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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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study published as a comprehensive article published in peer-reviewed journall "Toxicology".
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two equivalent groups of 10 and 8 rats were respectively dosed for 7 days with 2.73 g/kg/day of C14 labelled L(+) monosodium tartrate and DL-monosodiu tartrate. Animals were sacrificed at different intervals before and after completion of dosing and blood, liver, bone and kidney samples were taken and weighed and analysed. Animals were also sacrificed throughout the 8 day observation period after 7 days of dosing and immediately frozen to -70 °C and subjected to whole-body autoradiography of microtome slices. Radioaxtivity in whole blkood, plasma, kidneys, liver and bone was determined after processing of samples using a scintillation counter. Kidney extracts were analysed by paper chromatography and GC-MS ti identify the form in which tartaric acid is found. Finally tissue samples of kidney were fixed in formaline-saline and processed in paraffin wax for histological examination.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium hydrogen tartrate
- EC Number:
- 208-400-9
- EC Name:
- Sodium hydrogen tartrate
- Cas Number:
- 526-94-3
- Molecular formula:
- C4H6O6.Na
- IUPAC Name:
- sodium hydrogen tartarate
- Details on test material:
- 99% radiochemically pure 14C monosodium tartrate.
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male rats. 160 - 180 g at study initiation.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Animals received a single daily dose of 2.73 mg/kg of 99% pure 14C radiolabelled monosodium L(+) tartrate for a period of 7 consecutive days. The substance was dissolved in water for oral administration by gavage.
- Duration and frequency of treatment / exposure:
- Single daily oral dose, 7 consecutive days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.73 mg/kg
- No. of animals per sex per dose / concentration:
- Only one dose. 10 male animals per dose (for analytical tests and histology).
Another 8 males subjected to same dosing regime for whole-body autoradiography studies. - Control animals:
- not specified
- Details on study design:
- Two equivalent groups of 10 and 8 rats were respectively dosed for 7 days with 2.73 g/kg/day of C14 labelled L(+) monosodium tartrate and DL-monosodiu tartrate. Animals were sacrificed at different intervals before and after completion of dosing and blood, liver, bone and kidney samples were taken and weighed and analysed. Animals were also sacrificed throughout the 8 day observation period after 7 days of dosing and immediately frozen to -70 °C and subjected to whole-body autoradiography of microtome slices. Radioaxtivity in whole blkood, plasma, kidneys, liver and bone was determined after processing of samples using a scintillation counter. Kidney extracts were analysed by paper chromatography and GC-MS ti identify the form in which tartaric acid is found. Finally tissue samples of kidney were fixed in formaline-saline and processed in paraffin wax for histological examination.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Peak whole blood and plasma concentrations: 1 h after last dosage
- Type:
- metabolism
- Results:
- Biphasic decline in plasma conc. with halflives of 3 and 53 h fo monosodim (L+) tartrate
- Type:
- distribution
- Results:
- 3 h after lasrt dosage labelled material detected in gastrointestinal tract, liver, kidney and bone tissue
- Type:
- distribution
- Results:
- 24 h later only detectable radioactivity is in bone tissue, where it remains detectable for at least 192 h
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See table above
- Details on distribution in tissues:
- Labelled tartrate rapidly is distributed into liver, kidney, bones and gastrointestinal tract. Labelled material disappears from all tissues after 24 h except for bone tissue, where tartrate seems to remain associated to calsium in bones for at least 192 h. Approximately 0.4% of the administered dose is distributed to bone.
- Details on excretion:
- Not studied, although publication refers to other studies which indicate that absorbed tartaric acid is mostly excreted unchanged in urine.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The sodium salt of L(+) tartrate, which is considered suitable for read-across to Potassium Sodium Tartrate is partially absorbed through the gut after oral administration and rapidly distributed and partially metabolised in blood, liver, the kidneys and bone. Tartaric acid is mostly excreted as such via urine, although it is though to be metabolised and completely oxidised in the kidneys and liver. L-tartrate salts of sodium and potassium can thereby be considered to be rapidly adsorbed, distributed, elliminated and excreted from the body, with no ability to accumulate other than for a brief period of time (up to 8 days) in bone tissue presumably as calcium tartrate. - Executive summary:
The sodium salt of L(+) tartrate, which is considered suitable for read-across to Potassium Sodium Tartrate is partially absorbed through the gut after oral administration and rapidly distributed and partially metabolised in blood, liver, the kidneys and bone. Tartaric acid is mostly excreted as such via urine, although it is though to be metabolised and completely oxidosed in the kidneys and liver. L-tartrate salts of sodium and potassium can thereby be considered to be rapidly adsorbed, distributed, elliminated and excreted from the body, with no ability to accumulate other than for a brief period of time (up to 8 days) in bone tissue presumably as calcium tartrate.
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