Registration Dossier
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EC number: 206-156-8 | CAS number: 304-59-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- No metabolic activation employed
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Potassium hydrogen tartrate
- EC Number:
- 212-769-1
- EC Name:
- Potassium hydrogen tartrate
- Cas Number:
- 868-14-4
- Molecular formula:
- C4H6O6.K
- IUPAC Name:
- potassium 3-carboxy-2,3-dihydroxypropanoate
- Details on test material:
- Potassium bitartrate (potassium hydrogen tartrate). 100% purity reported.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Established originaly from lung of newborn female at the Cancer Research Institute, Tokyo (1970). Maintained by 4-day passages in Minnimum Essential Medoum (MEM) of GIBCO. The modal chromosomal number is 25 and the doubling time was approximately 15h.
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Three concentrations were used, although the report only states maximum concentration employed which is 2 mg/ml. This concentration is stated to be that producing 50% growth inhibition, as determined in a prelimnary study.
- Vehicle / solvent:
- Test medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- The cells were exposed to each sample at three different doses for 24 and 48 hr. No metabolic activation systems were applied. The maximum dose of each sample was selected by a preliminary test in which the dose needed for 50% cell-growth inhibition was estimated using a cell densitometer (Monocellater, Olympus Co., Ltd).
Previous studies indicated that the osmotic pressure of the medium generally rose with sample concentrations of more than 10 raM, SO that the maximum dose for some samples was limited to around this level, at which cytotoxic effects were not necessarily observed.
Chromosome preparations were made as follows. Colcemid (final concn 0.2/~g/ml) was added to the culture 2 hr before cell harvesting. The cells were then trypsinized and suspended in a hypotonic KCI solution (0.075 M) for 13 min at room temperature. After centrifugation the cells were fixed with acetic acid-methanol (1:3, v/v) and spread on clean glass slides. After air-drying, the slides were stained with Giemsa solution (1.5%, at pH 6.8; E. Merck) for 12-15 min. A hundred well-spread metaphases were observed under the microscope (x 600 with a nocover objective lens). The incidence of polyploid cells as well as of cells with structural chromosomal aberrations such as chromatid or chromosome gaps, breaks, exchanges, ring formations, fragmentations and others, was recorded on each culture plate.
. - Evaluation criteria:
- The results were considered to be negative if the incidence was less than 4.9%, equivocal if it was between 5.0 and 9.9%, and positive if it was more than 10.0 %. Untreated cells and solvent-treated cells served as negative controls, in which the incidence of aberrations was usually less than 3.0%
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- 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
- Positive controls validity:
- other: Reported as valid although not verifiable in report avaiable
- 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 without metabolic activation
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 2 mg/ml on a Chinse Hamster lung established cell line and tested without metabolic activation. Results obtained at maximum non severly toxic concentrations after 48 hours of exposure do not indicate any significant amounts of structural aberrations or polyploidy (1%). Thereby the results point to the tested substancxe as being negative for clastogenesis in this mammalian cell line. - Executive summary:
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 2 mg/ml on a Chinse Hamster lung established cell line and tested without metabolic activation. Results obtained at maximum non severly toxic concentrations after 48 hours of exposure do not indicate any significant amounts of structural aberrations or polyploidy (1%). Thereby the results point to the tested substancxe as being negative for clastogenesis in this mammalian cell line.
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