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:
2006
Report Date:
2006

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: 1-Aminotetralin
Test substance No.: 05/0560-1
Batch No.: 7346-05/67 Hauptlauf
Purity/composition: 98.2 %
Stability: The stability of the test substance under storage conditions throughout the study period is guaranteed as indicated by the sponsor, and the sponsor holds this responsibility.

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
The S-9 fraction is prepared according to Ames et al. 1975.
Test concentrations with justification for top dose:
20 - 5 000 µg/plate (PIT), 20 - 5000 µg/plate (SPT)
Controls
Negative controls:
yes
Remarks:
Parallel with each experiment, negative controls are carried out in order to check for possible contaminants (sterility control) and to determine the spontaneous mutation rate (vehicle control).
Solvent controls:
yes
Remarks:
The vehicle control with and without S-9 mix only contains the vehicle used for the test substance at the same concentration and volume for all tester strains.
True negative controls:
yes
Remarks:
Additional plates are treated with soft agar, S-9 mix, buffer, vehicle or the test substance but without the addition of tester strains
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine were also used as positive control substances.

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:
other: 2500 µg/plate onward
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 present study, the test substance 1-Aminotetralin is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions.
Executive summary:

The substance 1-Aminotetralin 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 S-9 mix or after the addition of a metabolizing system.