Registration Dossier

Administrative data

Description of key information

oral
rat (OECD 407) NOEL (m/f): >15 mg/kg bw/day (highest dose tested) [SafePharm Laboratories, 2004]
dermal
Actually, there is no information available.
inhalation
Actually, there is no information available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
15 mg/kg bw/day

Mode of Action Analysis / Human Relevance Framework

Additional information

oral

Currently, there are no studies available. Nevertheless, there is a reliable study existing, which may serve as read across: (S)-1-Phenyl-propylamine (CAS 3789-59-1).

 

A 28-day subacute study was conducted with rats which received 1.5, 5 or 15 mg/kg/d (S)-1-phenyl-propylamine (CAS 3789-59-1, read across) by gavage. Based on the results, the NOEL of the test substance was defined at the highest dose level tested. [SafePharm Laboratories, 2004]

 

dermal

Currently, there is no information available.

 

inhalation

Currently, there is no information available.

Justification for classification or non-classification

Based on the available data for (S)-1 -Phenyl-propylamine (CAS 3789-59-1, read across), (R)-1-Phenyl-propylamine is not subject to C&L according to Regulation 1272/2008/EC and Directive 67/548/EEC.