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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
Gene mutation toxicity study of the test chemical
Author:
Masataka Ichikawa et. al.
Year:
1986
Bibliographic source:
Carcinogenesis vol.7, 1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Ames assay was performed to determine the mutagenic nature of test chemical
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-furoic acid
EC Number:
201-803-0
EC Name:
2-furoic acid
Cas Number:
88-14-2
Molecular formula:
C5H4O3
IUPAC Name:
2-furoic acid
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: 2-furoic acid
- IUPAC name: furan-2-carboxylic acid
- Molecular formula: C5H4O3
- Molecular weight: 112.084 g/mole
- Smiles : c1(C(O)=O)ccco1
- Inchl: 1S/C5H4O3/c6-5(7)4-2-1-3-8-4/h1-3H,(H,6,7)
- Substance type: Organic
- Physical state: Solid powder (white)

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98 and TA100
Details on mammalian cell type (if applicable):
No data
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
not specified
Metabolic activation system:
No data
Test concentrations with justification for top dose:
0, 25, 50, 75 or 100 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Spectral grade DMSO
- Justification for choice of solvent/vehicle: The test chemical dissolved in Spectral grade DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
spectral grade DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data
- Exposure duration: 40 hrs in dark
- Expression time (cells in growth medium): 40 hrs in dark
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Duplicates

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other:

OTHER: Compounds showing any ambiguity in the assays were tested twice at concentrations of up to 100 /µg/plate.

The experiments on the effect of pH on the mutagenic activity of the 2-furoate derivatives were performed using a series of base agar plates buffered in the range of pH 6.2-7.2. Agar plates of varying pH were prepared using phosphate buffer.
Rationale for test conditions:
No data
Evaluation criteria:
Chemicals that caused dose-dependent induction of more than twice the number of spontaneous revertants were defined as mutagenic, and mutagenic activity is expressed as the number of revertants per nmol, which was calculated from the linear portion of the dose -response curve.
Statistics:
No data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98 and TA100
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No detailed data available
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data

RANGE-FINDING/SCREENING STUDIES: No data

COMPARISON WITH HISTORICAL CONTROL DATA: No data

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data
Remarks on result:
other: No mutagenic potential

Applicant's summary and conclusion

Conclusions:
Test chemical did not induce reversion in Salmonella typhumurium TA100 and TA98 and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Ames assay was performed to determine the mutagenic nature of test chemical The study was perfomed using Salmonella typhimurium strain TA100 and TA98. The test chemical was dissolved in spectral grade DMSO and used at dose levels of 0, 25, 50, 75 or 100µg/plate. The plates were incubated for 40 hrs and then observed for number of revertants/plate.The test chemical did not induce reversion inSalmonella typhumurium TA100 and TA98and hence it is not likely to classify as a gene mutant in vitro.