Registration Dossier
Registration Dossier
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EC number: 947-346-7 | CAS number: -
Endpoint summary
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).
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