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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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 Carboxy-TH-naphthyridin (CAS No. 1050477-45-6). According to expert opinion a (weaker) pharmacological action of the compound cannot be ruled out due to the structural similarity to 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 (selective, non steroidal mineralocorticoid receptor (MR) antagonist) a similar tolerability of the precursor is to be assumed. Although no in vitro assays, which reveal that Carboxy-TH-naphthyridin acts as (MR) antagonist, are available.

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).