Rat: hematopoietic/lymphoid hypoplasia, reproductive organ toxicity; monkey: GI effects, lymphoid/hematologic depletion
“Rats exhibited toxicological sequalae due to hematopoietic/lymphoid hypoplasia and male/female reproductive organ effects. Female rats also exhibited higher liver weights and/or centrilobular hepatocellular hypertrophy and/or increased mitotic figures. Monkeys exhibited gastrointestinal effects and lymphoid/hematologic depletion.”
✓ VerifiedFDA multi-discipline review, p. 30Source ↗