Methyl tetrahydro-2-furancarboxylate

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:

From 7 December 1995 to 9 January 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Methyl tetrahydro-2-furancarboxylate

EC Number:

420-670-1

EC Name:

Methyl tetrahydro-2-furancarboxylate

Cas Number:

37443-42-8

Molecular formula:

C6H10O3

IUPAC Name:

methyl oxolane-3-carboxylate

Test material form:

other: liquid

Details on test material:

Identity: Methfat
Chemical name: Methyl tetrahydro-2-furoate
Intended use: Pharmaceutical intermediate
Appearance: Clear colourless liquid
Storage conditions: Room temperature
Batch number: 17-5C03 (GLFC Bx No. 0002)
Expiry date: 7 November 1996
Purity: 99.40%
Date received: 17 November 1995
Supplier: Great Lakes Fine Chemicals Limited

Method

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:

S-9 mix

Test concentrations with justification for top dose:

0, 50, 150, 500, 1500, 5000 µg/plate

Vehicle / solvent:

Dimethyl sulphoxide

Controls

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl sulphoxide

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-aminoanthracene

Details on test system and experimental conditions:

Controls - Positive control compounds
In the absence of S-9 mix
N-Ethyl-N-nitro-N-nitrosoguanidine; 5 µg/plate for strain TA 1535; 3 µg/plate for strain TA 100
9-aminoacridine; 80 µg/plate for strain TA 1537
2-nitrofluorene; 1 µg/plate for strain TA98
In the presence of S-9 mix
2-aminoanthracene; 2 µg/plate for strains TA 1535 and TA 1537; 0.5 µg/plate for strain TA98; 1 µg/plate for strain TA100

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:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In the preliminary toxicity study, Methfat was not toxic towards the tester strains. therefore 5000 µg/plate was chosen as the top dose level in the mutation tests.
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with Methfat at any dose level, in the presence or absence of S-9 mix, in either mutation test.
The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

It is concluded that, when tested in dimethyl sulphoxide, Methfat shows no evidence of mutagenic activity in this bacterial system.