + I I + M M | 4 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Zymbal's Gland | M M + M + + + + + + + + + + + | 12 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Renal Tubule, Dilatation, Diffuse | 2 | 1 2.0| Renal Tubule, Dilatation, Focal | 1 1 1 2 1 1 | 6 1.2| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 5 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 3| 7| 7| | | | 8| 8| 8| 5| 8| 8| 5| 5| 8| 5| 5| 8| 6| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | VEHICLE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM - cont | | | Urinary Bladder | + + + + + + + + + + + + M + + | 14 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 6 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 7| 7| 7| 7| | | | 8| 5| 8| 5| 8| 8| 8| 8| 8| 8| 5| 8| 8| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 3125 PPM | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 | 3 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + | 1 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 1 1 1 1 | 13 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + M + + + + + | 14 | |__________________________________________________________________________|____________| Thyroid Gland | + M + + + + + + + A + + + + + | 13 | Ectopic Thymus | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 7 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 7| 7| 7| 7| | | | 8| 5| 8| 5| 8| 8| 8| 8| 8| 8| 5| 8| 8| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 3125 PPM | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Uterus | + + + + + + + + + + + + + + + | 15 | Hydrometra | 2 | 1 2.0| Endometrium, Hyperplasia, Cystic | 1 2 2 2 2 2 1 2 2 1 2 2 1 1 | 14 1.6| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + A + + + M + | 13 | Hyperplasia | 2 2 | 2 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + A + + + + + | 14 | Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + + + + + M M + + + + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Depletion Cellular, Diffuse | 4 | 1 4.0| Hematopoietic Cell Proliferation | 2 1 1 2 | 4 1.5| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + M + + + + + | 14 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 8 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 7| 7| 7| 7| | | | 8| 5| 8| 5| 8| 8| 8| 8| 8| 8| 5| 8| 8| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 3125 PPM | 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + A + + + + + | 14 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| Renal Tubule, Dilatation, Diffuse | 2 2 | 2 2.0| Renal Tubule, Dilatation, Focal | 1 1 1 1 1 | 5 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 9 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| | | | 8| 5| 8| 8| 5| 5| 8| 8| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 6250 PPM | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 | 4 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + I + + + + | 14 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + I + + + + | 14 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + I + + + + | 14 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + I + + + + | 14 | Hyperplasia, Focal | 1 | 1 1.0| Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 1 1 1 1 | 13 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + I + + + + | 14 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + I + M + + + + | 13 | Pars Intermedia, Hypertrophy | 1 | 1 1.0| |__________________________________________________________________________|____________| Thyroid Gland | M + + + + + + + + + + + + + + | 14 | Ectopic Thymus | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + I + + + + | 14 | Atrophy | 3 | 1 3.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 10 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| | | | 8| 5| 8| 8| 5| 5| 8| 8| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 6250 PPM | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + | 15 | Endometrium, Hyperplasia, Cystic | 2 1 2 2 1 2 3 1 2 2 1 1 1 2 2 | 15 1.7| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | M + + + + + + M + + + + + + + | 13 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + M + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + + + + + + + M + M + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 2 | 1 2.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + I + + + + | 14 | Hyperplasia | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + M + + + + | 14 | |__________________________________________________________________________|____________| Skin | + | 1 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + I + + + + | 14 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 11 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 6| 7| 7| 7| 7| | | | 8| 5| 8| 8| 5| 5| 8| 8| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 6250 PPM | 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| 4| 4| 4| 4| 4| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Lung | + + + + + + + + + + I + + + + | 14 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Renal Tubule, Dilatation, Diffuse | 1 2 1 | 3 1.3| Renal Tubule, Dilatation, Focal | 1 1 | 2 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 12 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 5| 8| 8| 5| 5| 5| 8| 5| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 12500 | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 1 1 | 6 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Focal | 1 | 1 1.0| Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 15 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + + + + + + + I | 14 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + I + + + + + + + + + | 14 | Ectopic Thymus | 1 1 1 | 3 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 13 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 5| 8| 8| 5| 5| 5| 8| 5| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 12500 | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Endometrium, Hyperplasia, Cystic | 2 2 2 2 2 2 2 2 2 2 1 2 1 2 | 14 1.9| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + M + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + M + + + + + + + M + M + + + | 12 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 3 1 1 | 3 1.7| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Atypical, Focal | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | Medulla, Cyst Epithelial Inclusion | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 14 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 5| 8| 8| 5| 5| 5| 8| 5| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 12500 | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| Renal Tubule, Dilatation, Focal | 1 1 1 1 1 | 5 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 15 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 8| 8| 5| 8| 5| 8| 8| 8| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 25000 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Intestine Large, Cecum | + | 1 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 2 | 4 1.3| Hepatocyte, Necrosis, Focal | 1 1 | 2 1.0| Hepatocyte, Vacuolization | | | Cytoplasmic, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Focal | 1 | 1 1.0| Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 15 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | + I + + + M + + M + I + + + + | 11 | Pars Intermedia, Hypertrophy | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Thyroid Gland | + I + + + + + + + M + + + + + | 13 | Ectopic Thymus | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 16 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 8| 8| 5| 8| 5| 8| 8| 8| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 25000 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + | 15 | Endometrium, Hyperplasia, Cystic | 2 2 2 2 2 2 2 2 2 2 2 1 2 2 2 | 15 1.9| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node | + | 1 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Congestion | 1 | 1 1.0| Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + + I + + M + + + + + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 1 | 1 1.0| Pigmentation | 1 | 1 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + M + M + M + + | 12 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 17 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 8| 5| 8| 8| 5| 8| 5| 8| 8| 8| 8| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 25000 | 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| 7| 7| 7| 7| 7| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Renal Tubule, Dilatation, Focal | 1 1 1 1 | 4 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 18 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 5| 8| 8| 8| 8| 5| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 50000 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + M + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Gallbladder | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 2 1 1 | 4 1.3| Necrosis, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 2 1 2 1 2 2 2 2 | 8 1.8| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 19 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 5| 8| 8| 8| 8| 5| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 50000 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 | 15 1.1| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + + + + M + M + + + M M + | 11 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + M + + + + + + + + + | 14 | Pars Intermedia, Hypertrophy | 2 2 | 2 2.0| |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | Ectopic Thymus | 1 1 | 2 1.0| _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + + + + + + + + | 15 | Endometrium, Hyperplasia, Cystic | 2 1 2 1 2 2 2 2 2 2 2 1 2 3 2 | 15 1.9| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 20 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 5| 8| 8| 8| 8| 5| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 50000 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Vagina | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + M + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 2 | 1 2.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | Femur, Fibrous Osteodystrophy, Focal | 2 | 1 2.0| |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 21 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 8| 5| 8| 8| 8| 8| 5| 5| 5| 8| 8| 5| 8| 8| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| | A | 50000 | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | I + M M + + I I I + I I I + I | 5 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 | 3 1.0| Inflammation, Chronic Active | 2 | 1 2.0| |__________________________________________________________________________|____________| Zymbal's Gland | + + + + + + M + + M + + M M + | 11 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Glomerulus, Hyalinization | 1 | 1 1.0| Renal Tubule, Dilatation, Focal | 1 1 1 1 | 4 1.0| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + | 15 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 22 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 0| 7| 7| 7| 7| 7| | | | 4| 5| 4| 4| 4| 4| 4| 5| 4| 2| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | VEHICLE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Gallbladder | I + + + + + + + + A + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 | 2 1.0| Inflammation, Chronic | 1 | 1 1.0| Inflammation, Chronic Active | 1 1 1 | 3 1.0| Necrosis, Focal | 1 2 | 2 1.5| Hepatocyte, Periportal, | | | Vacuolization Cytoplasmic, | | | Diffuse | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 2 1 1 1 1 1 2 1 1 | 9 1.2| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 23 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 0| 7| 7| 7| 7| 7| | | | 4| 5| 4| 4| 4| 4| 4| 5| 4| 2| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | VEHICLE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + M + | 14 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 2 1 2 2 2 1 1 1 2 2 1 1 1 1 | 14 1.4| Subcapsular, Hyperplasia, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Parathyroid Gland | + M + M M M M + M M + + M + M | 6 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + I + + I + + + + + | 13 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 24 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 0| 7| 7| 7| 7| 7| | | | 4| 5| 4| 4| 4| 4| 4| 5| 4| 2| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | VEHICLE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Preputial Gland | M + + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | Rete Testes, Inflammation, Focal | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + A + + + + + | 14 | Hyperplasia, Plasma Cell | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + M + + + + + + A + + + + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Atrophy | 2 1 | 2 1.5| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 25 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 0| 7| 7| 7| 7| 7| | | | 4| 5| 4| 4| 4| 4| 4| 5| 4| 2| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | VEHICLE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Peripheral Nerve | + | 1 | Vacuolization Cytoplasmic, Diffuse | 1 | 1 1.0| |__________________________________________________________________________|____________| Spinal Cord | + | 1 | Vacuolization Cytoplasmic, Focal | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | M + M M M M M M M M + M M + + | 4 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + A + + + + + | 14 | Inflammation, Acute | 1 | 1 1.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + A + + + + + | 14 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + A + + + + + | 14 | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 1 | 5 1.0| |__________________________________________________________________________|____________| Zymbal's Gland | + + + + + + + + + + M + M M + | 12 | _____________________________________________________________________________________________________________________| | * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 26 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 0| 7| 7| 7| 7| 7| | | | 4| 5| 4| 4| 4| 4| 4| 5| 4| 2| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | VEHICLE | 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| 2| 2| 2| 2| 2| | L | CONTROL | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + A + + + + + | 14 | Nephropathy | 1 1 1 1 | 4 1.0| |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + A + + + + + | 14 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 27 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 5| 4| 5| 4| 4| 5| 5| 4| 5| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 3125 PPM | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 | 2 1.0| Necrosis, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Salivary Glands | + | 1 | Infiltration Cellular, Focal, | | | Lymphocyte | 2 | 1 2.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 1 2 1 1 1 1 1 2 1 1 1 1 1 1 | 14 1.1| Hypertrophy, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | + + I + + I + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 28 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 5| 4| 5| 4| 4| 5| 5| 4| 5| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 3125 PPM | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | Epithelium, Degeneration, Focal | 3 | 1 3.0| |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | Mineralization, Focal | 1 | 1 1.0| Germinal Epithelium, Degeneration, | | | Diffuse | 2 | 1 2.0| Germinal Epithelium, Degeneration, | | | Focal | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 2 2 1 | 3 1.7| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + M + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + + + + + M + + + + + + | 14 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 29 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 5| 4| 5| 4| 4| 5| 5| 4| 5| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 3125 PPM | 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| 3| 3| 3| 3| 4| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM - cont | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | Ventricle, Hydrocephalus | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| Renal Tubule, Dilatation, Diffuse | 1 1 | 2 1.0| Renal Tubule, Dilatation, Focal | 1 1 | 2 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 30 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 1| 7| 7| 1| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 5| 4| 4| 5| 4| 0| 5| 4| 4| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 6250 PPM | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 | 4 1.0| |__________________________________________________________________________|____________| Salivary Glands | + | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 1 2 1 1 2 2 1 1 1 2 1 1 | 12 1.3| Hypertrophy, Focal | 1 1 1 | 3 1.0| Subcapsular, Hyperplasia, Focal | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | I I + + + + I + I + + + + + + | 11 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 31 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 1| 7| 7| 1| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 5| 4| 4| 5| 4| 0| 5| 4| 4| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 6250 PPM | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | I + + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + M + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | Hydrocephalus | 2 | 1 2.0| Corpus Callosum, Medulla, | | | Vacuolization Cytoplasmic, Focal | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 32 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 1| 7| 7| 1| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 5| 4| 4| 5| 4| 0| 5| 4| 4| 5| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 6250 PPM | 4| 4| 4| 4| 4| 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Inflammation, Chronic Active, Diffuse| 3 | 1 3.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + | 1 | Developmental Malformation | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 33 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 4| 4| 4| 4| 5| 4| 4| 4| 5| 4| 5| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 12500 | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 1 1 1 1 1 1 2 2 1 1 1 1 | 12 1.2| Hypertrophy, Focal | 1 1 | 2 1.0| Subcapsular, Hyperplasia, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | M + M I I I + + I I + + + + + | 8 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + I | 14 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 34 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 4| 4| 4| 4| 5| 4| 4| 4| 5| 4| 5| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 12500 | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | Germinal Epithelium, Degeneration, | | | Focal | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node | + | 1 | Iliac, Pigmentation, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 2 2 | 2 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + I + + + M + + + + | 13 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + M + + + M + + + + + + + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Thymus | M + + + + + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 35 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 5| 4| 4| 4| 4| 4| 4| 5| 4| 4| 4| 5| 4| 5| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 12500 | 5| 5| 5| 5| 6| 6| 6| 6| 6| 6| 6| 6| 6| 6| 7| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| Renal Tubule, Dilatation, Diffuse | 1 | 1 1.0| __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 36 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 9| 4| 5| 4| 4| 4| 5| 4| 5| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 25000 | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Liver | + + + + A + + + + + + + + + + | 14 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Salivary Glands | + | 1 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + A + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + A + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 2 1 1 1 1 1 1 1 3 1 | 10 1.3| Hypertrophy, Focal | 1 | 1 1.0| Subcapsular, Hyperplasia, Focal | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Pituitary Gland | + M + I A + + I + + + + + I + | 10 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + A + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 37 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 9| 4| 5| 4| 4| 4| 5| 4| 5| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 25000 | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Epididymis | + + + + A + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Prostate | + + + + A + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Testes | + + + + A + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + M + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + M + + + + + + + + + + | 14 | Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + + + + M + + M + + + + M + + | 12 | Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| Spleen | + + + + A + + + + + + + + + + | 14 | Hematopoietic Cell Proliferation | 2 | 1 2.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | Atrophy, Diffuse | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + A + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 38 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 4| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 9| 4| 5| 4| 4| 4| 5| 4| 5| 5| 5| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | A | 25000 | 7| 7| 7| 7| 7| 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| | L | PPM | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + A + + + + + + + + + + | 14 | Perivascular, Infiltration Cellular, | | | Lymphocyte | 1 1 | 2 1.0| _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + A + + + + + + + + + + | 14 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 39 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 5| 4| 5| 1| 4| 5| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | A | 50000 | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Gallbladder | + + M + + + + + + + M + M + + | 12 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 1 | 5 1.0| Inflammation, Chronic Active | 1 | 1 1.0| Necrosis, Focal | 1 | 1 1.0| Hepatocyte, Periportal, | | | Vacuolization Cytoplasmic, | | | Diffuse | 3 2 2 1 | 4 2.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 1 1 1 1 1 1 1 1 1 | 10 1.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 40 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 5| 4| 5| 1| 4| 5| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | A | 50000 | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Stomach, Glandular | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tooth | + | 1 | Peridontal Tissue, Cyst | X | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 1 1 1 2 1 1 2 1 1 2 1 2 1 | 13 1.3| Hypertrophy, Focal | 1 1 1 | 3 1.0| Subcapsular, Hyperplasia, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | + + + M + M + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + I I + + + + + + M + + | 12 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 41 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 5| 4| 5| 1| 4| 5| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | A | 50000 | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + M + M + + + + + | 13 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia, Plasma Cell | 2 1 | 2 1.5| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mediastinal | + M + + + + + + + + + M + + + | 13 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 3 3 | 2 3.0| Hyperplasia, Lymphoid | 1 | 1 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + I + + + + + + + + + | 14 | Atrophy, Focal | 1 3 | 2 2.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 42 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 5| 4| 5| 1| 4| 5| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | A | 50000 | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | Medulla, Vacuolization Cytoplasmic, | | | Focal | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | M + M M M M M I M M I M + M M | 2 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| Inflammation, Chronic Active | 1 | 1 1.0| _____________________________________________________________________________________________________________________|____________| * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 43 NTP Experiment-Test: 99033-02 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ASPARTAME) Date: 03/05/03 Route: DOSED FEED Time: 11:36:07 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 0| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 5| 4| 5| 1| 4| 5| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | P53+/-(C57BL/6) MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| | A | 50000 | 8| 8| 8| 8| 9| 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| | L | PPM | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| SPECIAL SENSES SYSTEM - cont | | | |__________________________________________________________________________|____________| Zymbal's Gland | + M + + + + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Nephropathy | 1 1 1 | 3 1.0| Renal Tubule, Dilatation, Diffuse | 1 | 1 1.0| |__________________________________________________________________________|____________| Urinary Bladder | + + M + + + + + + + + + + + + | 14 | __________________________________________________________________________________________________________________________________ * : Total animals with tissue examined microscopically; total animals with lesion and mean severity grade + : Tissue examined microscopically M : Missing tissue 1-4 : Lesion qualified as: X : Lesion present but not qualified A : Autolysis precludes examination 1) Minimal 3) Moderate I : Insufficient tissue BLANK : Not examined 2) Mild 4) Marked Page 44 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------