Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Gene mutation in bacteria

Currently, there are no studies available. Nevertheless, there are two reliable studies existing, which may serve as read across: rac-1 -Phenyl-propylamine (CAS 2941-20-0) and (S)-1-Phenyl-propylamine (CAS 3789-59-1). Both studies revealed essentially the same results.

 

(S)-1-phenylpropylamine (CAS 3789-59-1, read across) was not mutagenic Ames test with and without metabolic activation according to OECD guideline 471. Metabolic activation: liver S-9 mix from Aroclor-induced male Sprague-Dawley rats. [BASF, 1999, BioReliance, 2003]

 

Gene mutation in mammalian cells

Currently, there is no information available.

 

Cytogenicity in mammalian cells

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).

 

(S)-1 -Phenyl-propylamine (CAS 3789-59-1, read across) was investigated for cytogenicity in primary human lymphocytes according to OECD guideline 473. When incubated with these cells in presence and absence of an artificial metabolic activation system (liver S-9 mix) significant increase in the frequency of cells with structural chromosomal aberrations was noted. Under the experimental conditions, the test item (S)-1-Phenyl-propylamine did induce chromosome aberrations in cultured human lymphocytes. [SafePharm Laboratories, 2005]

 

Other studies

Currently, there is no information available.

 

Cytogenicity in vivo

Currently, there is no information available to cover this endpoint.


Short description of key information:
Gene mutation in bacteria
Ames test with and without metabolic activation (OECD 471): negative [BASF, 1999; BioReliance, 2003]

Gene mutation in mammalian cells
Currently, there is no information available.

Cytogenicity in mammalian cells
Chromosome aberration test with human lymphocytes with and without metabolic activation (OECD 473): positive [SafePharm Laboratories, 2005]

Cytogenicity in vivo
Currently, there is no information available to cover this endpoint.

Endpoint Conclusion: Adverse effect observed (positive)

Justification for classification or non-classification

The test substance was not genotoxic in in vitro experiments using bacteria but demonstrated clear cytogenic effects in human lymphocytes in vitro when incubated in presence or absence of an artificial external metabolic activation system. Therefore, based on the information currently available, the test substance needs to be investivated further in vivo.

Based on the available data for rac-1-Phenyl-propylamine (CAS 2941-20-0) and (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.