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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / micronucleus study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16/12/2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
Deviations:
yes
Remarks:
These deviations did not influence the quality or integrity of the present study.
GLP compliance:
yes (incl. QA statement)
Type of assay:
in vitro mammalian cell gene mutation test using the Hprt and xprt genes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
EC Number:
234-293-3
EC Name:
Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer
Cas Number:
11071-15-1
Molecular formula:
C8H4O12Sb2.2K
IUPAC Name:
(2R,3R)-2,3-dihydroxy-butanedioic acid, antimony potassium salt
Details on test material:
Batch No.: EM-19-33
Molecular Weight: 667.87 g/mol
pH at Room Temperature: 3.8 - 4.5 (in 2% water solution)
Physical State at RT: solid
Density: 2.6 g/cm3
Colour: colourless transparent crystals or white powder
Expiry Date: 25 March 2024
Storage Conditions: at room temperature
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.

Method

Species / strain
Species / strain / cell type:
other:
Details on mammalian cell type (if applicable):
V79 cells in vitro
Metabolic activation:
with and without
Metabolic activation system:
Name: DMBA; 7,12-dimethylbenz(a)anthracene
CAS: 57-97-6The V79 cells (ATCC, CCL-93) were stored over liquid nitrogen (vapour phase)
An appropriate quantity of the S9 supernatant was thawed and mixed with S9 cofactor solution to result in a final protein concentration of 0.75 mg/mL in the cultures. Cofactors were added to the S9 mix to reach the concentrations below:
8 mM MgCl2
33 mM KCl
5 mM Glucose-6-phosphate
5 mM NADP
in 100 mM sodium-phosphate-buffer pH 7.4. During the experiment the S9 mix was stored on ice. The percentage of S9 mix in the final treatment medium was 5% (v/v).
Test concentrations with justification for top dose:
with metabolic activation: 1.0, 2.5, 5.0, 10 and 20 μg/mL
without metabolic activation: 2.5, 5.0, 7.5, 10 and 15 μg/mL
The selection of the concentrations used in the main experiments was based on data from the pre-experiments according to the OECD guideline 476.
Vehicle / solvent:
With metabolic activation: DMSO, dimethylsulfoxide
Without metabolic activation: Medium (MEM)
Controls
True negative controls:
other:
Remarks:
Negative controls (treatment medium, duplicate cultures) were treated in the same way as all concentration groups. Since treatment medium was used as appropriate solvent no additional solvent control was necessary
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
ethylmethanesulphonate
Evaluation criteria:
According to the OECD guideline, the biological relevance is considered first for the interpretation of results.
Statistics:
The non-parametric Mann-Whitney test was applied to the mutation data to prove the concentration groups for any significant difference in mutant frequency compared to the negative controls. Mutant frequencies of the negative controls were used as reference.

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The main experiments were carried out without and with metabolic activation. The experiments with metabolic activation were performed by including liver microsomes and NADP for efficient detection of a wide variety of carcinogens requiring metabolic activation.
A biologically relevant growth inhibition (reduction of relative survival below 70%) was observed after the treatment with the test item in the experiment with and without metabolic activation. No induction of the mutant frequency was observed at this cytotoxic concentration.
All mean mutant values of the negative controls fall within the historical data range of the test facility and the cloning efficiencies of the negative and solvent controls are > 50%. The positive controls, DMBA (1.5 μg/mL) and EMS (300 μg/mL) showed statistically significant increases in mutant frequency, thereby demonstrating both the sensitivity and validity of the test systems.

Any other information on results incl. tables

Mutagenicity, without metabolic activation

Concentration [μg/mL]

 Mutant Frequency per 10^6 cells
 0  35.5
 0  37.7
 2.5  56.4
 5.0  44.8
 7.5  39.5
 10  42.6
 15  41.5
 300  272.0

Main Experiment – Mutagenicity, with metabolic activation

Concentration [μg/mL]

  Mutant Frequency per 10^6 cells
 0  53.1
 0  40.5
 1.0  37.0
 2.5  54.6
 5.0  39.1
 10  47.7
 20  42.3
 1.5  148.9

Applicant's summary and conclusion

Conclusions:
L(+) Antimony Potassium Tartrate is considered to be non-mutagenic in the HPRT locus using V79 cells of the Chinese Hamster.