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EC number: 701-284-5 | CAS number: 2137881-70-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
Test material
- Reference substance name:
- Formic acid
- EC Number:
- 200-579-1
- EC Name:
- Formic acid
- Cas Number:
- 64-18-6
- Molecular formula:
- CH2O2
- IUPAC Name:
- formic acid
- Details on test material:
- TS-Freetext:
Formic acid, analytical grade from Merck.
Constituent 1
- Specific details on test material used for the study:
- TS-Freetext:
Formic acid, analytical grade from Merck.
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor1254-induced male Wister rat liver
- Test concentrations with justification for top dose:
- 0, 18.4, 27.6, 46.0, 92.0 µg/mL (i. e. 0, 0.4, 0.6, 1.0, 2.0 mM)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
Controls
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: dimethylnitrosamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: test substance was added 18 h after seeding 5x10E05 cells.
- Exposure duration: 3 hours with metabolic activation, 28 hours without
- Expression time (cells in growth medium): 28 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 28 hours
SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): bromo-desoxy-uridine
NUMBER OF REPLICATIONS: no data
NUMBER OF CELLS EVALUATED: Twenty-five metaphases with harlequin stained chromosomes were evaluated per dose level w/without S-9 mix
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- Evaluation criteria:
- sister chromatid exchange
- Statistics:
- Results were analysed by Student's t-est.
Results and discussion
Test results
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not addressed
- Effects of osmolality: not addressed - Remarks on result:
- other: other: Chinese hamster V79 cells
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Formic acid (mM) |
SCE per metaphase |
|
|
exposure time 28 hours without S9-mix |
exposure time 3 hours with S9-mix |
0 |
5.5±2.1 |
7.4±2.1 |
0.4 |
7.4±2.5 |
9.2±4.6 |
0.6 |
- |
8.5±3.1 |
1.0 |
7.2±2.5 |
8.2±2.1 |
2.0 |
6.1±2.1 |
- |
10 mM dimethylnitrosamine |
25.8±2.1 |
25.1± 10.0 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
In a mammalian cell cytogenetics assay (SCE), Chinese hamster V79 cell cultures were exposed to formic acid at concentrations of 0, 18.4, 27.6, 46.0, 92.0 µg/mL (i. e. 0, 0.4, 0.6, 1.0, 2.0 mM) with and without metabolic activation, S9-mix containing Arochlor 1254-induced male rat liver supernatant.
Formic acid was tested in a concentration range that was not cytotoxic. Negative controls performed as expected. Positive controls (10 mM dimethylnitrosamine) induced the appropriate response. There was no evidence of SCE induced by formic acid over background.
This study is classified as acceptable because the documentation is sufficient for assessment. This study satisfies the requirement for Test Guideline OECD 479 for in vitro cytogenetic mutagenicity data.
Conclusion:
Formic acid did not induced Sister Chromatid Exchange in V79 cells, with or without metabolic activation.
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