Registration Dossier
Registration Dossier
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EC number: 948-534-1 | CAS number: 1639208-51-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Justification for classification or non-classification
Repeated oral gavage administration of NBI-98854 in rats was tolerated up to 15 mg/kg/day. The effects of dopamine depletion included sedation, lethargy, tremors at rest, rigidity, unsteady gait or posture, bradykinesia, respiratory depression, and hyperprolactinemia. Repeated oral doses of NBI-98854 administered over a period of 14 days (up to 35 mg/kg/day to dogs were tolerated up to 15 mg/kg/day. Clinical observations associated with all NBI-98854 doses included decreased activity, lethargy, and recumbency. Ataxia, trembling, unsteady head, and excessive salivation were observed consistently at >15 mg/kg/day. Convulsions and emesis were noted at the highest dose of NBI-98854 tested in dogs (35 mg/kg/day).
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