Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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 resultsopen allclose all
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
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.