Registration Dossier
Registration Dossier
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EC number: 908-114-0 | CAS number: -
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no preincubation test performed
- Justification for type of information:
- This information is used for read-across to Citronellyl Acetate Multi
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
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:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across information.
- Justification for type of information:
- The read-across justification is presented in the Endpoint summary Genetic toxicity. The accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- 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
- 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
- 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
- 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
- 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
- Remarks on result:
- other: read-across from Citronellyl Acetate ('mono')
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay, based on the results of the source substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- 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
- 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:
- liquid
Constituent 1
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)
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 resultsopen allclose all
- 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
- 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
- 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
- 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
- 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
- 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
Any other information on results incl. tables
Citronellyl acetate 'mono' 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
- Conclusions:
- Citronellyl Acetate 'mono' 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. Under the experimental conditions described, Citronellyl Acetate 'mono' was not mutagenic in bateria.
- Executive summary:
For Citronellyl Acetate ‘mono’, an Ames test was performed according to OECD TG 471 and in compliance with GLP criteria. The substance 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.
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