Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Based on the available data base on Genamin 3920 relevant information exists to make a qualitative evaluation of the toxicokinetic profile of this compound. This is also in line with animal welfare considerations because additional animal tests can be avoided by such an evaluation. 
The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Genamin 3920. The data indicate that there is little dermal absorption. On the other hand, Genamin 3920 is absorbed from the gastro-intestinal tract in toxicologically significant amounts. The structure as well as a computational model indicate a potential metabolism mainly via oxidative de-alkylation of the amine. Indications of a bio-accumulative potential as well as a metabolism towards genotoxic sub-structures do not exist. Excretion of systemically available Genamin 3920 and/or metabolites can be assumed.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Based on the available data base on Genamin 3920 relevant information exists to make a qualitative evaluation of the toxicokinetic profile of this compound. This is also in line with animal welfare considerations because additional animal tests can be avoided by such an evaluation.

 

The results of basic toxicity testing give no reason to anticipate unusual characteristics with regard to the toxicokinetics of Genamin 3920. The data indicate that there is little dermal absorption. On the other hand, Genamin 3920 is absorbed from the gastro-intestinal tract in toxicologically significant amounts. The structure as well as a computational model indicate a potential metabolism mainly via oxidative de-alkylation of the amine. Indications of a bio-accumulative potential as well as a metabolism towards genotoxic sub-structures do not exist. Excretion of systemically available Genamin 3920 and/or metabolites can be assumed.