Potassium hydrogencarbonate

Genetic toxicity: in vitro

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:

other: Test procedure according to national standards, test performed in governmental laboratory

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only strains TA 97 and TA 102 tested

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Potassium carbonate

EC Number:

209-529-3

EC Name:

Potassium carbonate

Cas Number:

584-08-7

Molecular formula:

CH2O3.2K

IUPAC Name:

dipotassium carbonate

Method

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA97, TA102

Metabolic activation:

with and without

Test concentrations with justification for top dose:

0, 100, 500, 1000, 5000, 10000 µg/plate

Vehicle / solvent:

Destilled water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Migrated to IUCLID6: 50 µg/plate for TA 97 without metabolic activation

Controls 2

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene 5 µg/plate for all strains with metabolic activation

Controls 3

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

Migrated to IUCLID6: 0,5 µg/plate for TA 102 without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 minutes

NUMBER OF REPLICATIONS:
- 3 plates for each concentration

The test was performed according to the procedures described by Ames et al. 1975

Results and discussion

Test results

Species / strain:

S. typhimurium, other: Salmonella typhimurium TA97, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: not reported

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

The test substance Potassium carbonate anhydrous was considered to be negative with and without metabolic activation in this study.

Executive summary:

In a reverse gene mutation assay in bacteria according to the method of Ames et al. (1975), S. typhimurium strains TA 97 and TA 102 of were exposed to Potassium carbonate anhydrous at concentrations of 100, 500, 1000, 5000 and 10 000 µg/plate in the presence and absence of mammalian metabolic activation using the pre-incubation method. 

 

Potassium carbonate anhydrous was tested far beyond the limit concentration of 5000 µg/plate. Cytotoxicity was not reported in this study.

There was no evidence of induced mutant colonies over background in any of the tested S. typhimurium strain up to and including the highest dose tested.