Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay (OECD 471).

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See chap. 13 read across justification
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

According to the results of the present study, the test substance rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) did not lead to an increase in the number of revertant colonies either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above. [BASF, 2013]

Justification for classification or non-classification

Based on the available data for rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) (R)-1 -(4 -Methylphenyl)ethylamine is not subject to C&L (according to Regulation 1272/2008/EC.