Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies are availabe for Bay 94 -8862 -DB tartrat. Bay 94 -8862 -DB tartrat is a salt which is prepared by solution crystallization of Dibenzoyltartaric acid (CAS No. 17026 -42 -5) with Rac-Amido-TH-naphthyridin (racemate of the API, CAS No. 1050477-27-4). The cation of Bay 94 -8862 -DB tartrat is thus the active pharmaceutical ingredient (API; CAS No. 1050477-31-0).

As the major findings of the toxicological studies with the API were considered to be related to its pharmacological action, a similar tolerability of its DB tartrat is suggested.

The acute oral toxicity of the API was determined to be: LD50 cut-off value = 300 mg/kg bw in rats according to OECD TG 423. Thus a classification in Category 3 is warranted.

Justification for classification or non-classification

According to the corresponding active pharmaceutical ingredient (CAS No. 1050477-31-0) the substance is classified in Category 3 (oral route).