Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: rac-1-(3-Methoxyphenyl)ethylamine
Test substance No.: 06/0647-1
Batch identification: VSVU0019/VU0962 Fr 6 + Fr 8 LJ 8248/06
Purity: 99.3 area-%
Homogeneity: The homogeneity of the test substance was guaranteed by mixing before preparation of the test substance formulations.
Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed as indicated by the spon or, and the sponsor holds this responsibility.

ADDITIONAL TEST SUBSTANCE INFORMATION
Date of production: Calendar week 41
Physical state, appearance: Liquid, colorless to yellow
Storage conditions: Room temperature (N2 conditions)

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
The S9 fraction was prepared according to Ames et al. 1975.
Test concentrations with justification for top dose:
20 μg - 5 000 μg/plate (SPT)
20 μg - 5 000 μg/plate (PIT)
Vehicle:
DMSO
Details on test system and conditions:
Standard plate test (SPT) and preincubation test (PIT) both with
and without metabolic activation (Aroclor-induced rat liver S9
mix).

Results and discussion

Test results
Species / strain:
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
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
According to the results of the study, the test substance rac-1-(3-Methoxyphenyl)ethylamine is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under experimental conditions.
Executive summary:

The substance rac-1-(3-Methoxyphenyl)ethylamine was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.