Difluoroacetic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of dichioroacetate, an ingredient of some formulations of pangamic acid (trade-named “vitamin B15”)

Author:

Victor Herbert, Ann Gardner, and Neville Colman

Year:

1980

Bibliographic source:

Am. J. Clin. Nutr. 33: 1179-1182, 1980.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: bacterial reverse mutation assay

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Dichloroacetic acid

EC Number:

201-207-0

EC Name:

Dichloroacetic acid

Cas Number:

79-43-6

IUPAC Name:

dichloroacetic acid

Details on test material:

- Name of test material (as cited in study report): dichloroacetic acid
- Molecular formula (if other than submission substance): C2H2Cl2O2
- Molecular weight (if other than submission substance): 128.94
- Substance type: Organic
- Analytical purity: Not available
- Impurities (identity and concentrations): Not available

Method

Target gene:

Salmonella typhimurium

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA 100, TA 1535, TA 1537, and TA 1538

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

metabolite of the anesthetic, methoxyflurane

Test concentrations with justification for top dose:

0-10 µg/Plate

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Benzopyrene hydroxylase

Remarks:

Positive control for TA 98 and TA 1538 tested with & without of S9

Details on test system and experimental conditions:

Effects of enzymatic conversion were tested using a commercially produced 9000 x g supernatant (S9) of liver from rats previously treated with Aroclor 1254 (Bionetics Corporation, Kensington, Md.). When S9 was used, the preparation to be added to each individual plate received 50 ıl of solution with 24.8 to 27.9 mg of protein per milliliter and benzopyrene hydroxylase activity approximating 0.4 nmole of hydrobenzopyrene per milligram of protein per 20 mm.

Evaluation criteria:

Not available

Statistics:

Not available

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA 100, TA 1535, TA 1537, and TA 1538

Metabolic activation:

with and without

Genotoxicity:

ambiguous

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

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 Ames Salmonella!mammalian microsome mutagenicity test, Dichloro acetic acid, from doses 1-10 micrograms per plate was not mutagenic in Salmonella typhimurium (TA98,TA 100, TA 1535, TA 1537, and TA 1538) with and without addition of S9 liver fractions from Aroclor induced rats.

Executive summary:

In Ames Salmonella!mammalian microsome mutagenicity test, Dichloro acetic acid, from doses 1-10 micrograms per plate was not mutagenic in Salmonella typhimurium (TA98,TA 100, TA 1535, TA 1537, and TA 1538) with and without addition of S9 liver fractions from Aroclor induced rats.