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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)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to OEDC guideline 471, GLP comliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
equivalent or similar to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Qualifier:
equivalent or similar to
Guideline:
other: EPA OPPTS 440/2008
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Soybeen oil, polymerized
- Analytical purity: Mixture
- Lot/batch No.: 1201204
- Storage condition of test material: at room temperature, in the dark

Method

Target gene:
Histidine or tryptophan locus.
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0, 50, 150, 500, 1500 and 5000 µg/plate.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
tetrahydrofuran
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
other: 2-Aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours

SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS: non for preliminary toxocity test, triplicate for main test

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: reduction in number of spontaneous revertants (below a factor 0.5 fold under the concurrent solvent control value and/or bacterial lawn should exhibit evidence of thinning when viewed microscopically.
Evaluation criteria:
A minimun of four non-toxic test item dose levels is required for the assay to be acceptable

A test item will be considered non-mutagenic (negative) in the test system if one or more of the following criteria are not met:
A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby 1979)
A reproducible increase at one or more concentrations
Biological relevance against in-house historical control ranges
Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-gistorical range response)
Statistics:
Statistical analysis of data as determinded by UKEMS (Mahon et al 1989)

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

The testing material was considered to be non-mutagenic under the conditions of this test.
Executive summary:

Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with the testing material, Soybeanoil, polymerized, using both the Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (S9). The dose range for the first experiment was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate.

No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.

The test item,Soybeanoil, polymerized, was considered to be non‑mutagenic under the conditions of this test.