Registration Dossier
Registration Dossier
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EC number: 810-201-2 | CAS number: 1050477-27-4
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 Rac-Amido-TH-naphthyridin (CAS No. 1050477-27-4). According to expert opinion a (weaker) pharmacological action of the compound can be assumed due to the structural similarity to the active pharmaceutical ingredient (API; CAS No. 1050477-31-0). In addition results of in vitro assays reveal that Rac-Amido-TH-naphthyridin acts as a non-steroidal mineralocorticoid receptor (MR) antagonist whereas the IC50 -value is 3 -times higher compared to the corresponding value of the API. As the major findings of the toxicological studies with the API were considered to be related to its pharmacological action, a similar tolerability of the precursor 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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