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Diss Factsheets
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EC number: 228-845-2 | CAS number: 6362-79-4
- 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, other
- Type of information:
- other: expert opinion
- Adequacy of study:
- supporting study
- Study period:
- 22 January 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- other: expert opinion
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- other: toxicokinetic assessment
- Principles of method if other than guideline:
- Expert judgement in the assessment of toxicokinetic parameters based on available data.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydrogen-5-sulphoisophthalate
- EC Number:
- 228-845-2
- EC Name:
- Sodium hydrogen-5-sulphoisophthalate
- Cas Number:
- 6362-79-4
- Molecular formula:
- C8H6O7S.Na
- IUPAC Name:
- Sodium 3,5-dicarboxybenzenesulfonate
- Reference substance name:
- 288-845-2
- IUPAC Name:
- 288-845-2
- Reference substance name:
- Sodium-3,5-dicarboxybenzenesulfonate
- IUPAC Name:
- Sodium-3,5-dicarboxybenzenesulfonate
- Reference substance name:
- 5-(Sodiosulfo)isophthalic acid
- IUPAC Name:
- 5-(Sodiosulfo)isophthalic acid
- Test material form:
- other: white powder
- Details on test material:
- - Name of test material (as cited in study report): 5-(sodiosulfo)isophthalic acid
- Physical state: white powder
- Analytical purity: 99.4%
- Lot/batch No.: 6F21174000
- Expiration date of the lot/batch: 2 December 2013
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark. The material is hygroscopic and must be stored in a well-sealed container.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Radiolabelling:
- no
Test animals
- Species:
- other: none
- Strain:
- other: none
Administration / exposure
- Route of administration:
- other: oral, dermal and inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- see assessment
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- assumed 100% by inhalation; 50% by oral/dermal
Any other information on results incl. tables
ASSESSMENT
Oral Bioavailability:
The subject material is a water soluble and ionizable material with a measured octanol/water partition coefficient (log) of -1.7 and a moderate molecular weight (MW=268). Such a material should readily dissolve in the gastro-intestinal fluid. However, the presence of ionizable groups will reduce the absorption potential. Given some measured systemic effects in experimental animals following oral exposures, absorption from the gastrointestinal tract cannot be precluded. Once absorbed, the highly ionized nature of the material suggests rapid elimination primarily through the urine. The material should not accumulate or bioconcentrate in tissues. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the oral route is assumed.
Dermal Bioavailability
Compounds most readily absorbed through the relatively impervious stratum corneum skin layer are those of moderate lipophilicity and having both some water and fat solubility. The subject material is highly water soluble but is of a low lipophilicity, as evidenced by a low octanol/wate partition coefficient. Such a material should not be readily absorbed through the skin. However, to provide a most conservative estimate and for risk assessment purposes, a 50% absorption of the subject material by the dermal route is assumed.
Inhalation Bioavailability
Based on the particle size distribution measured for the subject material, inhalation exposure should result primarily in deposition of material in the upper nasopharyngeal reagion of the repiratory tract and with little or no exposure of the alveolar region. However, due to subsequent uptake of the water soluble material into the mucous coating of the respiratory tract with subsequent oral exposure due to swallowing, the material should be considered to be bioavailable by the inhalation route. However, to provide a most conservative estimate and for risk assessment purposes, a 100% absorption by the inhalation route is assumed.
Applicant's summary and conclusion
- Conclusions:
- A toxicokinetic assessment based on the measured and known physical chemical properties of the material and on all available toxicological data was performed. It is concluded that once absorbed from the gastrointestinal tract, the subject material should be rapidly eliminated from the body though the urine. For the purposes of risk assessment, 50% absorption following oral or dermal exposures and 100% absorption following inhalation exposures is assumed. This represents a most conservative estimate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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