1-Naphthalenamine, 1,2,3,4-tetrahydro-, (1R)-

Genetic toxicity: in vitro

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

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,4-tetrahydro-1-naphthylamine

EC Number:

218-712-7

EC Name:

1,2,3,4-tetrahydro-1-naphthylamine

Cas Number:

2217-40-5

IUPAC Name:

1,2,3,4-tetrahydronaphthalen-1-amine

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 / cell type:

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

Untreated 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).

Negative solvent / vehicle 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 / choice of top concentrations:

other: 2500 µg/plate onward

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

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.