| Study | Species | Dose | Duration | Findings | |-------|---------|------|----------|----------| | | Rat (IV) | 200 mg kg⁻¹ | Single | No mortality; transient ↑ ALT/AST (< 2 × ULN) resolved by Day 3 | | 28‑day Repeat Dose | Dog (PO) | 10, 30, 100 mg kg⁻¹ | Daily | NOAEL = 30 mg kg⁻¹; at 100 mg kg⁻¹ – mild hepatic vacuolization, reversible | | Genotoxicity | Bacterial reverse mutation (Ames) | — | — | Negative across 5 strains | | Cardiovascular Safety | hERG assay | 10 µM | — | < 5 % inhibition (IC₅₀ > 30 µM) | | Reproductive Toxicity | Rat (Gestational Day 6–15) | 10, 30 mg kg⁻¹ | Oral | No embryofetal malformations; slight ↓ in fetal weight at 30 mg kg⁻¹ (non‑significant) | | Safety Pharmacology (CNS) | Telemetry‑implanted rats | 5, 20 mg kg⁻¹ | Single | No effect on locomotor activity, EEG power spectra, or seizure threshold |
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