Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat
Table 3
List of collected tissues.
Tissue and regions examined
26-week study
52-week study
Weight
Light microscopy
Weight
Light microscopy
Abnormalities
X
X
Adrenals
X
X
X
X
Aorta—thoracic
X
X
Brain (cerebellum, cerebrum, midbrain, and choroid plexus)
X
X
X
X
Caecum
X
X
Colon
X
X
Dosing site
X
X
Duodenum
X
X
Epididymis
X
X
X
X
Esophagus
X
X
Eyes
X
X
Femur (femorotibial joint)
a
a
Harderian glands
X
X
Heart (including auricular and ventricular regions)
X
X
X
X
Ileum
X
X
Jejunum
X
X
Kidneys
X
X
X
X
Lachrymal glands
X
X
Liver (section from two lobes)
X
X
X
X
Lungs (section from two major lobes including bronchi)
X
X
X
X
Lymph nodes—Inguinal (left and right)
X
X
Lymph nodes —Mesenteric
X
X
Optic nerves
X
X
Ovaries
X
X
X
X
Pancreas
X
X
Pituitary
X
X
X
X
Prostate
X
X
X
X
Rectum
X
X
Salivary glands
Submandibular
X
X
X
X
Parotid
X
X
Sublingual
X
X
X
Sciatic nerves
X
X
Seminal vesicles
X
X
Skeletal muscle (M. quadriceps)
b
a
Skin with mammary glands (inguinal area)
X
X
Spinal cord (transverse and longitudinal sections at the cervical, thoracic, and lumbar levels)
X
X
Spleen
X
X
X
X
Sternum
X
X
Stomach (including Brunner’s glands)
X
X
Testes
X
X
X
X
Thyroid with parathyroid
X
X
X
X
Tongue
X
X
Trachea
X
X
Ureters
X
X
Urinary bladder
X
X
Uterus with cervix
X
X
Vagina
X
X
No thymic remnants were found in any animals in either the 26- or 52-week studies. nly two sections of the tissues were examined, one in the 26-week and one in the 52-week studies. nly one section of tissue was examined in the 26-week study.