(-)-3,7-dimethyloct-6-enyl acetate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Oct. 18, 2000 - Dec. 01, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Oct. 18, 2000 - Dec. 01, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

See read-across justification attached in section 13.2

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

(if 0,0 then see remarks)
6-Octen-1-ol, 3,7-dimethyl-, acetate
EC-No: Chemical Name:
205-775-0
Remark Rel. 2: according to OECD 471 and GLP, but the plate incorporation method was used
for both experiments; AMES test using strains TA98, TA100, TA102, TA1535, TA1537
up to 5000 μg/plate in DMSO;

Target gene:

histidine

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 5, 15, 50, 150, 500, 1500 µg/Plate

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 0.1mL of bacteria

DURATION
- Preincubation period: 11-12 hours
- Exposure duration: 48 to 72 h at 37°C in the dark

NUMBER OF REPLICATIONS: 3

Rationale for test conditions:

This test uses several specially constructed histidine-requiring (his-) mutants of Salmonella typhimurium and measures his- to his+ reversion induced by chemicals which cause base changes or frameshift mutations in the genome of this organism.

Evaluation criteria:

A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of bacteriotoxicity.

Statistics:

X²-test

Key result

Species / strain:

S. typhimurium 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:

In the absence of S9-mix the test substance was bacteriotoxic towards the strains TA102 at 150µg/plate, towards the strains TA1537, and TA100 at 500µg/plate, towards the strain TA98 at 1500μg/plate, and towards the strain TA1535 at 5000μg/plate. In the presence of S9-mix the test substance was bacteriotoxic towards the strains TA102 at 500µg/plate and towards the strains TA1535, TA1537, TA100, and TA98 at 1500µg/plate. Precipitation of the test compound on the plates was not observed.

see attachment

Conclusions:

In conclusion, these results indicate that the test substance under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Citronellyl acetate

EC Number:

205-775-0

EC Name:

Citronellyl acetate

Cas Number:

150-84-5

IUPAC Name:

3,7-dimethyloct-6-en-1-yl acetate

Test material form:

liquid

Details on test material:

Designation: CITRONELLYL ACETATE EXTRA
Appearance: colourless to pale yellowish liquid

Specific details on test material used for the study:

Chemical Name: 6-Octen-1-ol, 3,7-dimethyl-, acetate
EC-No: 205-775-0

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 5, 15, 50, 150, 500, 1500 µg/Plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 0.1mL of bacteria

DURATION
- Preincubation period: 11-12 hours
- Exposure duration: 48 to 72 h at 37°C in the dark

NUMBER OF REPLICATIONS: 3

Rationale for test conditions:

This test uses several specially constructed histidine-requiring (his-) mutants of Salmonella typhimurium and measures his- to his+ reversion induced by chemicals which cause base changes or frameshift mutations in the genome of this organism.

Evaluation criteria:

A reduction in the number of revertant colonies and/or a diminution of the background lawn was taken as an indication of bacteriotoxicity.

Statistics:

X²-test

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

In the absence of S9-mix the test substance was bacteriotoxic towards the strains TA102 at 150µg/plate, towards the strains TA1537, and TA100 at 500µg/plate, towards the strain TA98 at 1500μg/plate, and towards the strain TA1535 at 5000μg/plate. In the presence of S9-mix the test substance was bacteriotoxic towards the strains TA102 at 500µg/plate and towards the strains TA1535, TA1537, TA100, and TA98 at 1500µg/plate. Precipitation of the test compound on the plates was not observed.

Any other information on results incl. tables

See attachment

Applicant's summary and conclusion

Conclusions:

In conclusion, these results indicate that the test substance under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.