Reaction mass of (E)-3,7-dimethylocta-2,6-dien-1-yl formate and 3,7-dimethyloct-6-en-1-yl formate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

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:

Geranyl formate

EC Number:

203-339-4

EC Name:

Geranyl formate

Cas Number:

105-86-2

Molecular formula:

C11H18O2

IUPAC Name:

(E)-3,7-dimethylocta-2,6-dien-1-yl formate

Constituent 2

Reference substance name:

Citronellyl formate

EC Number:

203-338-9

EC Name:

Citronellyl formate

Cas Number:

105-85-1

Molecular formula:

C11H20O2

IUPAC Name:

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

impurity 1

Reference substance name:

Geraniol

EC Number:

203-377-1

EC Name:

Geraniol

Cas Number:

106-24-1

Molecular formula:

C10H18O

IUPAC Name:

(E)-3,7-dimethylocta-2,6-dien-1-ol

impurity 2

Reference substance name:

Rhodinyl formate

EC Number:

205-456-6

EC Name:

Rhodinyl formate

Cas Number:

141-09-3

Molecular formula:

C11H20O2

IUPAC Name:

3,7-dimethyloct-7-en-1-yl formate

Test material form:

liquid

Specific details on test material used for the study:

Identification: Geranyl Formate
Appearance: Colourless to pale yellow liquid
Batch: SC00012058
Test substance storage: At room temperature protected from light
Stable under storage conditions until: 16 May 2015 (expiry date)

Method

Target gene:

Histidine [S. typhimurium] and tryptophan [E. coli]

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9, prepared from male Sprague-Dawley rats that had been injected intraperitoneally with Aroclor 1254 (500 mg/kg)

Test concentrations with justification for top dose:

Selection of an adequate range of doses was based on a dose range finding test with the strains TA100 and WP2uvrA, both with and without 5% (v/v) S9-mix. Eight concentrations, 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate were tested in triplicate. The highest concentration of Geranyl Formate used in the subsequent mutation assay was 5000 μg/plate or the level at which the test substance inhibited bacterial growth.

Bactericidal affects were observed for all strains.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO is known to be compatible with the survival of the bacteria and the activity of the S9-mix. It is not suspected of chemical reaction with the test substance

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene, ICR-191

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:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two experiments.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Geranyl Formate is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.