3-Furanol, tetrahydro-, (3S)-

Genetic toxicity: in vitro

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

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-090-2

EC Name:

-

Cas Number:

86087-23-2

Molecular formula:

C4 H8 O2

IUPAC Name:

(3S)-oxolan-3-ol

Method

Target gene:

His

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate

Vehicle / solvent:

Solvent: Sterile distilled water

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

mitomycin C

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

distilled water

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

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 nor precipitates, but tested up to recommended limit concentrations

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
The solvent control plates gave counts in the expected
ranges. All positive controls produced marked increases in
the revertant counts.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

1272W94 did not cause any significant increase in the frequency of revertant colonies in any of the bacterial strains tested either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of the test up to the maximum recommended dose of 5000mcg/plate.

Executive summary:

salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA 100 were treated with 1272W94 using the Ames plate incorporation method at five dose levels, in triplicate, both with and without metabolic activation. The vehicle (sterile distilled water0 and positive control chemicals produced the expected effect on revertant colonies. 1272W94 caused no visible reduction in the growth of the bacterial lawn at any dose levels to any strains of Salmonella tested. It was applied up to the maximum recommended dose of 5000mcg/plate. 1272W94 did not cause any significant increase in the frequency of revertant colonies in any of the bacterial strains tested either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of the test up to the maximum recommended dose of 5000mcg/plate.