Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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 data on fertility and early development in male and female rats (0, 3, 10, 30 mg/kg) are available for the API. In this study significant effects on reproductive parameters (the mean number of corpora lutea and thus the mean number of implantations sites and viable embryos were decreased at 30 mg/kg and absolute and relative ovary weights were decreased at 10 mg/kg and 30 mg/kg). The NOAEL for systemic tolerability was < 3 mg/kg. The NOAEL for fertility and early development was 3 mg/kg.

On the basis of these results API is allocated to Category 1B.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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 data on prenatal developmental toxicity in rats (0; 0.3; 1; 3 mg/kg) and rabbits (0; 0.25; 0.75 and 2.5 mg/kg) are available for the API. The NOAEL for maternal toxicity was 3 mg/kg (rat) and 0.75 mg/kg (rabbit). The NOAEL for intrauterine development was 3 mg/kg (rat) and 2.5 mg/kg (rabbit).

On the the basis of these results no classification of the API 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 1B (adverse effect on sexual function and fertility).