Formic acid, manufacture of, by-products from

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:

1985

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

Test material information

Constituent 1

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.

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.