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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Vinyl 2-ethylhexanoate
EC Number:
202-297-4
EC Name:
Vinyl 2-ethylhexanoate
Cas Number:
94-04-2
Molecular formula:
C10H18O2
IUPAC Name:
ethenyl 2-ethylhexanoate

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 Microsomes
Test concentrations with justification for top dose:
Cytotoxicity: 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, 1.0, 3.0, 5.0, 10.0 mg/plate
Genotoxicity: 0.1, 0.3, 1.0, 3.0, 10.0 mg/plate
Vehicle / solvent:
Phosphate buffered saline
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: multiple
Details on test system and experimental conditions:
Bacterial tester strains were grown overnight at 37C with shaking. Rat liver S-9 metabolic activation system was prepared and maintained on ice until used. Molten top agar was maintained at 39-40C before plating. Test substance dilution, 0.1 ml of appropriate bacterial culture and rat liver S-9 fraction as needed were added to the top agar test tubes. The tubes were vortexed to mix and the contents were poured over minimal glucose agar plates. The plates in triplicate per dose were then incubated at 37°C for 48 hr before the revertant colonies were counted. The bacterial tester strains were tested with specific positive control substances to assure the sensitivity of the assay. After 48 hours of incubation the plates were counted by a automatic colony counter.
Evaluation criteria:
A test chemical was considered a bacterial mutagen if it produced a dose-related increase in the mean reversion frequency of at least one bacterial strain as compared to the solvent control for that strain and at least one dose must have produced a mean reversion frequency 2 times that of the solvent control.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
without S9 activation
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Vinyl 2-ethylhexanoate did not cause gene-mutation in any of the Salmonella strains under the conditions of the assay.
Executive summary:

When evaluated in an Bacterial Reverse Mutation Test Vinyl 2 -ethylhexanoate did not induce an increase of the mutant frequency in any of the tester strains. Therefore, Vinyl 2 -ethylhexanoate is not a bacterial mutagen under the conditions of the assay.