Potassium hydrogen tartrate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

(No metabolic activation employed)

GLP compliance:

no

Remarks:

no data

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Specific details on test material used for the study:

100% purity reported

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium, other: TA 92 and TA 94

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction prepared from livers of pretreated rats with PCB compund Kanechlor KC-400

Test concentrations with justification for top dose:

Reported 6 concentrations. Maximum concentration tested is 0.5 mg/plate.

Vehicle / solvent:

Diluted in a solution of 0.1 N sodium hydroxyde.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: no data

Remarks:

Details nos providad in paper, althogh numerous positive substances are reported.

Details on test system and experimental conditions:

Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for e ach of six different concentrations of the sample.
The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Remarks:

TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

other: no data

Test results 2

Species / strain:

S. typhimurium, other: TA 92 and TA 94

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

other: no data

Additional information on results:

Interpretation of results: Negative

Remarks on result:

other: Test system: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

The substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 0.5 mg/ml on Salmonella strains TA 1535, TA 1537, TA 98, TA 92, TA 94 and TA 100, with and without metabolic activation as part of a programme sponsored by the Japanese Ministry of Health and Welfare to test common food additives. Results obtained on all strains tested at the maximum concentrations tested were negative.

Executive summary:

The substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 0.5 mg/ml on Salmonella strains TA 1535, TA 1537, TA 98, TA 92, TA 94 and TA 100, with and without metabolic activation as part of a programme sponsored by the Japanese Ministry of Health and Welfare to test common food additives. Results obtained on all strains tested at the maximum concentrations tested were negative.