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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: Study was not conducted under the GLP regulations.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconoate IUCLID4 Data Set

Method

Target gene:
his -
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: Salmonella typhimurium and Escherischia coli strains WP2 and WP2 uvr A were also included in the assay.
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S-9 fraction.
Test concentrations with justification for top dose:
Final concentrations were: 31.25, 62.5, 125, 250, 1000, 2000, or 4000 µg/plate.
Vehicle / solvent:
Acetone
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:
No data
Statistics:
Not required for this study.

Results and discussion

Test results
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:
no cytotoxicity
Additional information on results:
Vinyl Neodeconoate did not cause an increase in the background control mutant frequency values of any of the bacterial tester strains with or without rat liver S-9 metabolic activation system when tested up to the high dose level of 4 mg/mL. .
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Vinyl Neodeconoate did not cause gene-mutation in any of the Salmonella or E. coli tester strains under the conditions of the assay.
Executive summary:

When evaluated in an O.E.C.D. 471 "Bacterial Reverse Mutation Test" Vinyl Neodecanoate did not induce an increase of the mutant frequency in any of the tester strains. Therefore, Vinyl Neodecanoate is not a bacterial mutagen under the conditions of the assay.