Methyl formate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Methyl formate

EC Number:

203-481-7

EC Name:

Methyl formate

Cas Number:

107-31-3

Molecular formula:

C₂H₄O₂

IUPAC Name:

methyl formate

Details on test material:

- Test substance: Methyl formate
- Analytical purity: 98.4 %.

Method

Target gene:

operon coding for histidine biosynthesis

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:

from Aroclor 1254 induced rat liver

Test concentrations with justification for top dose:

20 - 5000 µg/plate

Vehicle / solvent:

- Vehicle used: DMSO
- Justification for choice of solvent/vehicle: commonly used

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

no

Remarks:

Migrated to IUCLID6: Without S-9 mix: N-methyl-N'-nitro-N-nitroso-guanidine, 4-nitro-o-phenylenediamine, 9-aminoacridine. With S-9 mix: 2-aminoanthracene.

Details on test system and experimental conditions:

- Standard plate test, SPT: according to Ames.
- Preincubation assay, PIA: 20 minutes at 37°C, according to Yahagi et al. (1977) and Matsushima et al. (1980).
- Metabolic activation: with and without metabolic microsomal enzyme systems (S-9 fraction) from Arochlor 1254-induced male Sprague-Dawley rat liver were used.

- Concentrations:
- 1st experiment (SPT, w/wo metabolic activation; TA1535, TA 100, TA1537, TA98): 0, 20, 100, 500, 2500, and 5000 µg/plate.
- 2nd experiment (SPT, w/wo metabolic activation; TA1535): 0, 100, 500, 750, and 1000 µg/plate.
- 3rd experiment (PIA, w/wo metabolic activation; TA1535, TA 100, TA1537, TA98): 0, 20, 100, 500, 2500, and 5000 µg/plate.

- Replicates: 3 plates per dose or control in each of the experiments.

Evaluation criteria:

Requirements to characterize a substance as positive: 
- doubling of the spontaneous mutation rate
- dose-response relationship
- reproducibility.

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:

cytotoxicity

Remarks:

> 5000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxicity was noted at any dose including the highest tested dose of 5000 µg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Methyl formate did not increase the number of revertants in any of the experiments, with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Conclusion:

 

Methylformate (20 – 5000 µg/plate) was negative in a valid Ames test conducted according to OECD 471 using S. typhimurium strains TA1535, TA 1537,TA98, and TA100, with and without metabolic activation. Positive and negative controls performed as expected.