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Toxicological information

Genetic toxicity: in vitro

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no preincubation test performed
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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion