Table 2.

Measurements and observations performed in an oral 4-week repeated dose toxicity study in rats, which were collected for the eTRANSAFE Virtual Control Group (VCG) database.

Category	Measured or Observed Parameters
Study definition	Route or administration, duration, test facility
Animal data	Species, strain, source, age, sex, initial body weight, body weight gain
Clinical chemistry	Sodium, potassium, calcium, chloride, inorganic phosphate, glucose, urea, creatinine, total bilirubin, cholesterol, triglycerides, bile acids, total protein, albumin, albumin/globulin ratio, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, glutamate dehydrogenase
Haematology	Erythrocytes, haemoglobin, haematocrit, mean cell volume, mean haemoglobin content, mean haemoglobin concentration, platelets, reticulocytes, leukocytes, neutrophilic granulocytes / (%) and (103/µL), lymphocytes/(%) and (103/µL), eosinophilic granulocytes/(%) and (103/µL), basophilic granulocytes/(%) and (103/µL), monocytes/(%) and (103/µL), large unstained cells/(%) and (103/µL), prothrombin time/(s), activated partial thromboplastin time/(s)
Urinalysis	pH value, protein (grading), glucose (grading), bilirubin (grading), blood (grading), ketone (grading), sediment, specific gravity, urine weight (g)
Organ weights	Liver, heart, kidneys, spleen, thymus, ovaries, uterus, brain, adrenal glands (both), thyroid/parathyroid, testes, prostate, seminal vesicles, epididymites
Histopathology	Adrenal gland, aorta, bone, bone marrow, brain, oesophagus, eye, heart, intestine large (cecum), intestine large (colon), intestine large (rectum), intestine small (duodenum), intestine small (ileum), intestine small (jejunum), kidney, knee joint, liver, lung, lymph node (mandibular), lymph node (mesenteric), mammary gland, muscle (skeletal), nerve (optic), nerve (sciatic), pancreas, parathyroid gland, Peyer’s patches, pituitary gland, reproductive organs (male, epididymis), reproductive organs (male, prostate), reproductive organs (male, seminal vesicle), reproductive organs (male, testis), salivary gland, skin, spinal cord, spleen, stomach, thymus, thyroid gland, trachea, ureter, urinary bladder, reproductive organs (female, ovary), reproductive organs (female, oviduct), reproductive organs (female, uterus), reproductive organs (female, vagina), gallbladder (mouse specific), larynx (fixation only)