Nonyl acetate

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

Study period:

16 August - 22 September 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline 471 with deviations: read-across substance

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

read-across substance

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Decyl acetate

EC Number:

203-942-2

EC Name:

Decyl acetate

Cas Number:

112-17-4

IUPAC Name:

decyl acetate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): DECYLACETATE
- Source: Haarmann & Reimer GmbH
- Physical state: Colorless to pale yellowish liquid
- Analytical purity: 99.1%
- Lot/batch No.: 29120015
- Date of receipt: 24 March 2000
- Storage condition of test material: Cool and dry

Method

Target gene:

None

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: see table 7.6.1/1

Metabolic activation:

with and without

Metabolic activation system:

10 % S9-fraction; S9 fraction prepared from liver homogenates of male Sprague-Dawley rats induced with Aroclor 1254 (500 mg/kg bw)

Test concentrations with justification for top dose:

Experiment 1 (Plate incorporation method):
- Without S9: 15, 50, 150, 500, 1500 and 5000 µg/plate in strains TA98, TA1535 and TA1537
- Without S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA100 and TA102
- With S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA1535, TA1537, TA98, TA100 and TA102

Experiment 2 (Plate incorporation method):
- Without S9: 5, 15, 50, 150 and 500 µg/plate in strains TA100 and TA1537
- Without S9: 50, 150, 500, 1500 and 5000 µg/plate in strain TA1535
- Without S9: 15, 50, 150, 500, 1500 and 5000 µg/plate in strain TA98
- Without S9: 1.5, 5, 15, 50, 150 and 500 µg/plate in strain TA102
- With S9: 1.5, 5, 15, 50, 150 and 500 µg/plate in strain TA100
- With S9: 15, 50, 150, 500 and 1500 µg/plate in strain TA1535
- With S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA98 and TA102
- With S9: 5, 15, 50, 150 and 500 µg/plate in strains TA1537

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethanol

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

Ethanol

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: sodium azide: 0.7 µg/plate for TA100 and TA1535; 2-nitrofluorene: 2.5 µg/plate for TA98; 9-aminoacridine: 50 µg/plate for TA1537; Mitomycin C: 0.15 µg/plate for TA102

Remarks:

without S9

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

Ethanol

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene: 0.7 µg/plate for TA98; 0.8 µg/plate for TA100; 1.2 µg/plate for TA1535; 1.5 µg/plate for TA1537; 1.7 µg/plate for TA102

Remarks:

with S9

Details on test system and experimental conditions:

SOURCE OF TEST SYSTEM: - All Salmonella typhimurium strains received from Dr. Bruce N. Ames, University of California, Berkeley, California, U.S.A.

METHOD OF APPLICATION: In agar (plate incorporation)

DURATION
- Incubation period: Plates were incubated in the dark at 37 °C for 48-72 h

NUMBER OF REPLICATIONS:
- 3 plates/dose for treatment, negative, vehicle and positive controls

DETERMINATION OF CYTOTOXICITY
- Method: To determine the toxicity of test item, plates were examined for the existence of a normal background lawn.

OTHER:
- The genotypes of the tester strains (histidine requirement, spontaneous reversion frequency, sensitivity to UV-light, crystal violet and ampicillin) were checked in each experiment.
- The Vogel-Bonner minimal plates, the test compound, and the S9-mix were checked for sterility.

Evaluation criteria:

No data

Statistics:

Estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level, using a X2-test (Mohn and Ellenberger, 1977).

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test compound on the plates was not observed.

COMPARISON WITH HISTORICAL CONTROL DATA: Results were compared with historical control data of the laboratory (1998-2000)

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In the absence of S9-mix, test item was bacteriotoxic towards the strains TA100 and TA102 at 500 μg/plate, towards strain TA1537 at 1500 μg/plate, and towards strain TA98 at 5000 μg/plate. In the presence of S9-mix test item was bacteriotoxic towards the strains TA1537 and TA102 at 500 μg/plate and towards the strains TA1535, TA98, and TA100 at 1500 μg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Full results can be found in the attached study report.

Read-across justification for the use of decyl acetate can also be found in the attached justification report.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

Under the test conditions, DECYLACETATE is not considered as mutagenic in S. typhimurium (TA1535, TA1537, TA98, TA100 and TA102) strains.

Executive summary:

In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to DECYLACETATE at the following concentrations:

Experiment 1 (Plate incorporation method):

- Without S9: 15, 50, 150, 500, 1500 and 5000 µg/plate in strains TA98, TA1535 and TA1537

- Without S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA100 and TA102

- With S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA1535, TA1537, TA98, TA100 and TA102

 

Experiment 2 (Plate incorporation method):

- Without S9: 5, 15, 50, 150 and 500 µg/plate in strains TA100 and TA1537

- Without S9: 50, 150, 500, 1500 and 5000 µg/plate in strain TA1535

- Without S9: 15, 50, 150, 500, 1500 and 5000 µg/plate in strain TA98

- Without S9: 1.5, 5, 15, 50, 150 and 500 µg/plate in strain TA102

- With S9: 1.5, 5, 15, 50, 150 and 500 µg/plate in strain TA100

- With S9: 15, 50, 150, 500 and 1500 µg/plate in strain TA1535

- With S9: 5, 15, 50, 150, 500 and 1500 µg/plate in strains TA98 and TA102

- With S9: 5, 15, 50, 150 and 500 µg/plate in strains TA1537

 

Metabolic activation system used in this test 10 % S9; S9 fraction prepared from liver homogenates of male Sprague-Dawley rats induced with Aroclor 1254 (500 mg/kg bw). Negative, vehicle and positive control groups were also included in mutagenicity tests.

 

In the absence of S9-mix, test item was bacteriotoxic towards the strains TA100 and TA102 at 500 μg/plate, towards strain TA1537 at 1500 μg/plate, and towards strain TA98 at 5000 μg/plate. In the presence of S9-mix test item was bacteriotoxic towards the strains TA1537 and TA102 at 500 μg/plate and towards the strains TA1535, TA98, and TA100 at 1500 μg/plate. Precipitation of the test compound on the plates was not observed. The test item did not induce a significant or dose related increase in the mutation frequency of the tester strains in the absence and presence of a metabolic activation system. The positive and negative/vehicle controls induced the appropriate responses in the corresponding strains indicating the validity of the study.

 

Under the test conditions, DECYLACETATE was considered as not mutagenic in this bacterial system.