Reaction mass of N,N-dimethylformamide and N,N-dimethylformamide hydrochloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Referenced sources in an international report.

Data source

Reference

Reference Type:

review article or handbook

Title:

Dimethylformamide, SIDS Initial Assessment Report For SIAM 13

Author:

OECD

Year:

2001

Bibliographic source:

UNEP PUBLICATIONS

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

standard plate incorporation assay, (Ames, 1975)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylformamide

EC Number:

200-679-5

EC Name:

N,N-dimethylformamide

Cas Number:

68-12-2

Molecular formula:

C3H7NO

IUPAC Name:

N,N-dimethylformamide

Test material form:

not specified

Method

Target gene:

No data

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix prepared from liver homogenate of Aroclor pretreated male Sprague-Dawley rats.

Test concentrations with justification for top dose:

9400, 24000, 47000, 94000, 190000, 470000 µg/plate

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

other: With metabolic activation: 2-Aminoanthracene: 5, 10 and 100 μg/plate. Without metabolic activation: N-Methyl-N'-nitro-N-nitrosoguanidine: 2 μg/plate (TA1535, TA100); 9-Aminoacridine: 50 μg/plate (TA1537); 2-Nitrofluorene: 25 μg/plate (TA1538, TA98)

Details on test system and experimental conditions:

Plates are incubated at 37°C for 48 hours. Cytotoxicity of the test sample as measured in strain TA1535 is the basis for selecting concentrations to be used in the present test. Concentrations of test sample that give less than 50% of control survival are normally not selected for the assay.

Evaluation criteria:

A chemical was classified as non-mutagenic if the reversion frequency was less than 2 times the spontaneous frequency. No statistical analysis was performed.
However, in the present assay 470000 μg/plate was chosen because this experiment was done to aid in evaluating a recent Utah Biological Testing Service report, that concluded that DMF is mutagenic in 4 of the Ames strains of Salmonella typhimurium. 470000 μg/plate led to toxicity as indicated by sparse background lawn.

Results and discussion

Test results

Species / strain:

other: TA98, TA100, TA1535, TA1537, and TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Cytotoxicity occurred at 190000 and 470000 μg/plate without metabolic activation and at 470000 μg/plate with metabolic activation

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In the Ames test, DMF was not found mutagenic even at concentrations that are cytotoxic.