TDMS Study 99039-01 Pathology Tables
NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 FINAL#3/TG.AC MICE Facility: BIORELIANCE Chemical CAS #: 55589-62-3 Lock Date: 07/20/01 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Include 001 VEHICLE CONTROL Include 002 0.3% Include 003 1.0 % Include 004 3.0 % Include 006 VEHICLE CONTROL Include 007 0.3 % Include 008 1.0% Include 009 3.0% Page 1 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 4| 3| 7| 2| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 0| 6| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | VEHICLE | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | CONTROL | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + A + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Gallbladder | + A + A + + + + + + M + + + + | 12 | |__________________________________________________________________________|____________| Intestine Large, Colon | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Inflammation, Chronic | 1 1 | 2 1.0| Necrosis, Focal | 1 | 1 1.0| Hepatocyte, Inflammation, Chronic | 1 | 1 1.0| Hepatocyte, Necrosis, Focal | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Mesentery | + + | 2 | Fat, Necrosis, Focal | 4 4 | 2 4.0| |__________________________________________________________________________|____________| Pancreas | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Salivary Glands | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Stomach, Forestomach | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Stomach, Glandular | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 4| 3| 7| 2| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 0| 6| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | VEHICLE | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | CONTROL | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM - cont | | | Tongue | + + + + + + + + + + + + + + + | 15 | Ulcer | 3 | 1 3.0| |__________________________________________________________________________|____________| Tooth | + + | 2 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + M + + + + + M M + + | 12 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + A + + + + + + + + + + + | 14 | Subcapsular, Hyperplasia, Focal | 1 1 1 1 1 1 1 1 1 | 9 1.0| Zona Reticularis, Vacuolization | | | Cytoplasmic | 2 2 1 2 1 1 2 2 2 | 9 1.7| |__________________________________________________________________________|____________| Adrenal Medulla | + + + A + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Islets, Pancreatic | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Parathyroid Gland | + A M M M + + M + + M M M M M | 5 | |__________________________________________________________________________|____________| Pituitary Gland | + I + + + + + I I + + + + + + | 12 | |__________________________________________________________________________|____________| Thyroid Gland | + A + + + + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + A + M + + + M I + + M + M + | 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 3 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 4| 3| 7| 2| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 0| 6| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | VEHICLE | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | CONTROL | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Ovary | + + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Uterus | + A + A + + + + + + + + + + + | 13 | Endometrium, Hyperplasia, Cystic | 2 1 2 3 2 1 2 | 7 1.9| |__________________________________________________________________________|____________| Vagina | + A + A + + + + + + + + + + + | 13 | Hyperplasia | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + A M + + + M + + + + + + | 12 | Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + A + A + + M + + + + + + + + | 12 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 2 1 2 1 2 2 2 2 1 1 1 1 | 12 1.5| Pigmentation | 2 1 1 | 3 1.3| |__________________________________________________________________________|____________| Thymus | + A + A + + + M + M + + + + + | 11 | Atrophy, Diffuse | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + A + A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + 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 4 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 4| 3| 7| 2| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 0| 6| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | VEHICLE | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | CONTROL | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| MUSCULOSKELETAL SYSTEM - cont | | | |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + A + + + + + + + + + + + + + | 14 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | M + I A I + I + I M I I I I M | 3 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Nose | + A + + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Pleura | + | 1 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + I + + + | 14 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + A + A + + + + + + + + + + + | 13 | Retina, Atrophy | 3 3 3 3 3 3 3 3 3 3 3 3 3 | 13 3.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + M + + + + + + + + + + | 14 | Infiltration Cellular, Focal, | | | Lymphocyte | 1 | 1 1.0| |__________________________________________________________________________|____________| Zymbal's Gland | + M M + + + + + + + + + M + M | 11 | _____________________________________________________________________________________________________________________| | 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 5 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 4| 3| 7| 2| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 0| 6| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | VEHICLE | 7| 7| 7| 7| 8| 8| 8| 8| 8| 8| 8| 8| 8| 8| 9| | L | CONTROL | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| URINARY SYSTEM - cont | | | Urinary Bladder | + A + A + + + + + + + + + + + | 13 | __________________________________________________________________________________________________________________________________ * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 5| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 6| 4| 6| 4| 7| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | 0.3 % | 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + | 1 | |__________________________________________________________________________|____________| Gallbladder | A | | |__________________________________________________________________________|____________| Intestine Large, Colon | A | | |__________________________________________________________________________|____________| Intestine Large, Rectum | A | | |__________________________________________________________________________|____________| Intestine Large, Cecum | A | | |__________________________________________________________________________|____________| Intestine Small, Duodenum | A | | |__________________________________________________________________________|____________| Intestine Small, Jejunum | A | | |__________________________________________________________________________|____________| Intestine Small, Ileum | A | | |__________________________________________________________________________|____________| Liver | + + | 2 | |__________________________________________________________________________|____________| Pancreas | + | 1 | |__________________________________________________________________________|____________| Salivary Glands | + | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + A + + A + | 9 | |__________________________________________________________________________|____________| Stomach, Glandular | A | | |__________________________________________________________________________|____________| Tongue | + | 1 | |__________________________________________________________________________|____________| Tooth | + | 1 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + | 1 | _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 5| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 6| 4| 6| 4| 7| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | 0.3 % | 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM - cont | | | |__________________________________________________________________________|____________| Heart | A | | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + | 1 | |__________________________________________________________________________|____________| Adrenal Medulla | + | 1 | |__________________________________________________________________________|____________| Islets, Pancreatic | + | 1 | |__________________________________________________________________________|____________| Parathyroid Gland | M | | |__________________________________________________________________________|____________| Pituitary Gland | M | | |__________________________________________________________________________|____________| Thyroid Gland | A | | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | + | 1 | |__________________________________________________________________________|____________| Ovary | A A + | 1 | |__________________________________________________________________________|____________| Uterus | + + A | 2 | Endometrium, Hyperplasia, Cystic | 3 2 | 2 2.5| |__________________________________________________________________________|____________| Vagina | A | | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + | 1 | _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 5| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 6| 4| 6| 4| 7| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | 0.3 % | 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| HEMATOPOIETIC SYSTEM - cont | | | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + | 1 | |__________________________________________________________________________|____________| Lymph Node, Mesenteric | A | | |__________________________________________________________________________|____________| Spleen | A | | |__________________________________________________________________________|____________| Thymus | + | 1 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + | 1 | |__________________________________________________________________________|____________| Skin | + + + + + | 5 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + | 2 | Mandible, Inflammation, Chronic | | | Active | 2 | 1 2.0| |__________________________________________________________________________|____________| Skeletal Muscle | + | 1 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + | 1 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | + | 1 | |__________________________________________________________________________|____________| Lung | A | | |__________________________________________________________________________|____________| Nose | + | 1 | _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 0| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 9| 7| 5| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 6| 4| 6| 4| 7| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| | A | 0.3 % | 9| 9| 9| 9| 9| 9| 9| 9| 9| 0| 0| 0| 0| 0| 0| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM - cont | | | |__________________________________________________________________________|____________| Trachea | + | 1 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | A | | |__________________________________________________________________________|____________| Harderian Gland | + | 1 | |__________________________________________________________________________|____________| Zymbal's Gland | + | 1 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + | 1 | |__________________________________________________________________________|____________| Urinary Bladder | A A | | __________________________________________________________________________________________________________________________________ * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 3| 7| 7| 7| 7| 0| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 2| 4| 0| 4| 4| 7| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 1.0% | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mesentery | + | 1 | Fat, Inflammation, Acute, Focal | 4 | 1 4.0| |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + | 10 | |__________________________________________________________________________|____________| Tooth | + + + + + + | 6 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Uterus | + | 1 | Endometrium, Hyperplasia, Cystic | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Spleen | + + + | 3 | Hematopoietic Cell Proliferation | 3 3 2 | 3 2.7| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Skin | + + + + + + | 6 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + | 1 | _____________________________________________________________________________________________________________________| | NERVOUS 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 11 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 3| 7| 7| 7| 7| 0| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 2| 4| 0| 4| 4| 7| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 1.0% | 0| 0| 0| 0| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 2| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY 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 12 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 3| 7| 7| 5| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| | | | 2| 4| 4| 6| 4| 4| 4| 4| 5| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 3.0% | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Gallbladder | + + + + + + + + A + + + + + + | 14 | |__________________________________________________________________________|____________| 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 | Inflammation, Chronic | 2 1 1 | 3 1.3| Tension Lipidosis, Focal | 1 | 1 1.0| Hepatocyte, Necrosis, Focal | 1 1 1 | 3 1.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + A + + + + + + | 14 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + A + + + + + + | 14 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tooth | + + + + | 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 13 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 3| 7| 7| 5| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| | | | 2| 4| 4| 6| 4| 4| 4| 4| 5| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 3.0% | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | L | | 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 | 1 1 1 1 1 1 | 6 1.0| Zona Reticularis, Vacuolization | | | Cytoplasmic | 1 2 2 2 2 2 1 1 1 2 | 10 1.6| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | M M + M + M M + + M M M M + + | 6 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + I + + + + + + | 14 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Clitoral Gland | M + + + + + + + + M I + + + + | 12 | |__________________________________________________________________________|____________| Ovary | + + + + + + + + A + + + + + + | 14 | |__________________________________________________________________________|____________| Uterus | + + + + + + + + A + + + + + + | 14 | Endometrium, Hyperplasia, Cystic | 1 2 2 2 1 2 2 2 1 2 | 10 1.7| |__________________________________________________________________________|____________| _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 3| 7| 7| 5| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| | | | 2| 4| 4| 6| 4| 4| 4| 4| 5| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 3.0% | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | L | | 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 | 2 3 1 | 3 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + M + + + + + + + | 14 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 1 2 2 2 3 2 4 2 1 2 2 1 2 | 13 2.0| Pigmentation | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Thymus | + + + + + + + + M + + + + + + | 14 | Atrophy, Diffuse | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | Mandible, Inflammation, Chronic | | | Active | 3 | 1 3.0| |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | 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 15 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 3| 7| 7| 5| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 7| | | | 2| 4| 4| 6| 4| 4| 4| 4| 5| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS FEMALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| 1| | A | 3.0% | 2| 2| 2| 2| 2| 2| 2| 2| 2| 3| 3| 3| 3| 3| 3| | L | | 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| | | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM - cont | | | Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | I I + + I + + + + I + + + + + | 11 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Hemorrhage, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Ear | + + | 2 | |__________________________________________________________________________|____________| Eye | + + + + + + + + A + + + + + + | 14 | Retina, Atrophy | 3 3 3 3 3 3 3 3 3 3 3 3 3 3 | 14 3.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Zymbal's Gland | + M + + + + + M + M I M + + + | 10 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Renal Tubule, Dilatation, Focal | 1 | 1 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 16 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 1| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 4| 7| 7| 7| | | | 4| 4| 4| 4| 4| 7| 4| 4| 4| 4| 4| 8| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | + + + + + + + + + + + + + M + | 14 | |__________________________________________________________________________|____________| Gallbladder | + + + M + + M + + I + + + + M | 11 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + A | 14 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 1 | 1 1.0| Inflammation, Chronic | 1 | 1 1.0| Hepatocyte, Necrosis, Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Mesentery | + + | 2 | Fat, Necrosis, Focal | 4 4 | 2 4.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | Inflammation, Chronic Active | 1 | 1 1.0| |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + + + | 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 1| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 4| 7| 7| 7| | | | 4| 4| 4| 4| 4| 7| 4| 4| 4| 4| 4| 8| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 - cont | | | Tongue | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tooth | + + + + | 4 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + + M + + + | 14 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + M | 14 | Atrophy | 3 3 3 3 2 2 3 1 2 2 | 10 2.4| Hypertrophy, Focal | 2 1 1 1 2 1 1 1 1 | 9 1.2| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + M | 14 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | + M + M M M I M M + M M M M M | 3 | |__________________________________________________________________________|____________| Pituitary Gland | + + + + + + + + M I + + + + + | 13 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Penis | + | 1 | _____________________________________________________________________________________________________________________|____________| * : 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 1| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 4| 7| 7| 7| | | | 4| 4| 4| 4| 4| 7| 4| 4| 4| 4| 4| 8| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + | 15 | Cyst | X | 1 | |__________________________________________________________________________|____________| Prostate | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Seminal Vesicle | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | Germinal Epithelium, Degeneration, | | | Focal | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + M + + + + + + + | 14 | Hyperplasia | 3 3 | 2 3.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + + + + + + + M + | 14 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Atrophy | 4 | 1 4.0| Hematopoietic Cell Proliferation | 2 1 2 2 1 2 1 2 2 1 | 10 1.6| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + + | 15 | Atrophy, Diffuse | 4 3 4 | 3 3.7| Atrophy, Focal | 1 1 | 2 1.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Mammary Gland | M M M M M M M M M M M M M M M | | |__________________________________________________________________________|____________| Skin | + + + + + + + + + + + + + + + | 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: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 1| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 4| 7| 7| 7| | | | 4| 4| 4| 4| 4| 7| 4| 4| 4| 4| 4| 8| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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| | | _____________________________________________________________________________________________________________________|____________| INTEGUMENTARY SYSTEM - cont | | | Sebaceous Gland, Hyperplasia, Focal | 1 | 1 1.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | |__________________________________________________________________________|____________| Bone | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | + + + + + + + + + + + I + M + | 13 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | Glands, Hyperplasia | 2 | 1 2.0| |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + + + + + + + | 15 | Retina, Atrophy | 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 | 15 3.0| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Zymbal's Gland | + + + + + + M M M M M M I + M | 7 | _____________________________________________________________________________________________________________________| | URINARY 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 20 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 1| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 5| 7| 7| 7| 7| 7| 4| 7| 7| 7| | | | 4| 4| 4| 4| 4| 7| 4| 4| 4| 4| 4| 8| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | 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 | | | Kidney | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Urinary Bladder | + + + + + + + + + + + + + + + | 15 | Edema | 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 21 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 0| | | DAY ON TEST | 7| 7| 7| 7| 7| 3| 4| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 3| 8| 1| 4| 4| 4| 4| 4| 4| 1| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 0.3% | 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 | | | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + | 6 | |__________________________________________________________________________|____________| Tooth | + + + | 3 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Penis | + | 1 | _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Spleen | + | 1 | Hematopoietic Cell Proliferation | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Skin | + + + + + + + | 7 | Subcutaneous Tissue, Pinna, | | | Inflammation, Acute, Focal | 4 | 1 4.0| _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS 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 22 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 0| | | DAY ON TEST | 7| 7| 7| 7| 7| 3| 4| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 3| 8| 1| 4| 4| 4| 4| 4| 4| 1| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 0.3% | 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| | | _____________________________________________________________________________________________________________________|____________| RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + | 1 | Infiltration Cellular, Plasma Cell | 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 23 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 6| 9| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 2| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 1.0 % | 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 | + | 1 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + | 3 | _____________________________________________________________________________________________________________________| | CARDIOVASCULAR SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Preputial Gland | + | 1 | Cyst | 3 | 1 3.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Spleen | + | 1 | _____________________________________________________________________________________________________________________| | INTEGUMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Skin | + + + + + + + + | 8 | _____________________________________________________________________________________________________________________| | MUSCULOSKELETAL SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | NERVOUS SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | 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 24 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 1| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| | | DAY ON TEST | 7| 7| 7| 6| 9| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 2| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 1.0 % | 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 | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | URINARY 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 25 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 2| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 3.0 % | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| ALIMENTARY SYSTEM | | | |__________________________________________________________________________|____________| Esophagus | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Gallbladder | + + A A + + + + + + + + + + + | 13 | |__________________________________________________________________________|____________| Intestine Large, Colon | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Rectum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Large, Cecum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Duodenum | + + A + + + + + + + + + + + + | 14 | |__________________________________________________________________________|____________| Intestine Small, Jejunum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Intestine Small, Ileum | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Liver | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Mesentery | + + | 2 | Fat, Necrosis, Focal | 1 1 | 2 1.0| |__________________________________________________________________________|____________| Pancreas | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Salivary Glands | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Forestomach | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Stomach, Glandular | + + + + + + + + + + + + + M + | 14 | |__________________________________________________________________________|____________| Tongue | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Tooth | + + | 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 26 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 2| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 3.0 % | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| CARDIOVASCULAR SYSTEM | | | |__________________________________________________________________________|____________| Blood Vessel | + + + + + + + + + + M + + + + | 14 | |__________________________________________________________________________|____________| Heart | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | ENDOCRINE SYSTEM | | | |__________________________________________________________________________|____________| Adrenal Cortex | + + + + + + + + + + + + + + + | 15 | Atrophy | 3 2 2 2 3 3 2 3 2 2 3 | 11 2.5| Hypertrophy, Focal | 1 1 1 1 1 | 5 1.0| |__________________________________________________________________________|____________| Adrenal Medulla | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Islets, Pancreatic | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Parathyroid Gland | M I M + M M M M M + M M M M M | 2 | |__________________________________________________________________________|____________| Pituitary Gland | + I + + + + + + + + I + I I + | 11 | |__________________________________________________________________________|____________| Thyroid Gland | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | GENERAL BODY SYSTEM | | | None | | | _____________________________________________________________________________________________________________________| | GENITAL SYSTEM | | | |__________________________________________________________________________|____________| Coagulating Gland | + | 1 | |__________________________________________________________________________|____________| Epididymis | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Preputial Gland | + + + + + + + + + + + + + + + | 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 27 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 2| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 3.0 % | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| GENITAL SYSTEM - cont | | | Seminal Vesicle | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Testes | + + + + + + + + + + + + + + + | 15 | Germinal Epithelium, Degeneration, | | | Focal | 2 | 1 2.0| _____________________________________________________________________________________________________________________| | HEMATOPOIETIC SYSTEM | | | |__________________________________________________________________________|____________| Bone Marrow | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 1 | 1 1.0| |__________________________________________________________________________|____________| Lymph Node, Mandibular | + + + + + + + + + + + + + + + | 15 | Hyperplasia | 2 2 | 2 2.0| |__________________________________________________________________________|____________| Lymph Node, Mesenteric | + + + + + + + M + + + + + + + | 14 | |__________________________________________________________________________|____________| Spleen | + + + + + + + + + + + + + + + | 15 | Hematopoietic Cell Proliferation | 2 1 1 1 1 1 1 | 7 1.1| |__________________________________________________________________________|____________| Thymus | + + + + + + + + + + + + + + M | 14 | Atrophy, Diffuse | 1 4 | 2 2.5| _____________________________________________________________________________________________________________________| | 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 | |__________________________________________________________________________|____________| Skeletal Muscle | + + + + + + + + + + + + + + + | 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 28 NTP Experiment-Test: 99039-01 NONNEOPLASTIC LESIONS BY INDIVIDUAL ANIMAL Report: PEIRPT09 Study Type: 26-39 WEEKS TRANSGENIC MODEL EVALUATION II (ACESULFAME POTASSIUM) Date: 02/21/03 Route: DOSED FEED Time: 10:24:35 __________________________________________________________________________________________________________________________________ | 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 2| 1| 2| 2| | | DAY ON TEST | 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| 7| | | | 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 4| 2| 4| 4| | | __________________________________________|__________________________________________________________________________| T (*) | | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | O | TGAC (FVB/N) HEMIZYGOUS MALE | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | T | ANIMAL ID | 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| 0| | A | 3.0 % | 4| 4| 4| 4| 5| 5| 5| 5| 5| 5| 5| 5| 5| 5| 6| | L | | 6| 7| 8| 9| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9| 0| | | _____________________________________________________________________________________________________________________|____________| NERVOUS SYSTEM | | | |__________________________________________________________________________|____________| Brain | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | RESPIRATORY SYSTEM | | | |__________________________________________________________________________|____________| Larynx | + + + I + + M + + M I + I I I | 8 | |__________________________________________________________________________|____________| Lung | + + + + + + + + + + + + + + + | 15 | Alveolar Epithelium, Alveolus, | | | Inflammation, Chronic Active, | | | Focal | 1 | 1 1.0| |__________________________________________________________________________|____________| Nose | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Trachea | + + + + + + + + + + + + + + + | 15 | _____________________________________________________________________________________________________________________| | SPECIAL SENSES SYSTEM | | | |__________________________________________________________________________|____________| Eye | + + + + + + + + + + + + + + + | 15 | Retina, Atrophy | 3 3 3 3 3 3 3 4 3 3 3 3 3 3 | 14 3.1| |__________________________________________________________________________|____________| Harderian Gland | + + + + + + + + + + + + + + + | 15 | |__________________________________________________________________________|____________| Zymbal's Gland | M + + M + M + + + + + M + + M | 10 | _____________________________________________________________________________________________________________________| | URINARY SYSTEM | | | |__________________________________________________________________________|____________| Kidney | + + + + + + + + + + + + + + + | 15 | Renal Tubule, Dilatation, Diffuse | 4 | 1 4.0| Renal Tubule, Dilatation, Focal | 2 1 | 2 1.5| |__________________________________________________________________________|____________| 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 29 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------