Lymphoid organs (lymph nodes, Peyer's patches, spleen, thymus) among rat target organs
“Additional organs of toxicity in the rat included middle ear, eye, gastrointestinal tract, kidney, lymph nodes, pancreas, Peyer’s patches, pituitary, skin, spleen, and thymus.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗
Biodistribution & persistence
No significant melanin binding; rat brain-to-plasma ratios 0.604 to 1.24
“There was no significant distribution to melanin-containing tissues. Brain to plasma ratios ranged from 0.604 to 1.24 in rats from the 28-day and 13-week repeat-dose general toxicology studies with ratios decreasing with an increase in dose.”
✓ VerifiedFDA multi-discipline review, p. 43Source ↗
Modality-specific risk
Hepatotoxicity in rats and monkeys (liver enzymes, hepatocellular hypertrophy), mirroring clinical findings
“In addition, hepatotoxicity observed clinically in patients also occurred in rats and monkeys with increased liver enzymes, increased liver weights, and microscopic findings of hepatocellular hypertrophy which partially recovered.”
✓ VerifiedFDA multi-discipline review, p. 44Source ↗