1-(5,6,7,8-tetrahydro-2-naphthyl)ethan-1-one

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Reverse Mutation Test:

AMES (1985): The test results indicated that the compound is not mutagenic under the test system used.

AMES (1987): The test results showed that the test substance is not mutagenic under the test system used.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 October 1985 - 18 Octobre 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: Principles and methods for their detections, modification mutagenic activity "Chemical Mutagens" T. Sugimura and M. Nagao, Vo1.6 pp.41-61 (1980) Plenum Press, (New York)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Target gene:

Histidin

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:

S9 mix

Test concentrations with justification for top dose:

0, 10, 25, 50, 70, 100, 250 and 500 micrograms

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-Aminoanthracene; 9-Aminoacridine hydrochloride

Details on test system and experimental conditions:

After mixing the test m aterial, phosphate buffer or S-9 mix, culture of tester strain, the mixture was incubated under shaking at 37°C in a test tube for 20 minutes, top agar was added to the mixture and then the mixture was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored for revertants.

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Positive controls validity:

not specified

Additional information on results:

See attachment for result tables.

Conclusions:

The mutagenic activity of the test item was tested by the in vitro direct and metabolic acitivation assays using Salmonella typhimurium TA100, TA1535, TA1537, TA98 and
Escherichia coli WP-2. The test results indicated that the compound is not mutagenic under the test system used.

Reference 2

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

January 5 - January 17, 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

Histidine

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Test concentrations with justification for top dose:

16, 31,63, 125, 250 and 500 µg/plate

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

N-ethyl-N-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

Cultures of each strain were prepared by incubating an aliquot of strain at 37°C for 8 hours.
Pre-incubation method:
After mixing the test material solution, the phosphate buffer (pH 7.4) or the S9 mix and the culture of the test strain in a test tube, the mixture was incubated at 37°C for 20 minutes. Then top agar was added in the test tube, the mixture of each tube was poured on minimal agar plate. The plates were incubated at 37°C for 2 days and scored for revertants.

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

See attachment for the results.

Conclusions:

The mutagenic activity of the test substance was tested by the in vitro direct and metabolic activation assays using Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Esherichia coli WP2uvrA.
The test results showed that the test item is not mutagenic under the test system used.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available