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
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
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 precursoris is suggested.
As part of the program of nonclinical studies for the development and registration of pharmaceuticals for human use several toxicological studies with repeated oral exposure up to 26 weeks (rat) and 39 weeks (dog) are available for the API. In these studies significant toxic effects, of relevance for human health , on kidney and adrenal were produced at 15 mg/kg (male rat)/5 mg/kg (female rat) and 1.5 mg/kg (male dog). For the female dog the high dose level of 5 mg/mg corresponds to the NOAEL. Therefore the API was allocated to STOT RE Category 2 (primary target organs of toxicity = kidney and adrenal).
Justification for classification or non-classification
According to the corresponding active pharmaceutical ingredient (CAS No. 1050477-31-0) the substance is classified in STOT RE Category 2 (primary target organs of toxicity = kidney and adrenal)
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