Citronellyl acetate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: according to guideline and GLP, no preincubation test performed

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)

Deviations:

yes

Remarks:

no preincubation test performed

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)

Remarks:

Freiburger Labor für Mutagenitätsprüfung der King & Harnasch GmbH

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

Molecular formula:

C12H22O2

IUPAC Name:

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

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): CITRONELLYL ACETATE EXTRA
- Product no. 106216 (Haarmann & Reimer GmbH)
- Batch No.: 50540393
- Purity: 96.2%
- Appearance: colourless to pale yellowish liquid
- Storage conditions of test material: cool and dry

Method

Target gene:

histidine operon

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:

liver homogenates (S9) from SD male rats (8-10 wks) induced with Aroclor 1254

Test concentrations with justification for top dose:

5-5000 µg/plate

Vehicle / solvent:

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

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9-mix: 0.7 µg/plate sodium azide (NaN3; TA100, TA1535), 2.5 µg/plate 2-nitrofluorene (2-NF; TA98), 50 µg/plate 9-aminoacridine (9-AA; TA1537), 0.15 µg/plate mytomycin C (TA102); with S9-mix: 0.8.-1.7 µg/plate 2-aminoanthracene (2-AA; all stains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 to 72 hours in the dark

NUMBER OF REPLICATIONS: triplicates; the whole experiment was repeated in full after at least 3 days

DETERMINATION OF CYTOTOXICITY, OTHER EXAMINATIONS:
The plates were examined for the existence of a normal background lawn and/or precipitates and microscopically for microcolony growth.

Statistics:

Using a X2-test, the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level were calculated.

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:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity observed in test systems
- without S9: 150 µg/plate for strain TA102; 500 μg/plate for strains TA100 and TA1537; 1500 µg/plate for stains TA98; 5000 µg/plate for stain TA1535
- with S9: 500 μg/plate for strain TA102; 1500 µg/plate for stains TA98, TA100, TA1535 and 1537

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Citronellyl acetate extra did not induce a significant increase in the mutation frequency of the mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100, and TA102) in the presence and absence of a metabolic activation system.