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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
According to the method of Marron and Ames (1983), modified pre-incubation Ames test (Yahagi et al., 1977)
Principles of method if other than guideline:
adapted to volatils
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Freshly dissolved in appropriate solvent before used.
Checked for purity by nuclear magnetic resonance spetroscopy.

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
six dose levels: 11 nmol - 1.1 mmol
Pre-assay performed to determine highest non-bactericidal dose in TA100
Vehicle / solvent:
methanol
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
methanol
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
mitomycin C
other: 2-aminofluorene
Details on test system and experimental conditions:
According to the method of Marron and Ames (1983), modified pre-incubation Ames test (Yahagi et al., 1977) due to the volatile nature of the test substance
Tested with all 3 strains at 6 dose levels (up to bactericidity).
Four plates per dose and solvent control.
Preparation of hepatic enzyme system (S9) using Aroclor 1254-induced rat livers.
Metabolic activation (30% S9) used when appropriate.
Plates incubated for 3 days and counted with automated colony counter.
Mutation factors (MF) (induced/spontaneous revertants) were counted at the dose levels that give the greatest effect.
Rationale for test conditions:
adapted due to the volatile nature of the test substance
Evaluation criteria:
not specified
Statistics:
not specified

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
The positive controls always gave strong mutagenic responses providing evidence for correct functioning of the test and the metabolic activation.
Remarks on result:
other: not mutagenic

Applicant's summary and conclusion

Conclusions:
2-Methylfuran was tested negative in the Ames test with the tester strains TA98, TA100 and TA102 with and without metabolic activation and at doses up to bactericidity.
Executive summary:

The test substance was tested for genotoxicity in an Ames test using three Salmonella typhimurium strains TA98, TA100 and TA102 with and without metabolic activation (30% S9). Due to the volatile nature of the substance, the test was performed according to the method of Marron and Ames (1983), a modified pre-incubation protocol (Yahagi et al., 1977). The test was not performed in accordance with OECD TG but with acceptable restrictions. The test was not performed under GLP.

The strains were tested at 6 dose levels ranging from 11.0 nmol - 1.1 mmol up to bactericidity which was determined in a pre-test with TA100. Four plates per dose and solvent control were tested. The plates were incubated for 3 days and counted with an automated colony counter. Mutation factors (MF) (induced/spontaneous revertants) were counted at the dose levels that give the greatest effect.

In conclusion, 2-methylfuran was tested negative in the Ames test with the tester strains TA98, TA100 and TA102 with and without metabolic activation and at doses up to bactericidity.