Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Quality of whole database:
Maximum Tolerated Acute Dose Oral /Rat <60 mg/kg
Maximum Tolerated Acute Dose Oral /Dog 50 mg/kg
In single dose studies in dogs and rats, morbidity was associated with a dose of 80 and >100 mg/kg NBI-98854, respectively

Additional information

Justification for classification or non-classification

Single oral gavage administration in the dog and rat were tolerated up to 15 mg/kg/day for NBI-98854.

Several of the clinical signs observed in animals were consistent with the intended pharmacological effect of the drug which is to deplete monoamines (primarily dopamine) in the nervous system.