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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 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.

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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