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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

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:
One recommended bacteria strain is missing (E.coli WP2 uvrA or E.coli WP2 uvrB or S. typhimurium TA 102).
Principles of method if other than guideline:
The mutagenic potential of potassium sorbate was tested in 4 different strains of Salmonella typhimurium according to the bacterial reverse mutation test proposed by Ames (1975). Concentrations of 2–200 µl Potassium sorbate/plate were tested. The conduct of the study was similar to EC method B.14.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed.
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium sorbate (Kaliumsorbat)

Method

Target gene:
not applicable
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
0, 2, 10, 50, 100, 200 µg/plate (both in the presence and in the absence of rat liver S9 fraction)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO or different solvents such as ethanol or distilled water
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
aqua dest.
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Procarbazine-HCl; 5 µl/plate for TA98 and TA100
Remarks:
without S9-mix
Untreated negative controls:
yes
Remarks:
aqua dest.
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Streptozotocin; 10 µl/plate for TA1535
Remarks:
without S9-mix
Untreated negative controls:
yes
Remarks:
aqua dest.
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S9-mix

Migrated to IUCLID6: 100 µl/plate for TA1537
Untreated negative controls:
yes
Remarks:
aqua dest.
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene, 5 µl/plate for TA98, TA100, TA1535 and TA1537
Remarks:
with and without S9-mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
- 2 to 200 µl volumes of solutions of test material dissolved in dimethyl sulphoxide (DMSO) or with different solvents such as ethanol or distilled water.

DURATION
- Preincubation period: none
- Exposure duration: 48 hours at 37 °C

NUMBER OF REPLICATIONS: 4

NUMBER OF CELLS EVALUATED: no data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: no data
Evaluation criteria:
revertant colonies

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
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

No increase in the reverse gene mutation rate was found in any of the tested strains either in presence or absence of rat liver S9 fraction. Potassium sorbate was considered to have no mutagenic potential to Salmonella typhimurium.

The extrapolation from sorbic acid to potassium sorbate or vice versa is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.