Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.