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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: GLP-guideline study, 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)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-2-butenyl acetate
EC Number:
214-730-4
EC Name:
3-methyl-2-butenyl acetate
Cas Number:
1191-16-8
Molecular formula:
C7H12O2
IUPAC Name:
3-methylbut-2-en-1-yl acetate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): PRENYL ACETATE
- Physical state: colourless to pale yellowish liquid
- Analytical purity: 98.7%
- Batch No.: 20010024
- Storage conditions: 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:
S9 from SD male rats induced with Aroclor 1254
Test concentrations with justification for top dose:
0, 50, 150, 500, 1500 and 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); 0.15 µg/plate mytomycin C (TA102); 50 µg/plate 9-aminoacridine (9-AA; TA1537). With S9-mix: 0.8-1.7 µg/plate 2-aminoanthracene (2-AA; all strains).
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:
background lawn and microcolony growth.
Evaluation criteria:
The test substance is considered positive if a significant or dose related increase in the mutation frequency of the tester strains in the absence and presence of a metabolic activation system is observed.
Statistics:
The statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was estimated using a X2-test.

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:
no 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 precipitation was observed

The results with the positive control substances confirmed the known reversion properties and specificity of the tester strains as well as the full activity of the metabolizing system.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion