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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:
other: modern OECD guideline study, conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name of test substance: 3-Formyltetrahydrofuran
Test substance No.: 13/0111-1
Batch identification: MK-2635Dest
Purity/composition: 100.0 area-% (see test substance information from the sponsor)
Homogeneity: The homogeneity of the test substance was ensured by
mixing before preparation of the test substance solutions. Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed until 05 Mar 2014 as indicated by the manufacturer, and the manufacturer holds this responsibility.
ADDITIONAL TEST SUBSTANCE INFORMATION
Date of production/supply: unknown
Physical state, appearance: Liquid, colorless, clear
Storage conditions: Room temperature (under N2 conditions)

Method

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:
33 μg - 5 000 μg/plate (SPT)
10 μg - 2 500 μg/plate (PIT; TA strains without S9 mix)
33 μg - 5 000 μg/plate (PIT; TA strains with S9 mix, E.coli with and without S9 mix)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine

Results and discussion

Test results
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:
cytotoxicity
Remarks:
SPT: from 1000 µg/plate; PIT: from 2500 µg/plate
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:
Under the experimental conditions chosen, it is concluded that 3-Formyltetrahydrofuran is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
Executive summary:

The test substance 3-Formyltetrahydrofuran was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance 3 -Formyltetrahydrofuran is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.